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Image Diagnosis: Interesting Chest Radiographs from the Emergency


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VOLUME 14 NO. 3 — FALL 2010


PRSRT STD
US POSTAGE Fall 2010 Volume 14 No. 3
500 NE Multnomah St, Suite 100
PAID
Portland, Oregon 97232
PORTLAND OR
PERMIT NO 1452
Change Service Requested

A peer-reviewed journal of medical science,


social science in medicine, and medical humanities

Original Research & Contributions


4 Factors Contributing to Door-to-Balloon
Times of ≤90 Minutes in 97% of Patients with
ST-Elevation Myocardial Infarction: Our One-
Year Experience with a Heart Alert Protocol
12 Reasons for Not Meeting Coronary Artery
Disease Targets of Care in Ambulatory Practice

THE PERMANENTE JOURNAL


18 The Protective Effect of Family
Strengths in Childhood against Adolescent
Pregnancy and Its Long-Term Psychosocial
Consequences
29 Effects of 12- and 24-Week Multimodal
Interventions on Physical Activity,
Nutritional Behaviors, and Body Mass Index
and Its Psychological Predictors in Severely
Obese Adolescents at Risk for Diabetes
2009 James A Vohs Award for Quality
38 Proactive Office Encounter: A Systematic
Approach to Preventive and Chronic Care
at Every Patient Encounter
Innovation
44 An Alternate Model for Medical Education:
Longitudinal Medical Education Within
an Integrated Health Care Organization—
A Vision of a Model for the Future?
Innovation
51 The Northern California Perinatal Research
Unit: A Hybrid Model Bridging Research,
10% Quality Improvement and Clinical Practice

Review Articles
57 Overview of Emerging Concepts
in Metabolic Surgery
64 Thiazolidinediones: A 2010 Perspective

Commentary
76 HAITI: The Kaiser Permanente

Experience—Part 1
The Permanente Journal
Fall 2010
Volume 14 No. 3
ISSN 1552-5767
www.permanentejournal.org
Fall 2010/ Volume 14 No. 3

PermanenteJournal
The
ORIGINAL RESEARCH 29 Effects of 12- and 24-Week Multimodal Books published by
& CONTRIBUTIONS Interventions on Physical Activity,
Nutritional Behaviors, and Body Mass Permanente authors:
4 Factors Contributing to Door-to-Balloon
Times of ≤90 Minutes in 97% of Patients Index and Its Psychological Predictors
Mission: The Permanente Journal advances in Severely Obese Adolescents
knowledge in scientific research, clinical with ST-Elevation Myocardial Infarction:
Our One-Year Experience with a Heart at Risk for Diabetes.
medicine, and innovative health care James J Annesi, PhD; Ann M Walsh,
Alert Protocol. Joel T Levis, MD, PhD,
delivery. MS, RD; Alice E Smith, MS, MBA, RD
FACEP, FAAEM; Mary P Mercer, MD; Stories of Adoption: Loss and
Mark Thanassi, MD; James Lin, MD Pediatricians seek effective behavioral Reunion (Family & Childcare)
Prompt percutaneous coronary inter- treatments for referral for 7% of US By Eric Blau
Circulation: 25,000 print readers per adolescents who have impaired fast-
quarter, and accessed by 660,000 unique vention for patients with ST-segment el- ISBN-10: 0939165171
evation myocardial infarction can signif- ing glucose. Data from 64 pediatrician-
Web readers in the last 12 months from referred patients with diabetes risk ISBN-13: 978-0939165179
164 countries.
icantly reduce mortality and morbidity if
factors (mean age, 14.1 years; BMI, Portland, OR: New Sage Press; 1993
not limited by delays in delivery. On a Paperback:132 pages
retrospective data and chart review, staff > 99th percentile) demonstrated nutri-
tion education alone may be insuf- $16.95
met the recommended door-to-balloon
time of ≤90 minutes (mean 57.3 ± 17.6) ficient for nutrition behavior change.
for 70 of 72 patients (97%). Sixty-five of Behavioral treatment lasting longer
the 72 patients (90.3%) survived to hos- than 12 weeks and having a specific
pital discharge. weight-loss goal may be useful for
BMI improvements, as is attention to
12 Reasons for Not Meeting Coronary participants’ self-concept and mood.
Artery Disease Targets of Care in
Ambulatory Practice. Thomas Erling 2009 James A Vohs Award for Quality What To Do Until
Kottke, MD, MSPH; Zacharia Ogwang, 38 Proactive Office Encounter: A Systematic The Learning
Approach to Preventive and Chronic Disabilitologist Arrives
ON THE COVER NP; James C Smith, MD
Care at Every Patient Encounter. By Joseph H Rosenthal, MD, PhD
“River Bottom Fall” is an In a retrospective review of patient Michael Kanter, MD; Osvaldo Martinez,
oil on canvas (30 x 48”) by records in a large multispecialty group Available from: jhrantique-
Susan Guy, MD. Dr Guy is MPH; Gail Lindsay, RN; Kristen [email protected]
practice’s coronary artery disease Andrews; Cristine Denver, SM
a Psychiatrist at the Oxnard VHS, 2 hours
registry, the most frequent reasons for
Medical Center in CA. Dr Guy A systematic program—the Proac- $35.00
not meeting all four targets of care—
paints en plein air to relax and tive Office Encounter—addresses the
to promote environmental blood pressure, low-density lipopro-
tein cholesterol level, daily aspirin, preventive care and management of
conservation. chronic disease. Identification of gaps
and tobacco use—were: 1) the patient
Dr Guy painted “River Bottom was in for a visit and the care team in care, using information technology,
Fall” while on Ojai Land assists physicians to improve consis-
failed to address an unmet target, 2)
Conservancy property. tency. This care was implemented in
the patient was asked to return for
More of Dr Guy’s work may be follow-up care but did not, and 3) the all outpatient settings in Kaiser Perma-
seen at: www.susankguy.com patient declined an intervention that nente’s Southern California Region’s
and www.roropublishing.com. was offered. 13 medical centers and 148 medical Flood Stage
office buildings. The program contrib-
By Kate Scannell
18 The Protective Effect of Family uted to significant improvements in
Strengths in Childhood against key clinical quality metrics, including ISBN-10: 1451552459
Adolescent Pregnancy and Its Long-Term cancer screenings, blood pressure ISBN-13: 978-1451552454
Psychosocial Consequences. control, and tobacco cessation. Scotts Valley, CA:
CreateSpace; 2010
Susan D Hillis, PhD, MS; Robert F Anda,
I nnovation Paperback: 278 pages
MD, MS; Shanta R Dube, PhD, MPH; $12.50
Vincent J Felitti, MD, FACP; Polly A 44 An Alternate Model for Medical
Marchbanks, PhD; Maurizio Macaluso, Education: Longitudinal Medical
MD, DrPH; James S Marks, MD, MPH Education Within an Integrated Health
Care Organization—A Vision of a
In this retrospective cohort of 4648 Model for the Future?
91 LETTERS TO THE EDITOR women (3082 participants—66%) Quentin Eichbaum, MD, PhD, MPH,
≥18 years (mean 56), teen pregnancy MFA, FCAP; Tim Grennan, MD, FACP;
94 BOOK REVIEWS decreased with increased childhood Howard Young, MD; Myra Hurt, PhD
95 CME EVALUATION FORM family strengths: family closeness,
If one accepts that large health care
support, loyalty, protection, love,
importance, and responsiveness to
health needs. This partly explained
systems are to remain part of the
medical landscape, can their strengths
Expert Guide to Pain
Management New Site.
be used in seeking solutions to the By Bill McCarberg, MD and
progressive delays in initiation of sex-
ual activity and psychosocial problems
occurring decades later: job, family,
country’s health care dilemmas. The
authors suggest that situating modular
Steven D Passik, PhD
ISBN-10: 1930513615
New Look.
finances, high stress, and uncontrol- and longitudinal medical education ISBN-13: 978-1930513617
lable anger. within a progressive integrated health
care system such as a large, multispe-
Philadelphia, PA: American
College of Physicians; 2005
www.permanentejournal.org
The Permanente Journal
cialty group model, nonprofit health Paperback: 357 pages
500 NE Multnomah St, Suite 100 maintenance organization might pro- $49.95
PermanenteJournal
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Portland, Oregon 97232 vide a valid alternate stream of educa-
www.permanentejournal.org tion and training for physicians.
ISSN 1552-5767

The Permanente Journal/ Fall 2010/ Volume 14 No. 3


I nnovation CLINICAL MEDICINE 74 Image Diagnosis: Interesting
51 The Northern California Perinatal 73 ECG Diagnosis: Hypothermia. Chest Radiographs from the
Research Unit: A Hybrid Model Joel T Levis, MD, PhD, FACEP, FAAEM Emergency Department.
Bridging Research, Quality Im- L Paige Sokolsky, MD; Gus M
provement and Clinical Practice. An Osborn wave (J wave) is a Garmel, MD, FACEP, FAAEM
Terhilda Garrido, MPH; Rosemarie characteristic electrocardiogram
finding for hypothermia consist- Five chest x-rays represent left
Barbeau upper lobe pneumonia, right
ing of an extra deflection at the
Now that Kaiser Permanente (KP) terminal junction of the QRS com- upper lobe pneumonia, right CME credits are
HealthConnect, the KP electronic third and fourth lateral rib available online at
plex and the ST segment takeoff, www.permanentejournal.org.
health record, is fully imple- and usually occurs when the core fractures, large pneumothorax,
The mail-in CME form can
mented, conducting research is body temperature falls below and pneumomediastinum with
be found on page 95.
supported by harnessing informa- 90°F (32°C). This is believed to pneumopericardium and sub-
tion systems to leverage internal result from an exaggerated out- cutaneous emphysema.
improvements in outcomes, effi- ward potassium current leading
ciency, and costs. Research chal- to repolarization abnormality.
lenges at KP are moving away
from data access toward mecha-
nisms through which raw data
create meaningful clinical knowl-
edge that is based on rigorous
COMMENTARY
research. This report describes HAITI: The Kaiser Permanente Experience—Part 1.
this research model. 76 Introduction. Sarah Beekley, MD
76 Tribute. Robert Pearl, MD SOUL OF
REVIEW ARTICLES 77 From Tragedy, Opportunity—A New Beginning for Haiti THE HEALER
57 Overview of Emerging Concepts and the Dominican Republic. John Freedman, MD Original Visual Art
in Metabolic Surgery. An important epiphenomenon created a new inflection point between Haiti 17 “Dance with Heart”
Michel Murr, MD, FACS; Arash and Dominican Republic, neighboring nations with a long history of violent Shenshen Dou
Rafiei, MD; Habib Ajami, MD; relations. The Dominican authorities allowed thousands of Haitian refugees 28 “Slot Canyon Lower
Tannous K Fakhry, MD to cross the border to seek care in our emergency relief hospital. Antelope Valley,
Obesity is a worldwide health 80 Haiti—Forgotten Already? Lee Jacobs, MD Page, Arizona”
epidemic, and about two-thirds Gerald Levy, MD, MBA
of US adults are overweight or The story yet to be written of the massive rebuilding and relocation that
must be supported by people and finances from around the world is a 50 “Scripps Pier,
obese. The link between dia-
challenge just too great to meet the basic living needs of displaced peoples. La Jolla, CA”
betes and obesity is because of
The Haitians wonder have you already forgotten them? Gevork Mosesi, MD
induction of insulin resistance by
excess adipose tissue and gener- 63 “HA 260 #3”
82 Mes Quatre Fils (My Four Sons). Mason Spain Turner, MD
alized low chronic inflammation. Josh Schechtel, MD
Metabolic or bariatric surgery In his late 30s, to restore the author’s balance and perspective realigning his
induces durable and sustainable life with his personal moral values, a watershed moment occurs within the Original Literary Art
weight loss, and its role is well unique family that was built with four young interpreters who had lost their 90 And The Beat Goes On.
established. This review includes: parents, siblings and many friends. Pattie Palmer-Baker
the types of metabolic surgery, 83 Disaster Medical Relief—Haiti Earthquake January 12, 2010.
preoperative evaluation, postop- Hernando Garzon, MD
erative care, follow-up, and the
future of metabolic surgery. Kaiser Permanente’s Global Health and volunteer programs support physician
volunteerism, relationships with multiple medical relief organizations, created a
64 Thiazolidinediones: A 2010 KP National Volunteerism Web site, and developed and delivered CME courses.
Perspective. Ashok Krishnaswami,
MD, FACC; Shalini Ravi-Kumar, MD; 85 Mentoring About Vector-borne Disease Control.
John M Lewis, MD D Scott Smith, MD, MSc, DTM&H
As the incidence of cardiovas- One million displaced people increased the risks of insect-borne diseases,
cular complications related to amplified by exposure—densely populated tent camps with little between
diabetes mellitus increases, there them and the elements; migration—large-scale movement to areas where
is a sense of urgency to produce disease rates are high; and the disruption of public health systems. The
antidiabetic medications that Kaiser MENTOR initiative focuses on clinical trainings, vector assessments,
achieve not only nontoxic gly- and control using indoor residual spraying and larviciding.
cemic control but also improved 86 First Responders: The DMAT Team. Judy O’Young, MD
cardiovascular outcomes, includ-
ing lowering mortality. The goal The Disaster Medical Assistance Team, cocooned inside the surgical field
of this review is to shed light hospital where they had arrived in darkness, isolated within and guarded Book Reviews
on the current understanding by the 82nd Airborne, they heard the hymns of prayer and gratitude from page 94
of, and the debate surrounding, the people in the adjacent tent city rise above the generator’s drone and
thiazolidinedione use. float back through the warm heavy air.
88 Disaster Readiness Tips Steeped in My Time in Haiti. Vivian Reyes, MD
The people around you during a disaster are the critical component to
whether you survive it. The more times you run through scenarios in
your mind or in a drill, the better you will react in a real event. “Crisis Care
Guidelines” help medical professionals navigate through these difficult times.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 1


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leaflet—medical lit-art e-journal: http://xnet.kp.org/permanentejournal/leaflet

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 3


credits available for this article — see page 95.

ORIGINAL RESEARCH & CONTRIBUTIONS

Factors Contributing to Door-to-Balloon Times of ≤90 Minutes


in 97% of Patients with ST-Elevation Myocardial Infarction:
Our One-Year Experience with a Heart Alert Protocol
Joel T Levis, MD, PhD, FACEP, FAAEM
Mary P Mercer, MD
Mark Thanassi, MD Introduction
James Lin, MD Abstract Prompt percutaneous coronary intervention (PCI)
Context: Prompt percutaneous coronary intervention (PCI)
for patients with ST-segment elevation myocardial in-
for patients with ST-segment elevation myocardial infarction
farction (STEMI) can significantly reduce mortality and
(STEMI) can significantly reduce mortality and morbidity,
morbidity; however, its effectiveness may be limited by
although its effectiveness may be limited by delays in deliv-
delays in delivery.1–3 Door-to-balloon time refers to the
ery. In March 2008, our hospital implemented a Heart Alert
interval from arrival of the patient with STEMI at the
protocol to rapidly identify and treat patients with STEMI
Emergency Department (ED) to balloon angioplasty of
presenting to our Emergency Department (ED) with PCI, us-
the occluded coronary artery in the cardiac catheteriza-
ing strategies previously described to reduce door-to-balloon
tion laboratory (CCL). Guidelines from the American
times. Before the Heart Alert protocol start date, patients with
College of Cardiology/American Heart Association and
STEMI presenting to our ED were treated with thrombolysis.
the European Society of Cardiology recommend a goal
Objective: We evaluated data from patients with STEMI
of ≤90 minutes for door-to-balloon time; this measure
after one year of use of our Heart Alert protocol to determine
is incorporated into national, publicly reported quality
protocol success on the basis of the percentage of patients
indicators for hospital performance.4–6 The Centers for
for whom the recommended door-to-balloon times of ≤90
Medicare and Medicaid Services and the Joint Com-
minutes were met. We examined factors involved in imple-
mission consider the ≤90 minute door-to-balloon time
mentation of the protocol that contributed to these results.
a benchmark goal, and facilities must track this as a
Design: We conducted a retrospective data and chart
core measure.7,8
review for patients in the ED with STEMI who underwent
Strategies associated with shorter door-to-balloon
PCI after a Heart Alert protocol activation between March
times have been identified and include Emergency
17, 2008, and March 17, 2009.
Medicine (EM) physician activation of the CCL through
Results: During the study period, our staff met the rec-
a single call to a central page operator while the patient
ommended door-to-balloon time of ≤90 minutes (mean
is en route to the hospital, arrival of staff in the CCL
door-to-balloon time, 57.3 ± 17.6 minutes) for 70 of 72
within 20 minutes of activation, constant presence of
patients (97%) presenting to our ED with STEMI. Sixty-five
an attending cardiologist on-site, real-time case feed-
of the 72 patients (90.3%) survived to hospital discharge.
back, and interdisciplinary collaboration throughout
Conclusion: Initiation of a Heart Alert protocol at
the process.9–11 The D2B Alliance was developed by
our hospital resulted in achievement of door-to-balloon
the American College of Cardiology to improve door-
times of ≤90 minutes for 97% of patients with STEMI.
to-balloon times for patients with STEMI undergoing
This achievement was obtained through careful prepara-
PCI, and it has enrolled approximately 1000 hospitals.12
tion, training, and interdepartmental collaboration and
The D2B Alliance strategies include 1) EM physician
occurred despite immediate conversion from a previous
activation of the CCL with a single call, 2) preparation
thrombolytic protocol.

Joel T Levis, MD, PhD, FACEP, FAAEM, is a Senior Emergency Physician at the Santa Clara Medical Center. He is a Clinical
Instructor of Emergency Medicine (Surgery) at Stanford University, and the Medical Director for the Foothill College Paramedic
Program in CA. E-mail: [email protected].
Mary P Mercer, MD, is an Emergency Medical Services & Disaster Management Fellow, University of California San Francisco-
San Francisco General Hospital Department of Emergency Medicine, San Francisco, CA, and graduate of the Stanford/Kaiser
Emergency Medicine Residency Program. E-mail: [email protected].
Mark Thanassi, MD, is a Senior Emergency Physician and Emergency Department Quality Chair at the Santa Clara Medical
Center in CA. E-mail: [email protected].
James Lin, MD, is a Senior Emergency Physician, Chief of Emergency Medicine, and an Assistant Physician in Chief at the
Santa Clara Medical Center in CA. E-mail: [email protected].

4 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
Factors Contributing
Factors Contributingto Door-to-BalloonTimesTimes
to Door-to-Balloon of ≤ 90of ≤90 Minutes
Minutes in 97% ofinPatients
97% of with ST-Elevation
Patients with Myocardial Infarction: Our One-Year Experience with a HeartAlert Protocol
ST-Elevation Myocardial Infarction: Our One-Year Experience with a Heart Alert Protocol

of the CCL team within 20 to 30 minutes of the call, College of Cardiology National Cardiovascular Data
3) real-time case feedback, 4) a team-based approach, Registry, to the Joint Commission, and to the Santa
and 5) administrative support. The use of prehospital Clara County EMS Agency.
electrocardiograms (ECG) by emergency medical ser- In developing the Heart Alert protocol, an inter-
vices (EMS) personnel to activate the CCL is an optional disciplinary group of cardiologists, EM physicians,
strategy. Hospitals have implemented several of these nurses, and administrators convened to outline the
strategies in attempts to improve door-to-balloon times, actions and procedures necessary for achieving door-
with varying levels of success.13–16 to-balloon times of ≤90 minutes. Strategies previously
In March 2008, our hospital initiated a Heart Alert demonstrated to reduce door-to-balloon time were
protocol involving close collaboration between the incorporated into our protocol, including EM physi-
Departments of EM, Cardiology, and Interventional cians activating the CCL through a single call, arrival
Cardiology to efficiently identify and treat patients with of staff in the CCL within 20 minutes after activation,
STEMI presenting to our ED. Our protocol includes real-time case feedback, and substantial interdisciplin-
several of the key strategies to reduce door-to-balloon ary collaboration throughout the process. Attending
times and was preceded by careful training of both cardiologists were available on-site during daytime
EM physicians, cardiology physicians, and staff before hours and were available by page to arrive in the ED
implementation. A unique feature of our protocol was within 20 minutes of a Heart Alert activation during all
the implementation of PCI for STEMI at the start of other hours. Heart Alert activation by the EM physician
the Heart Alert protocol; before initiation of the Heart
Alert protocol, all patients presenting with STEMI
were treated using a thrombolytic protocol. Despite Patient presents to ED by triage or EMS with
this, review of our first-year data indicates that we CP or anginal equivalent symptoms.
achieved door-to-balloon times of ≤90 minutes in
Door-to-ECG time ≤ 10 minutes
97% of patients with STEMI (70 of 72). This report
describes the development, implementation, and Triage–ECG obtained prior to detailed MSE/registration
key strategies of our system, as well as specific data EMS–Charge nurse/unit assistant calls for immediate ECG
resulting in the achievement of door-to-balloon times
ECG-to-CCL activation time ≤ 5 minutes
of ≤90 minutes. This report should benefit hospitals
preparing to implement primary PCI for patients with ECG immediately presented to EM MD; if
STEMI, as well as those struggling to achieve target STEMI present, EM MD activates Heart
door-to-balloon times. Alert by single call to central page operator

Lab activation-to-CCL door time ≤ 45 minutes


Methods
Development and Implementation IV, O2, monitor; informed consent obtained; pCXR,
of the Heart Alert System pre-PCI meds (ASA, NTG, heparin, eptifibitide,
metoprolol) from Heart Alert med box
The Santa Clara Medical Center is a suburban teach-
ing hospital located in Santa Clara, CA, sponsoring a CCL door-to-catheter access time ≤ 15 minutes
joint residency program in EM with Stanford University
(Stanford/Kaiser EM Residency Program) and its own Obtain PCI catheter access in CCL
residencies in internal medicine, obstetrics-gynecology, Catheter access-to-guidewire time ≤ 15 minutes
and podiatry. Our hospital also hosts Stanford surgery
and pediatrics residents, as well as Stanford University Catheter guidewire traverses lesion
and visiting medical students. The hospital has 327 Door-to-balloon time ≤ 90 minutes (cumulative)
inpatient beds, a 46-bed ED with approximately 60,000
annual patient visits, and three cardiac catheterization Balloon angioplasty with stenting of culprit lesion
laboratories and on-site cardiothoracic surgery. An
average of 2260 diagnostic coronary angiograms and Figure 1. Steps involved in the Heart Alert protocol for achieving door-to-balloon
1243 PCIs are performed each year. Our facility has times of ≤90 minutes in 97% of patients during the first year of protocol institution.
ASA = aspirin; CCL = cardiac catheterization laboratory; CP = chest pain; ECG = electrocardiogram;
six interventional cardiologists, each performing an
ED = emergency department; EM = emergency medicine; EMS = emergency medical services; MD = physician;
average of 220 coronary catheterizations each year. MSE = medical screening examination; NTG = nitroglycerin; PCI = percutaneous coronary intervention;
Door-to-balloon times are reported to the American pCXR = portable chest radiograph; STEMI = ST-segment elevation myocardial infarction.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 5


ORIGINAL RESEARCH & CONTRIBUTIONS
Factors Contributing to Door-to-BalloonTimes of ≤ 90 Minutes in 97% of Patients with ST-Elevation
Factors ContributingMyocardial Infarction: Our
to Door-to-Balloon Times of ≤90
One-Year Experience
Minutes with a Heart
in 97% Alert Protocol
of Patients with
ST-Elevation Myocardial Infarction: Our One-Year Experience with a Heart Alert Protocol

while a STEMI patient was en route to the hospital (on period. The following data were collected for each
the basis of a prehospital ECG report) was encouraged patient from electronic medical records: patient age,
but not mandated. Emergency medical services did not sex, race, presence and number of cardiac risk fac-
have the ability to transmit prehospital ECGs to our tors; history of coronary artery disease, previous PCI,
facility during this period. or coronary artery bypass graft; mode of presentation
The door-to-balloon time was broken down into the (triage vs EMS); time from symptom onset to ED ar-
following clinically relevant intervals: door-to-ECG time rival; initial troponin I level; PCI results; and survival
(goal, ≤10 minutes), ECG-to-CCL activation time (goal, to hospital discharge. Data were then analyzed using
≤5 minutes), CCL activation-to-CCL door time (goal, ≤45 the software program EpiInfo (Centers for Disease
minutes), CCL door-to-catheter access time (goal, ≤15 Control and Prevention, Atlanta, GA, USA) for statisti-
minutes), catheter access-to-guidewire time (goal, ≤15 cal analysis.
minutes), for a door-to-balloon time goal of ≤90 minutes.
Criteria for identification of STEMI on 12-lead ECGs includ- Table 1. Patient characteristics for STEMI Heart
ed ST-segment elevation ≥1 mm (0.1 mV) in at least two Alert cases (total 72 cases)
anatomically oriented (contiguous) precordial or limb Characteristic Value
leads and new or presumably new left bundle branch Sex (number and % male) 56 (77.8)
block with a strong clinical suspicion of acute Age (mean ± SD) 61.3 ± 13.5 years
Twelve myocardial infarction. Order sets were created Race Number (%)
percent of to streamline ordering of tests, procedures, and African American 2 (2.8)
patients had medication administration in the ED after CCL Asian 14 (19.4)
activation. For rapid procurement and adminis- Caucasian 50 (69.4)
no known
tration of medications (eg, aspirin, nitroglycerin, Hispanic 3 (4.2)
cardiac risk
heparin, eptifibatide, metoprolol), a Heart Alert Other 3 (4.2)
factors …
medication box was developed that would be Cardiac risk factors
immediately available in the event of a Heart Hypertension 42 (58.3)
Alert activation. Figure 1 outlines the steps involved at Hyperlipidemia 32 (44.4)
each time interval of the Heart Alert protocol. Diabetes 15 (20.8)
Our hospital began a number of educational ini- Tobacco 14 (19.4)
Family history of CAD 13 (18.1)
tiatives in advance of initiation of the Heart Alert
No known risk factors 9 (12.5)
protocol. The interventional cardiologists presented
Personal history of CAD 23 (31.9)
a STEMI lecture series to the EM physicians and staff.
Previous history of PCI 17 (23.6)
Interdisciplinary Critical Event Team Training sessions
Previous history of CABG 3 (4.2)
were conducted with mock activation of the Heart Alert
CABG = coronary artery bypass graft; CAD = coronary artery disease;
protocol, allowing staff in both the ED and the CCL to PCI = percutaneous coronary intervention; STEMI = ST-segment
familiarize themselves with the protocol procedures elevation myocardial infarction.
and identify any improvement opportunities. Finally,
results of each Heart Alert case (including STEMI ECG Results
image, interval times, catheterization results, and patient Patient characteristics for the 72 Heart Alert cases
outcomes void of patient identifiers) were provided to are shown in Table 1. Approximately 75% of the
all EM physicians, residents, and staff via e-mail within patients were men, with an average age of 61 years.
one week of each case. The majority of patients (70%) were Caucasian, with
a smaller percentage of Asian, Hispanic, and African-
Data Collection and Analysis American patients. The most prevalent cardiac risk
The Kaiser Permanente Northern California Insti- factor was hypertension (58%), followed by hyper-
tutional Review Board approved our retrospective lipidemia (44%), diabetes (21%), tobacco use (19%),
chart review and data analysis. We performed a chart and family history of CAD (18%). Twelve percent
review of all Heart Alert cases presenting to our ED of patients had no known cardiac risk factors, 25%
that received emergency PCI (angioplasty and stent had undergone previous PCI, and 4% had a history
placement) during the first 12 months of the Heart of CABG. Sixty-five of the 72 patients (90.3%) in the
Alert protocol (March 17, 2008, to March 17, 2009). A cohort survived to hospital discharge. Six men and
total of 72 cases met these criteria during the study 1 woman comprised the 7 patients not surviving

6 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
Factors Contributing
Factors Contributingto Door-to-BalloonTimesTimes
to Door-to-Balloon of ≤ 90of ≤90 Minutes
Minutes in 97% ofinPatients
97% of with ST-Elevation
Patients with Myocardial Infarction: Our One-Year Experience with a HeartAlert Protocol
ST-Elevation Myocardial Infarction: Our One-Year Experience with a Heart Alert Protocol

to discharge, with a mean age of 70.9 ± 17.5 years were able to achieve door-to-balloon times of ≤90
(range, 40–88 years). The causes of death in these minutes in 97% of our patients with STEMI during
7 patients were cardiogenic shock (n = 5), anoxic the first year of implementation. The success of the
brain injury after cardiac arrest (n = 1), and severe Heart Alert protocol is predicated on its develop-
sepsis (n = 1). ment on the basis of previous proven strategies,9–11
Table 2 shows the mean, standard deviation, median, including published, continuous quality-improvement
and range for each interval period comprising the door-
to-balloon times for the 72 patients with STEMI. The
mean door-to-ECG time was 3.3 ± 10.8 minutes (range, Table 2. Mean time intervals (minutes) for STEMI Heart Alert cases
–50 to 28 minutes). The mean ECG-to-CCL activation (total of 72 cases)
time was 7.5 ± 8.8 minutes, whereas the mean CCL Interval Mean ± SD Median Range
activation-to-CCL door time was 27.2 ± 11.4 minutes. Door-to-ECG time 3.3 ± 10.8 2.0 –50.0 to 28
The mean door-to-balloon time for the 72 patients was ECG-to-CCL activation time 7.5 ± 8.8 5.0 –12.0 to 42.0
CCL activation-to-CCL door time 27.2 ± 11.4 23.5 6.0 to 61.0
57.3 ± 17.6 minutes. The times for 2 patients fell outside
CCL door-to-access time 9.0 ± 3.7 8.5 3.0 to 24.0
of the 90-minute door-to-balloon goal of ≤90 minutes:
Access-to-guidewire time 10.6 ± 6.2 9.0 1.0 to 34.0
94 and 106 minutes.
Door-to-balloon time 57.3 ± 17.6 56.5 30.0 to 106.0
Table 3 lists ED arrival mode (EMS vs triage), time
CCL = cardiac catheterization laboratory; ECG = electrocardiogram; SD = standard deviation;
from symptom onset to ED arrival, and initial troponin STEMI = ST-segment elevation myocardial infarction.
I level. Nearly three-quarters of the patients arrived by
personal transportation. Analysis of time from symp-
Table 3. Mode of ED arrival, time from symptom onset
tom onset to ED arrival indicated that 35% of patients to ED arrival, and initial troponin I levels for STEMI
arrived to the ED within one hour of symptom onset; Heart Alert cases (total of 72)
28% arrived between two and six hours, and 7% ar- Aspect Value
rived >12 hours after symptom onset. The mean for Mode of ED arrival
the initial troponin I level was 1.02 ± 2.86 ng/mL, with Ambulance (EMS) 20 (27.8%)
a median of 0.05 ng/mL and a range of <0.02 to 14.92 Personal transportation 52 (72.2%)
ng/mL, with 58% of the measurements within the range Time from symptom onset to ED arrival
of 0.00 to 0.09 ng/mL. ≤1 hour 25 (35.2%)
Table 4 demonstrates the distribution of coronary 1–2 hours 14 (19.7%)
arteries (culprit lesions) involved in the 72 STEMIs. 2–6 hours 20 (28.2%)
The most common lesion involved the left anterior 6–12 hours 7 (9.9%)
descending coronary artery (42%), followed by the >12 hours 5 (7.0%)
right coronary artery (39%); one patient was found to Unknown 1 (1.4%)
have a left main coronary artery occlusion. Initial troponin I level
Mean ± SD 1.02 ± 2.86 ng/mL
Discussion Median 0.05 ng/mL
Primary PCI has become the preferred treatment op- Range <0.02–14.92 ng/mL
tion for patients presenting with STEMI because it has ED = emergency department; EMS = emergency medical services; SD = standard
deviation; STEMI = ST-segment elevation myocardial infarction.
helped achieve higher rates of TIMI (thrombolysis in
myocardial infarction) grade 3 flow than thrombolysis
Table 4. Coronary artery (culprit lesion) involved in
has.17,18 Primary PCI has also been shown to be su-
STEMI for Heart Alert cases (total of 72 cases)
perior to thrombolysis in reducing rates of mortality,
Coronary artery involved Number (%)
reinfarction, and stroke.19,20 This benefit appears to be
Left main 1 (1.4)
related to a much higher early mechanical reperfusion
LAD 30 (41.7)
rate compared with thrombolysis, to the ability of
RCA 28 (38.9)
simultaneously treating the underlying stenosis, and
LCx 6 (8.3)
to the lower risk of severe bleeding.21 In March 2008, Diagonal branch of LAD 2 (2.8)
our hospital converted from a thrombolysis protocol Obtuse marginal branch of LCx 1 (1.4)
to a PCI protocol for treating patients presenting to Posterior descending artery 4 (5.6)
our ED with STEMI. LAD = left anterior descending; LCx = left circumflex artery; RCA = right coronary
After development of a Heart Alert protocol, we artery; STEMI = ST-segment elevation myocardial infarction.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 7


ORIGINAL RESEARCH & CONTRIBUTIONS
Factors Contributing to Door-to-BalloonTimes of ≤ 90 Minutes in 97% of Patients with ST-Elevation
Factors ContributingMyocardial Infarction: Our
to Door-to-Balloon Times of ≤90
One-Year Experience
Minutes with a Heart
in 97% Alert Protocol
of Patients with
ST-Elevation Myocardial Infarction: Our One-Year Experience with a Heart Alert Protocol

analyses resulting in expedited PCI for patients with The majority of patients with STEMI in our study were
STEMI.22–24 Several factors contributed to the success men (78%; Table 1) with an average age of 61.3 years,
of our protocol, including similar to the sex and age distribution for patients
• Organization of an interdisciplinary working group of with STEMI found in a large retrospective review of
cardiologists, EM physicians, nurses, and administra- the National Registry of Myocardial Infarction (NRMI)
tors whose chief role was to develop and outline the for 2006.25 The racial and ethnic breakdown as well as
training and protocol implementation. the presence and distribution of documented cardiac
• Educational and training activities for staff and risk factors for our patients with STEMI were similar
physicians before protocol implementation, includ- to results found for patients with STEMI in the NRMI
ing STEMI lectures and critical-event team training data review. The percentage of our patients who had
involving mock Heart Alert simulations. previously undergone PCI was slightly higher than
• Breakdown of the door-to-balloon time into clinically that noted in the 2006 NRMI registry (23.6% vs 15.5%),
relevant intervals, with continued quality analysis of whereas the percentage of patients with previous CABG
these intervals to look for areas of improvement. in both studies was low (4.2% vs 7.9%).
• Continuous feedback on all Heart Alert cases to all Evaluation of the interval times for our protocol in-
EM physicians and residents, using a Heart Alert case dicated that the mean door-to-ECG time for all patients
series provided by e-mail within one week of each with STEMI was 3.3 ± 10.8 minutes, with a median of
case. A survey of EM physicians 20 months after 2.0 minutes and a range of -50.0 to +28.0 minutes (Table
implementation of this series indicated that most EM 2). Door-to-ECG times for 85% of patients were ≤10
physicians reviewed the Heart Alert cases and found minutes. In one patient, STEMI was diagnosed by ECG
them useful as an educational tool. in a clinic (door-to-ECG time, -50 minutes) before ED
Several strategies implemented at each door-to- transport. After omitting this time from the data analy-
balloon interval in our protocol have contributed sis, the mean door-to-ECG time for the remaining 71
to the ability to obtain door-to-balloon times of ≤90 patients was 4.1 ± 8.7 minutes. Phelan et al identified
minutes in such a large proportion of patients with two main causes of door-to-ECG times >10 minutes in a
STEMI (Figure 1). When patients present to our ED study to assess and find ways to decrease door-to-ECG
triage with chest discomfort or angina-equivalent times in their ED: 1) priority delay (eg, completing tri-
symptoms, a 12-lead ECG is obtained immediately age and registration data entry before obtaining ECGs)
before a detailed medical screening examination and and 2) failure to recognize patients with non-chest-pain
patient registration, enabling rapid ECG acquisition. STEMI.26 Before our protocol implementation, all ED
For similar patients presenting to the ED by EMS, an staff were educated about the importance of obtain-
ECG is immediately requested by the charge nurse or ing ECGs for all patients presenting with chest pain
unit assistant as the patient is being roomed (before or symptoms suggestive of ischemia without further
physician assignment), again reducing any potential delay, as well as about how to recognize potential
delays in ECG acquisition. Once obtained, the ECG non-chest-pain acute coronary syndrome symptoms.
must be presented to an EM physician as soon as Once obtained, ECGs are immediately presented to an
possible for early detection and recognition of STEMI. EM physician for rapid review.
When STEMI is diagnosed, the EM physician activates Use of prehospital ECGs for STEMI activation before
a Heart Alert through a single call to a central page patient arrival can improve door-to-balloon times.27–30
operator, requiring the CCL team to be prepared for This practice is noted as an optional strategy by the
emergency PCI within 20 minutes of the page. Use D2B Alliance. In the first year of our protocol, approxi-
of a Heart Alert medication box during the laboratory mately 28% of patients with STEMI arrived to the ED
activation–to–CCL door interval contributes signifi- by ambulance (Table 3), and half of those patients had
cantly to reducing this time interval, allowing nurses Heart Alert activations that were based on prehospital
to quickly obtain a single medication box containing ECG reports. All door-to-balloon times for the 10 STEMI
all of the necessary pre-PCI medications rather than cases in which an alert was activated before arrival
needing to remove each medication piecemeal from fell below 50 minutes (36.5 ± 5.7 minutes; median, 35
the automated medication-dispensing system. minutes; range, 30–49 minutes). Transmission of pre-
The number of STEMI cases in our first year of the hospital ECGs for rapid triage of patients with STEMI
protocol (72) is similar to those reported for other has also been shown to reduce door-to-balloon times
large hospitals with high-volume PCI capabilities.14,15 and can improve early survival of these patients.27,31

8 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
Factors Contributing
Factors Contributingto Door-to-BalloonTimesTimes
to Door-to-Balloon of ≤ 90of ≤90 Minutes
Minutes in 97% ofinPatients
97% of with ST-Elevation
Patients with Myocardial Infarction: Our One-Year Experience with a HeartAlert Protocol
ST-Elevation Myocardial Infarction: Our One-Year Experience with a Heart Alert Protocol

Our county is currently developing a prehospital ECG rival ranges from 1.5 to 6.0 hours.35 Numerous factors,
transmission system to better improve the sensitivity including old age, female sex, low education level, low
and specificity of this application. socioeconomic status, race and ethnic differences, and
EM physician activation of the CCL team decreases presence of chronic health conditions and high-risk
door-to-balloon times.32–34 Mean ECG-to-CCL activa- behaviors, have been associated with additional delays
tion time during our study period (7.5 ± 8.8 minutes) in patients seeking treatment for ACS.35
exceeded the recommended goal of ≤5 minutes, with Approximately 58% of the initial troponin I results for
a total of 31 of 72 cases exceeding this goal. One case patients with STEMI fell within the normal range of 0.00
demonstrated an ECG-to-CCL activation time of 42 to 0.09 ng/mL. Because troponin I levels rise within 4
minutes. Review of that case indicated that the chief to 6 hours of myocardial injury, these results
complaint was epigastric pain, and the door-to-ECG indicate that the majority of our patients with
The largest
time for the same case was 0 minutes. It is likely that STEMI presented to the ED relatively early in
component
the symptoms were not recognized as potentially the disease process. Although initial troponin
of door-to-
cardiac, possibly leading to delays in ECG presenta- I levels are less useful in diagnosing STEMI
balloon time
tion to and review by the EM physician. Evaluation (compared with non-STEMI and unstable
is typically
of ambiguous ECGs may also result in delay of CCL angina), baseline troponin levels have been
the time
activation (eg, ECGs obtained early in the evolution shown to be independent predictors of 30-
spent within
of a STEMI). Continued case feedback using the Heart day cardiovascular death in patients with
the ED before
Alert case series, as well as ability of EM physicians STEMI.36 The most common coronary artery
transfer to
to fax ambiguous ECGs to the on-call cardiologist 24 involved in STEMI in our patients was the
the CCL.
hours/day should aid in further reduction of this time left anterior descending (41.7%), followed
interval in our protocol. closely by the right coronary artery (38.9%)
The largest component of door-to-balloon time is and the left circumflex coronary artery (8.3%) (Table
typically the time spent within the ED before transfer 4). This distribution of coronary artery involvement
to the CCL.14 Our mean CCL activation-to-CCL door time is similar to that found in the Code STEMI study cited
fell well within our recommended interval (27.2 ± 11.4 earlier, in which the right coronary artery (31%), left
minutes; median, 23.5 minutes; recommended goal, anterior descending (27%), and left circumflex (14%)
≤45 minutes; Table 2). Only 5 cases (7%) fell outside were most commonly involved.14
of the recommended interval. Careful preparation and Sixty-five of the 72 patients (90.3%) in our study
training of the ED staff, well-designed and preprinted cohort survived to hospital discharge. The all-cause in-
STEMI order sets, use of a Heart Alert medication box hospital mortality rate for our cohort (9.7%) was higher
for pre-PCI medications, and careful coordination than rates reported after implementation of two similar
among EM physicians, interventional cardiologists, and STEMI protocols (4.2% and 4.7%, respectively).14,37 This
ancillary staff contributed to the efficiency of patient discrepancy may be due, in part, to the severity of
preparation prior to CCL transfer. Use of an electronic illness in the nonsurvivors in our cohort. Five of 7 pa-
STEMI order set implemented after the first year of tients not surviving to discharge died from cardiogenic
the Heart Alert protocol should further improve the shock, 1 after out-of-hospital cardiac arrest and 1 after
efficiency of this process. development of severe sepsis, all conditions associated
Time from symptom onset to ED arrival is listed in with significantly higher in-hospital mortality rates.38–40
Table 3. The percentage of patients presenting within Further data acquisition and analysis over a longer time
the first hour of symptom onset in our study (35.2%) is period will be required to determine a true survival
nearly identical to that found in a similar study involv- benefit from our Heart Alert protocol.
ing an identical number of patients (36%, Code STEMI Initiation of a Heart Alert protocol at our hospital has
study).14 In our study period, a smaller percentage of resulted in excellent door-to-balloon times during our
patients presented between 1 and 2 hours of symptom first year of implementation, with the achievement of
onset (19.7%), whereas more presented in the range of door-to-balloon times ≤90 minutes in 97% of patients
2 to 6 hours (28.2%). The lowest proportion of patients with STEMI. This achievement was made possible by
with STEMI in our study period presented in the range careful preparation, training, and interdepartmental col-
of 6 to 12 hours (9.9%) and after >12 hours (7%) range, laboration and occurred despite immediate conversion
findings similar to the Code STEMI study.14 In the US, from a previous thrombolytic protocol. A similar disci-
median delay time from symptom onset to hospital ar- plined system can be readily implemented in hospitals

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 9


ORIGINAL RESEARCH & CONTRIBUTIONS
Factors Contributing to Door-to-BalloonTimes of ≤ 90 Minutes in 97% of Patients with ST-Elevation
Factors ContributingMyocardial Infarction: Our
to Door-to-Balloon Times of ≤90
One-Year Experience
Minutes with a Heart
in 97% Alert Protocol
of Patients with
ST-Elevation Myocardial Infarction: Our One-Year Experience with a Heart Alert Protocol

that are considering developing PCI capability or by 9. Moscucci M, Eagle KA. Reducing the door-to-balloon time
those in need of improvement of door-to-balloon times, for myocardial infarction with ST-segment elevation [edito-
rial]. N Engl J Med 2006 Nov 30;355(22):2364–5.
using techniques described in this report. v
10. Bradley EH, Herrin J, Wang Y, et al. Strategies for reducing
the door-to-balloon time in acute myocardial infarction. N
Disclosure Statement
Engl J Med 2006 Nov 30;355(22):2308–20.
The author(s) have no conflicts of interest to disclose. 11. Bradley EH, Roumanis SA, Radford MJ, et al. Achieving
door-to-balloon times that meet quality guidelines: how
Acknowledgments do successful hospitals do it? J Am Coll Cardiol 2005 Oct
Gus Garmel, MD, FACEP, FAAEM, assisted with study concept 4;46(7):1236–41.
and design, and Avani Mehta and Lora Glasgow, RN, provided 12. Krumholz HM, Bradley EH, Nallamothu BK, et al. A cam-
assistance with data acquisition. paign to improve the timeliness of primary percutaneous
Katharine O’Moore-Klopf, ELS, of KOK Edit provided editorial coronary intervention: Door-to-Balloon: An Alliance for
assistance. Quality. JACC Cardiovasc Interv 2008 Feb;1(1):97–104.
13. Bradley EH, Nallamouthu BK, Stern AF, et al. Contemporary
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8. Cyr J, Paige P, Paige P, Fisher D. Sustaining and spreading 23. Ward MR, Lo ST, Herity NA, Lee DP, Yeung AC. Effect of
reduced door-to-balloon times for ST-segment elevation audit on door-to-inflation times in primary angioplasty/
myocardial infarction patients. Jt Comm J Qual Patient Saf stenting for acute myocardial infarction. Am J Cardiol 2001
2009 Jun;35(6):297–306. Feb 1;87(3):336–8, A9.

10 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
Factors Contributing
Factors Contributingto Door-to-BalloonTimesTimes
to Door-to-Balloon of ≤ 90of ≤90 Minutes
Minutes in 97% ofinPatients
97% of with ST-Elevation
Patients with Myocardial Infarction: Our One-Year Experience with a HeartAlert Protocol
ST-Elevation Myocardial Infarction: Our One-Year Experience with a Heart Alert Protocol

24. Caputo RP, Kosinski R, Walford G, et al. Effect of continu- 32. Kraft PL, Newman S, Hanson D, Anderson W, Bastani A.
ous quality improvement analysis on the delivery of primary Emergency physician discretion to activate the cardiac cath-
percutaneous revascularization for acute myocardial infarc- eterization team decreases door-to-balloon time for acute
tion: a community hospital experience. Catheter Cardiovasc ST-elevation myocardial infarction. Ann Emerg Med 2007
Interv 2005 Apr;64(4):428–33. Nov;50(5):520–6.
25. Rogers WJ, Frederick PD, Stoehr E, et al. Trends in present- 33. Kurz MC, Babcock C, Sinha S, Tupesis JP, Allegretti J. The
ing characteristics and hospital mortality among patients impact of emergency physician–initiated primary percutane-
with ST elevation and non-ST elevation myocardial infarc- ous coronary intervention on mean door-to-balloon time in
tion in the National Registry of Myocardial Infarction from patients with ST-segment-elevation myocardial infarction.
1990 to 2006. Am Heart J 2008 Dec;156(6):1026–34. Ann Emerg Med 2007 Nov;50(5):527–34.
26. Phelan MP, Glauser J, Smith E, et al. Improving emergency 34. Magid D, Bradley EH. Emergency physician activation of the
department door-to-electrocardiogram time in ST segment cath lab: saving time, saving lives. Ann Emerg Med 2007
elevation myocardial infarction. Crit Pathw Cardiol 2009 Nov;50(5):535–7.
Sep;8(3):119–21. 35. Moser DK, Kimble LP, Alberts MJ, et al. Reducing delay in
27. Ting HH, Krumholz HM, Bradley EH, et al; American Heart seeking treatment by patients with acute coronary syn-
Association Interdisciplinary Council on Quality of Care and drome and stroke: a scientific statement from the American
Outcomes Research, Emergency Cardiovascular Care Com- Heart Association Council on Cardiovascular Nursing and
mittee; American Heart Association Council on Cardiovascu- Stroke Council. Circulation 2006 Jul 11;114(2):168–82.
lar Nursing; American Heart Association Council on Clinical 36. Sherwood MW, Morrow DA, Scirica BM, et al. Abstract
Cardiology. Implementation and integration of prehospital 977: Baseline troponin levels predict 30 day CV mortal-
ECGs into systems of care for acute coronary syndromes: a ity in STEMI independent of clinical and electrocardio-
scientific statement from the American Heart Association graphic factors: analysis from CLARITY-TIMI 28. Circulation
Interdisciplinary Council on Quality of Care and Outcomes 2008;118:S_636.
Research, Emergency Cardiovascular Care Committee, 37. Le May M. Code STEMI: implementation of a city-wide pro-
Council on Cardiovascular Nursing, and Council on Clinical gram for rapid assessment and management of myocardial
Cardiology. Circulation 2008 Sep 2;118(10):1066–79. infarction. CMAJ 2009 Oct 13;181(18):E136–7.
28. Terkelsen CJ, Lassen JF, Nørgaard BL, et al. Reduction in 38. Peterson ED, Dai D, DeLong ER, et al; NCDR Registry
treatment delay in patients with ST-elevation myocardial in- Participants. Contemporary mortality risk prediction for
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2005 Apr;26(8):770–7. Am Coll Cardiol 2010 May 4;55(18):1923–32.
29. Morrison LJ, Brooks S, Sawadsky B, McDonald A, Verbeek 39. Lettieri C, Savonitto S, De Servi S, et al; LombardIMA Study
PR. Prehospital 12-lead electrocardiography impact on Group. Emergency percutaneous coronary intervention in
acute myocardial infarction treatment times and mortality: a patients with ST-elevation myocardial infarction complicated
systemic review. Acad Emerg Med 2006 Jan;13(1):84–9. by out-of-hospital cardiac arrest: early and medium-term
30. Brown JP, Mahmud E, Dunford JV, Ben-Yehuda O. Effect of outcome. Am Heart J 2009 Mar;157(3):569–75.
prehospital 12-lead electrocardiogram on activation of the 40. Levy MM, Dellinger RP, Townsend SR, et al; Surviving Sepsis
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in ST-segment elevation acute myocardial infarction. Am J international guideline-based performance improvement
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31. Sivagangabalan G, Ong AT, Narayan A, et al. Effect of Feb;38(2):367–74.
prehospital triage on revascularization times, left ventricular
function, and survival in patients with ST-elevation myocar-
dial infarction. Am J Cardiol 2009 Apr 1;103(7):907–12.

The Chief
Of all the ailments which may blow out life’s little candle,
heart disease is the chief.
—William Boyd, 1885-1979, Scottish-Canadian pathologist and academic

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 11


credits available for this article — see page 95.

ORIGINAL RESEARCH & CONTRIBUTIONS

Reasons for Not Meeting Coronary Artery Disease Targets


of Care in Ambulatory Practice
Thomas Erling Kottke, MD, MSPH
Zacharia Ogwang, NP
James C Smith, MD In the past, heart-disease man-
Abstract agement strategies have focused
Introduction: Four targets of care: control of blood pressure, control on developing new diagnostic tools
of low-density lipoprotein cholesterol level, taking aspirin daily, and not and therapeutic interventions for
using tobacco improve outcomes for patients with coronary artery disease the treatment of acutely ill patients.
(CAD). We sought to identify why, in a large multispecialty group, these However, numerous recent outcome
targets were not being met in patients with CAD. studies have shown that these strate-
Methods: We thus conducted a retrospective review of patient records gies produce only short-term health
in the group practice’s CAD registry, which is updated quarterly. benefits while increasing the cost of
Results: Of a random selection of 14,973 patients in the CAD registry, health care.4–7 Yet secondary pre-
353 charts were consecutively reviewed until theoretic saturation was vention treatments for patients with
achieved—that is, until no new information was found. We could not find heart disease have the potential to
any evidence of CAD in 14 patients, and we considered that all four targets reduce subsequent mortality by as
had been met for 169 patients. The most frequent reasons for not meeting much as 75% to 90%.8–10 One of the
all targets of care among the 170 remaining patients were 1) the patient authors (TEK) has published calcula-
was in for a visit and the care team failed to address an unmet target of tions showing that meeting all targets
care (n = 98), 2) the patient was asked to come back for follow-up care of care for patients with stable heart
but did not (n = 28), and 3) the patient declined an intervention that was disease could prevent or postpone
offered (n = 14). Blood pressure and low-density lipoprotein cholesterol nearly 25% of all US deaths among
levels were the targets that were most frequently out of range. those who are 30 to 84 years of age.11
Conclusion: Giving the health care team access to tools with which they With the current emphasis on value-
can identify the concurrent care needs of their patients could significantly driven care, coupled with a political
increase the proportion of patients with CAD for whom care targets are met. environment that is emphasizing a
Lists generated by these tools would also be significantly more accurate change in the way that health care
than lists generated from quarterly reports. is delivered, primary and secondary
disease-prevention strategies seem
Introduction 31%, these conditions continue to poised to dominate the future in-
Causing half a million deaths consume large quantities of health novations of health care delivery.
each year, coronary artery disease care resources.2 The Centers for Dis- Several national and local institutions
(CAD) is the leading cause of mor- ease Control and Prevention projects have set disease-reduction goals.
tality in the US.1 Close to 18 million that costs related to heart disease For example, the American Heart
Americans are thought to have the will be >$500 billion in 2010, largely Association has set a goal of improv-
condition and, if hypertension is because of an expected 72 million ing the cardiovascular health of the
included, the prevalence is thought office visits and nearly 7 million entire American population by 20%
to be >81 million people in the US hospitalizations.3 These statistics are as measured by the average change
alone. Despite a decline in the rate driving policy makers and clinicians in four behaviors (never smoked or
of hospitalization for myocardial to search for more effective ways to quit more than one year ago, body
infarction that may be as great as manage heart disease. mass index less than 25 kg/m2, physi-

Thomas Erling Kottke, MD, MSPH, is a Senior Clinical Investigator for HealthPartners Research
Foundation in Minneapolis, MN. He is Medical Director for Evidence-Based Health for HealthPartners
and Professor of Medicine at the University of Minnesota. E-mail: [email protected].
Zacharia Ogwang, NP, is a Nurse Practitioner for Regions Hospital in St Paul, MN.
E-mail: [email protected].
James C Smith, MD, is an Internist for HealthPartners Medical Group in Bloomington, MN.
E-mail: [email protected].

12 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
Reasons for Not Meeting Coronary Artery Disease Targets of Care in Ambulatory Practice

cal activity of at least 150 minutes Review Board and assigned proto- Only one target was identified for
each week, and four to five of the col number 09–007. HealthPartners each patient. Consecutive records
key components of a healthy diet maintains a register of patients with were reviewed until theoretical
consistent with current American CAD (“the CAD register”) who meet saturation was achieved. Theoreti-
Heart Association guideline recom- the following criteria: cal saturation is the point at which
mendations) and three biometric • Insured by HealthPartners no new information is gained from
measures (total cholesterol less than • Being between the ages of 18 and further collection of data.20 In this
200 mg/dl, blood pressure below 75 years particular case, theoretical satura-
120/80 mm Hg, and fasting blood • Having had a hospitalization or tion was considered to be achieved
glucose less than 100 mg/dl).12 The clinic visit within the last two when review of 30 consecutive
American Heart Association has also years, with at least one ICD-9-CM records did not identify a new rea-
set a goal of reducing deaths by the (International Statistical Classifi- son for a patient not meeting the
same percentage by 2020.12 These cation of Diseases and Related targets of care. The number 30 was … giving care
goals are consistent with the Healthy Health Problems, ninth edition) selected because it approaches the teams access
People 2020 national heart disease diagnostic code in the range of normal distribution and because if to timely data
and stroke management goals.13 To 410.0 to 414.99 (a “CAD code”), or a reason is not found in 30 charts, about the
encourage better care at a regional • Having been prescribed nitrates it is unlikely to contribute to more patients they
level and to respond to the Health- within the last two years. than 3% to 5% of failures. A total of treat could
care Effectiveness Data and Informa- The register is updated quarterly. 353 records were reviewed. contribute to
tion Set14 (HEDIS) and to Minnesota In the first quarter of 2009, one of the elimination
HealthScores,15 HealthPartners has two authors (JCS or TEK) reviewed Results of 80% to 90%
begun to report performance on the medical records of randomly At of the end of the third quarter of the reasons
four targets of care for participating selected patients who were in the of 2008, HealthPartners had 30,415 for failure
physicians who treat a significant CAD register at the time of the current members who had received to meet the
number of patients who have CAD: most recent available update—the a CAD code since January 1, 2000; targets of care.
blood pressure <140/90 mmHg, low- end of the third quarter of 2008. To 14,973 members were in the CAD
density lipoprotein (LDL) level <100 be selected for review, the patient register (Figure 1). The age of
mg/dL, taking aspirin daily, and not also was required to have had at members in the register ranged from
using tobacco.16–18 In 2006–2007, the least one visit to a HealthPartners 19 to 77 years (mean, 61.4 years;
average proportion of patients who Medical Group primary care clinic standard deviation [SD], 9.4 years),
met all four goals was only 37.5%, during 2008 and to have not met and 67% were men. A total of 15,442
and no participating physicians met one or more of the following criteria current members who had a CAD
all four targets of care for more than of optimal health as defined in the code were not in the register—93
45% of HealthPartners members. HealthPartners 2007 Clinical Indica- because they were <18 years old,
Data from another Medical Group tors Report17: 9011 because they were >75 years
suggests that significant improve- • Systolic blood pressure <140 mm old, and 6338 because they neither
ments in performance on metrics Hg and diastolic blood pressure had a visit with a CAD code within
of care require multicomponent <90 mm Hg two years nor were they prescribed
interventions.19 As the first step in a • LDL cholesterol level measured nitrates in the same period.
local initiative to improve outcomes in the preceding year The age of the patients who
for patients with CAD by improving • LDL cholesterol level <100 mg/ were randomly selected for review
the process of care, the goal of this dL when measured ranged from 31 to 77 years (mean,
project was to identify why patients • Taking aspirin daily 62.9 years; SD, 8.9 years), and 65%
cared for by HealthPartners Medi- • Not using tobacco. were men. Although 170 patients
cal Group fail to achieve the four To be considered met, a target of were confirmed to have CAD but
targets of care. care had to be documented. did not meet all four targets of care,
Each reviewing physician (TEK the reviewing physicians could find
Methods and JCS) was given a list of patients no evidence of CAD in the records
The research protocol was ap- and one target of care for which the of 14 patients and considered that
proved by the HealthPartners patient had out-of-range values at 169 patients met the targets of care
Research Foundation Institutional the end of the third quarter of 2008. at the time of review. More than

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 13


ORIGINAL RESEARCH & CONTRIBUTIONS
Reasons for Not Meeting Coronary Artery Disease Targets of Care in Ambulatory Practice

half (n = 98) of the 170 patients who Discussion teams benchmark their own per-
were confirmed to have CAD but The record-review data presented formance to identify opportunities
did not meet all targets of care did in this report document that the to improve care through process-
not meet criteria because the out-of- most common reasons HealthPart- improvement initiatives.
range target had not been addressed ners Medical Group patients do The data on which these con-
at the time that they were seen by not achieve CAD targets of care clusions are based have several
a primary care physician (Table 1). are simple: 1) most frequently, their limitations. Only one failure was
About 15% of the patients were needs are overlooked by the care examined for cause for each pa-
asked to come back for follow-up team when the patient is in the tient. Therefore, the proportion
care but did not, and <10% of the office; 2) the patient has failed to of patients with multiple failures
patients declined intervention. Other return for a visit; and 3) the patient cannot be calculated from these
reasons for failure to meet the targets declined an intervention that was data. The data are from one multi-
of care occurred less frequently. offered to them. These observa- specialty group practice; the causes
Blood pressure (n = 43) and LDL tions suggest that giving care teams of failure in other group practices
cholesterol level (n = 55) were the access to timely data about the may be different. About half of the
targets of care that were most fre- patients they treat could contribute patients who have CAD are not in
quently out of control. Failure to to the elimination of 80% to 90% of the CAD register, so it is possible
take aspirin was the reason that the the reasons for failure to meet the that patients in the CAD register are
patient did not achieve all targets targets of care. The same reporting not representative of patients who
of care in only 17 cases, and 26 tools that could be used to prepare are not in the CAD register. The hy-
patients continued to use tobacco. for patient visits could let the care potheses generated in this study will
be verified only when redesigned
care systems reduce failure rates by
addressing the reasons for failure
30,415 current
documented in this study.
HealthPartners members The selection cascade provides
with a CAD code information about why the report-
(ICD-9-CM 410-414) 15,442 current
since January 1, 2000 HealthPartners members
ing process must be tailored to the
with a CAD code needs of the clinical care teams. Be-
(ICD-9-CM 410-414) cause the main purpose of the CAD
since January 1, 2000,
not in register: register is to report performance
14,973 current
HealthPartners members 93 <18 years of age; to HEDIS and Minnesota Health-
in the CAD register 9011 >75 years of age; Scores,14,15 performance is reported
6338 without CAD
code or nitrates only for patients who are ≤75 years
within two years old and have had a CAD code as-
353 members of signed to one of their encounters
the CAD register within the preceding two years.
randomly selected for
record review
Additionally, the register is updated
14 patients without only quarterly. Although the selec-
evidence of CAD in
the medical record; tion criteria and quarterly updates
169 patients meeting are appropriate for performance
170 members of the all four targets of
CAD register with care at the time of
reporting, they miss older patients
medical record record review who are being actively treated by
evidence of CAD and their clinical care teams, and the
not meeting at least
one target of care data generated from the register are
frequently outdated at the time of
a clinical encounter. Both of these
Figure 1. The cascade from current HealthPartners members with at least problems, and the annoyance that
one coronary artery disease (CAD) code since January 1, 2000, to the 170
randomly selected members with medical record evidence of CAD and not data that are outdated or inaccurate,
meeting at least one target of care. could be avoided by giving care
ICD-9-CM = International Statistical Classification of Diseases and Related Health Problems, teams access to real-time analysis
ninth edition.

14 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
Reasons for Not Meeting Coronary Artery Disease Targets of Care in Ambulatory Practice

Table 1. Reasons the targets of care were not achieved (n)


Number of times each target of care was not achieved, by reason
BP LDL cholesterol LDL cholesterol Taking No Total
Reason target not achieved controlled measured <100 mg/dL aspirin daily tobacco
The patient was in for a visit, but the care team 29 10 28 14 17 98
failed to address a need
The patient was asked to come back but did not 5 12 9 1 1 28
The patient was offered an intervention but declined 1 — 6 — 7 14
The clinician changed a medication in response to an 6 — 4 — — 10
out-of-range value; the target was not due for reevaluation
The patient was not invited back for follow-up treatment 1 4 4 — — 9
Aggressive goals were not appropriate for the patient — 1 — — — 1
because of a comorbid condition
The physician who ordered the test failed to follow-up — — 1 — — 1
The patient was intolerant of statins — — 1 — — 1
All other reasons 1 2 2 2 1 8
Total 43 29 55 17 26 170
BP = blood pressure; LDL = low-density lipoprotein.

and reporting tools. However, cau- erate real-time, tailored reports from minder systems have shown strong
tion would have to be exercised if the medical record—will increase evidence in improving the quality
the data were to be used for other the proportion of patients who meet of care.28 The increased availability
than self-evaluation because of the their health care goals. For example, of an electronic medical record and
problem of small numbers lead- Gawande23 has observed that the collaboration among health care
ing to numeric instability and a adoption of checklists in complex institutions present an opportunity
multicomponent index having an industries such as airplane manu- to change the benchmark of accept-
achievable performance value that facturing and finance has reduced able care. v
is significantly <100%. both errors and inefficiencies. He
Despite the fact that changing also cited his own experience in Disclosure Statement
The author(s) have no conflicts of
the way in which care is delivered surgery, where brief checklists have
interest to disclose.
can improve outcomes, changing reduced deaths and complications
care processes can be a challenge.21 by more than one-third at hospitals Acknowledgments
Health care institutions, like many around the world. This study was supported by an
other organizations, can be slow in Although other interventions unrestricted grant from the Minnesota
adopting effective practices even such as public reporting of perfor- Department of Health Heart Disease and
Stroke Prevention Program.
when irrefutable evidence of their mance and pay for performance
Katharine O’Moore-Klopf, ELS, of KOK
effectiveness exists. For example, are also components of a compre- Edit provided editorial assistance.
Griffith et al22 found that close to hensive menu of interventions to
75% of hospitals analyzed in their improve patient care, the data pre- References
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The Permanente Journal/ Fall 2010/ Volume 14 No. 3 15


ORIGINAL RESEARCH & CONTRIBUTIONS
Reasons for Not Meeting Coronary Artery Disease Targets of Care in Ambulatory Practice

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16 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


soul of the healer

“Dance with Heart”


36 x 36”
acrylic on canvas

Shenshen Dou

Shenshen Dou is a former Molecular Biologist living in Portland, OR. This painting
was inspired by one of her husband’s patients: a young dancer with an abnormal
heart rhythm, which threatened her profession and her life. John Wu, MD, Ms Dou’s
husband, corrected the rhythm with a pacemaker, which can be seen in the painting,
and the young dancer, inspiration for this painting, is dancing again.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 17


ORIGINAL RESEARCH & CONTRIBUTIONS

The Protective Effect of Family Strengths in Childhood


against Adolescent Pregnancy and Its Long-Term
Psychosocial Consequences
Susan D Hillis, PhD, MS
Robert F Anda, MD, MS
Shanta R Dube, PhD, MPH
Vincent J Felitti, MD, FACP Abstract trend < 0.00001). When childhood abuse and household
Polly A Marchbanks, PhD
Background: Few reports have addressed associations dysfunction were present, adjusted odds ratios (ORs)
Maurizio Macaluso, MD, DrPH
James S Marks, MD, MPH between family strengths during childhood and adoles- for adolescent pregnancy demonstrated an increasingly
cent pregnancy and its consequences. We examined protective effect as numbers of childhood family strengths
relationships among a number of childhood family increased from 0 or 1 to 2 or 3, 4 or 5, and 6 or 7 (1.0 to
strengths and adolescent pregnancy, risk behavior, and 0.80), (1.0 to 0.80, 0.60, and 0.54, respectively). These
psychosocial consequences after adolescent pregnancy. findings were partly explained by progressive delays in
Methods: Our retrospective cohort of 4648 women initiation of sexual activity as the number of childhood
older than 18 years (mean age, 56 years) received primary family strengths increased. Adjusted ORs for psychoso-
care in San Diego, CA. Outcomes included adolescent cial problem occurring decades later decreased as the
pregnancy and psychosocial consequences compared number of childhood family strengths increased from 0
with number of the following childhood family strengths: or 1 to 2 or 3, 4 or 5, and 6 or 7 (job problems, 1.0, 0.8,
family closeness, support, loyalty, protection, love, im- 0.6, 0.4; family problems, 1.0, 1.1, 0.7, 0.6; financial
portance, and responsiveness to health needs. problems, 1.0, 0.9, 0.9, 0.6; high stress, 1.0, 1.1, 0.9,
Results: Of the cohort, 3082 participants (66%) re- 0.8; uncontrollable anger, 1.0, 0.7, 0.7, 0.4).
ported 6 or 7 categories of childhood family strengths. Conclusions: Childhood family strengths are strongly
Teen pregnancy occurred in 39%, 33%, 30%, 25%, protective against adolescent pregnancy, early ini-
24%, 21%, and 19% of those with 0 or 1, 2, 3, 4, 5, tiation of sexual activity, and long-term psychosocial
6, and 7 childhood family strengths, respectively (p for consequences.

National data describing adolescent childbearing ceeded those of other industrialized countries by 2 to
have been available for the US since 1940.1 Teen birth 15-fold.1–4 Of the approximately 900,000 pregnancies
rates over the ensuing 60 years reached an all-time in a typical year,3 about half end in live births and the
record low of 48.7 births per 1000 women age 15 to 19 other half are associated with abortion, miscarriage,
years in the year 2000.1 In spite of noteworthy reduc- or stillbirth.5
tions in rates of adolescent pregnancy and birthrates Research in prevention since 1990 has identified a
during the 1990s, teen pregnancy rates in the US ex- variety of factors, including individual, family, peer,

Susan D Hillis, PhD, MS, is a Senior HIV Scientist in the Fertility Epidemiology Section, Women’s Health and Fertility
Branch, Division of Reproductive Health at the Centers for Disease Control and Prevention and Adjunct Faculty
in Epidemiology at the Collins School of Public Health at Emory University in Atlanta, GA. E-mail: [email protected].
Robert F Anda, MD, MS, is a Senior Researcher in Preventive Medicine and Epidemiology at the Centers for Disease
Control and Prevention in Atlanta, GA. E-mail: [email protected].
Shanta R Dube, PhD, MPH, is an Epidemiologist and Director of the Adverse Childhood Experiences (ACE) Study for the
Centers for Disease Control and Prevention Division of Adult and Community Health in Atlanta, GA. E-mail: [email protected].
Vincent J Felitti, MD, FACP, is a retired Internist from the Department of Preventive Medicine at the Clairemont Mesa Medical
Office in San Diego, CA. He is a Clinical Professor of Medicine at the University of California in San Diego. E-mail: [email protected].
Polly A Marchbanks, PhD, is a Team Leader in the Fertility Epidemiology Section, Women’s Health and Fertility Branch,
Division of Reproductive Health National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease
Control and Prevention in Atlanta, GA. E-mail: [email protected].
Maurizio Macaluso, MD, DrPH, is a Branch Chief, in the Women’s Health and Fertility Branch, Division of Reproductive
Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention
in Atlanta, GA. E-mail: [email protected].
James S Marks, MD, MPH, is a Senior Vice President, Robert Wood Johnson Foundation in Princeton, NJ. E-mail: [email protected].

18 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
The Protective Effect of Family Strengths in Childhood against Adolescent Pregnancy and Its Long-Term Psychosocial Consequences
and Its Long-Term Psychosocial Consequences

and community influences, that protect against early CA. Approval was granted by the institutional review
sexual debut and adolescent pregnancy.3,6–11 Several boards of Emory University and KP and by the office
reports have examined the role of adolescents’ family of Human Research Protection, Department of Health
context in building resilience and in providing protec- and Human Services.
tion against unfavorable reproductive outcomes.6–9,12 Each year, more than 50,000 adult KP members un-
Adolescents reporting higher family assets have been derwent a standardized biopsychosocial health evalu-
significantly less likely to report early sexual debut or ation, and more than 80% of continuously enrolled
adolescent pregnancy. A limitation of these reports, members obtained this service at least once over a
however, is the absence of an analysis on whether typical four-year period. The evaluation included a
the protective effect of family assets persists when health history, psychosocial evaluation, laboratory Seven questions
the fuller constellation of negative family cofactors studies, and physical examination. The primary pur- used to assess
is considered. pose of the evaluation is to perform a complete health family strengths
Recent reports have used the Adverse Childhood assessment rather than to provide care that is based during
Experiences (ACE) Study to address the association on symptoms or illness. The ACE Study sample was childhood
between major causes of death and disability in the drawn from the Health Appraisal Center and consisted covered family
US and childhood abuse and family dysfunction.13–21 of two survey waves (wave I and wave II). Wave I closeness,
These and related reports demonstrate strong and was conducted among 13,494 consecutive KP mem- support, loyalty,
graded associations between cumulative exposure to bers attending the Health Appraisal Center between and protection;
categories of ACE and many unfavorable reproduc- August 1995 and March 1996, and the response rate feelings of
tive health outcomes, including early onset of sexual was 70% (N = 9508). Wave II was conducted between being loved and
activity, adolescent pregnancy, sexually transmitted June and October 1997 among 13,330 KP members, important; and
diseases, increased risk of HIV infection, violence and the response rate was 65% (N = 8667). The overall responsiveness
perpetration, unintended pregnancy in adulthood, response rate for both waves was 68%. Within two to needs for
and fetal death.13,14,16,22,23 Data collected in the second weeks after their clinic visit, participants received a health care.
wave of the study also included measures of family mailed ACE questionnaire that assessed exposure to
strengths, which should protect against these unfavor- childhood abuse or household dysfunction and child-
able outcomes. Seven questions used to assess family hood family strengths. The wave II survey included
strengths during childhood covered family closeness, questions on family strengths, which were not included
support, loyalty, and protection; feelings of being in wave I. Therefore, this study report includes only
loved and important; and responsiveness to needs wave II data. After the exclusion of women who had
for health care. missing data on race or education (n = 21) or on all
We recently reported that ACE had a dose-response categories of childhood family strengths (n = 26), our
effect on adolescent pregnancy and on long-term sample included 4648 women.
psychosocial outcomes commonly attributed to
adolescent pregnancy.22 Here, we examine whether Definitions of Childhood Family
childhood family strengths protect against adolescent Strengths, Adverse Childhood
pregnancy, against sexual risk behavior leading to Experiences, Adolescent Pregnancy,
adolescent pregnancy, and against long-term psycho- and Psychosocial Consequences
social outcomes commonly attributed to adolescent All questions about childhood family strengths and
pregnancy. Furthermore, we examine whether the ACE pertained to the respondent’s first 18 years of life
protective effect of family strengths remains among (Table 1). For the childhood family strengths ques-
women who were exposed to ACE (various types of tions, participants were asked about how applicable
abuse and household dysfunction, as detailed in the to their lives each of seven statements was regarding
“Methods” section). closeness, support, loyalty, protection, importance,
love, and responsiveness to health needs. Response
Methods categories included “never true,” “rarely true,” “some-
The methods used for the ACE Study have been times true,” “often true,” and “very often true.” The
described in detail.13–22 The study was a retrospective questions about ACE dealt with verbal and physical
cohort study conducted among adults enrolled in a abuse, contact sexual abuse, violence against one’s
large health maintenance organization (Kaiser Per- mother, household substance abuse and mental ill-
manente [KP] Medical Care Program) in San Diego, ness, having an incarcerated household member,

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 19


ORIGINAL RESEARCH & CONTRIBUTIONS
The Protective Effect of Family Strengths in Childhood against Effect
The Protective Adolescent Pregnancy
of Family andinIts
Strengths Long-Term
Childhood Psychosocial
against Consequences
Adolescent Pregnancy
and Its Long-Term Psychosocial Consequences

Table 1. Definitions of childhood family strengths and adverse childhood experiences


Questions Defining responses
Childhood family strengths questions
Family closeness: While you were growing up, during your first 18 years of Often true or very often true
life, how true were each of the following statements? People in your family felt
close to each other.
Family support: While you were growing up, during your first 18 years of life, Often true or very often true
how true were each of the following statements? Your family was a source of
support.
Family loyalty: While you were growing up, during your first 18 years of life, Often true or very often true
how true were each of the following statements? People in your family looked
out for each other.
Family protection: While you were growing up, during your first 18 years of life, Often true or very often true
how true were each of the following statements? You knew there was someone to
take care of you and to protect you.
Family importance: While you were growing up, during your first 18 years of Often true or very often true
life, how true were each of the following statements? There was someone in your
family who helped you feel important or special.
Family love: While you were growing up, during your first 18 years of life, how Often true or very often true
true were each of the following statements? You felt loved.
Responsiveness to health care needs: While you were growing up, during your Often true or very often true
first 18 years of life, how true were each of the following statements? There was
someone to take you to the doctor if you needed it.
Adverse childhood experiences questions
Verbal abuse: Sometimes parents or other adults hurt children. While you Often or very often to either
were growing up—that is, in your first 18 years of life, how often did a parent, question
stepparent, or adult living in your home 1) swear at you, insult you, or put you
down? 2) threaten to hit you or throw something at you but didn’t do it?
Physical abuse: Sometimes parents or other adults hurt children. While you Often or very often to the
were growing up—that is, in your first 18 years of life, how often did a parent, question 1 or sometimes,
stepparent, or adult living in your home: 1) push, grab, slap, or throw something often, or very often to
at you? 2) hit you so hard that you had marks or were injured? question 2
Sexual abuse: Some people, while they were growing up in their first 18 years Yes to any of the 4 questions
of life, had a sexual experience with an adult or someone at least 5 years older
than themselves. These experiences might have involved a relative, family friend,
or stranger. During your first 18 years of life, did an adult, relative, family friend,
or stranger ever 1) touch or fondle your body in a sexual way, 2) have you touch
their body in a sexual way, 3) attempt to have any type of sexual intercourse with
you (oral, anal, or vaginal), or 4) actually have any type of sexual intercourse
with you (oral, anal, or vaginal)?
Intimate-partner violence: Sometimes physical blows occur between parents. Sometimes, often, or very
While you were growing up in your first 18 years of life, how often did your often to at least 1 of the first
father (or stepfather) or mother’s boyfriend do any of these things to your 2 questions or any response
mother (or stepmother): 1) push, grab, slap, or throw something at her; 2) kick, other than never to at least
bite, hit her with a fist, or hit her with something hard; 3) repeatedly hit her one of the third and fourth
over at least a few minutes; or 4) threaten her with a knife or gun, or use a knife questions
or gun to hurt her?
Household substance abuse: During your first 18 years of life, did you live with Yes to either question
anyone who was a problem drinker or alcoholic? During your first 18 years of
life, did you live with anyone who used street drugs?
Mental illness in household: During your first 18 years of life, was anyone in Yes to either question
your household depressed or mentally ill? During your first 18 years of life, did
anyone in your household attempt to commit suicide?
Incarcerated household member: During your first 18 years of life, did anyone in Yes
your household go to prison?
Parental separation or divorce: Were your parents ever separated or divorced? Yes

20 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
The Protective Effect of Family Strengths in Childhood against Adolescent Pregnancy and Its Long-Term Psychosocial Consequences
and Its Long-Term Psychosocial Consequences

and parental separation or divorce. Each of these Maximum likelihood ratio χ2 were used to evaluate
areas has been described in detail.13–22 Our questions whether the effect of childhood family strengths was
regarding emotional and physical abuse, violence significantly modified by the presence of ACE.
against one’s mother,24 contact sexual abuse during Finally, we examined the protective associa-
childhood,25 and household substance abuse26 were tion between childhood family strengths and both
adapted from previously used scales. The child- adolescent pregnancy and unfavorable psychosocial
hood family strengths questions were taken from consequences persisted in analyses stratified by
the Childhood Trauma Questionnaire developed by birth cohort, to assess whether our findings might
Bernstein et al,27 which has been showed to have have been influenced by changes in these outcomes
high reliability and validity. over time.
Information about adolescent pregnancy, defined
as a pregnancy that occurs in a female between Results
the ages of 11 and 19 years, was obtained through Our study population was racially mixed (76%
self-report. The question was “How old were you white), most had attended or completed college,
the first time you became pregnant?” Age of ini- and more than half were age 50 years or older at
tiation of sexual activity was obtained through the the time of interview (Table 2). Those reporting
question “How old were you the first time you had 6 or 7 family strengths were significantly more likely
sexual intercourse?” Data describing psychosocial than those reporting fewer family strengths to be
consequences were obtained from the Kaiser Health age 65 years or older at interview and to be unem-
Appraisal questionnaire at the time of interview.
Problems with family, jobs, or finances were defined
as follows: “Are you now having serious or disturbing Table 2. Distribution of demographic and behavioral
problems with your family (yes/no), job (yes/no), characteristics by childhood family strengths
or financial matters (yes/no)?” The request used to Characteristic Number of family strengths
define high stress was “Please fill in the circle that 6 or 7 0–5
best describes your stress level (high/medium/low).” Total (N = 3082) (N = 1566)
participants percentage percentage
The question defining fear of uncontrollable anger
Race or ethnicitya
was “Have you ever had reason to fear your anger
White 3549 76.4 76.2
getting out of control (yes/no)?” Black 201 4.8 3.4
Hispanic 191 3.4 5.6
Statistical Analyses Asian 416 9.4 8.0
The unadjusted associations between each of the American Indian 18 0.4 0.5
seven categories of childhood family strengths and Other 273 5.6 6.5
adolescent pregnancy were estimated using relative Educationa
risks (RRs) and 95% confidence intervals (CIs). Sub- Some high school 381 7.3 9.9
sequently, logistic regression modeling was employed High school graduates 800 17.4 16.9
to evaluate the protective association between num- Some college 1505 40.9 44.9
bers of categories of childhood family strengths and College graduates 1962 34.4 28.4
adolescent pregnancy, as well as long-term psycho- Age at interview (years)a
social consequences associated with that event.28 The 19–34 547 11.8 11.8
Mantel-Haenszel χ2 test for linear trend in proportions 35–49 1252 24.5 31.7
was used to evaluate whether increasing numbers 50–64 1460 31.1 32.1
of family strengths (classified as 0, 1, 2, 3, 4, 5, 6, ≥65 1389 32.7 24.4
or 7) were associated with reductions in adolescent Employmenta
pregnancy and with reductions in early initiation of Full time 1969 41.9 47.1
sexual activity.29 Covariates in all models included age, Part time 684 14.4 16.6
education, and race (“other” vs “white”). Additionally, Unemployed 1851 43.6 36.0
both ACE and adolescent pregnancy were included Adverse childhood experiencesa
in models that examined whether there was a long- Yes 3097 57.3 85.1
lasting protective effect of childhood family strengths No 1551 42.7 14.9
on the psychosocial consequences described earlier. a
p < 0.0005.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 21


ORIGINAL RESEARCH & CONTRIBUTIONS
The Protective Effect of Family Strengths in Childhood against Effect
The Protective Adolescent Pregnancy
of Family andinIts
Strengths Long-Term
Childhood Psychosocial
against Consequences
Adolescent Pregnancy
and Its Long-Term Psychosocial Consequences

Table 3. Association between numbers of childhood family strengths and risk of adolescent pregnancy
Numbers of family Adolescent pregnancy,
strengthsa percentageb Unadjusted OR (95% CI) Adjusted ORc (95% CI)
0 or 1 (340) 38.8 1.0 (referent) 1.0 (referent)
2 (340) 33.2 0.82 (0.60–1.1) 0.86 (0.62–1.2)
3 (285) 29.5 0.69 (0.50–0.96) 0.74 (0.52–1.0)
4 (273) 25.3 0.56 (0.40–0.79) 0.59 (0.41–0.85)
5 (323) 23.5 0.51 (0.36–0.71) 0.55 (0.39–0.77)
6 (664) 21.4 0.45 (0.34–0.60) 0.48 (0.36–0.65)
7 (2407) 19.4 0.40 (0.32–0.50) 0.46 (0.36–0.59)
a
Sample decreased slightly because of missing data.
b
Percentage of those with the listed number of categories of childhood family strengths who experienced an adolescent pregnancy.
c
All ORs are adjusted for race, education, and age at interview.
CI = confidence interval. OR = odds ratio.
p for trend < 0.0001.

ployed or retired. Although more than half of those who experienced family strengths never, rarely, or
with a high number of childhood family strengths sometimes (“no” in Table 2), those reporting such
(6 or 7) reported having 1 or more ACE, they were experiences often or very often (“yes” in Table 2)
significantly less likely than the group with fewer had reductions in teen pregnancy for each family
family strengths (0–5) to report a history of ACE strength: 37% reduction for protection (35.3% vs
(57% vs 85%; p < 0.0005). 22.0%; RR, 0.63; 95% CI, 0.56–0.71); 42%, support
Exposure to each of the seven categories of (33.5% vs 19.6%; RR, 0.58; 95% CI, 0.53–0.65);
childhood family strengths was associated with a 34%, closeness (30.7% vs 20.1%; RR, 0.66; 95% CI,
significant 30% to 40% decreased risk of adolescent 0.59–0.73); 37%, loyalty (33.6% vs 21.0%; RR, 0.63;
pregnancy (data not shown). Compared with women 95% CI, 0.56–0.70); 29%, feeling important (29.0%
vs 20.8%; RR, 0.71; 95% CI, 0.63–0.77); 34%, feeling
loved (31.9% vs 21.0%; RR, 0.66; 95% CI, 0.59–0.74);
and 33%, responsiveness to health care needs (33.4%
Lovea vs 22.2%; RR, 0.67; 95% CI, 0.57–0.78). Furthermore,
a significant trend effect on adolescent pregnancy
Very often was observed as the frequency of each childhood
Importancea Often family strength increased, from “never/rarely” to
Sometimes “sometimes” to “often” to “very often” (Figure 1).
Childhood Family Strengths

Rarely/never
Health Care As the number of childhood family strengths in-
Needs Meta creased, the risk of adolescent pregnancy decreased
significantly (Table 3). Adjusted odds ratios (OR) for
Loyaltya adolescent pregnancy were 1.0, 0.86, 0.74, 0.59, 0.55,
0.48, and 0.46, respectively, among those with 0 to
Closenessa
1, 2, 3, 4, 5, 6, and 7 categories of family strengths.
The absolute percentage of adolescent pregnancies
for women with 7 family strengths (19%) was about
Supporta half that for women with 0 or 1 family strengths
(39%). We found that the magnitude of protective
effect of childhood family strengths on adolescent
Protectiona
pregnancy was significantly altered by the cofac-
0.0% 10.0% 20.0% 30.0% 40.0%
tor of ACE, which functioned as an effect modifier.
Among those reporting one or more ACE, there was
Adolescent Pregnancy
a highly significant protective (p < 0.000001) trend
Figure 1. Risk of adolescent pregnancy according to characterization of effect of childhood family strengths against adolescent
childhood family strengths. pregnancy. Adolescent pregnancy rates among those
a
p < 0.05. women with ACE decreased from 42% to 33%, 26%,

22 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
The Protective Effect of Family Strengths in Childhood against Adolescent Pregnancy and Its Long-Term Psychosocial Consequences
and Its Long-Term Psychosocial Consequences

and 24%, respectively, for those reporting 1 to 2, 2 to significant protective trends (p < 0.005) against initia-
3, 4 to 5, and 6 to 7 categories of childhood family tion of sexual activity either before age 15 years or
strengths (Table 4). After adjustment, we observed a at ages 15 to 19 years (compared with initiation of
46% reduction in adolescent pregnancy rates (adjusted sexual activity at ages 20 years and older) were seen
OR = 0.54) among with both high family strengths (6 with greater numbers of childhood family strengths;
or 7 categories) and coexisting ACE, compared with however, the lowest risk of early initiation of sexual
women with low childhood family strengths (0 or 1 activity was consistently observed among women
category) and coexisting ACE. without ACE and was consistent across the 0 to 7
Women without ACE, regardless of their family range of childhood family strengths. Of those with
strengths, were at lower risk of adolescent preg- ACE and 0 or 1 family strength, 67.6% initiated sex
nancy than the reference group (ACE, 0 or 1 family at age 15 to 19 years; among those with ACE and
strengths; Table 4). No significant difference was 6 or 7 family strengths, 57.5% initiated in this age
seen in the risk of adolescent pregnancy among range; among those without ACE and 0 to 7 family
those with 6 or 7 family strengths (14%) and those strengths, 40.4% of women initiated sexual activity
with 0 to 5 (combined rate of 17.3%). at age 15 to 19 years.
We also examined whether childhood family Finally, we analyzed long-term psychosocial
strengths were associated with delays in initiation consequences, which were measured at the time of
of sexual activity in analyses that simultaneously interview, when the interviewees were at a mean
considered ACE (Table 5). Among women with ACE, age of 56 years. We found significant positive trends

Table 4. Numbers of childhood family strengths and adolescent pregnancy until age 18 among
women with adverse childhood experiences and those without adverse childhood experiences
Numbers of childhood Adolescent pregnancy,
family strengths percentage (n) OR unadjusted (95% CI) OR adjusteda (95% CI)
With ACE (n = 3097)
0 or 1 42.0 (126) 1.0 (referent) 1.0 (referent)
2 or 3 33.2 0.72 (0.55–0.97) 0.80 (0.59–1.10)
4 or 5 26.1 0.52 (0.38–0.70) 0.60 (0.44–0.81)
6 or 7 24.2 0.47 (0.37–0.60) 0.54 (0.42–0.70)
No history of ACE (n = 1555)
0 or 1 15.0 (6) 0.26 (0.11–0.64) 0.20 (0.08–0.51)
2 or 3 17.9 (12) 0.32 (0.17–0.62) 0.34 (0.17–0.68)
4 or 5 17.4 (22) 0.32 (0.19–0.53) 0.29 (0.17–0.50)
6 or 7 14.0 (183) 0.24 (0.18–0.32) 0.29 (0.22–0.38)
a
All ORs are adjusted for race, education, and age at interview.
ACE = adverse childhood experiences; CI = confidence interval; OR = odds ratio.

Table 5. Childhood family strengths and adverse childhood experience status as predictor
of age of initiation of sexual activity
Numbers of family strengths Age of initiation of sexual activity (N = 4389)a
and ACE 15 years 15–19 years
Percentage (n/N) p for trend Percentage (n/N) P for trend
0 or 1 with ACE (N = 287) 8.7 (25/287) 67.6 (194/287)
2 or 3 with ACE (N = 532) 6.6 (35/532) 63.4 (337/532)
4 or 5 with ACE (N = 450) 6.9 (31/450) < 0.005b 58.4 (263/450) < 0.005b
6 or 7 with ACE (N = 1678) 3.0 (50/1678) 57.5 (965/1678)
0–7 without ACE (N = 1442) 1.0 (15/1442) 40.4 (582/1442)
a
Sample decreased because of missing data.
b
Compares age of initiation of sexual activity with that of women age ≥20 years, among whom the following distributions were observed: 23.7%
(68/287), 30.1% (160/532), 34.7%(156/450), 29.5% (663/1678), and 58.6%(845/1442) among women with these numbers of family strengths: 0 or
1 with ACE, 2 or 3 with ACE, 4 or 5 with ACE, 6 or 7 with ACE, 0–7 without ACE.
ACE = adverse childhood experiences.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 23


ORIGINAL RESEARCH & CONTRIBUTIONS
The Protective Effect of Family Strengths in Childhood against Effect
The Protective Adolescent Pregnancy
of Family andinIts
Strengths Long-Term
Childhood Psychosocial
against Consequences
Adolescent Pregnancy
and Its Long-Term Psychosocial Consequences

Table 6. Numbers of childhood family strengths and long-term psychosocial problemsa


Long-term psychosocial Numbers of categories of family strengths
consequences 0 or 1 2 or 3 4 or 5 6 or 7 p for trend
Job problems
Percentage (n) 14.4 (49) 12.2 (77) 9.1 (54) 5.7 (176) <0.0001
OR adj (95% CI) 1.0 (referent) 0.80 (0.54–1.2) 0.63 (0.41–0.96) 0.43 (0.30–0.61)
Family problems
Percentage (n) 19.1 (65) 19.2 (121) 12.6 (75) 9.6 (296) <0.0001
OR adj (95% CI) 1.0 (referent) 1.1 (0.78–1.5) 0.68 (0.47–0.98) 0.56 (0.41–0.75)
Financial problems
Percentage (n) 20.2 (69) 19.1 (120) 17.1 (102) 10.6 (325) <0.0001
OR adj (95% CI) 1.0 (referent) 0.93 (0.66–1.3) 0.95 (0.67–1.4) 0.63 (0.47–0.85)
High stress
Percentage (n) 20.8 (67) 22.1 (133) 17.8 (101) 15.8 (457) <0.0001
OR adj (95% CI) 1.0 (referent) 1.1 (0.77–1.5) 0.87 (0.62–1.2) 0.83 (0.62–1.1)
Uncontrollable anger
Percentage (n) 15.0 (51) 11.1 (70) 8.9 (53) 4.4 (135) <0.0001
OR adj (95% CI) 1.0 (referent) 0.73 (0.49–1.1) 0.65 (0.43–0.99) 0.36 (0.25–0.51)
a
ORs are adjusted for age, race, education, adolescent pregnancy and ACE.
ACE = adverse childhood experiences; CI = confidence interval; OR adj = adjusted odds ratio.

for childhood family strengths and each of the psy- graded fashion when the character of that childhood
chosocial outcomes considered, including serious is measured in identifiable family strengths. The
or disabling problems with jobs, family, or finances, progressively protective effects of childhood family
high stress, or uncontrollable anger (Table 6). After strengths were especially noteworthy among those
adjusting for age, race, education, adolescent preg- who reported ACE, where those with the highest
nancy, and history of coexisting childhood abuse or level of family strengths had roughly half the risk
family dysfunction, we found that a high number of of adolescent pregnancy of those with only one or
family strengths (6 or 7) led to a significant protective no family strengths. We also found that childhood
effect against job, family, and financial problems, as family strengths were especially protective of early
well as uncontrollable anger. These findings did not initiation of sexual intercourse among those women
vary by whether ACE were reported. who had experienced child abuse or household dys-
In analyses stratified by age cohort (19–34, 35–49, function, as measured by ACE. More than half of the
50–64, and ≥65 years), we found a significant trend women with high levels of childhood family strength
for each age cohort when we compared the num- reported one or more ACE, indicating that ACE are
ber of childhood family strengths with the rate of by no means incompatible with living in a family
adolescent pregnancy (data not shown). For 0 or with numerous strengths. Moreover, we observed
1, to 2 or 3, 4 or 5, and 6 or 7 family strengths, we that increases in the number of childhood family
found that the risk of adolescent pregnancy was strengths were associated with progressive reduc-
as follows (p for trend for each group < 0.0001): tions in long-term psychosocial problems that have
19–34 years: 42.9%, 25.6%, 28.1%, and 16.1%; 35–49 been attributed to adolescent pregnancy, including
years: 38.2%, 36.6%, 26.4%, and 21.0%; 50–64 years: serious problems with jobs, family, finances, and
39.7%, 35.2%, 26.3%, and 24.0%; and ≥65 years: uncontrollable anger.
36.6%, 22.7%, 18.0%, and 16.4%. Also, for each age Our findings are consistent with those of previous
cohort, the odds of psychosocial consequences reports, indicating that the quality of family relation-
decreased as numbers of family strengths increased ships influences the adoption of sexual risk behav-
(data not shown). iors associated with adolescent pregnancy. 7,9,30–34
Specifically, adolescents who perceive their family
Discussion communication as good or their parents as sup-
Our study findings indicate that a positive child- portive tend to engage in safer sexual behaviors,
hood protects against adolescent pregnancy in a including having a later sexual debut, having fewer

24 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
The Protective Effect of Family Strengths in Childhood against Adolescent Pregnancy and Its Long-Term Psychosocial Consequences
and Its Long-Term Psychosocial Consequences

sex partners, and increasing condom use. 7,9,30,31 decades since the older women in our cohort were
Similarly, adolescent females who have positive children, the question of whether our findings can
perceptions of their parental relationships appear be generalized to adolescents or young women of
less likely to experience adolescent pregnancy.7,32 today must be raised. However, even a prospective
The fundamental role of family strengths in pro- study addressing long-term sequelae would face this
moting adolescent health was persuasively demon- same limitation. The fact that our results regarding
strated through the National Longitudinal Study on both adolescent pregnancy and long-term sequelae
Adolescent Health,6,33,34 which showed that family for each of the birth cohorts followed the same pat-
assets protected adolescents from young age at tern seen in the general analysis suggests that our … family
sexual debut, emotional distress, suicidal thoughts findings of a protective effect of family strengths strengths
and behaviors, violence, cigarette use, alcohol use, against both adolescent pregnancy and long-term during
and marijuana use.6 outcomes are robust and enduring. childhood
This report extends our previous work, which At a national level, the Healthy People 2010 appear to be
demonstrated that ACE have a cumulative detri- initiative proposed lowering pregnancy rates for factors that
mental effect on both adolescent pregnancy and 15- to 17-year-olds by approximately 35% by 2010,39 protect women
long-term psychosocial problems that are often with programs strategically focused on youth de- against both
attributed to adolescent pregnancy.22,35 Here, we velopment and/or changing sexual practices.3,38 Our the harmful
found that family strengths during childhood appear findings suggest that reductions in teen pregnancy short-term
to be factors that protect women against both the may be facilitated by including programs that build and long-term
harmful short-term (eg, adolescent pregnancy) and family strengths and that such programs appear to effects …
long-term effects (eg, psychosocial consequences) have particular potential for prevention among those
of ACE. Furthermore, our findings suggest that the who have experienced adversity as children. Inter-
behavioral mechanisms through which childhood ventions directed at strengthening the family have a
family strengths act may delay initiation of sexual ac- unique potential to provide continuous, progressive,
tivity. Some of the same qualities believed to account and timely guidance that should improve decision
for the success of youth-development programs in making about sexual and reproductive health mat-
preventing adolescent pregnancy may explain the ters among adolescents, including promotion of
effectiveness of family strengths: Both may build abstinence and prevention of pregnancy among
competence and confidence by promoting support- adolescents. Olds et al40,41 have shown that interven-
ive relationships with parents, peers, and/or men- tions by public-health nurses directed at strengthen-
tors.3,36–38 It is also conceivable that strong familial ing at-risk families by home visits can be effective.
interpersonal connectedness during childhood may Public health, media, and Web-based programs that
reduce the tendency to seek that relational closeness build family strengths in childhood have a strong
by engaging in early sexual activity. potential to prevent adolescent pregnancy. Our
We considered limitations that might have bi- findings suggest that such strengths have favorable
ased our findings. The need to recall exposure to consequences for women’s health that likely persist
childhood family strengths and ACE might have for many years. v
led to either their under- or over-reporting, but we
would not expect mistakes in reporting to differ Disclosure Statement
The author(s) have no conflicts of interest to disclose.
between those who did and who did not experi-
ence an adolescent pregnancy. Thus, any errors in
Acknowledgments
reporting would likely have led to underestima- The original study was funded by the US Department of
tion of the strength of association between family Health & Human Services; the Centers for Disease Control and
childhood strengths and adolescent pregnancy. Prevention Foundation; and the Kaiser Permanente Garfield
A second concern is that our interest in whether Memorial Fund.
childhood family strengths protected against long- Katharine O’Moore-Klopf, ELS, of KOK Edit provided editorial
assistance.
term psychosocial sequelae commonly associated
with adolescent pregnancy required us to enroll a References
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The Permanente Journal/ Fall 2010/ Volume 14 No. 3 25


ORIGINAL RESEARCH & CONTRIBUTIONS
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Strengths Long-Term
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and Its Long-Term Psychosocial Consequences

cent sexual debut. Arch Pediatr Adolesc Med 2000 38. Nitz K. Adolescent pregnancy prevention: a review of
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Aug;18(4):505–24.

Prevention and Cure


“Just say no” prevents teenage pregnancy the way
“Have a nice day” cures depression.
— Anonymous

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 27


soul of the healer

“Slot Canyon Lower Antelope Valley, Page, Arizona”


photograph

Gerald Levy, MD, MBA

Gerald Levy, MD, MBA, is a Rheumatologist at the Downey Medical Center in CA.
Dr Levy has been taking pictures for more than 40 years, beginning with black
and white and processing the film with his father in their makeshift darkroom.
This photograph was taken with a Nikon D700 using a tripod.

28 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS

Effects of 12- and 24-Week Multimodal Interventions on


Physical Activity, Nutritional Behaviors, and Body Mass Index
and Its Psychological Predictors in Severely Obese Adolescents
at Risk for Diabetes
James J Annesi, PhD
Ann M Walsh, MS, RD
Introduction Alice E Smith, MS, MBA, RD
Abstract
In 2000, 7% of adolescents in the
Background: Although 7% of US adolescents have impaired fasting
US had impaired fasting glucose, a
glucose, a precursor of type 2 diabetes, research has suggested that few
precursor of type 2 diabetes.1 An
interventions for obese adolescents at risk for diabetes have been effective.
inappropriately high body weight
Therefore, pediatricians seek effective behavioral treatments for referral
is a major risk factor for the de-
for this age group.
velopment of diabetes in youth.2
Objective: We wanted to determine the effects of two different du-
Although it is also a problem for
rations of nutritional and exercise treatments on changes in nutrition,
younger children, recent data indi-
physical activity, body mass index (BMI), and psychological predictors
cate that more than one-third of US
of BMI change in overweight and obese adolescents at risk for type 2
adolescents between ages 12 and
diabetes.
19 years are overweight (body mass
Methods: We obtained data from 64 pediatrician-referred patients with
index [BMI] in the 85th to 94.9th
diabetes risk factors (mean age, 14.1 years; BMI, ≥ 99th percentile.) Study
percentile) or obese (BMI ≥ 95th per-
participants were assigned to nutrition and exercise treatments for 12 weeks
centile), with the highest prevalence
(n = 35) or 24 weeks (n = 29). A specific weight-loss goal was given only
of obesity being in African-American
for the 24-week group.
teenagers at 24%.3 It is suspected
Results: Both treatments demonstrated significant within-group changes
that an inadequate, high-calorie diet
over 12 weeks in days per week of physical activity of at least 60 minutes,
and a physically inactive lifestyle
physical self-concept, general self, and overall mood. However, they failed
are largely to blame.4 Objective
to demonstrate significant 12-week increases in fruit and vegetable intake,
analyses of physical activity of 12- to
decreases in sweetened-beverage consumption, or decreases in BMI.
15-year-olds suggest that only 8%
Between-group differences were found only in mood changes in favor of
obtain the minimum exercise level
the 12-week treatment. In the 24-week treatment, BMI change from week
of 60 minutes on each of 5 days per
12 to week 24 was significantly better than corresponding normative data
week (a total of 300 minutes/week).5
(d = 0.37). Physical self-concept, general self, and mood scores at week
Analyses of adolescents’ eating pat-
12 explained a significant portion of the variance in BMI change (R2 =
terns suggest that consumption of an
0.13, p = 0.04).
overabundance of sweetened bever-
Conclusion: Nutrition education alone may be insufficient for nutrition
ages6 and low consumption of fruits
behavior change. Behavioral treatment lasting longer than 12 weeks and
and vegetables7 predicts overweight
having a specific weight-loss goal may be useful for BMI improvements,
and obesity. Because it is a time
and attention to participants’ self-concept and mood may be important
of increasing independence from
treatment considerations.
parents, adolescence presents an im-

James J Annesi, PhD, is the Director of Wellness Advancement, YMCA of Metropolitan


Atlanta, GA. E-mail: [email protected].
Ann M Walsh, MS, RD, was a Program Coordinator in the Child Health Promotion
Department, Children’s Healthcare of Atlanta, in GA, at the time of this research.
Alice E Smith, MS, MBA, RD, was a Program Director in the Child Health Promotion
Department, Children’s Healthcare of Atlanta, in GA, at the time of this research.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 29


ORIGINAL RESEARCH & CONTRIBUTIONS
Effectsof12-and24-WeekMultimodalInterventionsonPhysicalActivity,Nutritional
Effects ofBehaviors,
12- andand BodyMass
24-Week IndexandItsPsychological
Multimodal Predictors
Interventions inSeverely
on Physical ObeseNutritional
Activity, AdolescentsatRiskforDiabetes
Behaviors, and
Body Mass Index and Its Psychological Predictors in Severely Obese Adolescents at Risk for Diabetes

portant opportunity for establishing some studies suggest that parental treatment length (in weeks) and
physical activity and eating patterns involvement is essential,17 others reduction in BMI gain,9 effective
that will minimize health risks such indicate no additional effect on interventions ranged widely from 5
as obesity throughout the life span.8 BMI.9 The intervention component to 84 weeks.26–28 Effects were also
Because pediatricians are rarely of promoting increased physical ac- significantly greater for girls than for
able to dedicate sufficient time to tivity has also appeared in divergent boys in this research.9 A meta-analy-
each patient, they seek to refer forms. Information approaches in- sis of school-based interventions for
adolescent patients with obesity and tended to be palatable specifically to youth suggested that treatments last-
risks for diabetes to external treat- adolescents have been attempted,18 ing longer than one year increased
ment providers.4 Overall, however, whereas more invasive, behavior- positive effects on obesity when
results of such treatments have been ally based methods that focus on contrasted with treatments of shorter
disappointing. Recent research sug- building feelings of competence durations.29 The Coach Approach
gests that only about 1 in 5 youth and improved feeling states through treatment demonstrated additional
… a true interventions studied since the measurable progress have also been effects on physical activity at weeks
picture of what mid-1980s were successful at sig- administered. 19 The Coach Ap- 12 through 24 in individuals 18 years
is specifically nificantly reducing gain in BMI, with proach protocol, for example, is an and older30; however, an interven-
required effect sizes being smallest in those extensively tested exercise support tion for 5- to 12-year-olds that was
to reliably who were beginning adolescence.9 protocol. It was originally intended based on the same behavior-change
induce weight Although increased physical activity for adults and seeks to increase principles demonstrated significant
management and an improved diet are consistent physical activity through building BMI improvements at only 12 weeks,
in this age strategies of overweight and obese self-regulatory skills to counter with no difference in effects by sex.31
group remains adolescents successful at weight lapses, even in the face of barriers Thus, we decided that a pre-
unclear. loss10 and are included in virtually such as physical discomfort, self- liminary study was warranted to
all interventions, a true picture of consciousness, and slow progress.20 investigate several of the treatment
what is specifically required to reli- Process goals such as increase in variables that are presently unclear
ably induce weight management minutes spent doing physical activity regarding their effects on adolescents
in this age group remains unclear. each week are initially emphasized, of an inappropriately high weight
For example, treatment approaches with outcome goals such as a spe- and at risk for diabetes. The study
range from an emphasis on social cific reduction in weight soon added. would incorporate into the protocol
support and acceptance of one’s Research suggests that the induction for each of the two tested groups a
body, with nominal accountability of self-competence, self-esteem, and 12-week educationally based nu-
for actual behavioral changes and improved mood through usage of trition treatment component with
results,11,12 to a high focus on measur- behavioral skills needed to maintain parental involvement, emphasiz-
able short- and long-term goals, use an exercise program also positively ing increased fruit and vegetable
of behavioral strategies (eg, positive affects weight loss through carry- intake and reduced consumption
self-talk, cognitive restructuring, over effects on eating behaviors.21,22 of sweetened beverages (TIPPs).16
stimulus control), and regular track- Physical activity has also been Additionally, the Coach Approach
ing of goal progress.13 shown to improve low mood,23 protocol would serve as the physi-
Regarding the nutritional com- which is associated with obesity in cal activity support component and
ponent of interventions, some adolescents.24 be abbreviated to 12 weeks in one
research points to the benefits of The length of treatment required group and would be incorporated
an educational approach,14 whereas for meaningful improvements in for its full 24 weeks in the other.
other studies suggest that a strong weight is also unclear. Such data Only the group with 24 weeks of
behavior-modification focus is criti- are needed for the development treatment would have a specific
cal.15 Treatments may also be edu- of comprehensive interventions amount of weight loss designated as
cational but have a high focus on that will also address maintenance a goal. This is consistent with Coach
specific nutrition behaviors such as of weight loss (which may require Approach processes that emphasize
consumption of fruits, vegetables, processes distinctly different from such outcome goals in weeks 12
and sweetened beverages (eg, Type losing weight).13,25 Although a meta- through 24. A YMCA setting would
2 Diabetes Intervention and Preven- analysis demonstrated a surprising be used for treatment administra-
tion Programs [TIPPs]).16 Although overall inverse relationship between tion to increase generalizability of

30 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
Effectsofof12-12-
Effects andand
24-WeekMultimodal
24-Week Interventions
Multimodal onPhysicalActivity,
Interventions Nutritional
on Physical Behaviors,
Activity, andBodyMass
Nutritional Indexandand
Behaviors, ItsPsychological
PredictorsinSeverelyObeseAdolescentsatRiskforDiabetes
Body Mass Index and Its Psychological Predictors in Severely Obese Adolescents at Risk for Diabetes

findings, which we deemed to be Group assignment was based Survey34 was used to measure the
an important consideration.32 We on date of referral. Approximately number of days “over a typical or
would assess changes in a 12-week 80% of referred patients and their usual week” that the respondent
period in physical activity, fruit and parents or guardians accepted the was “active for a total of at least
vegetable intake, consumption of offer to participate at no cost to 60 minutes per day” (excluding
sweetened beverages, physical self- them. Group 1 (n = 35) and group physical education classes). A
concept, general self, overall mood, 2 (n = 29) did not significantly differ minimum of 60 minutes is the
and BMI, as well as longer-term on sex (overall composition, 69% recommended daily duration of
effects on physical activity and BMI female), age (overall mean, 14.1 moderate-to-vigorous physical
for the 24-week group. Additionally, years; standard deviation [SD], 1.8), activity for children and adoles-
we would evaluate physical self- BMI (overall mean, 37.5 kg/m2; SD, cents.35 Instructions were to in-
concept, general self, and mood 7.0, which corresponded to above clude any kind of physical activ-
for their ability to predict short-term the 99th age- and sex-adjusted ity that increased heart rate and
change in BMI. We hoped that the percentile for BMI), or ethnic or caused hard breathing “at least
results of this preliminary investiga- racial group make-up (overall some of the time.” The directions
tion would help to inform future, composition: 8% white, 90% African required physical activity during
more comprehensive, research American, and 2% of other ethnic physical education to be excluded
where findings might ultimately be or racial groups). Written informed because as with recent research,36
applied to treatment design, dura- consent was obtained from parents physical activity carried out of
tion, and administration methods, or guardians, and written assent one’s own volition (rather than
and that our results would also was obtained from participants. because it was mandated) was of
contribute to theory related to psy- Appropriate approval was received primary interest.
chological factors’ effects on weight from the institutional review board Physical Self—The Physical Self-
management. of Children’s Healthcare of Atlanta. Concept Scale, a subscale of the
Tennessee Self-Concept Scale: 2
Methods Measures Child Form,37 measures feelings
Participants All surveys were intended by of adequacy regarding the physi-
Pediatricians referred patients their developers for the study’s cal self. Responses for the 12-item
fulfilling the inclusion criteria to age group and/or previously used scale (eg, “My body is healthy”)
health-promotion administrators in related research with that same range from 1 (always false) to 5
from Children’s Healthcare of At- age group. (always true). Internal consistency
lanta, who then contacted parents Nutrition—Two items from the for adolescents averaged 0.70, and
or guardians to determine interest Food Frequency Questionnaire test-retest reliability during a one-
in participation. Inclusion criteria for Youth33 were used to recall the week period was 0.71.37 Validity
were 1) age of 12 to 17 years, combined number of fruits and was supported through significant
2) age- and sex-adjusted BMI ≥ vegetables typically consumed per correlations between Physical Self-
85th percentile, 3) an additional day at the time of survey adminis- Concept Scale scores and scores
risk factor for diabetes (a list of tration. One item was used to recall on the Piers-Harris Children’s Self-
possible risk factors that included the number of sweetened bever- Concept Scale and other generally
race/ethnicity, family history, and ages consumed per day. Examples accepted inventories of physical
conditions associated with insulin of possible fruits, vegetables, and characteristics and activities.37
resistance [eg, acanthosis nigricans, sweetened beverages were given Overall Self—The General Self
hypertension, and dyslipidemia] in corresponding items. Items were Scale is a subscale of the Self-
was provided to the physicians), similar to those in the Behavioral Description Questionnaire.38 It mea-
and 4) willingness of parents or Risk Factor Surveillance System.34 sures an adolescent’s perceptions
guardians to attend scheduled class- Responses ranged from “3 or more of his or her overall self. The eight-
es concerning their child’s nutrition times a day” to “never.” Test-retest item scale (eg, “Overall I have a lot
and physical-activity needs. A writ- reliabilities over 48 hours ranged to be proud of”) requires responses
ten statement of sufficient health to from 0.67 to 0.77.33 that range from 1 (false) to 5 (true).
participate was also required from Physical Activity—An item adapt- Internal consistency of the scale was
the referring physician. ed from the Youth Risk Behavior 0.81.38 Although usual test-retest

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 31


ORIGINAL RESEARCH & CONTRIBUTIONS
Effectsof12-and24-WeekMultimodalInterventionsonPhysicalActivity,Nutritional
Effects ofBehaviors,
12- andand BodyMass
24-Week IndexandItsPsychological
Multimodal Predictors
Interventions inSeverely
on Physical ObeseNutritional
Activity, AdolescentsatRiskforDiabetes
Behaviors, and
Body Mass Index and Its Psychological Predictors in Severely Obese Adolescents at Risk for Diabetes

methods were considered inappro- ticipant was derived by subtracting adults with and without obesity.30
priate because of expected changes the score at baseline from the score Duration of the Coach Approach
in the measured construct over at week 12. treatment was reduced to 12 weeks
time, findings suggested systematic (four meetings) for group 1. It was
change during a six-month period.38 Procedure for the usual 24 weeks (six meet-
Validity was supported through For both groups, participants ings) for group 2. Within the meet-
significant correlations between and at least one parent or guardian ings, a focus was kept on specific
General Self Scale scores and scores reported to the YMCA that served as goals. Although short-term goals
on the Perceived Competence Scale the experimental facility for a brief were kept process-orientated (eg,
and other well-accepted inventories orientation with a study administra- increase cumulative cardiovascular
of the overall self.38 tor. Components of either the 12- exercise from 150 to 250 minutes
Mood—Total Mood Disturbance week (group 1) or 24-week (group per week within one month) for
is an aggregate measure of mood 2) treatment process were described the initial 12 weeks, outcome-
derived from the six subscales of to them on the basis of their date orientated goals (eg, lose 5 lb [2.3
the Profile of Mood States—Short of referral. For both groups, the kg] per month) were added in
Form.39 Respondents rate feelings 12-week TIPPs protocol16 was the the final 12 weeks for group 2. At
that occurred “over the past week” basis of the nutritional portion least 5% weight loss by treatment
on 30 items ranging from 0 (not at of the treatment. It included six termination (week 24) was incor-
all) to 4 (extremely). Internal consis- 30-minute group classes for parents porated as a long-term outcome
tency for the Tension, Depression, and six 45-minute group classes goal for all participants in group 2.
Fatigue, Confusion, Anger, and for participants and their parents Physical activity data were entered
Vigor subscales ranged from 0.84 or guardians (on alternate weeks) electronically so that goal progress
to 0.95, and test-retest reliability that were lead by specially trained could be highlighted.
at three weeks averaged 0.69. 39 registered dietitians. Structured A behavioral contract to complete
Concurrent validity was suggested education and interaction on topics an agreed-on volume of regular
through contrasts with generally ac- such as “Building a Healthy Plate,” exercise, along with training in an
cepted measures such as the Beck “Beverages for Teens,” “Healthy array of self-management and self-
Depression Inventory, Manifest Snack Sharing,” “Parents as Role regulatory skills such as cognitive
Anxiety Scale, and Minnesota Multi- Models,” “Meal Planning/Grocery restructuring, stimulus control, and
phasic Personality Inventory.39 Shopping,” and “Recipe Sharing” relapse prevention, was included
Body Composition—A digital was provided and supported by within meetings. Physical activ-
scale and stadiometer were used interactive workbooks. The dieti- ity modalities and volumes were
to calculate BMI, an estimate of tians were also available for brief selected in cooperation with an
health risks associated with body individual consultations if requested exercise specialist and revised on
fat, which is derived from a ratio by participants or their parents or the basis of individual progress.
of weight to height (kg/m2). Cor- guardians. Throughout the treat- Participants were free to use all
relations with the most precise ment, appropriate eating, with a YMCA exercise facilities anytime
measure of body fat, dual energy specific focus on reducing con- or, alternatively, exercise outside of
x-ray absorptiometry, have been sumption of sweetened beverages the facility. Typical exercise regi-
reported as ranging from 0.80 to and increasing fruit and vegetable mens included use of treadmills,
0.90 in other studies.40 Recent re- consumption, was emphasized. stationary bicycles, and resistance
search suggests that for children, The Coach Approach protocol20 bands; however, physical activities
direct measurement of BMI change was the basis of the physical ac- such as group exercise classes,
is advantageous, rather than ad- tivity support portion of the treat- walking on a track, or swimming
justment of BMI by percentile or ment. It was administered by a could also be selected.
z-score.41 However, we also used trained YMCA wellness specialist Treatment fidelity was moni-
age- and sex-adjusted BMI percen- via a series of monthly one-on-one tored by a study administrator.
tile data, which were based on data meetings, guided by a computer Physiological tests and surveys
from the National Center for Health program. The Coach Approach were administered at baseline and
Statistics,42 for descriptive purposes. has previously been associated at week 12 in a private area, and
A BMI change score for each par- with increased physical activity in participants’ identifying data were

32 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
Effectsofof12-12-
Effects andand
24-WeekMultimodal
24-Week Interventions
Multimodal onPhysicalActivity,
Interventions Nutritional
on Physical Behaviors,
Activity, andBodyMass
Nutritional Indexandand
Behaviors, ItsPsychological
PredictorsinSeverelyObeseAdolescentsatRiskforDiabetes
Body Mass Index and Its Psychological Predictors in Severely Obese Adolescents at Risk for Diabetes

removed. Only BMI and physical Physical Self-Concept Scale, Total ages consumed (F [1, 62] = 3.54;
activity level were also recorded at Mood Disturbance, and General p = 0.07). There were significant
week 24 (for group 2). Self Scale at week 12 as predictors improvements in physical activity
of change in BMI, was calculated. level (F [1, 62] = 68.27; p < 0.001;
Data Analyses η2 = 0.524), and Physical Self-
Statistical significance was set at Results Concept Scale (F [1, 62] = 9.73; p =
α = 0.05 (two-tailed). Consistent with Changes in Behavioral and 0.003; η2 = 0.135) and General Self
recent related research,43 imputation Psychological Variables Scale (F [1, 62] = 25.19; p < 0.001; η2
due to missing data (for the 8% of There were no significant be- = 0.289) with no significant between-
missing cases overall) was by the tween-group differences in physical group differences. Improvements
last-observation-carried-forward activity level, consumption of fruits in Total Mood Disturbance scores
method. Missing BMI scores were and vegetables, number of sweet- were significant (F [1, 62] = 36.68;
additionally adjusted for expected ened beverages consumed, and p < 0.001; η2 = 0.355), with group 1
increases associated with matura- Physical Self-Concept Scale, Total demonstrating significantly greater
tion.42 Analyses of skewness and Mood Disturbance, General Self improvements (F [1, 62] = 4.62; p
kurtosis suggested that the data were Scale and BMI scores at baseline. = 0.04; η2 = 0.045; see Table 1 for
distributed approximately normally, There were no significant improve- descriptive statistics). A planned
and thus use of parametric statistical ments during the 12 weeks in con- within-group contrast indicated that
testing was appropriate. Because of sumption of fruits and vegetables physical activity level at week 24
the exploratory nature of this small- scores (F [1, 62] = 0.36; p = 0.55) was not significantly different from
sample field investigation, and recent or number of sweetened bever- that at week 12 (for group 2).
suggestions,44 there were no statisti-
cal adjustments for multiple tests.
A series of mixed-model repeat- Table 1. Descriptive statistics for behavioral and psychological
ed-measures analyses of variance variables, plus body mass index (BMI)
(ANOVAs) were first conducted to Parameter Baseline Week 12 Week 24
determine whether changes during Mean SD Mean SD Mean SD
the 12-week period in physical Physical activity levela
Group 1 1.74 1.60 3.31 1.49
activity level, consumption of fruits
Group 2 1.97 1.09 3.55 1.21 3.67 1.19
and vegetables, number of sweet-
Combined number of fruits
ened beverages consumed, and and vegetables
scores on the Physical Self-Concept Group 1 2.71 0.86 2.77 0.94
Scale, Total Mood Disturbance, and Group 2 3.03 0.94 2.83 1.10
General Self Scale were significant, Number of sweetened
and, if so, whether those changes beverages consumed per day
significantly differed by group. Group 1 2.03 1.25 1.97 1.15
Next, consistent with previous Group 2 2.52 1.38 1.93 1.10
research,31 changes in BMI were Physical Self-Concept Scale
contrasted with expected changes Group 1 38.71 6.29 41.14 6.73
that were based on the age-, sex-, Group 2 39.52 4.39 41.45 5.52
and (baseline) BMI-adjusted values Total Mood Disturbance
from normative growth charts.42 Group 1 11.51 14.19 –1.89 11.59
Group differences in effects were Group 2 7.44 8.74 1.07 11.70
also assessed. Finally, to investigate General Self Scale
the ability of the psychological Group 1 30.57 4.83 33.06 5.06
factors focused on within the treat- Group 2 32.14 4.68 35.00 3.51
ments to account for short-term BMI
Group 1 36.51 7.63 36.63 7.60
changes in BMI, data from both
Group 2 38.80 6.14 38.88 6.07 38.35 5.44
groups were aggregated and a
a
Active for a total of at least 60 minutes per day.
multiple-regression model, with Group 1, n = 35; group 2, n = 29.
simultaneous entry of scores of SD = standard deviation.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 33


ORIGINAL RESEARCH & CONTRIBUTIONS
Effectsof12-and24-WeekMultimodalInterventionsonPhysicalActivity,Nutritional
Effects ofBehaviors,
12- andand BodyMass
24-Week IndexandItsPsychological
Multimodal Predictors
Interventions inSeverely
on Physical ObeseNutritional
Activity, AdolescentsatRiskforDiabetes
Behaviors, and
Body Mass Index and Its Psychological Predictors in Severely Obese Adolescents at Risk for Diabetes

adding group membership into the


.50 - equation (Table 2, model 2).
.40 -
.30 - Post Hoc Analyses
.20 - Effects of Sex—To test whether sex
.10 - affected the various relationships,
we conducted additional analyses.
-.10 - Linear bivariate correlations indi-
Change
-.20 - in BMI cated that participants’ sex was not
-.30 -
Group 1 significantly associated with physical
Group 2
Expected activity level, consumption of fruits
-.40 -
and vegetables, number of sweet-
-.50 -
Baseline Week 12 Week 24 ened beverages consumed, Physi-
cal Self-Concept Scale, Total Mood
Figure 1. Contrast of expected changes in body mass index (BMI) with ob- Disturbance, General Self Scale, or
served changes in group 1 and group 2.
BMI scores at week 12 (r values,
–0.10 to 0.14) or with changes from
Changes in Body Mass Index also more favorable from week 12 baseline to week 12 (r values = –0.22
When contrasted with normative to week 24 (mean, –0.35; SD, 0.96) to 0.23). Additionally, accounting for
changes in BMI during the 12-week when contrasted with normative the longer time frame for group 2,
period (mean, 0.23), changes in changes (mean, 0.23) (t [28] = 3.25; physical activity level and BMI were
both group 1 (mean, 0.12; SD, 1.39) p = 0.003; d = 0.37; 95% CI = –0.95 similarly not significantly related
and group 2 (mean, 0.08; SD, 0.81) to –0.21) (Figure 1). to participants’ sex at week 24
were not significantly different (t (r = –0.20 and 0.20, respectively) or
[34] = 0.46; p = 0.64; d = 0.05; 95% Prediction of Body Mass change during the 24-week period
confidence interval [CI] = –0.59 to Index Change (r = –0.17 and –0.09, respectively).
0.37 and t [28] = 1.00; p = 0.33; A significant 13% of the variance Frequency of Recommended Vol-
d = 0.19; 95% CI = –0.46 to 0.16, in BMI change was accounted for by umes of Physical Activity—In con-
respectively). In an analysis of simultaneous entry of Physical Self- trast to the expected 8% frequency
group 2 only, BMI changes during Concept Scale, Total Mood Distur- of the recommended 5 days per
the 24-week period (mean, –0.27; bance, and General Self Scale scores week of ≥ 60 minutes of moderate-
SD, 1.20) were significantly more at week 12 into a multiple-regression to-vigorous physical activity for
favorable than normative changes equation (Table 2, model 1). There population-based data for the partici-
(mean, 0.46) during the same period was no difference in the variance pants’ age range,5 participants’ corre-
(t [28] = 3.28; p = 0.003; d = .38; in BMI change explained, adjusted sponding data at the aforementioned
95% CI = –1.19 to –0.27) and were for number of predictors (R2adj), by criteria were 2% at baseline, 16% at
week 12, and 17% at week 24.

Table 2. Results of simultaneous multiple-regression analyses for the Discussion


prediction of changes in body mass index (BMI) in all participants (n = 64) In our samples of severely obese
β R R2 R2adj F df p adolescents, referred to interven-
Model 1 0.36 0.13 0.09 3.04 3, 60 0.04 tions because of their risk for dia-
Physical Self-Concept Scale –0.25 0.11
betes, we found useful preliminary
Total Mood Disturbance 0.28 0.04
findings. Both of the treatments
General Self Scale 0.36 0.03
consisting of nutrition education
Model 2 0.39 0.15 0.09 2.61 4, 59 0.05
and support of increased exercise
Physical Self-Concept Scale –0.27 0.09
through cognitive-behavioral means
Total Mood Disturbance 0.32 0.03
were associated with equivalent,
General Self Scale 0.41 0.01
significant increases in reported
Group –0.14 0.27
days per week of 60 minutes of
Scores of psychological variables are at week 12.
Adjusted R2 (R2adj) = 1 – (1 – R2) (N – 1)/(N – k –1), where k denotes number of predictors in the regression model. voluntary exercise and significant

34 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
Effectsofof12-12-
Effects andand
24-WeekMultimodal
24-Week Interventions
Multimodal onPhysicalActivity,
Interventions Nutritional
on Physical Behaviors,
Activity, andBodyMass
Nutritional Indexandand
Behaviors, ItsPsychological
PredictorsinSeverelyObeseAdolescentsatRiskforDiabetes
Body Mass Index and Its Psychological Predictors in Severely Obese Adolescents at Risk for Diabetes

improvements in perceptions of the nutritional approaches with a more focused research and interven-
physical and overall self and overall cognitive-behavioral focus, where tion trials, pediatricians may have
mood. BMI did not significantly de- specific parameters are provided increased confidence in referring
crease within 12 weeks; however, in and self-regulatory skills are a cen- their obese adolescent patients with
the 24-week treatment that included tral part of the intervention. The additional diabetes risk factors to
a specific goal of 5% weight loss, role of parents and guardians also efficient and reliable external treat-
significant BMI decreases emerged remains unclear and warrants addi- ments. Until then, it appears that
during weeks 12 through 24. It is tional research attention. Although nutrition and exercise treatments
unclear whether the extended treat- treatment components effectively lasting longer than three months,
ment or the mandated outcome goal addressing both nutrition and physi- with a behavior-change focus that is
(or both) was associated with this cal activity appear necessary to in- sensitive to participants’ self-concept
significant effect. It seemed clear, crease the minimal improvement in and mood, are prudent for referral.
however, that three months of treat- BMI observed here, further research We suggest that professionals with … nutrition
ment was not sufficient for signifi- into the effects of exercise-induced a medical focus, behavior change and exercise
cant BMI change to occur overall. psychological changes’ association focus, and program implementation treatments
The Physical Self-Concept Scale, with reductions in caloric intake has focus coordinate their efforts to lasting longer
General Self Scale, and Total Mood recently been suggested45 and will reliably improve health behaviors than three
Disturbance scores at week 12 sig- be important in future studies with in youths with modifiable health months, with
nificantly predicted change in BMI. youth at risk for diabetes. risk factors. v a behavior-
Although this suggests that these Because of the field nature of change focus
psychological factors should be an this research and because of lo- Disclosure Statement
that is sensitive
important focus of interventions, gistic limitations, provisions were The author(s) have no conflicts of to participants’
it was not clear what, specifically, not made for follow-up data for interest to disclose. self-concept
in the treatments induced these group 1 or for data collection and mood, are
changes. They were, however, con- beyond 12 weeks in nutrition and
Acknowledgment prudent for
The research reported here was sup- referral.
sistent with findings of the Coach psychological variables for group 2. ported by grants from Kaiser Permanente
Approach treatment with adults.20 Future research should extend data of Georgia and the Aetna Foundation to
Because there is a dearth of related collection to establish longer-term Children’s Healthcare of Atlanta.
research with samples like ours, treatment effects. Also, this study’s Katharine O’Moore-Klopf, ELS, of KOK
Edit provided editorial assistance.
considerable study is still needed of participants were primarily African
the association of treatment-induced American and had quite severe
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The Permanente Journal/ Fall 2010/ Volume 14 No. 3 35


ORIGINAL RESEARCH & CONTRIBUTIONS
Effectsof12-and24-WeekMultimodalInterventionsonPhysicalActivity,Nutritional
Effects ofBehaviors,
12- andand BodyMass
24-Week IndexandItsPsychological
Multimodal Predictors
Interventions inSeverely
on Physical ObeseNutritional
Activity, AdolescentsatRiskforDiabetes
Behaviors, and
Body Mass Index and Its Psychological Predictors in Severely Obese Adolescents at Risk for Diabetes

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36 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
Effectsofof12-12-
Effects andand
24-WeekMultimodal
24-Week Interventions
Multimodal onPhysicalActivity,
Interventions Nutritional
on Physical Behaviors,
Activity, andBodyMass
Nutritional Indexandand
Behaviors, ItsPsychological
PredictorsinSeverelyObeseAdolescentsatRiskforDiabetes
Body Mass Index and Its Psychological Predictors in Severely Obese Adolescents at Risk for Diabetes

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A Life Sentence
“Tell me about the benefits of obesity.” I asked them.
“What are the advantages of being fat?”
He had been quiet up to now, sitting in the back row
of the bariatric surgery group, arms folded across his belly.
“It don’t last as long,” he said.
Confused, I asked, “What doesn’t last as long?”
“Your life.” he answered.
—Vincent J Felitti, MD, FACP, retired Internist from the Department of
Preventive Medicine at the Clairemont Mesa Medical Office in San Diego, CA.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 37


ORIGINAL RESEARCH & CONTRIBUTIONS

2009 James A Vohs Award for Quality

Proactive Office Encounter: A Systematic Approach


to Preventive and Chronic Care at Every Patient Encounter
Michael Kanter, MD
Osvaldo Martinez, MPH
Gail Lindsay, RN in the Summer 2006 issue of The Permanente Journal),
Kristen Andrews Abstract but they could well have been written today to describe
Cristine Denver, SM In 2007, Kaiser Permanente’s (KP) Southern Califor- the growing demands on primary care, particularly for
nia Region designed and implemented a systematic preventive care and management of chronic disease.
in-reach program, the Proactive Office Encounter The medical literature reports that for a primary care
(POE), to address the growing needs of its three mil- physician to ensure that all patients on a hypothetical
lion patients for preventive care and management of panel of 2000 receive the preventive screenings and
chronic disease. The program sought staff from both treatment of chronic diseases that they need, the pri-
primary and specialty care departments to proactively mary care physician would need to devote an estimated
identify gaps in care and to assist physicians in clos- 18 hours per day.2,3 That being the case, it is hardly
ing those gaps. The POE engaged the entire health surprising that only 54.9% of adult patients receive the
team in a proactive patient-care experience, creating preventive care recommended by medical evidence.4
standard work flows and using information technol- Southern California Permanente Medical Group
ogy to identify gaps in patient care. The goals were to (SCPMG) now serves more than three million KP pa-
improve consistency of preventive care and improve tients, generating 12 million visits to outpatient offices
quality of care for chronic conditions and to improve with 60% of these visits occurring outside of primary
reliability of staff support for physicians. The POE has care. The concept of the Proactive Office Encounter
been implemented in all outpatient settings in KP’s (POE) began as a question: How can we turn each of
Southern California Region’s 13 medical centers and these encounters, in either primary or specialty care, into
148 medical office buildings. The program has con- preventive screenings and care for chronic conditions?
tributed to significant improvements in key clinical This is a simple idea to describe, but implementing it
quality metrics, including cancer screenings, blood meant a cultural shift. The POE, a regionwide in-reach
pressure control, and tobacco cessation. It is now being program, gave ancillary staff and specialty departments
extended into the inpatient setting and is being shared more responsibility for preventive screenings and man-
with other KP Regions. agement of chronic care. To succeed, the team had
to convince administrators, physicians, and staff of its
Introduction potential value. Other key elements included:
“The necessity of living with a limited supply of • Electronic tools to identify gaps in any patient’s care,
physicians in the face of increasing demand forces us regardless of which department they visited
to focus on the need for a medical care delivery system • New work flows and training modules to proactively
that utilizes scarce and costly medical manpower prop- identify gaps in care to draw them to a physician’s
erly.”1 Sidney Garfield, MD, the co-founder of Kaiser attention
Permanente (KP), wrote those words in 1970 for an • Reports to monitor improvement in closing gaps and
article that appeared in Scientific American (reprinted to identify areas needing more support.

Michael Kanter, MD, is the Medical Director of Quality and Clinical Analysis for the Southern
California Permanente Medical Group. E-mail: [email protected].
Osvaldo Martinez, MPH, is an Assistant Medical Group Administrator for the South Bay Medical
Center with the Southern California Permanente Medical Group. E-mail: [email protected].
Gail Lindsay, RN, is the Managing Director of Clinical Program Development for the Southern
California Permanente Medical Group. E-mail: [email protected].
Kristen Andrews is the Proactive Care Group Lead for the Southern California Permanente
Medical Group. E-mail: [email protected].
Cristine Denver, SM, is a Senior Communication Specialist for the Southern California
Permanente Medical Group. E-mail: [email protected].

38 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
Proactive Office Encounter: A Systematic Approach to Preventive and Chronic Care at Every Patient Encounter

Team members are noted in Table 1. Staff now play Additionally, the POE team created shortcuts known
a more active role in patient care and the culture has as SmartTools within KP HealthConnect to improve
changed so that specialty departments are also respon- efficiency in the medical office. By scrolling through a
sible for identifying and addressing preventive screenings list of common preventive care needs, a nurse or medi-
and chronic care needs. Since its inception, POE has cal assistant can set up pending orders for screening
contributed to sharp improvement in the Southern Cali- examinations or supplies, immunizations, or labora-
fornia Region’s clinical quality performance, including tory tests and can select and print appropriate patient
double-digit improvements in colorectal cancer screen- information on topics ranging from body mass index
ing, advice to quit smoking, and blood pressure control. to tobacco cessation. Using “SmartPhrases,” staff can
document preventive or chronic care actions taken.

Early Technical Challenges


Initially, patient information in POINT and KP
HealthConnect was not integrated, creating confusion
and mistrust early in the implementation of the POE
tool, because alerts were sometimes inaccurate or
redundant. The project team worked with Pharmacy
Analytics Services and the KP HealthConnect team to
integrate the POINT database and the EMR.
The team added functionality to document or to set
up pending orders, streamlining these processes to
make the POE tool more efficient and user-friendly.

Table 1. Proactive Office Encounter team members


Proactive Office Encounter
team members Job title
Kristen Andrews Proactive care group lead
Christopher Baek, MBA, PharmD Project manager
Figure 1. Computer-screen view of a Proactive Office
Encounter checklist for adult primary care. Robert Blair, MPH Medical Group administrator
Terry Bream, RN Manager, ambulatory clinical practice
Electronic Tools: Step 1 in Mark Eastman, MD Proactive care physician lead
the Proactive Office Encounter Sylvia Everroad Regional Medical Group administrator
Early attempts made to systematically identify and Amanda Hauser DeHaven, MPH Project Manager, SCPMG regional
operations
address preventive care needs were less comprehensive
Joyce Johnson, RN-BC, PhD Regional Director, education and research
than the POE; for example, a few years ago, identifying
Chris Jones, RN Senior management consultant
needs required a manual search through a patient’s Gail Lindsay, RN Managing Director, clinical program
chart and use of a paper checklist (the Care Manage- development
ment Summary Sheet) to identify preventive screen- Michael Kanter, MD Regional Medical Director of quality and
ings and gaps in chronic care. The Pharmacy Analytic clinical analysis
Services group converted the paper to an electronic Osvaldo Martinez, MPH Assistant Medical Group administrator
checklist on its Permanente Online Interactive Network Paul Minardi, MD Regional Medical Director of operations
Tools (POINT) database, though it was not used con- Diana Moulder Business analyst, pharmacy analytical
services
sistently in all medical offices until integrated into KP
Monica Padilla Staff specialist, SCPMG regional operations
HealthConnect, the electronic medical record (EMR).
Christine Ruygrok, RN Managing Director, business optimization
The electronic POE tools provide physicians and staff
SCPMG Medical Directors
with adult primary care, specialty care, and pediatric
SCPMG Medical Group administrators
care checklists (Figure 1), which identify gaps to be
SCPMG POE area leads
addressed and recommended actions. For example, a
SCPMG work flow consultants
patient due for a bone-density test or mammogram had
Kurt VanRiper, PharmD Director, Pharmacy Analytical Services
a pending order set up and an appointment made for Ralph Vogel, PhD Practice Leader
the required examination. POE = Proactive Office Encounter; SCPMG = Southern California Permanente Medical Group.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 39


ORIGINAL RESEARCH & CONTRIBUTIONS
Proactive Office Encounter: A Systematic Approach to Preventive and Chronic Care at Every Patient Encounter

Table 2. Standard work flows for all office visits


Setting or task Actions to take
category
Daily • If not acquainted, introduce yourself to the physician and ask if there are any special work flow requests.
preparations • Huddle with physician during early part of the shift to plan the day.
• Anticipate the needs of the physician for every office visit.
• Stock examination rooms daily. Confirm that examination-room equipment is working properly.
• Room patients in a timely manner so that physicians can start on time.
• Obtain and review the physician preference list for additional physician-preferred work flows.
Rooming • Enter chief complaint(s), with comments.
a patient • Enter vital information: blood pressure, pulse, respiratory rate, temperature, weight and height,
exercise vitals, last known menstrual period for females ages 11–65 years.
• Verify/edit tobacco history and provide local information for tobacco cessation.
• Recheck elevated blood pressures and enter the second reading as “New Set of Vitals.”
• Complete Interpretation Services Questionnaire as needed.
• Review allergies and enter any newly reported allergies or adverse reactions in the “Allergy” tab.
• New patients: Enter past medical and surgical history, social history, and family history in KP
HealthConnect.
• Select the preferred pharmacy, including outside pharmacy if relevant.
• Review medications with patient and place a red check mark next to active medications—
do not click “Reviewed.”
• Set up pending refill requests using the reorder edit tool.
• If an active medication is not in KP HealthConnect, gather the exact name, dose, and directions
and set up a pending order in the “Orders” area.
• Click the “Proactive Care” tab and advise the patient of any care gaps and the process for
resolving the gaps.
• Use the POE SmartSet to set up pending orders for POE Care Gaps, exclusion codes, and patient
instructions.
• Address any Best Practice Alerts that pop up.
… specialty • Set up pending orders for Point-of-Care Tests, immunizations, and nursing procedures.
departments • Perform any specialty-specific work flows.
are also • Document POE tasks in the “Nursing Notes” section using the .proactive or .pedsproactive Smart Phrase.
responsible Patient forms • Do not give blank patient forms to physicians for completion.
for identifying • Have patients complete their portion of forms, including medical/surgical/social history, medications,
and addressing allergies, and the context or reason for the form.
preventive • Complete the physician’s name, office address, phone number, Drug Enforcement Administration
and medical license numbers, and vitals or other patient information, if relevant.
screenings and
• Forward patient forms to the insurance department after visit, as appropriate.
chronic care
Preparing • Ensure that the patient is appropriately undressed, gowned, and prepared for the examination
needs. a patient on the basis of the chief complaint.
• Prepare needed supplies and instruments in advance, on the basis of the chief complaint.
• Review and carry out any specialty-specific guidelines for patient preparation.
Performing • Administer immunizations, injections, medications, and nursing procedures per physician orders.
ordered • Medical assistant to obtain medication verification by a licensed nurse or clinician for all medications
procedures and immunizations.
• Input immunization information into the Kaiser Immunization Tracking System and KP HealthConnect.
• Record results of Point-of-Care Tests using “Enter/Edit Results” tool.
Discharging • Schedule appointments as directed by the physician, using the Direct Booking Process if applicable.
a patient • Complete durable medical equipment orders as instructed by the physician.
• Set up a pending e-Referral at physician’s request.
• Complete and print Activity Rx forms per physician’s instructions.
• Print After-Visit Summary and review patient instructions and follow-up appointments with patient.
• Complete additional forms and documents as directed.
KP = Kaiser Permanente; POE = Proactive Office Encounter.

40 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
Proactive Office Encounter: A Systematic Approach to Preventive and Chronic Care at Every Patient Encounter

Methods
Developing and Implementing New Work
Flows: Step 2 in the Proactive Office Encounter
Information technology alone is not sufficient to trans-
form the approach to preventive and chronic care. A
standardized structure of work flows and processes was
built to address individual care gaps in every outpatient
setting (Table 2), to increase efficiency and to improve the
reliability and consistency of staff support for physicians.
The POE includes three main components, detailed
Figure 2. Summary of main components of the Proactive Office
in the next section (Figure 2). Encounter.

Before an Encounter (Pre Encounter)


Before a patient comes in, a medical assistant or nurse
reviews the patient’s record to identify needed laboratory
tests and health screenings, and to determine whether the
patient is registered with KP.org, which gives the patient
online access to most laboratory results, prescription and
immunization status, and the opportunity to e-mail the
physician’s office.

During an Encounter (Office Encounter)


In the office, the nurse or medical assistant follows
a standard workflow (Figure 3) that includes reviewing
and updating documentation of the patient’s chief com-
plaint, vital signs, physical activity levels, medications,
allergies, and preferred pharmacy. The nurse or medical
assistant then:
• identifies gaps in care using decision-support tools
• sets up any necessary pending orders and/or exclu-
sion codes for the clinician
• flags needed screenings and/or uncontrolled condi- Figure 3. Computer-screen view of Proactive Office Encounter
tions for the clinician to discuss during the visit work-flow efficiency for pediatrics.
• prepares the patient and examination room for
procedures (eg, Papanicolaou test, diabetic foot approach. In 2007, the POE team widely presented the
examination, etc), and concept to internal audiences, including Medical Direc-
• assists the clinician through the process. tors, Chiefs, nonphysician administrative leaders, and
department managers.
After an Encounter (Post Encounter) One challenge was ensuring that tasks remained
Immediately after the visit, the medical assistant or within the scope of practice for medical assistants and
nurse ensures that the patient receives information to nurses. They identified physicians and administrators
obtain preventive screenings or to address health issues, who could serve as POE team leads at the local level.
including providing an after-visit summary, after-care The team also developed extensive training materi-
instructions, health education materials, information als for both preventive screenings and management of
on accessing KP.org, and follow-up appointments or chronic conditions. Participants learned to use the tools
referrals. In addition, the patient may be contacted after and to perform new tasks, for example, communication
the visit at the clinician’s direction. tips about sensitive patient issues, such as weight. It also
provided instructions on how to prepare the patient and
Managing the Change the examination room for specific procedures, such as
Because the POE represented a cultural shift, it there- a diabetic foot examination.
fore required a comprehensive change in management Persuading people to work in a new way meant

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 41


ORIGINAL RESEARCH & CONTRIBUTIONS
Proactive Office Encounter: A Systematic Approach to Preventive and Chronic Care at Every Patient Encounter

engaging them emotionally. To demonstrate the dif- within 30 days of an appointment, including lead, chla-
ference that nonphysician staff can make identifying mydia, and osteoporosis screening (dual energy x-ray
care gaps, the POE team worked with California’s absorptiometry, or DEXA); pneumococcal immunizations;
Multimedia Department to produce videos of patients documentation of height and weight to capture body
telling how an early screening made a difference in mass index; asthma questionnaire completion; and health
their lives. The videos, which have since been shown education class attendance. These reports are e-mailed to
in internal meetings and are available on KP’s Intranet, regional leaders, medical center leaders, and local POE
included patients’ physicians and key staff (including leads for identification of strengths and areas for improve-
receptionists, medical assistants, and nurses). ment. Specialists in SCPMG have some of their at-risk
By the end of 2007, all primary care offices trained for moneys contingent on their performance on the Successful
Persuading the POE. The following year, specialty care staff trained Opportunities Report. This has been an important step in
people to on a streamlined version of the program. In 2009, staff getting the specialists involved in the POE.
work in a in Urgent Care and Emergency Departments (ED) used The conclusions drawn from the analysis of these data
new way work flows for the POE. Those concepts now extend reveal increased success in closing care gaps at every op-
meant to inpatient settings, with four pilot studies underway. portunity resulting in a 2% to 18.5% range of improvement
engaging in clinical quality for the conditions of diabetes, cancer,
them Results immunization, blood pressure, and smoking (Table 4).
emotionally. Measuring Improvement: Step 3
in the Proactive Office Encounter Future Potential for the
SCPMG measured the program’s success by tracking Proactive Office Encounter
Healthcare Effectiveness Data and Information Set results In the outpatient setting, the POE allowed a shift
on a bimonthly basis. In addition, SCPMG developed a from a reactive care-delivery model to one that is con-
new set of reports (dubbed “Successful Opportunities”) sistently proactive in addressing preventive and chronic
to measure improvements specific to the POE (Table 3). care needs. Because SCPMG is part of an integrated
These reports monitor the frequency of care gaps closure system that includes Kaiser Foundation Health Plan and

Table 3. Proactive Office Encounter: successful opportunity care gap targets met for July 2009a
  Medical Medical Medical Medical Medical Medical Medical Medical Medical Medical Medical Medical Medical
Percentage Center Center Center Center Center Center Center Center Center Center Center Center Center
of: 1 2 3 4 5 6 7 8 9 10 11 12 13
HbA1c 55 58 57 61 62 63 64 49 56 59 54 53 56
Microalbumin 35 33 36 45 39 45 42 36 40 38 39 35 36
LDL 43 40 43 46 46 45 44 39 44 43 41 37 43
Mammograms 34 31 33 30 24 31 28 26 34 29 27 29 32
Papanicolaou 56 54 55 51 57 56 57 55 55 52 49 54 60
test
DEXA 18 16 25 23 15 21 15 18 19 30 18 26 15
Pneumovax 20 15 25 21 20 27 24 21 18 24 18 22 14
Retinal 18 28 36 31 23 30 37 34 32 30 23 36 38
screening
BMI 93 91 92 81 95 94 88 81 89 91 88 88 83
Smoking 42 51 45 50 59 61 74 53 34 50 50 54 58
Chlamydia 49 52 64 48 60 61 58 53 53 60 49 59 48
Health 2 3 4 3 3 2 4 5 4 4 2 6 2
education
Asthma 18 35 65 45 61 45 29 27 26 36 43 46 13
questionnaire
a
Data source: Permanente Online Interactive Network Tools (POE Reports). Successful Opportunity for each gap identified as a resulting test or procedure 30 days after appointment.
Gray = POE Successful Opportunity rates are now as follows: retinal, Pneumovax, chlamydia, and DEXA at ≥25% per POE care gap identified. Diabetes Management health education
departments at 10%. HbA1c, microalbumin, LDL, mammograms, Papanicolaou test, asthma, and smoking at ≥40% per POE care gap identified. BMI department at a rate of ≥80% per
POE care gap identified.
White = POE Successful Opportunity target not met.
BMI = body mass index; BP = blood pressure; DEXA = dual energy x-ray absorptiometry; LDL = low-density lipoprotein cholesterol; POE = Proactive Office Encounter.

42 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
Proactive Office Encounter: A Systematic Approach to Preventive and Chronic Care at Every Patient Encounter

Table 4. Improvements on key quality measures since implementation of the Proactive Office Encounter
Percentage
2009, through improved
Clinical strategic goal 2006 2007 2008 2nd quarter (2006–2009)
Diabetes lipid screening (profile) performed 88.6 91 90.4 90.6 2
Influenza immunization rate (members age ≥65 years) 60.2 62 62 62.5 2.3
Breast cancer screening (patients ages 52–69 years) 85.6 88.1 88.7 88.3 2.7
Diabetes glycated HbA1c testing 88.8 90.8 91.2 92 3.2
Cervical cancer screening 82 85.6 86.6 85.7 3.7
Diabetes blood pressure control <140/90 mm Hg 76.1 74 79.5 82.6 6.5
Diabetes eye examination (retinal) performed 61.6 56.3 66.5 70.9 9.3
Controlling high blood pressure (patients ages 18–85 years) 70.4 72.8 79.6 82.6 12.2
Advising smokers to quit—January 2009 53 69 68 70 17
Colorectal cancer screening 52.5 65.5 69.7 71 18.5

Hospitals, there are more opportunities to expand and interest, including in community clinics in Southern Cali-
embed this approach throughout the organization where fornia and professional and national health organizations.
patients may seek care, from appointment call centers to
hospital discharge. Conclusion
In the near future, SCPMG intends to implement the The project’s impact has been widespread and posi-
POE in pharmacy and inpatient settings. Deployment in tive, changing the organization’s culture and providing
EDs and urgent-care settings is already in progress. Pre- a powerful tool for physician’s, staff, and patients.
encounter automated telephone calls were also piloted Proactive care is now an expectation of care delivery.
in 2008 and were deployed throughout SCPMG by year Barriers encountered by the team were overcome
end. Automated pre-encounter calls target patients with through a collaborative approach, which involved labor
HbA1c, lipid, and/or microalbumin laboratory care gaps partners, physicians, and leaders in the implementation
and ask that they complete the necessary tests before their from the early stages. Correlation data show a positive
office visit to maximize their encounter with their clinician. impact on the delivery of quality care. v
Implementing a proactive approach to care also in-
volves continual improvement to the work flows already a
Janice Beaverson, MD, Associate Medical Director, Quality
developed and requires refining the outpatient encounter and Health Management for the Mid-Atlantic Permanente
Medical Group, Rockville, MA.
with specialty-specific work flows, which are in develop-
ment, for obstetrics, oncology, and nephrology. Disclosure Statement
With modification of the work flow training materials The author(s) have no conflicts of interest to disclose.
for SCPMG, other KP Regions could adopt a similar pro-
active approach, because other Regions have access to Acknowledgment
the same KP HealthConnect functionality and SmartTools Katharine O’Moore-Klopf, ELS, of KOK Edit provided editorial
required to support proactive care. Fully implementing assistance.
this would require processes and structures for staff and
References
physicians to use those electronic tools to close care gaps. 1. Garfield SR. The delivery of medical care. Sci Am 1970
That will require a comprehensive change in manage- Apr;222(4):15–23. (Reprinted in Perm J 2006 Sum-
ment approach, including a communication strategy and mer;10[2]:46–55.)
an extensive training program. More information and 2. Østbye T, Yarnall KS, Krause KM, Pollak KI, Gradison M,
educational videos, job aides, and reference sheets are Michener JL. Is there time for management of patients with
chronic diseases in primary care? Ann Fam Med 2005 May–
available from: http://proactivecare.kp.org.
Jun;3(3):209–14.
KP’s Hawaii Region is now adopting a proactive 3. Yarnall KS, Pollak KI, Østbye T, Krause KM, Michener JL.
care approach, embracing principles of the POE. In Primary care: is there enough time for prevention? Am J
KP’s Mid-Atlantic Region, an ophthalmologist who saw Public Health 2003 Apr;93(4):635–41.
an 82-year-old patient ordered a DEXA scan, which 4. McGlynn EA, Asch SM, Adams J, et al. The quality of health
showed osteoporosis (Janice M Beaverson, MD, personal care delivered to adults in the United States. N Engl J Med
2003 Jun 26;348(26):2635–45.
communication, March 2010).a There is much external

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 43


ORIGINAL RESEARCH & CONTRIBUTIONS

Innovation

An Alternate Model for Medical Education: Longitudinal Medical


Education Within an Integrated Health Care Organization—
A Vision of a Model for the Future?
Quentin Eichbaum, MD, PhD, MPH, MFA, FCAP
Tim Grennan, MD, FACP
Howard Young, MD Editor’s note: This article was developed as a hy- from a broader but ultimately not less deserving pool
Myra Hurt, PhD
pothetical model from the June 2009 session of the of applicants and potentially also help alleviate certain
Harvard Macy Institute—Program for Leading Inno- health care worker shortages.
vations in Healthcare and Education on innovations We conceive of this alternate medical education
in medical curriculum. course operating alongside the traditional university-
As the health care debate in the US rages on, we based medical schools rather than replacing them.
need also to examine whether our medical education We suggest the hypothetical name Kaiser Permanente
system is keeping pace with the changing landscape of School of Medicine (KPSOM) to exemplify the alterna-
medicine and how well it will cope with the proposed tive model we describe. Kaiser Permanente (KP) is a
changes in health care delivery. Are we graduating large, integrated, prepaid Health Plan with 8.6 million
sufficient numbers of physicians in the correct spe- members and more than 14,000 physicians in eight
cialties and in a timely manner? Are medical trainees Regions.1 The organization has established for itself a
being adequately trained for the molecular and digital solid reputation as a progressive health care delivery or-
revolutions in science and technology? Are there other ganization with a focus on preventive, patient-centered
models of medical education outside of the universities care and patient satisfaction.
that we might explore for training outstanding physi- The KPSOM for the training of health care workers
cians in America in the 21st century? would be one that 1) uses the existing structures of
We propose situating a medical school program within a progressive health care management organization
one of the larger progressive, nonprofit, integrated, (with existing graduate physician-training programs)
managed care organizations in the US. At first, this may and does not require the construction of new medi-
appear an audacious suggestion. The recent health care cal schools; 2) co-trains physicians, physician’s as-
reform legislation and current policy discussions suggest sistants, nurses, nurse practitioners, and potentially
that these integrated delivery systems may become the even health care administrators; 3) has a streamlined
model for future care delivery. It seems legitimate to try and less costly admissions process and functions
to use their strengths in seeking solutions to the country’s alongside traditional university-based medical schools;
health care dilemmas. From this perspective, we suggest 4) acknowledges the student-centric learning style
that situating modular and longitudinal medical educa- and computer proficiency of the incoming Millennial
tion within a progressive integrated health care system Generation (or Generation Y) students; 5) maximizes
such as a large, multispecialty group model, nonprofit human potential by taking into account differences in
health maintenance organization might provide a valid learning styles and accommodating self-paced modular
alternate stream of education and training for physicians learning; 6) increases the number of physicians (as
(and other health care workers). It could draw its trainees well as other health care workers) by drawing on a

Quentin Eichbaum, MD, PhD, MPH, MFA, FCAP, is a College Master and Associate Professor of Pathology,
Microbiology and Immunology, Department of Medical Education and Department of Pathology, Paul L Foster
School of Medicine, Texas Tech University Health Sciences Center, El Paso, TX. E-mail: [email protected].
Tim Grennan, MD, FACP, is an Oncologist at the Sacramento Medical Center in Sacramento, CA, and a Clinical
Professor of Medicine at the University of California Davis School of Medicine, CA. E-mail: [email protected].
Howard Young, MD, is a Vice Dean of Postgraduate Medical Education at Cardiff University, United Kingdom.
E-mail: [email protected].
Myra Hurt, PhD, is a Professor of Biomedical Sciences and Senior Associate Dean for Research and Graduate
Programs, Florida State University College of Medicine, Tallahassee, FL. E-mail: [email protected].

44 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
AnAlternate
An Alternate Model for
forMedical
MedicalEducation:
Education:Longitudinal
LongitudinalMedical
MedicalEducation Within
Education an Integrated Health Care Organization—A Vision of a Model for the Future?
Within an Integrated Health Care Organization—A Vision of a Model for the Future?

pool of applicants, some of whom may convention- the organization to the required level of competence.
ally be considered underqualified for admission but The school would conduct its own in-house evalua-
will prove to be equally qualified after training; and tions, monitored by the Liaison Committee on Medical
7) enhances opportunities for medical careers to stu- Education (LCME), of students it admits. These could
dents from economically disadvantaged backgrounds. take the form of an initial basic competency test, fol-
lowed by formative and summative testing as students
Applicants to the Kaiser Permanente progressed through the modular self-paced learning
School of Medicine system (see the next section).
A central component of the school would be the This progressive admissions policy would
admission and training of what we call the pluripo- allow applicants from a broader range of We envisage
tential health care worker. The baseline 1 to 3 years educational backgrounds, not only from elite students
of learning in this school (depending on how the stu- schools but also from underserved areas. learning the
dents pace their learning) would involve the training This would make for a healthy diversity basic sciences
of a generic or pluripotential student apprentice who among trainees. It has been recently noted concurrently
would be well versed in both basic science and basic that about 75% of US medical students come with clinical
medical skills at a level of competence necessary for from the upper wage-earning quintile of the skills so that
medical students, physician’s assistants, and nurses or population. According to a report on the Web concepts from
nurse practitioners. site of the Association of American Medical these two
Because baseline training before specialist training Colleges (AAMC), the Matriculating Student spheres of
would be pluripotential, applicants could also be selected Questionnaire, All Schools Summary Report knowledge
from a broader background of applicants. In particular, for the years 2006, 2007, and 2008, 69% to would
applicants from underprivileged and underserved areas 71% of students reported that their parents’ reinforce each
might be accepted into the program because learning in gross income was $75,000 or more, and the other.
the program is self-paced and modular in nature, with average was between $149,779 (2006) and
backup mentoring and academic support (as described $164,483 (2008). In these same years, 15% or
in the following section). The school would be attrac- less reported that their parents’ gross income was less
tive to a diverse range of students, including those from than $40,000.2 In keeping with the community mission
resource-poor settings; students interested in a career in of KP, this new training model could help redress this
health care but undecided about the specific direction; imbalance by accepting minority and less-privileged
students who prefer the option of self-paced learning; students. Recruitment from a wider pool of applicants
and students attracted by the option of remaining within would likely also increase numbers of medical, nursing,
a large organization for residency, fellowship, and sub- and physician’s assistant graduates and might have the
sequent employment opportunities. added consequence of increasing the supply of quali-
An advantage of this hypothetical model would fied health care workers to underserved areas.
be that it could function without some of the current
constraints that render the current admissions process Modular Self-Paced Learning
to university medical schools cumbersome, expensive, Education and training at this new school would be
and drawn out. Students applying to the KPSOM would modular and self-paced but would be buttressed with
not need to apply to and interview at numerous medi- sophisticated academic support and mentoring. An or-
cal schools. The current highly competitive system is ganization the size of KP has ample resources to provide
draining and costly and entails students crossing the such academic support. Students would not study in
country for multiple interviews and schools investing lockstep with the entire class being at the same point
substantial time and money into screening applications in the curriculum at any one point, as in most current
and interviewing students—overall, an exhausting, medical school curricula, but would instead pace their
time-consuming, and costly process. This new hypo- own learning. Coursework would be completed in
thetical institution might not require the MCAT (Medi- modules, and trainees could be tested for competency
cal College Admission Test) for admission, because it at critical steps in their learning before being permitted
would conduct its own in-house assessment of candi- to move on to the next learning module.
dates. It would not directly compete with university Modular learning in the basic sciences would be
medical schools because it would accept trainees from largely Web based. Because it would not be a classic
a wider pool of applicants and nurture them within university, this new alternative medical school would

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 45


ORIGINAL RESEARCH & CONTRIBUTIONS
An Alternate Model for Medical Education: Longitudinal Medical Education Within
AnanAlternate
Integrated Health
Model forCare Organization—A
Medical Vision of a Model
Education: Longitudinal for the
Medical Future?
Education
Within an Integrated Health Care Organization—A Vision of a Model for the Future?

not employ basic science faculty for lecture-style teach- Millennial Generation or Generation Y:
ing. The school might partner with universities for parts Self-Based Style of Learning
of the basic science teaching. Students would be as- A curriculum of self-paced modular learning has a
signed (as apprentices) to KP clinical faculty members, number of advantages. First, it would accommodate
many of whom are already clinical faculty members differences in students’ learning styles and would be
at local universities and are engaged in the teaching advantageous to students from challenged backgrounds
of graduate physicians. The students would shadow by allowing them to proceed through the program at
the faculty in clinics and hospitals while they also en- their own learning pace (within certain time limits).
gaged in completing modules in clinical skills. Students Second, it would accommodate the self-based learn-
would not be permitted to proceed to the next level ing style of the “Millennial” or “Generation Y” students
of learning in the basic sciences or clinical skills until who are generally adept at computers and are swift at
they had demonstrated adequate competency at each information retrieval from the Internet, who ostensi-
prior level of learning. Although the program would bly have shorter attention spans than students in past
be self-paced, there would nonetheless be a limited generations, and who prefer to take charge and be at
time frame for completion of specific tracks (possibly the center of their own learning.4 Third, it would take
five to seven years). account of the exponential increase in medical knowl-
We envisage students learning the basic sciences edge by presenting it in modular form and allowing
concurrently with clinical skills so that concepts from students to pace their learning.
these two spheres of knowledge would reinforce each
other. The specifics of the school’s curriculum model The Pluripotential Baseline Trainee
would remain to be deliberated but would be based on The first benchmark phase of the KPSOM would be
recommendations of the AAMC for small interdisciplin- the training of a pluripotential health care worker who
ary group teaching that would incorporate aspects of would subsequently proceed with more specific training
problem-based and team-based learning as well the more along designated tracks toward becoming a physician,
recent recommendations of the Carnegie Foundation’s physician’s assistant, nurse, nurse practitioner, or health
2010 report for supportive learning environments that care administrator. Each track would have graduated
encourage curiosity, encourage feedback improvement, levels of competency in training, and trainees would
and promote learners’ ability to work collaboratively in have to demonstrate adequate competency at each level
health care teams.3 As recommended in the Carnegie before being admitted to the next.
Foundation report, the KPSOM would also, through Many students might know from the start which
its apprenticeship model, incorporate more clinical graduation track they wish to pursue, but all would
experiences earlier in the curriculum. Examples of cur- initially go through the gatekeeping pluripotential
rent curricula that may provide guidance are Harvard track, during which they would also be tested for
Medical School’s New Pathway MD Program (http://hms. their natural learning styles, aptitude, and acquired
harvard.edu/admissions/default.asp?page=pathway); the competencies before being admitted to the graduation
symptom-based curriculum of Calgary Medical School in track of their choice. Such monitoring would maximize
Canada (www.medicine.ucalgary.ca/) and the new human potential because there would presumably be a
Paul L Foster Medical School in El Paso, Texas (www. closer fit between candidates’ aspirations and their true
ttuhsc.edu/elpaso/); and the “longitudinal integrated” capabilities. A trainee who did not qualify for the physi-
clerkship curriculum of the Cambridge Health Alliance cian track might still be offered the choice of the less
and Harvard Medical School (www.cha.harvard.edu/ demanding physician’s assistant track. After completion
academics/integrated_clerkship.shtml) in Boston. of the basic gatekeeping pluripotential track, the differ-
It is anticipated that the students would learn bet- ent tracks would, however, not be melded but would
ter and more quickly because the program would be be separate and have strict competency attainment
embedded in an integrated health care system. While requirements. This hypothetical new school could af-
proceeding with their modules in the basic sciences, stu- ford having different tracks of health care professional
dents would work at KP as clinician apprentices. Initially, training because unlike a university medical school, it
they would do very basic clinical work while shadowing would ultimately offer employment to most graduates
experienced physicians in clinics and hospitals, and only in the different tracks.
after demonstrated basic clinical competencies would Regarding administrative regulation of the school,
they proceed to more self-reliant clinical work. the LCME—which currently appears to be interested

46 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
An Alternate Model
Modelfor
forMedical
MedicalEducation:
Education:Longitudinal Medical
Longitudinal Education
Medical Within
Education an Integrated Health Care Organization—A Vision of a Model for the Future?
Within an Integrated Health Care Organization—A Vision of a Model for the Future?

in innovative projects in medical education—would of the school’s student population and may ultimately
maintain its standard accrediting and regulatory role at all also increase the numbers of physicians choosing to
stages of the school’s development, as it does for all other return to work in resource-poor settings.
US medical schools. Students would be required to pass The financing of the school itself, which may re-
the standardized National Board of Medical Examiners quire some additional infrastructure but little physical
subject examinations as well as the US Medical Licens- construction, may come from KP itself, particularly if
ing Examination steps 1, 2, and 3 for licensure. In any it viewed the venture as a good investment. Because
case, in 2010, the centennial year of its groundbreak- the school would attract students from resource-poor
ing Flexner Report, the Carnegie Foundation released settings, additional financing might be obtained via
another call for reform, Educating Physicians: A Call the federal government, such as through new health
for Reform of Medical School and Residency,3 in which care legislation,6 or through state support, or from
it drew attention to the need for reform with regard large philanthropic organizations with an interest
to admissions, accrediting, certifying, and licensing in in education such as the Carnegie or Rockefeller
medical education in a manner that resolves conflicts Foundations.
but ensures diversity of medical schools. The first two
of the report’s seven recommendations read as follows3: The Lifelong Medical School:
1. AAMC and medical schools work together to revise Residency, Fellowship, Cross-Training,
premedical course requirements and admission and Continuing Medical Education
processes, ensuring the diversity of those in medical The KPSOM would continue and expand its own
schools. in-house residency and fellowship programs that
2. Accrediting, certifying, and licensing bodies together encompass a number of medical specialties and sub-
develop a coherent framework for the continuum specialties. Medical student trainees would apply from
of medical education and establish effective mecha- within the organization for specialty training at any one
nisms to coordinate standards and resolve jurisdic- of its many hospitals.
tional conflicts. Because the medical school and residency programs
would be housed within the same organization, applica-
Students as Reduced-Tuition tions for residency would also be greatly facilitated. The
Employees of the Organization drawn-out and costly process of the current residency
Tuition would be reduced because students would be application and cross-country interview process, which
admitted as part-time employees and would perform, in consumes the better part of the fourth year of medi-
their roles as clinical apprentices, basic clinical service cal school, would be obviated. This time saving could
functions for the organization’s clinics and hospitals. eliminate a year of medical training for the motivated,
Conceivably, as employees they might also receive a quicker-paced student or else provide the additional
reasonable stipend to cover living expenses. Analogous time required for the slower-working, self-paced stu-
education models exist within engineering schools in dent. During their ‘medical school’ training, students
which students may spend half the year within the uni- would be carefully monitored, evaluated, and assessed
versity and the other half employed by an engineering for their aptitudes and learning styles in deciding about
firm (Richard K Miller, personal communication, May residency. The processing of applications from within
2009).a,5 The organization would ensure that appropri- the organization would not only streamline the process
ate supervision is provided at all times to quarantee but also might improve quality control and standardiza-
that patient safety and quality of care is maintained. tion of applications. Residency programs would also
Students of the new school would graduate with be largely modular in structure and self-paced for the
less financial debt than students of university medical learning of clinical competencies.
schools and would therefore not be unduly influenced Although there might be some loss of diversity
by considerations of the size of tuition loans in their among residents who all derive from the same organiza-
choice of medical specialty training, as is happening tion, compared with residents entering from a variety of
with current medical school graduates applying for resi- different medical schools, the gain to the residency pro-
dency. Moreover, a less costly system may be enticing to gram would be in having a more carefully monitored,
students from disadvantaged educational backgrounds standardized, and appropriately matched (by aptitude,
as well as to more accomplished students from better learning style, and intellectual capability) program of
endowed institutions. This would enhance the diversity residents. Students would not be required, however, to

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 47


ORIGINAL RESEARCH & CONTRIBUTIONS
An Alternate Model for Medical Education: Longitudinal Medical Education Within
AnanAlternate
Integrated Health
Model forCare Organization—A
Medical Vision of a Model
Education: Longitudinal for the
Medical Future?
Education
Within an Integrated Health Care Organization—A Vision of a Model for the Future?

complete all their clerkships and rotations within the for patients over this extended period of participation
school but would be encouraged to do rotations outside in the organization. This would lead to both enhanced
of KP, which already has formal affiliations with medical patient care and, as a consequence, overall higher levels
schools such as those with the University of California, of patient satisfaction. Instead of experiencing continual
San Francisco; Stanford University; the University of disruptions in their care with frequent changes in physi-
California, Los Angeles; the University of California, cians and hospitals, patients would continue to see the
Davis; the University of Southern California; and the same physicians they initially encountered when these
University of California, Berkeley (public health). De- physicians were medical students or residents and who
pending on their examination grades, performance, would therefore have a more substantial grasp of their
and recommendations, students from KPSOM apply- ongoing health care needs over time.
ing for rotations, residencies, and fellowships In addition, with enhanced continuity of care, the
outside of the organization should be readily organization could implement highly effective longitu-
… with
competitive with students from other medi- dinal preventive-care programs, which would lead to
enhanced
cal schools. Applications to outside programs improved health outcomes and patient satisfaction. The
continuity
should not present a compatibility problem, integrated modular nature of this course would allow
of care, the
as KP already interfaces with several such for flexibility in learning styles to be matched with the
organization
residency programs. flexibility that would be needed of the future workforce.
could implement
The program might also admit a limited num- It would promote the concept of teamwork at an early
highly effective
ber of residents from other US medical schools stage, improve communication between trainees and
longitudinal
as well as graduates of foreign medical schools, teachers, and redefine the apprentice model in the
preventive-care
who would also be carefully assessed and then 21st century.
programs …
slotted into the appropriate phase of the train-
ing program. Currently, international medical Summary
applicants to US residency programs are required to In brief, the hypothetical KPSOM could be envis-
repeat their entire residency training regardless of their aged as a model of a lifetime medical school that
prior training and competency. In this proposed alterna- would initially draw candidates from a diverse socio-
tive medical school, foreign residency applicants would economic pool of applicants and guide them through
nonetheless still have to pass US medical board exami- a series of carefully monitored, modular, self-paced
nations and satisfy all LCME accrediting requirements. basic science and clinical skills learning programs, up
Applications to fellowship programs, which would to a phase where they would branch out into specialty
also be in-house, would be similarly handled. The programs leading to graduation as physician, physi-
proposed KPSOM would also readily accommodate cian’s assistant, nurse, nurse practitioner, or health
cross-training of its employed physicians into different care administrator.
associated subspecialties, a trend that is occurring in- Tuition would be less costly because students would
creasingly as medical knowledge expands. For instance, also be employees of the organization and would
the increasing role of invasive radiologic techniques likely remain in the organization throughout their ex-
and laparoscopic surgical techniques has changed tensive training careers, from medical school and into
management in a variety of surgical disciplines. Finally, subspecialty certification—and possibly as full-fledged
continuing medical education programs would be easier physician employees. This system would be satisfying
to implement and monitor from within the organization, to patients as well as students because it would provide
whereas the current system of accumulating continu- more effective longitudinal and preventive care.
ing education credits is often seemingly haphazard The model is offered as an alternate stream of medi-
and fragmented. cal education that would not supplant university medi-
cal schools but would operate alongside them. This
Continuity of Care, Preventive Care, alternate model might serve to increase the number of
and Patient Satisfaction in the qualified physicians without the need to build more
Lifelong/Longitudinal Medical School costly medical schools, and it would train a broader
Because most trainees would continue their training range of health care professionals from diverse back-
within the organization initially as medical students, grounds within the same organization. v
then as residents, fellows, and finally as fully employed
physicians, they could provide better continuity of care a
President, Franklin W Olin College of Engineering

48 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
An Alternate Model
Modelfor
forMedical
MedicalEducation:
Education:Longitudinal Medical
Longitudinal Education
Medical Within
Education an Integrated Health Care Organization—A Vision of a Model for the Future?
Within an Integrated Health Care Organization—A Vision of a Model for the Future?

Disclosure Statement 3. Cooke M, Irby DM, O’Brien BC. Educating physicians: a call
The author(s) have no conflicts of interest to disclose. for reform of medical school and residency. San Francisco:
Jossey-Bass; 2010.
Acknowledgments 4. Baron RA. Why it’s important to export our field—and how
We gratefully acknowledge Elizabeth Armstrong, PhD, Direc- we can do it effectively. In: Saville BK, Zinn TE, Meyers SA,
tor of the June 2009 session of the Harvard Macy Institute— Stowell JR, editors. Essays from e-xcellence in teaching,
Program for Leading Innovations in Health Care and Education 2006. Washington, DC: Society for the Teaching of Psychol-
and our seminar group for the ideas generated in the group on ogy; 2006 [cited 2010 Jul 7]. Available from: http://teach-
innovations in the medical curriculum. psych.org/resources/e-books/eit2006/eit06-05.pdf.
Katharine O’Moore-Klopf, ELS, of KOK Edit provided editorial 5. Miller RK. President’s message [monograph on the Internet].
assistance. Needham, MA: Franklin W Olin College of Engineering;
2010 [cited 2010 Jul 7]. Available from: www.olin.edu/
References about_olin/presidents_message.asp.
1. Fast facts about Kaiser Permanente [monograph on the 6. Patient Protection and Affordable Care Act of 2010, Pub L.
Internet]. Kaiser Permanente News Center. Oakland, CA: Kai- No. 111-148, 124 Stat 119. Title V. Health Care Workforce;
ser Permanente; © 2010 [cited 2010 Jul 5]. Available from: Subtitle B: Innovations in Health Care Workforce; Section
http://xnet.kp.org./newscenter/aboutkp/fastfacts.html. 5101: National health care workforce commission; Section
2. Matriculating Student Questionnaire, All Schools Summary 5102: State health care workforce development grants.
Report [Web page on the Internet]. Washington, DC: Available from: http://democrats.senate.gov/reform/patient-
Association of American Medical Colleges. © 1995–2010 protection-affordable-care-act-as-passed.pdf.
[cited 2010 Jul 5]. Available from: www.aamc.org/data/
msq/start.htm.

The Most Essential


The most essential part of a student’s instruction is obtained, as I believe,
not in the lecture room, but at the bedside. Nothing seen there is lost;
the rhythms of disease are learned by frequent repetition; its unforeseen
occurrences stamp themselves indelibly in the memory.
—Medical Essays, “Scholastic and Bedside Teaching,” Oliver Wendell Holmes,
1809-1894, American physician, professor, and author

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 49


soul of the healer

“Scripps Pier, La Jolla, CA”


photograph

Gevork Mosesi, MD

Gevork Mosesi, MD, is a Family Medicine Physician at the Bonita Medical Center in CA.
Photography is one of Dr Mosesi’s passions because it allows him to capture
beautiful moments; he feels that life around us is beautiful.
His favorite subjects are landscapes, architecture, and his daughter.

50 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS

Innovation

The Northern California Perinatal Research Unit:


A Hybrid Model Bridging Research, Quality Improvement
and Clinical Practice
Terhilda Garrido, MPH
Rosemarie Barbeau
literature—how did KP acquire the
Abstract ability to have this type of dialogue
Kaiser Permanente (KP) has a long-standing commitment to conduct and enable these kinds of informed,
research and report publicly. Simultaneously, it faces a different impera- data-driven, evidence-based, opera-
tive: harnessing information systems to leverage internal improvements tions decisions?
in outcomes, efficiency, and costs. Now that KP HealthConnect, the KP
electronic health record, is fully implemented, research challenges at KP Introduction
are moving away from issues of data access and toward the mechanisms Now that KP HealthConnect, the
through which raw data create meaningful clinical knowledge that is based KP electronic health record, is fully
on rigorous research. In this report we describe a model for research—the implemented, research challenges at
Northern California Division of Research Perinatal Research Unit—that KP are moving away from issues of
leverages internal and external resources to fulfill these twin missions. data access and toward the mecha-
nisms through which raw data create
The word Irish is seldom coupled using the Score for Neonatal Acute meaningful clinical knowledge that is
with the word civilization. Physiology (SNAP), forestalling a fre- based on rigorous research. Studies
—How the Irish Saved Western quent response: “But my babies are have documented that an average of
Civilization, by Thomas Cahill sicker!” The meeting is challenging 17 years elapses between the creation
but goes well, establishing a pattern of clinical knowledge and its general
The word improvement is seldom that continues to date: high-quality use at the front line of care.1 The
coupled with the word research. outcomes data, often combined with average time for the entire cycle of
—Gene Nelson, MD, algorithms derived from federally knowledge creation—from research
Dartmouth University funded research projects based at idea through funding, data collection,
Kaiser Permanente (KP), are shared analysis, conclusions, publication,
Prologue with clinicians, who respond by and finally, to broad dissemination—
The principal investigator (PI) changing their admission criteria. is even longer (Figure 1).
shares sensitive outcomes data in Over time, admissions decrease This article explores a model of
a meeting with the neonatology by almost 8%, with no increase in research and operations analysis
chiefs. The graphs clearly show that neonatal mortality or morbidity. In that has proven to be very effective:
facilities A and C admit infants with addition, infants and their families the Northern California Division of
suspected infections at rates that are spared the disruption and stress Research’s Perinatal Research Unit
are two to three times higher than associated with unnecessary admis- (PRU). This hybrid research model
those for facility B, despite infant sions and separations. Reduced combines the best of traditional re-
populations that are similar in terms costs with potentially better care, search capabilities with a rapid opera-
of birth weight, severity of illness, along with an impressive publica- tions research function. As KP strives
and mortality. Data are stratified tion record in the peer-reviewed to improve outcomes by bringing

Terhilda Garrido, MPH, is the Vice President of HIT Transformation and Analytics
for Kaiser Foundation Health Plan and Hospitals. E-mail: [email protected].
Rosemarie Barbeau is Senior Consultant for The Axelrod Group in Wilmette, IL.
E-mail: [email protected].

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 51


ORIGINAL RESEARCH & CONTRIBUTIONS
The Northern California Perinatal Research Unit: A Hybrid Model Bridging Research, Quality California
The Northern Improvement and Clinical
Perinatal Practice
Research Unit:
A Hybrid Model Bridging Research, Quality Improvement and Clinical Practice

research to bear directly on opera- for conducting research. Among ‘I wonder …,’ quantify it, and an-
tional questions this unit provides an routine PRU outputs are annual swer it accurately in a way that has
example of how KP can shorten the data sets sent to the State of Cali- meaning and can be generalized
“time to using knowledge” cycle and fornia on behalf of the six Northern to our entire neonatal population.”
effectively change clinical practice. California neonatal intensive-care Answers to operationally important
units (NICUs), required for NICU questions posed by one NICU are
The Perinatal Research certification by California Children’s often directly applicable to other
Unit Model Services. The group also generates units—and often serve as the start-
The mission of the PRU is three- analyses in response to ad hoc ing point for manuscripts and fed-
fold: research, reporting, and ad hoc queries from clinicians, using the eral grant applications.
analysis. PRU staff provide rapid- full array of available data at KP.2-4 The interdisciplinary staff at the
cycle summary and benchmarking Eileen Walsh, RN, MPH, PRU Project PRU includes a PI, a project manager,
data, as well as an excellent setting Manager, notes, “We take someone’s a statistician or analyst, programmers,
This hybrid
research model
combines
the best of
traditional
research
capabilities
with a rapid
operations
research
function.

Figure 1. Timeline from idea to actionable knowledge.


1
0.4-2.3 years from the time of application for funding until reciept of award (NIAID tutorial:aaa.niaid.nih.mgov/ncn/grants/cycle/part01.htm#a).
2
Average length of NCI/NHLBI trials is 2.91 years (Meinert CL, Tonascia S. Clinical trials: design, conduct, and analysis. New York, Oxford University Press,
1986:40).
3,4
Kumar PD. Publication lag intervals—a reason for authors’ apathy? J Assoc Physicians India 1992 Sep:40(9):623-4.
5
Poyer RK. Time lag in four indexing services. Spec Lib 1982 Apr;73:142-6.
6
Antman EM, Lau J, Kupelnick B, Mosterller F, Chalmers TC. A comparison of results of meta-analyses of randomized control trials and recommendations
of clinical experts. Treatments for myocardial infarction. JAMA 1992 Jul:268(2):240-8.
7
Balas ES, Boren SA. Managing clinical knowledge for health care improvement. Yearbook of Medical Informatics 2000: Patient-centered Systems.
Stuttgart, Germany: Schattauer, 2000:65-70.

52 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
The Northern California Perinatal Research Unit: A
Hybrid Model Bridging Research, Quality Improvement and Clinical Practice
A Hybrid Model Bridging Research, Quality Improvement and Clinical Practice

a research assistant, and other staff. showing them local data (baseline
The unit also partners with investiga- and postintervention), gathered from
tors at other institutions, including their own nurseries.
the University of California, San Figure 2 describes the interactions
Francisco; the University of California, between the key groups involved in
Santa Cruz; Harvard University; and exploring and identifying changes in
the University of Pennsylvania. The practice. Ideas for clinical practice re-
PRU’s strong research team, with search can come from the Neonatal
analytic and statistical expertise, is Chief’s Group, the KP HealthConnect
critical to the unit’s success. NICU/Newborn Governance Team, Figure 2. Flow of thought, information, and action in
The PI, Gabriel Escobar, MD, leads or the Neonatology Journal Club or the Northern California neonatal community.
research activities and sets unit priori- “collaboratory,”5 whereby a com- DOR = Division of Research; KPHC = Kaiser Permanente
HealthConnect, the Kaiser Permanente electronic health record;
ties. He brings several attributes to his munity of practice uses shared data NICU = neonatal intensive-care unit; PRU = Perinatal Research Unit.
role. Although he is a seasoned and to improve knowledge and results. (Courtesy of Allen Fischer, MD.)
successful traditional researcher, he The Journal Club meets online one
also has the mind-set of a practicing evening per month and draws an with regional operations leadership.
hospital-based physician. As a clini- audience that includes neonatolo- He shares data and findings, as well
cian, he understands which questions gists from Southern California and as their implications, with senior
are most pressing for operations and Hawaii as well as invited speakers leadership; in turn, senior leaders
is driven to find answers. Straddling from multiple universities. The needs have consistently supported the
the worlds of research and opera- of these groups drive much of the PRU. A number of his colleagues
tions, he is uniquely able to translate PRU’s work, and the Northern Cali- have noted that Dr Escobar “cares
between them. His goals have always fornia Nursery Directors’ group, of about what leadership cares about.”
been to 1) improve the frontline de- which Dr Escobar is a sitting mem- He concurs: “Senior leaders tend to
livery of care at KP and 2) conduct ber, actively participates in setting be interested in things that move the
rigorous research. Because Dr Esco- PRU priorities. whole system, and that’s what I am
bar is a physician who is translating Beyond the support that Dr Es- interested in.” For example, Philip
research and embedding it into cobar provides to neonatologists to Madvig, MD, Associate Executive
operations, his activities embody the identify needed changes in clinical Director of The Permanente Medical
concept of how research and quality practice, he brings a hands-on ap- Group (TPMG), sees the potential
improvement can be integrated into proach to implementing changes for the approach pioneered by Dr
the broader KP community. in the NICUs. Dr Fischer says that Escobar to bring value to medical
Dr Escobar focuses on the question specialties beyond neonatology.
A Key Partnership “‘How do you package new infor- He and Donald Dyson, MD, Asso-
The work of the PRU is tightly in- mation so that it changes practice?’ ciate Executive Director of TPMG,
tegrated with the decision making of As a practicing physician, he needs are very supportive of closing the
the neonatal chiefs in Northern Cali- decision support himself, so he un- gap between emerging knowledge
fornia, a small specialty group whose derstands how to make it work for about effective practices and subse-
visionary leadership has created a others.” Practice changes are facili- quent physician adoption.
highly effective learning community. tated through influence, as most of
According to Allen Fischer, MD, the key players in this process lack Areas of Demonstrated
Northern California’s Regional Di- the line authority to mandate prac- Success
rector of Neonatology, the value of tice changes. However, widespread The PRU has demonstrated effec-
the PRU is that “their efforts inform involvement of practicing clinicians tiveness in three dimensions: clinical
our action. When we consider a with the PRU facilitates buy-in. research, operations analysis and im-
change in practice, we ask the PRU, provement, and leveraging resources.
‘What does the literature look like? Senior Operations
What do KP outcomes look like?’” Leadership Sponsorship Clinical Research
The PRU supports neonatologists The work of the PRU to improve With 92 peer-reviewed publica-
as they work together to identify operations has also been furthered tions and 2945 citations during a
new practices by analyzing and through Dr Escobar’s relationships period of 15 years, the PRU is con-

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 53


ORIGINAL RESEARCH & CONTRIBUTIONS
The Northern California Perinatal Research Unit: A Hybrid Model Bridging Research, Quality California
The Northern Improvement and Clinical
Perinatal Practice
Research Unit:
A Hybrid Model Bridging Research, Quality Improvement and Clinical Practice

sidered an authority on newborn and impact) is 30,12 and its funding from a low level of analytic com-
treatment management in many rate is roughly 50%. plexity (eg, a clinician who re-
areas. For example, the National Another stream of research con- quests simple counts of number
Institute of Child Health and Hu- ducted during a multiyear period of ventilated babies younger than
man Development (NICHD) views centers on an issue that has not 32 weeks’ gestation) to moder-
KP as a resource on data on new- received rigorous research atten- ately complex (eg, a query about
borns because of the principal PRU tion in the academic literature: appropriate referral of mothers
database, the Neonatal Minimum respiratory distress in babies born at risk of delivering late-preterm,
Data Set (NMDS). The NMDS is an at 34 weeks’ gestation or later. multiple-gestation infants) and very
application based on SAS statistical PRU work in this area resulted in complex (eg, research studying
software (Cary, NC) populated with the “Big Babies Breathing Hard” the effects of neonatal nosocomial
a standard set of data gathered on project. Central to this work is the infection on hospital length of stay
all infants admitted to Northern Richardson score, which permits and mortality). The response time
California NICUs. It contains a total a rapid, quantitative assessment to queries depends on the level of
of more than 46,000 infant records of the severity and the prognosis complexity. Most simple queries
dated from 1993 to 2009; since of respiratory distress. Additional can be answered within days.
2000, enrollment averages 2969 areas of contribution are neonatal More complex queries (eg, “Are the
infants per year. Full data collection sepsis (identification, prevention, outcomes for respiratory distress in
for an infant who spends at least 72 clinical management, outcomes), full-term infants the same across
hours in the NICU comprises ap- effects of maternal substance abuse our units?”) often lead to more
proximately 150 data elements cor- during pregnancy, risk factors for elaborate answers13,14 and some-
responding to maternal and infant rehospitalization among newborns, times lead Dr Escobar to submit
demographics, maternal history, hyperbilirubinemia (effectiveness a formal grant proposal. Because
intrapartum and delivery details, of screening and treatment strate- publishing can take a longer time,
NICU diagnoses and procedures, gies), and longitudinal outcomes Dr Escobar accelerates knowledge
severity of illness, and disposi- for NICU survivors. An extensive sharing by circulating draft manu-
tion. Reliability of the NMDS data bibliography can be found at scripts internally with the Nursery
is enabled by ownership and strict http://dor-ent1.kaiser.org/staff/in- Directors, instead of waiting for
quality control by the PRU and its vestigators/escobar.htm (password publication (up to two years).
partners. Although the NMDS is a protected).a Under a long-standing collabo-
state-of-the-art database and the ration with the University of Cali-
defining product of the PRU, it sits Operations Analysis and fornia, San Francisco, the PRU has
with and is linked to a wide vari- Quality Improvement also played an important role in
ety of KP data resources. Project- An equally important area of how KP clinicians manage neonatal
specific data sets are created for focus for the PRU is operations hyperbilirubinemia. Working with
externally funded research studies. analysis and improvement. Driven a nationally recognized jaundice
PRU researchers are invited par- by clinician questions, this work expert, Thomas Newman, MD, the
ticipants at NICHD conferences on may or may not result in a publica- PRU initially contributed consider-
jaundice and late-preterm infants. tion, but it directly contributes to able data, consultation support, and
In a recent issue of Pediatrics fo- improved patient outcomes. PRU paper tools to efforts by the Chiefs
cusing on jaundice, PRU research- research on operational questions of Pediatrics and Nursery Directors
ers published a key article6 and is conducted with the same data to implement the American Acad-
were cited in five of six remaining and the same resources for analytic emy of Pediatrics clinical practice
articles,7-11 as well as in editorials. rigor as clinical research and often guideline for hyperbilirubinemia.
The official Centers for Disease uses the knowledge gained from These efforts continue, but the
Control Guidelines for Prevention traditional clinical research proj- PRU is now shifting its emphasis
of Perinatal Group B Streptococ- ects. The NMDS database, the PRU to KP HealthConnect, where it
cal Disease cite a study based on staffing structure, and strong ana- played a major role in developing
a PRU population on “rule out lytic expertise all enable analysis. and implementing an automated
sepsis.” The PRU’s H index (a The queries that PRU receives hyperbilirubinemia assessment tool
measure of research productivity from operations run the gamut embedded in the electronic health

54 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


ORIGINAL RESEARCH & CONTRIBUTIONS
The Northern California Perinatal Research Unit: A
Hybrid Model Bridging Research, Quality Improvement and Clinical Practice
A Hybrid Model Bridging Research, Quality Improvement and Clinical Practice

record. Currently in beta testing, this of the PRU’s ready and rigorous suppressed. In these situations, the
tool will be rolled out to the North- response to clinical questions are PRU simply refers the case to the
ern California Region this year. clear, but the close association appropriate facility authority (usu-
between research and opera- ally, the Nursery Director).
Leveraging Resources tions may also raise concerns. In the end, no attempt at The PRU
Ongoing support for PRU ac- For instance, allowing operations any kind of organizational brings to
tivities comes from KP and external leaders to influence the choice of censorship of the published knowledge
grants. Between 2000 and 2009, research topics may be perceived study has occurred, and the creation an
Kaiser Foundation Hospitals and as impinging on a PI’s intellectual Neonatology Chiefs’ culture effective
Health Plan provided an average integrity. However, Dr Escobar of transparency allows them balance
of approximately $600,000 per year finds interesting clinical research to improve care and to between
in direct support for the NMDS topics and contributes in mean- establish a precedent for rigor of
database, whereas TPMG provided ingful ways without jeopardizing performance improvement. methodology
approximately $200,000 per year his reputation or the integrity of and speed.
in support for programming and the research. Both the PI and KP Conclusions: What
consultation. Since 2000, the PRU operational leaders have a com- Differentiates the
has also averaged $1 million per mon goal (improved clinical care), Perinatal Research
year in external funding from the so there is much less potential Unit Model
federal government, foundations, conflict of interest than in other, A number of factors differentiate
and industry. Clearly, grantors more conventional relationships, the PRU model and contribute to
have benefited from Dr Escobar’s such as between researchers and its success:
operational insights and relation- pharmaceutical companies. • Data with high integrity and
ships, and KP has benefited from Equally important is the PRU’s granularity
the research conducted for external policy of transparency about re- • Statistical and analytic expertise
sources. Everyone wins. search results. Results from stud- and capacity
Although the NMDS database ies approved by the institutional • A PI with dual goals of improv-
was initially expensive to build and review board are always submitted ing patient care and building a
maintain, it provides value to KP on for publication, even if they make research reputation
multiple levels. Ready access to this clinicians uncomfortable. This was • Partnership with specialty and
database—with pilot data ready in the case with an Escobar study clinical leaders that includes vi-
days—makes the PRU very com- on neonatal “sepsis workup” that sionary specialty leadership and
petitive in securing external grants. found that only 78% of newborns a self-examining, data-driven
The results of research using the who met the study’s definition for learning culture
NMDS have answered clinical ques- “critical illness” had been treated • Senior operations leader spon-
tions and provided real benefit to with systemic antibiotics.3,18 Initial sorship.
KP in “rule out sepsis,” jaundice,15 reaction to this finding was con- Not all research units engage in
dehydration,16 outcomes13,14,17 for sternation, but after the results answering clinical and operations
late-preterm infants (Escobar GJ were confirmed by a repeat audit, questions with such agility, nor are
[PI]: Sepsis and critical illness in the neonatologists took a different many regional operations analysis
babies at 34 weeks gestation and stance: They changed the guideline units set up to manage the subtle
longer. Study in progress; funded for such infants. On the other hand, and clinical nature of some of
by the National Institute for General because the PRU aims at systematic these questions. The PRU brings
Medical Sciences), and respiratory knowledge, it handles incidental to knowledge creation an effective
distress in full-term babies. findings during the course of a balance between rigor of method-
study in a different manner. For ology and speed. Rigorous research
The Challenge of example, a study-required record work and research capability are
Bridging Research review might reveal an instance of leveraged to inform questions of
and Operations apparently inappropriate care. Be- day-to-day clinical practice in a
Serving the two masters of re- cause the PRU is not charged with more timely way.
search and operations is not without local quality assurance, this infor- The work of the PRU is en-
challenges. The benefits to KP mation is not published—nor is it abled by aligned interests and

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 55


ORIGINAL RESEARCH & CONTRIBUTIONS
The Northern California Perinatal Research Unit: A Hybrid Model Bridging Research, Quality California
The Northern Improvement and Clinical
Perinatal Practice
Research Unit:
A Hybrid Model Bridging Research, Quality Improvement and Clinical Practice

strong partnerships with clinicians, References 11. Peters KL, Rosychuk RJ, Hendson
medical leadership, and regional 1. Balas EA, Boren SA. Managing L, Coté JJ, McPherson C, Tyebkhan
clinical knowledge for health care JM. Improvement of short- and
executive operations leadership.
improvement. In: Yearbook of long-term outcomes for very low
The PRU has made a substantial medical informatics, 2000. Stutt- birth weight infants: Edmonton
contribution to Northern California gart, Germany: Schattauer; 2000. NIDCAP trial. Pediatrics 2009
neonatology’s reputation as among p 65–70. Oct;124(4):1009-20.
the best in the state. The model has 2. Escobar GJ, Fischer A, Kremers R, 12. UCSD physicist proposes new way
Usatin MS, Macedo AM, Gardner to rank scientists’ output [press
now been extended to adult hospi-
MN. Rapid retrieval of neonatal release on the Internet]. San Diego,
tal care in Northern California, and outcomes data: the Kaiser Perma- CA: University of California; 2005
a similar model is being explored nente Neonatal Minimum Data Nov 5 [cited 2010 Jul 7]. Available
in Southern California. Set. Qual Manag Health Care 1997 from: http://ucsdnews.ucsd.edu/
The PRU has developed a syn- Summer;5(4):19–33. ewsrel/science/MCH.asp.
ergistic approach to using internal 3. Escobar GJ, Li DK, Armstrong MA, 13. Escobar GJ, Shaheen SM, Breed
et al. Neonatal sepsis workups in EM, et al. Richardson score predicts
and external funding sources while
babies >/= 2000 grams at birth: A short-term adverse respiratory
effectively meeting the require- population-based study. Pediatrics outcomes in newborns >/= 34
ments of both. Dr Escobar has 2000 Aug;106(2 Pt 1):256–63. weeks gestation. J Pediatr 2004
maintained the highest standards of 4. Escobar GJ, Greene J, Hulac P, et Dec;145(6):754–60.
scholarship while exploring issues al. Rehospitalization after birth 14. Kuzniewicz M, Draper D, Escobar
hospitalization: patterns among GJ. Incorporation of physiological
that directly affect operations. Most
infants of all gestations. Arch Dis trend and interaction effects in
importantly, the leadership, trans- Child 2005 Feb;90(2):125–31. neonatal severity of illness scores:
parency, and partnership dem- 5. Wulf WA. The collabortory op- an experiment using a variant of
onstrated by Northern California portunity. Science 1993 Aug the Richardson score. Intensive
research, operations, and neonatol- 13;261(5123):854–5. Care Med 2007 Sep;33(9):1602–8.
ogy have resulted in demonstrably 6. Kuzniewicz MW, Escobar GJ, New- 15. Newman TB, Liljestrand P, Jeremy
man TB. Impact of universal biliru- RJ, et al; Jaundice and Infant Feed-
better care and outcomes for the
bin screening on severe hyperbili- ing Study Team. Outcomes among
mothers and babies of KP Northern rubinemia and phototherapy use. newborns with total serum bilirubin
California. v Pediatrics 2009 Oct;124(4):1031-9. levels of 25 mg per deciliter or
7. Trikalinos TA, Chung M, Lau J, Ip more. N Engl J Med 2006 May
a Those outside the Kaiser Permanente S. Systematic review of screen- 4;354(18):1889–900.
organization may send questions ing for bilirubin encephalopathy 16. Escobar GJ, Liljestrand P, Hudes ES,
concerning investigators to in neonates. Pediatrics 2009 et al. Five-year neurodevelopmental
[email protected]. Oct;124(4):1162-71. outcome of neonatal dehydration.
8. US Preventive Services Task Force; J Pediatr 2007 Aug;151(2):127–33,
Disclosure Statement Agency for Healthcare Research 133.e1.
The author(s) have no conflicts of and Quality. Screening of infants 17. Petrini JR, Dias T, McCormick MC,
interest to disclose. for hyperbilirubinemia to prevent Massolo ML, Green NS, Escobar
chronic bilirubin encephalopathy: GJ. Increased risk of adverse
Acknowledgments US Preventive Services Task Force neurological development for late
We are sincerely grateful for the recommendation statement. Pedi- preterm infants. J Pediatr 2009
open access to information and insights atrics 2009 Oct(4);124:1172-7. Feb;154(2):169–76.
provided by Gabriel Escobar, MD, and 9. Newman TB. Universal bili- 18. Escobar GJ. What have we learned
Eileen Walsh, RN, MPH. We also appreci- rubin screening, guidelines, from observational studies on neo-
ate the time and wisdom contributed and evidence. Pediatrics 2009 natal sepsis? Pediatr Crit Care Med
by senior TPMG leadership. Finally, we Oct;124(4):1199-1202. 2005 May;6(3 Suppl):S138–45.
thank the physicians and staff of the 10. Maisels MJ, Bhutani VK, Bogen D,
Northern California perinatal services in Newman TB, Stark AR, Watchko JF.
their continuing efforts to improve care Hyperbilirubinemia in the newborn
for our patients. infant > or = 35 weeks’ gesta-
Katharine O’Moore-Klopf, ELS, of KOK tion: an update with clarifications.
Edit provided editorial assistance. Pediatrics 2009 Oct;124(4):1193-8.

56 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


credits available for this article — see page 95.

REVIEW ARTICLE

Overview of Emerging Concepts in Metabolic Surgery


Michel Murr, MD, FACS
Arash Rafiei, MD
Introduction diabetes.12 The link between diabetes and obesity is Habib Ajami, MD
Tannous K Fakhry, MD
There is now a worldwide epidemic of obesity. Ac- due to induction of insulin resistance by excess adi-
cording to the Centers for Disease Control and Preven- pose tissue and generalized low chronic inflammation.
tion,1 the prevalence of obesity among all age groups The role of metabolic surgery in the treatment of
has increased significantly since 1990; about two-thirds obesity is well established.13 The Swedish Obese Sub-
of US adults are overweight or obese.2 jects (SOS) study demonstrated that metabolic surgery
Obesity is classified according to body mass index induces remission of diabetes in 69% of obese-diabetic
(BMI)3; overweight is a BMI of 25 to 29.9 kg/m2, class patients.14 Furthermore, in a meta-analysis of 136
I obesity is a BMI of 30 to 34.9 kg/m2, class II obesity studies, the proportion of patients who had diabe-
is a BMI of 35 to 39.9 kg/m2, and class III obesity is a tes before surgery (median, 11%; range, 3%–100%)
BMI of ≥40 kg/m2. and who showed fewer effects from or resolution
The 1998 National Heart, Lung, and Blood Institute of diabetes after surgery ranged from 64% to 100%
guidelines recommended a combination of low-calorie (median, 100%).15 Improvements in insulin sensitiv-
diet, exercise, and behavioral therapy as first-line treat- ity within the first few days after Roux-en-Y gastric
ment for obesity. Such a comprehensive approach re- bypass (RYGB), before any measurable weight loss,
sults in weight loss of 8% to 10%4; nonetheless, weight is commonly observed, and has been maintained at
regain is common after two years.5
Metabolic or bariatric surgery induces durable and
Table 1. Comorbidities associated with obesity
sustainable weight loss. The 1991 National Institutes
Category Comorbidity
of Health Consensus Conference Statement defined
Neurologic Pseudotumor cerebri
the criteria for bariatric surgery as a BMI of ≥40 kg/m2
Pulmonary Obstructive sleep apnea
or of ≥35 kg/m2 with comorbidities (Tables 1 and 2).6,7
Obesity hypoventilation syndrome
The most recent guidelines of the American Diabetes
Circulatory Hypertension
Association8 state that “bariatric surgery should be Cardiomyopathy
considered for adults with BMI >35 kg/m2 and type Pulmonary hypertension
2 diabetes, especially if the diabetes is difficult to Deep venous thrombosis
control with lifestyle modification and pharmacologic Gastrointestinal Gastroesophageal reflux disease
therapy.” Surgical candidates must have tried other Cholelithiasis
weight-loss modalities (diet, exercise, etc) before Nonalcoholic steatohepatitis
consideration of bariatric surgery. It is estimated that Genitourinary or gynecologic Stress urinary incontinence
about 3% of the US population, or approximately Polycystic ovary syndrome
five million people, meet the weight criteria for Musculoskeletal Mechanical arthropathy
bariatric surgery.9 Metabolic Diabetes mellitus
The prevalence of serious comorbidities such as Hyperlipidemia
metabolic syndrome is 39% among patients under- Hypercholesterolemia
going bariatric surgery.10 More importantly, among Metabolic syndrome
individuals with type 2 diabetes, 85% are overweight Psychiatric Depression
and 55% are obese.11 The Nurses’ Health Study dem- Binge-eating disorder
onstrated that individuals with a BMI of 35 kg/m2 had Somatization disorder
a 40-fold increase in their likelihood of developing Body dysmorphic disorder

Michel Murr, MD, FACS, is a Professor of Surgery and Director of Bariatric Surgery at the University of South Florida
Health Science Center in Tampa and a Bariatric Surgeon at Tampa General Hospital in FL. E-mail: [email protected].
Arash Rafiei, MD, is a General Surgeon at Tampa General Hospital in FL. E-mail: [email protected].
Habib Ajami, MD, is a Bariatric Surgeon at Tampa General Hospital in FL. E-mail: [email protected].
Tannous K Fakhry, MD, is a General Surgeon at Tampa General Hospital in FL. E-mail: [email protected].

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 57


REVIEW ARTICLE
Overview of Emerging Concepts in Metabolic Surgery

Table 2. Effects of bariatric surgery on obesity-related comorbidities surgery could lead to anemia, neurologic disorders,
Preoperative Remission >2 years
visual disorders, skin disorders, and edema.32 Therefore,
Comorbidity incidence (%) after surgery (%) patients who have undergone bariatric surgery require
Type 2 diabetes mellitus, IFG, or IGT 34 85 indefinite, regular follow-up care by their primary care
Hypertension 26 66 physicians. The surgical mortality rates are 0.1% for
Hypertriglyceridemia and low HDL 40 85 LAGB and 0.5% for RYGB.21
cholesterol level
Sleep apnea 22 (in men) 40 Types of Metabolic Procedures
1 (in women) Bariatric procedures fall into two categories: restric-
Obesity-hypoventilation syndrome 12 76 tive procedures, such as LAGB and sleeve gastrectomy
HDL = high-density lipoprotein; IFG = impaired fasting glucose; IGT = impaired glucose tolerance. (SG), which limit the amount of oral intake, and di-
Table adapted and reprinted from Endocrinology and Metabolism Clinics of North America 1996 Dec
1, 25(4), Greenway FL, Surgery for obesity:1005-27, Copyright 1996, with permission from Elsevier.6 versionary procedures that divert nutrients from the
stomach and duodenum and use the Roux anatomy
12 months after surgery.16 Similarly, in a randomized in combination with either mild restriction, such as in
study, laparoscopic adjustable gastric banding (LAGB) RYGB, or malabsorption, as in biliopancreatic diver-
was far superior to standard nonsurgical therapy in sion/duodenal switch. The vertical banded gastroplasty
inducing remission of diabetes.17 and jejunoileal bypass are no longer undertaken, owing
The remission of obesity-related comorbidities such to insufficient weight loss33 and devastating malabsorp-
as metabolic syndrome after bariatric surgery is ac- tive sequelae,34 respectively.
companied by increased longevity. In the SOS study, LAGB was first introduced in Europe during the
metabolic surgery reduced overall mortality by 29%.18 1990s and was approved for use in the US by the Food
In a larger cohort of patients who underwent RYGB, and Drug Administration in 2001. It involves placing a
deaths from coronary artery disease were reduced by band around the cardia of the stomach (Figure 1). The
56%, cancer-related deaths decreased by 60%, and more inner diameter of the band can be adjusted during an
importantly, disease-specific mortality from diabetes outpatient office visit by injecting normal saline into
decreased by 92%.19 a subcutaneous reservoir. Several studies suggest that
Surgically induced weight loss reduces other mark- LAGB is associated with fewer complications and a
The remission
ers of metabolic syndrome such as serum triglyceride lower mortality rate (0%–0.7%) than are other restrictive
of obesity-
and cholesterol levels,20 as well as hypertension in
related
at least 62% of patients.21,22 In addition, metabolic
comorbidities
surgery significantly improves obstructive sleep ap-
such as
nea,23 gastroesophageal reflux disease,24 mechanical
metabolic
arthropathy,25 fatty liver,26 fertility problems, and urinary
syndrome
incontinence.27
after bariatric
Moreover, metabolic surgery reduces obesity-related
surgery is
costs and use of health care resources. It is estimated
accompanied
that the cost of surgical interventions for class II to
by increased
class III obesity is offset by the subsequent reduction
longevity.
in pharmaceutical and hospitalization cost within the
first two years after bariatric surgery.28,29
Additionally, surgical treatment of obesity improves
quality-of-life measures. The SOS study found a positive
correlation between improvement in quality of life and
the degree of weight loss.30 This was echoed by another
study, in which 95% of those who had undergone bar-
iatric surgery had improvements in their quality of life.31
Physicians who care for patients after bariatric sur-
gery need to be familiar with common postoperative
syndromes that result from specific nutrient deficien-
cies: protein, vitamin, and trace-element (iron, zinc)
deficiencies.32 Nutritional consequences of bariatric
Figure 1. Adjustable gastric banding.

58 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


REVIEW ARTICLE
Overview of Emerging Concepts in Metabolic Surgery

Figure 2. Sleeve gastrectomy. Figure 3. Roux-en-Y gastric bypass.


From Karmali S, Schauer P, Birch D, Sharma AM, Sherman V. Laparoscopic
sleeve gastrectomy: an innovative new tool in the battle against the obesity
epidemic in Canada. Can J Surg 2010 Apr;53(2):126-32.38 Reprinted with with an overall complication rate of 10% and a mortal-
permission from Cleveland Clinic Center for Medical Art and Photography
© 2006-2010. All Rights Reserved. ity rate of 0.4%.42 Early complications include anasto-
motic leak (3%), deep vein thrombosis or pulmonary
embolism (3%), bleeding (3%), and wound infection
or diversionary procedures35,36; however, it is associated (4%). Late complications include anastomotic strictures
with a higher likelihood for reoperation.37,38 A meta- (5%), ulcers (2%), and incisional hernia or small bowel
analysis of 136 studies showed that weight loss after obstruction (2%).
LAGB ranged from 40% to 54%.21 The foregut and hindgut hypotheses have been pro-
SG, another restrictive procedure was introduced in posed to explain the resolution of diabetes after RYGB.
1993. It is a form of unbanded gastroplasty involving a Rubino et al43 offered the foregut hypothesis: that when
subtotal vertical gastrectomy (Figure 2).39 Complication food bypasses the duodenum and proximal jejunum
rates range from 0% to 24%, and the mortality rate is after bariatric surgery, a so-called anti-incretin or de-
0.4%.40 Resolution of comorbidities at 12 to 24 months cretin factor that is yet unknown is inhibited and thus
after SG has been satisfactory, but long-term data are insulin resistance is decreased and glucose tolerance
still lacking.41 improves. Cummings et al44 and Patriti et al45 proposed
RYGB is the most common bariatric procedure un- the hindgut explanation, suggesting that the quick
dertaken in North America. The stomach is divided to transit of nutrients to the distal bowel improves glucose
make a small pouch (15–30 mL) from the cardia. The metabolism by stimulating secretion of glucagon-like
midjejunum (Roux limb) is anastomosed to the gastric peptide-1 and peptide YY. Insulin secretion is increased
pouch. Gastrointestinal tract continuity is reestablished and glucose tolerance improves, affecting body weight
by anastomosing the biliopancreatic limb to the midje- and food intake.
junum forming the common channel where digestion Most patients undergoing bariatric surgery have some
and absorption occurs (Figure 3). RYGB is associated degree of hepatic steatosis: Approximately 25% have

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 59


REVIEW ARTICLE
Overview of Emerging Concepts in Metabolic Surgery

nonalcoholic steatohepatitis, and 1% to 3% have cir- Preoperative Evaluation


rhosis that is incidentally found in the operating room.46 A multidisciplinary and comprehensive approach is
All studies using standard RYGB have consistently preferred for the management of morbid obesity.50 All
demonstrated decreased steatosis on follow-up liver patients who are considering bariatric surgery should
biopsy. The alteration in the gut hormone’s response be evaluated and screened by an interdisciplinary
after RYGB—namely, the upregulation of glucagon-like team that includes a bariatric surgeon, a bariatri-
peptide-1—has been shown to decrease the nonalco- cian, a nutritionist, a psychologist, and an exercise
holic fatty liver disease induced by obesity.46 physiologist. In addition to conducting a routine
Biliopancreatic diversion (BPD) and biliopancreatic assessment, the interdisciplinary team should aim at
diversion with duodenal switch (BPD/DS) involve a reducing perioperative risks specifically in patients
partial gastric resection and a short common channel with a BMI of >50 kg/m2, hypertension, or previous
(Figure 4).46 Consequently, the likelihood of protein- history of thromboembolism as well as in men and
calorie malabsorption approaches 7%; a smaller number in patients older than 45 years.51 Risk reduction may
of patients will require additional operations to lengthen be achieved by preoperative weight loss, prophylac-
the common channel.47 In comparison to other bariat- tic inferior vena cava filter, and smoking cessation.51
ric procedures, patients who undergo BPD or BPD/ More importantly, the preoperative evaluation lays
DS have rapid and greater long-term weight loss that the foundation for healthy eating habits and lifelong
exceeds 70%.48 behavior modification.
In our practice, we recommend RYGB for patients
with diabetes or those with a BMI of >50 kg/m2. Our Postoperative Care
experience suggests that patients with a BMI of >50 kg/ Patients with severe cardiac disease, diabetes, or
m2 who undergo LAGB may not lose enough weight severe obstructive sleep apnea are monitored in an
to overcome their comorbidities and achieve the BMI intermediate or intensive care unit. Tachycardia is an
of <40 kg/m2 that is supported in the literature.49 In important indicator of postoperative complications and
addition, diabetes decreases immediately after RYGB, should be addressed promptly and treated accordingly.52
whereas the reduction of diabetes after LAGB depends In our practice, β-blockers are given immediately after
on how much weight is lost. surgery to patients who were taking them before surgery
and to selected high-risk patients. We initiate continuous
positive airway pressure or bilevel positive airway pres-
sure early in the recovery room by using the patient’s
own equipment. Oral food intake is initiated after an
upper gastrointestinal tract study for fast tracking.

Follow-up Care
Restrictive procedures are not associated with altera-
tions in intestinal continuity. As a result, nutritional
deficiencies are uncommon. The anatomic changes
because of diversionary surgical procedures, however,
increase the likelihood of various nutrient deficiencies;
therefore, we prescribe multivitamins with iron, vitamin
B12 injections, calcium, and vitamin D supplements.
Additionally, protein supplements should be given as
soon as patients can tolerate oral intake.
The first postoperative office visit is scheduled two
to three weeks after the procedure. By this time, most
patients can tolerate semisolid food, and therefore it is
important to differentiate between excessive oral intake,
Figure 4. (A) Biliopancreatic diversion. (B) Biliopancreatic diversion with duodenal anastomotic strictures, and ulcers that also manifest as
switch.
intolerance to food, nausea, and vomiting.
Reprinted from Clinics in Liver Disease, 13(4), Pillai AA, Rinella ME. Non-alcoholic fatty liver disease: is bariatric
surgery the answer? 689-710 2009, with permission from Elsevier. Available from: www.sciencedirect.com/
The frequency of follow-up visits depends on the
science/journal/10893261.45 type of procedure. Patients who undergo LAGB usu-

60 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


REVIEW ARTICLE
Overview of Emerging Concepts in Metabolic Surgery

ally need their first band fill between four and eight 7. Mechanick JI, Kushner RF, Sugerman HJ, et al; American
weeks after surgery and every two months thereafter. Association of Clinical Endocrinologists; Obesity Society;
American Society for Metabolic & Bariatric Surgery. Ameri-
Patients who have undergone RYGB are scheduled for
can Association of Clinical Endocrinologists, The Obesity
follow-up visits every three to four months in the first Society, and American Society for Metabolic & Bariatric
year and twice yearly thereafter. Surgery medical guidelines for clinical practice for the peri-
A complete blood cell count and liver function tests operative nutritional, metabolic, and nonsurgical support
are conducted once or twice yearly, and levels of total of the bariatric surgery patient. Obesity (Silver Spring) 2009
Apr;17 Suppl 1:S1–70,v. Erratum in Obesity (Silver Spring). … it is
serum protein, electrolytes, blood urea nitrogen, cre-
2010 Mar;18(3):649. important to
atinine, and albumin are measured on this schedule 8. Kirkman MS, Dunbar SA; American Diabetes Association. differentiate
too. Additionally, we recommend measuring levels of The American Diabetes Association (ADA) has been actively
between
parathyroid hormone, vitamins D and B12, folic acid, involved in the development and dissemination of diabetes
care standards, guidelines, and related documents for many excessive
iron, and ferritin every one to two years after bariatric
years. Introduction. Diabetes Care Jan 2009;32 Suppl 1:S1–2. oral intake,
surgery or as needed.
9. Nelson LG, Murr MM. Operative treatment of clinically anastomotic
significant obesity. Board review series. Hospital Physician strictures,
The Future of Metabolic Surgery 2005;8(2):2–12. and ulcers
The future of metabolic surgery lies with the innova- 10. Nguyen NT, Magno CP, Lane KT, Hinojosa MW, Lane JS. As-
that also
tive approaches of surgeons and the ever-expanding sociation of hypertension, diabetes, dyslipidemia, and meta-
bolic syndrome with obesity: findings from the National manifest as
understanding of obesity by nonsurgeons. Several stud-
Health and Nutrition Examination Survey, 1999 to 2004. intolerance
ies that are now examining the benefits of metabolic
J Am Coll Surg 2008 Dec;207(6):928–34. to food,
surgery in class II obesity are promising. Endoluminal
11. Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual nausea, and
applications and device interventions now in phase 1 causes of death in the United States, 2000. JAMA 2004 vomiting.
and 2 studies are other exciting areas of research. In Mar 10;291(10):1238–45. Erratum in: JAMA 2005 Jan
addition to preventing comorbidities, metabolic surgery 19;293(3):298; JAMA 2005 Jan 19;293(3):293-4.
may be used as a primary tool for the treatment of 12. Colditz GA, Willett WC, Rotnitzky A, Manson JE. Weight
gain as a risk factor for clinical diabetes mellitus in women.
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Ann Intern Med 1995 Apr 1;122(7):481–6.
13. Sjöström L, Lindroos AK, Peltonen M, et al; Swedish Obese
Disclosure Statement
Subjects Study Scientific Group. Lifestyle, diabetes, and
The author(s) have no conflicts of interest to disclose.
cardiovascular risk factors 10 years after bariatric surgery.
N Engl J Med 2004 Dec 23;351(26):2683–93.
Acknowledgment
14. Sjöström CD, Lissner L, Sjöström L. Relationships between
Katharine O’Moore-Klopf, ELS, of KOK Edit provided editorial
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assistance.
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May–Jun; 2(3):384–8. 42. Murr MM, Martin T, Haines K, et al. A state-wide review
26. Parsee A, Murr MM. Outcomes in bariatric surgery: im- of contemporary outcomes of gastric bypass in Florida:
provement in steatohepatitis and liver fibrosis. Surg Obes does provider volume impact outcomes? Ann Surg 2007
Relat Dis 2009 May;5(3 suppl):S46–S47. May;245(5):699–706.
27. Kuruba R, Almahmeed T, Martinez F, et al. Bariatric surgery 43. Rubino F, Forgione A, Cummings DE, et al. The mecha-
improves urinary incontinence in morbidly obese individuals. nism of diabetes control after gastrointestinal bypass
Surg Obes Relat Dis 2007 Nov–Dec;3(6):586–90. surgery reveals a role of the proximal small intestine in
28. Gallagher SF, Banasiak M, Gonzalvo JP, et al. The impact of the pathophysiology of type 2 diabetes. Ann Surg 2006
bariatric surgery on the Veterans Administration healthcare Nov;244(5):741–9.
system: a cost analysis. Obes Surg 2003 Apr;13(2):245–8. 44. Cummings DE, Overduin J, Foster-Schubert KE, Carlson MJ.
29. Cremieux PY, Buchwald H, Shikora SA, Ghosh A, Yang HE, Role of the bypassed proximal intestine in the anti-diabetic
Buessing M. A study on the economic impact of bariatric effects of bariatric surgery. Surg Obes Relat Dis 2007 Mar–
surgery. Am J Manag Care 2008 Sep;14(9):589–96. Apr;3(2):109–15.
30. Karlsson J, Sjöström L, Sullivan M. Swedish obese subjects 45. Patriti A, Aisa MC, Annetti C, et al. How the hindgut can
(SOS)—an intervention study of obesity. Two-year follow-up cure type 2 diabetes. Ileal transposition improves glucose
of health-related quality of life (HRQL) and eating behavior metabolism and beta-cell function in Goto-kakizaki rats
after gastric surgery for severe obesity. Int J Obes Relat through enhanced Proglucagon gene expression and L-cell
Metab Disord 1998 Feb;22(2):113–26. number. Surgery 2007 Jul;142(1):74–85.
31. Schauer PR, Ikramuddin S, Gourash W, Ramanathan R, 46. Pillai AA, Rinella ME. Non-alcoholic fatty liver disease:
Luketich J. Outcomes after Laparoscopic Roux-en-Y gastric is bariatric surgery the answer? Clin Liver Dis 2009
bypass for morbid obesity. Ann Surg 2000 Oct;232(4):515-29 Nov;13(4):689–710. Available from: www.sciencedirect.
32. Koch TR, Finelli FC. Postoperative metabolic and nutritional com/Science/journal/10893261.
complications of bariatric surgery. Gastroenterol Clin North 47. Sugerman HJ. Bariatric surgery for severe obesity. J Assoc
Am 2010 Mar;39(1):109–24. Acad Minor Phys 2001 Jul;12(3):129–36.
33. Balsiger BM, Poggio JL, Mai J, Kelly KA, Sarr MG. Ten and 48. Buchwald H, Estok R, Fahrbach K, et al. Weight and type 2
more years after vertical banded gastroplasty as primary diabetes after bariatric surgery: systematic review and meta-
operation for morbid obesity. J Gastrointest Surg 2000 Nov– analysis. Am J Med 2009 Mar;122(3):248–56.e5.
Dec;4(6):598–605. 49. Nguyen NT, Slone JA, Nguyen XM, Hartman JS, Hoyt DB. A
34. Hocking MP, Davis GL, Franzini DA, Woodward ER. Long- prospective randomized trial of laparoscopic gastric bypass
term consequences after jejunoileal bypass for morbid versus laparoscopic adjustable gastric banding for the treat-
obesity. Dig Dis Sci 1998 Nov;43(11):2493–9. ment of morbid obesity: outcomes, quality of life, and costs.
35. O’Brien PE, Dixon JB, Brown W, et al. The laparoscopic Ann Surg 2009 Aug 27;250(4):631–41.
adjustable gastric band (Lap-Band): a prospective study of 50. DeMaria EJ, Murr M, Byrne TK, et al. Validation
����������������������
of the obe-
medium-term effects on weight, health and quality of life. sity surgery mortality risk score in a multicenter study proves
Obes Surg 2002 Oct;12(5):652–60. it stratifies mortality risk in patients undergoing gastric by-
36. The Lap-Band Adjustable Gastric Banding System summary pass for morbid obesity. Ann Surg 2007 Oct;246(4):578–82;
of safety and effectiveness data [monograph on the Inter- discussion 583–4.
net]. Silver Spring, MD: US Food and Drug Administration: 51. Gonzalez R, Haines K, Nelson LG, Gallagher SF, Murr MM.
2001 [cited 2010 Jul 20]. Available from: www.accessdata. Predictive factors of thromboembolic events in patients
fda.gov/cdrh_docs/pdf/P000008b.pdf. undergoing Roux-en-Y gastric bypass. Surg Obes Relat Dis
37. O’Brien PE, Dixon JB. Weight loss and early and late com- 2006 Jan–Feb;2(1):30–5; discussion 35–6.
plications—the international experience. Am J Surg 2002 52. Gonzalez R, Sarr MG, Smith CD, et al. Diagnosis and con-
Dec;184(6B):42S–5S. temporary management of anastomotic leaks after gastric
bypass for obesity. J Am Coll Surg 2007 Jan;204(1):47–55.

62 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


soul of the healer

“HA 260 #3”


36 x 24”
acrylic on canvas

Josh Schechtel, MD

Josh Schechtel, MD, is a hospital-based Pediatrician and Chief


of Professional Staff Education at the Oakland Medical Center in CA.
He has been drawing, designing gardens, and fabricating tile mosaics for many
years and started painting about three years ago. This painting is one of
a series of abstracts based on aerial views of crops on Moloka’i.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 63


credits available for this article — see page 95.

REVIEW ARTICLE

Thiazolidinediones: A 2010 Perspective


Ashok Krishnaswami, MD, FACC
Shalini Ravi-Kumar, MD
John M Lewis, MD trials be further studied in a long-term cardiovascular
Abstract trial.1 The answer was resoundingly in the affirmative for
A large number of cardiology clinical trials have mor- the need to have future antidiabetic medications achieve
tality as an endpoint unless adequate surrogate endpoints a beneficial cardiovascular mortality profile before FDA
are available. Although there are nine classes of agents approval is given.
used in the treatment of diabetes mellitus, none have TZDs are a class of medications currently approved
shown a mortality benefit in clinical trials. The United by the FDA to treat type 2 diabetes mellitus. However,
Kingdom Prospective Diabetic Study was the first to sug- there is significant debate surrounding its safety. Trogli-
gest that metformin given for diabetes mellitus had a trend tazone, the first TZD to be approved by the FDA to treat
toward lowering mortality. The accidental discovery of type 2 diabetes mellitus was withdrawn in the year 2000
peroxisome proliferator-activated receptors (PPARs) led because of idiosyncratic hepatotoxicity. Currently there
to the introduction of the thiazolidinediones (TZD), a are two TZDs on the market: rosiglitazone (Avandia) and
PPAR agent with a suggestion of a promise for the fu- pioglitazone (Actos). Because they improve insulin sensi-
ture. As the incidence of cardiovascular complications tivity2 and carry a low risk of causing hypoglycemia, they
related to diabetes mellitus increases, there is a sense have been quickly incorporated into clinical practice and
of urgency to produce antidiabetic medications that represent as much as 25% of total prescriptions for oral
achieve not only nontoxic glycemic control but also im- hypoglycemia medications.3 However, the TZDs—specif-
proved cardiovascular outcomes. The goal of this review ically, rosiglitazone—have faced a great deal of criticism
is to aid the clinician to appropriately assess the benefits because of the discovery of worrisome adverse affects.
and risks of TZD use when prescribing for patients. This has affected TZD prescribing patterns within Kaiser
Permanente Northern California (KPNC) (Table 1). The
Introduction most debated side effect is whether rosiglitazone causes
It is well known that microvascular disease in type 2 heart attacks. The aim of this review is to shed light on
diabetes mellitus can be halted with aggressive glycemic the overall understanding of TZDs. Subsequently, we
control. Even with nine classes of antidiabetic agents hope that it provokes a healthy discussion regarding the
currently on the market, only the biguanide metformin appropriate use and placement of TZDs (specifically,
has shown a trend toward decreasing macrovascular dis- pioglitazone) within the KPNC PHASE (Prevent Heart
ease. The goal so far, understandably, has been focused Attack and Stroke Everyday) program.
on glycemic control. However, with the abundance of
hypoglycemic agents on the market, medications will Biology of Peroxisome Proliferator–
have to be chosen to not only achieve glycemic control Activated Receptors
but also decrease cardiovascular mortality. Peroxisome proliferator-activated receptors (PPARs)
The thiazolidinediones (TZDs) are the first group of are a family of intracellular receptors for fatty acids and
antidiabetic medications that attempted to scale this pin- fatty-acid derivatives. Three types of PPARs are expressed
nacle of reducing cardiovascular mortality within a highly in a variety of metabolic tissues: PPAR-α, PPAR-β/δ, and
competitive arena. In July 2008, the US Food and Drug PPAR-γ. PPARs, unlike other receptors, are located within
Administration (FDA) convened a meeting to discuss the cell nucleus, where they are thought to exert their
the question of whether there should be a requirement effect of regulating gene transcription directly within the
that any antidiabetic medications without a concerning cell. Each receptor has unique locations and functions.
cardiovascular safety signal during early-phase clinical PPAR-α is expressed in metabolically active tis-

Ashok Krishnaswami, MD, FACC, is a Staff Cardiologist and Local Research Chair in the Department
of Cardiology at the San Jose Medical Center in CA. E-mail: [email protected].
Shalini Ravi-Kumar, MD, is an Internal Medicine Resident at the University of New Mexico in
Albuquerque. E-mail: [email protected].
John M Lewis, MD, is an Ophthalmologist with an expertise in retinal diseases at Kaiser Permanente
Santa Clara Homestead in CA. E-mail: [email protected].

64 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


REVIEW ARTICLE
Thiazolidinediones: A 2010 Perspective

Table 1. Crude thiazolidinedione (pioglitazone and rosiglitazone) use within Kaiser Permanente
Northern California in two contiguous years
September 2006–August 2007 September 2007–August 2008
Pioglitazone prescriptions 84,882 83,011
Total number of patients taking pioglitazone 29,507 28,049
Rosiglitazone prescriptions 2227 737
Total number of patients taking rosiglitazone 851 276
Data from written personal communication from Jim Chan, PharmD, PhD, September 30, 2008.a

sues such as the liver and plays a large role in lipid is similar to the hypoglycemic effects of the sulfonylureas
and lipoprotein metabolism and also in suppressing and metformin.8 They do this primarily by increasing
vascular and systemic inflammation. Fenofibrate and skeletal muscle glucose uptake and less by decreasing
gemfibrozil are some important examples of ligands hepatic production of glucose. They also are thought to
for this receptor. PPAR-δ is the most widely distributed preserve β-cell function; this effect has been shown in
PPAR. Its exact role is yet unclear, but it too plays a role animal models as well as in human studies.
in lipid metabolism; it also plays a role in cholesterol They have varying effects on lipid metabolism. Both
homeostasis in macrophages, embryo implantation, and TZDs increase high-density lipoprotein (HDL) cholesterol
cell proliferation. PPAR-γ is mostly expressed in adipose and low-density lipoprotein (LDL) cholesterol. A varia-
tissue (adipocytes). It is also found in skeletal muscle, tion between the two TZDs has been noted in respect
hepatocytes, intestinal tissue, endothelial cells, cardiac to their effects on LDL particle concentration and size,
muscle, the renal collecting duct, and in macrophages. producing an overall shift to a larger, more buoyant LDL
The primary role of PPAR-γ appears to be in regulating particle. Triglyceride levels are also decreased with both
adipogenesis along with glucose and lipid metabolism. TZDs, with there being a larger decrease with piogli-
PPAR-γ is thought to enhance the actions of insulin and tazone. These effects may be related to pioglitazone’s
decrease resistance to insulin. Ligands for PPAR-γ include effect on hepatic PPAR-α.
free fatty acids, certain prostaglandin derivatives, non- TZDs also increase body weight by differentiation of
steroidal anti-inflammatory agents, and TZDs. All TZDs preadipocytes to adipocytes and increasing adipocyte
have varying selectivity for each PPAR receptor and thus mass. Although it is known that increased levels of
have a variety of effects on the human body besides their adiposity increase the propensity of cardiovascular risk,
primary action3–7 (Table 2). other features of TZDs are thought to perhaps attenuate
this risk. One such example is redistribution of fat from
Effects of Thiazolidinediones on visceral to subcutaneous depots, a pattern that is thought
Diabetes Mellitus, Lipids, and to be associated with decreased risk for cardiovascular
Adipocytes disease (CVD).3 This pattern of change is also associated
TZDs have additional effects besides their primary role with increased adiponectin and decreased tissue-necrosis
as antihypoglycemics. They typically reduce glycated factor–α levels. Both are associated with favorable
HbA1c by 1% to 2% when compared with placebo. This changes in CVD risk profile. TZDs also decrease circu-

Table 2. The beneficial and harmful effects of thiazolidinediones


Beneficial effects Harmful effects
Improvement in cardiac function Increase in body weight
Improvement in cardiac metabolism and glucose uptake Fluid retention
Coronary vasodilation Possible congestive heart failure
Regression of left ventricular hypertrophy Possible macular edema
Improvement in vascular insulin resistance Fractures
Decrease in blood pressure Increase in LDL-cholesterol
Improvement in endothelial function Highly debated risk of myocardial infarctiona
Increase in HDL cholesterol and decrease in triglycerides
Decrease in HbA1c by 1-2%
a
Exact risk is unknown. Prospective randomized clinical trial planned by GlaxoSmithKline, producer of rosiglitazone halted by the US Food and
Drug Administration.
LDL = low-density lipoprotein; HDL = high-density lipoprotein.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 65


REVIEW ARTICLE
Thiazolidinediones: A 2010 Perspective

lating free fatty acids, with resultant favorable effects in 1982 that intensive glycemic control decreases micro-
on the liver and skeletal muscle.3 vascular complications in type 1 diabetes mellitus, there
is yet no conclusive proof that a current FDA-approved
Effects of Thiazolidinediones on treatment can reduce the risk of macrovascular compli-
Inflammation and Endothelial Function cations in persons with type 2 diabetes mellitus. The
Vascular inflammation is a fundamental component University Group Diabetes Program actually showed
in the process of atherosclerosis. This process, with that tolbutamide increased cardiovascular mortality.8
subsequent thrombosis, is lengthy and complicated, The United Kingdom Prospective Diabetes Study was
developing usually over decades. The final rupture the first study to suggest that a diabetic medication had
of the atherosclerotic cap, with spillage of the highly a favorable CVD risk profile. It showed a nonsignificant
thrombogenic infracap contents into the coronary ves- reduction (p = 0.052) in myocardial infarction in patients
sel lumen, is the explanation for most fatal coronary treated intensively with insulin or sulfonylureas. It also
thromboses. However, for coronary plaque progression showed a reduction in diabetes-related death and all-
to occur, continued inflammation is needed. Numerous cause mortality in a substudy of 342 overweight persons
mediators of inflammation are expressed, such as adhe- given metformin.12 In a 10-year post-trial observational
sion molecules and growth factors, whereas release of follow-up assessment, the reduction in these CVD events
chemoattractants and elaboration of cytokines weaken became statistically significant.13
the fibrous atherosclerotic cap. It is thought that transcrip- Numerous studies have assessed the role of TZDs in
tion factor nuclear factor (NF)-kB mediates many of the persons with type 2 diabetes mellitus. Small controlled
inflammatory processes that occur during the develop- studies using surrogate markers such as carotid intimal-
ment of atherosclerosis. Multiple studies have suggested media thickness (IMT) have shown a decrease in the
that PPAR activation favorably modulates NF-kB action.3 progression of carotid IMT in persons treated with a
TZDs also favorably affect coronary and peripheral TZD. Protective effects against restenosis after percutane-
vasodilation, along with minimally improving blood ous intervention in TZD-treated patients have also been
pressure. These effects are thought to be mediated by noted.3 Large randomized, controlled trials that have
increasing endothelial release of nitric oxide, increased assessed the effects of TZDs on major CVD events that
expression of vascular endothelial growth factor, and are completed or ongoing are described in the following
decreased expression of endothelin-1. TZDs also par- paragraphs. In evaluating the results of all these trials,
tially inhibit voltage-gated L-type calcium channels. one should distinguish those that compare TZDs with
These channels are the mechanisms of action on the placebo as an add-on therapy to those that compare
nondihydropyridine calcium-channel blockers. Although TZDs with other hypoglycemic drugs.
the effect of blood pressure reduction is minimal, epi- PROactive14 (the PROspective pioglitAzone Clinical
demiologic estimates suggest that this small change may Trial In macroVascular Events) was the first study that
provide a significant decrease in the risk of stroke and assessed the effect of an antidiabetic medication on
myocardial infarctions.3 cardiovascular outcomes. PROactive was a well-run
prospective randomized-controlled trial in 5238 patients,
Data Favoring Thiazolidinediones designed to assess whether pioglitazone titrated to a
(the Good or Neutral) maximum dose of 45 mg/d, compared with placebo
The Diabetes Control and Complications Trial (DCCT) in addition to the usual standard of glycemic therapy
conclusively demonstrated that tight glucose control in care, decreased macrovascular events. The average
persons with type 1 diabetes significantly decreased follow-up period was 34.5 months. The results showed
microvascular complications such as retinopathy, ne- a statistically nonsignificant reduction in the primary
phropathy, and neuropathy.9 After a follow-up period of endpoint (all-cause mortality, nonfatal myocardial in-
7 to 9 years of 1205 persons with well-controlled type 1 farction, stroke, acute coronary syndrome, endovascular
diabetes who were involved in the DCCT study, the Epi- or surgical intervention in the coronary or leg arteries,
demiology of Diabetes Interventions and Complications or above-the-knee amputation) in the pioglitazone
study showed decreased macrovascular complications group. This was despite an adequate number of events
(coronary calcification).10 in both arms of the study (514 of 2605 in the piogli-
A decrease in microvascular complications in persons tazone group and 572 of 2633 in the placebo group;
with type 2 diabetes mellitus is thought to be backed up p = 0.095). However, the secondary endpoint that was
by reasonably strong data.11,12 Although it was shown predefined (all-cause mortality, myocardial infarction,

66 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


REVIEW ARTICLE
Thiazolidinediones: A 2010 Perspective

or stroke) was significantly reduced in the pioglitazone and ramipril was titrated to a maximum dose of 15 mg/d
group (301 patients in the pioglitazone group and 358 in in a 2 × 2 factorial design. The primary outcome was a
the placebo group; p = 0.027). It is noteworthy that the composite of incident type 2 diabetes mellitus or death.
time to permanent insulin use was significantly decreased The results of the study showed that fewer individuals
in the pioglitazone group. experienced the composite primary outcome in the
ADOPT15 (A Diabetes Outcome Progression Trial) rosiglitazone group compared with the placebo group
was a multicenter, randomized, double-blind, controlled [306 (11.6%), 686 (26.0%); p < 0.0001]. One-half of the
clinical trial that sought to answer whether monotherapy individuals in the rosiglitazone group and approximately
with either rosiglitazone, metformin, or glyburide was one-third of the placebo group achieved normoglycemia
sufficient to maintain euglycemia in persons in whom [1330 (50.5%), 798 (30.3%); p < 0.0001]. Also among
type 2 diabetes mellitus had recently been diagnosed individuals with impaired fasting glucose or impaired
and who had not taken any diabetes medications before. glucose tolerance, taking ramipril for 3 years significantly
The primary outcome was the time to monotherapy increased regression to normoglycemia but did not
failure (plasma glucose >180 mg/dL after an overnight significantly decrease the incidence of type 2 diabetes
fast). Analysis of the outcomes showed a cumulative mellitus or death.
incidence of monotherapy failure at 5 years of 15% The ACT NOW17 trial, presented at the American … the
with rosiglitazone, 21% with metformin, and 34% with Diabetes Association 2008 meeting, randomized par- unknown risk
glyburide. This was a 32% greater risk reduction for rosi- ticipants to placebo or pioglitazone titrated to 45 mg/d. of myocardial
glitazone compared with metformin, and a 63% greater Pioglitazone decreased the rate of progression to type 2 infarction with
risk reduction compared with glyburide (p < 0.0001 for diabetes mellitus (1.5% per year) compared with placebo rosiglitazone
both comparisons). However, some important limitations (6.8% per year; hazard ratio [HR], 0.19; p < 0.00001). The is the biggest
of the study should be mentioned: 1) the study was an risk of fracture, heart failure, and other adverse events and most
efficacy and safety trial and not a primary cardiovascular was similar except for a higher rate of edema in the pio- heated
endpoint trial; 2) there was a large withdrawal rate; and glitazone group compared with placebo (22% vs 15%). debate.
3) patients with type 2 diabetes mellitus were in a very In April 2008, results of the PERISCOPE18 (Comparison
early stage in this study, and thus they may not represent of Pioglitazone versus Glimepiride on Progression of
the general population of patients with type 2 diabetes Coronary Atherosclerosis in Patients with Type 2 Dia-
mellitus. Preliminary cardiovascular safety findings had betes) trial were published. PERISCOPE was a coronary
not detected a significant difference in cardiac ischemic intravascular ultrasound (IVUS) study in 547 patients
event rates between rosiglitazone and metformin or gly- with type 2 diabetes mellitus who underwent coronary
buride, but many believe that an increased risk cannot angiography for clinical indications with a “target vessel”
be ruled out.1 There were understandably more patients for IVUS that had a stenosis of <50% in an area of 40 mm
with heart-failure events with rosiglitazone than with or longer. The primary endpoint was change in percent
metformin or glyburide. atheroma volume (PAV) from baseline. They were then
The DREAM16 (Diabetes REduction Assessment with randomized to receive either glimepiride or pioglitazone,
ramipril and rosiglitazone Medication) trial was a primary which was then titrated to a maximum tolerated dose.
prevention study to assess whether rosiglitazone would If a patient required cardiac catheterization for a clinical
prevent type 2 diabetes mellitus in persons at high risk for indication at a point between 12 and 18 months, a follow-
developing the disease. The inclusion criteria included up IVUS study was performed. Only 181 patients in the
either impaired fasting glucose (fasting plasma glucose glimepiride group and 179 patients in the pioglitazone
of 110–126 mg/dL and 2-hour plasma glucose <200 mg/ group were included in the primary analysis (66% of
dL during the oral glucose tolerance test) or impaired the initial cohort). The least-squares mean of the PAV
glucose tolerance (either fasting plasma glucose <126 increased in patients taking glimepiride and decreased
mg/dL and 2-hour plasma glucose of 140–200 mg/dL). in patients taking pioglitazone (0.73 vs –0.16; p = 0.002).
The exclusion criteria were a history of type 2 diabetes RECORD (Rosiglitazone Evaluated for Cardiovascular
mellitus, CVD, or intolerance of either medication. For Outcomes in oRal agent combination therapy for type 2
the study, 24,592 patients were screened (18,784 were Diabetes) was a multicenter, open-label, noninferiority
excluded), with a total of 5269 patients randomized to trial that randomized persons who had inadequate
treatments (2635 to the rosiglitazone arm; 2634 to the glycemic control with metformin or sulfonylurea to
placebo arm) and followed for a median of 3.0 years. either receive add-on rosiglitazone or not. An interim
Rosiglitazone was titrated to a maximum dose of 8 mg/d analysis19 to assess for increased rates of myocardial

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 67


REVIEW ARTICLE
Thiazolidinediones: A 2010 Perspective

infarction was not conclusive. The final analysis20 again expansion because of the presence of PPAR-γ in the
noted no differences in the primary endpoint, with 321 epithelium of the renal collecting duct. There is some
events in the rosiglitazone group and 323 events in the thought that amiloride or spironolactone could decrease
control group (HR, 0.99; 95% confidence interval [CI], this effect. The second is the similarity of TZDs to
0.85–1.16). As suspected, there was an increased risk of perhaps the dihydropyridine type of calcium-channel
congestive heart failure (HR, 2.10; 95% CI, 1.35–3.27) blockers (eg, nifedipine, nicardipine, amlodipine) that
and fractures (HR, 1.57; 95% CI, 1.12–2.19). exert their effects through L-type calcium channels that
The APPROACH21 (Assessment on the Prevention may cause an increased fluid permeability.3,25
of Progression by ROsiglitazone on Atherosclerosis in
… no TZD diabetes patients with Cardiovascular History) trial, the Heart Failure
has shown a results of which were published recently, was an IVUS The second and more serious problem of heart fail-
harmful effect trial that randomized patients presenting to a cardiac ure is thought to occur much less frequently, in 0.25%
on cardiac catheterization laboratory who had at least one area in to 0.45% of persons with type 2 diabetes mellitus per
structure or their epicardial coronary arterial system that contained year.3,25 In May 2007, the FDA recommended, on the
function. an atherosclerotic plaque that was not intervened upon basis of clinical data, that TZD use in patients with
prior with a stenosis of 10-50%. This trial noted no any degree of heart failure be avoided. It is of interest,
change in the primary endpoint (PAV), whereas one however, that no TZD has shown a harmful effect on
secondary outcome, normalized total atheroma volume, cardiac structure or function. In fact, some small studies
was significantly reduced (–5.1 mm3; 95% CI, –10.0 to have shown improvement in hemodynamic values such
–0.3; p = 0.04). as stroke volume index and cardiac index. One small
Recently published findings of three clinical tri- randomized study assessed the effect of rosiglitazone
als—Action to Control CardiOvascular Risk in Diabetes versus placebo in patients with New York Heart As-
(ACCORD),22 the Veterans Administration Diabetes sociation class I and II heart failure and with a left ven-
Study,23 and the Bypass Angioplasty Revascularization tricular ejection fraction of <45%. This trial showed an
Investigation in Type 2 Diabetes (BARI 2D)24—showed increase in peripheral edema in the rosiglitazone group
no firm causal association between rosiglitazone and compared with the placebo group (25.5% vs 8.8%; p =
ischemic heart disease (IHD) events. 0.037). There was no deterioration of systolic function
and perhaps an improvement in diastolic function.3
Data Not Favoring Thiazolidinediones In the PROactive study, nonadjudicated heart-failure
(the Bad) events were more common in the pioglitazone group,
Known adverse effects that occur with the use of but no evidence of increase in heart failure mortality
TZDs are discussed in the following sections. Some was noted.14 A similar finding was noted in the interim
of these are thought be unique to a particular TZD, analysis of the RECORD study.19 These studies’ results
and others may be thought of as a class effect. Some suggest an overall low but distinct risk of hospitaliza-
have a more robust backing of scientific data; others tions for heart failure.
have less. The most-recognized adverse effects include
peripheral edema, heart failure, macular edema, and Macular Edema
fractures. The overall medical community now is well Although there have been case reports,26 and ret-
aware of the effects of TZDs on peripheral edema and rospective studies27–30 in the literature suggesting the
heart failure. However, the unknown risk of myocar- association of macular edema with use of a TZD, the
dial infarction with rosiglitazone is the biggest and overall evidence either proving or disproving it is fair
most heated debate. at best. However, most experts in the field believe
that TZDs probably exacerbate macular edema and
Edema that with discontinuation of TZDs, macular edema
The incidence of new or worsening edema is noted to may decrease or abate completely. A case example is
occur in 2.5% to 16.2% of persons with type 2 diabetes given in Figure 1.
mellitus. This risk increases with increasing age, higher
doses, female sex, and increasing creatinine levels, Bone Loss
with concomitant use of insulin. Two mechanisms are Another important aspect of TZDs is its effect on
thought to contribute to this problem with TZDs. The bone. Early basic science and preclinical work have
first is increasing sodium retention and plasma volume shown that TZDs decrease osteoblast differentiation

68 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


REVIEW ARTICLE
Thiazolidinediones: A 2010 Perspective

and increase osteoclast formation, suggesting overall


bone loss. The mechanism of TZD effect on bone has
not been completely elucidated but again appears to be
due to its effect on PPAR-γ. There is hope that eventu-
ally selective PPAR-γ modulators may overcome the
undesirable extraglycemic effects. In 2006, the ADOPT
group published a separate analysis of the fracture risk
associated with rosiglitazone in comparison with met-
formin and glyburide. Rosiglitazone had an increased
relative risk (RR) of 1.81 compared with metformin and
2.13 compared with glyburide. A sex-based association
of risk was noted, with women having an increased
risk for both upper and lower limb factures; men did
not have an increased risk in this study. The risk ratios
calculated showed the largest increases in fracture risk
for the foot (RR = 3.3), the hand (RR = 2.6), and the
proximal humerus (RR > 8). There was an insufficient
number of fractures of the hip and spine to assess the
risks for these fractures.31,32 Pioglitazone carried a similar
risk for all clinical fractures (1.9 per 100 person-years). Figure 1. Results of optical coherence tomography (OCT) and fluorescein angiography
Significant research is needed in many areas in this field. in a man with diabetes.a
Specifically, there is a need to further define which Foveal thickness and macular volume are noted for each date. On August 2, 2007, only the right eye was
subgroups are at high risk and also to determine the scanned. Rosiglitazone was stopped after the visit of May 11, 2007. Because of residual symptoms, the right
eye was treated by laser on August 2, 2007; follow-up evaluation on October 8, 2007, showed significant
effects of osteoporosis treatment in persons with type resolution. OCT uses a laser in a technique similar to ultrasound to obtain information about the macula. Laser
2 diabetes mellitus who are taking a TZD. light reflected from the retina is detected, and because of the partial transparency of the retina, different layers
reflect differing amounts of laser light. A computer-reconstructed scan is produced that allows very accurate
measurements of macular contour and thickness. OCT is extremely useful in the diagnosis and evaluation of
The Ugly? diabetic macular edema and can be used to monitor the effect of treatment on retinal thickness.
The possible association of TZDs with myocardial OD = ocular dextra (right eye); OS = ocular sinistra (left eye).
infarction came to light after a Peto fixed-effects meta- a
Figure available in color at: www.thepermanentejournal.org/images/Fall2010/p69.jpg.
analysis, published in 2007, of 42 clinical trials concern-
ing rosiglitazone use in approximately 28,000 patients
suggested an odds ratio (OR) of 1.43, or a 43% greater enrollment of 16,390. The duration of treatment was
risk, for myocardial infarction and an OR of 1.64, or between 4 months and 3.5 years. Death, myocardial
a 64% greater risk, for cardiovascular death compared infarction, or stroke occurred in 4.4% (375 of 8554) of
with placebo or other antidiabetics.33 A subsequent edi- participants receiving pioglitazone and 5.7% (450 of
torial suggested that there were numerous limitations to 7836) of participants receiving control therapy (HR,
this meta-analysis, including possible misclassification, 0.82; 95% CI, 0.72–0.94; p = 0.005).35
ascertainment errors, and a variability of entry criteria An excellent overview of the safety of TZDs in relation
and outcome definitions among the original studies. The to IHD risk is provided in a recent scientific advisory
Peto fixed-effects model that was used for analysis was reported by Kaul et al.36 The advisory statement ad-
also thought to be more favorable for obtaining statis- dressed 1) rosiglitazone and IHD risk, 2) pioglitazone
tical significance. The conclusion of the editorial was and IHD risk, and 3) pioglitazone versus rosiglitazone
that “the risk for myocardial infarction or death from and IHD risk. Their conclusions were that 1) an as-
cardiovascular patients taking rosiglitazone is uncertain: sociation between rosiglitazone and IHD outcomes
neither increased nor decreased risk is established.”34 has not yet been firmly established, but sufficient
Whether any risk is due to an individual drug or safety signals have emerged to raise concerns; 2) the
a class effect is not known. Another meta-analysis of majority of published study findings do not positively
randomized trials concerning pioglitazone use was correlate an increased risk for IHD in patients treated
undertaken that suggested that pioglitazone decreased with pioglitazone, and hence there has been no black-
rather than increased adverse CVD events. This study box warning issued for pioglitazone; and 3) current
evaluated 19 clinical trials, with a total participant evidence suggests that TZDs should not be used with
the expectation of benefit with respect to IHD events.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 69


REVIEW ARTICLE
Thiazolidinediones: A 2010 Perspective

Update of prescribing a TZD except for improving glycemic


In June of 2010, Nissen and Wolksi control, care should be taken to avoid subgroups of
published yet another meta-analysis: patients who may have a higher risk of developing
Rosiglitazone Revisited.37 The conclu- edema, congestive heart failure, fractures, and pos-
sion of this meta-analysis including sibly macular edema. These subgroups may include
data from the RECORD study noted patients of advancing age, those taking higher doses
an increased risk of myocardial in- of a TZD, women, those with renal insufficiency, and
farction (OR = 1.28; 95% CI 1.02-1.63, those who also take insulin. The type 2 diabetes mel-
p = 0.04) but not cardiovascular mor- litus treatment algorithm currently proposed may need
tality (OR = 1.03; 95% CI 0.78-1.36; to be further refined to balance adequate glycemic
p = 0.86). Excluding the RECORD control, costs, and expected future risks in individu-
trial yielded qualitatively similar re- als (Figure 2-4).40
sults but quantitatively higher odds
ratio disfavoring rosiglitazone.37 The
HbA1c ≥ 7.0%
firestorm over TZDs has continued
and led to an FDA advisory com-
mittee meeting again on July 14, Metformina HbA1c < 7.0%
2010 to decide the fate of Avandia. .
Numerous presentations were made HbA1c ≥ 7.0%
from many leaders in the academic
community as well from GlaxoSmith-
+ Pioglitazoneb HbA1c < 7.0%
Kline.38 Two decisions were made.
The first was to keep Avandia on the
HbA1c ≥ 7.0%
market but recommend stricter warn-
ing labels. The second was that the
postmarketing trial known as TIDE + Secretagoguec,
(Thiazolidinedione Intervention with α-glucosidase inhibitor,
Sitaglipin, HbA1c < 7.0%
vitamin D Evaluation) be placed
or Exenatide
on partial clinical hold.39 Under the
Figure 2. The diabetes mellitus por- partial clinical hold no new patients HbA1c ≥ 7.0%
tion of the current Kaiser Perma- may be enrolled into the trial until
nente Northern California PHASE further notice from the FDA. Patients
(Prevent Heart Attack and Stroke Insulind
Everyday) program.
already enrolled in the trial will be
Cr = creatinine; HF = heart failure; LFT =
allowed to continue to participate.
Figure 3. Proposed antihyperglycemic strategy in the
liver function test; NPH = neutral protamine
patient with type 2 diabetes mellitus and coronary artery
Hagedorn (insulin); SMBG = self-monitoring Conclusion disease.
of blood glucose; SQ = subcutaneous;
ULN = upper limit of normal; bid = twice daily;
In medicine, as in many other a
Because of the risk of lactic acidosis, metformin should be avoided in
hs = at bedtime; q2days = every 2 days. areas of innovation, initial enthu- patients whose coronary artery disease is complicated by acute or unstable
heart failure.
siasm is usually tempered with the b
Because of the risk of fluid retention, pioglitazone should be avoided in
realities of subsequent knowledge. patients whose coronary artery disease is complicated by heart failure; it
The evolution of TZD development is a prime ex- is contraindicated in those with New York Heart Association class III to IV
ample. Once seen as holding a promise of mortality symptoms. Because of recent concerns regarding the increased risk of myo-
cardial infarction with rosiglitazone, this drug is best avoided in coronary
reduction, TZDs are currently used with a focus on artery disease patients until further safety data become available.
additional glycemic control, with careful patient c
Secretagogues include the sulfonylureas and the nonsulfonylurea
selection to avoid possible toxicities. glinides. Certain sulfonylureas (eg, glyburide) may impair ischemic
preconditioning and are probably best avoided in patients with active
The primary prevention of type 2 diabetes mellitus coronary insufficiency.
and cardiovascular mortality in persons with type 2 d
Insulin can be added to or substituted for oral agents at any point in the
diabetes mellitus is of the utmost importance. The disease course. When more advanced regimens are used, insulin secre-
tagogues traditionally are discontinued. Reprinted with permission from
current PHASE program at KPNC addresses this exact
Inzucchi SE, McGuire DK. New drugs for treatment of diabetes: part II:
need of improving the outcome in these high-risk Incretin-based therapy and beyond. Circulation 2008 Jan 29;117(4):574-
patients. Without current data suggesting any benefits 84; Figure 1.

70 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


REVIEW ARTICLE
Thiazolidinediones: A 2010 Perspective

Aleglitazar, a promising novel dual PPAR agent that is sentation on the Internet from meeting on 2008 Jul 1–2].
currently being tested in a phase III clinical trial, again Silver Spring, MD: Endocrinologic and Metabolic Drugs
Advisory Committee, Diabetes Drug Group, US Food and
brings hope to this field. We will await the results of
Drug Administration; 2008 [cited 2010 Jul 15]. Available
this and other ongoing studies of diabetes medications from: www.fda.gov/ohrms/dockets/ac/08/slides/2008-
that can now enter the market only if a favorable car- 4368s1-08-FDA-Joffe.ppt.
diovascular risk profile is attained. v 2. Yki-Järvinen H. Thiazolidinediones. N Engl J Med 2004 Sep
9;351(11):1106–18.
a
Pharmacy Outcomes Research Group, KPNC 3. McGuire DK, Inzucchi SE. New drugs for the treatment
of diabetes mellitus: part I: Thiazolidinediones and their
Disclosure evolving cardiovascular implications. Circulation 2008 Jan
The author(s) have no conflicts of interest to disclose. 22;117(3):440–9.
4. Wang CH, Weisel RD, Liu PP, Fedak PW, Verma S. Gli-
tazones and heart failure: critical appraisal for the clinician.
Acknowledgments
Circulation 2003 Mar 18;107(10):1350–4.
We sincerely thank Saul Genuth, MD, Principal Investigator
and Director of the Diabetes Management Center of the BARI 5. Inzucchi SE. Oral antihyperglycemic therapy for type 2 dia-
2D study, Case Western Reserve, Cleveland, Ohio, for reviewing betes: scientific review. JAMA 2002 Jan 16;287(3):360–72.
our manuscript. 6. Levine TB, Levine AB. Metabolic syndrome and cardiovas-
Katharine O’Moore-Klopf, ELS, of KOK Edit provided editorial cular disease. Philadelphia, PA: WB Saunders; 2006.
assistance. 7. Little PJ, Topliss DJ, Madaliar S, Law RE, editors. Diabetes
and cardiovascular disease: integrating science and clinical
medicine. Baltimore, MD: Williams & Wilkins; 2004.
References
1. Joffe HV. Cardiovascular assessment in the pre-approval and 8. Effects of hypoglycemic agents on vascular complications in
post-approval settings for drugs and biologics developed for patients with adult-onset diabetes. VIII. Evaluation of insulin
the treatment of type 2 diabetes mellitus [PowerPoint pre- therapy: final report. Diabetes 1982 Nov;31 Suppl 5:1–81.
9. The effect of intensive treatment of diabetes on the de-
velopment and progression of long-term complications in
HbA1c ≥ 7.0% insulin-dependent diabetes mellitus. The Diabetes Control
and Complications Trial Research Group. N Engl J Med
1993 Sep 30;329(14):977–86.
Secretagoguea 10. Cleary PA, Orchard TJ, Genuth S, et al; DCCT/EDIC Re-
HbA1c < 7.0%
(and/or Metforminb) search Group. The effect of intensive glycemic treatment
on coronary artery calcification in type 1 diabetic partici-
pants of the Diabetes Control and Complications Trial/
HbA1c ≥ 7.0%
Epidemiology of Diabetes Interventions and Complications
(DCCT/EDIC) Study. Diabetes 2006 Dec;55(12):3556–65.
+ Exenatide, 11. Intensive blood-glucose control with sulphonylureas or
Sitaglipin, or HbA1c < 7.0% insulin compared with conventional treatment and risk
α-glucosidase inhibitor of complications in patients with type 2 diabetes (UKPDS
33). UK Prospective Diabetes Study (UKPDS) Group. Lancet
1998 Sep 12;352(9131):837–53. Erratum in: Lancet 1999
HbA1c ≥ 7.0%
Aug 14;354(9178):602.
12. Effect of intensive blood-glucose control with metformin
Insulinc on complications in overweight patients with type 2 dia-
betes (UKPDS 34). UK Prospective Diabetes Study (UKPDS)
Group. Lancet 1998 Sep 12;352(9131):854–65. Erratum
Figure 4. Proposed antihyperglycemic strategy in the
patient with type 2 diabetes mellitus and heart failure. in: Lancet 1998 Nov 7;352(9139):1558.
13. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA.
a
Secretagogues include the sulfonylureas and the nonsulfonylurea
glinides. Certain sulfonylureas (eg, glyburide) may impair ischemic
10-year follow-up of intensive glucose control in type 2
preconditioning and probably are best avoided in patients with active diabetes. N Engl J Med 2008 Oct 9;359(15):1577–89.
coronary insufficiency. 14. Dormandy JA, Charbonnel B, Eckland DJ, et al; PROac-
b
Metformin is no longer contraindicated in this setting and may be used tive Investigators. Secondary prevention of macrovascular
cautiously, but only in stable, compensated heart failure patients with events in patients with type 2 diabetes in the PROactive
normal renal function and acid/base status. Study (PROspective pioglitAzone Clinical Trial In macroVas-
c
Insulin can be added to or substituted for oral agents at any point in the cular Events): a randomised controlled trial. Lancet 2005
disease course. When more advanced regimens are used, insulin secre- Oct 8;366(9493):1279–89.
tagogues traditionally are discontinued. Because of the sodium-retaining
15. Kahn SE, Haffner SM, Heise MA, et al; ADOPT Study
properties of insulin, the lowest effective dose should be used, and the dose
should be titrated carefully. Reprinted with permission from Inzucchi SE,
Group. Glycemic durability of rosiglitazone, metformin,
McGuire DK. New drugs for treatment of diabetes: part II: Incretin-based or glyburide monotherapy. N Engl J Med 2006 Dec
therapy and beyond. Circulation 2008 Jan 29;117(4):574-84; Figure 2. 7;355(23):2427–43.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 71


REVIEW ARTICLE
Thiazolidinediones: A 2010 Perspective

16. DREAM Trial Investigators, Bosch J, Yusuf S, Gerstein HC, 28. Ryan EH Jr, Han DP, Ramsay RC, et al. Diabetic macular
et al;. Effect of ramipril on the incidence of diabetes. N edema associated with glitazone use. Retina 2006 May–
Engl J Med 2006 Oct 12;355(15):1551–62. Jun;26(5):562–70.
17. Phend C. ADA: diabetes prevention hopes revived for 29. Liazos E, Broadbent DM, Beare N, Kumar N. Sponta-
thiazolidinedione [monograph on the Internet]. MedPage neous resolution of diabetic macular oedema after
Today; 2008 [cited 2010 Jul 12]. Available from: www. discontinuation of thiazolidinediones. Diabet Med 2008
medpagetoday.com/MeetingCoverage/ADA/9784. Jul;25(7):860–2.
18. Nissen SE, Nicholls SJ, Wolski K, et al; PERISCOPE Inves- 30. Fong DS, Contreras R. Glitazone use associated with
tigators. Comparison of pioglitazone vs glimepiride on diabetic macular edema. Am J Ophthalmol 2009
progression of coronary atherosclerosis in patients with Apr;147(4):583–6.e1.
type 2 diabetes: the PERISCOPE randomized controlled 31. Evans R, Grey A, Clarke BL. Three perspectives on thiazoli-
trial. JAMA 2008 Apr 2;299(13):1561–73. dine and bone health. Endocrine News 2008 Sep:14–21.
19. Home PD, Pocock SJ, Beck-Nielsen H, et al; RECORD 32. Schwartz AV. TZDs and bone: a review of the recent clini-
Study Group. Rosiglitazone evaluated for cardiovascular cal evidence. PPAR Res [serial on the Internet] 2008 [2010
outcomes—an interim analysis. N Engl J Med 2007 Jul Jul 12]:297893 [about 6 pages]. Available from: www.
5;357(1):28–38. hindawi.com/journals/ppar/2008/297893.html.
20. Home PD, Pocock SJ, Beck-Nielsen H, et al; RECORD Study 33. Nissen SE, Wolski K. Effect of rosiglitazone on the risk
Team. Rosiglitazone evaluated for cardiovascular outcomes of myocardial infarction and death from cardiovascular
in oral agent combination therapy for type 2 diabetes (RE- causes. N Engl J Med 2007 Jun 14;356(24):2457–71. Er-
CORD): a multicentre, randomised, open-label trial. Lancet ratum in: N Engl J Med 2007 Jul 5;357(1):100.
2009 Jun 20;373(9681):2125–35. 34. Diamond GA, Bax L, Kaul S. Uncertain effects of rosigli-
21. Gerstein HC, Ratner RE, Cannon CP, et al; APPROACH tazone on the risk for myocardial infarction and cardiovas-
Study Group. Effect of rosiglitazone on progression of cular death. Ann Intern Med 2007 Oct 16;147(8):578–81.
coronary atherosclerosis in patients with type 2 diabetes 35. Singh S, Loke YK, Furberg CD. Long-term risk of cardio-
mellitus and coronary artery disease: the assessment on vascular events with rosiglitazone: a meta-analysis. JAMA
the prevention of progression by rosiglitazone on athero- 2007 Sep 12;298(10):1189–95.
sclerosis in diabetes patients with cardiovascular history 36. Kaul S, Bolger AF, Herrington D, Giugliano RP, Eckel RH.
trial. Circulation 2010 Mar 16;121(10):1176–87. Thiazolidinedione drugs and cardiovascular risks. a science
22. Action to Control Cardiovascular Risk in Diabetes Study advisory from the American Heart Association and Ameri-
Group, Gerstein HC, Miller ME, Byington RP, et al. Effects can College of Cardiology Foundation. Circulation 2010
of intensive glucose lowering in type 2 diabetes. N Engl J Apr 27;121(16):1868-77.
Med 2008 Jun 12;358(24):2545–59. 37. Nissen SE, Wolski K. Rosiglitazone revisited: An updated
23. Duckworth W, Abraira C, Moritz T, et al; VADT Investi- meta-analysis of risk for myocardial infarction and cardio-
gators. Glucose control and vascular complications in vascular mortality. Arch Intern Med 2010 Jun 28. [Epub
veterans with type 2 diabetes. N Engl J Med 2009 Jan ahead of print.]
8;360(2):129–39. Erratum in: N Engl J Med 2009 Sep 38. GlaxoSmithKline. Advisory Committee briefing document:
3;361(10):1028; N Engl J Med 2009 Sep 3;361(10);1024-5. Cardiovascular safety of rosiglitazone [monograph on the
24. BARI 2D Study Group, Frye RL, August P, Brooks MM, Internet]. Silver Spring, MD: US Food and Drug Admin-
et al. A randomized trial of therapies for type 2 diabe- istration: Endocrinologic and Metabolic Drugs Advisory
tes and coronary artery disease. N Engl J Med 2009 Jun Committee, Drug Safety and Risk Management Advisory
11;360(24):2503–15. Committee; 2010 Jul 13-14 [cite 2010 Aug 2]. Available
25. Nesto RW, Bell D, Bonow RO, et al; American Heart from: www.fda.gov/downloads/AdvisoryCommittees/Com-
Association; American Diabetes Association. Thiazolidin- mitteesMeetingMaterials/Drugs/EndocrinologicandMeta-
edione use, fluid retention, and congestive heart failure: a bolicDrugsAdvisoryCommittee/UCM218492.pdf.
consensus statement from the American Heart Association 39. FDA statement on Avandia TIDE trial [monograph on the
and American Diabetes Association. October 7, 2003. Internet]. Silver Spring, MD: US Food and Drug Adminis-
Circulation 2003 Dec 9;108(23):2941–8. tration; updated 2010 Jul 21 [cited 2010 Aug 2]. Available
26. Kendall C, Wooltorton E. Rosiglitazone (Avandia) and from: www.fda.gov/Drugs/DrugSafety/ucm219780.htm.
macular edema. CMAJ 2006 Feb 28;174(5):623. 40. Inzucchi SE, McGuire DK. New drugs for treatment of
27. Tatti P, Arrigoni F, Longobardi A, Costanza F, Di Blasi P, diabetes: part II: Incretin-based therapy and beyond. Circu-
Merante D. Retrospective analysis of rosiglitazone and lation 2008 Jan 29;117(4):574-84.
macular oedema in patients with type 2 diabetes mellitus.
Clin Drug Investig 2008;28(5):327–32.

72 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


CLINICAL MEDICINE

ECG Diagnosis: Hypothermia


Joel T Levis, MD, PhD, FACEP, FAAEM

An Osborn wave (also referred


to as the J wave) is a characteristic
ECG finding for hypothermia con-
sisting of an extra deflection on the
ECG at the terminal junction of the
QRS complex and the beginning of
the ST-segment takeoff. 1 Osborn
waves usually occur when the core
body temperature falls below 90°F
(32°C), and are believed to result
from an exaggerated outward po-
tassium current leading to repolar-
ization abnormality.2 They can also
Figure 1. 12-lead ECG from a man, age 38 years, with somnolence,
be found in other conditions such
altered mental status and core body temperature of 86°F (30°C)
as hypercalcemia.3 Other ECG find-
Demonstrates sinus bradycardia with a ventricular rate of 52 beats/minute,
ings in patients with hypothermia
with Osborn (J) waves at the terminal junction of the QRS complexes, consistent
can include prolongation of the PR,
with severe hypothermia.
QRS and QT intervals, T wave in-
versions, and various dysrhythmias
including atrial fibrillation, sinus
bradycardia, atrioventricular block,
and ventricular fibrillation. Fatal
ventricular fibrillation or asystole
can occur in hypothermic patients
when core body temperature falls
below 82.4°F (28°C).1 v

References
1. Mareedu RK, Grandhe NP, Gang-
ineni S, Quinn DL. Classic EKG
changes of hypothermia. Clin Med
Res 2008;6(3-4):107-8.
2. Olgers TJ, Ubels FL. The ECG in
hypothermia: Osborn waves. Neth J
Figure 2. 12-lead ECG from same patient following rewarming Med 2006 Oct;64(9):350,353.
to a core body temperature of 92°F (33.3°C) 3. Van Mieghem C, Sabbe M, Knock-
aert D. The clinical value of the ECG
Demonstrates a normal sinus rhythm with a ventricular rate of 75 beats/minute,
in noncardiac conditions. Chest
with resolution of the Osborn waves. 2004 Apr;125(4):1561-76.

Joel T Levis, MD, PhD, FACEP, FAAEM, is a Senior Emergency Medicine Physician at the Santa Clara
Medical Center, and Clinical Instructor of Emergency Medicine (Surgery) at Stanford University. He is the
Medical Director for the Foothill College Paramedic Program in Los Altos, CA. E-mail: [email protected].

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 73


CLINICAL MEDICINE

Image Diagnosis: Interesting Chest Radiographs


from the Emergency Department
L Paige Sokolsky, MD
Gus M Garmel, MD, FACEP, FAAEM

Figure 1. Left upper lobe pneumonia


Lobar pneumonia seen on chest x-ray
results in a somewhat homogenous opacifi-
cation of the lung with ill-defined margins.1
Air bronchograms are present in the image
on the left. The lateral film demonstrates
decreased retrosternal clear space and
increased opacity at the level of the aortic
arch (image on right).

Figure 2. Right middle lobe pneumonia


A “silhouette sign” is present when an
infiltrative process lies adjacent to a solid
organ or tissue, such as the heart or dia-
phragm. This is seen as the loss of the right
heart border in the image on the left. Mar-
gins are well defined where the consolida-
tion abuts an interlobar fissure.2 Both images
demonstrate an opacity overlying the heart
and a pronounced right oblique fissure.

L Paige Sokolsky, MD, is an Emergency Medicine Resident in the Stanford/Kaiser Emergency


Medicine Residency Program. E-mail: [email protected].
Gus M Garmel, MD, FACEP, FAAEM, is a Senior Emergency Medicine Physician at the Santa
Clara Medical Center, Co-Program Director of the Stanford/Kaiser Emergency Medicine Residency
Program, and Clinical Associate Professor of Emergency Medicine (Surgery) at Stanford University.
He is also a Senior Editor for The Permanente Journal. E-mail: [email protected].

74 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


CLINICAL MEDICINE
Image Diagnosis: Interesting Chest Radiographs from the Emergency Department

Figure 3. Rib fractures, right Figure 4. Large pneumothorax, right Figure 5. Pneumomediastinum with
This chest x-ray in a patient who fell A pneumothorax on chest x-ray results pneumopericardium and subcutaneous
15 feet demonstrates mildly displaced in the loss of peripheral lung markings with emphysema
right third and fourth lateral rib fractures, a straight white pleural line parallel to the This chest radiograph demonstrates air
a displaced right clavicle fracture, and a chest wall that does not pass outside the in the soft tissues of the neck and upper
widened mediastinum. Rib fractures can chest cavity. Skin folds, bed linens, and chest (seen within the myofascial planes),
be subtle (or nonexistent) findings on chest the medial scapular border may mimic in addition to air outlining the mediastinum
radiograph, and point tenderness with this condition.4 Classification schemes and superior pericardium.
pleuritic chest pain should be considered include small and large pneumothoraces, These findings occurred in a teenage
a rib fracture despite a lack of radiologic with large defined as being greater than 2-3 girl who presented with chest pain and
evidence. Dedicated rib views seldom add cm from the chest wall to visceral pleura, “crunchy” skin (Hamman’s sign) after vig-
relevant clinical information. In children, which correlates to 20% to 30% decreased orous coughing against a closed glottis. In
greater force is required to fracture a rib lung volume. Contrary to popular belief, this case, these findings did not result in
because of increased compliance. Thus, the most appropriate view to initially hemodynamic compromise, although may
children may have a pulmonary contu- screen for pneumothorax is an upright in some cases. Other causes of pneumome-
sion without rib fracture(s). Etiologies of inspiratory (not expiratory) film because diastinum or pneumopericardium include
rib fractures include blunt trauma, severe of the greater thoracic cavity size.5 A small blunt or penetrating chest trauma, heavy
coughing, physical abuse, and certain sport primary pneumothorax does not generally lifting, mechanical ventilation, rupture
movements (throwing, swinging).3 require treatment, but a large primary or of the esophagus, trachea, bronchus or
any size secondary pneumothorax requires alveoli, perforated viscus, and barotrauma.
treatment and close monitoring.5 Treatment ranges from reassurance, ob-
servation, or release of air, depending on
signs, symptoms, and amount of air. v
References
1. Howes DS, Peabody JF. Lung Infections. In: Adams J, Barton E, Collings J, DeBlieux P, Gisondi M,
Nadel E, eds. Emergency Medicine. Philadelphia, PA: Elsevier; 2008:457-76.
2. Schwartz, D. Emergency Radiology: Case Studies. New York, NY: McGraw-Hill; 2008:1-131.
3. De Maeseneer D, DeMey J, Debaere C, Meysman M, Osteaux M. Rib fractures induced by coughing:
an unusual cause of acute chest pain. Am J Emerg Med 2000 Mar;18(2):194-7.
4. O’Connor A, Morgan W. Radiological review of pneumothorax. BMJ 2005 Jun 25;330(7506):1493-7.
5. Manthey D, Nicks B. Pneumothorax. In: Adams J, Barton E, Collings J, DeBlieux P, Gisondi M, Nadel E,
eds. Emergency Medicine. Philadelphia, PA: Elsevier; 2008:487-96.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 75


COMMENTARY

HAITI: The Kaiser Permanente Experience—Part 1


Sarah Beekley, MD

“It is one of the beautiful compensations of life, privilege comes the opportunity, even the responsibil-
that no man can sincerely try to help another ity, to give back. Perhaps it is just the human desire
without helping himself.” to connect in an authentic and noncontractual way.
— Ralph Waldo Emerson These stories give us a glimpse into the many factors
that motivate us.
Our cause is health, our passion is service, and we Every physician and nurse who worked in Haiti did
are here to make lives better. This is the social mission so because colleagues and family at home made it pos-
of Kaiser Permanente (KP), and the personal mission sible. These stories are written both to inform and to
of the staff whose stories are shared in this collection express gratitude to the many silent partners that made
of essays. Each volunteered their time, sacrificed their this work possible. Many are extracted from letters,
personal safety and comfort, and challenged themselves blogs, or e-mails written while in Haiti or soon after re-
to extend well beyond their normal limits both person- turning to the US. They are written to honor the people
ally and professionally. And each of them would say of Haiti, suffering or healed, living or dead. They are
that they gained more than they gave. written to acknowledge the courage, the sacrifice, and
Why is volunteering such an elevating human ex- the skill of those who continue to dedicate themselves
perience? Why is being of service to someone who to making lives better.
cannot repay you so profoundly rewarding? Perhaps Because the desire to share the stories was as great as
it is legacy, knowing that one has truly made an in- the outpouring of compassion , this collection is being
valuable contribution to the lives of others. Perhaps published in two parts. This first part is an introduction
it is mastery, the challenge of testing one’s expertise, and commentary on the experience, the need, and the
resilience, and resourcefulness in an unfamiliar and organization of answering the need. The second part,
austere environment. Perhaps it is gratitude, the rec- in the Winter 2011 issue, will be the personal stories,
ognition that we live and work in a community of triumphs and failures of some of those who traveled
extraordinary wealth and privilege, and that with this to Haiti whose lives were changed. v

Tribute
Robert Pearl, MD

Kaiser Permanente (KP) began when Sidney Garfield, MD, went into the Mojave Desert to provide
care to the workers building the California Aqueduct. He went there out of a sense of mission to deliver
quality medical care to people in need. That spirit remains vibrant and powerful today in our many relief
efforts from the tsunami in Southeast Asia to Hurricane Katrina to Haiti. The stories of these brave volun-
teers serve as an inspiration to all of us. I am grateful to all of the people of KP who make sacrifices to
help others, whether in our local communities or across the globe. I hope all of us will take the time to
read about the work they did and the impact they had. v

Robert Pearl, MD, is the Executive Director and CEO of The Permanente
Medical Group in Oakland, CA. E-mail: [email protected].

Sarah Beekley, MD, is a Pediatric Hospitalist in Redwood City, CA,


and is the Regional Chair of The Permanente Medical Group
Professional Satisfaction and Wellness. E-mail: [email protected].

76 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


COMMENTARY

From Tragedy, Opportunity—A New Beginning


for Haiti and the Dominican Republic
John Freedman, MD

I went to Haiti in late January as the Haitian-Dominican border in real thing). Nurses and pharmacists
a member of an Operation Rainbow the Dominican Republic. Before the from all over the world worked
(www.operationrainbow.org) sur- earthquake, the facility was a yet-to- together, and I remember being
gical team which comprised both open complex comprising a chapel, particularly touched when I saw
Kaiser Permanente (KP) and non- an orphanage, and a dental clinic. a group of Israelis help an Arab
KP team members. As background, After the earthquake, the chapel team unload several tons of food
my own medical charity, Medical and the orphanage were rapidly that was brought in by the United
Exchange International (www.medi- converted to hospital wards, and the Arab Emirates. All this is to say that
calexchangeintl.org), had partnered dental clinic became our acute care there was a tremendous and truly
with Operation Rainbow in the past venue including a 4-room operating inspiring internationalism—a deep
to provide anesthesia equipment for suite. We estimated we had about 250 humanism was in full bloom here.
several surgical missions in the de- patients on site, almost all of whom
veloping world. In Haiti, we had an were injured Haitian refugees. We did
opportunity not only to provide pulse between 20 and 50 surgical cases a
oximeters and anesthesia supplies, day in 4 converted dental consulta-
but also to help out on the clinical tion rooms. The vast majority of our
front line. As an anesthesiologist surgical cases were orthopedic and
with a background in medicine and plastics procedures, as expected. In
critical care, I split my time about our makeshift ICU, I cared for 5 to

Photo by John Freedman, MD.


half and half between the operating 10 patients on any given day, and
rooms and the intensive care unit we also opened up a perinatal ward
(ICU), both of which were intense when we suddenly found ourselves
and busy. Whereas I could write at doing C-sections (if you build it, they
length about what we did and how will come …).
we coped with severely constrained The facility was staffed by vol-
Post-op patient.
resources, I want to focus this article unteers from all over the world.
on an important “epiphenomenon”: We worked closely with our own
the catalytic action of the earthquake superb Operation Rainbow ortho- This leads me to my main
tragedy to create a new inflection pedic surgeons, including our mis- point: I witnessed first-hand an
point in the long history of Haiti- sion lead Dave Atkin, MD, from San extraordinary stepping-up-to-the-
Dominican Republic relations. Francisco and pediatric specialist plate by the Dominican govern-
Although we experienced the Chris Comstock, MD, from Corpus ment and the Dominican people.
startling devastation in Port-au-Prince Christi, Texas, and with surgeons From the moment we arrived,
when we went into the city to de- from around the US and around the we saw that the Dominicans had
liver a pulse oximeter, our clinical globe. In the ICU, I worked closely dedicated their major interna-
work took place entirely at the Buen with an excellent emergency/criti- tional airport in Santo Domingo
Samaritano (or Bon Samaritain in cal care team from Barcelona (and to international relief efforts.
French) makeshift hospital in the by closely I mean cross-covering Because Haiti’s airports were
town of Jimani, one mile east of to maintain 24/7 on-site care—the marginally functional at best,

John Freedman, MD, is the Chief of Anesthesiology at the Santa Rosa Medical Center
in CA. He was the Lead Anesthesiologist and Intensivist on an Operation Rainbow
Surgical Team. He is President of Medical Exchange International, a nonprofit charity
dedicated to international health care collaboration. E-mail: [email protected].

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 77


COMMENTARY
From Tragedy, Opportunity—A New Beginning for Haiti and the Dominican Republic

Dominican Republic aid for Haiti to gency relief organization (known


date have exceeded $17 million, no as URN for Unidad de Rescate
small sum for a small island republic Nacional), as well as Dominican
that is itself a developing nation. We representatives from countless hu-
witnessed the Dominican army con- manitarian programs such as the
spicuously keeping the Dominican Pan-American Health Organization
Photo courtesy John Freedman, MD.

side of the relief corridor safe and (PAHO), US Agency for International
functional until the United Nations Development, the UN World Food
(UN) Peacekeeping Force (which Program, and Ninos de las Naciones.
fortuitously had been in Haiti prior The Dominican-based ARS Humano
to the earthquake) took over on provided the trailers we used for our
the Haitian side to assure the relief tuberculosis isolation ward and our
Dr John Freedman at Buen Samaritano Hospital. lifeline kept flowing. Thankfully, spinal cord injury care unit. Domini-
the Dominican authorities allowed can interpreters navigated the tricky
thousands of Haitian refugees to Creole-French-Spanish language
this was crucial to the immediate cross the border eastward into the challenges for us. The Dominican
relief efforts. The short aid corridor Dominican Republic to seek care in government allowed US military
between the Dominican Republic our emergency relief hospital and in transport choppers as well as those
border and Port-au-Prince was ac- other Dominican hospitals. of several private US entities into
tive 24/7 with an endless stream of At Buen Samaritano, I noted that their airspace to help us evacuate
trucks laden with food, water, tents, many of the drugs we used, and a some of our most critically ill patients
coal, firewood, blankets, medical hefty component of the supplies we to the USNS Comfort hospital ship.
supplies, and more from dozens of used such as oxygen masks, epidural The Dominican army was on-site day
countries and with a very notable kits, and IV catheters, came from the and night in Jimani, keeping us safe
contribution from the Dominican Dominican Republic. The Domini- and keeping the peace amidst the
Republic itself. For example, the can personnel presence was huge, influx of refugees. The Dominican
Dominican Republic sent 15 mobile literally hundreds of Dominicans charity Esperanza provided trans-
cafeterias serving 100,000 meals representing the Dominican Public portation and meals for our team.
a day into Haiti. Santo Domingo Health Department (known by its Last but certainly not least (from
Water Corporation sent dozens of Spanish acronym of SESPAS), the an anesthesiologist’s standpoint),
tank trucks, each containing 2000 Dominican Food Aid Program, the the Dominican Red Cross filled our
gallons of water. Estimates of total Dominican Republic’s major emer- rapidly depleting oxygen tanks every
few days—life-giving assistance,
literally and figuratively.
This Dominican largesse would be
worthy of praise and worth relating
in and of itself. But what makes it all
the more heartening and extraordi-
nary, in fact truly “game-changing” if
one can apply that adjective to inter-
national relations, is that it opens a
new era in the long history of tense
and violent relations between these
two neighboring nations. Columbus
landed on the island of Hispaniola
Photo by John Freedman, MD.

on his first voyage to the New World


in 1492 and promptly claimed it for
Spain. But it did not take long for
the French to wrest half of the island
from the Spanish, thus establishing
Buen Samaritano Hospital.

78 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


COMMENTARY
From Tragedy, Opportunity—A New Beginning for Haiti and the Dominican Republic

two separate but equal colonies with


political, cultural, and economic
disparities that persist to this day.
The Dominicans still resent a period
of Haitian occupation from 1822
through 1844, though some Haitian
scholars insist that the Haitians were
“invited” in to ensure abolition of
slavery in post-Spanish Dominica.
Little known to most outsiders, the

Photo by John Freedman, MD.


Dominicans ultimately had to win
their independence not from Spain
but from their Haitian overseers. The
Dominicans repaid the favor in kind
with a brutal retaliatory massacre of
over 20,000 Haitians by the despotic UN peacekeepers.
Trujillo regime in 1937. To make
matters worse, the persistent sharp
contrast in prosperity, and some say which was tendered the week after on the front lines, the Dominican ef-
an inherent racism in the Dominican the quake with the intent of assisting fort by my observation is more than
Republic—have continued to fuel the UN battalion in securing the aid pragmatic and more than PR. It is
the fires of hatred, fear, and mistrust. corridor in eastern Haiti. To many huge and robust, carefully thought
The Dominican Republic ranks a re- Haitians that offer was similar to the out, and thoroughly genuine.
spectable 90 out of 182 countries on idea of having Russian “peacekeep- Time will tell if this represents a
the UN’s Human Development In- ers” come into the Ukraine. true turning point and ushers in a
dex, a composite measure of wealth, But that long and mostly ugly new era for these two countries that
health, and educational indices. Haiti relationship which has prevailed for uneasily share an island in our own
comes in at a miserable 149, just a centuries may now be coming to an backyard. Haiti’s tragedy is the costli-
hair above Sudan. The Dominican end. The opening was there after est natural disaster in recorded his-
economy has long profited from January 12, 2010, and the Domini- tory according to the Inter-American
cheap Haitian labor: more than 90% cans took it. Some say it is in their Development Bank. But as with any
of the country’s sugar workers are of interest to prevent a “failed Haiti” (if great tragedy, there is great opportu-
Haitian origin. The average Domini- that is not already the case) and that nity inherent in the rebuilding phase,
can can expect to live into his or her the Dominicans are just pragmatists and the Dominicans seem to have
70s, whereas 61 is the average life working to stem the tide of refugees. grasped that. The Dominican effort
expectancy for Haitians and this is No doubt there is, as always, an and the healing of Haiti-Dominican
now surely reduced as a result of element of public relations at work Republic relations may turn out to be
the earthquake. All of this makes it here and in fact the Dominicans have a very major ingredient in the formu-
understandable that Haiti rejected an received some good press for their la for Haiti’s long-term (and I use the
offer of over 3000 Dominican troops efforts. But having seen it in action, word advisedly) reconstruction. v

No Need to Wait
How wonderful it is that nobody need wait a single moment
before starting to improve the world.
— Diary of a Young Girl, Anne Frank, 1929-1945,
Jewish-German diarist and holocaust victim

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 79


COMMENTARY

Haiti—Forgotten Already?
Lee Jacobs, MD

When Haiti suffered one of the countries and agencies provided difficulties of their present living
worst natural disasters ever to oc- food, living supplies and health conditions, especially during the
cur in the Western hemisphere, needs. After the initial response, heavy rains of May when water
people from all over the world care from outside Haiti has mark- would flow through the floors of
responded with donations of time edly decreased and now there their tents. One friend of mine lives
and money. The first response are only a precious few volunteer in a tent with 15 family members.
was excellent—although at times short-term teams, most faith-based, People are hungry. Initially, rice
overwhelming the fragile infra- assisting the Haitians. Haitian and beans were delivered, now
structure—it was substantial and leaders wonder: Have Americans only rice is being made available.
well intended. forgotten their plight already? Without jobs, many walk aimlessly
In the past The Permanente There is excellent ongoing sup- around these camps. Finally, there
Journal (TPJ) has chronicled the port by several large agencies, but are no regular communications
experiences of health professionals the challenge is just too great to from the Haitian government. No-
responding to disasters, includ- meet the basic living needs of the body knows what to expect.
ing the Katrina flooding1 and the Haitians. The destruction in Haiti is I’m certain talented people at
Bande Aceh tsunami.2 Here, TPJ more widespread and devastating the United Nations, World Health
shares the stories of those who than imaginable. Having been part Organization and US Agency for
responded to the earthquake in of a medical relief team in Bande International Development are
Haiti and of those who support Aceh, I have seen destruction and making plans to help the Haitian
them; more stories will appear in the plight of displaced people. people. InterAction, a coalition
the Winter 2011 issue. Although the challenges in Haiti of aid organizations, planned to
As important as these stories are, are quite different, it is my opinion divide their available funds for
they are only the first chapter in that the long-term relief needs in immediate relief and for long-term
the story yet to be told of Haiti’s Haiti will actually be greater than rebuilding.3 It can only be assumed
recovery: The story of a country Bande Aceh. that holding funds in reserve must
almost completely destroyed and Living conditions for most Hai- reflect the belief that no further
the story of a people caring for tians were bad before the earth- major inflow of relief funds is ex-
each other and coping with their quake, now the conditions are un- pected. If that is in fact the case,
present difficult situation. The story speakable. Thousands of Haitians then the overall funds available will
yet to be written will be of the mas- are living in tents creating clusters be tremendously inadequate. The
sive rebuilding and relocation that that look like refugee camps. funds donated for Haiti relief in
must be supported by people and Fortunately, large-scale disease the first 4 months was $1.3 billion,
finances from around the world. outbreaks have been avoided be- which is significantly less than the
During my recent trip to Haiti cause international agencies have donations in the first 4 months to
with a health care team, I had provided clean water and scores either 9/11 ($2.3 billion) or Katrina
several community leaders de- of port-a-potties. Tent life is aw- ($3.4 billion).4
scribe how immediately after the ful. Several Haitians I know who Several major needs over the
earthquake, groups from several are living in tents tell me of the next decade will include: orphan

Lee Jacobs, MD, is the Associate Editor-in-Chief of The Permanente


Journal and resides in Atlanta, GA. E-mail: [email protected].

80 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


COMMENTARY
Haiti—Forgotten Already?

care, medical and dental care, doesn’t change the need. Past 2. Beekley S, editor. Permanente and
optical support, microenterprise living conditions do not make cur- the tsunami relief efforts—one year
later—the volunteers’ stories: a
development, and, of course, light rent conditions any more tolerable:
journal. Perm J 2005;9(4):72-82.
and heavy construction. People the majority of Haitians are living 3. Moore MT. Haiti relief less than
and money will be badly needed in great uncertainty and in much Katrina, 9/11 [monograph on the
for years to come. poorer living conditions. Internet]. McLean, VA: USA Today;
The Haitians are a wonderful 2010 May 13 [cited 2010 Jul 28].
So What Can Be Done? Available from: www.usatoday.com/
people, a highly literate people,
news/sharing/2010-05-13-haiti-
First, the extent of this ongoing a caring people. Now they are a donations_N.htm.
disaster and the immediate needs people in need. 4. Parker S. Comparing contributions
of the Haitian people must return How would you answer the [graph on the Internet]. McLean,
to the awareness of the world, question asked by the Haitian VA: USA Today; 2010 May 13 [cited
especially those of us in North leaders? Have we already forgot- 2010 Jul 28]. Available from: www.
usatoday.com/news/sharing/2010-
America. Champions are needed ten them? v
05-13-haiti-donations_N.htm.
to advocate for the Haitian people,
beginning with President Obama References
1. Assisting hurricane evacuees in
and then others who can influence
Houston and Louisiana. Perm J 2006
Americans, such as celebrities. Fall;10(3):59-61.
Second, major funding far in
excess to what has already been
donated is needed. Giving must be
considered an ongoing need and
not an isolated fundraising event. I
remember the time when the trag-
edy of the African AIDS epidemic
eventually made such an impact
on the world that we started to see
regular fundraisers, documentaries,
and other ongoing reminders of
the needs of the African continent.
The living conditions of the Haitian
people need to be raised to a simi-
lar level of awareness.
Finally, we must make certain
that some of our erroneous as-
sumptions do not blunt relief
responses. The history of corrup-
tion in the Haitian government
Photo by John Freedman, MD.

A Port-au-Prince hospital reduced to rubble.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 81


COMMENTARY

Mes Quatre Fils (My Four Sons)


Mason Spain Turner, MD

Watershed: a chiefly British term that means the such as food and water, are tolerable when our fellow
crest or dividing line between two drainage areas or men and women help to nurture us through the cha-
bodies of water. In American English, this term has os. For Haitians, as for many societies worldwide, the
come to mean an important point of division between basic unit of relatedness is the family or the family of
two phases or conditions. In early 2010, I was badly choice: a source of advice, reinforcement, guidance,
in need of a watershed. My life had become a com- and support. As I arrived in Haiti and experienced
plicated morass of the personal and professional, the temporary loss of my own family, distant from
and in my late 30s, a watershed moment was needed my own support system and alone in a foreign land,
to restore balance and perspective as I moved into I needed that same support and strength. In a way,
my next decade. As I remember the call I received my experience with these four interpreters taught me
on Sunday morning, February 7, 2010, asking that I that I cannot live in a vacuum anymore than they.
come to Haiti, tears sprung to my eyes, because at Although I had not experienced their profound loss,
precisely that moment, a watershed began. I understood their need for companionship. Our very
…a Why would answering a call to humanitarian duty different experience of aloneness led to our mutual
watershed lead to such an important inflection point in one’s need for a surrogate family.
moment life? How could a mere two weeks create the transi- On February 28, 2010, this family was disrupted,
was needed tion that only a watershed moment can establish? For and the difficulty of separation from my adopted,
to restore those who have been part of relief efforts in the past, Haitian family had its own special level of intensity.
balance and the answer is clear: the unique relationships in which Leaving these four young men when I wondered
perspective one participates in this kind of intense situation are if I could have done more for them was tempered
as I moved the answer. In particular for me, a unique family that I only by the realization that in a short day, I would
into my next built with four interpreters who had lost their parents, be reunited with my own family. As I ascended from
decade. siblings, and many friends, Christophe, Robenson, Haiti on the jet that would carry me back to my daily
Hilaire, and Wilson helped to refine my perspective routines, familiar personal life, and career aspirations,
and re-align my life with my personal moral values. I realized the importance of intense personal relation-
As an only child without siblings, my experience ships with strangers in a unique situation: not just
of family is of intimate isolation, not of the broad, with my adopted sons, but also with the volunteers,
sweeping ties that a large extended family grants dedicated relief workers, and Haitian nationals who
and for which I have often pined. The many Haitians had helped to create the watershed moment for me.
who lost their families and were left without children, Life-changing experiences breed intensity and a
siblings, and parents were relegated to a condition unique brand of relational intimacy, the essence of
both alien and devastating. Indeed, the loss of fam- which is felt forever. My experience in Haiti was
ily was perhaps one of the greatest tragedies of the indeed a watershed moment. As a young woman
event. For me, my distance from my partner and named Dominique, another interpreter at the hos-
19-month-old son was also alien and challenging. pital told me: “Haiti is a land of contradictions and
In this catastrophic period in Haitian history, these paradoxes, as it holds you tightly in her arms and
personal and environmental factors collided in a never lets you go, even as you may try to leave her.
way that was unexpected, but extremely enriching. Haiti Pou Tou Tan (Haiti Forever) is how we refer
Humanity is defined by relationship. Loss of physi- to our Mother Land.” Indeed, Haiti will live in my
cal health, economic prosperity and even basic needs mind and heart forever. v

Mason Spain Turner, MD, is the Assistant Director of Regional Mental Health and Chemical
Dependency for Kaiser Permanente Northern California. He is Chief of the Department of
Psychiatry at the San Francisco Medical Center in CA. E-mail: [email protected].

82 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


COMMENTARY

Disaster Relief Organization

Disaster Medical Relief—


Haiti Earthquake January 12, 2010
Hernando Garzon, MD

Our collective organizational


response and my personal experi-
ence in Haiti were different from
any prior disaster response in
which I have been involved.
I have had the fortune to be in-
volved with Kaiser Permanente (KP)
volunteers and disaster relief efforts
during large-scale disasters since we
sent the first teams to Southeast Asia

Photo by Hernando Garzon, MD.


after the 2004 tsunami.  In addition
to the more than 40 people we sent
in relief efforts to Sri Lanka and
Indonesia for the tsunami, multiple
KP physicians volunteers traveled to
Kashmir after the earthquake in Tent city in Haiti.
Pakistan in late 2005 to work as part
of Relief International’s program.
KP physicians collaborated with the • Created a framework to sup- all KP staff to both post and
Department of Health and Human port physician volunteerism by search volunteer opportuni-
Services to provide medical care coordinating the efforts of the ties. In addition, it allows staff
in the Gulf Coast after Hurricane Assistant Physician-in-Chief of to register in a comprehensive
Katrina in 2005. Another KP physi- Health Promotion, Community disaster response database that
cian and I volunteered with Doctors Benefit, Public Affairs and dedi- was used, with the invaluable
Without Borders after postelection cated physicians at each facility support of Program Office’s
violence broke out in early 2008.   via the KPCares program. Community Benefit, to identify
In the years since we first sent • Developed relationships with skilled clinicians immediately af-
volunteer disaster medical relief multiple medical relief organiza- ter the Haitian earthquake. This
workers to provide aid after the tions including Doctors Without database continues to serve as a
tsunami, many changes have oc- Borders, Relief International, resource should a disaster occur
curred within KP’s Global Health International Medical Corps, in our own local communities.
and volunteer programs that have Medshare, and others. • Developed and delivered sev-
resulted in better support for this • Created a KP National Volunteer- eral Continuing Medical Edu-
distinctly important and rewarding ism Web site (www.KPCares.org) cation courses on the topics
work. Under the sponsorship of The for all employees of the North- of disaster medical relief and
Permanente Medical Group leader- ern California, Mid-Atlantic and humanitarian medical work in
ship, we have: Georgia Regions.  This enables austere environments.

Hernando Garzon, MD, is an Emergency Medicine Physician and Co-Chair of the Northern
California Regional Emergency Preparedness Committee. He is the Director of the Kaiser
Permanente Global Health Programs, Coordinator of Physician Volunteerism and Sacramento
County Emergency Medical Services Medical Director. E-mail: [email protected].

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 83


COMMENTARY
Disaster Medical Relief—Haiti Earthquake January 12, 2010

In total, these efforts created least two weeks of their time with
a KP response to the Haiti earth- the support of their departments
quake unlike any response we have and colleagues. We are now also
mounted in the past. A small num- involved with the Relief Interna-
ber of KP staff traveled to Haiti with tional long-term capacity building
organizations they had identified on project in Haiti, and contribute
their own immediately following the about two medical volunteers at
earthquake, or reconnected with a time for their efforts to run five
relief organizations with which they community clinics, staffed primarily
had worked in the past. The great- by Haitian medical personnel. Our
est impact however, was via KP’s volunteers provide teaching and
contribution as the main contributor educational support for the Haitian
of medical personnel and logistical national staff.
Photo by Hernando Garzon, MD.

support to Relief International’s di- On a personal level, as intense


saster response (see www.RI.org). and chaotic as the first few weeks
We used the KPCares.org Web site of the relief effort were, I was
to gather information on interested deeply inspired by the successful
volunteers, and in the first month development of our new capability
alone sent over 30 physicians and to respond. KP  now has the abil-
Father and son. nurses to Haiti with Relief Inter- ity to mobilize our volunteers and
national. In the first few weeks their expertise to assist in future
we staffed a team of emergency humanitarian disasters. I could not
physicians, nurses, and medics who be more proud to work for an or-
largely delivered trauma care. Our ganization that supports volunteer
subsequent waves of volunteers and community service efforts in
ran the spectrum of Family Medi- such a comprehensive and sys-
cine, Pediatrics, Ob/Gyn, Internal tematic way. There is no greater
Medicine, and Mental Health. They reward than to be of service in a
represented the Regions of North- time of need in a way that honors
ern California, Southern California, the principles of our professional
and the Mid-Atlantic. All donated at commitment to medicine. v

Full of Grace
Everybody can be great. Because anybody can serve.
You don’t have to have a college degree to serve.
You don’t have to make your subject and your verb agree to serve ….
You don’t have to know the second theory
of thermodynamics in physics to serve.
You only need a heart full of grace. A soul generated by love.
— The Reverend Dr Martin Luther King, Jr, 1929-1968,
Baptist minister, civil rights activist, 1964 Nobel Laureate for peace

84 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


COMMENTARY

Mentoring About Vector-borne Disease Control


D Scott Smith, MD, MSc, DTM&H

After the earthquake struck Haiti’s most populous people, leading to large scale movements and increas-
area in and around Port-au-Prince, and just before the ing risks of insect-borne diseases. This risk is amplified
rainy season started, several Kaiser Permanente (KP) by three factors: exposure, migrations, and infrastruc-
physicians moved in to coordinate the medical arm of ture disruption. In Haiti, the population has increased
the Malaria Emergency Technical Operational Response exposure as they are now living in densely populated
(MENTOR) program. Traditionally, MENTOR has focused tent camps with little between them and the elements.
on malaria in war zones and after major natural disasters. Rainy season starts in April and vectors burgeon. Second,
Several KP physicians initially worked with this French when people move from areas of low endemicity to
Nongovernmental Organization (NGO) after the 2004 areas where disease rates are high,
earthquake and tsunami in the Indian Ocean on the there are more susceptible people

Photo by D Scott Smith, MD, MSc, DTM&H.


Island of Sumatra in Indonesia. These physicians shared at risk. This also works in reverse
shifts for several months assisting in the rebuilding with to the disadvantage of a population
a focus on vector-borne disease reduction and control. when individuals who are infected
Since then, they have assisted MENTOR in other natural move into zones that have no disease
disasters. After the 2008 Cyclone Nagris in Myanmar, but the mosquito vectors are estab-
MENTOR implemented programs for not only malaria lished and can spread the disease
but also for other vector-borne diseases, such as dengue. into the nonimmune and previously
Between those disasters, KP physicians have also worked unaffected majority population. Mosquito larvae and pupae.
as trainers for MENTOR workshops on clinical program The third risk element is simply the
management of malaria and other vector-borne diseases disruption of public health systems that can coordinate
in such places as Uganda, Kenya and Japan and even the prevention of disease. The public health system
New York and Mill Valley, CA. was arguably underfunded and ineffective before the
Haiti’s earthquake was the sixth deadliest natural earthquake as the deadly Plasmodium falciparum and
disaster in recorded history (ranking just after the 2004 mosquito-borne parasitic disease, lymphatic filariasis
tsunami) and is estimated to have killed 230,000 people. continued to thrive in Haiti, one of the few places in the
Importantly, this event displaced over one million Americas it is still observed.
The KP-MENTOR initiative focuses on clinical train-
ings, vector assessments and control using indoor re-
sidual spraying and larviciding. We coordinate with the
health sectors of many of the 391 registered health NGOs
in Haiti to build capacity around vector-born disease
recognition, diagnosis, and treatment. We collaborate
with the Ministry of Public Health and Population to
promote guidelines and develop strategy for managing
these often silently persistent diseases that put a major
drag on human comfort and progress. v

D Scott Smith, MD, MSc, DTM&H, is an Infectious Disease specialist


and Internist at the Redwood City Medical Center in CA and coordinator
of the KP-MENTOR Haiti Initiative. E-mail: [email protected].

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 85


COMMENTARY

First Responders: The DMAT Team


Judy O’Young, MD

Twilight on Tuesday, January 12, 2010 in Port-au- grateful for our efforts. I loved this Pearl of the Antilles
Prince, Haiti: about 40 seconds of chaos. 7.0 magnitude. with its vibrant culture and people, rara music, voo-
Buildings begin to crack and the sound makes people doo, and native art. Despite Haiti’s turbulent history,
think of the gunfire that is all too frequent in the down- the indigenous spirituality and resourcefulness were
town area. For safety, people run inside. Buildings, shod- unparalleled by any country that I have traveled to.
dily constructed, crumple, trapping those inside. One of I check my ready bag that evening and prepare to
the best hotels, the Montana, on a verdant hillside over- depart. My Disaster Medical Assistance Team (DMAT)
looking the steaming plain of lowland Port-au-Prince, is on call in January and all members are on standby
pancakes entombing more than 300 people. The air is for deployment. DMATs and International Medical
thick with heat and the dust of concrete. Surgical Response Teams (IMSuRT) are groups avail-
Afternoon on Tuesday, January 12, 2010 in Oakland, able for national disasters and emergencies such as
CA: news on the car radio tells me I will make my fourth 9/11 and Hurricane Katrina. Recently the National
trip to Haiti sooner than planned. During 2009, I had Disaster Medical Service (NDMS) had been preparing
worked in and around Port-au-Prince as a volunteer DMAT and IMSuRT groups for work on a global scale.
anesthesiologist on three separate Smile Train-funded Months of team meetings involving disaster response
surgical mission trips. I had stayed at the Montana. I and planning, equipment training and orientation, and
had walked through the Cité de Soleil. My friends and numerous deployments have prepared team members
to provide triage, evaluation, and first-response treat-
ment of populations in times of disaster.
Wednesday, January 13, 14:53 pm: simultaneous cell
phone text, e-mail, and voice mail set us in motion. By
the grace of our Kaiser Permanente departmental sched-
uler and the generosity of my departmental chief and
colleagues, I commit as a rostered team member, and
leave the following day for Atlanta. After an overnight
briefing, including DMAT teams from Massachusetts,
Florida, and New Jersey, we board a government
Photo by Judy O’Young, MD.

charter aircraft and fly directly into Touissant L’Overture


airport in Port-au-Prince, landing Friday, January 15.
Long distance disaster relief is seldom smooth. Teams
arrive before the equipment caches. Security cannot be
guaranteed in the logical hospital sites where patients
Field hospital operating room in tent. are. Infrastructure and transportation are nonexistent.
Running water, electricity, cell phone, and Internet
colleagues lived in Delmas, now largely destroyed. We service are absent. An alphabet soup of international
had operated on nearly 200 children and adults with and federal agencies (PAHO, UN, USAID, and CDC)
congenital cleft lips and palates, tumors, and burns, after as well as the pre-existing nongovernmental organiza-
seeing and screening several hundreds more. Because tions are in disarray. Air traffic control and the airport
of the poverty, neglect and lack of long-needed medical terminal are destroyed. The one runway, unlit, is not
services, many more adults needed our teams’ atten- built for receiving overloaded flights.
tion. Despite the dire living circumstances and lack of All these issues become secondary once the teams
resources, locals were unfailingly polite, helpful, and find their sites and equipment and supply lines are

Judy O’Young, MD, is an Anesthesiologist at the Oakland and Richmond East Bay Medical Centers in
CA. She is a founding member of the medical advisory board to Smile Train, a charity that funds free
pediatric reconstructive surgery in 78 of the world’s poorest countries. E-mail: judy.o’[email protected].

86 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


COMMENTARY
First Responders: The DMAT Team

established. The Petionville Country Club becomes


a triage and day treatment center for the tent city
that forms on the nearby golf course. The Quisquiya
School in Port-au-Prince adjacent to the Ministry of
Public Heath’s Gheskio HIV clinic becomes a mobile
field hospital with surgical and obstetric capability for
the tented camp built on the neighboring soccer field.
Federally deployed US teams of medical volunteers
from different states are working cooperatively in a
single encampment.
The teams quickly adapt to the heat and insects, the

Photo by Judy O’Young, MD.


lack of running water, the MREs (“meals refused by en-
emy”), and to each other. Day and night shifts alternate
sleeping on cots in tents and battling mosquitoes and
heat rash. The US Army’s 82nd Airborne establishes a
helicopter landing zone across from the soccer field and
ensures a steady flow of the most critical patients evacu- Patients on stretchers.
ated from the University Hospital and the surrounding
neighborhood. The cases shift from week-old orthopedic
The work is constant, grueling because of the heat
crush injuries and long bone fractures to gunshot wounds
and uncertainties, and often hopeless. Bright spots
and day-old babies with sepsis and respiratory failure. We
appear in the camaraderie of shared adversity and in
deliver 11 babies and operate on 30 patients. We can run
the unexpected resilience of a particular patient. Guil-
2 simultaneous operations, but are limited by the lack of
lame, not expected to live, gets hope in the form of
oxygen and supplies for spinal or nerve block anesthesia.
an oxygen tank delivered by his brother’s motorcycle.
There seem to be babies and children everywhere. A
Micheline, upon being told she is paraplegic and will
respiratory therapist hand-ventilates a tiny premature
never walk again, finally consents to a much needed
infant overnight before she can be helicoptered out to
amputation of her gangrenous lower leg. Robert, a lost
the USNS Comfort. A pharmacist cradles a child while
child, is re-united with an uncle. Patient #361 gets the
dispensing medication. A warehouse supply logistician
next available spot for air evacuation out to Florida.
comforts a boy who has lost his leg.
At night and on Sunday morning, the hymns of prayer
and gratitude from the people in the adjacent tent city
rise above the generator’s drone and float back to us
through the warm heavy air. Arms are raised in suppli-
cation, and thanks are given for the “it could be worse”
scenarios. Small groups of team members pray together.
The scent of garlic and peppers being cooked mingles
with the acrid smoke of burning trash and decay.
After two weeks, word arrives that a plane is to take
the first teams back to the US. Landing and equip-
ment resupply schedules remain highly variable and
uncertain. However, replacement teams are en route
to relieve us. The transition is rapid but thorough, with
shifts overlapping and orientations completed. We
had been cocooned inside the surgical field hospital
Photo by Judy O’Young, MD.

where we had arrived in darkness, isolated within and


guarded by the 82nd Airborne, so it was a shock to
transit through the main streets of the still-ruined city.
Daily activity, as I had seen in my previous travels to
Haiti, is returning. Strangers were helping each other
Thumbs up from a patient.
and it is good. v

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 87


COMMENTARY

Disaster Readiness Tips Steeped in My Time in Haiti


Vivian Reyes, MD

March 10, 2010 I arrived in Haiti, local phone react better to such situations.
After leaving Haiti and returning coverage was intermittent, at best. Ms Ripley writes that the people
to my life in the Bay Area, I felt Even when calls went through, around you during a disaster are
as if I returned to another world.  the reception was often so bad the critical component to whether
The orderly rows of lights as I de- that it was more frustrating than you survive it. In Haiti, several days
scended into Miami airport were helpful. Satellite phones were un- passed before international aid
a stark contrast to the haphazard reliable and generally unusable. arrived. Before then, the Haitians
state of Port-au-Prince. There are Surprisingly, my iPhone seemed could rely only on those around
few similarities between the scene to send and receive text messages them.  Preparation makes a differ-
I left and that to which I returned. and e-mail without much prob- ence not only in how effective the
But, what if the same tragedy lem. Although this was good for response is, but ultimately in how
happened in our own country? I simple communications, texting many lives are saved. As a lesson
learned many lessons during my proved too time-consuming, and learned, each and every one of us
five-week mission to Haiti, and will time was a luxury I did not have. should think of how we will help
share a few of them here so that we Coordinating relief operations via our neighbors during a disaster. 
can be better prepared to respond any electronic means proved to The more times you run through
be difficult, and face-to-face com- scenarios in your mind or in a drill,
munication became invaluable. the better you will react in a real
As a lesson learned, I would urge event.  Now when you hear “Be
everyone to become adept at text prepared,” don’t just consider the
messaging so that you are better supplies you might need, but also
prepared for times when commu- think of what role you will play in
nication is limited.  I heard many the hours or days after a disaster
stories of trapped victims texting without communication.
Photo courtesy of Vivian Reyes, MD.

their friends and family. Through The next lesson is one that be-
this communication alone victims came a hot topic after Hurricane
were rescued. Katrina: “Crisis care guidelines,”
Although helpful, the time delay previously: “crisis standards of care”
and content limits of text messages or “alternate standards of care.” Dur-
made me realize how important it ing the management of disasters,
Dr Vivian Reyes measures a boy’s arm circumference to is to be self-sufficient and decisive resources are limited, and patients
assess for malnutrition. during the aftermath of a disaster. will not be able to get the same
“Be prepared,” is another common- quality of care that they would get
to future events on our own soil. ly heard statement in disaster readi- during an average, non-disaster-
We have all heard the statement, ness. Before I left for Haiti, I read stricken time. Crisis care guidelines
“Communication is always the big- The Unthinkable, Who Survives were developed to help medical
gest problem during a disaster.” In When Disaster Strikes—and Why professionals navigate through
retrospect, I realize I never truly by Amanda Ripley.1 She describes these difficult times. For instance,
understood the implications of human response to disasters and if there are too few ventilators
this statement until now.  When discusses ways in which we can for patients who require one,

Vivian Reyes, MD, is an Emergency Medicine Physician at the


San Francisco Medical Center in CA, and a volunteer Physician
for Relief International. E-mail: [email protected].

88 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


COMMENTARY
Disaster Readiness Tips Steeped in My Time in Haiti

which patients get the ventilators? I witnessed American physicians, that you trust now so that they
Similarly, mass casualty triage is nurses, and medical support vol- can appropriately coordinate their
another form of crisis care manage- unteers arriving unannounced and efforts and be prepared and ready
ment. In Haiti, the baseline country offering their expertise. Similarly, for the next disaster. If everyone
standard of care was generally not many donors sent large quantities followed these simple steps, I am
to intubate critically ill patients. As of supplies to various hospitals convinced that the level of chaos
disaster responders it is imperative in Haiti. Although these gestures would be more manageable and
that we have a grasp of the current are very much appreciated, the the efficiency of response efforts
standards of care. proper coordination of these would improve.
What also became apparent is activities would allow for better The people of Haiti may seem
that these standards change rap- productivity of volunteer medical like they live in a different world,
idly depending on the resources staff and better management and but as Amanda Ripley describes in
available. For instance, when the use of supplies. Similarly, better her book, “Fear is a primitive re-
German Red Cross set up a tent coordination would allow for bet- sponse.” Humans, no matter where
hospital 15 minutes away from our ter safety, security, and planning. they are, will have the same fear
clinic with ventilator and intensive The lesson learned from this is response. If we stand ready for
care unit capability, our clinic’s that if anyone is interested in par- disaster, we will fear it less, and we
standards of care changed. Simi- ticipating in future disaster efforts, will come together and manage it. 
larly, when the hospitals around signing up now to be a health care Let us learn from this tragedy and
us filled up and stopped taking volunteer is the best approach. prepare ourselves, so that this his-
critically ill patients, our standards You may do this through your toric tragedy will not repeat itself.
changed. This occurred day by hospital, www.kpcares.org (avail- Thank you for your tremendous
day, and sometimes hour by hour. able to any Kaiser Permanente support. v
This accentuated the fluid nature employee nationally), your county
of disaster work, and is something or state professional associations, Reference
1. Ripley A. The unthinkable, who
that should be considered when or various nongovernmental orga-
survives when disaster strikes—
we consider crisis care guidelines nizations. If you wish to donate and why. New York: Crown; 2008.
in our own hospitals and within money or supplies to future relief
our own communities. efforts, donate to organizations
Finally, the last lesson is organi-
zation. In a blog, I mentioned the
chaos in Haiti during the emer-
gency response. This is not unique
to Haiti, and is expected after any
catastrophic event. Whereas I
seem to thrive in chaotic environ-
ments, I also recognize the impor-
tance of trying to minimize chaos
to improve efficiency and produc-
tivity. During visits to several dif-
ferent hospitals in Port-au-Prince,
Photo by Vivian Reyes, MD.

Tent clinic in Carrefour.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 89


soul of the healer

And The Beat Goes On


Pattie Palmer-Baker

Autumn licks the maple’s outer


Branches where green heaves
With desire for the sunlight smashing
Stained-glass windows with red;
That long-wave extreme of the spectrum a heart pumps,

Red wave after wave. But my heart flutters


Like a weak fist clinching, opening
As wide as a cracked door. Blood backs up, thickening
Into a sticky red-black pool where tiny fists might float.
The doctor’s fear: one will break loose and hurtle
To my brain, punch a black hole that sucks words, moons, worlds.

Only a little dangerous, although.


Not like atrial fibrillation, a serial-killer; pumps
Wild, erratic, erotic. I would die for that beat.
But this heart flutter beats weakly, organizes
Into a saw-toothed pattern; perfect for me, a woman
Clutching her heart for fear of.

I accede to the doctor’s order: an anticoagulant to thin


Syrupy black-cherry blood until watery red races
In my veins, pumping up
Centers in the purple flowers my skin blooms.

A medical warning; my new blood,


High on thinners, might amass
Red until it ‘bleeds out.’
But why should I care? I am seasoned
In autumn. Color-drunk,
I welcome death for a dripping slice of life.

Pattie Palmer-Baker, a Kaiser Permanente patient in Portland, OR. Ms Palmer-Baker’s


diagnosis of atrial flutter put her in touch with powerful feelings about the disorder and
about suffering, aging, and death, which she has tried to express in poetry and in two
artworks based on this poem one of which was published in The Permanente Journal,
2009 Summer, 13(3):cover. Web site: www.pattiepalmerbaker.com.

90 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


LETTERS

Dear Editors and Readers,

Effects of 12- and 24-Week “Physical activity has also been shown to improve low
Multimodal Interventions on mood, which is associated with obesity in adolescents”)
Physical Activity, Nutritional but avoid exploration. Their conclusion thus rings particu-
Behaviors, and Body Mass Index larly true: “… and attention to participants’ self-concept
and Its Psychological Predictors and mood may be important treatment considerations.”
in Severely Obese Adolescents Indeed, the psychoactive benefits of eating for the
at Risk for Diabetes treatment of various levels of depression are profound.
Fall 2010, page 29 These benefits underlie the fact that almost every single
The approach taken in the cur- “diet pill” has been a stimulant that has had antidepres-
rent obesity article by James J An- sant activity. So too, physical activity has antidepressant
nesi, MD; Ann M Walsh, MS, RD; properties, just as inactivity is a commonplace marker
and Alice E Smith, MS, MBA, RD is so different than our for depression.
observations gleaned from a quarter-century of experience It is not our intent to engage in a polemic, sportive
treating obesity that some useful insight might be gained though that is in topics of difficulty and uncertainty.
by comparison. Their essential conclusion from their care- Rather, we propose that readers interested in the ori-
fully described and well-executed study is that a major gins and treatment of obesity go to the TPJ Web site
treatment effort focusing on diet and exercise as the key and review the Pre-Program Questionnaire (www.
treatment modalities failed to reduce weight meaningfully thepermanentejournal.org/files/Obesity/Preprogram-
in a group of morbidly obese adolescents. Because the Questionnaire.pdf) that we have developed and used
concepts of diet and exercise reflect conventional thinking in San Diego during the past quarter-century. Having a
about a problem whose treatment is rife with difficulty, few obese patients fill out that questionnaire at home
we propose that they are describing a treatment approach will provide the information base underlying the needed
whose basic premise is flawed. new direction of our approach to obesity. Nutrition and
The concept that obesity is the result of nutritional arithmetic are both important subjects, but the one is no
ignorance, while appealing, has no more demonstrable more relevant to the treatment of obesity than the other
validity than does the supposition that poverty results from is to the resolution of poverty.
an inability to count money. Each, however, provides the The change in direction that we propose will un-
comforting opportunity to busy ourselves in teaching doubtedly be resisted because it significantly raises the
rather than in understanding a more disturbing causality. performance bar for those choosing to be involved. The
It is axiomatic in medicine that etiologic diagnosis is article by Annesi et al has merit because it illustrates the
antecedent to treatment. Otherwise, we end up treating ineffectiveness of the usual approach to obesity. Hope-
cough instead of Gram-positive bacterial pneumonia, or fully, it will lead to explorations of other possible treat-
do not differentiate the shortness of breath of pulmo- ment approaches for obesity that incorporate awareness
nary embolism from that of anxiety. The question not of the benefits of overeating in unconsciously treating
addressed by Annesi et al (and by many others) is Why problems that are unrecognized, often distant, and almost
these children became obese, understanding that this is never explored. Additionally, those approaches must
not to be confused with How they became obese. In what incorporate an understanding of the benefits of obesity,
ways do their obese patients differ from demographically which are not at all in conflict with the manifest risks of
similar adolescents who do not significantly overeat? As obesity. Indeed, in biological systems, the simultaneous
we point out in our article in the Spring 2010 issue of The existence of varying levels of opposing forces is the norm
Permanente Journal (TPJ),1 with very rare exception, no of all our control systems. v
one is born fat. Thus, the age at which weight gain first
begins is a useful start in the differential diagnosis of the Vincent J Felitti, MD, FACP
physical sign of obesity. Family history is also important, Retired Internist from the Department of Preventive
not because of genetics, but because it allows us to see Medicine, Clairemont Mesa Medical Office, San Diego,
how others in the same household have responded to life’s CA; Senior Editor for The Permanente Journal
stresses, whether internal to the family or external to it.
Reference
In a number of places Annesi et al hint at these stresses 1. Felitti VJ, Jakstis K, Pepper V, Ray A. Obesity: problem, solu-
(“… self-concept, general self, and overall mood” and tion, or both? Perm J 2010 Spring;14(1):24-30.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 91


LETTERS
Letters to the Editor

Dear Editor,

Congratulations to Dr Felitti and stantial. More than 50% of accrued References


colleagues for publication of the weight loss is likely to be regained 1. Felitti VJ, Jakstis K, Pepper V, Ray A.
Obesity: problem, solution, or both?
article “Obesity: Problem, Solution, within two years after program
Perm J 2010 Spring;14(1):24-30.
or Both”1 in the Spring 2010 issue participation.3,4 Individuals con- 2. Practical guide: Identification, eval-
of The Permanente Journal (TPJ) as templating these programs need uation, treatment of obesity and
well as continued success for their to understand the high likelihood overweight in adults [monograph
weight loss program in San Diego. I of weight regain, and that long- on the Internet]. NIH Publication
No. 00-4084. Bethesda, MD: Na-
believe that readers of TPJ and indi- term participation in behavioral
tional Institutes of Health, National
viduals contemplating participation group treatment, continued use Heart, Lung, and Blood Institute,
in similar programs might appreciate of meal replacements, and high North American Association for the
a different perspective, evidence, levels of physical activity are the Study of Obesity: 2000 Oct [cited
and context regarding the use of best strategies to mitigate this risk. 2010 Jul 28]. Available from: www.
nhlbi.nih.gov/guidelines/obesity/
Very Low Calorie Diets (VLCD) for 5. Overall costs and “cost per pound
prctgd_b.pdf.
weight management. lost” is much higher in VLCD pro-
3. Tsai AG, Wadden TA . The evolution
1. Caloric restriction strategies for gram as compared to other noninva- of very-low-calorie diets: an update
weight loss using less than 1000- sive strategies for weight loss.5 This and meta-analysis. Obesity (Silver
1200 calories daily should only be is because of the need for medical Spring) 2006 Aug;14(8):1283-93.
undertaken with supervision of a supervision, laboratory monitoring, 4. Franz MJ, VanWormer JJ, Crain
AL, et al. Weight-loss outcomes: a
physician or other clinician with and purchases of food products,
systematic review and meta-analysis
significant expertise.  Marked fluid all services generally excluded of weight-loss clinical trials with a
and electrolyte shifts can occur and (whether appropriately or not) from minimum 1-year follow-up. J Am Diet
result in complications such as health insurance benefit packages. v Assoc 2007 Oct;107(10):1755-67.
potentially life-threatening arrhyth- 5. Tsai AG, Wadden TA.  Systematic
mias, syncope and hypotension. Keith Bachman, MD review: an evaluation of major com-
Clinical Lead for Kaiser Permanente’s mercial weight loss programs in the
Many individuals will experience
United States. Ann Intern Med. 2005
side effects such as fatigue, con- Care Management Institute
Jan 4;142(1):56-66.
stipation, and cold intolerance. Weight Management Initiative
2. Evidence-based practice guide-
lines from the National Institutes
of Health2 discourage use of diets
providing less than 800 calories
Response:
daily.  Studies comparing diets of
800 calories daily or more to diets We are pleased to respond to Keith in physician-supervised programs.
of less than 800 calories daily show Bachman, MD’s comments on our Because we actively supplement
that sustained weight-loss outcomes recent description of our extensive with potassium, and monitor
are similar, though risk and side ef- experience with treating obesity in weekly, our impression is that
fect profile are increased with diets the Southern California Perman- our patients on an absolute fast
using less than 800 calories daily.3 ente Medical Group San Diego area. supplemented with Optifast have
3. Metanalysis of VLCD meal re- Dr Bachman’s comments represent fewer electrolyte problems than pa-
placement programs indicate the usual views about treating tients taking prescription diuretics.
mean weight loss of 17.9 kg (16%) obesity, a serious problem that is As separate and minor issues,
at six months,4 significantly lower generally not handled easily or well. distinctly fewer bowel movements
than that reported in this study. 1. There is no question that unsu- are the natural consequence
Recent work has elucidated coun- pervised Very Low Calorie Diets of not eating. Cold intolerance
terregulatory biologic mechanisms (VLCDs) are dangerous, which and fatigue will be experienced
that decrease weight loss accrued is the point we made with our by a few as commonplace stress
from caloric restriction over time. example of the Irish Hunger Strik- responses to not being able to de-
4. Weight regain after use of VLCD and ers. Indeed, Optifast is not even stress by eating, but most patients
similar programs are rapid and sub- available by prescription, but only report increased energy levels

92 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


LETTERS
Letters to the Editor

and reduced asthma attacks be a function of how well the issues on a VLCD is also eating on the
and other allergic processes. The underlying any given patient’s side, the economic costs of failure
psychophysiology of this improve- obesity are understood, by the will indeed be high. The major
ment has not yet been described. program and the patient. This is reduction in office visits that we
Our San Diego Positive Choice not an easy concept to grasp if one documented during and in the
Program, developed as the result persists in misunderstanding the year subsequent to the Program
of many years experience, differs caloric origins of excess poundage are an additional benefit, either
markedly from the program sup- as the crux of the problem. That to the patient or to the health care
plied by the manufacturer of Op- misconception mistakes mecha- system. Beyond this, the details of
tifast. That program, although safe nism for cause, a common error. insurance programs other than
and well intentioned in our opin- We believe that our better-than- Kaiser Foundation Health Plan
ion, does not adequately pursue normal outcomes are the result of were not examined.
the psychological underpinnings the support from our program, in Although we believe we made
of obesity, thus needlessly limiting conjunction with the VLCD. these points clearly, we also un-
the effectiveness of their product. 4. Indeed, rapid regain sometimes derstand that they lie sufficiently
Dr Bachman accurately notes this occurs, and is a blight in some outside conventional thinking about
limitation in his Point 3. programs, just as it sometimes obesity that they perhaps need re-
2. Considering the approach usu- occurs after bariatric surgery. statement in different ways. To that
ally given to treating obesity, The question is why does it occur end, one of us (AR) has extended
the National Institutes of Health in these instances? How do these an offer to Dr Bachman to again
caution is appropriate to most of individuals differ from those visit the San Diego Positive Choice
these circumstances. However, who do not regain? The answer Program to see in action what we
with capable medical supervision to this question has absolutely are describing.
of electrolyte balance and related nothing to do with calorie intake Any major revision of commonly
biomedical matters, risk is not an in the weight-loss phase, a point held ideas is difficult, uncomfort-
issue, as we have illustrated in our made clear in our article. It is able, and sometimes threatening.
30,000 cases. Our experience with the program that is the key deter- The philosopher, Eric Hoffer, explored
treating these patients over 25 years minant of long-term outcomes. this problem well in his small mono-
demonstrated that maintaining Our program has been slow in graph, The Ordeal of Change.2 In
weight loss has nothing to do with development because we repeat- that regard, The Permanente Journal
calorie intake in the weight-loss edly tripped over counterintuitive offers us all in Kaiser Permanente an
phase. Maintenance is totally a aspects of obesity, such as the important sounding board for the
function of what is accomplished hidden benefits of obesity and the introduction of new thinking into an
or not accomplished in the ac- consequent threat of major weight old problem that is obviously getting
companying program, which loss to many individuals. worse in the face of usual approaches,
needs to be psychodynamically 5. This statement does not incor- even though those approaches are
(not nutritionally) oriented. This porate the cost savings to our supported by august governmental
point has further been demon- patients in not buying any food agencies. v
strated by those patients who have or caloric beverages for 5 months.
been able to eat their way out of Thus, while our cost-neutral Vincent J Felitti, MD, FACP;
bariatric surgery, as we illustrated charge to the patient is approxi- Kathy Jakstis; Victoria Pepper, RD;
by the quote in our article, “The mately $2500 for the Program, Albert Ray, MD
antidote [sic] to bariatric surgery including Optifast for 5 months
is Karo Syrup.”1 and the Maintenance Program
References
3. The whole point of our article cen- for the next 12 months, when cor-
1. Felitti VJ, Jakstis K, Pepper V, Ray A.
ters on our having outcomes better rected for food not purchased and Obesity: problem, solution, or both?
than usual. That said, weight loss dinners not eaten out, the actual Perm J 2010 Spring;14(1):24-30.
in any program is a function of net cost for most people will be 2. Hoffer E. The ordeal of change. New
patient compliance, which is a only a few hundred dollars for a York: Harper and Co; 1952.
function of the support provided 17-month Program. On the other
by the program. This, in turn, will hand, to the degree that a person

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 93


BOOK REVIEW

Obese from the Heart: A Fat Psychiatrist Discloses


by Sara L Stein, MD

Review by Vincent J Felitti, MD, FACP

This is an unusual book. It is an autobiographical a story of genetics. This is a story of separation and loss.
approach to obesity, written by a perceptive and un- And the bottomless hole it leaves inside of you. Is it
usually open psychiatrist who describes herself as fat possible that the genetics of food addiction are related
since second grade, and still fat. Its great virtue is that more to our family stories than to our chromosomes?”1p16
Cleveland, OH: Quantum it focuses on basic emotional causality, not avoidantly Various short chapters help one understand the role
Psych INK, 2009 escaping this by discussions of consequent intermedi- of eating in dealing with trauma, anxiety, anger, stress,
ISBN-10: 0982524811 ary biochemical mechanisms. Moreover, Obese from the and grief. Most of us are not comfortable discussing
ISBN-13: 978-0982524817 Heart is highly readable and easily understood, equally these in ourselves, much less with patients. That’s where
Paperback: 144 pages useful for physician as well as patient. A free chapter can the value of this book lies: it is an exemplar, it bears
$11.98
be read at the Web site: http://obesefromtheheart.com/ witness to what we might do in everyday practice.
The tone is set in the early pages: “The only difference When did we last ask a patient how they felt about
Vincent J Felitti, MD, FACP, between the food addict and the alcoholic or cocaine having cancer or a stroke or dying? What is the price
is a retired Internist from the addict or gambler or the shopaholic or the sex addict is that we each, as doctor or as patient, pay for this? v
Department of Preventive the drug of choice: Food.”1p11 Sara Stein, MD, then goes
Medicine at the Clairemont Reference
Mesa Medical Office in San on to point out repeatedly that something is being treated
1. Stein SL. Obese from the Heart: a Fat Psychiatrist Discloses.
Diego, CA. He is a Clinical and that the treatment almost works—at least for a brief
Cleveland, OH: Quantum Psych INK; 2009.
Professor of Medicine at the while. That something typically is depression: “This isn’t
University of California, San
Diego. E-mail: vjfmdsdca@
mac.com.

Grandparenting a Child with Special Needs


by Charlotte E Thompson, MD

Review by O D Collins, MD, PhD

This unique book, written by a highly experienced In addition to its extensive text covering topics
and caring pediatrician, addresses the important role from diagnosis to divorce, to dressing, and to social
of grandparents in raising children who have special occasions like parties, Grandparenting a Child with
needs and has information valuable for those grand- Special Needs provides extensive appendices of US
parenting normally developing children. There is also state-by-state resource locations and contacts, as well
London and Philadelphia: much information useful to the parents of both. It is as contact information for American associations and
Jessica Kingsley Publishers, written in an appealing, informal way with frequent societies helping with problems ranging from abuse
2009. anecdotes gleaned from the author’s long years of through osteogenesis imperfecta to visual impairment.
ISBN-10: 1843109069 pediatric practice and her role as a mother and grand- Web sites are listed for children’s resources both in the
ISBN-13: 978-1843109068
mother. Given the difficulty of raising any child to his US and in the UK. Those raising children with special
Paperback: 256 pages or her full potential, skilled, practical assistance is an needs, and the involved grandparents helping with
$19.95
invaluable asset. Many physicians will thus welcome those children, will welcome referral to this book, a
this book as a referral source for those caring for these copy of which might be a useful addition to the wait-
OD Collins, MD, PhD, is difficult patients. ing room of any pediatrician. v
a retired Chief of Pediatrics
in San Diego. He is formerly
an organic chemist and
beekeeper.

94 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


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Please return
Kaiser Permanente physicians (NUID required) may earn up to 4 AMA PRA Category 1 credits for reading completed
and analyzing the four designated CME articles, by selecting the most appropriate answer to the questions form by
below, and by successfully completing the evaluation form. Other clinicians for whom CME is acceptable in December 30,
meeting educational requirements may report up to four hours of attendance. Please return (fax or mail to the 2010
address listed on the back of this form) to The Permanente Journal by December 30, 2010. Forms may also
be completed and submitted online at: www.permanentejournal.org. You must complete all sections to
receive credit. (Completed forms will be accepted until December 2011. Acknowledgment will be mailed
within two months after receipt of form.)

Section A.
Article 1. (page 4) Article 2. (page 12)
Factors Contributing to Door-to-Balloon Times of Reasons for Not Meeting Coronary Artery
≤90 Minutes in 97% of Patients with ST-Elevation Disease Targets of Care in Ambulatory
Myocardial Infarction: Our One Year Experience with Practice
a Heart Alert Protocol
The main reason patients failed to achieve risk
All of the following have been identified as strategies to improve factor goals was because:
door-to-balloon times for percutaneous coronary intervention a. the patient failed to come back for follow-up care
(PCI) in patients presenting to the Emergency Department (ED) b. physicians believe treatment of acutely ill patients
with ST-elevation myocardial infarction except: is preferable to secondary prevention treatments
a. Emergency Medicine physician activation of the Cardiac Catheteriza- c. the patient came in for a visit and the care team
tion Laboratory (CCL) with a single call to a central page operator failed to address an unmet target
b. preparation of the CCL team within 20-30 minutes of the ED d. the patient was resistant to offered therapy
activation call
c. consultation of the case with the on-call cardiologist prior to ED Which of the following statements is inaccurate?
activation of the CCL a. lists generated for quality reporting have limited
d. real time case feedback to ED and cardiology staff age ranges
e. a team-based approach b. lists generated on a quarterly or monthly cycle are
acceptable and do not rapidly become out of date
Which of the following additional strategies can contribute c. care teams often overlook the chronic care needs
to further improvements in door-to-balloon times? of patients
a. ECG acquisition and interpretation from patients presenting with d. lists generated from real-time analysis using
potential Acute Coronary Syndromes (ACS) prior to complete tailored reporting tools by the care teams are
triage and patient registration preferred
b. use of Emergency Medical Services (EMS) prehospital ECGs for
CCL activation before patient arrival in the ED
c. breakdown of the door-to-balloon time into clinically relevant
intervals with continued quality analysis of each interval to
evaluate for areas of improvement
d. use of a pre-PCI medication box for rapid medication procure-
ment and administration during the CCL activation-to-CCL door
time interval
e. all of the above

The Kaiser Permanente National Continuing Medical Education Program (KPNCMEP) is accredited by the Accreditation Council
for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The KPNCMEP designates this
educational activity for 4 AMA PRA Category 1 credits. Each physician should claim only those hours of credit that s/he actually spent
in the educational activity. All editors, reviewers, and authors have no conflicts of interest to disclose; where any possible conflict is
indicated, it has been reviewed and found not to have any impact on the article content.

The Permanente Journal/ Fall 2010/ Volume 14 No. 3 95


CME
CME Evaluation Program

Article 3. (page 57) Article 4. (page 64)


Overview of Emerging Concepts in Metabolic Surgery Thiazolidinediones: A 2010 Perspective
Which of the following is true regarding the remission of type All the following are known risks of Thiazolidinedione
2 diabetes mellitus after Roux-en-Y gastric bypass (RYGB): (TZD) use except:
a. when food bypasses the duodenum and proximal jejunum, a. foot fracture
insulin resistance is decreased and glucose tolerance improves b. hand and humerus fracture
b. the quick transit of nutrients to the distal bowel improves c. weight gain
glucose metabolism by stimulating secretion of GLP-1 d. severe hypoglycemia
(Glucagon-Like Peptide-1) and PYY (Peptide YY) levels e. fluid retention with possible congestive heart failure
c. the resolution of type 2 diabetes mellitus is solely because
of the restrictive and malabsorptive properties of RYGB At the end of a long office visit, a 55-year-old man
d. all of the above employed as an engineer who recently was diagnosed
e. a and b with type 2 diabetes mellitus asks: “Doc, of the diabetes
medications we talked about, which has shown to prevent
Which of the following is inaccurate regarding the laparo- heart attacks and to make me live longer?” You answer:
scopic adjustable gastric band (LAGB): a. Pioglitazone has been shown to decrease deaths and heart attacks
a. in comparison with other bariatric procedures, it is associated b. Insulin, because it will help your diabetes the most efficiently
with fewer complications and lower mortality rates c. so far no medications that are used for diabetes has been
b. in comparison with other bariatric procedures, it is associated shown to prevent heart attacks and help people with diabetes
with a lower likelihood for reoperative surgery mellitus live longer. However, metformin (glucophage) has
c. it is not the procedure of choice for uncontrolled severe type been the closest without achieving it
2 diabetes mellitus d. combination of glipizide, exenatide and Insulin
d. weight loss after LAGB ranges from 40 to 54% e. none of the above

Objectives
1. to inculcate the use of evidence-based medicine as part of the science of medicine
2. to stress the art of medicine via enhanced patient-physician communication, improved care experience
for patients, and more satisfying caregiving experience for physicians and staff through better teamwork
3. to review appropriate updates on the diagnosis and treatment of clinical conditions
4. to describe infrastructure and systems improvements that lead to improvements in outcomes and patient care experiences
Section B. Referring to the CME articles and the stated objectives, please choose your level of agreement next to each
statement as appropriate.
Article 1 Article 2 Article 3 Article 4
strongly strongly strongly strongly strongly strongly strongly strongly
agree disagree agree disagree agree disagree agree disagree

The article covered the stated objectives.


I learned something new that was important.
I plan to use this information as appropriate.
I plan to seek more information on this topic.
I understood what the author was trying to say.

Section C. What change(s) (if any) do you Section D. (Please print)


plan to make in your practice as a result
of reading these articles? Name ______________________________________

____________________________________________ Title ______________________________________

____________________________________________ NUID # ______________________________________

____________________________________________ E-mail ______________________________________

____________________________________________ Address ______________________________________


Mail or fax completed form
to: The Permanente Journal ____________________________________________ ______________________________________
500 NE Multnomah Street
Suite 100 ____________________________________________ Signature ______________________________________
Portland, OR 97232
Phone: 503-813-2623 ____________________________________________ Date ___________________________________________
Fax: 503-813-2348

96 The Permanente Journal/ Fall 2010/ Volume 14 No. 3


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