To measure disparities in coronavirus disease 2019 (COVID-19) hospitalization and intensive care ... more To measure disparities in coronavirus disease 2019 (COVID-19) hospitalization and intensive care unit (ICU) transfer among racially/ethnically marginalized groups before and after implementation of the California statewide shelter-in-place (SIP) policy, we conducted a retrospective cohort study within a health-care system in California. COVID-19 patients diagnosed from January 1, 2020, to August 31, 2020, were identified from electronic health records. We examined hospitalizations and ICU transfers by race/ethnicity and pandemic period using logistic regression. Among 16,520 people with COVID-19 (mean age = 46.6 (standard deviation, 18.4) years; 54.2% women), during the post-SIP period, patients were on average younger and a larger proportion were Hispanic. In adjusted models, odds of hospitalization were 20% lower post-SIP as compared with the SIP period, yet all non-White groups had higher odds (odds ratios = 1.6-2.1) than non-Hispanic White individuals, regardless of period. Among hospitalized patients, odds of ICU transfer were 33% lower post-SIP than during SIP. Hispanic and Asian patients had higher odds than non-Hispanics. Disparities in hospitalization persisted and ICU risk became more pronounced for Asian and Hispanic patients post-SIP. Policy-makers should consider ways to proactively address racial/ethnic inequities in risk when considering future population-level policy interventions for public health crises.
Clinical trial participants do not reflect the racial and ethnic diversity of people with cancer.... more Clinical trial participants do not reflect the racial and ethnic diversity of people with cancer. ASCO and the Association of Community Cancer Centers collaborated on a quality improvement study to enhance racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials. The groups conducted a pilot study to examine the feasibility, utility, and face validity of a two-part clinical trial site self-assessment to enable diverse types of research sites in the United States to (1) review internal data to assess racial and ethnic disparities in screening and enrollment and (2) review their policies, programs, procedures to identify opportunities and strategies to improve EDI. Overall, 81% of 62 participating sites were satisfied with the assessment; 82% identified opportunities for improvement; and 63% identified specific strategies and 74% thought the assessment had potential to help their site increase EDI. The assessment increased awareness about performance (82%) an...
Arterial blood oxygen saturation as measured by pulse oximetry (peripheral oxygen saturation (SpO... more Arterial blood oxygen saturation as measured by pulse oximetry (peripheral oxygen saturation (SpO2)) may be differentially less accurate for people with darker skin pigmentation, which could potentially affect the course of coronavirus disease 2019 (COVID-19) treatment. We analyzed pulse oximeter accuracy and its association with COVID-19 treatment outcomes using electronic health record data from Sutter Health, a large, mixed-payer, integrated health-care delivery system in Northern California. We analyzed 2 cohorts: 1) 43,753 non-Hispanic White (NHW) or non-Hispanic Black/African-American (NHB) adults with concurrent arterial blood gas oxygen saturation/SpO2 measurements taken between January 2020 and February 2021; and 2) 8,735 adults who went to a hospital emergency department with COVID-19 between July 2020 and February 2021. Pulse oximetry systematically overestimated blood oxygenation by 1% more in NHB individuals than in NHW individuals. For people with COVID-19, this was as...
A concerted commitment across research stakeholders is necessary to increase equity, diversity, a... more A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors...
BackgroundThere is increased recognition in clinical settings of the importance of documenting, u... more BackgroundThere is increased recognition in clinical settings of the importance of documenting, understanding, and addressing patients’ social determinants of health (SDOH) to improve health and address health inequities. This study evaluated a pilot of a standardized SDOH screening questionnaire and workflow in an ambulatory clinic within a large integrated health network in Northern California.MethodsThe pilot screened for SDOH needs using an 11-question Epic-compatible paper questionnaire assessing eight SDOH and health behavior domains: financial resource, transportation, stress, depression, intimate partner violence, social connections, physical activity, and alcohol consumption. Eligible patients for the pilot receiving a Medicare wellness, adult annual, or new patient visits during a five-week period (February-March, 2020), and a comparison group from the same time period in 2019 were identified. Sociodemographic data (age, sex, race/ethnicity, and payment type), visit type, ...
Background Migraine–an episodic disorder characterized by severe headache that can lead to disabi... more Background Migraine–an episodic disorder characterized by severe headache that can lead to disability–affects over 1 billion people worldwide. Prior studies have found that short-term exposure to fine particulate matter (PM2.5), nitrogen dioxide (NO2), and ozone increases risk of migraine-related emergency department (ED) visits. Our objective was to characterize the association between long-term exposure to sources of harmful emissions and common air pollutants with both migraine headache and, among patients with migraine, headache severity. Methods From the Sutter Health electronic health record database, we identified 89,575 prevalent migraine cases between 2014 and 2018 using a migraine probability algorithm (MPA) score and 270,564 frequency-matched controls. Sutter Health delivers care to 3.5 million patients annually in Northern California. Exposures included 2015 annual average block group-level PM2.5 and NO2 concentrations, inverse-distance weighted (IDW) methane emissions f...
Background Urinary tract infection (UTI) accounts for a substantial portion of outpatient visits ... more Background Urinary tract infection (UTI) accounts for a substantial portion of outpatient visits and antibiotic prescriptions in the United States. Few studies have considered sociodemographic factors including low socioeconomic status (SES)—which may increase residential crowding, inappropriate antibiotic prescribing, or comorbidities—as UTI or multidrug-resistant (MDR) UTI risk factors. Methods We used 2015–2017 electronic health record data from 2 California health care systems to assess whether 3 sociodemographic factors—use of Medicaid, use of an interpreter, and census tract–level deprivation—were associated with overall UTI or MDR UTI. UTIs resistant to ≥3 antibiotic classes were considered MDR. Results Analyses included 601 352 UTI cases, 1 303 455 controls, and 424 977 urinary Escherichia coli isolates from Kaiser Permanente Southern California (KPSC) and Sutter Health in Northern California. The MDR prevalence was 10.4% at KPSC and 12.8% at Sutter Health. All 3 sociodemogr...
As the coronavirus disease (COVID-19) pandemic spreads throughout the United States, evidence is ... more As the coronavirus disease (COVID-19) pandemic spreads throughout the United States, evidence is mounting that racial and ethnic minorities and socioeconomically disadvantaged groups are bearing a disproportionate burden of illness and death. We conducted a retrospective cohort analysis of COVID-19 patients at Sutter Health, a large integrated health care system in northern California, to measure potential disparities. We used Sutter's integrated electronic health record to identify adults with suspected and confirmed COVID-19, and used multivariable logistic regression to assess risk of hospitalization, adjusting for known risk factors, such as race/ethnicity, sex, age, health, and socioeconomic variables. We analyzed 1,052 confirmed cases of COVID-19 from January 1-April 8, 2020. Among our findings, we observed that, compared with non-Hispanic white patients, African Americans had 2.7 times the odds of hospitalization, after adjusting for age, sex, comorbidities, and income. We explore possible explanations for this, including societal factors that either result in barriers to timely access to care or create circumstances in which patients view delaying care as the most sensible option. Our study provides real-world evidence that there are racial and ethnic disparities in the presentation of COVID-19.
Purpose The purpose of this electronic health record (EHR)–based retrospective cohort study was t... more Purpose The purpose of this electronic health record (EHR)–based retrospective cohort study was to characterize a population of patients participating in a 12-month, lifestyle change program in a community-based health system and to examine longitudinal weight outcomes. Methods Program participants were identified in the EHRs of a health care delivery system across 18 sites between 2010 and 2017. Outcomes were mean weight change and proportion of patients with ≥5% weight loss through 24 months from program initiation. Results Among 4463 program participants, 3156 met study eligibility criteria, with a mean ± SD age of 53.5 ± 13.1 years; 77.7% were women. Mean baseline weight ± SD was 101.3 ± 23.8 kg. Three main cardiometabolic risk groups were identified: prediabetes/high risk for diabetes (47.3%), overweight/obese in the absence of elevated diabetes risk (27.2%), and existing diabetes (23.9%). Maximal mean weight loss was 3.9% at 6 months from baseline. At 12 and 24 months from bas...
Centers for Disease Control and Prevention aligned lifestyle change programs are effective in pro... more Centers for Disease Control and Prevention aligned lifestyle change programs are effective in promoting weight loss among those with elevated cardiometabolic risk; yet, variability in weight outcomes among participants is high. Little is known about heterogeneity of short-term weight changes among participants in real-world clinical practice. We sought to identify short-term weight trajectory clusters among lifestyle change program participants in real-world clinical practice and to examine the relationship between cluster membership and long-term weight outcomes. We identified participants from the electronic health records (2010–2017) with weight measured ≤30 days prior to program initiation (baseline) and in four intervals (3-week segments) in the 12 weeks after baseline. Clustering analysis was performed to identify distinct trajectories in percent weight change over 12 weeks. Cluster-specific differences in weight change at 12 and 52 weeks were assessed. Among 1,148 participant...
Background: Migraine is one of the most common neurological disorders in clinical practice and is... more Background: Migraine is one of the most common neurological disorders in clinical practice and is a substantial cause of disability worldwide. Current approaches to therapy are primarily based on medication but are often limited by inadequate effectiveness and common side effects. Newer, more effective medications are expensive. Mindfulness-based stress reduction (MBSR), an 8-week classroom-based meditation intervention, is inexpensive, has no known side effects, and has demonstrated clinically meaningful effectiveness for several chronic-pain syndromes. In addition, MBSR has shown promising results for migraine therapy in a few small case studies and pilot studies. We present here the protocol for a two-arm randomized controlled pilot trial of MBSR for moderate-to-severe episodic migraine, which, if successful, will form the basis for a fully powered clinical trial. Methods/design: This study, set in Northern California, is a two-arm parallel-comparison single-blinded randomized controlled pilot trial with the goal of recruiting approximately 60 participants with moderate-to-severe episodic migraine. The feasibility outcomes include ability and time required to recruit, adherence to the MBSR treatment, and ability to measure outcomes using 31-day headache diaries and patient-reported questionnaire data. The active treatment arm consists of an 8-week community-based MBSR class plus usual care, and the wait-list control group is usual care. Recruitment is underway and expected to be complete by the end of 2018. Discussion: To our knowledge, this is the first pragmatic trial in the U.S. of MBSR for migraine using community-based classes, and if it proves viable, we plan to conduct a fully powered trial to determine the effectiveness of the intervention for reducing headache days for moderate-to-severe episodic migraineurs. Trial registration: Clinicaltrials.gov, NCT02824250. Registered on 6 July 2016.
Context: Relatively few patients with gout receive appropriate treatment. Objective: To determine... more Context: Relatively few patients with gout receive appropriate treatment. Objective: To determine whether a pharmacist-staffed gout management program is more effective than usual care in achieving target serum uric acid (sUA) levels in gout patients. Design: A parallel-group, randomized controlled trial of a pharmacist-staffed, telephone-based program for managing hyperuricemia vs usual care. Trial duration was 26 weeks. Main Outcome Measures: Primary outcome measure was achieving sUA levels at or below 6 mg/dL at the 26-week visit. Secondary outcome was mean change in sUA levels in the control and intervention groups. Participants were adults with recurrent gout and sUA levels above 6.0 mg/dL. Participants were randomly assigned to management by a clinical pharmacist following protocol or to monitoring of sUA levels but management of their gout by their usual treating physician. Results: Of 102 patients who met eligibility criteria, 77 subjects obtained a baseline sUA measurement and were entered into the trial. Among 37 participants in the intervention group, 13 (35%) had sUA levels at or below 6.0 mg/dL at 26 weeks, compared with 5 (13%) of 40 participants in the control group (risk ratio = 2.8, 95% confidence interval [CI] = 1.1 to 7.1, p = 0.03). The mean change in sUA levels among controls was +0.1 mg/dL compared with-1.5 mg/dL in the intervention group (sUA difference =-1.6, 95% CI =-0.9 to-2.4, p < 0.001). Conclusions: A structured pharmacist-staffed program was more effective than usual care for achieving target sUA levels. These results suggest a structured program could greatly improve gout management.
Cephalalgia : an international journal of headache, Jan 11, 2015
The growing availability of electronic health data provides an opportunity to ascertain diagnosis... more The growing availability of electronic health data provides an opportunity to ascertain diagnosis-specific cases via systematic methods for sample recruitment for clinical research and health services evaluation. We developed and implemented a migraine probability algorithm (MPA) to identify migraine from electronic health records (EHR) in an integrated health plan. We identified all migraine outpatient diagnoses and all migraine-specific prescriptions for a five-year period (April 2008-March 2013) from the Kaiser Permanente, Northern California (KPNC) EHR. We developed and evaluated the MPA in two independent samples, and derived prevalence estimates of medically-ascertained migraine in KPNC by age, sex, and race. The period prevalence of medically-ascertained migraine among KPNC adults during April 2008-March 2013 was 10.3% (women: 15.5%, men: 4.5%). Estimates peaked with age in women but remained flat for men. Prevalence among Asians was half that of whites. We demonstrate the fe...
IMPORTANCE Oral steroids are commonly used to treat acute sciatica due to a herniated disk but ha... more IMPORTANCE Oral steroids are commonly used to treat acute sciatica due to a herniated disk but have not been evaluated in an appropriately powered clinical trial. OBJECTIVE To determine if oral prednisone is more effective than placebo in improving function and pain among patients with acute sciatica. DESIGN, SETTING, AND PARTICIPANTS Randomized, double-blind, placebo-controlled clinical trial conducted from 2008 to 2013 in a large integrated health care delivery system in Northern California. Adults (n=269) with radicular pain for 3 months or less, an Oswestry Disability Index (ODI) score of 30 or higher (range, 0-100; higher scores indicate greater dysfunction), and a herniated disk confirmed by magnetic resonance imaging were eligible. INTERVENTIONS Participants were randomly assigned in a 2:1 ratio to receive a tapering 15-day course of oral prednisone (5 days each of 60 mg, 40 mg, and 20 mg; total cumulative dose = 600 mg; n = 181) or matching placebo (n = 88). MAIN OUTCOMES AND MEASURES The primary outcome was ODI change at 3 weeks; secondary outcomes were ODI change at 1 year, change in lower extremity pain (measured on a 0-10 scale; higher scores indicate more pain), spine surgery, and Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) scores (0-100 scale; higher scores better). RESULTS Observed baseline and 3-week mean ODI scores were 51.2 and 32.2 for the prednisone group and 51.1 and 37.5 for the placebo group, respectively. The prednisone-treated group showed an adjusted mean 6.4-point (95% CI, 1.9-10.9; P = .006) greater improvement in ODI scores at 3 weeks than the placebo group and a mean 7.4-point (95% CI, 2.2-12.5; P = .005) greater improvement at 52 weeks. Compared with the placebo group, the prednisone group showed an adjusted mean 0.3-point (95% CI, −0.4 to 1.0; P = .34) greater reduction in pain at 3 weeks and a mean 0.6-point (95% CI, −0.2 to 1.3; P = .15) greater reduction at 52 weeks. The prednisone group showed an adjusted mean 3.3-point (95% CI, 1.3-5.2; P = .001) greater improvement in the SF-36 PCS score at 3 weeks, no difference in the SF-36 PCS score at 52 weeks (mean, 2.5; 95% CI, −0.3 to 5.4; P = .08), no change in the SF-36 MCS score at 3 weeks (mean, 2.2; 95% CI, −0.4 to 4.8; P = .10), and an adjusted 3.6-point (95% CI, 0.6-6.7; P = .02) greater improvement in the SF-36 MCS score at 52 weeks. There were no differences in surgery rates at 52-week follow-up. Having 1 or more adverse events at 3-week follow-up was more common in the prednisone group than in the placebo group (49.2% vs 23.9%; P < .001). CONCLUSIONS AND RELEVANCE Among patients with acute radiculopathy due to a herniated lumbar disk, a short course of oral steroids, compared with placebo, resulted in modestly improved function and no improvement in pain. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00668434
Cephalalgia : an international journal of headache, Jan 9, 2015
Our understanding of risk factors for childhood stroke is incomplete. In adults, migraine with au... more Our understanding of risk factors for childhood stroke is incomplete. In adults, migraine with aura is associated with a two-fold increase in ischemic stroke risk. In this cohort study we examine the association between migraine and stroke among children in Kaiser Permanente Northern California (KPNC). Children ages 2-17 years who were members of KPNC for ≥6 months between 1997 and 2007 were included. Migraine cohort members had one or more of: an ICD-9 code for migraine, migraine listed as a significant health problem, or a prescription for a migraine-specific medication. The comparison group was children with no evidence of headache. Main outcome measures included stroke incidence rates and incidence rate ratios (IR). Among the 1,566,952 children within KPNC during the study period, 88,164 had migraine, and 1,323,142 had no evidence of headache. Eight migraineurs had a stroke (three (38%) hemorrhagic; five (63%) ischemic). Eighty strokes occurred in children without headache (53 (...
The study objective was to determine the feasibility of using a pharmacist-staffed, protocol-base... more The study objective was to determine the feasibility of using a pharmacist-staffed, protocol-based structured approach to improving the management of chronic, recurrent gout. The study was carried out in the outpatient clinic of a single Kaiser Permanente medical centre. This is a community-based clinic. We report on 100 consecutive patients between the ages of 21 and 94 (75% men) with chronic or recurrent gout, referred by their primary physicians for the purpose of management of urate-lowering therapy. Patients with stage 5 chronic kidney disease or end-stage kidney disease were excluded. The programme consisted of a trained clinical pharmacist and a rheumatologist. The pharmacist contacted each patient by phone, provided educational and dietary materials, and used a protocol that employs standard gout medications to achieve and maintain a serum uric acid (sUA) level of 6 mg/dL or less. Incident gout flares or adverse reactions to medications were managed in consultation with the ...
While group interventions for weight management have been shown to be efficacious, adherence is o... more While group interventions for weight management have been shown to be efficacious, adherence is often low, especially among men. This pilot study seeks to test whether group interventions using web-based group video conferencing (VC) technology is effective for weight loss. We adapted a 12-week curriculum based on the Diabetes Prevention Program, and delivered this intervention to a small group of men (BMI ≥30 kg/m 2), using web-based group VC. Participants were randomized to intervention (n=32) or delayed-intervention control group (n=32). The intervention group lost 3.5 % (95 % CI 2.1 %, 4.9 %) of their initial body weight. Difference in mean weight loss was 3.2 kg (p=0.0002) and mean BMI decrease was 1.0 kg/m 2 (p=0.0010) between the two groups. Virtual small groups may be an effective means of allowing face-to-face group interaction, while overcoming some barriers to access.
Background: Modern clinical-research practice favors placebo controls over usual-care controls wh... more Background: Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. Methods: We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. Results: We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Conclusions: Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.
To measure disparities in coronavirus disease 2019 (COVID-19) hospitalization and intensive care ... more To measure disparities in coronavirus disease 2019 (COVID-19) hospitalization and intensive care unit (ICU) transfer among racially/ethnically marginalized groups before and after implementation of the California statewide shelter-in-place (SIP) policy, we conducted a retrospective cohort study within a health-care system in California. COVID-19 patients diagnosed from January 1, 2020, to August 31, 2020, were identified from electronic health records. We examined hospitalizations and ICU transfers by race/ethnicity and pandemic period using logistic regression. Among 16,520 people with COVID-19 (mean age = 46.6 (standard deviation, 18.4) years; 54.2% women), during the post-SIP period, patients were on average younger and a larger proportion were Hispanic. In adjusted models, odds of hospitalization were 20% lower post-SIP as compared with the SIP period, yet all non-White groups had higher odds (odds ratios = 1.6-2.1) than non-Hispanic White individuals, regardless of period. Among hospitalized patients, odds of ICU transfer were 33% lower post-SIP than during SIP. Hispanic and Asian patients had higher odds than non-Hispanics. Disparities in hospitalization persisted and ICU risk became more pronounced for Asian and Hispanic patients post-SIP. Policy-makers should consider ways to proactively address racial/ethnic inequities in risk when considering future population-level policy interventions for public health crises.
Clinical trial participants do not reflect the racial and ethnic diversity of people with cancer.... more Clinical trial participants do not reflect the racial and ethnic diversity of people with cancer. ASCO and the Association of Community Cancer Centers collaborated on a quality improvement study to enhance racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials. The groups conducted a pilot study to examine the feasibility, utility, and face validity of a two-part clinical trial site self-assessment to enable diverse types of research sites in the United States to (1) review internal data to assess racial and ethnic disparities in screening and enrollment and (2) review their policies, programs, procedures to identify opportunities and strategies to improve EDI. Overall, 81% of 62 participating sites were satisfied with the assessment; 82% identified opportunities for improvement; and 63% identified specific strategies and 74% thought the assessment had potential to help their site increase EDI. The assessment increased awareness about performance (82%) an...
Arterial blood oxygen saturation as measured by pulse oximetry (peripheral oxygen saturation (SpO... more Arterial blood oxygen saturation as measured by pulse oximetry (peripheral oxygen saturation (SpO2)) may be differentially less accurate for people with darker skin pigmentation, which could potentially affect the course of coronavirus disease 2019 (COVID-19) treatment. We analyzed pulse oximeter accuracy and its association with COVID-19 treatment outcomes using electronic health record data from Sutter Health, a large, mixed-payer, integrated health-care delivery system in Northern California. We analyzed 2 cohorts: 1) 43,753 non-Hispanic White (NHW) or non-Hispanic Black/African-American (NHB) adults with concurrent arterial blood gas oxygen saturation/SpO2 measurements taken between January 2020 and February 2021; and 2) 8,735 adults who went to a hospital emergency department with COVID-19 between July 2020 and February 2021. Pulse oximetry systematically overestimated blood oxygenation by 1% more in NHB individuals than in NHW individuals. For people with COVID-19, this was as...
A concerted commitment across research stakeholders is necessary to increase equity, diversity, a... more A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors...
BackgroundThere is increased recognition in clinical settings of the importance of documenting, u... more BackgroundThere is increased recognition in clinical settings of the importance of documenting, understanding, and addressing patients’ social determinants of health (SDOH) to improve health and address health inequities. This study evaluated a pilot of a standardized SDOH screening questionnaire and workflow in an ambulatory clinic within a large integrated health network in Northern California.MethodsThe pilot screened for SDOH needs using an 11-question Epic-compatible paper questionnaire assessing eight SDOH and health behavior domains: financial resource, transportation, stress, depression, intimate partner violence, social connections, physical activity, and alcohol consumption. Eligible patients for the pilot receiving a Medicare wellness, adult annual, or new patient visits during a five-week period (February-March, 2020), and a comparison group from the same time period in 2019 were identified. Sociodemographic data (age, sex, race/ethnicity, and payment type), visit type, ...
Background Migraine–an episodic disorder characterized by severe headache that can lead to disabi... more Background Migraine–an episodic disorder characterized by severe headache that can lead to disability–affects over 1 billion people worldwide. Prior studies have found that short-term exposure to fine particulate matter (PM2.5), nitrogen dioxide (NO2), and ozone increases risk of migraine-related emergency department (ED) visits. Our objective was to characterize the association between long-term exposure to sources of harmful emissions and common air pollutants with both migraine headache and, among patients with migraine, headache severity. Methods From the Sutter Health electronic health record database, we identified 89,575 prevalent migraine cases between 2014 and 2018 using a migraine probability algorithm (MPA) score and 270,564 frequency-matched controls. Sutter Health delivers care to 3.5 million patients annually in Northern California. Exposures included 2015 annual average block group-level PM2.5 and NO2 concentrations, inverse-distance weighted (IDW) methane emissions f...
Background Urinary tract infection (UTI) accounts for a substantial portion of outpatient visits ... more Background Urinary tract infection (UTI) accounts for a substantial portion of outpatient visits and antibiotic prescriptions in the United States. Few studies have considered sociodemographic factors including low socioeconomic status (SES)—which may increase residential crowding, inappropriate antibiotic prescribing, or comorbidities—as UTI or multidrug-resistant (MDR) UTI risk factors. Methods We used 2015–2017 electronic health record data from 2 California health care systems to assess whether 3 sociodemographic factors—use of Medicaid, use of an interpreter, and census tract–level deprivation—were associated with overall UTI or MDR UTI. UTIs resistant to ≥3 antibiotic classes were considered MDR. Results Analyses included 601 352 UTI cases, 1 303 455 controls, and 424 977 urinary Escherichia coli isolates from Kaiser Permanente Southern California (KPSC) and Sutter Health in Northern California. The MDR prevalence was 10.4% at KPSC and 12.8% at Sutter Health. All 3 sociodemogr...
As the coronavirus disease (COVID-19) pandemic spreads throughout the United States, evidence is ... more As the coronavirus disease (COVID-19) pandemic spreads throughout the United States, evidence is mounting that racial and ethnic minorities and socioeconomically disadvantaged groups are bearing a disproportionate burden of illness and death. We conducted a retrospective cohort analysis of COVID-19 patients at Sutter Health, a large integrated health care system in northern California, to measure potential disparities. We used Sutter's integrated electronic health record to identify adults with suspected and confirmed COVID-19, and used multivariable logistic regression to assess risk of hospitalization, adjusting for known risk factors, such as race/ethnicity, sex, age, health, and socioeconomic variables. We analyzed 1,052 confirmed cases of COVID-19 from January 1-April 8, 2020. Among our findings, we observed that, compared with non-Hispanic white patients, African Americans had 2.7 times the odds of hospitalization, after adjusting for age, sex, comorbidities, and income. We explore possible explanations for this, including societal factors that either result in barriers to timely access to care or create circumstances in which patients view delaying care as the most sensible option. Our study provides real-world evidence that there are racial and ethnic disparities in the presentation of COVID-19.
Purpose The purpose of this electronic health record (EHR)–based retrospective cohort study was t... more Purpose The purpose of this electronic health record (EHR)–based retrospective cohort study was to characterize a population of patients participating in a 12-month, lifestyle change program in a community-based health system and to examine longitudinal weight outcomes. Methods Program participants were identified in the EHRs of a health care delivery system across 18 sites between 2010 and 2017. Outcomes were mean weight change and proportion of patients with ≥5% weight loss through 24 months from program initiation. Results Among 4463 program participants, 3156 met study eligibility criteria, with a mean ± SD age of 53.5 ± 13.1 years; 77.7% were women. Mean baseline weight ± SD was 101.3 ± 23.8 kg. Three main cardiometabolic risk groups were identified: prediabetes/high risk for diabetes (47.3%), overweight/obese in the absence of elevated diabetes risk (27.2%), and existing diabetes (23.9%). Maximal mean weight loss was 3.9% at 6 months from baseline. At 12 and 24 months from bas...
Centers for Disease Control and Prevention aligned lifestyle change programs are effective in pro... more Centers for Disease Control and Prevention aligned lifestyle change programs are effective in promoting weight loss among those with elevated cardiometabolic risk; yet, variability in weight outcomes among participants is high. Little is known about heterogeneity of short-term weight changes among participants in real-world clinical practice. We sought to identify short-term weight trajectory clusters among lifestyle change program participants in real-world clinical practice and to examine the relationship between cluster membership and long-term weight outcomes. We identified participants from the electronic health records (2010–2017) with weight measured ≤30 days prior to program initiation (baseline) and in four intervals (3-week segments) in the 12 weeks after baseline. Clustering analysis was performed to identify distinct trajectories in percent weight change over 12 weeks. Cluster-specific differences in weight change at 12 and 52 weeks were assessed. Among 1,148 participant...
Background: Migraine is one of the most common neurological disorders in clinical practice and is... more Background: Migraine is one of the most common neurological disorders in clinical practice and is a substantial cause of disability worldwide. Current approaches to therapy are primarily based on medication but are often limited by inadequate effectiveness and common side effects. Newer, more effective medications are expensive. Mindfulness-based stress reduction (MBSR), an 8-week classroom-based meditation intervention, is inexpensive, has no known side effects, and has demonstrated clinically meaningful effectiveness for several chronic-pain syndromes. In addition, MBSR has shown promising results for migraine therapy in a few small case studies and pilot studies. We present here the protocol for a two-arm randomized controlled pilot trial of MBSR for moderate-to-severe episodic migraine, which, if successful, will form the basis for a fully powered clinical trial. Methods/design: This study, set in Northern California, is a two-arm parallel-comparison single-blinded randomized controlled pilot trial with the goal of recruiting approximately 60 participants with moderate-to-severe episodic migraine. The feasibility outcomes include ability and time required to recruit, adherence to the MBSR treatment, and ability to measure outcomes using 31-day headache diaries and patient-reported questionnaire data. The active treatment arm consists of an 8-week community-based MBSR class plus usual care, and the wait-list control group is usual care. Recruitment is underway and expected to be complete by the end of 2018. Discussion: To our knowledge, this is the first pragmatic trial in the U.S. of MBSR for migraine using community-based classes, and if it proves viable, we plan to conduct a fully powered trial to determine the effectiveness of the intervention for reducing headache days for moderate-to-severe episodic migraineurs. Trial registration: Clinicaltrials.gov, NCT02824250. Registered on 6 July 2016.
Context: Relatively few patients with gout receive appropriate treatment. Objective: To determine... more Context: Relatively few patients with gout receive appropriate treatment. Objective: To determine whether a pharmacist-staffed gout management program is more effective than usual care in achieving target serum uric acid (sUA) levels in gout patients. Design: A parallel-group, randomized controlled trial of a pharmacist-staffed, telephone-based program for managing hyperuricemia vs usual care. Trial duration was 26 weeks. Main Outcome Measures: Primary outcome measure was achieving sUA levels at or below 6 mg/dL at the 26-week visit. Secondary outcome was mean change in sUA levels in the control and intervention groups. Participants were adults with recurrent gout and sUA levels above 6.0 mg/dL. Participants were randomly assigned to management by a clinical pharmacist following protocol or to monitoring of sUA levels but management of their gout by their usual treating physician. Results: Of 102 patients who met eligibility criteria, 77 subjects obtained a baseline sUA measurement and were entered into the trial. Among 37 participants in the intervention group, 13 (35%) had sUA levels at or below 6.0 mg/dL at 26 weeks, compared with 5 (13%) of 40 participants in the control group (risk ratio = 2.8, 95% confidence interval [CI] = 1.1 to 7.1, p = 0.03). The mean change in sUA levels among controls was +0.1 mg/dL compared with-1.5 mg/dL in the intervention group (sUA difference =-1.6, 95% CI =-0.9 to-2.4, p < 0.001). Conclusions: A structured pharmacist-staffed program was more effective than usual care for achieving target sUA levels. These results suggest a structured program could greatly improve gout management.
Cephalalgia : an international journal of headache, Jan 11, 2015
The growing availability of electronic health data provides an opportunity to ascertain diagnosis... more The growing availability of electronic health data provides an opportunity to ascertain diagnosis-specific cases via systematic methods for sample recruitment for clinical research and health services evaluation. We developed and implemented a migraine probability algorithm (MPA) to identify migraine from electronic health records (EHR) in an integrated health plan. We identified all migraine outpatient diagnoses and all migraine-specific prescriptions for a five-year period (April 2008-March 2013) from the Kaiser Permanente, Northern California (KPNC) EHR. We developed and evaluated the MPA in two independent samples, and derived prevalence estimates of medically-ascertained migraine in KPNC by age, sex, and race. The period prevalence of medically-ascertained migraine among KPNC adults during April 2008-March 2013 was 10.3% (women: 15.5%, men: 4.5%). Estimates peaked with age in women but remained flat for men. Prevalence among Asians was half that of whites. We demonstrate the fe...
IMPORTANCE Oral steroids are commonly used to treat acute sciatica due to a herniated disk but ha... more IMPORTANCE Oral steroids are commonly used to treat acute sciatica due to a herniated disk but have not been evaluated in an appropriately powered clinical trial. OBJECTIVE To determine if oral prednisone is more effective than placebo in improving function and pain among patients with acute sciatica. DESIGN, SETTING, AND PARTICIPANTS Randomized, double-blind, placebo-controlled clinical trial conducted from 2008 to 2013 in a large integrated health care delivery system in Northern California. Adults (n=269) with radicular pain for 3 months or less, an Oswestry Disability Index (ODI) score of 30 or higher (range, 0-100; higher scores indicate greater dysfunction), and a herniated disk confirmed by magnetic resonance imaging were eligible. INTERVENTIONS Participants were randomly assigned in a 2:1 ratio to receive a tapering 15-day course of oral prednisone (5 days each of 60 mg, 40 mg, and 20 mg; total cumulative dose = 600 mg; n = 181) or matching placebo (n = 88). MAIN OUTCOMES AND MEASURES The primary outcome was ODI change at 3 weeks; secondary outcomes were ODI change at 1 year, change in lower extremity pain (measured on a 0-10 scale; higher scores indicate more pain), spine surgery, and Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) scores (0-100 scale; higher scores better). RESULTS Observed baseline and 3-week mean ODI scores were 51.2 and 32.2 for the prednisone group and 51.1 and 37.5 for the placebo group, respectively. The prednisone-treated group showed an adjusted mean 6.4-point (95% CI, 1.9-10.9; P = .006) greater improvement in ODI scores at 3 weeks than the placebo group and a mean 7.4-point (95% CI, 2.2-12.5; P = .005) greater improvement at 52 weeks. Compared with the placebo group, the prednisone group showed an adjusted mean 0.3-point (95% CI, −0.4 to 1.0; P = .34) greater reduction in pain at 3 weeks and a mean 0.6-point (95% CI, −0.2 to 1.3; P = .15) greater reduction at 52 weeks. The prednisone group showed an adjusted mean 3.3-point (95% CI, 1.3-5.2; P = .001) greater improvement in the SF-36 PCS score at 3 weeks, no difference in the SF-36 PCS score at 52 weeks (mean, 2.5; 95% CI, −0.3 to 5.4; P = .08), no change in the SF-36 MCS score at 3 weeks (mean, 2.2; 95% CI, −0.4 to 4.8; P = .10), and an adjusted 3.6-point (95% CI, 0.6-6.7; P = .02) greater improvement in the SF-36 MCS score at 52 weeks. There were no differences in surgery rates at 52-week follow-up. Having 1 or more adverse events at 3-week follow-up was more common in the prednisone group than in the placebo group (49.2% vs 23.9%; P < .001). CONCLUSIONS AND RELEVANCE Among patients with acute radiculopathy due to a herniated lumbar disk, a short course of oral steroids, compared with placebo, resulted in modestly improved function and no improvement in pain. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00668434
Cephalalgia : an international journal of headache, Jan 9, 2015
Our understanding of risk factors for childhood stroke is incomplete. In adults, migraine with au... more Our understanding of risk factors for childhood stroke is incomplete. In adults, migraine with aura is associated with a two-fold increase in ischemic stroke risk. In this cohort study we examine the association between migraine and stroke among children in Kaiser Permanente Northern California (KPNC). Children ages 2-17 years who were members of KPNC for ≥6 months between 1997 and 2007 were included. Migraine cohort members had one or more of: an ICD-9 code for migraine, migraine listed as a significant health problem, or a prescription for a migraine-specific medication. The comparison group was children with no evidence of headache. Main outcome measures included stroke incidence rates and incidence rate ratios (IR). Among the 1,566,952 children within KPNC during the study period, 88,164 had migraine, and 1,323,142 had no evidence of headache. Eight migraineurs had a stroke (three (38%) hemorrhagic; five (63%) ischemic). Eighty strokes occurred in children without headache (53 (...
The study objective was to determine the feasibility of using a pharmacist-staffed, protocol-base... more The study objective was to determine the feasibility of using a pharmacist-staffed, protocol-based structured approach to improving the management of chronic, recurrent gout. The study was carried out in the outpatient clinic of a single Kaiser Permanente medical centre. This is a community-based clinic. We report on 100 consecutive patients between the ages of 21 and 94 (75% men) with chronic or recurrent gout, referred by their primary physicians for the purpose of management of urate-lowering therapy. Patients with stage 5 chronic kidney disease or end-stage kidney disease were excluded. The programme consisted of a trained clinical pharmacist and a rheumatologist. The pharmacist contacted each patient by phone, provided educational and dietary materials, and used a protocol that employs standard gout medications to achieve and maintain a serum uric acid (sUA) level of 6 mg/dL or less. Incident gout flares or adverse reactions to medications were managed in consultation with the ...
While group interventions for weight management have been shown to be efficacious, adherence is o... more While group interventions for weight management have been shown to be efficacious, adherence is often low, especially among men. This pilot study seeks to test whether group interventions using web-based group video conferencing (VC) technology is effective for weight loss. We adapted a 12-week curriculum based on the Diabetes Prevention Program, and delivered this intervention to a small group of men (BMI ≥30 kg/m 2), using web-based group VC. Participants were randomized to intervention (n=32) or delayed-intervention control group (n=32). The intervention group lost 3.5 % (95 % CI 2.1 %, 4.9 %) of their initial body weight. Difference in mean weight loss was 3.2 kg (p=0.0002) and mean BMI decrease was 1.0 kg/m 2 (p=0.0010) between the two groups. Virtual small groups may be an effective means of allowing face-to-face group interaction, while overcoming some barriers to access.
Background: Modern clinical-research practice favors placebo controls over usual-care controls wh... more Background: Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. Methods: We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. Results: We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Conclusions: Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.
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Papers by Alice Pressman