BackgroundBy participating in priority-setting activities in research, patients and members of th... more BackgroundBy participating in priority-setting activities in research, patients and members of the public help ensure that important questions are incorporated into future research agendas. Surveys, focus groups, and online crowdsourcing are increasingly used to obtain input, yet little is known about how they compare for prioritizing research topics. To address this gap, the Study of Methods for Assessing Research Topic Elicitation and pRioritization (SMARTER) evaluated participant satisfaction with the engagement experience across three prioritization activities.MethodsRespondents from Back pain Outcomes using Longitudinal Data (BOLD), a registry of patients 65 years and older with low back pain (LBP), were randomly assigned to one of three interactive prioritization activities: online crowd-voting, in-person focus groups using nominal group technique, and two rounds of a mailed survey (Delphi). To assess quality of experience, participants completed a brief survey; a subset were ...
Background: Outcomes derived from longitudinal self-reported health-related quality of life measu... more Background: Outcomes derived from longitudinal self-reported health-related quality of life measures can be confounded by response shift. This study was aimed to detect response shift phenomena among patients with hypertension attending a community-based disease management program. Methods: 240 consecutive consulting or followed up patients with diagnosed hypertension were recruited. The SF-36 instruments were self-administered at 12 community health service stations and four weeks after attending the program. RS was assessed by the 4-step structural equation modeling approach. Results: Data from 203 (84.6%) patients were eligible for analyses (mean age 65.9±10.8 years, 46,3% female). The results showed uniform recalibration of social functioning ( X2SBdiff(1)=22.98, P<0.001), and non-uniform recalibration of role limitations due to physical problems ( X2SBdiff(1)=8.84, P=0.003), and bodily pain ( X2SBdiff(1)=17.41, P<0.001). The effects of response shift were calculated as “s...
International Journal of Environmental Research and Public Health, 2019
The aim of this study was to examine various psychosocial, behavioral, and socio-environmental fa... more The aim of this study was to examine various psychosocial, behavioral, and socio-environmental factors in a multiethnic sample of healthy-weight, overweight, and obese youths in the United States (US) and Mexico and determine differences by sex. We conducted a cross-sectional analysis of 633 youths aged 11–18 years who completed a self-reported questionnaire. Height and weight were measured to determine body mass index (BMI). Overweight and obese youth in both countries were significantly more likely to report a higher body image dissatisfaction (Odds Ratio (OR) = 1.67 and OR= 2.95, respectively), depressive symptoms (OR = 1.08 and OR = 1.12, respectively), perceive themselves as overweight (OR = 2.57) or obese (OR = 5.30), and a lower weight-specific quality of life (OR = 0.97 and OR = 0.95, respectively) than healthy-weight youth. Obese youth have lower healthy lifestyle priorities (OR = 0.75) and are less likely to be physically active (OR = 0.79) and eat breakfast (OR = 0.47) th...
Purpose-Patient-reported outcomes are important clinical trial endpoints. Young children may not ... more Purpose-Patient-reported outcomes are important clinical trial endpoints. Young children may not be able to reliably report on how they feel or function, so observer-reported outcomes (ObsROs) may be more appropriate for them. The purpose of this study was to develop and pilot field test electronic parent-reported observational instruments for children with cystic fibrosis (CF) 0-6 and 7-11 years of age. Methods-We performed concept elicitation interviews with parents of children with CF ≤ 11 years of age to elicit the respiratory signs they could observe at baseline and during an acute respiratory illness. The resulting instruments were refined based on interviews with parents and clinicians. We conducted a pilot field test to evaluate test-retest reliability and the ability of items to distinguish well and sick periods. Results-The instruments consist of 17 items assessing respiratory signs and observable CFrelated impacts. Test-retest reliability was acceptable for both age groups but discrimination was low for ages 7-11, likely reflecting less direct observation of older children by their parents. Conclusions-An ObsRO for children with CF ages 0-6 appears promising, while self-report may be more appropriate for children >6 years of age. Next steps for the 0-6 year old instrument
The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association, Jan 9, 2018
To explore, using semistructured qualitative interviews, parent observations of their infant'... more To explore, using semistructured qualitative interviews, parent observations of their infant's health as they relate to having a cleft lip or cleft lip and cleft palate (CL±P) and/or associated treatments. Cross-sectional, qualitative study across 3 sites. Parents were recruited from 3 academic craniofacial centers. Most interviews were conducted over the telephone, audio-recorded, and transcribed. Forty-one parents (31 English-, 10 Spanish-speaking) were interviewed. Parents had a child ages 1 to 35 months diagnosed with CL±P. Twelve domains reflecting infant health and well-being, likely affected by a CL±P and/or associated treatments, were identified from clinical experience and literature review. Study investigators conducted semistructured interviews based on 12 identified domains. After transcripts of the interviews were reviewed, our multidisciplinary team selected illustrative quotes from each domain that reflected consistent observations made by parents. Parents' re...
Research in Social and Administrative Pharmacy, 2017
Background-Low health literacy is associated with poor medication adherence and poor health outco... more Background-Low health literacy is associated with poor medication adherence and poor health outcomes. Limited understanding of prescribed medications may decrease validity of patientreported adherence measures. Objectives-To assess knowledge of names and purposes of prescribed medications among patients with multiple chronic conditions. Methods-Individual interviews were conducted with a convenience sample of patients from six U.S. primary care clinics. Participants (n=57) were English and/or Spanish-speaking patients prescribed 3+ medications for chronic conditions, for which non-adherence may lead to disability or death. In individual interviews, patients were asked to name their medications, explain the purpose of each, and to explain how they distinguish them from one another. Interviews were
INTRODUCTION AND OBJECTIVES: Patient reported outcome measures (PROMs) are an invaluable resource... more INTRODUCTION AND OBJECTIVES: Patient reported outcome measures (PROMs) are an invaluable resource that allows the patient to communicate about how they feel about their health and wellbeing. As these measures become more integrated into evidencebased medicine and health care delivery, a comprehensive urethral stricture-specific PROM is needed. We present research aimed to develop such a PROM. Cognitive interviews and item prioritization were performed to reduce previously generated items for development of a urethral-specific PROM. The input of clinicians was queried to compare for comparison to patient data. METHODS: We identified potential items during concept elicitation interviews. Six domains were created based on urinary or sexual items (function, impact, symptoms/signs). Two iterative rounds of cognitive interviews were performed among a separate cohort of five and four patients, respectively, to further test patient understanding of these items (n¼33 urinary, n¼5 sexual). Changes were made to the existing items based upon patient feedback. Item prioritization was conducted among a separate cohort of 20 patients who rated degree of bothersomeness from their urethral stricture (very much, somewhat, does not bother). Male reconstructive urologists (n¼22) also rated the items in regards to importance in making treatment decisions. RESULTS: Of the top 15 items that patients rated by bother, urinary issues predominated. There was only one sexual item (slow force of ejaculation). On average, the patient cohort was most bothered by anxiety about being unable to void, post-void dribbling, and trouble aiming their stream. There was only 53% agreement between patients and clinicians in the 15 items they independently rated as of highest importance. CONCLUSIONS: Based upon the patient-driven item prioritization, we plan to create a PROM, test measurement properties, and modify our instrument, as needed, to create a patient-driven urethral stricture-specific PROM. Discord between patients and clinicians highlight the need for a stricture-specific PROM.
International journal of pediatric otorhinolaryngology, 2016
Management of children with unilateral hearing loss is not standardized. The primary goal of this... more Management of children with unilateral hearing loss is not standardized. The primary goal of this study was to elicit patient- and parent-reported perspectives regarding usage of hearing devices in pediatric UHL and to suggest a basic algorithmic approach to management. Our tertiary care center recruited families of youth ages 5-19 years with unilateral hearing loss from January 2014 through October 2015. Parents of all youths completed a 36-item survey, and some youth ages 11-19 years participated in hour-long interviews. We assessed patterns of hearing device usage among participants, and performed qualitative data analysis to understand factors considered by youths when deciding whether or not to use a hearing device. Survey information was collected for 50 patients. Distribution of hearing loss severity in affected ear was mild 14%, moderate 26%, severe 22%, and profound 38%. The majority of children had sensorineural hearing loss (57%), followed by mixed (32%), and then conduct...
prescriptions given at the first or second visit, and urine drug testing (UDT) performed at the f... more prescriptions given at the first or second visit, and urine drug testing (UDT) performed at the first or second visit. After the initial data collection period, providers at the pain clinic were educated on the importance of initial urine drug testing in chronic opioid management as recommended by the American Society of Interventional Pain Physicians. One month after the educational session, the same data were collected on 152 new patients to the pain clinic. Main Outcome Measures: Frequency of urine drug testing in patients prescribed opioids at the pain clinic both preand postintervention. Frequency of males and females prescribed opioids and the frequency of UDT in males and females prescribed opioids. Results: There were a total of 300 patients with 195 females (65%) and 105 males (35%). Prior to the intervention, 6.25% of patients prescribed opiates in their first two visits had UDT performed. After the intervention, 69.7% of patients prescribed opiates in their first two visits had UDT performed. There was a significant difference in the urine drug testing performed preand postintervention (Z-Score 1⁄4 -5.2565, P 1⁄4 .00). There was no significant gender differences in patients prescribed opiates at their first or second visit (X 1⁄43.6262, P1⁄4.0569). There was no significant gender differences in urine drug screen testing in patients prescribed opiates (X 1⁄4 0.0028, P 1⁄4 .9580). Conclusions: Education of providers at a chronic pain clinic improved adherence to routine urine drug testing of new patients prescribed opiates. Among the same population, there was no gender difference among opioid prescription and urine drug testing at the initial visits. Level of Evidence: Level III
Background New therapeutics are moving into phase 3 clinical trials for the treatment of coeliac ... more Background New therapeutics are moving into phase 3 clinical trials for the treatment of coeliac disease, a condition with no established therapies other than gluten-free diet. These trials will require a meaningful, validated and fit for purpose patient-reported outcome measure (PROM) to quantify the symptomatic improvement of patients. Aim To evaluate existing PROMs for suitability in a Food and Drug Administration (FDA) approval trial for a coeliac disease therapeutic. Method We performed a systematic search in five online databases (MedLine, EmBase, Web of Science, CENTRAL, CINAHL) for studies that enrolled patients with coeliac disease and used PROMs. Studies included in this review had to measure some PROM concept, be patient administered and based upon a previously validated instrument with published measurement properties. Results Our literature search identified 2706 unique records of which 199 ultimately qualified for abstraction. The majority of PROMs used in studies of coeliac disease was generic and did not measure numerous symptoms or concerns of interest to patients. Four PROMs were found to contain appropriate content for use in an FDA trial: the coeliac disease-specific modification of the Gastrointestinal Symptoms Rating Scale (CeD-GSRS), Psychological General Well-Being Index (PGWB), the Celiac Disease Symptom Diary (CDSD) and the Celiac Disease Patient Reported Outcome (CeD-PRO). The GSRS and PGWB are most often used together and are two of the most extensively used measures in coeliac disease. The CDSD and CeD-PRO were developed exclusively for trials in coeliac disease but have much less published information on their measurement properties. Conclusions While we did not find PROMs that currently meet the stated expectations of the FDA for regulatory purposes, four PROMs (CeD-GSRS, PGWB, CDSD and CeD-PRO) appear to contain appropriate content and with modest additional validation work could meet scientific standards for valid and sensitive measures of disease and treatment outcome. Specifically, what is needed for these instruments is an understanding of how sensitive they are to real changes in-patient condition, how stable they are over a period of time when health status should not have changed (test-retest reliability) as well as how they correlate with other measures of patient functioning such as intestinal biopsy. All of these objectives could feasibly be accomplished over a short cohort study of patients with biopsy-defined coeliac disease undergoing gluten challenge.
Study Design-Secondary analysis of Lumbar Epidural steroid injections for Spinal Stenosis randomi... more Study Design-Secondary analysis of Lumbar Epidural steroid injections for Spinal Stenosis randomized controlled trial data. Objective-To re-evaluate whether outcomes for older adults receiving epidural steroid injections with or without corticosteroid improve after using patient-prioritized Roland-Morris Disability Questionnaire (RDQ) items. Summary of Background Data-Epidural corticosteroid injections are commonly used to treat lumbar spinal stenosis symptoms, despite limited evidence for their effectiveness in clinical trials. It is unclear whether evaluating patient-prioritized outcomes would alter results of a large clinical trial. Methods-Outcomes from the LESS trial were re-analyzed using RDQ, Sickness Impact Profile-SIP weights assigned to the RDQ items, and patient-prioritized RDQ items. Differences between
Purpose-The purpose of this study was to create symptom indices-that is, scores derived from ques... more Purpose-The purpose of this study was to create symptom indices-that is, scores derived from questionnaires-to accurately and efficiently measure symptoms of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome, collectively referred to as urologic chronic pelvic pain syndromes (UCPPS). We created these indices empirically, by investigating the structure of symptoms using exploratory factor analysis.
Purpose-To assess content validity and patient and provider prioritization of Patient Reported Ou... more Purpose-To assess content validity and patient and provider prioritization of Patient Reported Outcomes Measurement Information System (PROMIS) Depression, Anxiety, Fatigue, and Alcohol Use items in the context of clinical care for people living with HIV (PLWH), and to develop and assess new items as needed. Methods-We conducted concept elicitation interviews (n=161), item pool matching, prioritization focus groups (n=227 participants), and cognitive interviews (n=48) with Englishspeaking (~75%) and Spanish-speaking (~25%) PLWH from clinical sites in Seattle, San Diego, Birmingham, and Boston. For each domain we also conducted item review and prioritization with two HIV provider panels of 3 to 8 members each. Results-Among items most highly prioritized by PLWH and providers were those that included information regarding personal impacts of the concept being assessed, in addition to severity level. Items that addressed impact were considered most actionable for clinical care. We developed additional items addressing this. For depression we developed items related to suicide and other forms of self-harm, and for all domains we developed items addressing impacts PLWH and/or providers indicated were particularly relevant to clinical care. Across the 4 domains, 16 new items were retained for further psychometric testing. Conclusion-PLWH and providers had priorities for what they believed providers should know to provide optimal care for PLWH. Incorporation of these priorities into clinical assessments used in clinical care of PLWH may facilitate patient-centered care.
The spine journal : official journal of the North American Spine Society, Jan 16, 2015
There is growing concern that commonly used patient-reported outcomes (PROs) used in clinical res... more There is growing concern that commonly used patient-reported outcomes (PROs) used in clinical research evaluating treatments such as epidural steroid injections (ESI) for lumbar spinal stenosis may not adequately capture outcomes of greatest important to older adults. To determine what outcomes are most important to older adults with spinal stenosis, how well commonly used PROs reflect what is most important to these participants and which outcomes older adults with spinal stenosis would want improved to consider having ESI. Outcomes prioritization study. Community sample of 33 older adults with spinal stenosis. Swiss Spinal Stenosis Questionnaire and Roland-Morris Disability Questionnaire. Individual sorting and ranking exercises followed by facilitated focus groups. This study was funded by a contract with the Patient-Centered Outcomes Research Institute (Contract # CE-12-11-4469). None of the authors have conflicts of interest to report related to this study. Highest rated proble...
Purpose-To examine differences in self-reported perceived mental and physical health status (PHS)... more Purpose-To examine differences in self-reported perceived mental and physical health status (PHS), as well as known cardiometabolic risk factors in a sample of normal weight, overweight, and obese Mexican youths. Methods-Cross-sectional analysis of 164 youths aged 11-18 years recruited in Cuernavaca, Mexico. Participants completed a self-administered questionnaire that included measures of generic and weight-specific quality of life (QoL), perceived health, physical function, depressive symptoms, and body shape satisfaction. Height, weight and waist circumference were measured and body mass index (BMI) was determined. Fasting blood samples from participants yielded levels of glucose, triglycerides, and cholesterol (total, HDL and LDL). Results-Nearly 50% of participants were female, 21% had a normal BMI, 39% were overweight, and 40% were obese. Obese youths reported significantly lower measures of PHS and showed an increase in cardiometabolic risk, compared to normal weight youths. Physical functioning, generic and weight-specific QoL were inversely associated with BMI, waist circumference and glucose. Depressive symptoms were positively correlated with BMI, waist circumference, glucose levels and HDL cholesterol. No correlation was found between PHS and cardiometabolic risk measures after controlling for BMI. Conclusions-In this sample of Mexican youths, obesity was associated with a significantly lower PHS and increased cardiometabolic risk.
Adolescence is a life stage with rapid and major developmental changes, yet little is known about... more Adolescence is a life stage with rapid and major developmental changes, yet little is known about how these changes influence the quality of life of young people who are deaf or hard of hearing (DHH). Objective: To determine differences in the 3 domains of a hearing-specific quality-of-life instrument between youth who had severe to profound sensorineural hearing loss based on whether they used no technology, hearing aids, or cochlear implants. Design and Setting: A multi-institutional prospective cohort study. Participants: A convenience sample of 11-to 18-yearold youths with severe to profound sensorineural hearing loss recruited between January 1 and December 31, 2008. Main Outcome Measures: Youth Quality of Life-Research Instrument and Youth Quality of Life Instrument-Deaf and Hard of Hearing (YQoL-DHH) scores. The YQoL-DHH was composed of 3 domains: participation, self-acceptance/advocacy, and stigma-related quality of life. Results: A total of 157 individuals participated. Overall mean (SD) age was 14.1 (2.3) years, and the femalemale ratio was 82:75. Forty-nine individuals (31.2%) were not using any technology, 45 (28.7%) were using hearing aids, and 63 (40.1%) were using cochlear implants. Mean age of unilateral or first cochlear implant was 62.9 months. Thirty-eight individuals (24.2%) attended schools with DHH programs, 55 (35.0%) attended schools without DHH programs, and 58 (36.9%) attended schools for the deaf. Statistically significant differences were noted in YQoL-DHH participation and perceived stigma scores between the groups when stratified by technology used and school setting. Conclusions: These data suggest that the domains of quality of life as measured by our instrument differ significantly among youth based on technology used and school setting. Youth using no technology or cochlear implants tended to score higher than those using hearing aids in mainstream schools with or without DHH programs and in schools for the deaf. The YQoL-DHH instrument is able to detect differences in quality of life within a group of youth with severe to profound hearing loss.
Encyclopedia of Quality of Life and Well-Being Research, 2014
Physical body Energy body Mental body Regulation of prana flow Rich in prana Proper Nutrition (Yo... more Physical body Energy body Mental body Regulation of prana flow Rich in prana Proper Nutrition (Yogic Diet) Less stimulation Better Nutrition Prana flow disturbance Lifestyle Stress Yogic practices Yoga and the Quality of Life, Fig. 1 Effects of lifestyle stress, yogic practices, and yogic diet on the health Lifestyle Stress Yogic practices Gain of insight Calming effects of the yogic diet Mental body Wisdom body Bliss body Loss of discrimination Loss of quality of life Blissful experiences Enhanced quality of life Yoga and the Quality of Life, Fig. 2 Effects of the lifestyle stress, yogic practices, and yogic diet on the quality of life
Given the important role of parent-youth communication in adolescent well-being and quality of li... more Given the important role of parent-youth communication in adolescent well-being and quality of life, we sought to examine the relationship between specific communication variables and youth perceived quality of life in general and as a deaf or hard-of-hearing (DHH) individual. A convenience sample of 230 youth (mean age = 14.1, standard deviation = 2.2; 24% used sign only, 40% speech only, and 36% sign 1 speech) was surveyed on communication-related issues, generic and DHH-specific quality of life, and depression symptoms. Higher youth perception of their ability to understand parents' communication was significantly correlated with perceived quality of life as well as lower reported depressive symptoms and lower perceived stigma. Youth who use speech as their single mode of communication were more likely to report greater stigma associated with being DHH than youth who used both speech and sign. These findings demonstrate the importance of youths' perceptions of communication with their parents on generic and DHH-specific youth quality of life. For youth with hearing loss, there is consensus by both clinicians and researchers that having access to communication at home, school, and with peers is important for language as well as cognitive and socioemotional development (
Objective. Quality-of-life (QOL) measures targeting youth with hearing loss are useful in populat... more Objective. Quality-of-life (QOL) measures targeting youth with hearing loss are useful in population needs assessment, educational placement, and program design and evaluation. This study assesses the cross-sectional validity of the Youth Quality of Life Instrument–Deaf and Hard of Hearing Module (YQOL-DHH). Study Design. Instrument development and cross-sectional survey. Setting. Recruitment through schools, professional organizations, clinics, and programs for youth who are deaf or hard of hearing. Subjects and Methods. Thirty-five candidate items were administered to 230 adolescents aged 11 to 18 years: 49% female, 61% white, 11% mild hearing loss, 20% moderate/moderate-severe, 41% severe/profound, and 28% with cochlear implants. Participants completed individual or group-administered questionnaires by paper and pencil (58%), Web-based English (29%), American Sign Language (ASL) or Pidgin Signed English (PSE) (9%) on DVD, or interviewer-supervised ASL or PSE DVD (4%). The Childre...
BackgroundBy participating in priority-setting activities in research, patients and members of th... more BackgroundBy participating in priority-setting activities in research, patients and members of the public help ensure that important questions are incorporated into future research agendas. Surveys, focus groups, and online crowdsourcing are increasingly used to obtain input, yet little is known about how they compare for prioritizing research topics. To address this gap, the Study of Methods for Assessing Research Topic Elicitation and pRioritization (SMARTER) evaluated participant satisfaction with the engagement experience across three prioritization activities.MethodsRespondents from Back pain Outcomes using Longitudinal Data (BOLD), a registry of patients 65 years and older with low back pain (LBP), were randomly assigned to one of three interactive prioritization activities: online crowd-voting, in-person focus groups using nominal group technique, and two rounds of a mailed survey (Delphi). To assess quality of experience, participants completed a brief survey; a subset were ...
Background: Outcomes derived from longitudinal self-reported health-related quality of life measu... more Background: Outcomes derived from longitudinal self-reported health-related quality of life measures can be confounded by response shift. This study was aimed to detect response shift phenomena among patients with hypertension attending a community-based disease management program. Methods: 240 consecutive consulting or followed up patients with diagnosed hypertension were recruited. The SF-36 instruments were self-administered at 12 community health service stations and four weeks after attending the program. RS was assessed by the 4-step structural equation modeling approach. Results: Data from 203 (84.6%) patients were eligible for analyses (mean age 65.9±10.8 years, 46,3% female). The results showed uniform recalibration of social functioning ( X2SBdiff(1)=22.98, P<0.001), and non-uniform recalibration of role limitations due to physical problems ( X2SBdiff(1)=8.84, P=0.003), and bodily pain ( X2SBdiff(1)=17.41, P<0.001). The effects of response shift were calculated as “s...
International Journal of Environmental Research and Public Health, 2019
The aim of this study was to examine various psychosocial, behavioral, and socio-environmental fa... more The aim of this study was to examine various psychosocial, behavioral, and socio-environmental factors in a multiethnic sample of healthy-weight, overweight, and obese youths in the United States (US) and Mexico and determine differences by sex. We conducted a cross-sectional analysis of 633 youths aged 11–18 years who completed a self-reported questionnaire. Height and weight were measured to determine body mass index (BMI). Overweight and obese youth in both countries were significantly more likely to report a higher body image dissatisfaction (Odds Ratio (OR) = 1.67 and OR= 2.95, respectively), depressive symptoms (OR = 1.08 and OR = 1.12, respectively), perceive themselves as overweight (OR = 2.57) or obese (OR = 5.30), and a lower weight-specific quality of life (OR = 0.97 and OR = 0.95, respectively) than healthy-weight youth. Obese youth have lower healthy lifestyle priorities (OR = 0.75) and are less likely to be physically active (OR = 0.79) and eat breakfast (OR = 0.47) th...
Purpose-Patient-reported outcomes are important clinical trial endpoints. Young children may not ... more Purpose-Patient-reported outcomes are important clinical trial endpoints. Young children may not be able to reliably report on how they feel or function, so observer-reported outcomes (ObsROs) may be more appropriate for them. The purpose of this study was to develop and pilot field test electronic parent-reported observational instruments for children with cystic fibrosis (CF) 0-6 and 7-11 years of age. Methods-We performed concept elicitation interviews with parents of children with CF ≤ 11 years of age to elicit the respiratory signs they could observe at baseline and during an acute respiratory illness. The resulting instruments were refined based on interviews with parents and clinicians. We conducted a pilot field test to evaluate test-retest reliability and the ability of items to distinguish well and sick periods. Results-The instruments consist of 17 items assessing respiratory signs and observable CFrelated impacts. Test-retest reliability was acceptable for both age groups but discrimination was low for ages 7-11, likely reflecting less direct observation of older children by their parents. Conclusions-An ObsRO for children with CF ages 0-6 appears promising, while self-report may be more appropriate for children >6 years of age. Next steps for the 0-6 year old instrument
The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association, Jan 9, 2018
To explore, using semistructured qualitative interviews, parent observations of their infant'... more To explore, using semistructured qualitative interviews, parent observations of their infant's health as they relate to having a cleft lip or cleft lip and cleft palate (CL±P) and/or associated treatments. Cross-sectional, qualitative study across 3 sites. Parents were recruited from 3 academic craniofacial centers. Most interviews were conducted over the telephone, audio-recorded, and transcribed. Forty-one parents (31 English-, 10 Spanish-speaking) were interviewed. Parents had a child ages 1 to 35 months diagnosed with CL±P. Twelve domains reflecting infant health and well-being, likely affected by a CL±P and/or associated treatments, were identified from clinical experience and literature review. Study investigators conducted semistructured interviews based on 12 identified domains. After transcripts of the interviews were reviewed, our multidisciplinary team selected illustrative quotes from each domain that reflected consistent observations made by parents. Parents' re...
Research in Social and Administrative Pharmacy, 2017
Background-Low health literacy is associated with poor medication adherence and poor health outco... more Background-Low health literacy is associated with poor medication adherence and poor health outcomes. Limited understanding of prescribed medications may decrease validity of patientreported adherence measures. Objectives-To assess knowledge of names and purposes of prescribed medications among patients with multiple chronic conditions. Methods-Individual interviews were conducted with a convenience sample of patients from six U.S. primary care clinics. Participants (n=57) were English and/or Spanish-speaking patients prescribed 3+ medications for chronic conditions, for which non-adherence may lead to disability or death. In individual interviews, patients were asked to name their medications, explain the purpose of each, and to explain how they distinguish them from one another. Interviews were
INTRODUCTION AND OBJECTIVES: Patient reported outcome measures (PROMs) are an invaluable resource... more INTRODUCTION AND OBJECTIVES: Patient reported outcome measures (PROMs) are an invaluable resource that allows the patient to communicate about how they feel about their health and wellbeing. As these measures become more integrated into evidencebased medicine and health care delivery, a comprehensive urethral stricture-specific PROM is needed. We present research aimed to develop such a PROM. Cognitive interviews and item prioritization were performed to reduce previously generated items for development of a urethral-specific PROM. The input of clinicians was queried to compare for comparison to patient data. METHODS: We identified potential items during concept elicitation interviews. Six domains were created based on urinary or sexual items (function, impact, symptoms/signs). Two iterative rounds of cognitive interviews were performed among a separate cohort of five and four patients, respectively, to further test patient understanding of these items (n¼33 urinary, n¼5 sexual). Changes were made to the existing items based upon patient feedback. Item prioritization was conducted among a separate cohort of 20 patients who rated degree of bothersomeness from their urethral stricture (very much, somewhat, does not bother). Male reconstructive urologists (n¼22) also rated the items in regards to importance in making treatment decisions. RESULTS: Of the top 15 items that patients rated by bother, urinary issues predominated. There was only one sexual item (slow force of ejaculation). On average, the patient cohort was most bothered by anxiety about being unable to void, post-void dribbling, and trouble aiming their stream. There was only 53% agreement between patients and clinicians in the 15 items they independently rated as of highest importance. CONCLUSIONS: Based upon the patient-driven item prioritization, we plan to create a PROM, test measurement properties, and modify our instrument, as needed, to create a patient-driven urethral stricture-specific PROM. Discord between patients and clinicians highlight the need for a stricture-specific PROM.
International journal of pediatric otorhinolaryngology, 2016
Management of children with unilateral hearing loss is not standardized. The primary goal of this... more Management of children with unilateral hearing loss is not standardized. The primary goal of this study was to elicit patient- and parent-reported perspectives regarding usage of hearing devices in pediatric UHL and to suggest a basic algorithmic approach to management. Our tertiary care center recruited families of youth ages 5-19 years with unilateral hearing loss from January 2014 through October 2015. Parents of all youths completed a 36-item survey, and some youth ages 11-19 years participated in hour-long interviews. We assessed patterns of hearing device usage among participants, and performed qualitative data analysis to understand factors considered by youths when deciding whether or not to use a hearing device. Survey information was collected for 50 patients. Distribution of hearing loss severity in affected ear was mild 14%, moderate 26%, severe 22%, and profound 38%. The majority of children had sensorineural hearing loss (57%), followed by mixed (32%), and then conduct...
prescriptions given at the first or second visit, and urine drug testing (UDT) performed at the f... more prescriptions given at the first or second visit, and urine drug testing (UDT) performed at the first or second visit. After the initial data collection period, providers at the pain clinic were educated on the importance of initial urine drug testing in chronic opioid management as recommended by the American Society of Interventional Pain Physicians. One month after the educational session, the same data were collected on 152 new patients to the pain clinic. Main Outcome Measures: Frequency of urine drug testing in patients prescribed opioids at the pain clinic both preand postintervention. Frequency of males and females prescribed opioids and the frequency of UDT in males and females prescribed opioids. Results: There were a total of 300 patients with 195 females (65%) and 105 males (35%). Prior to the intervention, 6.25% of patients prescribed opiates in their first two visits had UDT performed. After the intervention, 69.7% of patients prescribed opiates in their first two visits had UDT performed. There was a significant difference in the urine drug testing performed preand postintervention (Z-Score 1⁄4 -5.2565, P 1⁄4 .00). There was no significant gender differences in patients prescribed opiates at their first or second visit (X 1⁄43.6262, P1⁄4.0569). There was no significant gender differences in urine drug screen testing in patients prescribed opiates (X 1⁄4 0.0028, P 1⁄4 .9580). Conclusions: Education of providers at a chronic pain clinic improved adherence to routine urine drug testing of new patients prescribed opiates. Among the same population, there was no gender difference among opioid prescription and urine drug testing at the initial visits. Level of Evidence: Level III
Background New therapeutics are moving into phase 3 clinical trials for the treatment of coeliac ... more Background New therapeutics are moving into phase 3 clinical trials for the treatment of coeliac disease, a condition with no established therapies other than gluten-free diet. These trials will require a meaningful, validated and fit for purpose patient-reported outcome measure (PROM) to quantify the symptomatic improvement of patients. Aim To evaluate existing PROMs for suitability in a Food and Drug Administration (FDA) approval trial for a coeliac disease therapeutic. Method We performed a systematic search in five online databases (MedLine, EmBase, Web of Science, CENTRAL, CINAHL) for studies that enrolled patients with coeliac disease and used PROMs. Studies included in this review had to measure some PROM concept, be patient administered and based upon a previously validated instrument with published measurement properties. Results Our literature search identified 2706 unique records of which 199 ultimately qualified for abstraction. The majority of PROMs used in studies of coeliac disease was generic and did not measure numerous symptoms or concerns of interest to patients. Four PROMs were found to contain appropriate content for use in an FDA trial: the coeliac disease-specific modification of the Gastrointestinal Symptoms Rating Scale (CeD-GSRS), Psychological General Well-Being Index (PGWB), the Celiac Disease Symptom Diary (CDSD) and the Celiac Disease Patient Reported Outcome (CeD-PRO). The GSRS and PGWB are most often used together and are two of the most extensively used measures in coeliac disease. The CDSD and CeD-PRO were developed exclusively for trials in coeliac disease but have much less published information on their measurement properties. Conclusions While we did not find PROMs that currently meet the stated expectations of the FDA for regulatory purposes, four PROMs (CeD-GSRS, PGWB, CDSD and CeD-PRO) appear to contain appropriate content and with modest additional validation work could meet scientific standards for valid and sensitive measures of disease and treatment outcome. Specifically, what is needed for these instruments is an understanding of how sensitive they are to real changes in-patient condition, how stable they are over a period of time when health status should not have changed (test-retest reliability) as well as how they correlate with other measures of patient functioning such as intestinal biopsy. All of these objectives could feasibly be accomplished over a short cohort study of patients with biopsy-defined coeliac disease undergoing gluten challenge.
Study Design-Secondary analysis of Lumbar Epidural steroid injections for Spinal Stenosis randomi... more Study Design-Secondary analysis of Lumbar Epidural steroid injections for Spinal Stenosis randomized controlled trial data. Objective-To re-evaluate whether outcomes for older adults receiving epidural steroid injections with or without corticosteroid improve after using patient-prioritized Roland-Morris Disability Questionnaire (RDQ) items. Summary of Background Data-Epidural corticosteroid injections are commonly used to treat lumbar spinal stenosis symptoms, despite limited evidence for their effectiveness in clinical trials. It is unclear whether evaluating patient-prioritized outcomes would alter results of a large clinical trial. Methods-Outcomes from the LESS trial were re-analyzed using RDQ, Sickness Impact Profile-SIP weights assigned to the RDQ items, and patient-prioritized RDQ items. Differences between
Purpose-The purpose of this study was to create symptom indices-that is, scores derived from ques... more Purpose-The purpose of this study was to create symptom indices-that is, scores derived from questionnaires-to accurately and efficiently measure symptoms of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome, collectively referred to as urologic chronic pelvic pain syndromes (UCPPS). We created these indices empirically, by investigating the structure of symptoms using exploratory factor analysis.
Purpose-To assess content validity and patient and provider prioritization of Patient Reported Ou... more Purpose-To assess content validity and patient and provider prioritization of Patient Reported Outcomes Measurement Information System (PROMIS) Depression, Anxiety, Fatigue, and Alcohol Use items in the context of clinical care for people living with HIV (PLWH), and to develop and assess new items as needed. Methods-We conducted concept elicitation interviews (n=161), item pool matching, prioritization focus groups (n=227 participants), and cognitive interviews (n=48) with Englishspeaking (~75%) and Spanish-speaking (~25%) PLWH from clinical sites in Seattle, San Diego, Birmingham, and Boston. For each domain we also conducted item review and prioritization with two HIV provider panels of 3 to 8 members each. Results-Among items most highly prioritized by PLWH and providers were those that included information regarding personal impacts of the concept being assessed, in addition to severity level. Items that addressed impact were considered most actionable for clinical care. We developed additional items addressing this. For depression we developed items related to suicide and other forms of self-harm, and for all domains we developed items addressing impacts PLWH and/or providers indicated were particularly relevant to clinical care. Across the 4 domains, 16 new items were retained for further psychometric testing. Conclusion-PLWH and providers had priorities for what they believed providers should know to provide optimal care for PLWH. Incorporation of these priorities into clinical assessments used in clinical care of PLWH may facilitate patient-centered care.
The spine journal : official journal of the North American Spine Society, Jan 16, 2015
There is growing concern that commonly used patient-reported outcomes (PROs) used in clinical res... more There is growing concern that commonly used patient-reported outcomes (PROs) used in clinical research evaluating treatments such as epidural steroid injections (ESI) for lumbar spinal stenosis may not adequately capture outcomes of greatest important to older adults. To determine what outcomes are most important to older adults with spinal stenosis, how well commonly used PROs reflect what is most important to these participants and which outcomes older adults with spinal stenosis would want improved to consider having ESI. Outcomes prioritization study. Community sample of 33 older adults with spinal stenosis. Swiss Spinal Stenosis Questionnaire and Roland-Morris Disability Questionnaire. Individual sorting and ranking exercises followed by facilitated focus groups. This study was funded by a contract with the Patient-Centered Outcomes Research Institute (Contract # CE-12-11-4469). None of the authors have conflicts of interest to report related to this study. Highest rated proble...
Purpose-To examine differences in self-reported perceived mental and physical health status (PHS)... more Purpose-To examine differences in self-reported perceived mental and physical health status (PHS), as well as known cardiometabolic risk factors in a sample of normal weight, overweight, and obese Mexican youths. Methods-Cross-sectional analysis of 164 youths aged 11-18 years recruited in Cuernavaca, Mexico. Participants completed a self-administered questionnaire that included measures of generic and weight-specific quality of life (QoL), perceived health, physical function, depressive symptoms, and body shape satisfaction. Height, weight and waist circumference were measured and body mass index (BMI) was determined. Fasting blood samples from participants yielded levels of glucose, triglycerides, and cholesterol (total, HDL and LDL). Results-Nearly 50% of participants were female, 21% had a normal BMI, 39% were overweight, and 40% were obese. Obese youths reported significantly lower measures of PHS and showed an increase in cardiometabolic risk, compared to normal weight youths. Physical functioning, generic and weight-specific QoL were inversely associated with BMI, waist circumference and glucose. Depressive symptoms were positively correlated with BMI, waist circumference, glucose levels and HDL cholesterol. No correlation was found between PHS and cardiometabolic risk measures after controlling for BMI. Conclusions-In this sample of Mexican youths, obesity was associated with a significantly lower PHS and increased cardiometabolic risk.
Adolescence is a life stage with rapid and major developmental changes, yet little is known about... more Adolescence is a life stage with rapid and major developmental changes, yet little is known about how these changes influence the quality of life of young people who are deaf or hard of hearing (DHH). Objective: To determine differences in the 3 domains of a hearing-specific quality-of-life instrument between youth who had severe to profound sensorineural hearing loss based on whether they used no technology, hearing aids, or cochlear implants. Design and Setting: A multi-institutional prospective cohort study. Participants: A convenience sample of 11-to 18-yearold youths with severe to profound sensorineural hearing loss recruited between January 1 and December 31, 2008. Main Outcome Measures: Youth Quality of Life-Research Instrument and Youth Quality of Life Instrument-Deaf and Hard of Hearing (YQoL-DHH) scores. The YQoL-DHH was composed of 3 domains: participation, self-acceptance/advocacy, and stigma-related quality of life. Results: A total of 157 individuals participated. Overall mean (SD) age was 14.1 (2.3) years, and the femalemale ratio was 82:75. Forty-nine individuals (31.2%) were not using any technology, 45 (28.7%) were using hearing aids, and 63 (40.1%) were using cochlear implants. Mean age of unilateral or first cochlear implant was 62.9 months. Thirty-eight individuals (24.2%) attended schools with DHH programs, 55 (35.0%) attended schools without DHH programs, and 58 (36.9%) attended schools for the deaf. Statistically significant differences were noted in YQoL-DHH participation and perceived stigma scores between the groups when stratified by technology used and school setting. Conclusions: These data suggest that the domains of quality of life as measured by our instrument differ significantly among youth based on technology used and school setting. Youth using no technology or cochlear implants tended to score higher than those using hearing aids in mainstream schools with or without DHH programs and in schools for the deaf. The YQoL-DHH instrument is able to detect differences in quality of life within a group of youth with severe to profound hearing loss.
Encyclopedia of Quality of Life and Well-Being Research, 2014
Physical body Energy body Mental body Regulation of prana flow Rich in prana Proper Nutrition (Yo... more Physical body Energy body Mental body Regulation of prana flow Rich in prana Proper Nutrition (Yogic Diet) Less stimulation Better Nutrition Prana flow disturbance Lifestyle Stress Yogic practices Yoga and the Quality of Life, Fig. 1 Effects of lifestyle stress, yogic practices, and yogic diet on the health Lifestyle Stress Yogic practices Gain of insight Calming effects of the yogic diet Mental body Wisdom body Bliss body Loss of discrimination Loss of quality of life Blissful experiences Enhanced quality of life Yoga and the Quality of Life, Fig. 2 Effects of the lifestyle stress, yogic practices, and yogic diet on the quality of life
Given the important role of parent-youth communication in adolescent well-being and quality of li... more Given the important role of parent-youth communication in adolescent well-being and quality of life, we sought to examine the relationship between specific communication variables and youth perceived quality of life in general and as a deaf or hard-of-hearing (DHH) individual. A convenience sample of 230 youth (mean age = 14.1, standard deviation = 2.2; 24% used sign only, 40% speech only, and 36% sign 1 speech) was surveyed on communication-related issues, generic and DHH-specific quality of life, and depression symptoms. Higher youth perception of their ability to understand parents' communication was significantly correlated with perceived quality of life as well as lower reported depressive symptoms and lower perceived stigma. Youth who use speech as their single mode of communication were more likely to report greater stigma associated with being DHH than youth who used both speech and sign. These findings demonstrate the importance of youths' perceptions of communication with their parents on generic and DHH-specific youth quality of life. For youth with hearing loss, there is consensus by both clinicians and researchers that having access to communication at home, school, and with peers is important for language as well as cognitive and socioemotional development (
Objective. Quality-of-life (QOL) measures targeting youth with hearing loss are useful in populat... more Objective. Quality-of-life (QOL) measures targeting youth with hearing loss are useful in population needs assessment, educational placement, and program design and evaluation. This study assesses the cross-sectional validity of the Youth Quality of Life Instrument–Deaf and Hard of Hearing Module (YQOL-DHH). Study Design. Instrument development and cross-sectional survey. Setting. Recruitment through schools, professional organizations, clinics, and programs for youth who are deaf or hard of hearing. Subjects and Methods. Thirty-five candidate items were administered to 230 adolescents aged 11 to 18 years: 49% female, 61% white, 11% mild hearing loss, 20% moderate/moderate-severe, 41% severe/profound, and 28% with cochlear implants. Participants completed individual or group-administered questionnaires by paper and pencil (58%), Web-based English (29%), American Sign Language (ASL) or Pidgin Signed English (PSE) (9%) on DVD, or interviewer-supervised ASL or PSE DVD (4%). The Childre...
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Papers by Todd Edwards