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ObjectivesVaccine hesitancy among essential workers remains a significant public health challenge. We examined psychological constructs of perceived susceptibility, threat, and self-efficacy and their associations with COVID-19 vaccine hesitancy among a racially and ethnically diverse essential workforce population.MethodsWe performed a cross-sectional survey of essential workers from September-December 2020 at a large Los Angeles safety-net medical center as part of a program offering free COVID-19 serology testing. Program participants completed a standardized survey at the time of phlebotomy. Hierarchical logistic regression was utilized to determine factors independently associated with vaccine hesitancy.ResultsAmong 1327 persons who had serology testing, 1235 (93%) completed the survey. Of these, 958 (78%) were healthcare workers. Based on expressed intent, 22% were vaccine-hesitant 78% were vaccine acceptors. In our multivariate model, vaccine hesitancy was associated with female gender [aOR = 2.09; 95% CI (1.44-3.05)], African American race [aOR = 4.32; (2.16-8.62)], LatinX ethnicity [aOR = 2.47; 95% CI (1.51-4.05)] and history of not/sometimes receiving influenza vaccination [aOR = 4.39; 95% CI (2.98-6.48)]. Compared to nurses, vaccine hesitancy was lower among physicians [aOR = 0.09; 95% CI (0.04-0.23)], non-nursing/non-physician healthcare workers [aOR = 0.55; 95% CI (0.33-0.92)], and non-healthcare care workers [aOR = 0.53; 95% CI (0.36-0.78)].ConclusionsAmong a racially/ethnically diverse group of safety net medical center essential workers, COVID-19 vaccine hesitancy was associated with racial/ethnic minority groups, employment type, and prior influenza vaccination hesitancy. Interestingly, we found no association with the Health Belief Model construct measures of perceived susceptibility, threat, and self-efficacy. Psychological constructs not assessed may be drivers of vaccine hesitancy in our population.

This study reports the results of focus groups with school nurses and teachers from elementary, middle, and high schools to explore their perceptions of child and adolescent oral health. Participants included 14 school nurses and 15 teachers (83% female; 31% Hispanic; 21% White; 21% Asian; 14% African American; and 13% Others). Respondents were recruited from Los Angeles County schools and scheduled by school level for six one-hour focus groups using Zoom. Audio recordings were transcribed, reviewed, and saved with anonymization of speaker identities. NVivo software (QSR International, Melbourne, Australia) was used to facilitate content analysis and identify key themes. The nurses' rate of "Oral Health Education" comments statistically exceeded that of teachers, while teachers had higher rates for "Parental Involvement" and "Mutual Perception" comments. "Need for Care" was perceived to be more prevalent in immigrants to the United States based on student behaviors and complaints. "Access to Care" was seen as primarily the nurses' responsibilities. Strong relationships between community clinics and schools were viewed by some as integral to students achieving good oral health. The results suggest dimensions and questions important to item development for oral health surveys of children and parents to address screening, management, program assessment, and policy planning.

Cardiovascular disease (CVD) is an increasingly important cause of morbidity and mortality among people living with HIV (PLWH) now that HIV is a manageable chronic disease. Identification and treatment of comorbid medical conditions for PLWH, including CVD and its risk factors, typically lack a critical component of care: integrated care for histories of trauma. Experiences of trauma are associated with increased HIV infection, CVD risk, inconsistent treatment adherence, and poor CVD outcomes. To address this deficit among those at greatest risk and disproportionately affected by HIV and trauma-i.e., Black and Latinx individuals-a novel culturally-congruent, evidence-informed care model, "Healing our Hearts, Minds and Bodies" (HHMB), has been designed to address patients' trauma histories and barriers to care, and to prepare patients to engage in CVD risk reduction. Further, in recognition of the need to ensure that PLWH receive guideline-concordant cardiovascular care, implementation strategies have been identified that prepare providers and clinics to address CVD risk among their Black and Latinx PLWH. The focus of this paper is to describe the hybrid Type 2 effectiveness/implementation study design, the goal of which is to increase both patient and organizational readiness to address trauma and CVD risk among 260 Black and Latinx PLWH recruited from two HIV service organizations in Southern California. This study is expected to produce important information regarding the value of the HHMB intervention and implementation processes and strategies designed for use in implementing HHMB and other evidence-informed programs in diverse, resource-constrained treatment settings, including those that serve patients living in deep poverty. Clinical trials registry: NCT04025463.

ObjectivesTo develop computerized adaptive testing (CAT) and short forms of self-report oral health measures that are predictive of both the children's oral health status index (COHSI) and the children's oral health referral recommendation (COHRR) scales, for children and adolescents, ages 8-17.Material and methodsUsing final item calibration parameters (discrimination and difficulty parameters) from the item response theory analysis, we performed post hoc CAT simulation. Items most frequently administered in the simulation were incorporated for possible inclusion in final oral health assessment toolkits, to select the best performing eight items for COHSI and COHRR.ResultsTwo previously identified unidimensional sets of self-report items consisting of 19 items for the COHSI and 22 items for the COHRR were administered through CAT resulting in eight-item short forms for both the COHSI and COHRR. Correlations between the simulated CAT scores and the full item bank representing the latent trait are r = .94 for COHSI and r = .96 for COHRR, respectively, which demonstrated high reliability of the CAT and short form.ConclusionsUsing established rigorous measurement development standards, the CAT and corresponding eight-item short form items for COHSI and COHRR were developed to assess the oral health status of children and adolescents, ages 8-17. These measures demonstrated good psychometric properties and can have clinical utility in oral health screening and evaluation and clinical referral recommendations.

We investigated the use of a system with an ingestible sensor (Proteus Digital Health Feedback system) coencapsulated with antiretrovirals (ARVs) to measure real-time adherence. To assess the safety and impact, if any, coencapsulation might have on ARV concentrations, we evaluated the pharmacokinetics of ARVs coencapsulated with an ingestible sensor for eight commonly used fixed-dose combination ARVs: emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF); FTC/tenofovir alafenamide (TAF); efavirenz (EFV)/FTC/TDF; abacavir (ABC)/lamivudine (3TC); dolutegravir (DTG)/ABC/3TC; rilpivirine (RPV)/TAF/FTC; elvitegravir (EVG)/cobicistat (COBI)/FTC/TAF; and bictegravir (BIC)/FTC/TAF. The steady-state apparent peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) were determined from plasma concentrations measured at predose, 1, 2, 4, and 6 h postdose, and compared with literature values. A total of 49 unique patients on stable regimens for at least 12 weeks with undetectable viral loads were recruited. Cmax and AUC values were not statistically significantly different from literature values for all of the formulations except the Cmax of FTC/TDF, Cmax of BIC, and the Cmax of RPV. In a subsequent evaluation of FTC/TDF and BIC/FTC/TAF using a crossover design, the geometric mean ratio (GMR) between the coencapsulated and the unencapsulated formulations for FTC/TDF were the following: FTC, 84.6% (90% confidence interval [CI] 66.6-107.4) for AUC and 77.5% (60.1-99.9) for Cmax. For tenofovir (TFV), the GMR was 96.2% (90% CI 89.2-103.8) for AUC and 87.3% (64.2-118.7) for Cmax. The GMR for BIC (from the BIC/FTC/TAF formulation) was 98.0% (90% CI 84.5-113.5) for AUC and 89.9% (84.5-95.7) for Cmax. The observed deviation in FTC/TDF (Truvada) may be due to participant characteristics, fasted/fed conditions, and/or random variation and may warrant further investigations with a larger sample size. These findings provide assurance for use of coencapsulated ARVs for future HIV treatment-adherence research.

Adherence with antiretroviral therapy is important for preventing disease progression and HIV transmission. The co-encapsulated pill sensor system sends a signal through a cutaneous patch and allows real-time monitoring of pill ingestion. A 16-week pilot study used a sensor system in 15 HIV-infected individuals with real-time monitoring of pill-taking with a personalized short message system text. System acceptability was assessed by survey at weeks 4, 8, 12, and 16. Follow-up occurred in 80% of subjects through 8 weeks. The system effectively collected measures of pill ingestion, which triggered text message reminders. Only 2 of 14 participants stated that co-encapsulated pills were "unable to take" or "poorly tolerated." At least 75% of respondents stated at each visit that the patch was very or somewhat comfortable. With regard to text message reminders, only 10-15% of the participants at any visit did not find the messages to be helpful. Larger studies will define the utility of this system to assess antiretroviral adherence relative to standard measures.

ObjectivesTo develop child- and parent-reported toolkits for active caries and caries experience in children and adolescents, ages 8-17.MethodsA sample of 398 child/parent dyads recruited from 12 dental practices in Los Angeles County completed a computer-assisted survey that assessed oral health perceptions. In addition, children received a dental examination that identified the presence or absence of active caries and caries experience. A Multiple Adaptive Regression Splines model was used to identify a subset of survey items associated with active caries and caries experience. The splines and coefficients were refined by generalized cross-validation. Sensitivity and specificity for both dependent variables were evaluated.ResultsEleven child self-reported items were identified that had sensitivity of 0.82 and specificity of 0.45 relative to active caries. Twelve parent-reported items had a sensitivity of 0.86 and specificity of 0.50. Seven child self-reported items had a sensitivity of 0.86 and specificity of 0.34, and 11 parent-reported items had a sensitivity of 0.86 and specificity of 0.47 for caries experience.ConclusionsThe survey items identified here are useful in distinguishing children with and without active caries and with and without caries experience. This research presents a path towards using children's and their parents' reports about oral health to screen for clinically determined caries and caries exposure. The items identified in this study can be useful when clinical information is unavailable.

ObjectiveTo describe preferences for survey instruments on health-related quality of life (HRQOL) and subjective well-being (SWB) among adults with spinal cord injury (SCI), and compare perspectives on the instruments between the United States and the United Kingdom.DesignWe conducted 20 in-depth interviews.SettingParticipants were interviewed in their homes, some in person and some via Skype.ParticipantsA convenience sample of 20 adults with SCI (10 in the US and 10 in the UK) were recruited via print and on-line advertisements.InterventionsNot applicable.Main outcome measuresInterviewees reviewed six instruments and rated how important it was for their medical providers to know answers to each survey. Two coders analyzed verbatim transcriptions independently using an inductive approach. Keyword-in-context (KWIC) analysis identified the most frequently used words by interviewees to discuss the merits of each instrument.ResultsParticipants in both samples identified the Fatigue Severity Scale (FSS) as "vital" that their medical providers know about it. This was followed by the Spinal Cord Injury Independence Measure III, and a stand-alone Eudaimonic Well-Being question. The KWIC analysis showed that the most distinctive words used to discuss FSS were "fatigue" and "pain."ConclusionsUnderstanding what HRQOL and SWB measures are valued by adults living with SCI can lead to selection of informative instruments, which could help clinicians to complement and tailor established care and rehabilitation protocols for individual needs. Participants identified fatigue as a significant issue, and the FSS as a vitally important instrument to share with medical providers.

ObjectiveTo develop and evaluate psychometrically a self-reported instrument assessing physical fatigability (PF) and mental fatigability (MF) in adults with spinal cord injury (SCI).DesignCross-sectional.SettingPeer-support groups at rehabilitation centers, online support groups.ParticipantsAdults with SCI (N=464) in the United States.InterventionsNot applicable.Main outcome measuresThe dimensional structure was assessed by confirmatory factor analysis. The relationship between item responses and fatigability was measured with item response theory (graded response model). Reliability was measured with test information functions. Differential item functioning was evaluated with Wald chi-square tests and the weighted area between the curves. Construct validity was assessed using the known groups method.ResultsAn 82-item pool was developed from prior qualitative research and consultations with rehabilitation experts. A non-probability sample (N=464) was used to evaluate the psychometric properties of the PF and MF scales. The item pool was reduced to 75 based on factor loadings and R2. Both scales are primarily unidimensional, despite moderate multidimensionality. There is good discrimination overall: 18 PF items and 26 MF items have high or very high discrimination power (slopes > 1.35). The measurement precision in the theta range -2.0 to 2.5 is the equivalent of 0.94 reliability for PF and 0.91 for MF. For both measures, F statistics P values were significant at P

PurposeChildren and adolescents are vulnerable to dental problems and oral diseases. This paper presents the development of two multi-item self-report scales for use in assessing oral health status of children and adolescents.MethodsFollowing the Patient-Reported Outcome Measurement Information System framework, survey questions were designed using a newly developed conceptual model. These items were administered to 334 children and adolescents (8-17 years) along with concurrent dental exams. Exploratory and confirmatory factor analyses were conducted and the item response theory graded response model was used to estimate item parameters and oral health status scores and to identify short-form items. The items were selected by high level of information and wide coverage of different domains to assess Child Oral Health Status Index (COHSI) and treatment referral recommendations (RR).ResultsThe long form consists of 28 items. The short-form includes 12 items (8 for COHSI and 7 for RR with 3 common items).The intra-class correlations between long form and short-form were 0.90 for COHSI and 0.87 for RR.ConclusionThe short-forms provide a possible solution for the longstanding challenge of oral health evaluation for large populations of children and adolescents. The calibrated long form provides the foundation for computer adaptive test administration. These oral health assessment toolkits can be used for oral health screening, surveillance program, policy planning, and research.

PurposeTo identify which aspects of life are most important to adults with spinal cord injury (SCI) and compare perspectives in the United States and the United Kingdom.MethodsWe conducted 20 in-depth interviews with adults with SCI (ten in the US and ten in the UK). Verbatim transcriptions were independently analyzed line-by-line by two coders using an inductive approach. Codes were grouped into themes about factors that constitute and affect quality of life (QOL).ResultsFive overarching themes emerged: describing QOL in the context of SCI; functional adjustment; medical care; financial resources; and socio-political issues. Twenty subthemes emerged on factors that affect QOL. Participants in both samples identified medical care as a key influence on QOL. The US group talked about a predominantly negative influence (e.g., fragmented primary and specialist care, insurance constraints, bureaucracy), whereas UK interviewees mentioned a predominantly positive influence (e.g., universal provision, including free and continuous care, free wheelchairs and home care, and length of rehabilitation commensurate with level of injury). Functional adjustment, such as physical and mental adjustment post-discharge and aging with SCI, was another important contributor to QOL, and varied by country. Most US interviewees reported poor knowledge about self-care post-discharge and poor quality of home adaptations compared to the UK group.ConclusionsFor adults living with SCI, good QOL is essential for successful rehabilitation. Differences between interviewees from the two countries in perceived medical care and functional adjustment suggest that factors affecting QOL may relate to broader health system characteristics.

BackgroundOral health is an important component of daily functioning and well-being. A comprehensive patient-reported oral health measure is needed to gauge the impact of oral health status on children and adolescents. This study aims to develop oral health item banks and associated short-form surveys for children and adolescents 2-17 year olds.MethodsUsing children and adolescents, ages 2-17 years, selected from diverse dental sites in Greater Los Angeles Area, we propose to develop state-of-the-science methods to create oral health item banks to effectively measure oral health outcomes for children and adolescents. Methods include a literature review of existing measures, focus groups, cognitive interviews, drafting and field testing of survey items, and evaluation of the psychometric properties of the measures.ResultsBased on the systematic literature search and focus groups, we identified core (physical health, mental health, and social function domains) and peripheral (e.g., need and access) oral health domains. We then drafted survey items and revised them based on 66 cognitive interviews (27 children/adolescents and 39 parents) with 39 families. The revised items will be administered in a field test of 500 children and adolescents ages 2-17, and their parents.ConclusionsThe qualitative methods used in the initial phases of the project (focus group and cognitive interviews) are the initial steps in the development of oral health item banks and associated short-form surveys for children and adolescents. The oral health items can potentially be used to create effective computerized adaptive test and/or create ad hoc short forms targeting specific areas of oral health to survey large populations of children with much less cost compared with traditional clinical oral health examination.

ImportanceIt remains unclear whether telemonitoring approaches provide benefits for patients with heart failure (HF) after hospitalization.ObjectiveTo evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmissions among a broad population of older adults hospitalized with HF.Design, setting, and participantsWe randomized 1437 patients hospitalized for HF between October 12, 2011, and September 30, 2013, to the intervention arm (715 patients) or to the usual care arm (722 patients) of the Better Effectiveness After Transition-Heart Failure (BEAT-HF) study and observed them for 180 days. The dates of our study analysis were March 30, 2014, to October 1, 2015. The setting was 6 academic medical centers in California. Participants were hospitalized individuals 50 years or older who received active treatment for decompensated HF.InterventionsThe intervention combined health coaching telephone calls and telemonitoring. Telemonitoring used electronic equipment that collected daily information about blood pressure, heart rate, symptoms, and weight. Centralized registered nurses conducted telemonitoring reviews, protocolized actions, and telephone calls.Main outcomes and measuresThe primary outcome was readmission for any cause within 180 days after discharge. Secondary outcomes were all-cause readmission within 30 days, all-cause mortality at 30 and 180 days, and quality of life at 30 and 180 days.ResultsAmong 1437 participants, the median age was 73 years. Overall, 46.2% (664 of 1437) were female, and 22.0% (316 of 1437) were African American. The intervention and usual care groups did not differ significantly in readmissions for any cause 180 days after discharge, which occurred in 50.8% (363 of 715) and 49.2% (355 of 722) of patients, respectively (adjusted hazard ratio, 1.03; 95% CI, 0.88-1.20; P = .74). In secondary analyses, there were no significant differences in 30-day readmission or 180-day mortality, but there was a significant difference in 180-day quality of life between the intervention and usual care groups. No adverse events were reported.Conclusions and relevanceAmong patients hospitalized for HF, combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions.Trial registrationclinicaltrials.gov Identifier: NCT01360203.

PurposeTo evaluate the reliability and construct validity of measures from the Patient-Reported Outcomes Measurement Information System(®) (PROMIS(®)) for patients with heart failure before and after heart transplantation.MethodsWe assessed reliability of the PROMIS short forms using Cronbach's alpha and the average marginal reliability. To assess the construct validity of PROMIS computerized adaptive tests and short-form measures, we calculated Pearson product moment correlations between PROMIS measures of physical function, fatigue, depression, and social function and existing PRO measures of similar domains (i.e., convergent validity) as well as different domains (i.e., discriminate validity) in patients with heart failure awaiting heart transplant. We evaluated the responsiveness of these measures to change after heart transplant using effect sizes.ResultsForty-eight patients were included in the analyses. Across the many domains examined, correlations between conceptually similar domains were larger than correlations between different domains of health, demonstrating construct validity. Health status improved substantially after heart transplant (standardized effect sizes, 0.63-1.24), demonstrating the responsiveness of the PROMIS measures. Scores from the computerized adaptive tests and the short forms were similar.ConclusionsThis study provides evidence for the reliability and construct validity (including responsiveness to change) of four PROMIS domains in patients with heart failure before and after heart transplant. PROMIS measures are a reasonable choice in this context and will facilitate comparisons across studies and health conditions.

PurposeTo elicit perceptions of oral health in children and adolescents as an initial step in the development of oral health item banks for the Patient-Reported Oral Health Outcomes Measurement Information System project.MethodsWe conducted focus groups with ethnically, socioeconomically, and geographically diverse youth (8-12, 13-17 years) to identify perceptions of oral health status. We performed content analysis, including a thematic and narrative analysis, to identify important themes.ResultsWe identified three unique themes that the youth associated with their oral health status: (1) understanding the value of maintaining good oral health over the life course, with respect to longevity and quality of life in the adult years; (2) positive association between maintaining good oral health and interpersonal relationships at school, and dating, for older youth; and (3) knowledge of the benefits of orthodontic treatment to appearance and positive self-image, while holding a strong view as to the discomfort associated with braces.ConclusionsThe results provide valuable information about core domains for the oral health item banks to be developed and generated content for new items to be developed and evaluated with cognitive interviews and in a field test.

The high burden of exposure to chronic life adversities and trauma is quite prevalent, but assessment of this risk burden is uncommon in primary care settings. This calls for a brief, multiple dimensional mental health risk screening tool in primary care settings. We aimed to develop such a screening tool named the University of California, Los Angeles (UCLA) Life Adversities Screener (LADS). Using pooled data across 4 studies from the UCLA Center for Culture, Trauma, and Mental Health Disparities, 5 domains of mental health risk including perceived discrimination, sexual abuse histories, family adversity, intimate partner violence, and trauma histories, were identified. Regression models for depression (Centers for Epidemiology Studies Depression Scale) and posttraumatic stress disorder (Posttraumatic Diagnostic Scale), controlling for demographic factors, were fitted to develop a weighted continuous scale score for the UCLA LADS. Confirmatory factor analysis supported the 5-domain structure, while item response theory endorsed the inclusion of each item. Receiver operating characteristic analysis indicated that the score was predictive for classifying subjects as reaching clinical threshold criteria for either depression (Beck Depression Inventory-II ≥ 14 or Patient Health Questionnaire-9 ≥ 10) or anxiety (Patient Health Questionnaire-13 ≥10). An optimal cut of 0.33 is suggested based on maximizing sensitivity and specificity of the LADS score, identifying patients at high risk for mental health problems. Given its predictive utility and ease of administration, the UCLA LADS could be useful as a screener to identify racial minority individuals in primary care settings who have a high trauma burden, needing more extensive evaluation.

This study examined the utility of a lifetime cumulative adversities and trauma model in predicting the severity of mental health symptoms of depression, anxiety, and posttraumatic stress disorder. We also tested whether ethnicity and gender moderate the effects of this stress exposure construct on mental health using multigroup structural equation modeling. A sample of 500 low-socioeconomic status African American and Latino men and women with histories of adversities and trauma were recruited and assessed with a standard battery of self-report measures of stress and mental health. Multiple-group structural equation models indicated good overall model fit. As hypothesized, experiences of discrimination, childhood family adversities, childhood sexual abuse, other childhood trauma, and chronic stresses all loaded on the latent cumulative burden of adversities and trauma construct (CBAT). The CBAT stress exposure index in turn predicted the mental health status latent variable. Although there were several significant univariate ethnic and gender differences, and ethnic and gender differences were observed on several paths, there were no significant ethnic differences in the final model fit of the data. These findings highlight the deleterious consequences of cumulative stress and trauma for mental health and underscore a need to assess these constructs in selecting appropriate clinical interventions for reducing mental health disparities and improving human health.

ObjectiveRegular HIV RNA testing for all HIV-positive patients on antiretroviral therapy (ART) is expensive and has low yield since most tests are undetectable. Selective testing of those at higher risk of failure may improve efficiency. We investigated whether a novel analysis of adherence data could correctly classify virological failure and potentially inform a selective testing strategy.DesignMultisite prospective cohort consortium.MethodsWe evaluated longitudinal data on 1478 adult patients treated with ART and monitored using the Medication Event Monitoring System (MEMS) in 16 US cohorts contributing to the MACH14 consortium. Because the relationship between adherence and virological failure is complex and heterogeneous, we applied a machine-learning algorithm (Super Learner) to build a model for classifying failure and evaluated its performance using cross-validation.ResultsApplication of the Super Learner algorithm to MEMS data, combined with data on CD4 T-cell counts and ART regimen, significantly improved classification of virological failure over a single MEMS adherence measure. Area under the receiver operating characteristic curve, evaluated on data not used in model fitting, was 0.78 (95% confidence interval: 0.75 to 0.80) and 0.79 (95% confidence interval: 0.76 to 0.81) for failure defined as single HIV RNA level >1000 copies per milliliter or >400 copies per milliliter, respectively. Our results suggest that 25%-31% of viral load tests could be avoided while maintaining sensitivity for failure detection at or above 95%, for a cost savings of $16-$29 per person-month.ConclusionsOur findings provide initial proof of concept for the potential use of electronic medication adherence data to reduce costs through behavior-driven HIV RNA testing.

PurposeThe Patient-Reported Outcomes Measurement Information System (PROMIS(®)) initiative was developed to advance the methodology of PROs applicable to chronic diseases. Chronic obstructive pulmonary disease (COPD) is a progressive chronic disease associated with poor health. This study was designed to examine the correlation of PROMIS health-related quality of life (HRQOL) scales and clinical measures among COPD patients.MethodsA cross-sectional analysis was conducted comparing patients who were stable (n = 100) with those currently experiencing a COPD exacerbation (n = 85). All PROMIS measures for adults available at the time of the study (2008), disease-targeted and other HRQOL instruments, health literacy, percent predicted FEV1, and a 6-min walk distance were assessed when patients were considered clinically stable.ResultsStable COPD patients reported significantly (p ≤ 0.05) better health-related quality of life on PROMIS domains than patients experiencing an exacerbation. PROMIS domain scores were significantly (p ≤ 0.01) correlated with each of legacy measures. Six-min walk scores were most highly correlated with the PROMIS physical function domain scores (r = 0.53) followed by the fatigue (r = -0.26), social (r = 0.24) and to a lesser extent depression (r = -0.23), and anxiety (r = -0.22) domain scores. Percent predicted FEV1 score was significantly associated with PROMIS physical function scores (r = 0.27).ConclusionThis study provides support for the validity of the PROMIS measures in COPD patients.

BackgroundThe HIV/AIDS epidemic continues to disproportionately affect African American communities in the US, particularly those located in urban areas. Despite the fact that HIV is often transmitted from one sexual partner to another, most HIV prevention interventions have focused only on individuals, rather than couples. This five-year study investigates community-based implementation, effectiveness, and sustainability of 'Eban II,' an evidence-based risk reduction intervention for African-American heterosexual, serodiscordant couples.Methods/designThis hybrid implementation/effectiveness implementation study is guided by organizational change theory as conceptualized in the Texas Christian University Program Change Model (PCM), a model of phased organizational change from exposure to adoption, implementation, and sustainability. The primary implementation aims are to assist 10 community-based organizations (CBOs) to implement and sustain Eban II; specifically, to partner with CBOs to expose providers to the intervention; facilitate its adoption, implementation and sustainment; and to evaluate processes and determinants of implementation, effectiveness, fidelity, and sustainment. The primary effectiveness aim is to evaluate the effect of Eban II on participant (n = 200 couples) outcomes, specifically incidents of protected sex and proportion of condom use. We will also determine the cost-effectiveness of implementation, as measured by implementation costs and potential cost savings. A mixed methods evaluation will examine implementation at the agency level; staff members from the CBOs will complete baseline measures of organizational context and climate, while key stakeholders will be interviewed periodically throughout implementation. Effectiveness of Eban II will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and three-month follow-up. Multi-level hierarchical modeling with a multi-level nested structure will be used to evaluate the effects of agency- and couples-level characteristics on couples-level outcomes (e.g., condom use).DiscussionThis study will produce important information regarding the value of the Eban II program and a theory-guided implementation process and tools designed for use in implementing Eban II and other evidence-based programs in demographically diverse, resource-constrained treatment settings.Trial registrationNCT00644163.

BACKGROUND: The prevalence of periodontal diseases is high, and >15% of adults have severe gum disease. Clinical attachment loss (AL) is one of the most important measures for periodontal disease severity. With AL, one could measure the worst scenario, the average, or the cumulative sum of AL among all teeth. The objective of this study is to evaluate which of the 15 measures of periodontal problems (e.g., maximum, mean, and cumulative AL) best predict the need for periodontal treatment. METHODS: Using detailed periodontal data obtained through clinical examination from the National Health and Nutrition Examination Survey 1999 to 2002, weighted logistic regression was used to model the periodontal treatment need of 15 different periodontal disease measures. The outcome measure is the clinically determined periodontal need. RESULTS: After adjustment for the covariates of age, sex, ethnicity, education, smoking status, and diabetes, the three most predictive measures were identified as: 1) the sum of the maximum mid-buccal (B) and mesio-buccal (MB) measures, which reflects the worst case of both B and MB measures; 2) the sum of the maximum MB measure or the worst case of the MB measure; and 3) the sum of all B and MB measures, or the cumulative AL measures. CONCLUSIONS: Cumulative periodontal morbidity, particularly the worst case of B and MB measures, has the strongest impact on the need for periodontal care. All the demographic variables and covariates follow the classic pattern of association with periodontal disease.

Experiences of past and current gender-based violence are common among HIV-positive women in the United States, who are predominantly from ethnic minority groups. However, culturally congruent, feasible interventions for HIV-positive women who have experienced past and/or current violence are not widely available. The Office on Women's Health Gender Forum has made several recommendations for responding to the National HIV/AIDS Strategy Implementation Plan, including recommendations to incorporate gender-based violence prevention into a comprehensive, gender-responsive national strategy. This paper draws on an example of a community-based project for HIV-positive women, the Healing Our Women Project, to illustrate how violence prevention can be achieved within peer-led and community-based programming. Strong community partnerships, responsiveness to community needs and local cultural norms, a trained workforce, and culturally competent care are programmatic cornerstones of gender-responsive services. HIV-positive women with histories of gender-based violence and risk factors for current and future violence deserve the highest quality gender-responsive services to ensure that they can address their health needs within contexts of safety and respect.

ObjectiveThe validity of quality of care measurement has important implications for practicing clinicians, their patients, and all involved with health care delivery. We used empirical data from managed care patients enrolled in west coast physician organizations to test the hypothesis that observed changes in health-related quality of life across a 2.5-year window reflecting process of care.Data sources/study settingPatient self-report data as well as clinically detailed medical record review regarding 963 patients with chronic disease associated with managed care from three west coast states.Study designProspective cohort study of change in health-related quality of life scores across 30 months as measured by change in SF-12 physical component scores.Data collection/extraction methodsPatient self-report and medical record abstraction.Principal findingsWe found a positive relationship between better process scores and higher burden of illness (p

BackgroundThe validity of quality of care assessments relies upon data quality, yet little is known about the relative completeness and validity of data sources for evaluating the quality of care.ObjectivesWe evaluated concordance between ambulatory medical record and patient survey data. Levels of concordance, variations by type of item, sources of disagreement between data sources, and implications for quality of care assessment efforts are discussed.Design and subjectsThis was an observational study that included 1270 patients sampled from 39 West Coast medical organizations with at least 1 of the following: diabetes, ischemic heart disease, asthma or chronic obstructive pulmonary disease, or low back pain.MeasuresItems from both data sources were grouped into 4 conceptual domains: diagnosis, clinical services delivered, counseling and referral, and medication use. We present total agreement, kappa, sensitivity, and specificity at the item and domain-levels and for all items combined.ResultsWe found good concordance between survey and medical records overall, but there was substantial variation within and across domains. The worst concordance was in the counseling and referrals domain, the best in the medication use domain. Patients were able to report with good sensitivity on memorable items.ConclusionsQuality ratings are likely to vary in differing directions, depending on the data source used. The most appropriate data source for analyses of components of and overall quality of care must be considered in light of study objectives and resources. We recommend data collection from multiple sources to most accurately portray the patient and provider experience of medical care.

ObjectiveTo create an efficient imputation algorithm for imputing the SF-12 physical component summary (PCS) and mental component summary (MCS) scores when patients have one to eleven SF-12 items missing.Study settingPrimary data collection was performed between 1996 and 1998.Study designMulti-pattern regression was conducted to impute the scores using only available SF-12 items (simple model), and then supplemented by demographics, smoking status and comorbidity (enhanced model) to increase the accuracy. A cut point of missing SF-12 items was determined for using the simple or the enhanced model. The algorithm was validated through simulation.Data collectionThirty-thousand-three-hundred and eight patients from 63 physician groups were surveyed for a quality of care study in 1996, which collected the SF-12 and other information. The patients were classified as "chronic" patients if they reported that they had diabetes, heart disease, asthma/chronic obstructive pulmonary disease, or low back pain. A follow-up survey was conducted in 1998.Principal findingsThirty-one percent of the patients missed at least one SF-12 item. Means of variance of prediction and standard errors of the mean imputed scores increased with the number of missing SF-12 items. Correlations between the observed and the imputed scores derived from the enhanced models were consistently higher than those derived from the simple model and the increments were significant for patients with > or =6 missing SF-12 items (p or =6 items missing, leading to estimated scores that are as accurate as that of patients with

ObjectiveTo illustrate, using empirical data, methodological challenges associated with patient responses to longitudinal surveys regarding the quality of process of care and health status, including overall response rate, differential response rate, and stability of responses with time.Data sources/study settingPrimary patient self-report data were collected from 30,308 patients in 1996 and 13,438 patients in 1998 as part of a two-year longitudinal study of quality of care and health status of patients receiving care delivered by 63 physician organizations (physician groups) across three West Coast states.Study designWe analyzed longitudinal, observational data collected by Pacific Business Group on Health (PBGH) from patients aged 18-70 using a four-page survey in 1996 and a similar survey in 1998 to assess health status, satisfaction, use of services, and self-reported process of care. A subset of patients with self-reported chronic disease in the 1996 study received an enriched survey in 1998 to more fully detail processes of care for patients with chronic disease.Data collection/extraction methodsWe measured response rate overall and separately for patients with chronic disease. Logistic regression was used to assess the impact of 1996 predictors on response to the follow-up 1998 survey. We compared process of care scores without and with nonresponse weights. Additionally, we measured stability of patient responses over time using percent agreement and kappa statistics, and examined rates of gender inconsistencies reported across the 1996 and 1998 surveys.Principal findingsIn 1998, response rates were 54 percent overall and 63 percent for patients with chronic disease. Patient demographics, health status, use of services, and satisfaction with care in 1996 were all significant predictors of response in 1998, highlighting the importance of analytic strategies (i.e., application of nonresponse weights) to minimize bias in estimates of care and outcomes associated with longitudinal quality of care and health outcome analyses. Process of care scores weighted for nonresponse differed from unweighted scores (p

ObjectivesTo describe women who attribute new disability to old age and to identify demographic, medical, behavioral, and psychosocial characteristics that correlate with attributing new disability to old age.DesignProspective cohort study with 4-year follow-up.SettingFour geographic regions of the United States.Participants9704 women aged > or = 67 years participating in the Study of Osteoporotic Fractures. Of these, 657 who reported no disability at baseline but at follow-up reported difficulty carrying out 1 or more of 13 functional activities were eligible for our analysis.MeasurementsAll women reporting difficulty in any functional activity at follow-up were asked "What is the main condition that causes you to have difficulty or prevents you from (doing the activity)?" and were shown a card listing 14 medical conditions as well as the option "old age," from which they could choose only one response. Women attributing difficulty or inability in 1 or more functional activities to old age were classified as attributing new disability to old age. We examined the relationship between attributing new disability to old age and the following characteristics measured at baseline: age, level of education, medical comorbidity, cognitive function, body mass index (BMI), gait speed, grip strength, visual acuity, physical activity level, smoking status, social network level, and depressed mood.ResultsOverall, 13.5% of women attributed new disability to old age. Age was a strong independent correlate of attributing new disability to old age: compared with women age 67 to 69, the odds of attributing new disability to old age for women age 70 to 79 was 3.6 times as large (95% confidence interval [CI] = 1.6-8.3), and for women age 80 or over was 5.5 times as large (95% CI = 2.1-14.7). The only other characteristic that remained an independent correlate of attributing new disability to old age was grip strength; for each decile decrease in grip strength, a woman's odds of attributing new disability to old age increased by 9% (odds ratio [OR] = 1.09, 95% CI = 1.01-1.19).ConclusionsDespite great advances in geriatric medicine, old age is still perceived as a causal agent in functional decline, especially among our oldest patients. Further study is needed to determine whether, how often, and under what circumstances older adults who attribute new disability to old age have medical conditions amenable to interventions that could preserve their functioning and improve their quality of life.

ObjectiveTo identify modifiable predictors of functional decline among community-residing older women and to derive and validate a clinical prediction tool for functional decline based only on modifiable predictors.DesignA prospective cohort study.SettingFour geographic areas of the United States.ParticipantsCommunity-residing women older than age 65 recruited from population-based listings between 1986 and 1988 (n = 6632).MeasurementsModifiable predictors were considered to be those that a clinician seeing an older patient for the first time could reasonably expect to change over a 4-year period: benzodiazepine use, depression, low exercise level, low social functioning, body-mass index, poor visual acuity, low bone mineral density, slow gait, and weak grip. Known predictors of functional decline unlikely to be amenable to intervention included age, education, medical comorbidity, cognitive function, smoking history, and presence of previous spine fracture. All variables were measured at baseline; only modifiable predictors were candidates for the prediction tool. Functional decline was defined as loss of ability over the 4-year interval to perform one or more of five vigorous or eight basic daily activities.ResultsSlow gait, short-acting benzodiazepine use, depression, low exercise level, and obesity were significant modifiable predictors of functional decline in both vigorous and basic activities. Weak grip predicted functional decline in vigorous activities, whereas long-acting benzodiazepine use and poor visual acuity predicted functional decline in basic activities. A prediction rule based on these eight modifiable predictors classified women in the derivation set into three risk groups for decline in vigorous activities (12%, 25%, and 39% risk) and two risk groups for decline in basic activities (2% and 10% risk). In the validation set, the probabilities of functional decline were nearly identical.ConclusionsA substantial portion of the variation of functional decline can be attributed to risk factors amenable to intervention over the short term. Using eight modifiable predictors that can be identified in a single office visit, clinicians can identify older women at risk for functional decline.