Gauging treatment impact: The development of exposure variables in a large-scale evaluation study.

While guidance on how to design rigorous evaluation studies abounds, prescriptive guidance on how to include critical process and context measures through the construction of exposure variables is lacking. Capturing nuanced intervention dosage information within a large-scale evaluation is particularly complex. The Building Infrastructure Leading to Diversity (BUILD) initiative is part of the Diversity Program Consortium, which is funded by the National Institutes of Health. It is designed to increase participation in biomedical research careers among individuals from underrepresented groups. This chapter articulates methods employed in defining BUILD student and faculty interventions, tracking nuanced participation in multiple programs and activities, and computing the intensity of exposure. Defining standardized exposure variables (beyond simple treatment group membership) is crucial for equity-focused impact evaluation. Both the process and resulting nuanced dosage variables can inform the design and implementation of large-scale, diversity training program, outcome-focused, evaluation studies.

Mentoring Experiences and Publication Productivity among Early Career Biomedical Investigators and Trainees.

Objective: To identify which mentoring domains influence publication productivity among early career researchers and trainees and whether publication productivity differs between underrepresented minority (URM) and well-represented groups (WRGs). The mentoring aspects that promote publication productivity remain unclear. Advancing health equity requires a diverse workforce, yet URM trainees are less likely to publish and URM investigators are less likely to obtain federal research grants, relative to WRG counterparts. Methods: A mentoring-focused online follow-up survey was administered to respondents of the NRMN Annual Survey who self-identified as mentees. Publications were identified from a public database and validated with participant CV data. Bivariate and multivariate analyses tested the associations of publication productivity with mentoring domains. Results: URM investigators and trainees had fewer publications (M = 7.3) than their WRG counterparts (M = 13.8). Controlling for career stage and social characteristics, those who worked on funded projects, and received grant-writing or research mentorship, had a higher probability of any publications. Controlling for URM status, gender, and career stage, mentorship on grant-writing and funding was positively associated with publication count (IRR=1.72). Holding career stage, gender, and mentoring experiences constant, WRG investigators and trainees had more publications than their URM counterparts (IRR=1.66). Conclusions: Grant-writing mentorship is particularly important for publication productivity. Future research should investigate whether grant-writing mentorship differentially impacts URM and WRG investigators and should investigate how and why grant-writing mentorship fosters increased publication productivity.

Natural History of Pressure Injury Among Ethnically/Racially Diverse Nursing Home Residents: The Pressure Ulcer Detection Study.

The current observational study provides descriptive data on 270 pressure injuries (PrIs) among 142 racially/ethnically diverse nursing home (NH) residents over 16 weeks. Weekly assessments were conducted with the Bates-Jensen Wound Assessment Tool. NH data were obtained from public government websites. NH, resident, and PrI characteristics across race/ethnicity groups were compared using analysis of variance and chi-square. Participants were 62% female and 89% functionally dependent. More Black and Asian individuals had peripheral vascular disease. More Black individuals had persistent trunk and Stage 4 PrIs. Black and Hispanic individuals had normal skin color surrounding PrIs. More Asian individuals had PrIs surrounded by purple/red discolored skin. More Black individuals' heel PrIs were unstageable, necrotic, and showed no granulation. Black and Hispanic individuals exhibited more deep tissue injury. No NH or prevention differences existed. Health disparities found validate administrative data results. Differences in PrI characteristics should be further examined among diverse NH residents. [Journal of Gerontological Nursing, 47(3), 37-46.].

Baseline Characteristics of the 2015-2019 First Year Student Cohorts of the NIH Building Infrastructure Leading to Diversity (BUILD) Program.

Objective: The biomedical/behavioral sciences lag in the recruitment and advancement of students from historically underrepresented backgrounds. In 2014 the NIH created the Diversity Program Consortium (DPC), a prospective, multi-site study comprising 10 Building Infrastructure Leading to Diversity (BUILD) institutional grantees, the National Research Mentoring Network (NRMN) and a Coordination and Evaluation Center (CEC). This article describes baseline characteristics of four incoming, first-year student cohorts at the primary BUILD institutions who completed the Higher Education Research Institute, The Freshmen Survey between 2015-2019. These freshmen are the primary student cohorts for longitudinal analyses comparing outcomes of BUILD program participants and non-participants. Design: Baseline description of first-year students entering college at BUILD institutions during 2015-2019. Setting: Ten colleges/universities that each received <$7.5mil/yr in NIH Research Project Grants and have high proportions of low-income students. Participants: First-year undergraduate students who participated in BUILD-sponsored activities and a sample of non-BUILD students at the same BUILD institutions. A total of 32,963 first-year students were enrolled in the project; 64% were female, 18% Hispanic/Latinx, 19% African American/Black, 2% American Indian/Alaska Native and Native Hawaiian/Pacific Islander, 17% Asian, and 29% White. Twenty-seven percent were from families with an income <$30,000/yr and 25% were their family's first generation in college. Planned Outcomes: Primary student outcomes to be evaluated over time include undergraduate biomedical degree completion, entry into/completion of a graduate biomedical degree program, and evidence of excelling in biomedical research and scholarship. Conclusions: The DPC national evaluation has identified a large, longitudinal cohort of students with many from groups historically underrepresented in the biomedical sciences that will inform institutional/national policy level initiatives to help diversify the biomedical workforce.

Sleep problems in adolescence are prospectively linked to later depressive symptoms via the cortisol awakening response.

Sleep disturbance is a symptom of and a well-known risk factor for depression. Further, atypical functioning of the HPA axis has been linked to the pathogenesis of depression. The purpose of this study was to examine the role of adolescent HPA axis functioning in the link between adolescent sleep problems and later depressive symptoms. Methods: A sample of 157 17-18 year old adolescents (61.8% female) completed the Pittsburgh Sleep Quality Inventory (PSQI) and provided salivary cortisol samples throughout the day for three consecutive days. Two years later, adolescents reported their depressive symptoms via the Center for Epidemiological Studies Depression Scale (CES-D). Results: Individuals (age 17-18) with greater sleep disturbance reported greater depressive symptoms two years later (age 19-20). This association occurred through the indirect effect of sleep disturbance on the cortisol awakening response (CAR) (indirect effect = 0.14, 95%CI [.02 -.39]). Conclusions: One pathway through which sleep problems may lead to depressive symptoms is by up-regulating components of the body's physiological stress response system that can be measured through the cortisol awakening response. Behavioral interventions that target sleep disturbance in adolescents may mitigate this neurobiological pathway to depression during this high-risk developmental phase.

Reliability of the Bates-Jensen wound assessment tool for pressure injury assessment: The pressure ulcer detection study.

The Bates-Jensen Wound Assessment Tool (BWAT) is used to assess wound healing in clinical practice. The purpose of this study was to evaluate BWAT use among nursing home residents with pressure injury. Findings and reliability estimates from the BWAT related to pressure injury characteristics (stage, anatomic location) and natural history (resolved, persisted) among 142 ethnically and racially diverse residents are reported. In this prospective 16-week study, 305 pressure injuries among 142 participants (34% prevalence) are described by stage, anatomic location, and BWAT scores. Visual and subepidermal moisture assessments were obtained from sacrum, buttock, ischial, and heel ulcers weekly. Participants were 14% Asian, 28% Black, 18% Hispanic, 40% White with a mean age of 78 ± 14 years, and were 62% female; 80% functionally dependent (bed mobility extensive/total assistance) and at risk (Braden Scale score 14 ± 2.7). The reliability coefficient for BWAT score (all participants, all anatomic locations) was high (r = 0.90; p < 0.0001; n = 1,161 observations). Weighted Kappas for characteristics ranging from 0.46 (skin color surrounding wound) to 0.79 (undermining) were consistent for all participants. BWAT scores showed strongest agreement coefficients for stage 4 pressure injury (r = 0.69), pressure injuries among Asian and White ethnicity/racial groups (r = 0.89, and r = 0.91, respectively), and sacrum anatomic location (r = 0.92) indicating scores are better correlated to fair skin tones. Lower agreement coefficients were demonstrated for stage 2 pressure injury (r = 0.38) and pressure injuries among African American and Hispanic ethnicity/racial groups (r = 0.88 and 0.87, respectively). BWAT scores were significantly different by pressure injury stage (F = 496.7, df = 6, p < 0.001) and anatomic location (F = 33.76, df = 8, p < 0.001). BWAT score correlated with pressure injury natural history (ulcer resolved 18.4 ± 7.4, ulcer persisted 24.9 ± 10.0; F = 70.11, df = 2, p < 0.001), but not with comorbidities. The BWAT provides reliable, objective data for assessing pressure injury healing progress.

"Worth the Walk": Culturally Tailored Stroke Risk Factor Reduction Intervention in Community Senior Centers.

Background Racial/ethnic minority older adults have worse stroke burden than non-Hispanic white and younger counterparts. Our academic-community partner team tested a culturally tailored 1-month (8-session) intervention to increase walking and stroke knowledge among Latino, Korean, Chinese, and black seniors. Methods and Results We conducted a randomized wait-list controlled trial of 233 adults aged 60 years and older, with a history of hypertension, recruited from senior centers. Outcomes were measured at baseline (T0), immediately after the 1-month intervention (T1), and 2 months later (T2). The primary outcome was pedometer-measured change in steps. Secondary outcomes included stroke knowledge (eg, intention to call 911 for stroke symptoms) and other self-reported and clinical measures of health. Mean age of participants was 74 years; 90% completed T2. Intervention participants had better daily walking change scores than control participants at T1 (489 versus -398 steps; mean difference in change=887; 97.5% CI, 137-1636), but not T2 after adjusting for multiple comparisons (233 versus -714; mean difference in change=947; 97.5% CI, -108 to 2002). The intervention increased the percent of stroke symptoms for which participants would call 911 (from 49% to 68%); the control group did not change (mean difference in change T0-T1=22%; 99.9% CI, 9-34%). This effect persisted at T2. The intervention did not affect measures of health (eg, blood pressure). Conclusions This community-partnered intervention did not succeed in increasing and sustaining meaningful improvements in walking levels among minority seniors, but it caused large, sustained improvements in stroke preparedness. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 02181062.

Subepidermal moisture detection of heel pressure injury: The pressure ulcer detection study outcomes.

We examined subepidermal moisture (SEM) and visual skin assessment of heel pressure injury (PrI) among 417 nursing home residents in 19 facilities over 16 weeks. Participants were older (mean age 77 years), 58% were female, over half were ethnic minorities (29% African American, 12% Asian American, 21% Hispanic), and at risk for PrI (mean Braden Scale Risk score = 15.6). Blinded concurrent visual assessments and SEM measurements were obtained at heels weekly. Visual skin damage was categorised as normal, erythema, stage 1 PrI, deep tissue injury (DTI) or stage 2 or greater PrI. PrI incidence was 76%. Off-loading occurred with pillows (76% of residents) rather than heel boots (21%) and often for those with DTI (91%). Subepidermal moisture was measured with a device where higher readings indicate greater moisture (range: 0-70 tissue dielectric constant), with normal skin values significantly different from values in the presence of skin damage. Subepidermal moisture was associated with concurrent damage and damage 1 week later in generalised multinomial logistic models adjusting for age, diabetes and function. Subepidermal moisture detected DTI and differentiated those that resolved, remained and deteriorated over 16 weeks. Subepidermal moisture may be an objective method for detecting PrI.

Racial/Ethnic Differences in Expectations Regarding Aging Among Older Adults.

Purpose of the Study: The study identifies differences in age-expectations between older adults from Korean, Chinese, Latino, and African American backgrounds living in the United States. Design and Methods: This study uses baseline demographic, age-expectation, social, and health data from 229 racial/ethnic minority seniors in a stroke-prevention intervention trial. Unadjusted regression models and pair-wise comparisons tested for racial/ethnic differences in age-expectations, overall, and across domain subscales (e.g., physical-health expectations). Adjusted regression models tested whether age-expectations differed across racial/ethnic groups after controlling for demographic, social, and health variables. Regression and negative binomial models tested whether age-expectations were consistently associated with health and well-being across racial/ethnic groups. Results: Age-expectations differed by race/ethnicity, overall and for each subscale. African American participants expected the least age-related functional decline and Chinese American participants expected the most decline. Although African American participants expected less decline than Latino participants in unadjusted models, they had comparable expectations adjusting for education. Latino and African American participants consistently expected less decline than Korean and Chinese Americans. Acculturation was not consistently related to age-expectations among immigrant participants over and above ethnicity. Although some previously observed links between expectations and health replicated across racial/ethnic groups, in adjusted models age-expectations were only related to depression for Latino participants. Implications: With a growing racial/ethnic minority older population in the United States, it is important to note older adults' age-expectations differ by race/ethnicity. Moreover, expectation-health associations may not always generalize across diverse samples.

Subepidermal moisture detection of pressure induced tissue damage on the trunk: The pressure ulcer detection study outcomes.

We examined the relationship between subepidermal moisture measured using surface electrical capacitance and visual skin assessment of pressure ulcers at the trunk location (sacral, ischial tuberosities) in 417 nursing home residents residing in 19 facilities. Participants were on average older (mean age of 77 years), 58% were female, over half were ethnic minorities (29% African American, 12% Asian American, and 21% Hispanic), and at risk for pressure ulcers (mean score for Braden Scale for Predicting Pressure Ulcer Risk of 15.6). Concurrent visual assessments and subepidermal moisture were obtained at the sacrum and right and left ischium weekly for 16 weeks. Visual assessment was categorized as normal, erythema, stage 1 pressure ulcer, Deep Tissue Injury or stage 2+ pressure ulcer using the National Pressure Ulcer Advisory Panel 2009 classification system. Incidence of any skin damage was 52%. Subepidermal moisture was measured with a dermal phase meter where higher readings indicate greater moisture (range: 0-70 tissue dielectric constant), with values increasing significantly with the presence of skin damage. Elevated subepidermal moisture values co-occurred with concurrent skin damage in generalized multinomial logistic models (to control for repeated observations) at the sacrum, adjusting for age and risk. Higher subepidermal moisture values were associated with visual damage 1 week later using similar models. Threshold values for subepidermal moisture were compared to visual ratings to predict skin damage 1 week later. Subepidermal moisture of 39 tissue dielectric constant units predicted 41% of future skin damage while visual ratings predicted 27%. Thus, this method of detecting early skin damage holds promise for clinicians, especially as it is objective and equally valid for all groups of patients.

Evaluating efforts to diversify the biomedical workforce: the role and function of the Coordination and Evaluation Center of the Diversity Program Consortium.

BACKGROUND: The National Institutes of Health (NIH)-funded Diversity Program Consortium (DPC) includes a Coordination and Evaluation Center (CEC) to conduct a longitudinal evaluation of the two signature, national NIH initiatives - the Building Infrastructure Leading to Diversity (BUILD) and the National Research Mentoring Network (NRMN) programs - designed to promote diversity in the NIH-funded biomedical, behavioral, clinical, and social sciences research workforce. Evaluation is central to understanding the impact of the consortium activities. This article reviews the role and function of the CEC and the collaborative processes and achievements critical to establishing empirical evidence regarding the efficacy of federally-funded, quasi-experimental interventions across multiple sites. The integrated DPC evaluation is particularly significant because it is a collaboratively developed Consortium Wide Evaluation Plan and the first hypothesis-driven, large-scale systemic national longitudinal evaluation of training programs in the history of NIH/National Institute of General Medical Sciences. KEY HIGHLIGHTS: To guide the longitudinal evaluation, the CEC-led literature review defined key indicators at critical training and career transition points - or Hallmarks of Success. The multidimensional, comprehensive evaluation of the impact of the DPC framed by these Hallmarks is described. This evaluation uses both established and newly developed common measures across sites, and rigorous quasi-experimental designs within novel multi-methods (qualitative and quantitative). The CEC also promotes shared learning among Consortium partners through working groups and provides technical assistance to support high-quality process and outcome evaluation internally of each program. Finally, the CEC is responsible for developing high-impact dissemination channels for best practices to inform peer institutions, NIH, and other key national and international stakeholders. IMPLICATIONS: A strong longitudinal evaluation across programs allows the summative assessment of outcomes, an understanding of factors common to interventions that do and do not lead to success, and elucidates the processes developed for data collection and management. This will provide a framework for the assessment of other training programs and have national implications in transforming biomedical research training.

Quality of Care Provided by a Comprehensive Dementia Care Comanagement Program.

Multiple studies have shown that quality of care for dementia in primary care is poor, with physician adherence to dementia quality indicators (QIs) ranging from 18% to 42%. In response, the University of California at Los Angeles (UCLA) Health System created the UCLA Alzheimer's and Dementia Care (ADC) Program, a quality improvement program that uses a comanagement model with nurse practitioner dementia care managers (DCM) working with primary care physicians and community-based organizations to provide comprehensive dementia care. The objective was to measure the quality of dementia care that nurse practitioner DCMs provide using the Assessing Care of Vulnerable Elders (ACOVE-3) and Physician Consortium for Performance Improvement QIs. Participants included 797 community-dwelling adults with dementia referred to the UCLA ADC program over a 2-year period. UCLA is an urban academic medical center with primarily fee-for-service reimbursement. The percentage of recommended care received for 17 dementia QIs was measured. The primary outcome was aggregate quality of care for the UCLA ADC cohort, calculated as the total number of recommended care processes received divided by the total number of eligible quality indicators. Secondary outcomes included aggregate quality of care in three domains of dementia care: assessment and screening (7 QIs), treatment (6 QIs), and counseling (4 QIs). QIs were abstracted from DCM notes over a 3-month period from date of initial assessment. Individuals were eligible for 9,895 QIs, of which 92% were passed. Overall pass rates of DCMs were similar (90-96%). All counseling and assessment QIs had pass rates greater than 80%, with most exceeding 90%. Wider variation in adherence was found among QIs addressing treatments for dementia, which patient-specific criteria triggered, ranging from 27% for discontinuation of medications associated with mental status changes to 86% for discussion about acetylcholinesterase inhibitors. Comprehensive dementia care comanagement with a nurse practitioner can result in high quality of care for dementia, especially for assessment, screening, and counseling. The effect on treatment QIs is more variable but higher than previous reports of physician-provided dementia care.

Use of Munsell color charts to measure skin tone objectively in nursing home residents at risk for pressure ulcer development.

AIMS: To assess the feasibility of classifying skin tone using Munsell color chart values and to compare Munsell-based skin tone categories to ethnicity/race to predict pressure ulcer risk. BACKGROUND: Pressure ulcer classification uses level of visible tissue damage, including skin discoloration over bony prominences. Prevention begins with early detection of damage. Skin discoloration in those with dark skin tones can be difficult to observe, hindering early detection. DESIGN: Observational cohort of 417 nursing home residents from 19 nursing homes collected between 2009-2014, with weekly skin assessments for up to 16 weeks. METHODS: Assessment included forearm and buttocks skin tone based on Munsell values (Dark, Medium, Light) at three time points, ethnicity/race medical record documentation, and weekly skin assessment on trunk and heels. RESULTS: Inter-rater reliability was high for forearm and buttock values and skin tone. Mean Munsell buttocks values differed significantly by ethnicity/race. Across ethnicity/race, Munsell value ranges overlapped, with the greatest range among African Americans. Trunk pressure ulcer incidence varied by skin tone, regardless of ethnicity/race. In multinomial regression, skin tone was more predictive of skin damage than ethnicity/race for trunk locations but ethnicity/race was more predictive for heels. CONCLUSIONS: Given the overlap of Munsell values across ethnicity/race, color charts provide more objective measurement of skin tone than demographic categories. An objective measure of skin tone can improve pressure ulcer risk assessment among patients for whom current clinical guidelines are less effective.

A Strategy for Identifying and Disseminating Best Practice Innovations in the Care of Patients with Multiple Chronic Conditions or End-of-Life Care Needs.

Patients with multiple chronic conditions and those with end-of-life care needs experience high health care costs and needs for skilled coordination and well-trained staff. Focusing on these populations presents an opportunity to improve the patient experience toward the goal of more patient-centered care and reduced costs. Although innovative programs that provide better care to these patient populations have been developed, these innovations are often localized and not actively disseminated to other settings. This paper describes a quality-improvement project aimed at developing a process to identify best practices implemented in community-based clinical settings, develop a platform to share and disseminate these best practices, and facilitate the adoption of successful practices across other similar settings. The facilitation process involved structured coaching by clinicians and researchers experienced with practice change and quality improvement. The coaching component ensured that implementation teams receive guidance in the planning and adoption process, stay on track with implementation, and have access to timely support in addressing unanticipated barriers.

Do internal medicine residents know enough about skilled nursing facilities to orchestrate a good care transition?

BACKGROUND: Although many older adults require skilled nursing facility (SNF) care after acute hospitalization, it is unclear whether internal medicine residents have sufficient knowledge of the care that can be provided at this site. METHODS: We developed a 10-item multiple choice pre-test that assessed knowledge of the definition of a SNF, SNF staffing requirements, and SNF services provided on-site. The test was administered to trainees on the first day of a mandatory SNF rotation that occurred during their first, second or third year of training. RESULTS: Sixty-seven internal medicine residents [41 postgraduate year (PGY)-1, 11 PGY-2, and 15 PGY-3] were assessed with the test. The mean number of questions answered correctly was 4.9, with a standard deviation of 1.6. Regardless of their level of training, residents had a poor baseline knowledge of SNF care (mean scores 4.2 for PGY-1, 5.3 for PGY-2, and 6.3 for PGY-3) (P < .0001). Performance on some questions improved with increased level of training but others did not. CONCLUSIONS: Medical residents have insufficient knowledge about the type of care that can be provided at a SNF and efforts to improve this knowledge are needed to assure proper triage of patients and safe transitions to the SNF.

Effect of nurse practitioner comanagement on the care of geriatric conditions.

OBJECTIVES: To determine whether community-based primary care physician (PCP)-nurse practitioner (NP) comanagement implementing the Assessing Care of Vulnerable Elders (ACOVE)-2 model: (case finding, delegation of data collection, structured visit notes, physician and patient education, and linkage to community resources) can improve the quality of care for geriatric conditions. DESIGN: Case study. SETTING: Two community-based primary care practices. PARTICIPANTS: Patients aged 75 and older who screened positive for at least one condition: falls, urinary incontinence (UI), dementia, and depression. INTERVENTION: The ACOVE-2 model augmented by NP comanagement of conditions. MEASUREMENTS: Quality of care according to medical record review using ACOVE-3 quality indicators (QIs). Individuals receiving comanagement were compared with those who received PCP care alone in the same practices. RESULTS: Of 1,084 screened individuals, 658 (61%) screened positive for more than one condition; 485 of these were randomly selected for chart review and triggered a mean of seven QIs. A NP saw 49% for comanagement. Overall, individuals received 57% of recommended care. Quality scores for all conditions (falls, 80% vs 34%; UI, 66% vs 19%; dementia, 59% vs 38%) except depression (63% vs 60%) were higher for individuals who saw a NP. In analyses adjusted for sex and age of patient, number of conditions, site, and a NP estimate of medical management style, NP comanagement remained significantly associated with receiving recommended care (P < .001), as did NP estimate of medical management style (P = .02). CONCLUSION: NP comanagement is associated with better quality of care for geriatric conditions in community-based primary care than usual care using the ACOVE-2 model.

Motor assessment using the NIH Toolbox.

Motor function involves complex physiologic processes and requires the integration of multiple systems, including neuromuscular, musculoskeletal, and cardiopulmonary, and neural motor and sensory-perceptual systems. Motor-functional status is indicative of current physical health status, burden of disease, and long-term health outcomes, and is integrally related to daily functioning and quality of life. Given its importance to overall neurologic health and function, motor function was identified as a key domain for inclusion in the NIH Toolbox for Assessment of Neurological and Behavioral Function (NIH Toolbox). We engaged in a 3-stage developmental process to: 1) identify key subdomains and candidate measures for inclusion in the NIH Toolbox, 2) pretest candidate measures for feasibility across the age span of people aged 3 to 85 years, and 3) validate candidate measures against criterion measures in a sample of healthy individuals aged 3 to 85 years (n = 340). Based on extensive literature review and input from content experts, the 5 subdomains of dexterity, strength, balance, locomotion, and endurance were recommended for inclusion in the NIH Toolbox motor battery. Based on our validation testing, valid and reliable measures that are simultaneously low-cost and portable have been recommended to assess each subdomain, including the 9-hole peg board for dexterity, grip dynamometry for upper-extremity strength, standing balance test, 4-m walk test for gait speed, and a 2-minute walk test for endurance.

A randomized trial of Raltegravir replacement for protease inhibitor or non-nucleoside reverse transcriptase inhibitor in HIV-infected women with lipohypertrophy.

Lipohypertrophy in HIV-infected patients is associated with metabolic abnormalities. Raltegravir (RAL) is not known to induce fat changes or severe metabolic perturbations. HIV-infected women with central adiposity and HIV-1 RNA less than 50 copies per milliliter on non-nucleoside reverse transcriptase inhibitor (NNRTI)- or protease inhibitor (PI)-based antiretroviral therapy (ART) continued their nucleoside reverse transcriptase inhibitor (NRTI) backbone and were randomized to switch to open label RAL immediately or after 24 weeks. The primary end point was 24-week between-group change in computed tomography (CT)-quantified visceral adipose tissue (AT) volume. Fasting lipids, glucose, C-reactive protein (CRP), anthropometric measurements, and patient-reported quality of life assessments were also measured. Thirty-six subjects provided 80% power to detect a 10% between-group difference in visceral AT over 24 weeks. Thirty-seven of 39 enrolled subjects completed week 24. At entry, subjects were 75% black or Hispanic, and on 62% PI-based and 38% NNRTI-based regimens. The median age was 43 years, CD4 count 558 cells per microliter, and body mass index (BMI) 32 kg/m(2). After 24 weeks, no statistically significant changes in visceral or subcutaneous AT, anthropometrics, BMI, glucose, or CRP were observed. In subjects receiving RAL, significant improvements in total and LDL cholesterol (p=0.04), self-reported belly size (p=0.02) and composite body size (p=0.02) were observed. Body size changes correlated well with percent visceral AT change. No RAL-related adverse events occurred. Compared to continued PI or NNRTI, switch to RAL was associated with statistically significant 24-week improvements in total and LDL cholesterol but not AT volumes. Additional insights into AT and metabolic changes in women on RAL will be provided by 48-week follow-up of the immediate-switch arm.

Assessing dexterity function: a comparison of two alternatives for the NIH Toolbox.

STUDY DESIGN: Clinical measurement. INTRODUCTION: Manual dexterity is an important aspect of motor function across the age span. PURPOSE OF THE STUDY: To identify a single measure of manual dexterity for inclusion in the National Institutes of Health (NIH) Toolbox Assessment of Neurological and Behavioral Function. METHODS: A total of 340 subjects participated in our study. Two alternatives, Rolyan® 9-Hole Peg Test (9-HPT) and Grooved Pegboard test, were compared by assessing their score range across age groups (3-85 yr) and their test-retest reliability, concurrent, and known groups validity. RESULTS: The 9-HPT was a simple, efficient, and low-cost measure of manual dexterity appropriate for administration across the age range. Test-retest reliability coefficients were 0.95 and 0.92 for right and left hands, respectively. The 9-HPT correlated with Bruininks-Oseretsky Test (BOT) of Motor Proficiency, dexterity subscale, at -0.87 to -0.89 and with Purdue Pegboard at -0.74 to -0.75. The Grooved Pegboard had good test-retest reliability (0.91 and 0.85 for right and left hands, respectively). The Grooved Pegboard correlated with BOT at -0.50 to -0.63 and with Purdue Pegboard at -0.73 to -0.78. However, the Grooved Pegboard required longer administration time and was challenging for the youngest children and oldest adults. CONCLUSIONS: Based on its feasibility and measurement properties, the 9-HPT was recommended for inclusion in the motor battery of the NIH Toolbox. LEVEL OF EVIDENCE: NA.