Background Community-based health workers (CBHWs) are frontline public health workers who are trusted members of the community they serve. Recently, considerable attention has been drawn to CBHWs in promoting healthy behaviors and health outcomes among vulnerable populations who often face health inequities. Objectives This systematic review synthesized evidence concerning the types of CBHW interventions, the qualification and characteristics of CBHWs, and patient outcomes and cost effectiveness of such interventions in vulnerable populations with chronic, non-communicable conditions. Search methods Four electronic database searches, including PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Cochrane, and hand searches of reference collections were undertaken to identify randomized controlled trials published in English before August 2014. Selection A total of 934 unique citations were screened initially for titles and abstracts. Two reviewers then independently evaluated 166 full-text articles that were passed onto review processes. Sixty-one studies and six companion articles (e.g., cost-effectiveness analysis) met eligibility criteria for inclusion. Data collection and analysis Data were extracted by 4 trained research assistants (RA) using a standardized data extraction form developed by the authors. Subsequently, an independent RA reviewed extracted data to check accuracy. Discrepancies were resolved through discussions among the study team members. Each study was evaluated for its quality by two RAs who extracted relevant study information. Inter-rater agreement rates ranged from 61% to 91% (average 86%). Any discrepancies in terms of quality rating were resolved through team discussions. Main results All but 4 studies were conducted in the U.S. The two most common areas for CBHW interventions were cancer prevention (n=30) and cardiovascular disease risk reduction (n=26). The roles assumed by CBHWs included: health education (n=48), counseling (n=36), navigation assistance (n=21), case management (n=4), social services (n=7), and social support (n=18). Fifty-three studies provided information regarding CBHW training, yet CBHW competency evaluation (n=9) and supervision procedures (n=24) were largely underreported. The length and duration of CBHW training ranged from 4 hours to 240 hours with an average of 41.3 hours (median: 16.5 hours) in 24 studies that reported length of training. Eight studies reported the frequency of supervision, which ranged from weekly to monthly. There was a trend toward improvements in cancer prevention (n=21) and cardiovascular risk reduction (n=16). Eight articles documented cost effective analysis and found that integrating CBHWs into the healthcare delivery system was associated with cost-effective and sustainable care. Conclusions CBHW interventions appear to be effective when compared to alternatives and also cost-effective for certain health conditions particularly when partnering with low-income, underserved, and racial a...
Objective To investigate whether associations of hearing impairment (HI) with functional outcomes in older adults differ when using self-report versus pure-tone-audiometry. Methods We examined 1669 participants ≥70 years in National Health and Examination Survey from 2005–2006 and 2009–2010 whose hearing was assessed by self-report and pure-tone-audiometry. We explored functional outcomes associated with audiometric HI (low physical activity, poor physical functioning, and hospitalization). Results In adjusted models, we found significant associations of audiometric HI with both subjective and objective outcomes, (e.g., dichotomous HI with self-reported difficulty in activities of daily living (ADLs), OR=1.47[95%CI:1.05–2.06] and low accelerometer-measured physical activity, OR=2.19[95%CI:1.11–4.34]). In contrast, self-reported HI was only associated with subjective outcomes and not with objective outcomes (e.g., dichotomous HI with difficulty in ADLs, OR=1.63 [95%CI:1.12–2.38] and low accelerometer-measured physical activity OR=0.95 [95%CI:0.66–1.35]). Discussion Results using self-reported hearing should not be considered representative of results using audiometry and may provide distinct aspects of HI in older adults.
IMPORTANCE Underrepresentation of many racial/ethnic groups in Alzheimer disease (AD) clinical trials limits generalizability of results and hinders opportunities to examine potential effect modification of candidate treatments.OBJECTIVE To examine racial and ethnic differences in recruitment methods and trial eligibility in a multisite preclinical AD trial. DESIGN, SETTING, AND PARTICIPANTSThis cross-sectional study analyzed screening data from the Anti-Amyloid in Asymptomatic AD study, collected from April 2014 to December 2017.Participants were categorized into 5 mutually exclusive ethnic/racial groups (ie, Hispanic, Black, White, Asian, and other) using participant self-report. Data were analyzed from May through December 2020 and included 5945 cognitively unimpaired older adults between the ages of 65 and 85 years screened at North American study sites. MAIN OUTCOMES AND MEASURESPrimary outcomes included recruitment sources, study eligibility, and ineligibility reasons. To assess the probability of trial eligibility, regression analyses were performed for the likelihood of being eligible after the first screening visit involving clinical and cognitive assessments. RESULTSScreening data were included for 5945 participants at North American sites (mean [SD] age, 71.7 [4.9] years; 3524 women [59.3%]; 5107 White [85.9%], 323 Black [5.4%], 261 Hispanic [4.4%], 112 Asian [1.9%], and 142 [2.4%] who reported race or ethnicity as other). Recruitment sources differed by race and ethnicity. While White participants were recruited through a variety of sources, site local recruitment efforts resulted in the majority of Black (218 [69.2%]), Hispanic (154 [59.7%]), and Asian (61 [55.5%]) participants. Participants from underrepresented groups had lower mean years of education (eg, mean [SD] years: Hispanic participants, 15.5 [3.2] years vs White participants, 16.7 [2.8] years) and more frequently were women (226 [70.0%] Black participants vs 1364 [58.5%] White participants), were unmarried (184 [56.9%] Black participants vs 1364 [26.7%] White participants), and had nonspousal study partners (237 [73.4%] Black participants vs 2147 [42.0%] White participants). They were more frequently excluded for failure to meet cognitive inclusion criteria (eg, screen failures by specific inclusion criteria: 147 [45.5%] Black participants vs 1338 [26.2%] White participants). Compared with White participants, Black (odds ratio [OR], 0.43;95% CI, 0.34-0.54; P < .001), Hispanic (OR, 0.53; 95% CI, 0.41-0.69; P < .001), and Asian participants (OR, 0.56; 95% CI, 0.38-0.82; P = .003) were less likely to be eligible after screening visit 1.CONCLUSIONS AND RELEVANCE Racial/ethnic groups differed in sources of recruitment, reasons for screen failure, and overall probability of eligibility in a preclinical AD trial. These results highlight (continued) Key Points Question Are there racial/ethnic differences associated with recruitment sources and reasons for ineligibility among preclinical Alzheimer disease clinical trial participants? Findings In th...
IMPORTANCE Oligomeric amyloid-β peptide binds to cellular prion protein on the neuronal cell surface, activating intracellular fyn kinase to mediate synaptotoxicity and tauopathy. AZD0530 is an investigational kinase inhibitor specific for the Src family, including fyn, that has been repurposed for the treatment of Alzheimer disease. OBJECTIVE To determine whether AZD0530 treatment slows the decline in cerebral metabolic rate for glucose (CMRgl) and is safe and well tolerated. DESIGN, SETTING, AND PARTICIPANTS This multicenter phase 2a randomized clinical trial enrolled participants between December 23, 2014, and November 30, 2016. Participants (n = 159) had mild Alzheimer dementia and positron emission tomography (PET) evidence of elevated levels of amyloid-β peptide. Efficacy analyses of all primary and secondary outcomes were conducted in a modified intention-to-treat population. Final analyses were conducted from February 9, 2018, to July 25, 2018. INTERVENTIONS AZD0530 (100 mg or 125 mg daily) vs placebo for 52 weeks. MAIN OUTCOMES AND MEASURES Primary outcome was the reduction in relative CMRgl, as measured by 18 F-fluorodeoxyglucose (18 F-FDG) PET, at 52 weeks in an Alzheimer disease-associated prespecified statistical region of interest. Secondary end points included change in cognition, function, and other biomarkers. RESULTS Among the 159 participants, 79 were randomized to receive AZD0530 and 80 to receive placebo. Of the 159 participants, 87 (54.7%) were male, with a mean (SD) age of 71.0 (7.7) years. Based on a week-2 plasma drug level (target = 180 ng/mL; 30nM free), 15 participants (19.2%) had their AZD0530 dose escalated from 100 mg to 125 mg. Mean plasma levels from weeks 13 to 52 were 220 ng/mL and 36nM free. More participants discontinued treatment with AZD0530 than with placebo (21 vs 11), most commonly because of adverse events. The most frequent adverse events were gastrointestinal disorders (primarily diarrhea), which occurred in 38 participants (48.1%) who received AZD0530 and in 23 (28.8%) who received placebo. In the primary outcome, the treatment groups did not differ in 52-week decline in relative CMRgl (mean difference: −0.006 units/y; 95% CI, −0.017 to 0.006; P = .34). The treatment groups also did not differ in the rate of change in Alzheimer's Disease Assessment Scale-Cognitive Subscale, Alzheimer's Disease Cooperative Study-Activities of Daily Living, Clinical Dementia Rating, Neuropsychiatric Inventory, or Mini-Mental State Examination scores. Secondary volumetric magnetic resonance imaging analyses revealed no treatment effect on total brain or ventricular volume but did show trends for slowing the reduction in hippocampal volume and entorhinal thickness. CONCLUSIONS AND RELEVANCE Statistically significant effects of AZD0530 treatment were not found on relative CMRgl reduction in an Alzheimer disease-associated region of interest or on secondary clinical or biomarker measures.
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