Faculty Bibliography

Objectives: This study sought to assess the current impact of health insurance coverage on medication adherence and blood pressure control of patients being managed for hypertension in Ghana and Nigeria. Methods: The study was a prospective study among 109 patients with hypertension in two health facilities with similar population dynamics in Ghana and Nigeria. Patients were systematically selected, categorized as having health insurance coverage or not, and followed up monthly for 6 months. The outcome variables (medication adherence and blood pressure control) were then measured and compared at 6 months. Analysis was done using Stata with level of significance set at p ⩽ 0.05. Results: There was a 90% insurance coverage among participants from Ghana compared to 15% from Nigeria. National Health Insurance Authority enrolees in both countries had better blood pressure control and medication adherence compared to non-enrolees (adjusted odds ratio = 2.6 and 4.5, respectively). Conclusion: National Health Insurance Authority enrolment was found to be poor among respondents in Nigeria compared to Ghana. Enrolment into the National health financing schemes in both countries led to better blood pressure control and medication adherence among patients with hypertension at primary health facilities. There is therefore the need for system strengthening to improve their sustainability.

IMPORTANCE:Although peer review is an important component of publication for new research, the viability of this process has been questioned, particularly with the added stressors of the COVID-19 pandemic. OBJECTIVE:To characterize rates of peer reviewer acceptance of invitations to review manuscripts, reviewer turnaround times, and editor-assessed quality of reviews before and after the start of the COVID-19 pandemic at a large, open-access general medical journal. DESIGN, SETTING, AND PARTICIPANTS:This retrospective, pre-post cohort study examined all research manuscripts submitted to JAMA Network Open between January 1, 2019, and June 29, 2021, either directly or via transfer from other JAMA Network journals, for which at least 1 peer review of manuscript content was solicited. Measures were compared between the period before the World Health Organization declaration of a COVID-19 pandemic on March 11, 2020 (14.3 months), and the period during the pandemic (15.6 months) among all reviewed manuscripts and between pandemic-period manuscripts that did or did not address COVID-19. MAIN OUTCOMES AND MEASURES:For each reviewed manuscript, the number of invitations sent to reviewers, proportions of reviewers accepting invitations, time in days to return reviews, and editor-assessed quality ratings of reviews were determined. RESULTS:In total, the journal sought review for 5013 manuscripts, including 4295 Original Investigations (85.7%) and 718 Research Letters (14.3%); 1860 manuscripts were submitted during the prepandemic period and 3153 during the pandemic period. Comparing the prepandemic with the pandemic period, the mean (SD) number of reviews rated as high quality (very good or excellent) per manuscript increased slightly from 1.3 (0.7) to 1.5 (0.7) (P < .001), and the mean (SD) time for reviewers to return reviews was modestly shorter (from 15.8 [7.6] days to 14.4 [7.0] days; P < .001), a difference that persisted in linear regression models accounting for manuscript type, study design, and whether the manuscript addressed COVID-19. CONCLUSIONS AND RELEVANCE:In this cohort study, the speed and editor-reported quality of peer reviews in an open-access general medical journal improved modestly during the initial year of the pandemic. Additional study will be necessary to understand how the pandemic has affected reviewer burden and fatigue.

OBJECTIVES/OBJECTIVE:Although technology-supported interventions are effective for reducing chronic disease risk, little is known about the relative and combined efficacy of mobile health strategies aimed at multiple lifestyle factors. The purpose of this clinical trial is to evaluate the efficacy of technology-supported behavioral intervention strategies for managing multiple lifestyle-related health outcomes in overweight adults with type 2 diabetes (T2D) and chronic kidney disease (CKD). DESIGN AND METHODS/METHODS:, age ≥40 years), T2D, and CKD stages 2-4 were randomized to an advice control group, or remotely delivered programs consisting of synchronous group-based education (all groups), plus (1) Social Cognitive Theory-based behavioral counseling and/or (2) mobile self-monitoring of diet and physical activity. All programs targeted weight loss, greater physical activity, and lower intakes of sodium and phosphorus-containing food additives. RESULTS:Of 256 randomized participants, 186 (73%) completed 6-month assessments. Compared to the ADVICE group, mHealth interventions did not result in significant changes in weight loss, or urinary sodium and phosphorus excretion. In aggregate analyses, groups receiving mobile self-monitoring had greater weight loss at 3 months (P = .02), but between 3 and 6 months, weight losses plateaued, and by 6 months, the differences were no longer statistically significant. CONCLUSIONS:When engaging patients with T2D and CKD in multiple behavior changes, self-monitoring diet and physical activity demonstrated significantly larger short-term weight losses. Theory-based behavioral counseling alone was no better than baseline advice and demonstrated no interaction effect with self-monitoring.

PURPOSE OF REVIEW/OBJECTIVE:To identify intervention strategies that were effective in promoting medication adherence and HTN control among racial/ethnic minority groups in the US. RECENT FINDINGS/RESULTS:Twelve articles were included in this review and 4 categories of intervention strategies were identified as counseling by trained personnel, mHealth tools, mHealth tools in combination with counseling by trained personnel, and quality improvement. The findings show that interventions delivered by trained personnel are effective in lowering BP and improving medication adherence, particularly for those delivered by health educators, CHWs, medical assistants, and pharmacists. Additionally, the combination of mHealth tools with counseling by trained personnel has the potential to be more effective than either mHealth or counseling alone and report beneficial effects on medication adherence and BP control. This review provides potential next steps for future research to examine the effectiveness of mHealth interventions in combination with support from trained health personnel and its effects on racial disparities in HTN outcomes.

BACKGROUND:Hypertension (HTN) control among Blacks in the USA has become a major public health challenge. Barriers to HTN control exist at multiple levels including patient, physician, and the health system. Patients also encounter significant community-level barriers, such as poor linkage to social services that impact health (unstable housing, food access, transportation). We describe a multi-component needs assessment to inform the development, implementation, and evaluation of a program to improve HTN management within a large healthcare system in New York City (NYC). METHODS:Guided by the Community-Based Participatory Research (CBPR) and Consolidated Framework for Implementation Research (CFIR) frameworks, data will be collected from four main sources: (1) quantitative surveys with health systems leadership, providers, and staff and with community-based organizations (CBOs) and faith-based organizations (FBOs); (2) qualitative interviews and focus groups with health systems leadership, providers, and staff and with CBOs and FBOs; (3) NYC Community Health Survey (CHS); and (4) New York University (NYU) Health system Epic Electronic Health Record (EHR) system. The data sources will allow for triangulation and synthesis of findings. DISCUSSION/CONCLUSIONS:Findings from this comprehensive needs assessment will inform the development of a clinic-community-based practice facilitation program utilizing three multi-level evidence-based interventions (nurse case management, remote blood pressure (BP) monitoring, and social determinants of health (SDoH) support) integrated as a community-clinic linkage model for improved HTN control in Black patients. Integration of stakeholders' priorities, perspectives, and practices into the development of the program will improve adoption, sustainability, and the potential for scale-up. TRIAL REGISTRATION/BACKGROUND:NCT05208450; registered on January 26, 2022.

BACKGROUND:Maintaining blood pressure (BP) control over time may contribute to lower risk for cardiovascular disease (CVD) among individuals who are taking antihypertensive medication. METHODS:The Jackson Heart Study (JHS) enrolled 5,306 African-American adults ≥21 years of age and was used to determine the proportion of African Americans that maintain persistent BP control, identify factors associated with persistent BP control, and determine the association of persistent BP control with CVD events. This analysis included 1,604 participants who were taking antihypertensive medication at Visit 1 and had BP data at Visits 1 (2000-2004), 2 (2005-2008), and 3 (2009-2013). Persistent BP control was defined as systolic BP <140 mm Hg and diastolic BP <90 mm Hg at all three visits. CVD events were assessed from Visit 3 through December 31, 2016. Hazard ratios (HR) for the association of persistent BP control with CVD outcomes were adjusted for age, sex, systolic BP, smoking, diabetes, and total and high-density lipoprotein cholesterol at Visit 3. RESULTS:At Visit 1, 1,226 of 1,604 participants (76.4%) with hypertension had controlled BP. Overall, 48.9% of participants taking antihypertensive medication at Visit 1 had persistent BP control. After multivariable adjustment for demographic, socioeconomic, clinical, behavioral, and psychosocial factors, and access-to-care, participants were more likely to have persistent BP control if they were <65 years of age, women, had family income ≥$25,000 at each visit, and visited a health professional in the year prior to each visit. The multivariable adjusted HR (95% confidence interval) comparing participants with versus without persistent BP control was 0.71 (0.46-1.10) for CVD, 0.68 (0.34-1.34) for coronary heart disease, 0.65 (0.27-1.52) for stroke, and 0.55 (0.33-0.90) for heart failure. CONCLUSION/CONCLUSIONS:Less than half of JHS participants taking antihypertensive medication had persistent BP control, putting them at increased risk for heart failure.

BACKGROUND:The prevalence of hypertension continues to rise in low- and middle-income- countries (LMICs) where scalable, evidence-based interventions (EBIs) that are designed to reduce morbidity and mortality attributed to hypertension have yet to be fully adopted or disseminated. We sought to evaluate evidence from published randomized controlled trials using EBIs for hypertension control implemented in LMICs, and identify the WHO/ExpandNet scale-up components that are relevant for consideration during "scale-up" implementation planning. METHODS:Systematic review of RCTs reporting EBIs for hypertension control implemented in LMICs that stated "scale-up" or a variation of scale-up; using the following data sources PubMed/Medline, Web of Science Biosis Citation Index (BCI), CINAHL, EMBASE, Global Health, Google Scholar, PsycINFO; the grey literature and clinicaltrials.gov from inception through June 2021 without any restrictions on publication date. Two reviewers independently assessed studies for inclusion, conducted data extraction using the WHO/ExpandNet Scale-up components as a guide and assessed the risk of bias using the Cochrane risk-of-bias tool. We provide intervention characteristics for each EBI, BP results, and other relevant scale-up descriptions. MAIN RESULTS/RESULTS:Thirty-one RCTs were identified and reviewed. Studies reported clinically significant differences in BP, with 23 studies reporting statistically significant mean differences in BP (p < .05) following implementation. Only six studies provided descriptions that captured all of the nine WHO/ExpandNet components. Multi-component interventions, including drug therapy and health education, provided the most benefit to participants. The studies were yet to be scaled and we observed limited reporting on translation of the interventions into existing institutional policy (n = 11), cost-effectiveness analyses (n = 2), and sustainability measurements (n = 3). CONCLUSION/CONCLUSIONS:This study highlights the limited data on intervention scalability for hypertension control in LMICs and demonstrates the need for better scale-up metrics and processes for this setting. TRIAL REGISTRATION/BACKGROUND:Registration PROSPERO (CRD42019117750).

BACKGROUND:Evidence-based task-strengthening strategies for hypertension (HTN) control (TASSH) are not readily available for patients living with HIV in sub-Saharan Africa where the dual burden of HTN and HIV remains high. We are conducting a cluster randomized controlled trial comparing the effectiveness of practice facilitation versus a self-directed control (i.e., receipt of TASSH with no practice facilitation) in reducing blood pressure and increasing the adoption of task-strengthening strategies for HTN control within HIV clinics in Nigeria. Prior to implementing the trial, we conducted formative research to identify factors that may influence the integration of TASSH within HIV clinics in Nigeria. METHODS:This mixed-methods study was conducted with purposively selected healthcare providers at 29 HIV clinics, followed by a 1-day stakeholder meeting with 19 representatives of HIV clinics. We collected quantitative practice assessment data using two instruments: (a) an adapted Service Availability and Readiness Assessment (SARA) tool to assess the capacity of the clinic to manage NCDs and (b) Implementation Climate Scale to assess the degree to which there is a strategic organizational climate supportive of the evidence-based practice implementation. The quantitative data were analyzed using descriptive statistics and measures of scale reliability. We also used the Consolidated Framework for Implementation Research (CFIR), to thematically analyze qualitative data generated and relevant to the aims of this study. RESULTS:Across the 29 clinics surveyed, the focus on TASSH (mean=1.77 (SD=0.59)) and educational support (mean=1.32 (SD=0.68)) subscales demonstrated the highest mean score, with good-excellent internal consistency reliability (Cronbach's alphas ranging from 0.84 to 0.96). Within the five CFIR domains explored, the major facilitators of the intervention included relative advantage of TASSH compared to current practice, compatibility with clinic organizational structures, support of patients' needs, and intervention alignment with national guidelines. Barriers included the perceived complexity of TASSH, weak referral network and patient tracking mechanism within the clinics, and limited resources and diagnostic equipment for HTN. CONCLUSION/CONCLUSIONS:Optimizing healthcare workers' implementation of evidence-based TASSH within HIV clinics requires attention to both the implementation climate and contextual factors likely to influence adoption and long-term sustainability. These findings have implications for the development of effective practice facilitation strategies to further improve the delivery and integration of TASSH within HIV clinics in Nigeria. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov , NCT04704336.

BACKGROUND:Several tools to improve reporting of implementation studies for evidence-based decision making have been created; however, no tool for critical appraisal of implementation outcomes exists. Researchers, practitioners, and policy makers lack tools to support the concurrent synthesis and critical assessment of outcomes for implementation research. Our objectives were to develop a comprehensive tool to (1) describe studies focused on implementation that use qualitative, quantitative, and/or mixed methodologies and (2) assess risk of bias of implementation outcomes. METHODS:A hybrid consensus-building approach combining Delphi Group and Nominal Group techniques (NGT) was modeled after comparative methodologies for developing health research reporting guidelines and critical appraisal tools. First, an online modified NGT occurred among a small expert panel (n = 5), consisting of literature review, item generation, round robin with clarification, application of the tool to various study types, voting, and discussion. This was followed by a larger e-consensus meeting and modified Delphi process with implementers and implementation scientists (n = 32). New elements and elements of various existing tools, frameworks, and taxonomies were combined to produce the ASSESS tool. RESULTS:The 24-item tool is applicable to a broad range of study designs employed in implementation science, including qualitative studies, randomized-control trials, non-randomized quantitative studies, and mixed methods studies. Two key features are a section for assessing bias of the implementation outcomes and sections for describing the implementation strategy and intervention implemented. An accompanying explanation and elaboration document that identifies and describes each of the items, explains the rationale, and provides examples of reporting and appraising practice, as well as templates to allow synthesis of extracted data across studies and an instructional video, has been prepared. CONCLUSIONS:The comprehensive, adaptable tool to support both reporting and critical appraisal of implementation science studies including quantitative, qualitative, and mixed methods assessment of intervention and implementation outcomes has been developed. This tool can be applied to a methodologically diverse and growing body of implementation science literature to support reviews or meta-analyses that inform evidence-based decision-making regarding processes and strategies for implementation.