Background: Mendelian randomization (MR) provides unconfounded estimates. MR is open to selection bias when the underlying sample is selected on surviving to recruitment on the genetically instrumented exposure and competing risk of the outcome. Few methods to address this bias exist.Methods: We show that this selection bias can sometimes be addressed by adjusting for common causes of survival and outcome. We use multivariable MR to obtain a corrected MR estimate for statins on stroke. Statins affect survival, and stroke typically occurs later in life than ischemic heart disease (IHD), making estimates for stroke open to bias from competing risk.Results: In univariable MR in the UK Biobank, genetically instrumented statins did not protect against stroke [odds ratio (OR) 1.33, 95% confidence interval (CI) 0.80–2.20] but did in multivariable MR (OR 0.81, 95% CI 0.68–0.98) adjusted for major causes of survival and stroke [blood pressure, body mass index (BMI), and smoking initiation] with a multivariable Q-statistic indicating absence of selection bias. However, the MR estimate for statins on stroke using MEGASTROKE remained positive and the Q statistic indicated pleiotropy.Conclusion: MR studies of harmful exposures on late-onset diseases with shared etiology need to be conceptualized within a mechanistic understanding so as to identify any potential bias due to survival to recruitment on both genetically instrumented exposure and competing risk of the outcome, which may then be investigated using multivariable MR or estimated analytically and results interpreted accordingly.
Background-South Asians (SAs) experience a disproportionate burden of high blood pressure (BP) in the US, arguably the most preventable risk factor for cardiovascular disease. Objective-We report 12-month results of an electronic health record (EHR)-based intervention, as a component of a larger project, "IMPACT". The EHR intervention included launching hypertension patient registries and implementing culturally-tailored alerts and order sets to improve hypertension control among patients treated in 14 New York City practices located in predominantly SA immigrant neighborhoods. Design-Using a modified stepped wedge quasi-experimental study design, practice-level EHR data were extracted, and individual-level data were obtained on a subset of patients insured by a Medicaid insurer via their data warehouse. The primary aggregate outcome was change in proportion of hypertensive patients with controlled BP; individual-level outcomes included average systolic BP (SBP) and diastolic BP (DBP) at last clinic visit. Qualitative interviews were conducted to assess intervention feasibility. Measures-Hypertension was defined as having at least one hypertension ICD-9/10 code. Wellcontrolled hypertension was defined as SBP<140 mmHg and DBP<90 mmHg. Results-Post-intervention, we observed a significant improvement in hypertension control at the practice level, adjusting for age and sex patient composition (aRR: 1.09, 95% CI: 1.04-1.14). Among the subset of Medicaid patients, we observed a significant reduction in average SBP and
BackgroundThe Million Hearts® initiative aims to prevent heart disease and stroke in the United States by mobilizing public and private sectors around a core set of objectives, with particular attention on improving blood pressure control. South Asians in particular have disproportionately high rates of hypertension and face numerous cultural, linguistic, and social barriers to accessing healthcare. Interventions utilizing Health information technology (HIT) and community health worker (CHW)-led patient coaching have each been demonstrated to be effective at advancing Million Hearts® goals, yet few studies have investigated the potential impact of integrating these strategies into a clinical-community linkage initiative. Building upon this initiative, we present the protocol and preliminary results of a research study, Project IMPACT, designed to fill this gap in knowledge.MethodsProject IMPACT is a stepped wedge quasi-experimental study designed to test the feasibility, adoption, and impact of integrating CHW-led health coaching with electronic health record (EHR)-based interventions to improve hypertension control among South Asian patients in New York City primary care practices. EHR intervention components include the training and implementation of hypertension-specific registry reports, alerts, and order sets. Fidelity to the EHR intervention is assessed by collecting the type, frequency, and utilization of intervention components for each practice. CHW intervention components consist of health coaching sessions on hypertension and related risk factors for uncontrolled hypertensive patients. The outcome, hypertension control (<140 mmHg systolic blood pressure (BP) and <90 mmHg diastolic BP), is collected at the aggregate- and individual-level for all 16 clinical practices enrolled.DiscussionProject IMPACT builds upon the evidence base of the effectiveness of CHW and Million Hearts® initiatives and proposes a unique integration of provider-based EHR and community-based CHW interventions. The project informs the effectiveness of these interventions in team-based care approaches, thereby, helping to develop relevant sustainability strategies for improving hypertension control among targeted racial/ethnic minority populations at small primary care practices.Trial registrationThis study protocol has been approved and is made available on Clinicaltrials.gov by NCT03159533 as of May 17, 2017.
Introduction This study examined feasibility of a place-based community health worker (CHW) and health advocate (HA) initiative in five public housing developments selected for high chronic disease burden and described early outcomes. Methods This intervention was informed by a mixed-method needs assessment performed December 2014–January 2015 (representative telephone survey, n=1,663; six focus groups, n=55). Evaluation design was a non-randomized, controlled quasi-experiment. Intake and 3-month follow-up data were collected February–December 2015 (follow-up response rate, 93%) on 224 intervention and 176 comparison participants, and analyzed in 2016. All participants self-reported diagnoses of hypertension, diabetes, or asthma. The intervention consisted of chronic disease self-management and goal setting through six individual CHW-led health coaching sessions, instrumental support, and facilitated access to insurance/clinical care navigation from community-based HAs. Feasibility measures included CHW service satisfaction and successful goal setting. Preliminary outcomes included clinical measures (blood pressure, BMI); disease management behaviors and self-efficacy; and preventive behaviors (physical activity). Results At the 3-month follow-up, nearly all intervention participants reported high satisfaction with their CHW (90%) and HA (76%). Intervention participants showed significant improvements in self-reported physical activity (p=0.005) and, among hypertensive participants, self-reported routine blood pressure self-monitoring (p=0.013) compared with comparison participants. No improvements were observed in self-efficacy or clinical measures at the 3-month follow-up. Conclusions Housing-based initiatives involving CHW and HA teams are acceptable to public housing residents and can be effectively implemented to achieve rapid improvements in physical activity and chronic disease self-management. At 3-month assessment, additional time and efforts are required to improve clinical outcomes.
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