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Background: Cardiovascular disease (CVD) is the leading cause of mortality worldwide, with >80% of CVD deaths occurring in low and middle income countries (LMICs). Diabetes mellitus and pre-diabetes are risk factors for CVD, and CVD is the major cause of morbidity and mortality among individuals with DM. There is a critical period now during which reducing CVD risk among individuals with diabetes and pre-diabetes may have a major impact. Cost-effective, culturally appropriate, and context-specific approaches are required. Two promising strategies to improve health outcomes are group medical visits and microfinance.Methods/design: This study tests whether group medical visits integrated into microfinance groups are effective and cost-effective in reducing CVD risk among individuals with diabetes or at increased risk for diabetes in western Kenya. An initial phase of qualitative inquiry will assess contextual factors, facilitators, and barriers that may impact integration of group medical visits and microfinance for CVD risk reduction. Subsequently, we will conduct a four-arm cluster randomized trial comparing: (1) usual clinical care, (2) usual clinical care plus microfinance groups only, (3) group medical visits only, and (4) group medical visits integrated into microfinance groups. The primary outcome measure will be 1-year change in systolic blood pressure, and a key secondary outcome measure is 1-year change in overall CVD risk as measured by the QRISK2 score. We will conduct mediation analysis to evaluate the influence of changes in social network characteristics on intervention outcomes, as well as moderation analysis to evaluate the influence of baseline social network characteristics on effectiveness of the interventions. Cost-effectiveness analysis will be conducted in terms of cost per unit change in systolic blood pressure, percent change in CVD risk score, and per disability-adjusted life year saved.Discussion: This study will provide evidence regarding effectiveness and cost-effectiveness of interventions to reduce CVD risk. We aim to produce generalizable methods and results that can provide a model for adoption in low-resource settings worldwide. [ABSTRACT FROM AUTHOR]

Background: The Mediterranean and Dietary Approaches to Stop Hypertension (DASH) diets are characterized by higher intake of fruit, vegetables, whole grains, and unsaturated fatty acids. All of these foods and nutrients may affect cholesterol, inflammation, the development of atherosclerosis, and, therefore, risk of cardiac death. Objective: Our objective was to examine the association between the Mediterranean and DASH dietary patterns and risk of sudden cardiac death (SCD) in women. Design: We used a prospective cohort of 93,122 postmenopausal women enrolled in the Women's Health Initiative study between 1993 and 1998 and followed for an average of 10.5 y. Women completed a food-frequency questionnaire (FFQ) twice during follow-up. We scored their diets according to how closely the reported diet resembled each dietary pattern. SCD was defined as death that occurred within 1 h of symptom onset. Results: A higher Mediterranean diet score was associated with lower risk of SCD (HR: 0.64; 95% CI: 0.43, 0.94) when women in the highest quintile were compared with women in the lowest quintile after adjustment for age, total energy, race, income, smoking, and physical activity. After adjustment for potential mediators, the association was similar (HR: 0.67; 95% CI: 0.46, 0.99). A higher DASH diet score was not associated with risk of SCD. However, sodium intake, which is a crucial component of the DASH dietary pattern, was not well characterized by the FFQ. Conclusion: The Mediterranean dietary pattern may be associated with lower risk of SCD in women. This trial was registered at clinicaltrials.gov as NCT00000611. [ABSTRACT FROM AUTHOR]

The role of symptomatology in decisions to quit smoking among the 18-34, 35-54 and 55-and-above age groups in a managed-care setting was analyzed using stages of change and intention to stop as measures of readiness to quit smoking. Ordinal logistic regression data showed that smokers in the middle and oldest age groups who had suffered at least three of five symptoms in the last two weeks were more likely to be in higher stages of readiness. Smokers who attributed symptoms to smoking were more motivated to try to quit, while those who attributed symptoms to aging were less likely to decide to quit smoking, age notwithstanding. A symptom-based approach to smoking cessation is thus recommended.

Background: Alcohol and caffeine intakes may play a role in the development of sudden cardiac death (SCD) because of their effects on cholesterol, blood pressure, heart rate variability, and inflammation. Objective: Our objective was to examine the association between long-term alcohol and caffeine intakes and risk of SCD in women. Design: We examined 93,676 postmenopausal women who participated in the Women's Health Initiative Observational Study. Women were enrolled between 1993 and 1998 and were followed until August 2009. Women completed a food-frequency questionnaire at baseline and again at year 3. We modeled exposure to alcohol 3 ways: by using baseline intake only, a cumulative average of baseline and year 3 intake, and the most recent reported intake (a simple time-varying analysis). Results: Intake of 5-15 g alcohol/d (about one drink) was associated with a nonsignificantly reduced risk of SCD compared with 0.1-5 g/d of baseline intake (HR: 0.64; 95% CI: 0.40, 1.02), of cumulative average intake (HR: 0.69; 95% CI: 0.43, 1.11), and of most recent intake (HR: 0.58; 95% CI: 0.35, 0.96), with adjustment for age, race, income, smoking, body mass index, physical activity, hormone use, and total energy. No association was found between SCD and total caffeine intake (mg/d) or cups of caffeinated coffee, decaffeinated coffee, and caffeinated tea. Conclusions: Our results suggest that about one drink per day (or 5.1-15 g/d) may be associated with a reduced risk of SCD in this population; however, this association was only statistically significant for a model using the most recent alcohol intake. Total caffeine, regular coffee, decaffeinated coffee, and regular tea intake were not associated with the risk of SCD. This trial was registered at clinicaltrials.gov as NCT00000611. [ABSTRACT FROM AUTHOR]

Abstract: Increased access to sterile syringes reduces the transmission of HIV, viral hepatitis and other infectious diseases, without increasing injection drug use. In Rhode Island, in 2000, syringes were legalized to reduce spread of disease but remained outlawed in Massachusetts until 2006. Drug users undergoing inpatient detoxification in Rhode Island and Massachusetts were surveyed about their syringe usage between October 2001 and August 2003. Two hundred forty-seven Rhode Island, and 226 Massachusetts inpatients completed surveys. Of these, 61% (n =151) from Rhode Island and 46% (n =105) from Massachusetts reported injecting within 6 months. Respondents from Rhode Island reported reusing a syringe in the last 30 days less often than Massachusetts respondents (0.35 versus 0.50; 95% CI on difference 0.01–0.29). Syringe re-use and sharing among drug injectors in Rhode Island was markedly lower than in Massachusetts. This difference is attributed at least in part to the legalization of non-prescription sterile syringes in Rhode Island in 2000. Laws and policies that increase legal syringe availability can decrease injection related transmission of HIV and other infectious diseases. [Copyright &y& Elsevier]

In patients undergoing in vitro fertilization, the presence of higher E2 levels at the time of hCG administration predict a greater likelihood of ongoing pregnancy. [Copyright &y& Elsevier]

Background: Incorporating social determinants of health into care delivery for chronic diseases is a priority.Objectives: The goal of this study was to evaluate the impact of group medical visits and/or microfinance on blood pressure reduction.Methods: The authors conducted a cluster randomized trial with 4 arms and 24 clusters: 1) usual care (UC); 2) usual care plus microfinance (MF); 3) group medical visits (GMVs); and 4) GMV integrated into MF (GMV-MF). The primary outcome was 1-year change in systolic blood pressure (SBP). Mixed-effects intention-to-treat models were used to evaluate the outcomes.Results: A total of 2,890 individuals (69.9% women) were enrolled (708 UC, 709 MF, 740 GMV, and 733 GMV-MF). Average baseline SBP was 157.5 mm Hg. Mean SBP declined -11.4, -14.8, -14.7, and -16.4 mm Hg in UC, MF, GMV, and GMV-MF, respectively. Adjusted estimates and multiplicity-adjusted 98.3% confidence intervals showed that, relative to UC, SBP reduction was 3.9 mm Hg (-8.5 to 0.7), 3.3 mm Hg (-7.8 to 1.2), and 2.3 mm Hg (-7.0 to 2.4) greater in GMV-MF, GMV, and MF, respectively. GMV and GMV-MF tended to benefit women, and MF and GMV-MF tended to benefit poorer individuals. Active participation in GMV-MF was associated with greater benefit.Conclusions: A strategy combining GMV and MF for individuals with diabetes or hypertension in Kenya led to clinically meaningful SBP reductions associated with cardiovascular benefit. Although the significance threshold was not met in pairwise comparison hypothesis testing, confidence intervals for GMV-MF were consistent with impacts ranging from substantive benefit to neutral effect relative to UC. Incorporating social determinants of health into care delivery for chronic diseases has potential to improve outcomes. (Bridging Income Generation With Group Integrated Care [BIGPIC]; NCT02501746). [ABSTRACT FROM AUTHOR]

Background: Elevated blood pressure (BP) is the leading global risk factor for mortality. Delay in seeking hypertension care is associated with increased mortality.Objectives: This study investigated whether community health workers, equipped with behavioral communication strategies and smartphone technology, can increase linkage of individuals with elevated BP to a hypertension care program in western Kenya and significantly reduce BP.Methods: The study was a cluster randomized trial with 3 arms: 1) usual care (standard training); 2) "paper-based" (tailored behavioral communication, using paper-based tools); and 3) "smartphone" (tailored behavioral communication, using smartphone technology). The co-primary outcomes were: 1) linkage to care; and 2) change in systolic BP (SBP). A covariate-adjusted mixed-effects model was used, adjusting for differential time to follow-up. Bootstrap and multiple imputation were used to handle missing data.Results: A total of 1,460 individuals (58% women) were enrolled (491 usual care, 500 paper-based, 469 smartphone). Average baseline SBP was 159.4 mm Hg. Follow-up measures of linkage were available for 1,128 (77%) and BP for 1,106 (76%). Linkage to care was 49% overall, with significantly greater linkage in the usual care and smartphone arms of the trial. Average overall follow-up SBP was 149.9 mm Hg. Participants in the smartphone arm experienced a modestly greater reduction in SBP versus usual care (-13.1 mm Hg vs. -9.7 mm Hg), but this difference was not statistically significant. Mediation analysis revealed that linkage to care contributed to SBP change.Conclusions: A strategy combining tailored behavioral communication and mobile health (mHealth) for community health workers led to improved linkage to care, but not statistically significant improvement in SBP reduction. Further innovations to improve hypertension control are needed. (Optimizing Linkage and Retention to Hypertension Care in Rural Kenya [LARK]; NCT01844596). [ABSTRACT FROM AUTHOR]

The effect of different types of care environment on orphaned and separated children and adolescents' (OSCA) experiences of abuse in sub-Saharan Africa is uncertain. Our two primary objectives were 1) to compare recent child abuse (physical, emotional, and sexual) between OSCA living in institutional environments and those in family-based care; and 2) to understand how recent child abuse among street-connected children and youth compared to these other vulnerable youth populations. This project followed a cohort of OSCA in Uasin Gishu County, Kenya (2009–2019). This analysis includes 2393 participants aged 18 years and below, 1017 from institutional environments, 1227 from family-based care, and 95 street-connected participants. The primary outcome of interest was recent abuse. Multiple logistic regression was used to estimate the odds of recent abuse at baseline, follow-up, and chronically for each abuse domain and adjusted odds ratios (AOR) between care environments, controlling for multiple factors. In total, 47 % of OSCA reported ever experiencing any kind of recent abuse at baseline and 54 % in follow-up. Compared to those in family-based care, street-connected participants had a much higher reported prevalence of all types of recent abuse at baseline (AOR: 5.01, 95 % CI: 2.89, 9.35), in follow-up (AOR: 5.22, 95 % CI: 2.41, 13.98), and over time (AOR: 3.44, 95 % CI: 1.93, 6.45). OSCA in institutional care were no more likely than those in family-based care of reporting any recent abuse at baseline (AOR: 0.85 95 % CI: 0.59–1.17) or incident abuse at follow-up (AOR: 0.91, 95 % CI: 0.61–1.47). OSCA, irrespective of care environment, reported high levels of recent physical, emotional, and sexual abuse. Street-connected participants had the highest prevalence of all kinds of abuse. OSCA living in institutional care did not experience more child abuse than those living in family-based care. [ABSTRACT FROM AUTHOR]

Objectives: To recommend methodological standards in the prevention and handling of missing data for primary patient-centered outcomes research (PCOR). Study Design and Setting: We searched National Library of Medicine Bookshelf and Catalog as well as regulatory agencies' and organizations' Web sites in January 2012 for guidance documents that had formal recommendations regarding missing data. We extracted the characteristics of included guidance documents and recommendations. Using a two-round modified Delphi survey, a multidisciplinary panel proposed mandatory standards on the prevention and handling of missing data for PCOR. Results: We identified 1,790 records and assessed 30 as having relevant recommendations. We proposed 10 standards as mandatory, covering three domains. First, the single best approach is to prospectively prevent missing data occurrence. Second, use of valid statistical methods that properly reflect multiple sources of uncertainty is critical when analyzing missing data. Third, transparent and thorough reporting of missing data allows readers to judge the validity of the findings. Conclusion: We urge researchers to adopt rigorous methodology and promote good science by applying best practices to the prevention and handling of missing data. Developing guidance on the prevention and handling of missing data for observational studies and studies that use existing records is a priority for future research. [ABSTRACT FROM AUTHOR]

Abstract: Over two-thirds of Americans access the Internet and therefore, the Internet may be an important channel for reaching the large population of sedentary individuals. The purpose of this paper is to describe the methods for a randomized controlled trial examining the efficacy of an Internet-based physical activity intervention relative to a print intervention that has been shown to be effective in previous trials. Specifically, 249 sedentary participants were randomized to receive one of three interventions: 1) Internet-based motivationally-tailored individualized feedback (Tailored Internet); 2) print-based motivationally-tailored individualized feedback (Tailored Print); or 3) physical activity websites currently available to the public (Standard Internet). Participants completed the 7-Day Physical Activity Recall interview, wore an objective physical activity monitor (i.e., ActiGraph), and participated in a treadmill fitness test at baseline, 6, and 12 months. The sample consisted of mostly women (84.2%) and Caucasian individuals (76.4%) who reported exercising an average of 21 min per week at baseline. This is the first study that we are aware of, that has examined the efficacy of a tailored Internet-based physical activity intervention. This study will have implications for the dissemination of Internet-based physical activity interventions. [Copyright &y& Elsevier]