BackgroundDifferent tools exist for assessing risk of bias of intervention studies for systematic reviews. We present a tool for assessing risk of bias across both randomized and non-randomized study designs. The tool was developed by the Evidence Project, which conducts systematic reviews and meta-analyses of behavioral interventions for HIV in low- and middle-income countries.MethodsWe present the eight items of the tool and describe considerations for each and for the tool as a whole. We then evaluate reliability of the tool by presenting inter-rater reliability for 125 selected studies from seven published reviews, calculating a kappa for each individual item and a weighted kappa for the total count of items.ResultsThe tool includes eight items, each of which is rated as being present (yes) or not present (no) and, for some items, not applicable or not reported. The items include (1) cohort, (2) control or comparison group, (3) pre-post intervention data, (4) random assignment of participants to the intervention, (5) random selection of participants for assessment, (6) follow-up rate of 80% or more, (7) comparison groups equivalent on sociodemographics, and (8) comparison groups equivalent at baseline on outcome measures. Together, items (1)–(3) summarize the study design, while the remaining items consider other common elements of study rigor. Inter-rater reliability was moderate to substantial for all items, ranging from 0.41 to 0.80 (median κ = 0.66). Agreement between raters on the total count of items endorsed was also substantial (κw = 0.66).ConclusionsStrengths of the tool include its applicability to a range of study designs, from randomized trials to various types of observational and quasi-experimental studies. It is relatively easy to use and interpret and can be applied to a range of review topics without adaptation, facilitating comparability across reviews. Limitations include the lack of potentially relevant items measured in other tools and potential threats to validity of some items. To date, the tool has been applied in over 30 reviews. We believe it is a practical option for assessing risk of bias in systematic reviews of interventions that include a range of study designs.
Objective To review the effectiveness of interventions to increase HIV serostatus disclosure in low- and middle-income countries. Design Systematic review of peer-reviewed articles providing pre-post or multi-arm evaluations of disclosure interventions, defined broadly as any intervention with the goal of increasing rates of voluntary disclosure of HIV serostatus through self-disclosure or partner notification. Methods Articles were included if they reported post-intervention evaluation results and were published between January 1, 1990 and August 1, 2014. Searching was conducted through 5 electronic databases, secondary searching of four journals, and hand searching reference lists of included articles. Systematic methods were used for screening and data abstraction, which was conducted in duplicate. Study quality (rigor) was assessed with eight items. Results Fourteen articles evaluating 13 interventions met the inclusion criteria, all from sub-Saharan Africa. Most interventions focused on people living with HIV and used cognitive-behavioral group sessions or peer/community health worker support to encourage disclosure to sexual partners, family members, or friends. One focused on maternal disclosure to HIV-uninfected children, while two examined voluntary partner notification interventions. Several studies had limitations due to weak designs, small sample sizes, or high attrition. Findings on disclosure were mixed, with most effect sizes being relatively small and some, more rigorous studies showing no effect. Partner notification interventions had the strongest evidence of impact. Conclusion The existing evidence base for interventions to increase disclosure is limited and shows variable results. Further research is needed to determine whether current approaches to increasing disclosure are effective or whether new approaches should be considered.
Background Whether left ventricular hypertrophy (LVH) is determined by similar genomic and environmental risk factors with stroke, or is simply an intermediate stroke marker, is unknown. We present a research plan and preliminary findings to explore the overlap in the genomic and environmental determinants of LVH and stroke among Africans participating in the Stroke Investigative Research and Education Network (SIREN) study. Methods SIREN is a transnational, multi-centre study involving acute stroke patients and age, ethnicity and sex-matched controls recruited from 9 sites in Ghana and Nigeria. Genomic and environmental risk factors and other relevant phenotypes for stroke and LVH are being collected and compared using standard techniques. Results This preliminary analysis included only 725 stroke patients (mean age 59.1±13.2 years; 54.3% males). Fifty- five percent of the stroke subjects had LVH with greater proportion among women (51.6% vs 48.4%, p<0.001). Those with LVH were younger (57.9±12.8 vs 60.6±13.4; p=0.006) and had higher mean systolic and diastolic BP (167.1/99.5 mmHg vs 151.7/90.6 mmHg, p <0.001). Uncontrolled blood pressure (BP) at presentation was prevalent in subjects with LVH (76.2% vs 57.7%; p <0.001). Significant independent predictors of LVH were age, < 45 years (AOR =1.91, 95% CI: 1.14 to 3.19), female gender (AOR = 2.01; 95% CI:1.44 to 2.81), and diastolic BP > 90mmHg (AOR = 2.10; 95% CI:1.39 to 3.19, p <0.001). Conclusion The prevalence of LVH was high among stroke patients especially the younger ones suggesting a genetic component to LVH. Hypertension was a major modifiable risk factor for stroke as well as LVH. It is envisaged that the SIREN project will elucidate polygenic overlap (if present) between left ventricular hypertrophy and stroke among Africans, thereby defining the role of LVH as a putative intermediate cardiovascular phenotype and therapeutic target to inform interventions to reduce stroke risk in populations of African ancestry.
Objective - to update the prior review from nine-years ago with any additional studies of condom social marketing that examine its effect on condom use. Data Sources - PubMed, CINAHL, PsycINFO, Sociological Abstracts, and EMBASE. Hand searching of AIDS, AIDS and Behavior, AIDS Care, and AIDS Education and Prevention. Study Inclusion and Exclusion Criteria - (a) published 1990 - January 16, 2019; (b) low- or middle-income country; (c) evaluated CSM; (d) analyses across pre-intervention to post-intervention exposure or across multiple study arms; (e) measured condom use behavior; and (f) sought to prevent HIV transmission. Data Extraction - Using PRISMA guidelines two reviewers extracted citation, inclusion criteria, methods, study population, setting, sampling, study design, unit of analysis, loss to follow, comparison groups characteristics, intervention characteristics, eligible outcome results. Data Synthesis - The 2012 review found six studies (combined N=23,048). In meta-analysis, the pooled odds for condom use was 2.01 (95% CI: 1.42–2.84) for the most recent sexual encounter and 2.10 (95% CI: 1.51–2.91) for a composite of all condom use outcomes. Studies had significant methods limitations. Of 518 possible new citations identified in the update, no new articles met our inclusion criteria. Conclusions - More studies with stronger methodological rigor are needed to help provide evidence for the continued use of this approach globally.
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