Evaluation and pilot implementation of essential interventions for the management of hypertension and prevention of cardiovascular diseases in primary health care in the Republic of Tajikistan.

Background: Non-communicable diseases (NCDs) are the leading cause of death worldwide and are a major burden in Tajikistan. The health system of Tajikistan is still shaped by the country's Soviet legacy and the pace of reform has been slow, with high patient out-of-pocket expenditure. The aim of this study is to determine the feasibility of implementing and evaluating essential interventions for the management of hypertension and prevention of cardiovascular disease in primary health care in Tajikistan. Methods and analysis: A pragmatic, sequential mixed methods explanatory design, composed of quantitative and qualitative strands will be used with greater weighting of the quantitative strand. A single geographic district was nominated by the Ministry of Health and chosen for implementation. All primary health care centres in the district that meet inclusion criteria will be included; half will be randomly assigned to the intervention arm and half to the control arm. The overall process is organized into seven steps: (1) refresh clinical decision-making tools including open source WHO PEN and HEARTS resources; (2) update training package for primary health care workers; (3) collection of baseline data; (4) training staff in intervention clinics; (5) implementation of protocols and implementation coaching; (6) collection of follow-up data after 12 months; (7) evaluation of results and sharing experience. Ethics and dissemination: Ethical review and approval have been obtained. Findings will be disseminated at the participant level, national level through a national conference of key stakeholders, and internationally through publication in an open-access peer review journal.

Benefits and Harms in Pivotal Trials of Oral Centrally Acting Antiobesity Medicines: A Systematic Review and Meta-Analysis.

OBJECTIVE: To evaluate the benefits and harms of oral centrally acting antiobesity medicinal products in pivotal trials. METHODS: The European Medicines Agency and Federal Drug Administration websites, PubMed, and ClinicalTrials.gov were searched to identify pivotal trials used to gain marketing authorizations. Pivotal phase III trials on which marketing authorizations were based were included. The data were analyzed by using Cochrane Review Manager (RevMan), and quality assessments for each outcome were performed by using the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE). RESULTS: Five products (16 trials with 24,555 participants) were included. Significantly more participants who took the antiobesity products achieved ≥ 5% reduction in body weight (risk ratio [RR] 2.39; 95% CI: 2.09-2.74; GRADE = low). However, the products significantly increased the risk of adverse events (RR 1.12; 95% CI: 1.07-1.17; GRADE = very low) and the risk of discontinuation because of adverse events (RR 1.52; 95% CI: 1.33-1.74; GRADE = low). There were no significant differences for most outcomes between currently approved and withdrawn products. CONCLUSIONS: Although oral centrally acting antiobesity products generate modest weight losses, they also increase the risks of adverse events and discontinuations because of adverse events. The premarketing benefit-to-harm profiles of currently available products and products that were later withdrawn because of harms are similar. Targeted study designs, better outcomes reporting, and improved postmarketing monitoring of harms are needed.

Cardiovascular disease risk and prevention amongst Syrian refugees: mixed methods study of Médecins Sans Frontières programme in Jordan.

BACKGROUND: The growing burden of non-communicable diseases (NCDs) presented new challenges for medical humanitarian aid and little was known about primary health care approaches for these diseases in humanitarian response. We aimed to evaluate Médecins Sans Frontières (MSF's) use of total CVD risk based prevention strategies amongst Syrian refugees in northern Jordan to identify opportunities to improve total CVD risk based guidance for humanitarian settings. METHODS: We evaluated CVD risk assessment and management in two outpatient NCD clinics in the Irbid governorate of Jordan using a mixed methods design with qualitative and quantitative strands of equal priority, integrated during data collection and interpretation. World Health Organisation/International Society of Hypertension (WHO/ISH) CVD risk charts requiring measured cholesterol were used in the clinics and in our analysis. An electronic database of routine clinical information was used to determine the CVD risk profile of the clinic population, the pattern and concordance of lipid-lowering treatment prescriptions, and the prevalence and accuracy of documented CVD risk scores. This was combined with semi-structured interviews with MSF health workers, which were recorded, transcribed verbatim, and analysed thematically. RESULTS: We reviewed the clinical records of 2907 patients. One fifth (20.9%; 95% CI 19.5, 22.4) of patients had a history of CVD while 56.8% (95% CI 54.9, 58.6) of patients had a WHO/ISH risk of <10%. Only 23.3% (95% CI 21.9, 25.0) of patients had a documented WHO/ISH risk score of which 65% were correct. 60.4% (95% CI 58.6, 62.2) of patients were eligible for lipid-lowering treatment and 48.3% (95% CI 45.9, 50.6) of these patients were prescribed it. Analysis of interviews with sixteen MSF staff identified nine explanatory themes. Providers had confusion about when and how to use the risk charts, tended to favour lifestyle intervention over drug treatment, and had uncertainty about the role of lipid-lowering treatment in primary but not secondary prevention. Patients were reluctant to start, stop, or change medication and were less able to modify risk factors and benefit from health education because of their social and economic context. CONCLUSIONS: Four priority areas to improve CVD risk-based guidance for prevention in humanitarian settings include: practical training for health workers on total CVD risk assessment and associated guidance; supporting the use of CVD risk charts as a communication tool and task sharing; contextualising risk scoring in a broader, single consultation, total CVD risk-based algorithm; and targeting popular health myths amongst the community.

Global cardiovascular risk assessment in the primary prevention of cardiovascular disease in adults: systematic review of systematic reviews.

OBJECTIVE: To identify, critically appraise and summarise existing systematic reviews on the impact of global cardiovascular risk assessment in the primary prevention of cardiovascular disease (CVD) in adults. DESIGN: Systematic review of systematic reviews published between January 2005 and October 2016 in The Cochrane Library, EMBASE, MEDLINE or CINAHL databases, and post hoc analysis of primary trials. PARTICIPANTS, INTERVENTIONS, OUTCOMES: Systematic reviews of interventions involving global cardiovascular risk assessment relative to no formal risk assessment in adults with no history of CVD. The primary outcomes of interest were CVD-related morbidity and mortality and all-cause mortality; secondary outcomes were systolic blood pressure (SBP), cholesterol and smoking. RESULTS: We identified six systematic reviews of variable but generally of low quality (mean Assessing the Methodological Quality of Systematic Reviews 4.2/11, range 0/11 to 7/11). No studies identified by the systematic reviews reported CVD-related morbidity or mortality or all-cause mortality. Meta-analysis of reported randomised controlled trials (RCTs) showed small reductions in SBP (mean difference (MD) -2.22 mm Hg (95% CI -3.49 to -0.95); I2=66%; n=9; GRADE: very low), total cholesterol (MD -0.11 mmol/L (95% CI -0.20 to -0.02); I2=72%; n=5; GRADE: very low), low-density lipoprotein cholesterol (MD -0.15 mmol/L (95% CI -0.26 to -0.05), I2=47%; n=4; GRADE: very low) and smoking cessation (RR 1.62 (95% CI 1.08 to 2.43); I2=17%; n=7; GRADE: low). The median follow-up time of reported RCTs was 12 months (range 2-36 months). CONCLUSIONS: The quality of existing systematic reviews was generally poor and there is currently no evidence reported in these reviews that the prospective use of global cardiovascular risk assessment translates to reductions in CVD morbidity or mortality. There are reductions in SBP, cholesterol and smoking but they may not be clinically significant given their small effect size and short duration. Resources need to be directed to conduct high-quality systematic reviews focusing on hard patient outcomes, and likely further primary RCTs. TRIAL REGISTRATION NUMBER: CRD42015019821.

Factors Associated with Sequelae of Campylobacter and Non-typhoidal Salmonella Infections: A Systematic Review.

Despite the significant global burden of gastroenteritis and resulting sequelae, there is limited evidence on risk factors for sequelae development. We updated and extended previous systematic reviews by assessing the role of antibiotics, proton pump inhibitors (PPI) and symptom severity in the development of sequelae following campylobacteriosis and salmonellosis. We searched four databases, including PubMed, from 1 January 2011 to 29 April 2016. Observational studies reporting sequelae of reactive arthritis (ReA), Reiter's syndrome (RS), irritable bowel syndrome (IBS) and Guillain-Barré syndrome (GBS) following gastroenteritis were included. The primary outcome was incidence of sequelae of interest amongst cases of campylobacteriosis and salmonellosis. A narrative synthesis was conducted where heterogeneity was high. Of the 55 articles included, incidence of ReA (n=37), RS (n=5), IBS (n=12) and GBS (n=9) were reported following campylobacteriosis and salmonellosis. A pooled summary for each sequela was not estimated due to high level of heterogeneity across studies (I2>90%). PPI usage and symptoms were sparsely reported. Three out of seven studies found a statistically significant association between antibiotics usage and development of ReA. Additional primary studies investigating risk modifying factors in sequelae of GI infections are required to enable targeted interventions.