Background: Poor recruitment to randomised controlled trials (RCTs) is a widespread problem. Provision of interventions aimed at supporting or incentivising clinicians may improve recruitment to RCTs.Objectives: To quantify the effects of strategies aimed at improving the recruitment activity of clinicians in RCTs, complemented with a synthesis of qualitative evidence related to clinicians' attitudes towards recruiting to RCTs. Study eligibility criteria: Quantitative studies were included if they evaluated interventions aimed at improving the recruitment activity of clinicians or compared recruitment by different groups of clinicians. Information about host trial, study design, participants, interventions, outcomes and host RCT was extracted by one researcher and checked by another. Studies that met the inclusion criteria were assessed for quality using a standardised tool, the Effective Public Health Practice Project tool. Qualitative studies were included if they investigated clinicians' attitudes to recruiting patients to RCTs. All results/findings were extracted, and content analysis was carried out. Overarching themes were abstracted, followed by a metasummary analysis. Studies that met the inclusion criteria were assessed for quality using the Critical Appraisal Skills Programme qualitative checklist.Data extraction: Data extraction was carried out by one researcher using predefined data fields, including study quality indicators, and verified by another.Results: Eight quantitative studies were included describing four interventions and a comparison of recruiting clinicians. One study was rated as strong, one as moderate and the remaining six as weak when assessed for quality using the Effective Public Health Practice Project tool. Effective interventions included the use of qualitative research to identify and overcome barriers to recruitment, reduction of the clinical workload associated with participation in RCTs and the provision of extra training and protected research time. Eleven qualitative studies were identified, and eight themes were abstracted from the data: understanding of research, communication, perceived patient barriers, patienteclinician relationship, effect on patients, effect on clinical practice, individual benefits for clinicians and methods associated with successful recruitment. Metasummary analysis identified the most frequently reported subthemes to be: difficulty communicating trial methods, poor understanding of research and priority given to patient well-being. Overall, the qualitative studies were found to be of good quality when assessed using the Critical Appraisal Skills Programme checklist.Conclusions: There were few high-quality trials that tested interventions to improve clinicians' recruitment activity in RCTs. The most promising intervention was ARTICLE SUMMARYArticle focus -A systematic review to identify and synthesise evidence of evaluations of interventions aimed at improving clinician recruitment activity in RCTs, and evidence of clinicians' attitudes t...
BackgroundThe evidence on the economic burden of cardiovascular disease (CVD) in low- and middle- income countries (LMICs) remains scarce. We conducted a comprehensive systematic review to establish the magnitude and knowledge gaps in relation to the economic burden of CVD and hypertension on households, health systems and the society.MethodsWe included studies using primary or secondary data to produce original economic estimates of the impact of CVD. We searched sixteen electronic databases from 1990 onwards without language restrictions. We appraised the quality of included studies using a seven-question assessment tool.ResultsEighty-three studies met the inclusion criteria, most of which were single centre retrospective cost studies conducted in secondary care settings. Studies in China, Brazil, India and Mexico contributed together 50% of the total number of economic estimates identified. The quality of the included studies was generally low. Reporting transparency, particularly for cost data sources and results, was poor. The costs per episode for hypertension and generic CVD were fairly homogeneous across studies; ranging between $500 and $1500. In contrast, for coronary heart disease (CHD) and stroke cost estimates were generally higher and more heterogeneous, with several estimates in excess of $5000 per episode. The economic perspective and scope of the study appeared to impact cost estimates for hypertension and generic CVD considerably less than estimates for stroke and CHD. Most studies reported monthly costs for hypertension treatment around $22. Average monthly treatment costs for stroke and CHD ranged between $300 and $1000, however variability across estimates was high. In most LMICs both the annual cost of care and the cost of an acute episode exceed many times the total health expenditure per capita.ConclusionsThe existing evidence on the economic burden of CVD in LMICs does not appear aligned with policy priorities in terms of research volume, pathologies studied and methodological quality. Not only is more economic research needed to fill the existing gaps, but research quality needs to be drastically improved. More broadly, national-level studies with appropriate sample sizes and adequate incorporation of indirect costs need to replace small-scale, institutional, retrospective cost studies.Electronic supplementary materialThe online version of this article (10.1186/s12889-018-5806-x) contains supplementary material, which is available to authorized users.
Objective To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery.Design Multicentre observer blinded randomised controlled trial.Participants Patients undergoing laparotomy at 21 UK hospitals.Interventions Standard care or the use of a wound edge protection device during surgery.Main outcome measures Surgical site infection within 30 days of surgery, assessed by blinded clinicians at seven and 30 days and by patient’s self report for the intervening period. Secondary outcomes included quality of life, duration of stay in hospital, and the effect of characteristics of the patient and operation on the efficacy of the device.Results 760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group. Six patients in the device group and five in the control group did not undergo laparotomy. Fourteen patients, seven in each group, were lost to follow-up. A total of 184 patients experienced surgical site infection within 30 days of surgery, 91/369 (24.7%) in the device group and 93/366 (25.4%) in the control group (odds ratio 0.97, 95% confidence interval 0.69 to 1.36; P=0.85). This lack of benefit was consistent across wound assessments performed by clinicians and those reported by patients and across all secondary outcomes. In the secondary analyses no subgroup could be identified in which there was evidence of clinical benefit associated with use of the device.Conclusions Wound edge protection devices do not reduce the rate of surgical site infection in patients undergoing laparotomy, and therefore their routine use for this role cannot be recommended.Trial registration Current Controlled Trials ISRCTN 40402832
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