Objective To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials.Design Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting. Data sources A validated Medline search strategy.Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8.Results There were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals. ConclusionThe quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are needed to improve both reporting and methodology. IntroductionIn recent years, increasing attention has been paid to the importance of good reporting practices as they relate to the potential utility of a manuscript. 1 The CONSORT (consolidated standards of reporting trials) statement, originally published in 1996 and updated in 2001 and 2010, provides authors and editors with a checklist for a minimum set of recommendations for RESEARCHreporting the trial design, analysis, and results. 2 Although certain inadequacies remain common, the quality of reporting of randomised controlled trials in medical journals seems to be improving over time. 3 A recent systematic review indicated that the CONSORT statement has played an important role in this progression. 4 Unfortunately, reviews of published cluster randomised trials (see box 1) have repeatedly found important shortcomings in their methodological conduct and reporting. [5][6][7][8][9][10][11][12][13][14][15][16][17][18] For example, a review of 152 c...

Background Adults with severe obesity [body mass index (BMI) of ≥ 35 kg/m2] have an increased risk of comorbidities and psychological, social and economic consequences. Objectives Systematically review bariatric surgery, weight-management programmes (WMPs) and orlistat pharmacotherapy for adults with severe obesity, and evaluate the feasibility, acceptability, clinical effectiveness and cost-effectiveness of treatment. Data sources Electronic databases including MEDLINE, EMBASE, PsycINFO, the Cochrane Central Register of Controlled Trials and the NHS Economic Evaluation Database were searched (last searched in May 2017). Review methods Four systematic reviews evaluated clinical effectiveness, cost-effectiveness and qualitative evidence for adults with a BMI of ≥ 35 kg/m2. Data from meta-analyses populated a microsimulation model predicting costs, outcomes and cost-effectiveness of Roux-en-Y gastric bypass (RYGB) surgery and the most effective lifestyle WMPs over a 30-year time horizon from a NHS perspective, compared with current UK population obesity trends. Interventions were cost-effective if the additional cost of achieving a quality-adjusted life-year is < £20,000–30,000. Results A total of 131 randomised controlled trials (RCTs), 26 UK studies, 33 qualitative studies and 46 cost-effectiveness studies were included. From RCTs, RYGB produced the greatest long-term weight change [–20.23 kg, 95% confidence interval (CI) –23.75 to –16.71 kg, at 60 months]. WMPs with very low-calorie diets (VLCDs) produced the greatest weight loss at 12 months compared with no WMPs. Adding a VLCD to a WMP gave an additional mean weight change of –4.41 kg (95% CI –5.93 to –2.88 kg) at 12 months. The intensive Look AHEAD WMP produced mean long-term weight loss of 6% in people with type 2 diabetes mellitus (at a median of 9.6 years). The microsimulation model found that WMPs were generally cost-effective compared with population obesity trends. Long-term WMP weight regain was very uncertain, apart from Look AHEAD. The addition of a VLCD to a WMP was not cost-effective compared with a WMP alone. RYGB was cost-effective compared with no surgery and WMPs, but the model did not replicate long-term cost savings found in previous studies. Qualitative data suggested that participants could be attracted to take part in WMPs through endorsement by their health-care provider or through perceiving innovative activities, with WMPs being delivered to groups. Features improving long-term weight loss included having group support, additional behavioural support, a physical activity programme to attend, a prescribed calorie diet or a calorie deficit. Limitations Reviewed studies often lacked generalisability to UK settings in terms of participants and resources for implementation, and usually lacked long-term follow-up (particularly for complications for surgery), leading to unrealistic weight regain assumptions. The views of potential and actual users of services were rarely reported to contribute to service design. This study may have failed to identify unpublished UK evaluations. Dual, blinded numerical data extraction was not undertaken. Conclusions Roux-en-Y gastric bypass was costly to deliver, but it was the most cost-effective intervention. Adding a VLCD to a WMP was not cost-effective compared with a WMP alone. Most WMPs were cost-effective compared with current population obesity trends. Future work Improved reporting of WMPs is needed to allow replication, translation and further research. Qualitative research is needed with adults who are potential users of, or who fail to engage with or drop out from, WMPs. RCTs and economic evaluations in UK settings (e.g. Tier 3, commercial programmes or primary care) should evaluate VLCDs with long-term follow-up (≥ 5 years). Decision models should incorporate relevant costs, disease states and evidence-based weight regain assumptions. Study registration This study is registered as PROSPERO CRD42016040190. Funding The National Institute for Health Research Health Technology Assessment programme. The Health Services Research Unit and Health Economics Research Unit are core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorate.

No abstract

ObjectivesTo undertake a meta-ethnographic synthesis of findings from primary studies reporting qualitative data that have explored participant-reported factors influencing non-retention within a clinical trial context.DesignA systematic search and meta-ethnography was conducted for published papers (from 1946 to July 2018) that contained qualitative data from trial non-retainers.ParticipantsWe identified 11 studies reporting qualitative data from 13 trials. The studies were undertaken between 2008 and 2018. Each study included between 3 and 40 people who had dropped out from a trial, with findings from 168 people in total reported across the papers.ResultsEmergent from our synthesis was the significance of trial non-retainers’ perceptions around the personal ‘fit’ of key aspects of the trial with their personal beliefs, preferences, capabilities or life circumstances. These related to their own health state; preferences for receiving trial ‘care’; individual capabilities; beliefs about or experiences of trial medication and considerations whether trial participation could be accommodated into their broader lives. All these factors raise important issues around the extent to which initial decisions to participate were fully informed.ConclusionsTo improve retention in clinical trials, researchers should work to reduce the burden on trial participants both through the design of the intervention itself as well as through simplified data collection processes. Providing more detail on the nature of the trial interventions and what can be expected by ‘participation’ at the consenting stage may prove helpful in order to manage expectations.

No abstract