scholarly journals The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews

BMJ ◽  
2010 ◽  
Vol 340 (feb15 1) ◽  
pp. c365-c365 ◽  
Author(s):  
J. J Kirkham ◽  
K. M Dwan ◽  
D. G Altman ◽  
C. Gamble ◽  
S. Dodd ◽  
...  
Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Alice MacLachlan ◽  
Karen Crawford ◽  
Shona Shinwell ◽  
Catherine Nixon ◽  
Marion Henderson

Abstract Background Recruiting participants to randomised controlled trials (RCTs) is often challenging, particularly when working with socially disadvantaged populations who are often termed ‘hard-to-reach’ in research. Here we report the recruitment strategies and costs for the Trial for Healthy Relationship Initiatives in the Very Early years (THRIVE), an RCT evaluating two group-based parenting interventions for pregnant women. Methods THRIVE aimed to recruit 500 pregnant women with additional health and social care needs in Scotland between 2014 and 2018. Three recruitment strategies were employed: (1) referrals from a health or social care practitioner or voluntary/community organisation (practitioner-led referral), (2) direct engagement with potential participants by research staff (researcher-led recruitment) and (3) self-referral in response to study advertising (self-referral). The number of referrals and recruited participants from each strategy is reported along with the overall cost of recruitment. The impact of recruitment activities and the changes in maternity policy/context on recruitment throughout the study are examined. Results THRIVE received 973 referrals: 684 (70%) from practitioners (mainly specialist and general midwives), 273 (28%) from research nurses and 16 (2%) self-referrals. The time spent in antenatal clinics by research nurses each month was positively correlated with the number of referrals received (r = 0.57; p < 0.001). Changes in maternity policies and contexts were reflected in the number of referrals received each month, with both positive and negative impacts throughout the trial. Overall, 50% of referred women were recruited to the trial. Women referred via self-referral, THRIVE research nurses and specialist midwives were most likely to go on to be recruited (81%, 58% and 57%, respectively). Key contributors to recruitment included engaging key groups of referrers, establishing a large flexible workforce to enable recruitment activities to adapt to changes in context throughout the study and identifying the most appropriate setting to engage with potential participants. The overall cost of recruitment was £377 per randomised participant. Conclusions Recruitment resulted from a combination of all three strategies. Our reflections on the successes and challenges of these strategies highlight the need for recruitment strategies to be flexible to adapt to complex interventions and real-world challenges. These findings will inform future research in similar hard-to-reach populations. Trial registration International Standard Randomised Controlled Trials Number Registry ISRCTN21656568. Retrospectively registered on 28 February 2014


1998 ◽  
Vol 65 (3) ◽  
pp. 144-151 ◽  
Author(s):  
Robyn L. Hayes ◽  
John J. McGrath

This paper describes how occupational therapists can become involved in the Cochrane Collaboration — a well-developed tool for facilitating the involvement of health professionals and lay people in evidence-based practice. The Cochrane Collaboration is a growing international project intended to systematically locate, conduct systematic reviews (including metaanalyses) of, and disseminate information on all available randomised controlled trials of interventions in any area of health. In particular, occupational therapists can use the Cochrane Collaboration to become better informed about best practice and evaluate research in their areas of interest, and learn skills related to conducting randomised controlled trials, systematic reviews, and meta-analyses.


BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e025135 ◽  
Author(s):  
Amber E Young ◽  
Anna Davies ◽  
Sophie Bland ◽  
Sara Brookes ◽  
Jane M Blazeby

IntroductionSystematic reviews collate trial data to provide evidence to support clinical decision-making. For effective synthesis, there must be consistency in outcome reporting. There is no agreed set of outcomes for reporting the effect of burn care interventions. Issues with outcome reporting have been identified, although not systematically investigated. This study gathers empirical evidence on any variation in outcome reporting and assesses the need for a core outcome set for burn care research.MethodsElectronic searches of four search engines were undertaken from January 2012 to December 2016 for randomised controlled trials (RCTs), using medical subject headings and free text terms including ‘burn’, ‘scald’ ‘thermal injury’ and ‘RCT’. Two authors independently screened papers, extracted outcomes verbatim and recorded the timing of outcome measurement. Duplicate outcomes (exact wording ± different spelling), similar outcomes (albumin in blood, serum albumin) and identical outcomes measured at different times were removed. Variation in outcome reporting was determined by assessing the number of unique outcomes reported across all included trials. Outcomes were classified into domains. Bias was reduced using five researchers and a patient working independently and together.Results147 trials were included, of which 127 (86.4%) were RCTs, 13 (8.8%) pilot studies and 7 (4.8%) RCT protocols. 1494 verbatim clinical outcomes were reported; 955 were unique. 76.8% of outcomes were measured within 6 months of injury. Commonly reported outcomes were defined differently. Numbers of unique outcomes per trial varied from one to 37 (median 9; IQR 5,13). No single outcome was reported across all studies demonstrating inconsistency of reporting. Outcomes were classified into 54 domains. Numbers of outcomes per domain ranged from 1 to 166 (median 11; IQR 3,24).ConclusionsThis review has demonstrated heterogeneity in outcome reporting in burn care research which will hinder amalgamation of study data. We recommend the development of a Core Outcome Set.PROSPERO registration numberCRD42017060908.


2020 ◽  
Vol 15 (8) ◽  
pp. 1182-1199
Author(s):  
Elena M. C. Riedel ◽  
David T. Turner ◽  
Loulou Hassan Kobeissi ◽  
Eirini Karyotaki ◽  
Lale Say ◽  
...  

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