Abstract
BackgroundRandomised controlled trials are widely acknowledged as the gold standard in medical research although their validity can be undermined by non-compliance with the randomly allocated treatment and missing data. Due to the nature of the intervention, surgical trials face particular threat to compliance and data collection. For example, ineligibility for the intervention may only become apparent once the operation has commenced. It is unclear how such cases are reported and handled.ObjectiveThe objective was to assess non-compliance and missing data in reports of trials of surgical interventions.MethodsSearches for reports of trials involving at least one surgical procedure and published in 2010 were carried out in the Medical Literature Analysis and Retrieval System Online (MEDLINE®). Data on missing data, non-compliance and methods of handling missing data were extracted from full texts. Descriptive data analyses were carried out on the data.ResultsForty-five (55 %) studies reported non-compliance with treatment allocation and 52 (63 %) reported primary outcome missing data. The median levels of non-compliance and missing data were 2 % [IQR (0, 5), range (0–29)] and 6 % [IQR (0, 15), range (0–57)], respectively. Fifty-two (63 %) studies analysed as randomised, 17 (21 %) analysed per protocol and 3 (4 %) analysed as treated. Complete case analysis was the most common method used to deal with missing data, 35/52 (67 %).ConclusionsThe reporting of non-compliance to allocation and the handling of missing data were typically suboptimal. There is still room for improvement on the use of the CONSORT statement particularly in accounting for study participants. Transparency in reporting would facilitate evidence synthesis.Electronic supplementary materialThe online version of this article (doi:10.1186/s13104-015-1364-9) contains supplementary material, which is available to authorized users.
Highlights
Randomised controlled trials are widely acknowledged as the gold standard in medical research their validity can be undermined by non-compliance with the randomly allocated treatment and missing data
Complete case analysis was the most common method used to deal with missing data, 35/52 (67 %)
This review shows that non-compliance and missing data commonly occur in surgical trials but the reported levels are typically low where reported
Summary
Randomised controlled trials are widely acknowledged as the gold standard in medical research their validity can be undermined by non-compliance with the randomly allocated treatment and missing data. Due to the nature of the intervention, surgical trials face particular threat to compliance and data collection. Ineligibility for the intervention may only become apparent once the operation has commenced. It is unclear how such cases are reported and handled. A randomised controlled trial (RCT) is the optimal type of experimental design [1] for evaluating causal effect of treatments. The theoretical advantages of the RCT design can be undermined by non-compliance to the treatment and group allocation and missing data, potentially introducing bias and applying the findings becomes problematic. Difficulties include achieving adequate sample size and potentially higher levels of non-compliance because
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