Research waste in surgical randomized controlled trials

Abstract

Background: Research waste is a major challenge for evidence-based medicine. It implicates misused resources and increased risks for research participants. The aim of this study was to quantify constituent components of waste in surgical RCTs and explore targets for improvement. Methods: ClinicalTrials.gov was searched for RCTs registered between January 2011 and December 2012 using the keyword 'surgery'. The primary outcome was research waste, defined as non-publication, inadequate reporting or presence of an avoidable design limitation. Serial systematic searches of PubMed and Scopus databases were performed to determine publication status. Adequacy of reporting was assessed using the CONSORT checklist. Avoidable design limitations were evaluated according to the presence of bias and/or the absence of a cited systematic review of the literature. Results: Of 5617 registered RCTs, 304 met all eligibility criteria. Overall, 259 of 304 (85⋅2 per cent) demonstrated at least one feature of waste. Of these, 221 (72⋅7 per cent) were published in a peer-reviewed journal and 219 were accessible for full-text review. Only 73 of 131 (55⋅7 per cent) RCTs with a pharmacological intervention and 24 of 88 (27 per cent) with a non-pharmacological intervention were reported adequately, and 159 of 219 (72⋅6 per cent) demonstrated an avoidable design limitation. Multicentre (odds ratio 0⋅31, 95 per cent c.i. 0⋅11 to 0⋅88) and externally funded (OR 0⋅35, 0⋅15 to 0⋅82) RCTs were less associated with research waste. Conclusion: This study identified a considerable burden of research waste in surgical RCTs. Future initiatives should target improvements in single-centre, poorly supported RCTs.

Characteristics and Research Waste Among Randomized Clinical Trials in Gastric Cancer

“…A trial was considered to be published if a full-text manuscript (available in print or online) was identified in a peer-reviewed journal. 7 The search was performed by 2 independent investigators (M.L. and J.-B.…”

“…The full-text manuscript and correspondence supplementary materials were reviewed to determine whether a protocol was available. 7 Manuscripts that met 75% of items (ie, 28 of 37 pharmacological items or 30 of 40 nonpharmacological items) were considered to be reported adequately, as previously described. 7 …”

“… 7 Manuscripts that met 75% of items (ie, 28 of 37 pharmacological items or 30 of 40 nonpharmacological items) were considered to be reported adequately, as previously described. 7 …”

“…This means that wasteful RCTs used resources while the risks to participants increased. Chapman et al 7 found that 85.2% of surgical-related RCTs had research waste. This waste may occur at any stage of the research cycle.…”

Clinical trials—Designing, implementing, and collaborating

“…What compounds the dearth of prospective evidence in surgical care is the lack of well‐planned, completed surgical trials. Although >300 surgery trials were registered in http://clinicaltrials.gov between January 2011 and December 2012, a significant number (72.7%) were associated with research waste, defined as non‐publication, inadequate reporting or presence of avoidable design limitations 5 . This reality may account for a recent statistic that among 9961 oncology‐related trials registered between 2001‐2011, only 10% included a surgical intervention 6 …”