Research waste in surgical randomized controlled trials

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. Antecedentes El despilfarro en investigación es uno de los mayores retos para la medicina basada en la evidencia. Conlleva mala utilización de los recursos y aumento de los riesgos para los participantes en las investigaciones. El objetivo de este trabajo fue cuantificar los componentes que conforman este despilfarro en los ensayos aleatorizados y controlados (randomised controlled trials, RCTs) del ámbito quirúrgico y explorar los aspectos clave de mejora. Métodos Se realizó una búsqueda de los RCTs registrados en la base de datos ClinicalTrials.gov entre enero de 2011 y diciembre de 2012, utilizando la palabra clave cirugía. La variable primaria fue el despilfarro en investigación, definido como la no publicación, el informe inadecuado o la presencia de debilidades del diseño evitables. Para