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. 2019 Oct;106(11):1464-1471.
doi: 10.1002/bjs.11266. Epub 2019 Aug 8.

Research waste in surgical randomized controlled trials

S J Chapman  1 , M Aldaffaa  2 , C L Downey  1 , D G Jayne  1
Affiliations

Research waste in surgical randomized controlled trials

S J Chapman et al. Br J Surg. 2019 Oct.

Abstract
in English, Spanish

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 determinar el estado de las publicaciones, se realizaron búsquedas sistemáticas en las bases de datos PubMed y Scopus. La adecuación del informe se evaluó usando la lista de verificación CONSORT. Las debilidades del diseño evitables se evaluaron de acuerdo con la presencia de sesgo y/o la ausencia de citación en revisiones sistemáticas publicadas en la literatura.

Resultados: De los 5.617 RCTs registrados, 304 cumplieron con los criterios de elegibilidad. De ellos, 259/304 (85%) cumplieron al menos una de las características de despilfarro. De estos, 221 (73%) se publicaron en una revista con peer review y 219 eran accesibles a texto completo. Únicamente 73/131 (56%) RCTs con una intervención farmacológica y 24/88 (27%) con una intervención no farmacológica presentaban un informe adecuado, y 159/219 (73%) se demostró una debilidad del diseño evitable. Los RCTs multicéntricos (OR: 0,31; i.c. del 95%: 0,11 a 0,88) y con financiación externa (OR: 0,35; i.c. del 95%: 0,15 a 0,82) se asociaron con menos despilfarro de investigación. CONCLUSIÓN: Este estudio constató una carga considerable de despilfarro en investigación en los RCTs quirúrgicos. Se deberían promover iniciativas de mejora, especialmente dirigidas a los RCTs realizados en un solo centro y con menos financiación.

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References

    1. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009; 374: 86-89.
    1. Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC et al. Increasing value and reducing waste: addressing inaccessible research. Lancet 2014; 383: 257-266.
    1. Glasziou P, Altman DG, Bossuyt P, Boutron I, Clarke M, Julious S et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet 2014; 383: 267-276.
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    1. Chalmers I, Bracken MB, Djulbegovic B, Garattini S, Grant J, Gülmezoglu AM et al. How to increase value and reduce waste when research priorities are set. Lancet 2014; 383: 156-165.

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