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Completion and Publication Rates of Randomized Controlled Trials in Surgery An Empirical Study

Authordc.contributor.authorRosenthal, Rachel 
Authordc.contributor.authorKasenda, Benjamin 
Authordc.contributor.authorDell-Kuster, Salome 
Authordc.contributor.authorElm, Erik von 
Authordc.contributor.authorYou, John 
Authordc.contributor.authorBluemle, Anette 
Authordc.contributor.authorTomonaga, Yuki 
Authordc.contributor.authorSaccilotto, Ramón 
Authordc.contributor.authorAmstutz, Alain 
Authordc.contributor.authorBengough, Theresa 
Authordc.contributor.authorMeerpohl, Joerg J. 
Authordc.contributor.authorStegert, Mihaela 
Authordc.contributor.authorTikkinen, Kari A. O. 
Authordc.contributor.authorNeumann, Ignacio 
Authordc.contributor.authorCarrasco Labra, Alonso 
Authordc.contributor.authorFaulhaber, Markus 
Authordc.contributor.authorSohail, Mulla 
Authordc.contributor.authorMertz, Dominik 
Authordc.contributor.authorAkl, Elie A. 
Authordc.contributor.authorBassler, Dirk 
Authordc.contributor.authorBusse, Jason W. 
Authordc.contributor.authorFerreira González, Ignacio 
Authordc.contributor.authorLamontagne, Francois 
Authordc.contributor.authorNordmann, Alain 
Authordc.contributor.authorGloy, Viktoria 
Authordc.contributor.authorOlu, Kelechi K. 
Authordc.contributor.authorRaatz, Heike 
Authordc.contributor.authorMoja, Lorenzo 
Authordc.contributor.authorEbrahim, Shanil 
Authordc.contributor.authorSchandelmaier, Stefan 
Authordc.contributor.authorSun, Xin 
Authordc.contributor.authorVandvik, Per O. 
Authordc.contributor.authorBradley C., Johnston 
Authordc.contributor.authorWalter, Martin A. 
Authordc.contributor.authorBurnand, Bernard 
Authordc.contributor.authorSchwenkglenks, Matthias 
Authordc.contributor.authorHemkens, Lars G. 
Authordc.contributor.authorBucher, Heiner C. 
Authordc.contributor.authorGuyatt, Gordon H. 
Authordc.contributor.authorBriel, Matthias 
Cita de ítemdc.identifier.citationAnnals of Surgery Volumen: 262 Número: 1 Páginas: 68-73en_US
Identifierdc.identifier.otherDOI: 10.1097/SLA.0000000000000810
General notedc.descriptionArtículo de publicación ISIen_US
General notedc.descriptionSin acceso a texto completo
Abstractdc.description.abstractObjective: To investigate the prevalence of discontinuation and nonpublication of surgical versus medical randomized controlled trials (RCTs) and to explore risk factors for discontinuation and nonpublication of surgical RCTs. Background: Trial discontinuation has significant scientific, ethical, and economic implications. To date, the prevalence of discontinuation of surgical RCTs is unknown. Methods: All RCT protocols approved between 2000 and 2003 by 6 ethics committees in Canada, Germany, and Switzerland were screened. Baseline characteristics were collected and, if published, full reports retrieved. Risk factors for early discontinuation for slow recruitment and nonpublication were explored using multivariable logistic regression analyses. Results: In total, 863 RCT protocols involving adult patients were identified, 127 in surgery (15%) and 736 in medicine (85%). Surgical trials were discontinued for any reason more often than medical trials [43% vs 27%, risk difference 16% (95% confidence interval [CI]: 5%-26%); P = 0.001] and more often discontinued for slow recruitment [18% vs 11%, risk difference 8% (95% CI: 0.1%-16%); P = 0.020]. The percentage of trials not published as full journal article was similar in surgical and medical trials (44% vs 40%, risk difference 4% (95% CI: -5% to 14%); P = 0.373). Discontinuation of surgical trials was a strong risk factor for nonpublication (odds ratio = 4.18, 95% CI: 1.45-12.06; P = 0.008). Conclusions: Discontinuation and nonpublication rates were substantial in surgical RCTs and trial discontinuation was strongly associated with nonpublication. These findings need to be taken into account when interpreting surgical literature. Surgical trialists should consider feasibility studies before embarking on full-scale trials.en_US
Publisherdc.publisherLippicott Williams & Wilkinsen_US
Keywordsdc.subjectrandomized controlled trialen_US
Títulodc.titleCompletion and Publication Rates of Randomized Controlled Trials in Surgery An Empirical Studyen_US
Document typedc.typeArtículo de revistaen_US

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