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

Rosenthal, Rachel and Kasenda, Benjamin and Dell-Kuster, Salome and von Elm, Erik and You, John and Blümle, Anette and Tomonaga, Yuki and Saccilotto, Ramon and Amstutz, Alain and Bengough, Theresa and Meerpohl, Joerg J. and Stegert, Mihaela and Tikkinen, Kari A. O. and Neumann, Ignacio and Carrasco-Labra, Alonso and Faulhaber, Markus and Mulla, Sohail and Mertz, Dominik and Akl, Elie A. and Bassler, Dirk and Busse, Jason W. and Ferreira-González, Ignacio and Lamontagne, Francois and Nordmann, Alain and Gloy, Viktoria and Olu, Kelechi K. and Raatz, Heike and Moja, Lorenzo and Ebrahim, Shanil and Schandelmaier, Stefan and Sun, Xin and Vandvik, Per O. and Johnston, Bradley C. and Walter, Martin A. and Burnand, Bernard and Schwenkglenks, Matthias and Hemkens, Lars G. and Bucher, Heiner C. and Guyatt, Gordon H. and Briel, Matthias. (2015) Completion and Publication Rates of Randomized Controlled Trials in Surgery: An Empirical Study. Annals of Surgery, 262 (1). pp. 68-73.

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Abstract

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.; Trial discontinuation has significant scientific, ethical, and economic implications. To date, the prevalence of discontinuation of surgical RCTs is unknown.; 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.; 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).; 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.
Faculties and Departments:03 Faculty of Medicine > Departement Klinische Forschung > Clinical Epidemiology and Biostatistics CEB > Klinische Epidemiologie (Bucher H)
UniBasel Contributors:Kasenda, Benjamin
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Lippincott, Williams & Wilkins
ISSN:0003-4932
e-ISSN:1528-1140
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
Identification Number:
Last Modified:06 Jun 2018 14:06
Deposited On:06 Oct 2017 10:08

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