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

Rosenthal, Rachel; Kasenda, Benjamin; Dell-Kuster, Salome; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; ... (2015). Completion and Publication Rates of Randomized Controlled Trials in Surgery: An Empirical Study. Annals of surgery, 262(1), pp. 68-73. Lippincott Williams & Wilkins 10.1097/SLA.0000000000000810

[img] Text
00000658-900000000-97756_WAL.pdf - Published Version
Restricted to registered users only
Available under License Publisher holds Copyright.

Download (160kB) | Request a copy

OBJECTIVE: 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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Radiology, Neuroradiology and Nuclear Medicine (DRNN) > Clinic of Nuclear Medicine
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Forschungsbereich Pavillon 52 > Forschungsgruppe Klinische Radiopharmazie
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Forschungsbereich Pavillon 52 > Forschungsgruppe Klinische Radiopharmazie

UniBE Contributor:

Gloy, Viktoria and Walter, Martin Alexander

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0003-4932

Publisher:

Lippincott Williams & Wilkins

Language:

English

Submitter:

Franziska Nicoletti

Date Deposited:

31 Mar 2015 09:00

Last Modified:

20 Mar 2018 13:23

Publisher DOI:

10.1097/SLA.0000000000000810

PubMed ID:

24979608

BORIS DOI:

10.7892/boris.67173

URI:

https://boris.unibe.ch/id/eprint/67173

Actions (login required)

Edit item Edit item
Provide Feedback