TY - JOUR
T1 - Completion and publication rates of randomized controlled trials in surgery
T2 - An empirical study
AU - Rosenthal, Rachel
AU - Kasenda, Benjamin
AU - Dell-Kuster, Salome
AU - Von Elm, Erik
AU - You, John
AU - Blümle, Anette
AU - Tomonaga, Yuki
AU - Saccilotto, Ramon
AU - Amstutz, Alain
AU - Bengough, Theresa
AU - Meerpohl, Joerg J.
AU - Stegert, Mihaela
AU - Tikkinen, Kari A O
AU - Neumann, Ignacio
AU - Carrasco-Labra, Alonso
AU - Faulhaber, Markus
AU - Mulla, Sohail
AU - Mertz, Dominik
AU - Akl, Elie A.
AU - Bassler, Dirk
AU - Busse, Jason W.
AU - Ferreira-González, Ignacio
AU - Lamontagne, Francois
AU - Nordmann, Alain
AU - Gloy, Viktoria
AU - Olu, Kelechi K.
AU - Raatz, Heike
AU - Moja, Lorenzo
AU - Ebrahim, Shanil
AU - Schandelmaier, Stefan
AU - Sun, Xin
AU - Vandvik, Per O.
AU - Johnston, Bradley C.
AU - Walter, Martin A.
AU - Burnand, Bernard
AU - Schwenkglenks, Matthias
AU - Hemkens, Lars G.
AU - Bucher, Heiner C.
AU - Guyatt, Gordon H.
AU - Briel, Matthias
PY - 2015/7/1
Y1 - 2015/7/1
N2 - 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.
AB - 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.
KW - Discontinuation
KW - Publication
KW - Randomized controlled trial
KW - Recruitment
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UR - http://www.scopus.com/inward/citedby.url?scp=84939428872&partnerID=8YFLogxK
U2 - 10.1097/SLA.0000000000000810
DO - 10.1097/SLA.0000000000000810
M3 - Article
C2 - 24979608
AN - SCOPUS:84939428872
VL - 262
SP - 68
EP - 73
JO - Annals of Surgery
JF - Annals of Surgery
SN - 0003-4932
IS - 1
ER -