title: Completion and Publication Rates of Randomized Controlled Trials in Surgery: An Empirical Study.
abstract: 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.
authors: *Department of Surgery, University Hospital Basel, Spitalstrasse, Basel, Switzerland †Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Hebelstrasse, Basel, Switzerland ‡Department of Oncology, Basel University Hospital, Basel, Switzerland §Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland ¶Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada ‖Department of Medicine, McMaster University, Hamilton, Ontario, Canada **German Cochrane Centre, Department of Medical Biometry and Medical Informatics, University Medical Center Freiburg, Freiburg, Germany ††Institute of Social and Preventive Medicine, University of Zurich, Zurich, Switzerland ‡‡Department of Public Health, University of Helsinki, Helsinki, Finland §§Department of Urology, Helsinki University Central Hospital and University of Helsinki, Helsinki, Finland ¶¶Department of Internal Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile ‖‖Evidence-Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile ***Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada †††Michael G. DeGroote Institute for Infectious Diseases Research, McMaster University, Hamilton, Ontario, Canada ‡‡‡Department of Internal Medicine, American University of Beirut, Riad-El-Solh, Beirut, Lebanon §§§Department of Medicine, State University of New York at Buffalo, Buffalo, NY ¶¶¶Center for Pediatric Clinical Studies, Department of Neonatology, University Children's Hospital, Tuebingen, Germany and Division of Neonatology, University Hospital Zurich, Zurich, Switzerland ‖‖‖Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada ****Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada ††††Epidemiolo
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mesh_terms: D000328:Adult; D002170:Canada; D005858:Germany; D006801:Humans; D016015:Logistic Models; D008511:Medicine / Q000706:statistics & numerical data; D018579:Patient Selection; D015995:Prevalence; D011643:Publishing / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012307:Risk Factors; D013043:Specialties, Surgical / Q000706:statistics & numerical data*; D013557:Switzerland