手术随机对照试验的完成率和发表率：一项实证研究。

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

机构信息

*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

出版信息

Ann Surg. 2015 Jul;262(1):68-73. doi: 10.1097/SLA.0000000000000810.

DOI:10.1097/SLA.0000000000000810

PMID:24979608

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.

摘要

目的

调查手术与医学随机对照试验（RCT）的停药和未发表率，并探讨手术 RCT 停药的危险因素。

背景

试验停药具有重要的科学、伦理和经济意义。迄今为止，手术 RCT 停药率尚不清楚。

方法

筛选了 2000 年至 2003 年加拿大、德国和瑞士的 6 个伦理委员会批准的所有 RCT 方案。收集基线特征，并检索已发表的完整报告。使用多变量逻辑回归分析探讨因招募缓慢而早期停药和未发表的危险因素。

结果

共确定了 863 项涉及成年患者的 RCT 方案，其中手术组 127 项（15%），医学组 736 项（85%）。手术试验因任何原因停药的比例高于医学试验[43%比 27%，差异风险 16%（95%可信区间：5%-26%）；P=0.001]，且因招募缓慢而停药的比例更高[18%比 11%，差异风险 8%（95%可信区间：0.1%-16%）；P=0.020]。手术和医学试验未发表为完整期刊文章的比例相似[44%比 40%，差异风险 4%（95%可信区间：-5%至 14%）；P=0.373]。手术试验的停药是未发表的强烈危险因素（比值比=4.18，95%可信区间：1.45-12.06；P=0.008）。