危重症与急诊护理中随机试验的提前终止：一项回顾性队列研究
Premature Discontinuation of Randomized Trials in Critical and Emergency Care: A Retrospective Cohort Study.
作者信息
Schandelmaier Stefan, von Elm Erik, You John J, Blümle Anette, Tomonaga Yuki, Lamontagne Francois, Saccilotto Ramon, Amstutz Alain, Bengough Theresa, Meerpohl Joerg J, Stegert Mihaela, Olu Kelechi K, Tikkinen Kari A O, Neumann Ignacio, Carrasco-Labra Alonso, Faulhaber Markus, Mulla Sohail M, Mertz Dominik, Akl Elie A, Sun Xin, Bassler Dirk, Busse Jason W, Ferreira-González Ignacio, Nordmann Alain, Gloy Viktoria, Raatz Heike, Moja Lorenzo, Rosenthal Rachel, Ebrahim Shanil, Vandvik Per O, Johnston Bradley C, Walter Martin A, Burnand Bernard, Schwenkglenks Matthias, Hemkens Lars G, Cook Deborah J, Meade Maureen O, Bucher Heiner C, Kasenda Benjamin, Briel Matthias
机构信息
1Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.2Department of Medicine, Academy of Swiss Insurance Medicine, University Hospital Basel, Basel, Switzerland.3Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.4Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.5Department of Medicine, McMaster University, Hamilton, Ontario, Canada.6German Cochrane Centre, Medical Center-University of Freiburg, Freiburg, Germany.7Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.8Centre de Recherche Clinique du Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, Canada.9Department of Health and Society, Austrian Federal Institute for Health Care, Vienna, Austria.10Departments of Urology and Public Health, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.11Department of Internal Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile.12Evidence-Based Dentistry Unit, Faculty of Dentistry, Universidad de Chile, Santiago, Chile.13Michael G. DeGroote Institute for Infectious Diseases Research, McMaster University, Hamilton, Ontario, Canada.14Department of Internal Medicine, American University of Beirut, Beirut, Lebanon.15Department of Medicine, State University of New York at Buffalo, Buffalo, NY.16Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.17Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.18Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada.19Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada.20Epidemiology Unit, Department of Cardiology, Vall d'Hebron Hospital and CIBER de Epidem
出版信息
Crit Care Med. 2016 Jan;44(1):130-7. doi: 10.1097/CCM.0000000000001369.
OBJECTIVES
Randomized clinical trials that enroll patients in critical or emergency care (acute care) setting are challenging because of narrow time windows for recruitment and the inability of many patients to provide informed consent. To assess the extent that recruitment challenges lead to randomized clinical trial discontinuation, we compared the discontinuation of acute care and nonacute care randomized clinical trials.
DESIGN
Retrospective cohort of 894 randomized clinical trials approved by six institutional review boards in Switzerland, Germany, and Canada between 2000 and 2003.
SETTING
Randomized clinical trials involving patients in an acute or nonacute care setting.
SUBJECTS AND INTERVENTIONS
We recorded trial characteristics, self-reported trial discontinuation, and self-reported reasons for discontinuation from protocols, corresponding publications, institutional review board files, and a survey of investigators.
MEASUREMENTS AND MAIN RESULTS
Of 894 randomized clinical trials, 64 (7%) were acute care randomized clinical trials (29 critical care and 35 emergency care). Compared with the 830 nonacute care randomized clinical trials, acute care randomized clinical trials were more frequently discontinued (28 of 64, 44% vs 221 of 830, 27%; p = 0.004). Slow recruitment was the most frequent reason for discontinuation, both in acute care (13 of 64, 20%) and in nonacute care randomized clinical trials (7 of 64, 11%). Logistic regression analyses suggested the acute care setting as an independent risk factor for randomized clinical trial discontinuation specifically as a result of slow recruitment (odds ratio, 4.00; 95% CI, 1.72-9.31) after adjusting for other established risk factors, including nonindustry sponsorship and small sample size.
CONCLUSIONS
Acute care randomized clinical trials are more vulnerable to premature discontinuation than nonacute care randomized clinical trials and have an approximately four-fold higher risk of discontinuation due to slow recruitment. These results highlight the need for strategies to reliably prevent and resolve slow patient recruitment in randomized clinical trials conducted in the critical and emergency care setting.
目的
由于招募时间窗口狭窄且许多患者无法提供知情同意，在重症或急诊护理（急性护理）环境中招募患者的随机临床试验具有挑战性。为了评估招募挑战导致随机临床试验中止的程度，我们比较了急性护理和非急性护理随机临床试验的中止情况。
设计
对2000年至2003年间瑞士、德国和加拿大的六个机构审查委员会批准的894项随机临床试验进行回顾性队列研究。
设置
涉及急性或非急性护理环境中患者的随机临床试验。
受试者和干预措施
我们从方案、相应出版物、机构审查委员会文件以及对研究者的调查中记录了试验特征、自我报告的试验中止情况以及自我报告的中止原因。
测量和主要结果
在894项随机临床试验中，64项（7%）为急性护理随机临床试验（29项重症护理和35项急诊护理）。与830项非急性护理随机临床试验相比，急性护理随机临床试验更频繁地中止（64项中的28项，44% 对830项中的221项，27%；p = 0.004）。招募缓慢是中止的最常见原因，在急性护理（64项中的13项，20%）和非急性护理随机临床试验（64项中的7项，11%）中均如此。逻辑回归分析表明，在调整了包括非行业赞助和小样本量等其他既定风险因素后，急性护理环境是随机临床试验因招募缓慢而中止的独立风险因素（比值比，4.00；95% CI，1.72 - 9.31）。
结论
与非急性护理随机临床试验相比，急性护理随机临床试验更容易过早中止，因招募缓慢而中止的风险大约高四倍。这些结果凸显了在重症和急诊护理环境中进行的随机临床试验中，需要采取策略来可靠地预防和解决患者招募缓慢的问题。
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