1Department of Medicine, McMaster University, Hamilton, ON, Canada. 2Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. 3Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada. 4Department of Medicine, University of Toronto, Toronto, ON, Canada. 5Department of Physiology, University of Toronto, Toronto, ON, Canada. 6Division of Respirology, Department of Medicine, University Health Network, University of Toronto, Toronto, ON, Canada. 7Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada. 8Department of Critical Care Medicine, Sunnybrook Health Science Centre, Toronto, ON, Canada. 9Department of Critical Care Medicine, Orlando Regional Medical Center, Orlando, FL. 10Department of Critical Care, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. 11Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada. 12Adult Critical Care Department, University Hospital of Wales, Cardiff, United Kingdom. 13Department of Critical Care, University of British Columbia, Vancouver, BC, Canada.
Crit Care Med. 2015 Feb;43(2):328-38. doi: 10.1097/CCM.0000000000000692.
Enrollment of individual patients into more than one study has been poorly evaluated. The objective of this study was to describe the characteristics of patients, researchers and centers involved in coenrollment, studies precluding coenrollment, and the prevalence, patterns, predictors, and outcomes of coenrollment in a randomized clinical trial.
DESIGN, SETTING, METHODS: We conducted an observational study nested within the OSCILLation for Acute Respiratory Distress Syndrome Treated Early Trial, which compared high-frequency oscillatory ventilation to conventional ventilation. We collected patient, center, and study data on coenrollment in randomized patients. Multilevel regression examined factors independently associated with coenrollment, considering clustering within centers. We examined the effect of coenrollment on safety and the trial outcome.
None.
Overall, 127 of 548 randomized patients (23.2%) were coenrolled in 25 unique studies. Coenrollment was reported in 17 of 39 centers (43.6%). Patients were most commonly coenrolled in one additional randomized clinical trial (76; 59.8%). Coenrollment was less likely in older patients (odds ratio, 0.87; 95% CI, 0.76-0.997), and in ICUs with greater than 26 beds (odds ratio, 0.56; 95% CI, 0.34-0.94), and more likely by investigators with more than 11 years of experience (odds ratio, 1.73; 95% CI, 1.06-2.82), by research coordinators with more than 8 years of experience (odds ratio, 1.87; 95% CI, 1.11-3.18) and in Canada (odds ratio, 4.66; 95% CI, 1.43-15.15). Serious adverse events were similar between coenrolled high-frequency oscillatory ventilation and control patients. Coenrollment did not modify the treatment effect of high-frequency oscillatory ventilation on hospital mortality.
Coenrollment occurred in 23% of patients, commonly in younger patients, in smaller centers with more research infrastructure, and in Canada. Coenrollment did not influence patient safety or trial results.
将单个患者纳入多项研究的情况评估不佳。本研究的目的是描述共同入组患者、研究人员和中心的特征，排除共同入组的研究，并描述一项随机临床试验中共同入组的普遍性、模式、预测因素和结果。
设计、地点、方法：我们进行了一项嵌套在 OSCILLation for Acute Respiratory Distress Syndrome Treated Early 试验中的观察性研究，该试验比较了高频振荡通气与常规通气。我们收集了随机患者的患者、中心和研究数据，以了解共同入组情况。多水平回归分析考虑了中心内的聚类，分析了与共同入组独立相关的因素。我们还检查了共同入组对安全性和试验结果的影响。
无。
共有 548 名随机患者中的 127 名（23.2%）被纳入 25 项不同的研究中，这些患者共同入组了 25 项不同的研究。在 39 个中心中的 17 个中心（43.6%）报告了共同入组的情况。患者最常见的是在一项额外的随机临床试验中共同入组（76 人，占 59.8%）。年龄较大的患者（比值比，0.87；95%可信区间，0.76-0.997）、床位超过 26 张的 ICU（比值比，0.56；95%可信区间，0.34-0.94）以及经验超过 11 年的研究者（比值比，1.73；95%可信区间，1.06-2.82）更不可能被共同入组，而经验超过 8 年的研究协调员（比值比，1.87；95%可信区间，1.11-3.18）和加拿大的研究者（比值比，4.66；95%可信区间，1.43-15.15）则更有可能被共同入组。共同入组高频振荡通气与对照组患者的严重不良事件相似。共同入组并未改变高频振荡通气对住院死亡率的治疗效果。
23%的患者存在共同入组情况，常见于年龄较小的患者、研究基础设施较少的较小中心以及加拿大。共同入组并不影响患者安全性或试验结果。
