Can Response-Adaptive Randomization Increase Participation in Acute Stroke Trials?
Can Response-Adaptive Randomization Increase Participation in Acute Stroke Trials?
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DOI：
10.1161/strokeaha.114.005418
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发表时间：
2014-07-01
期刊：
影响因子：
8.3
通讯作者：
Meurer, William J.
中科院分区：
文献类型：
--
作者：
Tehranisa, Jason S.;Meurer, William J.
背景和目的-反应适应性随机化（RAR）试验设计积极调整分配到每个试验组的受试者比例，通过使用已参加试验的受试者的结局数据，有利于更好地进行治疗。与标准的临床试验相比，RAR研究设计有可能提高患者参与急性中风trials. Methods，这一横断面随机调查包括成人急诊科患者，年龄>= 18，没有中风或其他严重疾病的症状。使用标准化方案，受试者随机分配至RAR或标准假设急性卒中试验。在观看描述假设试验的视频（http：//youtu.be/cKIWduCaPZc）、审查知情同意书并回答问题后，受试者表示他们是否同意参加试验。一个多变量logistic回归模型拟合估计RAR的影响，同时控制人口因素和患者的理解design.Results-A共418名受试者（210标准和208 RAR）被招募。所有基线特征在两组之间平衡。RAR试验（67.3%）的参与率显著高于标准试验（54.5%），绝对增加：12.8%（95%置信区间，3.7-22.2）。RAR组同意研究的优势比更高（优势比，1.89; 95%置信区间，1.2-2.9），同时调整患者水平因素。试验设计一般都很好地理解的participants. Conclusions，假设RAR试验吸引了更多的研究参与比标准随机化。RAR有可能增加招募并为未来的试验参与者提供获益。
Background and Purpose-A response-adaptive randomization (RAR) trial design actively adjusts the ratio of participants assigned to each trial arm, favoring the better performing treatment by using outcome data from participants already in the trial. Compared with a standard clinical trial, an RAR study design has the potential to improve patient participation in acute stroke trials.Methods-This cross-sectional randomized survey included adult emergency department patients, age >= 18, without symptoms of stroke or other critical illness. A standardized protocol was used, and subjects were randomized to either an RAR or standard hypothetical acute stroke trial. After viewing the video describing the hypothetical trial (http://youtu.be/cKIWduCaPZc), reviewing the consent form, and having questions answered, subjects indicated whether they would consent to the trial. A multivariable logistic regression model was fitted to estimate the impact of RAR while controlling for demographic factors and patient understanding of the design.Results-A total of 418 subjects (210 standard and 208 RAR) were enrolled. All baseline characteristics were balanced between groups. There was significantly higher participation in the RAR trial (67.3%) versus the standard trial (54.5%), absolute increase: 12.8% (95% confidence interval, 3.7-22.2). The RAR group had a higher odds ratio of agreeing to research (odds ratio, 1.89; 95% confidence interval, 1.2-2.9) while adjusting for patient level factors. Trial designs were generally well understood by the participants.Conclusions-The hypothetical RAR trial attracted more research participation than standard randomization. RAR has the potential to increase recruitment and offer benefit to future trial participants.