Veroniki Areti Angeliki, Straus Sharon E, Ashoor Huda, Stewart Lesley A, Clarke Mike, Tricco Andrea C
Li Ka Shing Knowledge Institute of St. Michael's Hospital, 209 Victoria Street, East Building, Toronto, ON, M5B 1T8, Canada.
Department of Geriatric Medicine, University of Toronto, Toronto, ON, Canada.
Trials. 2016 Mar 15;17(1):138. doi: 10.1186/s13063-016-1238-z.
Individual patient data (IPD) meta-analysis is considered the "gold standard" for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the process for retrieval of IPD from such researchers. Our aim is to examine the impact of providing incentives to the researchers responsible for the trials eligible for a meta-analysis to submit their IPD.
METHODS/DESIGN: We updated our previously published systematic reviews for type 1 diabetes mellitus comparing long- and intermediate-acting insulin regimens (from January 2013 to June 2015) and for Alzheimer's dementia comparing cognitive enhancers (from January 2015 to May 2015). Eligible were randomized controlled trials (RCTs) fulfilling the eligibility criteria of the systematic reviews. We will randomly allocate authors of the reports of these RCTs into an intervention or control group. Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and will be given a financial incentive. Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive. Our primary outcome will be the proportion of authors who provide the IPD. The secondary outcomes will be the time to return the dataset (defined as the period between the information request and the authors' response with the dataset), and completeness of data. We will compare the response rates in the two groups using the odds ratio and the corresponding 95 % confidence interval. We will also use binary logistic regression and cox regression analyses to examine whether different RCT characteristics, such as study size and sponsor information, influence the probability of providing IPD and the time needed to share the data.
This study will determine whether a financial incentive affects response rates when seeking IPD from the original researchers. We will disseminate our findings in an open access scientific journal and present results at national and international conferences.
This trial is registered in Clinical Trials.gov, ID number NCT02569411 . Date of registration 5 October 2015.
个体患者数据（IPD）荟萃分析被认为是探索干预措施在不同亚组患者中有效性的“金标准”。然而，获取IPD耗时且通常需要与原始试验的研究者联系。迄今为止，尚无研究评估优化从此类研究者处检索IPD流程的不同策略。我们的目的是研究向符合荟萃分析条件的试验的研究者提供激励措施以促使他们提交IPD的影响。
方法/设计：我们更新了之前发表的关于1型糖尿病比较长效和中效胰岛素方案（2013年1月至2015年6月）以及阿尔茨海默病比较认知增强剂（2015年1月至2015年5月）的系统评价。符合条件的是满足系统评价纳入标准的随机对照试验（RCT）。我们将把这些RCT报告的作者随机分配到干预组或对照组。分配到干预组的作者将通过电子邮件、信件和电话联系，并被要求提供其RCT的IPD，且会给予经济激励。分配到对照组的作者也将通过电子邮件、信件和电话联系，但不会获得经济激励。我们的主要结局将是提供IPD的作者比例。次要结局将是返回数据集的时间（定义为信息请求与作者回复数据集之间的时间段）以及数据的完整性。我们将使用比值比和相应的95%置信区间比较两组的回复率。我们还将使用二元逻辑回归和Cox回归分析来研究不同的RCT特征，如研究规模和资助者信息，是否会影响提供IPD的概率以及共享数据所需的时间。
本研究将确定在向原始研究者寻求IPD时经济激励是否会影响回复率。我们将在开放获取的科学期刊上传播我们的研究结果，并在国内和国际会议上展示结果。
本试验已在ClinicalTrials.gov注册，注册号为NCT02569411。注册日期为2015年10月5日。
