Vas Aurelia, D'sa Prashanth, Gokhale Sandeep, Agarwal Tanvi, Roberts Gareth L, Mohanty Khitish
General Surgery, Princess of Wales Hospital, Bridgend, GBR.
Trauma and Orthopaedics, University Hospital of Wales, Cardiff, GBR.
Cureus. 2021 Oct 20;13(10):e18920. doi: 10.7759/cureus.18920. eCollection 2021 Oct.
Recruitment of patients to participate in randomized control trials (RCT) is a challenging task, especially for trauma trials in which the identification and recruitment are time-limited. Multiple strategies have been tried to improve the participation of doctors and the recruitment of patients. The aim was to study the effect of a trainee principal investigator (TPI) on the efficacy of recruitment for a multicenter hip fracture RCT.
A retrospective study comparing the number of junior doctors participating in the WHiTE 8 COPAL RCT and patients recruited before and after the introduction of formal TPI role at a major trauma center in the UK. Data was collected for nine months "before" (Nov 2018-July 2019) and six months "after" (Sept 2019-Feb 2020) the role of TPI was assigned.
From November 2018 to February 2020, a total of 292 patients were eligible for recruitment into this trial, out of which 196 (67.12 %) were successfully recruited. Excluding the research team, there were seven junior doctors actively recruiting in the "before period" in comparison with 10 in the "after period." Significantly more patients were recruited by junior doctors after a TPI was assigned. Overall, more percentage of eligible patients were recruited into the trial after a TPI was assigned, and this was statistically significant.
The allocation of a formal TPI significantly improved the recruitment of patients in a national RCT. TPI can work alongside the principal investigator and research team to be a valuable link person coordinating and engaging local trainees to take part in trials.
招募患者参与随机对照试验（RCT）是一项具有挑战性的任务，尤其是对于创伤试验而言，其识别和招募工作有时间限制。人们已经尝试了多种策略来提高医生的参与度和患者的招募率。本研究旨在探讨实习首席研究员（TPI）对多中心髋部骨折RCT招募效果的影响。
一项回顾性研究，比较了在英国一家主要创伤中心引入正式TPI角色前后，参与WHiTE 8 COPAL RCT的初级医生数量以及招募的患者数量。在TPI角色分配前的九个月（2018年11月至2019年7月）和之后的六个月（2019年9月至2020年2月）收集数据。
从2018年11月到2020年2月，共有292名患者符合该试验的招募条件，其中196名（67.12%）成功招募。排除研究团队，“之前阶段”有7名初级医生积极参与招募，而“之后阶段”有10名。TPI分配后，初级医生招募的患者明显更多。总体而言，TPI分配后，有更高比例的符合条件的患者被招募到试验中，且具有统计学意义。
正式TPI的分配显著改善了一项全国性RCT中的患者招募情况。TPI可以与首席研究员和研究团队合作，成为协调和促使当地实习生参与试验的重要联络人。
