Arundel Catherine, Zahra Sabeen, Chetter Ian
York Trials Unit, University of York, York, YO10 5DD, UK.
University of Hull, Hull, HU6 7RX, UK.
Pilot Feasibility Stud. 2025 Jul 2;11(1):90. doi: 10.1186/s40814-025-01658-w.
Randomised controlled trials are the most rigorous way of investigating the effectiveness of intervention(s) in healthcare settings. During their conduct, trials often run into challenges which if not overcome can lead to significant research waste. Inclusion of a pilot phase provides a way to evaluate elements such as recruitment rate, site set-up and participant follow-up and to address any difficulties early in the trial. The number of trials including a pilot phase is increasing; however, findings are rarely shared in detail, meaning relevant information and learning may not benefit the wider research community. We aimed to report the learning from the SWHSI-2 internal pilot phase, to inform internal pilot trial design and conduct and to also share the subsequent learnings from the main trial phase.
The design and outcomes of the 6-month internal pilot phase were embedded within the surgical wounds healing by secondary intention trial. The internal pilot phase assessed site set-up, participant randomisation, intervention delivery and follow-up rates using a pre-specified grading. Details of the impact of the pilot phase on, and subsequent changes to, the main trial phase are also presented. We highlighted the challenges faced during the study and detail strategies that were included to minimise or mitigate these.
The trial achieved satisfactory site set-up and intervention delivery levels; however, recruitment and follow-up rates were lower than anticipated. Approval was received from the funder to proceed to the main trial. Following the pilot phase, and continually during the main trial phase, processes and documentation were reviewed, revised and evaluated to mitigate challenges observed in relation to site engagement, participant recruitment and outcome data collection.
Inclusion of an internal pilot enabled early identification of recruitment and retention challenges with a comprehensive suite of interventions subsequently introduced to mitigate these. There was a successful main trial. The findings from this pilot phase add to the evidence base on the design and evaluation of internal pilot phases of a RCT. Future studies including an internal pilot phase should be encouraged to report their experiences for the benefit of others.
ISRCTN26277546. Prospectively registered 25 March 2019, https://www.isrctn.com/ISRCTN26277546.
随机对照试验是研究医疗环境中干预措施有效性的最严谨方法。在试验过程中，试验常常会遇到挑战，如果这些挑战得不到克服，可能会导致大量研究资源浪费。纳入一个试点阶段提供了一种评估诸如招募率、场地设置和参与者随访等因素的方法，并在试验早期解决任何困难。包括试点阶段的试验数量正在增加；然而，研究结果很少被详细分享，这意味着相关信息和经验教训可能无法使更广泛的研究群体受益。我们旨在报告从SWHSI - 2内部试点阶段获得的经验教训，为内部试点试验的设计和实施提供参考，并分享主要试验阶段随后的经验教训。
为期6个月的内部试点阶段的设计和结果被纳入二期愈合手术伤口试验中。内部试点阶段使用预先指定的分级方法评估场地设置、参与者随机分组、干预措施实施和随访率。还介绍了试点阶段对主要试验阶段的影响以及随后的变化细节。我们强调了研究过程中面临的挑战，并详细说明了为尽量减少或缓解这些挑战而采取的策略。
试验实现了令人满意的场地设置和干预措施实施水平；然而，招募率和随访率低于预期。获得了资助者进行主要试验的批准。在试点阶段之后，并在主要试验阶段持续进行过程中，对流程和文件进行了审查、修订和评估，以缓解在场地参与、参与者招募和结果数据收集方面观察到的挑战。
纳入内部试点能够早期识别招募和保留方面的挑战，并随后引入一套全面的干预措施来缓解这些挑战。主要试验取得了成功。该试点阶段的结果为随机对照试验内部试点阶段设计和评估的证据基础增添了内容。应鼓励未来包括内部试点阶段的研究报告其经验，以造福他人。
ISRCTN26277546。于2019年3月25日前瞻性注册，https://www.isrctn.com/ISRCTN26277546。
