Duane Sinead, Vellinga Akke, Smith Valerie, Tierney Marie, Beecher Claire, Burke Megan, Murphy Andrew W, Devane Declan
J.E. Cairnes School of Business & Economics, National University of Ireland, Galway, Ireland.
HRB Trials Methodology Research Network, National University of Ireland, Galway, Ireland.
HRB Open Res. 2020 Mar 30;3:10. doi: 10.12688/hrbopenres.12994.1. eCollection 2020.
Studies within trials (SWATs) present an opportunity to examine design factors that may impact on the successful delivery of trials. One area in need of research is trial recruitment. Recruiting patients to trials is a major challenge facing trialists. Failure to meet recruitment targets can result in delays and underpowered studies. This SWAT evaluates the effectiveness of hand-held digital multimedia presentation of trial information and standard written patient information to potential participants on recruitment and retention to a host trial. : This is the protocol for SWAT 15, a two-group, embedded parallel randomised controlled trial (RCT) (ISRCTN12838042) designed within a host trial - the SATIN trial (ISRCTN88111427), a RCT designed for implementation in the Irish primary care setting. The SWAT eligibility criteria was determined by the host trial. General practices who agree to participate in the host trial will provide women (participants) who are willing to consider participating in the host trial with either a multimedia digital information resource facilitated through a handheld tablet device, plus a written participant information leaflet (Intervention) or a written participant information leaflet (comparator). Outcomes are recruitment and retention to the host SATIN trial and participant's quality of decision-making. : Although designed to be implemented in a host trial, the host trial, was suspended and therefore this SWAT was not implemented. The protocol and the lessons learnt whilst developing it offer guidance to researchers who wish to answer similar research questions in the future in a similar context or setting. : ISRCTN Registry ISRCTN12838042 (11/10/2017).
试验中的研究（SWATs）为考察可能影响试验成功实施的设计因素提供了契机。一个需要研究的领域是试验招募。招募患者参与试验是试验者面临的一项重大挑战。未能达到招募目标可能导致试验延迟以及研究效能不足。本SWAT评估向潜在参与者以手持数字多媒体形式呈现试验信息和标准书面患者信息对于一项主要试验的招募和保留率的有效性。：这是SWAT 15的方案，一项两组嵌入式平行随机对照试验（RCT）（ISRCTN12838042），在一项主要试验——SATIN试验（ISRCTN88111427）中设计，SATIN试验是一项为在爱尔兰初级保健环境中实施而设计的RCT。SWAT的纳入标准由主要试验确定。同意参与主要试验的全科诊所将为愿意考虑参与主要试验的女性（参与者）提供通过手持平板电脑设备提供的多媒体数字信息资源，外加一份书面参与者信息手册（干预组）或一份书面参与者信息手册（对照组）。结局指标是参与主要SATIN试验的招募率和保留率以及参与者的决策质量。：尽管本试验设计为在一项主要试验中实施，但主要试验已暂停，因此本SWAT未实施。该方案以及在制定过程中吸取的经验教训为未来希望在类似背景或环境中回答类似研究问题的研究人员提供了指导。：ISRCTN注册编号ISRCTN12838042（2017年10月11日）。
