Buist D S M, Tiro J A, Thayer C, Beatty T, Miglioretti D L, Lin J, Winer R L
Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA, 98101, USA.
Department of Clinical Sciences, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390, USA.
Contemp Clin Trials Commun. 2019 Jul 19;15:100413. doi: 10.1016/j.conctc.2019.100413. eCollection 2019 Sep.
Despite increased attention on how to conduct pragmatic trials and their importance, there remains an under-appreciation for the reality of what they take to design, compete and secure funding and execute. Many barriers are surmountable through increased exposure to experiences from completed trials. This report summarizes our experience in designing, securing funding and implementing the Home-Based Options to Make screening Easier (HOME) pragmatic trial, which was designed to evaluate home human papillomavirus testing for cervical cancer screening in underscreened women (women who had not received a cervical cancer screening test in ≥3.5 years). This report highlights factors at the level of research teams, organizations seeking to conduct embedded research, reviewers and funding agencies that challenge pragmatic trial design and execution. There is an urgent need to train on peer-reviewers how to evaluate embedded trial grant proposals, for agencies to pursue more rapid and innovative funding strategies, and to consider strategies for reviewers and funders to evaluate stakeholder buy-in (beyond letters of support). These factors together are needed to realize the promise of pragmatic trials to more efficiently and effectively generate critical data that inform changes in health care delivery and benefit patients.
尽管人们对如何开展实用性试验及其重要性的关注度有所提高，但对于设计、竞争、获得资金以及实施实用性试验的实际情况，仍然缺乏足够的认识。通过更多地接触已完成试验的经验，许多障碍是可以克服的。本报告总结了我们在设计、获得资金以及实施“让筛查更轻松的居家选择”（HOME）实用性试验方面的经验，该试验旨在评估针对筛查不足女性（即≥3.5年未接受宫颈癌筛查检测的女性）进行宫颈癌筛查的居家人乳头瘤病毒检测。本报告强调了研究团队、寻求开展嵌入式研究的组织、评审人员和资助机构层面存在的挑战实用性试验设计与实施的因素。迫切需要对同行评审人员进行培训，使其了解如何评估嵌入式试验资助提案，资助机构要采用更快速、创新的资助策略，并考虑评审人员和资助者评估利益相关者支持度的策略（不仅仅是支持信）。要实现实用性试验的前景，即更高效、有效地生成关键数据，为医疗服务的变革提供依据并使患者受益，所有这些因素都是必不可少的。
