School of Public Health and Preventive Medicine, Monash University, 553 St Kilda Rd, Melbourne, VIC, 3004, Australia.
South Australian Health & Medical Research Institute, PO BOX 11060, Adelaide, SA, 5001, Australia.
Trials. 2021 Mar 26;22(1):232. doi: 10.1186/s13063-021-05185-w.
The translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the 'implementability' of trials as they are designed and conducted. Implementability of trials refers to characteristics of the design, execution and reporting of a late-phase clinical trial that can influence the capacity for the evidence generated by that trial to be implemented. On behalf of the Australian Clinical Trials Alliance (ACTA), the national peak body representing networks of clinician researchers conducting investigator-initiated clinical trials, we conducted a pragmatic literature review to develop a concept map of implementability.
Documents were included in the review if they related to the design, conduct and reporting of late-phase clinical trials; described factors that increased or decreased the capacity of trials to be implemented; and were published after 2009 in English. Eligible documents included systematic reviews, guidance documents, tools or primary studies (if other designs were not available). With an expert reference group, we developed a preliminary concept map and conducted a snowballing search based on known relevant papers and websites of key organisations in May 2019.
Sixty-five resources were included. A final map of 38 concepts was developed covering the domains of validity, relevance and usability across the design, conduct and reporting of a trial. The concepts drew on literature relating to implementation science, consumer engagement, pragmatic trials, reporting, research waste and other fields. No single resource addressed more than ten of the 38 concepts in the map.
The concept map provides trialists with a tool to think through a range of areas in which practical action could enhance the implementability of their trials. Future work could validate the strength of the associations between the concepts identified and implementability of trials and investigate the effectiveness of steps to address each concept. ACTA will use this concept map to develop guidance for trialists in Australia.
This review did not include health-related outcomes and was therefore not eligible for registration in the PROSPERO register.
将临床试验中的证据转化为实践是复杂的。一种促进这种转化的方法是在设计和进行试验时考虑试验的“可实施性”。试验的可实施性是指设计、执行和报告后期临床试验的特征，这些特征可能会影响该试验产生的证据的实施能力。代表澳大利亚临床试验联盟（ACTA），这是一个代表进行研究者发起的临床试验的临床研究人员网络的国家最高机构，我们进行了一项实用的文献综述，以制定一个可实施性概念图。
如果文献与后期临床试验的设计、进行和报告有关；描述了增加或减少试验实施能力的因素；并且是在 2009 年以后用英文发表的，则将文献纳入综述。合格的文献包括系统评价、指南文件、工具或原始研究（如果没有其他设计）。我们与一个专家参考小组一起，根据已知的相关论文和关键组织的网站，在 2019 年 5 月开发了一个初步的概念图，并进行了滚雪球式搜索。
共纳入 65 篇资源。最终开发了一个包含 38 个概念的概念图，涵盖了试验设计、进行和报告的有效性、相关性和可用性领域。这些概念借鉴了与实施科学、消费者参与、实用试验、报告、研究浪费和其他领域相关的文献。没有一个单一的资源涉及到概念图中的 38 个概念中的 10 个以上。
概念图为试验设计者提供了一个工具，让他们可以考虑一系列可以提高试验可实施性的实际行动领域。未来的工作可以验证确定的概念与试验的可实施性之间的关联强度，并研究解决每个概念的步骤的有效性。ACTA 将使用这个概念图为澳大利亚的试验设计者制定指南。
本综述不包括与健康相关的结果，因此不符合在 PROSPERO 注册的条件。
