York Trials Unit, Department of Health Sciences, Faculty of Science, Lower Ground Floor ARRC Building, University of York, York, YO10 5DD, UK.
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Headington, Oxford, UK.
Trials. 2024 Mar 12;25(1):183. doi: 10.1186/s13063-024-08004-0.
Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential; however, SWAT publications are often the first to be abandoned in the face of other time pressures. Reporting guidance for embedded methodology trials does exist but is not widely used. We sought therefore to build on these guidelines to develop a straightforward, concise reporting standard, which remains adherent to the CONSORT guideline.
An iterative process was used to develop the guideline. This included initial meetings with key stakeholders, development of an initial guideline, pilot testing of draft guidelines, further iteration and pilot testing, and finalisation of the guideline.
We developed a reporting guideline applicable to randomised SWATs, including replications of previous evaluations. The guideline follows the Consolidated Standards for Reporting Trials (CONSORT) statement and provides example text to ensure ease and clarity of reporting across all domains.
The SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline.
EQUATOR Network - Guidelines Under Development ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#SWAT ). Registered on 25 March 2021.
支持试验过程决策的证据很少。生成此证据的一种方法是使用嵌套试验中的研究（SWAT）来测试试验过程或探索方法学上的不确定性。SWAT 证据依赖于复制以确保发现具有足够的功效和广泛的适用性。因此，及时报告至关重要；但是，在面临其他时间压力时，SWAT 出版物通常是最先被放弃的。嵌入式方法试验的报告指南确实存在，但并未广泛使用。因此，我们寻求在这些指南的基础上制定一个简单明了的报告标准，该标准仍然符合 CONSORT 指南。
采用迭代过程制定指南。这包括与主要利益相关者进行初步会议、制定初始指南、对指南草案进行试点测试、进一步迭代和试点测试以及最终确定指南。
我们制定了适用于随机 SWAT 的报告指南，包括对以前评估的重复。该指南遵循 CONSORT 声明，并提供示例文本，以确保在所有领域报告的清晰性和结构。
SWAT 报告指南将有助于作者、评审员和期刊编辑生成和审查清晰、结构化的随机 SWAT 报告，同时也符合 CONSORT 指南。
EQUATOR 网络-正在制定的指南（https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#SWAT）。于 2021 年 3 月 25 日注册。
