Eldridge Sandra M, Chan Claire L, Campbell Michael J, Bond Christine M, Hopewell Sally, Thabane Lehana, Lancaster Gillian A
Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
School of Health and Related Research, University of Sheffield, Sheffield, UK.
Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor's note: In order to encourage its wide dissemination this article is freely accessible on and journal websites.
《试验报告的统一标准》（CONSORT）声明是一项旨在提高随机对照试验（RCT）报告透明度和质量的指南。在本文中，我们针对在未来确定性RCT之前进行的随机预试验和可行性试验，提出了该声明的一个扩展版本。该清单适用于任何随机研究，其中未来确定性RCT或其一部分在较小规模上进行，无论其设计（如整群、析因、交叉）或作者用于描述该研究的术语（如预试验、可行性研究、试验、研究）如何。该扩展版本不适用于纳入主试验设计中的内部预试验、非随机预试验和可行性研究或II期研究，但这些研究都与随机预试验和可行性研究有一些相似之处，因此许多原则可能也适用。扩展版本的制定是由于被描述为可行性研究或预试验的研究数量不断增加，以及已确定其报告和实施存在弱点的研究。我们遵循推荐的良好做法来制定扩展版本，包括开展德尔菲调查、召开共识会议和研究团队会议，以及对清单进行试点。预试验和可行性随机研究的目的与其他随机试验不同。因此，尽管这些试验中要报告的许多信息与评估有效性和疗效的随机对照试验（RCT）中的信息相似，但在信息类型和对CONSORT标准报告项目的适当解释方面存在一些关键差异。我们保留了原始CONSORT声明中的一些项目，但大多数已进行了调整，一些被删除，并添加了新项目。新项目涵盖了如何识别参与者以及如何获得同意；如果适用，用于判断是否或如何推进未来确定性RCT的预先指定标准；如果相关，其他重要的意外后果；从预试验推进到未来确定性RCT的影响，包括任何提议的修改；以及伦理批准或研究审查委员会的批准，并注明参考编号。本文包括26项清单、单独的摘要清单、这些研究的CONSORT流程图模板，以及对所做更改的解释和支持示例。我们相信，常规使用这个提议的CONSORT声明扩展版本将改善预试验的报告。编辑注：为鼓励广泛传播，本文可在 和 期刊网站上免费获取。
