试点试验和可行性试验方案报告指南。
A guide to the reporting of protocols of pilot and feasibility trials.
作者信息
Thabane Lehana, Lancaster Gillian
机构信息
1Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON Canada.
2Institute of Primary Care and Health Sciences, Keele University, Keele, UK.
出版信息
Pilot Feasibility Stud. 2019 Feb 28;5:37. doi: 10.1186/s40814-019-0423-8. eCollection 2019.
Abstract
Publishing protocols of trials including protocols of pilot and feasibility trials-designed to inform the designs of main trials-has been advocated as an important strategy towards improving transparency in the conduct and reporting of main trials and pilot/feasibility trials. This editorial aims to provide some general guidance on how to report protocols of pilot and feasibility trials, drawing upon two available resources-the CONSORT extension to pilot trials and the SPIRIT guideline for main trials. We describe how these might be adapted for the reporting of protocol manuscripts of pilot and feasibility trials for submission in journal.
摘要
公布试验方案，包括旨在为主要试验设计提供信息的预试验和可行性试验方案，已被倡导为提高主要试验以及预试验/可行性试验实施和报告透明度的一项重要策略。本社论旨在借鉴两项现有资源——预试验的CONSORT扩展版和主要试验的SPIRIT指南，就如何报告预试验和可行性试验方案提供一些一般性指导。我们描述了如何对这些资源进行调整，以便用于报告预试验和可行性试验方案手稿，以供提交给期刊发表。
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