Introduction

Chinese medicine (CM) /integrative medicine has been widely used to treat dampness syndrome which has been regarded as the main pathogenesis of many chronic diseases. Many clinical trials of CM/integrative medicine for dampness syndrome have been conducted. However, most of their conclusions should be viewed with caution because of their methodological quality defects. One of the defects is the inconsistency of outcomes, which results in obstacles to comparing and combining the results of related studies. This issue could be addressed by developing a core outcome set (COS).

Method

This study aims to develop a COS for clinical research of CM dampness syndrome (COS-CMDS). We will set up a study advisory group to organize and guide the development of the COS. The study consists of four stages: (1) a systematic review of CM dampness syndrome; (2) qualitative interviews with experts and patients to construct a preliminary outcome pool based on the systematic review; (3) a two-round Delphi survey; and (4) a consensus meeting to determine the final COS-CMDS. This study has been approved by the institute review board and has been registered at the Core Outcome Measures in Effectiveness Trials Initiative (COMET) database (https://www.comet-initiative.org/Studies/Details/1950).

Discussion

The development of COS-CMDS will provide a reference for outcome selection in clinical research on CM dampness syndrome, and contribute to the combination and comparison of results reported during systematic reviews and meta-analyses. It may help generate more high-quality evidence.

Conclusion

COS-CMDS will standardize the selection and reporting of outcomes in clinical research of CM dampness syndrome. It will be published in appropriate ways to promote further widespread use after completion.

中文翻译：

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中医湿证临床研究成果：制定核心成果集方案

介绍

中医/中西医结合已广泛用于治疗湿证，湿证已被视为许多慢性疾病的主要病机。中西医结合治疗湿证的临床试验已经开展了很多。然而，由于其方法论质量缺陷，他们的大多数结论应谨慎看待。缺陷之一是结果的不一致，导致相关研究结果的比较和组合遇到障碍。这个问题可以通过制定核心成果集（COS）来解决。

方法

本研究旨在开发一种用于CM湿证临床研究的COS（COS-CMDS）。我们将成立研究顾问组，组织指导COS的发展。研究分为四个阶段：（1）中药湿证的系统综述；（2）与专家和患者进行定性访谈，在系统评价的基础上构建初步结果库；(3) 两轮德尔菲调查；(4) 共识会议确定最终的 COS-CMDS。这项研究已获得研究所审查委员会的批准，并已在有效性试验倡议核心结果衡量标准（COMET）数据库中注册（https://www.comet-initiative.org/Studies/Details/1950）。

讨论

COS-CMDS的开发将为中湿证临床研究的结果选择提供参考，并有助于系统评价和荟萃分析中报告结果的组合和比较。它可能有助于产生更多高质量的证据。

结论

COS-CMDS 将规范中湿证临床研究结果的选择和报告。完成后将通过适当方式发布，以促进进一步广泛使用。