Outcomes for clinical research on Chinese medicine dampness syndrome: A protocol of developing a core outcome set

Abstract

Introduction

Chinese medicine (CM)/integrative medicine have been widely used to treat dampness syndrome, 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.