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

IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE
Xingying Qiu , Jun Tan , Wencong Cao , Zehuai Wen , Geng Li
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引用次数: 0

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.

中医湿证临床研究结果:核心结果集制定方案
中医/中西医结合已被广泛应用于治疗湿证,湿证被认为是许多慢性疾病的主要病机。中医与中西医结合治疗湿证的临床试验较多。然而,他们的大多数结论应该谨慎看待,因为他们的方法质量缺陷。其中一个缺陷是结果的不一致性,这给相关研究结果的比较和结合带来了障碍。这个问题可以通过开发核心结果集(COS)来解决。方法本研究旨在建立中医湿证(COS- cmds)临床研究的COS。我们将成立一个研究咨询小组,组织和指导COS的发展。本研究分为四个阶段:(1)CM湿证的系统综述;(2)对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)召开协商一致会议,确定最终的COS-CMDS。本研究已获得研究所评审委员会批准,并已在COMET (Core Outcome Measures in Effectiveness Trials Initiative)数据库注册(https://www.comet-initiative.org/Studies/Details/1950).DiscussionThe),为CM湿证临床研究的结局选择提供参考,并有助于系统评价和meta分析中报告的结果的合并和比较。它可能有助于产生更多高质量的证据。结论cos - cmds将规范CM湿证临床研究结果的选择和报告。完成后将以适当方式出版,以促进进一步广泛使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
European Journal of Integrative Medicine
European Journal of Integrative Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
4.70
自引率
4.00%
发文量
102
审稿时长
33 days
期刊介绍: The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education. EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians. The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.
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