中医非药物疗法临床试验报告评估规程

IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE European Journal of Integrative Medicine Pub Date : 2024-06-20 DOI:10.1016/j.eujim.2024.102381
Hanzhi Tan , Nana Wang , Han Li , Chung Wah Cheng , Yalin Jiao , Dongni Shi , Juan Wang , Jiashuai Deng , Ji Li , Fei Han , Ping Wang , Zhaoxiang Bian , Xuan Zhang
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引用次数: 0

摘要

导言:中医非药物治疗(NPTCM)在临床实践中发挥着重要而独特的作用,在随机对照试验(RCT)中的作用也越来越大。随着针灸、艾灸、拔罐和推拿/按摩的《试验报告统一标准》(Consort)扩展版的陆续出版,本研究旨在根据这些特定的报告核对表评估已发表的 RCT 的报告特点和质量。感兴趣的干预措施是涉及针灸、艾灸、拔罐或推拿/按摩的 RCT,语言限于中文或英文。由两名审稿人进行筛选,第三名审稿人进行复核。数据提取的目的是总结这四类干预措施的研究设计和实施特点,并使用预先设计的数据提取表。在质量评估方面,将根据 CONSORT 四项扩展的核对表项目制定标准操作程序 (SOP)。每篇文章将由两名审稿人以背靠背的方式进行配对审阅,并计算科恩卡帕统计量以评估审稿人之间的一致性。将使用描述性统计来说明报告的质量。本研究旨在确定和评估上述四类 NPTCM 介入性试验的报告特点和质量。本研究旨在识别和评估上述四类 NPTCM 干预试验目前的报告特点和质量,并希望根据评估结果,为 NPTCM 未来应用或推广 CONSORT 扩展提供建议。
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Protocol for the reporting assessment of clinical trials with non-pharmacological therapies in Chinese medicine

Introduction

Non-pharmacological treatment in Chinese Medicine (NPTCM) plays a crucial and distinct role in clinical practice, and increasingly within randomized controlled trials (RCTs). With the successive publication of Consolidated Standards Of Reporting Trials (CONSORT) extensions for acupuncture, moxibustion, cupping, and Tuina/massage, this study aims to assess the reporting characteristics and quality of published RCTs based on these specific reporting checklists.

Methods

Databases including All EBM Reviews, AMED, Embase, Ovid MEDLINE(R), CNKI, VIP Chinese Medical Journal Database, and Wanfang Data will be searched, with the publication date limited to January 1, 2022 to December 31, 2022. The interventions of interest are RCTs involving acupuncture, moxibustion, cupping or Tuina/massage, with language restricted to Chinese or English. Two reviewers will conduct the screening process with double-checking by the third reviewer. The purpose of data extraction is to summarize the study designs and implementation characteristics of these four types of interventions, and a pre-designed data extraction form will be utilized. For quality assessment, a standard operating procedure (SOP) will be developed, using an assessment form based on the checklist items of the four CONSORT extensions. Each article will be reviewed by two reviewers in a paired back-to-back manner, and Cohen's kappa statistic will be calculated to assess inter-rater agreement. Descriptive statistics will be used to present the quality of reporting. Subgroup comparisons will be conducted regarding different types of interventions, locations and publication languages.

Discussion

This study aims to identify and assess the current reporting characteristics and quality of the above four types of NPTCM interventional trials. Based on the results, it is hoped to provide suggestions for future application or promotion of the CONSORT extensions for NPTCM.

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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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