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
{"title":"中医非药物疗法临床试验报告评估规程","authors":"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","doi":"10.1016/j.eujim.2024.102381","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Discussion</h3><p>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.</p></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"69 ","pages":"Article 102381"},"PeriodicalIF":1.9000,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1876382024000519/pdfft?md5=8866f83e65c4f29c875c6be8434107ea&pid=1-s2.0-S1876382024000519-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Protocol for the reporting assessment of clinical trials with non-pharmacological therapies in Chinese medicine\",\"authors\":\"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\",\"doi\":\"10.1016/j.eujim.2024.102381\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Discussion</h3><p>This study aims to identify and assess the current reporting characteristics and quality of the above four types of NPTCM interventional trials. 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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.
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.