Niu Bohan, Zhang Mingyan, Chua Hui Zi, Li Kai, Zhang Junhua
Evidence-Based Medicine Centre, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
Chinese Clinical Trials Core Outcome Set Research Centre, Tianjin, China.
Evid Based Complement Alternat Med. 2021 Apr 12;2021:5559883. doi: 10.1155/2021/5559883. eCollection 2021.
Treatment of chronic pulmonary heart disease (CPHD), a common disease, has over recent years been studied using traditional Chinese medicine (TCM) due to many high-profile benefits. These can be evaluated by the measurement and analysis of related outcomes. Because of selective reporting bias and the heterogeneity of study outcomes, it is not possible to combine similar studies in a meta-analysis. Consequently, not only does the low quality of original studies fails to support evidence-based decision-making, but also the value of those clinical studies cannot be evaluated. To solve these problems, the development of a core outcome set for traditional Chinese medicines for the treatment of chronic pulmonary heart disease (COS-TCM-CPHD) is required.
The development is conducted in five steps: (1) a library of outcomes through systematic review, the retrieval of libraries from two clinical trials registries, and semistructured interviews is established; (2) following data extraction and analysis of the library of outcomes, each outcome can be classified into seven outcome domains, including TCM disease, symptoms/signs, physical and chemical testing, quality of life, long-term prognosis, economic evaluation, and adverse events to form a preliminary list of outcomes; (3) stakeholder groups for participation are selected; (4) stakeholder groups are invited to participate in two rounds of Delphi surveys to score outcomes and provide additional outcomes; (5) a consensus meeting is organized to produce the final COS-TCM-CPHD. The protocol is consistent with the guidelines defined by the Core Outcome Set-STAndardised Protocol (COS-STAP) statement and formulated with reference to Core Outcome Set-STAndards for development (COS-STAD). The COS-TCM-CPHD will improve the consistency of study reports and reduce publication bias, thereby improving the quality of TCM clinical trials and decision-making for evidence-based medicine. The study has been registered on the COMET website (http://www.comet-initiative.org/Studies/Details/1677).
慢性肺源性心脏病（CPHD）是一种常见疾病，近年来由于诸多显著益处，一直采用中医（TCM）进行治疗。这些益处可通过对相关结局的测量和分析来评估。由于存在选择性报告偏倚和研究结局的异质性，无法在荟萃分析中合并相似研究。因此，不仅原始研究质量低无法支持循证决策，而且这些临床研究的价值也无法评估。为解决这些问题，需要制定治疗慢性肺源性心脏病的中药核心结局集（COS-TCM-CPHD）。
制定过程分五步进行：（1）通过系统评价、检索两个临床试验注册库以及半结构化访谈建立结局库；（2）对结局库进行数据提取和分析后，每个结局可分为七个结局领域，包括中医疾病、症状/体征、理化检查、生活质量、长期预后、经济评估和不良事件，以形成初步结局清单；（3）选择参与的利益相关者群体；（4）邀请利益相关者群体参与两轮德尔菲调查以对结局进行评分并提供其他结局；（5）组织共识会议以产生最终的COS-TCM-CPHD。该方案符合核心结局集标准化方案（COS-STAP）声明所定义的指南，并参考核心结局集开发标准（COS-STAD）制定。COS-TCM-CPHD将提高研究报告的一致性并减少发表偏倚，从而提高中医临床试验的质量和循证医学决策水平。该研究已在COMET网站（http://www.comet-initiative.org/Studies/Details/1677）上注册。
