Fu Guojing, Chen Yunmeng, Liang Xiao, Guo Chunli, Fan Xueming, Gong Xiao, Chen Wenjie, Teng Jing, Tang Jun, Liao Xing, Wei Jingjing, Zhang Yunling
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.
JMIR Res Protoc. 2025 Feb 5;14:e63481. doi: 10.2196/63481.
Tension-type headache (TTH) is the most common type of headache and the second most common health-related complaint among children and adults. Traditional Chinese medicine (TCM) offers unique therapeutic benefits in treating TTH. However, the lack of standardized evidence-such as inconsistencies in outcome selection and reporting in clinical studies, a lack of consensus on outcomes and measures, high risks of selective reporting bias, and missing data-has limited the development of robust evidence supporting the efficacy of TCM in treating TTH. Therefore, establishing a core outcome set (COS) is crucial for standardizing TCM clinical studies for TTH, thereby enhancing the quality and comparability of research findings.
This study aims to develop a COS for future clinical studies on the treatment of TTH with TCM.
The COS will be developed through the following 3 stages. First, systematic reviews and semistructured interviews will be conducted to identify potential essential outcomes, which will be evaluated by the steering committee to finalize a preliminary list of outcomes. Data will be processed using thematic analysis to ensure comprehensive coverage of relevant outcomes. Second, a 2-round Delphi survey will be conducted, inviting stakeholders, including health care experts and patients with tension-type headaches, to determine the importance of each outcome. Statistical analysis will be used to assess the level of consensus and prioritize outcomes based on predefined criteria. Third, a face-to-face consensus meeting will be held to finalize the COS and recommend measurement times for each outcome. Key outcomes will be interpreted based on their clinical relevance and feasibility of measurement, ensuring the COS is comprehensive and applicable in clinical settings.
The protocol has been registered in PROSPERO, with the review commencing on October 1, 2024, and anticipated results by November 15, 2024. The systematic reviews will be finalized, followed by the Delphi survey and consensus conference in late 2024 and early 2025. The COS findings will be reported per COS-STAR (Core Outcome Set-STAndards for Reporting) guidelines, published in an international journal, presented at conferences, and disseminated to participants for clinical application.
This study is necessary as developing a COS for future TCM clinical studies in the treatment of TTH can maximize the value of data from individual trials and provide high-quality research evidence.
Core Outcome Measures in Effectiveness Trials Initiative 1473; https://tinyurl.com/3ts62s2p.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/63481.
紧张型头痛（TTH）是最常见的头痛类型，也是儿童和成人中第二常见的与健康相关的主诉。中医在治疗紧张型头痛方面具有独特的治疗优势。然而，缺乏标准化证据，如临床研究中结局选择和报告的不一致、对结局和测量方法缺乏共识、选择性报告偏倚的高风险以及数据缺失，限制了支持中医治疗紧张型头痛疗效的有力证据的发展。因此，建立核心结局集（COS）对于规范中医治疗紧张型头痛的临床研究至关重要，从而提高研究结果的质量和可比性。
本研究旨在为未来中医治疗紧张型头痛的临床研究制定一个核心结局集。
核心结局集将通过以下三个阶段制定。首先，进行系统评价和半结构化访谈以确定潜在的关键结局，由指导委员会对这些结局进行评估，以确定结局的初步清单。将使用主题分析对数据进行处理，以确保全面涵盖相关结局。其次，将进行两轮德尔菲调查，邀请包括医疗保健专家和紧张型头痛患者在内的利益相关者，以确定每个结局的重要性。将使用统计分析来评估共识水平，并根据预定义标准对结局进行优先排序。第三，将举行面对面的共识会议，以最终确定核心结局集，并为每个结局推荐测量时间。将根据关键结局的临床相关性和测量的可行性对其进行解释，确保核心结局集全面且适用于临床环境。
该方案已在国际前瞻性系统评价注册库（PROSPERO）中注册，审查于2024年10月1日开始，预计2024年11月15日得出结果。系统评价将在2024年底完成，随后在2024年底和2025年初进行德尔菲调查和共识会议。核心结局集的结果将按照核心结局集报告标准（COS-STAR）指南进行报告，发表在国际期刊上，在会议上展示，并分发给参与者以供临床应用。
本研究很有必要，因为为未来中医治疗紧张型头痛的临床研究制定核心结局集可以最大限度地提高单个试验数据的价值，并提供高质量的研究证据。
有效性试验核心结局测量计划1473；https://tinyurl.com/3ts62s2p。
国际注册报告识别号（IRRID）：PRR1-10.2196/63481。
