Cui Ying, Li Bo, Jiang Shiyi, Li Yuxian, Wang Sixuan
Department of Acupuncture, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, People's Republic of China.
Department of Acupuncture, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, People's Republic of China.
J Pain Res. 2025 Jul 28;18:3745-3756. doi: 10.2147/JPR.S533561. eCollection 2025.
To systematically review the current research status of Core Outcome Sets (COS) for pain-related diseases and to evaluate the methodological quality of existing COS.
Two researchers independently conducted a comprehensive search of both English and Chinese databases. Studies were screened and data were extracted based on predefined inclusion criteria. The methodological quality of the identified COS was assessed using the Core Outcome Set-STAndards for Development (COS-STAD), which includes 11 criteria covering the scope, stakeholder involvement, and the consensus process.
24 COS were included in the final analysis out of 2150 records initially identified. These COS were primarily developed by organizations or research teams in Europe, Asia, and North America. The included COS covered 22 pain-related disorders, most of which (8 [33%]) were classified as symptoms, signs, or clinical findings according to the ICD-11 classification. One or more of the eight recognized methodologies were used in developing each COS. The most common combination included systematic reviews, Delphi surveys, qualitative interviews, and consensus meetings (6 [25%]). Among key stakeholder groups, clinical experts were most frequently involved (22 [92%]), whereas industry representatives were less engaged (5 [21%]). Only 5 COS (20%) fully met the 11 COS-STAD criteria, indicating room for methodological improvement. The highest scores were for health issue coverage (24/24 points), followed by the involvement of healthcare professionals in reflecting disease experiences (23/24 points). In contrast, the average score for intervention coverage was lowest (15/24), followed by constructing the initial outcome list (18/24). These findings suggest that greater emphasis should be placed on incorporating the perspectives of both professionals and patients during the initial outcome selection process.
The development of Core Outcome Sets should adhere closely to guidelines established by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. Greater emphasis should be placed on the inclusion and evaluation of interventions. In addition, the perspectives of healthcare professionals and patients should be more thoroughly integrated during the design of the initial outcome list to enhance the relevance and applicability of COS in clinical practice.
系统回顾疼痛相关疾病核心结局集（COS）的当前研究现状，并评估现有COS的方法学质量。
两名研究人员独立对英文和中文数据库进行全面检索。根据预先定义的纳入标准筛选研究并提取数据。使用核心结局集-发展标准（COS-STAD）评估所确定的COS的方法学质量，该标准包括涵盖范围、利益相关者参与度和共识过程的11项标准。
在最初识别的2150条记录中，最终纳入分析24个COS。这些COS主要由欧洲、亚洲和北美的组织或研究团队制定。纳入的COS涵盖22种疼痛相关疾病，根据国际疾病分类第11版（ICD-11）分类，其中大部分（8个[33%]）被归类为症状、体征或临床发现。每个COS在制定过程中使用了一种或多种公认的方法。最常见的组合包括系统评价、德尔菲调查、定性访谈和共识会议（6个[25%]）。在关键利益相关者群体中，临床专家参与最为频繁（22个[92%]），而行业代表参与较少（5个[21%]）。只有5个COS（20%）完全符合11项COS-STAD标准，表明在方法学上有改进空间。得分最高的是健康问题覆盖范围（24/24分），其次是医疗保健专业人员参与反映疾病经历（23/24分）。相比之下，干预措施覆盖范围的平均得分最低（15/24），其次是构建初始结局列表（18/24）。这些发现表明，在初始结局选择过程中，应更加重视纳入专业人员和患者的观点。
核心结局集的制定应严格遵循有效性试验核心结局指标（COMET）倡议制定的指南。应更加重视干预措施的纳入和评估。此外，在设计初始结局列表时，应更全面地整合医疗保健专业人员和患者的观点，以提高COS在临床实践中的相关性和适用性。
