慢性腰背痛中医临床研究核心结局指标集的构建与优化

The inconsistent report of outcome indexes, measurements and the treatment response criteria have been shown among the clinical trials of Chronic Back Pain (CBP). Such problems failed the meta analyses in systematic review, leading to the low-level medical evidence. At abroad, the Core Outcomes Sets (COS) of CBP (COS-CBP) have been established to solve such problems. However, the foreign COS-CBP does not work to the TCM clinical studies of CBP, due to that the foreign COS-CBP cannot reflect the TCM characteristics in clinical studies, and that the COSs from foreign studies are inconsistent between each other, and the measurements recommended by the foreign COSs lack psychometric property in China. Besides, the COS-CBP who reflects the TCM characteristics in studies among Chinese population has not been established. Therefore, based on the methods and results from previous studies, this study aims to establish and optimize the COS-CBP and their Core Measurements Sets (CMS-CBP) for the TCM clinical study for CBP. The checklists of core outcomes and measurements will be formed from the literature review, experts' recommendation and existing foreign COSs. The COS-CBP and CMS-CBP will be established based on the checklists through the Delphi method and consensus meeting. After the establishment, the recommended measurements will be tested and optimized with the clinical practice data. Along with the results of COS-CBP and CMS-CBP, the methodology of COS establishment for TCM will be discussed and explored. This study will help improve the quality of methodology in the Chinese clinical studies, and provide the scientific and reasonable clinical decision-making.

慢性腰背痛（CBP）临床研究中存在报告指标、测量工具、判效标准不一致问题，导致研究结果不能纳入系统评价或Meta分析，无法提供高级别的证据。国外建立CBP核心结局指标集（COS-CBP）来解决此问题，但由于西医COS不能反映中医临床研究特点、国外COS-CBP结果不一致、推荐工具缺少我国的测量学性能评价等问题，导致国外成果不适合中医临床研究，而且我国尚未构建适合中医临床研究的COS-CBP。因此，基于前期中医药COS构建方法与实例研究，本项目构建中医临床研究COS-CBP及核心指标测量工具集（CMS-CBP），以适应CBP中医临床研究。基于文献、专家推荐等建立CBP中医临床研究的结局指标及测量工具清单，通过2-3轮德尔菲调查问卷与专家共识会议构建COS-CBP及CMS-CBP，进而通过临床实践对其进行检验、优化，并探索构建中医药COS的方法学流程，提高国内临床研究质量，提供科学临床决策。

腰痛影响60%-80%的世界人口，其中20%的人发展为慢性腰痛（Chronic Back Pain, CBP）。针对CBP临床研究中结局指标、测量工具异质性的问题，课题组构建具有循证证据支持的慢性腰痛中医临床研究的核心结局指标集（COS-CBP，Core Outcome Sets of Chronic Back Pain）及核心结局指标测量工具集（CMS-CBP，Core Measures Sets of Chronic Back Pain, CMS-CBP）。.结合慢性腰痛临床试验系统评价、定性Meta、专家推荐与患者访谈及国外相关COS-CBP，共有57个结局指标及348个结局指标测量工具进入结局指标池。经过两轮德尔菲调查，共有10个结局指标进入专家共识会议，这10个结局指标分别是有效率、肌肉相关结局、疼痛或不适、运动功能、日常生活活动能力、腰部功能障碍、疾病病程、疾病发作频率、对生活质量的影响和安全性指标。经过最终的专家共识会议，构建的COS-CBP是：疼痛或不适、运动功能、日常生活活动能力、腰部功能障碍、对生活质量的影响和安全性指标。其对应的CMS-CBP为：疼痛或不适用数字评分(Numerical Rating Scale-Pain, NRS-P)和视觉模拟评分（Visual Analogue Scale/Score-Pain, VAS-P）量表测量；运动功能用功能评分指数（Functional Rating Index, FRI）测量；日常生活活动能力用日常生活活动能力评分（Activities of Daily Living, ADL）量表测量；腰部功能障碍用Oswestry功能障碍指数（the Oswestry Disability Index, ODI）测量；对生活质量的影响用健康调查36条目简表(36-Item Short Form Survey, SF-36)测量；安全性指标无对应的测量工具。其对应的测量时间点是治疗前；治疗后即刻；治疗后1周、2周、4周和8周。.课题组基于医患共建理念所构建的COS-CBP及COS-CMP为慢性腰背痛疗效评价提供多视角观点，为慢性腰痛临床实践及试验提供循证证据，还可以为中医临床研究COS的构建提供方法学参考，具有广泛的实用价值和理论指导意义。