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Summary of the theoretical framework of outcome for clinical efficacy evaluation |
ZHANG Ying1* CHEN Hong2* SUN Ya’nan3 YU Changhe2 |
1.Department of the First Clinical, Beijing University of Chinese Medicine, Beijing 100700, China;
2.Department of Tuina and Pain Management, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing 100700, China;
3.Department of Traditional Chinese Medicine, Xuanwu Hospital Capital Medical University, Beijing 100053, China |
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Abstract No consensus has been reached on the taxonomy and terminology of outcome, which hinders the comparison and merger of outcomes between studies. This study narrates and synthesizes nine outcome frameworks, including World Health Organization’s definition of health, 5Ds, international classification of functioning, patient-reported outcomes measurement information system, Porter’s outcome hierarchy, health-related quality of life conceptual model, outcome measurement in rheumatdogy Filter 2.0 core set, Cochrane outcome framework, and Williamson/Clarke outcome, introduces and compare framework’ contents. It is concluded that the Williamson/Clarke outcome framework has a clear hierarchical structure and comprehensive content, which is suitable for the taxonomy of all disease outcomes, and clarify the consistency of outcome expression between studies. It should be recommended in clinical trials and practice.
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