膝骨关节炎中医证候患者报告结局评价量表的研制

The development of the knee osteoarthritis TCM syndrome evaluation scale as the Patient-Reported Outcome

目的：研制膝骨关节炎（knee osteoarthritis, KOA）中医证候患者报告结局（Patient-Reported Outcome, PRO）评价量表。方法通过查阅文献、访谈患者收集各种证候类型KOA的主观症状，整理归类后获得包含24个主观症状的原始条目池；通过专家问卷对原始条目的重要性进行评判，获得包含11个条目的KOA中医证候PRO评价量表条目池；根据患者对11个条目的关注程度，得到条目权重。结果获得包含疼痛、肿胀、僵硬等11个与KOA中医证候相关的PRO评价量表的条目，以及不同的条目权重。结论 KOA中医证候PRO评价量表把PRO评价量表形式引入中医证候疗效评价，符合中医证候疗效评价的自身规律与特点，可为中医疗法在KOA中医临床疗效评价中提供客观化、标准化的测量工具。

Objective To develop the knee osteoarthritis （KOA） TCM syndrome evaluation scale. Methods Resrarch team collected subjective symptoms from all kinds of syndrome types of KOA and classified the subjective symptoms, which formed the first version of item pool containing 24 subjective symptoms. Expert questionnaires were conducted to calculate the weight coefficient of items, and formed the item pool of the Knee Osteoarthritis TCM Syndrome Evaluation Scale. According to the patient＇s attention to the 11 items, the items were weighted.Results The Knee Osteoarthritis TCM Syndrome Evaluation Scale contained 11 items, including pain, swelling and stiffness with different weighted scores.Conclusions The Knee Osteoarthritis TCM Syndrome Evaluation Scale were introduced to assess the KOA outcomes on the basis of TCM syndromes. It showed the characteristic of TCM and TCM syndrome.It could provide an objective and standardized measurement for TCM treating KOA.