慢性便秘患者报告临床结局评估量表条目池的建立和筛选

Construction and screening of the item pool for the Patient-Reported Outcome of Chronic Constipation rating scale

目的:建立慢性便秘报告临床结局(patientreported outcome,PRO)评估量表(patient-reported outcome of chronic constipation rating scale,CC-PRO)条目池,对条目池进行初步筛选.方法:以患者为中心,遵循PRO量表制作指南(FDA,2009),在中医理论指导下建立病证结合的综合指标体系,具体研究方法如下:(1)提出量表理论模型,包括4个维度:生理(慢性便秘特有症状和证侯效应指标)、心理、社会和满意度;(2)通过文献法和访谈法,对慢性便秘患者自觉感受的相关描述进行典型收集,共96个条目,建立条目池初稿;(3)通过第一轮专家问卷和患者问卷对条目进行初次筛选,剩余63个条目;(4)按照量表条目设定要求对条目进行合并、删除和修改,实现条目池优化;(5)建立条目池,含45个条目,包括生理维度29项、心理维度9项、社会维度3项和满意度4项,并对条目量化;(6)进行第二轮专家问卷,根据专家意见修改条目及量化方法,剩余43个条目;(7)量表语言调适和要素完善,建立量表初稿;(8)量表初稿预调查,通过条目分布法、离散程度法、相关系数法、因子分析法、判别分析法和克郎巴赫?系数法对条目二次筛选;(9)确定量表评分方法;(10)建立CC-PRO V2.0.结果:量表条目池由96条削减为32条.CC-PRO V2.0最终含32个条目,其中生理维度慢性便秘特有症状指标10条,生理维度证侯效应指标9条,心理维度指标9条,社会维度指标2条,满意度指标2条.结论:量表条目池的建立和筛选按照多种方法进行,全面反映慢性便秘的内涵,且语言通俗易懂,具有较好的内容效度,为CC-PRO正式版的制定奠定基础.

AIM： To construct and screen the item pool for the Patient-Reported Outcome of Chronic Con- stipation rating scale （CC-PRO）.METHODS： Following the FDA guidelines onPRO, the synthetic index system combining symptom with syndrome was developed un- der the guidance of TCM theory. The theoreti- cal mode of the questionnaire was established, including four domains： physiology （specific symptom of chronic constipation and effect in- dex of syndrome）, psychological, society and satisfaction. Through literature search and in- terview, typical feelings of patients with chronic constipation, which included 96 items, were col- lected to establish the first draft of item pool. Af- ter screening the items using the first expert and patient questionnaire, 63 items were retained. The item pool was then optimized by combin- ing, deleting and revising the items according to the setting request of the questionnaire. The item pool containing 45 items, including physiology domain （29 items）, psychological domain （9 items）, society domain （3 items）, and satisfaction domain （4 items）, was obtained, and quantifica- tion of the item was performed. The presenta- tion and quantification of the item were then modified using the second expert questionnaire, and 43 items were retained. After accomplishing language polishing and consummating the im- portant elements of the questionnaire, the first draft of the questionnaire was obtained. Pre- investigation was then performed to screen the items for the second time on item distribution, dispersion degree, coefficient correlation, factor analysis, discriminating analysis and Cronbach a. The scoring method of the questionnaire was then determined, and the Patient-Reported Out- come of Chronic Constipation rating scale V2.0 was finally developed.RESULTS： The item pool was composed of 96 items. After the preliminary screening, there were 32 items remained, which consisted of 10 items on specific symptom of chronic constipa- tion, 9 for effect index of syndrome, 9 for psy- chological domain, 2 for society domain and 2 for satisfaction domain.CONCLUSION： The establishment and screen- ing of CC-PRO were implemented through a va- riety of ways. The preliminary items completely cover the body function, psychological function,and society function of patients and systemati- cally reflect the connotation of chronic constipa- tion, and the easy-to-understand language also contributes to good content-related validity.