中医整体观下中医卒中后失语患者报告结局量表研制

Development of A Patient-reported Outcomes Scale for Post-stroke Aphasia Based on Traditional Chinese Medicine Holism

目的研制中医整体观指导下的卒中后失语患者报告结局(PRO)量表。方法根据PRO量表研制规范,参考中医整体观,构建理论模型;通过病例回顾法、患者访谈法、专家问卷调查法、共识会议法,建立并优化条目池,编制量表。结果围绕生理、心理、社会领域,构建基于中医整体观的条目池。通过对条目池整理,形成专家评议表。结合专家调查和会议讨论结果,最终筛选出40项条目,形成中医卒中后失语患者报告结局量表(第一版)。结论构建了基于中医整体观的中医卒中后失语患者报告结局量表,可供进一步临床验证。

Objective To develop a patient-reported outcomes(PRO)scale for post-stroke aphasia based on the Traditional Chinese Medicine(TCM)holism.Methods Referring to the TCM holism,the theoretical model was established following the standard process for the development of the PRO scale.An item pool was established and optimized with case review,patient interview,expert questionnaire survey and consensus conference.The PRO scale was established finally.Results A pool of post-stroke aphasia items based on the holistic view of TCM was constructed in the physical,psychological and social model.The Expert Comment Form for the PRO Scale for Aphasia after Stroke was formed after sorting out the item pool.After expert surveys and meeting discussion,40 items were finally selected to form the first version of Patient-reported Outcomes Scale for Post-stroke Aphasia-TCM.Conclusion The first version of Patient-reported Outcomes Scale for Post-stroke Aphasia-TCM has been developed based on the TCM holism and the concept of PRO,which can be evaluated clinically.