ABSTRACT
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.