Background Perimenopausal depressive disorder (PDD) is a serious mood disorder that occurs before and after menopause, traditional Chinese medicine have advantages such as holistic regulation and syndrome differentiation and treatment in treating PDD, but currently lacks a specialized traditional Chinese medicine efficacy evaluation tool for PDD.
Objective To introduce patient-reported outcomes (PROs) and construct a PDD-PROs scale and its theoretical model under the guidance of traditional Chinese medicine theory.
Methods From April to June 2022, computer searches were conducted on databases such as CNKI, Wanfang Data, VIP, SinoMed, PubMed, Web of Science, and Cochrane Library for literature on traditional Chinese medicine treatment of PDD published up to April 17, 2022, and literature analysis was performed. From September to November 2022, a retrospective analysis of the medical records of 136 PDD patients who visited the outpatient departments of Shenzhen Hospital (Longgang), Beijing University of Chinese Medicine, and Dongfang Hospital of Beijing University of Chinese Medicine from January 2017 to August 2022 was conducted. Based on a self-designed interview outline, one-to-one semi-structured interviews with PDD patients were conducted to establish an item pool. A multidisciplinary expert consultation group related to PDD was selected and established, and three rounds of expert consensus using the Delphi method began in December 2022.
Results A total of 123 articles were included, involving 5 categories and 12 postmenopausal depression outcome evaluation scales. Retrospective medical record analysis and patient interviews showed that, the cumulative frequency of clinical symptoms of PDD was 1 465 times, involving 176 clinical symptoms. After three rounds of expert consensus using the Delphi method, the Traditional Chinese Medicine PROs Scale for PDD and its theoretical model were ultimately formed, including 4 dimensions (psychological dimension, physiological dimension, social dimension, and overall evaluation) and 43 items.
Conclusion This study introduced the internationally mature PROs, used literature analysis, medical record review, and patient interview methods to construct an item pool, and successfully constructed the PDD-PROs scale and its theoretical model through three rounds of expert consensus using the Delphi method under the guidance of traditional Chinese medicine theory, which can be used in the research of efficacy evaluation of traditional Chinese medicine TCM treatment for PDD.
