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.

To introduce patient-reported outcomes (PROs) and construct a PDD-PROs scale and its theoretical model under the guidance of traditional Chinese medicine theory.

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.

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.

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.

围绝经期抑郁障碍（PDD）是发生在绝经前后的一种严重情绪障碍，中医药治疗PDD具有整体调节、辨证论治等优势，但目前缺乏专用的中医药治疗PDD疗效评价工具。

引入患者报告结局（PROs），在中医理论指导下构建PDD-PROs量表及其理论模型。

2022年4—6月，使用计算机检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献服务系统（SinoMed）、PubMed、Web of Science、Cochrane Library建库至2022-04-17发表的中医药治疗PDD相关文献，并进行文献分析；2022年9—11月，选取2017年1月—2022年8月在北京中医药大学深圳医院（龙岗）、北京中医药大学东方医院门诊就诊的136例PDD患者的病历进行回顾性分析，并根据自拟访谈提纲对PDD患者进行一对一半结构化访谈，建立条目池；筛选并建立PDD相关多学科专家咨询小组，2022年12月开始进行3轮Delphi法专家论证。

最终纳入文献123篇，涉及5类12个PPD结局评价量表；回顾性病历分析与患者访谈结果显示，PPD临床症状累计出现频次为1 465次，共涉及176个临床症状，经3轮Delphi法专家论证后，最终形成包含4个维度（心理维度、生理维度、社会维度、整体评价）43个条目的PDD中医PROs量表及理论模型。

本研究引入国际上应用较为成熟的PROs，运用文献分析法、病历回顾法、患者访谈法等构建条目池，通过3轮Delphi法专家论证，在中医理论指导下成功构建PDD-PROs量表及其理论模型，可供中医药治疗PDD疗效评价研究等参考使用。