Abstract
PURPOSE: Symptom assessment is central to appropriate adenomyosis management. Using a WeChat mini-program-based portal, we aimed to establish a valid symptom assessment scale of adenomyosis (AM-SAS) to precisely and timely identify needs of symptom management and ultimately, to alert disease recurrence. METHODS: A combination of intensive interviews of patients with adenomyosis and natural language processing on WeChat clinician-patient group communication was used to generate a pool of symptom items-related to adenomyosis. An expert panel shortened the list to form the provisional AM-SAS. The AM-SAS was built in a Wechat mini-programmer and sent to patients to exam the psychotically validity and clinical applicability through classic test theory and item response theory. RESULTS: Total 338 patients with adenomyosis (29 for interview, 179 for development, and 130 for external validation) and 86 gynecologists were included. The over 90% compliance to the WeChat-based symptom evaluate. The AM-SAS demonstrated the uni-dimensionality through Rasch analysis, good internal consistency (all Cronbach's alphas above 0.8), and test-retest reliability (intraclass correlation coefficients ranging from 0.65 to 0.84). Differences symptom severity score between patients in the anemic and normal hemoglobin groups (3.04 ± 3.17 vs. 5.68 ± 3.41, P < 0.001). In external validation, AM-SAS successfully detected differences in symptom burden and physical status between those with or without relapse. CONCLUSION: Electronic PRO-based AM-SAS is a valuable instrument for monitoring AM-related symptoms. As an outcome measure of multiple symptoms in clinical trials, the AM-SAS may identify patients who need extensive care after discharge and capture significant beneficial changes of patients may have been overlooked. TRIAL REGISTRATION: This trial was approved by the institutional review board of the Chongqing Medical University and three participating hospitals (Medical Ethics Committee of Nanchong Central Hospital, Medical Ethics Committee of Affiliated Hospital of Southwest Medical University, and Medical Ethics Committee of Haifu Hospital) and registered in the Chinese Clinical Trial Registry (registration number ChiCTR2000038590), date of registration was 26/10/2020.