PDF(Pubmed)
Abstract：
OBJECTIVE: 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.
CONCLUSIONS: 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.
BACKGROUND: 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.
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.
CONCLUSIONS: 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.
BACKGROUND: 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.
摘要：
目的：症状评估是子宫腺肌病治疗的核心。使用基于微信小程序的门户，目的建立有效的子宫腺肌病症状评估量表(AM-SAS),准确、及时地识别症状管理的需求,提醒疾病复发。
方法：将对子宫腺肌病患者的强化访谈和基于微信临床医生-患者群交流的自然语言处理相结合，以生成与子宫腺肌病相关的症状项目库。一个专家小组缩短了名单，形成了临时的AM-SAS。AM-SAS构建在微信迷你程序员中，并通过经典测试理论和项目反应理论发送给患者以检查心理有效性和临床适用性。
结果：总共338例子宫腺肌病患者（访谈29例，179用于发展，和130个外部验证）和86个妇科医生被包括在内。对基于微信的症状进行90%以上的依从性评价。AM-SAS通过Rasch分析证明了单维性，良好的内部一致性(所有克朗巴赫的阿尔法都在0.8以上)，和重测可靠性(组内相关系数范围从0.65到0.84)。贫血和正常血红蛋白组患者的症状严重程度评分差异（3.04±3.17vs.5.68±3.41,P<0.001)。在外部验证中，AM-SAS成功检测到有或没有复发的患者之间症状负担和身体状况的差异。
结论：基于电子PRO的AM-SAS是监测AM相关症状的有价值的工具。作为临床试验中多种症状的结果指标，AM-SAS可以识别出院后需要广泛护理的患者，并捕捉到可能被忽视的患者的显著有益变化。
背景：该试验得到了重庆医科大学机构审查委员会和三家参与医院的批准（南充市中心医院医学伦理委员会，西南医科大学附属医院医学伦理委员会,和海富医院医学伦理委员会），并在中国临床试验注册中心注册（注册号ChiCTR2000038590），注册日期为2020年10月26日。
方法：将对子宫腺肌病患者的强化访谈和基于微信临床医生-患者群交流的自然语言处理相结合，以生成与子宫腺肌病相关的症状项目库。一个专家小组缩短了名单，形成了临时的AM-SAS。AM-SAS构建在微信迷你程序员中，并通过经典测试理论和项目反应理论发送给患者以检查心理有效性和临床适用性。
结果：总共338例子宫腺肌病患者（访谈29例，179用于发展，和130个外部验证）和86个妇科医生被包括在内。对基于微信的症状进行90%以上的依从性评价。AM-SAS通过Rasch分析证明了单维性，良好的内部一致性(所有克朗巴赫的阿尔法都在0.8以上)，和重测可靠性(组内相关系数范围从0.65到0.84)。贫血和正常血红蛋白组患者的症状严重程度评分差异（3.04±3.17vs.5.68±3.41,P<0.001)。在外部验证中，AM-SAS成功检测到有或没有复发的患者之间症状负担和身体状况的差异。
结论：基于电子PRO的AM-SAS是监测AM相关症状的有价值的工具。作为临床试验中多种症状的结果指标，AM-SAS可以识别出院后需要广泛护理的患者，并捕捉到可能被忽视的患者的显著有益变化。
背景：该试验得到了重庆医科大学机构审查委员会和三家参与医院的批准（南充市中心医院医学伦理委员会，西南医科大学附属医院医学伦理委员会,和海富医院医学伦理委员会），并在中国临床试验注册中心注册（注册号ChiCTR2000038590），注册日期为2020年10月26日。
