PDF(Pubmed)
Abstract：
BACKGROUND: This qualitative research study was conducted to develop a novel, comprehensive, patient-reported outcome measure (PRO), the \"Symptoms and Impacts of Androgen Deprivation Therapy (ADT) for Prostate Cancer\" (SIADT-PC), assessing hormonal therapy-related symptoms and their impacts on men with advanced prostate cancer.
METHODS: Concept elicitation (CE) interviews were conducted among adult men with prostate cancer to evaluate their experiences with ADT. Based on key symptom and impact concepts mentioned, an initial PRO measure was developed. The draft measure was further assessed in cognitive debriefing (CD) interviews with men with prostate cancer, in which participants reviewed items, response options, and recall periods. Initial item-based psychometric analyses were conducted using interview data. The draft questionnaire was revised on the basis of participant feedback, quantitative psychometric results, and consultation with clinical experts.
RESULTS: A total of 21 participants were interviewed (CE concept elicitation, n = 12; CD cognitive debriefing, n = 17; n = 8 completed both). Mean participant age (SD) was 59.7 (8.7) years and 76.2% were white. The de novo SIADT-PC measure consists of 27 items: 11 symptoms (e.g., fatigue, hot flashes, and erectile dysfunction), 2 long-term symptoms (e.g., weight gain), 10 impacts (e.g., impacts on physical activities and relationships), and 4 related to mode of administration (i.e., injection-site reactions). Items were assessed with a 5-point verbal rating scale, with answer choices that capture frequency or severity.
CONCLUSIONS: Once fully validated, this de novo measure may be used in clinical studies and clinical practice to assess hormone therapy-related symptoms and impacts, enabling physicians to identify timely and appropriate interventions.
METHODS: Concept elicitation (CE) interviews were conducted among adult men with prostate cancer to evaluate their experiences with ADT. Based on key symptom and impact concepts mentioned, an initial PRO measure was developed. The draft measure was further assessed in cognitive debriefing (CD) interviews with men with prostate cancer, in which participants reviewed items, response options, and recall periods. Initial item-based psychometric analyses were conducted using interview data. The draft questionnaire was revised on the basis of participant feedback, quantitative psychometric results, and consultation with clinical experts.
RESULTS: A total of 21 participants were interviewed (CE concept elicitation, n = 12; CD cognitive debriefing, n = 17; n = 8 completed both). Mean participant age (SD) was 59.7 (8.7) years and 76.2% were white. The de novo SIADT-PC measure consists of 27 items: 11 symptoms (e.g., fatigue, hot flashes, and erectile dysfunction), 2 long-term symptoms (e.g., weight gain), 10 impacts (e.g., impacts on physical activities and relationships), and 4 related to mode of administration (i.e., injection-site reactions). Items were assessed with a 5-point verbal rating scale, with answer choices that capture frequency or severity.
CONCLUSIONS: Once fully validated, this de novo measure may be used in clinical studies and clinical practice to assess hormone therapy-related symptoms and impacts, enabling physicians to identify timely and appropriate interventions.
摘要：
背景：这项定性研究旨在开发一种新颖的，全面,患者报告结果测量(PRO)，“前列腺癌雄激素剥夺治疗(ADT)的症状和影响”(SIADT-PC)，评估激素治疗相关症状及其对晚期前列腺癌男性的影响.
方法：对患有前列腺癌的成年男性进行概念启发（CE）访谈，以评估他们的ADT经历。根据提到的关键症状和影响概念，制定了初步的PRO措施。在对前列腺癌男性的认知汇报（CD）访谈中进一步评估了该草案。参与者审查了项目，响应选项,和召回期。使用访谈数据进行了基于项目的初始心理测量分析。问卷草案是在参与者反馈的基础上修订的，定量心理测量结果，并咨询临床专家。
结果：总共对21名参与者进行了访谈（CE概念启发，n=12；CD认知汇报，n=17；n=8完成两者）。参与者平均年龄（SD）为59.7（8.7）岁，白人占76.2％。从头SIADT-PC测量包括27个项目：11个症状(例如，疲劳,潮热,和勃起功能障碍)，2长期症状(例如，体重增加)，10个影响(例如，对身体活动和人际关系的影响)，和4与给药模式相关(即，注射部位反应)。项目用5分口头评定量表进行评估，带有捕获频率或严重性的答案选择。
结论：一旦完全验证，这种从头测量可用于临床研究和临床实践，以评估激素治疗相关的症状和影响，使医生能够确定及时和适当的干预措施。
方法：对患有前列腺癌的成年男性进行概念启发（CE）访谈，以评估他们的ADT经历。根据提到的关键症状和影响概念，制定了初步的PRO措施。在对前列腺癌男性的认知汇报（CD）访谈中进一步评估了该草案。参与者审查了项目，响应选项,和召回期。使用访谈数据进行了基于项目的初始心理测量分析。问卷草案是在参与者反馈的基础上修订的，定量心理测量结果，并咨询临床专家。
结果：总共对21名参与者进行了访谈（CE概念启发，n=12；CD认知汇报，n=17；n=8完成两者）。参与者平均年龄（SD）为59.7（8.7）岁，白人占76.2％。从头SIADT-PC测量包括27个项目：11个症状(例如，疲劳,潮热,和勃起功能障碍)，2长期症状(例如，体重增加)，10个影响(例如，对身体活动和人际关系的影响)，和4与给药模式相关(即，注射部位反应)。项目用5分口头评定量表进行评估，带有捕获频率或严重性的答案选择。
结论：一旦完全验证，这种从头测量可用于临床研究和临床实践，以评估激素治疗相关的症状和影响，使医生能够确定及时和适当的干预措施。
