PROMIS Validation in Prospective Population-based Prostate Cancer Research Study

描述（由申请人提供）：采用创新的定性和定量方法，患者报告结果测量信息系统（PROMIS(r)）计划开发了高质量和临床相关的患者报告结果测量方法，用于评估疾病和干预措施对患者生活的影响。本研究将通过对参与前瞻性比较有效性研究（CER）的前列腺癌患者人群队列进行广泛的心理测量评估，增加对PROMIS测量的可靠性、有效性和反应性的新认识。这包括跨种族、教育和年龄组的测量等效性测试，以及PROMIS测量的管理模式：通过电话访谈与计算机自我管理问卷。这项评估还将包括最近开发的PROMIS领域，包括性功能、社会心理疾病影响、睡眠相关损害和胃肠道症状——这些与前列腺癌患者相关。根据医学研究所的一份报告，前列腺癌的CER治疗是前100个优先事项，北卡罗莱纳大学从医疗保健研究质量机构获得了一笔拨款，用于开展一项前瞻性研究。北卡罗莱纳前列腺癌比较疗效和生存研究是一项基于人群的队列研究，包括1400名不同种族、教育程度和年龄水平的前列腺癌患者。参与者通过电话访谈提供患者报告的数据，包括治疗前、治疗后3个月、12个月和24个月的健康相关生活质量（HRQOL）。这些时间点是至关重要的，因为多项研究表明，从治疗前到治疗后，许多症状（即性、尿、肠功能障碍；还有疲劳、抑郁、焦虑）显著增加，然后在12个月和24个月时部分恢复。这种趋势为评估响应性和估计PROMIS措施的最小重要差异提供了极好的机会。目的1：利用项目反应理论模型和其他心理测量方法评价PROMIS量表的测量特性。目的2：评估PROMIS检测不同年龄组、种族、治疗类型和合并症状态的健康相关生活质量差异的能力。目的3：评估PROMIS措施相对于遗留措施的响应性，以检测从基线（预处理）到治疗后两年的临床有意义的变化。目的4：检验PROMIS对主要前列腺癌亚组的测量等效性，包括种族、教育程度和年龄。目的5：评价电话访谈和计算机自评调查两种评估模式的测量等效性。该多学科团队在心理测量学和前列腺癌护理和研究方面拥有丰富的经验。研究结果将为PROMIS在前列腺癌中的应用提供重要信息，并提供PROMIS措施的关键验证数据。

DESCRIPTION (provided by applicant): Using innovative qualitative and quantitative methodologies, the Patient-Reported Outcomes Measurement Information System(r) (PROMIS(r)) initiative has developed high quality and clinically relevant patient-reported outcomes measures to be used to evaluate the impact of both disease and interventions on patients' lives. This study will add new knowledge of the reliability, validity, and responsiveness of PROMIS measures through an extensive psychometric evaluation within a population-based cohort of men with prostate cancer participating in a prospective comparative effectiveness research (CER) study. This includes a test of measurement equivalence across race, education, and age groups, as well as mode of administration of the PROMIS measures: via phone interviewer versus computer self-administered questionnaire. This evaluation will also include recently developed PROMIS domains including Sexual Function, Psychosocial Illness Impact, Sleep Related Impairment, and Gastro-Intestinal Symptoms - which are relevant for prostate cancer patients. In response to an Institute of Medicine report that indicated CER of prostate cancer treatments as a top 100 priority, the University of North Carolina was awarded a grant from the Agency for Healthcare Research Quality to conduct a prospective study. The North Carolina Prostate cancer Comparative Effectiveness & Survivorship Study is a population-based cohort of 1,400 prostate cancer patients with diverse race, education and age levels. Participants provide patient-reported data through phone interviews on their health-related quality of life (HRQOL) pretreatment, and at 3, 12, and 24 months post-treatment. These time points are critical as multiple studies have documented that many symptoms (i.e., sex, urinary, and bowel dysfunction; also fatigue, depression, anxiety) increase significantly from pretreatment to post-treatment, and then partially recover by 12 and 24 months. This trend provides an excellent opportunity to evaluate the responsiveness and to estimate minimally important differences of the PROMIS measures. The specific aims include: Aim 1: Evaluate the measurement properties of the PROMIS measures using item response theory models and other psychometric methods. Aim 2: Evaluate the ability of PROMIS measures to detect differences in health-related quality of life across age groups, race groups, treatment types, and comorbidity status. Aim 3: Evaluate the responsiveness of the PROMIS measures relative to legacy measures to detect clinically meaningful changes from baseline (pretreatment) through two years post-treatment. Aim 4: Test for measurement equivalence for the PROMIS measures for key prostate cancer subgroups including race, education, and age. Aim 5: Evaluate measurement equivalence across assessment modes of phone interview and computer self-administered survey. The multi-disciplinary team has extensive experience in psychometrics and prostate cancer care and research. Study results will significantly inform both the use of PROMIS in prostate cancer and provide key validation data on the PROMIS measures. PUBLIC HEALTH STATEMENT: Using innovative qualitative and quantitative methodologies, the NIH Patient-Reported Outcomes Measurement Information System(r) (PROMIS(r)) initiative has developed high quality and clinically relevant patient-reported measures to be used to evaluate the impact of both disease and interventions on patients' lives. This study will add new knowledge of the reliability, validity, and responsiveness of PROMIS measures through an extensive psychometric evaluation within a population-based cohort of men with prostate cancer participating in a prospective comparative effectiveness research (CER) study. Study results will provide key validation data on the PROMIS measures and will inform the adoption of PROMIS measures in prostate cancer CER and outcomes research.