PROMIS Validation in Prospective Population-based Prostate Cancer Research Study

描述(申请人提供)：利用创新的定性和定量方法，患者报告结果测量信息系统(PROIS(R))倡议开发了高质量和临床相关的患者报告结果衡量标准，用于评估疾病和干预措施对患者生活的影响。这项研究将通过参加前瞻性比较有效性研究(CER)研究的前列腺癌男性人群中的广泛心理测量评估，增加关于PROMIS测量的可靠性、有效性和响应性的新知识。这包括对种族、教育程度和年龄组的测量等价性进行测试，以及PROMIS测量的管理模式：通过电话采访者与计算机自填式问卷。这项评估还将包括最近开发的PROMIS领域，包括与前列腺癌患者相关的性功能、心理社会疾病影响、睡眠相关障碍和胃肠道症状。为了回应一份医学研究所的报告，该报告将前列腺癌治疗的CER列为首要任务，北卡罗来纳大学获得了医疗保健研究质量机构的拨款，用于进行一项前瞻性研究。北卡罗来纳州前列腺癌比较有效性和存活率研究是一个基于人群的队列，1400名前列腺癌患者来自不同的种族、教育和年龄水平。参与者通过电话采访提供患者报告的治疗前以及治疗后3、12和24个月的健康相关生活质量(HRQOL)数据。这些时间点是至关重要的，因为多项研究证明，许多症状(即性功能障碍、排尿和肠道功能障碍；还有疲倦、抑郁、焦虑)从治疗前到治疗后显著增加，然后在12个月和24个月后部分恢复。这一趋势为评估PROMIS措施的反应性和估计最小的重要差异提供了一个极好的机会。具体目标包括：目标1：运用项目反应理论模型和其他心理测量学方法对PROMIS量表的测量特性进行评价。目的2：评估PROMIS措施检测不同年龄组、种族组、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措施相对于传统措施的响应性，以检测从基线(治疗前)到治疗后两年的临床有意义的变化。目的4：对包括种族、教育程度和年龄在内的关键前列腺癌亚组的PROMIS测量的测量等价性进行测试。目的5：评价电话访谈和计算机自测两种评价模式的测量等效性。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。研究结果将为前列腺癌的PROMIS的使用提供重要的信息，并提供关于PROMIS措施的关键验证数据。 公共卫生声明：利用创新的定性和定量方法，NIH患者报告结果测量信息系统(PROIS(R))倡议开发了高质量和临床相关的患者报告指标，用于评估疾病和干预措施对患者生活的影响。这项研究将通过参加前瞻性比较有效性研究(CER)研究的前列腺癌男性人群中的广泛心理测量评估，增加关于PROMIS测量的可靠性、有效性和响应性的新知识。研究结果将提供PROMIS措施的关键验证数据，并将为在前列腺癌CER和结果研究中采用PROMIS措施提供信息。

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.