PROMIS Validation in Prospective Population-based Prostate Cancer Research Study

基于人群的前瞻性前列腺癌研究中的 PROMIS 验证

• 批准号: 8458339
• 负责人: Ronald Chen
• 金额: $ 28.39万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-21 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8458339
• 关键词: Adoption; African American; Aftercare; Age; Anxiety; Award; Cancer Patient; Cancer Survivor; Chronic Disease; Cohort Studies; Comorbidity; Complement; Computers; Data; Data Reporting; Development; Diagnosis; Disease; Education; Evaluation; Familiarity; Fatigue; Functional disorder; General Population; Grant; Health; High Prevalence; Illness impact; Impairment; Information Systems; Institute of Medicine (U.S.); Intervention; Interview; Interviewer; Intestines; Knowledge; Literature; Malignant Neoplasms; Malignant neoplasm of prostate; Measurement; Measures; Mental Depression; Methodology; Methods; Modeling; Names; North Carolina; Not Hispanic or Latino; Outcome Measure; Outcomes Research; Participant; Patient Outcomes Assessments; Patients; Performance; Population; Property; Prospective Studies; Psychometrics; Public Health; Publishing; Questionnaires; Race; Relative (related person); Reporting; Research; Research Personnel; Sampling; Self-Administered; Sex Functioning; Site; Sleep; Staging; Structure of base of prostate; Subgroup; Surveys; Survivors; Symptoms; Telephone; Testing; Time; United States Agency for Healthcare Research and Quality; United States National Institutes of Health; Universities; Validation; Validity and Reliability; age group; aged; anticancer research; cancer care; cancer therapy; clinically relevant; cohort; comparative effectiveness; effectiveness research; experience; health related quality of life; high school; innovation; men; multidisciplinary; population based; prospective; psychosocial; research study; response; sex; survivorship; theories; trend; urinary

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.

描述（由申请人提供）：使用创新的定性和定量方法，患者报告结局测量信息系统（PROMIS（r））倡议开发了高质量和临床相关的患者报告结局测量，用于评价疾病和干预措施对患者生活的影响。本研究将通过在参与前瞻性比较有效性研究（CER）研究的前列腺癌男性人群队列中进行广泛的心理测量评估，增加对PROMIS措施的可靠性、有效性和反应性的新知识。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填问卷。该评估还将包括最近开发的PROMIS领域，包括性功能、心理社会疾病影响、睡眠相关损害和胃肠症状--这些与前列腺癌患者相关。医学研究所的一份报告指出，前列腺癌治疗的CER是前100名的优先事项，北卡罗来纳州大学获得了医疗保健研究质量机构的资助，进行了一项前瞻性研究。北卡罗来纳州前列腺癌比较有效性和生存率研究是一项基于人群的队列研究，包括1,400名不同种族、教育和年龄水平的前列腺癌患者。参与者通过电话采访提供患者报告的数据，这些数据涉及治疗前以及治疗后3个月、12个月和24个月的健康相关生活质量（HRQOL）。这些时间点是关键的，因为多项研究已经记录了许多症状（即，性、泌尿和肠功能障碍;还有疲劳、抑郁、焦虑）从治疗前到治疗后显著增加，然后在12个月和24个月时部分恢复。这一趋势提供了一个很好的机会，以评估的反应，并估计最低限度的重要差异的PROMIS措施。具体目标包括：目标1：使用项目反应理论模型和其他心理测量方法评估PROMIS测量的测量属性。目标二：评价PROMIS指标检测不同年龄组、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。目标3：评价PROMIS指标相对于传统指标的反应性，以检测从基线（治疗前）到治疗后2年的有临床意义的变化。目标4：关键前列腺癌亚组（包括种族、教育和年龄）的PROMIS指标的测量等效性测试。目的5：评估电话访谈和计算机自填式调查评估模式的测量等效性。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。 公共卫生声明：使用创新的定性和定量方法，美国国立卫生研究院患者报告的结果测量信息系统（R）（PROMIS（R））倡议已经开发出高质量和临床相关的患者报告的措施，用于评估疾病和干预措施对患者生活的影响。本研究将通过在参与前瞻性比较有效性研究（CER）研究的前列腺癌男性人群队列中进行广泛的心理测量评估，增加对PROMIS措施的可靠性、有效性和反应性的新知识。研究结果将提供PROMIS指标的关键验证数据，并将为在前列腺癌CER和结局研究中采用PROMIS指标提供信息。