Lubeck D P, Litwin M S, Henning J M, Carroll P R
Technology Assessment Group, San Francisco, CA 94107, USA.
Qual Life Res. 1997 Jul;6(5):385-92. doi: 10.1023/a:1018439528024.
This paper reviews the reliability and validity of an instrument for assessing health-related quality of life (HRQOL) in CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor), an observational database of men with biopsy-confirmed prostate cancer. The questionnaire includes the RAND 36 item Health Survey 1.0, the UCLA Prostate Cancer Index and items measuring self-esteem and the impact of prostate cancer in general and on the family. The reliability and validity of this instrument are reported for a group of 2,382 men enrolled in CaPSURE. Individuals complete HRQOL questionnaires at enrollment and quarterly thereafter. The subscales of the instrument resulted in a high internal-consistency reliability across all subscales (range = 0.75-0.94). The test-retest reliability was good with the exception of the comparative health item (intraclass correlation coefficient (ICC) = 0.55). The concurrent validity data included moderately strong associations with subscales of similar concepts and the ability to distinguish between patients who are known to be different--newly diagnosed (within 6 months) and patients diagnosed and treated an average of 3 years ago. Overall, this instrument demonstrated good reliability and validity and supported the need for incorporating HRQOL as a component of outcomes assessment in the management of patients with prostate cancer.
本文回顾了一种用于评估CaPSURE（前列腺癌战略泌尿学研究计划）中与健康相关生活质量（HRQOL）的工具的可靠性和有效性，CaPSURE是一个针对经活检确诊的前列腺癌男性的观察性数据库。该问卷包括兰德36项健康调查1.0、加州大学洛杉矶分校前列腺癌指数以及测量自尊以及前列腺癌对总体和家庭影响的项目。报告了该工具在一组纳入CaPSURE的2382名男性中的可靠性和有效性。个体在入组时以及此后每季度完成一次HRQOL问卷。该工具的各个分量表在所有分量表中都具有较高的内部一致性可靠性（范围 = 0.75 - 0.94）。重测可靠性良好，但比较健康项目除外（组内相关系数（ICC） = 0.55）。同时效度数据包括与类似概念的分量表有中度强关联，以及能够区分已知不同的患者——新诊断（6个月内）的患者和平均在3年前被诊断和治疗的患者。总体而言，该工具显示出良好的可靠性和有效性，并支持将HRQOL纳入前列腺癌患者管理的结果评估组成部分的必要性。
