Medical Social Sciences, Northwestern University, 710 North LakeShore Drive, Chicago, IL 60611, USA.
J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
Patient-reported outcomes (PROs) are essential when evaluating many new treatments in health care; yet, current measures have been limited by a lack of precision, standardization, and comparability of scores across studies and diseases. The Patient-Reported Outcomes Measurement Information System (PROMIS) provides item banks that offer the potential for efficient (minimizes item number without compromising reliability), flexible (enables optional use of interchangeable items), and precise (has minimal error in estimate) measurement of commonly studied PROs. We report results from the first large-scale testing of PROMIS items.
Fourteen item pools were tested in the U.S. general population and clinical groups using an online panel and clinic recruitment. A scale-setting subsample was created reflecting demographics proportional to the 2000 U.S. census.
Using item-response theory (graded response model), 11 item banks were calibrated on a sample of 21,133, measuring components of self-reported physical, mental, and social health, along with a 10-item Global Health Scale. Short forms from each bank were developed and compared with the overall bank and with other well-validated and widely accepted ("legacy") measures. All item banks demonstrated good reliability across most of the score distributions. Construct validity was supported by moderate to strong correlations with legacy measures.
PROMIS item banks and their short forms provide evidence that they are reliable and precise measures of generic symptoms and functional reports comparable to legacy instruments. Further testing will continue to validate and test PROMIS items and banks in diverse clinical populations.
在评估医疗保健中许多新疗法时,患者报告的结果(PROs)至关重要;然而,目前的衡量标准受到缺乏精确性、标准化以及研究和疾病之间分数可比性的限制。患者报告的结果测量信息系统(PROMIS)提供了项目库,这些项目库具有高效(在不影响可靠性的情况下最小化项目数量)、灵活(允许可选使用可互换项目)和精确(估计误差最小)的潜力,可用于测量常用的 PROs。我们报告了 PROMIS 项目首次大规模测试的结果。
使用在线面板和诊所招募,在美国普通人群和临床人群中对 14 个项目库进行了测试。创建了一个量表设定子样本,反映了与 2000 年美国人口普查成比例的人口统计学。
使用项目反应理论(等级反应模型),在一个包含 21133 名参与者的样本上对 11 个项目库进行了校准,这些样本测量了自我报告的身体、心理和社会健康的组成部分,以及一个 10 项的全球健康量表。每个库都开发了简短形式,并与整个库以及其他经过良好验证和广泛接受的(“传统”)测量方法进行了比较。所有项目库在大多数分数分布中都表现出良好的可靠性。与传统测量方法的中度至强相关性支持了结构有效性。
PROMIS 项目库及其简短形式提供了证据,表明它们是可靠和精确的通用症状和功能报告测量方法,与传统仪器相当。进一步的测试将继续在不同的临床人群中验证和测试 PROMIS 项目和项目库。