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Identifying important outcome domains for chronic pain clinical trials: an IMMPACT survey of people with pain.确定慢性疼痛临床试验的重要结局领域:对疼痛患者的IMMPACT调查
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患者报告结果测量信息系统(PROMIS)疼痛行为条目库的开发与心理测量分析

Development and psychometric analysis of the PROMIS pain behavior item bank.

作者信息

Revicki Dennis A, Chen Wen-Hung, Harnam Neesha, Cook Karon F, Amtmann Dagmar, Callahan Leigh F, Jensen Mark P, Keefe Francis J

机构信息

Center for Health Outcomes Research, United BioSource Corporation, 7101 Wisconsin Ave., Suite 600, Bethesda, MD 20814, USA.

出版信息

Pain. 2009 Nov;146(1-2):158-69. doi: 10.1016/j.pain.2009.07.029. Epub 2009 Aug 15.

DOI:10.1016/j.pain.2009.07.029
PMID:19683873
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2775487/
Abstract

The measurement of pain behavior is a key component of the assessment of persons with chronic pain; however, few self-reported pain behavior instruments have been developed. We developed a pain behavior item bank as part of the Patient-Reported Outcome Measurement Information System (PROMIS). For the Wave I testing, because of the large number of PROMIS items, a complex sampling approach was used where participants were randomly assigned to either respond to two full-item banks or to multiple 7-item blocks of items. A web-based survey was designed and completed by 15,528 members of the general population and 967 individuals with different types of chronic pain. Item response theory (IRT) analysis models were used to evaluate item characteristics and to scale both items and individuals on the pain behavior domain. The pain behavior item bank demonstrated good fit to a unidimensional model (Comparative Fit Index = 0.94). Several iterations of IRT analyses resulted in a final 39-item pain behavior bank, and different IRT models were fit to the total sample and to those participants who experienced some pain. The results indicated that these items demonstrated good coverage of the pain behavior construct. Pain behavior scores were strongly related to pain intensity and moderately related to self-reported general health status. Mean pain behavior scores varied significantly by groups based on pain severity and general health status. The PROMIS pain behavior item bank can be used to develop static short-form and dynamic measures of pain behavior for clinical studies.

摘要

疼痛行为的测量是慢性疼痛患者评估的关键组成部分;然而,很少有自我报告的疼痛行为工具被开发出来。作为患者报告结局测量信息系统(PROMIS)的一部分,我们开发了一个疼痛行为项目库。在第一轮测试中,由于PROMIS项目数量众多,采用了一种复杂的抽样方法,参与者被随机分配去回答两个完整的项目库或多个7项的项目块。设计并完成了一项基于网络的调查,共有15528名普通人群成员和967名患有不同类型慢性疼痛的个体参与。使用项目反应理论(IRT)分析模型来评估项目特征,并在疼痛行为领域对项目和个体进行量表化。疼痛行为项目库显示出对单维模型的良好拟合(比较拟合指数 = 0.94)。经过几次IRT分析迭代,最终形成了一个包含39个项目的疼痛行为库,不同的IRT模型适用于总样本以及那些经历过某种疼痛的参与者。结果表明,这些项目对疼痛行为结构有良好的覆盖。疼痛行为得分与疼痛强度密切相关,与自我报告的总体健康状况中度相关。根据疼痛严重程度和总体健康状况分组,平均疼痛行为得分有显著差异。PROMIS疼痛行为项目库可用于开发用于临床研究的静态简表和动态疼痛行为测量方法。