骨质疏松症评估问卷——身体功能（OPAQ-PF）的开发：一种针对骨质疏松症的、患者报告的身体功能结局（PRO）测量方法。
Development of the Osteoporosis Assessment Questionnaire--physical Function (OPAQ-PF): an osteoporosis-targeted, patient-reported outcomes (PRO) measure of physical function.
作者信息
Naegeli A N, Nixon A, Burge R, Gold D T, Silverman S
机构信息
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA,
出版信息
Osteoporos Int. 2014 Feb;25(2):579-88. doi: 10.1007/s00198-013-2448-9. Epub 2013 Aug 9.
UNLABELLED
We have developed a short, patient-reported outcome questionnaire--the Osteoporosis Assessment Questionnaire--Physical Function (OPAQ-PF)--that assesses the impact of osteoporosis on physical function. OPAQ-PF contains 15 items in three domains (mobility, physical positions, and transfers) and has content validity in osteoporosis patients with and without a history of fracture.
INTRODUCTION
This paper describes the development of the Osteoporosis Assessment Questionnaire--Physical Function (OPAQ-PF), a patient-reported outcome (PRO) questionnaire based on OPAQ v.2.0 (60 items, 14 domains) that assesses the impact of osteoporosis on physical function.
METHODS
OPAQ v.2.0 was administered to patients with osteoporosis. Item response theory methodology and clinical judgment were used to retain/eliminate items. The resulting instrument was modified during two sets of concept elicitation and cognitive debriefing interviews with osteoporosis patients.
RESULTS
Item response theory-based analysis of OPAQ v.2.0 (n = 1,478) coupled with clinician input resulted in the generation of a 21-item, six-domain instrument with a frequency response format. Interview data from 32 participants were used to modify this version and led to generation of the final instrument, OPAQ-PF. This final version has a severity response format and contains 15 items in three domains (mobility, physical positions, and transfers) that group together to provide an overall assessment of physical function in patients with osteoporosis. Twenty-two of the 32 interview participants (69 %) had previously sustained a fracture. Symptoms occurred primarily in these patients.
CONCLUSIONS
OPAQ-PF represents a brief, focused, PRO instrument that assesses physical function in patients with osteoporosis, specifically related to mobility, physical positions, and transfers. This questionnaire has content validity in osteoporosis patients who have, and have not, sustained a prior fracture.
未标注
我们研发了一份简短的、由患者报告的结局问卷——骨质疏松症评估问卷——身体功能（OPAQ-PF），用于评估骨质疏松症对身体功能的影响。OPAQ-PF包含15个条目，分为三个领域（活动能力、身体姿势和转移），在有骨折史和无骨折史的骨质疏松症患者中均具有内容效度。
引言
本文描述了骨质疏松症评估问卷——身体功能（OPAQ-PF）的研发过程，这是一份基于OPAQ v.2.0（60个条目，14个领域）的患者报告结局（PRO）问卷，用于评估骨质疏松症对身体功能的影响。
方法
对骨质疏松症患者进行OPAQ v.2.0问卷调查。采用项目反应理论方法和临床判断来保留/剔除条目。在对骨质疏松症患者进行的两组概念激发和认知反馈访谈中，对所得工具进行了修改。
结果
基于项目反应理论对OPAQ v.2.0（n = 1478）进行分析，并结合临床医生的意见，生成了一份包含21个条目的、六个领域的具有频率反应格式的工具。来自32名参与者的访谈数据用于修改该版本，最终生成了最终工具OPAQ-PF。这个最终版本具有严重程度反应格式，包含15个条目，分为三个领域（活动能力、身体姿势和转移），这些领域共同构成对骨质疏松症患者身体功能的总体评估。32名访谈参与者中有22名（69%）曾发生过骨折。症状主要出现在这些患者中。
结论
OPAQ-PF是一份简短、针对性强的PRO工具，用于评估骨质疏松症患者的身体功能，特别是与活动能力、身体姿势和转移相关的功能。该问卷在有和没有既往骨折的骨质疏松症患者中均具有内容效度。
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