QualityMetric, OptumInsight, 34 Albion Road, Bldg 400, Lincoln, RI 02865, USA.
Osteoporos Int. 2013 Sep;24(9):2423-32. doi: 10.1007/s00198-013-2317-6. Epub 2013 Mar 28.
This paper presents a multi-method research project to develop a conceptual framework for measuring outcomes in studies of osteoporotic kyphosis. The research involved literature research and qualitative interviews among clinicians who treat patients with kyphosis and among patients with the condition.
Kyphosis due to at least one vertebral compression fracture is prevalent among osteoporotic patients, resulting in well-documented symptoms and impact on functioning and well-being. A three-part study led to development of a conceptual measurement framework for comprehensive assessment of symptoms, impact, and treatment benefit for kyphosis.
A literature-based disease model (DM) was developed and tested with physicians (n = 10) and patients (n = 10), and FDA guidelines were used to develop a final disease model and a conceptual framework.
The DM included signs, symptoms, causes/triggers, exacerbations, and functional status associated with kyphosis. The DM was largely confirmed, but physicians and patients added several concepts related to impact on functioning, and some concepts were not confirmed and removed from the DM.
This study confirms the need for more comprehensive assessment of health outcomes in kyphosis, as most current studies omit key concepts.
本研究旨在开发一个用于评估骨质疏松性后凸畸形研究结局的概念框架，采用多方法研究项目。研究涉及文献研究和对治疗后凸畸形患者的临床医生以及患者的定性访谈。
骨质疏松性椎体压缩性骨折导致的后凸畸形在骨质疏松患者中较为常见，其导致的症状和对功能及健康状况的影响已有充分记录。该研究分为三部分，最终开发出了一个用于全面评估后凸畸形症状、影响和治疗获益的概念性测量框架。
基于文献的疾病模型（DM）与医生（n=10）和患者（n=10）共同开发和测试，并使用 FDA 指南制定最终的疾病模型和概念框架。
DM 包括后凸畸形相关的体征、症状、病因/诱因、加重因素和功能状态。DM 基本得到证实，但医生和患者增加了一些与功能影响相关的概念，一些概念没有得到证实并从 DM 中删除。
本研究证实，需要更全面地评估后凸畸形的健康结局，因为目前大多数研究都忽略了一些关键概念。
