ICON Clinical Research, Abingdon, Oxfordshire, UK.
Formerly ICON Clinical Research, Oxford, Oxfordshire, UK.
Value Health. 2018 Sep;21(9):1115-1123. doi: 10.1016/j.jval.2018.02.005. Epub 2018 Apr 11.
To assess the content validity of performance outcome (PerfO) measures for use with patients undergoing hip fracture (HF) surgery and elective total hip replacement (eTHR).
This study was a substudy of a broader evaluation of measurement properties of PerfO measures. The PerfO measures assessed were timed up and go (TUG), four-step stair climb (4SC), long stair climb (LSC), and repeated chair stand (RCS). For this substudy, HF and eTHR participants were interviewed to evaluate the relevance and difficulty of each PerfO measure. Qualitative analysis was conducted on interview transcripts, and summaries of coded data were produced to assess saturation.
All 18 HF participants related the PerfO measures (TUG, 4SC, and RSC) to activities they completed in daily life, with slight variations in some specific aspects. For the eight eTHR participants, the correspondence between the PerfO measures (TUG, 4SC, and LSC) and activities in daily life varied: all participants saw similarity in the movements for the TUG; most undertook short stair climbs in daily life, but most did not regularly undertake LSC in daily life. Nevertheless, all HF and eTHR participants reported that the PerfO measures were relevant and had a level of difficulty similar to daily activities.
This study contributes novel methods that adapt US regulatory guidance for patient-reported outcome measures to the evaluation of PerfO measures. A structured approach was used to explore specific details of each measure and correspondence to everyday life. This study demonstrates how content validity of PerfO measures can be meaningfully assessed.
评估用于髋部骨折(HF)手术和择期全髋关节置换术(eTHR)患者的表现结果(PerfO)测量的内容效度。
本研究是对 PerfO 测量的更广泛测量特性评估的子研究。评估的 PerfO 测量包括计时起立行走(TUG)、四步楼梯爬(4SC)、长楼梯爬(LSC)和重复椅子站立(RCS)。对于本子研究,HF 和 eTHR 参与者接受了访谈,以评估每个 PerfO 测量的相关性和难度。对访谈记录进行了定性分析,并生成了编码数据的摘要,以评估饱和度。
所有 18 名 HF 参与者都将 PerfO 测量(TUG、4SC 和 RCS)与他们在日常生活中完成的活动联系起来,有些特定方面略有不同。对于 8 名 eTHR 参与者,PerfO 测量(TUG、4SC 和 LSC)与日常生活活动之间的对应关系各不相同:所有参与者都看到 TUG 运动的相似性;大多数人在日常生活中进行短楼梯爬,但大多数人在日常生活中不经常进行 LSC。然而,所有 HF 和 eTHR 参与者都报告说 PerfO 测量具有相关性,并且具有与日常活动相似的难度水平。
本研究为评估 PerfO 测量提供了新的方法,这些方法改编了美国患者报告结果测量的监管指南。使用结构化方法来探索每个测量的具体细节及其与日常生活的对应关系。本研究展示了如何有意义地评估 PerfO 测量的内容效度。