ICON Clinical Research, Abingdon, Oxfordshire, UK.
Formerly ICON Clinical Research, San Francisco, California, USA.
Value Health. 2018 Sep;21(9):1104-1114. doi: 10.1016/j.jval.2018.02.006. Epub 2018 Apr 12.
To evaluate the measurement properties of four performance outcome (PerfO) measures (timed up and go, four-step stair climb, long stair climb, and repeated chair stand) in three patient populations(elective total hip replacement [eTHR], elective total knee replacement [eTKR], and hip fracture [HF]).
A cross-sectional and longitudinal design was used to assess the PerfO measurement properties using the US Food and Drug Administration guidance for industry around patient-reported outcome measures to support labeling claims. Patient-reported outcome measures and patient- and clinician-reported global concept items were completed along with four PerfO measures at visit 1 and two follow-up visits. Measurement properties assessed included reliability, construct validity, ability to detect change, and estimates of meaningful change.
A total of 280 patients (100 eTHR, 105 eTKR, and 75 HF) were recruited, with most (n = 276) providing data at visit 1. Most of the patients were female (64%) and retired (64%), and had at least one comorbidity (91%). Inter-rater and test-retest reliability ranged from good to excellent (0.73 ≤ intraclass correlation coefficient ≤ 0.95) for each PerfO measure. Known-groups validity was demonstrated for all PerfO measures, with those reporting less pain better physical functioning and those who did not use an assistive device having quicker mean completion times. Construct validity and ability to detect change were demonstrated and estimates of meaningful change derived.
This study found the measurement properties of four PerfO measures in samples of patients with eTHR, eTKR, and HF to be supported for consideration of future use, and provided estimates for interpretation of change.
评估四种绩效结局(PerfO)测量(计时起立行走、四步登梯、长登梯和反复坐立)在三种患者人群(择期全髋关节置换术[eTHR]、择期全膝关节置换术[eTKR]和髋部骨折[HF])中的测量性能。
采用横断面和纵向设计,根据美国食品和药物管理局(FDA)关于支持标签声明的患者报告结局测量指南,评估 PerfO 的测量性能。在第 1 次就诊时,患者报告结局测量和患者及临床医生报告的整体概念项目,以及四项 PerfO 测量,在 2 次随访中完成。评估的测量性能包括可靠性、结构效度、改变检测能力和有意义变化的估计。
共招募了 280 名患者(100 例 eTHR、105 例 eTKR 和 75 例 HF),其中大多数(n=276)在第 1 次就诊时提供了数据。大多数患者为女性(64%)和退休人员(64%),至少有 1 种合并症(91%)。每项 PerfO 测量的组内相关系数为 0.73~0.95,表明其具有良好到极好的观察者间和重测信度。所有 PerfO 测量均显示出已知组间的有效性,报告疼痛程度较低的患者具有更好的躯体功能,不使用辅助器具的患者完成时间更快。已证明结构有效性和改变检测能力,且得出有意义变化的估计值。
本研究发现,在接受 eTHR、eTKR 和 HF 治疗的患者样本中,四种 PerfO 测量的测量性能得到支持,可考虑未来使用,并提供了对变化的解释估计。