Physical Therapy Service, Maccabi Healthcare Services, 27 Hamered St, Tel Aviv, 68125, Israel.
Phys Ther. 2011 Jul;91(7):1072-84. doi: 10.2522/ptj.20100175. Epub 2011 May 19.
Comparative effectiveness research (CER) requires valid outcome measures that discriminate patients by risk factors in similar ways across settings. Standardized functional status (FS) measures in physical therapy are used routinely in multiple countries, creating the potential for CER among countries.
The purpose of this study was to assess known-groups construct validity of a knee-specific FS measure within and between 2 countries for patients receiving outpatient physical therapy due to knee impairments.
This was a longitudinal, observational cohort study.
The participants were 4,972 and 2,964 adult (age ≥18 years) patients with knee impairments from Israel and the United States, respectively. Differences in patient characteristics between the 2 countries were assessed using chi-square statistics and 2-sample t tests, as appropriate. Known-groups validity within and between the countries was assessed using 2-way analysis of covariance predicting FS at discharge, with sex, age, symptom acuity, surgical and exercise history, intake medication use, and country as risk-adjustment factors. Intake FS was the covariate. To compare how FS discriminated patient groups between countries, each factor was tested separately with models including an interaction term between the factor and country.
Patients were different between countries but had similar discharge FS trends, including: higher outcomes in patients who were male, were younger, had acute conditions, had one surgical procedure related to their knee impairment, were more physically active, and did not use related medication at admission. Interactions were not significant for sex, symptom acuity, and exercise history but were significant for age, surgical history, and medication use. Limitations Although strict patient selection criteria were set, some patient selection bias still might have existed.
The results demonstrated the knee FS measures would be valid for use in CER between Hebrew-speaking patients (Israel) and English-speaking patients (United States).
比较疗效研究（CER）需要有效的结局测量指标，这些指标能够以相似的方式根据风险因素区分患者在不同环境下的情况。在物理治疗中，标准化的功能状态（FS）测量指标在多个国家得到常规应用，这为国家间的 CER 提供了可能性。
本研究旨在评估一种膝关节特定 FS 测量指标在 2 个国家的门诊物理治疗患者中，用于评估已知群体的结构有效性。
这是一项纵向、观察性队列研究。
参与者分别为来自以色列和美国的 4972 名和 2964 名成年（年龄≥18 岁）膝关节受损患者。使用卡方检验和两样本 t 检验，评估两国间患者特征的差异。使用两因素协方差分析，以性别、年龄、症状严重程度、手术和运动史、摄入药物使用以及国家作为风险调整因素，预测出院时的 FS，评估国家内和国家间的已知群体有效性。入院 FS 为协变量。为了比较 FS 在国家间如何区分患者群体，使用包括该因素与国家之间交互项的模型，分别测试每个因素。
患者在国家间存在差异，但出院 FS 趋势相似，包括：男性、年龄较小、急性疾病、与膝关节损伤相关的单一手术、更活跃的身体活动以及入院时未使用相关药物的患者，其结局更高。性别、症状严重程度和运动史的交互作用不显著，但年龄、手术史和药物使用的交互作用显著。
尽管设定了严格的患者选择标准，但仍可能存在一定程度的患者选择偏倚。
结果表明，膝关节 FS 测量指标将在希伯来语患者（以色列）和英语患者（美国）之间的 CER 中有效。
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