Oak Sameer R, Strnad Gregory J, Bena James, Farrow Lutul D, Parker Richard D, Jones Morgan H, Spindler Kurt P
Cleveland Clinic Orthopaedic and Rheumatologic Institute, Cleveland, Ohio, USA.
Cleveland Clinic Quantitative Health Sciences, Cleveland, Ohio, USA.
Orthop J Sports Med. 2016 Dec 17;4(12):2325967116674714. doi: 10.1177/2325967116674714. eCollection 2016 Dec.
The EuroQol 5 dimensions questionnaire (EQ-5D), Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Health, and Veterans RAND 12-Item Health Survey (VR-12) are generic patient-reported outcome (PRO) questionnaires that assess a patient's general health. In choosing a PRO to track general health status, it is necessary to consider which measure will be the most responsive to change after treatment. To date, no studies exist comparing responsiveness among the EQ-5D, PROMIS 10 Global Health, and the Veterans Rand 12-Item Health Survey (VR-12).
To determine which of the generic PROs are most responsive internally and externally in the setting of knee arthroscopy.
Cohort study (diagnosis); Level of evidence, 3.
Fifty patients who underwent knee arthroscopy were surveyed preoperatively and a mean 3.6 months postoperatively, with 90% follow-up. PROs included the EQ-5D, EQ-5D visual analog scale, PROMIS 10 Global Health (PROMIS 10) physical and mental components, VR-12 physical and mental components, and the Knee injury and Osteoarthritis Outcome Score (KOOS)-pain subscale. Internal responsiveness was evaluated by performing paired tests on the changes in measures and calculating 2 measures of effect size: Cohen and standardized response mean (SRM). External responsiveness was evaluated by comparing Pearson correlation measures between the disease-specific reference KOOS-pain and generic PROs.
For internal responsiveness, 3 PROs showed a statistically significant improvement in score after treatment (EQ-5D: +0.10 [95% CI, 0.06-0.15], VR-12 physical: +7.2 [95% CI, 4.0-10.4]), and PROMIS 10 physical: +4.4 [95% CI, 2.6-6.3]) and effect size statistics with moderate change (Cohen and SRM, 0.5-0.8). Assessing external responsiveness, a high correlation with the disease-specific reference (KOOS-pain score) was found for EQ-5D (0.65), VR-12 physical (0.57), and PROMIS 10 physical (0.77). For both internal and external responsiveness, the EQ-5D, VR-12 physical, and PROMIS 10 physical showed significantly greater responsiveness compared with the other general PRO measures but no statistical differences among themselves.
There is no statistical difference in internal or external responsiveness to change among the EQ-5D, VR-12 physical, and PROMIS 10 physical instruments. In tracking longitudinal patient health, researchers and administrators have the flexibility to choose any of the general PROs among the EQ-5D, VR-12 physical, and PROMIS 10 physical. We recommend that any study tracking PROs in knee arthroscopy include 1 of these generic instruments.
欧洲五维度健康量表（EQ - 5D）、患者报告结局测量信息系统（PROMIS）10项全球健康量表以及退伍军人兰德12项健康调查（VR - 12）都是用于评估患者总体健康状况的通用患者报告结局（PRO）问卷。在选择一种PRO来跟踪总体健康状况时，有必要考虑哪种测量方法对治疗后的变化最敏感。迄今为止，尚无研究比较EQ - 5D、PROMIS 10项全球健康量表和退伍军人兰德12项健康调查（VR - 12）之间的反应度。
确定在膝关节镜检查背景下，哪种通用PRO在内部和外部反应度方面最为敏感。
队列研究（诊断）；证据等级，3级。
对50例行膝关节镜检查的患者在术前及术后平均3.6个月进行调查，随访率为90%。PRO包括EQ - 5D、EQ - 5D视觉模拟量表、PROMIS 10项全球健康量表（PROMIS 10）的生理和心理分量表、VR - 12的生理和心理分量表以及膝关节损伤和骨关节炎结局评分（KOOS）-疼痛子量表。通过对测量指标的变化进行配对t检验并计算两种效应量指标（科恩d值和标准化反应均值（SRM））来评估内部反应度。通过比较疾病特异性参考指标KOOS - 疼痛与通用PRO之间的皮尔逊相关系数来评估外部反应度。
对于内部反应度，3种PRO在治疗后得分有统计学显著改善（EQ - 5D：+0.10 [95%可信区间，0.06 - 0.15]，VR - 12生理分量表：+7.2 [95%可信区间，4.0 - 10.4]），以及PROMIS 10生理分量表：+4.4 [95%可信区间，2.6 - 6.3]），效应量统计显示变化适中（科恩d值和SRM，0.5 - 0.8）。在评估外部反应度时，发现EQ - 5D（0.65）、VR - 12生理分量表（0.57）和PROMIS 10生理分量表（0.77）与疾病特异性参考指标（KOOS - 疼痛评分）高度相关。对于内部和外部反应度，EQ - 5D、VR - 12生理分量表和PROMIS 10生理分量表与其他一般PRO测量指标相比，显示出显著更高的反应度，但它们之间无统计学差异。
EQ - 5D、VR - 12生理分量表和PROMIS 10生理分量表在对变化的内部或外部反应度方面无统计学差异。在跟踪患者的长期健康状况时，研究人员和管理人员可以灵活地在EQ - 5D、VR - 12生理分量表和PROMIS 10生理分量表这几种通用PRO中任选其一。我们建议在任何跟踪膝关节镜检查中PRO的研究中纳入这些通用工具中的一种。
