D. I. Dabija, Vanderbilt University School of Medicine, Vanderbilt University, Nashville, TN, USA J. S. Pennings, K. R. Archer, J. E. Kuhn, N. B. Jain, Department of Orthopaedics and Rehabilitation, Vanderbilt University Medical Center, Nashville, TN, USA K. R. Archer, N. B. Jain, Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, TN, USA G. D. Ayers, Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA L. D. Higgins, E. Matzkin, Department of Orthopaedic Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA K. M. Baumgarten, Orthopedic Institute, Sioux Falls, SD, USA.
Clin Orthop Relat Res. 2019 Aug;477(8):1869-1878. doi: 10.1097/CORR.0000000000000800.
The American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES), the Shoulder Pain and Disability Index (SPADI), and the shortened Disability of the Arm, Shoulder, and Hand (quickDASH) are patient-reported upper extremity-specific outcome scales currently used to evaluate patients with rotator cuff tears. This heterogeneity does not allow for a uniform metric for research and patient care.
QUESTIONS/PURPOSES: Our objective was to determine psychometric properties (reliability, convergent and discriminant validity, and responsiveness) of five commonly used outcome instruments (the ASES, the SPADI, the quickDASH, the SF-12, and the EuroQol-5D) in a longitudinal study of patients undergoing treatment for rotator cuff tears.
From February 2011 through June 2015, 120 patients completed a standardized history, the five outcome scales under study, a physical examination, and an MRI. Of these, 47 (39%) were lost to followup before 18 months, and another 24 (20%) were accounted for at 18 months but had missing data at one or more of the earlier prespecified followup intervals (3, 6, or 12 months). Reliability (the reproducibility of an outcome instrument between subjects; tested by Cronbach's alpha), convergent and discriminant validity (determining which outcome measures correlate most strongly with others; tested by Spearman's correlation coefficients), and responsiveness (the change in outcome scales over time based on percent improvement in shoulder functionality using the minimal clinically important difference [MCID] and the subjective shoulder value) were calculated.
All outcomes measures had a Cronbach's alpha above 0.70 (range, 0.74-0.94) and therefore were considered reliable. Convergent validity was demonstrated as the upper extremity-specific measures (SPADI, ASES, and quickDASH) were more strongly correlated with each other (rho = 0.74-0.81; p < 0.001) than with any of the other measures. Discriminant validity was demonstrated because the Spearman's correlation coefficients were stronger for the relationships between upper extremity measures compared with the correlations between upper extremity measures and general health measures for 53 of the 54 correlations that were compared. Both internal and external responsiveness of the measures was supported. Patients who achieved the MCID and at least a 30% change on the subjective shoulder value had more positive change in scores over time compared with those who did not. Mixed model linear regressions revealed that all three upper extremity-specific measures had a group by time interaction for the MCID, indicating that patients who achieved the MCID had greater change over time compared with those who did not achieve the MCID. Results showed that the measure with the best discrimination between groups, or best internal responsiveness, was the ASES (beta = -8.26, 95% confidence interval [CI], -11.39 to -5.14; p < 0.001; η = 0.089) followed by the SPADI (beta = 6.88, 95% CI, 3.78-9.97; p < 0.001; η = 0.088) then the quickDASH (beta = 3.43, 95% CI, 0.86-6.01; p = 0.009, η = 0.027). Measures with the best external responsiveness followed the same pattern of results.
All the upper extremity-specific scales had acceptable psychometric properties. Correlations were high and thus only one upper extremity-specific instrument is needed for outcome assessment. Given the overall psychometric assessment, we recommend SPADI be the shoulder-specific instrument used to assess outcomes in patients with rotator cuff tears.
Level III, diagnostic study.
美国肩肘外科医生标准化肩部评分（ASES）、肩部疼痛和残疾指数（SPADI）和简化残疾的上肢、肩部和手（quickDASH）是目前用于评估肩袖撕裂患者的上肢特定的患者报告结局量表。这种异质性不允许用于研究和患者护理的统一指标。
问题/目的：我们的目的是确定在接受肩袖撕裂治疗的患者的纵向研究中，五种常用结局工具（ASES、SPADI、quickDASH、SF-12 和 EuroQol-5D）的心理测量学特性（可靠性、收敛和判别有效性以及反应性）。
从 2011 年 2 月至 2015 年 6 月，120 名患者完成了标准化病史、正在研究的五种结局量表、体格检查和 MRI。其中，47 名（39%）在 18 个月前失访，另外 24 名（20%）在 18 个月时得到随访，但在一个或多个更早的预定随访间隔（3、6 或 12 个月）时出现缺失数据。可靠性（在受试者之间的结果工具的再现性；通过 Cronbach 的 alpha 进行测试）、收敛和判别有效性（确定哪些结果测量与其他结果测量相关性最强；通过 Spearman 的相关系数进行测试）和反应性（基于使用最小临床重要差异 [MCID] 和主观肩部值的肩部功能改善百分比来衡量的结果量表随时间的变化）进行了计算。
所有结局量表的 Cronbach 的 alpha 值均大于 0.70（范围为 0.74-0.94），因此被认为是可靠的。收敛有效性通过以下方式得到证明：上肢特定的测量值（SPADI、ASES 和 quickDASH）彼此之间的相关性更强（rho = 0.74-0.81；p < 0.001），而与任何其他测量值的相关性较弱。判别有效性通过以下方式得到证明：在 54 个比较的相关性中，53 个相关性的 Spearman 相关系数在上肢测量值之间的关系更强，而与上肢测量值和一般健康测量值之间的关系较弱。这些测量值的内部和外部反应性都得到了支持。与那些没有达到 MCID 和主观肩部值至少 30%变化的患者相比，达到 MCID 和主观肩部值至少 30%变化的患者在评分随时间的变化中具有更积极的变化。混合模型线性回归显示，所有三个上肢特定的测量值在 MCID 上都有组与时间的交互作用，这表明达到 MCID 的患者与未达到 MCID 的患者相比，随着时间的推移变化更大。结果表明，具有最佳组间区分度或最佳内部反应性的测量值是 ASES（beta = -8.26，95%置信区间 [CI]，-11.39 至 -5.14；p < 0.001；η = 0.089），其次是 SPADI（beta = 6.88，95% CI，3.78-9.97；p < 0.001；η = 0.088），然后是 quickDASH（beta = 3.43，95% CI，0.86-6.01；p = 0.009，η = 0.027）。具有最佳外部反应性的测量值也遵循相同的模式。
所有上肢特定的量表都具有可接受的心理测量学特性。相关性很高，因此仅需要一种上肢特定的仪器进行结局评估。考虑到整体心理测量评估，我们建议使用 SPADI 作为评估肩袖撕裂患者结局的肩部特定仪器。
III 级，诊断研究。
