Abstract
Objectives:
The is an ever-increasing demand within the emerging health care arena to demonstrate the efficacy of orthopedic interventions. Widespread implementation of patient reported outcomes are limited in part due to the barriers of clinical infrastructure and resources in a busy orthopedic practice. Prior studies have shown the single alpha-numeric evaluation (SANE) score to correlate at a single point in time with the American Shoulder and Elbow Surgeons(ASES) score. However, no study has validated the SANE in terms of test-retest reliability, responsiveness or clinical utility. Therefore, the purpose of this study was to validate SANE compared to the ASES across a sample of patients with the most common orthopedic shoulder diagnoses.
Methods:
Shoulder patients (n=105 age=52.7 ± 1.2; female=67) undergoing rotator cuff repair (cuff=44), total shoulder replacement (TSA=23), or physical therapy (PT=38) were administered the SANE and ASES less than 14 days apart prior to surgery and again at their 3 month follow up from initial care or surgery. Interclass Correlation Coefficients (ICC(2,1)) and standard error of the measure(SEM) were used to evaluate the test-retest reliability of the SANE and the validity between the SANE and ASES scores. An ANOVA (treatment group by time) was used to evaluate the responsiveness to treatment, and a Receiver Operating Curve was used to establish the minimally important clinical difference (MCID) for the SANE compared to the ASES (α =0.05).
Results:
The SANE demonstrated good reliability (ICC(2,1) =0.76 ± 3.4) similar to the ASES (ICC(2,1) =0.82 ± 3.4) pre-treatment. The SANE demonstrated good agreement with the SANE across all treatment groups (Cuff= ICC(2,1) 0.85 ± 3.4; TSA- ICC(2,1) =0.72 ± 5.2;PT- ICC(2,1) =0.82 ± 2.9) pre and post treatment. The SANE displayed similar responsiveness to the ASES after treatment (Figure 1) with similar mean change and standard deviations within each treatment group. The ROC curve revealed an area under the curve of .79 (SE, 0.62; P<.001) and a cutoff of 9.5% on the SANE with a sensitivity of 83% and a specificity of 31% to establish the MCID.
Conclusion:
Our study is the first to demonstrate the SANE is valid across a range of common shoulder diagnoses to assess patient outcomes across operative and non-operative treatment for shoulder complaints. The MCID of 9.5% is similar to the ASES (11%) suggesting that the SANE is a simple and efficient tool to assess treatment effects for shoulder disorders. Future studies are warranted to confirm these results and compare across other body parts and diagnoses.