TY - JOUR
T1 - Which Is the Best Outcome Measure for Rotator Cuff Tears?
AU - Dabija, Dominique I.
AU - Pennings, Jacquelyn S.
AU - Archer, Kristin R.
AU - Ayers, Gregory D.
AU - Higgins, Laurence D.
AU - Kuhn, John E.
AU - Baumgarten, Keith M.
AU - Matzkin, Elizabeth
AU - Jain, Nitin B.
N1 - Funding Information:
The institution of one or more of the authors (NBJ) has received, during the study period, funding from the NIAMS (1K23AR059199 and 1U34AR069201). The institution of one or more of the authors (GDA) has received, during the study period, funding from the NIAMS (1U34AR069201). This work was supported by CTSA award Number UL1TR000445 from the National Center for Advancing Translational Sciences. We thank the entire ROW team for their efforts. We also thank our clinical staff at the Orthopedic and Arthritis Center at Brigham and Women's Hospital, Shoulder Service at Massachusetts General Hospital, and clinical staff at Vanderbilt Orthopaedic Institute for their efforts and cooperation.
Funding Information:
The institution of one or more of the authors (NBJ) has received, during the study period, funding from the NIAMS (1K23AR059199 and 1U34AR069201). The institution of one or more of the authors (GDA) has received, during the study period, funding from the NIAMS (1U34AR069201). This work was supported by CTSA award Number UL1TR000445 from the National Center for Advancing Translational Sciences. One of the authors certifies that she (KRA), or a member of her immediate family, has received or may receive personal fees, during the study period, in an amount of less than USD 10,000 from Pacira Pharmaceuticals Inc (Parsippany, NJ, USA); personal fees in an amount of less than USD 10,000 from Palladian Health (New York, NY, USA); personal fees in an amount of less than USD 10,000, from APTA (Alexandria, Virginia, USA); and personal fees in an amount of less than USD 10,000) from NeuroPoint Alliance (Rolling Meadows, IL, USA), all outside the submitted work. Clinical Orthopaedics and Related Research® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA approval status, of any drug or device before clinical use. Each author certifies that his or her institution approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research. This work was performed at Vanderbilt University Medical Center, Nashville, TN, USA.
Publisher Copyright:
© 2019 by the Association of Bone and Joint Surgeons.
PY - 2019/8/1
Y1 - 2019/8/1
N2 - BackgroundThe 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/purposesOur 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.MethodsFrom 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.ResultsAll 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; η2 = 0.089) followed by the SPADI (beta = 6.88, 95% CI, 3.78-9.97; p < 0.001; η2 = 0.088) then the quickDASH (beta = 3.43, 95% CI, 0.86-6.01; p = 0.009, η2 = 0.027). Measures with the best external responsiveness followed the same pattern of results.ConclusionsAll 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.
AB - BackgroundThe 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/purposesOur 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.MethodsFrom 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.ResultsAll 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; η2 = 0.089) followed by the SPADI (beta = 6.88, 95% CI, 3.78-9.97; p < 0.001; η2 = 0.088) then the quickDASH (beta = 3.43, 95% CI, 0.86-6.01; p = 0.009, η2 = 0.027). Measures with the best external responsiveness followed the same pattern of results.ConclusionsAll 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.
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U2 - 10.1097/CORR.0000000000000800
DO - 10.1097/CORR.0000000000000800
M3 - Article
C2 - 31335605
AN - SCOPUS:85070503199
SN - 0009-921X
VL - 477
SP - 1869
EP - 1878
JO - Clinical orthopaedics and related research
JF - Clinical orthopaedics and related research
IS - 8
ER -