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251C OPYRIGHT Ó 2016BYT HE J OURNALOFB ONEAND J OINTS URGERY, I NCORPORATEDA commentary by Michael Khazzam, MD, islinked to the online version of this article atjbjs.org.Mental Health Has a Stronger Associationwith Patient-Reported Shoulder Pain andFunction Than Tear Size in Patients withFull-Thickness Rotator Cuff TearsJames D. Wylie, MD, MHS, Thomas Suter, MD, Michael Q. Potter, MD, Erin K. Granger, MPH, and Robert Z. Tashjian, MDInvestigation performed at the Department of Orthopaedics, University of Utah, Salt Lake City, UtahBackground: Patient-reported outcome measures have increasingly accompanied objective examination findings in theevaluation of orthopaedic interventions. Our objective was to determine whether a validated measure of mental health (ShortForm-36 Mental Component Summary [SF-36 MCS]) or measures of tear severity on magnetic resonance imaging were morestrongly associated with self-assessed shoulder pain and function in patients with symptomatic full-thickness rotator cuff tears.Methods: One hundred and sixty-nine patients with full-thickness rotator cuff tears were prospectively enrolled. Patientscompleted the Short Form-36, visual analog scales for shoulder pain and function, the Simple Shoulder Test (SST), and theAmerican Shoulder and Elbow Surgeons (ASES) instrument at the time of diagnosis. Shoulder magnetic resonance imagingexaminations were reviewed to document the number of tendons involved, tear size, tendon retraction, and tear surface area. Age,sex, body mass index, number of medical comorbidities, smoking status, and Workers’ Compensation status were recorded.Bivariate correlations and multivariate regression models were calculated to identify associations with baseline shoulder scores.Results: The SF-36 MCS had the strongest correlation with the visual analog scale for shoulder pain (Pearson correlationcoefficient, 20.48; p 0.001), the visual analog scale for shoulder function (Pearson correlation coefficient, 20.33; p 0.001), the SST (Pearson correlation coefficient, 0.37; p 0.001), and the ASES score (Pearson correlation coefficient,0.51; p 0.001). Tear severity only correlated with the visual analog scale for shoulder function; the Pearson correlationcoefficient was 0.19 for tear size (p 0.018), 0.18 for tendon retraction (p 0.025), 0.18 for tear area (p 0.022), and0.20 for the number of tendons involved (p 0.011). Tear severity did not correlate with other scores in bivariatecorrelations (all p 0.05). In all multivariate models, the SF-36 MCS had the strongest association with the visual analogscale for shoulder pain, the visual analog scale for shoulder function, the SST, and the ASES score (all p 0.001).Conclusions: Patient mental health may play an influential role in patient-reported pain and function in patients with full-thicknessrotator cuff tears. Further studies are needed to determine its effect on the outcome of the treatment of rotator cuff disease.Level of Evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.Peer Review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewedby an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication.Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party insupport of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six monthsprior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is writtenin this work. Also, one or more of the authors has had another relationship, or has engaged in another activity, that could be perceived to influence or havethe potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are alwaysprovided with the online version of the article.J Bone Joint Surg Am. 44

252TH E JO U R NA L O F B O N E & JO I N T SU RG E RY J B J S . O RGV O L U M E 98-A N U M B E R 4 F E B R UA R Y 17, 2 016ddOdver the past twenty years, the evaluation of clinicalresults after surgical intervention has trended awayfrom using only clinician-centered objective measuresand toward including patient-reported outcome scales; currently,there are more than twenty patient-reported questionnaires formeasuring shoulder pain, function, and shoulder-specific healthrelated quality of life1. With many questionnaires from which tochoose, investigators must determine which is most appropriatefor their chosen research question. Given the movement towardpatient-reported outcomes to evaluate the results of shouldersurgical procedures, it is important to understand how psychosocial factors and objective clinical measures of pathology relateto and influence patients’ self-assessment of pain, function, anddisability.Multiple measures of mental health have been shown tonegatively correlate with patient-reported shoulder pain andfunction. Patients with shoulder pathology and high scoreson the Distress Risk Assessment Method (DRAM)2, HospitalAnxiety and Depression Scale (HADS)3, or Center for Epidemiological Studies Depression scale (CESD) questionnaires4report worse shoulder pain on a visual analog scale (VAS) andinferior Simple Shoulder Test (SST), Disabilities of the Arm,Shoulder and Hand (DASH) questionnaire, and AmericanShoulder and Elbow Surgeons (ASES) scores compared withnon-distressed patients. Similarly, an inferior Short Form-36Mental Component Summary (SF-36 MCS) score has beenshown to be a significant negative predictor of the PennsylvaniaShoulder Score in patients with rotator cuff tears or shoulderarthritis5.Commonly used measures of rotator cuff tear severityinclude the size of the tear from anterior to posterior, thenumber of tendons involved in the tear, the distance thatthe tendon edge has retracted, and the degree of atrophy of theinvolved muscles. However, the correlation of these measureswith patient self-assessment of shoulder pain and functionis variable. For patients with full-thickness rotator cuff tears,Dunn et al. found that tear severity did not correlate with painat preoperative evaluation6. Similarly, tear size and tendon retraction did not correlate with preoperative ASES or WesternOntario Rotator Cuff Index scores in other studies. Patientswith massive tears (defined as three-tendon involvement) didreport lower ASES scores than patients with isolated supraspinatus tears7. By contrast, a number of patient characteristics other than tear morphology, including sex, level ofeducation, shoulder range of motion, number of medicalcomorbidities, and body mass index (BMI), have been shownto influence preoperative shoulder health-related quality-oflife measures5,7-10.Given the uncertain relationship among objective pathology, mental health, and self-reported shoulder outcomescores, we aimed to determine which factors are associated withpreoperative VAS for shoulder pain and function and SST andASES scores for patients with full-thickness rotator cuff tears.We hypothesized that mental health as assessed by the SF-36MCS would show a stronger association with patient-reportedshoulder measures than tear morphology on magnetic resonanceM E N TA L H E A LT H A N D P AT I E N T - R E P O R T E D S H O U L D E R P A I NF U N C T I O N I N R O TAT O R C U F F T E A R SANDimaging (MRI). We also hypothesized that morphological tearseverity would be more highly correlated with patient-assessedVAS for shoulder function than with the VAS for pain, SST score,or ASES score.Materials and MethodsStudy DesignPatients diagnosed with symptomatic full-thickness rotator cuff tears onshoulder MRI were prospectively enrolled. Our institutional review boardapproved the study before enrollment commenced. All patients were enrolledby a single surgeon (R.Z.T.) between September 2009 and July 2014. The studywas compliant with the Health Insurance Portability and Accountability Act(HIPAA). Inclusion criteria were patient age of eighteen years or older, an MRIconfirmed full-thickness rotator cuff tear, and documentation of a completepre-treatment evaluation. Exclusion criteria were patient age of younger thaneighteen years, partial-thickness rotator cuff tears on MRI, pregnancy, Spanishas the primary language, a diagnosis of rotator cuff tear arthropathy, or anincomplete patient evaluation as described below.Patient EvaluationOn enrollment, patients completed SF-36, VAS for shoulder pain, VAS forshoulder function, SST, and ASES evaluation forms. The SF-36 measures eightspecific domains of general health-related quality of life and two compositescores, the Physical Component Summary (PCS) and the MCS. The mean score(and standard deviation) in the general non-patient population is 50 1011,12points. Higher scores correspond to better health-related quality of life. TheMCS was chosen as a validated measure of patients’ mental health that couldimpact shoulder-specific health-related quality of life.The VAS for pain measures pain from the affected shoulder from 0 to 10points, with 0 points representing no pain at all and 10 points representing painas bad as it can be. The VAS for shoulder function measures the function of theaffected shoulder on a scale from 0 to 10 points, with 0 points indicating thatthe patient can use the shoulder easily and 10 points indicating that the patientcannot use the shoulder at all. The SST is a patient-reported outcome measurethat asks the patient ten yes-or-no questions about the ability to performfunctions with the shoulder and activities of daily living and two questionsabout the comfort (pain) level in the shoulder. Each response of yes is given131 point, with higher scores representing better shoulder function . The ASESTABLE I Distribution of Patient-Reported Shoulder Measuresand Measures of Rotator Cuff Tear Severity*Patient-Reported Outcome MeasureResult†VAS pain (points)4.8 2.8 (0 to 10)VAS function (points)5.6 2.5 (0 to 10)SST score (points)4.4 3.1 (0 to 12)ASES score (points)47.5 21.6 (5 to 98.3)SF-36 MCS score (points)48.2 12.2 (17 to 72)MRI measures of tear severityTear size (cm)2.7 1.4 (0.7 to 7.5)Tendon retraction (cm)2.4 1.3 (0.2 to 6.0)Tear area (cm2)7.7 7.5 (0.3 to 33.2)*The mean number of tendons torn was 1.6; 91 patients (54%) hadone torn tendon, 62 patients (37%) had two torn tendons, and 16patients (9%) had three torn tendons. †The values are given as themean and the standard deviation, with the range in parentheses.

253TH E JO U R NA L O F B O N E & JO I N T SU RG E RY J B J S . O RGV O L U M E 98-A N U M B E R 4 F E B R UA R Y 17, 2 016dddTABLE II Bivariate Correlation of Patient Mental Well-Beingwith Patient-Reported Shoulder MeasuresPatient-Reported ShoulderScoreM E N TA L H E A LT H A N D P AT I E N T - R E P O R T E D S H O U L D E R P A I NF U N C T I O N I N R O TAT O R C U F F T E A R SANDsumptions. The final analysis used multivariate general linear modeling withblock entry of all predictor variables and the four shoulder scores as dependentvariables. Regression coefficients are reported. Significance was set at p 0.05.Correlation with SF-36MCS*VAS shoulder pain20.476VAS shoulder function20.332SST0.367ASES0.505*The values are given as the Pearson correlation coefficient; allvalues were significant at p 0.001.TABLE III Multivariate Analysis of the Effect of Patient Factors,Mental Well-Being, and Rotator Cuff Tear Size onPatient-Reported Shoulder MeasuresVariableVAS painVAS functionSST scoreStatistical MethodsThe significance of differences in means of continuous variables between twogroups was determined by the Student t test. When there were three groups, ananalysis of variance (ANOVA) was used with a post hoc Tukey test for significance between groups. The difference in categorical variables between groupswas determined by the Pearson chi-square test. Bivariate correlations weredetermined by Pearson correlation coefficients. Multivariate linear regressionmodels were built with categorical variables coded as dummy variables (i.e., forsex, 0 represented male and 1 represented female). Models included patient age,sex, BMI, number of medical comorbidities, Workers’ Compensation status,smoking status, SF-36 MCS scores, and measures of rotator cuff tear morphology as predictor variables. VAS for shoulder pain, VAS for shoulderfunction, SST score, and ASES score were dependent variables. Individualmodels were built for tear size, tendon retraction, tear area, and number oftendons torn. Preliminary data analysis targeted applicability of linear as-P ValueAge in yrASES scorescore is a validated, reliable, and responsive measure of shoulder function andpain. Fifty percent of the score is determined by a VAS pain score as describedabove. The remaining 50% of the score is determined by ten questions thatassess sports participation and activities of daily living on a Likert scale. Thetotal score ranges from 0 points (debilitating pain, poor function) to 100 points14(no pain, normal function) .Important risk adjustors were collected, including a medical comorbidity questionnaire. The patients were asked a series of binary (yes-or-no)questions with regard to the presence of comorbid medical conditions. This listof questions is included in the Musculoskeletal Outcomes Data Evaluation andManagement System (MODEMS) comorbidity questionnaire for the shoulder15or arm . Patient height and weight were collected to calculate BMI. Patient sex,age at the time of diagnosis, Workers’ Compensation status, smoking status,and whether the patient underwent operative intervention were recorded.All patients had shoulder MRI performed as part of their clinicalevaluation. MRI was done on a Siemens 1.5-T Avanto system with use of adedicated shoulder protocol. Three of the authors of this study (R.Z.T., J.D.W.,and T.S.) read the shoulder MRI without knowledge of other patient factors.Tear characteristics, including tear size, tendon retraction, tear area, and thenumber of torn tendons, were recorded. Tear size was measured in centimetersas the anterior to posterior distance of the bare area on the tuberosity footprinton T2-weighted sagittal images. Tendon retraction was measured as the maximum distance from the tendon edge stump of the supraspinatus to the lateralaspect of the greater tuberosity tendon footprint on T2-weighted coronal images. Tear surface area was calculated as the tear size multiplied by the tendonretraction. The number of torn tendons was defined by summing each tendon(subscapularis, supraspinatus, and infraspinatus) involved in the full-thicknessaspect of the tear; partially torn tendons were not included. Differentiating thesupraspinatus from the infraspinatus was done at the discretion of the imageevaluators. A tear of 2.5 cm in the anterior-posterior width was considered toinvolve the infraspinatus.Regression Female sexVAS pain0.570.267VAS function20.640.179ASES scoreSST score23.5620.350.3500.545VAS pain0.060.102VAS function0.050.128BMI in kg/m2ASES score20.660.011*SST score20.110.004*No. of medicalcomorbiditiesVAS painVAS function0.160.010.1170.961ASES score21.230.098SST score20.120.296Workers’ CompensationVAS painVAS functionASES 50.1200.519ASES score21.100.719SST score20.610.185VAS pain20.09 0.001*VAS function20.07 0.001*ASES score0.79 0.001*SST score0.09 0.001*0.020.887SST scoreSmokingVAS painVAS functionSF-36 MCSTear size in cmVAS painVAS functionASES score0.3421.940.008*0.059SST score20.280.070*A significant association at p 0.05.

254TH E JO U R NA L O F B O N E & JO I N T SU RG E RY J B J S . O RGV O L U M E 98-A N U M B E R 4 F E B R UA R Y 17, 2 016dddTABLE IV Multivariate Analysis of the Effect of AlternativeMeasures of Tear Severity on Patient-ReportedShoulder MeasuresVariableRegression CoefficientP ValueTendon retraction in cmVAS pain0.130.368VAS function0.390.006*ASES score22.040.069SST score20.410.013*0.010.070.7760.007*Tear area in cm2VAS painVAS functionASES score20.370.057SST score20.060.056No. of tendons tornVAS pain20.08VAS function0.790.7870.005*ASES score22.840.206SST score20.420.214*A significant association at p 0.05.Source of FundingOne author of this study (R.Z.T.) received a merit grant from the United StatesDepartment of Veterans Affairs. Funds were used to pay for salaries, supplies,and testing.ResultsPatient Cohorthe cohort consisted of 169 patients prospectively enrolledat diagnosis of their full-thickness rotator cuff tear by asingle surgeon (R.Z.T.). During the entire study period, this surgeon had 429 total patients diagnosed with a full-thickness rotatorcuff tear. Of the 260 patients who were not enrolled, seven declined enrollment, 185 were unable to be enrolled because ofscheduling conflicts with study personnel, and sixty-eight wereexcluded because of the above exclusion criteria. Of the includedpatients, fourteen (8%) had Workers’ Compensation claims,seventy-six (45%) were active smokers, and 123 (73%) underwenta surgical procedure to repair the tear. There were thirty-fourfemale patients (20%) and 135 male patients (80%). The meannumber of medical comorbidities (and standard deviation) was2.4 2.1 comorbidities, and the range was zero to ten comorbidities: thirty-six patients (21%) had zero comorbidities, thirtytwo patients (19%) had one comorbidity, twenty-nine patients(17%) had two comorbidities, thirty patients (18%) had threecomorbidities, sixteen patients (9%) had four comorbidities,thirteen patients (8%) had five comorbidities, and thirteenpatients (8%) had six or more comorbidities. The mean patientage was 62.3 years (range, thirty-three to eighty-one years). Themean patient BMI was 29.9 kg/m2 (range, 18 to 50 kg/m2).Patient-reported measures and measures of the severityof rotator cuff tears for the cohort are reported in Table I. TheTM E N TA L H E A LT H A N D P AT I E N T - R E P O R T E D S H O U L D E R P A I NF U N C T I O N I N R O TAT O R C U F F T E A R SANDmean MCS represented normal mental health compared withthe general population.Relationship Among Patient Mental Health, Morphologyof Rotator Cuff Tears, Other Patient Factors, andPatient-Reported Shoulder Pain, Function, andShoulder-Specific Health-Related Quality of LifeIn the bivariate analysis, BMI was positively correlated with theVAS for shoulder pain (r 0.153, p 0.049) and negativelycorrelated with the SST score (r 20.218, p 0.005) and theASES score (r 20.222, p 0.004). Age was negatively correlated with the VAS for shoulder pain (r 20.169, p 0.029).The number of medical comorbidities was positively correlatedwith the VAS for shoulder pain (r 0.221, p 0.004) andnegatively correlated with the SSTscore (r 20.210, p 0.006)and the ASES score (r 20.262, p 0.001). All morphologicalmeasures of tear severity were positively correlated with theVAS for shoulder function, including tear size (r 0.186, p 0.018), tendon retraction (r 0.176, p 0.025), tear area (r 0.179, p 0.022), and number of tendons torn (r 0.199,p 0.011). There were no significant bivariate correlationsbetween morphological measures of tear severity and the VASfor shoulder pain, SST score, or ASES score (all p 0.05). TheSF-36 MCS had the strongest negative correlation of any variable with the VAS for shoulder pain and VAS for shoulderfunction and a positive correlation with the SST and ASESscores (all p

scale for shoulder pain, the visual analog scale for shoulder function, the SST, and the ASES score (all p 0.001). . include the size of the tear from anterior to posterior, the number of tendons involved in the tear, the distance that . aspect of the tear; partially torn tendons were not included.

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