Investigation performed at the Department of Orthopaedics, University of Utah, Salt Lake City, Utah

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1 251 COPYRIGHT Ó 2016 BY THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED A commentary by Michael Khazzam, MD, is linke to the online version of this article at jbjs.org. Mental Health Has a Stronger Association with Patient-Reporte Shouler Pain an Function Than Tear Size in Patients with Full-Thickness Rotator Cuff Tears James D. Wylie, MD, MHS, Thomas Suter, MD, Michael Q. Potter, MD, Erin K. Granger, MPH, an Robert Z. Tashjian, MD Investigation performe at the Department of Orthopaeics, University of Utah, Salt Lake City, Utah Backgroun: Patient-reporte outcome measures have increasingly accompanie objective examination finings in the evaluation of orthopaeic interventions. Our objective was to etermine whether a valiate measure of mental health (Short Form-36 Mental Component Summary [SF-36 MCS]) or measures of tear severity on magnetic resonance imaging were more strongly associate with self-assesse shouler pain an function in patients with symptomatic full-thickness rotator cuff tears. Methos: One hunre an sixty-nine patients with full-thickness rotator cuff tears were prospectively enrolle. Patients complete the Short Form-36, visual analog scales for shouler pain an function, the Simple Shouler Test (SST), an the American Shouler an Elbow Surgeons (ASES) instrument at the time of iagnosis. Shouler magnetic resonance imaging examinations were reviewe to ocument the number of tenons involve, tear size, tenon retraction, an tear surface area. Age, sex, boy mass inex, number of meical comorbiities, smoking status, an Workers Compensation status were recore. Bivariate correlations an multivariate regression moels were calculate to ientify associations with baseline shouler scores. Results: The SF-36 MCS ha the strongest correlation with the visual analog scale for shouler pain (Pearson correlation coefficient, 20.48; p < 0.001), the visual analog scale for shouler function (Pearson correlation coefficient, 20.33; p < 0.001), the SST (Pearson correlation coefficient, 0.37; p < 0.001), an the ASES score (Pearson correlation coefficient, 0.51; p < 0.001). Tear severity only correlate with the visual analog scale for shouler function; the Pearson correlation coefficient was 0.19 for tear size (p = 0.018), 0.18 for tenon retraction (p = 0.025), 0.18 for tear area (p = 0.022), an 0.20 for the number of tenons involve (p = 0.011). Tear severity i not correlate with other scores in bivariate correlations (all p > 0.05). In all multivariate moels, the SF-36 MCS ha the strongest association with the visual analog scale for shouler pain, the visual analog scale for shouler function, the SST, an the ASES score (all p < 0.001). Conclusions: Patient mental health may play an influential role in patient-reporte pain an function in patients with full-thickness rotator cuff tears. Further stuies are neee to etermine its effect on the outcome of the treatment of rotator cuff isease. Level of Evience: Prognostic Level II. See Instructions for Authors for a complete escription of levels of evience. Peer Review: This article was reviewe by the Eitor-in-Chief an one Deputy Eitor, an it unerwent bline review by two or more outsie experts. It was also reviewe by an expert in methoology an statistics. The Deputy Eitor reviewe each revision of the article, an it unerwent a final review by the Eitor-in-Chief prior to publication. Final corrections an clarifications occurreuring one or more exchanges between the author(s) an copyeitors. Disclosure: One or more of the authors receive payments or services, either irectly or inirectly (i.e., via his or her institution), from a thir party in support of an aspect of this work. In aition, one or more of the authors, or his or her institution, has ha a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomeical arena that coul be perceive to influence or have the potential to influence what is written in this work. Also, one or more of the authors has ha another relationship, or has engage in another activity, that coul be perceive to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitte by authors are always provie with the online version of the article. J Bone Joint Surg Am. 2016;98:

2 252 Over the past twenty years, the evaluation of clinical results after surgical intervention has trene away from using only clinician-centere objective measures an towar incluing patient-reporte outcome scales; currently, there are more than twenty patient-reporte questionnaires for measuring shouler pain, function, an shouler-specific healthrelate quality of life 1. With many questionnaires from which to choose, investigators must etermine which is most appropriate for their chosen research question. Given the movement towar patient-reporte outcomes to evaluate the results of shouler surgical proceures, it is important to unerstan how psychosocial factors an objective clinical measures of pathology relate to an influence patients self-assessment of pain, function, an isability. Multiple measures of mental health have been shown to negatively correlate with patient-reporte shouler pain an function. Patients with shouler pathology an high scores on the Distress Risk Assessment Metho (DRAM) 2, Hospital Anxiety an Depression Scale (HADS) 3, or Center for Epiemiological Stuies Depression scale (CESD) questionnaires 4 report worse shouler pain on a visual analog scale (VAS) an inferior Simple Shouler Test (SST), Disabilities of the Arm, Shouler an Han (DASH) questionnaire, an American Shouler an Elbow Surgeons (ASES) scores compare with non-istresse patients. Similarly, an inferior Short Form-36 Mental Component Summary (SF-36 MCS) score has been shown to be a significant negative preictor of the Pennsylvania Shouler Score in patients with rotator cuff tears or shouler arthritis 5. Commonly use measures of rotator cuff tear severity inclue the size of the tear from anterior to posterior, the number of tenons involve in the tear, the istance that the tenon ege has retracte, an the egree of atrophy of the involve muscles. However, the correlation of these measures with patient self-assessment of shouler pain an function is variable. For patients with full-thickness rotator cuff tears, Dunn et al. foun that tear severity i not correlate with pain at preoperative evaluation 6. Similarly, tear size an tenon retraction i not correlate with preoperative ASES or Western Ontario Rotator Cuff Inex scores in other stuies. Patients with massive tears (efine as three-tenon involvement) i report lower ASES scores than patients with isolate supraspinatus tears 7. By contrast, a number of patient characteristics other than tear morphology, incluing sex, level of eucation, shouler range of motion, number of meical comorbiities, an boy mass inex (BMI), have been shown to influence preoperative shouler health-relate quality-oflife measures 5,7-10. Given the uncertain relationship among objective pathology, mental health, an self-reporte shouler outcome scores, we aime to etermine which factors are associate with preoperative VAS for shouler pain an function an SST an ASES scores for patients with full-thickness rotator cuff tears. We hypothesize that mental health as assesse by the SF-36 MCS woul show a stronger association with patient-reporte shouler measures than tear morphology on magnetic resonance imaging (MRI). We also hypothesize that morphological tear severity woul be more highly correlate with patient-assesse VAS for shouler function than with the VAS for pain, SST score, or ASES score. Materials an Methos Stuy Design Patients iagnose with symptomatic full-thickness rotator cuff tears on shouler MRI were prospectively enrolle. Our institutional review boar approve the stuy before enrollment commence. All patients were enrolle by a single surgeon (R.Z.T.) between September 2009 an July The stuy was compliant with the Health Insurance Portability an Accountability Act (HIPAA). Inclusion criteria were patient age of eighteen years or oler, an MRIconfirme full-thickness rotator cuff tear, anocumentation of a complete pre-treatment evaluation. Exclusion criteria were patient age of younger than eighteen years, partial-thickness rotator cuff tears on MRI, pregnancy, Spanish as the primary language, a iagnosis of rotator cuff tear arthropathy, or an incomplete patient evaluation as escribe below. Patient Evaluation On enrollment, patients complete SF-36, VAS for shouler pain, VAS for shouler function, SST, an ASES evaluation forms. The SF-36 measures eight specific omains of general health-relate quality of life an two composite scores, the Physical Component Summary (PCS) an the MCS. The mean score (an stanareviation) in the general non-patient population is 50 ± 10 points. Higher scores correspon to better health-relate quality of life 11,12. The MCS was chosen as a valiate measure of patients mental health that coul impact shouler-specific health-relate quality of life. The VAS for pain measures pain from the affecte shouler from 0 to 10 points, with 0 points representing no pain at all an 10 points representing pain as ba as it can be. The VAS for shouler function measures the function of the affecte shouler on a scale from 0 to 10 points, with 0 points inicating that the patient can use the shouler easily an 10 points inicating that the patient cannot use the shouler at all. The SST is a patient-reporte outcome measure that asks the patient ten yes-or-no questions about the ability to perform functions with the shouler an activities of aily living an two questions about the comfort (pain) level in the shouler. Each response of yes is given 1 point, with higher scores representing better shouler function 13. The ASES TABLE I Distribution of Patient-Reporte Shouler Measures an Measures of Rotator Cuff Tear Severity* Patient-Reporte Outcome Measure Result 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 severity Tear size (cm) 2.7 ± 1.4 (0.7 to 7.5) Tenon retraction (cm) 2.4 ± 1.3 (0.2 to 6.0) Tear area (cm 2 ) 7.7 ± 7.5 (0.3 to 33.2) *The mean number of tenons torn was 1.6; 91 patients (54%) ha one torn tenon, 62 patients (37%) ha two torn tenons, an 16 patients (9%) ha three torn tenons. The values are given as the mean an the stanareviation, with the range in parentheses.

3 253 TABLE II Bivariate Correlation of Patient Mental Well-Being with Patient-Reporte Shouler Measures Patient-Reporte Shouler Score Correlation with SF-36 MCS* VAS shouler pain VAS shouler function SST ASES *The values are given as the Pearson correlation coefficient; all values were significant at p < score is a valiate, reliable, an responsive measure of shouler function an pain. Fifty percent of the score is etermine by a VAS pain score as escribe above. The remaining 50% of the score is etermine by ten questions that assess sports participation an activities of aily living on a Likert scale. The total score ranges from 0 points (ebilitating pain, poor function) to 100 points (no pain, normal function) 14. Important risk ajustors were collecte, incluing a meical comorbiity questionnaire. The patients were aske a series of binary (yes-or-no) questions with regar to the presence of comorbi meical conitions. This list of questions is inclue in the Musculoskeletal Outcomes Data Evaluation an Management System (MODEMS) comorbiity questionnaire for the shouler or arm 15. Patient height an weight were collecte to calculate BMI. Patient sex, age at the time of iagnosis, Workers Compensation status, smoking status, an whether the patient unerwent operative intervention were recore. All patients ha shouler MRI performe as part of their clinical evaluation. MRI was one on a Siemens 1.5-T Avanto system with use of a eicate shouler protocol. Three of the authors of this stuy (R.Z.T., J.D.W., an T.S.) rea the shouler MRI without knowlege of other patient factors. Tear characteristics, incluing tear size, tenon retraction, tear area, an the number of torn tenons, were recore. Tear size was measure in centimeters as the anterior to posterior istance of the bare area on the tuberosity footprint on T2-weighte sagittal images. Tenon retraction was measure as the maximum istance from the tenon ege stump of the supraspinatus to the lateral aspect of the greater tuberosity tenon footprint on T2-weighte coronal images. Tear surface area was calculate as the tear size multiplie by the tenon retraction. The number of torn tenons was efine by summing each tenon (subscapularis, supraspinatus, an infraspinatus) involve in the full-thickness aspect of the tear; partially torn tenons were not inclue. Differentiating the supraspinatus from the infraspinatus was one at the iscretion of the image evaluators. A tear of >2.5 cm in the anterior-posterior with was consiere to involve the infraspinatus. Statistical Methos The significance of ifferences in means of continuous variables between two groups was etermine by the Stuent t test. When there were three groups, an analysis of variance (ANOVA) was use with a post hoc Tukey test for significance between groups. The ifference in categorical variables between groups was etermine by the Pearson chi-square test. Bivariate correlations were etermine by Pearson correlation coefficients. Multivariate linear regression moels were built with categorical variables coe as ummy variables (i.e., for sex, 0 represente male an 1 represente female). Moels inclue patient age, sex, BMI, number of meical comorbiities, Workers Compensation status, smoking status, SF-36 MCS scores, an measures of rotator cuff tear morphology as preictor variables. VAS for shouler pain, VAS for shouler function, SST score, an ASES score were epenent variables. Iniviual moels were built for tear size, tenon retraction, tear area, an number of tenons torn. Preliminary ata analysis targete applicability of linear assumptions. The final analysis use multivariate general linear moeling with block entry of all preictor variables an the four shouler scores as epenent variables. Regression coefficients are reporte. Significance was set at p < TABLE III Multivariate Analysis of the Effect of Patient Factors, Mental Well-Being, an Rotator Cuff Tear Size on Patient-Reporte Shouler Measures Variable Regression Coefficient P Value Age in yr VAS pain VAS function ASES score SST score Female sex VAS pain VAS function ASES score SST score BMI in kg/m 2 VAS pain VAS function ASES score * SST score * No. of meical comorbiities VAS pain VAS function ASES score SST score Workers Compensation VAS pain VAS function ASES score SST score Smoking VAS pain VAS function ASES score SST score SF-36 MCS VAS pain <0.001* VAS function <0.001* ASES score 0.79 <0.001* SST score 0.09 <0.001* Tear size in cm VAS pain VAS function * ASES score SST score *A significant association at p < 0.05.

4 254 TABLE IV Multivariate Analysis of the Effect of Alternative Measures of Tear Severity on Patient-Reporte Shouler Measures Variable Regression Coefficient P Value Tenon retraction in cm VAS pain VAS function * ASES score SST score * Tear area in cm 2 VAS pain VAS function * ASES score SST score No. of tenons torn VAS pain VAS function * ASES score SST score *A significant association at p < Source of Funing One author of this stuy (R.Z.T.) receive a merit grant from the Unite States Department of Veterans Affairs. Funs were use to pay for salaries, supplies, an testing. Results Patient Cohort The cohort consiste of 169 patients prospectively enrolle at iagnosis of their full-thickness rotator cuff tear by a single surgeon (R.Z.T.). During the entire stuy perio, this surgeon ha 429 total patients iagnose with a full-thickness rotator cuff tear. Of the 260 patients who were not enrolle, seven ecline enrollment, 185 were unable to be enrolle because of scheuling conflicts with stuy personnel, an sixty-eight were exclue because of the above exclusion criteria. Of the inclue patients, fourteen (8%) ha Workers Compensation claims, seventy-six (45%) were active smokers, an 123 (73%) unerwent a surgical proceure to repair the tear. There were thirty-four female patients (20%) an 135 male patients (80%). The mean number of meical comorbiities (an stanareviation) was 2.4 ± 2.1 comorbiities, an the range was zero to ten comorbiities: thirty-six patients (21%) ha zero comorbiities, thirtytwo patients (19%) ha one comorbiity, twenty-nine patients (17%) ha two comorbiities, thirty patients (18%) ha three comorbiities, sixteen patients (9%) ha four comorbiities, thirteen patients (8%) ha five comorbiities, an thirteen patients (8%) ha six or more comorbiities. The mean patient age was 62.3 years (range, thirty-three to eighty-one years). The mean patient BMI was 29.9 kg/m 2 (range, 18 to 50 kg/m 2 ). Patient-reporte measures an measures of the severity of rotator cuff tears for the cohort are reporte in Table I. The mean MCS represente normal mental health compare with the general population. Relationship Among Patient Mental Health, Morphology of Rotator Cuff Tears, Other Patient Factors, an Patient-Reporte Shouler Pain, Function, an Shouler-Specific Health-Relate Quality of Life In the bivariate analysis, BMI was positively correlate with the VAS for shouler pain (r = 0.153, p = 0.049) an negatively correlate with the SST score (r = , p = 0.005) an the ASES score (r = , p = 0.004). Age was negatively correlate with the VAS for shouler pain (r = , p = 0.029). The number of meical comorbiities was positively correlate with the VAS for shouler pain (r = 0.221, p = 0.004) an negatively correlate with the SSTscore (r = , p = 0.006) an the ASES score (r = , p = 0.001). All morphological measures of tear severity were positively correlate with the VAS for shouler function, incluing tear size (r = 0.186, p = 0.018), tenon retraction (r = 0.176, p = 0.025), tear area (r = 0.179, p = 0.022), an number of tenons torn (r = 0.199, p = 0.011). There were no significant bivariate correlations between morphological measures of tear severity an the VAS for shouler pain, SST score, or ASES score (all p > 0.05). The SF-36 MCS ha the strongest negative correlation of any variable with the VAS for shouler pain an VAS for shouler function an a positive correlation with the SST an ASES scores (all p < 0.001) (Table II). In all multivariate moels (Tables III an IV), the SF-36 MCS ha the strongest associations with the VAS for shouler pain, the VAS for shouler function, the SST score, an the ASES score (all p < 0.001) (Tables II an III). BMI correlate with SST an ASES scores but not with the VAS for shouler pain or VAS for shouler function. Workers Compensation claims correlate with worse VAS function but were unrelate to other measures. All morphological measures of tear severity correlate with the VAS for shouler function. Iniviual risk ajustors may have shown nonsignificant associations ue to lack of statistical power. For example, we ha only thirty-four female patients an fourteen patients with Workers Compensation claims in our cohort. Discussion The objective of the stuy was to compare the relationships between patient mental health an objective measures of rotator cuff tear size with patient-reporte outcome measures (shouler pain, function, an shouler-specific health-relate quality of life). In our cohort of patients with full-thickness rotator cuff tears, we foun that the patient s mental health as assesse by the SF-36 MCS ha the strongest association with several common preoperative patient-reporte measures of shouler health, incluing the VAS for shouler pain, VAS for shouler function, SST score, an ASES score. Measures of tear severity on MRI were not as strongly associate with patient selfassessment on the same scales. The MCS was the only significant preictor in our multivariate moels that woul lea to a clinically important change in the shouler scores teste. Although

5 255 the regression coefficients were small, a change of 15 to 20 points in the MCS woul lea to clinically important changes in the VAS for pain, the ASES score, an the SST score, as etermine by the minimum clinically important ifferences in these scores. Morphological tear characteristics were correlate with patientreporte VAS for shouler function but i not correlate with pain or health-relate quality-of-life metrics. As assessment of outcomes of orthopaeic care has shifte from relying solely on more objective physicianreporte outcomes measures to inclusion of patient-reporte outcomes measures, there has been growing interest in the role that psychosocial factors play in shaping patient self-assessment of pain an function 2,3,16. Greater levels of psychological istress, epression, an anxiety an lower mental health scores are correlate with inferior patient-reporte outcomes among patients with a variety of musculoskeletal conitions 2,5, Structure psychological interviews woul be the gol stanar in evaluating patient mental health, but these are unrealistically time-consuming in the typical outpatient setting of clinical orthopaeic evaluation. Other stuies have use alternative patient-reporte scales for mental health In this stuy, we relie on the SF-36 MCS, which can also be obtaine from the Short Form-12 (SF-12) 12,24. Using the SF-12 to obtain the MCS woul result in a lower responent buren compare with alternative scales measuring mental health. In aition, the SF-36 an the SF-12 have been use for years to evaluate orthopaeic patients, making them an attractive option for comparisons across stuies an time perios 11. Another stuy etermine the MCS to be a significant preictor of inferior preoperative Pennsylvania Shouler Scores in patients with shouler isease 5. Here, we have further shown the SF-36 MCS to have a strong association with patient-reporte shouler measures in patients with fullthickness rotator cuff tears. Aitional future stuies are require to etermine whether the MCS plays a similar role in preicting response to treatment or outcomes after rotator cuff surgical proceures. Although SF-36 MCS scores showe the strongest association with patient-reporte shouler pain an function in our cohort, tear severity on MRI also significantly correlate with the VAS for shouler function, although not with the VAS for shouler pain. Tear size may correlate more with function because of other factors affecting pain such as concomitant shouler abnormalities. The size of the tear may be more irectly correlate with function, but many other factors contribute to the patient s pain level. This fining aligns with the results of Dunn et al., who conclue that morphological characteristics of tear severity i not correlate with scores on the VAS for shouler pain 6. In our stuy, morphological measures of tear severity were less preictive of SSTan ASES scores. This is likely because of the weighting of pain in etermining these scores. The VAS for shouler pain contributes half of the total ASES score, with the other half erive from questions that assess shouler function 14. Similarly, the SST inclues two questions on patient comfort (pain) an ten questions on ability to perform activities (function) 13. Thus, both scales may be more sensitive to pain an less sensitive to function compare with the uniimensional VAS for shouler function. Prior stuies showe that other patient factors incluing BMI an meical comorbiity correlate with patient-reporte shouler measures; however, some of these stuies i not control for mental health status, a potentially important confouner on the basis of our results 5,8. In a population of patients with full-thickness rotator cuff tears, Tashjian et al. foun that the number of meical comorbiities was correlate with the SF-36 MCS, but they i not inclue the SF-36 MCS in their multivariate moels assessing the effect of patient characteristics on outcome scores 8. Although our bivariate analysis foun correlations between meical comorbiity an the VAS for shouler pain, the ASES score, an the SST score, these relationships i not remain significant when the SF-36 MCS was inclue in our multivariate moels. The ifferences between bivariate correlations an the multivariate moel are likely ue to intercorrelation between the preictor variables. Although meical comorbiity an mental health may co-vary, mental health may be a more important preictor of baseline shouler scores. In our multivariate moels, BMI continue to be a preictor of the ASES an SST scores, supporting prior reports that higher BMI correlates negatively with patientreporte shouler measures 5. There were several limitations to this stuy. This was a cross-sectional analysis of a prospectively collecte cohort, allowing us to etermine associations but not causal relationships between patient factors an shouler outcomes. During the recruitment perio, 429 full-thickness rotator cuff tears were iagnose, but only 169 were enrolle in the stuy, suggesting a selection bias. Given this bias, the cohort may not have been fully representative of the entire patient population in our practice, which also inclues patients with symptomatic rotator cuff tears not confirme by imaging. The use of tear area as a morphological measurement of rotator cuff tears was limite by the fact that tears o not generally have a quarilateral shape. Given the variation in tear shapes that we see clinically, it may not be a great measure of tear severity. However, it is esigne to take into account both the size of the tear an the amount that the tenons have retracte in a single variable. Because this stuy only shows patient ata prior to surgical intervention, we cannot raw conclusions about the effect of mental health on outcomes; follow-up of this cohort will investigate the impact of mental health on postoperative shouler scores an will examine whether surgical correction of shouler pathology influences mental health. In conclusion, patient mental health assesse by the SF-36 MCS ha a stronger association than the other variables teste with patient-reporte shouler pain, function, an shouler-specific health-relate quality of life among patients with an MRI-iagnose full-thickness rotator cuff tear. Morphological tear severity was associate with patient-reporte shouler function but not with patient-reporte shouler pain. The SF-36 MCS may represent a valuable risk ajustor in stuies investigating the treatment of rotator cuff isease. Further research is neee to unerstan the relationship

6 256 between psychosocial variables an patient-reporte shouler health relate to rotator cuff tears. n 1 Department of Orthopaeics, University of Utah, Salt Lake City, Utah 2 Department of Orthopaeic Surgery, Kantonsspital Basellan, Liestal, Switzerlan James D. Wylie, MD, MHS 1 Thomas Suter, MD 1,2 Michael Q. Potter, MD 3 Erin K. Granger, MPH 1 Robert Z. Tashjian, MD 1 3 Department of Orthopeics, Stanfor University, Rewoo City, California aress for R.Z. Tashjian: Robert.Tashjian@hsc.utah.eu References 1. Wylie JD, Beckmann JT, Granger E, Tashjian RZ. Functional outcomes assessment in shouler surgery. Worl J Orthop Nov 18;5(5): Potter MQ, Wylie JD, Greis PE, Burks RT, Tashjian RZ. Psychological istress negatively affects self-assessment of shouler function in patients with rotator cuff tears. Clin Orthop Relat Res Dec;472(12): Epub 2014 Jul Cho CH, Seo HJ, Bae KC, Lee KJ, Hwang I, Warner JJ. 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