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Minimal clinically important difference (MCID) and substantial clinical benefit (SCB) of upper extremity PROMIS scores following arthroscopic rotator cuff repairs

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Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

Abstract

Purpose

To calculate and determine what factors are associated with achieving the Minimal Clinically Important Difference (MCID) and the Substantial Clinical Benefit (SCB) of Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Testing v2.0 (UE), Pain Interference (P-Interference), and Pain Intensity (P-Intensity) in patients undergoing arthroscopic rotator cuff repair (aRCR).

Methods

The change in PROMIS scores representing the optimal cutoff for a ROC curve with an area under the curve analysis was used to calculate the anchor-based MCID and SCB. To assess the responsiveness of each PROM, effect sizes and standardized response means (SRM) were calculated. To identify factors associated with attaining the MCID and SCB, univariate and multivariate logistic regression analyses were performed.

Results

A total of 323 patients with an average age of 59.9 ± 9.5 were enrolled in this study, of which, 187/323 [57.9%] were male and 136/323 [42.1%] were female. The anchor-based MCID for PROMIS UE, P-Interference, and P-Intensity was: 9.0, 7.5, and 11.2, respectively. The respective SCB was 10.9, 9.3, and 12.7. Effect size and SRM were: PROMIS UE (1.4, 1.3), P-Interference (1.8, 1.5), and P-Intensity (2.3, 2.0). Lower preoperative P-Intensity scores (p = 0.02), dominant arm involvement (p = 0.03), and concomitant biceps tenodesis (p = 0.03) were associated with patients achieving the SCB for PROMIS UE.

Conclusion

A large responsiveness for each of the PROMIS instruments due to the majority of patients reporting great improvement after aRCR and a small standard deviation across all outcome measures was shown in our study. Lower preoperative P-Intensity scores and concomitant biceps tenodesis were associated with higher odds of achieving the SCB for PROMIS UE. The knowledge of MCID and SCB values for PROMIS instruments will allow the surgeon to determine whether the improvements in the PROMIS scores after aRCR are clinically meaningful.

Level of evidence

Level III.

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Data availability

The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.

References

  1. Aflatooni JO, Meeks BD, Froehle AW, Bonner KF (2020) Biceps tenotomy versus tenodesis: patient-reported outcomes and satisfaction. J Orthop Surg Res 15(1):56

    Article  PubMed  PubMed Central  Google Scholar 

  2. Ahmed AF, Toubasi A, Mahmoud S, Ahmed GO, AlDosari AAM, Zikria BA (2021) Long head of biceps tenotomy versus tenodesis: a systematic review and meta-analysis of randomized controlled trials. Shoulder Elbow 13(6):583–591

    Article  PubMed  Google Scholar 

  3. Anthony CA, Glass N, Hancock K, Bollier M, Hettrich CM, Wolf BR (2017) Preoperative performance of the patient-reported outcomes measurement information system in patients with rotator cuff pathology. Arthroscopy 33(10):1770-1774.e1

    Article  PubMed  Google Scholar 

  4. Ateschrang A, Eggensperger F, Ahrend MD, Schröter S, Stöckle U, Kraus TM (2018) Obesity causes poorer clinical results and higher re-tear rates in rotator cuff repair. Arch Orthop Trauma Surg 138(6):835–842

    Article  CAS  PubMed  Google Scholar 

  5. Beckerman H, Roebroeck ME, Lankhorst GJ, Becher JG, Bezemer PD, Verbeek AL (2001) Smallest real difference, a link between reproducibility and responsiveness. Qual Life Res 10(7):571–578

    Article  CAS  PubMed  Google Scholar 

  6. Berglund DD, Kurowicki J, Giveans MR, Horn B, Levy CJ (2018) Comorbidity effect on speed of recovery after arthroscopic rotator cuff repair. JSES Open Access 2(1):60–68

    Article  PubMed  PubMed Central  Google Scholar 

  7. Bernstein ND, Houck JR, Mahmood B, Hammert CW (2019) Minimal clinically important differences for PROMIS physical function, upper extremity, and pain interference in carpal tunnel release using region- and condition-specific PROM tools. J Hand Surg 44(8):635–640

    Article  Google Scholar 

  8. Bjorner JB, Rose M, Gandek B, Stone AA, Junghaenel DU, Ware JE Jr (2014) Method of administration of PROMIS scales did not significantly impact score level, reliability, or validity. J Clin Epidemiol 67(1):108–113

    Article  PubMed  PubMed Central  Google Scholar 

  9. Brodke DJ, Saltzman CL, Brodke DS (2016) PROMIS for orthopaedic outcomes measurement. J Am Acad Orthop Surg 24(11):744–749

    Article  PubMed  Google Scholar 

  10. Bykerk VP (2019) Patient-reported outcomes measurement information system versus legacy instruments: are they ready for prime time? Rheum Dis Clin North Am 45(2):211–229

    Article  PubMed  Google Scholar 

  11. Christiansen DH, Frost P, Falla D, Haahr JP, Frich LH, Svendsen SW (2015) Responsiveness and minimal clinically important change: a comparison between 2 shoulder outcome measures. J Orthop Sports Phys Ther 45(8):620–625

    Article  PubMed  Google Scholar 

  12. Cheung EC, Moore LK, Flores SE, Lansdown DA, Feeley BT, Zhang AL (2019) Correlation of PROMIS with orthopaedic patient-reported outcome measures. JBJS Rev 7(8):e9

    Article  PubMed  Google Scholar 

  13. Colvin AC, Egorova N, Harrison AK, Moskowitz A, Flatow EL (2012) National trends in rotator cuff repair. J Bone Joint Surg Am 94(3):227–233

    Article  PubMed  PubMed Central  Google Scholar 

  14. Cvetanovich GL, Gowd AK, Liu JN, Nwachukwu BU, Cabarcas BC, Cole BJ, Forsythe B, Romeo AA, Verma NN (2019) Establishing clinically significant outcome after arthroscopic rotator cuff repair. J Shoulder Elbow Surg 28(5):939–948

    Article  PubMed  Google Scholar 

  15. Day MA, Westermann RW, Bedard NA, Glass NA, Wolf BR (2019) Trends associated with open versus arthroscopic rotator cuff repair. HSS J 15(2):133–136

    Article  PubMed  Google Scholar 

  16. DeOrio JK, Cofield RH (1984) Results of a second attempt at surgical repair of a failed initial rotator-cuff repair. J Bone Joint Surg Am 66(4):563–567

    Article  CAS  PubMed  Google Scholar 

  17. Fisk F, Franovic S, Tramer JS, Gulledge C, Kuhlmann NA, Chen C, Moutzouros V, Muh S, Makhni CE (2019) PROMIS CAT forms demonstrate responsiveness in patients following arthroscopic rotator cuff repair across numerous health domains. J Shoulder Elbow Surg 28(12):2427–2432

    Article  PubMed  Google Scholar 

  18. Fries JF, Witter J, Rose M, Cella D, Khanna D, Morgan-DeWitt E (2014) Item response theory, computerized adaptive testing, and PROMIS: assessment of physical function. J Rheumatol 41(1):153–158

    Article  PubMed  Google Scholar 

  19. Gambhir N, Shankar D, Alben M, Kwon Y, Rokito A, Virk MS (2022) The effects of obesity on 1-year functional outcomes after arthroscopic rotator cuff tear repair. JSES Int 6(4):631–637

    Article  PubMed  PubMed Central  Google Scholar 

  20. Gordon D, Pines Y, Ben-Ari E, Rokito AS, Kwon YW, Zuckerman JD, Virk MS (2021) Minimal clinically important difference, substantial clinical benefit, and patient acceptable symptom state of PROMIS upper extremity after total shoulder arthroplasty. JSES Int 5(5):894–899

    Article  PubMed  PubMed Central  Google Scholar 

  21. Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN, REDCap Consortium (2019) The REDCap consortium: building an international community of software platform partners. J Biomed Inform 95:103208

    Article  Google Scholar 

  22. Haunschild ED, Gilat R, Fu MC, Tauro T, Huddleston HP, Yanke AB, Forsythe B, Verma NN, Cole BJ (2020) Establishing the minimal clinically important difference, patient acceptable symptomatic state, and substantial clinical benefit of the promis upper extremity questionnaire after rotator cuff repair. Am J Sports Med 48(14):3439–3446

    Article  PubMed  Google Scholar 

  23. Horn ME, Reinke EK, Yan X, Luo S, Bolognesi M, Reeve BB, George SZ, Comprehensive Outcomes in Orthopaedics and Rehabilitation Data System (COORDS) group (2021) Use of patient-reported outcomes measurement information system (PROMIS) measures to characterise health status for patients seeking care from an orthopaedic provider: a retrospective cohort study. BMJ Open 11(9):e047156

    Article  PubMed  PubMed Central  Google Scholar 

  24. Hung M, Saltzman CL, Kendall R, Bounsanga J, Voss MW, Lawrence B, Spiker R, Brodke D (2018) What are the MCIDs for PROMIS, NDI, and ODI instruments among patients with spinal conditions? Clin Orthop Relat Res 476(10):2027–2036

    Article  PubMed  PubMed Central  Google Scholar 

  25. Jaeschke R, Singer J, Guyatt GH (1989) Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 10(4):407–415

    Article  CAS  PubMed  Google Scholar 

  26. Karhade AV, Bernstein DN, Desai V, Bedair HS, O’Donnell EA, Tanaka MJ, Bono CM, Harris MB, Schwab JH, Tobert DG (2022) What is the clinical benefit of common orthopaedic procedures as assessed by the PROMIS versus other validated outcomes tools? Clin Orthop Relat Res 480(9):1672–1681

    Article  PubMed  Google Scholar 

  27. Kelly MA, Mc Donald CK, Boland A, Groarke PJ, Kaar K (2017) The effect of hand dominance on functional outcome following single row rotator cuff repair. Open J Orthop 11:562–566

    Article  Google Scholar 

  28. Kim MD, Kim HT, Kholinne E, Park JH, Shin MJ, Kim H, Park D, Jeon IH, Koh KH (2020) Minimal clinically important difference, substantial clinical benefit, and patient acceptable symptomatic state after arthroscopic rotator cuff repair. Am J Sports Med 48(11):2650–2659

    Article  PubMed  Google Scholar 

  29. Kolade O, Ghosh N, Luthringer TA, Rosenthal Y, Kwon YW, Rokito AS, Zuckerman JD, Virk MS (2021) Correlation of patient reported outcome measurement information system (PROMIS) with American shoulder and elbow surgeon (ASES), and constant (CS) scores in idiopathic adhesive capsulitis. J Shoulder Elbow Surg 30(3):554–560

    Article  PubMed  Google Scholar 

  30. Kurowicki J, Berglund DD, Momoh E, Disla S, Horn B, Giveans MR, Levy JC (2017) Speed of recovery after arthroscopic rotator cuff repair. J Shoulder Elbow Surg 26(7):1271–1277

    Article  PubMed  Google Scholar 

  31. Longo UG, Berton A, De Salvatore S, Piergentili I, Casciani E, Faldetta A, De Marinis MG, Denaro V (2021) Minimal clinically important difference and patient acceptable symptom state for the pittsburgh sleep quality index in patients who underwent rotator cuff tear repair. Int J Environ Res Public Health 18(16):8666

    Article  PubMed  PubMed Central  Google Scholar 

  32. Louwerens J, van den Bekerom M, van Royen BJ, Eygendaal D, van Noort A, Sierevelt IN (2020) Quantifying the minimal and substantial clinical benefit of the Constant-Murley score and the disabilities of the arm, shoulder and hand score in patients with calcific tendinitis of the rotator cuff. JSES Int 4(3):606–611

    Article  PubMed  PubMed Central  Google Scholar 

  33. MacDonald P, Verhulst F, McRae S, Old J, Stranges G, Dubberley J, Mascarenhas R, Koenig J, Leiter J, Nassar M, Lapner P (2020) Biceps tenodesis versus tenotomy in the treatment of lesions of the long head of the biceps tendon in patients undergoing arthroscopic shoulder surgery: a prospective double-blinded randomized controlled Trial. Am J Sports Med 48(6):1439–1449

    Article  PubMed  Google Scholar 

  34. Malavolta EA, Yamamoto GJ, Bussius DT, Assunção JH, Andrade-Silva FB, Gracitelli M, Ferreira Neto AA (2021) Establishing minimal clinically important difference for the UCLA and ASES scores after rotator cuff repair. Orthop Traumatol Sur 108(2):102894

    Article  Google Scholar 

  35. Mollon B, Mahure SA, Roche CP, Zuckerman JD (2016) Impact of glenosphere size on clinical outcomes after reverse total shoulder arthroplasty: an analysis of 297 shoulders. J Shoulder Elbow Surg 25(5):763–771

    Article  PubMed  Google Scholar 

  36. Nicholson AD, Kassam HF, Pan SD, Berman JE, Blaine TA, Kovacevic D (2019) Performance of PROMIS global-10 compared with legacy instruments for rotator cuff disease. Am J Sports Med 47(1):181–188

    Article  PubMed  Google Scholar 

  37. Norman GR, Wyrwich KW, Patrick DL (2007) The mathematical relationship among different forms of responsiveness coefficients. Qual Life Res 16(5):815–822

    Article  CAS  PubMed  Google Scholar 

  38. Ogura T, Ackermann J, Barbieri Mestriner A, Merkely G, Gomoll AH (2020) Minimal clinically important differences and substantial clinical benefit in patient-reported outcome measures after autologous chondrocyte implantation. Cartilage 11(4):412–422

    Article  CAS  PubMed  Google Scholar 

  39. O’Hara NN, Richards JT, Overmann A, Slobogean GP, Klazinga NS (2020) Is PROMIS the new standard for patient-reported outcomes measures in orthopaedic trauma research? Injury 51(Suppl 2):S43–S50

    Article  PubMed  Google Scholar 

  40. Patterson BM, Orvets ND, Aleem AW, Keener JD, Calfee RP, Nixon DC, Chamberlain AM (2018) Correlation of patient-reported outcomes measurement information system (PROMIS) scores with legacy patient-reported outcome scores in patients undergoing rotator cuff repair. J Shoulder Elbow Surg 27(6S):S17–S23

    Article  PubMed  Google Scholar 

  41. Pines Y, Gordon D, Alben M, Kwon YW, Zuckerman JD, Virk MS (2022) Performance and responsiveness to change of PROMIS UE in patients undergoing total shoulder arthroplasty. J Orthop Res. https://doi.org/10.1002/jor.25263

    Article  PubMed  Google Scholar 

  42. Rai SK, Yazdany J, Fortin PR, Aviña-Zubieta JA (2015) Approaches for estimating minimal clinically important differences in systemic lupus erythematosus. Arthritis Res Ther 17(1):143

    Article  PubMed  PubMed Central  Google Scholar 

  43. Rose M, Bjorner JB, Becker J, Fries JF, Ware JE (2008) Evaluation of a preliminary physical function item bank supported the expected advantages of the patient-reported outcomes measurement information system (PROMIS). J Clin Epidemiol 61(1):17–33

    Article  CAS  PubMed  Google Scholar 

  44. Schwarz I, Smith JH, Houck DA, Frank RM, Bravman JT, McCarty EC (2020) Use of the patient-reported outcomes measurement information system (PROMIS) for operative shoulder outcomes. Orthop J Sports Med 8(6):2325967120924345

    Article  PubMed  PubMed Central  Google Scholar 

  45. Sedaghat AR (2019) Understanding the minimal clinically important difference (MCID) of patient-reported outcome measures. Otolaryngol Head Neck Surg 161(4):551–560

    Article  PubMed  Google Scholar 

  46. Sullivan GM, Feinn R (2012) Using effect size-or why the p value is not enough. J Grad Med Educ 4(3):279–282

    Article  PubMed  PubMed Central  Google Scholar 

  47. Vadhera AS, Beletsky A, Singh H, Chahla J, Cole BJ, Verma NN (2021) Preoperative psychometric properties of patient-reported outcomes measurement information system upper extremity, pain interference, and depression in bankart repair and rotator cuff repair. J Shoulder Elbow Surg 30(10):2225–2230

    Article  PubMed  Google Scholar 

  48. Warrender WJ, Brown OL, Abboud JA (2011) Outcomes of arthroscopic rotator cuff repairs in obese patients. J Shoulder Elbow Surg 20(6):961–967

    Article  PubMed  Google Scholar 

  49. Wells G, Beaton D, Shea B, Boers M, Simon L, Strand V, Brooks P, Tugwell P (2001) Minimal clinically important differences: review of methods. J Rheumatol 28(2):406–412

    CAS  PubMed  Google Scholar 

  50. Wong LH, Meeker JE (2022) The promise of computer adaptive testing in collection of orthopaedic outcomes: an evaluation of PROMIS utilization. J Patient Rep Outcomes 6(1):2

    Article  PubMed  PubMed Central  Google Scholar 

  51. Yanik EL, Chamberlain AM, Keener JD (2021) Trends in rotator cuff repair rates and comorbidity burden among commercially insured patients younger than the age of 65 years, United States 2007–2016. JSES Rev Rep Tech 1(4):309–316

    PubMed  PubMed Central  Google Scholar 

  52. Xu S, Chen JY, Lie H, Hao Y, Lie D (2019) Minimal clinically important difference of Oxford, constant, and UCLA shoulder score for arthroscopic rotator cuff repair. J Orthop 19:21–27

    Article  PubMed  PubMed Central  Google Scholar 

  53. Zhou P, Liu J, Deng X, Li Z (2021) Biceps tenotomy versus tenodesis for lesions of the long head of the biceps tendon: a systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore) 100(3):e23993

    Article  PubMed  Google Scholar 

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Funding

This study was funded by New York University Langone Health, no external funding was received. The authors of this paper certify that they have no affiliations with or involvement in any organization or entity with any financial or non-financial interests pertinent to the subject matter discussed in this manuscript.

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Authors and Affiliations

  1. Division of Shoulder and Elbow Surgery, Department of Orthopedic Surgery, NYU Grossman School of Medicine, NYU Langone Orthopedic Hospital, NYU Langone Health, 246 East 20Th Street, New York, NY, 10003, USA

    Matthew G. Alben, Neil Gambhir, Matthew T. Kim, Paul V. Romeo, Andrew S. Rokito, Joseph D. Zuckerman & Mandeep S. Virk

  2. Department of Orthopedic Surgery, Baylor University Medical Center Dallas, Dallas, TX, USA

    Dan Gordon

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  1. Matthew G. Alben
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  3. Neil Gambhir
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Correspondence to Mandeep S. Virk.

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Ethical approval

This study was approved by the NYU Langone Health Institutional Review Board (s20-00287).

Conflict of interest

Joseph D. Zuckerman, MD: Apos Therapy, Inc. (Stock); Hip Innovation Technology (Stock); Musculoskeletal Transplant Foundation (Board Member); SLACK Inc. (Publishing Royalties); Thieme Inc. (Publishing Royalties); Wolters Kluwer Health (Publishing Royalties); Exactech (Design Surgeon, Royalties). Mandeep S. Virk, MD: Exactech (Paid Consultant); Acumed Inc. (Paid Consultant). The other authors of this paper certify that they have NO affiliations with or involvement in any organization or entity with any financial or non-financial interests pertinent to the subject matter discussed in this manuscript.

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Alben, M.G., Gordon, D., Gambhir, N. et al. Minimal clinically important difference (MCID) and substantial clinical benefit (SCB) of upper extremity PROMIS scores following arthroscopic rotator cuff repairs. Knee Surg Sports Traumatol Arthrosc 31, 2602–2614 (2023). https://doi.org/10.1007/s00167-022-07279-7

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