Advertisement

The Responsiveness of the Patient-Reported Outcomes Measurement Information System Upper Extremity and Physical Function in Patients With Cubital Tunnel Syndrome

      Purpose

      The Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) and PROMIS Physical Function (PF) are increasingly referenced patient-reported outcomes. To interpret treatment effects with these patient-reported outcomes, investigators must understand magnitudes of change that represent clinically relevant improvement. This study assessed the responsiveness of PROMIS UE and PF in patients with cubital tunnel syndrome.

      Methods

      A retrospective analysis of PROMIS UE and PROMIS PF computer adaptive test scores was performed for patients treated nonoperatively for cubital tunnel syndrome over 3 years at a tertiary institution. The Patient-Reported Outcomes Measurement Information System UE and PROMIS PF outcome scores were collected at initial and return clinic visits. At follow-up appointments, patients completed clinical anchor questions evaluating their degree of interval clinical improvement. Anchor questions allowed categorization of patients into groups that had experienced “no change,” “minimal change,” and “much change.” Minimal clinically important difference (MCID) values were calculated for the PROMIS assessments with anchor-based and distribution-based methods.

      Results

      A total of 304 patients with PROMIS PF scores and 111 with PROMIS UE scores were analyzed. The MCID for the PROMIS UE was 3.1 (95% confidence interval, 1.4–4.8) using the anchor-based method and 3.7 (95% confidence interval, 2.9–4.4) using the distribution-based method. These point estimates exceeded the minimal detectable change of 2.3. The MCID for the PROMIS PF was unable to be determined in this patient sample because patients reporting mild change did not have score changes exceeding measurement error.

      Conclusions

      The PROMIS UE v2.0 computer adaptive test detected minimal change in patients managed nonoperatively for cubital tunnel syndrome with an estimated MCID range of 3.1–3.7. While PROMIS PF has demonstrated acceptable performance in patients with a variety of upper extremity conditions, for cubital tunnel syndrome, it was less able to detect subtle change. PROMIS UE appears more responsive to subtle changes in cubital tunnel syndrome symptoms.

      Clinical Relevance

      Patient-reported outcomes may have varied responsiveness depending on the condition studied.

      Key words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Hand Surgery
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Porter M.E.
        What is value in health care?.
        N Engl J Med. 2010; 363: 2477-2481
        • Smith M.V.
        • Calfee R.P.
        • Baumgarten K.M.
        • Brophy R.H.
        • Wright R.W.
        Upper extremity-specific measures of disability and outcomes in orthopaedic surgery.
        J Bone Joint Surg Am. 2012; 94: 277-285
        • Calfee R.P.
        • Adams A.A.
        Clinical research and patient-rated outcome measures in hand surgery.
        J Hand Surg Am. 2012; 37: 851-855
        • Calfee R.
        • Chu J.
        • Sorensen A.
        • Martens E.
        • Elfar J.
        What is the impact of comorbidities on self-rated hand function in patients with symptomatic trapeziometacarpal arthritis?.
        Clin Orthop Relat Res. 2015; 473: 3477-3483
        • Vranceanu A.M.
        • Jupiter J.B.
        • Mudgal C.S.
        • Ring D.
        Predictors of pain intensity and disability after minor hand surgery.
        J Hand Surg Am. 2010; 35: 956-960
        • Hsu J.E.
        • Nacke E.
        • Park M.J.
        • Sennett B.J.
        • Huffman G.R.
        The Disabilities of the Arm, Shoulder, and Hand questionnaire in intercollegiate athletes: validity limited by ceiling effect.
        J Shoulder Elbow Surg. 2010; 19: 349-354
        • Shauver M.J.
        • Chung K.C.
        The minimal clinically important difference of the Michigan hand outcomes questionnaire.
        J Hand Surg Am. 2009; 34: 509-514
        • Sears E.D.
        • Chung K.C.
        Validity and responsiveness of the Jebsen-Taylor Hand Function Test.
        J Hand Surg Am. 2010; 35: 30-37
        • Beleckas C.M.
        • Padovano A.
        • Guattery J.
        • Chamberlain A.M.
        • Keener J.D.
        • Calfee R.P.
        Performance of Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) versus Physical Function (PF) computer adaptive tests (CATs) in upper extremity clinics.
        J Hand Surg Am. 2017; 42: 867-874
        • Tyser A.R.
        • Hung M.
        • Bounsanga J.
        • Voss M.W.
        • Kazmers N.H.
        Evaluation of version 2.0 of the PROMIS Upper Extremity Computer Adaptive Test in nonshoulder upper extremity patients.
        J Hand Surg Am. 2019; 44: 267-273
        • Doring A.C.
        • Nota S.P.
        • Hageman M.G.
        • Ring D.C.
        Measurement of upper extremity disability using the Patient-Reported Outcomes Measurement Information System.
        J Hand Surg Am. 2014; 39: 1160-1165
        • Tyser A.R.
        • Beckmann J.
        • Franklin J.D.
        • et al.
        Evaluation of the PROMIS physical function computer adaptive test in the upper extremity.
        J Hand Surg Am. 2014; 39: 2047-2051.e4
        • Beleckas C.
        • Padovano A.
        • Guattery J.
        • Chamberlain A.
        • Keener J.
        • Calfee R.P.
        Ceiling Effect of the PROMIS Upper Extremity Function Assessment.
        J Hand Surg Am. 2017; 42: S28-S29
        • Sandvall B.
        • Okoroafor U.C.
        • Gerull W.
        • Guattery J.
        • Calfee R.P.
        Minimal clinically important difference for PROMIS physical function in patients with distal radius fractures.
        J Hand Surg Am. 2019; 44: 454-459.e1
        • Kazmers N.H.
        • Qiu Y.
        • Yoo M.
        • et al.
        The minimal clinically important difference of the PROMIS and QuickDASH instruments in a nonshoulder hand and upper extremity patient population.
        J Hand Surg Am. 2020; 45: 399-407.e6
        • Bernstein D.N.
        • Houck J.R.
        • Mahmood B.
        • Hammert W.C.
        Responsiveness of the PROMIS and its concurrent validity with other region- and condition-specific PROMs in patients undergoing carpal tunnel release.
        Clin Orthop Relat Res. 2019; 477: 2544-2551
        • Bae D.S.
        • Canizares M.F.
        • Miller P.E.
        • Waters P.M.
        • Goldfarb C.A.
        Functional impact of congenital hand differences: early results from the congenital upper limb differences (CoULD) registry.
        J Hand Surg Am. 2018; 43: 321-330
        • Okoroafor U.C.
        • Gerull W.
        • Wright M.
        • Guattery J.
        • Sandvall B.
        • Calfee R.P.
        The impact of social deprivation on pediatric PROMIS health scores after upper extremity fracture.
        J Hand Surg Am. 2018; 43: 897-902
        • Beleckas C.M.
        • Gerull W.
        • Wright M.
        • et al.
        Variability of PROMIS scores across hand conditions.
        J Hand Surg Am. 2019; 44: 186-191.e1
        • Gholson J.J.
        • Shah A.S.
        • Buckwalter IV JAt
        • Buckwalter V JAt
        Long-term clinical and radiographic follow-up of preaxial polydactyly reconstruction.
        J Hand Surg Am. 2019; 44: 244.e1-244.e6
        • Wu M.
        • Miller P.E.
        • Waters P.M.
        • Bae D.S.
        Early results of surgical treatment of triangular fibrocartilage complex tears in children and adolescents.
        J Hand Surg Am. 2020; 45: 449.e1-449.e9
        • Pet M.A.
        • Assi P.E.
        • Yousaf I.S.
        • et al.
        Outcomes of the medial femoral trochlea osteochondral free flap for proximal scaphoid reconstruction.
        J Hand Surg Am. 2020; 45: 317-326.e3
        • Grandizio L.C.
        • Gehrman M.D.
        • Graham J.
        • et al.
        The ability of upper extremity surgeons to assess patient's functional status.
        J Hand Surg Am. 2021; 46: 819.e1-819.e8
        • Shetty P.N.
        • Hawken J.
        • Sanghavi K.K.
        • Giladi A.M.
        Correlation of patient-reported outcomes measurement information system questionnaires with the brief Michigan Hand Questionnaire in patients with 5 common hand conditions.
        J Hand Surg Am. 2021; 46: 709.e1-709.e11
        • Ploetze K.
        • Goldfarb C.
        • Roberts S.
        • Wall L.
        Radiographic and clinical outcomes of the shoulder in long-term follow-up of brachial plexus birth injury.
        J Hand Surg Am. 2020; 45: 1115-1122
        • Kazmers N.H.
        • Qiu Y.
        • Ou Z.
        • Presson A.P.
        • Tyser A.R.
        • Zhang Y.
        Minimal clinically important difference of the PROMIS upper-extremity computer adaptive test and QuickDASH for ligament reconstruction tendon interposition patients.
        J Hand Surg Am. 2021; 46: 516-516.e7
        • Kleiss I.I.M.
        • Kortlever J.T.P.
        • Ring D.
        • Vagner G.A.
        • Reichel L.M.
        A randomized controlled trial of decision aids for upper-extremity conditions.
        J Hand Surg Am. 2021; 46: 338.e1-338.e15
        • Wall L.B.
        • Wright M.
        • Samora J.
        • Bae D.S.
        • Steinman S.
        • Goldfarb
        • CoULD Study Group
        Social deprivation and congenital upper extremity differences—an assessment using PROMIS.
        J Hand Surg Am. 2021; 46: 114-118
        • Cella D.
        • Yount S.
        • Rothrock N.
        • et al.
        The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years.
        Med Care. 2007; 45: S3-S11
        • Cella D.
        • Riley W.
        • Stone A.
        • et al.
        The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008.
        J Clin Epidemiol. 2010; 63: 1179-1194
        • Brodke D.J.
        • Saltzman C.L.
        • Brodke D.S.
        PROMIS for Orthopaedic outcomes measurement.
        J Am Acad Orthop Surg. 2016; 24: 744-749
        • Hammert W.C.
        • Calfee R.P.
        Understanding PROMIS.
        J Hand Surg Am. 2020; 45: 650-654
        • Bernstein D.N.
        • Englert C.H.
        • Hammert W.C.
        Evaluation of PROMIS’ ability to detect immediate postoperative symptom improvement following carpal tunnel release.
        J Hand Surg Am. 2021; 46: 445-453
        • Bernstein D.N.
        • Houck J.R.
        • Mahmood B.
        • Hammert W.C.
        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 Am. 2019; 44: 635-640
        • Dellon A.L.
        • Hament W.
        • Gittelshon A.
        Nonoperative management of cubital tunnel syndrome: an 8-year prospective study.
        Neurology. 1993; 43: 1673-1677
        • Shah C.M.
        • Calfee R.P.
        • Gelberman R.H.
        • Goldfarb C.A.
        Outcomes of rigid night splinting and activity modification in the treatment of cubital tunnel syndrome.
        J Hand Surg Am. 2013; 38: 1125-1130.e1
        • Svernlöv B.
        • Larsson M.
        • Rehn K.
        • Adolfsson L.
        Conservative treatment of the cubital tunnel syndrome.
        J Hand Surg Eur Vol. 2009; 34: 201-207
        • Staples J.R.
        • Calfee R.
        Cubital tunnel syndrome: current concepts.
        J Am Acad Orthop Surg. 2017; 25: e215-e224
        • Health Measures
        Transforming how health is measured 2018.
        http://www.healthmeasures.net
        Date accessed: July 30, 2020
        • Tubach F.
        • Ravaud P.
        • Baron G.
        • et al.
        Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement.
        Ann Rheum Dis. 2005; 64: 29-33
        • Lee D.J.
        • Calfee R.P.
        The minimal clinically important difference for PROMIS physical function in patients with thumb carpometacarpal arthritis.
        Hand (N Y). 2021; 16: 638-643
        • Juniper E.F.
        • Guyatt G.H.
        • Willan A.
        • Griffith L.E.
        Determining a minimal important change in a disease-specific Quality of Life Questionnaire.
        J Clin Epidemiol. 1994; 47: 81-87
        • Amtmann D.
        • Kim J.
        • Chung H.
        • Askew R.L.
        • Park R.
        • Cook K.F.
        Minimally important differences for Patient Reported Outcomes Measurement Information System pain interference for individuals with back pain.
        J Pain Res. 2016; 9: 251-255
        • Yost K.J.
        • Eton D.T.
        • Garcia S.F.
        • Cella D.
        Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients.
        J Clin Epidemiol. 2011; 64: 507-516
        • Rai S.K.
        • Yazdany J.
        • Fortin P.R.
        • Aviña-Zubieta J.A.
        Approaches for estimating minimal clinically important differences in systemic lupus erythematosus.
        Arthritis Res Ther. 2015; 17: 143
        • Copay A.G.
        • Subach B.R.
        • Glassman S.D.
        • Polly Jr., D.W.
        • Schuler T.C.
        Understanding the minimum clinically important difference: a review of concepts and methods.
        Spine J. 2007; 7: 541-546
        • Norman G.R.
        • Sloan J.A.
        • Wyrwich K.W.
        Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation.
        Med Care. 2003; 41: 582-592
        • Mukaka M.M.
        Statistics corner: a guide to appropriate use of correlation coefficient in medical research.
        Malawi Med J. 2012; 24: 69-71
        • Akoglu H.
        User’s guide to correlation coefficients.
        Turk J Emerg Med. 2018; 18: 91-93
        • Schober P.
        • Boer C.
        • Schwarte L.A.
        Correlation coefficients: appropriate use and interpretation.
        Anesth Analg. 2018; 126: 1763-1768
        • Northwestern University
        Health Measures: meaningful change for PROMIS. 2021.
        • King M.T.
        A point of minimal important difference (MID): a critique of terminology and methods.
        Expert Rev Pharmacoecon Outcomes Res. 2011; 11: 171-184
        • Overbeek C.L.
        • Nota S.P.
        • Jayakumar P.
        • Hageman M.G.
        • Ring D.
        The PROMIS physical function correlates with the QuickDASH in patients with upper extremity illness.
        Clin Orthop Relat Res. 2015; 473: 311-317