The Minimum Clinically Important Difference of the Patient-rated Wrist Evaluation Score for Patients With Distal Radius Fractures

Monique M J Walenkamp, Robert-Jan de Muinck Keizer, J Carel Goslings, Lara M Vos, Melvin P Rosenwasser, Niels W L Schep, Monique M J Walenkamp, Robert-Jan de Muinck Keizer, J Carel Goslings, Lara M Vos, Melvin P Rosenwasser, Niels W L Schep

Abstract

Background: The Patient-rated Wrist Evaluation (PRWE) is a commonly used instrument in upper extremity surgery and in research. However, to recognize a treatment effect expressed as a change in PRWE, it is important to be aware of the minimum clinically important difference (MCID) and the minimum detectable change (MDC). The MCID of an outcome tool like the PRWE is defined as the smallest change in a score that is likely to be appreciated by a patient as an important change, while the MDC is defined as the smallest amount of change that can be detected by an outcome measure. A numerical change in score that is less than the MCID, even when statistically significant, does not represent a true clinically relevant change. To our knowledge, the MCID and MDC of the PRWE have not been determined in patients with distal radius fractures.

Questions/purposes: We asked: (1) What is the MCID of the PRWE score for patients with distal radius fractures? (2) What is the MDC of the PRWE?

Methods: Our prospective cohort study included 102 patients with a distal radius fracture and a median age of 59 years (interquartile range [IQR], 48-66 years). All patients completed the PRWE questionnaire during each of two separate visits. At the second visit, patients were asked to indicate the degree of clinical change they appreciated since the previous visit. Accordingly, patients were categorized in two groups: (1) minimally improved or (2) no change. The groups were used to anchor the changes observed in the PRWE score to patients' perspectives of what was clinically important. We determined the MCID using an anchor-based receiver operator characteristic method. In this context, the change in the PRWE score was considered a diagnostic test, and the anchor (minimally improved or no change as noted by the patients from visit to visit) was the gold standard. The optimal receiver operator characteristic cutoff point calculated with the Youden index reflected the value of the MCID.

Results: In our study, the MCID of the PRWE was 11.5 points. The area under the curve was 0.54 (95% CI, 0.37-0.70) for the pain subscale and 0.71 (95% CI, 0.57-0.85) for the function subscale. We determined the MDC to be 11.0 points.

Conclusions: We determined the MCID of the PRWE score for patients with distal radius fractures using the anchor-based approach and verified that the MDC of the PRWE was sufficiently small to detect our MCID.

Clinical relevance: We recommend using an improvement on the PRWE of more than 11.5 points as the smallest clinically relevant difference when evaluating the effects of treatments and when performing sample-size calculations on studies of distal radius fractures.

Figures

Fig. 1
Fig. 1
The global rating of change (GRC) scale used in the Patient-rated Wrist Evaluation (PRWE) questionnaire is shown. The anchor questions allowed patients to assess their current health status regarding wrist function and wrist pain, and compare their status with that of their previous visit.
Fig. 2
Fig. 2
The flowchart shows patient selection methods used for the study.

References

    1. Beaton DE, Boers M, Wells GA. Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. Curr Opin Rheumatol. 2002;14:109–114. doi: 10.1097/00002281-200203000-00006.
    1. Beaton DE, Bombardier C, Katz JN, Wright JG, Wells G, Boers M, Strand V, Shea B. Looking for important change/differences in studies of responsiveness. OMERACT MCID Working Group. Outcome measures in rheumatology: minimal clinically important difference. J Rheumatol. 2001;28:400–405.
    1. Beerekamp MS, Ubbink DT, Maas M, Luitse JS, Kloen P, Blokhuis TJ, Segers MJ, Marmor M, Schep NW, Dijkgraaf MG, Goslings JC. Project group of the EF3X-trial. Fracture surgery of the extremities with the intra-operative use of 3D-RX: q randomized multicenter trial (EF3X-trial) BMC Musculoskelet Disord. 2011;12:151. doi: 10.1186/1471-2474-12-151.
    1. Calfee RP, Adams AA. Clinical research and patient-rated outcome measures in hand surgery. J Hand Surg Am. 2012;37:851–855. doi: 10.1016/j.jhsa.2012.01.043.
    1. Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol. 2003;56:395–407. doi: 10.1016/S0895-4356(03)00044-1.
    1. de Vet HC, Ostelo RW, Terwee CB, van der Roer N, Knol DL, Beckerman H, Boers M, Bouter LM. Minimally important change determined by a visual method integrating an anchor-based and a distribution-based approach. Qual Life Res. 2007;16:131–142. doi: 10.1007/s11136-006-9109-9.
    1. de Vet HC, Terwee CB, Ostelo RW, Beckerman H, Knol DL, Bouter LM. Minimal changes in health status questionnaires: distinction between minimally detectable change and minimally important change. Health Qual Life Outcomes. 2006;4:54. doi: 10.1186/1477-7525-4-54.
    1. Gupta S, Halai M, Al-Maiyah M, Muller S. Which measure should be used to assess the patient’s functional outcome after distal radius fracture? Acta Orthop Belg. 2014;80:116–118.
    1. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR, Clinical Significance Consensus Meeting Group Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002;77:371–383. doi: 10.4065/77.4.371.
    1. Jaeschke R, Singer J, Guyatt GH. Measurement of health status: ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407–415. doi: 10.1016/0197-2456(89)90005-6.
    1. Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17:163–170. doi: 10.1179/jmt.2009.17.3.163.
    1. Kim JK, Park ES. Comparative responsiveness and minimal clinically important differences for idiopathic ulnar impaction syndrome. Clin Orthop Relat Res. 2013;471:1406–1411. doi: 10.1007/s11999-013-2843-8.
    1. Lydick E, Epstein RS. Interpretation of quality of life changes. Qual Life Res. 1993;2:221–226. doi: 10.1007/BF00435226.
    1. MacDermid JC. The patient-rated wrist evaluation (PRWE) user manual.2007. Available at: . Accessed September 18, 2014.
    1. MacDermid JC, Turgeon T, Richards RS, Beadle M, Roth JH. Patient rating of wrist pain and disability: a reliable and valid measurement tool. J Orthop Trauma. 1998;12:577–586. doi: 10.1097/00005131-199811000-00009.
    1. Mukaka MM. Statistics corner: a guide to appropriate use of correlation coefficient in medical research. Malawi Med J. 2012;24:69–71.
    1. Müller ME, Nazarian S, Koch P, Schatzker J. The Comprehensive Classification of Fractures of Long Bones. Berlin, Germany: Springer-Verlag; 1990.
    1. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life the remarkable universality of half a standard deviation. Med Care. 2003;41:582–592.
    1. Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008;61:102–109. doi: 10.1016/j.jclinepi.2007.03.012.
    1. Schmitt JS, Di Fabio RP. Reliable change and minimum important difference (MID) proportions facilitated group responsiveness comparisons using individual threshold criteria. J Clin Epidemiol. 2004;57:1008–1018. doi: 10.1016/j.jclinepi.2004.02.007.
    1. Smith MV, Calfee RP, Baumgarten KM, Brophy RH, Wright RW. Upper extremity-specific measures of disability and outcomes in orthopaedic surgery. J Bone Joint Surg Am. 2012;94:277–285. doi: 10.2106/JBJS.J.01744.
    1. Sorensen AA, Howard D, Tan WH, Ketchersid J, Calfee RP. Minimal clinically important differences of 3 patient-rated outcomes instruments. J Hand Surg Am. 2013;38:641–649. doi: 10.1016/j.jhsa.2012.12.032.
    1. Stratford PW, Binkley JM, Riddle DL, Guyatt GH. Sensitivity to change of the Roland-Morris back pain questionnaire: part 1. Phys Ther. 1998;78:1186–1196.
    1. Tashjian RZ, Deloach J, Green A, Porucznik CA, Powell AP. Minimal clinically important differences in ASES and simple shoulder test scores after nonoperative treatment of rotator cuff disease. J Bone Joint Surg Am. 2010;92:296–303. doi: 10.2106/JBJS.H.01296.
    1. Walenkamp MM, Goslings JC, Beumer A, Haverlag R, Leenhouts PA, Verleisdonk EJ, Liem RS, Sintenie JB, Bronkhorst MW, Winkelhagen J, Schep NW. Surgery versus conservative treatment in patients with type A distal radius fractures: a randomized controlled trial. BMC Musculoskelet Disord. 2014;15:90. doi: 10.1186/1471-2474-15-90.
    1. Wang YC, Hart DL, Stratford PW, Mioduski JE. Baseline dependency of minimal clinically important improvement. Phys Ther. 2011;91:675–688. doi: 10.2522/ptj.20100229.
    1. Wright JG. The minimal important difference: who’s to say what is important? J Clin Epidemiol. 1996;49:1221–1222. doi: 10.1016/S0895-4356(96)00207-7.

Source: PubMed

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