The online version of this article (doi:10.1186/s12891-017-1464-x) contains supplementary material, which is available to authorized users.
A patient- and surgeon-Delphi-derived Outcome Measures in Rheumatology (OMERACT) draft core domain set for total joint arthroplasty (TJR) trials was recently developed. Our objective was to obtain further patient stakeholder endorsement of draft core domain set for TJR clinical trials.
We surveyed two patient groups: (1) OMERACT patient partners; and (2) patients who had undergone hip or knee TJR. Patients received an introductory email with explanations about the core domain set and instructions to rate the core domains, i.e., important aspects, of OMERACT TJR clinical trial draft core domain set. Rating was on a nominal scale, where 1–3 indicated a domain of limited importance, 4–6 an important, but not critical domain, and 7–9 a critical domain. We used Mann–Whitney test (a non-parametric test) to compare the distribution of ratings between the two groups.
Thirty one survey participants from the OMERACT patient partner group and 118 knee/hip TJR patients responded with response rates of 66 and 80%, respectively. Majority of the survey respondents were female, 87 vs. 53%, and were 55 years or older, 57 vs. 94%. Median (interquartile range [IQR]) scores for six core domains by OMERACT and knee/hip TJR patient groups were, respectively: pain, 8 [8, 9] and 9 [8, 9]; function, 9 [8, 9] and 9 [8, 9]; patient satisfaction, 8 [8, 9] and 8 [7, 9]; revision surgery, 7 [7, 8] and 7 [5, 9]; adverse events, 8 [7, 9] and 8 [6, 9]; and death, 9 [6, 9] and 9 [4, 9]. No statistically significant differences in rating were noted for any of the six core domains between the two groups (p ≥ 0.31). Among the additional domains, ratings for patient participation did not differ by group (p = 0.98), but ratings for cost were significantly different (p = 0.005). Patients provided qualitative feedback regarding core domains, and did not propose any modifications to the draft core domain set.
Two separate patient stakeholder groups endorsed the OMERACT TJR draft core domain set for TJR trials.
Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg (Br). 2010;92(9):1253–8. CrossRef
Singh JA, Lewallen DG. Better functional and similar pain outcomes in osteoarthritis compared to rheumatoid arthritis after primary total knee arthroplasty: a cohort study. Arthritis Care Res. 2013;65(12):1936–41. CrossRef
Singh JA, Lewallen DG. Medical and psychological comorbidity predicts poor pain outcomes after total knee arthroplasty. Rheumatology (Oxford). 2013;52(5):916–23. CrossRef
Brander V, Gondek S, Martin E, Stulberg SD. Pain and depression influence outcome 5 years after knee replacement surgery. Clin Orthop Relat Res. 2007;464:21–6. PubMed
Brander VA, Stulberg SD, Adams AD, Harden RN, Bruehl S, Stanos SP, et al. Predicting total knee replacement pain: a prospective, observational study. Clin Orthop Relat Res. 2003;416:27–36. CrossRef
Gagnier JJ, Mullins M, Huang H, Marinac-Dabic D, Ghambaryan A, Eloff B, et al. A Systematic Review of Measurement Properties of Patient-Reported Outcome Measures Used in Patients Undergoing Total Knee Arthroplasty. J Arthroplasty. 2017.
Lange T, Rataj E, Kopkow C, Lützner J, Günther K-P, Schmitt J. Outcome Assessment in Total Knee Arthroplasty: A Systematic Review and Critical Appraisal. J Arthroplasty. 2017;32(2):653–65.e1.
Singh JA, Dohm M, Sprowson AP, Wall PD, Richards BL, Gossec L, et al. Outcome Domains and Measures in Total Joint Replacement Clinical Trials: Can We Harmonize Them? An OMERACT Collaborative Initiative. J Rheumatol. 2015;42:2496-502.
Baker PN, van der Meulen JH, Lewsey J, Gregg PJ. The role of pain and function in determining patient satisfaction after total knee replacement. Data from the National Joint Registry for England and Wales. J Bone Joint Surg (Br). 2007;89(7):893–900. CrossRef
Singh JA, Dohm M, Choong PF. Consensus on draft OMERACT core domains for clinical trials of Total Joint Replacement outcome by orthopaedic surgeons: a report from the International consensus on outcome measures in TJR trials (I-COMiTT) group. BMC Musculoskelet Disord. 2017;18(1):45. CrossRefPubMedPubMedCentral
Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625–39. CrossRef
Singh JA, Dohm M. Towards Consensus on the Reporting of Core Outcome Domains in Total Joint Replacement Clinical Trials: The Derivation of the Preliminary Core Outcome Domain Set. J Arthritis. 2016;5:6. CrossRef
Boers M, Brooks P, Strand CV, Tugwell P. The OMERACT filter for Outcome Measures in Rheumatology. J Rheumatol. 1998;25(2):198–9. PubMed
- Patient Endorsement of the Outcome Measures in Rheumatology (OMERACT) Total Joint Replacement (TJR) clinical trial draft core domain set
Jasvinder A. Singh
Peter F. Choong
- BioMed Central
Neu im Fachgebiet Orthopädie und Unfallchirurgie
Mail Icon II