title: Patient Endorsement of the Outcome Measures in Rheumatology (OMERACT) Total Joint Replacement (TJR) clinical trial draft core domain set.
abstract: 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.
authors.affiliation: University of Alabama at Birmingham, 510 20th Street S, Faculty Office Tower 805B, Birmingham, AL, 35294, USA. Jasvinder.md@gmail.com.|Birmingham Veterans Affairs Medical Center, 700 19th St S, Birmingham, AL, 35233, USA. Jasvinder.md@gmail.com.
authors.forename: Jasvinder A
authors.initials: JA
authors.lastname: Singh
authors.affiliation: Department of Surgery, University of Melbourne, St. Vincent's Hospital, Melbourne, Australia.
authors.forename: Michelle
authors.initials: M
authors.lastname: Dowsey
authors.affiliation: Department of Surgery, University of Melbourne, St. Vincent's Hospital, Melbourne, Australia.
authors.forename: Peter F
authors.initials: PF
authors.lastname: Choong
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019644:Arthroplasty, Replacement, Hip / Q000706:statistics & numerical data*; D019645:Arthroplasty, Replacement, Knee / Q000706:statistics & numerical data*; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D003697:Delphi Technique; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010358:Patient Participation / Q000379:methods*; D000071066:Patient Reported Outcome Measures; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D010817:Physician-Patient Relations; D020127:Recovery of Function; D012086:Reoperation / Q000706:statistics & numerical data; D055815:Young Adult