title: Patient-reported outcome measures in arthroplasty registries Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries Part II. Recommendations for selection, administration, and analysis.
abstract: - The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain question ("During the past 4 weeks, how would you describe the pain you usually have in your [right/left] [hip/knee]?"; response: none, very mild, mild, moderate, or severe) and a single-item satisfaction outcome ("How satisfied are you with your [right/left] [hip/knee] replacement?"; response: very unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals, frequency of response, missing values, and factors in establishing a PROMs registry program. The Working Group recommends including age, sex, diagnosis at joint, general health status preoperatively, and joint pain and function score in case-mix adjustment models. Interpretation and statistical analysis should consider the absolute level of pain, function, and general health status as well as improvement, missing data, approaches to analysis and case-mix adjustment, minimal clinically important difference, and minimal detectable change. The Working Group recommends data collection immediately before and 1 year after surgery, a threshold of 60% for acceptable frequency of response, documentation of non-responders, and documentation of incomplete or missing data.
authors.affiliation: a Swedish Hip Arthroplasty Register and Sahlgrenska Academy, University of Gothenburg , Gothenburg , Sweden ;
authors.forename: Ola
authors.initials: O
authors.lastname: Rolfson
authors.affiliation: b Canadian Joint Replacement Registry and University of Manitoba , Winnipeg , Manitoba , Canada ;
authors.forename: Eric
authors.initials: E
authors.lastname: Bohm
authors.affiliation: c FORCE-TJR and University of Massachusetts Medical School , Worcester , MA , USA ;
authors.forename: Patricia
authors.initials: P
authors.lastname: Franklin
authors.affiliation: d Hospital for Special Surgery and Weill Cornell Medical College , New York , NY , USA ;
authors.forename: Stephen
authors.initials: S
authors.lastname: Lyman
authors.affiliation: e Dutch Arthroplasty Register , Hertogenbosch , the Netherlands ;
authors.forename: Geke
authors.initials: G
authors.lastname: Denissen
authors.affiliation: f Nuffield Department of Population Health and University of Oxford . Oxford , UK ;
authors.forename: Jill
authors.initials: J
authors.lastname: Dawson
authors.affiliation: g New Zealand Joint Registry and University of Otago , Christchurch , New Zealand ;
authors.forename: Jennifer
authors.initials: J
authors.lastname: Dunn
authors.affiliation: h California Joint Replacement Registry , San Francisco , CA , USA ;
authors.forename: Kate
authors.initials: K
authors.lastname: Eresian Chenok
authors.affiliation: i Canadian Joint Replacement Registry and Dalhousie University , Halifax , Nova Scotia , Canada ;
authors.forename: Michael
authors.initials: M
authors.lastname: Dunbar
authors.affiliation: j Danish Hip Arthroplasty Register and University of Southern Denmark , Odense , Denmark ;
authors.forename: Søren
authors.initials: S
authors.lastname: Overgaard
authors.affiliation: a Swedish Hip Arthroplasty Register and Sahlgrenska Academy, University of Gothenburg , Gothenburg , Sweden ;
authors.forename: Göran
authors.initials: G
authors.lastname: Garellick
authors.affiliation: k Geneva Arthroplasty Registry, Division of Orthopaedic Surgery , Geneva University Hospitals , Geneva , Switzerland.
authors.forename: Anne
authors.initials: A
authors.lastname: Lübbeke
mesh_terms: D019644:Arthroplasty, Replacement, Hip; D019645:Arthroplasty, Replacement, Knee; D006801:Humans; D000071066:Patient Reported Outcome Measures; D017060:Patient Satisfaction; D011788:Quality of Life; D012042:Registries; D011795:Surveys and Questionnaires; D016896:Treatment Outcome