Feasibility of 4 patient-reported outcome measures in a registry setting.
OBJECTIVE
Feasibility is an important parameter when choosing which patient-reported outcomes (PRO) to use in a study. We assessed the feasibility of PROs in a hip registry setting.


METHODS
Primary total hip arthroplasty (THA) patients (n = 5,747) who had been operated on 1-2, 5-6, or 10-11 years previously were randomly selected from the Danish Hip Arthroplasty Register and sent 2 PRO questionnaires: 1 generic (EuroQoL-5D or SF-12 health survey) and 1 disease-specific (hip dysfunction and osteoarthritis outcome score (HOOS) or Oxford 12-item hip score). We compared response rates, floor and ceiling effects, missing items, and the need for manual validation of forms.


RESULTS
4,784 patients (mean age 71 years, 57% females) were included (83%). The response rates ranged from 82-84%. Statistically significantly different floor and ceiling effects ranged from 0% to 0.5% and from 6.1% to 46%, respectively. Missing items ranged from 1.2% to 3.4%, and 0.8-4.3% required manual validation (p < 0.009). A hypothetical repeat study found that group sizes from 51 to 1,566 are needed for subgroup analysis, depending on descriptive factor and choice of PRO.


CONCLUSIONS
All 4 PROs fulfilled a priori set criteria, with the exception of ceiling effects. The high ceiling effects were attributed to postoperative administration and good outcome for THA. We conclude that all 4 PROs are appropriate for administration in a hip registry.
Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. akselpaulsen@gmail.com
Aksel
A
Paulsen
Alma B
AB
Pedersen
Søren
S
Overgaard
Ewa M
EM
Roos
D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D019644:Arthroplasty, Replacement, Hip / Q000379:methods* / Q000534:rehabilitation; D003430:Cross-Sectional Studies; D003718:Denmark; D005260:Female; D005500:Follow-Up Studies; D006622:Hip Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D015207:Osteoarthritis, Hip / Q000601:surgery*; D010147:Pain Measurement; D018579:Patient Selection; D011182:Postoperative Care / Q000379:methods; D011788:Quality of Life; D016059:Range of Motion, Articular / Q000502:physiology; D020127:Recovery of Function; D012042:Registries; D011795:Surveys and Questionnaires; D016896:Treatment Outcome