TY - JOUR

T1 - Feasibility of 4 patient-reported outcome measures in a registry setting

AU - Paulsen, Aksel

AU - Pedersen, Alma Becic

AU - Overgaard, Søren

AU - Roos, Ewa M.

PY - 2012

Y1 - 2012

N2 - Background and purpose 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. Interpretation 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.

AB - Background and purpose 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. Interpretation 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.

U2 - 10.3109/17453674.2012.702390

DO - 10.3109/17453674.2012.702390

M3 - Journal article

C2 - 22900909

VL - 83

SP - 321

EP - 327

JO - Acta Orthopaedica

JF - Acta Orthopaedica

SN - 1745-3674

IS - 4

ER -