OBJECTIVES: To evaluate the responsiveness of the EuroQol (EQ-5D) and Short-Form 36 (SF-36) instruments, i.e. their ability to capture clinically important changes, in elderly patients with a displaced femoral neck fracture. The study was part of a prospective randomised study comparing two different surgical procedures, internal fixation (IF) and total hip replacement (THP). SETTING:University hospital. PATIENTS: A total of 110 patients, mean age 80 years with an acute displaced femoral neck fracture (Garden III and IV). The inclusion criteria were age > or = 70, absence of severe cognitive dysfunction, independent living status and independent walking capability. INTERVENTION: The patients were randomised to IF or to a THR. MAIN OUTCOME MEASUREMENTS: Health-related quality of life according to EQ-5D and SF-36. Responsiveness measured by the ability of the EQ-5D and the SF-36 to detect clinically relevant differences in the study population according to an external criterion (EC) for outcome (good or less good clinical outcome). Responsiveness was measured in terms of change scores, standardised effect size (SES) and standardised response mean (SRM). RESULTS: The rated prefracture EQ-5D(index) scores and SF-36 scores showed good correspondence with the scores of age-matched Swedish reference populations. The relationship between the EC and EQ-5D(index) score and the SF-36 global score showed significant differences in both comparisons (p < 0.001). The responsiveness expressed with the SES and SRM were large for both the EQ-5D (1.37 and 0.90, respectively) and for the SF-36 global score (0.89 and 0.82, respectively). The correlation between the change scores for the SF-36 global score and the EQ-5D was 0.39 (p < 0.001). CONCLUSION: The results showed high responsiveness for both the EQ-5D and the SF-36, indicating that both instruments are suitable for use as outcome measures in clinical trials in elderly hip fracture patients.
RCT Entities:
OBJECTIVES: To evaluate the responsiveness of the EuroQol (EQ-5D) and Short-Form 36 (SF-36) instruments, i.e. their ability to capture clinically important changes, in elderly patients with a displaced femoral neck fracture. The study was part of a prospective randomised study comparing two different surgical procedures, internal fixation (IF) and total hip replacement (THP). SETTING: University hospital. PATIENTS: A total of 110 patients, mean age 80 years with an acute displaced femoral neck fracture (Garden III and IV). The inclusion criteria were age > or = 70, absence of severe cognitive dysfunction, independent living status and independent walking capability. INTERVENTION: The patients were randomised to IF or to a THR. MAIN OUTCOME MEASUREMENTS: Health-related quality of life according to EQ-5D and SF-36. Responsiveness measured by the ability of the EQ-5D and the SF-36 to detect clinically relevant differences in the study population according to an external criterion (EC) for outcome (good or less good clinical outcome). Responsiveness was measured in terms of change scores, standardised effect size (SES) and standardised response mean (SRM). RESULTS: The rated prefracture EQ-5D(index) scores and SF-36 scores showed good correspondence with the scores of age-matched Swedish reference populations. The relationship between the EC and EQ-5D(index) score and the SF-36 global score showed significant differences in both comparisons (p < 0.001). The responsiveness expressed with the SES and SRM were large for both the EQ-5D (1.37 and 0.90, respectively) and for the SF-36 global score (0.89 and 0.82, respectively). The correlation between the change scores for the SF-36 global score and the EQ-5D was 0.39 (p < 0.001). CONCLUSION: The results showed high responsiveness for both the EQ-5D and the SF-36, indicating that both instruments are suitable for use as outcome measures in clinical trials in elderly hip fracturepatients.
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