Responsiveness of SF-36 and Lower Extremity Functional Scale for assessing outcomes in traumatic injuries of lower extremities.

OBJECTIVE

To assess the responsiveness of one generic questionnaire, Medical Outcomes Study Short Form-36 (SF-36), and one region-specific outcome measure, Lower Extremity Functional Scale (LEFS), in patients with traumatic injuries of lower extremities.

DESIGN

A prospective and observational study of patients after traumatic injuries of lower extremities. Assessments were performed at baseline and 3 months later.

SETTING

In-patients and out-patients in two university hospitals in Taiwan.

PARTICIPANTS

A convenience sample of 109 subjects were evaluated and 94 (86%) were followed.

INTERVENTIONS

Not applicable.

MAIN OUTCOME MEASURE(S): Assessments of responsiveness with distribution-based approach (effect size, standardized response mean [SRM], minimal detectable change) and anchor-based approach (receiver's operating curve analysis, ROC analysis).

RESULTS

LEFS and physical component score (PCS) of SF-36 were all responsive to global improvement, with fair-to-good accuracy in discriminating between participants with and without improvement. The area under curve gained by ROC analysis for LEFS and SF-36 PCS was similar (0.65 vs. 0.70, p=0.26).

CONCLUSIONS

Our findings revealed comparable responsiveness of LEFS and PCS of SF-36 in a sample of subjects with traumatic injuries of lower limbs. Either type of functional measure would be suitable for use in clinical trials where improvement in function was an endpoint of interest.