Multi-item outcome measures for lateral ligament injury of the ankle: a structured review.

OBJECTIVE: To identify and review evidence relating to the measurement properties of published multi-item outcome measures for the conservative management of lateral ligament injuries of the ankle. METHODS: Systematic literature searches were used to identify measures, which were then assessed against pre-defined criteria relating to development, item content, reliability, validity and responsiveness. RESULTS: Seven disease-specific measures of ankle status [Ankle Joint Functional Assessment Tool, Clinical Trauma Severity Score, Composite Inversion Injury Scale, Kaikkonen Functional Scale (KFS), Karlsson Ankle Function Score (KAFS), Olerud and Molander Ankle Score (OMAS), and the Point System] and two generic measures of health (McGill Pain Questionnaire, Sickness Impact Profile) met the review inclusion criteria. While all measures had been used in acute injuries, only two had also been applied during later stages of recovery (>6 months). The studies covered a comprehensive range of graded ligament injuries. Expert opinion dominated item generation for all measures. All measures lack evidence of test-retest or internal consistency reliability in patients with ankle sprain. Several measures were assessed for validity through comparison with other measures, but there was limited evidence of construct validity and no formal assessment of responsiveness for any measure. CONCLUSION: The disappointing lack of evidence for measurement properties suggests that any measure should be used with caution until appropriate evidence is provided. On the basis of limited evidence, the KFS offers the most promising approach to a combined clinician- and patient-assessment of ankle function, and the KAFS or OMAS if a patient-assessed evaluation of function is required.