An Introduction to Clinical Significance in Orthopaedic Outcomes Research

Significance reporting in clinical trials can be misleading because of factors such as overpowering, choosing clinically insignificant outcomes, and inappropriate subgroup analysis. Clinical significance generally refers to a change that is important to a patient, although clinical significance can also be reported through the viewpoints of health-care providers or health-care policy-makers. Clinical significance can be measured in a number of ways, including minimally important difference, responder analysis, patient acceptable symptom state, and substantial clinical benefit. Orthopaedic cost-effectiveness and value analyses should include a measure of clinical significance to ensure relevance to patients.