An Introduction to Clinical Significance in Orthopaedic Outcomes Research

The primary goal of clinical orthopaedic research is determining how to evaluate the safety and efficacy of orthopaedic interventions, with a focus on outcomes that are important to patients. On March 23, 2010, the Patient Protection and Affordable Care Act (PPACA) introduced the Patient Centered Outcomes Research Institute, emphasizing the importance of patient-centered care1. Patient-centered outcomes research helps to answer the following questions: > (1) “Given my personal characteristics, conditions and preferences, what should I expect will happen to me?” > > (2) “What are my options and what are the potential benefits and harms of those options?” > > (3) “What can I do to improve the outcomes that are most important to me?” > > (4) “How can clinicians and the care delivery systems they work in help me make the best decisions about my health and healthcare?”2 Patient-centered care has created a trend toward complementing clinician-based measures with patient-reported outcome measures3. Both disease-specific patient-reported outcome measures and generic health-related quality-of-life measures enhance the measurement of value of orthopaedic care. Orthopaedic clinical outcomes research is aimed at determining the best treatment for individual patients. In order to ensure that the effect of treatment is not based on chance alone, measures of significance were developed …