Demonstrating the value of orthopaedic surgery through multicenter trials: AOA critical issues.

Orthopaedic surgery is expensive and will be carefully scrutinized in the U.S. under health-care reform. Unfortunately, although the orthopaedic literature is replete with clinical outcomes studies, there is still a paucity of meaningful clinical outcomes data that are free from bias. It is possible that orthopaedic procedures may be among the most cost-effective medical treatments for the aging population. However, it is only through the collection of patient-generated outcomes data in prospective randomized and observational studies that orthopaedic surgery can be shown to provide high value (defined as high-quality outcomes at a relatively low cost) to society.The burden of musculoskeletal disease in the U.S. is high; nearly half of all adults describe themselves as having a chronic musculoskeletal condition, and approximately one-quarter of all health-care dollars are spent treating musculoskeletal disease. For this reason, treatment for osteoarthritis, the costliest condition in the elderly population, has drawn great scrutiny from insurers and the government. In the absence of clinical outcomes data that prove the value of orthopaedic interventions, there will be pressure to reduce payments or even deny treatments for these conditions if they are perceived to be too expensive or lack outcomes data supporting their use.Multicenter trials are expensive; this paper analyzes challenges to, and opportunities for, funding. Although National Institutes of Health (NIH) funding has dropped nearly 20% over the past ten years in inflation-adjusted dollars, it has begun a gradual reorientation toward clinical research, which comprised almost 50% of its budget in 2013. The Patient Protection and Affordable Care Act focused more attention on clinical outcomes research, with the establishment of the Patient-Centered Outcomes Research Institute (PCORI), which will ultimately fund $750 million of comparative effectiveness research annually. Another new funding source within the Centers for Medicare & Medicaid Services (CMS) is the Center for Medicare & Medicaid Innovation (CMMI), which recently funded several major initiatives, including a $1 billion health-care innovations grant program in 2012.The purpose of this article is to promote increased participation in prospective orthopaedic multicenter trials, which can answer clinical questions that affect the care of millions of patients. Some have enrolled large numbers of patients and have demonstrated the cost-effectiveness of surgery, provided subgroup analyses to define the optimal timing of surgery, and identified which patients are most and least helped by surgery. These studies have the power to establish new standards of care and prove the value of orthopaedic surgery.