CORR Insights®: What Is the Clinical Benefit of Common Orthopaedic Procedures as Assessed by the PROMIS Versus Other Validated Outcomes Tools?

Where Are We Now?

The outcomes of the care we provide—specifically, patient-reported outcomes—are the “coin of the realm” in orthopaedic clinical research, and for easy-to-understand reasons. As orthopaedic surgeons, it is essential that we document the outcomes—and hopefully benefits—of the care we provide. This is most important for patients and is especially relevant to healthcare financing as healthcare costs become increasingly scrutinized. How well we document our outcomes is a foundational component of our ability to justify the care we provide. Although there is unanimous agreement that documentation of outcomes is essential, there is far less agreement on how we should do this, and which method is the most reliable.

An article in this month’s Clinical Orthopaedics and Related Research ® by Karhade et al. [1] describes this issue—or maybe “confusion” is a better word—exceedingly well. They compared the achievement of the minimum clinically important difference (MCID) for common orthopaedic procedures using the Patient-Reported Outcomes Measurement Information System (PROMIS) compared with other patient-reported outcome measures (PROMs), called legacy PROMs because they have been used for many years. The authors focused on the impact of these different outcome measures in determining MCIDs, and the results were quite different depending on the outcome measure and method used. This represents a very real issue for the readers of these reports: Is the outcome truly “successful” or does it depend on the method of assessment? Karhade et al. [1] make it quite clear that we have a long way to go to standardize how we assess and report outcomes.

Where Do We Need To Go?

We have many methods to assess outcomes. These include the PROMs we have used for many years and more recently, the PROMIS, as developed by the National Institutes of Health. There has been a major emphasis on using the PROMIS over the legacy PROMs in order to have a uniform and general approach to documenting outcomes. However, a look beneath the surface reveals the problems that need to be addressed. Although there is general agreement that MCIDs are important measures, the methods used to determine MCIDs vary. Anchor-based and distribution-based methods have advantages and disadvantages. Most would agree that anchor-based scores are preferable, but the lack of these scores for commonly performed orthopaedic procedures has driven the need for distribution-based approaches. The article by Karhade et al. [1] clearly indicates the complexity of the issue. PROMIS, PROMs, MCID, anchor-based, distribution-based, one-third to one-half standard deviation, minimal detectable change (MDC) 50, MDC 95, and MDC 99 are just some of the terms and abbreviations used in the paper. Our goal must be to determine how to best measure and document outcomes in a clear, understandable, and reproducible way. Setting the goal is easy; achieving it is much, much more difficult.

How Do We Get There?

As orthopaedic surgeons, we know it is important to document outcomes and report the data. We do this in our journals after a thorough peer-review process. Journals often establish requirements for a study to be considered for publication, including follow-up (for example, 2-year minimum for studies about reconstructive approaches), statistical methods, and appropriate institutional review board documentation. Now is the time for orthopaedic journals to establish the acceptable and preferred methods of reporting outcomes for an article to be considered for publication. This can be done in conjunction with the appropriate specialty societies (subject experts), who are also often the sponsors of the journals. For example, the American Shoulder and Elbow Surgeons (subject experts) could establish a task force to determine the methods that should be used to report outcomes for commonly performed procedures including anatomic shoulder arthroplasty, reverse shoulder arthroplasty, arthroscopic rotator cuff repair, and arthroscopic anterior shoulder repair, to name a few. The recommendations of the task force could then be adopted by the specialty journal, The Journal of Shoulder and Elbow Surgery. Similar approaches can be used for hip and knee arthroplasty, ACL reconstruction, and a multitude of other procedures by combining subject experts with the appropriate journal. Thus, the requirements and format for reporting outcomes could be established. These requirements would be an extension of the instructions for authors that already exist for each journal. This would go a long way to help readers understand the outcomes reported and to be able to compare one study with another. The benefit of this approach is clear: Orthopaedic surgeons—the readers—would have the information they need to decide what is best for their patients, because the patients should ultimately benefit from our contributions to orthopaedic research.