Abstract
In this issue, Pinsker et al 1 provide a concise and timely guidance on how to report patient-reported outcome measures (PROMs) in clinical research. PROMs are now central to assessing treatment success—especially in orthopaedics, where pain, function, and quality of life are critical. But their value depends entirely on their appropriate selection, meticulous reporting of methods and results, and thoughtful interpretation grounded in clinical relevance and patient-centered meaning.
Yet many studies still fall short. All too often, PROMs are included in clinical studies without clear justification, detailed description, or meaningful interpretation. The consequences are significant: findings that lack clinical relevance, studies that are difficult to compare, and ultimately, diminished impact on patient care.
This short primer addresses that problem. It distills core reporting principles and established reporting standards—such as the CONSORT-PRO extension—and adapts them for both clinical trials and observational studies in foot and ankle surgery. The message is simple: better PROM reporting does not require more work—just more intention.
Why PROM Reporting Needs Improvement
Clinicians often assume that including a PROM in a study automatically makes it patient-centered. But if readers cannot tell why a PROM was chosen, how it was scored, or whether the changes reported are meaningful, then the data are of limited value—and may even mislead.
Many of us have read studies where a statistically significant change on a PROM is reported without explaining its clinical significance. A 2-point improvement on a 10-point pain scale may achieve P < .05, but unless it exceeds the minimum clinically important difference (MCID), it may not reflect a true benefit. Conversely, a study with no statistically significant group differences but where 60% of patients exceeded the MCID may actually offer stronger clinical insights.
A Simple Framework for Better PROM Use
The article outlines a practical checklist to enhance the use and reporting of PROMs. Among the most important recommendations:
Clearly state whether the PROM is a primary or secondary outcome in both the abstract and methods.
Explain your choice of PROM—including what it measures, whether it is validated in the population of interest, and whether it was modified and why.
Justify your sample size if the PROM is a primary endpoint, using the MCID when possible (available).
Report the average, range, and distribution of PROM scores, along with the proportion of patients who exceeded a clinically meaningful threshold (eg, MCID).
Address missing data transparently and describe how it was handled.
Include effect sizes and CIs, not just P values.
These practices, although straightforward, substantially enhance the interpretability, reproducibility, and clinical utility of PROM-based findings.
A Collective Responsibility
Improving the quality of PROM reporting requires engagement from all stakeholders. Authors must adhere to best practices. Reviewers and editors must reinforce them throughout the peer review process. And readers—especially clinicians—should expect clarity, context, and clinical relevance when interpreting PROM data. Demanding better reporting is how we make PROMs more useful in practice.
We are pleased to publish this guidance and hope it will serve as a reference point for future submissions to Foot & Ankle International and Foot & Ankle Orthopaedics. PROMs give patients a voice in clinical research. But unless we report and interpret those outcomes with care, that voice can be distorted.
Let us use PROMs in ways that are not just statistically sound—but clinically meaningful. We encourage authors, reviewers, and readers to treat this guidance not just as a reference but as a shared standard for future research and reporting.