Most-Cited Patient-Reported Outcome Measures Within Otolaryngology—Revisiting the Minimal Clinically Important Difference

Abstract

ImportancePatient-reported outcome measures (PROMs) allow clinicians and researchers to assess health-related information from a patient’s perspective. These measures have been used more frequently over the last several decades, but an associated minimal clinically important difference (MCID) is needed to optimize their utility. This narrative review identified the top 100 most-cited otolaryngology-related PROM development and validation publications and assessed the presence and characteristics of the PROMs’ associated MCID.ObservationsIn this narrative review, a literature search in Scopus and Web of Science was conducted on June 29, 2022, using keywords related to PROM development and validation studies in otolaryngology and reference lists. Studies that met the definition of a PROM and assessed an otolaryngologic disorder or study population were included for full-text review. After full-text review of 188 articles, the top 100 most-cited PROM development and validation publications, resulting in 106 total PROMs, were chosen for review. A total of 39 (37%) of the identified PROMs had an associated MCID. Of those reporting an MCID, 14 (35.9%) used an anchor-based method, 12 (30.8%) used a distribution-based method, 10 (25.6%) used both, and 3 (7.7%) did not specify or used neither method. Rhinology had the greatest number of PROMs with an associated MCID (16 of 24, 66%), and pediatrics had the fewest (1 of 13, 7.7%). The median number of citations of PROMs with an MCID was higher than those without an MCID.Conclusions and RelevanceThe majority of the most-cited PROMs in otolaryngology lack an associated MCID. These data indicated that there are a multitude of PROMs that have been cited hundreds of times and used for decades without the ability to identify whether a particular change in score on the instrument is clinically meaningful. There is a need to determine and validate MCIDs for commonly used PROMs to aid clinical research and trial interpretation.

Conditional Minimal Detectable Change for the Cochlear Implant Quality of Life-35 Profile Associated With Improved Functional Abilities 12 Months After Cochlear Implantation

“…Establishing detectable change thresholds for PROMs or other outcome measures has rarely been performed in CI or hearing research or, more broadly, in otolaryngology research or for clinical outcome measures . Application of these values enhances the interpretation of PROMs and increases the potential for their use for individual patient care.…”

New Directions for Improving the Minimal Clinically Important Difference in Patient-Reported Outcome Measures for Use in Clinical Care and Research

“…The MCID improves the PROM's utility both for patientcentered research and for use at the point of care. Traditional approaches for estimating the MCID described in the review by Peterson et al 1 Over the past 20 years, there has also been steady criticism challenging the nature and utility of the MCID. 2-4 Three limitations are highlighted.…”

“…However, the quality of these PROMs is highly variable owing largely to the specialized expertise and resources required to rigorously develop PROMs. In their review in this issue of JAMA Otolaryngology–Head & Neck Surgery , Peterson and coauthors focus on an important PROM attribute—the minimal clinically important difference (MCID)—which is intrinsic to interpreting PROM scores. These MCIDs are changes in a functional state considered clinically meaningful and valuable to patients; MCIDs are used when interpreting PROM scores to determine whether a measured change is clinically significant.…”

“…The MCID improves the PROM’s utility both for patient-centered research and for use at the point of care. Traditional approaches for estimating the MCID described in the review by Peterson et al are primarily based on the distribution within a population, an anchor question, or the Delphi method. The authors highlight the relative strength of anchor-based methods for calculating the MCID as reflecting a true change in the clinical condition.…”

“…The review by Peterson et al highlights a deficiency in physicians’ ability to interpret many of the commonly used PROMs in otolaryngology. An important lesson is that otolaryngologists and researchers must be aware of interpretability issues when choosing a new PROM for use in clinic or research.…”