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.

OBJECTIVES/GOALS: The primary aim is to evaluate the efficacy of a Mandibular Advancement Device (MAD) vs conservative treatment for adults with non-apneic snoring, as measured by the sleeping partner. The secondary aim is to evaluate the effectiveness of treatment of snoring on the sleeping partner’s sleep quality. METHODS/STUDY POPULATION: We plan to enroll 60 pairs of primary snorers and their sleeping partners in our randomized clinical trial. Snorers will be randomized to either 4 weeks of conservative therapy, consisting of nightly Mometasone nasal rinse, breathe-rite strips, mouth taping, and lateral positional therapy, or 4 weeks of Mandibular Advancement Device therapy (MAD). 30 pairs of snorers and their partners will be in each arm. At follow up the primary outcome measure, the Clinical Global Impression of Improvement Scale (CGI-I), will be assessed by the sleeping partner to evaluate the response to snoring treatment. RESULTS/ANTICIPATED RESULTS: To date, there is no study reporting the rate of response in participants using MAD in Primary Snoring. Due to lack of preliminary data and effect size, we hypothesize that the rate of the responders in the MAD group will be 20% higher than the rate of responders in the active control group based on literature studies and preliminary results. A responder will be classified as someone whose sleeping partner rates on the CGI-I scale that the snoring was much improved or very much improved. MAD has been shown previously to be an effective therapy at treating sleep apnea and reducing snoring, and we anticipate it will continue to be so for patients who do not have sleep apnea. DISCUSSION/SIGNIFICANCE: Snoring is a nearly ubiquitous problem that prevents restful sleep for spouses of snorers, which is known to have detrimental health effects. Yet it does not have scientifically proven treatments. Our study will evaluate these treatments in an effort to improve the health of the sleeping partners.