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: To evaluate clinical characteristics and outcomes of patients diagnosed with anterior (ASB) or lateral skull base (LSB) spontaneous cerebrospinal fluid (sCSF) leak. Methods: Single center retrospective review of patients diagnosed with sCSF leaks of ASB or LSB between 1/1/2009 and 11/1/2019 (n = 69). Body mass index (BMI), gender, age at diagnosis, origin of CSF leak (ASB vs LSB), surgical approach, lumbar drain use, recurrence, pre-operative diagnosis of diabetes mellitus (DM), and obstructive sleep apnea (OSA) were collected. Results: 69 patients included in this study met criteria for sCSF leak without a traumatic or iatrogenic cause (Female: 51 (74%); average BMI: 37.0 ± 7.9). Forty-eight (70.0%) presented with sCSF leaks of the lateral skull base. All ASB leaks were treated with an endoscopic transnasal approach. Eleven (22.9%) LSB leak patients were treated using transmastoid approaches and 35 (72.9%) patients with a middle cranial fossa approach. Eleven patients (15.9%) reported sCSF leak recurrence. Two patients (9.5%) with anterior skull base and 9 patients (18.8%) with lateral skull base leaks had recurrence. LSB sCSF leaks had a relative risk of 2.192 of recurrence compared to ASB leaks (95% CI: 0.431-11.157, P = .483). A 5.017 times increased risk (95% CI: 1.285-19.583, P = .020) was reported for patients with OSA, while the risks for DM and BMI were 1.351 (95% CI: 0.67-9.105, P = .177) and 1.026 (95% CI: 0.963-1.094, P = .426) respectively. Patients with sCSF leak recurrence had significantly lower lumbar drain use (33.3%) than those without recurrence (72.7%) ( P = .049). Conclusion: Spontaneous CSF leak recurrence is complex and multifactorial, and while patients with both DM and OSA had the higher risk of recurrence, OSA is likely an independent clinical risk factor for sCSF leak recurrence in this patient population.
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