Variability in Minimal Clinically Important Difference Calculation and Reporting in the Otolaryngology Literature.

OBJECTIVE: Best practices for calculation of the minimal clinically important difference (MCID) of outcome measures include the use of complementary methodologies (broadly classified as anchor-based and distribution-based) and reporting of the MCID's predictive ability. We sought to determine MCID calculation and reporting patterns within the otolaryngology literature. METHODS: A systematic search strategy of Embase, PubMed, and Web of Science databases was developed and implemented to identify studies reporting the determination of an MCID for an outcome measure. Studies specifically within the otolaryngology literature (defined as journals classified as "otorhinolaryngology" in the Journal Citation Reports database) were included. All those journals were additionally searched for relevant articles. RESULTS: There were 35 articles that met the inclusion criteria. Of these studies, 88.6% reported MCID of a patient-reported outcome measure and the remainder were for objective outcome measurements. Anchor-based methods were used by 82.9% of studies and distribution-based methods were used by 68.6% of studies. Of all studies, 31.4% utilized anchor-based methods alone, 17.1% utilized distribution-based methods alone, and 51.4% used both methods. Only 25.7% of studies reported the sensitivity (median: 60.8%, range: 40.5%-86.7%) and specificity (median: 80.4%, range: 63.5%-88.0%) of the MCID to detect patients experiencing clinically important change. CONCLUSION: Deviation from best practices in MCID calculation and reporting exists within the otolaryngology literature, with almost half of all studies only using one method of MCID calculation and almost three-quarters not reporting the predictive ability (sensitivity/specificity) of the calculated MCID. When predictive ability is reported, however, MCIDs appear to be more specific than sensitive. LEVEL OF EVIDENCE: NA Laryngoscope, 134:2059-2069, 2024.

Heterogeneity in the definition of chronic rhinosinusitis disease control: a systematic review of the scientific literature.

PURPOSE: Disease control is conceptually recognized to be an important outcome measure for chronic rhinosinusitis (CRS). However, inconsistent usage is a significant factor in disadoption of important concepts and it is presently unclear how consistently the construct of CRS 'control' is being defined/applied. The objective of this study was to determine the heterogeneity of CRS disease control definitions in the scientific literature. METHODS: Systematic review of PubMed and Web of Science databases from inception through December 31, 2022. Included studies used CRS disease control as an explicitly stated outcome measure. The definitions of CRS disease control were collected. RESULTS: Thirty-one studies were identified with more than half published in 2021 or later. Definitions of CRS control were variable, although 48.4% of studies used the EPOS (2012 or 2020) criteria to define control, 14 other unique definitions of CRS disease control were also implemented. Most studies included the burden CRS symptoms (80.6%), need for antibiotics or systemic corticosteroids (77.4%) or nasal endoscopy findings (61.3%) as criteria in their definitions of CRS disease control. However, the specific combination of these criteria and prior time periods over which they were assessed were highly variable. CONCLUSION: CRS disease control is not consistently defined in the scientific literature. Although many studies conceptually treated 'control' as the goal of CRS treatment, 15 different criteria were used to define CRS disease control, representing significant heterogeneity. Scientific derivation of criteria and collaborative consensus building are needed for the development of a widely-accepted and -applied definition of CRS disease control.

Minimal Radiographic Mucosal Thickness or Opacification Criterion for Sinus-Specific Endoscopic Sinus Surgery for Chronic Rhinosinusitis.

OBJECTIVE: Primary chronic rhinosinusitis (CRS) is typically a diffuse process and the extent of endoscopic sinus surgery (ESS) performed for medically recalcitrant CRS is impacted by many factors. However, some third-party payors have implemented policies to authorize coverage for ESS in a sinus-by-sinus manner based on a minimal measurement of millimeters of mucosal thickening or sinus opacification in the corresponding sinus that is being surgically addressed. Our objective was to determine whether such policies are based on scientific evidence that in patients with medically recalcitrant CRS, a minimum measurement of mucosal thickening or sinus opacification is a predictor of CRS in that sinus or improved outcomes after ESS on a sinus-by-sinus basis. DATA SOURCES: Medline, Embase, Scopus, and Web of Science databases, from inception through May 2022. REVIEW METHODS: A systematic review was performed. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines were followed. RESULTS: We identified 6070 abstracts which were screened and from which 112 studies ultimately underwent a full-text review. From these studies, we found that none investigated (or provided evidence of) whether any minimal degree of radiographic mucosal thickening or sinus opacification predicted CRS or better outcomes after ESS in a sinus-specific manner. CONCLUSION: We were unable to find evidence supporting a minimum millimeter measurement of mucosal thickening or sinus opacification as predictors of CRS or better post-ESS outcomes in a sinus-specific manner in patients with medically recalcitrant CRS. The extent of ESS for CRS should be determined through personalized medical decision-making that considers all patient-specific factors.