The Minimally Clinically Important Difference of The Anterior Skull Base Nasal Inventory-12

Object: Determining the minimal clinically important difference (MCID), defined as the smallest change in health-related quality of life (QOL) which patients consider meaningful, is essential for identifying clinically significant changes, rather than simply statistically significant changes, in QOL scores. The Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12), a site-specific sinonasal QOL instrument that contains 12 items (score range 0–5) validated in patients undergoing transsphenoidal surgery, has emerged as a standard instrument for assessing QOL. In this study, we determine the MCID for ASK Nasal-12.

Methods: Distribution and anchor-based methods were used to determine the MCID for the ASK Nasal-12 using raw data from 218 patients obtained in a multicenter prospective QOL study.

Results: Two distribution-based statistical methods, the one-half standard deviation method and effect size method, yielded MCIDs of 0.37 and 0.37 (medium effect), respectively. The first anchor-based method, using the Overall Nasal Functioning item as anchor yielded an MCID of 0.31. The second anchor-based method using the SF-8 Bodily Pain item yielded an MCID of 0.29.

Conclusion: The MCID for the ASK Nasal-12 was determined to be 0.29 to 0.37 using four methods. This information is essential to provide clinicians with the context to determine the clinical significance of QOL scores. This study will help clinicians better interpret QOL scores and design future studies that are powered to detect meaningful QOL changes.

 

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Die Autoren geben an, dass kein Interessenkonflikt besteht.