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.