Quantification of hematoma and perihematomal edema volumes in intracerebral hemorrhage study: Design considerations in an artificial intelligence validation (QUANTUM) study.

BACKGROUND: Hematoma and perihematomal edema volumes are important radiographic markers in spontaneous intracerebral hemorrhage. Accurate, reliable, and efficient quantification of these volumes will be paramount to their utility as measures of treatment effect in future clinical studies. Both manual and semi-automated quantification methods of hematoma and perihematomal edema volumetry are time-consuming and susceptible to inter-rater variability. Efforts are now underway to develop a fully automated algorithm that can replace them. A (QUANTUM) study to establish inter-quantification method measurement equivalency, which deviates from the traditional use of measures of agreement and a comparison hypothesis testing paradigm to indirectly infer quantification method measurement equivalence, is described in this article. The Quantification of Hematoma and Perihematomal Edema Volumes in Intracerebral Hemorrhage study aims to determine whether a fully automated quantification method and a semi-automated quantification method for quantification of hematoma and perihematomal edema volumes are equivalent to the hematoma and perihematomal edema volumes of the manual quantification method. METHODS/DESIGN: Hematoma and perihematomal edema volumes of supratentorial intracerebral hemorrhage on 252 computed tomography scans will be prospectively quantified in random order by six raters using the fully automated, semi-automated, and manual quantification methods. Primary outcome measures for hematoma and perihematomal edema volumes will be quantified via computed tomography scan on admission (<24 h from symptom onset) and on day 3 (72 ± 12 h from symptom onset), respectively. Equivalence hypothesis testing will be conducted to determine if the hematoma and perihematomal edema volume measurements of the fully automated and semi-automated quantification methods are within 7.5% of the hematoma and perihematomal edema volume measurements of the manual quantification reference method. DISCUSSION: By allowing direct equivalence hypothesis testing, the Quantification of Hematoma and Perihematomal Edema Volumes in Intracerebral Hemorrhage study offers advantages over radiology validation studies which utilize measures of agreement to indirectly infer measurement equivalence and studies which mistakenly try to infer measurement equivalence based on the failure of a comparison two-sided null hypothesis test to reach the significance level for rejection. The equivalence hypothesis testing paradigm applied to artificial intelligence application validation is relatively uncharted and warrants further investigation. The challenges encountered in the design of this study may influence future studies seeking to translate artificial intelligence medical technology into clinical practice.

Comparison and evolution of transcranial versus endoscopic endonasal approaches for suprasellar Meningiomas: A systematic review.

BACKGROUND: Meningiomas of the tuberculum sellae (TS) and planum sphenoidale (PS) are challenging to treat surgically. Transcranial approaches (TCAs) were the mainstay before endoscopic endonasal approaches (EEA) were developed, however the efficacy and safety of EEA approaches relative to TCA approaches remains unclear. METHODS: The authors conducted a PRISMA-compliant systematic review of existing literature detailing the outcomes of both approaches. PubMed, Embase, Cochrane Library, and Clinicaltrials.gov were searched. Studies were included if they analyzed TS and/or PS meningiomas, included ≥ 5 patients, and reported at least one outcome of interest. RESULTS: Overall, 44 retrospective studies met inclusion criteria, the majority being from single centers, between 2004 and 2020. In studies directly comparing postoperative outcomes among TCA and EEA approaches, EEA had significantly higher odds of visual improvement (OR = 3.24, p = 0.0053) and significantly higher odds of CSF leak (OR = 3.71, p = 0.0098) relative to TCA. Further, there were no significant differences between visual worsening (p = 0.17), complications (p = 0.51), and GTR rates (p = 0.30) for the two approaches. Meta-analysis demonstrated no significant association between nasoseptal flap (NSF) use and postoperative outcomes among EEA patients. There was also no significant association between study publication year and postoperative EEA outcomes. CONCLUSION: The present study demonstrates that EEA offers a viable alternative to TCA in the treatment of suprasellar meningiomas. In particular, EEA shows promise for superior visual outcomes, though postoperative CSF leaks are an important consideration among patients undergoing this approach.