Changes in Short-Term Outcomes After Discharge in Patients with Aneurysmal Subarachnoid Hemorrhage: A Multicenter, Prospective, Observational Study

Hosogai, Masahiro; Ikawa, Fusao; Hidaka, Toshikazu; Matsuda, Shingo; Ozono, Iori; Inamasu, Joji; Kobata, Hitoshi; Murayama, Yuichi; Sato, Akira; Kato, Yōkō; Sano, Hirotoshi; Yamaguchi, Shûhei; Horie, Nobutaka

doi:10.1016/j.wneu.2022.05.140

Cited by 2 publications

(2 citation statements)

References 30 publications

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“…The expected distribution of WFNS grades is largely skewed toward grade 1. For exemplary purposes, we retrieved a few large RCTs with broad eligibility criteria and cohort studies from different regions of the world 2–6 (which should possess less selection bias common to research studies in Supplemental Material) and estimated the proportion of WFNS grade 1 to 5 (in %): 41, 22, 7, 15, and 15 (Figure 1A; Figure S1), with grade 2 being the median. For each WFNS grade, we acquired the outcome on the full mRS from the ULTRA (Ultra-Early Tranexamic Acid After Subarachnoid Haemorrhage) 3 RCT (Figure 1B).…”

Section: Expected Wfns Distribution Is Skewedmentioning

confidence: 99%

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Subarachnoid Hemorrhage Trials: Cutting, Sliding, or Keeping mRS Scores and WFNS Grades

Mistry,

Saver,

Mack

et al. 2024

Stroke

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Rigorous evidence generation with randomized controlled trials has lagged for aneurysmal subarachnoid hemorrhage (SAH) compared with other forms of acute stroke. Besides its lower incidence compared with other stroke subtypes, the presentation and outcome of patients with SAH also differ. This must be considered and adjusted for in designing pivotal randomized controlled trials of patients with SAH. Here, we show the effect of the unique expected distribution of the SAH severity at presentation (World Federation of Neurological Surgeons grade) on the outcome most used in pivotal stroke randomized controlled trials (modified Rankin Scale) and, consequently, on the sample size. Furthermore, we discuss the advantages and disadvantages of different options to analyze the outcome and control the expected distribution of the World Federation of Neurological Surgeons grades in addition to showing their effects on the sample size. Finally, we offer methods that investigators can adapt to more precisely understand the effect of common modified Rankin Scale analysis methods and trial eligibility pertaining to the World Federation of Neurological Surgeons grade in designing their large-scale SAH randomized controlled trials.

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Section: Expected Wfns Distribution Is Skewedmentioning

confidence: 99%

“…C , Expected distribution of mRS scores. Data in panel A are derived from a weighted average of 8 large studies 2–6 in Supplemental References and Figure S1 and ( B ) from the ULTRA trial (Ultra-Early Tranexamic Acid After Subarachnoid Haemorrhage).…”

Section: Expected Wfns Distribution Is Skewedmentioning

confidence: 99%

Subarachnoid Hemorrhage Trials: Cutting, Sliding, or Keeping mRS Scores and WFNS Grades

Mistry,

Saver,

Mack

et al. 2024

Stroke

View full text Add to dashboard Cite

show abstract

Subarachnoid Hemorrhage Trials: Cutting, Sliding, or Keeping mRS Scores and WFNS Grades

Mistry,

Saver,

Mack

et al. 2023

Preprint

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Rigorous evidence generation with randomized controlled trials (RCTs) has lagged for aneurysmal subarachnoid hemorrhage (SAH) compared to other forms of acute stroke. Besides its lower incidence compared to other stroke subtypes, the presentation and outcome of SAH patients also differ. This must be considered and adjusted for in designing pivotal RCTs of SAH patients. Here, we show the effect of the unique expected distribution of the SAH severity at presentation (World Federation of Neurological Surgeons, WFNS, grade) on the outcome most used in pivotal stroke RCTs (modified Rankin Scale, mRS) and consequently on the sample size. Further, we discuss the advantages and disadvantages of different options to analyze the outcome and control the expected distribution of WFNS grades in addition to showing their effects on the sample size. Last, we offer methods that investigators can adapt to more precisely understand the effect of common mRS analysis methods and trial eligibility pertaining to the WFNS grade in designing their large-scale SAH RCTs.PurposeThe generation of rigorous evidence to inform the management of patients with aneurysmal subarachnoid hemorrhage (SAH) has lagged other types of acute strokes. The reason for this lag is multifactorial—one being that SAH has the lowest incidence of all forms of stroke. However, the paucity of SAH randomized controlled trials (RCTs) can also be self-exacerbating. Rather than adopting existing trial designs and biostatistical methods, it forces new investigators to craft these anew. Here, we provide a basic biostatistical guide for investigators to navigate two foundational dilemmas in designing large-scale SAH RCTs.

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Changes in Short-Term Outcomes After Discharge in Patients with Aneurysmal Subarachnoid Hemorrhage: A Multicenter, Prospective, Observational Study

Cited by 2 publications

References 30 publications

Subarachnoid Hemorrhage Trials: Cutting, Sliding, or Keeping mRS Scores and WFNS Grades

Subarachnoid Hemorrhage Trials: Cutting, Sliding, or Keeping mRS Scores and WFNS Grades

Subarachnoid Hemorrhage Trials: Cutting, Sliding, or Keeping mRS Scores and WFNS Grades

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