@VR_Cornelius

Medical Statistics and Trial Methodology. Director of Imperial Clinical Trials Unit.

 London, England
imperial.ac.uk/people/v.cornelius
Joined July 2015
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Victoria Cornelius retweeted
StatsCI@stats_ci18 Jun 2025
Attending NIHR stats conference this week @NIHRStatistics ? Don’t miss @Annie_Stats , @LeilaJTF , @JakElkes , @marie_miller_ , and Francesco Lala, who will be presenting these exciting topics:
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Victoria Cornelius retweeted
Marion Campbell@MarionKCampbell13 Jun 2025
Fantastic presentation of the #GASTROSAM trial at #CCR25 - IV rehydration strategies for children with severe acute malnutrition & gastroenteritis. Amazing commitment to generating evidence in the hardest of circumstances incl a coup and flooding. Bravo! nejm.org/doi/full/10.1056/NE…

Intravenous Rehydration for Severe Acute Malnutrition with Gastroenteritis | NEJM

International recommendations advise against the use of intravenous rehydration therapy in children with severe acute malnutrition because of the concern about fluid overload, but evidence to suppo...

nejm.org
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This trial result from #GASTROSAM at #CCR25 reviewed there is so much more here for interpretation than headline journal conclusions. Large effect of the trial as an intervention on outcomes but important new understanding of safety (albeit under ideal conditions).
NEJM
@NEJM13 Jun 2025
Presented at #CCR25: A trial involving children with severe acute malnutrition and gastroenteritis showed no evidence of a difference in mortality at 96 hours between oral and intravenous rehydration strategies. Full GASTROSAM trial results: nej.md/3TjfSP7 @CritCareReviews
A graph showing the primary end point, which was death at 96 hours.

ALT A graph showing the primary end point, which was death at 96 hours.

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Final trial for the day at #CCR25 its the #FLUIDtrial Does hospital universal supply of Ringer’s Lactate reduce 90D death or readmission to hospital compared to usual care fluids? Lauralyn McIntyre HUGE cluster crossover trial..1/
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Brilliantly designed by Monica Taljaard, with careful planning using RWD for two correlation estimates, and inflating clusters for caution but then trial not quite reaching those. 2/
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Fabulous editorial from John Myburgh on many aspects including interpretation and other nuances. don’t walk away only with the ‘no evidence of a difference’ conclusion 3/
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#ANH at #CCR25 Does acute normovolemic hemodilution for elective cardiac surgery reduce transfusion rate? No evidence from this large double blind pragmatic trial. Methods wise the dichotomisation of outcome >=1 unit would lose information and I wonder about site heterogeneity
NEJM
@NEJM12 Jun 2025
Presented at #CCR25: In the ANH phase 3 trial involving adult patients undergoing elective cardiac surgery, acute normovolemic hemodilution did not reduce the number of patients receiving allogeneic red-cell transfusion. Full trial results: nej.md/3FxdMrW @CritCareReviews
Table 3. Clinical Outcomes.

ALT Table 3. Clinical Outcomes.

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What’s needed next for this area? No doubt some suggestions coming up from expert panel at #CCR25!
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Does Nasal high flow O2 therapy after cardiac surgery requiring bypass improve days alive at home (without additional support)? #CCR25 #NOTACS Some thoughts for the adaptive design features, especially in light of the results that so similar almost no need for analysis! 1/
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Sample size re-estimation after n=350 increased from 850 to 1280 based on ⬆️ SD observed, to protect type 1 error the treatment effect not considered. Learning for future that maybe we should pair SS reestimation with Group sequential to stop for futility (& efficiency!) 5/
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No doubts about the result for no difference in this trial as consistent across primary and secondary outcomes, and great learning for future. 6/
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Day 2 at #CCR25 & #UKROX Is conservative O2 therapy in MV in ICU patients beneficial? Ambitious #NIHR data-enabled trial & great example of how to do this. 3 data sources used for 16,500 patients in 97 sites with enhanced data for 15% for adherence Great cast list! 1/3
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Results don’t find evidence for a difference.. paper live 2/3 shorturl.at/uVe6L
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Powered for a 2.5% mortality difference, found point estimate 0.7% Is aligned with MEGA-ROX (powered for a 1.5% - in progress) Meanwhile there is much to unpick in discussion here at #CCR25 for these results … Including overly pragmatic collection of safety outcome ? 3/3
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First day at #CCR25 (and already loving it) and the first trial result for #TARGETproteintrial No clear clinical conclusions here but a fantastic example of a statically efficient cluster trial design with double crossover. 1/2 jamanetwork.com/journals/jam…

Augmented Enteral Protein During Critical Illness

This randomized clinical trial examines whether augmenting enteral protein increases days alive and free from hospitalization in critically ill patients.

jamanetwork.com
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Though combining the design with the primary outcome distribution would bring the heebie-jeebies to most statisticians- they managed it. Lovely example of ICEMAN for subgroups and reported in full in supp 3 2/2
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🚨UK-ROX TRIAL Results at #CCR25🚨 📍 ~100 🇬🇧 ICUs 👥 ~16,500 pts 🎯 Conservative vs usual oxygen therapy in invasively ventilated adults 🩺 Outcome: Mortality day 90 🤔 Will less oxygen save lives? 📺 Free livestream — but it's better in person! 🔗 criticalcarereviews.com/ccr2…
Flyer for the UK-ROX trial results presentation at CCR25

ALT Flyer for the UK-ROX trial results presentation at CCR25

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