Anders Granholm

Estimating effective sample sizes using standard errors from appropriate analyses of cluster-randomised trials - Journal of Clinical Epidemiology www.jclinepi.com/article/S089...

At #CCR25, we saw some trials use a #CompositeOutcome (an endpoint that combines more than one outcome into a single measure) & also saw some of the problems these can throw up. I have discussed these before but thought it would be useful to revisit 1/9
#MethodologyMonday #120

Interested in adaptive platform trials?
INCEPT (www.incept.dk) recently got approved along with the first domain, and we expect to start inclusion soon. A protocol/design paper is available at doi.org/10.1111/aas.... along with the full protocol docs at incept.dk/documents
@andersperner.bsky.social

This past month has seen the publication of a couple of new helpful papers providing further insights into the thorny issue of #MultipleTesting in trials 1/7
#MethodologyMonday #112

The Intensive Care Platform Trial (INCEPT) research programme aims to prepare, initiate and run an adaptive platform trial assessing commonly used interventions in acutely ill intensive care unit (ICU) patients.

Good news for ICUs and patients

The Intensive Care Platform Trial - INCEPT - was approved by the regulators

INCEPT is a very broad domain based, adaptive platform trial assessing everyday interventions in ICUs

1. enrolled in first domain (albumin use vs no use in shock) in april 2025

incept.dk

Most PRNG functions in R rely on random unif/norm/exp numbers, e.g., rbeta uses a rejection method relying on uniform random numbers (github.com/wch/r-source...) - if they were reimplemented with the RNG calls replaced with the ziggurat functions, I would imagine that all could be speed up?

Are there any plans to expand to cover PRNG of other distributions in R? Would be really useful (I use rbeta a lot). A lot of them seem to rely on random uniform/normal distributions, so I would assume they could be sped up as well if the ziggurat algorithm was used under the hood? 2/2

Very interesting work! I use a lot of PRNG for simulation, and it often takes the majority of computation time (50-80%). On this machine the speedups seem around times 6 (norm), 8 (exp), but somewhat less for unif (~1.9) 1/2

An issue that often comes up is how to set a “non-inferiority margin” in a non-inferiority trial and how to ensure it is appropriate 1/8
#MethodologyMonday #109

Interested in design and evaluation of advanced adaptive trial designs?

See our new preprint: doi.org/10.48550/arX...

Here we summarise key methodological considerations and how to specify and evaluate them using simulations via our 'adaptr' #Rstats package (inceptdk.github.io/adaptr/)
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Feedback, comments, and questions on the preprint is welcome! 4/4

The Intensive Care Platform Trial (INCEPT) research programme aims to prepare, initiate and run an adaptive platform trial assessing commonly used interventions in acutely ill intensive care unit (ICU) patients.

This framework is used for our upcoming EMPRESS trial (www.cric.nu/empress) and all currently planned domains on our upcoming INCEPT platform trial (incept.dk).

We hope that this will serve as a useful help for others considering or planning the use of similar trials.
3/..

We cover Bayesian adaptive trials with adaptive stopping and arm dropping and response-adaptive randomisation. In addition to describing and providing guidance on the methodological decisions, we included complete analysis code to evaluate such trial designs.
2/..

Interested in design and evaluation of advanced adaptive trial designs?

See our new preprint: doi.org/10.48550/arX...

Here we summarise key methodological considerations and how to specify and evaluate them using simulations via our 'adaptr' #Rstats package (inceptdk.github.io/adaptr/)
1/..

A Core Outcome Set for Adult General ICU Patients should include survival, free of life support, free of delirium, out of hospital, health-related quality of life, and cognitive function.
Excellent international Delphi study from Denmark
journals.lww.com/ccmjournal/f...

A Core Outcome Set for Adult General ICU Patients : Critical Care Medicine nts exist, for example, respiratory failure, delirium, and COVID-19, but not for ICU patients in general. Accordingly, we aimed to develop a core outcome set for adult general ICU patients. Design: ...

A core outcome set for general ICU patients aimed for clinical trials - developed with many stakeholder and internationally validated

Amazing work by #INCEPT trial team led by @maj-brit.bsky.social with contribution from a large group of international colleagues

journals.lww.com/ccmjournal/a...

Reference Collection to push back against "Common Statistical Myths" Note: This topic is a wiki, meaning that this main body of the topic can be edited by others. Use the Reply button only to post questions or comments about material contained in the body, or to sugge...

In clinical research, you will often receive feedback on study design, stats, and/or data analysis from an editor or reviewer that is simply wrong. Here is a list of common "statistical myths" and references you can use to push back.

discourse.datamethods.org/t/reference-...

This is a list of statistical myths and misconceptions that I keep coming back to. So many common avoidable mistakes. Should be read by all clinician researchers and all who want to critically read studies! #cardiosky #emimcc #stats