This is about the THAPCA trial, published in NEJM in 2015 (paper here) .  It’s a trial of hypothermia after paediatric cardiac arrest, randomising children aged between 2 days and 18 years to either normothermia or hypothermia, started within 6 hours of return of circulation.  First of all, let me say that’s a challenging trial, … Continue reading Cool

NEJM again

Some time ago I wrote a post complaining that the New England Journal of Medicine was promoting testing of baseline characteristics in randomised trials, in their Instructions for Authors (post is here).  After I wrote that I wondered if I was being fair; it could possibly refer to comparisons of outcomes, not baseline characteristics. The … Continue reading NEJM again

Unintentional hilarity in statistical analysis plan guidelines

Maybe hilarity is a bit strong. I've just been looking at the recently published (in JAMA) Guidelines for the Content of Statistical Analysis Plans in Clinical Trials.  Most of the action is in the eAppendix2 "Explanation and Elaboration of Essential Items," where they go through the essential items in exhaustive and sometimes mind-numbing detail. It's … Continue reading Unintentional hilarity in statistical analysis plan guidelines

The Vest

Via Twitter, I came across a blog post by Dr John Mandrola (here) on the VEST trial, whose results have recently been presented at the American College of Cardiology Annual Scientific Session.  The trial evaluated a wearable cardioverter-defibrillator in patients after myocardial infarction (conference abstract (without results) here). Dr Mandrola seems not to like the … Continue reading The Vest

Language, confidence intervals and beliefs

People often speak and write about values of treatment effects outside their confidence intervals as being “excluded.” For example; “the risk ratio for major morbidity was 0.98 (95% CI 0.91, 1.06), which excluded any clinically important effects.” I just made that up but you often see and hear similar statements. What understanding do people take from … Continue reading Language, confidence intervals and beliefs