Tag Archives: Research Design

Composite outcomes for research; this is how to do it!

As regular readers of the blog will know, I have been very critical of some very important, otherwise excellent, trials over one vital part of their design, that is, the use of composite outcomes such as “death or BPD”, “death … Continue reading

Posted in Neonatal Research | Tagged , | 2 Comments

Should we feed insulin to preterm babies?

This was an idea I had not heard about prior to seeing this newly published trial (Mank E, et al. Efficacy and Safety of Enteral Recombinant Human Insulin in Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2022). The introduction … Continue reading

Posted in Neonatal Research | Tagged , , | 4 Comments

Which is worse; death or a low Bayley score? Comparing composite outcomes between groups, taking into account clinical priorities.

I keep harping on about this issue as I think we make a mistake in the design of our research studies when we include death and a much less important outcome in composite outcomes. For example in the STOP-BPD trial, … Continue reading

Posted in Neonatal Research | Tagged , | Leave a comment

Longer term outcomes; what should we measure? part 1.

Many important trials include follow-up to about 2 years in order to ascertain longer-term effects. Such as this one: Adams-Chapman I, et al. Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial. J Perinatol. 2021. Ira Adams-Chapman was … Continue reading

Posted in Neonatal Research | Tagged , , | 2 Comments

What respiratory outcomes are important?

When bronchopulmonary dysplasia was first described by Northway in 1967 he didn’t try to produce a definition, his paper was a description of a small number of preterm survivors of high oxygen and positive pressure ventilation. He noted some years … Continue reading

Posted in Neonatal Research | Tagged , , , | 1 Comment

Research Outcomes in Neonatology : must do better.

When planning a research project with neonatal patients the first question should be, what am I investigating? The PICO outline : standing for Patients, Intervention, Controls (or comparison) and Outcome, is a standardized way of asking the simple question. If … Continue reading

Posted in Neonatal Research | Tagged , | 3 Comments

To p or not to p, what is the alternative?

I started writing the previous post several weeks ago, and, of course, the ideas are not original with me, in fact, a whole recent issue of “The American Statistician” is dedicated to not just trying to eliminate talk of statistical … Continue reading

Posted in Neonatal Research | Tagged , | 2 Comments

To p or not to p, that is the question.

I can’t claim preference for this title, although I wish I could. I copied it from an article published in an ENT journal (Buchinsky FJ, Chadha NK. To P or Not to P: Backing Bayesian Statistics. Otolaryngol Head Neck Surg. … Continue reading

Posted in Neonatal Research | Tagged , | Leave a comment

Death or oxygen, which is worse?

We have a big problem in neonatal research. We have constructed composite outcomes that have become the “standard of design”, but are not of much use for anyone. Because we are, rightly, concerned that death and other diagnoses may be … Continue reading

Posted in Neonatal Research | Tagged , , , | 6 Comments

Reading Research: Subgroups and Observational studies

In publications of randomized controlled trials, subgroup analyses are frequently performed. The idea behind such analyses being to determine whether one group or another has a different result to the overall results, for example, whether boys or girls have more … Continue reading

Posted in Neonatal Research | Tagged | Leave a comment