Tag Archives: Research Design

Is this article trustworthy?

There are many ways that an article in the medical literature may not be worthy of trust, and whose results may be unreliable. I remember one of my own trials, LACUNA, which was a pilot RCT of lactoferrin supplementation to … Continue reading

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Clinical examination and treatment of septic shock. Not neonatology.

Andromeda-Shock-2 Investigators for the Andromeda Research Network SSoAR, et al. Personalized Hemodynamic Resuscitation Targeting Capillary Refill Time in Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial. JAMA. 2025. This is a very interesting trial evaluating the usefulness of clinical assessment … Continue reading

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Return to the Regression to the Mean

After my post on regression to the mean, and its importance in studies of apnoea therapy, I was thinking of other examples. Some which have been most evident to me are those which impact on areas of medicine that I … Continue reading

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Do blood transfusions treat apnoea of prematurity?

There has for a long time been a thought that anemic babies with many apnoeas could benefit from a blood transfusion which would decrease their apnoeic spells. This idea has never been directly tested by an RCT. That is, a … Continue reading

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Unethical research practice, fraud and abuse of trust.

One of the worst kinds of unethical research practice is to fail to publish results after a prospective study. Parents consent to research for altruistic motives, in the belief that their baby’s participation will help the care of other, future, … Continue reading

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Is it a duck? Is it a mole? Platipus and Trial Design Innovations.

When the platypus was first captured, killed, skinned and the pelt sent to a zoologist in London, George Shaw in 1799, he thought he was being scammed. He tried to find the stitches that had been used to cobble together … Continue reading

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Making Clinical Research Oversight Fit-for-Purpose

The title is a slightly edited copy of the title a discussion article in JAMA, that discusses some important issues in IRB oversight of clinical research. (Kass NE, et al. Making the Ethical Oversight of All Clinical Trials Fit for … Continue reading

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Badly performed, badly presented, unethical published research; what to do?

Since at least 2013 the World Medical Association Declaration of Helsinki has mandated registration of clinical trials prior to enrolment of the first subject. Since 2005 the International Committee of Medical Journal Editors has required trial registration as a condition … Continue reading

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Time to open the DOOR

I have written many times about the problems with classical composite outcomes in neonatal research. “Death or BPD”, “death or NDI”, or sometimes “death or NEC or Sepsis or BPD or severe IVH” have been used as a way of … Continue reading

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How to express negative results… or positive ones

After any trial result, there is always a possibility that the true effect of an intervention is different to that shown in the sample who were studied. That is the whole rationale behind using statistics, a trial on a small … Continue reading

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