Tag Archives: Research Design

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

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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

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Two New Publications

After a few weeks break (for a number of reasons), I’m ready to start blogging again! I’m sure you have all missed the succinct and perceptive critiques of the recent neonatal literature, but today I will start with 2 publications … Continue reading

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The best outcome variable for very preterm newborns?

Death or ‘neurodevelopmental impairment’ (NDI) as a combined outcome has become a sort of de facto standard as the primary outcome for neonatal clinical trials. Because many very preterm infants have developmental delay, intellectual and learning difficulties, and some have … Continue reading

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Conflicts of interest are not all financial, but they are conflicts none the less. Name change not required.

Another poorly argued article trying to minimize the reality of conflicts of interest in medical research. Cappola AR, FitzGerald GA. Confluence, not conflict of interest: Name change necessary. JAMA. 2015;314(17):1791-2. If someone stands to have a personal advantage as a result … Continue reading

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Late Surfactant may not be effective, probably.

A large multi-center trial (n=511) led by Roberta Ballard has just been published. (Ballard RA, et al. Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide. J Pediatr 2015.) In this trial infants had similar … Continue reading

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Murky Guidance

After the OHRP meetings and their evaluation of the SUPPORT controversy, the OHRP have now released what they call “Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care” The conclusion of the draft guidance starts with … Continue reading

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