Some of you might recall a report in Early Human Development that I strongly criticized on this blog. The title was ‘The effect of in-hospital developmental care on neonatal morbidity, growth and development of preterm Taiwanese infants: A randomized controlled trial.’
When I wrote the blog post I also sent a letter to the editor suggesting in quite strong terms that the article was fatally flawed and should be retracted. I never received any reply from the editor, but the publishers sent me an automated message asking me to submit the letter on their website. There was actually no way to submit a letter on the website, it had to be submitted as a regular article submission. Which I did, almost a year ago. I recently received an automated email congratulating me that my article had been accepted!
Anyhow, the letter has now been published, as I originally wrote it, along with a reply from the authors.
My letter is actually very rude, and I would not have written it quite like that if I had thought it would just go to publication, I intended it to be read by the editors, the tone is much more the kind of thing I write in this blog, but I will have to live with that.
The authors’ reply is, I think, entirely inadequate. you can read it yourselves, but the authors now state that some of the exclusion criteria were actually ‘early dropout’ criteria. In other words they planned the trial from the start to not be an ‘intention to treat’ analysis but to exclude certain babies after they had been enrolled. These early dropout criteria include, for example, severe intraventricular hemorrhage, and they state that there were 7 babies with intracranial hemorrhage or calcification who were enrolled and then dropped out because of those findings. Again, this makes no sense, IVH occurs in the first couple of days of life, there would be no reason for enrolling such babies and the dropping them out again.
The authors state that the publication did indeed follow the CONSORT statement, but there are many ways in which that statement is not accurate. One major example is the following, item 6a from the CONSORT statement of things which must be included in the report:
Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed
As I mentioned before there is no primary outcome mentioned in their report, the authors state in their reply to my letter :
the primary purpose of our study was to investigate the effect of early intervention (consisting of in-hospital and after-discharge developmental care) on child, parent and mother–child interaction outcomes in VLBW infants
Which is so vague as to be meaningless. they go on to state
Previous in-hospital intervention studies and have commonly used child medical, growth and developmental variables as the short-term outcome measures. Our paper has therefore considered all these variables as the primary outcomes.
Which just shows that they don’t understand what a primary outcome variable is. Rather than continue to beat down on these authors, I really want to ask the question, how on earth did all this get through peer review? Someone clearly did not do their job.