Some of you may remember my rant about the article that was supposedly about in-hospital developmental care recently published in Early Human Development. Well I sent a note to the editor through the web page telling him about my concerns. I received a reply, not from the editor, but from someone at Elsevier asking me to submit a letter to the editor. I found this a little strange, as I did not write to Elsevier and it is the editors responsibility what is published in the journal, but nevertheless I went to the website to submit the letter. The journal website now has instructions for authors available on the appropriate page, which was blank when I visited previously, maybe it was just a glitch, but the instructions to authors clearly state that all RCT reports should comply with CONSORT. Which this one did not.

The text of my letter is reproduced below. I will keep you posted.

To the editor:

Re: Chen L-C, Wu Y-C, Hsieh W-S, Hsu C-H, Leng C-H, Chen WJ, Chiu N-C, Lee W-T, Yang MC, Fang L-J et al: The effect of in-hospital developmental care on neonatal morbidity, growth and development of preterm Taiwanese infants: A randomized controlled trial. Early Human Development 2013, 89(5):301-306.

This recent publication is an embarrassment to the medical community. The authors have been allowed to publish an article in which the infants were enrolled before they were eligible, where some of the outcome variables are used as exclusion criteria, where other outcome variables could not possibly have been affected by the intervention, where the number of outcome variables and statistical analyses is so great that one can have no confidence whatsoever in the results. In addition the interventions are so poorly described that it is impossible to know what they were investigating.

Unfortunately the investigators have used substantial resources, enrolled large numbers of infants, and I am sure had the best of intentions.

Even the title of the article is profoundly misleading, as the intervention started at 34.7 weeks, and continued after discharge (apparently, even though even this is not clear), and we are informed that all groups received ‘in-hospital developmental care’ including the controls. The different interventions, which started on enrollment into the study, commenced at 34.7 weeks PMA as noted in table 2.

Eligibility criteria: the authors state in the eligibility criteria that these include being ‘physiologically stable, i.e., no ventilator use, absence of apnea, bradycardia, or desaturation with or without oxygen use at post-menstrual age (PMA) of 36 weeks; [6] hospital discharge prior to PMA of 44 weeks’ so the infants were not eligible until 44 weeks PMA, but they were enrolled and had intervention started by 34 .7 weeks, i.e. 10 weeks before they were eligible, if the authors did not have access to a time machine this is clearly impossible.

Outcome variables: the outcome variables used include BPD, as infants were not eligible until after 36 weeks the authors would already know if they had BPD when enrolled. RoP is also used as an outcome variable, when it is also an exclusion criterion, and again would have been diagnosed by the time the infants were eligible. Feeding desaturation; as noted above infants were ineligible for the study if they had desaturation, so to include feeding desaturation as an outcome variable is incomprehensible.

Significance of statistics. The authors never state which outcomes were primary or secondary, they have therefor performed 18 t tests (having decided to ignore the fact that there were 2 different intervention protocols). There is no adjustment for multiple testing which means that there was over a 60% chance of a type 1 error. The 2 outcomes which are supposed to be different between groups are outcomes which could not have been different between groups, as RoP occurred before the children were eligible and feeding desaturation made the infants ineligible.

It is inconceivable that an intervention which commences at 34.7 weeks could have any effect on BPD or on RoP.

Your instructions to authors page clearly states in detail that all RCT reports should comply with CONSORT. This publication did not. There is no flow sheet, it does not specify primary and secondary outcomes, and there are many other failings.

The publication of this trial in your journal makes clear that the editorial standards and refereeing of ‘Early Human Development’ are inadequate. It makes it impossible to have any confidence in any of the articles published in your journal. This article should be retracted.

Sincerely