Our commentary has just been published in Paediatrics and Child Health, the CPS journal together with a response from the Society. (they seem to be open access, but I am not certain).
I am disappointed by the response, but not surprised. Our commentary was co-written with over 30 academic neonatologists from around the world, 16 of whom are Canadians, and a Canadian parent representative. The concerns that we have about the process and the content were largely dismissed. I would have hoped that the opposition of many high profile Canadian Neonatologists, including 3 with a PhD in ethics and the past chair of that very committee, to some of the recommendations would have led to a more thoughtful response.
The response notes some things which I think were positive about the position statement, including the description of the shared decision-making model, and the recognition in the text of the statement, that risk factors other than gestational age should be taken into account. However it fails to acknowledge many of our other concerns.
The response states that ‘the substantive question is: Should GA be used for counseling an decision making?’ I disagree that that is the substantive question. I do not think there is any question that GA should be one of the factors taken into account in constructing a risk model for an individual family. I think the question is rather: should GA be the over-riding factor in decision-making? When GA is subject to substantial inaccuracy in 96% of pregnancies, when GA is less important in prognosis than birth weight, when the implications of being born at a particular GA are so different between boys and girls, between those with and without steroids, between infants with chorioamnionitis and without. I think that GA must be included in our considerations, but not as the major focus, and not as the critical decision-making threshold that it is in these recommendations.
The response notes that many mothers present initially to primary or secondary level facilities, and it was for them that much of this simplification was introduced. Unfortunately however, the recommendations are not written in order to be useful for those practitioners; there is no recommendation about when to consult with the tertiary referral unit, nor when to transfer a mother with threatened preterm labour. Such a recommendation could indeed be very useful, but is missing from the position statement.
The points that still need to be addressed by the CPS and are not mentioned in this response are as follows:
Why are the thresholds for changing intervention at those particular points? What is the ethically relevant distinction between an infant born at 22 weeks and 6 days, and one born at 23 weeks and 0 days? In a statement regarding ethical decision making it seems strange that the ethical underpinnings are nowhere discussed.
On a related point, why was there no discussion of quality of life? As QoL does not differ between survivors of different gestational ages, what is the justification for recommending intervention at some GA and not at others? In their response, the CPS mention that they agree that discussion with parents should include balanced information about quality of life, that is a welcome acknowledgement, but is absent from the position statement as published and approved.
In their response the CPS deny that there are any errors in table 2. As I noted in a previous post, every one of the percentages in table 2 is incorrect. To give one example again, table 2 states that the percentage of survival free of adverse outcome at 18 to 24 months in the article by Synnes et al was 35% at 23 weeks GA. In reality the original paper notes that the survival rate among live births rate was 22.5% (9 of 40), in another part of the article it is noted that the risk of moderate impairment at 4 1/2 years was 20% and of severe impairment was 10% (a statement that appears to relate to infants of all gestational ages, but without a definition of ‘severe impairment’ and there are no data about outcomes at 18 to 24 months). So survival free of serious adverse outcome, is either about 20% or about 16%. Table 2 also gives the survival free of disability at 23 weeks from the paper by Jacobs as being 35% at 23 weeks, whereas overall survival was lower than that, 29% pre-surfactant and 21% post-surfactant. Jacobs et al includes 24 babies of 23 weeks who were followed, of whom 4 were severely impaired at 18 to 24 months. So survival without severe impairment is actually somewhere around 23% pre-surfactant and 17% post-surfactant. Furthermore, survival at 24 weeks was 53% pre surfactant and 58% post-surfactant, with 39% pre and 21% post-surfactant being severely impaired, while the table states that there was 57% survival without severe impairment. Finally the article by Charlene Robertson doesn’t include any of the numbers in the table. There are bar charts showing survival rates for each week of gestational age, divided into groups of 3 years. So to get numbers for the table, you have to estimate what the number is for each group of 3 years, then add them together, and hope that you have it about right, there isn’t even a group of infants at 23 weeks, the figures are given of infants less than or equal to 23 weeks, and we don’t know how many are 23 weeks, and how many are less. When I try to replicate that questionable process, I get about 86 babies of 23 weeks or less with around a 10% survival, about half of whom have an impairment. This is nowhere near the 50% survival without severe neurodevelopmental outcome as stated in the position statement.
In some ways this is unimportant as the CPS never state how low a ‘survival free of adverse outcomes’ should be in order for active intervention to be inappropriate. But it is important that a position statement is at least accurate in its presentation of prior data. If you can’t trust those figures, can you trust any of the figures in the statement?