Public Citizen are a public danger: part 1

Posted on 24 August 2013 by Keith Barrington

They are at it again.

The people in the Public Citizen health research group don’t understand evidence based practice, they don’t understand clinical research and they don’t understand neonatology. Which doesn’t stop them from making a fuss about high quality important neonatal research, claiming that it is unethical, and that the consent forms and IRBs are again inadequate.

This time they are claiming that the TOP trial is unethical, and the consent forms and IRB approvals are inadequate. The TOP trial (Transfusion of Preterms) is a large multi-center RCT comparing 2 different treatment algorithms, it is designed to address a serious area of clinical uncertainty. The situation is very analogous to the oxygen saturation uncertainties prior to SUPPORT, COT and the BOOST trials.

Speaking of which John Lantos has published a vigorous defense of SUPPORT and the support investigators, even while a Nature editorial is much more ambivalent. I will quote the penultimate paragraph from the Nature editorial as I think it illuminates much of the misunderstanding of these trials.

Put yourself in the position of a parent with an extremely premature infant. Would you make the decision to enrol your child in the trial if the consent form stated in simple language that babies assigned to one group were more likely to go blind, and that those in the other were at a higher risk of getting neurodevelopmental disabilities? Equally, would you decide to enrol if the form spelled out that, if you do not take part, your own physician and institution might keep your infant in the middle of the range, trying to avoid either outcome? Perhaps you might, but you would do so with full knowledge of the attendant risks. The parents in this case could not do so.

My first response is to note that the babies did not have more blindness in one group or the other. There was also no difference in neurodevelopmental disabilities. The paragraph also fails to note that being in the middle of the range might well be worse than either of the other 2 ranges (they could theoretically have both a higher rate of RoP and more deaths), we actually don’t know, and the consent forms did note that infants outside of the study might be treated with any of the currently used target ranges. Which would include the lower range which is now known to increase mortality.

So what is the current situation with transfusion thresholds. They are extremely variable, from NICU to NICU and from neonatologist to neonatologist. There are no clear indications for transfusion in the majority of babies. Those who are actively bleeding and are hypovolemic are clearly appropriately transfused urgently, but that is the minority of transfusions in the NICU. Most are given simply because the hemoglobin number is low. But we don’t know what the best number is at which to transfuse, if there is one.

There are all sorts of reasons why transfusing at a higher or lower threshold might be preferable, stored blood has risks relating to ages of the cells, abnormalities of the cells due to the storage media, infections, etc. But they do increase oxygen carrying capacity and in cases where oxygen transport might be limited this could affect outcomes.

 The members of Public Citizen writing to the Secretary of the HHS in the USA note the 2 previous relevant trials. One is the trial by Ed Bell, which enrolled 100 babies between 500 and 1300g birth weight with a primary outcome which was the number of transfusions received. Of note some of the babies in each group (about half) had already been transfused before being randomized. One of the secondary outcomes, and there were 17 of them, was different between the groups, that is, the combined incidence of grade 4 hemorrhage and PVL, which was more common in the restricted transfusion group 6 babies vs 0. Now usually we include all serious IVH (grade 3 and 4) when talking about serious brain injury. There were actually more grade 3 hemorrhages in the liberal transfusion group, 8 vs 1. So using the usual definition of serious brain injury, it was actually more frequent in the liberal transfusion group: 8 babies vs 11.

According to the wording of the Public Citizen document, this is evidence which suggests poorer outcome in the conservative group. Er, no. It is evidence which is rather unreliable which might possibly mean something and needs to be confirmed with an adequately powered trial.

The authors of the letter do note that the long term follow up of Bell’s trial was actually better in the restricted transfusion group. But they don’t like that finding so they criticize the low follow up rate, while not making any criticisms of the selection of the outcome variable in the initial publication.

The second trial was one I was involved in, the PINT trial. That was an RCT in 10 NICUs in Canada, the US and Australia, of restricted versus liberal transfusion regimens in 451 babies under 1 kg birth weight. That study showed no differences between any clinical outcomes, the primary composite outcome, which included brain injury, was not different between groups. Also the components of that outcome, specifically brain injury on ultrasound were not any different (there were actually slightly more babies with liberal transfusions who had brain injury).

The follow up publication from that study included nearly all the surviving babies, and showed no significant differences in the outcomes. There were a few more babies with a delay in their development (Bayley2 MDI at 18 to 21 months which was <70) , 38/156 (24.4) with restricted transfusions vs 29/165 (17.6) with liberal transfusions. This was not significant, and in any case Bayley scores at this age have little predictive power for outcomes of clinical importance. An unplanned post hoc analysis showed that more restricted infants had a Bayley which was below -1SD.

So we clearly have NO data to support transfusing at any particular hemoglobin threshold: the 2 trials which are analogous to TOP had some minor differences in outcomes, neither of which was confirmed by the other trial. What does this mean? Well in the best of worlds that would mean that we should mount a larger multi–center trial, which adequate power to determine if there is any difference, comparing transfusion threshold practices which are within current limits of practice. That is exactly what we have in TOP.

We are finally doing some of those trials that we have needed for a very long time, and this trial, planned to have 1800 infants of less than 1000g is sorely needed to give us some evidence base for future practice.

What on earth do public citizen have against that? Their arguments are about the study design and about the consent forms.

The study design argument, after vaguely stating that there are ‘many features of the protocol which raise ethical concerns’ they only mention one feature which they think makes the study unethical.

A. Lack of a control group. They state that usual clinical care is that

‘decisions regarding the level of hemoglobin at which to transfuse blood would be individualized, based on multiple clinical factors.’

Just like their lack of understanding of how saturation ranges were chosen, they completely misunderstand how we decide to transfuse a baby. As I mentioned above, most transfusions are given because the complete blood count shows a hemoglobin below a certain level. That level may be fully protocolized in some units, or it may be according to individual physician preference. But in 2 NICUs in the same city exactly the same baby will get transfused according to different thresholds. When the on-call doctor changes, the decision to transfuse may change. This is actually entirely reasonable as we have little  evidence on which to base practice, and what evidence we have shows no effect of different transfusion thresholds.

According to Public Citizen transfusions are currently given according to individual patient factors including:

Current level of anemia
Active bleeding or coagulopathy
The degree of supplementary oxygen required
Level of respiratory support (e.g. intubation, positive pressure ventilation, nasal cannula)
Age of the baby
Reticulocyte count (count of new red blood cells)
The need for medication to help the heart pump blood (inotropic support) and
Major comorbidities, such as heart disease or sepsis
Other factors sometimes taken into account that support transfusion include
Lactic acidosis
Increasing episodes of apnea (stopping breathing)
Persistent tachycardia (abnormally fast heart rate)
Persistent tachypnea (fast breathing) and
Poor weight gain
At least some of that is true, as a description of current practice. Unfortunately almost none of it is evidence based, some of it makes no physiologic sense, and those parts which are clinically important are allowed anyway in TOP, or are exclusion criteria.
In detail:
Current level of anemia: Yes we do this, but we don’t know when we should, that’s what this trial is about.
Active bleeding or coagulopathy: transfusions are allowed for this in TOP
The degree of supplementary oxygen required and the Level of respiratory support (e.g. intubation, positive pressure ventilation, nasal cannula): Yes we do this, and the TOP algorithms include whether the child is on respiratory support, however, in fact it makes no sense. If your saturation is 92%, then what difference does it make to your transfusion requirement if you are in room air or ventilated with 40% oxygen? The cardiac function should perhaps affect transfusion requirements, but not pulmonary function.
Age of the baby. We don’t know if, or when, transfusion thresholds should change, but they do, arbitrarily, in the TOP protocols.
Reticulocyte count (count of new red blood cells). I don’t use retic counts for when to transfuse.
The need for medication to help the heart pump blood (inotropic support): Babies who are in shock will be allowed to get transfusions,
Major comorbidities, such as heart disease or sepsis: Babies with heart disease are ineligible, with sepsis can get transfusion if they are thought to need them.
Other factors sometimes taken into account that support transfusion include
Lactic acidosis: I don’t know if anyone uses lactates as a sign to transfuse, except maybe for babies in shock (see above)
Increasing episodes of apnea (stopping breathing). There is no good evidence that apnea is affected by transfusions, there was no effect on apnea in the PINT trial.
Persistent tachycardia (abnormally fast heart rate) I don’t think anyone transfuses for this alone.
Persistent tachypnea (fast breathing): no evidence to support this.
Poor weight gain: no evidence.

Public Citizen think there should be a ‘usual care control group’. By which they mean a 3rd group which is treated according to whatever the hell you feel like. I don’t know how on earth they think that will help.

Yes if there was an evidence-based ‘best therapy’ which was known to be better than other algorithms, then a standard-of-care group would be required ethically. Just as now, if someone wants to do another trial of oxygen saturation targeting, the control group would have to be the high saturation limits as studied in SUPPORT, COT and the BOOST2 trials.

By the arguments that Public Citizen are making a large proportion of clinical research is unethical. Any study that compares to protocols of care is unethical if there isn’t a 3rd group which is: carry on doing whatever you feel like.

That is what I meant by saying at the start of this long post, that they don’t understand evidence-based practice. Our care for our patients should be based on some evidence about what is the preferred approach. If we currently have enormous variations in practice, no reason for choosing one approach rather than another, it is ethically preferable to perform the randomized trial comparing two protocols of care than just continuing to guess what might be best for our patients, using our prejudices and our cognitive biases. Including a treatment arm which is non-evidence based, in which patients get treated according to the whims of the doctor is a terrible, unethical, way to perform research.

I will quote from John Lantos regarding the belief by OHRP and Public Citizen that we should exaggerate the risks of our research projects:

Why would they require this? The ideas that research is risky compared to non-validated therapy and that care by protocol is inferior to care by individualised clinical judgment have been around for a long time. They used to be widely held by doctors and criticised by bioethicists as unjustifiable medical paternalism. William Silverman, a pioneer of neonatology and a staunch advocate of better clinical studies, was familiar with such arguments. He identified them as a belief in ‘mystical certainty’ rather than an acceptance of ‘scientific uncertainty.’

Public Citizen are of the opinion that being treating according to the doctor’s gut feeling is somehow safer than being in a clinical trial. We know that is not true, it is an argument from medical infallibility, and it is ridiculous.

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More about SUPPORT, but this time not the consent forms

Posted on 23 August 2013 by Keith Barrington

The main, surprising, finding of SUPPORT, now confirmed by the other oxygen trials, is that aiming for O2 saturations that were a little lower led to higher mortality.

The big question is why? Having a saturation of 85% to 90% should surely not create such a tissue injury, immune reaction, circulatory dysfunction (or whatever else is implicated), that very preterm babies are more likely to die as a result, should it?

I think an observation of Juliann Di Fiore (free access) from Richard Martin’s group might be very relevant. This analysis of high-resolution oximetry data from SUPPORT quantified episodes of intermittent hypoxia in 115 infants from the 2 groups (from 2 hospitals in the trial). IH was defined as a fall in saturation to less than 80%, for at least 10 seconds but less than 3 minutes. The low saturation group had many more such events, especially during the first few days, and then again after 2 months. The average lowest saturation during these episodes was usually below 70%, so very far below the ranges that we thought we were testing, large numbers of profound desaturations like that could well be dangerous, causing hypoxia/re-oxygenation many times a day.

Another, new, publication is also suggestive, this time looking at cerebral saturations  Schmid MB, Hopfner RJ, Lenhof S, Hummler HD, Fuchs H: Cerebral desaturations in preterm infants: A crossover trial on influence of oxygen saturation target range. Archives of Disease in Childhood – Fetal and Neonatal Edition 2013. The authors did a cross-over study, changing the saturation limits from 80–92% to 85–96% for 4 h each. The periods of time with the lower limits had more episodes of intermittent desaturation, and more episodes of intermittent cerebral desaturation also using NIRS, confirming Di Fiore’s results, and showing that there is an impact at the level of cerebral oxygenation.

Interestingly the graphs in this new study show, very clearly, the missing saturation values between 87 and 91% that are now known to be due to mis-calibration of the Pulse Oximeter. The authors note that this mis-calibration leads to “an artefactual elevation of SpO2 readings between 87% and 90%”. This reduces the difference between groups, depending on the target ranges chosen. Hence the separation in mortality which occurred in the BOOST2 trials and COT only after the algorithm was changed. Which begs the question, why was the mortality difference there with the old algorithm in SUPPORT? I can’t answer that, the intervention in SUPPORT started much earlier in life than the other studies, maybe that magnifies the effects of lower saturations, certainly the lower sats give you more severe intermittent hypoxia in early life. The babies in Di Fiore’s study were all from SUPPORT, so using the old algorithms, and they did see the increase in hypoxic spells in the low sat target group.

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Who should get surfactant?

Posted on 23 August 2013 by Keith Barrington

I think the literature is clear, if you need surfactant, the earlier you get it the better. If you don’t need surfactant you are better off never being intubated. So how do we decide? Current management protocols usually put babies on CPAP if possible at first, then watch to see if the O2 requirements go up, and then intubate when it seems inevitable that the baby will benefit from surfactant, often this is at 30%, or 40% (as in the Vermont DR management trial), or 50% (such as in the SUPPORT trial), or 60% (as in the COIN trial). This variability is evidence that we are not really sure when we should intervene.

What would help would be a simple test, minimally invasive which could predict, shortly after birth, whether a baby is producing enough of their own surfactant to avoid intubation. here have been a few attempts to do this, and measuring some aspect of surfactant production on the gastric aspirate is promising.

Why gastric aspirate? Mostly because it is easily available without intubation. Fetuses swallow what is in the pharynx, a mixture of fetal lung fluid and amniotic fluid.  Remember that amniotic fluid in late gestation is a mixture of fetal urine and fetal lung fluid, FLF is a product of the cells lining the future air sacs, which is produced under the influence of an alveolar cell chloride pump. So FLF has a much higher Cl than amniotic fluid. Anyway, if the fetus is producing a lot of surfactant there will be lamellar bodies and surfactant in the stomach of the newly delivered infant.

If you put some gastric aspirate in a blood counter, the lamellar bodies will be counted as platelets, so you can get a quick answer with equipement that your hospital already has.

This newly published study marks I think a potentially important advance. Henrik Verder and his associates, in Denmark and Sweden, have performed an RCT of a diagnostic test: which in itself is fairly innovative. They have tested whether gastric aspiration for testing whether there are enough lamellar bodies allows more selective treatment of the preterm infant, and whether their clinical outcomes would be better as a result.

The authors randomized about 400 preterms less than 30 weeks gestation to one of two groups. Everyone was on CPAP and had a gastric aspirate analyzed before 1.5 h of age, and then they either were intubated for surfactant if the lamellar body count was less than 8000 per microliter after centrifugation, or they were intubated when their a/APO2 was <0.36 (based on transcutaneous gas values). The primary outcome variable of the study was not affected, that is the proportion of infants who needed to be intubated in the first 5 days of life.

But the babies treated according to the lamellar body count got their surfactant significantly earlier, at 3 hours rather than 5 hours for the controls. And they were off supplemental oxygen earlier, which was significant for the more mature babies 26 to 29 weeks, 2 days of O2 on average compared to 9 days.

I think that we do not to be a little careful, as the primary outcome was not affected (and there was some difference in the numbers of very immature babies in the two groups), but I don’t think the lack of effect on proportion intubated is too surprising, the test was previously shown to predict who will get RDS, so the equal numbers treated are just confirmation that the test does predict which babies will get RDS. Treating them earlier in several previous studies makes a difference to lung injury, with differences of only 1 hour in the OSIRIS study leading to improved outcomes.

There were quite a few babies that they were unable to get enough aspirate to do the testing, so that will be one limitation, but this looks simple (and cheap!) if you can persuade your lab to do the test.

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Susceptibility to Sepsis

Posted on 20 August 2013 by Keith Barrington

It looks like those Toll-like receptors may indeed be important. I included a review article in a previous Neonatal Updates, which was nice introduction to these transmembrane receptors that are important in immune responses. A new article suggests that variants in Toll-like receptors are important in determining susceptibility to sepsis. Out of 408 very low birth weight babies, the 90 that developed infections had a different profile of the SNPs of their TLRs than those that did not.

Sampath V, Mulrooney NP, Garland JS, He J, Patel AL, Cohen JD, et al. Toll-like receptor genetic variants are associated with Gram-negative infections in VLBW infants. J Perinatol. 2013 Jul 18..

I hope that sounds like I understand all this stuff, I like sounding well-informed!

If you read this blog, (and I guess if you are reading this blog you are a reader of this blog….) you know I will often be rather skeptical, so I would say for this study that the results are preliminary, that if you look for associations between 9 different SNPs and infection you might well find some that turn out to be spurious in the future; however, these authors did apply a Bonferroni correction for multiple statistical testing and it seems plausible that if the SNPs affect TLR function there could well be effects on sepsis susceptibility. Confirmatory studies will I am sure be forthcoming.

The next question is what to do with this information? Sepsis in very preterm babies is very important; it is frequent, and leads to long term disability, cognitive and motor (free access). The NICHD network published a long term follow up of infants with Candida and other septic episodes earlier this year (the first author is my friend and previously a fellow from when I was in San Diego: great study Ira!) This article confirms what we knew about late onset sepsis and adds much new information about the long term effects of Candida.

So if we can somehow in the future use the understanding of TLR variants and sepsis susceptibility to find ways to reduce sepsis then we may have a big impact on the lives of our patients.

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Teaching Well

Posted on 19 August 2013 by Keith Barrington

If you are a clinical teacher, and you have access to the Lancet, you should read this Reilly BM: Inconvenient truths about effective clinical teaching. The Lancet, 370(9588):705-711.

Great insights, and good guidance for teachers.

 
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End of Life, at Birth

Posted on 19 August 2013 by Keith Barrington

An Op-Ed piece in the NY Times a couple of weeks ago had that title.

I was rather disappointed by the piece, written by an experienced neonatologist; now I suppose for a piece written for the NY Times the fact that it is a very superficial look at perinatal decision-making is somewhat understandable, she makes some good points, but I think it shows a very old-fashioned approach to the issues.

Take this paragraph:

‘Sometimes, I think we doctors need to do more than inform. On occasion, I’ve offered to make a life-or-death decision for parents. If they agree, they are essentially making the decision, but are shifting the burden to me. It’s harder for parents to say, “I unplugged my baby,” than to let the doctor do it.’

I think if the author really thinks that all the doctor should do is inform, then she is very mistaken. Offering to make life-or-death decisions ‘for’ the parents is also extremely disturbing, especially given the whole tone of the article, which makes me wonder how often such a decision would be a ‘life’ rather than a ‘death’ decision. Does she even make that offer if she thinks the decision should be ‘life’?

The whole model of shared decision-making is missing from this piece; rather than imparting knowledge, these difficult discussions need to be about sharing what is important to the parents and the caregivers, exploring values together, working together over the course of the hospitalization to make the best decisions for the baby. There should be no dichotomy between either just informing and then leaving the parents to it, or making the decision in their place.

The whole tone of the article is very negative about the outcomes of the extremely preterm baby, while noting that ‘many’ extremely preterm babies ‘will need treatment long after birth, sometimes for life, at great financial and emotional cost to them and those around them’ she nowhere mentions that the majority do not. And, just as important, that the majority of those who do have long term impairments find their lives quite acceptable.

She also makes the classic, almost universal, error of talking about “survival or having a moderate to severe neurodevelopmental impairment”. I say that is an error as I don’t know how to interpret those numbers; if the risk of that combined outcome is truly 92% (and I imagine she used the NICHD calculator to come up with that exact number) it means something very different if the risk of death is 2%, but that 90% of babies survive with an impairment; compared to the risk of death is 90% but 2 out of 10 survivors have an impairment. We should avoid giving that number, if parents want an estimate of numerical outcomes, talking about the proportion who survive, and separately the proportion who have serious long term impairments among survivors is much more appropriate.

I also think it is an error to focus on the antenatal consultation as the time to make active treatment decisions. Our predictions are so unreliable that making decisions about life-sustaining interventions, at a variable time before birth, when there are great uncertainties about gestational age, and even greater uncertainties abut fetal weight, is really questionable.

What we do need, and don’t really have as yet is a way to predict survival or impairment during the hospital course. We can calculate the percentage survival for the whole group of preterm babies with each additional day of survival, which shows by the way, that once you are born and survive the first day or so, that gestational age has no influence on survival rates. What we can’t yet do is to predict after each day of additional intensive care, or each additional complication, what is the likelihood of going home.

Many of the comments after the piece are also very negatively slanted, many expressing a belief that all these babies end up dependent for life and profoundly impaired.

There are many parent-of-premie blogs out there, some of which I quietly follow. Several have posted responses to Dr Dworetz’s article. See here, and here, and here, and here and here. Those responses are really worth a read, to get parental feelings about the article; they should make you think, I hope, and take some time to reflect on what we mean by Quality of Life, and how that may be different to the Value of a Life.

These parent websites are very often a good source to reflect on how doctors and families interact, for one example the website/blog “life with jack” has a good post “The doctor is not God” which has a list of things that doctors often predict with great certainty, and then turn out to be mistaken, and how that affects families.

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Nutritional Catch-Up

Posted on 19 August 2013 by Keith Barrington

This is my attempt to catch up with some interesting publications from the last few weeks, about nutritional interventions and necrotizing enterocolitis.

Karagol BS, Zenciroglu A, Okumus N, Polin RA: Randomized controlled trial of slow vs rapid enteral feeding advancements on the clinical outcomes of preterm infants with birth weight 750–1250 g. Journal of Parenteral and Enteral Nutrition 2013, 37(2):223-228. 92 babies of 750-1250g birth weight were randomized to a feeding regime which increased by 20 mL/kg/d or 30 mL/kg/d. Although there weren’t any very tiny babies in this study, the results are consistent with all the small number of other prospective studies, that is, there is no effect of how we feed babies on Necrotizing Enterocolitis or other complications. The only effect of feeding babies faster is to get them fed faster! They get off IV feeding more quickly.

Ramani M, Ambalavanan N: Feeding practices and necrotizing enterocolitis. Clinics in Perinatology 2013, 40(1):1-10. That is the opinion also of the authors of this nice review article, they also note ‘Human milk compared with formula reduces the incidence of NEC. Feeding practices do not increase the incidence of NEC in preterm infants. There is no evidence supporting continuous versus intermittent tube feedings in preterm infants… Human milk-based fortifier compared with bovine-based fortifier may reduce the incidence of NEC but additional studies are required.’

That article is part of an issue of Clinics in Perinatology which is all about NEC.

Moore JE: Newer monitoring techniques to determine the risk of necrotizing enterocolitis. Clinics in Perinatology 2013, 40(1):125-134. This one, for example, is about monitoring techniques such as NIRS, a good review which motes that there is little current evidence that we can predict NEC with any of the techniques, but that there is hope for the future.

Stoltz Sjöström E, Öhlund I, Ahlsson F, Engström E, Fellman V, Hellström A, Källén K, Norman M, Olhager E, Serenius F et al: Nutrient intakes independently affect growth in extremely preterm infants: Results from a population-based study. Acta Paediatrica 2013. This population based study tries to answer the question ‘is the poor growth of very sick babies due to their inability to use the nutrition that they are given, or are they just not given enough?’ The answer is that we don’t give them enough, and even after correcting for severity of illness, nutritional intakes were the most important factor in poor growth. Give them more.

Neubauer V, Griesmaier E, Pehböck-Walser N, Pupp-Peglow U, Kiechl-Kohlendorfer U: Poor postnatal head growth in very preterm infants is associated with impaired neurodevelopment outcome. Acta Paediatrica 2013, 102(9):883-888. This is one of the consequences of poor nutrition. Smaller heads. Which are associated with poorer development.

Valentine CJ, Morrow G, Pennell M, Morrow AL, Hodge A, Haban-Bartz A, Collins K, Rogers LK: Randomized controlled trial of docosahexaenoic acid supplementation in midwestern U.S. Human milk donors. Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine 2013, 8(1):86-91. This RCT shows that there is little DHA in breast milk of donors to a milk bank in Ohio, but supplementing the mothers increases their milk DHA content, and increases the DHA received by the baby to within an acceptable range (whatever that is) and certainly suggests that it might be a valuable thing to do, if we can prove that clinical outcomes are improved, which is certainly a possibility.

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On the Radio

Posted on 15 August 2013 by Keith Barrington

I was interviewed for an edition of the NPR Radiolab program a couple of months ago. I have only just had the chance to listen to the program, (called ’23 weeks and 6 days’) and I think the emission was rather well done. I am only on for about 3 minutes total, but that was fine, the show was based around the experiences of a couple of journalists who have written about their time with a very preterm baby in an NICU in Florida.

I was pleased that the presenters talked about the issues without searching for simplistic responses.

 
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Don’t text and drive

Posted on 15 August 2013 by Keith Barrington

That might seem self-evident, but texting while driving has become a major cause of road traffic collisions, and other major incidents, involving pedestrians and others.

AT&T have sponsored a new documentary movie (directed by Werner Herzog), which you can see on youtube, about the problem. It is not easy viewing, but very moving.

I was once in a taxi when the driver started texting, he seemed a bit put out when I told him to stop! But at least he did.

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Long term outcomes, Quality of Life.

Posted on 15 August 2013 by Keith Barrington

I heard a presentation of this excellent study when I was in Melbourne last year, and have been waiting for it to be available in print.

There are now about 30 studies of quality of life in subjects who were formerly very preterm babies, as well as a couple of systematic reviews. Many of those studies have been from regional or national samples, and the results have really challenged how we see the lives of our former patients.

This new study is from a different cohort to those previous studies, a cohort which has been studied before for a number of different measures at 2,5, and 8 years of age. It is a cohort which is more recent than many others, born in 1991-1992.

Roberts G, Burnett AC, Lee KJ, Cheong J, Wood SJ, Anderson PJ, Doyle LW, Victorian Infant Collaborative Study G: Quality of life at age 18 years after extremely preterm birth in the post-surfactant era. The Journal of pediatrics 2013.

As in the other studies there is very little difference between any of the quality of life outcomes of the former extremely preterm or extremely low birth weight babies and the term controls. The only differences were a trivial difference in dexterity score, and a slightly lower score for physical functioning. The EP/ELBW patients were also less likely to be sexually active and less likely to get drunk.

Of major importance also, there was no correlation between quality of life and completed weeks of gestational age. As this figure shows:

QUality of life

There are not many infants at the lowest gestational ages, but no sign of an effect on quality of life.

The systematic reviews that I mentioned earlier also show no correlation between gestational age and quality of life; which I think should make us question guidelines for active treatment which use arguments based on rates of short-term impairment to determine at which gestational ages neonatal intensive care is indicated. Also, most large follow up cohorts have shown no effect of GA on rates of impairment, and a systematic review presented at the last PAS meeting, by Dr Moore and colleagues from Ottawa, was also unable to show an effect of GA on cognitive impairment among extremely preterm newborns, if they are examined late enough (4 to 8 years for their study) to have some prediction for the very long term.

If neuro-cognitive outcomes among survivors is not affected by gestational age, and also quality of life among survivors is not affected by gestational age, and is not significantly different to term babies, then I think that it is really only the survival rates which are relevant to decisions making around birth. Decision-making after birth can take into account other prognostic characteristics, including the number and severity of post-natal complications, factors which may be more relevant to the long term.

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