Vitamin K: the stories behind the evidence

I have come to realise that questions about vitamin K and the newborn can often be best answered by telling what I have come to call vitamin K stories. Or, the stories behind the evidence.

I come across these a lot in my work as a researcher and author. Often, it takes time, patience and a deep understanding of one’s subject area to dig them out.

For instance:

Why do we not have better evidence on the most effective dose of oral vitamin K?

Because it hasn’t been a research priority, and so we can only guess that is it somewhere between the dose that was shown to be effective and the dose that was shown to not be effective enough.

Why don’t we have more evidence on possible alternatives?

Perhaps because those who fund research find it difficult to see outside their own belief. ‘It works and improves short-term physical outcomes, so let’s give it to everyone’.

Why do we still see so many websites which tell women that babies who had instrumental births are at higher risk of VKDB?

Because that was what we thought at one time, but later research proved us wrong. Unfortunately some people don’t check their sources and keep up-to-date and are still giving out-of-date information.

So many stories.

So much that we can learn about the wider context of our knowledge, if we are open to that.

The vitamin K book story

I started to really pay attention to these stories when I began to update the ‘vitamin K and the Newborn’ booklet that I had first written in 2002 (Wickham 2017).

The book is aimed both at parents and professionals and my aim was to explain the evidence and offer a resource which would support decision making without being prescriptive.

At some point on this updating journey, the booklet grew into a book. But although there were some important changes and updates to the evidence, this is one of the areas in which there STILL haven’t been any randomised controlled trials.

One of the key reasons behind the growing length of the book was my keenness to ensure that readers didn’t just get to hear about the issues and the evidence ‘at face value’.

I wanted to help people better understand the issues behind the headlines.

I have for many years shared my view that research evidence is not enough. Evidence needs to be put within a context and blended with other kinds of knowledge. And both of those things involve the telling of stories. So today I’m sharing a few of these stories, as a way of illustrating how I think we have to look beyond the evidence in order to truly understand the issues and the decisions that we need to make.

Laura’s story

“I learned early on in my midwifery education that vitamin K was a vital, lifesaving substance. I was taught that it should be given to all newborn babies within a couple of hours of their birth, ideally by injection. It could also be given by mouth but the injection was considered to be better, because the drug would remain in the baby’s system for longer and would be released slowly over time. I learned to explain to parents that vitamin K was necessary to prevent their baby from bleeding. The suggestion that their baby could bleed without vitamin K is enough to scare anyone into agreeing to its administration, but we were taught to explain other things too. So I learned to tell parents that all babies are born without the vitamin K that they need, which is why we administer it in the birthing room. Like all student midwives, I learned all of these ‘facts’ and I practised giving vitamin K injections safely and proficiently before documenting its administration in the medical notes.

And then I met Laura.” (Wickham 2017: 1)

I shared Laura’s story on page 1 of my book. But it is also the story of my own learning and, frankly, ignorance. As a student midwife who was at that point being educated in the scientifically-focused, evidence-based setting of a university, I hadn’t really questioned the value of vitamin K. Some of my mentors had focused solely on informing me of its benefits and of the very serious nature of what we then called haemorrhagic disease of the newborn and now call vitamin K deficiently bleeding, or VKDB. As a consequence, I was ill-equipped to answer the questions of parents like Laura, who also wanted to know about the potential downsides, side effects and alternatives to having this substance injected into their tiny, new babies. That soon changed, but this realisation became an important part of my story, and of the story I tell others. Because there is always more to learn and there are always other perspectives to consider.

There’s an ignorance in only being aware of the downsides of a medicine or intervention, too, and of not telling parents about why medicines like vitamin K are offered. It’s all about balance, information and parents being able to make the decisions that are right for them.

The effectiveness story

Another important story relates to the way in which vitamin K was found to be effective as prophylaxis against VKDB. It was this story that led to it being brought into practice as a routine intervention. In one sense, this is perhaps inevitable, because it worked so well, but there are some other important numbers which tell a slightly different story.

“Early researchers in this field estimated that, before vitamin K was given routinely, around 1 in every 10,000 healthy newborn babies suffered from VKDB (McNinch and Tripp 1991, Von Kries and Hanawa 1993, Passmore et al 1988). Later reviews suggested that, in Europe, between 1 in 14,000 and 1 in 25,000 babies were affected by late onset VKDB without prophylaxis (Shearer 2009). More recently, Sankar et al (2016) conducted a systematic review of this area for the World Health Organization (WHO) in relation to global rates of late onset VKDB, and their figures show that, “The median (interquartile range) burden of late VKDB was 35 (10.5 to 80) per 100 000 live births in infants who had not received prophylaxis at birth; the burden was much higher in low- and middle-income countries as compared with high-income countries – 80 (72 to 80) vs 8.8 (5.8 to 17.8) per 100 000 live births.” (Sankar et al 2016) … In other words … If you are living in a high-income country, the average chance of a baby experiencing late onset VKDB without vitamin K prophylaxis is 1 in 11,363.” (Wickham 2017: 14-15).

As this demonstrates, we are giving a substance to thousands of babies to prevent a problem which will only occur occasionally. This chapter in the story shows how our perspective and position can change our priorities. If you are a policymaker considering what you will put in the guideline and your overarching priority is the short-term safety of those in your care, you might well decide to offer vitamin K to every baby. If you are a parent who wants to think more widely about whether there are long-term consequences or downsides and who perhaps wonders if there is a good reason to explain why all babies are perceived to be born with a relatively low level of a particular substance, then your priorities and your decision and the information you seek may differ.

The ‘half a story’ stories

But there are still wider contexts and stories to tell. Some of those parents who began to seek information before they made their decision will have encountered the stories in the mass media about a supposed increased risk of childhood leukaemia with vitamin K. There’s an important bigger picture there, too, and it is complex. The research on which those media stories was based wasn’t the most robust, and yet the fact that the methods were questioned didn’t mean that the risk disappeared. The research had been set up in the first place because previous data had highlighted a potential problem, so the questioning of the research should have led to better research, not an immediate throwing out of the concerns. As it turns out, later work and analysis has been a bit more reassuring, but it hasn’t answered the question completely. So this is another key element of the vitamin K story which paints a deeper and more nuanced picture than most of us usually get to see.

There are other important stories which lie behind the question of what gets published, where and by whom. There is, for instance, an important story which explains why you might have seen estimates of the incidence of VKDB that are far higher than the figures I mentioned above. This looked worrying, but experts now agree that this was most likely the result of an anomalous series of cases of VKDB.

I was involved in one of the stories about the development of our knowledge on vitamin K, in a tale which also features a lovely (and sadly now late) paediatrician who corresponded with me in the midwifery literature a few years ago. Edmund Hey (2003) responded to one of the first articles that I wrote about vitamin K (Wickham 2000) which drew upon the questions of women like Laura. Over the next few years this conversation highlighted the importance of hearing and addressing the different perspectives and types of knowledge in this area, and I still value it enormously.

Story and Context

Find out everything you need to know about vitamin K; why it’s offered to newborn babies, why are there different viewpoints on it and what do parents need to know in order to make the decision that is right for them and their baby?

Some of the most frequently asked questions on this topic can only truly be answered with reference to story and context. Why do we not have better evidence on the most effective dose of oral vitamin K? (Because it hasn’t been a research priority, and so we can only guess that is it somewhere between the dose that was shown to be effective and the dose that was shown to not be effective enough). Why don’t we have more evidence on possible alternatives? (Perhaps because those who fund research find it difficult to see outside the ‘it works and improves short-term physical outcomes, so let’s give it to everyone’ paradigm?) Why do we still see so many websites which tell women that babies who had instrumental births are at higher risk of VKDB? (Because that was what we thought at one time, but when we checked it out, we found that wasn’t the case, but unfortunately that news didn’t get around so lots of people are still giving out-of-date information). So many stories. So much that we can learn about the wider context of our knowledge, if we are open to that.

A participant in one of my online courses said, “The more I learn, the more I realise I don’t know. But I don’t think that’s a bad thing.”

I couldn’t agree more with that, and as someone who spends a lot of her time writing and updating books and information, I would even go a step further. I would say that, the more I learn, the more I want to emphasise the importance of deepening our knowledge by focusing not just on the evidence, but on the stories behind the issues, the guidelines and the research.

Conversely, it’s no good telling just the stories without any thought to the evidence, because the numbers and the population viewpoint can be really helpful too. For me, it’s the blending of both that is the key.

Click here to see details of my book, Vitamin K and the Newborn.

References

Hey E (2003). Vitamin K — can we improve on nature? MIDIRS Midwifery Digest 13(1): 7-12.

McNinch AW, Tripp JH (1991). Haemorrhagic disease of the newborn in the British Isles. British Medical Journal 303: 1105-09.

Passmore SJ, Draper G, Brownbill P et al (1998). Ecological studies of relation between hospital policies on neonatal vitamin K administration and subsequent occurrence of childhood cancer. British Medical Journal 316: 184-89.

Sankar MJ, Chandrasekaran A, Kumar P et al (2016). Vitamin K prophylaxis for prevention of vitamin K deficiency bleeding: a systematic review. Journal of Perinatology 36 Suppl 1: S29-35.

von Kries R & Hanawa Y (1993). Neonatal vitamin K prophylaxis. Report of Scientific and Standardization Subcommittee on Perinatal Haemostasis. Thrombosis and Haemostasis 69: 293-95.

Wickham S (2000). Vitamin K: a flaw in the blueprint? Midwifery Today (56): 39-41.

Wickham S (2017). Vitamin K and the Newborn. Avebury: Birthmoon Creations.