Category Archives: Acute Medicine

Glasgow Blatchford Score 2 – The case for an RCT!

Thanks for a great post, Gareth.  If you’ve landed here without reading that post, hit the link – this is a follow on, a ‘deep dive’ in the words of Smart EM – to be taken in the context of Gareth’s main post.

This is a landmark study in Emergency Medicine and gives us something useful that could reduce admissions.  With a critical appraisal hat on, however, I do think it’s important to point out a few flaws in the methodology.

Methodology of the Lancet study

The authors have essentially prospectively evaluated the performance of the GBS at several centres by reviewing case notes of patients presenting with upper GI bleed.  They then prospectively implemented the GBS, discharging patients with GBS of 0 and found that it was safe and reduced admissions.  It sounds pretty good, so why is there a problem?

The issue is that there’s no control group in the implementation phase.  When clinicians are told to use a tool that enables discharge of low risk patients, they may decide to use it in particularly low risk patients, who they’re happy to consider early discharge for.  There’s some evidence that this actually happened, as the proportion of low risk patients is greater in the implementation phase (22% vs. 16%) and the overall number of patients is enrolled is greater in the implementation phase (572 vs. 334), despite the overall recruitment period being shorter.  This is the classic problem with simple before and after analyses, and it makes the comparison of admission rates before and after implementation subject to substantial bias.

What’s more, there’s the issue of resource utilisation.  In the derivation phase, 96% of patients were admitted compared to 71% after implementation, which is great.  However, the median length of stay didn’t change (2 days in each group) although the mean length of stay reduced.  This suggests that the patients we’re avoiding admission for after implementation of the GBS would have had a short length of stay anyway (<2 days), so the reductions in length of stay are occurring in that group.  That’s still OK – so far, we’re still on to a cost saving and patients get to go home earlier.

However, you also have to consider that the low risk patients who were discharged were all given outpatient endoscopies and outpatient follow-up.  OK, only 40% actually attended for the endoscopy.  But what we don’t know is how many of them would have undergone endoscopy and out-patient follow-up with standard care – it may well have been less than 40%.  What’s more, using the score might tempt physicians to over-investigate or over-treat those who aren’t in the low risk group.

Overall impact on resource utilisation

It’s therefore possible that implementation of this protocol actually leads to a rebound overuse of resources.  To get a better idea of whether this actually happens, we need a control group.  The most obvious way to do that is to run an RCT.  Patients could be individually randomised to care guided by the GBS or standard care, or we could use cluster randomisation (e.g. randomise each centre to deliver care guided by one intervention or the other).  Alternatively, we could use a stepped wedge design, whereby we enrol a number of centres and all of them sign up to implementation of the GBS-based protocol.  Each centre is given a randomly allocated implementation date.  We then run a before and after analysis to evaluate admission rates and overall resource utilisation.  This is still a before and after analysis, but we have contemporaneous control groups at different centres.

What’s a Service Evaluation?

There’s a final point to make here.  The implementation phase was a service evaluation.  What does this mean?  Essentially, two centres implemented the protocol in practice and audited what happened.  They didn’t get consent from patients.  (They didn’t need it for this type of work).  However, it does mean that they couldn’t actually follow patients up as they would in a research study.  That means that the 60% of low risk patients who failed to show for their endoscopy went out into the ether.  They could have attended other hospitals for further care, perhaps because they were disgusted at being inappropriately discharged!  They may have undergone intervention at those centres – we just don’t know with this design.

The bottom line for clinical practice

Does this stop us from using the Glasgow Blatchford score?  No, excepting a few methodological flaws I think these authors have, on the whole, shown its safety.  I think we can use it.  Even NICE says we can use it!  We shouldn’t be so confident about the overall impact on resource utilisation though, as we just haven’t shown that in this study.

NICE faces the sickle

New guidance out on sickle disease from NICE in the BMJ

I must admit to having a bit of an interest in sickle cell disease and the ED. There are two reasons for this.

Firstly, and most importantly, it is a really important disease to manage well. It’s a proper disease that we have learnt about since the very first weeks of med school, one for which the pathology, pathophysiology and treatment is well described and understood.

Secondly, I am constantly intrigued to see new docs arrive in the ED with preconceptions about the disease and it’s sufferers that I cannot understand or explain.
So, back to basics. Sickle cell anaemia is a ‘proper disease’, it can kill you, and shortens your life expectancy which is bad, very bad indeed. Living with sickle disease can be tough and patients suffer painful vaso-occlusive crises that may require them to come to our EDs for help. If you work in a multi-ethnic practice like Virchester then you will meet many patients with Sickle disease so it’s important that we understand how to help them. In our ED that means that we have a really good working relationship with our haematologists and in particular a specialist nurse in sickle disease who knows our local population really well and who has encouraged the development of personalised treatment plans. These are shared with the ED (the pink file), the patients, and with the haematology team. If not then we have a great pathway for the treatment of ‘unknown’ patients with sickle disease. It’s safe, evidence based and it works. Many of our local patients manage their disease very well at home and only come to see us when home management has failed. With few exceptions they only come to us when they really need help.

So, in Virchester everything is rosy. Except it’s not because I still occasionally come up against ideas which I find difficult to explain and understand, and this is almost always around the use of analgesia in vaso-occlusive crises.

So, let’s think about analgesia. In many ways I think that sickle disease is the poster boy for good analgesia management in the ED. Get this right and you probably have an ED that manages most pain well (there is a poster girl as well – but that’s for another day).

Why is it the poster boy? Well, because the management of sickle disease is one where analgesia is a cornerstone of management, where there are few physical signs, but where I see clinicians manage patients in very different ways. Such variation is not just an issue in my practice, but also in past studies and papers where the experiences of patients attending EDs is far from optimal. Take this quote from a 1999 paper in the BMJ

“The experiences of patients with sickle cell disease of hospital care are characterised by mistrust, stigmatisation, control, and neglect”

Now that was a long time ago (1999) and I like think we have made fantastic progress locally, but I am not convinced that this is the case everywhere because I still see suspicion and concern amongst some junior docs rotating in from St Elsewhere. Why is this I wonder? Where and how did they learn it? Why is it that we have a disease that causes pain, suffering, shortens lives but for which I sometimes see docs and nurses ‘not believe’ that the patient is genuinely in pain and as a result their analgesic management is suboptimal.

Why then? Is it the disease itself? Well perhaps as there are often few physical signs in sickle disease that ‘justify’ the pain to the physician. There is no bleeding, deformity and often few physiological signs. I hear odd comments such as ‘nobody in that much pain has a pulse less than 110’……! Really, do you want me to demonstrate whilst I take your pulse….? Until we have a pain-ometer that can quantify pain then we have to presume that the patient is telling the truth unless we know otherwise. In law we are innocent until proven guilty and the same should apply here. Similarly, on a general approach to pain then we must decide whether analgesia is something that we should freely offer, or should it be something that is earned? What do I mean by this? Well, its that I believe that analgesia is one of the most important things that we can do to improve the patient experience of illness and injury. We should be seeking out pain and treating it, not waiting for our patients to beg for it to be taken away.

This cannot be right and we cannot accept it, but how can we make it better.

I would suggest the following.

  • 1. Speak to your local haematologists and devise a protocol for the management of sickle pain. Why not use something like that advised by NICE and abstracted in this weeks BMJ
  • 2. Use sickle as a teaching tool for analgesia. Ask your colleagues about their attitudes towards sickle disease and the patients. Challenge, argue and question any attitudes that trouble you.
  • 3. Role model the care of sickle patients in the ED. As a senior these are great cases to see with a junior doc. Great for the patient as they get great care. Great for you as it tells you a lot about their attitude towards the disease and analgesia in general. Ask them how they ‘measure pain’, you might be surprised at the results…
  • 4. Talk to your local haematologists. Establish a mechanism for them to tell you about difficult or complex patients.
  • 5. Train the whole team. Analgesia is something often prescribed by docs but prioritised by the nurses. If you only train one of the tribes then you will fail.
  • 6. Listen to Dr Gentile.

When the patient is comfortable ask them what they felt about their experiences in your ED. It’s highly unlikely that this will be their first attendance at the ED. Ask them how you did, ask them about good and bad experiences in the past. In general they will tell you.

Lastly, another plug for the unbelievably fantastic podcast from Dr Gentile on pain management in the ED. Whilst not strictly about sickle disease you just know that if you did have sickle disease (or anything else painful) you would want Dr Gentile to look after you.

I am told that my posts might be too thought provoking where some people just want the answers. I think not. I’d rather write about things that we all find challenging. Where there are answers we can give them, but so much of our practice is dependent not just on the evidence but also on ourselves. We should never stop questioning the evidence, we should never stop questioning ourselves.

vb

Simon C

PS. This is our current management protocol for ‘unknown’ sickle patients. Time for a review I think, but even so this works pretty well at the moment. Advice on changes welcome.

EDP_2003-22_Sickle_Cell_Crisis