Cost-effectiveness analysis of soft bandage and immediate discharge versus rigid immobilization in children with distal radius torus fractures

Listen to Andrew Duckworth and Daniel C. Perry discuss the paper 'Cost-effectiveness analysis of soft bandage and immediate discharge versus rigid immobilization in children with distal radius torus fractures' published in the June 2024 issue of The Bone & Joint Journal.

Click here to read the paper.

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Transcript

[00:00:00] Welcome everyone to our BJJ podcast for the month of June. I'm Andrew Duckworth, and a warm welcome back to you all from your team here at The Bone & Joint Journal. As always, we'd like to thank you all for your continued comments and support for our series, as well as a big gratitude to our many authors and colleagues who take part. That highlights just some of the great work published by our authors each month. 

So today for our monthly podcast, I have the pleasure of being joined by the lead author from a paper published in the June edition of the BJJ entitled 'Cost-effectiveness analysis of soft bandage and immediate discharge versus rigid immobilization in children with distal radius torus fractures: the FORCE trial'.

So it comes as no surprise that I'm absolutely delighted to welcome back our specialist for Pediatrics at the BJJ and an all-round top guy, Professor Dan Perry. Dan, great to have you back with us. Thanks so much for having me, Andrew. 

So Dan, the aim of the FORCE trial was to and this study in particular, which was published in the BJJ, was to assess the cost-effectiveness of a soft bandage and immediate discharge when compared with rigid immobilization in children who are aged four to 15 years with a torus fracture of the distal radius.

So Dan, maybe as a background to this study, but also the trial itself, can you give us a brief overview of the current literature, but more importantly, why you [00:01:00] decided to look at this question in particular? 

Okay, so, so this question actually came out of the NICE guidelines. So the NICE non-complex fracture guidelines asked the question, should we be treating torus fractures of the distal radius at all?

Should we do anything at all? And it's a big question because there's about 50-60,000 of these in the UK each year. So, so whilst many of us think it's just a torus fracture, you know, why does it matter? Well, it matters because there's so many of them and they come to ED and there's lots of uncertainty about whether they should be followed up, whether they should have any immobilization at all.

And the literature prior to this was, so there was a general movement towards doing less and less, but the literature was very uncertain and there was lots of, yeah, lots of unknowns and uncertainties. Absolutely. And would you say that, like you've alluded to, there was quite a variance in practice across the UK as well?

Yeah, when we first did an audit, it was about 50-50. So about 50 percent of people were putting them in a cast and 50 percent of people were doing something different. 50 percent of people were were kind of primarily discharging from ED and about 50 percent [00:02:00] weren't. So, so there was lots and lots of uncertainties.

Absolutely. And so, for the, obviously, this is like the results of the cost-effectiveness analysis of the study, but for those, for those of the audience who've not sort of read or seen the actual paper which is published in The Lancet, what would you just briefly say about the clinical outcomes from that paper before we move on to this?

Okay, so, so I guess, so if we look at the intervention, so we compared what we do now and so for most people, what we do now was was actually a removable splint in most cases versus the offer of a soft bandage. So, so, so we said to patients, here's a bandage. You can wear it if you want, you don't have to wear it, whatever you want to do.

Most people chose to wear it. But it was the offer of a soft bandage. It was an equivalent study and so there's lots of different types of trial design, but the equivalent study is the most difficult sort of trial design because we're not saying, is it, is it better than this or is it no different?

We're saying, is it completely and utterly equivalent? And guess what? It's completely and utterly equivalent. There's absolutely no difference [00:03:00] at all in pain scores at any single point or functional outcomes in terms of giving them immobilization and not giving them immobilization. It's just completely and utterly equivalent.

It's cool. So yeah, we published that in The Lancet and we made some really snazzy materials to, to get everyone on board. And we've, that's all available for free on the forcestudy.org website. And and yeah, but, but this is really asking the question, well, you know, is it cost-effective? Is it cost-effective to, to do less?

Because potentially could not be, because people could come back to the ED more or you know, there could be some problems around it So so this is the big cost-effectiveness question.

Brilliant. That's a lovely summary. I like to say there's lots of material that you've done for the results as well which I encourage all our listeners to go and look at because they're really useful and I think are really helpful as you know better than anybody for explaining it to patients and to parents in particular as well. So if we move on to this this study. This was sort of the economic evaluation based on the data collected from FORCE, I say it's a large multicentre randomized controlled trial in the UK. So Dan if you maybe [00:04:00] just give us a brief overview just to give that some concept of the inclusion/exclusion criteria to the trial. So how did the patients get into the study? 

Okay, so, so it was anyone with a, with a newly diagnosed torus fracture of the distal radius, aged between four and 15 years old. We stratified based on age, so, so we had two populations essentially, and in essence it was actually two trials.

And so we did a trial for the under-eights and a trial for the over-eights. And this was all about the fact that we knew these were so common, and we thought this would be so easy to recruit to, that we wanted to make it the world's most definitive study that no one could ever doubt any part of the results. So essentially, it's two trials for the price of one.

We excluded people who were more than 36-hours post the end of injury. And anyone who got a bilateral fracture was also excluded. Now, actually, I never even thought about bilateral fractures being a common thing, but actually it's reasonably common. Like, when you've got a big WhatsApp group of thousands of people, hundreds of people recruiting throughout the night, then suddenly you realize there's all these bilateral fractures, poor kids who can't wipe their bum or [00:05:00] anything. It's like, it's a disaster. 

That's amazing. So that is so common. Yeah, that's really interesting. And just in terms of we'll, we'll come on to the cost estimates, but in terms of the following up, you sort of saw them at, it was at day-three, day-seven, week-three and week-six. Is that correct? 

Yeah. So that's it. So so we, we, yeah, we got to follow up at 24 hours at three days. So three days was the primary clinical outcome. Pain was the primary clinical outcome. Yeah. Then then one-week, three weeks, six weeks. And so six weeks was the final. 

And so for this study, you know, an important part of this, and I think I've talked about this before with yourself and I know with Matt is that the health economic side of these big trials, the data there, that's where a lot of the, well, the a lot of data is needed, isn't it?

It's actually the, the, the workhorse where a lot of information is required to actually generate this information. And so, for this study, how was data on sort of resource use collected and how was the valuation of costs sort of done for it? 

So I think life's a little bit easier with children, to be honest. And so I think you have it slightly easier. And, and so FORCE was the first time we'd used an online, [00:06:00] a completely text-message-based system to run our trials and it worked amazingly well. And we got a 94 percent primary outcome follow up, but what it also meant is that that we lost very, very few patients completing the health economic forms as well.

So our health economic evaluation completion was like 90 percent or I can't remember the exact number, but it was, it was astonishing. And the health economics guys didn't know what to do with it because it's the first time they'd have really complete data on any of the trials. And and it was awesome.

So, so yeah, it was just as, you know, the parents just filled in the form, just like completing a bank form. They asked some questions. So the, the kind of things we look at are so obviously the costs we look at are the hospital costs, like, you know what split did they get? How much they cost, how much staff-time did that involve?

But then of the parents, it's, you know, do you have to return to hospital? You know, any out-of-pocket costs involved in the return to hospital? Do you have to take days off work? Yeah. Did, did you have to get additional days childcare for other children in order to, to, to take [00:07:00] your child to hospital? So it's all those, and then of course, you know, other kind of costs like drugs and stuff.

But we, we really try and look at it from a big societal perspective about how much this overall intervention is costing.

Absolutely. And so, obviously related to that is sort of the health outcome bit, or the, how you generate the QALYs, and what did you collect for that? 

So, so there was a lot of debate for that. There's always debate about how you, how you collect QALYs. And so we use EQ-5D, which is which is a standard utility score. So utility is is how we define quality of life in most of the trials. And it's actually EQ-5D-Y, the youth version. So I mentioned before that, that we actually run two trials.

So we run a trial in the younger age group and the trial in the older age group. And one of the reasons for that is the younger age group under-eight is parent-reported, so it's proxy-reported outcomes and over-eight, is self-reported. And so, so conceptually, there may be a difference between the two approaches, and that's why we run it as two separate trials in terms of both the kind of clinical outcomes and, well, more for the health outcomes, we kind of merged everything together. But, but there's, [00:08:00] there's conceptual differences, but overall, it didn't actually matter, but we wanted to prove it didn't matter. 

Absolutely. And in terms of sort of the cost-utility assessment you performed, I thought it would be quite just helpful just to reiterate to our listeners, you know, how NICE basically determines cost-effectiveness in terms of the thresholds that are used and how they were employed in the study. And I thought also might be worth talking about EVPI, which you mentioned in the study, and I thought was a really interesting concept that you brought into it. 

Cool. Okay. So, so health economics. So this is one of those massive topics that, that recently a very kind health economist, when I was writing this up, sat down with me for about an hour just to give me a lecture on health economics.

So I'm going to try and share some of the key concepts with you. Wonderful. So basically NICE uses EQ-5D, uses utility-score, in order to assess what it's going to fund. And, and broadly NICE likes to pay around 20,000 pounds per quality adjusted life year. So, so if [00:09:00] you get a new intervention that lives, that makes you live, one year longer at 100 percent life, so 100 percent quality of life, then that's one quality-adjusted life year gain.

NICE will pay 20,000 pounds for that, that one quality adjusted life year. In special circumstances, it may pay a bit more, so in some circumstances it'll pay 30,000 pounds for cancer drugs. There's this kind of a secret cancer drug fund and it'll pay kind of 60,000 pounds for the cancer drugs, which is how some of the big cancer drugs get funded.

But broadly, it likes to pay as little as possible. And so 20,000 pounds is kind of a good ballpark. And we kind of, in the modelling, in the study, we even pushed it a little bit lower. So we said, okay, if, if a quality-adjusted life year was 15,000 pounds if that was the threshold NICE were willing to pay, would, would we still have have effectiveness? Would, would NICE still pay for this intervention? 

 And in terms of the EVPI work you did, so the expected value of perfect information, I thought that was quite an interesting concept that I hadn't really come across [00:10:00] regularly before. Can you just tell us our readers a bit about that? 

So, so my understanding of EVPI is, is it describes, it's one of the ways of it describing uncertainty within data.

So, so whenever you've got a health economic study, there's, there's always uncertainties that go on within the data. And and then you ask the question, okay, if we have so how much what's the value of uncertainty within the data? So, so if we were going to do another study how much would that study cost?

And, and we then compare that to the EVPI. So if the cost of a study was a million pounds. But, but by doing a study of a million pounds, you are only potentially gonna, that there was only kind of 400,000 pounds worth of uncertainty, then that study would never be worthwhile. 

Yeah, absolutely. That's a really interesting concept, isn't it? Because it sort of helps us guide. Where you go moving forward as well. I thought it was like quite a nice concept.

No, it's really interesting. It's a bit, [00:11:00] I mean, it's a complete nightmare to get your head around. But but I think it is really interesting. And there's some of the other stuff that we're doing at the moment where EVPI is like really hugely valuable because you can say to the funders, look, you know, this, this, this question's got you know, 30 million pounds worth of uncertainty. Surely a study to to address some of that is going to be really valuable. 

Absolutely. Yeah, no, absolutely. I thought that was really cool. So if we move on to, great overview of the analysis and why you do that, that was really nice and I think really helpful, not just for this paper, but for all cost-effective papers, which can be, like you say, difficult to get your head around.

So, then if you move on to the results of the study, and just to sort of recap for the, for the listeners. FORCE, you know, recruited 965 children with a distal radius torus fracture. 23 UK centres, and there was 489 in the soft bandage and immediate discharge group, and 476 in the rigid immobilization group.

And as you've already said, so the completion of the data was extraordinarily high. So I think you said in your study, it was sort of less than five percent or less in both groups and in both economic periods when there was missing data, so really impressive. So. Dan, if we sort of, what did you find, what was sort of the key [00:12:00] sort of take home lines you got in terms of costs, in terms of the two interventions and sort of any other NHS resource use?

Okay. So, so I mean, the overall bottom line, the spoiler alert is that it was cheaper. So, so it was cheaper, even if you account for the fact there was slightly higher returns in the bandage group, and we might talk about why that may be in a minute. But so there was slightly higher returns in that group to, to hospital.

But even if you take that into account, it was still cheaper and the overall quality of life was slightly better in the bandage group, presumably because they took it off a bit sooner and they got going a little bit sooner. So, so you've got an intervention that's lower-cost and, and gives you better quality of life and therefore it's an absolute no brainer.

It's cost-effective for every single which way you look at it. And what did you find, could you do some sensitivity analysis as well? What did they sort of show? 

Really interesting question, Andrew. So, so the sensitivity analysis showed that in the older sorry, the younger age group, there was more uncertain costs and quality-adjusted life years than the older age group. Qualitatively, they were quite similar. [00:13:00] 

Yeah, absolutely. Great. And so in terms of, you know, if we move on to sort of the implications of the study, Dan, and particularly that, that cost-effectiveness, you know, the strengths of the study are clear, you know, large UK-based multicentre trial, excellent design and execution, you know, comprehensive collection assessment of resource use.

And costs associated with it and really robust analysis before and as you say, you know, it really does definitively show that the offer of bandage, reduces cost of treatment and children with a torus fracture of the disarray is when compared to rigid immobilization on a consistent, very much consistent with the clinical results from FORCE, which you published in in The Lancet, which showed equivalence of pay and reported pain at three days through six weeks without any real safety issues.

But you know, what do you feel the key take home messages are in terms of the economic data and maybe touching upon that, that, that point that you made about how in the bandage group, there was a slightly higher return rate. 

Yes, so there was a slightly higher return rate and it was, you know, it was very small. And I think some of that may be accounted for with the kind of bias that, that may be in there. And so none [00:14:00] of these patients were blinded. None of the participants were blinded. And therefore, if you imagine for a second, you're a parent and you've got Johnny, who's your son, by the way, you've got Johnny and Johnny's just been Johnny's got a distal radius and he's quite sore in ED and someone's just randomized between the two interventions and you were hoping for a splint and suddenly you've just got a bandage.

And so what's likely to happen is you're going to give Johnny a bit of extra paracetamol this evening. And we saw that we saw that the, the bandage group did get higher, slightly high paracetamol, despite them having exactly the same pain score. They had slightly more paracetamol use, so it was kind of 82 percent used sorry, yeah, 82 percent used paracetamol compared to 78 percent.

So I'm not actually sure it was a true real thing. I think it was just a slight bias that got in there. And at the same time, there was a slightly higher return to hospital rate. And I think that was probably for the same thing, you know, these parents were worried. Because there were returns in both groups, but it was just slightly higher in this group.

But even if you kind of take into all of that into account, it makes, you know, there was, it [00:15:00] was still cost-effective, even if you factor in, you know, those additional hospital visits and stuff, every which way you look at it, it was cost-effective. Yeah, absolutely. But it very much is the most definitive study we're going to do because in terms of that EVPI, I think we talked about before that expected value of perfect information, the, the kind of the, the uncertainty in there is only worth about, about 300,000 pounds.

And if you look at the cost to deliver a study, so this, this study was super cheap. This is, this was about 700, 000 pounds, but the cost of the study is way, way more than the EVPI nowadays. So this is the most definitive study. We're not going to get better. We just need to, to listen to the results of this one. And just just stop treating these things in casts and stop bringing them back to clinic.

I think that's very true. I think that's sort of a good place to finish with my final question, which is, you know, since the publication of this and maybe even during the trial at first, do you feel it maybe has changed practice across the EDs across the UK? Is that the feel that you're getting from the work? 

So, so changing practice [00:16:00] is always tough and we've looked at lots of different ways to do it with all these materials with kind of patient information leaflets in eight different languages, including American and all sorts of different things all available on FORCE.

And there is a change, but it's never quite overnight. It's never as fast as you want it to be. Interestingly, the results kind of go all over the world. And so, so there's a, I know there's a hospital in, in Australia kind of somewhere in the outback that sent me the results of their audit and they've like implemented it amazingly.

And then in my own hospital, there was an audit done recently and it was less good than the place in Australia. I'm like, this is crazy. This is just so frustrating, but, but we're doing a big nationwide audit at the moment to, to relook at how it's changing practice. And, and hopefully we're going to, you know, I want the trainees to use this as one of the things that they're going to audit and use for their audits because it's really valuable. You know, this is really high-quality evidence to, to, to make a change.

Absolutely. Like you said we will not get anything more than this. So that's all we need, isn't it? And I think it should be, should be changing practice. Well, I think that's all we have time for that, but thank you [00:17:00] so much for taking the time to join me and congratulations again on a really outstanding study and trial that, you know, that's been done in a really, really great way.

And, and, and, you know, as, as really definitively added to the literature in this area, and it was, it's great to have you with us as well. Thanks so much, mate. Thanks for having me. And to our listeners, we do hope you've enjoyed joining us, and we do encourage you all to share your thoughts and comments on the various platforms and the like.

Feel free to post about anything we've discussed here today, and thanks again for joining us. Take care, everyone.