The FORCE study: St Emlyn’s

As someone who works across both PEM and adult EM it’s interesting to reflect on how the workload varies. These days my adult work is heavily skewed to complex majors and resus patients. This is largely the result of a co-located Urgent Care Centre and Minor Injuries unit which sees a lot of the more ambulatory patients. Those areas of our department certainly take a workload out of the main ED (and this is very welcome), but it does mean that the experience of EM is very different to that which I started in the early part of my career. Back when I was an SHO we did spend a lot of time dealing with minor injuries and to be honest it was a lot of fun. We did a lot of minor procedures that are now done by our ENP colleagues or which are referred on to plastics or orthopaedics. It’s kind of sad, but these are the ways of the world and it’s ‘progress’ of sorts. That said, PEM is different. One of the reasons why I still enjoy my PEM days is that I get to see a lot of minor injuries, and I genuinely think I (we) have lots to offer there.

That was a long and arguably rose tinted introduction to the fact that the management of paediatric minor/moderate trauma is important, and interesting. In recent years the trend has been for us to be more conservative in terms of management in this area as we have realised that children are often very good at healing and remodelling their injuries as they grow. I’m also really delighted to see a number of well conducted trials either come to fruition, or be in progress on the management of paediatric injury. It’s absolutely vital that we have good quality evidence in children, and the previous feeling that research in kids was just too difficult is increasingly being challenged and I’m delighted to see that (Ed – follow @periuktweep for more on this)

So. Back to the FORCE trial (Forearm Fracture Recovery in Children Evaluation). This is published in the Lancet this month and is a randomised controlled trial looking at the treatment of buckle fractures of the wrist. The trial sought to compare the effectiveness of rigid immobilisation vs. simple bandaging. The abstract is below, but as we always say, please read the full paper yourself and come to your own conclusions.

What type of paper is this?

This is a randomised controlled trial which is the most appropriate design to test or compare an intervention. You can understand more about randomisation and randomised controlled trials here. Patients were randomised in a 1:1 ratio.


Tell me about the patients.

Buckle fractures are simple and minor fractures that commonly occur at the wrist following a fall onto the hand. In this study children aged 4-15 with a radiological diagnosis of buckle fracture to the distal radius were potentially eligible. Those with an associated ulna fracture were also eligible (Ed – interesting as this is often seen as an indication for rigid immobilisation in a POP in some departments). Greenstick fractures were not included.

965 patients were randomised into the trial (51% to rigid, 49% to bandage). Patient groups were pretty similar at baseline.

What about the interventions.

Patients in the rigid immobilisation group were treated in either a rigid splint (e.g. Futura splint) or immobilised in a plaster of paris cast (POP). The choice was down to the treating clinician (I typically put these in rigid splints rather than POP).

In the bandage group patients were treated with a gauze roller bandage that stayed on at the families/patient discretion.

Importantly, patients were ‘offered’ the interventions, but they could decline or go for the alternative. The authors addressed this issue by pre-planning both intention to treat analyses and pre-protocol analyses.

What were the outcomes?

The main outcome was pain at 3 days post randomisation. This was collected electronically via SMS/email links to an electronic reporting system. This was done on days 1,3, &7, and then again at 3 and 6 weeks. Pain was measured using Wong-Baker FACES pain rating scales.

Example of a Wong-Baker scale from https://en.wikipedia.org/wiki/Wong%E2%80%93Baker_Faces_Pain_Rating_Scale#/media/File:Wong-Baker_scale_with_emoji.png

A number of secondary outcomes related to patient experience, upper limb specific scores and general health outcomes, including pain at other time points were also recorded.

A difference in one face (i.e. two points) on the Wong-Baker scale was considered clinically important in the analysis.

What were the main results?

The main finding was that there was no significance difference in the treatment of patients by bandage or rigid immobilisation by day 3. This did not change between intention to treat or by per-protocol analysis. Interestingly 7% of patients in the bandage group had elected to change to a rigid splint as opposed to only one patient (0.2%) in the other direction.

Pain scores at 3 days were 3.21 in the bandage group vs. 3.14 in the rigd immobilisation group (Effect size 0.1 CI -0.37-0.17).

In the secondary analyses of pain at day 1, 7, 21, and 42 there was no clinical or statistical difference. Similarly there was no difference in PROMIS scores either. Nor was there any difference in complications (which were minimal).

What does this mean in practice.

This study is pretty definitive that there is unlikely to be any significant difference in the outcome for patients with these fractures (they always heal anyway and remodel if required – which they usually hardly need to at all). I really like the modified intention to treat model here. By doing this the authors reflect the real world conversations that are to follow. Essentially we can offer either treatment to patients, but they can then choose which if they have a particular preference.

One of the highlights of this study, and other studies run by Dan Perry and this team is the use of technology in the consent and knowledge translation aspects. This is once again shown by the care that they have taken in communicating the results in a meaningful way as exemplified in the tweets below.

Final thoughts

For your patient with a buckle fracture of the distal forearm you can feel confident in offering them support in either a bandage or in a rigid splint. They both work.

vb

S

@EMManchester

References

  1. FORCE study https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01015-7/fulltext
  2. Critical Appraisal Nugget: Randomisation. https://www.stemlynsblog.org/critical-appraisal-nuggets-the-st-emlyns-can-podcast/
  3. Buckle fractures on Radiopaedia. https://radiopaedia.org/cases/buckle-fracture


Cite this article as: Simon Carley, "The FORCE study: St Emlyn’s," in St.Emlyn's, July 10, 2022, https://www.stemlynsblog.org/the-force-study-st-emlyns/.

Posted by Simon Carley

Simon Carley MB ChB, PGDip, DipIMC (RCS Ed), FRCS (Ed)(1998), FHEA, FAcadMed, FRCEM, MPhil, MD, PhD is Creator, Webmaster, owner and Editor in Chief of the St Emlyn’s blog and podcast. He is visiting Professor at Manchester Metropolitan University and a Consultant in adult and paediatric Emergency Medicine at Manchester Foundation Trust. He is co-founder of BestBets, St.Emlyns and the MSc in emergency medicine at Manchester Metropolitan University. He is an Education Associate with the General Medical Council and is an Associate Editor for the Emergency Medicine Journal. His research interests include diagnostics, MedEd, Major incidents & Evidence based Emergency Medicine. He is verified on twitter as @EMManchester

Thanks so much for following. Viva la #FOAMed