Three recent large NIHR trials have findings that can apply to many patients. These studies help healthcare professionals and patients to make decisions when discussing the most suitable treatment options. However, healthcare professionals still need to consider what is best for individual patients.
There is little to choose between the outcomes or cost effectiveness of open surgery compared with keyhole surgery to repair shoulder cuff injury. This common shoulder injury is due to tears in rotator cuff tendons, which connect the muscles and bones in the shoulder. Damage to these tendons becomes more likely from middle age onwards, and can impair ability to carry out everyday activities.
The UK Rotator Cuff Surgery study (UKUFF) was one of the first NIHR trials to look at shoulder surgery.
The trial took place in 47 hospitals throughout the UK, involving 273 participants, who were aged over 50. Treatment success was measured by improvement of the Oxford Shoulder Score, which covers pain levels and ability to do everyday activities like dress and eat.
The main finding was that by two years after the operation, there was no difference in treatment success or costs.
The trial originally set out to evaluate a conservative treatment (rest then exercise) in addition to the two surgeries. However this was abandoned as more than three quarters of the patients in this group had surgery.
Professor Andy Carr, principal investigator for the UKUFF trial, comments on the trial and the issues involved in surgical research.
Treatment with a sling and active rehabilitation works as well as surgery for upper arm bone displaced fractures, but is much cheaper.
The Proximal Fracture of the Humerus: Evaluation by Randomisation (ProFHER) trial looked at a treatment for displaced fracture to the upper arm bone, a situation where the broken ends of bone are out of alignment. It compared surgery to fix the bone in position with placing the arm in a sling. Both groups of patients received physiotherapy.
“We aimed, and succeeded, in getting a good standard of conservative and rehabilitation care for the trial participants,” says Professor Amar Rangan, principal investigator for the ProFHER trial. “This included good patient compliance with home exercises, which crucially was very similar in the two treatment groups. Throughout the trial we emphasised the importance of equivalent care to both surgically and non-surgically treated patients.”
Non-surgical treatment with a sling is already the main treatment for humerus fractures where the bones are not displaced. When they are displaced, surgery is becoming more common. Reviews of published evidence showed uncertainty in what was best. NIHR funded this trial to address an important gap in knowledge.
The trial found that, by two years, there was no difference in treatment success between operative and conservative approaches, however the sling treatment was cheaper. Treatment success was again measured by improvement of the Oxford Shoulder Score.
This large UK trial prompted an update of the relevant Cochrane review, which was able to give a clear message to practitioners that surgery was not better for this type of fracture. This trial also informed new clinical guidelines in 2016.
Specialist plaster casting may work as well as surgery for treating unstable ankle fractures, at less cost. There were trade-offs between the two procedures. Specialist plaster casting carried greater risk of bones not rejoining properly, whereas surgery carried greater risk of infection and wound problems. Research is continuing into costs and outcomes in the longer term, from six months to two years after the fracture.
Reviews of existing research suggested uncertainty in the management of ankle fracture. The NIHR funded this trial to find out which treatment was best for patients.
The study compared a surgical treatment with a specialised plaster cast treatment, for people aged over 60 with ankle fractures. This injury is common, but can have serious adverse impact on an older person’s ability to care for themselves.
Surgical treatment involved aligning the bone fragments and fixing them in place with plates and / or screws. The plaster cast treatment involved using a technique called close contact casting. This has been proven in the diabetes field for healing fragile skin, by distributing weight more evenly than in a conventional plaster cast.
See the trial results
Professor Keith Willett, principal investigator for the AIM trial, describes the importance of gathering patients’ views:
“We carried out semi-structured interviews with patient in both arms of the trial, to look at what it meant to people having an ankle fracture at their age. We wanted to understand the sort of impact it had on their life, what it was like going into a trial and the patients thoughts about having to undergo surgery. Many people fear anaesthesia and surgery when they’re older,while others may have had concerns about the necessity for a cast. The findings will feed into the consent process in future, because it’s important not just to help them decide which treatment to have, but to find out what it means to them as an individual.”
There are many aspects of healthcare which need to be taken into account when estimating cost effectiveness, for example cost of equipment for surgery, training costs, length of stay in hospital, risk of complications, need for follow up visits, and need for care at home.
The benefits gained by patients may offset a more expensive treatment.
From the best estimates of cost effectiveness:
The AIM trial’s results are yet to be published, but unlike the other trials, it will include costs to carers of looking after someone at home after treatment. This is important because of the difficulty in walking during recovery from ankle fracture and the impact this has on independence.
Professor Keith Willett, principal investigator for the AIM trial, says:
“An older person leaving hospital has an increased care need, which they may not be able to meet themselves. So there is often a family cost to support them, for instance in terms of home care and shopping. We calculated what else, in addition to health care costs, was required for those patients.”