Our research report has been peer reviewed, edited and published by our funders the NIHR HTA programme, so we can now share our findings with you. This blog is to give you a flavour of what we did, what we found and our recommendations going forward. Links to the full report and a variety of summaries catering for every level of interest are provided at the end.
What were the views of users of orthotic devices?
We talked directly to users of orthoses for knee instability resulting from a neuromuscular disease (NMD) or central nervous system (CNS) condition. We wanted to know what makes a device acceptable, how much they used their devices and what influences use. In-depth interviews with a diverse range of users revealed that orthotic devices are vital for users to live as normal a life as possible, engage in daily activities and have independence for as long as possible. Malfunctions of a device can therefore have serious consequences for the wearer. To ensure devices are used and not left lying in cupboards, they need to be effective, reliable, comfortable and durable. Many of those interviewed were frustrated with what they saw as deficiencies in service provision relating to appointment and administrative systems and referral pathways.
It’s important for us as researchers to make sure that when we carry out research into whether something works, that what we take as an indication of success or failure (the outcome) can be measured, but also is relevant and important to patients. In our interviews with users of orthotics we got consistent feedback that a reduction in pain, falls or trips, with improved balance and stability were of primary importance. These outcomes tended not to be measured in the research we found assessing the effectiveness of devices. They were also only seen to a limited extent in the responses from health professionals to our survey of practice.
We recommend that future research should include more qualitative studies to build on our work, and investigate in further depth some of the issues raised in our interviews with users of orthotic devices.
What did we learn from the healthcare professionals?
Orthotists, physiotherapists and rehabilitation medicine physicians were among the 238 healthcare professionals who responded to our on-line survey. They told us they prescribe a range of orthoses for knee instability related to NMD or CNS conditions. These included knee-ankle-foot orthoses (KAFOs) ankle-foot-orthoses (AFOs) and knee braces; with shoe adaptations and insoles also prescribed by many. About half the devices prescribed or fitted were reported to be custom-made.
The majority of healthcare professionals thought comfort and confidence in mobility were extremely important outcomes from treatment, matching in part the priorities for patients. When it came to outcomes for assessing the effectiveness of the devices provided, about a quarter of the health professionals said that no formal outcome measure was used. No single outcome measure was used by the rest and only a third said they formally assessed patient satisfaction. The good news is that having identified this gap in service delivery, our interview work with users of orthotic devices can help provide an understanding of what a core set of patient reported outcome measures in the clinical setting should look like. We recommend development of a core outcome measure set, and that reduction in pain, falls and trips, improved balance and stability as well as participation in paid employment, outdoor activities (such as gardening), family visits and social events should be considered. This should ensure a more patient relevant assessment of the impact of any change in device or management strategy on individual patients.
We also suggest that future research should explore different models of delivery of orthotic service for people with NMD and CNS conditions to identify best practice in terms of greatest benefit to patients and value for money.
What does the existing evidence tell us?
We took a systematic look at the existing evidence to assess how well the various orthotic options for knee instability actually help patients in every-day life. Unfortunately the few studies we found had small numbers of participants, were generally poorly reported and all were at risk of bias, meaning the findings cannot be relied upon. Disappointingly, we also found that the studies we did identify, assessed mostly mechanical outcomes such as gait analysis and energy consumption. While these are important aspects of assessing a device, they were not supplemented by assessment of outcomes important to patients such as daily activities. Given all of this, it wouldn’t be right for us to draw any specific conclusions about individual devices. What we have been able to do is make specific recommendations for future research in this area.
Research on the effectiveness of devices for knee instability in NMD and CNS conditions is needed using outcome measures relevant to patients’ everyday lives. Given the challenges we have identified in our work, future trials should start with a feasibility study. Because of the relative rarity of some NMD and CNS conditions and the personalised nature of the orthotic device or devices needed, a national registry may be a more useful approach than trials.
This blog should give you a flavour of what we did, what we found and the recommendations we have made. Depending on how much detail you would like, there are various options for reading more in the NIHR Journals Library:
The full report is 296 pages long and obviously includes full details of the background, methods, results and implications. A plain English summary provides an overview in lay language in just 249 words; or there is a scientific summary in 2,730 words.
A four page short report can be downloaded from here: Orthotics for Knee Instability We also have a limited number of paper copies available: to receive one, send your name and address to email@example.com
Did our engagement strategy work?
We would really like to know your thoughts on our blog for this project; what you have found useful, interesting, helpful, and what was missing or unhelpful. Please post a comment in response to this blog or email me, Alison Booth, at firstname.lastname@example.org