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.
Where
can you read more?
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 kneeorthotics@gmail.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 kneeorthotics@gmail.com
