ORTHOSES FOR INSTABILITY OF THE KNEE: THE GAP BETWEEN WHAT IS IMPORTANT TO PATIENTS AND OUTCOMES STUDIED IN EFFECTIVENESS RESEARCH

McDaid C.1
1University of York, Health Sciences, York, United Kingdom

Background: Patients who have knee instability associated with neuromuscular disease (NMD) and central nervous system (CNS) conditions can be treated using orthoses, such as knee-ankle-foot orthoses (KAFOs). The UK National Institute for Health Research commissioned research on
(i) the devices that are used in the National Health Service for these conditions,
(ii) the evidence available on their effectiveness, and
(iii) the perspective of patients.
This presentation will report on (ii) and (iii).

Purpose: The objectives were to identify the most important outcomes for patients and to assess the effectiveness of orthotic devices for management of instability of the knee in adults who have a NMD or CNS disorder.

Methods: A qualitative in-depth interview study was undertaken to explore patient’s perspectives about orthotic devices. A topic guide was used and interviews were audio-recorded, fully transcribed and a sample checked for accuracy. Data were analysed for thematic content. A coding scheme was developed and an inductive approach used to identify themes. A systematic review was undertaken to assess the evidence on effectiveness. Eighteen databases were searched (November 2014) without language restrictions. Studies of adults using an orthosis to manage impaired walking ability due to instability of the knee related to NMD or a CNS disorder were included, provided the orthosis had been used in a real-life setting. Randomised controlled trials and other study designs with and without a comparator group were eligible. Data were extracted and quality assessed by two researchers. Narrative synthesis was undertaken.

Results: Twenty four people participated in the qualitative study. Being able to engage in daily activities was of vital importance. The most important outcomes to participants were reduced pain, falls or trips, with improved balance and stability. Effectiveness, reliability, comfort and durability were the most valued features of orthoses. The systematic review included 21 studies (478 participants) of people with post-polio, inclusion body myositis, post-stroke and spinal cord injury. The studies evaluated KAFOs including stance control and hip KAFOs. All the studies were at risk of bias and in general were poorly reported. The most systematically assessed outcomes were mechanical outcomes such as gait analysis and energy consumption. In contrast participants in the qualitative study wanted their orthosis to reduce pain, falls or trips, improve balance and stability and allow participation in work and a range of other family and social activities.

Conclusion(s): Evidence on the effectiveness of the orthoses for these conditions is limited, especially in relation to the outcomes that are important to orthoses users.

Implications: Further research is required on the effectiveness of orthoses in managing knee instability related to NMD and CNS conditions and using outcome measures relevant to patients’ everyday lives. Development of a core set of outcome measures for use in research and the clinical setting would be beneficial. To date there is scant evidence about the views and experiences of people who are given orthoses for knee instability, and further studies are required to investigate further some of the issues raised in our exploratory study.

Funding acknowledgements: This project was funded by the NIHR Health Technology Assessment programme (Project number 13/30/02).

Topic: Research methodology & knowledge translation

Ethics approval: The qualitative study received NHS research ethics (REC reference: 14/LO/1132) and governance approvals to recruit patients through NHS sites.


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