Title: Orthotic management of instability of the knee in neuromuscular disease
Funder: Department of Health (England)

Abstract: Design: Systematic review survey and qualitative study.Target population: Adults with knee instability related to a neuromuscular disease.Health technologies being assessed: Orthoses with the clinical aim of controlling knee instability: knee-ankle-foot orthoses (KAFO) ankle-foot orthoses (AFO) and knee orthoses (KO) or mixed designs. To meet the first objective a systematic review will be undertaken of the best available evidence on the effectiveness of orthotic devices for knee instability in adults who have neuromuscular disease. A database of published and unpublished literature will be assembled from searches of electronic sources hand searching reference checking and contacting manufacturers. Studies will be assessed for risk of bias. Standard systematic review methods will be used to reduce error and bias. It is likely that a narrative synthesis will be the most appropriate approach to synthesis of effectiveness data. Data will also be mapped in relation to the neuromuscular conditions where the orthotic devices have been evaluated details of the specific types of devices and outcome measures used. To meet the second objective a survey of orthotists and physiotherapists will be undertaken and audit data will be sought. We intend to distribute the electronic questionnaire through relevant professional bodies. A range of sources and methods will be used to derive information on the two key elements of cost: the devices and the staff and other resource costs related to fitting (e.g. number of fittings and length of appointment) and ongoing monitoring and maintenance. Sources will include orthotists list prices and manufacturers.To meet the third objective we will use qualitative research methods to collate the views of people with NMD who have been fitted with an orthotic device for knee instability. 25-30 people will be interviewed. Purposive sampling will be used to ensure that a diverse sample of NMDs age length of time using orthotics high and low usage and regions is achieved. Focus groups will be undertaken with 1-2 prevalent neuromuscular disease populations to allow more in-depth examination of important outcomes and associated factors. A predominantly thematic analysis will be used.To meet the fourth objective the three sources of evidence - healthcare professionals patients and the systematic review - will be interrogated and the different sources will be integrated. For example we will compare outcomes of importance to patients (derived through the qualitative study) with the outcomes that are being used to measure effectiveness in clinical trials (derived through the systematic review) with any formal outcome measures that are being used to assess patient outcomes in clinical practice (derived through the survey of healthcare professionals). Similarly we will explore whether there are any disparities between the devices being used in clinical practice and those being evaluated in research studies. Implications for practice evidence gaps and future research needs will be clearly linked to the evidence source/s from which they have been derived.The project will be 12 months duration. The team doing the work consists of experts in managing the walking problems of people with neuromuscular disease and prescribing and fitting orthotic devices as well as experts in systematic reviews surveys health economics qualitative research and research project management.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: MUSCULOSKELETAL