Standardisation of Outcome Measures in Trials of Upper Limb Rehabilitation after Stroke

Background: Stroke affects approximately 150,000 people each year in the UK. It can result in weakness, somatosensory disruption or tonal changes to one side of the body. Between 30% and 66% of stroke survivors experience chronic upper limb weakness. This can restrict a person’s ability to carry out activities of daily living such as washing, dressing and domestic chores, which in turn affects a person’s quality of life.Many interventions have been developed with the aim of addressing these impairments and activity limitations. In order to determine the efficacy of these interventions, changes in levels of impairment, ability to perform activities of daily living and societal participation need to be assessed. These measures should be valid, reliable and sensitive in order to accurately and consistently measure changes due to treatment, and thereby identify effective therapies.
Stroke rehabilitation research, particularly on interventions for upper limb impairments, has been hampered by the wide range of outcome measures currently in use. Analysis of one review of upper limb interventions revealed that 159 different outcome measures were recorded for 30 different interventions. Standardisation of outcome measures in this domain has the potential to facilitate meta-analyses of upper limb trial data, examine treatment effects more robustly and subsequently make firm recommendations for clinical practice. However, there is a lack of consensus on the recommended tools to measure arm and hand function after stroke.

Aims: This study aims to develop a standardised set of upper limb outcome measures for use in future stroke rehabilitation trials and explore facilitators and barriers to their routine use.

Methods:
1. We will (i) identify and (ii) examine the evidence base for use of upper limb assessment tools in stroke rehabilitation research settings.
2. We will assess the relevance of these measures to researchers, trialists, clinicians, stroke survivors and their carers; methods include Delphi techniques, focus groups and interviews. We will generate consensus based recommendations for a standardised set of outcome measures in stroke upper limb rehabilitation.
3. Facilitators and barriers to the routine use of agreed measures will be explored via survey of researchers, trialists and clinicians.

Intended contribution to stroke rehabilitation research: Upper limb impairment represents a significant problem following stroke, affecting functional ability and quality of life. Standardisation of data collection in upper limb intervention trials will increase the uniformity of trial output, enhance comparability of results and permit meta-analyses to examine efficacy of interventions. Recommendations for a core standardised toolkit of outcome measures with robust psychometric properties will enhance the likelihood that future trials will collect data that are valid, reliable, responsive and comparable across trials for ease of evidence synthesis. In turn, this will enable firm recommendations to be put forward to inform guidelines and policies, and advance patient care.

Contributors

PhD Student: Julie Duncan Millar, NMAHP Research Unit, Glasgow Caledonian University.

Supervisory team:
Dr Myzoon Ali, Research Fellow, NMAHP Research Unit.
Dr. Alex Pollock, Research Fellow, NMAHP Research Unit.
Prof Frederike van Wijck, Professor in Neurological Rehabilitation, Glasgow Caledonian University.

Further Study Information

Current Stage: Completed – pending publication
Date: October 2014 - September 2017
Funding source(s): Glasgow Caledonian University


Health Area

Disease Category: Neurology

Disease Name: Stroke

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Rehabilitation

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Researchers
- Trialists

Study Type

- COS for clinical trials or clinical research

Method(s)

- Delphi process
- Focus group(s)
- Interview
- Survey
- Systematic review

Phase 1: Identification of Upper Limb Outcome Measures in Current use across Stroke Rehabilitation Trials.
A Cochrane overview of systematic reviews of trials of upper limb stroke rehabilitation was recently completed. All upper limb outcome measures identified in the trials will be systematically recorded. Consideration will be given to the ICF domains of functioning and disability and the OMERACT filters of truth, discrimination and feasibility for measurement applicability.

Phase 2: Consensus Building.
Consensus on the relevance of these measures will be determined using a variety of methods including Delphi techniques, focus groups and interviews with stroke survivors and their carers, stroke upper limb researchers, trialists and clinicians. We will generate consensus based recommendations for standardised outcome measures in stroke upper limb rehabilitation.

Phase 3: Identification of Facilitators & Barriers to Routine Use.
Facilitators and barriers to the routine use of these agreed measures will be explored via survey of researchers, trialists and clinicians.

Anticipated Contribution to Research:
Recommendations for a standardised set of upper limb outcome measures.