Title: REhabilitation and recovery of peopLE with Aphasia after StrokE (RELEASE): Utilizing secondary data to enhance speech and language therapy interventions for people with aphasia after stroke
Funder: Chief Scientist Office, Scotland

Abstract: INTRODUCTION: Aphasia (language impairment after stroke) has an annual UK incidence of 50,600 people, and an estimated prevalence of 367,000 people. Impacting on the ability to speak, understand speech, read and write. It is associated with poor functional recovery, activities of daily living, and emotional well-being after stroke. Aphasia subsequently affects hospital discharge destination and the likelihood of successful return to work. Families share the burden of aphasia. Much uncertainty remains around the optimum speech and language therapy intervention (for example optimal timing after stroke, intensity, duration, therapeutic mechanisms and theoretical approach are unclear). Conflicting evidence relating to the contribution patient factors (e.g. age, sex, handedness) make to language recovery creates uncertainty about which patients will recover well and those that are likely or unlikely to benefit from therapy. Clinically effective, affordable approaches, based on an informed prognosis of recovery from aphasia after stroke, are urgently required. Pooling comparable pre-existing aphasia research datasets may provide some insight into these uncertainties. Through a multidisciplinary, international collaboration of aphasia researchers, we seek to utilise individual patient data (IPD) for exploratory analyses. Similar IPD analyses of occupational therapy data highlighted the importance of task specific, functionally relevant tasks which were particularly beneficial for older people and those with a severe stroke. Better understanding of the natural patterns of aphasia recovery and effective interventions is urgently required. AIM: To explore the contribution individual characteristics, stroke and aphasia profiles and therapy components make to the recovery of people with aphasia. RESEARCH QUESTIONS: 1) What is the natural history of language recovery after stroke related aphasia? 2) What are the predictors of language recovery outcomes? 3) What are the components of effective aphasia interventions? 4) Are some interventions (or intervention components) more beneficial for some subgroups of people with aphasia (individual, stroke or aphasia characteristics) than others? METHODS: Phase 1: We plan to combine existing international clinical trials, cohort and clinical registry datasets to facilitate large scale, novel analyses. We have secured commitments to contribute 52 aphasia research datasets equating to more than 3000 IPDs. We will also invite additional researchers to participate in RELEASE and these entries will further strengthen our planned analyses. Datasets will be compiled into an archive, merging common variables (e.g. patient age, sex, stroke type) and intervention methods, diagnostic tools and outcome measures. Where possible, data will be standardised across outcome measures (e.g. standardised means differences) or other variables to facilitate pooled analyses. Phase 2: Pooled analyses will allow credible meta-regression. We will report descriptive statistics and analyse the data using linear models. The main analyses will be IPD meta-analyses adjusting for potential confounders and baseline values where possible, and treating individual study as a fixed effect. We will examine heterogeneity, explore the effect of potential biases (e.g. publication), conduct missing data analyses and if appropriate, use network meta-analysis. RESULTS: We anticipate our analyses will improve our understanding of the natural history and predictors of recovery, outcomes and components of effective therapy. This will in turn inform clinically effective and affordable rehabilitation tailored to individuals’ needs.

Lay abstract: BACKGROUND: Aphasia, a language problem caused by stroke-related damage in the language area of the brain, affects about 50,600 people in the UK every year. People with aphasia may have difficulty in speaking, understanding speech, reading and writing. Speech and language therapy for aphasia after stroke is beneficial. However, therapists have little information to support them in predicting someone’s recovery and need better information on the best ‘dose’ and delivery of therapy: How often? How long? Which approach? Some therapies may suit some patients better than others. We believe that the best approach to providing therapy is to tailor it to each patient's needs and prognoses. AIM: We want to explore how patients’ profiles (including for example their age, sex, stroke, whether they are right of left handed), their language problems and the therapy they receive impact on the recovery of their language after stroke. BENEFITS TO PATIENTS AND NHS: A James Lind Alliance partnership between stroke survivors, carers and healthcare professionals highlighted aphasia twice in their ‘top 10’ research priorities for life after stroke. A better understanding of recovery and rehabilitation of aphasia would allow therapists to tailor treatments to specific individuals (and families) resulting in better therapy and recovery. RESEARCH ACTIVITIES: Many researchers have investigated how best to support the recovery and rehabilitation of people with aphasia after stroke. Studies tend to involve small numbers of people with aphasia which limited how confident we can be in the findings of these studies. We are a collaboration of many aphasia researchers from around the world. We plan to gather information collected during previous research (on more than 3000 people with aphasia) that we will bring together and analyse. We will also work to identify more research projects that might be willing to contribute to our database. Where possible we will combine these data or use it to make comparisons to answer new research questions about aphasia. This is a highly efficient, cost effective method of exploring our research questions. OUTCOMES: We will produce information on: 1) The usual patterns of language recovery from stroke related aphasia 2) The characteristics shared by people who made a good (or not so good) recovery from aphasia 3) The common elements to therapy that facilitated recovery (e.g. timing after stroke, intensity, frequency, duration, repetition etc) 4) Whether people with particular stroke or aphasia characteristics do better with specific therapies. ETHICAL ISSUES: All data contributed will be anonymised. Appropriate approvals will have been obtained prior to data sharing. Extensions to historic ethical approvals may be needed. The pooled data archive will be held securely. Findings will be presented in summary form, ensuring continued anonymisation. TEAM: We are a collaborative group of international aphasia researchers and part of the Collaboration of Aphasia Trialists (CATs). Funded by the COST Association (IS1208 www.aphasiatrials.org) our network seeks to facilitate the development of high quality aphasia research which addresses the needs of people with aphasia after stroke. Our proposal is essential to progress the field of aphasia rehabilitation. We are grateful to the NIHR Health Services and Delivery Research funding stream for their support to conduct this research.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: STROKE