Inclusion of People With Aphasia in Stroke Trials: A Systematic Search and Review.

BACKGROUND: Although people with aphasia (PwA) represent 30% of stroke survivors, they are frequently excluded from stroke research, or their inclusion is unclear. Such practice significantly limits the generalizability of stroke research, increases the need to duplicate research in aphasia-specific populations, and raises important ethical and human rights issues. OBJECTIVE: To detail the extent and nature of inclusion of PwA in contemporary stroke randomized controlled trials (RCTs). METHODS: We conducted a systematic search to identify completed stroke RCTs and RCT protocols published in 2019. Web of Science was searched using terms "stroke" and "randomized controlled trial". These articles were reviewed by extracting rates of PwA inclusion/exclusion, whether "aphasia" or related terms were referred to in the article or supplemental files, eligibility criteria, consent procedures, adaptations made to support the inclusion of PwA, and attrition rates of PwA. Data were summarized, and descriptive statistics applied when appropriate. RESULTS: 271 studies comprising 215 completed RCTs and 56 protocols were included. 36.2% of included studies referred to aphasia/dysphasia. Of completed RCTs, only 6.5% explicitly included PwA, 4.7% explicitly excluded PwA, and inclusion was unclear in the remaining 88.8%. Among RCT protocols, 28.6% of studies intended inclusion, 10.7% intended excluding PwA, and in 60.7%, inclusion was unclear. In 45.8% of included studies, sub-groups of PwA were excluded, either explicitly (ie, particular types/severities of aphasia, eg, global aphasia) or implicitly, by way of ambiguous eligibility criteria which could potentially relate to a sub-group of PwA. Little rationale for exclusion was provided. 71.2% of completed RCTs did not report any adaptations that could support the inclusion of PwA, and minimal information was provided about consent procedures. Where it could be determined, attrition of PwA averaged 10% (range 0%-20%). CONCLUSION: This paper details the extent of inclusion of PwA in stroke research and highlights opportunities for improvement.

Inclusion of adults with conditions that have the potential to affect capacity and or communication in research: triangulation from a mixed-methods study of current practice and values across multiple stakeholders.

OBJECTIVES: We aimed to: (A) describe researcher decision-making when including or excluding adults with conditions that have the potential to affect capacity and/or communication in research and (B) explore the underlying values and reasoning of stakeholders in research which falls under the provisions of the Mental Capacity Act, 2005. DESIGN: The mixed-methods design included semistructured interviews with adults with conditions that have the potential to affect capacity and/or communication, supporters, researchers, research ethics committee members and an online survey with researchers. Triangulation was used to integrate the data and examine the complementarity of the findings. SETTING: England and Wales. PARTICIPANTS: There were 61 participants who took part in semistructured interviews, of which 39 were adults with conditions with potential to affect capacity and/or communication, 6 were in support roles for adults with conditions with potential to affect capacity and/or communication (including family members and professionals in advocacy organisations), 8 were members of research ethics committees flagged under the Mental Capacity Act to review research where there could be issues of mental capacity and 8 were researchers with experience of working with adults with conditions that have the potential to affect capacity and/or communication. The online survey had 128 participants, researchers with experience of working with adults with conditions that have the potential to affect capacity and/or communication. RESULTS: All stakeholders were supportive of the genuine inclusion of adults with conditions that have the potential to affect capacity and/or communication in research, and exclusion was seen as a form of discrimination. Many researchers were daunted by meeting the threshold within the legislation for including participants who may lack capacity. CONCLUSION: Further training, expertise and resources are required to promote the successful inclusion in research of adults with conditions that have the potential to affect capacity and/or communication.

Towards the Consistent Inclusion of People With Aphasia in Stroke Research Irrespective of Discipline.

People with aphasia have been systematically excluded from stroke research or included without the necessary modifications, threatening external study validity. In this paper, we propose that 1) the inclusion of people with aphasia should be considered as standard in stroke research irrespective of discipline and that 2) modifications should be made to stroke research procedures to support people with aphasia to achieve meaningful and valid inclusion. We argue that outright exclusion of this heterogenous population from stroke research based purely on a diagnosis of aphasia is rarely required and present a rationale for deliberate inclusion of people with aphasia in stroke research. The purpose of this paper is fourfold: 1) to highlight the issue and implications of excluding people with aphasia from stroke research; 2) to acknowledge the current barriers to including people with aphasia in stroke research; 3) to provide stroke researchers with methods to enable inclusion, including recommendations, resources, and guidance; and 4) to consider research needed to develop aphasia inclusive practices in stroke research.

How are adults with capacity-affecting conditions and associated communication difficulties included in ethically sound research? A documentary-based survey of ethical review and recruitment processes under the research provisions of the Mental Capacity Act (2005) for England and Wales.

OBJECTIVES: This study aimed to determine the characteristics of ethical review and recruitment processes, concerning the inclusion of adults with capacity-affecting conditions and associated communication difficulties in ethically sound research, under the provisions of the Mental Capacity Act (MCA, 2005) for England and Wales. DESIGN: A documentary-based survey was conducted focusing on adults with capacity-affecting conditions and associated communication difficulties. The survey investigated: (1) retrospective studies during the implementation period of the MCA (2007-2017); (2) prospective applications to MCA-approved Research Ethics Committees (RECs) during a 12-month period (2018-19); (3) presentational and linguistic content of participant information sheets used with this population. SETTING: Studies conducted and approved in England and Wales. SAMPLE: Studies focused on adults with the following capacity-affecting conditions: acquired brain injury; aphasia after stroke; autism; dementia; intellectual disabilities; mental health conditions. The sample comprised: (1) 1605 studies; (2) 83 studies; (3) 25 participant information sheets. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the inclusion/exclusion of adults with capacity-affecting conditions from studies. The secondary outcome was the provisions deployed to support their inclusion. RESULTS: The retrospective survey showed an incremental rise in research applications post-MCA implementation from 2 (2012) to 402 (2017). The prospective survey revealed exclusions of people on the bases of: 'lack of capacity' (n=21; 25%); 'communication difficulties' (n=5; 6%); 'lack of consultee' (n=11; 13%); and 'limited English' (n=17; 20%). REC recommendations focused mainly on participant-facing documentation. The participant information sheets were characterised by inconsistent use of images, typography and layout, volume of words and sentences; some simplified language content, but variable readability scores. CONCLUSIONS: People with capacity-affecting conditions and associated communication difficulties continue to be excluded from research, with recruitment efforts largely concentrated around participant-facing documentation. There is a need for a more nuanced approach if such individuals are to be included in ethically sound research.

Management of communication disability in the first 90 days after stroke: a scoping review.

INTRODUCTION: People with communication disability after stroke need interventions to optimise healthcare communication and rehabilitation outcomes. Current evidence syntheses do not adequately inform the management of communication disability during the first 90 days post-stroke. PURPOSE: To explore the scope of literature for the management of communication disability in the first 90 days after stroke. MATERIALS AND METHODS: A scoping review was conducted using a systematic keyword search of six databases. A descriptive synthesis was generated using communication-related domains related to the biopsychosocial framework of the International Classification of Functioning, Disability, and Health (ICF). RESULTS: A total of 129 studies met eligibility criteria. Aphasia was the most frequently addressed communication disability after stroke (76/129 studies) with a paucity of evidence investigating other acquired neurogenic communication impairments. Management predominantly focused on communication-related: body functions and structures (62 studies) (e.g., linguistic-behavioural therapies), followed by environmental factors (39 studies) (e.g., communication partner training/support); activities and participation (15 studies) (e.g., augmentative and alternative communication); and personal factors (13 studies) (e.g., assessment of depression after aphasia). CONCLUSION: A coordinated, integrated approach to developing and testing acute and subacute interventions for all communication disabilities across all communication-related domains is required.IMPLICATIONS FOR REHABILITATIONInterdisciplinary stroke clinicians need to manage communication disabilities in the first 90 days after stroke to optimise healthcare communication and rehabilitation outcomes.There is some evidence to guide clinicians in aphasia management but less in other disabilities of speech and cognitive functioning.Most interventions to inform clinical practice address communication-related body functions and structures (e.g., linguistic and speech therapies). Clinicians need to address all domains and more evidence is needed to address environmental factors (e.g., communication support); activities and participation (e.g., person-centred goal setting); and personal factors (e.g., psychological care).

A systematic review of non-drug interventions to prevent and treat anxiety in people with aphasia after stroke.

PURPOSE: To investigate the effectiveness of non-drug interventions for people with aphasia in the prevention and/or treatment of anxiety post-stroke as either a primary or secondary outcome. MATERIALS AND METHODS: A systematic search of Medline, CINAHL, PsycINFO and Cochrane Library up to March 2021 was carried out. Studies of stroke populations were included if people with aphasia represented 25% or more of the enrolled participants. Quality of the evidence was assessed. A narrative synthesis of results is presented. The PROSPERO record ID for this study is 106451. RESULTS: Ten studies were included: five randomised controlled trials (RCTs), a single case experimental design, and four pre-post studies. The quality of the RCT trials was at least adequate but none demonstrated a benefit to anxiety outcomes. Those studies that reported benefit were of lower-level evidence with respect to National Health and Medical Research Classifications. No studies were found that evaluated the prevention of anxiety after stroke for people with aphasia. CONCLUSION: Definitive conclusions about the effectiveness of non-drug interventions for the prevention and/or treatment of anxiety in people with aphasia post-stroke cannot be made. Interventions that may show promise for those with aphasia and symptoms of anxiety include mindfulness meditation, modified cognitive behaviour therapy, unilateral nostril breathing, and the "Enhance Psychological Coping after Stroke" programme. Further high-quality research with better reporting of the inclusion of participants with aphasia and their specific sub-group results are required.Implications for RehabilitationIt is important for rehabilitation professionals to consider prevention of anxiety post-stroke as well as treatment.Mindfulness meditation, modified cognitive behavioural therapy, unilateral nostril breathing, and the and the "Enhance Psychological Coping after Stroke" programme may be of benefit to people with aphasia post-stroke.Adapting intervention protocols to be more communicatively accessible and training health professionals in supported communication may help people with aphasia engage in psychological therapies.

A systematic review and narrative synthesis of the research provisions under the Mental Capacity Act (2005) in England and Wales: Recruitment of adults with capacity and communication difficulties.

BACKGROUND: The Mental Capacity Act (MCA, 2005) and its accompanying Code of Practice (2007), govern research participation for adults with capacity and communication difficulties in England and Wales. We conducted a systematic review and narrative synthesis to investigate the application of these provisions from 2007 to 2019. METHODS AND FINDINGS: We included studies with mental capacity in their criteria, involving participants aged 16 years and above, with capacity-affecting conditions and conducted in England and Wales after the implementation of the MCA. Clinical trials of medicines were excluded. We searched seven databases: Academic Search Complete, ASSIA, MEDLINE, CINAHL, PsycArticles, PsycINFO and Science Direct. We used narrative synthesis to report our results. Our review follows Preferred Reporting Items for Systematic Reviews and is registered on PROSPERO, CRD42020195652. 28 studies of various research designs met our eligibility criteria: 14 (50.0%) were quantitative, 12 (42.9%) qualitative and 2 (7.1%) mixed methods. Included participants were adults with intellectual disabilities (n = 12), dementia (n = 9), mental health disorders (n = 2), autism (n = 3) and aphasia after stroke (n = 2). We found no studies involving adults with acquired brain injury. Diverse strategies were used in the recruitment of adults with capacity and communication difficulties with seven studies excluding individuals deemed to lack capacity. CONCLUSIONS: We found relatively few studies including adults with capacity and communication difficulties with existing regulations interpreted variably. Limited use of consultees and exclusions on the basis of capacity and communication difficulties indicate that this group continue to be under-represented in research. If health and social interventions are to be effective for this population, they need to be included in primary research. The use of strategic adaptations and accommodations during the recruitment process, may serve to support their inclusion.

Inclusion under the Mental Capacity Act (2005): A review of research policy guidance and governance structures in England and Wales.

OBJECTIVE: To investigate how people with communication and understanding difficulties, associated with conditions such as dementia, autism and intellectual disability, are represented in research guidance supplementary to the Mental Capacity Act (MCA: 2005) in England and Wales. METHODS: A documentary survey was conducted. The sample comprised the MCA Code of Practice (CoP: 2007) and 14 multi-authored advisory documents that were publicly available on the Health Research Authority website. Textual review of key words was conducted followed by summative content analysis. RESULTS: Representation of people with communication and understanding difficulties was confined to procedural information and position statements that focused mainly on risk management and protection. Whilst a need to engage potential participants was recognized, guidance provided was imprecise. CONCLUSIONS: Tensions exist between the protection versus empowerment of people with communication and understanding difficulties in research. The development of structured, evidence-based guidance is indicated. PATIENT OR PUBLIC CONTRIBUTION: People with communication and understanding difficulties and carers participated in a working group to explore, discuss and interpret the findings.