Initial evaluation of the Consent Support Tool: A structured procedure to facilitate the inclusion and engagement of people with aphasia in the informed consent process

This study evaluated the Consent Support Tool (CST), a procedure developed to identify the optimum format in which to present research information to people with different severities of aphasia, in order to support their understanding during the informed consent process. Participants were a convenience sample of 13 people with aphasia who had mixed comprehension ability. The CST was used to profile each participant's language ability and identify an information format that should maximize her/his understanding. Next, participants were shown information presented in three formats: standard text and two ‘aphasia-friendly’ versions providing different levels of support. Participants’ understanding of the information was measured for each format. The format recommended by the CST was compared with the format observed to maximize understanding for each participant. The CST accurately predicted the optimum format for 11/13 participants and differentiated people who could understand fully with support from those who could not in 12/13 cases. All participants interviewed (10/10) found the adapted formats helpful and 9/10 preferred them to the standard version. These findings suggest that the CST could usefully support researchers to determine whether a person with aphasia is likely to be able to provide informed consent, and which information format will maximize that individual's understanding. The CST and different information formats are available as Supplementary Appendices to be found online at http://www.informahealthcare.com/doi/abs/10.3109/17549507.2013.795999

Person-centered care for people with aphasia: tools for shared decision-making

Shared decision-making is a fundamental aspect of person-centered care, and can and should be part of many different aspects of the rehabilitation process. Communication disabilities like aphasia, which affects people's ability to use and understand spoken and written language, can make shared decision-making especially challenging to the resources and skills of rehabilitation practitioners. The purpose of this narrative review is to provide a comprehensive description of tools that can support successful shared decision-making with people with aphasia in the rehabilitation environment. These tools and strategies are appropriate for use by physicians, nurses, social workers, physical therapists (also referred to as physiotherapists), occupational therapists, and other service or care providers. The important role of speech-language pathologists as consultants is also described. Case scenarios throughout the paper illustrate the application of recommended tools and strategies along with best practices

Stroke Research Staff's Experiences of Seeking Consent from People with Communication Difficulties: Results of a National Online Survey

Background: The process of obtaining informed consent from people with communication difficulties is challenging. An online survey was conducted to explore the experiences of stroke research staff in seeking consent from this population. Objectives: To identify how stroke research staff seek consent from people with communication difficulties, potential barriers to effective practice, and ways to improve practice. Methods: All research staff working for the National Institute for Health Research Stroke Research Network in England were invited to complete an online questionnaire. Data were collected anonymously between March and June 2013. Quantitative data were analyzed using descriptive statistics, and qualitative data were coded using thematic analysis. Results: Seventy-five research staff responded, corresponding to a response rate of 10%. There were 97% who had sought consent from people with communication difficulties and 52% did this regularly; 65% had received training in consenting this population. Most staff were aware of appropriate methods for supporting communication needs, but only 18% regularly used accessible information and 35% regularly used augmentative communication techniques. Lack of specific training and lack of access to ethically approved materials were suggested barriers to using these methods. Respondents indicated that people with impaired communication may be excluded from the consent process because they are not eligible for inclusion in studies or because assent is obtained from third parties. Conclusions: For research staff to work more effectively with this population, study protocols need to be more inclusive of people with communication difficulties, and staff need better access to ethically approved, accessible communication resources and appropriate training

AAC users and nursing staff’s thoughts and perceptions of current AAC training with content considerations for future training interventions

As life expectancy increases, more adults are living with conditions affecting their communication, and many of these will reside within care settings such as hospitals or long-term care, cared for by nurses and health care assistants (HCAs). The current workload and role of a nurse or HCA is complex and busy, and when caring for a patient who is also an Augmentative and Alternative Communication (AAC) user, they need additional skills and knowledge to be an effective communication partner. Nursing staff also need to undertake the various tasks that an AAC facilitator has to assume, such as high-tech AAC system maintenance - updating software, battery charging, cleaning as well as liaising with companies or therapists for help (Beukelman et al., 2008). Research has identified difficult and distressing experiences of AAC users within hospitals, and nurses have reported feeling frustrated when caring for AAC users due to a lack of knowledge about AAC e.g. Hemsley et al. (2011). Many barriers to implementing AAC, particularly in hospital settings have been identified, including a lack of staff knowledge and skills (Gormley and Light, 2019). The COVID-19 pandemic’s impact on communication function has escalated the need for communication aids and subsequently a nurse’s need for awareness of alternative and supportive communication tools and strategies (Altschuler, 2021). Training nursing staff in inpatient settings is complicated by a need to train a large number of healthcare workers on overlapping shift work patterns, 24 hours a day, 7 days a week. Globally, nurses and AAC users are diverse culturally and linguistically, and training needs to ensure these factors are considered. In terms of opportunities to support nursing staff, recent research by Barnard et al. (2021) found that most interactions between speech and language therapists (SLTs) and nurses were punctuated by interruptions to the conversations in which SLTs seized moments in between nursing tasks to explain communication needs and strategies. Compounding these factors, we have a limited research-evidence-base for how we train our nursing colleagues. To meet the demands of the healthcare setting, clinicians and researchers are challenged with the task of developing and evaluating innovative, flexible communication supports and communication partner training (Altschuler et al., 2021). This article explores current research and practice in this area and describes a research study exploring nurses’ and AAC users’ views about current and future training

"I feel dumb, embarrassed, and frustrated”: A qualitative exploration of the lived experience of acalculia.

Introduction: Acalculia is an acquired disability following stroke or brain injury, which involves difficulty processing numerical information (e.g. phone numbers, measurements) or problems with calculations and understanding quantities. Acalculia is not routinely screened for as part of standard post-stroke assessment. As a result, there is a lack of understanding of the nature and prevalence of poststroke acalculia, and the impact it has on stroke survivors. This qualitative study aimed to explore stroke survivors’ experiences of acalculia. Stroke survivors with a strong interest in acalculia and its rehabilitation initiated the study and contributed to its design. Methods: We explored the impact of acalculia on the lives of 16 stroke/brain injury survivors with acalculia and 7 carers using semi-structured online interviews. Participants ranged in age, gender, time post onset, lesion localisation, country of residence and numeracy level prior to brain injury. Data were analysed using thematic analysis. Results: Three main themes were identified: Awareness and Diagnosis, Emotional and Physical Impact, and Coping Strategies and Independence. Participants and carers repeatedly referred to the lack of awareness and treatment for acalculia and the devastating impact acalculia has had on their lives and independence. Practical impacts included managing money, making appointments, using timetables, organising social activities and employment, and managing medication. Conclusions: Our results highlight the urgent need to develop suitable assessments and interventions for acalculia and the scope for this to be PCPI-led. The data also reveal useful strategies and suggestions regarding effective timing and approaches for intervention

A qualitative exploration of the lived experience of, and quality of professional support for, number processing deficits after brain injury or stroke

Introduction: Acalculia is an acquired disability following brain-injury (hence forth, including stroke) (Ardila & Rosselli, 2002), which involves difficulty processing numerical information (e.g. ‘phone numbers) or problems with calculations and understanding quantities (money, time). While difficulties may result from damage to quantity-processing units in the parietal region, or executive frontal regions, common difficulties are closely related to aphasic symptoms - for example, difficulties articulating numbers, understanding spoken number words, or reading digits or number words. Acalculia is not routinely screened for as part of standard brain-injury assessment, but studies suggest a prevalence of between 35%-60%. Aims: To understand the impact of acalculia on adults with acquired brain-injury, and to explore professional support available for patients with acalculia. Methods: We explored the impact of acalculia on the lives of 16 brain-injury survivors (7 males) with acalculia and 7 carers (4 males), using semi-structured online interviews (mean length of interview = 56min). Interviews investigated participants’ experiences of living with acalculia and the type and quality of professional support they received post brain-injury. Fifteen participants with acalculia also reported aphasic symptoms. Participants ranged in age (mean = 58 years, SD=12.95), time post onset (mean =7.39 years; SD=6.52), lesion localisation, country of residence, severity of aphasic symptoms, and numeracy level prior to brain injury. Data were analysed using thematic analysis. Results: Three main themes were identified: Awareness and Diagnosis, Emotional and Physical Impact, and Coping Strategies and Independence. Participants emphasised that concerns about language and mobility took precedence in the period immediately post brain-injury, and they only became aware of their specific difficulties with numbers later in their recovery. Both participants and carers repeatedly referred to the lack of awareness of, and treatment for, acalculia by all professionals they came across. This contrasted markedly to identification and support given for equally prevalent conditions such as aphasia. Many mentioned the devastating impact acalculia has had on their lives and independence. Practical impacts included managing money or medication, making appointments, using timetables, organising social activities and employment. Conclusions: Our results highlight the urgent need to increase awareness of acalculia amongst patients and professionals involved in post brain-injury care. There is a substantial and presently unmet clinical need to support professionals and patients by developing suitable assessments and interventions for acalculia. Contribution to new knowledge: While a lot is known about numerical cognition, this study highlights the gap between advances in theory and the lack of translational research that positively impact patient care. Implications for practice and/or policy service-user engagement and/or involvement in the study: This study was initiated by stroke survivors with a strong interest in acalculia and its rehabilitation, and the findings are testimony to the contribution of PCPI-led research. Going forward, findings will be used to identify and develop screening tests and interventions, and to increase awareness of acalculia among brain-injury survivors, their carers and professionals

Improving Practice in Supported Decision-Making and Mental Capacity Assessment

Current models of evidence-based practice are predicated on the inclusion of patients / service users in decisions about their healthcare. In the United Kingdom (UK), healthcare policy and legislation requires practitioners to provide support with decision-making and, if necessary, complete mental capacity assessments to identify if service users can make informed decisions. People with communication disabilities may have difficulties understanding, thinking and talking about decisions and may require communication support. In this paper, I discuss the current challenges associated with mental capacity assessment and supported decision-making. I propose that healthcare professionals should look beyond legal and policy imperatives to consider the ethical foundations for their practice, when they face such challenges. I compare two conceptual approaches to ethical reasoning. I describe a practical solution to the clinical challenge – the development of the MCAST, a toolkit to support multidisciplinary staff to assess mental capacity and provide support to service users with communication disabilities during the decision-making proces

Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action

Background: Informed consent is considered a fundamental requirement for participation in trials, yet obtaining consent is challenging in a number of populations and settings. This may be due to participants having communication or other disabilities, their capacity to consent fluctuates or they lack capacity, or in emergency situations where their medical condition or the urgent nature of the treatment precludes seeking consent from either the participant or a representative. These challenges, and the subsequent complexity of designing and conducting trials where alternative consent pathways are required, contribute to these populations being underserved in research. Recognising and addressing these challenges is essential to support trials involving these populations and ensure that they have an equitable opportunity to participate in, and benefit from, research. Given the complex nature of these challenges, which are encountered by both adults and children, a cross-disciplinary approach is required. Discussion: A UK-wide collaboration, a sub-group of the Trial Conduct Working Group in the MRC-NIHR Trial Methodology Research Partnership, was formed to collectively address these challenges. Members are drawn from disciplines including bioethics, qualitative research, trials methodology, healthcare professions, and social sciences. This commentary draws on our collective expertise to identify key populations where particular methodological and ethical challenges around consent are encountered, articulate the specific issues arising in each population, summarise ongoing and completed research, and identify targets for future research. Key populations include people with communication or other disabilities, people whose capacity to consent fluctuates, adults who lack the capacity to consent, and adults and children in emergency and urgent care settings. Work is ongoing by the sub-group to create a database of resources, to update NIHR guidance, and to develop proposals to address identified research gaps. Conclusion: Collaboration across disciplines, sectors, organisations, and countries is essential if the ethical and methodological challenges surrounding trials involving complex and alternate consent pathways are to be addressed. Explicating these challenges, sharing resources, and identifying gaps for future research is an essential first step. We hope that doing so will serve as a call to action for others seeking ways to address the current consent-based exclusion of underserved populations from trials

Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action

Background: Informed consent is considered a fundamental requirement for participation in trials, yet obtaining consent is challenging in a number of populations and settings. This may be due to participants having communication or other disabilities, their capacity to consent fluctuates or they lack capacity, or in emergency situations where their medical condition or the urgent nature of the treatment precludes seeking consent from either the participant or a representative. These challenges, and the subsequent complexity of designing and conducting trials where alternative consent pathways are required, contribute to these populations being underserved in research. Recognising and addressing these challenges is essential to support trials involving these populations and ensure that they have an equitable opportunity to participate in, and benefit from, research. Given the complex nature of these challenges, which are encountered by both adults and children, a cross-disciplinary approach is required. Discussion: A UK-wide collaboration, a sub-group of the Trial Conduct Working Group in the MRC-NIHR Trial Methodology Research Partnership, was formed to collectively address these challenges. Members are drawn from disciplines including bioethics, qualitative research, trials methodology, healthcare professions, and social sciences. This commentary draws on our collective expertise to identify key populations where particular methodological and ethical challenges around consent are encountered, articulate the specific issues arising in each population, summarise ongoing and completed research, and identify targets for future research. Key populations include people with communication or other disabilities, people whose capacity to consent fluctuates, adults who lack the capacity to consent, and adults and children in emergency and urgent care settings. Work is ongoing by the sub-group to create a database of resources, to update NIHR guidance, and to develop proposals to address identified research gaps. Conclusion: Collaboration across disciplines, sectors, organisations, and countries is essential if the ethical and methodological challenges surrounding trials involving complex and alternate consent pathways are to be addressed. Explicating these challenges, sharing resources, and identifying gaps for future research is an essential first step. We hope that doing so will serve as a call to action for others seeking ways to address the current consent-based exclusion of underserved populations from trials

Improving mental capacity assessment: iterative, user-centred design of a toolkit and examination of its use in clinical practice.

Introduction: The Mental Capacity Act (MCA, 2005) requires health and social care professionals to complete a mental capacity assessment if a patient appears to have difficulty making decisions. This thesis explores current practice variations and professionals’ support needs and describes the development and testing of the Mental Capacity Assessment Support Toolkit (MCAST). Aims: To develop a toolkit to facilitate and improve mental capacity assessment and test the feasibility of its use in healthcare settings. Method: A sequential, mixed methods design was employed. Published research evidence and case law were reviewed. Multidisciplinary healthcare professionals were interviewed about their practice in focus groups. This evidence informed a design specification for the MCAST. User-centred design methods were employed to develop the prototype MCAST. Design modifications were identified from survey, interview and ethnographic data collected during professional, service user and topic expert reviews of prototype iterations. Professionals piloted using the MCAST to assess hospital and intermediate care patients. Document analysis, professional surveys and patient and family carer interviews were used to investigate the MCAST’s usability, acceptability and its effects on compliance with the MCA and professionals’ confidence levels. Results: The reviews and focus group data identified barriers and facilitators to good practice and suggested that current practice varies and professionals require support to improve their assessments, especially for patients with communication disorders. The MCAST was designed to enable professionals to: i) prepare, complete and document capacity assessments; ii) identify and support patients with communication disorders during capacity assessments. Most professional participants reported that the MCAST was easy to use and helped them to assess capacity. The MCAST was considered acceptable and potentially beneficial by all patients and family carers interviewed. Use of the MCAST was associated with improved assessment documentation and increased professional confidence. Conclusion: This study provides new knowledge about capacity assessment, especially in relation to people with communication disorders. The MCAST appears feasible to use in healthcare settings. Further research to refine the prototype and test its effectiveness is warranted