Background Hearing and vision loss is highly prevalent in residents with dementia (RwD) living in... more Background Hearing and vision loss is highly prevalent in residents with dementia (RwD) living in long-term care (LTC) facilities. Sensory loss often has a negative impact on quality of life and other dementia-related outcomes. Optimising sensory function may improve dementia-related outcomes in LTC facilities. The SENSE-Cog Residential Care pilot trial will evaluate whether a multi-faceted hearing and vision intervention for RwD and concurrent sensory loss is suitable for definitive testing in a large-scale cluster randomised control trial (RCT) in Ireland, and how this can best be achieved. Methods This is a six-month feasibility-pilot observer-blind, multicentre, cluster RCT. Between eight and 15 LTC facilities (with an average of 5 RwD recruited per home) will be randomly assigned to receive either "care as usual" (CAU) or a multi-component sensory intervention comprising: (1) personalised resident hearing and vision support; (2) staff training in sensory health; (3) f...
Background: Dementia research prioritisation allows for the systematic allocation of investment i... more Background: Dementia research prioritisation allows for the systematic allocation of investment in dementia research by governments, funding agencies and the private sector. There is currently a lack of information available in Ireland regarding priority areas for dementia research. To address this gap, a dementia research prioritisation exercise was undertaken, consisting of an online survey of professionals in the dementia field and workshops for people living with dementia and family carers. Methods: (1) An anonymous online survey of professionals, based on an existing WHO global survey: The global survey was adapted to an Irish context and participants were asked to score 65 thematic research avenues under 5 criteria; (2) A mixed-methods exercise for people living with dementia and family carers: This involved two facilitated workshops where participants voted on the research themes they felt were important to them and should be addressed through research. Results: Eight of the ...
Background Older adults frequently attend the emergency department (ED) and experience high rates... more Background Older adults frequently attend the emergency department (ED) and experience high rates of adverse events following ED presentation. This randomised controlled trial evaluated the impact of early assessment and intervention by a dedicated team of health and social care professionals (HSCPs) in the ED on the quality, safety, and clinical effectiveness of care of older adults in the ED. Methods and findings This single-site randomised controlled trial included a sample of 353 patients aged ≥65 years (mean age = 79.6, SD = 7.01; 59.2% female) who presented with lower urgency complaints to the ED a university hospital in the Mid-West region of Ireland, during HSCP operational hours. The intervention consisted of early assessment and intervention carried out by a HSCP team comprising a senior medical social worker, senior occupational therapist, and senior physiotherapist. The primary outcome was ED length of stay. Secondary outcomes included rates of hospital admissions from t...
Background Care home residents are mainly inactive, leading to increased dependency and low mood.... more Background Care home residents are mainly inactive, leading to increased dependency and low mood. Although exercise classes may increase activity, a more sustainable model is to engage staff and residents in increasing routine activity. Objectives The objectives were to develop and preliminarily test strategies to enhance the routine physical activity of care home residents to improve their physical, psychological and social well-being through five overlapping workstreams. Design This trial had a mixed-methods research design to develop and test the feasibility of undertaking an evaluative study consisting of gaining an understanding of the opportunities for and barriers to enhancing physical activity in care homes (workstream 1); testing physical activity assessment instruments (workstream 2); developing an intervention through a process of intervention mapping (workstream 3); refining the provisional intervention in the care home setting and clarifying outcome measurement (workstr...
Alzheimer's & Dementia: Translational Research & Clinical Interventions, 2021
Demonstrating that treatments are clinically meaningful across the Alzheimer's disease (AD) c... more Demonstrating that treatments are clinically meaningful across the Alzheimer's disease (AD) continuum is critical for meeting our goals of accelerating a cure by 2025. While this topic has been a focus of several Alzheimer's Association Research Roundtable (AARR) meetings, there remains no consensus as to what constitutes a “clinically meaningful outcome” in the eyes of patients, clinicians, care partners, policymakers, payers, and regulatory bodies. Furthermore, the field has not come to agreement as to what constitutes a clinically meaningful treatment effect at each stage of disease severity. The AARR meeting on November 19–20, 2019, reviewed current approaches to defining clinical meaningfulness from various perspectives including those of patients and care partners, clinicians, regulators, health economists, and public policymakers. Participants discussed approaches that may confer clinical relevance at each stage of the disease continuum and fostered discussion about what should guide us in the future.
Background: The COMET Initiative promotes the development and use of ‘core outcome sets’ (COS), a... more Background: The COMET Initiative promotes the development and use of ‘core outcome sets’ (COS), agreed standardised sets of outcomes that should be measured and reported in all studies in a particular clinical condition. COS are determined by consensus amongst key stakeholders, including health professionals, policymakers and patients, ensuring that the priorities and expertise of these representatives inform the choice of the most important outcomes to measure for a given condition. There is increased recognition of the need to integrate COS across the healthcare system and with existing regulatory apparatus, to ensure that outcomes being recorded are those of key relevance to important stakeholders. The aim of this study is to assess the degree of concordance between outcomes recommended in COS for research and in guidance provided by two key regulators: US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Methods: COS for research published during 2015-2...
Background Hearing and vision loss is highly prevalent in residents with dementia (RwD) living in... more Background Hearing and vision loss is highly prevalent in residents with dementia (RwD) living in long-term care (LTC) facilities. Sensory loss often has a negative impact on quality of life and other dementia-related outcomes. Optimising sensory function may improve dementia-related outcomes in LTC facilities. The SENSE-Cog Residential Care pilot trial will evaluate whether a multi-faceted hearing and vision intervention for RwD and concurrent sensory loss is suitable for definitive testing in a large-scale cluster randomised control trial (RCT) in Ireland, and how this can best be achieved. Methods This is a six-month feasibility-pilot observer-blind, multicentre, cluster RCT. Between eight and 15 LTC facilities (with an average of 5 RwD recruited per home) will be randomly assigned to receive either "care as usual" (CAU) or a multi-component sensory intervention comprising: (1) personalised resident hearing and vision support; (2) staff training in sensory health; (3) f...
Background: Dementia research prioritisation allows for the systematic allocation of investment i... more Background: Dementia research prioritisation allows for the systematic allocation of investment in dementia research by governments, funding agencies and the private sector. There is currently a lack of information available in Ireland regarding priority areas for dementia research. To address this gap, a dementia research prioritisation exercise was undertaken, consisting of an online survey of professionals in the dementia field and workshops for people living with dementia and family carers. Methods: (1) An anonymous online survey of professionals, based on an existing WHO global survey: The global survey was adapted to an Irish context and participants were asked to score 65 thematic research avenues under 5 criteria; (2) A mixed-methods exercise for people living with dementia and family carers: This involved two facilitated workshops where participants voted on the research themes they felt were important to them and should be addressed through research. Results: Eight of the ...
Background Older adults frequently attend the emergency department (ED) and experience high rates... more Background Older adults frequently attend the emergency department (ED) and experience high rates of adverse events following ED presentation. This randomised controlled trial evaluated the impact of early assessment and intervention by a dedicated team of health and social care professionals (HSCPs) in the ED on the quality, safety, and clinical effectiveness of care of older adults in the ED. Methods and findings This single-site randomised controlled trial included a sample of 353 patients aged ≥65 years (mean age = 79.6, SD = 7.01; 59.2% female) who presented with lower urgency complaints to the ED a university hospital in the Mid-West region of Ireland, during HSCP operational hours. The intervention consisted of early assessment and intervention carried out by a HSCP team comprising a senior medical social worker, senior occupational therapist, and senior physiotherapist. The primary outcome was ED length of stay. Secondary outcomes included rates of hospital admissions from t...
Background Care home residents are mainly inactive, leading to increased dependency and low mood.... more Background Care home residents are mainly inactive, leading to increased dependency and low mood. Although exercise classes may increase activity, a more sustainable model is to engage staff and residents in increasing routine activity. Objectives The objectives were to develop and preliminarily test strategies to enhance the routine physical activity of care home residents to improve their physical, psychological and social well-being through five overlapping workstreams. Design This trial had a mixed-methods research design to develop and test the feasibility of undertaking an evaluative study consisting of gaining an understanding of the opportunities for and barriers to enhancing physical activity in care homes (workstream 1); testing physical activity assessment instruments (workstream 2); developing an intervention through a process of intervention mapping (workstream 3); refining the provisional intervention in the care home setting and clarifying outcome measurement (workstr...
Alzheimer's & Dementia: Translational Research & Clinical Interventions, 2021
Demonstrating that treatments are clinically meaningful across the Alzheimer's disease (AD) c... more Demonstrating that treatments are clinically meaningful across the Alzheimer's disease (AD) continuum is critical for meeting our goals of accelerating a cure by 2025. While this topic has been a focus of several Alzheimer's Association Research Roundtable (AARR) meetings, there remains no consensus as to what constitutes a “clinically meaningful outcome” in the eyes of patients, clinicians, care partners, policymakers, payers, and regulatory bodies. Furthermore, the field has not come to agreement as to what constitutes a clinically meaningful treatment effect at each stage of disease severity. The AARR meeting on November 19–20, 2019, reviewed current approaches to defining clinical meaningfulness from various perspectives including those of patients and care partners, clinicians, regulators, health economists, and public policymakers. Participants discussed approaches that may confer clinical relevance at each stage of the disease continuum and fostered discussion about what should guide us in the future.
Background: The COMET Initiative promotes the development and use of ‘core outcome sets’ (COS), a... more Background: The COMET Initiative promotes the development and use of ‘core outcome sets’ (COS), agreed standardised sets of outcomes that should be measured and reported in all studies in a particular clinical condition. COS are determined by consensus amongst key stakeholders, including health professionals, policymakers and patients, ensuring that the priorities and expertise of these representatives inform the choice of the most important outcomes to measure for a given condition. There is increased recognition of the need to integrate COS across the healthcare system and with existing regulatory apparatus, to ensure that outcomes being recorded are those of key relevance to important stakeholders. The aim of this study is to assess the degree of concordance between outcomes recommended in COS for research and in guidance provided by two key regulators: US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Methods: COS for research published during 2015-2...
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