Measuring the success of programmes of care for people living with dementia: a protocol for consensus building with consumers to develop a set of Core Outcome Measures for Improving Care (COM-IC).

INTRODUCTION: The Core Outcome Measures for Improving Care (COM-IC) project aims to deliver practical recommendations on the selection and implementation of a suite of core outcomes to measure the effectiveness of interventions for dementia care. METHODS AND ANALYSIS: COM-IC embeds a participatory action approach to using the Alignment-Harmonisation-Results framework for measuring dementia care in Australia. Using this framework, suitable core outcome measures will be identified, analysed, implemented and audited. The methods for analysing each stage will be codesigned with stakeholders, through the conduit of a Stakeholder Reference Group including people living with dementia, formal and informal carers, aged care industry representatives, researchers, clinicians and policy actors. The codesigned evaluation methods consider two key factors: feasibility and acceptability. These considerations will be tested during a 6-month feasibility study embedded in aged care industry partner organisations. ETHICS AND DISSEMINATION: COM-IC has received ethical approval from The University of Queensland (HREC 2021/HE001932). Results will be disseminated through networks established over the project, and in accordance with both the publication schedule and requests from the Stakeholder Reference Group. Full access to publications and reports will be made available through UQ eSpace (https://espace.library.uq.edu.au/), an open access repository hosted by The University of Queensland.

Dementia research in Ireland: What should we prioritise?

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 five 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 top ten research priorities in the survey of professionals ( n=108) were focused on the delivery and quality of care and services for people with dementia and carers. Other research avenues ranked in the top ten focused on themes of timely and accurate diagnosis of dementia in primary health-care practices and diversifying therapeutic approaches in clinical trials. Participants in the workshops ( n=13) ranked 'better drugs and treatment for people with dementia', 'dementia prevention/ risk reduction' and 'care for people with dementia and carers' as their top priority areas. Conclusions: Findings from this prioritisation exercise will inform and motivate policymakers, funders and researchers to support and conduct dementia-focused research and ensure that the limited resources made available are spent on research that has the most impact for those who will benefit from and use the results of research.

A Physiotherapy-Led Transition to Home Intervention for Older Adults Following Emergency Department Discharge: A Pilot Feasibility Randomised Controlled Trial (ED PLUS).

Background: Older adults frequently attend the emergency department (ED) and experience high rates of subsequent adverse outcomes including functional decline, ED re-presentation and unplanned hospital admission. The development of effective interventions to prevent such outcomes is a key priority for research and service provision. Our aim was to evaluate the feasibility of a physiotherapy-led integrated care intervention for older adults discharged from the ED (ED PLUS). Patients and Methods: Older adults presenting to the ED of a university teaching hospital with undifferentiated medical complaints and discharged within 72 hours were computer randomised in a ratio of 1:1:1 to deliver usual care, Comprehensive Geriatric Assessment (CGA) in the ED, or ED PLUS. ED PLUS is an evidence-based and stakeholder-informed intervention to bridge the care transition between the ED and community by initiating a CGA in the ED and implementing a six-week, multi-component, self-management programme in the patient's home. Feasibility and acceptability were assessed quantitatively and qualitatively. All clinical and process outcomes were assessed by a research nurse blinded to group allocation. Data analyses were primarily descriptive. Results: Twenty-nine participants were recruited indicating a 67% recruitment rate. At 6 months, there was 100% retention in the usual care group, 88% in the CGA group and 90% in the ED PLUS group. ED PLUS participants expressed positive feedback, and there was a trend towards improved function and quality of life and less ED revisits and unscheduled hospitalisations in the ED PLUS group. Conclusion: ED PLUS bridges the transition of care between the index visit to the ED and the community and is feasible using systematic recruitment strategies. Despite recruitment challenges in the context of COVID-19, the intervention was successfully delivered and well received by participants. There was a lower incidence of functional decline and improved quality of life in the ED PLUS group. Trial Registration: The trial was registered in Clinical Trials Protocols and Results System as of 21st July 2021, with registration number NCT04983602.

Geriatric assessment for older people with cancer: policy recommendations.

Most cancers occur in older people and the burden in this age group is increasing. Over the past two decades the evidence on how best to treat this population has increased rapidly. However, implementation of new best practices has been slow and needs involvement of policymakers. This perspective paper explains why older people with cancer have different needs than the wider population. An overview is given of the recommended approach for older people with cancer and its benefits on clinical outcomes and cost-effectiveness. In older patients, the geriatric assessment (GA) is the gold standard to measure level of fitness and to determine treatment tolerability. The GA, with multiple domains of physical health, functional status, psychological health and socio-environmental factors, prevents initiation of inappropriate oncologic treatment and recommends geriatric interventions to optimize the patient's general health and thus resilience for receiving treatments. Multiple studies have proven its benefits such as reduced toxicity, better quality of life, better patient-centred communication and lower healthcare use. Although GA might require investment of time and resources, this is relatively small compared to the improved outcomes, possible cost-savings and compared to the large cost of oncologic treatments as a whole.

Association Between Neuroticism and Dementia on Healthcare Use: A Multi-Level Analysis Across 27 Countries from The Survey of Health, Ageing and Retirement in Europe (SHARE).

BACKGROUND: People with high levels of neuroticism are greater users of health services. Similarly, people with dementia have a higher risk of hospitalization and medical visits. As a result, dementia and a high level of neuroticism increase healthcare use (HCU). However, how these joint factors impact the HCU at the population level is unknown. Similarly, no previous study has assessed the degree of generalization of such impacts, considering relevant variables including age, gender, socioeconomic, and country-level variability. OBJECTIVE: To examine how neuroticism and dementia interact in the HCU. METHODS: A cross-sectional study was performed on a sample of 76,561 people (2.4% with dementia) from 27 European countries and Israel. Data were analyzed with six steps multilevel non-binomial regression modeling, a statistical method that accounts for correlation in the data taken within the same participant. RESULTS: Both dementia (Incidence Rate Ratio (IRR): 1.537; α= 0.000) and neuroticism (IRR: 1.122; α= 0.000) increased the HCU. The effect of having dementia and the level of neuroticism increased the HCU: around 53.67% for the case of having dementia, and 12.05% for each increment in the level of neuroticism. Conversely, high levels of neuroticism in dementia decreased HCU (IRR: 0.962; α= 0.073). These results remained robust when controlling for age, gender, socioeconomic, and country-levels effects. CONCLUSION: Contrary to previous findings, neuroticism trait in people with dementia decreases the HCU across sociodemographic, socioeconomic, and country heterogeneity. These results, which take into account this personality trait among people with dementia, are relevant for the planning of health and social services.

The prevalence and incidence of progressive supranuclear palsy and corticobasal syndrome: a systematic review and meta-analysis.

INTRODUCTION: Progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS) are progressive neurodegenerative syndromes characterised by Parkinsonism with additional features including cognitive dysfunction, falls, and oculomotor abnormalities. Understanding the epidemiology of these conditions is critical to planning for future service provision. METHODS: We conducted a systematic review of studies reporting incidence and prevalence of CBS and PSP. A search of the PubMed and EMBASE data bases was conducted from their date of inception to 13th July 2021. Meta-analysis of studies sharing similar methodologies was carried out to generate estimated pooled prevalence and incidence. RESULTS: We found 32 studies meeting our criteria for inclusion. There were 20 studies with data on prevalence and 12 with incidence data of PSP. Prevalence of CBS was reported in eight studies while seven studies reported incidence. Reported estimates of prevalence for PSP ranged from 1.00 (0.9-1.1) to 18 (8-28) per 100,000 while prevalence rates for CBS ranged from 0.83 (0.1-3.0) to 25 (0-59). Incidence rates for PSP and CBS respectively ranged from 0.16 (0.07-0.39) to 2.6 per 100,000 person-years and 0.03 (0-0.18) to 0.8 (0.4-1.3) per 100,000 person-years. A random effects model meta-analysis of studies with similar methodologies yielded a pooled prevalence estimate for PSP of 6.92 (4.33-11.06, I2 = 89%, τ2 = 0.3907) and 3.91 (2.03-7.51, I2 = 72%, τ2 = 0.2573) per 100,000 for CBS. CONCLUSION: Studies of the epidemiology of PSP and CBS report highly heterogeneous findings. There is a need for further studies using rigorous phenotyping and the most recent diagnostic criteria to understand the true burden of these conditions.

Is There Evidence of an Association Between Acute Health Care Utilization and Function in Older Adults Over Time? A Population-Based Cohort Study.

Background and Objectives: Acute health care use varies by age, with older adults the highest users of acute health care services. Using data from The Irish Longitudinal Study on Ageing (TILDA), the aim of this study was to investigate the association between acute health care utilization (emergency department [ED] visit with or without hospitalization) at baseline and subjective and objective measures of function measured at 4-year follow-up. Research Design and Methods: This study represents a secondary analysis of a prospective cohort study, where data from Wave 1 (baseline) and Wave 3 of TILDA were analyzed in conjunction with a public and patient involvement group of older adults. Acute health care utilization was defined as an ED visit with or without hospitalization in the previous 12 months. Function was assessed objectively using the Timed Up and Go (TUG) test and a measure of grip strength, and subjectively using self-report limitations in activities of daily living (ADL) and instrumental ADL (IADL). Results: A total of 1 516 participants met the study inclusion criteria. Mean age was 70.9 ± 4.6 years and 48% were male. At baseline, 1 280 participants reported no acute health care use. One hundred and eighteen indicated an ED visit but no hospitalization in the previous 12 months and 118 reported both an ED visit and hospitalization. Adjusting for all covariates, compared to those with no acute health care utilization, those with an ED visit with no hospital admission had poorer TUG performance at follow-up (ß = 0.67, 95% confidence interval: 0.34, 1.29, p = .039). Discussion and Implications: This paper supports previous research that acute health care events, specifically ED usage, are associated with reduced function for older adults as assessed by TUG at follow-up. No associations were observed for grip strength, ADL, or IADL. Further research is required in this area, exploring ED visits and the possible benefits of evaluating older adults at this stage.

A physiotherapy-led transition to home intervention for older adults following Emergency Department discharge: a pilot feasibility randomised controlled trial.

INTRODUCTION: Older adults frequently attend the emergency department (ED) and experience high rates of adverse outcomes following ED presentation including functional decline, ED re-presentation and unplanned hospital admission. Our aim was to evaluate the feasibility of a physiotherapy-led integrated care intervention for older adults discharged from the ED (ED-PLUS). METHODS: Older adults presenting to the ED with undifferentiated medical complaints and discharged within 72 hours were computer randomised in a ratio of 1:1:1 to deliver usual care, Comprehensive Geriatric Assessment (CGA) in the ED, or ED-PLUS (trial registration: NCT04983602). ED-PLUS is an evidence-based and stakeholder-informed intervention to bridge the care transition between the ED and community by initiating a CGA in the ED and implementing a 6-week, multi-component, self-management programme in the patient's own home. Feasibility (recruitment and retention rates) and acceptability of the programme were assessed quantitatively and qualitatively. Functional decline was examined post-intervention using the Barthel Index. All outcomes were assessed by a research nurse blinded to group allocation. RESULTS: Twenty-nine participants were recruited, indicating 97% of our recruitment target; 90% of participants completed the ED-PLUS intervention. All participants expressed positive feedback about the intervention. The incidence of functional decline at 6 weeks was 10% in the ED-PLUS group versus 70%-89% in the usual care and CGA-only groups. DISCUSSION: High adherence and retention rates were observed among participants and preliminary findings indicate a lower incidence of functional decline in the ED-PLUS group. Recruitment challenges existed in the context of COVID-19. Data collection is ongoing for 6-month outcomes.

An Overview of Systematic Reviews and Meta-Analyses on the Effect of Medication Interventions Targeting Polypharmacy for Frail Older Adults.

Frailty refers to the lack of resilience and a reduction in a person's ability to recover following a health problem, and it is increasingly becoming a challenging aspect of ageing populations. Many older adults are exposed to polypharmacy; i.e., they continue to be on medications without timely re-evaluation. Medication reviews have proven successful in managing polypharmacy in the general population, but there is uncertainty regarding their effect among frail older adults. This overview of published systematic reviews assesses the impact of medication reviews on polypharmacy in frail older adults. Embase was searched from its inception to January 2021 and 28 systematic reviews were identified, out of which 10 were included in the overview. Medication reviews were the most common intervention in 8 out of 10 systematic reviews. The frailty score was reported as an outcome in one systematic review that found no evidence for fundamental pharmacological effects on frailty. Six systematic reviews reported a statistically significant reduction in the number of inappropriately prescribed medications. Four systematic reviews reported on hospital admissions, with two of them reporting a decrease in hospitalisations. The quality assessment was moderate in six and critically low in four of the systematic reviews. We conclude that medication reviews help in reducing the use of inappropriate medications in frail older adults, but that there is insufficient evidence in terms of frailty score and hospital admissions.

Cost-effectiveness of clinical interventions for delirium: A systematic literature review of economic evaluations.

OBJECTIVE: Little is known about the economic value of clinical interventions for delirium. This review aims to synthesise and appraise available economic evidence, including resource use, costs, and cost-effectiveness of interventions for reducing, preventing, and treating delirium. METHODS: Systematic review of published and grey literature on full and partial economic evaluations. Study quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). RESULTS: Fourteen economic evaluations (43% full, 57% partial) across nine multicomponent and nonpharmacological intervention types met inclusion criteria. The intervention costs ranged between US$386 and $553 per person in inpatient settings. Multicomponent delirium prevention intervention and the Hospital Elder Life Program (HELP) reported statistically significant cost savings or cost offsets somewhere else in the health system. Cost savings related to inpatient, outpatient, and out-of-pocket costs ranged between $194 and $6022 per person. The average CHEERS score was 74% (±SD 10%). CONCLUSION: Evidence on a joint distribution of costs and outcomes of delirium interventions was limited, varied and of generally low quality. Directed expansion of health economics towards the evaluation of delirium care is necessary to ensure effective implementation that meets patients' needs and is cost-effective in achieving similar or better outcomes for the same or lower cost.

The effectiveness of interventions to reduce adverse outcomes among older adults following Emergency Department discharge: umbrella review.

BACKGROUND: Population ageing is increasing rapidly worldwide. Older adults are frequent users of health care services including the Emergency Department (ED) and experience a number of adverse outcomes following an ED visit. Adverse outcomes include functional decline, unplanned hospital admission and an ED revisit. Given these adverse outcomes a number of interventions have been examined to improve the outcomes of older adults following presentation to the ED. The aim of this umbrella review was to evaluate the effectiveness of ED interventions in reducing adverse outcomes in older adults discharged from the ED. METHODS: Systematic reviews of randomised controlled trials investigating ED interventions for older adults presenting to the ED exploring clinical, patient experience and healthcare utilisation outcomes were included. A comprehensive search strategy was employed in eleven databases and the PROSPERO register up until June 2020. Grey literature was also searched. Quality was assessed using the A MeaSurement Tool to Assess Systematic Reviews 2 tool. Overlap between systematic reviews was assessed using a matrix of evidence table. An algorithm to assign the Grading of Recommendations Assessment, Development and Evaluation to assess the strength of evidence was applied for all outcomes. RESULTS: Nine systematic reviews including 29 randomised controlled trials were included. Interventions comprised of solely ED-based or transitional interventions. The specific interventions delivered were highly variable. There was high overlap and low methodological quality of the trials informing the systematic reviews. There is low quality evidence to support ED interventions in reducing functional decline, improving patient experience and improving quality of life. The quality of evidence of the effectiveness of ED interventions to reduce mortality and ED revisits varied from very low to moderate. Results were presented narratively and summary of evidence tables created. CONCLUSION: Older adults are the most important emerging group in healthcare for several economic, social and political reasons. The existing evidence for the effectiveness of ED interventions for older adults is limited. This umbrella review highlights the challenge of synthesising evidence due to significant heterogeneity in methods, intervention content and reporting of outcomes. Higher quality intervention studies in line with current geriatric medicine research guidelines are recommended, rather than the publication of further systematic reviews. TRIAL REGISTRATION: UMBRELLA REVIEW REGISTRATION: PROSPERO ( CRD42020145315 ).

Value of Nonpharmacological Interventions for People With an Acquired Brain Injury: A Systematic Review of Economic Evaluations.

OBJECTIVES: Acquired brain injury (ABI) has long-lasting effects, and patients and their families require continued care and support, often for the rest of their lives. For many individuals living with an ABI disorder, nonpharmacological rehabilitation treatment care has become increasingly important care component and relevant for informed healthcare decision making. Our study aimed to appraise economic evidence on the cost-effectiveness of nonpharmacological interventions for individuals living with an ABI. METHODS: This systematic review was registered in PROSPERO (CRD42020187469), and a protocol article was subject to peer review. Searches were conducted across several databases for articles published from inception to 2021. Study quality was assessed according the Consolidated Health Economic Evaluation Reporting Standards checklist and Population, Intervention, Control, and Outcomes criteria. RESULTS: Of the 3772 articles reviewed 41 publications met the inclusion criteria. There was a considerable heterogeneity in methodological approaches, target populations, study time frames, and perspectives and comparators used. Keeping these issues in mind, we find that 4 multidisciplinary interventions studies concluded that fast-track specialized services were cheaper and more cost-effective than usual care, with cost savings ranging from £253 to £6063. In 3 neuropsychological studies, findings suggested that meditated therapy was more effective and saved money than usual care. In 4 early supported discharge studies, interventions were dominant over usual care, with cost savings ranging from £142 to £1760. CONCLUSIONS: The cost-effectiveness evidence of different nonpharmacological rehabilitation treatments is scant. More robust evidence is needed to determine the value of these and other interventions across the ABI care pathway.

Healthcare costs of dementia diseases before, during and after diagnosis: Longitudinal analysis of 17 years of Swedish register data.

INTRODUCTION: This study examines health-care costs attributed to dementia diseases in the 10 years prior to, during, and 6 years after diagnosis. METHODS: Using administrative register data for people diagnosed with dementia (2010-2016) in southern Sweden (n = 21,184), and a comparison group without dementia, health-care costs over 17 years were examined using longitudinal regression analysis. RESULTS: Average annual health-care costs per person were consistently higher before diagnosis in the dementia group (10 years before: Swedish krona (SEK) 2063, P < .005 and 1 year before: SEK8166, P < .005). At diagnosis, health-care costs were more than twice as high (SEK44,410, P < .005). Four to 6 years after diagnosis, there was no significant different in costs compared to comparators. DISCUSSION: Excess health-care cost arise as early as 10 years before a formal diagnosis of dementia, and while there is a spike in cost after diagnosis, health-care costs are no different 4 years after. These findings question currently accepted assumptions on costs of dementia.

A physiotherapy-led transition to home intervention for older adults following emergency department discharge: protocol for a pilot feasibility randomised controlled trial.

BACKGROUND: Older adults frequently attend the emergency department (ED) and experience high rates of adverse outcomes following ED presentation including functional decline, ED re-presentation and unplanned hospital admission. The development of effective interventions to prevent such outcomes is a key priority for research and service provision. This paper reports a protocol designed to evaluate the feasibility of conducting a three arm randomised controlled trial (RCT) within the ED setting and in the patient's home. The interventions are comprehensive geriatric assessment (CGA), ED PLUS and usual care. METHODS: The ED PLUS pilot trial is designed as a feasibility RCT conducted in the ED and Acute Medical Assessment Unit of a university teaching hospital in the mid-west region of Ireland. We aim to recruit 30 patients, aged 65 years and over presenting to the ED with undifferentiated medical complaints and discharged within 72 h of index visit. Patients will be randomised by a computer in a ratio of 1:1:1 to deliver usual care, CGA or ED PLUS during a 6-month study period. A randomised algorithm is used to perform randomization. CGA will include a medical assessment, medication review, nursing assessment, falls assessment, assessment of mobility and stairs, transfers, personal care, activities of daily living (ADLs), social supports and baseline cognition. ED PLUS, a physiotherapist led, multidisciplinary intervention, aims to bridge the transition of care between the index visit to the ED and the community by initiating a CGA intervention in the ED and implementing a 6-week follow-up self-management programme in the patient's own home following discharge from the ED. The outcomes will be parameters of the feasibility of the intervention and trial methods and will be assessed quantitatively and qualitatively. DISCUSSION: Rising ED visits and an ageing population with chronic health issues render ED interventions to reduce adverse outcomes in older adults a research priority. This feasibility RCT will generate data and experience to inform the conduct and delivery of a definite RCT. TRIAL REGISTRATION: The trial was registered in Clinical Trials Protocols and Results System as of 21st July 2021, with registration number NCT049836020 .

Comparison of published core outcome sets with outcomes recommended in regulatory guidance from the US Food and Drug Administration and European Medicines Agency: cross sectional analysis.

Objective: To compare the outcomes in published core outcome sets with the outcomes recommended in corresponding guidance documents from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), matched by health condition. Design: Cross sectional analysis. Setting: US and Europe. Population: Sample of core outcome sets related to drugs, devices, and gene therapy that involved patients in the consensus process, published between 1 January 2015 and 31 December 2019; and corresponding EMA and FDA guidance documents. Main outcome measures: The extent of matches between outcomes included within core outcome sets and those recommended in corresponding EMA and FDA guidance documents were assessed. Matches were considered to be general (ie, non-specific) or specific (ie, exact). General matches were assessed to determine whether the core outcome set or guidance document outcome was narrower. Results: Relevant guidance documents were found for for 38 (39%) of 98 eligible published core outcome sets. Among outcomes in core outcome sets, medians of 70% (interquartile range 48-86%) and 52% (33-77%) were matches with outcomes recommended in EMA and FDA documents, respectively. Medians of 46% (27-68%) and 26% (18-46%) were specific matches with outcomes in EMA and FDA documents, respectively. When outcomes were generally matched, the outcomes from core outcome sets were more frequently narrower than the regulatory outcomes (83% and 75% for EMA and FDA, respectively). Conclusion: Greater adoption of, and reference to, core outcome sets in regulatory guidance documents can encourage clinical trialists, especially those in industry, to measure and report consistent and agreed outcomes and improve the quality of guidance. Given the overlap between outcomes in core outcome sets and regulatory guidance, and given that most core outcome sets now involve patients in the consensus process, these sets could serve as a useful resource for regulators when recommending outcomes for studies evaluating regulated products. Developers are encouraged to appraise recommended outcomes in salient regulatory documents when planning a core outcome set.

Representation of published core outcome sets for research in regulatory guidance: protocol.

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 2015-2019 with patient involvement and covering drug or device interventions will be compared against relevant regulatory guidelines, matched by condition. Guidance documents which match in scope (relating to intervention and population) to a COS for research will be scrutinised to identify all suggested outcomes for comparison against the core outcomes in the corresponding COS. Discussion: This study will identify variation between outcomes suggested in EMA and FDA regulatory guidance relative to outcomes included in published COS for research, thus demonstrating the degree of representation of COS in regulatory guidance and vice versa. If the findings of this study reveal a lack of concordance between COS and regulatory guidance overall or for particular disease areas, we will invite feedback from FDA and EMA and will seek to highlight where findings support the recommendations towards using well-developed COS or will make recommendations to COS developers on outcomes of importance to these key regulators.

Building clinically relevant outcomes across the Alzheimer's disease spectrum.

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.

Impact of assessment and intervention by a health and social care professional team in the emergency department on the quality, safety, and clinical effectiveness of care for older adults: A randomised controlled trial.

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 the ED; hospital length of stay for admitted patients; patient satisfaction with index visit; ED revisits, mortality, nursing home admission, and unscheduled hospital admission at 30-day and 6-month follow-up; and patient functional status and quality of life (at index visit and follow-up). Demographic information included the patient's gender, age, marital status, residential status, mode of arrival to the ED, source of referral, index complaint, triage category, falls, and hospitalisation history. Participants in the intervention group (n = 176) experienced a significantly shorter ED stay than the control group (n = 177) (6.4 versus 12.1 median hours, p < 0.001). Other significant differences (intervention versus control) included lower rates of hospital admissions from the ED (19.3% versus 55.9%, p < 0.001), higher levels of satisfaction with the ED visit (p = 0.008), better function at 30-day (p = 0.01) and 6-month follow-up (p = 0.03), better mobility (p = 0.02 at 30 days), and better self-care (p = 0.03 at 30 days; p = 0.009 at 6 months). No differences at follow-up were observed in terms of ED re-presentation or hospital admission. Study limitations include the inability to blind patients or ED staff to allocation due to the nature of the intervention, and a focus on early assessment and intervention in the ED rather than care integration following discharge. CONCLUSIONS: Early assessment and intervention by a dedicated ED-based HSCP team reduced ED length of stay and the risk of hospital admissions among older adults, as well as improving patient satisfaction. Our findings support the effectiveness of an interdisciplinary model of care for key ED outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03739515; registered on 12 November 2018.