• A randomised controlled trial of calcium channel blockade (CCB) with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT): Study protocol

      Jones, Rob G. (2016)
      Background: Vascular dementia is the second most common cause of dementia affecting over seven million people worldwide, yet there are no licensed treatments. There is an urgent need for a clinical trial in this patient group. Subcortical ischaemic vascular dementia is the most common variant of vascular dementia. This randomised trial will investigate whether use of calcium channel blockade with amlodipine, a commonly used agent, can provide the first evidence-based pharmacological treatment for subcortical ischaemic vascular dementia. Methods/Design: This is a randomised controlled trial of calcium channel blockade with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT) to test the hypothesis that treatment with amlodipine can improve outcomes for these patients in a phase IIb, multi-centre, double-blind, placebo-controlled randomised trial. The primary outcome is the change from baseline to 12 months in the Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog). Secondary outcomes include cognitive function, executive function, clinical global impression of change, change in blood pressure, quantitative evaluation of lesion accrual based on magnetic resonance imaging (MRI), health-related quality of life, activities of daily living, non-cognitive dementia symptoms, care-giver burden and care-giver health-related quality of life, cost-effectiveness and institutionalisation. A total of 588 patients will be randomised in a 1:1 ratio to either amlodipine or placebo, recruited from sites across the UK and enrolled in the trial for 104 weeks. Discussion: There are no treatments licensed for vascular dementia. The most common subtype is subcortical ischaemic vascular dementia (SIVD). This study is designed to investigate whether amlodipine can produce benefits compared to placebo in established SIVD. It is estimated that the numbers of people with VaD and SIVD will increase globally in the future and the results of this study should inform important treatment decisions. Trial registration: Current Controlled Trials ISRCTN31208535. Registered on 7 March 2014. Copyright © 2016 Greenan et al.
    • A strategy for Switzerland

      Dening, Karen H.; Dening, Tom (2014)
      Johanna Niederberger-Burgherr, Karen Harrison Dening and Tom Dening introduce Switzerland’s new national dementia strategy and show how an innovative new course is preparing nurses to deliver on some of the strategy’s goals
    • A systematic review of dementia focused assistive technology

      Craven, Michael P. (2015)
      This paper presents a systematic review which explores the nature of assistive technologies currently being designed, developed and evaluated for dementia sufferers and their carers. A search through four large databases, followed by filtering by relevance, led to the identification and subsequent review of papers. Our review revealed that the majority of research in this area focuses on the support of day-to-day living activities, safety monitoring, memory aids and preventing social isolation. We conclude that the majority of AT currently available support day-to-day living activities, safety monitoring and assisting healthcare. However these devices merely address the ‘ease of living’ rather than focusing on ‘quality of life’. Although there are some devices which address social symptoms of Dementia, few address behavioural issues such as aggression and virtually none are available to support recreational activities. After discussing the implications of these findings, we finally reflect on general design issues for assistive technologies in this domain that became apparent during the review. © Springer International Publishing Switzerland 2015
    • A systematic review of the relationship between behavioral and psychological symptoms (BPSD) and caregiver well-being

      Orrell, Martin (2016)
      Background:: Behavioral and psychological symptoms in dementia (BPSD) are important predictors of institutionalization as well as caregiver burden and depression. Previous reviews have tended to group BPSD as one category with little focus on the role of the individual symptoms. This review investigates the role of the individual symptoms of BPSD in relation to the impact on different measures of family caregiver well-being. Methods:: Systematic review and meta-analysis of papers published in English between 1980 and December 2015 reporting which BPSD affect caregiver well-being. Paper quality was appraised using the Downs and Black Checklist (1998). Results:: Forty medium and high quality quantitative papers met the inclusion criteria, 16 were suitable to be included in a meta-analysis of mean distress scores. Depressive behaviors were the most distressing for caregivers followed by agitation/aggression and apathy. Euphoria was the least distressing. Correlation coefficients between mean total behavior scores and mean distress scores were pooled for four studies. Irritability, aberrant motor behavior and delusions were the most strongly correlated to distress, disinhibition was the least correlated. Conclusions:: The evidence is not conclusive as to whether some BPSD impact caregiver well-being more than others. Studies which validly examined BPSD individually were limited, and the included studies used numerous measures of BPSD and numerous measures of caregiver well-being. Future research may benefit from a consistent measure of BPSD, examining BPSD individually, and by examining the causal mechanisms by which BPSD impact well-being by including caregiver variables so that interventions can be designed to target BPSD more effectively. Copyright © International Psychogeriatric Association 2016
    • A two decade dementia incidence comparison from the Cognitive Function and Ageing Studies I and II

      Dening, Tom (2016)
      Dramatic global increases in future numbers of people with dementia have been predicted. No multicentre population-based study powered to detect changes over time has reported dementia incidence. MRC Cognitive Function and Ageing Study (CFAS) undertook baseline interviews in populations aged 65+ years in England and Wales (1989-1994). Three areas (CFAS I) were selected for new sampling two decades later (2008-2011) with same geographical boundaries, sampling and approach methods (CFAS II). At 2 years CFAS I interviewed 5,156 (76% response) with 5,288 interviewed in CFAS II (74% response). Here we report a 20% drop in incidence (95% CI: 0-40%), driven by a reduction in men across all ages above 65. In the UK we estimate 209,600 new dementia cases per year. This study was uniquely designed to test for differences across geography and time. A reduction of age-specific incidence means that the numbers of people estimated to develop dementia in any year has remained relatively stable.
    • Access to timely formal care in dementia: Baseline results of the Actifcare cohort study with a focus on the Portuguese sample

      Orrell, Martin (2016)
      Introduction: Persons with dementia (PwD) and their informal carers have unmet needs, partly related to untimely access to services (e.g. day care, home support). We lack international comparisons on how these issues impact on quality of life, namely in the intermediate stages of dementia. The Actifcare (ACcess to Timely Formal Care) EU-JPND project aims to evaluate access to and (non)utilization of dementia formal care in eight countries (The Netherlands, UK, Germany, Sweden, Norway, Ireland, Italy, Portugal), as related to unmet needs and quality of life. Methods: Besides conducting reviews on access/utilization of services and qualitative explorations of PwD, carers and professionals' views, Actifcare includes a prospective study (one year follow-up) of PwD and their informal carers. Assessments include the Camberwell Assessment of Need for the Elderly and QoL-AD. We describe the baseline characteristics of our cohort, focusing on Portuguese data (FCT-JPND-HC/0001/2012). Results: We recruited 453 dyads (n = 66 in Portugal), generally interviewed at home. PwD were mostly women (54%), aged 47-98 years; Alzheimer's disease was the most frequent diagnosis (48%). Carers were spouses (60%), women (66%), mean age 66 (SD = 14) years. In Portugal, recruitment took place in primary care, neurology and psychiatry outpatient services, NGOs and Alzheimer Portugal. Conclusions: The cohort study is being successfully conducted. By mid-2016, we will start to analyse international differences regarding the (un)timely access to services and its impact on quality of life and needs for care. Some differences amongst countries are already becoming apparent. We hope to contribute significantly to best practice recommendations in dementia.
    • Achieving Quality and Effectiveness in Dementia Using Crisis Teams (AQUEDUCT): a study protocol for a randomised controlled trial of a Resource Kit

      Coleston-Shields, Donna M.; Challis, David; Worden, Angela; Broome, Emma; Dening, Tom; Guo, Boliang; Prothero, David; Orrell, Martin (2022)
      Improving care at home for people with dementia is a core policy goal in the dementia strategies of many European countries. A challenge to effective home support is the occurrence of crises in the care of people with dementia which arise from changes in their health and social circumstances. Improving the management of these crises may prevent hospital admissions and facilitate better and longer care at home. This trial is part of a National Institute for Health Research funded programme, AQUEDUCT, which aims to improve the quality and effectiveness of teams working to manage crises in dementia.
    • Actively involving people with dementia in qualitative research

      Repper, Julie (2010)
      Aims and objectives. This paper aims to: Consider the major challenges to involving people with dementia in qualitative research. Critique a process consent framework. Demonstrate the need for nurses and researchers to explore these issues in research and practice with people with dementia. Consider the impact of the Mental Capacity Act 2005 on research with people with dementia. To achieve its aims, the authors will draw on current literature and use examples which explores the use of life story work with people with dementia by taking a qualitative approach. Background. There is acceptance that researchers should consider ways of actively involving people with dementia in research as participants where appropriate to answering specific research questions. Process consent methods have been advocated as an ethical way forward in recruiting and gaining consent for people with dementia, the Mental Capacity Act offers guidance to both practitioners and researchers. Design and method. This paper does not seek to be a comprehensive review of the current literature but is a discussion paper appraising a process consent framework against current literature and drawing on the lead author's PhD study, exploring life story work with older people with dementia. Results and conclusions. The Mental Capacity Act and process consent frameworks compliment one another, and their use should be considered when researching issues affecting older people with dementia. Researchers and practitioners should work more closely to ensure that the principles of process consent are achieved. Process consent models can equally be applied to everyday nursing practice. Relevance to clinical practice. Process consent models can provide an ethical and practical framework to ensure that consent is continually assessed in people with dementia with all clinical interventions. The paper also draws on literature exploring practical ways of involving people with dementia in evaluating service delivery.
    • Adherence to exercise interventions in older people with mild cognitive impairment and dementia: A systematic review and meta-analysis

      Di Lorito, Claudio; Bosco, Alessandro (2020)
      Adherence to physical exercise is associated with multiple benefits in people with mild cognitive impairment (MCI) and dementia. Given the gap in research, this systematic literature review aimed to determine in the context of exercise intervention studies for people with MCI and dementia: 1. How adherence is defined, monitored and recorded; 2. Adherence rates; 3. Attrition, compliance and adverse events and 4. Intervention characteristics associated with adherence. Embase, Medline, PsychInfo, SPORTDiscus, AMED, CINAHL and the International Bibliography of Social Sciences were searched in November 2018. The data were analyzed through descriptive and correlation/inferential statistics. Forty-one studies were included, 34 involving participants with dementia (n = 2149) and seven participants with MCI (n = 970). Half of the studies operationally defined adherence. Mean adherence rate was 70% [CI, 69–73%]. Adherence was significantly associated with endurance/resistance training, and interventions not including walking. The review found a lack of consistency around reporting of adherence and of key variables mediating adherence, including compliance, attrition and adverse events. Further research using more reliable measures is needed to confirm whether a correlation exists between length of interventions and adherence in participants with MCI and dementia and to identify the factors or strategies that mediate adherence in this population. Relevant implications for practice include a consideration in the development of new interventions of elements associated with higher adherence in this review, such as endurance/resistance training, and the provision of exercise in group formats.
    • Agency in dementia care: Systematic review and meta-ethnography

      Bosco, Alessandro; Coleston-Shields, Donna M.; Jawahar, Kaanthan (2019)
      Objectives: Dementia often limits the agency of the person to such an extent that there is need for external support in making daily life decisions. This support is usually provided by family members who are sometimes legally empowered to engage in decision-making on behalf of the person for whom they care. However, such family carers receive little or no information on how to best provide support when there is a lack of capacity. This may have an impact on the agency of the person with dementia. This review explores the experience of agency in people living with dementia. <br/>Design(s): A systematic search was conducted on IBSS, MedLine, PsychINFO, EMBASE, and CINAHL. Two independent researchers screened the studies and conducted the quality appraisal. We used meta-ethnography for data analysis. As part of the synthesis, we identified behavioral mechanisms underlying the process of decision-making and looked at how the support of carers comes into play in making deliberate choices. <br/>Result(s): The meta-ethnography involved 20 studies. Three levels of third-order constructs were identified, each describing a decision-making pathway and reflecting the degree of autonomy of the person with dementia: autonomous decision-making, shared decision-making, and pseudo decision-making. Findings highlight those inter-relational processes that promote or negatively impact on the agency of people with dementia. <br/>Conclusion(s): Our review will provide health and social care personnel with an understanding of the role of the carer in the decision-making process, and therefore which mechanisms need to be promoted or discouraged through training.<br/>Copyright &#xa9; International Psychogeriatric Association 2018.
    • An evaluation of a specialist multiagency home support service for older people with dementia using qualitative methods

      Rothera, Ian; Waite, Jonathan (2008)
      Background: Standard home care support for people with dementia has been criticised in statutory inspection reports, and may lead to unnecessary crises, hospital or care home admissions.; Objective: To establish whether a specialist multiagency home care service for older people with dementia delivered better quality care than standard services, and how any improvements were achieved.; Design: Qualitative study, using semi-structured interviews, focus groups and small group interviews.; Setting: Two demographically similar areas in Nottingham, one served by a specialist home care team, the other by standard services.; Participants: Twenty-seven service users, 18 family carers, 17 home care workers, 20 health/social care professionals, across both services.; Results: The specialist service demonstrated greater flexibility and responsiveness to the particular needs and circumstances of service users and family carers, who were encouraged to participate in routine decision-making and activities. By sharing responsibilities, the specialist service helped reduce carer stress and prevent crises. These outcomes depended on the configuration of the service, including multidisciplinary health and social services input, careworker autonomy and independence, continuous reassessment of clients' circumstances and preferences and the capacity to develop long-term relationships, through careworker continuity. The standard service, which used a task-orientated approach, lacked these characteristics.; Conclusions: This study provides evidence of the benefits of a specialist multiagency home support service over standard home care, in the opinion of service users, carers and careworkers, and defines the operational model that achieves this. Findings confirm best practice recommendations, based on models of dementia care which emphasise respect for 'personhood'.;
    • Analysing the use of music to facilitate social interaction in care home residents with dementia: Narrative synthesis systematic review

      Waters, Bryony; Orrell, Martin; McDermott, Orii (2022)
      IntroductionIndividuals with dementia residing in care homes can rely heavily on care staff to access activities and meaningful interactions. Previous research suggests that care home interactions can be short, fragmented and task-orientated due to staff workload and residents? language impairments. However, music has the potential to be an alternative communication form that remains intact in the later stages of dementia. This systematic review aims to explore how care home music interventions can facilitate social interactions.MethodsA narrative synthesis was conducted to explore the mechanisms behind how and why care home music intervention facilitate social interactions. The four-element framework guided analysis; (1) Developing a theory, (2) Developing a preliminary synthesis, (3) Exploring relationships, (4) Assessing robustness.FindingsThe final synthesis included 23 articles. The studies consisted of music therapy sessions, personalised music listening, structured music singing or instrument playing sessions and music therapeutic care. Despite the difference in music interventions, most studies reported an increase in residents? sociable verbal and non-verbal communication and a decrease in unsociable communication. Music interventions allowed residents to reminisce, express themselves, focus and connect with others.DiscussionThe studies highlighted music interventions are accessible to all residents with dementia despite their impairments. The adaptability allows individuals to continue to connect and express themselves even when language deteriorates. More research is needed into the enablers and barriers to implementing interventions into practice, as this systematic review has highlighted that some form of music intervention for all residents can be highly beneficial. Care homes use of music could increase social interactions and meaningful activities.
    • Anticholinergic drug exposure and the risk of dementia: A nested case-control study

      Dening, Tom; Morriss, Richard K. (2019)
      Importance: Anticholinergic medicines have short-term cognitive adverse effects, but it is uncertain whether long-term use of these drugs is associated with an increased risk of dementia.Objective: To assess associations between anticholinergic drug treatments and risk of dementia in persons 55 years or older.Design, Setting, and Participants: This nested case-control study took place in general practices in England that contributed to the QResearch primary care database. The study evaluated whether exposure to anticholinergic drugs was associated with dementia risk in 58 769 patients with a diagnosis of dementia and 225 574 controls 55 years or older matched by age, sex, general practice, and calendar time. Information on prescriptions for 56 drugs with strong anticholinergic properties was used to calculate measures of cumulative anticholinergic drug exposure. Data were analyzed from May 2016 to June 2018.Exposures: The primary exposure was the total standardized daily doses (TSDDs) of anticholinergic drugs prescribed in the 1 to 11 years prior to the date of diagnosis of dementia or equivalent date in matched controls (index date).Main Outcomes and Measures: Odds ratios (ORs) for dementia associated with cumulative exposure to anticholinergic drugs, adjusted for confounding variables.Results: Of the entire study population (284 343 case patients and matched controls), 179 365 (63.1%) were women, and the mean (SD) age of the entire population was 82.2 (6.8) years. The adjusted OR for dementia increased from 1.06 (95% CI, 1.03-1.09) in the lowest overall anticholinergic exposure category (total exposure of 1-90 TSDDs) to 1.49 (95% CI, 1.44-1.54) in the highest category (>1095 TSDDs), compared with no anticholinergic drug prescriptions in the 1 to 11 years before the index date. There were significant increases in dementia risk for the anticholinergic antidepressants (adjusted OR [AOR], 1.29; 95% CI, 1.24-1.34), antiparkinson drugs (AOR, 1.52; 95% CI, 1.16-2.00), antipsychotics (AOR, 1.70; 95% CI, 1.53-1.90), bladder antimuscarinic drugs (AOR, 1.65; 95% CI, 1.56-1.75), and antiepileptic drugs (AOR, 1.39; 95% CI, 1.22-1.57) all for more than 1095 TSDDs. Results were similar when exposures were restricted to exposure windows of 3 to 13 years (AOR, 1.46; 95% CI, 1.41-1.52) and 5 to 20 years (AOR, 1.44; 95% CI, 1.32-1.57) before the index date for more than 1095 TSDDs. Associations were stronger in cases diagnosed before the age of 80 years. The population-attributable fraction associated with total anticholinergic drug exposure during the 1 to 11 years before diagnosis was 10.3%.Conclusions and Relevance: Exposure to several types of strong anticholinergic drugs is associated with an increased risk of dementia. These findings highlight the importance of reducing exposure to anticholinergic drugs in middle-aged and older people.
    • Anticholinergic drugs and risk of dementia: Time for action?

      Orrell, Martin (2021)
      Evidence suggests that the prescription of bladder anticholinergics is increasing. Recent studies have accentuated concerns about whether certain prescribed medications could increase risk of dementia, including anticholinergic drugs, and specifically anticholinergics used for bladder symptoms. Nevertheless, it can be difficult to draw together the evidence to review the case for possible causation. Recognising this issue in 1965, Bradford-Hill set out nine criteria to help assess whether evidence of a causal relationship could be inferred between a presumed cause and an observed effect. In this commentary, we explore the extent to which associations between anticholinergics and dementia satisfy the Bradford-Hill criteria and examine the potential implications. First, we look at studies that have examined the relationship between anticholinergic drugs with urological properties (bladder drugs) and the onset of dementia, and then present those studies which specifically focus on the cognitive effects of bladder drugs that affect muscarinic receptors in the brain versus the bladder on older people along with suggestions for future research. We also discuss the risks and benefits of these drugs for treating overactive bladder. If it can be shown that certain medications carry a specific risk of dementia, it is possible that initiatives to change prescribing could become a key tool in reducing the risk of dementia and may be easier to implement than some lifestyle changes.
    • Apathy and its response to antipsychotic review and nonpharmacological interventions in people with dementia living in nursing homes: WHELD, a factorial cluster randomized controlled trial

      Orrell, Martin (2016)
      OBJECTIVES: Apathy is common, impactful, and difficult to manage in people with dementia. We evaluated the efficacy of nonpharmacological interventions, exercise, and social interaction, in combination with antipsychotic review, to reduce apathy in people with dementia living in nursing homes in a cluster randomized controlled trial (RCT).
    • Applying a new concept of embedding qualitative research: an example from a quantitative study of carers of people with later stage dementia

      Challis, David (2019)
      BACKGROUND: Qualitative methods are increasingly included in larger studies to provide a richer understanding of people's experience. This paper explores the potential of using a novel approach to embedded qualitative design as part of an observational study examining the effectiveness of home support for people in later stage dementia in England. The method involved collecting and analysing unsolicited conversational comments made by participants as they completed standardised measures. An evaluation of the method is presented using the voices of participants to illustrate its potential. METHODS: The conversations of 17 carers recruited to an observational study were audio recorded to gather commentary made while completing a structured interview. Data were interrogated using thematic analysis to investigate the feasibility of conducting an embedded qualitative study, the potential richness of the material and participants' reactions to formal questioning and participating in research. RESULTS: The findings revealed that qualitative data were available from this approach. Analysis generated three themes from carers: conflicting carer emotions; the importance of maintaining normality and agency within day-to-day life; and tensions between these desires and making use of formal services. Important issues for carers were revealed establishing the benefit of using the method. The advantages of exploiting unsolicited conversation included enhancing understanding of people's lived experience, reducing participant burden in research and easing the process of data collection. In addition, it provided an opportunity to evaluate individuals' experience of the research process. CONCLUSIONS: The findings demonstrate how unsolicited comments during structured interviews may appear incidental but can reveal important aspects of living with dementia. The method also emphasised methodological challenges for research in dementia, including the influence and impact of the research context. Further research is required to evaluate the method with other groups including people with dementia themselves.
    • AQUEDUCT intervention for crisis team quality and effectiveness in dementia: Protocol for a feasibility study

      Broome, Emma; Coleston-Shields, Donna M.; Dening, Tom; Stanyon, Miriam R.; Orrell, Martin (2020)
      BACKGROUNDSpecialist community teams often support people with dementia who experience crisis. These teams may vary in composition and models of practice, which presents challenges when evaluating their effectiveness. A best practice model for dementia crisis services could be used by teams to improve the quality and effectiveness of the care they deliver.OBJECTIVEThe aim of this study is to examine the feasibility of conducting a large-scale randomized controlled trial comparing the AQUEDUCT (Achieving Quality and Effectiveness in Dementia Using Crisis Teams) Resource Kit intervention to treatment as usual.METHODSThis is a multisite feasibility study in preparation for a future randomized controlled trial. Up to 54 people with dementia (and their carers) and 40 practitioners will be recruited from 4 geographically widespread teams managing crisis in dementia. Quantitative outcomes will be recorded at baseline and at discharge. This study will also involve a nested health economic substudy and qualitative research to examine participant experiences of the intervention and acceptability of research procedures.RESULTSEthical approval for this study was granted in July 2019. Participant recruitment began in September 2019, and as of September 2020, all data collection has been completed. Results of this study will establish the acceptability of the intervention, recruitment rates, and will assess the feasibility and appropriateness of the outcome measures in preparation for a large-scale randomized controlled trial.CONCLUSIONSThere is a need to evaluate the effectiveness of crisis intervention teams for older people with dementia. This is the first study to test the feasibility of an evidence-based best practice model for teams managing crisis in dementia. The results of this study will assist in the planning and delivery of a large-scale randomized controlled trial.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)DERR1-10.2196/18971.
    • The arts as a medium for care and self-care in dementia: Arguments and evidence

      Schneider, Justine (2018)
      The growing prevalence of dementia, combined with an absence of effective pharmacological treatments, highlights the potential of psychosocial interventions to alleviate the effects of dementia and enhance quality of life. With reference to a manifesto from the researcher network Interdem, this paper shows how arts activities correspond to its definition of psycho-social care. It presents key dimensions that help to define different arts activities in this context, and illustrates the arts with reference to three major approaches that can be viewed online; visual art, music and dance. It goes on to discuss the features of each of these arts activities, and to present relevant evidence from systematic reviews on the arts in dementia in general. Developing the analysis into a template for differentiating arts interventions in dementia, the paper goes on to discuss implications for future research and for the uptake of the arts by people with dementia as a means to self-care.
    • Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial

      Majid, Shazmin (2021)
      Background: Understanding intervention delivery as intended, particularly in complex interventions, should be underpinned by good quality fidelity assessment. We present the findings from a fidelity assessment embedded as part of a trial of a complex community-based psychosocial intervention, Journeying through Dementia (JtD). The intervention was designed to equip individuals with the knowledge and skills to successfully self-manage, maintain independence, and live well with dementia and involves both group and individual sessions. The methodological challenges of developing a conceptual framework for fidelity assessment and creating and applying purposely designed measures derived from this framework are discussed to inform future studies.Methods: A conceptual fidelity framework was created out of core components of the intervention (including the intervention manual and training for delivery), associated trial protocols and pre-defined fidelity standards and criteria against which intervention delivery and receipt could be measured. Fidelity data collection tools were designed and piloted for reliability and usability. Data collection in four selected sites (fidelity sites) was via non-participatory observations of the group aspect of the intervention, attendance registers and interventionist (facilitator and supervisor) self-report.Results: Interventionists from all four fidelity sites attended intervention training. The majority of group participants at the four sites (71%) received the therapeutic dose of 10 out of 16 sessions. Weekly group meeting attendance (including at 'out of venue' sessions) was excellent at 80%. Additionally, all but one individual session was attended by the participants who completed the intervention. It proved feasible to create tools derived from the fidelity framework to assess in-venue group aspects of this complex intervention. Results of fidelity assessment of the observed groups were good with substantial inter-rater reliability between researchers KAPPA 0.68 95% CI (0.58-0.78). Self-report by interventionists concurred with researcher assessments.Conclusions: There was good fidelity to training and delivery of the group aspect of the intervention at four sites. However, the methodological challenges of assessing all aspects of this complex intervention could not be overcome due to practicalities, assessment methods and ethical considerations. Questions remain regarding how we can assess fidelity in community-based complex interventions without impacting upon intervention or trial delivery.Trial Registration: ISRCTN17993825 .
    • Assessing the predictive validity of simple dementia risk models in harmonized stroke cohorts

      Stephan, Blossom C. M. (2020)
      BACKGROUND AND PURPOSEStroke is associated with an increased risk of dementia. To assist in the early identification of individuals at high risk of future dementia, numerous prediction models have been developed for use in the general population. However, it is not known whether such models also provide accurate predictions among stroke patients. Therefore, the aim of this study was to determine whether existing dementia risk prediction models that were developed for use in the general population can also be applied to individuals with a history of stroke to predict poststroke dementia with equivalent predictive validity.METHODSData were harmonized from 4 stroke studies (follow-up range, ≈12-18 months poststroke) from Hong Kong, the United States, the Netherlands, and France. Regression analysis was used to test 3 risk prediction models: the Cardiovascular Risk Factors, Aging and Dementia score, the Australian National University Alzheimer Disease Risk Index, and the Brief Dementia Screening Indicator. Model performance or discrimination accuracy was assessed using the C statistic or area under the curve. Calibration was tested using the Grønnesby and Borgan and the goodness-of-fit tests.RESULTSThe predictive accuracy of the models varied but was generally low compared with the original development cohorts, with the Australian National University Alzheimer Disease Risk Index (C-statistic, 0.66) and the Brief Dementia Screening Indicator (C-statistic, 0.61) both performing better than the Cardiovascular Risk Factors, Aging and Dementia score (area under the curve, 0.53).CONCLUSIONSDementia risk prediction models developed for the general population do not perform well in individuals with stroke. Their poor performance could have been due to the need for additional or different predictors related to stroke and vascular risk factors or methodological differences across studies (eg, length of follow-up, age distribution). Future work is needed to develop simple and cost-effective risk prediction models specific to poststroke dementia.