Journal articles
Allan LM (In Press). Is it possible to Develop a complex Intervention to improve the outcome of Fall-Related Injuries in people with Dementia? a mixed methods study to develop and assess the feasibility of the DIFRID intervention. Health Technology Assessment
Banerjee S, Farina N, Henderson C, High J, Stirling S, Shepstone L, Fountain J, Ballard C, Bentham P, Burns A, et al (2023). A pragmatic, multicentre, double-blind, placebo-controlled randomised trial to assess the safety, clinical and cost-effectiveness of mirtazapine and carbamazepine in people with Alzheimer's disease and agitated behaviours: the HTA-SYMBAD trial.
Health technology assessment (Winchester, England),
27(23), 1-108.
Abstract:
A pragmatic, multicentre, double-blind, placebo-controlled randomised trial to assess the safety, clinical and cost-effectiveness of mirtazapine and carbamazepine in people with Alzheimer's disease and agitated behaviours: the HTA-SYMBAD trial.
BackgroundAgitation is common and impacts negatively on people with dementia and carers. Non-drug patient-centred care is first-line treatment, but we need other treatment when this fails. Current evidence is sparse on safer and effective alternatives to antipsychotics.ObjectivesTo assess clinical and cost-effectiveness and safety of mirtazapine and carbamazepine in treating agitation in dementia.DesignPragmatic, phase III, multicentre, double-blind, superiority, randomised, placebo-controlled trial of the clinical effectiveness of mirtazapine over 12 weeks (carbamazepine arm discontinued).SettingTwenty-six UK secondary care centres.ParticipantsEligibility: probable or possible Alzheimer's disease, agitation unresponsive to non-drug treatment, Cohen-Mansfield Agitation Inventory scoreâ€
≥â€
45.InterventionsMirtazapine (target 45 mg), carbamazepine (target 300 mg) and placebo.Outcome measuresPrimary: Cohen-Mansfield Agitation Inventory score 12 weeks post randomisation. Main economic outcome evaluation: incremental cost per six-point difference in Cohen-Mansfield Agitation Inventory score at 12 weeks, from health and social care system perspective. Data from participants and informants at baseline, 6 and 12 weeks. Long-term follow-up Cohen-Mansfield Agitation Inventory data collected by telephone from informants at 6 and 12 months.Randomisation and blindingParticipants allocated 1 : 1 : 1 ratio (to discontinuation of the carbamazepine arm, 1 : 1 thereafter) to receive placebo or carbamazepine or mirtazapine, with treatment as usual. Random allocation was block stratified by centre and residence type with random block lengths of three or six (after discontinuation of carbamazepine, two or four). Double-blind, with drug and placebo identically encapsulated. Referring clinicians, participants, trial management team and research workers who did assessments were masked to group allocation.ResultsTwo hundred and forty-four participants recruited and randomised (102 mirtazapine, 102 placebo, 40 carbamazepine). The carbamazepine arm was discontinued due to slow overall recruitment; carbamazepine/placebo analyses are therefore statistically underpowered and not detailed in the abstract. Mean difference placebo-mirtazapine (-1.74, 95% confidence interval -7.17 to 3.69; pâ€
=â€
0.53). Harms: the number of controls with adverse events (65/102, 64%) was similar to the mirtazapine group (67/102, 66%). However, there were more deaths in the mirtazapine group (nâ€
=â€
7) by week 16 than in the control group (nâ€
=â€
1). Post hoc analysis suggests this was of marginal statistical significance (pâ€
=â€
0.065); this difference did not persist at 6- and 12-month assessments. At 12 weeks, the costs of unpaid care by the dyadic carer were significantly higher in the mirtazapine than placebo group [difference: £1120 (95% confidence interval £56 to £2184)]. In the cost-effectiveness analyses, mean raw and adjusted outcome scores and costs of the complete cases samples showed no differences between groups.LimitationsOur study has four important potential limitations: (1) we dropped the proposed carbamazepine group; (2) the trial was not powered to investigate a mortality difference between the groups; (3) recruitment beyond February 2020, was constrained by the COVID-19 pandemic; and (4) generalisability is limited by recruitment of participants from old-age psychiatry services and care homes.ConclusionsThe data suggest mirtazapine is not clinically or cost-effective (compared to placebo) for agitation in dementia. There is little reason to recommend mirtazapine for people with dementia with agitation.Future workEffective and cost-effective management strategies for agitation in dementia are needed where non-pharmacological approaches are unsuccessful.Study registrationThis trial is registered as ISRCTN17411897/NCT03031184.FundingThis project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 23. See the NIHR Journals Library website for further project information.
Abstract.
Fox C, Hammond SP, Backhouse T, Poland F, Waring J, Penhale B, Cross JL (2023). Implementing PERFECT-ER with Plan-Do-Study-Act on acute orthopaedic hospital wards: Building knowledge from an implementation study using Normalization Process Theory.
PLoS One,
18(2).
Abstract:
Implementing PERFECT-ER with Plan-Do-Study-Act on acute orthopaedic hospital wards: Building knowledge from an implementation study using Normalization Process Theory.
BACKGROUND: Delivering care to growing numbers of patients with increasingly 'complex' needs is currently compromised by a system designed to treat patients within organizational clinical specialties, making this difficult to reconfigure to fit care to needs. Problematic experiences of people with cognitive impairment(s) admitted to hospitals with a hip fracture, exemplify the complex challenges that result if their care is not tailored. This study explored whether a flexible, multicomponent intervention, adapting services to the needs of this patient group, could be implemented in acute hospital settings. METHODS: We used action research with case study design to introduce the intervention using a Plan-Do-Study-Act (PDSA) model to three different hospital sites (cases) across England. The qualitative data for this paper was researcher-generated (notes from observations and teleconference meetings) and change agent-generated (action plans and weekly reflective reports of change agents' activities). Normalization Process Theory (NPT) was used to analyze and explain the work of interacting actors in implementing and then normalizing (embedding) the intervention across contexts and times. Data analysis was abductive, generating inductive codes then identified with NPT constructs. Across the three cases, change agents had to work through numerous implementation challenges: needing to make sense of the intervention package, the PDSA model as implementation method, and their own role as change agents and to orientate these within their action context (coherence). They had to work to encourage colleagues to invest in these changes (cognitive participation) and find ways to implement the intervention by mobilising changes (collective action). Finally, they created strategies for clinical routines to continue to self-review, reconfiguring actions and future plans to enable the intervention to be sustained (reflexive monitoring). CONCLUSIONS: Successful implementation of the (PERFECT-ER) intervention requires change agents to recognize and engage with local values, and then to enable its fit with practice and wider contextual goals. A context of constant change fragments normalization. Thus, sustaining practice change over time is fragile and requires change agents to continue a recursive two-way sense-making process. This enables implementation and normalization to re-energize and overcome barriers to change.
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Logan PA, Horne JC, Allen F, Armstrong SJ, Clark AB, Conroy S, Darby J, Fox C, Gladman JR, Godfrey M, et al (2022). A multidomain decision support tool to prevent falls in older people: the FinCH cluster RCT.
Health Technol Assess,
26(9), 1-136.
Abstract:
A multidomain decision support tool to prevent falls in older people: the FinCH cluster RCT.
BACKGROUND: Falls in care home residents are common, unpleasant, costly and difficult to prevent. OBJECTIVES: the objectives were to evaluate the clinical effectiveness and cost-effectiveness of the Guide to Action for falls prevention in Care Homes (GtACH) programme. DESIGN: a multicentre, cluster, parallel, 1 : 1 randomised controlled trial with embedded process evaluation and economic evaluation. Care homes were randomised on a 1 : 1 basis to the GtACH programme or usual care using a secure web-based randomisation service. Research assistants, participating residents and staff informants were blind to allocation at recruitment; research assistants were blind to allocation at follow-up. NHS Digital data were extracted blindly. SETTING: Older people's care homes from 10 UK sites. PARTICIPANTS: Older care home residents. INTERVENTION: the GtACH programme, which includes care home staff training, systematic use of a multidomain decision support tool and implementation of falls prevention actions, compared to usual falls prevention care. OUTCOMES: the primary trial outcome was the rate of falls per participating resident occurring during the 90-day period between 91 and 180 days post randomisation. The primary outcome for the cost-effectiveness analysis was the cost per fall averted, and the primary outcome for the cost-utility analysis was the incremental cost per quality adjusted life-year. Secondary outcomes included the rate of falls over days 0-90 and 181-360 post randomisation, activity levels, dependency and fractures. The number of falls per resident was compared between arms using a negative binomial regression model (generalised estimating equation). RESULTS: a total of 84 care homes were randomised: 39 to the GtACH arm and 45 to the control arm. A total of 1657 residents consented and provided baseline measures (mean age 85 years, 32% men). GtACH programme training was delivered to 1051 staff (71% of eligible staff) over 146 group sessions. Primary outcome data were available for 630 GtACH participants and 712 control participants. The primary outcome result showed an unadjusted incidence rate ratio of 0.57 (95% CI 0.45 to 0.71; p
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Secchi A, Mamayusupova H, Sami S, Maidment I, Coulton S, Myint PK, Fox C (2022). A novel Artificial Intelligence-based tool to assess anticholinergic burden: a survey.
Age Ageing,
51(8).
Abstract:
A novel Artificial Intelligence-based tool to assess anticholinergic burden: a survey.
BACKGROUND: many medications possess anticholinergic activity. Their use is associated with a number of serious adverse effects including cognitive effects. The cumulative anticholinergic effect of medications as assessed by tools such as the anticholinergic burden scale (AchB) can identify people particularly at risk of anticholinergic side-effects. Currently, >20 tools are available for clinicians to use, but there is no consensus on the most appropriate tool. METHODS: a newly created online tool-International Anticholinergic Cognitive Burden Tool (IACT)-based on natural language processing and chemical structure analysis, was developed and made available for clinicians to test its functions. We carried out a survey (between 8th of February and 31st of March 2021) to assess the overall need for an assessment tool as well as the usability of the IACT. RESULTS: a total of 110 responses were received from different countries and practitioners' groups. The majority of the participants (86.11%) stated they would use a tool for AchB assessment if available and when they were asked to rate the IACT against other tools, amongst 34 responders, 20.59% rated it better and 8.82% rated it significantly better, 44.12% rated it neither better, nor worse, 14.71% rated it worse and 11.76% somewhat worse. CONCLUSION: there is a need for an anticholinergic burden calculator to assess the anticholinergicity of medications. Tools such as the IACT potentially could meet this demand due to its ability to assign scores to current and new medications appearing on the market based both on their chemical structure and reported adverse pharmacological effects.
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Henderson C, Knapp M, Stirling S, Shepstone L, High J, Ballard C, Bentham P, Burns A, Farina N, Fox C, et al (2022). Cost-effectiveness of mirtazapine for agitated behaviors in dementia: findings from a randomized controlled trial.
International Psychogeriatrics,
34(10), 905-917.
Abstract:
Cost-effectiveness of mirtazapine for agitated behaviors in dementia: findings from a randomized controlled trial
ABSTRACTObjectives:To examine the costs and cost-effectiveness of mirtazapine compared to placebo over 12-week follow-up.Design:Economic evaluation in a double-blind randomized controlled trial of mirtazapine vs. placebo.Setting:Community settings and care homes in 26 UK centers.Participants:People with probable or possible Alzheimer’s disease and agitation.Measurements:Primary outcome included incremental cost of participants’ health and social care per 6-point difference in CMAI score at 12 weeks. Secondary cost-utility analyses examined participants’ and unpaid carers’ gain in quality-adjusted life years (derived from EQ-5D-5L, DEMQOL-Proxy-U, and DEMQOL-U) from the health and social care and societal perspectives.Results:One hundred and two participants were allocated to each group; 81 mirtazapine and 90 placebo participants completed a 12-week assessment (87 and 95, respectively, completed a 6-week assessment). Mirtazapine and placebo groups did not differ on mean CMAI scores or health and social care costs over the study period, before or after adjustment for center and living arrangement (independent living/care home). On the primary outcome, neither mirtazapine nor placebo could be considered a cost-effective strategy with a high level of confidence. Groups did not differ in terms of participant self- or proxy-rated or carer self-rated quality of life scores, health and social care or societal costs, before or after adjustment.Conclusions:On cost-effectiveness grounds, the use of mirtazapine cannot be recommended for agitated behaviors in people living with dementia. Effective and cost-effective medications for agitation in dementia remain to be identified in cases where non-pharmacological strategies for managing agitation have been unsuccessful.
Abstract.
Pontifex MG, Martinsen A, Saleh RNM, Harden G, Fox C, Muller M, Vauzour D, Minihane A-M (2022). DHA-Enriched Fish Oil Ameliorates Deficits in Cognition Associated with Menopause and the APOE4 Genotype in Rodents. Nutrients, 14(9).
Sanghavi R, Pana TA, Mamayusupova H, Maidment I, Fox C, Boekholdt SM, Mamas MA, Wareham NJ, Khaw K-T, Myint PK, et al (2022). Higher anticholinergic burden from medications is associated with significant increase in markers of inflammation in the EPIC-Norfolk prospective population-based cohort study.
Br J Clin Pharmacol,
88(7), 3297-3306.
Abstract:
Higher anticholinergic burden from medications is associated with significant increase in markers of inflammation in the EPIC-Norfolk prospective population-based cohort study.
BACKGROUND: Higher medication anticholinergic burden is associated with increased risk of cardiovascular disease and cognitive decline. A mechanistic pathway has not been established. We aimed to determine whether inflammation may mediate these associations. METHODS: Participants were drawn from the European Prospective Investigation into Cancer, Norfolk cohort (40-79 years at baseline). Anticholinergic burden score (ACB) was calculated at first (1HC) (1993/97) and second (2HC) (1998/2000) health checks. Fibrinogen and C-reactive protein (CRP) were measured during 1HC and tumour necrosis factor alpha (TNF-α) and interleukin 6 (IL-6) during 2HC. Cross-sectional associations between ACB and inflammatory markers were examined for both health checks. Prospective associations were also examined between 1HC ACB and 2HC inflammatory markers. Models were adjusted for age, sex, lifestyle factors, comorbidities and medications. RESULTS: in total, 17 678 and 22 051 participants were included in cross-sectional analyses for CRP, and fibrinogen, respectively. Furthermore, 5101 participants with data on TNF-α and IL-6 were included in the prospective analyses. Cross-sectionally, compared to ACB = 0, ACB ≥ 4 was associated with higher fibrinogen, beta (95% confidence interval) = 0.134 g/L (0.070, 0.199), CRP 1.175 mg/L (0.715, 1.634), IL-6 0.593 pg/mL (0.254, 0.932) and TNF-α 0.137 pg/mL (0.033, 0.241). In addition, a point increase in ACB was associated with higher levels of all markers. Prospectively, compared to ACB = 0, ACB ≥ 4 was associated with higher IL-6(pg/mL) of 0.019 (-0.323, 0.361) and TNF-α (pg/mL) of 0.202% (0.81, 0.323). A unit increase in ACB was associated with a significantly higher TNF-α and IL-6. CONCLUSION: Higher ACB was associated with higher inflammatory markers. Inflammation may mediate the relationship between anticholinergic medications and adverse outcomes.
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Banerjee S, Jones C, Wright J, Grosvenor W, Hebditch M, Hughes L, Feeney Y, Farina N, Mackrell S, Nilforooshan R, et al (2021). A comparative study of the effect of the Time for Dementia programme on medical students.
INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY,
36(7), 1011-1019.
Author URL.
Moriarty F, Savva GM, Grossi CM, Bennett K, Fox C, Maidment I, Loke YK, Steel N, Kenny RA, Richardson K, et al (2021). Cognitive decline associated with anticholinergics, benzodiazepines and Z-drugs: Findings from the Irish Longitudinal Study on Ageing (TILDA).
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY,
87(7), 2818-2829.
Author URL.
Logan PA, Horne JC, Gladman JRF, Gordon AL, Sach T, Clark A, Robinson K, Armstrong S, Stirling S, Leighton P, et al (2021). Multifactorial falls prevention programme compared with usual care in UK care homes for older people: multicentre cluster randomised controlled trial with economic evaluation.
BMJ,
375Abstract:
Multifactorial falls prevention programme compared with usual care in UK care homes for older people: multicentre cluster randomised controlled trial with economic evaluation.
OBJECTIVES: to determine the clinical and cost effectiveness of a multifactorial fall prevention programme compared with usual care in long term care homes. DESIGN: Multicentre, parallel, cluster randomised controlled trial. SETTING: Long term care homes in the UK, registered to care for older people or those with dementia. PARTICIPANTS: 1657 consenting residents and 84 care homes. 39 were randomised to the intervention group and 45 were randomised to usual care. INTERVENTIONS: Guide to Action for Care Homes (GtACH): a multifactorial fall prevention programme or usual care. MAIN OUTCOME MEASURES: Primary outcome measure was fall rate at 91-180 days after randomisation. The economic evaluation measured health related quality of life using quality adjusted life years (QALYs) derived from the five domain five level version of the EuroQoL index (EQ-5D-5L) or proxy version (EQ-5D-5L-P) and the Dementia Quality of Life utility measure (DEMQOL-U), which were self-completed by competent residents and by a care home staff member proxy (DEMQOL-P-U) for all residents (in case the ability to complete changed during the study) until 12 months after randomisation. Secondary outcome measures were falls at 1-90, 181-270, and 271-360 days after randomisation, Barthel index score, and the Physical Activity Measure-Residential Care Homes (PAM-RC) score at 91, 180, 270, and 360 days after randomisation. RESULTS: Mean age of residents was 85 years. 32% were men. GtACH training was delivered to 1051/1480 staff (71%). Primary outcome data were available for 630 participants in the GtACH group and 712 in the usual care group. The unadjusted incidence rate ratio for falls between 91 and 180 days was 0.57 (95% confidence interval 0.45 to 0.71, P
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Deane KHO, Jimoh OF, Biswas P, O'Brien A, Hanson S, Abdelhamid AS, Fox C, Hooper L (2021). Omega-3 and polyunsaturated fat for prevention of depression and anxiety symptoms: systematic review and meta-analysis of randomised trials.
BRITISH JOURNAL OF PSYCHIATRY,
218(3), 135-142.
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Lariviere M, Poland F, Woolham J, Newman S, Fox C (2021). Placing assistive technology and telecare in everyday practices of people with dementia and their caregivers: findings from an embedded ethnography of a national dementia trial.
BMC GERIATRICS,
21(1).
Author URL.
Steyaert J, Deckers K, Smits C, Fox C, Thyrian R, Jeon Y-H, Vernooij-Dassen M, Kohler S (2021). Putting primary prevention of dementia on everybody's agenda.
AGING & MENTAL HEALTH,
25(8), 1376-1380.
Author URL.
Howard R, Gathercole R, Bradley R, Harper E, Davis L, Pank L, Lam N, Talbot E, Hooper E, Winson R, et al (2021). The effectiveness and cost-effectiveness of assistive technology and telecare for independent living in dementia: a randomised controlled trial.
Age Ageing,
50(3), 882-890.
Abstract:
The effectiveness and cost-effectiveness of assistive technology and telecare for independent living in dementia: a randomised controlled trial.
OBJECTIVES: the use of assistive technology and telecare (ATT) has been promoted to manage risks associated with independent living in people with dementia but with little evidence for effectiveness. METHODS: Participants were randomly assigned to receive an ATT assessment followed by installation of all appropriate ATT devices or limited control of appropriate ATT. The primary outcomes were time to institutionalisation and cost-effectiveness. Key secondary outcomes were number of incidents involving risks to safety, burden and stress in family caregivers and quality of life. RESULTS: Participants were assigned to receive full ATT (248 participants) or the limited control (247 participants). After adjusting for baseline imbalance of activities of daily living score, HR for median pre-institutionalisation survival was 0.84; 95% CI, 0.63 to 1.12; P = 0.20. There were no significant differences between arms in health and social care (mean -£909; 95% CI, -£5,336 to £3,345, P = 0.678) and societal costs (mean -£3,545; 95% CI, -£13,914 to £6,581, P = 0.499). ATT group members had reduced participant-rated quality-adjusted life years (QALYs) at 104 weeks (mean - 0.105; 95% CI, -0.204 to -0.007, P = 0.037) but did not differ in QALYs derived from proxy-reported EQ-5D. DISCUSSION: Fidelity of the intervention was low in terms of matching ATT assessment, recommendations and installation. This, however, reflects current practice within adult social care in England. CONCLUSIONS: Time living independently outside a care home was not significantly longer in participants who received full ATT and ATT was not cost-effective. Participants with full ATT attained fewer QALYs based on participant-reported EQ-5D than controls at 104 weeks.
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Pieper NT, Grossi CM, Chan W-Y, Loke YK, Savva GM, Haroulis C, Steel N, Fox C, Maidment ID, Arthur AJ, et al (2020). Anticholinergic drugs and incident dementia, mild cognitive impairment and cognitive decline: a meta-analysis.
AGE AND AGEING,
49(6), 939-947.
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Davison WJ, Myint PK, Loke YK, Ravenhill G, Turner D, Fox C, Shepstone L, Potter JF (2020). Can cardiovascular risk management be improved by shared care with general practice to prevent cognitive decline following stroke/TIA? a feasibility randomised controlled trial (SERVED memory).
BMC GERIATRICS,
20(1).
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Fox C, Robinson K, Allen F, Darby J, Gordon AL, Horne JC, Leighton P, Sims E, Logan PA (2020). Contamination in complex healthcare trials: the falls in care homes (FinCH) study experience.
BMC Med Res Methodol,
20(1).
Abstract:
Contamination in complex healthcare trials: the falls in care homes (FinCH) study experience.
BACKGROUND: Trials are at risk of contamination bias which can occur when participants in the control group are inadvertently exposed to the intervention. This is a particular risk in rehabilitation studies where it is easy for trial interventions to be either intentionally or inadvertently adopted in control settings. The Falls in Care Homes (FinCH) trial is used in this paper as an example of a large randomised controlled trial of a complex intervention to explore the potential risks of contamination bias. We outline the FinCH trial design, present the potential risks from contamination bias, and the strategies used in the design of the trial to minimise or mitigate against this. The FinCH trial was a multi-centre randomised controlled trial, with embedded process evaluation, which evaluated whether systematic training in the use of the Guide to Action Tool for Care Homes reduced falls in care home residents. Data were collected from a number of sources to explore contamination in the FinCH trial. Where specific procedures were adopted to reduce risk of, or mitigate against, contamination, this was recorded. Data were collected from study e-mails, meetings with clinicians, research assistant and clinician network communications, and an embedded process evaluation in six intervention care homes. During the FinCH trial, there were six new falls prevention initiatives implemented outside the study which could have contaminated our intervention and findings. Methods used to minimise contamination were: cluster randomisation at the level of care home; engagement with the clinical community to highlight the risks of early adoption; establishing local collaborators in each site familiar with the local context; signing agreements with NHS falls specialists that they would maintain confidentiality regarding details of the intervention; opening additional research sites; and by raising awareness about the importance of contamination in research among participants. CONCLUSION: Complex rehabilitation trials are at risk of contamination bias. The potential for contamination bias in studies can be minimized by strengthening collaboration and dialogue with the clinical community. Researchers should recognise that clinicians may contaminate a study through lack of research expertise.
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Brayne CE, Barnes LE, Breteler MMB, Brooks RL, Dufouil C, Fox C, Fratiglioni L, Ikram MA, Kenny RA, Kivipelto M, et al (2020). Dementia Research Fit for the Planet: Reflections on Population Studies of Dementia for Researchers and Policy Makers Alike.
NEUROEPIDEMIOLOGY,
54(2), 157-170.
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Grossi CM, Richardson K, Savva GM, Fox C, Arthur A, Loke YK, Steel N, Brayne C, Matthews FE, Robinson L, et al (2020). Increasing prevalence of anticholinergic medication use in older people in England over 20 years: cognitive function and ageing study I and II.
BMC GERIATRICS,
20(1).
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Maidment ID, Barton G, Campbell N, Shaw R, Seare N, Fox C, Iliffe S, Randle E, Hilton A, Brown G, et al (2020). MEDREV (pharmacy-health psychology intervention in people living with dementia with behaviour that challenges): the feasibility of measuring clinical outcomes and costs of the intervention.
BMC HEALTH SERVICES RESEARCH,
20(1).
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Backhouse T, Hammond SP, Cross JL, Lambert N, Varley A, Penhale B, Fox C, Poland F (2020). Making body work sequences visible: an ethnographic study of acute orthopaedic hospital wards.
SOCIOLOGY OF HEALTH & ILLNESS,
42(5), 1139-1154.
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Howard R, Zubko O, Gray R, Bradley R, Harper E, Kelly L, Pank L, O’Brien J, Fox C, Tabet N, et al (2020). Minocycline 200 mg or 400 mg versus placebo for mild Alzheimer’s disease: the MADE Phase II, three-arm RCT.
Abstract:
Minocycline 200 mg or 400 mg versus placebo for mild Alzheimer’s disease: the MADE Phase II, three-arm RCT
BackgroundMinocycline is an anti-inflammatory drug and protects against the toxic effects of β-amyloid in vitro and in animal models of Alzheimer’s disease. To the best of our knowledge, no randomised placebo-controlled clinical trials in patients with Alzheimer’s disease looking at the efficacy and tolerability of minocycline have been carried out.ObjectivesThe trial investigated whether or not minocycline was superior to placebo in slowing down the rate of decline in cognitive and functional ability over 2 years. The safety and tolerability of minocycline were also assessed.DesignA Phase II, three-arm, randomised, double-blind, multicentre trial with a semifactorial design. Participants continued on trial treatment for up to 24 months.SettingPatients were identified from memory services, both within the 32 participating NHS trusts and within the network of memory services supported by the Dementias and Neurodegenerative Diseases Research Network (also known as DeNDRoN).ParticipantsPatients with standardised Mini Mental State Examination scores of > 23 points and with Alzheimer’s disease assessed by the National Institute on Aging–Alzheimer’s Association’s criteria were identified from memory services.InterventionPatients with mild Alzheimer’s disease were randomly allocated 1 : 1 : 1 to receive one of three treatments: arm 1 – 400 mg per day of minocycline; arm 2 – 200 mg per day of minocycline; or arm 3 – placebo. Patients continued treatment for 24 months. Participants, investigators and outcome assessors were blind to treatment allocation.Main outcome measuresPrimary outcome measures were decline in standardised Mini Mental State Examination and Bristol Activities of Daily Living Scale scores of combined minocycline treatment arms versus placebo, as analysed by intention-to-treat repeated measures regression.ResultsBetween 23 May 2014 and 14 April 2016, 554 participants were randomised. of the 544 eligible participants, the mean age was 74.3 years and the average standardised Mini Mental State Examination score was 26.4 points. A total of 252 serious adverse events were reported, with the most common categories being neuropsychiatric and cardiocirculatory. Significantly fewer participants completed treatment with 400 mg of minocycline [29% (53/184)] than 200 mg [62% (112/181)] or placebo [64% (114/179)] (p
Abstract.
Richardson K, Wharton SB, Grossi CM, Matthews FE, Fox C, Maidment I, Loke YK, Steel N, Arthur A, Myint PK, et al (2020). Neuropathological Correlates of Cumulative Benzodiazepine and Anticholinergic Drug Use />.
JOURNAL OF ALZHEIMERS DISEASE,
74(3), 999-1009.
Author URL.
Aldus CF, Arthur A, Dennington-Price A, Millac P, Richmond P, Dening T, Fox C, Matthews FE, Robinson L, Stephan BCM, et al (2020). Undiagnosed dementia in primary care: a record linkage study.
Abstract:
Undiagnosed dementia in primary care: a record linkage study
BackgroundThe number of people living with dementia is greater than the number with a diagnosis of dementia recorded in primary care. This suggests that a significant number are living with dementia that is undiagnosed. Little is known about this group and there is little quantitative evidence regarding the consequences of diagnosis for people with dementia.ObjectivesThe aims of this study were to (1) describe the population meeting the criteria for dementia but without diagnosis, (2) identify predictors of being diagnosed and (3) estimate the effect of diagnosis on mortality, move to residential care, social participation and well-being.DesignA record linkage study of a subsample of participants (n = 598) from the Cognitive Function and Ageing Study II (CFAS II) (n = 7796), an existing cohort study of the population of England aged ≥ 65 years, with standardised validated assessment of dementia and consent to access medical records.Data sourcesData on dementia diagnoses from each participant’s primary care record and covariate and outcome data from CFAS II.SettingA population-representative cohort of people aged ≥ 65 years from three regions of England between 2008 and 2011.ParticipantsA total of 598 CFAS II participants, which included all those with dementia who consented to medical record linkage (n = 449) and a stratified sample without dementia (n = 149).Main outcome measuresThe main outcome was presence of a diagnosis of dementia in each participant’s primary care record at the time of their CFAS II assessment(s). Other outcomes were date of death, cognitive performance scores, move to residential care, hospital stays and social participation.ResultsAmong people with dementia, the proportion with a diagnosis in primary care was 34% in 2008–11 and 44% in 2011–13. In both periods, a further 21% had a record of a concern or a referral but no diagnosis. The likelihood of having a recorded diagnosis increased with severity of impairment in memory and orientation, but not with other cognitive impairment. In multivariable analysis, those aged ≥ 90 years and those aged
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Grossi CM, Richardson K, Fox C, Maidment I, Steel N, Loke YK, Arthur A, Myint PK, Campbell N, Boustani M, et al (2019). Anticholinergic and benzodiazepine medication use and risk of incident dementia: a UK cohort study.
BMC GERIATRICS,
19(1).
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Burn A-M, Bunn F, Fleming J, Turner D, Fox C, Malyon A, Brayne C (2019). Case finding for dementia during acute hospital admissions: a mixed-methods study exploring the impacts on patient care after discharge and costs for the English National Health Service.
BMJ OPEN,
9(6).
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Shenkin SD, Fox C, Godfrey M, Siddiqi N, Goodacre S, Young J, Anand A, Gray A, Hanley J, MacRaild A, et al (2019). Delirium detection in older acute medical inpatients: a multicentre prospective comparative diagnostic test accuracy study of the 4AT and the confusion assessment method.
BMC Med,
17(1).
Abstract:
Delirium detection in older acute medical inpatients: a multicentre prospective comparative diagnostic test accuracy study of the 4AT and the confusion assessment method.
BACKGROUND: Delirium affects > 15% of hospitalised patients but is grossly underdetected, contributing to poor care. The 4 'A's Test (4AT, www.the4AT.com ) is a short delirium assessment tool designed for routine use without special training. The primary objective was to assess the accuracy of the 4AT for delirium detection. The secondary objective was to compare the 4AT with another commonly used delirium assessment tool, the Confusion Assessment Method (CAM). METHODS: This was a prospective diagnostic test accuracy study set in emergency departments or acute medical wards involving acute medical patients aged ≥ 70. All those without acutely life-threatening illness or coma were eligible. Patients underwent (1) reference standard delirium assessment based on DSM-IV criteria and (2) were randomised to either the index test (4AT, scores 0-12; prespecified score of > 3 considered positive) or the comparator (CAM; scored positive or negative), in a random order, using computer-generated pseudo-random numbers, stratified by study site, with block allocation. Reference standard and 4AT or CAM assessments were performed by pairs of independent raters blinded to the results of the other assessment. RESULTS: Eight hundred forty-three individuals were randomised: 21 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome, and 785 were included in the analysis. Mean age was 81.4 (SD 6.4) years. 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT had an area under the receiver operating characteristic curve of 0.90 (95% CI 0.84-0.96). The 4AT had a sensitivity of 76% (95% CI 61-87%) and a specificity of 94% (95% CI 92-97%). The CAM had a sensitivity of 40% (95% CI 26-57%) and a specificity of 100% (95% CI 98-100%). CONCLUSIONS: the 4AT is a short, pragmatic tool which can help improving detection rates of delirium in routine clinical care. TRIAL REGISTRATION: International standard randomised controlled trial number (ISRCTN) 53388093. Date applied 30/05/2014; date assigned 02/06/2014.
Abstract.
Author URL.
Richardson K, Mattishent K, Loke YK, Steel N, Fox C, Grossi CM, Bennett K, Maidment I, Boustani M, Matthews FE, et al (2019). History of Benzodiazepine Prescriptions and Risk of Dementia: Possible Bias Due to Prevalent Users and Covariate Measurement Timing in a Nested Case-Control Study.
AMERICAN JOURNAL OF EPIDEMIOLOGY,
188(7), 1228-1236.
Author URL.
MacLullich AM, Shenkin SD, Goodacre S, Godfrey M, Hanley J, StÃobhairt A, Lavender E, Boyd J, Stephen J, Weir C, et al (2019). The 4 'A's test for detecting delirium in acute medical patients: a diagnostic accuracy study.
Health Technol Assess,
23(40), 1-194.
Abstract:
The 4 'A's test for detecting delirium in acute medical patients: a diagnostic accuracy study.
BACKGROUND: Delirium is a common and serious neuropsychiatric syndrome, usually triggered by illness or drugs. It remains underdetected. One reason for this is a lack of brief, pragmatic assessment tools. The 4 'A's test (Arousal, Attention, Abbreviated Mental Test - 4, Acute change) (4AT) is a screening tool designed for routine use. This project evaluated its usability, diagnostic accuracy and cost. METHODS: Phase 1 - the usability of the 4AT in routine practice was measured with two surveys and two qualitative studies of health-care professionals, and a review of current clinical use of the 4AT as well as its presence in guidelines and reports. Phase 2 - the 4AT's diagnostic accuracy was assessed in newly admitted acute medical patients aged ≥ 70 years. Its performance was compared with that of the Confusion Assessment Method (CAM; a longer screening tool). The performance of individual 4AT test items was related to cognitive status, length of stay, new institutionalisation, mortality at 12 weeks and outcomes. The method used was a prospective, double-blind diagnostic test accuracy study in emergency departments or in acute general medical wards in three UK sites. Each patient underwent a reference standard delirium assessment and was also randomised to receive an assessment with either the 4AT (n = 421) or the CAM (n = 420). A health economics analysis was also conducted. RESULTS: Phase 1 found evidence that delirium awareness is increasing, but also that there is a need for education on delirium in general and on the 4AT in particular. Most users reported that the 4AT was useful, and it was in widespread use both in the UK and beyond. No changes to the 4AT were considered necessary. Phase 2 involved 785 individuals who had data for analysis; their mean age was 81.4 (standard deviation 6.4) years, 45% were male, 99% were white and 9% had a known dementia diagnosis. The 4AT (n = 392) had an area under the receiver operating characteristic curve of 0.90. A positive 4AT score (> 3) had a specificity of 95% [95% confidence interval (CI) 92% to 97%] and a sensitivity of 76% (95% CI 61% to 87%) for reference standard delirium. The CAM (n = 382) had a specificity of 100% (95% CI 98% to 100%) and a sensitivity of 40% (95% CI 26% to 57%) in the subset of participants whom it was possible to assess using this. Patients with positive 4AT scores had longer lengths of stay (median 5 days, interquartile range 2.0-14.0 days) than did those with negative 4AT scores (median 2 days, interquartile range 1.0-6.0 days), and they had a higher 12-week mortality rate (16.1% and 9.2%, respectively). The estimated 12-week costs of an initial inpatient stay for patients with delirium were more than double the costs of an inpatient stay for patients without delirium (e.g. in Scotland, £7559, 95% CI £7362 to £7755, vs. £4215, 95% CI £4175 to £4254). The estimated cost of false-positive cases was £4653, of false-negative cases was £8956, and of a missed diagnosis was £2067. LIMITATIONS: Patients were aged ≥ 70 years and were assessed soon after they were admitted, limiting generalisability. The treatment of patients in accordance with reference standard diagnosis limited the ability to assess comparative cost-effectiveness. CONCLUSIONS: These findings support the use of the 4AT as a rapid delirium assessment instrument. The 4AT has acceptable diagnostic accuracy for acute older patients aged > 70 years. FUTURE WORK: Further research should address the real-world implementation of delirium assessment. The 4AT should be tested in other populations. TRIAL REGISTRATION: Current Controlled Trials ISRCTN53388093. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 40. See the NIHR Journals Library website for further project information. The funder specified that any new delirium assessment tool should be compared against the CAM, but had no other role in the study design or conduct of the study.
Abstract.
Author URL.
Mattishent K, Richardson K, Dhatariya K, Savva GM, Fox C, Loke YK (2019). The effects of hypoglycaemia and dementia on cardiovascular events, falls and fractures and all-cause mortality in older individuals: a retrospective cohort study.
DIABETES OBESITY & METABOLISM,
21(9), 2076-2085.
Author URL.
Boyd PJ, Nevard M, Ford JA, Khondoker M, Cross JL, Fox C (2019). The electronic frailty index as an indicator of community healthcare service utilisation in the older population.
AGE AND AGEING,
48(2), 273-277.
Author URL.
Howard R, Cort E, Bradley R, Harper E, Kelly L, Bentham P, Ritchie C, Reeves S, Fawzi W, Livingston G, et al (2018). Amisulpride for very late-onset schizophrenia-like psychosis: the ATLAS three-arm RCT.
HEALTH TECHNOLOGY ASSESSMENT,
22(67), 1-+.
Author URL.
Richardson K, Fox C, Maidment I, Steel N, Loke YK, Arthur A, Myint PK, Grossi CM, Mattishent K, Bennett K, et al (2018). Anticholinergic drugs and risk of dementia: case-control study.
BMJ-BRITISH MEDICAL JOURNAL,
361 Author URL.
Howard R, Cort E, Bradley R, Harper E, Kelly L, Bentham P, Ritchie C, Reeves S, Fawzi W, Livingston G, et al (2018). Antipsychotic treatment of very late-onset schizophrenia-like psychosis (ATLAS): a randomised, controlled, double-blind trial.
LANCET PSYCHIATRY,
5(7), 553-563.
Author URL.
Burn A-M, Fleming J, Brayne C, Fox C, Bunn F (2018). Dementia case-finding in hospitals: a qualitative study exploring the views of healthcare professionals in English primary care and secondary care.
BMJ OPEN,
8(3).
Author URL.
Smith T, Clark A, Dodd E, Khoo M-E, Heneker S, Cross J, Cheston R, Gray R, Fox C, Nolan F, et al (2018). Feasibility study suggests no impact from protected engagement time on adverse events in mental health wards for older adults.
INTERNATIONAL JOURNAL OF MENTAL HEALTH NURSING,
27(2), 756-764.
Author URL.
Maidment ID, Damery S, Campbell N, Seare N, Fox C, Iliffe S, Hilton A, Brown G, Barnes N, Wilcock J, et al (2018). Medication review plus person-centred care: a feasibility study of a pharmacy-health psychology dual intervention to improve care for people living with dementia.
BMC PSYCHIATRY,
18 Author URL.
Dodd E, Cheston R, Procter C, Heneker S, Gray R, Fox C, Nolan F (2018). Protected engagement time on older adult mental health wards: a thematic analysis of the views of patients, carers, and staff.
INTERNATIONAL JOURNAL OF MENTAL HEALTH NURSING,
27(2), 608-618.
Author URL.
Smith T, Cross J, Poland F, Clay F, Brookes A, Maidment I, Penhale B, Laidlaw K, Fox C (2018). Systematic Review Investigating Multi-disciplinary Team Approaches to Screening and Early Diagnosis of Dementia in Primary Care - What are the Positive and Negative Effects and Who Should Deliver it?.
CURRENT ALZHEIMER RESEARCH,
15(1), 5-17.
Author URL.
Maidment ID, Aston L, Moutela T, Fox CG, Hilton A (2017). A qualitative study exploring medication management in people with dementia living in the community and the potential role of the community pharmacist.
HEALTH EXPECTATIONS,
20(5), 929-942.
Author URL.
Savulich G, Piercy T, Fox C, Suckling J, Rowe JB, O'Brien JT, Sahakian BJ (2017). Cognitive Training Using a Novel Memory Game on an iPad in Patients with Amnestic Mild Cognitive Impairment (aMCI).
INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY,
20(8), 624-633.
Author URL.
Smith TO, Cooper A, Peryer G, Griffiths R, Fox C, Cross J (2017). Factors predicting incidence of post-operative delirium in older people following hip fracture surgery: a systematic review and meta-analysis.
Int J Geriatr Psychiatry,
32(4), 386-396.
Abstract:
Factors predicting incidence of post-operative delirium in older people following hip fracture surgery: a systematic review and meta-analysis.
OBJECTIVE: Delirium is one of the most common complications following hip fracture surgery in older people. This study identified pre- and peri-operative factors associated with the development of post-operative delirium following hip fracture surgery. METHODS: Published and unpublished literature were searched to identify all evidence reporting variables on patient characteristics, on-admission, intra-operative and post-operative management assessing incident delirium in older people following hip fracture surgery. Pooled odds ratio (OR) and mean difference of those who experienced delirium compared to those who did not were calculated for each variable. Evidence was assessed using the Downs and Black appraisal tool and interpreted using the GRADE approach. RESULTS: a total of 6704 people (2090 people with post-operative delirium) from 32 studies were analysed. There was moderate evidence of nearly a two-times greater probability of post-operative delirium for those aged 80 years and over (OR: 1.77; 95% CI: 1.09, 2.87), whether patients lived in a care institution pre-admission (OR: 2.65; 95% CI: 1.79, 3.92), and a six-times greater probability of developing post-operative delirium with a pre-admission diagnosis of dementia (OR: 6.07, 95% CI: 4.84, 7.62). There was no association with intra-operative variables and probability of delirium. CONCLUSION: Clinicians treating people with a hip fracture should be vigilant towards post-operative delirium if their patients are older, have pre-existing cognitive impairment and poorer overall general health. This is also the case for those who experience post-operative complications such as pneumonia or a urinary tract infection. Copyright © 2017 John Wiley & Sons, Ltd.
Abstract.
Author URL.
Savulich G, Piercy T, Brühl AB, Fox C, Suckling J, Rowe JB, O'Brien JT, Sahakian BJ (2017). Focusing the Neuroscience and Societal Implications of Cognitive Enhancers.
Clin Pharmacol Ther,
101(2), 170-172.
Abstract:
Focusing the Neuroscience and Societal Implications of Cognitive Enhancers.
Cognitive enhancement can benefit the individual and society, but also has associated risks and ethical concerns. Cognitive-enhancing drugs are used in the treatment of neuropsychiatric disorders. Nonpharmacological strategies are also emerging, which have the potential to improve motivational deficits associated with neuropsychiatric symptoms and should be prioritized for development. The increasing lifestyle use of "smart" and other drugs indicates the desire for healthy people to improve themselves. Safety and ethical implications are discussed.
Abstract.
Author URL.
Hammond SP, Cross JL, Poland FM, Patel M, Penhale B, Smith TO, Fox C (2017). Freedom of Information Act: scalpel or just a sharp knife?.
JOURNAL OF MEDICAL ETHICS,
43(1), 60-62.
Author URL.
Coxon A, Nielsen K, Cross J, Fox C (2017). Implementing enhanced recovery pathways: a literature review with realist synthesis.
Hosp Pract (1995),
45(4), 165-174.
Abstract:
Implementing enhanced recovery pathways: a literature review with realist synthesis.
OBJECTIVES: Enhanced Recovery Pathways (ERPs) are an increasingly popular, evidenced-based approach to surgery, designed to improve patient outcomes and reduce costs. Despite evidence demonstrating the benefits of these pathways, implementation and adherence have been inconsistent. METHODS: Using realist synthesis, this review explored the current literature surrounding the implementation of ERPs in the UK. Knowledge consolidation between authors and consulting with field experts helped to guide the search strategy. Relevant medical and social science databases were searched from 2000 to 2016, as well as a general web search. A total of 17 papers were identified, including original research, reviews, case studies and guideline documents. Full texts were analysed, cross-examined, and data extracted and synthesised. RESULTS: Several implementation strategies were identified, including the contexts in which these operated, the subsequent mechanisms of action that were triggered, and the outcome patterns they produced. Context-Mechanism-Outcome (CMO) configurations were generated, tested, and refined. These were grouped to develop two programme theories concerning ERP implementation, one related to the strategy of consulting with staff, the other with appointing a change agent to coordinate and drive the implementation process. These theories highlight instances in which implementation could be improved. CONCLUSION: Current literature in ERP research is primarily focussed on measuring patient outcomes and cost effectiveness, and as a result, important detail regarding the implementation process is often not reported or described robustly. This review not only provides recommendations for future improvements in ERP implementation, but also highlights specific areas of focus for furthering ERP implementation research.
Abstract.
Author URL.
Gill N, Hammond S, Cross J, Smith T, Lambert N, Fox C (2017). Optimising care for patients with cognitive impairment and dementia following hip fracture.
ZEITSCHRIFT FUR GERONTOLOGIE UND GERIATRIE,
50, S39-S43.
Author URL.
Myint PK, Loke YK, Davison W, Mattishent K, Fox GC, Fleetcroft R, Turner D, Shepstone L, Potter JF (2017). Protocol for a feasibility randomised controlled trial of Screening and Enhanced Risk management for Vascular Event-related Decline in Memory (SERVED Memory).
BMJ open,
7(11).
Abstract:
Protocol for a feasibility randomised controlled trial of Screening and Enhanced Risk management for Vascular Event-related Decline in Memory (SERVED Memory).
IntroductionStroke is a leading cause of death and disability. The development of dementia after stroke is common. Vascular risk factors (VRF) which contribute to stroke risk can also contribute to cognitive decline, especially in vascular dementia (VaD). There is no established treatment for VaD, therefore strategies for prevention could have major health resource implications. This study was designed to assess whether patients with early cognitive decline after stroke/transient ischaemic attack (TIA) can be easily identified and whether target-driven VRF management can prevent progression to dementia.ObjectivesThe primary objective is to establish the feasibility of recruitment and retention of patients with early cognitive decline to a randomised controlled trial of enhanced VRF management. Secondary objectives include: (a) to determine the potential clinical benefit of the intervention; (b) to estimate the sample size for a future definitive multicentre randomised controlled trial; (c) to inform a future economic evaluation; (d) to explore the link between VRF control and the incidence of cognitive impairment on longitudinal follow-up in a UK population after stroke/TIA with current routine management.Methods100 patients with cognitive decline poststroke/TIA will be recruited from stroke services at the Norfolk and Norwich University Hospital. After collection of baseline data, they will be randomised to intervention (3 monthly follow-up with enhanced management) or control (treatment as usual by the general practitioner). At 12 months outcomes (repeat cognitive testing, VRF assessment) will be assessed. A further 100 patients without cognitive decline will be recruited to a parallel observational group from the same site. At 12 months they will have repeat cognitive testing.Ethics and disseminationEthical approval has been granted in England. Dissemination is planned via publication in peer-reviewed medical journals and presentation at relevant conferences.Trial registration number42688361; Pre-results.
Abstract.
Nolan FM, Fox C, Cheston R, Turner D, Clark A, Dodd E, Khoo M-E, Gray R (2016). A feasibility study comparing UK older adult mental health inpatient wards which use protected engagement time with other wards which do not: study protocol.
Pilot Feasibility Stud,
2Abstract:
A feasibility study comparing UK older adult mental health inpatient wards which use protected engagement time with other wards which do not: study protocol.
BACKGROUND: Protected engagement time (PET) is a concept of managing staff time on mental health inpatient wards with the aim of increasing staff and patient interaction. Despite apparent widespread use of PET, there remains a dearth of evidence as to how it is implemented and whether it carries benefits for staff or patients. This protocol describes a study which is being carried out on mental health wards caring for older adults (aged over 65) in England. The study shares a large proportion of the procedures, measures and study team membership of a recently completed investigation of the impact of PET in adult acute mental health wards. The study aims to identify prevalence and components of PET to construct a model for the intervention, in addition to testing the feasibility of the measures and procedures in preparation for a randomised trial. METHODS/DESIGN: the study comprises four modules and uses a mixed methods approach. Module 1 involves mapping all inpatient wards in England which provide care for older adults, including those with dementia, ascertaining how many of these provide PET and in what way. Module 2 uses a prospective cohort method to compare five older adult mental health wards that use PET with five that do not across three National Health Service (NHS) Foundation Trust sites. The comparison comprises questionnaires, observation tools and routinely collected clinical service data and combines validated measures with questions developed specifically for the study. Module 3 entails an in-depth case study evaluation of three of the participating PET wards (one from each NHS Trust site) using semi-structured interviews with patients, carers and staff. Module 4 describes the development of a model and fidelity scale for PET using the information derived from the other modules with a working group of patients, carers and staff. DISCUSSION: This is a feasibility study to test the application of the measures and methods in inpatient wards for older adults and develop a draft model for the intervention. The next stage will prospectively involve testing of the model and fidelity scale in randomised conditions to provide evidence for the effectiveness of PET as an intervention. TRIAL REGISTRATION: ISRCTN31919196.
Abstract.
Author URL.
Abdelhamid A, Bunn D, Copley M, Cowap V, Dickinson A, Gray L, Howe A, Killett A, Lee J, Li F, et al (2016). Effectiveness of interventions to directly support food and drink intake in people with dementia: systematic review and meta-analysis.
BMC Geriatr,
16Abstract:
Effectiveness of interventions to directly support food and drink intake in people with dementia: systematic review and meta-analysis.
BACKGROUND: Eating and drinking difficulties are recognised sources of ill health in people with dementia. In the EDWINA (Eating and Drinking Well IN dementiA) systematic review we aimed to assess effectiveness of interventions to directly improve, maintain or facilitate oral food and drink intake, nutrition and hydration status, in people with cognitive impairment or dementia (across all settings, levels of care and support, types and degrees of dementia). Interventions included oral nutrition supplementation, food modification, dysphagia management, eating assistance and supporting the social element of eating and drinking. METHODS: We comprehensively searched 13 databases for relevant intervention studies. The review was conducted with service user input in accordance with Cochrane Collaboration's guidelines. We duplicated assessment of inclusion, data extraction, and validity assessment, tabulating data, carrying out random effects meta-analysis and narrative synthesis. RESULTS: Forty-three controlled interventions were included, disappointingly none were judged at low risk of bias. Oral nutritional supplementation studies suggested small positive short term but unclear long term effects on nutritional status. Food modification or dysphagia management studies were smaller and of low quality, providing little evidence of an improved nutritional status. Eating assistance studies provided inconsistent evidence, but studies with a strong social element around eating/drinking, although small and of low quality provided consistent suggestion of improvements in aspects of quality of life. There were few data to address stakeholders' questions. CONCLUSIONS: We found no definitive evidence on effectiveness, or lack of effectiveness, of specific interventions but studies were small and short term. People with cognitive impairment and their carers have to tackle eating problems despite this lack of evidence, so promising interventions are listed. The need remains for high quality trials tailored for people with cognitive impairment assessing robust outcomes. SYSTEMATIC REVIEW REGISTRATION: the systematic review protocol was registered (CRD42014007611) and is published, with the full MEDLINE search strategy, on Prospero.
Abstract.
Author URL.
Bunn DK, Abdelhamid A, Copley M, Cowap V, Dickinson A, Howe A, Killett A, Poland F, Potter JF, Richardson K, et al (2016). Effectiveness of interventions to indirectly support food and drink intake in people with dementia: Eating and Drinking Well IN dementiA (EDWINA) systematic review.
BMC GERIATRICS,
16 Author URL.
Maidment ID, Shaw RL, Killick K, Damery S, Hilton A, Wilcock J, Barnes N, Brown G, Gillespie S, Fox C, et al (2016). Improving the management of behaviour that challenges associated with dementia in care homes: protocol for pharmacy-health psychology intervention feasibility study.
BMJ OPEN,
6(3).
Author URL.
Woehrling EK, Parri HR, Tse EHY, Hill EJ, Maidment ID, Fox GC, Coleman MD (2015). A predictive in vitro model of the impact of drugs with anticholinergic properties on human neuronal and astrocytic systems.
PloS one,
10(3).
Abstract:
A predictive in vitro model of the impact of drugs with anticholinergic properties on human neuronal and astrocytic systems.
The link between off-target anticholinergic effects of medications and acute cognitive impairment in older adults requires urgent investigation. We aimed to determine whether a relevant in vitro model may aid the identification of anticholinergic responses to drugs and the prediction of anticholinergic risk during polypharmacy. In this preliminary study we employed a co-culture of human-derived neurons and astrocytes (NT2.N/A) derived from the NT2 cell line. NT2.N/A cells possess much of the functionality of mature neurons and astrocytes, key cholinergic phenotypic markers and muscarinic acetylcholine receptors (mAChRs). The cholinergic response of NT2 astrocytes to the mAChR agonist oxotremorine was examined using the fluorescent dye fluo-4 to quantitate increases in intracellular calcium [Ca2+]i. Inhibition of this response by drugs classified as severe (dicycloverine, amitriptyline), moderate (cyclobenzaprine) and possible (cimetidine) on the Anticholinergic Cognitive Burden (ACB) scale, was examined after exposure to individual and pairs of compounds. Individually, dicycloverine had the most significant effect regarding inhibition of the astrocytic cholinergic response to oxotremorine, followed by amitriptyline then cyclobenzaprine and cimetidine, in agreement with the ACB scale. In combination, dicycloverine with cyclobenzaprine had the most significant effect, followed by dicycloverine with amitriptyline. The order of potency of the drugs in combination frequently disagreed with predicted ACB scores derived from summation of the individual drug scores, suggesting current scales may underestimate the effect of polypharmacy. Overall, this NT2.N/A model may be appropriate for further investigation of adverse anticholinergic effects of multiple medications, in order to inform clinical choices of suitable drug use in the elderly.
Abstract.
Martin S, Kelly S, Khan A, Cullum S, Dening T, Rait G, Fox C, Katona C, Cosco T, Brayne C, et al (2015). Attitudes and preferences towards screening for dementia: a systematic review of the literature.
BMC GERIATRICS,
15 Author URL.
Sakel M, Boukouvalas A, Buono R, Moten M, Mirza F, Chan W-Y, Maidment I, Cross J, Smith TO, Myint PK, et al (2015). Does anticholinergics drug burden relate to global neuro-disability outcome measures and length of hospital stay?.
Brain Inj,
29(12), 1426-1430.
Abstract:
Does anticholinergics drug burden relate to global neuro-disability outcome measures and length of hospital stay?
PRIMARY OBJECTIVE: to assess the relationship between disability, length of stay (LOS) and anticholinergic burden (ACB) with people following acquired brain or spinal cord injury. RESEARCH DESIGN: a retrospective case note review assessed total rehabilitation unit admission. METHODS AND PROCEDURES: Assessment of 52 consecutive patients with acquired brain/spinal injury and neuropathy in an in-patient neuro-rehabilitation unit of a UK university hospital. Data analysed included: Northwick Park Dependency Score (NPDS), Rehabilitation complexity Scale (RCS), Functional Independence Measure and Functional Assessment Measure FIM-FAM (UK version 2.2), LOS and ACB. Outcome was different in RCS, NPDS and FIM-FAM between admission and discharge. MAIN OUTCOMES AND RESULTS: a positive change was reported in ACB results in a positive change in NPDS, with no significant effect on FIM-FAM, either Motor or Cognitive, or on the RCS. Change in ACB correlated to the length of hospital stay (regression correlation = -6.64; SE = 3.89). There was a significant harmful impact of increase in ACB score during hospital stay, from low to high ACB on NPDS (OR = 9.65; 95% CI = 1.36-68.64) and FIM-FAM Total scores (OR = 0.03; 95% CI = 0.002-0.35). CONCLUSIONS: There was a statistically significant correlation of ACB and neuro-disability measures and LOS amongst this patient cohort.
Abstract.
Author URL.
Smith TO, Hameed YA, Cross JL, Henderson C, Sahota O, Fox C (2015). Enhanced rehabilitation and care models for adults with dementia following hip fracture surgery.
COCHRANE DATABASE OF SYSTEMATIC REVIEWS(6).
Author URL.
Martin S, Fleming J, Cullum S, Dening T, Rait G, Fox C, Katona C, Brayne C, Lafortune L (2015). Exploring attitudes and preferences for dementia screening in Britain: contributions from carers and the general public.
BMC GERIATRICS,
15 Author URL.
Teipel S, Drzezga A, Grothe MJ, Barthel H, Chetelat G, Schuff N, Skudlarski P, Cavedo E, Frisoni GB, Hoffmann W, et al (2015). Multimodal imaging in Alzheimer's disease: validity and usefulness for early detection.
LANCET NEUROLOGY,
14(10), 1037-1053.
Author URL.
Myint PK, Fox C, Kwok CS, Luben RN, Wareham NJ, Khaw K-T (2015). Total anticholinergic burden and risk of mortality and cardiovascular disease over 10 years in 21,636 middle-aged and older men and women of EPIC-Norfolk prospective population study.
AGE AND AGEING,
44(2), 219-225.
Author URL.
Richardson K, Bennett K, Maidment ID, Fox C, Smithard D, Kenny RA (2015). Use of Medications with Anticholinergic Activity and Self-Reported Injurious Falls in Older Community-Dwelling Adults.
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY,
63(8), 1561-1569.
Author URL.
Dodd E, Cheston R, Fear T, Brown E, Fox C, Morley C, Jefferies R, Gray R (2014). An evaluation of primary care led dementia diagnostic services in Bristol.
BMC HEALTH SERVICES RESEARCH,
14 Author URL.
Underwood BR, Fox C (2014). Citalopram decreases agitation in the context of Alzheimer's disease, but at doses higher than those commonly prescribed and at the expense of side effects.
Evid Based Med,
19(5).
Author URL.
Ebert TJ, Fox CA (2014). Competency-based Education in Anesthesiology <i>History and Challenges</i>.
ANESTHESIOLOGY,
120(1), 24-31.
Author URL.
Fox C, Smith T, Maidment I, Chan W-Y, Bua N, Myint PK, Boustani M, Kwok CS, Glover M, Koopmans I, et al (2014). Effect of medications with anti-cholinergic properties on cognitive function, delirium, physical function and mortality: a systematic review.
AGE AND AGEING,
43(5), 604-615.
Author URL.
Iliffe S, Robinson L, Bamford C, Waugh A, Fox C, Livingston G, Manthorpe J, Brown P, Stephens B, Brittain K, et al (2014). Introducing case management for people with dementia in primary care: a mixed-methods study.
BRITISH JOURNAL OF GENERAL PRACTICE,
64(628), E735-E741.
Author URL.
Brownlie K, Schneider C, Culliford R, Fox C, Boukouvalas A, Willan C, Maidment ID (2014). Medication reconciliation by a pharmacy technician in a mental health assessment unit.
INTERNATIONAL JOURNAL OF CLINICAL PHARMACY,
36(2), 303-309.
Author URL.
Poland F, Mapes S, Pinnock H, Katona C, Sorensen S, Fox C, Maidment ID (2014). Perspectives of carers on medication management in dementia: lessons from collaboratively developing a research proposal.
BMC Res Notes,
7Abstract:
Perspectives of carers on medication management in dementia: lessons from collaboratively developing a research proposal.
BACKGROUND: the need for carers to manage medication-related problems for people with dementia living in the community raises dilemmas, which can be identified by carers and people with dementia as key issues for developing carer-relevant research projects. A research planning Public Patient Involvement (PPI) workshop using adapted focus group methodology was held at the Alzheimer's Society's national office, involving carers of people with dementia who were current members of the Alzheimer's Society Research Network (ASRN) in dialogue with health professionals aimed to identify key issues in relation to medication management in dementia from the carer viewpoint. The group was facilitated by a specialist mental health pharmacist, using a topic guide developed systematically with carers, health professionals and researchers. Audio-recordings and field notes were made at the time and were transcribed and analysed thematically. The participants included nine carers in addition to academics, clinicians, and staff from DeNDRoN (Dementias and Neurodegenerative Diseases Research Network) and the Alzheimer's Society. FINDINGS: Significant themes, for carers, which emerged from the workshop were related to: (1) medication usage and administration practicalities, (2) communication barriers and facilitators, (3) bearing and sharing responsibility and (4) weighing up medication risks and benefits. These can form the basis for more in-depth qualitative research involving a broader, more diverse sample. DISCUSSION: the supported discussion enabled carer voices and perspectives to be expressed and to be linked to the process of identifying problems in medications management as directly experienced by carers. This was used to inform an agenda for research proposals which would be meaningful for carers and people with dementia.
Abstract.
Author URL.
Smith T, Maidment I, Hebding J, Madzima T, Cheater F, Cross J, Poland F, White J, Young J, Fox C, et al (2014). Systematic review investigating the reporting of comorbidities and medication in randomized controlled trials of people with dementia.
AGE AND AGEING,
43(6), 868-872.
Author URL.
Iliffe S, Waugh A, Poole M, Bamford C, Brittain K, Chew-Graham C, Fox C, Katona C, Livingston G, Manthorpe J, et al (2014). The effectiveness of collaborative care for people with memory problems in primary care: results of the CAREDEM case management modelling and feasibility study.
Health Technol Assess,
18(52), 1-148.
Abstract:
The effectiveness of collaborative care for people with memory problems in primary care: results of the CAREDEM case management modelling and feasibility study.
BACKGROUND: People with dementia and their families need support in different forms, but currently services are often fragmented with variable quality of care. Case management offers a way of co-ordinating services along the care pathway and therefore could provide individualised support; however, evidence of the effectiveness of case management for dementia is inconclusive. OBJECTIVE: to adapt the intervention used in a promising case management project in the USA and test its feasibility and acceptability in English general practice. DESIGN: in work package 1, a design group of varied professionals, with a carer and staff from the voluntary sector, met six times over a year to identify the skills and personal characteristics required for case management; protocols from the US study were adapted for use in the UK. The feasibility of recruiting general practices and patient-carer dyads and of delivering case management were tested in a pilot study (work package 2). An embedded qualitative study explored stakeholder views on study procedures and case management. SETTING: Four general practices, two in the north-east of England (Newcastle) one in London and one in Norfolk, took part in a feasibility pilot study of case management. PARTICIPANTS: Community-dwelling people with dementia and their carers who were not already being case managed by other services. INTERVENTION: a social worker shared by the two practices in the north-east and practice nurses in the other two practices were trained to deliver case management. We aimed to recruit 11 people with dementia from each practice who were not already being case managed. MAIN OUTCOME MEASURES: Numbers of people with dementia and their carers recruited, numbers and content of contacts, needs identified and perceptions of case management among stakeholders. RESULTS: Recruitment of practices and patients was slow and none of the practices achieved its recruitment target. It took more than 6 months to recruit a total of 28 people with dementia. Practice Quality and Outcome Framework registers for dementia contained only 60% of the expected number of people, most living in care homes. All stakeholders were positive about the potential of case management; however, only one of the four practices achieved a level of case management activity that might have influenced patient and carer outcomes. Case managers' activity levels were not related solely to time available for case management. Delivery of case management was hindered by limited clarity about the role, poor integration with existing services and a lack of embeddedness within primary care. There were discrepancies between case manager and researcher judgements about need, and evidence of a high threshold for acting on unmet need. The practice nurses experienced difficulties in ring-fencing case management time. CONCLUSIONS: the model of case management developed and evaluated in this feasibility study is unlikely to be sustainable in general practice under current conditions and in our view it would not be appropriate to attempt a definitive trial of this model. This study could inform the development of a case management role with a greater likelihood of impact. Different approaches to recruiting and training case managers, and identifying people with dementia who might benefit from case management, are needed, as is exploration of the scale of need for this type of working. TRIAL REGISTRATION: Current Controlled Trials ISRCTN74015152. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 52. See the NIHR Journals Library website for further project information.
Abstract.
Author URL.
Fox C, Smith T, Maidment I, Hebding J, Madzima T, Cheater F, Cross J, Poland F, White J, Young J, et al (2014). The importance of detecting and managing comorbidities in people with dementia?.
AGE AND AGEING,
43(6), 741-743.
Author URL.
Fox C, Alessi C, Ahluwalia S, Hachinski V (2014). The use of wide-scale mental agility testing to identify people at risk of dementia: crucial or harmful?.
J R Coll Physicians Edinb,
44(1), 30-35.
Abstract:
The use of wide-scale mental agility testing to identify people at risk of dementia: crucial or harmful?
The prevalence of dementia in the UK is rising rapidly and is predicted to double over the next 30 years. The NHS in England has been told to push for a rapid rise in dementia diagnosis rates, so that by 2015, two out of three cases are identified. The Prime Minister has raised the 'dementia challenge' as a priority for the NHS. While there is agreement on the need for action, debate arises over the nature of that intervention. Some, including Professor Alessi, argue that tools exist to support the diagnosis of mild cognitive impairment and they should be used because the disease is amenable to interventions. He believes that we need a shift in knowledge and attitude from thresholds to a continuum of cognitive impairment, from late to early stages and from effects to causes. The Montreal Cognitive Assessment (MoCa) should become part of the routine NHS Health Check after people reach age 40. Dr Fox argues on the other hand that widespread testing could lead to unnecessary anxiety and panic among those at risk and that funding should be focused on learning more about the early stages of dementia. While the concept of early testing is appealing, there is a large knowledge gap; instruments in use have not been tested in pre-dementia patients and have limited validity. While there is debate over the approach, we can agree that the economic and social impacts of this condition need to be addressed sooner rather than later.
Abstract.
Author URL.
Bamford C, Poole M, Brittain K, Chew-Graham C, Fox C, Iliffe S, Manthorpe J, Robinson L, CAREDEM team (2014). Understanding the challenges to implementing case management for people with dementia in primary care in England: a qualitative study using Normalization Process Theory.
BMC Health Serv Res,
14Abstract:
Understanding the challenges to implementing case management for people with dementia in primary care in England: a qualitative study using Normalization Process Theory.
BACKGROUND: Case management has been suggested as a way of improving the quality and cost-effectiveness of support for people with dementia. In this study we adapted and implemented a successful United States' model of case management in primary care in England. The results are reported elsewhere, but a key finding was that little case management took place. This paper reports the findings of the process evaluation which used Normalization Process Theory to understand the barriers to implementation. METHODS: Ethnographic methods were used to explore the views and experiences of case management. Interviews with 49 stakeholders (patients, carers, case managers, health and social care professionals) were supplemented with observation of case managers during meetings and initial assessments with patients. Transcripts and field notes were analysed initially using the constant comparative approach and emerging themes were then mapped onto the framework of Normalization Process Theory. RESULTS: the primary focus during implementation was on the case managers as isolated individuals, with little attention being paid to the social or organizational context within which they worked. Barriers relating to each of the four main constructs of Normalization Process Theory were identified, with a lack of clarity over the scope and boundaries of the intervention (coherence); variable investment in the intervention (cognitive participation); a lack of resources, skills and training to deliver case management (collective action); and limited reflection and feedback on the case manager role (reflexive monitoring). CONCLUSIONS: Despite the intuitive appeal of case management to all stakeholders, there were multiple barriers to implementation in primary care in England including: difficulties in embedding case managers within existing well-established community networks; the challenges of protecting time for case management; and case managers' inability to identify, and act on, emerging patient and carer needs (an essential, but previously unrecognised, training need). In the light of these barriers it is unclear whether primary care is the most appropriate setting for case management in England. The process evaluation highlights key aspects of implementation and training to be addressed in future studies of case management for dementia.
Abstract.
Author URL.
Smith T, Hameed Y, Cross J, Sahota O, Fox C (2013). Assessment of people with cognitive impairment and hip fracture: a systematic review and meta-analysis.
ARCHIVES OF GERONTOLOGY AND GERIATRICS,
57(2), 117-126.
Author URL.
Fox C (2013). Beyond software: foundations for advanced labor management.
Health Manag Technol,
34(10).
Author URL.
Fox C (2013). Consolidating healthcare.
Health Manag Technol,
34(4), 14-15.
Author URL.
Waugh A, Austin A, Manthorpe J, Fox C, Stephens B, Robinson L, Iliffe S (2013). Designing a complex intervention for dementia case management in primary care.
BMC FAMILY PRACTICE,
14 Author URL.
Kok D, Gill S, Bressel M, Byrne K, Kron T, Fox C, Duchesne G, Tai KH, Foroudi F (2013). Late toxicity and biochemical control in with and without dose escalated image 554 prostate cancer patients treated guided radiotherapy.
RADIOTHERAPY AND ONCOLOGY,
107(2), 140-146.
Author URL.
Fox C, Maidment I, Moniz-Cook E, White J, Thyrian JR, Young J, Katona C, Chew-Graham CA (2013). Optimising primary care for people with dementia.
Ment Health Fam Med,
10(3), 143-151.
Abstract:
Optimising primary care for people with dementia.
This review considers key areas in primary care regarding the diagnosis of dementia. Issues surrounding assessment, policy and incentives are considered. In addition, the relevance of non-medication approaches for dementia in primary care, which aim to enhance or maintain quality of life by maximising psychological and social function in the context of existing disabilities, is deliberated. Finally, key issues about primary care medication management are considered, and relevant therapeutic strategies with recommendation for a collaborative approach that improve outcomes by linking primary and secondary healthcare services - including general practice and pharmacy - with social care needs are weighed up. A key aspect of such a collaborative approach is to support informal carers in optimising medication.
Abstract.
Author URL.
Tan J, Heriot AG, Mackay J, Van Dyk S, Bressel MAB, Fox CD, Hui AC, Lynch AC, Leong T, Ngan SY, et al (2013). Prospective single-arm study of intraoperative radiotherapy for locally advanced or recurrent rectal cancer.
JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY,
57(5), 617-625.
Author URL.
Fox C, Lafortune L, Boustani M, Dening T, Rait G, Brayne C (2013). Screening for dementia--is it a no brainer?.
Int J Clin Pract,
67(11), 1076-1080.
Abstract:
Screening for dementia--is it a no brainer?
As people are living longer, dementia is becoming a significant issue for society. Dementia is now recognised as a major concern in society, and the numbers of people estimated to have dementia in the UK population appear to have stabilised at around 700,000. Globally, 35.6 million people are estimated to meet criteria for dementia, a number predicted to double every 20 years. Given the absence of treatments that significantly alter the natural history of the clinical syndrome of dementia, there has been increased emphasis on early diagnosis, with research exploring assessment tools and biomarkers that might predict with certainty a particular clinical outcome. At the same time, there has been pressure to focus on biomedical profiles, which assume a very close link between the pathobiology and the manifest clinical syndrome.
Abstract.
Author URL.
Fox C, Lafortune L, Boustani M, Brayne C (2013). The pros and cons of early diagnosis in dementia.
BRITISH JOURNAL OF GENERAL PRACTICE,
63(612), E510-E512.
Author URL.
Child A, Clarke A, Fox C, Maidment I (2012). A pharmacy led program to review anti-psychotic prescribing for people with dementia.
BMC PSYCHIATRY,
12 Author URL.
Rolinski M, Fox C, Maidment I, McShane R (2012). Cholinesterase inhibitors for dementia with Lewy bodies, Parkinson's disease dementia and cognitive impairment in Parkinson's disease.
COCHRANE DATABASE OF SYSTEMATIC REVIEWS(3).
Author URL.
Khan BA, Zawahiri M, Campbell NL, Fox GC, Weinstein EJ, Nazir A, Farber MO, Buckley JD, Maclullich A, Boustani MA, et al (2012). Delirium in hospitalized patients: implications of current evidence on clinical practice and future avenues for research--a systematic evidence review.
Journal of hospital medicine,
7(7), 580-589.
Abstract:
Delirium in hospitalized patients: implications of current evidence on clinical practice and future avenues for research--a systematic evidence review.
BackgroundDespite the significant burden of delirium among hospitalized adults, critical appraisal of systematic data on delirium diagnosis, pathophysiology, treatment, prevention, and outcomes is lacking.PurposeTo provide evidence-based recommendations for delirium care to practitioners, and identify gaps in delirium research.Data sourcesMedline, PubMed, the Cochrane Library, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) information systems from January 1966 to April 2011.Study selectionAll published systematic evidence reviews (SERs) on delirium were evaluated.Data extractionThree reviewers independently extracted the data regarding delirium risk factors, diagnosis, prevention, treatment, and outcomes, and critically appraised each SER as good, fair, or poor using the United States Preventive Services Task Force criteria.Data synthesisTwenty-two SERs graded as good or fair provided the data. Age, cognitive impairment, depression, anticholinergic drugs, and lorazepam use were associated with an increased risk for developing delirium. The Confusion Assessment Method (CAM) is reliable for delirium diagnosis outside of the intensive care unit. Multicomponent nonpharmacological interventions are effective in reducing delirium incidence in elderly medical patients. Low-dose haloperidol has similar efficacy as atypical antipsychotics for treating delirium. Delirium is associated with poor outcomes independent of age, severity of illness, or dementia.ConclusionDelirium is an acute, preventable medical condition with short- and long-term negative effects on a patient's cognitive and functional states.
Abstract.
Maidment ID, Fox C, Boustani M, Katona C (2012). Medication managementuthe missing link in dementia interventions.
INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY,
27(5), 439-442.
Author URL.
Koch T, Iliffe S, Manthorpe J, Stephens B, Fox C, Robinson L, Livingston G, Coulton S, Knapp M, Chew-Graham C, et al (2012). The potential of case management for people with dementia: a commentary.
Int J Geriatr Psychiatry,
27(12), 1305-1314.
Abstract:
The potential of case management for people with dementia: a commentary.
BACKGROUND: a recent review of studies of case management in dementia argues that lack of evidence of cost-effectiveness should discourage the use of this approach to care. We argue that that this is too conservative a stance, given the urgent need throughout the world to improve the quality of care for people with dementia and their caregivers. We propose a research agenda on case management for people with dementia. METHOD: a critical comparison was made of the studies identified in two systematic reviews of trials of case management for dementia, with selective inclusion of non-trial studies and economic evaluations. RESULTS: Our interpretation of the literature leads us to four provisional conclusions. First, studies with long follow-up periods tend to show delayed relocation of people with dementia to care homes. Second, the quality of life of people with dementia and their caregivers may also influence the likelihood of relocation. Third, different understandings of what constitutes case management make interpretation of studies difficult. Fourth, we agree that the population most likely to benefit from case management needs to be characterised. Earlier intervention may be more beneficial than intervening when the condition has progressed and the individual's situation is highly complex. However, this runs counter to some definitions of case management as an administrative, professional, and systemic focus on people with high needs and where expensive support is accessed or in prospect. CONCLUSIONS: More work needs to be carried out in a more focused way in order to establish the value of case management for people with dementia. Since care home residence is such a sizeable contributor to the costs of dementia care, studies need to be long enough to capture possible postponed relocation. However, case management studies with shorter follow-up periods can still contribute to our understanding, since they can demonstrate improved quality of life. Future research should be built around a common, agreed definition of types of case management.
Abstract.
Author URL.
Gill S, Thomas J, Fox C, Kron T, Rolfo A, Leahy M, Chander S, Williams S, Tai KH, Duchesne GM, et al (2011). Acute toxicity in prostate cancer patients treated with and without image-guided radiotherapy.
RADIATION ONCOLOGY,
6 Author URL.
Fox C, Richardson K, Maidment ID, Savva GM, Matthews FE, Smithard D, Coulton S, Katona C, Boustani MA, Brayne C, et al (2011). Anticholinergic Medication Use and Cognitive Impairment in the Older Population: the Medical Research Council Cognitive Function and Ageing Study.
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY,
59(8), 1477-1483.
Author URL.
Fox C, Livingston G, Maidment ID, Coulton S, Smithard DG, Boustani M, Katona C (2011). The impact of anticholinergic burden in Alzheimer's Dementia-the Laser-AD study.
AGE AND AGEING,
40(6), 730-735.
Author URL.
Treloar A, Crugel M, Prasanna A, Solomons L, Fox C, Paton C, Katona C (2010). Ethical dilemmas: should antipsychotics ever be prescribed for people with dementia?.
BRITISH JOURNAL OF PSYCHIATRY,
197(2), 88-90.
Author URL.
Fox C (2010). Evidence summary: what do we know from qualitative research about people's care-seeking about oral health?.
BRITISH DENTAL JOURNAL,
209(5), 225-231.
Author URL.
Kron T, Thomas J, Fox C, Thompson A, Owen R, Herschtal A, Haworth A, Tai K-H, Foroudi F (2010). Intra-fraction prostate displacement in radiotherapy estimated from pre- and post-treatment imaging of patients with implanted fiducial markers.
RADIOTHERAPY AND ONCOLOGY,
95(2), 191-197.
Author URL.
Shotbolt P, Samuel M, Fox C, David AS (2009). A randomized controlled trial of quetiapine for psychosis in Parkinson's disease.
NEUROPSYCHIATRIC DISEASE AND TREATMENT,
5, 327-332.
Author URL.
Justiss MD, Boustani M, Fox C, Katona C, Perkins AJ, Healey PJ, Sach G, Hui S, Callahan CM, Hendrie HC, et al (2009). Patients' attitudes of dementia screening across the Atlantic.
INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY,
24(6), 632-637.
Author URL.
Campbell N, Boustani MA, Ayub A, Fox GC, Munger SL, Ott C, Guzman O, Farber M, Ademuyiwa A, Singh R, et al (2009). Pharmacological management of delirium in hospitalized adults--a systematic evidence review.
Journal of general internal medicine,
24(7), 848-853.
Abstract:
Pharmacological management of delirium in hospitalized adults--a systematic evidence review.
Background and objectivesDespite the significant burden of delirium among hospitalized adults, there is no approved pharmacologic intervention for delirium. This systematic review evaluates the efficacy and safety of pharmacologic interventions targeting either prevention or management of delirium.Data sourcesWe searched Medline, PubMed, the Cochrane Register of Controlled Trials, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) information systems from January 1966 to October 2008. We included randomized, controlled trials comparing pharmacologic compounds either to each other or placebo. We excluded non-comparison trials, studies with patients aged < 18 years, a history of an Axis I psychiatric disorder, and patients with alcohol-related delirium.Review methodsThree reviewers independently extracted the data for participants, interventions and outcome measures, and critically appraised each study using the JADAD scale.ResultsWe identified 13 studies that met our inclusion criteria and evaluated 15 compounds: second-generation antipsychotics, first-generation antipsychotics, cholinergic enhancers, an antiepileptic agent, an inhaled anesthetic, injectable sedatives, and a benzodiazepine. Four trials evaluated delirium treatment and suggested no differences in efficacy or safety among the evaluated treatment methods (first and second generation antipsychotics). Neither cholinesterase inhibitors nor procholinergic drugs were effective in preventing delirium. Multiple studies, however, suggest either shorter severity and duration, or prevention of delirium with the use of haloperidol, risperidone, gabapentin, or a mixture of sedatives in patients undergoing elective or emergent surgical procedures.ConclusionThe existing limited data indicates no superiority for second-generation antipsychotics over haloperidol in managing delirium. Although preliminary results suggest delirium prevention may be accomplished through various mechanisms, further studies are necessary to prove effectiveness.
Abstract.
Herschtal A, Kron T, Fox C (2009). Radiotherapy margin design with particular consideration of high curvature CTVs.
MEDICAL PHYSICS,
36(3), 684-697.
Author URL.
Campbell N, Boustani M, Limbil T, Ott C, Fox C, Maidment I, Schubert CC, Munger S, Fick D, Miller D, et al (2009). The cognitive impact of anticholinergics: a clinical review.
CLINICAL INTERVENTIONS IN AGING,
4, 225-233.
Author URL.
Campbell N, Ayub A, Boustani MA, Fox C, Farlow M, Maidment I, Howard R (2008). Impact of cholinesterase inhibitors on behavioral and psychological symptoms of Alzheimer's disease: a meta-analysis.
CLINICAL INTERVENTIONS IN AGING,
3(4), 719-728.
Author URL.
Boustani M, Perkins AJ, Monahan P, Fox C, Watson L, Hopkins J, Fultz B, Hui S, Unverzagt FW, Callahan CM, et al (2008). Measuring primary care patients' attitudes about dementia screening.
INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY,
23(8), 812-820.
Author URL.
Maidment ID, Haw C, Stubbs J, Fox C, Katona C, Franklin BD (2008). Medication errors in older people with mental health problems: a review.
INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY,
23(6), 564-573.
Author URL.
Joshi D, Vosough A, Raymond TM, Fox C, Dhiman A (2007). Bouveret's syndrome as an unusual cause of gastric outlet obstruction: a case report.
J Med Case Rep,
1Abstract:
Bouveret's syndrome as an unusual cause of gastric outlet obstruction: a case report.
An 83 year old caucasian gentleman presented with vomiting and left sided abdominal pain. A subsequent upper GI endoscopy demonstrated a large smooth mass impacted within the duodenum. A cholecysto-duodenal fistula was discovered at laparotomy, with a large gallstone impacted in the duodenum. A diagnosis of Bouveret's syndrome was made. The management of this rare cause of gastric outlet obstruction is discussed.
Abstract.
Author URL.
Brayne C, Fox C, Boustani M (2007). Dementia screening in primary care - is it time?.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION,
298(20), 2409-2411.
Author URL.
Maidment I, Fox C, Boustani M (2006). Cholinesterase inhibitors for Parkinson's disease dementia.
Cochrane Database Syst Rev(1).
Abstract:
Cholinesterase inhibitors for Parkinson's disease dementia.
BACKGROUND: the loss of cholinergic, dopaminergic and noradrenergic innervations seen in Parkinson's Disease Dementia (PDD) suggest a potential role for cholinesterase inhibitors. Concerns have been expressed about a theoretical worsening of Parkinson's disease related symptoms particularly movement symptoms. OBJECTIVES: to assess the efficacy, safety, tolerability and health economic data relating to the use of cholinesterase inhibitors in PDD. SEARCH STRATEGY: the trials were identified from the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 19 April 2005 using the search term parkinson*This register contains records from major health care databases and many ongoing trial databases and is updated regularly.Comprehensive searches of abstracts from major scientific meetings were performed. Pharmaceutical companies were approached for information regarding additional and ongoing studies. SELECTION CRITERIA: Randomized, double-blind, placebo-controlled studies assessing the effectiveness of cholinesterase inhibitors in PDD. Inclusion and exclusion criteria were stated to limit bias. DATA COLLECTION AND ANALYSIS: Two reviewers (IM, CF) independently reviewed the quality of the studies utilising criteria from the Cochrane Collaboration Handbook. Medications were examined separately and as a group. The outcome measures assessed were in the following domains: neuropsychiatric features, cognition, global impression, daily living activities, quality of life, burden on caregiver, Parkinsonian related symptoms, treatment acceptability as determined by withdrawal from trials, safety as determined by the frequency of adverse events, institutionalisation, death and health economic factors. MAIN RESULTS: a detailed and systematic search of relevant databases identified one published randomized, double-blind, placebo-controlled study (Emre 2004) involving 541 patients that compared rivastigmine with placebo. Rivastigmine produced statistically significant improvements in several outcome measures. On the primary cognitive measure, the ADAS-Cog, rivastigmine was associated with a 2.80 point ADAS-Cog improvement [WMD -2.80, 95% Cl -4.26 to -1.34, P = 0.0002] and a 2.50 point ADCS-ADL improvement [95% Cl 0.43 to 4.57, P = 0.02] relative to placebo. Clinically meaningful (moderate or marked) improvement occurred in 5.3% more patients on rivastigmine, and meaningful worsening occurred in 10.1% more patients on placebo. Tolerability appeared to be a significant issue. Significantly more patients on rivastigmine dropped out of the study due to adverse events [62/362 versus 14/179, OR 2.44, 95% Cl 1.32 to 4.48, P = 0.004]. Nausea [20/179 versus 105/362, OR 3.25, 95% Cl 1.94 to 5.45, P < 0.00001], tremor [7/179 versus 37/362, OR 2.80, 95% Cl 1.22 to 6.41, P = 0.01] and in particular vomiting [3/179 versus 60/362, OR 11.66, 95% Cl 3.60 to 37.72, P < 0.0001] were significantly more common with rivastigmine. However, significantly fewer patients died on rivastigmine than placebo [4/362 versus 7/179, OR 0.27, 95% CI 0.08 to 0.95, P = 0.04] AUTHORS' CONCLUSIONS: Rivastigmine appears to improve cognition and activities of daily living in patients with PDD. This results in clinically meaningful benefit in about 15% of cases. There is a need for more studies utilising pragmatic measures such as time to residential care facility and both patient and carer quality of life assessments. Future trials should involve other cholinesterase inhibitors, utilise tools to analyse the data that limit any bias and measure health economic factors. It is unlikely that relying solely on the last observation carried forward (LOCF) is sufficient. Publication of the observed case data in the largest trial would assist (Emre 2004). Adverse events were associated with the cholinergic activity of rivastigmine, but may limit patient acceptability as evidenced by the high drop out rate in the active arm.
Abstract.
Author URL.
Schubert CC, Boustani M, Callahan CM, Perkins AJ, Carney CP, Fox C, Unverzagt F, Hui S, Hendrie HC (2006). Comorbidity profile of dementia patients in primary care: Are they sicker?.
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY,
54(1), 104-109.
Author URL.
Maidment I, Fox C, Livingston G, Katona C (2006). Drug treatment for Alzheimer's disease: the way forward.
INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY,
21(1), 6-8.
Author URL.
Fox C, Maidment ID, Boustani M, Katona C (2006). Memantine combined with an acetyl cholinesterase inhibitor - hope for the future?.
Neuropsychiatr Dis Treat,
2(2), 121-125.
Abstract:
Memantine combined with an acetyl cholinesterase inhibitor - hope for the future?
BACKGROUND: Memantine and cholinesterase inhibitors (ChEI) have distinct pharmacological actions, and interest in the use of combination therapy for Alzheimer's disease (AD) is increasing. OBJECTIVE: to assess the available data on the use of memantine-ChEI combination and to develop evidence-based recommendations. METHOD: a systematic literature review with detailed discussion of the current evidence base. RESULTS: AVAILABLE DATA ARE LIMITED: five studies of which two were randomized, double-blind, placebo-controlled trials. One study indicated that memantine-ChEI combination is not significantly more effective than placebo-ChEI in mild to moderate AD, but data were published in abstract and poster form only. A second study indicated that the memantine-ChEI combination is significantly more effective than placebo-ChEI in moderate to severe AD. The calculated effect sizes of 0.36 on cognition and 0.12 on function, which were the primary outcomes, were small, indicating a clinically minimal effect on cognition and no effect on function. No data are available on whether combination treatment is more effective than memantine monotherapy. CONCLUSION: the available data do not justify the use of combination therapy. Future studies should include three arms (memantine-placebo, placebo-ChEI, and memantine-ChEI), be of an adequate size and duration, and use pragmatic measures. Clinicians should have full access to data from any future trials.
Abstract.
Author URL.
Boustani M, Perkins AJ, Fox C, Unverzagt F, Austrom MG, Fultz B, Hui S, Callahan CM, Hendrie HC (2006). Who refuses the diagnostic assessment for dementia in primary care?.
INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY,
21(6), 556-563.
Author URL.
Maidment ID, Fox C, Boustani M (2005). A review of studies describing the use of acetyl cholinesterase inhibitors in Parkinson's disease dementia.
Acta Psychiatr Scand,
111(6), 403-409.
Abstract:
A review of studies describing the use of acetyl cholinesterase inhibitors in Parkinson's disease dementia.
OBJECTIVE: to review the literature relating to the use of acetyl cholinesterase inhibitors in Parkinson's disease dementia (PDD). METHOD: MEDLINE (1966--December 2004), PsychINFO (1972--December 2004), EMBASE (1980--December 2004), CINHAL (1982--December 2004), and the Cochrane Collaboration were searched in December 2004. RESULTS: Three controlled trials and seven open studies were identified. Efficacy was assessed in three key domains: cognitive, neuropsychiatric and parkinsonian symptoms. CONCLUSION: Cholinesterase inhibitors have a moderate effect against cognitive symptoms. There is no clear evidence of a noticeable clinical effect against neuropsychiatric symptoms. Tolerability including exacerbation of motor symptoms--in particular tremor--may limit the utility of cholinesterase inhibitors.
Abstract.
Author URL.
Metcalfe P, Chapman A, Arnold A, Arnold B, Tangboonduangjit P, Capp A, Fox C (2004). Intensity-modulated radiation therapy: not a dry eye in the house.
Australas Radiol,
48(1), 35-44.
Abstract:
Intensity-modulated radiation therapy: not a dry eye in the house.
Inverse planned intensity-modulated radiation therapy (IMRT) has been applied to patients in a conformal fashion in order to avoid the lacrimal gland. In the present study, we report a patient in which a potential planned dose of 63 Gy to the lacrimal gland for a conventional plan was reduced to 12 Gy to the lacrimal gland for the IMRT plan. Dose objective inverse planning was provided using a Pinnacle treatment planning computer and treatment was delivered using a Varian dynamic multileaf collimator (MLC) on a Varian linear accelerator. Because multiple MLC segments are used to deliver the modulated treatment, conventional dose checks by manual calculation are not practical. To aid in an alternative dosimetric verification process, the Pinnacle planning computer has two unique dose tools, which provide axial and beams eye view doses on user-specified check phantoms. The combined field axial dose tool matched our ion chamber dose checks within +/- 2.4% at the isocentre. The individual beams eye view dose tool matched film dose maps within +/- 3% in the umbra.
Abstract.
Author URL.
Edwards C, Fox C (2001). Quality of care for people with dementia. Dementia care mapping is inadequate tool for research.
BMJ,
323(7326), 1427-1428.
Author URL.
Fox C, Edwards C, Rennick S (2000). Behavioural difficulties.
Int J Geriatr Psychiatry,
15(5), 467-468.
Author URL.
Duffy P, Fox C, Reid G (1999). Post-traumatic stress disorder.
J R Soc Med,
92(3).
Author URL.
Neal LA, Shapland W, Fox C (1997). An open trial of moclobemide in the treatment of post-traumatic stress disorder.
Int Clin Psychopharmacol,
12(4), 231-237.
Abstract:
An open trial of moclobemide in the treatment of post-traumatic stress disorder.
Traditional monoamine oxidase inhibitors have shown efficacy in the treatment of post-traumatic stress disorder, but their use is limited by some serious drug and food interactions. Moclobemide, which is a reversible inhibitor of monoamine oxidase-A, is relatively free of these limitations and is therefore potentially useful in the treatment of post-traumatic stress disorder. Twenty patients who met Diagnostic and Statistical Manual of Mental Disorders, Third Edition Revised (DSM-III-R) criteria for post-traumatic stress disorder were entered into a 12-week open study with moclobemide. Assessments were completed every 4 weeks. Eleven participants no longer met DSM-III-R criteria for post-traumatic stress disorder by week 12. The severity of post-traumatic stress disorder reduced by 2.09 SD (95% confidence interval 1.49-2.69; p < 0.001) and functional impairment improved by 1.08 SD (95% confidence interval 0.46-1.69; p < 0.01). Adverse events were minimal. Controlled, double-blind studies should be considered to confirm these findings.
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Neal LA, Fox C, Carroll N, Holden M, Barnes P (1997). Development and validation of a computerized screening test for personality disorders in DSM-III-R.
Acta Psychiatr Scand,
95(4), 351-356.
Abstract:
Development and validation of a computerized screening test for personality disorders in DSM-III-R.
The available self-report instruments designed to measure personality disorder (PD) are time-consuming to administer and/or score and can be impractical for routine clinical use. There is a need for a computerized method of personality assessment based on contemporary systems of classification. A computerized DSM-III-R-based questionnaire was developed and validated against the structured clinical interview for DSM-III-R Axis-II disorders on a sample of 60 subjects. The computerized test showed moderate validity as a diagnostic instrument (mean kappa coefficient = 0.47). With adjusted cut-off scores it was valid as a screening instrument (mean sensitivity = 0.87). Antisocial, borderline and avoidant PD scores were strongly correlated across measures and not subject to significant observer bias.
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