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1.  Improving the experience of dementia and enhancing active life - living well with dementia: study protocol for the IDEAL study 
Enabling people with dementia and carers to ‘live well’ with the condition is a key United Kingdom policy objective. The aim of this project is to identify what helps people to live well or makes it difficult to live well in the context of having dementia or caring for a person with dementia, and to understand what ‘living well’ means from the perspective of people with dementia and carers.
Over a two-year period, 1500 people with early-stage dementia throughout Great Britain will be recruited to the study, together with a carer wherever possible. All the participants will be visited at home initially and again 12 months and 24 months later. This will provide information about the way in which well-being, life satisfaction and quality of life are affected by social capitals, assets and resources, the challenges posed by dementia, and the ways in which people adjust to and cope with these challenges. A smaller group will be interviewed in more depth.
The findings will lead to recommendations about what can be done by individuals, communities, health and social care practitioners, care providers and policy-makers to improve the likelihood of living well with dementia.
PMCID: PMC4260182  PMID: 25433373
Quality of life; Life satisfaction; Well-being; Person with dementia; Carer; Alzheimer’s disease; Vascular dementia; Fronto-temporal dementia; Parkinson’s disease dementia; Lewy body dementia
2.  Cost-effectiveness of telecare for people with social care needs: the Whole Systems Demonstrator cluster randomised trial 
Age and Ageing  2014;43(6):794-800.
Purpose of the study: to examine the costs and cost-effectiveness of ‘second-generation’ telecare, in addition to standard support and care that could include ‘first-generation’ forms of telecare, compared with standard support and care that could include ‘first-generation’ forms of telecare.
Design and methods: a pragmatic cluster-randomised controlled trial with nested economic evaluation. A total of 2,600 people with social care needs participated in a trial of community-based telecare in three English local authority areas. In the Whole Systems Demonstrator Telecare Questionnaire Study, 550 participants were randomised to intervention and 639 to control. Participants who were offered the telecare intervention received a package of equipment and monitoring services for 12 months, additional to their standard health and social care services. The control group received usual health and social care.
Primary outcome measure: incremental cost per quality-adjusted life year (QALY) gained. The analyses took a health and social care perspective.
Results: cost per additional QALY was £297,000. Cost-effectiveness acceptability curves indicated that the probability of cost-effectiveness at a willingness-to-pay of £30,000 per QALY gained was only 16%. Sensitivity analyses combining variations in equipment price and support cost parameters yielded a cost-effectiveness ratio of £161,000 per QALY.
Implications: while QALY gain in the intervention group was similar to that for controls, social and health services costs were higher. Second-generation telecare did not appear to be a cost-effective addition to usual care, assuming a commonly accepted willingness to pay for QALYs.
Trial registration number: ISRCTN 43002091.
PMCID: PMC4204660  PMID: 24950690
telecare; economic evaluation; social care; older people
3.  Issues in the incorporation of economic perspectives and evidence into Cochrane reviews 
Systematic Reviews  2013;2:83.
Methods for systematic reviews of the effects of health interventions have focused mainly on addressing the question of 'What works?’ or 'Is this intervention effective in achieving one or more specific outcomes?’ Addressing the question 'Is it worth it given the resources available?’ has received less attention. This latter question can be addressed by applying an economic lens to the systematic review process.
This paper reflects on the value and desire for the consideration by end users for coverage of an economic perspective in a Cochrane review and outlines two potential approaches and future directions.
Two frameworks to guide review authors who are seeking to include an economic perspective are outlined. The first involves conducting a full systematic review of economic evaluations that is integrated into a review of intervention effects. The second involves developing a brief economic commentary. The two approaches share a set of common stages but allow the tailoring of the economic component of the Cochrane review to the skills and resources available to the review team.
The number of studies using the methods outlined in the paper is limited, and further examples are needed both to explore the value of these approaches and to further develop them. The rate of progress will hinge on the organisational leadership, capacity and resources available to the CCEMG, author teams and other Cochrane entities. Particular methodological challenges to overcome relate to understanding the key economic trade-offs and casual relationships for a given decision problem and informing the development of evaluations designed to support local decision-makers.
Methods for incorporating economic perspectives and evidence into Cochrane intervention reviews are established. Their role is not to provide a precise estimate of 'cost-effectiveness’ but rather to help end-users of Cochrane reviews to determine the implications of the economic components of reviews for their own specific decisions.
PMCID: PMC3849717  PMID: 24050504
Cost-utility analysis; Cost-effectiveness analysis; Systematic review; Meta-analysis; Cochrane collaboration
4.  Patient satisfaction with medication for gastroesophageal reflux disease: A systematic review 
Patient satisfaction is increasingly regarded as an important aspect of measuring treatment success in individuals with gastroesophageal reflux disease (GERD).
To review how satisfied patients with GERD are with their medication, and to analyze the usefulness of patient satisfaction as a clinical end point by comparing it with symptom improvement.
Systematic searches of the PubMed and EMBASE databases identified clinical trials and patient surveys published between 1966 and 2009.
Twelve trials reported that 56% to 100% of patients were ‘satisfied’ or ‘very satisfied’ with proton pump inhibitor (PPI) treatment for GERD. Patient satisfaction levels were higher for PPIs than other GERD medications in two trials. The sample-size-weighted average proportion of patients ‘satisfied’ with their PPI after four weeks of treatment in trials was 93% (95% CI 87% to 99%), with 73% (95% CI 62% to 83%) being ‘very satisfied’. In four surveys, the average proportion of patients ‘satisfied’ with their PPI treatment was 82% (95% CI 73% to 90%) and 62% (95% CI 48% to 75%) were ‘very satisfied’. Seven trials found a positive association between patient satisfaction and symptom improvement, and two surveys between satisfaction and improved health-related quality of life. Three trials found that continuous treatment yielded higher rates of satisfaction than on-demand therapy.
More than one-half of patients were satisfied with their PPI medication in trials, and more patients were satisfied with PPIs than other medication types. An association between patient satisfaction and symptom resolution was found, suggesting that patient satisfaction is a useful end point for evaluating GERD treatment success.
PMCID: PMC3354888  PMID: 22506259
GERD; Medication; Patient-reported outcome; Satisfaction; Therapy
5.  Effect of telecare on use of health and social care services: findings from the Whole Systems Demonstrator cluster randomised trial 
Age and Ageing  2013;42(4):501-508.
Objective: to assess the impact of telecare on the use of social and health care. Part of the evaluation of the Whole Systems Demonstrator trial.
Participants and setting: a total of 2,600 people with social care needs were recruited from 217 general practices in three areas in England.
Design: a cluster randomised trial comparing telecare with usual care, general practice being the unit of randomisation. Participants were followed up for 12 months and analyses were conducted as intention-to-treat.
Data sources: trial data were linked at the person level to administrative data sets on care funded at least in part by local authorities or the National Health Service.
Main outcome measures: the proportion of people admitted to hospital within 12 months. Secondary endpoints included mortality, rates of secondary care use (seven different metrics), contacts with general practitioners and practice nurses, proportion of people admitted to permanent residential or nursing care, weeks in domiciliary social care and notional costs.
Results: 46.8% of intervention participants were admitted to hospital, compared with 49.2% of controls. Unadjusted differences were not statistically significant (odds ratio: 0.90, 95% CI: 0.75–1.07, P = 0.211). They reached statistical significance after adjusting for baseline covariates, but this was not replicated when adjusting for the predictive risk score. Secondary metrics including impacts on social care use were not statistically significant.
Conclusions: telecare as implemented in the Whole Systems Demonstrator trial did not lead to significant reductions in service use, at least in terms of results assessed over 12 months.
International Standard Randomised Controlled Trial Number Register ISRCTN43002091.
PMCID: PMC3684109  PMID: 23443509
telecare; assistive technology; randomised controlled trial; administrative data; older people
6.  Individual Cognitive Stimulation Therapy for dementia (iCST): study protocol for a randomized controlled trial 
Trials  2012;13:172.
Improving the quality of care for people with dementia and their carers has become a national priority in many countries. Cognitive Stimulation Therapy (CST) groups can be beneficial in improving cognition and quality of life for people with dementia. The aim of the current study is to develop and evaluate a home-based individual Cognitive Stimulation Therapy (iCST) programme for people with dementia which can be delivered by their family carer.
This multi-centre, pragmatic randomised controlled trial (RCT) will compare the effectiveness and cost-effectiveness of iCST for people with dementia with a treatment as usual control group. The intervention consists of iCST sessions delivered by a carer for 30 minutes, 3 times a week over 25 weeks.
For people with dementia the primary outcome measures are cognition assessed by the ADAS-Cog, and quality of life assessed by QoL-AD. For carers, quality of life using the SF-12 is the primary outcome measure. Using a 5% significance level, comparison of 306 participants will yield 80% power to detect an effect size of 0.35 for cognition as measured by the ADAS-Cog, and quality of life as measured by the QoL-AD. Quality of life for the carer will be measured using the SF-12. The trial will include a cost-effectiveness analysis from a public sector perspective.
The UK Department of Health has recently stressed that improving access to psychological therapies is a national priority, but many people with dementia are unable to access psychological interventions. The development of a home-based individual version of CST will provide an easy to use, widely available therapy package that will be evaluated for effectiveness and cost-effectiveness in a multi centre RCT.
PMCID: PMC3522062  PMID: 22998983
7.  The impact on carers of individuals with social care needs: the Whole Systems Demonstrator study 
Carers of individuals with social care needs (including frail elderly people, those at risk of falls and those requiring night sitting), are subject to high levels of carer burden, social isolation and poor psychological outcomes. Carers’ worries and concerns include leaving the individual alone; risks of harm to the care-recipient; or household emergencies in their absence. At present there is a lack of research on the impact of telecare interventions on carer outcomes. It is feasible that carers’ anxieties and level of strain may be ameliorated with concomitant increases in quality of life, with the introduction of telecare systems for their care-recipient.
This study investigates the secondary impact of telecare on carers, specifically whether the use of telecare reduces informal carer burden and social isolation and whether it improves carers’ psychological well-being and confidence in leaving the care-recipient alone.
We report on the prospective analysis of a pragmatic controlled trial on carers of telecare users and controls within the WSD evaluation of telecare (a pragmatic cluster randomised controlled trial investigating the effectiveness of telecare for social care recipients).
Carers of individuals with social care needs were identified and recruited to the study via a combination of snowball sampling, light touch visits (to users) and self selection. Over 200 carers completed a questionnaire pack at baseline, and at short and long-term follow-ups; with roughly equal numbers of carers of recipients of telecare and recipients of usual care. The questionnaire pack included measures of quality of life (ICECAP), health related quality of life (SF12, EQ5D), psychosocial well-being (STAI-6, CESD10) and care-giver strain measures (CGSI, Carer confidence and anxiety).
Results and Conclusions
Multi-level modelling of difference in outcomes between carer groups and across time was conducted with appropriate covariates. Specific findings from the Telecare Carers Study are embargoed until these analyses have been peer-reviewed and accepted for publication.
PMCID: PMC3571154
carers; telecare; quality of life; carer outcomes; social care needs
8.  Cost-effectiveness of telehealth in people with social care needs: the Whole Systems Demonstrator cluster randomised trial 
The Whole Systems Demonstrator pilots introduced telehealth and telecare into three local authority areas using an integrated approach to deliver health and social care to those with high care needs and long-term conditions. Proponents of these technologies have given cost savings as one rationale for advocating their introduction and widespread implementation; proponents have also advocated their potential to improve the quality of life for their users. Until recently, evaluations of telehealth and telecare in high-income countries have been based on relatively small-scale pilots; few such evaluations have been designed as randomised controlled trials. The WSD study was a pragmatic cluster-randomised control trial, representing the largest-scale trial of telehealth and telecare to be carried out in the UK. This presentation focuses on the results of the WSD telecare questionnaire study.
To examine the costs and cost-effectiveness of telecare compared to standard support and treatment.
Economic evaluation conducted in parallel with a pragmatic cluster-randomised controlled trial of Telecare. 2600 people with social care needs participated in a trial of a community-based telecare intervention in three English local authority areas. Approximately half of the participants in the telecare trial also consented to participate in the WSD telecare questionnaire study, which collected information on a number of patient-reported outcome measures and also on the self-reported use of a range of health and social services. Health and social costs were calculated by attaching nationally applicable unit costs to self-reported service use data. The unit costs of telecare support and treatment provided were calculated drawing on administrative and financial data sources and interviews with key informants. The primary outcome for the cost-effectiveness analysis was the quality-adjusted life year (QALY). Secondary outcomes included measures of health-related quality of life and well-being. We employed multivariate analyses to explore the cost-effectiveness of the intervention
The presentation will describe the results of the economic evaluation of telecare, addressing the cost of care and treatment packages used by those participating in the telecare questionnaire study and the results of the cost-effectiveness analysis. These results will be available by the time of the presentation.
These will be available by the time of the presentation.
PMCID: PMC3571183
economic evaluation; social care; cost analysis; telecare
9.  A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: protocol for the whole systems demonstrator cluster randomised trial 
It is expected that increased demands on services will result from expanding numbers of older people with long-term conditions and social care needs. There is significant interest in the potential for technology to reduce utilisation of health services in these patient populations, including telecare (the remote, automatic and passive monitoring of changes in an individual's condition or lifestyle) and telehealth (the remote exchange of data between a patient and health care professional). The potential of telehealth and telecare technology to improve care and reduce costs is limited by a lack of rigorous evidence of actual impact.
We are conducting a large scale, multi-site study of the implementation, impact and acceptability of these new technologies. A major part of the evaluation is a cluster-randomised controlled trial of telehealth and telecare versus usual care in patients with long-term conditions or social care needs. The trial involves a number of outcomes, including health care utilisation and quality of life. We describe the broad evaluation and the methods of the cluster randomised trial
If telehealth and telecare technology proves effective, it will provide additional options for health services worldwide to deliver care for populations with high levels of need.
Trial Registration
Current Controlled Trials ISRCTN43002091
PMCID: PMC3169462  PMID: 21819569
10.  Pathogens: the plight of plants 
Genome Biology  2004;5(3):315.
A report on the British Society for Plant Pathology, Presidential meeting 'Plant pathogen genomics - from, sequence to application', University of Nottingham, UK, 15-18 December 2003.
A report on the British Society for Plant Pathology Presidential meeting 'Plant pathogen genomics - from sequence to application', University of Nottingham, UK, 15-18 December 2003.
PMCID: PMC395762  PMID: 15003115
11.  Phosphorylation and Rapid Relocalization of 53BP1 to Nuclear Foci upon DNA Damage 
Molecular and Cellular Biology  2001;21(5):1719-1729.
53BP1 is a human BRCT protein that was originally identified as a p53-interacting protein by the Saccharomyces cerevisiae two-hybrid screen. Although the carboxyl-terminal BRCT domain shows similarity to Crb2, a DNA damage checkpoint protein in fission yeast, there is no evidence so far that implicates 53BP1 in the checkpoint. We have identified a Xenopus homologue of 53BP1 (XL53BP1). XL53BP1 is associated with chromatin and, in some cells, localized to a few large foci under normal conditions. Gamma-ray irradiation induces increased numbers of the nuclear foci in a dose-dependent manner. The damage-induced 53BP1 foci appear rapidly (in 30 min) after irradiation, and de novo protein synthesis is not required for this response. In human cells, 53BP1 foci colocalize with Mrel1 foci at later stages of the postirradiation period. XL53BP1 is hyperphosphorylated after X-ray irradiation, and inhibitors of ATM-related kinases delay the relocalization and reduce the phosphorylation of XL53BP1 in response to X-irradiation. In AT cells, which lack ATM kinase, the irradiation-induced responses of 53BP1 are similarly affected. These results suggest a role for 53BP1 in the DNA damage response and/or checkpoint control which may involve signaling of damage to p53.
PMCID: PMC86718  PMID: 11238909
12.  Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial 
Objective To assess the effect of home based telehealth interventions on the use of secondary healthcare and mortality.
Design Pragmatic, multisite, cluster randomised trial comparing telehealth with usual care, using data from routine administrative datasets. General practice was the unit of randomisation. We allocated practices using a minimisation algorithm, and did analyses by intention to treat.
Setting 179 general practices in three areas in England.
Participants 3230 people with diabetes, chronic obstructive pulmonary disease, or heart failure recruited from practices between May 2008 and November 2009.
Interventions Telehealth involved remote exchange of data between patients and healthcare professionals as part of patients’ diagnosis and management. Usual care reflected the range of services available in the trial sites, excluding telehealth.
Main outcome measure Proportion of patients admitted to hospital during 12 month trial period.
Results Patient characteristics were similar at baseline. Compared with controls, the intervention group had a lower admission proportion within 12 month follow-up (odds ratio 0.82, 95% confidence interval 0.70 to 0.97, P=0.017). Mortality at 12 months was also lower for intervention patients than for controls (4.6% v 8.3%; odds ratio 0.54, 0.39 to 0.75, P<0.001). These differences in admissions and mortality remained significant after adjustment. The mean number of emergency admissions per head also differed between groups (crude rates, intervention 0.54 v control 0.68); these changes were significant in unadjusted comparisons (incidence rate ratio 0.81, 0.65 to 1.00, P=0.046) and after adjusting for a predictive risk score, but not after adjusting for baseline characteristics. Length of hospital stay was shorter for intervention patients than for controls (mean bed days per head 4.87 v 5.68; geometric mean difference −0.64 days, −1.14 to −0.10, P=0.023, which remained significant after adjustment). Observed differences in other forms of hospital use, including notional costs, were not significant in general. Differences in emergency admissions were greatest at the beginning of the trial, during which we observed a particularly large increase for the control group.
Conclusions Telehealth is associated with lower mortality and emergency admission rates. The reasons for the short term increases in admissions for the control group are not clear, but the trial recruitment processes could have had an effect.
Trial registration number International Standard Randomised Controlled Trial Number Register ISRCTN43002091.
PMCID: PMC3381047  PMID: 22723612
13.  Effect of telehealth on quality of life and psychological outcomes over 12 months (Whole Systems Demonstrator telehealth questionnaire study): nested study of patient reported outcomes in a pragmatic, cluster randomised controlled trial  
Objective To assess the effect of second generation, home based telehealth on health related quality of life, anxiety, and depressive symptoms over 12 months in patients with long term conditions.
Design A study of patient reported outcomes (the Whole Systems Demonstrator telehealth questionnaire study; baseline n=1573) was nested in a pragmatic, cluster randomised trial of telehealth (the Whole Systems Demonstrator telehealth trial, n=3230). General practice was the unit of randomisation, and telehealth was compared with usual care. Data were collected at baseline, four months (short term), and 12 months (long term). Primary intention to treat analyses tested treatment effectiveness; multilevel models controlled for clustering by general practice and a range of covariates. Analyses were conducted for 759 participants who completed questionnaire measures at all three time points (complete case cohort) and 1201 who completed the baseline assessment plus at least one other assessment (available case cohort). Secondary per protocol analyses tested treatment efficacy and included 633 and 1108 participants in the complete case and available case cohorts, respectively.
Setting Provision of primary and secondary care via general practices, specialist nurses, and hospital clinics in three diverse regions of England (Cornwall, Kent, and Newham), with established integrated health and social care systems.
Participants Patients with chronic obstructive pulmonary disease (COPD), diabetes, or heart failure recruited between May 2008 and December 2009.
Main outcome measures Generic, health related quality of life (assessed by physical and mental health component scores of the SF-12, and the EQ-5D), anxiety (assessed by the six item Brief State-Trait Anxiety Inventory), and depressive symptoms (assessed by the 10 item Centre for Epidemiological Studies Depression Scale).
Results In the intention to treat analyses, differences between treatment groups were small and non-significant for all outcomes in the complete case (0.480≤P≤0.904) or available case (0.181≤P≤0.905) cohorts. The magnitude of differences between trial arms did not reach the trial defined, minimal clinically important difference (0.3 standardised mean difference) for any outcome in either cohort at four or 12 months. Per protocol analyses replicated the primary analyses; the main effect of trial arm (telehealth v usual care) was non-significant for any outcome (complete case cohort 0.273≤P≤0.761; available case cohort 0.145≤P≤0.696).
Conclusions Second generation, home based telehealth as implemented in the Whole Systems Demonstrator Evaluation was not effective or efficacious compared with usual care only. Telehealth did not improve quality of life or psychological outcomes for patients with chronic obstructive pulmonary disease, diabetes, or heart failure over 12 months. The findings suggest that concerns about potentially deleterious effect of telehealth are unfounded for most patients.
Trial Registration ISRCTN43002091.
PMCID: PMC3582704  PMID: 23444424

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