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1.  Self-management support interventions to reduce health care utilisation without compromising outcomes: a systematic review and meta-analysis 
Background
There is increasing interest in the role of ‘self-management’ interventions to support the management of long-term conditions in health service settings. Self-management may include patient education, support for decision-making, self-monitoring and psychological and social support. Self-management support has potential to improve the efficiency of health services by reducing other forms of utilisation (such as primary care or hospital use), but a shift to self-management may lead to negative outcomes, such as patients who feel more anxious about their health, are less able to cope, or who receive worse quality of care, all of which may impact on their health and quality of life. We sought to determine which models of self-management support are associated with significant reductions in health services utilisation without compromising outcomes among patients with long-term conditions.
Methods
We used systematic review with meta-analysis. We included randomised controlled trials in patients with long-term conditions which included self-management support interventions and reported measures of service utilisation or costs, as well as measures of health outcomes (standardized disease specific quality of life, generic quality of life, or depression/anxiety).We searched multiple databases (CENTRAL, CINAHL, Econlit, EMBASE, HEED, MEDLINE, NHS EED and PsycINFO) and the reference lists of published reviews. We calculated effects sizes for both outcomes and costs, and presented the results in permutation plots, as well as conventional meta-analyses.
Results
We included 184 studies. Self-management support was associated with small but significant improvements in health outcomes, with the best evidence of effectiveness in patients with diabetic, respiratory, cardiovascular and mental health conditions. Only a minority of self-management support interventions reported reductions in health care utilisation in association with decrements in health. Evidence for reductions in utilisation associated with self-management support was strongest in respiratory and cardiovascular problems. Studies at higher risk of bias were more likely to report benefits.
Conclusions
Self-management support interventions can reduce health service utilization without compromising patient health outcomes, although effects were generally small, and the evidence was strongest in respiratory and cardiovascular disorders. Further work is needed to determine which components of self-management support are most effective.
Electronic supplementary material
The online version of this article (doi:10.1186/1472-6963-14-356) contains supplementary material, which is available to authorized users.
doi:10.1186/1472-6963-14-356
PMCID: PMC4177163  PMID: 25164529
Self-management support interventions; Long-term conditions; Health outcomes; Quality of life; Health care utilization; Hospitalizations; Costs; Cost-effectiveness; Systematic review; Meta-analysis
2.  Effect of telehealth on glycaemic control: analysis of patients with type 2 diabetes in the Whole Systems Demonstrator cluster randomised trial 
Background
The Whole Systems Demonstrator was a large, pragmatic, cluster randomised trial that compared telehealth with usual care among 3,230 patients with long-term conditions in three areas of England. Telehealth involved the regular transmission of physiological information such as blood glucose to health professionals working remotely. We examined whether telehealth led to changes in glycosylated haemoglobin (HbA1c) among the subset of patients with type 2 diabetes.
Methods
The general practice electronic medical record was used as the source of information on HbA1c. Effects on HbA1c were assessed using a repeated measures model that included all HbA1c readings recorded during the 12-month trial period, and adjusted for differences in HbA1c readings recorded before recruitment. Secondary analysis averaged multiple HbA1c readings recorded for each individual during the trial period.
Results
513 of the 3,230 participants were identified as having type 2 diabetes and thus were included in the study. Telehealth was associated with lower HbA1c than usual care during the trial period (difference 0.21% or 2.3 mmol/mol, 95% CI, 0.04% to 0.38%, p = 0.013). Among the 457 patients in the secondary analysis, mean HbA1c showed little change for controls following recruitment, but fell for intervention patients from 8.38% to 8.15% (68 to 66 mmol/mol). A higher proportion of intervention patients than controls had HbA1c below the 7.5% (58 mmol/mol) threshold that was targeted by general practices (30.4% vs. 38.0%). This difference, however, did not quite reach statistical significance (adjusted odds ratio 1.63, 95% CI, 0.99 to 2.68, p = 0.053).
Conclusions
Telehealth modestly improved glycaemic control in patients with type 2 diabetes over 12 months. The scale of the improvements is consistent with previous meta-analyses, but was relatively modest and seems unlikely to produce significant patient benefit.
Trial registration number
International Standard Randomized Controlled Trial Number Register ISRCTN43002091.
doi:10.1186/1472-6963-14-334
PMCID: PMC4128403  PMID: 25100190
3.  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.
doi:10.1093/ageing/afu067
PMCID: PMC4204660  PMID: 24950690
telecare; economic evaluation; social care; older people
4.  Non-Adherence in Patients on Peritoneal Dialysis: A Systematic Review 
PLoS ONE  2014;9(2):e89001.
Background
It has been increasingly recognized that non-adherence is an important factor that determines the outcome of peritoneal dialysis (PD) therapy. There is therefore a need to establish the levels of non-adherence to different aspects of the PD regimen (dialysis procedures, medications, and dietary/fluid restrictions).
Methods
A systematic review of peer-reviewed literature was performed in PubMed, PsycINFO and CINAHL databases using PRISMA guidelines in May 2013. Publications on non-adherence in PD were selected by two reviewers independently according to predefined inclusion and exclusion criteria. Relevant data on patient characteristics, measures, rates and factors associated with non-adherence were extracted. The quality of studies was also evaluated independently by two reviewers according to a revised version of the Effective Public Health Practice Project assessment tool.
Results
The search retrieved 204 studies, of which a total of 25 studies met inclusion criteria. Reported rates of non-adherence varied across studies: 2.6–53% for dialysis exchanges, 3.9–85% for medication, and 14.4–67% for diet/fluid restrictions. Methodological differences in measurement and definition of non-adherence underlie the observed variation. Factors associated with non-adherence that showed a degree of consistency were mostly socio-demographical, such as age, employment status, ethnicity, sex, and time period on PD treatment.
Conclusion
Non-adherence to different dimensions of the dialysis regimen appears to be prevalent in PD patients. There is a need for further, high-quality research to explore these factors in more detail, with the aim of informing intervention designs to facilitate adherence in this patient population.
doi:10.1371/journal.pone.0089001
PMCID: PMC3934877  PMID: 24586478
5.  Does telecare prolong community living in dementia? A study protocol for a pragmatic, randomised controlled trial 
Trials  2013;14:349.
Background
Assistive technology and telecare (ATT) are relatively new ways of delivering care and support to people with social care needs. It is claimed that ATT reduces the need for community care, prevents unnecessary hospital admission, and delays or prevents admission into residential or nursing care. The current economic situation in England has renewed interest in ATT instead of community care packages. However, at present, the evidence base to support claims about the impact and effectiveness of ATT is limited, despite its potential to mitigate the high financial cost of caring for people with dementia and the social and psychological cost to unpaid carers.
Method/design
ATTILA (Assistive Technology and Telecare to maintain Independent Living At Home for People with Dementia) is a pragmatic, multi-centre, randomised controlled trial over 104 weeks that compares outcomes for people with dementia who receive ATT and those who receive equivalent community services but not ATT. The study hypothesis is that fewer people in the ATT group will go into institutional care over the 4-year period for which the study is funded. The study aims to recruit 500 participants, living in community settings, with dementia or significant cognitive impairment, who have recently been referred to social services.
Primary outcome measures are time in days from randomisation to institutionalisation and cost effectiveness. Secondary outcomes are caregiver burden, health-related quality of life in carers, number and severity of serious adverse events, and data on acceptability, applicability and reliability of ATT intervention packages. Assessments will be undertaken in weeks 0 (baseline), 12, 24, 52 and 104 or until institutionalisation or withdrawal of the participant from the trial.
Discussion
In a time of financial austerity, CASSRs in England are increasingly turning to ATT in the belief that it will deliver good outcomes for less money. There is an absence of robust evidence for the cost-effectiveness and benefit of using assistive technology and telecare. The ATTILA trial meets a pressing need for robust, generalisable evidence to either justify continuing investment or reappraise the appropriate scale of ATT use.
Trial registration
Current Controlled Trials ISRCTN86537017
doi:10.1186/1745-6215-14-349
PMCID: PMC4015839  PMID: 24152600
Assistive technology; Telecare; Dementia; Randomised control trial; Independence; Community living
6.  The Impact of Mobile Monitoring Technologies on Glycosylated Hemoglobin in Diabetes: A Systematic Review 
Background
A new development in the field of telehealth is the use of mobile health technologies (mhealth) to help patients record and track medical information. Mhealth appears particularly advantageous for conditions that require intense and ongoing monitoring, such as diabetes, and where people are of working age and not disabled. This review aims to evaluate the evidence for the effectiveness of mhealth interventions in diabetes management on glycosylated hemoglobin.
Method
A comprehensive search strategy was developed and applied to eight electronic databases to identify studies that investigated the clinical effectiveness of mobile-based applications that allowed patients to record and send their blood glucose readings to a central server. The eligibility of 8543 papers was assessed against the selection criteria, and 24 papers were reviewed. All studies reviewed were assessed for quality using a standardized quality assessment tool.
Results
Results for patients with type 1 and type 2 diabetes were examined separately. Study variability and poor reporting made comparison difficult, and most studies had important methodological weaknesses. Evidence on the effectiveness of mhealth interventions for diabetes was inconsistent for both types of diabetes and remains weak.
PMCID: PMC3570854  PMID: 23063046
diabetes; glycemic control; mobile health; monitoring; self-management
7.  Adaptation of the methotrexate in rheumatoid arthritis knowledge questionnaire (MiRAK) for use with parents of children with juvenile idiopathic arthritis: a qualitative study 
Background
Although Methotrexate (MTX) is one of the most commonly prescribed disease-modifying drugs in JIA no questionnaire exists that assesses the knowledge of parents about this drug. A 60-item questionnaire was recently developed to measure rheumatoid arthritis (RA) patients’ knowledge about MTX; the Methotrexate in Rheumatoid Arthritis Knowledge Test (MiRAK; Ciciriello et al. (Arthritis Rheum 62:10–1009, 2010)). This study aimed to adapt the MiRAK for parents of children with JIA.
Methods
Adaption of the MiRAK involved: 1) email consultations with clinicians working in the field of paediatric rheumatology (Panel 1) to ascertain the potential adaptations of the MiRAK from a clinical perspective, 2) synthesis of clinicians’ suggestions by a panel of experts, researchers and MiRAK developers (Panel 2) to reach consensus on which items needed to be modified and create a draft Methotrexate in Juvenile Idiopathic Arthritis Knowledge Test (MiJIAK), 3) a review of the draft by 5 parents of children with JIA (Panel 3) using the cognitive ‘think-aloud’ method, 4) a second consultation with Panel 2 to review parents’ suggestions and determine the final items.
Results
A total of 9 items remained unchanged, e.g. “Methotrexate is effective at relieving joint stiffness”, 19 were deemed inappropriate in the paediatric setting and deleted, e.g. “It is safe to become pregnant 3 weeks after methotrexate has been stopped”, 32 underwent editorial changes largely to indicate that the questionnaire was about the children with JIA, e.g. “If you forget to give a dose of Methotrexate, you can still take it the next day” became “If your child misses a dose of Methotrexate, they can still take it the next day”, and 1 new item was added. A new 42-item questionnaire was produced and was found to be well understood by parents of children with JIA.
Conclusions
The systematic modification of the MiRAK, a patient-centred MTX knowledge questionnaire, has generated a comprehensive new questionnaire for use in the JIA setting. The wide consultation process, including cognitive testing, has ensured the tool is both relevant and acceptable to clinicians and will therefore be a valuable addition in understanding the parents’ perspective of this treatment in JIA.
doi:10.1186/1546-0096-11-27
PMCID: PMC3704946  PMID: 23822803
Juvenile idiopathic arthritis; Questionnaire adaptation; Methotrexate; Cognitive interviews; Parent measures
8.  Determinants of Health-Related Quality of Life (HRQoL) in the Multiethnic Singapore Population – A National Cohort Study 
PLoS ONE  2013;8(6):e67138.
Background
HRQoL is an important outcome to guide and promote healthcare. Clinical and socioeconomic factors may influence HRQoL according to ethnicity.
Methodology
A multiethnic cross-sectional national cohort (N = 7198) of the Singapore general population consisting of Chinese (N = 4873), Malay (N = 1167) and Indian (N = 1158) adults were evaluated using measures of HRQoL (SF-36 version 2), family functioning, health behaviours and clinical/laboratory assessments. Multiple regression analyses were performed to identify determinants of physical and mental HRQoL in the overall population and their potential differential effects by ethnicity. No a priori hypotheses were formulated so all interaction effects were explored.
Principal Findings
HRQoL levels differed between ethnic groups. Chinese respondents had higher physical HRQoL (PCS) than Indian and Malay participants (p<0.001) whereas mental HRQoL (MCS) was higher in Malay relative to Chinese participants (p<0.001). Regressions models explained 17.1% and 14.6% of variance in PCS and MCS respectively with comorbid burden, income and employment being associated with lower HRQoL. Age and family were associated only with MCS. The effects of gender, stroke and musculoskeletal conditions on PCS varied by ethnicity, suggesting non-uniform patterns of association for Chinese, Malay and Indian individuals.
Conclusions
Differences in HRQoL levels and determinants of HRQoL among ethnic groups underscore the need to better or differentially target population segments to promote well-being. More work is needed to explore HRQoL and wellness in relation to ethnicity.
doi:10.1371/journal.pone.0067138
PMCID: PMC3695030  PMID: 23826215
9.  Mothers’ reports of the difficulties that their children experience in taking methotrexate for Juvenile Idiopathic Arthritis and how these impact on quality of life 
Background
Children who take methotrexate for juvenile idiopathic arthritis may experience side effects, including nausea and vomiting, leading to anticipatory nausea in some children, and fear of injections or blood tests. The aim of this study was to examine the prevalence and extent of these difficulties and their impact on quality of life.
Methods
Participants were mothers of children with JIA who were currently taking methotrexate (MTX). Mothers completed a questionnaire about MTX that was developed for the study, two questions from the treatment subscale of the Pediatric Quality of Life Inventory (PedsQL) Rheumatology scale to assess needle-related problems and the Child Health Questionnaire 50-item parent version (CHQ-PF50) to assess health-related quality of life (HRQoL).
Results
171 mothers participated in the study. More than half of children were reported to have experienced one or more of: nausea or vomiting after taking MTX, anticipatory nausea, fear of blood tests or fear of injections. There was no significant difference in reported rates of sickness or needle-related problems between MTX responders (ACR70 or above), partial responders (ACR30 or ACR50) and non-responders. In multivariate analyses, variables that were significant independent predictors of one or more MTX-related difficulties included younger age, taking MTX subcutaneously and having a larger number of currently active joints. Feeling sick after taking MTX was a significant independent predictor of poorer scores on the physical summary scale of the CHQ-PF50. Anxiety about injections and feeling sick after taking MTX were significant independent predictors of poorer scores on the psychosocial summary scale.
Conclusions
Difficulties in taking MTX are experienced by a significant proportion of children with JIA and these may have an adverse impact on HRQoL. Approaches to help minimize these difficulties are required.
doi:10.1186/1546-0096-11-23
PMCID: PMC3679741  PMID: 23714105
Juvenile idiopathic arthritis; Methotrexate; Side effects; Intolerance; Anticipatory nausea; Psychological; Quality of life
10.  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.
doi:10.1093/ageing/aft008
PMCID: PMC3684109  PMID: 23443509
telecare; assistive technology; randomised controlled trial; administrative data; older people
11.  An organisational analysis of the implementation of telecare and telehealth: the whole systems demonstrator 
Background
To investigate organisational factors influencing the implementation challenges of redesigning services for people with long term conditions in three locations in England, using remote care (telehealth and telecare).
Methods
Case-studies of three sites forming the UK Department of Health’s Whole Systems Demonstrator (WSD) Programme. Qualitative research techniques were used to obtain data from various sources, including semi-structured interviews, observation of meetings over the course programme and prior to its launch, and document review. Participants were managers and practitioners involved in the implementation of remote care services.
Results
The implementation of remote care was nested within a large pragmatic cluster randomised controlled trial (RCT), which formed a core element of the WSD programme. To produce robust benefits evidence, many aspect of the trial design could not be easily adapted to local circumstances. While remote care was successfully rolled-out, wider implementation lessons and levels of organisational learning across the sites were hindered by the requirements of the RCT.
Conclusions
The implementation of a complex innovation such as remote care requires it to organically evolve, be responsive and adaptable to the local health and social care system, driven by support from front-line staff and management. This need for evolution was not always aligned with the imperative to gather robust benefits evidence. This tension needs to be resolved if government ambitions for the evidence-based scaling-up of remote care are to be realised.
doi:10.1186/1472-6963-12-403
PMCID: PMC3532839  PMID: 23153014
Telecare; Telehealth; Whole system redesign; Organisational change; Adoption; Implementation; Ethnographic methods
12.  Exploring barriers to participation and adoption of telehealth and telecare within the Whole System Demonstrator trial: a qualitative study 
Background
Telehealth (TH) and telecare (TC) interventions are increasingly valued for supporting self-care in ageing populations; however, evaluation studies often report high rates of non-participation that are not well understood. This paper reports from a qualitative study nested within a large randomised controlled trial in the UK: the Whole System Demonstrator (WSD) project. It explores barriers to participation and adoption of TH and TC from the perspective of people who declined to participate or withdrew from the trial.
Methods
Qualitative semi-structured interviews were conducted with 22 people who declined to participate in the trial following explanations of the intervention (n = 19), or who withdrew from the intervention arm (n = 3). Participants were recruited from the four trial groups (with diabetes, chronic obstructive pulmonary disease, heart failure, or social care needs); and all came from the three trial areas (Cornwall, Kent, east London). Observations of home visits where the trial and interventions were first explained were also conducted by shadowing 8 members of health and social care staff visiting 23 people at home. Field notes were made of observational visits and explored alongside interview transcripts to elicit key themes.
Results
Barriers to adoption of TH and TC associated with non-participation and withdrawal from the trial were identified within the following themes: requirements for technical competence and operation of equipment; threats to identity, independence and self-care; expectations and experiences of disruption to services. Respondents held concerns that special skills were needed to operate equipment but these were often based on misunderstandings. Respondents’ views were often explained in terms of potential threats to identity associated with positive ageing and self-reliance, and views that interventions could undermine self-care and coping. Finally, participants were reluctant to risk potentially disruptive changes to existing services that were often highly valued.
Conclusions
These findings regarding perceptions of potential disruption of interventions to identity and services go beyond more common expectations that concerns about privacy and dislike of technology deter uptake. These insights have implications for health and social care staff indicating that more detailed information and time for discussion could be valuable especially on introduction. It seems especially important for potential recipients to have the opportunity to discuss their expectations and such views might usefully feed back into design and implementation.
doi:10.1186/1472-6963-12-220
PMCID: PMC3413558  PMID: 22834978
Telehealth; Telecare; Patients’ perspectives; Non-adoption; Non-participation; Barriers; Qualitative research; Whole System Demonstrator
13.  The effect of Telehealth on disease-specific quality of life in patients with heart failure: the Whole Systems Demonstrator Telehealth Questionnaire Study 
Introduction
Primary studies and systematic reviews that have examined the effect of Telehealth (TH) on Health-Related Quality of Life (HRQoL) typically conclude that TH leads to quality of life improvements. The evidence base on which such conclusions rest is characterised by methodologically weak studies that generate equivocal findings. The effectiveness of TH, in terms of quality of life benefits, has yet to be substantiated in high-quality trials.
Aims
Using data from the WSD Telehealth Questionnaire Study we assessed the impact of TH on disease-specific HRQoL, generic HRQoL and psychological outcomes (anxiety and depression) in patients with heart failure, over a 12-month period.
Design
The WSD Telehealth Questionnaire Study is pragmatic cluster-randomised controlled trial evaluating a broad range of patient-reported outcome measures. Participants were recruited from three Sites in the UK (Cornwall, Kent and Newham). The current analyses focus on participants with heart failure.
Methods
Over 500 participants with heart failure completed measures of disease-specific HRQoL (MLHFQ), generic HRQoL (UK SF-12; EQ5D), anxiety (Brief STAI) and depression (CESD-10) at baseline. Follow-up assessments were conducted at 4 and 12 months.
Results
Primary and sensitivity analyses will be presented for the heart failure cohort and interpreted in light of existing WSD findings that examine generic HRQoL in a pooled clinical sample comprising participants with heart failure, COPD and diabetes. Specific findings from the WSD Telehealth Questionnaire Study are embargoed until these analyses have been peer-reviewed and accepted for publication.
Conclusions
Conclusions cannot be released until the analyses have been peer-reviewed and accepted for publication.
PMCID: PMC3571121
telehealth; heart failure; quality of life; Whole System Demonstrator
14.  A pragmatic cluster randomised controlled trial of telehealth on disease specific quality of life in patients’ with chronic obstructive pulmonary disease and their health-related quality of life and psychological distress over 1 year in the Whole System Demonstrator programme 
Introduction
There is limited evidence for the effectiveness of TH on quality of life (QoL) in patients with COPD. A systematic review in the area inclusive of all respiratory conditions indicated that there were no UK based studies, or randomised controlled trials (RCTs) evaluating the effectiveness of TH for COPD (Janna et al. 2009). A more recent systematic review found 6 studies, only two of which measured QoL as an outcome (Bolton et al. 2010). One of these studies was a RCT and found improvements in QoL at 3 months (Koff 2009), while the other was a non-controlled before and after study which found no difference in quality of life scores at 6 months (Trappenburg, 2008). Research in this area is plagued by small sample sizes, absence of longer-term follow-ups, insufficient descriptions of the intervention, poor internal validity of whether using the device in the context of a complex healthcare intervention leads to improved outcomes for the patient, and few attempts to measure quality of life in patients with COPD following the introduction of these devices.
Aims and objectives
The current investigation is part of the Whole System Demonstrator (WSD) programme that aims to evaluate the effectiveness of telehealth (TH) for patient reported outcomes with Chronic Obstructive Pulmonary Disease (COPD). The primary objective was to evaluate the effectiveness of telehealth for COPD specific QoL and to examine whether there were improvements in HRQoL and psychological distress at short-term and long-term follow-up in this cohort of patients with COPD.
Methods
WSD is one of the largest pragmatic cluster randomised controlled trials evaluating TH in the UK. Patients with COPD from three regions in England (Cornwall, Kent and Newham) were recruited from 179 GP practices randomised balancing for region, practice size, deprivation index, non-white proportion and prevalence of COPD. Over 570 patients with COPD completed a comprehensive battery of questionnaires assessing a range of patient reported outcomes. Measures of generic Health-Related Quality of Life (HRQoL) (Short Form-12), disease specific QoL including perceived control over COPD, fatigue caused by the disease and the emotional impact of the disease (Chronic Respiratory Questionnaire). Psychological distress was measured by depression (CESD-10) and anxiety (STAI).
Results
Multi-level modelling was utilised to evaluate the effect of trial arm on HRQoL and COPD specific QoL. Results for intention-to-treat analysis, participants that received the intervention as per the research protocol, complete case analysis for cases with all baseline, short-term and longer-term follow-ups completed and an available case analysis of patients with either a short or long-term follow-up available. The results will be discussed and have important clinical implications for COPD management.
Conclusions
Results and conclusions are censored until any findings are published in peer-reviewed journals.
PMCID: PMC3571149
telehealth; COPD; Quality of life; Whole System Demonstrator
15.  The impact on carers of individuals with social care needs: the Whole Systems Demonstrator study 
Introduction
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.
Objectives
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.
Design
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).
Methods
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
16.  Exploring the impact of a Tele-health intervention on specific quality of life domains and psychological well-being in diabetic patients within the Whole Systems Demonstrator Questionnaire Study 
Introduction
Much is written about the promise of Telehealth (TH) and there is great enthusiasm about its potential. However, many studies of TH do not meet orthodox quality standards. Evidence-based on assimilating findings from a few small trials of variable methodological quality presents equivocal findings and makes results difficult to interpret. Robust evidence to inform policy decisions is considered to be lacking (Ekeland et al., 2010). This remains the case when specific long-term conditions such as diabetes are considered with regards to health related quality of life (HRQoL) outcomes. The WSD study aimed to address some of these concerns.
Aims
This study investigated the impact of TH on disease-specific HRQoL, generic HRQoL and psychological outcomes (anxiety and depression) in patients with diabetes, utilising longitudinal questionnaire data from the WSD Telehealth Study.
Design
The WSD Telehealth Questionnaire Study is pragmatic cluster-randomised controlled trial evaluating a broad range of patient-reported outcome measures. Participants were recruited from three sites in the UK (Cornwall, Kent and Newham). The current analyses focus on participants with diabetes.
Methods
Over 400 participants with diabetes completed measures of disease-specific HRQoL (DHP), generic HRQoL (UK SF-12; EQ5D), anxiety (Brief STAI) and depression (CESD-10) at baseline. Short- and long-term follow-up assessments were conducted. Multi-level modelling analyses of difference in outcomes between trial arm groups and across time were conducted with appropriate covariates.
Results and Conclusions
Findings and conclusions from the WSD Telehealth Study are embargoed until these analyses have been peer-reviewed and accepted for publication.
PMCID: PMC3571160
telehealth; diabetes; quality of life; psychological outcomes; Whole System Demonstrator
17.  Cost-effectiveness of telehealth in people with social care needs: the Whole Systems Demonstrator cluster randomised trial 
Introduction
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.
Objectives
To examine the costs and cost-effectiveness of telecare compared to standard support and treatment.
Methods
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
Results
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.
Conclusions
These will be available by the time of the presentation.
PMCID: PMC3571183
economic evaluation; social care; cost analysis; telecare
18.  Cerebral artery dilatation maintains cerebral oxygenation at extreme altitude and in acute hypoxia—an ultrasound and MRI study 
Transcranial Doppler is a widely used noninvasive technique for assessing cerebral artery blood flow. All previous high altitude studies assessing cerebral blood flow (CBF) in the field that have used Doppler to measure arterial blood velocity have assumed vessel diameter to not alter. Here, we report two studies that demonstrate this is not the case. First, we report the highest recorded study of CBF (7,950 m on Everest) and demonstrate that above 5,300 m, middle cerebral artery (MCA) diameter increases (n=24 at 5,300 m, 14 at 6,400 m, and 5 at 7,950 m). Mean MCA diameter at sea level was 5.30 mm, at 5,300 m was 5.23 mm, at 6,400 m was 6.66 mm, and at 7,950 m was 9.34 mm (P<0.001 for change between 5,300 and 7,950 m). The dilatation at 7,950 m reversed with oxygen. Second, we confirm this dilatation by demonstrating the same effect (and correlating it with ultrasound) during hypoxia (FiO2=12% for 3 hours) in a 3-T magnetic resonance imaging study at sea level (n=7). From these results, we conclude that it cannot be assumed that cerebral artery diameter is constant, especially during alterations of inspired oxygen partial pressure, and that transcranial 2D ultrasound is a technique that can be used at the bedside or in the remote setting to assess MCA caliber.
doi:10.1038/jcbfm.2011.81
PMCID: PMC3208157  PMID: 21654697
brain imaging; cerebral blood flow; high altitude; MRI; transcranial Doppler
19.  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 
Background
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.
Methods/Design
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
Discussion
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
doi:10.1186/1472-6963-11-184
PMCID: PMC3169462  PMID: 21819569
20.  Prospective Changes in Health-Related Quality of Life and Emotional Outcomes in Kidney Transplantation over 6 Years 
Journal of Transplantation  2011;2011:671571.
Little is known on long-term outcomes in kidney transplantation. This study evaluated changes and predictors of generic and transplantation-specific health-related quality of life (HQoL) over six years in N = 102 kidney transplant survivors using the Short-form Health Survey-36 and the Transplant Effects questionnaire. Mixed models analysis was used to determine long-term outcomes. Emotional HQoL improved over time: Mental Component score, Mental Health, Energy (Ps = .000). Physical HQoL deteriorated: Physical Component Score (P = .001), Pain (P = .002). LRD transplant recipients had greater decline in physical functioning (P = .003) and PCS (P = .000) compared to cadaver recipients. Worry about the transplant (P = .036) and feelings of responsibility (P = .008) increased significantly over time. Worry about the transplant and perceived ability to work predicted 12.7% and 31.1% in variance in MCS and PCS, respectively. Efforts should be made to maintain HQoL and emotional outcomes with ongoing monitoring and support programs throughout the course of posttransplant care.
doi:10.1155/2011/671571
PMCID: PMC3142681  PMID: 21822474
21.  Cerebral Microembolization during Primary Total Hip Arthroplasty and Neuropsychologic Outcome: A Pilot Study 
Background
Intraoperative cerebral microembolization occurs in a substantial proportion of patients undergoing THA. Historically, postoperative cognitive dysfunction has been attributed to different factors, including anesthesia, but the influence of the surgery has not been thoroughly examined.
Questions/purposes
We conducted a prospective, controlled clinical trial to assess intraoperative cerebral microembolization during THA and neuropsychologic outcome.
Methods
The presence of a patent foramen ovale (PFO) also was investigated, using transcranial Doppler, to determine whether this affected cerebral microembolic incidence and load and whether microemboli occurred as a result of specific surgical activity. Forty-five patients were recruited who underwent THA and neuropsychologic assessment; a battery of tests was administered preoperatively and at 6 weeks and 6 months postoperatively.
Results
Overall, patients showed improvement in total neuropsychologic change scores at both postoperative intervals. The incidence of cerebral microembolization for THA was 23%. The prevalence of PFO was 37%. PFO did not appear to influence microemboli load or incidence. More microemboli were seen during femoral component insertion and impaction.
Conclusions
Intraoperative cerebral microembolization occurs in a substantial proportion of patients during THA recorded by transcranial Doppler. The microemboli load is low and is not influenced by the presence of PFO. Certain surgical activities seem responsible for greater cerebral microemboli generation. However, neuropsychologic outcome was not affected postoperatively by microemboli or other operative or patient variables.
doi:10.1007/s11999-009-1140-z
PMCID: PMC2865620  PMID: 19838644
22.  The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients 
BMC Nephrology  2011;12:4.
Background
Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care.
Methods/Design
This is a multicentre parallel arm block randomized controlled trial (RCT) of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change.
Discussion
The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes. This program, if found to be effective, has the potential to be implemented within the existing renal services delivery model in Singapore, particularly as this is being delivered by health care professionals already working with hemodialysis patients in these settings who are specifically trained in facilitating self management in renal patients.
Trial registration
Current Controlled Trials ISRTN31434033
doi:10.1186/1471-2369-12-4
PMCID: PMC3048524  PMID: 21272382
23.  Patients’ beliefs about their cardiovascular disease 
Heart  2005;91(9):1235-1239.
doi:10.1136/hrt.2003.025262
PMCID: PMC1769080  PMID: 16103576
24.  Psycho-education programme for temporomandibular disorders: a pilot study 
Background
Temporomandibular disorders (TMDs) are by far the most predominant condition affecting the temporomandibular joint (TMJ), however many patients have mild self-limiting symptoms and should not be referred for specialist care.
The aim of this pilot study was to develop a simple, cost-effective management programme for TMDs using CD-ROM. 41 patients (age 18–70) participated in this study, patients were divided into three groups: the 1st group were involved in an attention placebo CD-ROM (contain anatomical information about the temporomandibular system), the 2nd group received information on CD-ROM designed to increase their control and self efficacy, while the 3rd group received the same programme of the 2nd group added to it an introduction to self-relaxing techniques followed by audio tape of progressive muscle relaxation exercises. Each of the groups was asked to complete a number of questionnaires on the day of initial consultation and six weeks afterwards.
Results
The two experimental groups (2nd & 3rd) were equally effective in reducing pain, disability and distress, and both were more effective than the attention placebo group (1st), however the experimental groups appeared to have improved at follow-up relative to the placebo-group in terms of disability, pain and depressed mood.
Conclusion
This pilot study demonstrates the feasibility and acceptability of the design. A full, randomized, controlled trial is required to confirm the efficacy of the interventions developed here.
doi:10.1186/1477-5751-6-4
PMCID: PMC1839113  PMID: 17381840
25.  Self management for men with lower urinary tract symptoms: randomised controlled trial 
BMJ : British Medical Journal  2006;334(7583):25.
Objective To evaluate the effectiveness of self management as a first line intervention for men with lower urinary tract symptoms.
Design Randomised controlled trial.
Setting A teaching hospital and a district general hospital in London.
Participants 140 men (mean age 63 (SD 10.7) years), recruited between January 2003 and April 2004, referred by general practitioners to urological outpatient departments with uncomplicated lower urinary tract symptoms.
Interventions Self management and standard care (n=73) or standard care alone (n=67). The self management group took part in three small group sessions comprising education, lifestyle advice, and training in problem solving and goal setting skills.
Main outcome measures The primary outcome measure was treatment failure measured at 3, 6, and 12 months. Symptom severity (international prostate symptom score; higher scores represent a poorer outcome) was used as a secondary outcome.
Results At three months, treatment failure had occurred in 7 (10%) of the self management group and in 27 (42%) of the standard care group (difference=32%, 95% confidence interval 18% to 46%). Corresponding differences in the frequency of treatment failure were 42% (27% to 57%) at six months and 48% (32% to 64%) at 12 months. At three months, the mean international prostate symptom score was 10.7 in the self management group and 16.4 in the standard care group (difference=5.7, 3.7 to 7.7). Corresponding differences in score were 6.5 (4.3 to 8.7) at six months and 5.1 (2.7 to 7.6) at 12 months.
Conclusions Self management significantly reduced the frequency of treatment failure and reduced urinary symptoms. Because of the large observed benefit of self management, the results of this study support the case for a large multicentre trial to confirm whether self management could be considered as first line treatment for men with lower urinary tract symptoms.
Trial registration National Research Register N0263115137; Clinical trials NCT00270309.
doi:10.1136/bmj.39010.551319.AE
PMCID: PMC1764065  PMID: 17118949

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