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1.  Hospital at home admission avoidance 
Background
Admission avoidance hospital at home is a service that provides active treatment by health care professionals in the patient’s home for a condition that otherwise would require acute hospital in-patient care, and always for a limited time period. In particular, hospital at home has to offer a specific service to patients in their home requiring health care professionals to take an active part in the patients’ care. If hospital at home were not available then the patient would be admitted to an acute hospital ward. Many countries are adopting this type of care in an attempt to reduce the demand for acute hospital admission.
Objectives
To determine, in the context of a systematic review and meta analysis, the effectiveness and cost of managing patients with admission avoidance hospital at home compared with in-patient hospital care.
Search methods
The following databases were searched through to January 2008: MEDLINE, EMBASE, CINAHL, EconLit and the Cochrane Effective Practice and Organisation of Care Group (EPOC) register. We checked the reference lists of articles identified electronically for evaluations of hospital at home and obtained potentially relevant articles. Unpublished studies were sought by contacting providers and researchers who were known to be involved in this field.
Selection criteria
Randomised controlled trials recruiting patients aged 18 years and over. Studies comparing admission avoidance hospital at home with acute hospital in-patient care. The admission avoidance hospital at home interventions may admit patients directly from the community thereby avoiding physical contact with the hospital, or may admit from the emergency room.
Data collection and analysis
Two authors independently extracted data and assessed study quality. Our statistical analyses sought to include all randomised patients and were done on an intention to treat basis. We requested individual patient data (IPD) from trialists, and relied on published data when we did not receive trial data sets or the IPD did not include the relevant outcomes. When combining outcome data was not possible because of differences in the reporting of outcomes we have presented the data in narrative summary tables.
For the IPD meta-analysis, where at least one event was reported in both study groups in a trial, Cox regression models were used to calculate the log hazard ratio and its standard error for mortality and readmission separately for each data set (where both outcomes were available). We included randomisation group (admission avoidance hospital at home versus control), age (above or below the median), and gender in the models. The calculated log hazard ratios were combined using fixed effects inverse variance meta analysis. If there were no events in one group we used the Peto odds ratio method to calculate a log odds ratio from the sum of the log-rank test ‘O-E’ statistics from a Kaplan Meier survival analysis. Statistical significance throughout was taken at the two-sided 5% level (p<0.05) and data are presented as the estimated effect with 95% confidence intervals. For each comparison using published data for dichotomous outcomes we calculated risk ratios using a fixed effects model to combine data.
Main results
We included 10 RCTs (n=1333), seven of which were eligible for the IPD. Five out of these seven trials contributed to the IPD meta-analysis (n=850/975; 87%). There was a non significant reduction in mortality at three months for the admission avoidance hospital at home group (adjusted HR 0.77, 95% CI 0.54 to 1.09; p=0.15), which reached significance at six months follow-up (adjusted HR 0.62, 95% CI 0.45 to 0.87; p=0.005). A non significant increase in admissions was observed for patients allocated to hospital at home (adjusted HR 1.49, 95% CI 0.96 to 2.33; p=0.08). Few differences were reported for functional ability, quality of life or cognitive ability. Patients reported increased satisfaction with admission avoidance hospital at home. Two trials conducted a full economic analysis, when the costs of informal care were excluded admission avoidance hospital at home was less expensive than admission to an acute hospital ward.
Authors’ conclusions
We performed meta-analyses where there was sufficient similarity among the trials and where common outcomes had been measured. There is no evidence from the analysis to suggest that admission avoidance hospital at home leads to outcomes that differ from inpatient hospital care.
doi:10.1002/14651858.CD007491
PMCID: PMC4033791  PMID: 18843751
Home Care Services [economics; *organization & administration]; Home Care Services, Hospital-Based [economics; *organization & administration]; Hospitalization; Outcome and Process Assessment (Health Care); Randomized Controlled Trials as Topic; Humans
2.  Alternatives to inpatient mental health care for children and young people 
Background
Current policy in the UK and elsewhere places emphasis on the provision of mental health services in the least restrictive setting, whilst also recognising that some children will require inpatient care. As a result, there are a range of mental health services to manage young people with serious mental health problems who are at risk of being admitted to an inpatient unit in community or outpatient settings.
Objectives
1. To assess the effectiveness, acceptability and cost of mental health services that provide an alternative to inpatient care for children and young people.
2. To identify the range and prevalence of different models of service that seek to avoid inpatient care for children and young people.
Search methods
Our search included the Cochrane Effective Practice and Organisation of Care Group Specialised Register (2007), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2006, issue 4), MEDLINE (1966 to 2007), EMBASE (1982 to 2006), the British Nursing Index (1994 to 2006), RCN database (1985 to 1996), CINAHL (1982 to 2006) and PsycInfo (1972 to 2007).
Selection criteria
Randomised controlled trials of mental health services providing specialist care, beyond the scope of generic outpatient provision, as an alternative to inpatient mental health care, for children or adolescents aged from five to 18 years who have a serious mental health condition requiring specialist services beyond the capacity of generic outpatient provision. The control group received mental health services in an inpatient or equivalent setting.
Data collection and analysis
Two authors independently extracted data and assessed study quality. We grouped studies according to the intervention type but did not pool data because of differences in the interventions and measures of outcome. Where data were available we calculated confidence intervals (CIs) for differences between groups at follow up. We also calculated standardised mean differences (SMDs) and 95% CIs for each outcome in terms of mean change from baseline to follow up using the follow-up SDs. We calculated SMDs (taking into account the direction of change and the scoring of each instrument) so that negative SMDs indicate results that favour treatment and positive SMDs favour the control group.
Main results
We included seven randomised controlled trials (recruiting a total of 799 participants) evaluating four distinct models of care: multi-systemic therapy (MST) at home, specialist outpatient service, intensive home treatment and intensive home-based crisis intervention (‘Homebuilders’ model for crisis intervention). Young people receiving home-based MST experienced some improved functioning in terms of externalising symptoms and they spent fewer days out of school and out-of-home placement. At short term follow up the control group had a greater improvement in terms of adaptability and cohesion; this was not sustained at four months follow up. There were small, significant patient improvements reported in both groups in the trial evaluating the intensive home-based crisis intervention using the ‘Homebuilders’ model. No differences at follow up were reported in the two trials evaluating intensive home treatment, or in the trials evaluating specialist outpatient services.
Authors’ conclusions
The quality of the evidence base currently provides very little guidance for the development of services. If randomised controlled trials are not feasible then consideration should be given to alternative study designs, such as prospective systems of audit conducted across several centres, as this has the potential to improve the current level of evidence. These studies should include baseline measurement at admission along with demographic data, and outcomes measured using a few standardised robust instruments.
doi:10.1002/14651858.CD006410.pub2
PMCID: PMC4014676  PMID: 19370634
3.  The routine collection of patient-reported outcome measures (PROMs) for long-term conditions in primary care: a cohort survey 
BMJ Open  2014;4(2):e003968.
Objectives
To evaluate the feasibility of using patient-reported outcome measures (PROMs) for long-term conditions (LTCs) in primary care.
Design
A cohort postal survey conducted from September 2010 to April 2012.
Setting
Primary care practices (n=33) in London and the North-West of England.
Participants
4484 patients with a diagnosis of asthma, chronic obstructive pulmonary disease, diabetes, epilepsy, heart failure or stroke were sent a survey at baseline.
Main outcome
The main outcome was to evaluate the feasibility of and the recruitment strategies for collecting PROMs data in LTCs by assessing the response rates for the baseline and follow-up surveys. Secondary outcomes were the evaluation of change scores of the EQ-5D index and visual analogue scale (VAS) between baseline and follow-up surveys.
Results
The baseline survey achieved a response rate of 38.4% (n=1721/4485) and at follow-up 71.5% (n=1136/1589). Response rates varied by LTC. Little change was found in health-related quality of life for the total sample (−0.001 for the EQ-5D index score and 0.12 for the EQ-5D VAS) between patients responding to both the baseline and follow-up surveys.
Conclusions
The response rate to the baseline survey was similar to that of other general practice surveys. Current UK policy aims to assess health service performance in LTCs by means of using PROMs. It thus would be desirable to improve response rates by making the invitation to self-reports of health-related quality of life more engaging for patients. Results on the EQ-5D score raise questions about optimal indicators for LTCs and appropriate timelines for assessment.
doi:10.1136/bmjopen-2013-003968
PMCID: PMC3931992  PMID: 24561495
Patient-reported outcome measures; Long-term conditions; PRIMARY CARE; Cohort study
5.  Impact of telehealth on general practice contacts: findings from the whole systems demonstrator cluster randomised trial 
Background
Telehealth is increasingly used in the care of people with long term conditions. Whilst many studies look at the impacts of the technology on hospital use, few look at how it changes contacts with primary care professionals. The aim of this paper was to assess the impacts of home-based telehealth interventions on general practice contacts.
Method
Secondary analysis of data from a Department of Health funded cluster-randomised trial with 179 general practices in three areas of England randomly assigned to offer telehealth or usual care to eligible patients. Telehealth included remote exchange of vitals signs and symptoms data between patients and healthcare professionals as part of the continuing management of patients. Usual care reflected the range of services otherwise available in the sites, excluding telehealth. Anonymised data from GP systems were used to construct person level histories for control and intervention patients. We tested for differences in numbers of general practitioner and practice nurse contacts over twelve months and in the number of clinical readings recorded on general practice systems over twelve months.
Results
3,230 people with diabetes, chronic obstructive pulmonary disease or heart failure were recruited in 2008 and 2009. 1219 intervention and 1098 control cases were available for analysis. No statistically significant differences were detected in the numbers of general practitioner or practice nurse contacts between intervention and control groups during the trial, or in the numbers of clinical readings recorded on the general practice systems.
Conclusions
Telehealth did not appear associated with different levels of contact with general practitioners and practice nurses. We note that the way that telehealth impacts on primary care roles may be influenced by a number of other features in the health system. The challenge is to ensure that these systems lead to better integration of care than fragmentation.
Trial registration number
International Standard Randomised Controlled Trial Number Register ISRCTN43002091.
doi:10.1186/1472-6963-13-395
PMCID: PMC3852608  PMID: 24099334
Telemedicine; Telemonitoring; General practice; Workload; Chronic disease
6.  Inpatient Cognitive Behaviour Therapy for Anorexia Nervosa: A Randomized Controlled Trial 
Psychotherapy and Psychosomatics  2013;82(6):390-398.
Background
The aim of this study was to compare the immediate and longer-term effects of two cognitive behaviour therapy programmes for hospitalized patients with anorexia nervosa, one focused exclusively on the patients' eating disorder features and the other focused also on mood intolerance, clinical perfectionism, core low self-esteem or interpersonal difficulties. Both programmes were derived from enhanced cognitive behaviour therapy (CBT-E) for eating disorders.
Methods
Eighty consecutive patients with severe anorexia nervosa were randomized to the two inpatient CBT-E programmes, both of which involved 20 weeks of treatment (13 weeks as an inpatient and 7 as a day patient). The patients were then followed up over 12 months. The assessments were made blind to treatment condition.
Results
Eighty-one percent of the eligible patients accepted inpatient CBT-E, of whom 90% completed the 20 weeks of treatment. The patients in both programmes showed significant improvements in weight, eating disorder and general psychopathology. Deterioration after discharge did occur but it was not marked and it was restricted to the first 6 months. There were no statistically significant differences between the effects of the two programmes.
Conclusions
These findings suggest that both versions of inpatient CBT-E are well accepted by these severely ill patients and might be a viable and promising treatment for severe anorexia nervosa. There appears to be no benefit from using the more complex form of the treatment.
doi:10.1159/000350058
PMCID: PMC3884188  PMID: 24060628
Anorexia nervosa; Body mass index; Cognitive behaviour therapy; Eating disorders, diagnosis, therapy; Female; Follow-up studies; Humans; Inpatient treatment; Relapse

7.  Total or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial 
Trials  2013;14:292.
Background
In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two fundamentally different approaches to knee replacement for patients with unicompartmental disease: some surgeons feel that it is always best to replace both the knee compartments with a total knee replacement (TKR); whereas others feel it is best to replace just the damaged component of the knee using a partial or unicompartment replacement (UKR). Both interventions are established and well-documented procedures. Little evidence exists to prove the clinical and cost-effectiveness of either management option. This provides an explanation for the high variation in treatment of choice by individual surgeons for the same knee pathology.
The aim of the TOPKAT study will be to assess the clinical and cost effectiveness of TKRs compared to UKRs in patients with medial compartment osteoarthritis.
Methods/Design
The design of the study is a single layer multicentre superiority type randomised controlled trial of unilateral knee replacement patients. Blinding will not be possible as the surgical scars for each procedure differ.
We aim to recruit 500 patients from approximately 28 secondary care orthopaedic units from across the UK including district general and teaching hospitals. Participants will be randomised to either UKR or TKR. Randomisation will occur using a web-based randomisation system. The study is pragmatic in terms of implant selection for the knee replacement operation. Participants will be followed up for 5 years. The primary outcome is the Oxford Knee Score, which will be collected via questionnaires at 2 months, 1 year and then annually to 5 years. Secondary outcomes will include cost-effectiveness, patient satisfaction and complications data.
Trial registration
Current Controlled Trials ISRCTN03013488; ClinicalTrials.gov Identifier: NCT01352247
doi:10.1186/1745-6215-14-292
PMCID: PMC3848560  PMID: 24028414
Medial compartment osteoarthritis; Total knee replacement; Unicompartmental knee replacement; Equipoise; Expertise
8.  Carer quality of life and experiences of health services: a cross-sectional survey across three neurological conditions 
Background
Neurological conditions have a substantial impact on carers, with carer well-being having been shown to be influenced by a number of demographic, patient and caregiving factors. Support given to carers can lead to better coping. This study investigated the relationship between carer well-being and experiences with health and social services.
Methods
A cross-sectional survey was conducted of 1910 (37.4%) of carers of 5109 people with motor neuron disease (MND) (n=434, 54.9%), multiple sclerosis (MS) (n=721, 30.7%) and Parkinson’s disease (PD) (n=755, 38.2%). Carers completed a generic health status measure (SF-12), a carer strain measure (Carer Strain Index- CSI) and a newly developed questionnaire on health and social care experiences. Data were analysed by analysis of variance with p set at <0.05.
Results
Carer well-being was found to be compromised and differed significantly between the three conditions. Furthermore, a considerable number of carers experienced problems with aspects of health and social care, although there was no clear pattern according to the condition that was cared for. The total number of problems reported did not differ significantly between conditions but was significantly (all p<0.001) associated with carer quality of life (both physical and mental health) and strain, even when other influencing factors (demographic and caregiving variables) were corrected for. The association was particularly strong for carer strain, and less strong (but still significant) for quality of life.
Conclusions
The results show that carer well-being is compromised, in line with previous studies. Furthermore, the link of carer well-being to the number of problems reported suggests that minimizing problems experienced could improve carer well-being. This stresses the importance of health and social services appropriately supporting carers.
doi:10.1186/1477-7525-11-103
PMCID: PMC3698129  PMID: 23800348
Carer; Quality of life; Experiences; Health care; Neurology
9.  Enhanced cognitive behaviour therapy for adolescents with anorexia nervosa: An alternative to family therapy? 
Behaviour research and therapy  2012;51(1):R9-R12.
A specific form of family therapy (family-based treatment) is the leading treatment for adolescents with anorexia nervosa. As this treatment has certain limitations, alternative approaches are needed. “Enhanced” cognitive behaviour therapy (CBT-E) is a potential candidate given its utility as a treatment for adults with eating disorder psychopathology. The aim of the present study was to establish, in a representative cohort of patients with marked anorexia nervosa, the immediate and longer term outcome following CBT-E. Forty-nine adolescent patients were recruited from consecutive referrals to a community-based eating disorder clinic. Each was offered 40 sessions of CBT-E over 40 weeks from a single therapist. Two-thirds completed the full treatment with no additional input. In these patients there was a substantial increase in weight together with a marked decrease in eating disorder psychopathology. Over the 60-week post-treatment follow-up period there was little change despite minimal subsequent treatment. These findings suggest that CBT-E may prove to be a cost-effective alternative to family-based treatment.
doi:10.1016/j.brat.2012.09.008
PMCID: PMC3662031  PMID: 23123081
Anorexia nervosa; Treatment; Cognitive behaviour therapy; Eating disorder; Family therapy
10.  Enhanced cognitive behaviour therapy for adults with anorexia nervosa: A UK—Italy study 
Behaviour research and therapy  2012;51(1):R2-R8.
Anorexia nervosa is difficult to treat and no treatment is supported by robust evidence. As it is uncommon, it has been recommended that new treatments should undergo extensive preliminary testing before being evaluated in randomized controlled trials. The aim of the present study was to establish the immediate and longer-term outcome following “enhanced” cognitive behaviour therapy (CBT-E). Ninety-nine adult patients with marked anorexia nervosa (body mass index ≤ 17.5) were recruited from consecutive referrals to clinics in the UK and Italy. Each was offered 40 sessions of CBT-E over 40 weeks with no concurrent treatment. Sixty-four percent of the patients were able to complete this outpatient treatment and in these patients there was a substantial increase in weight (7.47 kg, SD 4.93) and BMI (2.77, SD 1.81). Eating disorder features also improved markedly. Over the 60-week follow-up period there was little deterioration despite minimal additional treatment. These findings provide strong preliminary support for this use of CBT-E and justify its further evaluation in randomized controlled trials. As CBT-E has already been established as a treatment for bulimia nervosa and eating disorder not otherwise specified, the findings also confirm that CBT-E is transdiagnostic in its scope.
doi:10.1016/j.brat.2012.09.010
PMCID: PMC3662032  PMID: 23084515
Anorexia nervosa; Treatment; Cognitive behaviour therapy; Eating disorder
11.  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
12.  Enhanced cognitive behaviour therapy for adolescents with anorexia nervosa: An alternative to family therapy? 
Behaviour Research and Therapy  2013;51(1):R9-R12.
A specific form of family therapy (family-based treatment) is the leading treatment for adolescents with anorexia nervosa. As this treatment has certain limitations, alternative approaches are needed. “Enhanced” cognitive behaviour therapy (CBT-E) is a potential candidate given its utility as a treatment for adults with eating disorder psychopathology. The aim of the present study was to establish, in a representative cohort of patients with marked anorexia nervosa, the immediate and longer term outcome following CBT-E. Forty-nine adolescent patients were recruited from consecutive referrals to a community-based eating disorder clinic. Each was offered 40 sessions of CBT-E over 40 weeks from a single therapist. Two-thirds completed the full treatment with no additional input. In these patients there was a substantial increase in weight together with a marked decrease in eating disorder psychopathology. Over the 60-week post-treatment follow-up period there was little change despite minimal subsequent treatment. These findings suggest that CBT-E may prove to be a cost-effective alternative to family-based treatment.
Highlights
► CBT-E is designed to address eating disorder psychopathology in adults. ► The present findings show that CBT-E can also be used with adolescents. ► Almost two-thirds of the adolescent patients completed CBT-E. ► Among the completers there was a substantial, and well maintained, response. ► CBT-E may be a cost-effective alternative to family-based treatment.
doi:10.1016/j.brat.2012.09.008
PMCID: PMC3662031  PMID: 23123081
Anorexia nervosa; Treatment; Cognitive behaviour therapy; Eating disorder; Family therapy
13.  Enhanced cognitive behaviour therapy for adults with anorexia nervosa: A UK–Italy study 
Behaviour Research and Therapy  2013;51(1):R2-R8.
Anorexia nervosa is difficult to treat and no treatment is supported by robust evidence. As it is uncommon, it has been recommended that new treatments should undergo extensive preliminary testing before being evaluated in randomized controlled trials. The aim of the present study was to establish the immediate and longer-term outcome following “enhanced” cognitive behaviour therapy (CBT-E). Ninety-nine adult patients with marked anorexia nervosa (body mass index ≤ 17.5) were recruited from consecutive referrals to clinics in the UK and Italy. Each was offered 40 sessions of CBT-E over 40 weeks with no concurrent treatment. Sixty-four percent of the patients were able to complete this outpatient treatment and in these patients there was a substantial increase in weight (7.47 kg, SD 4.93) and BMI (2.77, SD 1.81). Eating disorder features also improved markedly. Over the 60-week follow-up period there was little deterioration despite minimal additional treatment. These findings provide strong preliminary support for this use of CBT-E and justify its further evaluation in randomized controlled trials. As CBT-E has already been established as a treatment for bulimia nervosa and eating disorder not otherwise specified, the findings also confirm that CBT-E is transdiagnostic in its scope.
Highlights
► CBT-E is designed to address eating disorder psychopathology. ► The findings show that CBT-E can be used with patients with marked anorexia nervosa. ► Two-thirds of the patients completed treatment. ► Among the completers there was a substantial, and well maintained, response. ► The findings confirm that CBT-E is transdiagnostic in its scope.
doi:10.1016/j.brat.2012.09.010
PMCID: PMC3662032  PMID: 23084515
Anorexia nervosa; Treatment; Cognitive behaviour therapy; Eating disorder
15.  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
16.  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
17.  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
18.  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
19.  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
20.  The rise of cholesterol testing: how much is unnecessary 
Background
Laboratory testing has increased dramatically over recent decades, which is a consequence particularly of repeat testing or monitoring, as either a response to treatment or follow-up.
Aim
To assess rates of measurement of lipid levels (total cholesterol, high-density lipoprotein, triglyceride) for diagnosis and monitoring over the last 20 years.
Design of study
Audit of electronic database.
Setting
A single region in the UK (Oxfordshire).
Method
Specimens from individual patients were matched over time. All tests that were the third or more in a 3-year period were considered to be for monitoring, while the first and second were considered to be for diagnosis. As recent evidence-based recommendations suggest that frequent monitoring of cholesterol may reflect measurement error rather than true changes, between one and three tests in each 3-year period were considered to be ‘necessary’.
Results
Over the 20 years from 1987 there has been a more than 15-fold rise in the overall number of lipid tests requested. After a small decline in the early 1990s, testing rose steadily after publication of several large statin trials, particularly tests requested in primary rather than secondary care. Repeat testing (likely to be for monitoring) rose from 24% of tests (1993–1995) to 61% (2005–2007), with between 42% and 79% of tests in 2005–2007 possibly being unnecessary. Mean cholesterol values declined over time from 1996 onwards.
Conclusion
In the last decade, the number of cholesterol tests performed in Oxfordshire has risen dramatically. Much of this appears to be for monitoring purposes rather than case finding or risk assessment. The majority of cholesterol tests requested may be unnecessary.
doi:10.3399/bjgp11X556245
PMCID: PMC3026174  PMID: 21276328
cholesterol; laboratories, hospital; patient monitoring; testing, lipid; statin
21.  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
22.  Transdiagnostic Cognitive-Behavioral Therapy for Patients With Eating Disorders: A Two-Site Trial With 60-Week Follow-Up 
The American journal of psychiatry  2008;166(3):311-319.
Objective
The aim of this study was to compare two cognitive-behavioral treatments for outpatients with eating disorders, one focusing solely on eating disorder features and the other a more complex treatment that also addresses mood intolerance, clinical perfectionism, low self-esteem, or interpersonal difficulties.
Method
A total of 154 patients who had a DSM-IV eating disorder but were not markedly underweight (body mass index over 17.5), were enrolled in a two-site randomized controlled trial involving 20 weeks of treatment and a 60-week closed period of follow-up. The control condition was an 8-week waiting list period preceding treatment. Outcomes were measured by independent assessors who were blind to treatment condition.
Results
Patients in the waiting list control condition exhibited little change in symptom severity, whereas those in the two treatment conditions exhibited substantial and equivalent change, which was well maintained during follow-up. At the 60-week follow-up assessment, 51.3% of the sample had a level of eating disorder features less than one standard deviation above the community mean. Treatment outcome did not depend on eating disorder diagnosis. Patients with marked mood intolerance, clinical perfectionism, low self-esteem, or interpersonal difficulties appeared to respond better to the more complex treatment, with the reverse pattern evident among the remaining patients.
Conclusions
These two transdiagnostic treatments appear to be suitable for the majority of outpatients with an eating disorder. The simpler treatment may best be viewed as the default version, with the more complex treatment reserved for patients with marked additional psychopathology of the type targeted by the treatment.
doi:10.1176/appi.ajp.2008.08040608
PMCID: PMC3035831  PMID: 19074978
23.  Identifying Dieters Who Will Develop an Eating Disorder: A Prospective, Population-Based Study 
The American journal of psychiatry  2005;162(12):2249-2255.
Objective
The aims of the study were to identify the characteristics of the dieters most at risk of subsequently developing an eating disorder and to evaluate the feasibility of using a brief questionnaire to identify such dieters in advance.
Method
A general population cohort of 2,992 young women who were dieting was identified. On four occasions over the subsequent 2 years, this cohort was sent a questionnaire concerning eating habits and attitudes. Participants whose responses suggested that they had developed an eating disorder were interviewed to establish their true case status. The baseline questionnaires of those who did and did not subsequently develop an eating disorder were compared to identify features that predicted future case status.
Results
One hundred four of the dieters developed an eating disorder of clinical severity during the 2 years of follow-up. Their baseline questionnaire scores differed in many respects from those who had not developed an eating disorder. Items associated with developing an eating disorder were selected by using three different statistical methods. A simple case-predicting instrument based on one of five items scoring above an optimal cut point had a sensitivity of 71% and a specificity of 72% (overall efficiency of 72%).
Conclusions
Dieters who will develop an eating disorder within the next 2 years have distinctive features. It is feasible to identify them in advance with reasonable efficiency with a brief questionnaire. This questionnaire could be incorporated into routine health assessments, thereby identifying those at high risk.
doi:10.1176/appi.ajp.162.12.2249
PMCID: PMC3035832  PMID: 16330587
24.  Testing a new cognitive behavioural treatment for obesity: A randomized controlled trial with three-year follow-up 
Behaviour Research and Therapy  2010;48(8):706-713.
It is remarkably difficult for people with obesity to maintain a new lower weight following weight loss. The aim of the present study was to examine the immediate and longer-term effects of a new cognitive behavioural treatment that was explicitly designed to minimise this post-treatment weight regain. One hundred and fifty female participants with obesity were randomized to the new treatment, behaviour therapy (the leading alternative psychological treatment) or guided self-help (a minimal intervention). Both of the main treatments resulted in an average weight loss of about ten percent of initial weight whereas weight loss was more modest with guided self-help. The participants were subsequently followed-up for three years post-treatment. The great majority regained almost all the weight that they had lost with the new treatment being no better than the behavioural treatment in preventing weight regain. These findings lend further support to the notion that obesity is resistant to psychological methods of treatment, if anything other than a short-term perspective is taken. It is suggested that it is ethically questionable to claim that psychological treatments for obesity “work” in the absence of data on their longer-term effects.
doi:10.1016/j.brat.2010.03.008
PMCID: PMC2923743  PMID: 20691328
Obesity; Treatment; Cognitive behaviour therapy; Behaviour therapy; Self-help; Randomized controlled trial
25.  Avoiding hospital admission through provision of hospital care at home: a systematic review and meta-analysis of individual patient data 
Background
Avoidance of admission through provision of hospital care at home is a scheme whereby health care professionals provide active treatment in the patient's home for a condition that would otherwise require inpatient treatment in an acute care hospital. We sought to compare the effectiveness of this method of caring for patients with that type of in-hospital care.
Methods
We searched the MEDLINE, EMBASE, CINAHL and EconLit databases and the Cochrane Effective Practice and Organisation of Care Group register from the earliest date in each database until January 2008. We included randomized controlled trials that evaluated a service providing an alternative to admission to an acute care hospital. We excluded trials in which the program did not offer a substitute for inpatient care. We performed meta-analyses for trials for which the study populations had similar characteristics and for which common outcomes had been measured.
Results
We included 10 randomized trials (with a total of 1327 patients) in our systematic review. Seven of these trials (with a total of 969 patients) were deemed eligible for meta-analysis of individual patient data, but we were able to obtain data for only 5 of these trials (with a total of 844 patients [87%]). There was no significant difference in mortality at 3 months for patients who received hospital care at home (adjusted hazard ratio [HR] 0.77, 95% confidence interval [CI] 0.54–1.09, p = 0.15). However, at 6 months, mortality was significantly lower for these patients (adjusted HR 0.62, 95% CI 0.45–0.87, p = 0.005). Admissions to hospital were greater, but not significantly so, for patients receiving hospital care at home (adjusted HR 1.49, 95% CI 0.96–2.33, p = 0.08). Patients receiving hospital care at home reported greater satisfaction than those receiving inpatient care. These programs were less expensive than admission to an acute care hospital ward when the analysis was restricted to treatment actually received and when the costs of informal care were excluded.
Interpretation
For selected patients, avoiding admission through provision of hospital care at home yielded similar outcomes to inpatient care, at a similar or lower cost.
doi:10.1503/cmaj.081491
PMCID: PMC2621299  PMID: 19153394

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