A systematic mapping review of clinical guidelines for the management of fatigue in long-term physical health conditions.

PURPOSE: Despite a high prevalence of fatigue and its importance to patients, many people with long-term conditions do not receive fatigue management as part of their treatment. This review is aimed to identify clinical guidance for the management of fatigue in long-term physical health conditions. METHODS: A systematic mapping review was conducted in accordance with Social Care Institute for Excellence systematic review guidance. Bibliographic databases and guideline repositories were searched for clinical guidelines for long-term conditions, published between January 2008 and July 2018, with a search for updates conducted in May 2023. Data were extracted on the recommendations made for managing fatigue and, where cited, the underlying research evidence used to support these recommendations was also extracted. RESULTS: The review included 221 guidelines on 67 different long-term conditions. Only 30 (13.6%) of the guidelines contained recommendations for managing fatigue. These were categorised as clinical (e.g. conduct further investigations), pharmacological, behavioural (e.g. physical activity), psychological, nutritional, complementary, environmental, and multicomponent. The guidelines rated much of the evidence for fatigue management as fairly low quality, highlighting the need to develop and test fatigue-management strategies in high-quality trials. CONCLUSION: This review highlights that management of fatigue is a very important neglected area in the clinical guidelines for managing long-term conditions.

Fatigue is a common and debilitating symptom of many long-term physical health conditions; however, many people do not receive treatment for fatigue.This mapping review found that very few clinical guidelines contain recommendations for managing fatigue, even where published evidence exists.It is essential that developers of clinical guidelines address this important neglected area.

The impact of chemotherapy on cognitive performance post-surgery in patients with colorectal cancer: A prospective cohort study.

OBJECTIVES: Subjective reports of cognitive impairment following chemotherapy are frequent in cancer patients. Objective cognitive impairment has been observed in cancer patients regardless of treatment regimen suggesting the relationship between cognitive impairment and chemotherapy is not clear cut. Little research has explored the effects of chemotherapy on cognition following surgery in colorectal cancer (CRC). The present study explored the effects of chemotherapy on cognitive performance in a sample of CRC patients. METHODS: 136 participants were recruited into a prospective cohort study: 78 CRC patients undergoing surgery and adjuvant chemotherapy, 58 CRC patients undergoing surgery only. A battery of neuropsychological tests was administered to participants 4 weeks post-surgery (T1), 12 weeks after first chemotherapy (T2) and 3 months after last chemotherapy (T3) or equivalent time-points. RESULTS: Using the criterion of scoring at least two standard-deviations below the group norm on at least one neuropsychological test, 45%-55% of all CRC patients showed cognitive deficits 10 months after surgery (T3) and 14% on at least 3 tests. However, cognition did not significantly differ between patients who had chemotherapy and those who did not. A time by group interaction effect was found on the composite cognition score using multi-level modelling suggesting a greater improvement in cognition in the surgery only group over time (p < 0.05). CONCLUSIONS: CRC patients display cognitive impairment 10 months after surgery. Chemotherapy did not worsen cognitive impairment but did appear to slow cognitive recovery relative to those undergoing surgery only. The findings demonstrate a clear need for supportive cognitive interventions for all CRC patients following treatment.

Prioritising target non-pharmacological interventions for research in Parkinson's disease: achieving consensus from key stakeholders.

BACKGROUND: In 2014 Parkinson's UK conducted a research prioritisation exercise with stakeholders highlighting important clinical research questions. The exercise highlighted the need for effective interventions to be developed and tested to tackle a range of non-motor symptoms including: sleep quality, stress and anxiety, mild cognitive impairment, dementia and urinary problems. The present work set out to build on this exercise by prioritising types of non-pharmacological interventions to be tested to treat the identified non-motor symptoms. METHODS: A Patient and Public Involvement exercise was used to reach consensus on intervention priorities for the treatment of non-motor symptoms. A Delphi structure was used to support the feedback collected. A first-round prioritisation survey was conducted followed by a panel discussion. Nineteen panellists completed the first-round survey (9 people with Parkinson's and 10 professionals working in Parkinson's) and 16 participated in the panel discussion (8 people with Parkinson's and 8 professionals working in Parkinson's). A second-round prioritization survey was conducted after the panel discussion with 13 people with Parkinson's. RESULTS: Physical activity, third wave cognitive therapies and cognitive training were rated as priority interventions for the treatment of a range of non-motor symptoms. There was broad agreement on intervention priorities between health care professionals and people with Parkinson's. A consensus was reached that research should focus on therapies which could be used to treat several different non-motor symptoms. In the context of increasing digitisation, the need for human interaction as an intervention component was highlighted. CONCLUSION: Bringing together Parkinson's professionals and people with Parkinson's resulted in a final treatment priority list which should be both feasible to carry out in routine clinical practice and acceptable to both professionals and people with Parkinson's. The workshop further specified research priorities in Parkinson's disease based on the current evidence base, stakeholder preferences, and feasibility. Research should focus on developing and testing non-pharmacological treatments which could be effective across a range of symptoms but specifically focusing on tailored physical activity interventions, cognitive therapies and cognitive training.

How the Integration of Telehealth and Coordinated Care Approaches Impact Health Care Service Organization Structure and Ethos: Mixed Methods Study.

BACKGROUND: Coordinated care and telehealth services have the potential to deliver quality care to chronically ill patients. They can both reduce the economic burden of chronic care and maximize the delivery of clinical services. Such services require new behaviors, routines, and ways of working to improve health outcomes, administrative efficiency, cost-effectiveness, and user (patient and health professional) experience. OBJECTIVE: The aim of this study was to assess how health care organization setup influences the perceptions and experience of service managers and frontline staff during the development and deployment of integrated care with and without telehealth. METHODS: As part of a multinational project exploring the use of coordinated care and telehealth, questionnaires were sent to service managers and frontline practitioners. These questionnaires gathered quantitative and qualitative data related to organizational issues in the implementation of coordinated care and telehealth. Three analytical stages were followed: (1) preliminary analysis for a direct comparison of the responses of service managers and frontline staff to a range of organizational issues, (2) secondary analysis to establish statistically significant relationships between baseline and follow-up questionnaires, and (3) thematic analysis of free-text responses of service managers and frontline staff. RESULTS: Both frontline practitioners and managers highlighted that training, tailored to the needs of different professional groups and staff grades, was a crucial element in the successful implementation of new services. Frontline staff were markedly less positive than managers in their views regarding the responsiveness of their organization and the pace of change. CONCLUSIONS: The data provide evidence that the setup of health care services is positively associated with outcomes in several areas, particularly tailored staff training, rewards for good service, staff satisfaction, and patient involvement.

Barriers to reporting non-motor symptoms to health-care providers in people with Parkinson's.

BACKGROUND: Non-motor symptoms (NMS) are common in Parkinson's disease (PD) and cause significant distress. A high rate of non-declaration of NMS by patients to healthcare providers (HCP) means that many NMS remain untreated. Current understanding of the factors preventing disclosure of NMS to HCPs is limited. The present study aimed to i) further assess the prevalence of NMS and associated distress, ii) establish current rates of NMS reporting across a range of sources, and iii) explore overall and any symptom specific barriers to help-seeking for NMS. METHODS: 358 PD patients completed a cross-sectional survey of NMS severity, reporting and barriers to help-seeking. A series of Generalised Estimating Equations were used to determine whether barriers were symptom specific. RESULTS: A mean of 10.5 NMS were reported by each patient. Rates of non-reporting of NMS ranged from 15 to 72% of those experiencing distressing symptoms. The most commonly reported barriers to help-seeking were acceptance of symptoms; lack of awareness that a symptom was associated with PD, and belief that no effective treatments were available. Symptom specific barriers were found for sexual dysfunction (embarrassment), unexplained pain and urinary problems (belief about lack of treatment availability). CONCLUSION: A diverse range of barriers prevent PD patients reporting NMS to HCPs and these barriers differ between NMS. The study provides the foundations for developing interventions to increase reporting by targeting individual NMS. Increasing rates of help-seeking for NMS by patients to their Parkinson's healthcare providers will increase appropriate clinical care which may improve quality of life and well-being.

Improving storytelling and vocabulary in secondary school students with language disorder: a randomized controlled trial.

BACKGROUND: Although language and communication difficulties are common in secondary school students, there has been limited research into the efficacy of interventions for adolescents with language and communication difficulties. AIMS: To investigate the efficacy of teaching assistant (TA)-delivered narrative and vocabulary interventions to mainstream secondary school-aged students with language disorder. METHODS & PROCEDURES: A randomized controlled trial (RCT) of a language and communication intervention was used to evaluate the efficacy of vocabulary and narrative interventions to improve the vocabulary and narrative performance of adolescents (mean age = 12.8 years) with language disorder. The language and communication programmes (narrative, vocabulary and combined narrative and vocabulary) were delivered by TAs in the classroom, three times per week, for 45-60 min each, over 6 weeks, totalling 18 sessions. Standardized and intervention-specific measures were used as outcomes. OUTCOMES & RESULTS: Twenty-one schools with 358 eligible participants were recruited. The three intervention groups showed significant improvements (d = .296) on a narrative latent variable defined by a standardized narrative assessment (the Expression, Reception and Recall of Narrative Instrument-ERRNI), but there were no significant improvements on an overall vocabulary latent variable compared with the waiting control group. Differential effects were found on some non-standardized intervention-specific measures with the narrative group making significantly more progress on narrative tasks compared with the waiting control group, the vocabulary group showing the same pattern on specific vocabulary tasks, and the combined narrative and vocabulary group making significantly more progress on some of the intervention-specific narrative, and all the intervention-specific vocabulary outcomes compared with the waiting control group. CONCLUSIONS & IMPLICATIONS: It is possible to improve narrative but not vocabulary skills, as assessed by standardized measures, in secondary school students with a relatively brief group TA-delivered intervention. There were differential effects for both narrative and vocabulary with intervention-specific measures. Future work is required to explore whether more intensive and longer lasting interventions would be more effective and to identify which students in this age group are most likely to benefit from such interventions.

Identifying barriers to help-seeking for non-motor symptoms in people with Parkinson's disease.

Non-motor symptoms of Parkinson's disease have a significant impact on quality of life. Despite this, many non-motor symptoms remain unreported by patients and consequently untreated. This study explored barriers to help-seeking using two theoretical frameworks, the Common Sense Model of illness perception and Theoretical Domains Framework. A total of 20 participants completed semi-structured interviews to explore symptom beliefs and help-seeking behaviour. Uncertainty about the relationship of non-motor symptoms to Parkinson's disease and lack of clarity around treatments were common. Embarrassment and communication difficulties were common for potentially sensitive symptoms such as sexual dysfunction. Symptom perceptions and beliefs about help-seeking acted as barriers to reporting non-motor symptoms.

The Effect of Telehealth on Quality of Life and Psychological Outcomes Over a 12-Month Period in a Diabetes Cohort Within the Whole Systems Demonstrator Cluster Randomized Trial.

BACKGROUND: Much is written about the promise of telehealth and there is great enthusiasm about its potential. However, many studies of telehealth do not meet orthodox quality standards and there are few studies examining quality of life in diabetes as an outcome. OBJECTIVE:  To assess the impact of home-based telehealth (remote monitoring of physiological, symptom and self-care behavior data for long-term conditions) on generic and disease-specific health-related quality of life, anxiety, and depressive symptoms over 12 months in patients with diabetes. Remote monitoring provides the potential to improve quality of life, through the reassurance it provides patients. METHODS: The study focused on participant-reported outcomes of patients with diabetes within the Whole Systems Demonstrator (WSD) Telehealth Questionnaire Study, nested within a pragmatic cluster-randomized trial of telehealth (the WSD Telehealth Trial), held across 3 regions of England. Telehealth was compared with usual-care, with general practice as the unit of randomization. Participant-reported outcome measures (Short-Form 12, EuroQual-5D, Diabetes Health Profile scales, Brief State-Trait Anxiety Inventory, and Centre for Epidemiological Studies Depression Scale) were collected at baseline, short-term (4 months) and long-term (12months) follow-ups. Intention-to-treat analyses testing treatment effectiveness, were conducted using multilevel models controlling for practice clustering and a range of covariates. Analyses assumed participants received their allocated treatment and were conducted for participants who completed the baseline plus at least one follow-up assessment (n=317). RESULTS:  Primary analyses showed differences between telehealth and usual care were small and only reached significance for 1 scale (diabetes health profile-disinhibited eating, P=.006). The magnitude of differences between trial arms did not reach the trial-defined minimal clinically important difference of 0.3 standard deviations for most outcomes. Effect sizes (Hedge's g) ranged from 0.015 to 0.143 for Generic quality of life (QoL) measures and 0.018 to 0.394 for disease specific measures. CONCLUSIONS: Second generation home-based telehealth as implemented in the WSD evaluation was not effective in the subsample of people with diabetes. Overall, telehealth did not improve or have a deleterious effect quality of life or psychological outcomes for patients with diabetes over a 12-month period.

A RCT of telehealth for COPD patient's quality of life: the whole system demonstrator evaluation.

INTRODUCTION/OBJECTIVES: Despite some concerns that the introduction of telehealth (TH) may lead to reductions in quality of life (QoL), lower mood and increased anxiety in response to using assistive technologies to reduce health care utilisation and manage long term conditions, this research focuses on the extent to which providing people with tools to monitor their condition can improve QoL. METHODS: The Chronic Obstructive Pulmonary Disease (COPD) cohort of the Whole Systems Demonstrator Trial is a pragmatic General Practitioner (GP) clustered randomised controlled trial (RCT) evaluating TH in the UK from three regions in England. All patients at a participating GP practice were deemed eligible for inclusion in the study if they were diagnosed with COPD. RESULTS: 447 participants completed baseline and either a short (4 months) or long term (12 months) follow-up. There was a trend of improved QoL and mood in the TH group at longer-term follow-up, but not short term follow-up. Emotional functioning (g = 0.280 95%CI, 0.051-0.510) and mastery reached (g = 2.979 95%CI, 0-0.46) significance at P < 0.05 (all Hedges g <0.3). CONCLUSIONS: TH showed minimal benefit to QoL in COPD patients who were not preselected to be at increased risk of acute exacerbations. Benefits were more likely in disease specific measures at longer term follow-up. TH is a complex intervention and should be embedded in a service that is evidenced based. Outcome measures must be sensitive enough to detect changes in the target population for the specific intervention.

Is there a relationship between objectively measured cognitive changes in patients with solid tumours undergoing chemotherapy treatment and their health-related quality of life outcomes? A systematic review.

BACKGROUND: This systematic review examines whether there is a relationship between objective measures of chemotherapy-related cognitive impairment in patients with solid cancer tumours and health-related quality of life (HRQoL). METHODS: Multiple online databases were searched (including Ovid MEDLINE, EMBASE, PsycINFO, PsycARTICLES, CINAHL, PubMed, and Web of Science) to identify articles published between 1980 and 2016 examining the extent of chemotherapy-related cognitive deficit and its relationship with HRQoL in cancer patients. Of 2769 potentially relevant articles, 17 studies met the inclusion criteria for the current review. RESULTS: Evidence for the presence of cognitive impairment in patients treated with chemotherapy was found in 15 of the 17 studies. Of the 15 studies finding some sort of cognitive impairment, 12 were in female breast cancer patients, 2 in bowel cancer, and 1 each in ovarian and lung cancer. Three of the 15 studies found a significant relationship between various objectively measured cognitively impaired domains and specific HRQoL outcomes. There was, however, only limited testing of the relationships between quantifiable cognitive dysfunction and HRQoL domains. CONCLUSIONS: This review suggests that in patients with solid tumours, where there is a relationship between chemotherapy treatment and cognitive impairment, the type and level of cognitive decline does not consistently appear to affect such patients' HRQoL. This could be partly explained by variations in study design, measures used, definitions of cognitive impairment, varying measurement time frames, small sample sizes, and differences in disease severity and type of treatment regimes.

Cognitive dysfunction in adult CHD with different structural complexity.

OBJECTIVE: We carried out a cross-sectional study to assess cognitive function in a sample of adult CHD patients, within the Functioning in Adult Congenital Heart Disease study London. The association between cognitive functioning and disease complexity was examined. METHODS: A total of 310 patients participated in this study. Patients were classified into four structural complexity groups - tetralogy of Fallot, transposition of the great arteries, single ventricle, and simple conditions. Each patient underwent neuropsychological assessment to evaluate cognitive function, including memory and executive function, and completed questionnaires to assess depression and anxiety. RESULTS: Among all, 41% of the sample showed impaired performance (>1.5 SD below the normative mean) on at least three tests of cognitive function compared with established normative data. This was higher than the 8% that was expected in a normal population. The sample exhibited significant deficits in divided attention, motor function, and executive functioning. There was a significant group difference in divided attention (F=5.01, p=0.002) and the mean total composite score (F=5.19, p=0.002) between different structural complexity groups, with the simple group displaying better cognitive function. CONCLUSION: The results indicate that many adult CHD patients display impaired cognitive function relative to a healthy population, which differs in relation to disease complexity. These findings may have implications for clinical decision making in this group of patients during childhood. Possible mechanisms underlying these deficits and how they may be reduced or prevented are discussed; however, further work is needed to draw conclusive judgements.

Quantifying beliefs regarding telehealth: Development of the Whole Systems Demonstrator Service User Technology Acceptability Questionnaire.

Introduction Telehealth (TH) is a potential solution to the increased incidence of chronic illness in an ageing population. The extent to which older people and users with chronic conditions accept and adhere to using assistive technologies is a potential barrier to mainstreaming the service. This study reports the development and validation of the Whole Systems Demonstrator (WSD) Service User Technology Acceptability Questionnaire (SUTAQ). Methods Questionnaires measuring the acceptability of TH, quality of life, well-being and psychological processes were completed by 478 users of TH. The 22 acceptability items were subject to principal components analysis (PCA) to determine sub-scales. Scale scores, relationships between scales and other patient-reported outcome measures (PROMs), and group differences on scales were utilised to check the reliability and validity of the measure. Results PCAs of SUTAQ items produced six TH acceptability scales: enhanced care, increased accessibility, privacy and discomfort, care personnel concerns, kit as substitution and satisfaction. Significant correlations within these beliefs and between these scales and additional PROMs were coherent, and the SUTAQ sub-scales were able to predict those more likely to refuse TH. Discussion The SUTAQ is an instrument that can be used to measure user beliefs about the acceptability of TH, and has the ability to discriminate between groups and predict individual differences in beliefs and behaviour. Measuring acceptability beliefs of TH users can provide valuable information to direct and target provision of services to increase uptake and maintain use of TH.

Methods used to address fidelity of receipt in health intervention research: a citation analysis and systematic review.

BACKGROUND: The American Behaviour Change Consortium (BCC) framework acknowledges patients as active participants and supports the need to investigate the fidelity with which they receive interventions, i.e. receipt. According to this framework, addressing receipt consists in using strategies to assess or enhance participants' understanding and/or performance of intervention skills. This systematic review aims to establish the frequency with which receipt is addressed as defined in the BCC framework in health research, and to describe the methods used in papers informed by the BCC framework and in the wider literature. METHODS: A forward citation search on papers presenting the BCC framework was performed to determine the frequency with which receipt as defined in this framework was addressed. A second electronic database search, including search terms pertaining to fidelity, receipt, health and process evaluations was performed to identify papers reporting on receipt in the wider literature and irrespective of the framework used. These results were combined with forward citation search results to review methods to assess receipt. Eligibility criteria and data extraction forms were developed and applied to papers. Results are described in a narrative synthesis. RESULTS: 19.6% of 33 studies identified from the forward citation search to report on fidelity were found to address receipt. In 60.6% of these, receipt was assessed in relation to understanding and in 42.4% in relation to performance of skill. Strategies to enhance these were present in 12.1% and 21.1% of studies, respectively. Fifty-five studies were included in the review of the wider literature. Several frameworks and operationalisations of receipt were reported, but the latter were not always consistent with the guiding framework. Receipt was most frequently operationalised in relation to intervention content (16.4%), satisfaction (14.5%), engagement (14.5%), and attendance (14.5%). The majority of studies (90.0%) included subjective assessments of receipt. These relied on quantitative (76.0%) rather than qualitative (42.0%) methods and studies collected data on intervention recipients (50.0%), intervention deliverers (28.0%), or both (22.0%). Few studies (26.0%) reported on the reliability or validity of methods used. CONCLUSIONS: Receipt is infrequently addressed in health research and improvements to methods of assessment and reporting are required.

The role of illness perceptions in adherence to surveillance in patients with familial adenomatous polyposis (FAP).

OBJECTIVE: The aim of the study was to examine patients' beliefs about having familial adenomatous polyposis (FAP), a hereditary colorectal cancer syndrome, and how these beliefs are associated with adherence to endoscopic surveillance. METHODS: Adult patients diagnosed with FAP on the national Swedish polyposis register who had undergone prophylactic colorectal surgery (n 209, response rate 76%) completed the Illness Perception Questionnaire (IPQ). Logistic regression analysis was used to investigate the relationships between illness perceptions and adherence, when controlling for demographic and clinical factors. RESULTS: FAP was less distressing in men and those with fewer symptoms, reporting less serious consequences and more coherent understanding of FAP. Non-adherence (14%) to surveillance was associated with being older, having undergone surgery less recently and no history of malignancy. Patients' beliefs about their FAP were able to explain unique variance in non-adherence, in particular those who believed FAP was less distressing. CONCLUSIONS: Patients who were non-adherent to endoscopic surveillance had more positive perceptions about their FAP and, in particular, were less emotionally affected compared to those who adhered. As non-adherence implies a greater risk of future malignancies, special efforts are required to effectively prevent cancer in all patients with FAP. Those who have lived with the condition for a long time, and are not troubled by gastrointestinal symptoms or worried about their FAP, may be in need of specific information and support. Further prospective research is required to examine emotional predictors and consequences of non-adherence. Copyright © 2015 John Wiley & Sons, Ltd.

Examining the effects of adjuvant chemotherapy on cognition and the impact of any cognitive impairment on quality of life in colorectal cancer patients: study protocol.

BACKGROUND: Research suggests that chemotherapy can cause deficits in both patients' objectively measured and self-reported cognitive abilities which can in turn affect their quality of life (QoL). The majority of research studies have used post-treatment retrospective designs or have not included a control group in prospective cohorts. This has limited the conclusions that can be drawn from the results. There have also been a disproportionate number of studies focussed on women with breast cancer, which has limited the generalisability of the results to other cancer populations. AIM: This study aims to identify the extent and impact of chemotherapy-induced cognitive decline in colorectal cancer patients. Possible associations with poorer QoL will also be explored. DESIGN: This will be a longitudinal controlled cohort study. Questionnaires measuring subjective cognitive functioning, QoL, fatigue and mood, and neuropsychological assessments of objective cognitive function will be collected pre-, mid- and post- chemotherapy treatment from a consecutive sample of 78 colorectal cancer patients from five London NHS Trusts. A further 78 colorectal cancer surgery only patients will be assessed at equivalent time points; this will allow the researchers to compare the results of patients undergoing surgery, but not chemotherapy against those receiving both treatments. Pre- and post-chemotherapy difference scores will be calculated to detect subtle changes in cognitive function as measured by the objective neuropsychological assessments and the self-reported questionnaires. A standardised z-score will be computed for every patient on each neuropsychological test, and for each test at each time point. The post-chemotherapy score will then be subtracted from the pre-chemotherapy score to produce a relative difference score for each patient. ANCOVA will be used to compare mean difference z-scores between the chemotherapy and surgery-only groups while controlling for the effects of gender, age, depression, anxiety, fatigue and education. DISCUSSION: The result from this study will indicate whether a decline in cognitive functioning can be attributed to chemotherapy or to disease, surgical or some other confounding factor. Identification of risk factors for cognitive deficits may be used to inform targeted interventions, in order to improve QoL and help patients' cope.

Cost-effectiveness of telecare for people with social care needs: the Whole Systems Demonstrator cluster randomised trial.

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.

The effect of telecare on the quality of life and psychological well-being of elderly recipients of social care over a 12-month period: the Whole Systems Demonstrator cluster randomised trial.

BACKGROUND: home-based telecare (TC) is utilised to manage risks of independent living and provide prompt emergency responses. This study examined the effect of TC on health-related quality of life (HRQoL), anxiety and depressive symptoms over 12 months in patients receiving social care. DESIGN: a study of participant-reported outcomes [the Whole Systems Demonstrator (WSD) Telecare Questionnaire Study; baseline n = 1,189] was nested in a pragmatic cluster-randomised trial of TC (the WSD Telecare trial), held across three English Local Authorities. General practice (GP) was the unit of randomisation and TC was compared with usual care (UC). METHODS: participant-reported outcome measures were collected at baseline, short-term (4 months) and long-term (12 months) follow-up, assessing generic HRQoL, anxiety and depressive symptoms. Primary intention-to-treat analyses tested treatment effectiveness and were conducted using multilevel models to control for GP clustering and covariates for participants who completed questionnaire measures at baseline assessment plus at least one other assessment (n = 873). RESULTS: analyses found significant differences between TC and UC on Short Form-12 mental component scores (P < 0.05), with parameter estimates indicating being a member of the TC trial-arm increases mental component scores (UC-adjusted mean = 40.52; TC-adjusted mean = 43.69). Additional significant analyses revealed, time effects on EQ5D (decreasing over time) and depressive symptoms (increasing over time). CONCLUSIONS: TC potentially contributes to the amelioration in the decline in users' mental HRQoL over a 12-month period. TC may not transform the lives of its users, but it may afford small relative benefits on some psychological and HRQOL outcomes relative to users who only receive UC. International Standard Randomised Controlled Trial Number Register: ISRCTN 43002091.

Systematic review of the effects of telecare provided for a person with social care needs on outcomes for their informal carers.

Telecare devices have been put forward as a potentially effective intervention to benefit the well-being and functioning of informal carers of people with social care needs, and to reduce the negative effects of providing care to a family member or friend. Much of the evidence used to support this view is qualitative, and therefore does not provide good-quality evidence to answer questions about its effect on carer outcomes. This review aimed to document and evaluate the quantitative evidence base for the effect of telecare interventions on outcomes for informal carers. A systematic search was conducted between October 2009 and January 2010 to identify peer-reviewed and 'grey' intervention evaluations, using electronic databases and expert/interested party recommendations. Clear inclusion and exclusion criteria and a reliable screening process were applied to select papers for inclusion in the review, and a checklist was used to assess risk of bias for each evaluation. Of 1071 identified evaluations, seven fulfilled the inclusion and exclusion criteria. Of these, two were peer-reviewed, and the remainder were unpublished or internal reports. Included evaluations were heterogeneous; they had investigated diverse technologies and outcomes, using varied evaluation designs and measures. All included evaluations were rated as being of weak methodological quality, indicating risk of bias within the evidence base. The evidence tentatively indicated that telecare exerts a positive effect on carer stress and strain, but there is no evidence to indicate benefits on burden or quality of life. The evidence is conflicting about the effect of telecare on the amount of time carers spend on their caring duties, and on relationships between the carer, cared-for person and other family members. Additional good-quality evaluations are required to establish the effects of telecare on informal carer outcomes.

Cost effectiveness of telehealth for patients with long term conditions (Whole Systems Demonstrator telehealth questionnaire study): nested economic evaluation in a pragmatic, cluster randomised controlled trial.

OBJECTIVE: To examine the costs and cost effectiveness of telehealth in addition to standard support and treatment, compared with standard support and treatment. DESIGN: Economic evaluation nested in a pragmatic, cluster randomised controlled trial. SETTING: Community based telehealth intervention in three local authority areas in England. PARTICIPANTS: 3230 people with a long term condition (heart failure, chronic obstructive pulmonary disease, or diabetes) were recruited into the Whole Systems Demonstrator telehealth trial between May 2008 and December 2009. Of participants taking part in the Whole Systems Demonstrator telehealth questionnaire study examining acceptability, effectiveness, and cost effectiveness, 845 were randomised to telehealth and 728 to usual care. INTERVENTIONS: Intervention participants received a package of telehealth equipment and monitoring services for 12 months, in addition to the standard health and social care services available in their area. Controls received usual health and social care. MAIN OUTCOME MEASURE: Primary outcome for the cost effectiveness analysis was incremental cost per quality adjusted life year (QALY) gained. RESULTS: We undertook net benefit analyses of costs and outcomes for 965 patients (534 receiving telehealth; 431 usual care). The adjusted mean difference in QALY gain between groups at 12 months was 0.012. Total health and social care costs (including direct costs of the intervention) for the three months before 12 month interview were £1390 (€1610; $2150) and £1596 for the usual care and telehealth groups, respectively. Cost effectiveness acceptability curves were generated to examine decision uncertainty in the analysis surrounding the value of the cost effectiveness threshold. The incremental cost per QALY of telehealth when added to usual care was £92 000. With this amount, the probability of cost effectiveness was low (11% at willingness to pay threshold of £30 000; >50% only if the threshold exceeded about £90 000). In sensitivity analyses, telehealth costs remained slightly (non-significantly) higher than usual care costs, even after assuming that equipment prices fell by 80% or telehealth services operated at maximum capacity. However, the most optimistic scenario (combining reduced equipment prices with maximum operating capacity) eliminated this group difference (cost effectiveness ratio £12 000 per QALY). CONCLUSIONS: The QALY gain by patients using telehealth in addition to usual care was similar to that by patients receiving usual care only, and total costs associated with the telehealth intervention were higher. Telehealth does not seem to be a cost effective addition to standard support and treatment. TRIAL REGISTRATION: ISRCTN43002091.

Effect of telecare on use of health and social care services: findings from the Whole Systems Demonstrator cluster randomised trial.

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.