Stakeholders perspectives and deployment strategies of health information exchange illustrated through an in-depth case study of Pakistan.

Background: Ready access to reliable data is essential to support decision-making in patient care planning and delivery. Health information exchange (HIE), which is fundamental to achieve this, is currently limited in many low- and middle-income countries (LMICs), reflecting the lack of prioritization of this issue and the many barriers to its successful implementation.Objective: We sought to explore and understand stakeholders' perspectives on the context of and deployment strategies for HIE in Pakistan.Method: Data collection comprised interviews with purposefully selected groups of stakeholders across Pakistan, field notes, and a critical review of key national and international policy documents.Results: We identified reports of small pockets of effective HIE existing mainly in private hospitals, but in a patchy and fragmented form overall. Many problems were attributed to the absence of effective HIE, these ranging from 'delays in retrieving records' to contributing to 'the increase in antibiotic resistance'. The mindset of policymakers, poor infrastructure, lack of finance, training and data interoperability, and health-care providers' resistance to recording consultations due to poor documentation skills and concerns about liability considerations were highlighted as major barriers to HIE. Sharing regional health information with international organizations was perceived by some participants to increase the risk of regional espionage. A clear government policy directive for evidence-based decision-making, constant supply of electricity, training, widespread adoption of common data standards and public pressure to adopt mobile technology frameworks were identified as potential facilitators of HIE.Conclusion: HIE can be achieved with the support of the federal and provincial governments coupled with financial and technical backing from international donor organizations. The transition to HIE is likely to be very dependent on improving governance capabilities and bolstering the informatics skill-base in Pakistan and indeed many other LMICs.

Remote consulting with telemonitoring of continuous positive airway pressure usage data for the routine review of people with obstructive sleep apnoea hypopnoea syndrome: A systematic review.

INTRODUCTION: Telehealth has the potential to offer more convenient care and reduce travel. We aimed to systematically review studies that assessed the effectiveness of teleconsultation plus telemonitoring in the review of people with obstructive sleep apnoea hypopnoea syndrome receiving continuous positive airway pressure therapy versus face-to-face care. METHODS: Following Cochrane methodology, we searched 10 electronic databases (November 2015), trial registries, and reference lists of included studies, for trials testing interventions that combined remote consultations with telemonitoring of usage/continuous positive airway pressure data. Outcomes measures were: proportion reviewed, continuous positive airway pressure adherence, symptom control, and satisfaction/acceptability and cost effectiveness. RESULTS: From 362 potentially relevant papers, we identified five randomised controlled trials ( n = 269 patients): four from North America and one from Spain. Risk of bias was moderate in one, and moderate/high in four trials. Two trials reported number/duration of reviews with inconsistent results. The teleconsultation/telemonitoring improved continuous positive airway pressure adherence in two trials ( n = 19; n = 75); two ( n = 114 and n = 75) reported no between-groups differences. Two studies, both at moderate/high risk of bias, showed no between-group difference in the Epworth Sleepiness Score. Satisfaction was generally reported positively in all five trials; one trial reported that the teleconsultation/telemonitoring patients were 'more likely to continue' with continuous positive airway pressure therapy treatment. One study reported teleconsultation/telemonitoring as cost effective. DISCUSSION: The evidence for teleconsultation/telemonitoring in continuous positive airway pressure users is limited; however, no safety concerns have been raised. Adequately powered, well-designed trials are needed to establish whether real-time telemonitoring and remote teleconsultation is a clinically and cost effective option for people using continuous positive airway pressure therapy.

Predicting Out-of-Office Blood Pressure in the Clinic for the Diagnosis of Hypertension in Primary Care: An Economic Evaluation.

Clinical guidelines in the United States and United Kingdom recommend that individuals with suspected hypertension should have ambulatory blood pressure (BP) monitoring to confirm the diagnosis. This approach reduces misdiagnosis because of white coat hypertension but will not identify people with masked hypertension who may benefit from treatment. The Predicting Out-of-Office Blood Pressure (PROOF-BP) algorithm predicts masked and white coat hypertension based on patient characteristics and clinic BP, improving the accuracy of diagnosis while limiting subsequent ambulatory BP monitoring. This study assessed the cost-effectiveness of using this tool in diagnosing hypertension in primary care. A Markov cost-utility cohort model was developed to compare diagnostic strategies: the PROOF-BP approach, including those with clinic BP ≥130/80 mm Hg who receive ambulatory BP monitoring as guided by the algorithm, compared with current standard diagnostic strategies including those with clinic BP ≥140/90 mm Hg combined with further monitoring (ambulatory BP monitoring as reference, clinic, and home monitoring also assessed). The model adopted a lifetime horizon with a 3-month time cycle, taking a UK Health Service/Personal Social Services perspective. The PROOF-BP algorithm was cost-effective in screening all patients with clinic BP ≥130/80 mm Hg compared with current strategies that only screen those with clinic BP ≥140/90 mm Hg, provided healthcare providers were willing to pay up to £20 000 ($26 000)/quality-adjusted life year gained. Deterministic and probabilistic sensitivity analyses supported the base-case findings. The PROOF-BP algorithm seems to be cost-effective compared with the conventional BP diagnostic options in primary care. Its use in clinical practice is likely to lead to reduced cardiovascular disease, death, and disability.

Tele-pharmacy in rural Scotland: a proof of concept study.

INTRODUCTION: Technology enables medical services to be provided to rural communities. This proof of concept study assessed the feasibility and acceptability of delivering community pharmacy services (CPS; including advice, sale of over-the-counter products and dispensing of prescriptions) by tele-technology (the Telepharmacy Robotic Supply Service (TPRSS)) to a rural population in Scotland. METHODS: Data collection included the following: postal surveys to local residents; focus groups/ interviews with pharmacists, other healthcare professionals (HCPs) and service users, at baseline and follow-up; TPRSS logs. Interviews/focus groups were audio-recorded, transcribed and thematically analysed. Descriptive statistics were reported for survey data. RESULTS: Qualitative results: Pre-installation: residents expressed satisfaction with current pharmacy access. HCPs believed the TPRSS would improve pharmacy access and reduce pressure on GPs. Concerns included costs, confidentiality, patient safety and 'fear' of technology. Post-installation: residents and pharmacy staff were positive, finding the service easy to use. Quantitative results: Pre-installation: almost half the respondents received regular prescription medicines and a third used an over-the-counter (OTC) medicine at least monthly. More than 80% (124/156) reported they would use the TPRSS. There was low awareness of the minor ailment service (MAS; 38%; 59/156). Post-installation: prescription ordering and OTC medicine purchase were used most frequently; the video link was used infrequently. Reasons for non-use were lack of need (36%; 40/112) and linkage to only one pharmacy (31%; 35/112). DISCUSSION: Community pharmacy services delivered remotely using tele-technology are feasible and acceptable. A larger study should be undertaken to confirm the potential of the TPRSS to reduce health inequalities in rural areas.

Telehealth Interventions to Support Self-Management of Long-Term Conditions: A Systematic Metareview of Diabetes, Heart Failure, Asthma, Chronic Obstructive Pulmonary Disease, and Cancer.

BACKGROUND: Self-management support is one mechanism by which telehealth interventions have been proposed to facilitate management of long-term conditions. OBJECTIVE: The objectives of this metareview were to (1) assess the impact of telehealth interventions to support self-management on disease control and health care utilization, and (2) identify components of telehealth support and their impact on disease control and the process of self-management. Our goal was to synthesise evidence for telehealth-supported self-management of diabetes (types 1 and 2), heart failure, asthma, chronic obstructive pulmonary disease (COPD) and cancer to identify components of effective self-management support. METHODS: We performed a metareview (a systematic review of systematic reviews) of randomized controlled trials (RCTs) of telehealth interventions to support self-management in 6 exemplar long-term conditions. We searched 7 databases for reviews published from January 2000 to May 2016 and screened identified studies against eligibility criteria. We weighted reviews by quality (revised A Measurement Tool to Assess Systematic Reviews), size, and relevance. We then combined our results in a narrative synthesis and using harvest plots. RESULTS: We included 53 systematic reviews, comprising 232 unique RCTs. Reviews concerned diabetes (type 1: n=6; type 2, n=11; mixed, n=19), heart failure (n=9), asthma (n=8), COPD (n=8), and cancer (n=3). Findings varied between and within disease areas. The highest-weighted reviews showed that blood glucose telemonitoring with feedback and some educational and lifestyle interventions improved glycemic control in type 2, but not type 1, diabetes, and that telemonitoring and telephone interventions reduced mortality and hospital admissions in heart failure, but these findings were not consistent in all reviews. Results for the other conditions were mixed, although no reviews showed evidence of harm. Analysis of the mediating role of self-management, and of components of successful interventions, was limited and inconclusive. More intensive and multifaceted interventions were associated with greater improvements in diabetes, heart failure, and asthma. CONCLUSIONS: While telehealth-mediated self-management was not consistently superior to usual care, none of the reviews reported any negative effects, suggesting that telehealth is a safe option for delivery of self-management support, particularly in conditions such as heart failure and type 2 diabetes, where the evidence base is more developed. Larger-scale trials of telehealth-supported self-management, based on explicit self-management theory, are needed before the extent to which telehealth technologies may be harnessed to support self-management can be established.

Cohort profile: the Scottish Research register SHARE. A register of people interested in research participation linked to NHS data sets.

PURPOSE: Recruitment to trials is often difficult. Many trials fail to meet recruitment targets resulting in underpowered studies which waste resources and the time of those who participated. While there is evidence that many people are willing to take part in research, particularly if it involves a condition from which they suffer, researchers are unable to easily contact such people often relying on busy clinicians to identify them. Many clinicians perceive themselves as too busy to take part in research activities. The Scottish Health Research Register SHARE adopts an approach which asks the public to consent to their data held in National Health Service databases to be used to determine their suitability for research projects. Additionally, participants can consent for spare blood, left after routine venepuncture to be automatically identified in the laboratory and stored for future research studies. PARTICIPANTS: Anyone over the age of 16 years in Scotland can participate. Participants are approached through a range of methods including directly at outpatient clinics and general practitioners practices, leaflets with hospital letters and personal email from employers. FINDINGS TO DATE: SHARE has recruited around 130 000 people. SHARE has demonstrated that it can quickly and efficiently recruit to studies, over 20 until now. In addition, it can be used to administer questionnaire studies by email and recruit to patient and public involvement groups. FUTURE PLANS: SHARE continues to steadily recruit with the ambition of eventually achieving 1 000 000 people in Scotland. We are steadily increasing the number of data sets we use for identifying participants. We are adding a mobile app which will facilitate dissemination about research and allow the collection of physiological and activity data if desired. We anticipate that SHARE will soon become the main source of health research recruitment in Scotland.

The acceptability to patients of video-consulting in general practice: semi-structured interviews in three diverse general practices.

BACKGROUND: To improve patient access to healthcare, the UK government has encouraged technology-based approaches including internet video-consulting. However, little is known about patient acceptance of video-consulting as a consulting method. We aimed to explore primary care patients' views video-consulting. METHOD: We used semi-structured interviews to survey 270 patients in NHS Lothian. Three diverse General Practices were chosen purposively and sequential patients attending the practice at a range of different times of day were invited to participate. Patients were asked to indicate their level of computer proficiency and provide their views on the use of video-call consulting and what specific applications it might have. We found that 135 of 270 respondents (50%, 95% CI 43.9%-56.1%) would use video-consulting. Patients under 60 years were over two times more likely to use it (OR 2.2, 95% CI 2.1-6.6, n = 248) and evidence of a positive trend between increasing computer proficiency and those who would video-consult was found, (χ2 = 43.97, p < 0.0005, n=270). Patients who had previously used video-calling services (such as Skype™)were approximately six times more likely to favour video-consulting than those who had not (OR 5.9, 95% CI 3.5-9.9, n = 270). CONCLUSIONS: This suggests strong patient interest in video-consulting in primary care, however, it is possible that in the short to medium term there may be access inequality favouring younger and more technically able people. Further studies are needed to determine the content, safety, efficacy and cost-effectiveness of employing this medium.

The epidemiology, healthcare and societal burden and costs of asthma in the UK and its member nations: analyses of standalone and linked national databases.

BACKGROUND: There are a lack of reliable data on the epidemiology and associated burden and costs of asthma. We sought to provide the first UK-wide estimates of the epidemiology, healthcare utilisation and costs of asthma. METHODS: We obtained and analysed asthma-relevant data from 27 datasets: these comprised national health surveys for 2010-11, and routine administrative, health and social care datasets for 2011-12; 2011-12 costs were estimated in pounds sterling using economic modelling. RESULTS: The prevalence of asthma depended on the definition and data source used. The UK lifetime prevalence of patient-reported symptoms suggestive of asthma was 29.5 % (95 % CI, 27.7-31.3; n = 18.5 million (m) people) and 15.6 % (14.3-16.9, n = 9.8 m) for patient-reported clinician-diagnosed asthma. The annual prevalence of patient-reported clinician-diagnosed-and-treated asthma was 9.6 % (8.9-10.3, n = 6.0 m) and of clinician-reported, diagnosed-and-treated asthma 5.7 % (5.7-5.7; n = 3.6 m). Asthma resulted in at least 6.3 m primary care consultations, 93,000 hospital in-patient episodes, 1800 intensive-care unit episodes and 36,800 disability living allowance claims. The costs of asthma were estimated at least £1.1 billion: 74 % of these costs were for provision of primary care services (60 % prescribing, 14 % consultations), 13 % for disability claims, and 12 % for hospital care. There were 1160 asthma deaths. CONCLUSIONS: Asthma is very common and is responsible for considerable morbidity, healthcare utilisation and financial costs to the UK public sector. Greater policy focus on primary care provision is needed to reduce the risk of asthma exacerbations, hospitalisations and deaths, and reduce costs.

Supporting Goal-Oriented Primary Health Care for Seniors with Complex Care Needs Using Mobile Technology: Evaluation and Implementation of the Health System Performance Research Network, Bridgepoint Electronic Patient Reported Outcome Tool.

BACKGROUND: Older adults experiencing multiple chronic illnesses are at high risk of hospitalization and health decline if they are unable to manage the significant challenges posed by their health conditions. Goal-oriented care approaches can provide better care for these complex patients, but clinicians find the process of ascertaining goals "too complex and too-time consuming," and goals are often not agreed upon between complex patients and their providers. The electronic patient reported outcomes (ePRO) mobile app and portal offers an innovative approach to creating and monitoring goal-oriented patient-care plans to improve patient self-management and shared decision-making between patients and health care providers. The ePRO tool also supports proactive patient monitoring by the patient, caregiver(s), and health care provider. It was developed with and for older adults with complex care needs as a means to improve their quality of life. OBJECTIVE: Our proposed project will evaluate the use, effectiveness, and value for money of the ePRO tool in a 12-month multicenter, randomized controlled trial in Ontario; targeting individuals 65 or over with two or more chronic conditions that require frequent health care visits to manage their health conditions. METHODS: Intervention groups using the ePRO tool will be compared with control groups on measures of quality of life, patient experience, and cost-effectiveness. We will also evaluate the implementation of the tool. RESULTS: The proposed project presented in this paper will be funded through the Canadian Institute for Health Research (CIHR) eHealth Innovation Partnerships Program (eHIPP) program (CIHR-348362). The expected completion date of the study is November, 2019. CONCLUSIONS: We anticipate our program of work will support improved quality of life and patient self-management, improved patient-centered primary care delivery, and will encourage the adoption of goal-oriented care approaches across primary health care systems. We have partnered with family health teams and quality improvement organizations in Ontario to ensure that our research is practical and that findings are shared widely. We will work with our established international network to develop an implementation framework to support continued adaptation and adoption across Canada and internationally.

Barriers and facilitators to health information exchange in low- and middle-income country settings: a systematic review.

The exchange and use of health information can help healthcare professionals and policymakers make informed decisions on ways of improving patient and population health. Many low- and middle-income countries (LMICs) have however failed to embrace the approaches and technologies to facilitate health information exchange (HIE). We sought to understand the barriers and facilitators to the implementation and adoption of HIE in LMICs. Two reviewers independently searched 11 academic databases for published and on-going qualitative, quantitative and mixed-method studies and searched for unpublished work through the Google search engine. The searches covered the period from January 1990 to July 2014 and were not restricted by language. Eligible studies were independently, critically appraised and then thematically analysed. The searches yielded 5461 citations after de-duplication of results. Of these, 56 articles, three conference abstracts and four technical reports met the inclusion criteria. The lack of importance given to data in decision making, corruption and insecurity, lack of training and poor infrastructure were considered to be major challenges to implementing HIE, but strong leadership and clear policy direction coupled with the financial support to acquire essential technology, improve the communication network, and provide training for staff all helped to promote implementation. The body of work also highlighted how implementers of HIE needed to take into account local needs to ensure that stakeholders saw HIE as relevant and advantageous. HIE interventions implemented through leapfrog technologies such as telehealth/telemedicine and mHealth in Brazil, Kenya, and South Africa, provided successful examples of exchanging health information in LMICs despite limited resources and capability. It is important that implementation of HIE is aligned with national priorities and local needs.

Using alternatives to face-to-face consultations: a survey of prevalence and attitudes in general practice.

BACKGROUND: The ubiquitous use of communication technologies has led to an expectation that a similar approach should extend to health care. Despite considerable rhetoric about the need for general practices to offer alternatives to face-to-face consultations, such as telephone, email, and internet video consultations, the extent to which such technologies are actually used at present is unclear. AIM: The aim of the survey was to identify the frequency and range of ways in which general practices are providing (or planning) alternatives to face-to-face consultations. DESIGN AND SETTING: A postal survey of practices around Bristol, Oxford, Lothian, the Highlands, and the Western Isles of Scotland. METHOD: A postal questionnaire survey was sent to each of the GPs and practice managers of 421 practices between January and May 2015. RESULTS: A response was received from 319/421 practices (76%). Although the majority of the practices reported that they were conducting telephone consultations frequently (n = 211/318, 66%), fewer were implementing email consultations (n = 18/318, 6%), and most (n = 169/318, 53%) had no plans to introduce this. None were currently using internet video, and 86% (n = 273/318) had no plans to introduce internet video consultations. These findings were repeated in the reported use of alternatives to face-to-face consultations at an individual GP level. Optional free text responses were completed by 28% of responders, and offered an explanation for the (often perceived) barriers and incentives for implementation. CONCLUSION: Despite policy pressure to introduce consultations by email and internet video, there is a general reluctance among GPs to implement alternatives to face-to-face consultations. This identifies a substantial gap between rhetoric and reality in terms of the likelihood of certain alternatives (email, video) changing practice in the near future.

Correction of: Supporting Goal-Oriented Primary Health Care for Seniors with Complex Care Needs Using Mobile Technology: Evaluation and Implementation of the Health System Performance Research Network, Bridgepoint Electronic Patient Reported Outcome Tool.

[This corrects the article DOI: 10.2196/resprot.5756.].

Telemonitoring for chronic obstructive pulmonary disease: a cost and cost-utility analysis of a randomised controlled trial.

We compared the costs and cost-effectiveness of telemonitoring vs usual care for patients with chronic obstructive pulmonary disease (COPD). A total of 256 patients were randomised to either telemonitoring or usual care. In the telemonitoring arm, the touch-screen telemonitoring equipment transmitted data to clinical teams monitoring the patients. Total healthcare costs were estimated over a 12-month period from a National Health Service perspective and quality adjusted life year (QALYs) were estimated by the EQ-5D tool. Telemonitoring was not significantly more costly than usual care (mean difference per patient £2065.90 (P < 0.18). The increased costs were predominantly due to telemonitoring service costs and non-significantly higher secondary care costs. Telemonitoring for COPD was not cost-effective at a base case of £137,277 per QALY with only 15% probability of being cost-effective at the usual threshold of £30,000 per QALY. Although there was some statistical and methodological uncertainty in the measures used, telemonitoring was not cost-effective in the sensitivity analyses performed. It seems unlikely that a telemonitoring service of the kind that was trialled would be cost-effective in providing care for people with COPD.

Estimating the incidence, prevalence and true cost of asthma in the UK: secondary analysis of national stand-alone and linked databases in England, Northern Ireland, Scotland and Wales-a study protocol.

INTRODUCTION: Asthma is now one of the most common long-term conditions in the UK. It is therefore important to develop a comprehensive appreciation of the healthcare and societal costs in order to inform decisions on care provision and planning. We plan to build on our earlier estimates of national prevalence and costs from asthma by filling the data gaps previously identified in relation to healthcare and broadening the field of enquiry to include societal costs. This work will provide the first UK-wide estimates of the costs of asthma. In the context of asthma for the UK and its member countries (ie, England, Northern Ireland, Scotland and Wales), we seek to: (1) produce a detailed overview of estimates of incidence, prevalence and healthcare utilisation; (2) estimate health and societal costs; (3) identify any remaining information gaps and explore the feasibility of filling these and (4) provide insights into future research that has the potential to inform changes in policy leading to the provision of more cost-effective care. METHODS AND ANALYSIS: Secondary analyses of data from national health surveys, primary care, prescribing, emergency care, hospital, mortality and administrative data sources will be undertaken to estimate prevalence, healthcare utilisation and outcomes from asthma. Data linkages and economic modelling will be undertaken in an attempt to populate data gaps and estimate costs. Separate prevalence and cost estimates will be calculated for each of the UK-member countries and these will then be aggregated to generate UK-wide estimates. ETHICS AND DISSEMINATION: Approvals have been obtained from the NHS Scotland Information Services Division's Privacy Advisory Committee, the Secure Anonymised Information Linkage Collaboration Review System, the NHS South-East Scotland Research Ethics Service and The University of Edinburgh's Centre for Population Health Sciences Research Ethics Committee. We will produce a report for Asthma-UK, submit papers to peer-reviewed journals and construct an interactive map.

The use of global positional satellite location in dementia: a feasibility study for a randomised controlled trial.

BACKGROUND: Getting lost outside is stressful for people with dementia and their caregivers and a leading cause of long-term institutionalisation. Although Global Positional Satellite (GPS) location has been promoted to facilitate safe walking, reduce caregivers' anxiety and enable people with dementia to remain at home, there is little high quality evidence about its acceptability, effectiveness or cost-effectiveness. This observational study explored the feasibility of recruiting and retaining participants, and the acceptability of outcome measures, to inform decisions about the feasibility of a randomised controlled trial (RCT). METHODS: People with dementia who had been provided with GPS devices by local social-care services and their caregivers were invited to participate in this study. We undertook interviews with people with dementia, caregivers and professionals to explore the perceived utility and challenges of GPS location, and assessed quality of life (QoL) and mental health. We piloted three methods of calculating resource use: caregiver diary; bi-monthly telephone questionnaires; and interrogation of health and social care records. We asked caregivers to estimate the time spent searching if participants became lost before and whilst using GPS. RESULTS: Twenty people were offered GPS locations services by social-care services during the 8-month recruitment period. Of these, 14 agreed to be referred to the research team, 12 of these participated and provided data. Eight people with dementia and 12 caregivers were interviewed. Most participants and professionals were very positive about using GPS. Only one person completed a diary. Resource use, anxiety and depression and QoL questionnaires were considered difficult and were therefore declined by some on follow-up. Social care records were time consuming to search and contained many omissions. Caregivers estimated that GPS reduced searching time although the accuracy of this was not objectively verified. CONCLUSIONS: Our data suggest that a RCT will face challenges not least that widespread enthusiasm for GPS among social-care staff may challenge recruitment and its ready availability may risk contamination of controls. Potential primary outcomes of a RCT should not rely on caregivers' recall or questionnaire completion. Time spent searching (if this could be accurately captured) and days until long-term admission are potentially suitable outcomes.

Telemonitoring for chronic heart failure: the views of patients and healthcare professionals - a qualitative study.

AIMS AND OBJECTIVES: To understand the views of patients and professionals on the acceptability and perceived usefulness of telemonitoring in the management of chronic heart failure in the context of day-to-day care provision. BACKGROUND: There is an increasing interest in the potential for telemonitoring to support the home-based management of patients with chronic heart failure. However, little is known about the views of patients and professionals on the use of telemonitoring in this context. A chronic heart failure telemonitoring service was set-up by NHS Lothian, Scotland, to evaluate the intervention. DESIGN: A qualitative design was adopted to explore the views of patients and professionals participating in the service. METHODS: Semi-structured interviews were undertaken with 18 patients (61% male, mean age 75 years) and five professionals participating at different time points in this new service. Interviews were audio recorded, coded and thematically analysed using the Framework approach. RESULTS: Five main themes were identified: 'information, support and reassurance'; 'compliance and dependence'; 'changes and challenges'; 'determining the criteria for patient applicability to telemonitoring'; and 'continuity of care'. CONCLUSION: Patients and professionals considered telemonitoring useful in the management of chronic heart failure, although with some caveats. Telemonitoring was popular with patients because they felt reassurance arising from what was perceived as continuous practitioner surveillance. Professionals expressed concern regarding perceived patient dependence on practitioner support. Increased workload was also a concern. Both groups acknowledged the need for improved technology and changes to service provision in order to better meet the intended objectives of the service. RELEVANCE TO CLINICAL PRACTICE: Although popular with patients, professionals emphasised the importance of case selection and adequate training and support, both for patients and themselves, in order to maximise the expected benefits of the service, particularly with regard to enabling self-management.

The impact of supported telemetric monitoring in people with type 2 diabetes: study protocol for a randomised controlled trial.

BACKGROUND: Diabetes prevalence is increasing and current methods of management are unsustainable. Effective approaches to supporting self-management are required. The aim of this randomized controlled trial is to establish whether supported telemetric monitoring of glycemic control and blood pressure results in reductions in glycosylated hemoglobin (HbA1c; the primary outcome of a measure of long-term glycemic control) and secondary outcomes of blood pressure and weight among people with poorly controlled diabetes compared to a control group receiving usual care. METHODS/DESIGN: Design: multi-center, randomized controlled trial with embedded qualitative study. Setting: primary care in Lothian, Kent, Glasgow and Borders regions in the UK. Participants: people with type 2 diabetes and confirmed HbA1c>7.5% (58 mmol/mol). Intervention/comparison: randomization to intervention or control groups will be performed by the Edinburgh Clinical Trials Unit. Participants in the intervention group will be shown how to use blood glucose and blood pressure monitors and weighing scales which use Bluetooth wireless technology to transmit readings via modem to a remote server. These participants will be asked to provide at least twice weekly measurements of morning and evening blood glucose and weekly measurements of weight and blood pressure. Measurements will be checked at least weekly by practice nurses who will contact the patients to adjust therapy according to guidelines and reinforce lifestyle advice. Participants in the control group will receive usual care. All participants will receive an individual education session. Follow-up: measurements will be performed at practices 9 months after randomization by research nurses blinded to allocation. The primary outcome measure is HbA1c and secondary outcomes measure are daytime systolic and diastolic blood pressure, weight and cost per quality-adjusted life year. Analysis: intention-to-treat analyses will be performed. The sample size of 320 participants allows for 20% drop-out and has 80% power at 5% significance to detect a 0.5% absolute (6 mmol/mol) fall in HbA1c in the intervention group. The qualitative study will explore the experiences of patients and professionals using the intervention. TRIAL REGISTRATION: Trial registration number ISRCTN71674628.

Telemonitoring-based service redesign for the management of uncontrolled hypertension (HITS): cost and cost-effectiveness analysis of a randomised controlled trial.

OBJECTIVES: To compare the costs and cost-effectiveness of managing patients with uncontrolled blood pressure (BP) using telemonitoring versus usual care from the perspective of the National Health Service (NHS). DESIGN: Within trial post hoc economic evaluation of data from a pragmatic randomised controlled trial using an intention-to-treat approach. SETTING: 20 socioeconomically diverse general practices in Lothian, Scotland. PARTICIPANTS: 401 primary care patients aged 29-95 with uncontrolled daytime ambulatory blood pressure (ABP) (≥135/85, but <210/135 mm Hg). INTERVENTION: Participants were centrally randomised to 6 months of a telemonitoring service comprising of self-monitoring of BP transmitted to a secure website for review by the attending nurse/doctor and patient, with optional automated patient decision-support by text/email (n=200) or usual care (n-201). Randomisation was undertaken with minimisation for age, sex, family practice, use of three or more hypertension drugs and self-monitoring history. MAIN OUTCOME MEASURES: Mean difference in total NHS costs between trial arms and blinded assessment of mean cost per 1 mm Hg systolic BP point reduced. RESULTS: Home telemonitoring of BP costs significantly more than usual care (mean difference per patient £115.32 (95% CI £83.49 to £146.63; p<0.001)). Increased costs were due to telemonitoring service costs, patient training and additional general practitioner and nurse consultations. The mean cost of systolic BP reduction was £25.56/mm Hg (95% CI £16.06 to £46.89) per patient. CONCLUSIONS: Over the 6-month trial period, supported telemonitoring was more effective at reducing BP than usual care but also more expensive. If clinical gains are maintained, these additional costs would be very likely to be compensated for by reductions in the cost of future cardiovascular events. Longer-term modelling of costs and outcomes is required to fully examine the cost-effectiveness implications. TRIAL REGISTRATION: International Standard Randomised Controlled Trials, number ISRCTN72614272.