Andrew Stoddart

Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial

Objective To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. Design Researcher blind, multicentre, randomised controlled trial. Setting UK primary care (Lothian, Scotland). Participants Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unable to provide informed consent or complete the study, or who had other significant social or clinical problems. Interventions Participants were recruited between 21 May 2009 and 28 March 2011, and centrally randomised to receive telemonitoring or conventional self monitoring. Using a touch screen, telemonitoring participants recorded a daily questionnaire about symptoms and treatment use, and monitored oxygen saturation using linked instruments. Algorithms, based on the symptom score, generated alerts if readings were omitted or breached thresholds. Both groups received similar care from existing clinical services. Main outcome measures The primary outcome was time to hospital admission due to COPD exacerbation up to one year after randomisation. Other outcomes included number and duration of admissions, and validated questionnaire assessments of health related quality of life (using St George’s respiratory questionnaire (SGRQ)), anxiety or depression (or both), self efficacy, knowledge, and adherence to treatment. Analysis was intention to treat. Results Of 256 patients completing the study, 128 patients were randomised to telemonitoring and 128 to usual care; baseline characteristics of each group were similar. The number of days to admission did not differ significantly between groups (adjusted hazard ratio 0.98, 95% confidence interval 0.66 to 1.44). Over one year, the mean number of COPD admissions was similar in both groups (telemonitoring 1.2 admissions per person (standard deviation 1.9) v control 1.1 (1.6); P=0.59). Mean duration of COPD admissions over one year was also similar between groups (9.5 days per person (standard deviation 19.1) v 8.8 days (15.9); P=0.88). The intervention had no significant effect on SGRQ scores between groups (68.2 (standard deviation 16.3) v 67.3 (17.3); adjusted mean difference 1.39 (95% confidence interval −1.57 to 4.35)), or on other questionnaire outcomes. Conclusions In participants with a history of admission for exacerbations of COPD, telemonitoring was not effective in postponing admissions and did not improve quality of life. The positive effect of telemonitoring seen in previous trials could be due to enhancement of the underpinning clinical service rather than the telemonitoring communication. Trial registration ISRCTN96634935. Funding: The trial was funded by an NHS applied research programme grant from the Chief Scientist Office of the Scottish government (ARPG/07/03). The funder had no role in study design and the collection, analysis, and interpretation of data and the writing of the article and the decision to submit it for publication. NHS Lothian supported the telemonitoring service and the clinical services.

Telemonitoring based service redesign for the management of uncontrolled hypertension: multicentre randomised controlled trial.

Objective To determine if an intervention consisting of telemonitoring and supervision by usual primary care clinicians of home self measured blood pressure and optional patient decision support leads to clinically important reductions in daytime systolic and diastolic ambulatory blood pressure in patients with uncontrolled blood pressure. Design Multicentre randomised controlled trial. Setting 20 primary care practices in south east Scotland. Participants 401 people aged 29-95 years with uncontrolled blood pressure (mean daytime ambulatory measurement ≥135/85 mm Hg but ≤210/135 mm Hg). Intervention Self measurement and transmission of blood pressure readings to a secure website for review by the attending nurse or doctor and participant, with optional automated patient decision support by text or email for six months. Main outcome measures Blinded assessment of mean daytime systolic ambulatory blood pressure six months after randomisation. Results 200 participants were randomised to the intervention and 201 to usual care; primary outcome data were available for 90% of participants (182 and 177, respectively). The mean difference in daytime systolic ambulatory blood pressure adjusted for baseline and minimisation factors between intervention and usual care was 4.3 mm Hg (95% confidence interval 2.0 to 6.5; P=0.0002) and for daytime diastolic ambulatory blood pressure was 2.3 mm Hg (0.9 to 3.6; P=0.001), with higher values in the usual care group. The intervention was associated with a mean increase of one general practitioner (95% confidence interval 0.5 to 1.6; P=0.0002) and 0.6 (0.1 to 1.0; P=0.01) practice nurse consultations during the course of the study. Conclusions Supported self monitoring by telemonitoring is an effective method for achieving clinically important reductions in blood pressure in patients with uncontrolled hypertension in primary care settings. However, it was associated with increase in use of National Health Service resources. Further research is required to determine if the reduction in blood pressure is maintained in the longer term and if the intervention is cost effective. Trial registration Current Controlled Trials ISRCTN72614272.

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.

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.

Investigating the effectiveness of the Mediterranean diet in pregnant women for the primary prevention of asthma and allergy in high-risk infants: protocol for a pilot randomised controlled trial

BackgroundOver recent decades there has been a substantial increase in asthma and allergic disease especially in children. Given the high prevalence, and the associated high disease burden and costs, there is a need to identify effective strategies for the primary prevention of asthma and allergy. A recent systematic review of the literature found strong supportive epidemiological evidence for a protective role of the Mediterranean diet, which now needs to be confirmed through formal experimental studies. This pilot trial in pregnant women aims to establish recruitment, retention and acceptability of a dietary intervention, and to assess the likely impact of the intervention on adherence to a Mediterranean diet during pregnancy.Methods/DesignThis study was a pilot, two-arm, randomised controlled trial in a sample population of pregnant women at high risk of having a child who will develop asthma or allergic disease.DiscussionThe work ultimately aims to contribute to improving health outcomes through seeking to reduce the incidence of asthma and allergic problems. This pilot trial will prove invaluable in informing the subsequent planned large-scale, parallel group, randomised controlled trial.Trial registrationClinicalTrials.gov: NCT01634516

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 Divisions Privacy Advisory Committee, the Secure Anonymised Information Linkage Collaboration Review System, the NHS South-East Scotland Research Ethics Service and The University of Edinburghs 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.

Challenges of harmonising data from UK national health surveys: a case study of attempts to estimate the UK prevalence of asthma.

Bright I Nwaru, Mome Mukherjee, Ramyani P Gupta, Angela Farr, Martin Heaven, Andrew Stoddart, Amrita Bandyopadhyay, Deborah Fitzsimmons, Michael Shields, Ceri Phillips, George Chamberlain, Colin Fischbacher, Christopher Dibben, Chantelle Aftab, Colin R Simpson, Ronan Lyons, David Strachan, Gwyneth A Davies, Brian McKinstry and Aziz Sheikh Asthma UK Centre for Applied Research, Centre for Medical Informatics, Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, EH8 9AG, UK Edinburgh Health Services Research Unit, Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, UK Population Health Research Institute, St George’s, University of London, UK Swansea Centre for Health Economics (SCHE), College of Human and Health Science, Swansea University, UK CIPHER – Centre for the Improvement of Population Health through e-Records Research, Centre for Health Information, Research and Evaluation (CHIRAL), College of Medicine, Institute of Life Science 2 (ILS2), Swansea University, UK Centre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, Health Sciences Building, Queen’s University Belfast, UK Information Services Division (ISD), NHS National Services Scotland, Edinburgh, UK School of Geography & Geosciences, Department of Geography & Sustainable Development, The University of Edinburgh, UK Asthma & Allergy Group, Institute of Life Science, College of Medicine, Swansea University, UK Corresponding author: Aziz Sheikh. Email: aziz.sheikh@ed.ac.uk

Diagnostic accuracy, risk assessment, and cost-effectiveness of component-resolved diagnostics for food allergy: A systematic review

Component‐resolved diagnostics (CRD) are promising tools for diagnosing food allergy, offering the potential to determine specific phenotypes and to develop patient‐tailored risk profiles. Nevertheless, the diagnostic accuracy of these tests varies across studies; thus, their clinical utility remains unclear. Therefore, we synthesized the evidence from studies investigating the diagnostic accuracy, risk assessment ability, and cost‐effectiveness of CRD for food allergy.

Investigating the accuracy, risk impact, and cost-effectiveness of component-resolved diagnostic test for food allergy: a systematic review protocol

BACKGROUND Food allergy—particularly immunoglobulin E (IgE)-mediated food allergy—is now a global public health problem. It results in considerable morbidity, healthcare utilisation, and impairment in quality of life. Food allergy reactions range in severity from relatively mild features to life-threatening anaphylaxis. 3 Estimates of the prevalence of food allergy vary, but overall lifetime prevalence has been estimated as affecting up to 7% of children and 6% of adults. 5 Careful avoidance of offending foods is the mainstay preventive strategy for food allergy. 3 Accurate diagnosis is essential in order to provide appropriate, potentially life-saving advice on how to prevent and manage reactions. This will also help to prevent unwarranted dietary restrictions. 3 The diagnosis of food allergy is typically based on a combination of clinical history and an objective marker of allergic sensitisation, namely, skin prick tests (SPT) and/or immunoassays of serum-specific IgE levels. While these approaches have reasonable sensitivity, they have suboptimal specificity and are in general poorly predictive of the severity of reactions. Further diagnostic confirmation with a double-blinded placebo-controlled food challenge (DBPCFC)—the gold standard diagnostic test—is therefore often required. 3, 7 DBPCFC is however costly, technically challenging, time-consuming, labour-intensive, and associated with important safety risks as the procedure can trigger anaphylaxis. 3, 8 Nevertheless, although risky, DBPCFCs offer a reliable diagnosis, which in turn increases patients’ quality of life. The limitations of conventional methods for diagnosing food allergy have stimulated promising developments in molecularbased diagnostic techniques, collectively referred to as component-resolved diagnosis (CRD). 8, 10 Molecular diagnosis of food allergy involves examining the specific proteins in foods, primarily at the molecular level. In this case, rather than providing a summary of all the allergen proteins in a particular food (e.g., peanuts), molecular-based methods quantify the individual proteins within a food that may be responsible for allergic reactions. In CRD, specific IgE responses are evaluated against individual allergenic molecules or the epitopes of those allergens. Therefore, CRD techniques have the potential to enhance the specificity and sensitivity of serum-specific IgE responses to foods. They may also: facilitate our ability to determine specific food allergy phenotypes; help improve compilation of a patient-tailored risk profile to specific food allergens, given that IgE antibodies to food molecules vary from patient to patient and also geographically; and boost the ability to distinguish between primary and secondary sensitisers. 8, 10 Importantly, in CRD approaches, diagnosis can be undertaken either in single test formats or in a microarray by simultaneously evaluating a range of allergens. 8, 10 There is now a substantial body of evidence on using CRD to diagnose food allergy, which needs to be synthesised in order to generate robust estimates of diagnostic accuracy and assess costeffectiveness in comparison with conventional approaches. Furthermore, a synthesis of the underlying evidence will help to inform deliberations on whether and how CRD should be deployed for (i) diagnosing food allergy, and (ii) assessing patient risk through the prediction of food allergy severity (i.e., the likelihood of life-threatening anaphylaxis as opposed to relatively mild features) across differing healthcare service contexts.

P218 The epidemiological, healthcare and societal burden and costs of asthma in the UK and member nations: analyses of national databases

Background Developing a comprehensive picture of the burden of asthma in the UK will enable informed national decisions about care provision and planning. We sought to provide the first UK-wide estimates of the epidemiology, healthcare utilisation and costs of asthma. Methods We undertook analyses of national health surveys, routine healthcare and administrative datasets over the period 2010–12. Economic modelling was carried out to estimate costs. Estimates were calculated for each nation and the UK as a whole. Results The UK lifetime prevalence of patient-reported symptoms suggestive of asthma in 2010–11 was 30.7% (95% Confidence Intervals [CI] 29.2–32.2; equivalent to [~] 18,949,516 people), lifetime prevalence of patient-reported physician-diagnosed asthma was 15.9% (95% CI 14.7–17.1; ~10,841,030 people), annual prevalence of patient-reported physician-diagnosed-and-treated asthma was 9.1% (95% CI 8.0–10.2; ~5,765,237 people), annual prevalence of GP reported-and-diagnosed asthma was 8.2% (95% CI 8.2–8.2; ~5,215,607 people) and annual prevalence of GP reported-and-diagnosed-and-treated asthma was 6.0% (95% CI 6.0–6.0; ~3,946,796 people). In 2011–12, asthma resulted in an estimated: 6,392,670 primary-care consultations; 93,916 inpatient-care episodes; 1,864 (317 paediatric and 1,547 adult) intensive-care unit episodes; 36,800 disability living allowance (DLA) claims; and 1,160 deaths. The estimated cost of asthma in the UK was at least £1.1billion in 2011–12: 75% of this was for primary-care (60% prescribing and 15% consultations), 13% for DLA claims, and 10% for hospital care. Conclusions We found that asthma is very common, affecting at least 3.95 million people, and that it is responsible for substantial morbidity, healthcare and societal costs in the UK. Setting ambitious targets for improving asthma outcomes is paramount and resources should be targeted to improving community-based prescribing decisions and reducing the risk of asthma exacerbations and associated hospitalisations and deaths. Funding Asthma UK, with additional support from the Edinburgh Health Services Research Unit and Farr Institute, UK.