MyAirCoach: The use of home-monitoring and mHealth systems to predict deterioration in asthma control and the occurrence of asthma exacerbations; Study protocol of an observational study

© Published by the BMJ Publishing Group Limited. Introduction Asthma is a variable lung condition whereby patients experience periods of controlled and uncontrolled asthma symptoms. Patients who experience prolonged periods of uncontrolled asthma have a higher incidence of exacerbations and increased morbidity and mortality rates. The ability to determine and to predict levels of asthma control and the occurrence of exacerbations is crucial in asthma management. Therefore, we aimed to determine to what extent physiological, behavioural and environmental data, obtained by mobile healthcare (mHealth) and home-monitoring sensors, as well as patient characteristics, can be used to predict episodes of uncontrolled asthma and the onset of asthma exacerbations. Methods and analysis In an 1-year observational study, patients will be provided with mHealth and home-monitoring systems to record daily measurements for the first-month (phase I) and weekly measurements during a follow-up period of 11 months (phase II). Our study population consists of 150 patients, aged ≥18 years, with a clinician's diagnosis of asthma, currently on controller medication, with uncontrolled asthma and/or minimally one exacerbation in the past 12 months. They will be enrolled over three participating centres, including Leiden, London and Manchester. Our main outcomes are the association between physiological, behavioural and environmental data and (1) the loss of asthma control and (2) the occurrence of asthma exacerbations. Ethics This study was approved by the Medical Ethics Committee of the Leiden University Medical Center in the Netherlands and by the NHS ethics service in the UK. Trial registration number NCT02774772

MyAirCoach: the use of home-monitoring and mHealth systems to predict deterioration in asthma control and the occurrence of asthma exacerbations; study protocol of an observational study.

INTRODUCTION: Asthma is a variable lung condition whereby patients experience periods of controlled and uncontrolled asthma symptoms. Patients who experience prolonged periods of uncontrolled asthma have a higher incidence of exacerbations and increased morbidity and mortality rates. The ability to determine and to predict levels of asthma control and the occurrence of exacerbations is crucial in asthma management. Therefore, we aimed to determine to what extent physiological, behavioural and environmental data, obtained by mobile healthcare (mHealth) and home-monitoring sensors, as well as patient characteristics, can be used to predict episodes of uncontrolled asthma and the onset of asthma exacerbations. METHODS AND ANALYSIS: In an 1-year observational study, patients will be provided with mHealth and home-monitoring systems to record daily measurements for the first-month (phase I) and weekly measurements during a follow-up period of 11 months (phase II). Our study population consists of 150 patients, aged ≥18 years, with a clinician's diagnosis of asthma, currently on controller medication, with uncontrolled asthma and/or minimally one exacerbation in the past 12 months. They will be enrolled over three participating centres, including Leiden, London and Manchester. Our main outcomes are the association between physiological, behavioural and environmental data and (1) the loss of asthma control and (2) the occurrence of asthma exacerbations. ETHICS: This study was approved by the Medical Ethics Committee of the Leiden University Medical Center in the Netherlands and by the NHS ethics service in the UK. TRIAL REGISTRATION NUMBER: NCT02774772

People in Public Health – A Study of Approaches to Develop and Support People in Public Health Roles

‘People in Public Health’ is a study about approaches to develop and support lay people in public health roles. The use of participatory approaches in public health programmes, both in national and international contexts, is well established and seen as necessary to deliver sustainable improvements in public health (Bracht and Tsouros, 1990; Rifkin et al., 2000; World Health Organization, 2002). Indeed a central argument in the Wanless reviews was that a ‘fully engaged scenario’ with high levels of public engagement in health would result in lower levels of public expenditure and better health outcomes (Wanless, 2002; Wanless, 2004). Government policy supports greater community engagement in health as a means of addressing public health priorities and tackling health inequalities (Department of Health, 2003). The health agenda on community involvement resonates with arguments for citizen empowerment and greater democratisation of services, not only in the NHS but across the public sector, in national agencies and local authorities (Campbell et al., 2008). Recent national guidance on community engagement noted the wide variety of approaches, indicating that those approaches based on higher levels of participation and greater community control were more likely to lead to increased health and social outcomes1 (National Institute for Health and Clinical Effectiveness, 2008). There was a recommendation to recruit what were termed ‘agents of change’ in communities who become involved ‘to plan, design and deliver health promotion activities and to help address the wider social determinants of health’ by taking on roles such as peer educators, health champions or neighbourhood wardens (National Institute for Health and Clinical Effectiveness, 2008:28). The concept of empowerment, the process of individuals and communities being enabled to undertake local action to effect change, is seen as core to health promotion (Tones and Tilford, 2001; World Health Organization, 1986; Wallerstein, 2006). Government policy on community empowerment advocates increased citizen involvement in planning and running services (Secretary of State for Communities and Local Government, 2008) and this agenda is linked to the personalisation of health and social services and patient and public involvement (Department of Health, 2005b; Department of Health, 2006; Secretary of State for Health, 2006). More evidence is required, however, about effective mechanisms for lay engagement and how public services can best enhance, support and sustain community involvement

The SESAMI evaluation of employment support in the UK: background and baseline data

Aims: This study evaluates real world employment support for people with severe mental health problems in the UK. Given a policy context which promotes social inclusion and welfare to work, we wanted to find out about typical employment services and their effects on people with mental health problems. Method: A case study design was adopted, incorporating qualitative and quantitative interviews with staff and users of each service. After screening for severity, 182 individuals met our inclusion criteria for current use of the services. They were interviewed about their current engagement with support services, their employment and job satisfaction if employed. Measures of self esteem, hope/optimism and job satisfaction were taken as outcomes. Results: We report here associations between the outcome measures and: current working status; support from the agency; and demographic features at baseline. People who were working had higher outcome scores than those who were in work preparation or training. People working with support had higher job satisfaction. Conclusions: The study highlights the methodological issues raised by doing real world research. These findings were generated by heterogeneous interventions in non-experimental settings. Despite this, they tend to support previous evidence in favour of early placement and ongoing support in work

Effectiveness of myAirCoach: A mHealth Self-Management System in Asthma

Background: Self-management programs have beneficial effects on asthma control, but their implementation in clinical practice is poor. Mobile health (mHealth) could play an important role in enhancing self-management. Objective: To assess the clinical effectiveness and technology acceptance of myAirCoach-supported self-management on top of usual care in patients with asthma using inhalation medication. Methods: Patients were recruited in 2 separate studies. The myAirCoach system consisted of an inhaler adapter, an indoor air-quality monitor, a physical activity tracker, a portable spirometer, a fraction exhaled nitric oxide device, and an app. The primary outcome was asthma control; secondary outcomes were exacerbations, quality of life, and technology acceptance. In study 1, 30 participants were randomized to either usual care or myAirCoach support for 3 to 6 months; in study 2, 12 participants were provided with the myAirCoach system in a 3-month before-after study. Results: In study 1, asthma control improved in the intervention group compared with controls (Asthma Control Questionnaire difference, 0.70; P = .006). A total of 6 exacerbations occurred in the intervention group compared with 12 in the control group (hazard ratio, 0.31; P = .06). Asthma-related quality of life improved (mini Asthma-related Quality of Life Questionnaire difference, 0.53; P = .04), but forced expiratory volume in 1 second was unchanged. In study 2, asthma control improved by 0.86 compared with baseline (P = .007) and quality of life by 0.16 (P = .64). Participants reported positive attitudes toward the system. Discussion: Using the myAirCoach support system improves asthma control and quality of life, with a reduction in severe asthma exacerbations. Well-validated mHealth technologies should therefore be further studied

A thematic analysis of factors influencing recruitment to maternal and perinatal trials

Background: Recruitment of eligible participants remains one of the biggest challenges to successful completion of randomised controlled trials (RCTs). Only one third of trials recruit on time, often requiring a lengthy extension to the recruitment period. We identified factors influencing recruitment success and potentially effective recruitment strategies. Methods: We searched MEDLINE and EMBASE from 1966 to December Week 2, 2006, the Cochrane Library Methodology Register in December 2006, and hand searched reference lists for studies of any design which focused on recruitment to maternal/perinatal trials, or if no studies of maternal or perinatal research could be identified, other areas of healthcare. Studies of nurses' and midwives' attitudes to research were included as none specifically about trials were located. We synthesised the data narratively, using a basic thematic analysis, with themes derived from the literature and after discussion between the authors. Results: Around half of the included papers (29/53) were specific to maternal and perinatal healthcare. Only one study was identified which focused on factors for maternal and perinatal clinicians and only seven studies considered recruitment strategies specific to perinatal research. Themes included: participant assessment of risk; recruitment process; participant understanding of research; patient characteristics; clinician attitudes to research and trials; protocol issues; and institutional or organisational issues. While no reliable evidence base for strategies to enhance recruitment was identified in any of the review studies, four maternal/perinatal primary studies suggest that specialised recruitment staff, mass mailings, physician referrals and strategies targeting minority women may increase recruitment. However these findings may only be applicable to the particular trials and settings studied. Conclusion: Although factors reported by both participants and clinicians which influence recruitment were quite consistent across the included studies, studies comparing different recruitment strategies were largely missing. Trials of different recruitment strategies could be embedded in large multicentre RCTs, with strategies tailored to the factors specific to the trial and institution.Rebecca L Tooher, Philippa F Middleton and Caroline A Crowthe

Examining the stability of membrane proteins within SMALPs

Amphipathic co-polymers such as styrene-maleic acid (SMA) have gained popularity over the last few years due to their ability and ease of use in solubilising and purifying membrane proteins in comparison to conventional methods of extraction such as detergents. SMA2000 is widely used for membrane protein studies and is considered as the optimal polymer for this technique. In this study a side-by-side comparison of SMA2000 with the polymer SZ30010 was carried out as both these polymers have similar styrene:maleic acid ratios and average molecular weights. Ability to solubilise, purify and stabilise membrane proteins was tested using three structurally different membrane proteins. Our results show that both polymers can be used to extract membrane proteins at a comparable efficiency to conventional detergent dodecylmaltoside (DDM). SZ30010 was found to give a similar protein yield and, SMALP disc size as SMA2000, and both polymers offered an increased purity and increased thermostability compared to DDM. Further investigation was conducted to investigate SMALP sensitivity to divalent cations. It was found that the sensitivity is polymer specific and not dependent on the protein encapsulated. Neither is it affected by the concentration of SMALPs. Larger divalent cations such as Co2+ and Zn2+ resulted in an increased sensitivity