Recommendations following a modified UK-Delphi consensus study on best practice for referral and management of severe asthma.

INTRODUCTION: Severe asthma affects an estimated 3%-5% of people with asthma and is associated with frequent exacerbations, poor symptom control and significant morbidity from the disease itself, as well as high dose of inhaled and systemic steroids used to treat it. The introduction of specialist asthma services across the UK has attempted to improve quality of care and ensure that patients undergo a full systematic assessment prior to initiation of advanced biological therapies. However, improvements are required in the patient pathway to minimise avoidable harm. OBJECTIVES: To define standards of care in areas where the evidence base is lacking through patient and healthcare professional (HCP) consensus. METHODS: The precision UK National Working Group of asthma experts identified 42 statements formed from 7 key themes. An online four-point Likert scale questionnaire was sent to HCPs working in asthma throughout the UK to assess agreement (consensus) with these statements; a subset of the statements formed a patient questionnaire. Consensus was defined as high if ≥75% and very high if ≥90% of respondents agreed with a statement. RESULTS: A total of 117/197 responses (59.3% response rate) were received from severe asthma patients (n=15) and HCPs (n=102) including respiratory physicians, respiratory nurse specialists, respiratory pharmacists, specialist physiotherapists and general practitioners. Consensus was very high in 25 (60%) statements, high in 12 (29%) statements and was not achieved in 5 (12%) statements. Based on the consensus scores, the precision UK National Working Group derived 10 key recommendations. These focus on referrals from primary and secondary care, accessing specialist asthma services, homecare provision for severe asthma patients and outcome measures. CONCLUSIONS: Implementation of these 10 recommendations across the severe asthma pathway in the UK has the potential to improve outcomes for patients by reducing delays to assessment and initiation of advanced phenotype-specific therapies.

What factors affect patients' ability to access healthcare? An overview of systematic reviews.

OBJECTIVES: This overview aims to synthesise global evidence on factors affecting healthcare access, and variations across low- and middle-income countries (LMICs) vs. high-income countries (HICs); to develop understanding of where barriers to healthcare access lie, and in what context, to inform tailored policies aimed at improving access to healthcare for all who need it. METHODS: An overview of systematic reviews guided by a published protocol was conducted. Medline, Embase, Global Health and Cochrane Systematic Reviews databases were searched for published articles. Additional searches were conducted on the Gates Foundation, WHO and World Bank websites. Study characteristics and findings (barriers and facilitators to healthcare access) were documented and summarised. The methodological quality of included studies was assessed using an adapted version of the AMSTAR 2 tool. RESULTS: Fifty-eight articles were included, 23 presenting findings from LMICs and 35 presenting findings from HICs. While many barriers to healthcare access occur in HICs as well as LMICs, the way they are experienced is quite different. In HICs, there is a much greater emphasis on patient experience; as compared to the physical absence of care in LMICs. CONCLUSIONS: As countries move towards universal healthcare access, evaluation methods that account for health system and wider cultural factors that impact capacity to provide care, healthcare finance systems and the socio-cultural environment of the setting are required. Consequently, methods employed in HICs may not be appropriate in LMICs due to the stark differences in these areas.

What factors affect patients' access to healthcare? Protocol for an overview of systematic reviews.

BACKGROUND: The importance of access to healthcare for all is internationally recognised as a global goal, high on the global agenda. Yet inequalities in health exist within and between countries which are exacerbated by inequalities in access to healthcare. In order to address these inequalities, we need to better understand what drives them. While there exists a wealth of research on access to healthcare in different countries and contexts, and for different patient groups, to date no attempt has been made to bring this evidence together through a global lens. This study aims to address that gap by bringing together evidence of what factors affect patients' access to healthcare and exploring how those factors vary in different countries and contexts around the world. METHODS: An overview of reviews will be conducted using a comprehensive search strategy to search four databases: Medline, Embase, Global Health and Cochrane Systematic Reviews. Additional searches will be conducted on the Gates Foundation, the World Health Organisation (WHO) and World Bank websites. Titles and abstracts will be screened against the eligibility criteria and full-text articles will be obtained for all records that meet the inclusion criteria or where there is uncertainty around eligibility. A data extraction table will be developed during the review process and will be piloted and refined before full data extraction commences. Methodological quality/risk of bias will be assessed for each included study using the AMSTAR 2 tool. The quality assessment will be used to inform the narrative synthesis, but a low-quality score will not necessarily lead to study exclusion. DISCUSSION: Factors affecting patients' ability to access healthcare will be identified and analysed according to different country and context characteristics to shed light on the importance of different factors in different settings. Results will be interpreted accounting for the usual challenges associated with conducting such reviews. The results may guide future research in this area and contribute to priority setting for development initiatives aimed at ensuring equitable access to healthcare for all. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019144775.

Temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations: FAST.

BACKGROUND: Asthma exacerbations affect the quality of life of patients with asthma and have a major effect on the overall costs of asthma care. An asthma self-management plan that advises the temporary quadrupling of inhaled corticosteroid dose may prevent asthma exacerbations, but this needs to be confirmed before being adopted widely. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of an asthma self-management plan that advises patients to temporarily quadruple the dose of inhaled corticosteroid when asthma control starts to deteriorate with a standard self-management plan. DESIGN: A multicentre, parallel-group, pragmatic randomised trial, with follow-up for 12 months. SETTING: Primary and secondary care across 207 sites in the UK. PARTICIPANTS: Asthma patients aged ≥ 16 years treated with an inhaled corticosteroid who had experienced at least one exacerbation in the previous 12 months. INTERVENTIONS: Participants were randomised (1 : 1) to a usual-care self-management plan or to a modified self-management plan that advised a temporary quadrupling of the inhaled corticosteroid at the point of asthma deterioration, both of which were actively implemented and supported by local research staff. PRIMARY OUTCOME: The primary outcome of 'time to first asthma exacerbation' was defined as the need for systemic corticosteroids (for at least 3 consecutive days) and/or unscheduled health-care consultations for asthma (i.e. reaching zone 3 or 4 of the Asthma UK self-management plan). RESULTS: A total of 1922 participants were randomised: the primary analysis included 938 participants (97%) in the usual-care group and 933 participants (97%) in the modified self-management group. The number of participants having at least one exacerbation of asthma in the year after randomisation was 484 (51.6%) in the usual-care group and 420 (45.0%) in the modified self-management group [adjusted hazard ratio 0.81, 95% confidence interval (CI) 0.71 to 0.92; p = 0.002]. There were fewer serious adverse events reported in the modified self-management group than in the usual-care group (11 vs. 32, respectively). Eight and six events of pneumonia, lower respiratory tract infections or influenza were reported in the usual-care group and the modified self-management group, respectively. Health-care-related costs were lower in the modified self-management group. The modified self-management group was £24 (bootstrapped 95% CI -£122 to £71) less costly than usual care, with a greater quality-adjusted life-year gain of 0.02 (bootstrapped 95% CI -0.005 to 0.04). Therefore, the modified self-management group was 'dominant', with a 94-95% probability of being cost-effective at the £20,000-30,000 threshold. LIMITATIONS: As the Fourfold Asthma STudy (FAST) was an open-label pragmatic trial, the possibility of treatment bias that may have affected the participants in the modified self-management group cannot be ruled out. Poorer than expected completion of participant diary cards, particularly within the usual-care self-management group, could have led to a null bias, underestimating the true effect of the intervention. CONCLUSIONS: An asthma self-management plan that advises patients to temporarily quadruple their dose of inhaled corticosteroid at the point of asthma symptoms worsening does reduce clinically important asthma exacerbations. In addition, the plan is cost-effective compared with the usual-care self-management plan. FUTURE WORK: To effectively implement asthma self-management plans that advise a temporary quadrupling of inhaled steroid at asthma deterioration into routine practice. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15441965. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 70. See the NIHR Journals Library website for further project information.

Cost-effectiveness of a complex intervention to reduce children's exposure to second-hand smoke in the home.

BACKGROUND: Second-hand smoke (SHS) causes numerous health problems in children such as asthma, respiratory tract infections and sudden infant death syndrome. The home is the main source of exposure to SHS for children, particularly for young children. We estimated the cost-effectiveness of a complex intervention designed to reduce SHS exposure of children whose primary caregiver feels unable or unwilling to quit smoking. METHODS: A cost-effectiveness analysis was carried out alongside an open-label, parallel, randomised controlled trial in deprived communities in Nottingham, England. A complex intervention combining behavioural support, nicotine replacement therapy and personalised feedback on home air quality was compared with usual care. A total number of 205 households were recruited, where the main caregivers were aged 18 and over, with a child aged under five years living in their household reporting smoking inside their home. Analyses for this study were undertaken from the National Health Service/Personal Social Services perspective. All costs were estimated in UK pounds (£) at 2013/14 prices. The primary outcome was the incremental cost-effectiveness of change in air quality in the home, measured as average 16-24 h levels of particulate matter of < 2.5 µm diameter (PM2.5), between baseline and 12 weeks. Secondary outcomes included incremental cost per quitter, quit attempts and cigarette consumption in the home. A non-parametric bootstrap re-sampling technique was employed to explore uncertainty around the calculated incremental cost-effectiveness ratios. RESULTS: The complex intervention achieved reduced PM2.5 by 21.6 µg/m3 (95% CI: 5.4 to 37.9), with an incremental cost of £283 (95% CI: £254-£313), relative to usual care. The incremental cost-effectiveness ratio was £131 (bootstrapped 95% CI: £72-£467) per additional 10µg/m3 reduction in PM2.5, or £71 (bootstrapped 95% CI: -£57-£309) per additional quitter. CONCLUSIONS: This trial targeted a socio-economically disadvantaged population that has been neglected within the literature. The complex intervention was more costly but more effective in reducing PM2.5 compared with the usual care. It offers huge potential to reduce children's' tobacco-related harm by reducing exposure to SHS in the home. The intervention is considered cost-effective if the decision maker is willing to pay £131 per additional 10µg/m3 of PM2.5 reduction. TRIAL REGISTRATION: The Smoke Free Homes trial was registered with isrctn.com on 29 January 2013 with the identifier ISRCTN81701383 .

Youth social behaviour and network therapy (Y-SBNT): adaptation of a family and social network intervention for young people who misuse alcohol and drugs - a randomised controlled feasibility trial.

BACKGROUND: Family interventions appear to be effective at treating young people's substance misuse. However, implementation of family approaches in UK services is low. This study aimed to demonstrate the feasibility of recruiting young people to an intervention based on an adaptation of adult social behaviour and network therapy. It also sought to involve young people with experience of using substance misuse services in the research process. OBJECTIVES: To demonstrate the feasibility of recruiting young people to family and social network therapy and to explore ways in which young people with experience of using substance misuse services could be involved in a study of this nature. DESIGN: A pragmatic, two-armed, randomised controlled open feasibility trial. SETTING: Two UK-based treatment services for young people with substance use problems, with recruitment taking place from May to November 2014. PARTICIPANTS: Young people aged 12-18 years, newly referred and accepted for structured interventions for drug and/or alcohol problems. INTERVENTIONS: A remote, web-based computer randomisation system allocated young people to adapted youth social behaviour and network therapy (Y-SBNT) or treatment as usual (TAU). Y-SBNT participants were intended to receive up to six 50-minute sessions over a maximum of 12 weeks. TAU participants continued to receive usual care delivered by their service. MAIN OUTCOME MEASURES: Feasibility was measured by recruitment rates, retention in treatment and follow-up completion rates. The main clinical outcome was the proportion of days on which the main problem substance was used in the preceding 90-day period as captured by the Timeline Follow-Back interview at 3 and 12 months. RESULTS: In total, 53 young people were randomised (Y-SBNT, n = 26; TAU, n = 27) against a target of 60 (88.3%). Forty-two young people attended at least one treatment session [Y-SBNT 22/26 (84.6%); TAU 20/27 (74.1%)]; follow-up rates were 77.4% at month 3 and 73.6% at month 12. Data for nine young people were missing at both months 3 and 12, so the main clinical outcome analysis was based on 24 young people (92.3%) in the Y-SBNT group and 20 young people (74.1%) in the TAU group. At month 12, the average proportion of days that the main problem substance was used in the preceding 90 days was higher in the Y-SBNT group than in the TAU group (0.54 vs. 0.41; adjusted mean difference 0.13, 95% confidence interval -0.12 to 0.39; p = 0.30). No adverse events were reported. Seventeen young people with experience of substance misuse services were actively involved throughout the study. They informed key elements of the intervention and research process, ensuring that the intervention was acceptable and relevant to our target groups; contributing to the design of key trial documents, ideas for a new model of public involvement and this report. Two parents were also involved. CONCLUSIONS: The adapted intervention could be delivered in young people's services, and qualitative interviews found that Y-SBNT was acceptable to young people, family members and staff. Engagement of family and network members proved difficult within the intervention and research aspects. The study proved the feasibility of this work in routine services but outcome measurement based on narrow substance use variables may be limited and may fail to capture other important changes in wider areas of functioning for young people. Validation of the EuroQol-5 Dimensions for young people aged 12-18 years should be considered and flexible models for involvement of young people in research are required to achieve inclusive representation throughout all aspects of the research process. Although recommendation of a full trial of the Y-SBNT intervention compared with TAU is not supported, this study can inform future intervention development and UK research within routine addiction services. TRIAL REGISTRATION: Current Controlled Trials ISRCTN93446265. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 15. See the NIHR Journals Library website for further project information.

Comparison of active treatments for impaired glucose regulation: a Salford Royal Foundation Trust and Hitachi collaboration (CATFISH): study protocol for a randomized controlled trial.

BACKGROUND: Diabetes is highly prevalent and contributes to significant morbidity and mortality worldwide. Behaviour change interventions that target health and lifestyle factors associated with the onset of diabetes can delay progression to diabetes, but many approaches rely on intensive one-to-one contact by specialists. Health coaching is an approach based on motivational interviewing that can potentially deliver behaviour change interventions by non-specialists at a larger scale. This trial protocol describes a randomized controlled trial (CATFISH) that tests whether a web-enhanced telephone health coaching intervention (IGR3) is more acceptable and efficient than a telephone-only health coaching intervention (IGR2) for people with prediabetes (impaired glucose regulation). METHODS: CATFISH is a two-parallel group, single-centre individually randomized controlled trial. Eligible participants are patients aged ≥18 years with impaired glucose regulation (HbA1c concentration between 42 and 47 mmol/mol), have access to a telephone and home internet and have been referred to an existing telephone health coaching service at Salford Royal NHS Foundation Trust, Salford, UK. Participants who give written informed consent will be randomized remotely (via a clinical trials unit) to either the existing pathway (IGR2) or the new web-enhanced pathway (IGR3) for 9 months. The primary outcome measure is patient acceptability at 9 months, determined using the Client Satisfaction Questionnaire. Secondary outcome measures at 9 months are: cost of delivery of IGR2 and IGR3, mental health, quality of life, patient activation, self-management, weight (kg), HbA1c concentration, and body mass index. All outcome measures will be analyzed on an intention-to-treat basis. A qualitative process evaluation will explore the experiences of participants and providers with a focus on understanding usability of interventions, mechanisms of behaviour change, and impact of context on delivery and user acceptability. Qualitative data will be analyzed using Framework. DISCUSSION: The CATFISH trial will provide a pragmatic assessment of whether a web-based information technology platform can enhance acceptability of a telephone health coaching intervention for people with prediabetes. The data will prove critical in understanding the role of web applications to improve engagement with evidence-based approaches to preventing diabetes. TRIAL REGISTRATION: ISRCTN16534814 . Registered on 7 February 2016.