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Item Clinical and economic systematic literature review to support the development of an integrated care programme for chronic disease prevention and management for the Irish health system(Health Service Executive, 2015-07) Savage, Eileen; Hegarty, Josephine; Weathers, Elizabeth; Mulligan, Lydia; O'Reilly, Anthony; Cronly, Jennifer; Condon, Carol; McCarthy, Vera; Lehane, Elaine; Hartigan, Irene; Horgan, Aine; Bradley, Colin; Browne, John; Murphy, Aileen; Cronin, Jodi; Flynn, Maura; Drennan, Jonathan; Health Service ExecutiveBased on a clinical and economic systematic review of the international literature, this report presents the evidence on integrated care programmes and generic models of care designed for chronic disease prevention and management. This evidence will support the work of integrated clinical care programmes in Ireland through the Clinical Strategy and Programmes Division of the HSE.Item PLEASANT: Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term - a cluster randomised controlled trial and economic evaluation(NIHR Journals Library, 2016-12) Julious, Steven A.; Horspool, Michelle J.; Davis, Sarah; Bradburn, Mike J.; Norman, Paul; Shephard, Neil; Cooper, Cindy L.; Smithson, W. Henry; Boote, Jonathan; Elphick, Heather; Loban, Amanda; Franklin, Matthew; Kua, Wei Sun; May, Robin; Campbell, Jennifer; Williams, Rachael; Rex, Saleema; Bortolami, Oscar; National Institute for Health ResearchBackground: Asthma episodes and deaths are known to be seasonal. A number of reports have shown peaks in asthma episodes in school-aged children associated with the return to school following the summer vacation. A fall in prescription collection in the month of August has been observed, and was associated with an increase in the number of unscheduled contacts after the return to school in September. Objective: The primary objective of the study was to assess whether or not a NHS-delivered public health intervention reduces the September peak in unscheduled medical contacts. Design: Cluster randomised trial, with the unit of randomisation being 142 NHS general practices, and trial-based economic evaluation. Setting: Primary care. Intervention: A letter sent (n = 70 practices) in July from their general practitioner (GP) to parents/carers of school-aged children with asthma to remind them of the importance of taking their medication, and to ensure that they have sufficient medication prior to the start of the new school year in September. The control group received usual care. Main outcome measures: The primary outcome measure was the proportion of children aged 5–16 years who had an unscheduled medical contact in September 2013. Supporting end points included the proportion of children who collected prescriptions in August 2013 and unscheduled contacts through the following 12 months. Economic end points were quality-adjusted life-years (QALYs) gained and costs from an NHS and Personal Social Services perspective. Results: There is no evidence of effect in terms of unscheduled contacts in September. Among children aged 5–16 years, the odds ratio (OR) was 1.09 [95% confidence interval (CI) 0.96 to 1.25] against the intervention. The intervention did increase the proportion of children collecting a prescription in August (OR 1.43, 95% CI 1.24 to 1.64) as well as scheduled contacts in the same month (OR 1.13, 95% CI 0.84 to 1.52). For the wider time intervals (September–December 2013 and September–August 2014), there is weak evidence of the intervention reducing unscheduled contacts. The intervention did not reduce unscheduled care in September, although it succeeded in increasing the proportion of children collecting prescriptions in August as well as having scheduled contacts in the same month. These unscheduled contacts in September could be a result of the intervention, as GPs may have wanted to see patients before issuing a prescription. The economic analysis estimated a high probability that the intervention was cost-saving, for baseline-adjusted costs, across both base-case and sensitivity analyses. There was no increase in QALYs. Limitation: The use of routine data led to uncertainty in the coding of medical contacts. The uncertainty was mitigated by advice from a GP adjudication panel. Conclusions: The intervention did not reduce unscheduled care in September, although it succeeded in increasing the proportion of children both collecting prescriptions and having scheduled contacts in August. After September there is weak evidence in favour of the intervention. The intervention had a favourable impact on costs but did not demonstrate any impact on QALYs. The results of the trial indicate that further work is required on assessing and understanding adherence, both in terms of using routine data to make quantitative assessments, and through additional qualitative interviews with key stakeholders such as practice nurses, GPs and a wider group of children with asthma.Item A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial(National Institute for Health Research, 2017-04) Heller, Simon; White, David; Lee, Ellen; Lawton, Julia; Pollard, Daniel; Waugh, Norman; Amiel, Stephanie; Barnard, Katharine; Beckwith, Anita; Brennan, Alan; Campbell, Michael J.; Cooper, Cindy L.; Dimairo, Munyaradzi; Dixon, Simon; Elliott, Jackie; Evans, Mark; Green, Fiona; Hackney, Gemma; Hammond, Peter; Hallowell, Nina; Jaap, Alan; Kennon, Brian; Kirkham, Jackie; Lindsay, Robert; Mansell, Peter; Papaioannou, Diana; Rankin, David; Royle, Pamela; Smithson, W. Henry; Taylor, Carolin; National Institute for Health ResearchBackground: Insulin is generally administered to people with type 1 diabetes mellitus (T1DM) using multiple daily injections (MDIs), but can also be delivered using infusion pumps. In the UK, pumps are recommended for patients with the greatest need and adult use is less than in comparable countries. Previous trials have been small, of short duration and have failed to control for training in insulin adjustment. Objective: To assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for adults with T1DM, with both groups receiving equivalent structured training in flexible insulin therapy. Design: Pragmatic, multicentre, open-label, parallel-group cluster randomised controlled trial, including economic and psychosocial evaluations. After participants were assigned a group training course, courses were randomly allocated in pairs to either pump or MDI. Setting: Eight secondary care diabetes centres in the UK. Participants: Adults with T1DM for > 12 months, willing to undertake intensive insulin therapy, with no preference for pump or MDI, or a clinical indication for pumps. Interventions: Pump or MDI structured training in flexible insulin therapy, followed up for 2 years. MDI participants used insulin analogues. Pump participants used a Medtronic Paradigm® VeoTM (Medtronic, Watford, UK) with insulin aspart (NovoRapid, Novo Nordisk, Gatwick, UK). Main outcome measures: Primary outcome – change in glycated haemoglobin (HbA1c) at 2 years in participants whose baseline HbA1c was ≥ 7.5% (58 mmol/mol). Key secondary outcome – proportion of participants with HbA1c ≤ 7.5% at 2 years. Other outcomes at 6, 12 and 24 months – moderate and severe hypoglycaemia; insulin dose; body weight; proteinuria; diabetic ketoacidosis; quality of life (QoL); fear of hypoglycaemia; treatment satisfaction; emotional well-being; qualitative interviews with participants and staff (2 weeks), and participants (6 months); and ICERs in trial and modelled estimates of cost-effectiveness. Results: We randomised 46 courses comprising 317 participants: 267 attended a Dose Adjustment For Normal Eating course (132 pump; 135 MDI); 260 were included in the intention-to-treat analysis, of which 235 (119 pump; 116 MDI) had baseline HbA1c of ≥ 7.5%. HbA1c and severe hypoglycaemia improved in both groups. The drop in HbA1c% at 2 years was 0.85 on pump and 0.42 on MDI. The mean difference (MD) in HbA1c change at 2 years, at which the baseline HbA1c was ≥ 7.5%, was –0.24% [95% confidence interval (CI) –0.53% to 0.05%] in favour of the pump (p = 0.098). The per-protocol analysis showed a MD in change of –0.36% (95% CI –0.64% to –0.07%) favouring pumps (p = 0.015). Pumps were not cost-effective in the base case and all of the sensitivity analyses. The pump group had greater improvement in diabetes-specific QoL diet restrictions, daily hassle plus treatment satisfaction, statistically significant at 12 and 24 months and supported by qualitative interviews. Limitation: Blinding of pump therapy was not possible, although an objective primary outcome was used. Conclusion: Adding pump therapy to structured training in flexible insulin therapy did not significantly enhance glycaemic control or psychosocial outcomes in adults with T1DM. Research priority: To understand why few patients achieve a HbA1c of < 7.5%, particularly as glycaemic control is worse in the UK than in other European countries.