scholarly journals Home treatment of COPD exacerbation selected by DECAF score: a non-inferiority, randomised controlled trial and economic evaluation

Thorax ◽  
2018 ◽  
Vol 73 (8) ◽  
pp. 713-722 ◽  
Author(s):  
Carlos Echevarria ◽  
Joanne Gray ◽  
Tom Hartley ◽  
John Steer ◽  
Jonathan Miller ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Length Of Stay ◽  
Controlled Trial ◽  
Prognostic Score ◽  
Cost Effective ◽  
Low Risk ◽  
Copd Exacerbation ◽  
Hospitalised Patients ◽  
Life Years ◽  
Randomised Controlled

BackgroundPrevious models of Hospital at Home (HAH) for COPD exacerbation (ECOPD) were limited by the lack of a reliable prognostic score to guide patient selection. Approximately 50% of hospitalised patients have a low mortality risk by DECAF, thus are potentially suitable.MethodsIn a non-inferiority randomised controlled trial, 118 patients admitted with a low-risk ECOPD (DECAF 0 or 1) were recruited to HAH or usual care (UC). The primary outcome was health and social costs at 90 days.ResultsMean 90-day costs were £1016 lower in HAH, but the one-sided 95% CI crossed the non-inferiority limit of £150 (CI −2343 to 312). Savings were primarily due to reduced hospital bed days: HAH=1 (IQR 1–7), UC=5 (IQR 2–12) (P=0.001). Length of stay during the index admission in UC was only 3 days, which was 2 days shorter than expected. Based on quality-adjusted life years, the probability of HAH being cost-effective was 90%. There was one death within 90 days in each arm, readmission rates were similar and 90% of patients preferred HAH for subsequent ECOPD.ConclusionHAH selected by low-risk DECAF score was safe, clinically effective, cost-effective, and preferred by most patients. Compared with earlier models, selection is simpler and approximately twice as many patients are eligible. The introduction of DECAF was associated with a fall in UC length of stay without adverse outcome, supporting use of DECAF to direct early discharge.Trial registration numberRegistered prospectively ISRCTN29082260.

scholarly journals Protocol for an economic evaluation of the randomised controlled trial of culprit lesion only PCI versus immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: CULPRIT-SHOCK trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e014849 ◽  
Author(s):  
Zahidul Quayyum ◽  
Andrew Briggs ◽  
Jose Robles-Zurita ◽  
Keith Oldroyd ◽  
Uwe Zeymer ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Cardiogenic Shock ◽  
Controlled Trial ◽  
Culprit Lesion ◽  
Link Type ◽  
Trial Analysis ◽  
Life Years ◽  
Randomised Controlled

IntroductionEmergency percutaneous coronary intervention (PCI) of the culprit lesion for patients with acute myocardial infarctions is an accepted practice. A majority of patients present with multivessel disease with additional relevant stenoses apart from the culprit lesion. In haemodynamically stable patients, there is increasing evidence from randomised trials to support the practice of immediate complete revascularisation. However, in the presence of cardiogenic shock, the optimal management strategy for additional non-culprit lesions is unknown. A multicentre randomised controlled trial, CULPRIT-SHOCK, is examining whether culprit vessel only PCI with potentially subsequent staged revascularisation is more effective than immediate multivessel PCI. This paper describes the intended economic evaluation of the trial.Methods and analysisThe economic evaluation will be conducted using a pre-trial decision model and within-trial analysis. The modelling-based analysis will provide expected costs and health outcomes, and incremental cost-effectiveness ratio over the lifetime for the cohort of patients included in the trial. The within-trial analysis will provide estimates of cost per life saved at 30 days and in 1 year, and estimates of health-related quality of life. Bootstrapping and cost-effectiveness acceptability curves will be used to address any uncertainty around these estimates. Different types of regression models within a generalised estimating equation framework will be used to examine how the total cost and quality-adjusted life years are explained by patients’ characteristics, revascularisation strategy, country and centre. The cost-effectiveness analysis will be from the perspective of each country’s national health services, where costs will be expressed in euros adjusted for purchasing power parity.Ethics and disseminationEthical approval for the study was granted by the local Ethics Committee at each recruiting centre. The economic evaluation analyses will be published in peer-reviewed journals of the concerned literature and communicated through the profiles of the authors atwww.twitter.comandwww.researchgate.net.Trial registration numberNCT01927549; Pre-results.

scholarly journals Economic evaluation plan of a randomised controlled trial of intra-nodular injection of anti-TNF and placebo among patients with early Dupuytren’s disease: Repurposing Anti-TNF for Treating Dupuytren’s Disease (RIDD)

2018 ◽  
Vol 3 ◽  
pp. 156
Author(s):  
May Ee Png ◽  
Melina Dritsaki ◽  
Alastair Gray ◽  
Rafael Pinedo-Villanueva ◽  
Oliver Rivero-Arias ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Randomised Controlled Trial ◽  
Resource Use ◽  
Early Stage ◽  
Controlled Trial ◽  
Dupuytren’S Disease ◽  
Decision Analytic Model ◽  
Dupuytren's Disease ◽  
Life Years ◽  
Randomised Controlled

Dupuytren’s disease (DD) is a common fibroproliferative condition of the palmar and digital fascia of the hand; however, there is currently no approved treatment for early stage DD. The objective of this paper is to describe the methods applied to assess the cost-effectiveness of adalimumab injections compared to placebo for controlling the progression of early stage DD in the Repurposing Anti-TNF for Treating Dupuytren’s Disease (RIDD) trial. Measure of effectiveness and resource use will be obtained from a randomised clinical trial, carried out in three healthcare centres, and recruiting a minimum of 138 patients aged 18 years and above with a diagnosis of early stage DD. Resource use and utility measures (quality-adjusted life years) will be collected at 3, 6, 9, 12 (primary outcome endpoint) and 18 months post-randomisation. A within-trial cost-utility analysis (CUA) will be conducted at 12 months and if the intervention is effective, a decision analytic model will be applied to estimate the lifetime effectiveness and costs. The analysis will be performed from a health system (National Health Service and personal social services) perspective. Sensitivity analysis will be conducted to assess the robustness of the results. RIDD is the first randomised controlled trial with an economic evaluation conducted among patients with early stage DD. The protocol described here records our intent to conduct both a within-trial CUA alongside the RIDD study and a lifetime CUA using decision-analytic modelling.

scholarly journals Cost-effectiveness of habit-based advice for weight control versus usual care in general practice in the Ten Top Tips (10TT) trial: economic evaluation based on a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e017511 ◽  
Author(s):  
Nishma Patel ◽  
Rebecca J Beeken ◽  
Baptiste Leurent ◽  
Rumana Z Omar ◽  
Irwin Nazareth ◽  
...  
Keyword(s):  
General Practice ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Health Service ◽  
Usual Care ◽  
Controlled Trial ◽  
Cost Effective ◽  
The Mean ◽  
Randomised Controlled

ObjectiveTen Top Tips (10TT) is a primary care-led behavioural intervention which aims to help adults reduce and manage their weight by following 10 weight loss tips. The intervention promotes habit formation to encourage long-term behavioural changes. The aim of this study was to estimate the cost-effectiveness of 10TT in general practice from the perspective of the UK National Health Service.DesignAn economic evaluation was conducted alongside an individually randomised controlled trial.Setting14 general practitioner practices in England.ParticipantsAll patients were aged ≥18 years, with body mass index ≥30 kg/m2. A total of 537 patients were recruited; 270 received the usual care offered by their practices and 267 received the 10TT intervention.Outcomes measuresHealth service use and quality-adjusted life years (QALYs) were measured over 2 years. Analysis was conducted in terms of incremental net monetary benefits (NMBs), using non-parametric bootstrapping and multiple imputation.ResultsOver a 2-year time horizon, the mean costs and QALYs per patient in the 10TT group were £1889 (95% CI £1522 to £2566) and 1.51 (95% CI 1.44 to 1.58). The mean costs and QALYs for usual care were £1925 (95% CI £1599 to £2251) and 1.51 (95% CI 1.45 to 1.57), respectively. This generated a mean cost difference of −£36 (95% CI −£512 to £441) and a mean QALY difference of 0.001 (95% CI −0.080 to 0.082). The incremental NMB for 10TT versus usual care was £49 (95% CI −£1709 to £1800) at a maximum willingness to pay for a QALY of £20 000. 10TT had a 52% probability of being cost-effective at this threshold.ConclusionsCosts and QALYs for 10TT were not significantly different from usual care and therefore 10TT is as cost-effective as usual care. There was no evidence to recommend nor advice against offering 10TT to obese patients in general practices based on cost-effectiveness considerations.Trial registration numberISRCTN16347068; Post-results.

scholarly journals Securing All intraVenous devices Effectively in hospitalised patients—the SAVE trial: study protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2015 ◽  
Vol 5 (9) ◽  
pp. e008689 ◽  
Author(s):  
Claire M Rickard ◽  
Nicole Marsh ◽  
Joan Webster ◽  
E Geoffrey Playford ◽  
Matthew R McGrail ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Hospitalised Patients ◽  
Randomised Controlled
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