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AIMS: The objective of this paper is to assess whether cardiac contractility modulation (via the Optimizer System) plus standard of care (SoC) is a cost-effective treatment for people with heart failure [New York Heart Association (NYHA) III, left ventricular ejection fraction of 25-45%, and narrow QRS] compared against SoC alone from the perspective of the English National Health Service.
METHODS AND RESULTS: We developed a regression equation-based cost-effectiveness model, using individual patient data from three randomized control trials (FIX-HF-5 Phases 1 and 2, and FIX-HF-5C) to populate the majority of parameters. A series of regression equations predicted NYHA class over time, mortality, all-cause hospitalization rates, and health-related quality of life. We conducted the analysis in line with the National Institute for Health and Care Excellence reference case, modelling costs from an English National Health Service perspective, and considering outcomes in quality-adjusted life years (QALYs) over a patient lifetime perspective. Our base case analysis produced an incremental cost per additional QALY of GBP22 988 (€25 750) when comparing Optimizer + SoC to SoC alone. This result was not sensitive to parameter uncertainty but was sensitive to the time horizon over which costs and QALYs were captured and the duration over which a survival benefit with Optimizer + SoC can be assumed to apply.
CONCLUSIONS: Cardiac contractility modulation is likely to be cost-effective in people with heart failure with reduced ejection fraction, NYHA III, and narrow QRS, provided that the treatment benefit can be maintained beyond the duration of the existing clinical trial follow-up. This analysis supports the current recommendations of the European Society of Cardiology that this therapy may be considered for such patients.
Vaccination against putative causal organisms is a frequently used and preferred approach to controlling bovine respiratory disease complex (BRD) because it reduces the need for antibiotic use. Because approximately 90% of feedlots use and 90% of beef cattle receive vaccines in the USA, information about their comparative efficacy would be useful for selecting a vaccine. We conducted a systematic review and network meta-analysis of studies assessing the comparative efficacy of vaccines to control BRD when administered to beef cattle at or near their arrival at the feedlot. We searched MEDLINE, MEDLINE In-Process, MEDLINE Daily Epub Ahead of Print, AGRICOLA, Cambridge Agricultural and Biological Index, Science Citation Index, and Conference Proceedings Citation Index - Science and hand-searched the conference proceedings of the American Association of Bovine Practitioners and World Buiatrics Congress. We found 53 studies that reported BRD morbidity within 45 days of feedlot arrival. The largest connected network of studies, which involved 17 vaccine protocols from 14 studies, was included in the meta-analysis. Consistent with previous reviews, we found little compelling evidence that vaccines used at or near arrival at the feedlot reduce the incidence of BRD diagnosis.
Faecal calprotectin (FC) and the faecal immunochemical test for haemoglobin (FIT) are recommended for use in primary care where colorectal cancer (CRC) is not suspected.We are unclear how best to use these two biomarkers in younger patients where lower gastrointestinal symptoms are extremely common. Distinguishing irritable bowel syndrome from inflammatory bowel disease (IBD) from CRC on clinical grounds is often an uncertain exercise. Currently, there is no direct comparative evidence base on which to identify the optimal use of each biomarker. We undertook an illustrative comparison of the diagnostic accuracy of FC in a patient dataset at 'low risk' of CRC stratified by age and symptoms, and of FIT, from three existing published studies that included both CRC and IBD in their outcomes. From an existing dataset of patients using the York Faecal Calprotectin Care Pathway (YFCCP), we identified 1919 patients fulfilling National Institute for Health and Care Excellence (NICE) DG30 criteria. Patients were stratified based on age, symptomatology and diagnosis, either (1) CRC or (2) a composite of CRC, significant adenomatous polyps (=10 mm or high-grade dysplasia or =5 subcentimetre polyps) and IBD (organic enteric disease). Fishers' exact test was used to compare the data for FC of =100 µg/g faeces against the previously published data using FIT=10 µg Hb/g faeces.
OBJECTIVES: A systematic literature review (SLR) was conducted to identify utilities in acute myeloid leukaemia (AML).
METHODS: SLR methods conformed to National Institute for Health and Care Excellence technology appraisal requirements. Eligible studies were economic evaluations (cost-effectiveness, cost-utility and cost-benefit analyses), utility studies, SLRs and health technology assessments. Nine bibliographic databases and 4 conferences were searched (November 2018) and retrieved 2,278 unique records. Two reviewers independently selected records and one extracted data.
RESULTS: Twenty-six studies (28 documents) met inclusion criteria. Data were derived using: EQ-5D (14 studies, including 2 using EQ-5D-5L), TTO (4), VAS (4), DCE (2), HUI2 (1), QLQ-PBM (1), EORTC-8D (1), standard gamble (1), as well as proxy data (1) and data mapped to utility (1, from QLQ-C30). Studies were conducted in Canada, Japan, the Netherlands, UK, USA, and one study was across Europe. Mean utility data were identified for these health states: induction chemotherapy (-0.15 to 0.706), consolidation chemotherapy (-0.11 to 0.71), maintenance (0.81 to 0.95 [median]), complete remission (0.62 to 0.99) [in transplant: 0.61 to 0.71; prior to transplant: 0.826], no relapse (0.83 to 0.90 [median]), temporary remission (0.66), partial remission (0.6574 to 0.7160), relapse (0.1 to 0.79), refractory (-0.1 to 0.568) and transplant (-0.21 to 0.94) [short-term: 0.4; recovery: 0.75 to 0.826; graft versus host disease (GVHD): 0.37 to 0.691; without GVHD: 0.79 to 0.864; long term: 0.94 to 1 [median]]. Disutilities were reported for chemotherapy (0.42) and transplant (0.57).
CONCLUSIONS: The SLR reported wide variations in utility values across AML health states, with most studies referring to first line treatment with induction/consolidation rather than relapse/refractory. Variations could be due to underlying disease activity within health states, differences utility elicitation methods, and health state definitions. Choice of utility values for decision analytic models should consider these differences to improve validity.
No abstract available.
AIMS: To revisit the data analysis used to inform National Institute of Health and Care Excellence (NICE) NG17 guidance for initiating basal insulin in adults with type 1 diabetes mellitus (diabetes).
METHODS: We replicated the data, methodology and analysis used by NICE diabetes in the NG17 network meta-analysis (NMA). We expanded this data cohort to a more contemporary data set (extended 2017 NMA) and restricted the studies included to improve the robustness of the data set (restricted 2017 NMA) and in a post hoc analysis, changed the index comparator from neutral protamine Hagedorn (NPH) insulin twice daily to insulin detemir twice daily.
RESULTS: The absolute changes in HbA1c were similar to those reported in the NG17. However, all 95% credible intervals for change in HbA1c point estimates crossed the line of null effect, except for detemir twice daily (in the NICE and extended 2017 NMAs) and NPH four times daily. In the detemir twice-daily centred post hoc analysis, the 95% credible intervals for change in HbA1c crossed the line of null effect for all basal therapies, except NPH.
CONCLUSION: In NG17, comparisons of basal insulins were based solely on efficacy of glycaemic control. Many of the trials used in this analysis were treat-to-target, which minimize differences in HbA1c. In the NMAs, statistical significance was severely undermined by the wide credible intervals. Despite these limitations, point estimates of HbA1c were used to rank the insulins and formed the basis of NG17 guidance. This study queries whether such analyses should be used to make specific clinical recommendations.
