SummaryTwo consecutive, randomised, cross-over trials compared intubation success rates in third-year paramedic students and experienced prehospital practitioners using the Airtraq or a Macintosh laryngoscope with flexible stylet in a manikin model of a Cormack and Lehane grade III ⁄ IV laryngoscopic view. First-time intubation rates for the Macintosh and Airtraq for students were 0 ⁄ 23 (0%) vs 10 ⁄ 23 (44%) (44% difference, 95% CI 26-63%, p < 0.001) and for experienced laryngoscopists were 14 ⁄ 56 (25%) vs 47 ⁄ 56 (84%) (59% difference, 95% CI 42-72%, p < 0.0001), respectively. First-time oesophageal intubation rates for students were 15 ⁄ 23 (65%) vs 3 ⁄ 23 (13%) () 52% difference, 95% CI ) 25 to ) 72%, p < 0.001) and for experienced practitioners 9 ⁄ 56 (16%) vs 0 ⁄ 56 (0%) () 16% difference, 95% CI ) 9 to ) 28%, p = 0.0014). Student paramedics and experienced prehospital laryngoscopists managing a manikin model of a grade III ⁄ IV view had increased first-time intubation rates and had lower rates of oesophageal intubation with the Airtraq compared with a standard laryngoscope. One of the main criticisms of paramedics' tracheal intubation skills concerns the frequency of unrecognised misplaced tracheal tubes. An observational study of 108 paramedic tracheal intubations identified that 25% of patients had misplaced tracheal tubes, of which 67% were noted to be in the oesophagus [1]. A similar study of 167 paramedic tracheal intubations reported that 12% were misplaced with > 75% in the oesophagus [2], and a prospective observational study of 208 paramedic tracheal intubations reported unrecognised misplaced tracheal tubes in 5.8% of patients (95% CI = 2.6-8.9%) [3].A UK study of paramedic tracheal intubation in 52 patients reported a cumulative success rate of only 71.2% after two attempts [4]. This research also found that although 87.5% of patients with a Cormack and Lehane grade I view and 56.3% of patients with a grade II view were successfully intubated, no patient with a grade III or IV view had a tracheal tube correctly placed. These findings led the authors to suggest that intubation be withdrawn from the UK paramedic skill base. A recent literature review examining out-of-hospital intubation has also identified concerns about 'adverse events and errors, interaction with other important resuscitation interventions, and challenges in providing and maintaining procedural skill ' [5]. The review highlighted the need for new strategies to improve airway management in this setting.
PurposeClostridium difficile infection (CDI) represents a significant economic healthcare burden, especially the cost of recurrent disease. Fidaxomicin produced significantly lower recurrence rates and higher sustained cure rates in clinical trials. We evaluated the cost-effectiveness and budget impact of fidaxomicin compared with vancomycin in Germany in the first-line treatment of patient subgroups with CDI at increased risk of recurrence.MethodsA semi-Markov model was used to compare the cost-effectiveness and budget impact of fidaxomicin vs. vancomycin from a payer perspective in Germany. The model cycle length was 10 days. The time horizon was 1 year. Model inputs were probability of clinical cure, 30-day probability of recurrence, and 30-day attributable mortality based on evidence from two randomized controlled trials comparing fidaxomicin and vancomycin in patients with CDI. Cost-effectiveness outcomes were cost per quality-adjusted life year gained, cost per bed-day saved, and cost per recurrence avoided.ResultsDespite higher drug acquisition costs, fidaxomicin was dominant in the cancer subgroup (less costly and more effective) and cost-effective in the other subgroups, with incremental cost-effectiveness ratios vs. vancomycin ranging from €26,900 to €44,500. Hospitalization costs of the first-line treatment of CDI with fidaxomicin vs. vancomycin were lower in every patient subgroup, resulting in budget impacts ranging from −€1325 (in patients ≥65 years) to −€2438 (in cancer patients). Reductions in the cost of treating recurrence with fidaxomicin ranged from −€574.32 per patient in those receiving concomitant antibiotics to −€1500.68 per patient in renally impaired patients.ConclusionsIn patient subgroups with CDI at increased recurrence risk, fidaxomicin was cost-effective vs. vancomycin, and less costly and more effective in patients with cancer.Electronic supplementary materialThe online version of this article (doi:10.1007/s15010-016-0894-y) contains supplementary material, which is available to authorized users.
ObjectivesThe randomized Phase IIIb/IV EXTEND trial showed that extended-pulsed fidaxomicin significantly improved sustained clinical cure and reduced recurrence versus vancomycin in patients ≥60 years old with Clostridium difficile infection (CDI). Cost-effectiveness of extended-pulsed fidaxomicin versus vancomycin as first-line therapy for CDI was evaluated in this patient population.MethodsClinical results from EXTEND and inputs from published sources were used in a semi-Markov treatment-sequence model with nine health states and a 1 year time horizon to assess costs and QALYs. The model was based on a healthcare system perspective (NHS and Personal Social Services) in England. Sensitivity analyses were performed.ResultsPatients receiving first-line extended-pulsed fidaxomicin treatment had a 0.02 QALY gain compared with first-line vancomycin (0.6267 versus 0.6038 QALYs/patient). While total drug acquisition costs were higher for extended-pulsed fidaxomicin than for vancomycin when used first-line (£1356 versus £260/patient), these were offset by lower total hospitalization costs (which also included treatment monitoring and community care costs; £10 815 versus £11 459/patient) and lower costs of managing adverse events (£694 versus £1199/patient), reflecting the lower incidence of CDI recurrence and adverse events with extended-pulsed fidaxomicin. Extended-pulsed fidaxomicin cost £53 less per patient than vancomycin over 1 year. The probability that first-line extended-pulsed fidaxomicin was cost-effective at a willingness-to-pay threshold of £30 000/QALY was 76% in these patients.ConclusionsWhile fidaxomicin acquisition costs are higher than those of vancomycin, the observed reduced recurrence rate with extended-pulsed fidaxomicin makes it a more effective and less costly treatment strategy than vancomycin for first-line treatment of CDI in older patients.
BackgroundWe evaluated the cost-effectiveness of nivolumab versus everolimus in patients with advanced renal cell carcinoma (RCC) from a US payer perspective.MethodsA partitioned survival model consisting of three health states, progression-free survival (PFS), progressive disease, and death, was developed to evaluate the cost-effectiveness of intravenous nivolumab versus oral everolimus over a lifetime. The proportion of patients in each state was calculated based on parametric distributions fitted to PFS and overall survival (OS) data from CheckMate 025 (N = 821), a large randomized phase 3 trial of nivolumab versus everolimus for advanced RCC. Health state utility data were derived from CheckMate 025 EQ-5D data. Scenario analyses and deterministic and probabilistic sensitivity analyses assessed the impact of uncertainty in model inputs on outcomes.ResultsOver a 25-year lifetime horizon, treatment with nivolumab resulted in a gain of 0.64 quality-adjusted life-years (QALYs) versus everolimus. Nivolumab had greater total costs versus everolimus ($US197,089 vs. $US163,902), mainly due to higher acquisition costs. The incremental cost-utility ratio (ICUR), a measure of incremental costs divided by incremental QALYs, was $US51,714 per QALY gained for nivolumab versus everolimus, and an incremental cost-effectiveness ratio was $US44,576 per life-year gained for nivolumab versus everolimus. In sensitivity analyses, average body weight had the greatest impact on the ICUR for nivolumab versus everolimus (base case $US51,714; range $US8863–$US94,566). At a $US150,000 willingness-to-pay (WTP) threshold, nivolumab had a 91.7% probability of being cost-effective versus everolimus.ConclusionsIn the United States, at a WTP threshold of $US150,000 per QALY, nivolumab was found to be cost-effective. Key drivers of cost-effectiveness were survival inputs for OS and the average weight of patients; the latter directly affects nivolumab drug acquisition cost.Electronic supplementary materialThe online version of this article (10.1186/s40164-018-0095-8) contains supplementary material, which is available to authorized users.
Introduction: Limited data exist on real-world treatment patterns and the effectiveness of cyclin-dependent kinase (CDK) 4/6 inhibitors in germline BRCA (gBRCA)-mutated breast cancer. Methods: Adults with hormone receptor-positive (HR?), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC) treated with CDK4/6 inhibitor therapy between 2013 and 2018 were retrospectively selected from the Flatiron Health database. Patients with known gBRCA status were classified as mutated (gBRCAm) or wild type (gBRCAwt). Time-to-first subsequent therapy or death (TFST) and overall survival (OS) were calculated from the earliest line of therapy with a CDK4/6 inhibitor. Results: Of 2968 patients with HR?/HER2-mBC receiving a CDK4/6 inhibitor, 859 (28.9%) had known gBRCA status, of whom 9.9% were gBRCAm and 90.1% gBRCAwt. Median (95% confidence interval [CI]) TFST was 10 (7-11) months in the gBRCAm group, 10 (9-11) months in the gBRCAwt group, and 11 (10)(11)(12)
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