Upper Bound Of Confidence Interval Research Articles

SYNERGY—Everolimus-Eluting Stent With a Bioabsorbable Polymer in ST-Elevation Myocardial Infarction: CLEAR SYNERGY OASIS-9 Registry

Our objective was to evaluate the clinical effectiveness of the SYNERGY stent in patients with ST elevation myocardial infarction (STEMI). The only drug eluting stent approved for treatment of STEMI by the FDA is the Taxus stent which is no longer commercially available, so further data are needed. The CLEAR SYNERGY stent registry was embedded into a larger randomized trial of patients with STEMI (N=7000), comparing colchicine vs. placebo and spironolactone vs. placebo. The primary outcome for the SYNERGY stent registry is major adverse cardiac events (MACE) as defined by cardiovascular death, recurrent MI, or unplanned ischemia driven target vessel revascularization (TVR) within 12 months. We estimated a MACE rate of 6.3% at 12 months after primary percutaneous coronary intervention (PPCI) for STEMI based on the TOTAL trial. Success was defined as upper bound of confidence interval (CI) to be less than the performance goal of 9.45%.Overall, 733 patients were enrolled from 8 countries with a mean age 60.2 years, 19% diabetes, 41.3% anterior MI and median door to balloon time of 72 minutes. The MACE rate was 4.8% (95% CI 3.2-6.3%) at 12 months which met the success criteria against performance goal of 9.45%. The rates of cardiovascular death, recurrent MI or TVR were 2.7%, 1.9%, 1.0% respectively. The rates of acute definite stent thrombosis were 0.3%, subacute 0.4%, late 0.4% and cumulative stent thrombosis of 1.1% at 12 months. In conclusion, the SYNERGY stent in STEMI performed well and was successful compared to the performance goal based on prior trials.Trial Registration: ClinicalTrials.gov Identifier: NCT03048825

Analysis of data collected in the European Society for Blood and Marrow Transplantation (EBMT) Registry on a cohort of lymphoma patients receiving plerixafor

Plerixafor + granulocyte-colony stimulating factor (G-CSF) is administered to patients with lymphoma who are poor mobilizers of hematopoietic stem cells (HSCs) in Europe. This international, multicenter, non-interventional registry study (NCT01362972) evaluated long-term follow-up of patients with lymphoma who received plerixafor for HSC mobilization versus other mobilization methods. Propensity score matching was conducted to balance baseline characteristics between comparison groups. The following mobilization regimens were compared: G-CSF + plerixafor (G + P) versus G-CSF alone; G + P versus G-CSF + chemotherapy (G + C); and G-CSF + plerixafor + chemotherapy (G + P + C) versus G + C. The primary outcomes were progression-free survival (PFS), overall survival (OS), and cumulative incidence of relapse (CIR). Overall, 313/3749 (8.3%) eligible patients were mobilized with plerixafor-containing regimens. After propensity score matching, 70 versus 36 patients were matched in the G + P versus G-CSF alone cohort, 124 versus 124 in the G + P versus G + C cohort, and 130 versus 130 in the G + P + C versus G + C cohort. For both PFS and OS, the upper bound of confidence interval for the hazard ratio was >1.3 for all comparisons, implying that non-inferiority was not demonstrated. No major differences in PFS, OS, and CIR were observed between the plerixafor and comparison groups.

Rebuilding the Distress Thresholds for Pavement Warranty Program in Mississippi

Pavement warranty is an innovative contracting procedure increasingly adopted by state transportation agencies to protect investment in pavement construction and maintenance. In Mississippi, the pavement warranty program was initiated in 2000 and the pavement distress thresholds were set based on the deduct points calculated by conversion equations from distress measurements of unacceptable pavement conditions. The conversion of distress measurements into deduct points using empirically regressed conversion equations has been questioned, however, on the grounds that it actually reduces the accuracy of the objective distress measurements by adding subjective and random errors. Moreover, the validity and applicability of continual use of these conversion equations has become problematic with time, because the equations were empirically developed in the 1990s, reflecting the data, experience, and technologies at that time. This research aims to develop analytically new distress thresholds based on direct measurements of pavement distresses for the pavement warranty program in Mississippi. The bootstrapping method was employed to process the skewed historical distress measurement data into normal distributions. The upper bound of confidence interval or standard deviations of the normalized distress measurement data was determined as an alternative method to rebuild the threshold for each distress type. The confusion matrix was employed to consider a smooth transition of updating the thresholds from the current deduct point based system to a new measurement based system. This study provides a practical procedure for developing a set of measurement based thresholds to renew the pavement warranty program using the available pavement management system data.

The maximum expected earthquake magnitudes in different future time intervals of six seismotectonic zones of Iran and its surroundings

One of the crucial components in seismic hazard analysis is the estimation of the maximum earthquake magnitude and associated uncertainty. In the present study, the uncertainty related to the maximum expected magnitude μ is determined in terms of confidence intervals for an imposed level of confidence. Previous work by Salamat et al. (Pure Appl Geophys 174:763-777, 2017) shows the divergence of the confidence interval of the maximum possible magnitude mmax for high levels of confidence in six seismotectonic zones of Iran. In this work, the maximum expected earthquake magnitude μ is calculated in a predefined finite time interval and imposed level of confidence. For this, we use a conceptual model based on a doubly truncated Gutenberg-Richter law for magnitudes with constant b-value and calculate the posterior distribution of μ for the time interval Tf in future. We assume a stationary Poisson process in time and a Gutenberg-Richter relation for magnitudes. The upper bound of the magnitude confidence interval is calculated for different time intervals of 30, 50, and 100 years and imposed levels of confidence α = 0.5, 0.1, 0.05, and 0.01. The posterior distribution of waiting times Tf to the next earthquake with a given magnitude equal to 6.5, 7.0, and 7.5 are calculated in each zone. In order to find the influence of declustering, we use the original and declustered version of the catalog. The earthquake catalog of the territory of Iran and surroundings are subdivided into six seismotectonic zones Alborz, Azerbaijan, Central Iran, Zagros, Kopet Dagh, and Makran. We assume the maximum possible magnitude mmax = 8.5 and calculate the upper bound of the confidence interval of μ in each zone. The results indicate that for short time intervals equal to 30 and 50 years and imposed levels of confidence 1 − α = 0.95 and 0.90, the probability distribution of μ is around μ = 7.16 − 8.23 in all seismic zones.

Optimization design of a disc brake system with hybrid uncertainties

Squeal reduction of disc brake systems have been extensively investigated for both academic and industrial purposes. However, most of the existing optimization designs of squeal reduction are based on deterministic approaches which have not considered the uncertainties of material properties, loading conditions, geometric dimensions, etc. In this paper, a hybrid probabilistic and interval model is introduced to deal with the uncertainties existing in a disc brake system for squeal reduction. The uncertain parameters of the brake system with enough information are treated as probabilistic variables, while the parameters with limited information are treated as interval variables. To improve computational efficiency, the response surface methodology (RSM) is introduced to replace the time-consuming finite element (FE) simulations. By the hybrid uncertain model, an optimization design based on reliability and confidence interval is proposed to explore the optimal design for squeal reduction. In the proposed optimization, both the design objective and the design constraint are interval probabilistic functions due to the effects of hybrid uncertainties. In this case, the maximum of the upper bound of confidence interval of design objective is selected as the objective function, while the minimal value of the probabilistic constraint is selected as the constraint function. The combinational algorithm of Genetic Algorithm and Monte-Carlo method is employed to perform the optimization. The results of a numerical example demonstrate the effectiveness of the proposed optimization on reducing squeal propensity of the disc brake systems with hybrid uncertainties.

The efficacy and safety of once-daily nifedipine administered without food: the coat-core formulation compared with the gastrointestinal therapeutic system formulation in patients with mild-to-moderate hypertension

A parallel-group, randomized, double-blind, forced-titration, multicenter study was done to compare the efficacy and safety of once-daily nifedipine coat-core (NIF CC) and once-daily nifedipine gastrointestinal therapeutic system (NIF GITS) dosed in the fasting state in patients with mild-to-moderate essential hypertension. Both formulations have been shown to effectively and safely lower blood pressure in placebo-controlled trials. After a 4-week placebo run-in period, 228 patients were randomized to 4 weeks of treatment with either NIF CC 30 mg daily or NIF GITS 30 mg daily. This period was followed by a forced-titration period to nifedipine 60 mg daily for an additional 4 weeks of double-blind therapy. After the 30-mg treatment period (the primary time point), there were no statistically significant differences between treatment groups in mean change from baseline in trough supine diastolic blood pressure, the primary efficacy variable (NIF CC patients, −7.0 mm Hg; NIF GITS patients, −8.4 mm Hg; P = 0.139). Also, because the upper bound of the treatment difference confidence interval was <3.0 mm Hg, equivalence—as defined in the protocol—was established. After the 60-mg treatment period, the change from baseline in trough supine diastolic blood pressure was significant greater for patients treated with NIF GITS than for patients treated with NIF CC (NIF GITS patients, −12.0 mm Hg; NIF CC patients, −8.4 mm Hg; P < 0.001). Because the upper bound of the confidence interval was >3 mm Hg, equivalence cannot be claimed. No statistically significant differences were noted for the comparison of mean 24-hour ambulatory blood pressure monitoring changes. Both formulations were well tolerated.