The hazard ratio as a measure of effect in clinical trials of elderly populations: common pitfalls and misconceptions.

The hazard ratio is a measure of effect which is of paramount importance in etiological research, that is in studies aimed at assessing the strength of the causal relationship between a given treatment/exposure and a certain outcome. Despite the widespread use of the hazard ratio as a measure of effect in scientific reports and articles, the interpretation of this index is often accompanied by some misconceptions which can jeopardize the critical appraisal of randomized clinical trials (RCTs) and observational studies as well. Herein, using a series of examples derived from RCTs in the elderly subjects, we address major pitfalls regarding the interpretation of the hazard ratio in geriatric research.

Statistical methods to assess the prognostic value of risk prediction rules in clinical research.

Prognosis aims at estimating the future course of a given disease in probabilistic terms. As in diagnosis, where clinicians are interested in knowing the accuracy of a new test to identify patients affected by a given disease, in prognosis they wish to accurately identify patients at risk of a future event conditional to one or more prognostic factors. Thus, accurate risk predictions play a primary role in all fields of clinical medicine and in geriatrics as well because they can help clinicians to tailor the intensity of a treatment and to schedule clinical surveillance according to the risk of the concerned patient.

Etelcalcetide in Patients on Hemodialysis with Severe Secondary Hyperparathyroidism. Multicenter Study in "Real Life".

Etelcalcetide is a new calcimimetic indicated for the treatment of secondary hyperparathyroidism (SHPT) in dialysis patients. Etelcalcetide efficacy in SHPT has been ascertained only in randomized controlled trials. This multicenter study was carried out in "real world" setting that is different from randomized controlled trials (RCTs) to (1) evaluate the effectiveness of etelcalcetide in SHPT, (2) to assess calcium, phosphorus, alkaline phosphatase changes, (3) to register gastrointestinal side effects.

Challenge to Predict Mobilized Peripheral Blood Stem Cells on the Fourth Day of Granulocyte Colony-Stimulating Factor Treatment in Healthy Donors: Predictive Value of Basal CD34 Cell and Platelet Counts.

A longitudinal, prospective, observational, single-center cohort study on healthy donors was designed to identify predictors of CD34 cell mobilization on day 4 after granulocyte colony-stimulating factor (G-CSF) administration. As potential predictors of mobilization, age, sex, body weight, height, blood volume, WBC count, peripheral blood (PB) mononuclear cell count, platelet (Plt) count, and hematocrit and hemoglobin levels were considered. Two different evaluations of CD34 cell counts were determined for each donor: baseline (before G-CSF administration) and in PB on day 4 after G-CSF administration.

How can LVAD support influence ventricular energetics parameters in advanced heart failure patients? A retrospective study.

Background And Objective: Here we present a retrospective analysis of six heart failure patients previously discussed at a multidisciplinary team meeting. Only three out of six patients underwent LVAD insertion as the most appropriate management option.

Methods: We sought to reproduce the baseline conditions of these patients on hospital admission using our cardiovascular software simulator (CARDIOSIM).

Pulse Wave Velocity and Prognosis in End-Stage Kidney Disease.

High pulse wave velocity (PWV) is a hallmark of end-stage kidney disease (ESKD) where it is considered useful for risk stratification. We investigated whether PWV adds meaningful prognostic information to 2 simple, well-validated, clinical risk scores specific to ESKD (the Annualized Rate of Occurrence scores) for predicting all-cause and cardiovascular mortality by applying state-of-the-art prognostic tests including discrimination (Harrell C-index), risk reclassification (integrated discrimination improvement), and calibration. We performed these analyses in the 2 largest ESKD cohorts with available PWV data, the Manhes-Hospital cohort in Paris (n=287 patients) and the Quebec Research Center cohort in Canada (n=246 patients).

Basal CD34 Cell Count Predicts Peripheral Blood Stem Cell Mobilization in Healthy Donors after Administration of Granulocyte Colony-Stimulating Factor: A Longitudinal, Prospective, Observational, Single-Center, Cohort Study.

A longitudinal, prospective, observational, single-center, cohort study on healthy donors (HDs) was designed to identify predictors of CD34 cells on day 5 with emphasis on the predictive value of the basal CD34 cell count. As potential predictors of mobilization, age, sex, body weight, height, blood volume as well as white blood cell count, peripheral blood (PB) mononuclear cells, platelet count, hematocrit, and hemoglobin levels were considered. Two different evaluations of CD34 cell counts were determined for each donor: baseline (before granulocyte colony-stimulating factor [G-CSF] administration) and in PB after G-CSF administration on the morning of the fifth day (day 5).

Reappraisal in two European cohorts of the prognostic power of left ventricular mass index in chronic kidney failure.

Left ventricular hypertrophy is a strong causal risk factor of cardiovascular morbidity and death in end stage kidney failure, and its prognostic value is taken for granted in this population. However, the issue has never been formally tested by state-of-art prognostic analyses. Therefore, we determined the prognostic power of the left ventricular mass index (LVMI) for all-cause and cardiovascular death beyond and above that provided by well validated clinical risk scores, the annualized rate of occurrence cohort risk scores (ARO, all cause death risk and cardiovascular risk).

A Dental Prosthesis from the Early Modern Age in Tuscany (Italy).

Background: During archaeological excavation, carried out in the S. Francesco Monastery at Lucca (Tuscany, Italy), a golden dental appliance was discovered. The prosthesis was found, together with commingled human remains, in the collective tomb of the aristocratic family of the Guinigi, a powerful family who governed Lucca from 1392 until 1429.

Biological and proteomic characterization of a composite mesh for abdominal wall hernia treatment: Reference Study.

Aims: The industrial development of a product requires performing a deep analysis to highlight its characteristics useful for future design. The clinical use of a product stimulates knowledge improvement about it in a constant effort of progress. This work shows the biological characterization of CMC composite mesh.