3 research outputs found
Shaping ability of Procodile and R6 Reziflow nickel-titanium reciprocating instruments in curved mesial root canals of mandibular molars: A MicroCT study
To compare the shaping ability of Procodileand R6 Reziflow instruments used in reciprocating motion in severely curved root canals, assessed with micro-computed tomography (mu CT). Fourteen extracted human mandibular first molars were randomly assigned to two instrumentation techniques (n = 14 mesial root canals): Procodile or R6 Reziflow. For both groups, root canals were prepared to the working length up to a size 25,.06 taper. Molars were virtually divided into apical, middle and coronal thirds and mu CT was used to scan all samples pre- and post-root canal. Canal transportation, centring ability, volume, surface area and unprepared area were evaluated. Geometrical parameter changes were compared with preoperative values (one-way analyses of variance and Tukey multiple comparison post-hoc test) between groups and Student t-test within groups (alpha = 0.05) Significantly less transportation was observed associated with the Procodile technique in the molar's coronal third compared to the R6 Reziflow technique (p <.05). No significant differences in root canal centring ability, volume, surface area and unprepared area were observed. Procodile showed a lower percentage increase of surface area compared to R6 Reziflow (p <.05). The Procodile and R6 Reziflow techniques applied to first molar root canal performed similarly except for the less transportation observed in the coronal third using Procodile.Research Highlights MicroCT analysis of canal geometry before and after instrumentation revealed that Procodile and R6 Reziflow showed a similar shaping ability to shape curved root canals without substantially modifications of the original tooth anatomy
Valorization of clinical trials from the Italian National Health Service perspective: definition and first application of a model to estimate avoided costs
Introduction: From the perspective of healthcare organizations and public health care systems, the value of a clinical trial can be assessed from a clinical and economical perspective. However, to date, there is no standardized model for systematically capturing the economic value of clinical trials at organizational and system levels. The aim of this study was to develop and test a methodology for estimating the avoided costs deriving from the management of patients as part of a clinical trial.
Methods: Our methodology is based on the assumption that the economic value of a clinical trial derives from 1) the funding received by the experimental site from a trial's sponsor, and from 2) the cost avoided by the experimental site with the treatment of patients within a study and not according to standard care by the experimental site.
Results: By applying the methodology to onco-hematological clinical trials conducted in two academic hospitals from 2011 to 2016, we demonstrate that savings between 2 million and 4 million euros were achieved over a five-year period. Thus, for every 1,000 euros invested by the pharmaceutical company into the clinical studies conducted at these hospitals, the hospitals saved on average 2,200 euros due to costs not incurred as a result of the trials.
Conclusions: The study has proposed and tested a methodology for estimating the economic value of clinical trials by taking into account avoided costs deriving from the treatment of patients enrolled in sponsored trials. The study has proposed a management tool for healthcare institutions to govern clinical trials
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Community-Based Cluster-Randomized Trial to Reduce Opioid Overdose Deaths
BACKGROUNDEvidence-based practices for reducing opioid-related overdose deaths include overdose education and naloxone distribution, the use of medications for the treatment of opioid use disorder, and prescription opioid safety. Data are needed on the effectiveness of a community-engaged intervention to reduce opioid-related overdose deaths through enhanced uptake of these practices.METHODSIn this community-level, cluster-randomized trial, we randomly assigned 67 communities in Kentucky, Massachusetts, New York, and Ohio to receive the intervention (34 communities) or a wait-list control (33 communities), stratified according to state. The trial was conducted within the context of both the coronavirus disease 2019 (Covid-19) pandemic and a national surge in the number of fentanyl-related overdose deaths. The trial groups were balanced within states according to urban or rural classification, previous overdose rate, and community population. The primary outcome was the number of opioid-related overdose deaths among community adults.RESULTSDuring the comparison period from July 2021 through June 2022, the population-averaged rates of opioid-related overdose deaths were similar in the intervention group and the control group (47.2 deaths per 100,000 population vs. 51.7 per 100,000 population), for an adjusted rate ratio of 0.91 (95% confidence interval, 0.76 to 1.09; P = 0.30). The effect of the intervention on the rate of opioid-related overdose deaths did not differ appreciably according to state, urban or rural category, age, sex, or race or ethnic group. Intervention communities implemented 615 evidence-based practice strategies from the 806 strategies selected by communities (254 involving overdose education and naloxone distribution, 256 involving the use of medications for opioid use disorder, and 105 involving prescription opioid safety). Of these evidence-based practice strategies, only 235 (38%) had been initiated by the start of the comparison year.CONCLUSIONSIn this 12-month multimodal intervention trial involving community coalitions in the deployment of evidence-based practices to reduce opioid overdose deaths, death rates were similar in the intervention group and the control group in the context of the Covid-19 pandemic and the fentanyl-related overdose epidemic. (Funded by the National Institutes of Health; HCS ClinicalTrials.gov number, NCT04111939.)