The limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical ...processes. These limitations can result in slow evidence generation that is not responsive to population health needs, yielding evidence that is not generalizable. Clinically integrated trials, which integrate clinical research into routine care, represent a potential solution to this challenge and an opportunity to support learning health systems. The operational and design features of clinically integrated trials include a focused scope, simplicity in design and requirements, the leveraging of existing data structures, and patient participation in the entire trial process. These features are designed to minimize barriers to participation and trial execution and reduce additional research burdens for participants and clinicians alike. Broad adoption and scalability of clinically integrated trials are dependent, in part, on continuing regulatory, healthcare system, and payer support. This analysis presents a framework of the strengths and challenges of clinically integrated trials and is based on a multidisciplinary expert “Think Tank” panel discussion that included representatives from patient populations, academia, non-profit funding agencies, the U.S. Food and Drug Administration, and industry.
In this trial involving overweight or obese outpatients with Covid-19, investigators found that none of three repurposed drugs (metformin, ivermectin, and fluvoxamine) reduced the risk of serious ...disease.
Aim
To evaluate in a laboratory setting the performance of two reciprocating glide path systems, WaveOne Gold Glider (WO) and R‐Pilot (RP), to create a glide path in mesial root canals of mandibular ...molars and to assess the torsional resistance of instruments after performing the glide path.
Methodology
A total of 60 mesial root canals of extracted human mandibular molars were divided into two groups (n = 30) according to the glide path system to be used. The data from the volume of each canal, acquired by microcomputed tomography (micro‐CT), were validated statistically for the anatomical pairing of the groups. Preparation time, frequency in gaining apical patency, plastic deformation rate of instruments, and canal transportation and centring ability were recorded and compared statistically. The torsional fatigue of the instruments after use was also evaluated. Data were analysed using Fisher’s exact test and Mann–Whitney U‐test with a 5% significance level.
Results
No significant differences were found between groups regarding the time required to perform the glide path, the frequency distributions of the canals classified as patent and the instruments with plastic deformation after use (P > 0.05). No significant differences were found between groups regarding the degree of canal transportation and centring ability at the cervical, middle and apical thirds (P > 0.05). The RP groups had significantly greater maximum torsional strength values compared with the WO groups (P < 0.05). The used WO group had greater angular deflection to fracture when compared to the new WO group (P < 0.05). A significant difference was also found in the percentage of loss of angular deflection in a comparison of the WO group with the RP group (P < 0.05).
Conclusions
The WO and RP instruments performed the same in terms of preparation time, plastic deformation, gaining apical patency, degree of canal transportation and centring ability. The RP instruments had greater torsional strength, less angular deflection and lower percentage of loss in angular deflection than the WO. The used WO group had the greatest angular deflection values.
Background
There is growing interest in identifying and recruiting research participants from health systems using electronic health records (EHRs). However, few studies have described the practical ...aspects of the recruitment process or compared electronic recruitment methods to in-person recruitment, particularly across health systems.
Objective
The objective of this study was to describe the steps and efficiency of the recruitment process and participant characteristics by recruitment strategy.
Methods
EHR-based eligibility criteria included being an adult patient engaged in outpatient primary or bariatric surgery care at one of 5 health systems in the PaTH Clinical Research Network and having ≥2 weight measurements and 1 height measurement recorded in their EHR within the last 5 years. Recruitment strategies varied by site and included one or more of the following methods: (1) in-person recruitment by study staff from clinical sites, (2) US postal mail recruitment letters, (3) secure email, and (4) direct EHR recruitment through secure patient web portals. We used descriptive statistics to evaluate participant characteristics and proportion of patients recruited (ie, efficiency) by modality.
Results
The total number of eligible patients from the 5 health systems was 5,051,187. Of these, 40,048 (0.8%) were invited to enter an EHR-based cohort study and 1085 were enrolled. Recruitment efficiency was highest for in-person recruitment (33.5%), followed by electronic messaging (2.9%), including email (2.9%) and EHR patient portal messages (2.9%). Overall, 779 (65.7%) patients were enrolled through electronic messaging, which also showed greater rates of recruitment of Black patients compared with the other strategies.
Conclusions
We recruited a total of 1085 patients from primary care and bariatric surgery settings using 4 recruitment strategies. The recruitment efficiency was 2.9% for email and EHR patient portals, with the majority of participants recruited electronically. This study can inform the design of future research studies using EHR-based recruitment.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
To describe an investigation into 5 clinical cases of carbapenem-resistant Acinetobacter baumannii (CRAB).
Epidemiological investigation supplemented by whole-genome sequencing (WGS) of clinical and ...environmental isolates.
A tertiary-care academic health center in Boston, Massachusetts.
Individuals identified with CRAB clinical infections.
A detailed review of patient demographic and clinical data was conducted. Clinical isolates underwent phenotypic antimicrobial susceptibility testing and WGS. Infection control practices were evaluated, and CRAB isolates obtained through environmental sampling were assessed by WGS. Genomic relatedness was measured by single-nucleotide polymorphism (SNP) analysis.
Four clinical cases spanning 4 months were linked to a single index case; isolates differed by 1-7 SNPs and belonged to a single cluster. The index patient and 3 case patients were admitted to the same room prior to their development of CRAB infection, and 2 case patients were admitted to the same room within 48 hours of admission. A fourth case patient was admitted to a different unit. Environmental sampling identified highly contaminated areas, and WGS of 5 environmental isolates revealed that they were highly related to the clinical cluster.
We report a cluster of highly resistant Acinetobacter baumannii that occurred in a burn ICU over 5 months and then spread to a separate ICU. Two case patients developed infections classified as community acquired under standard epidemiological definitions, but WGS revealed clonality, highlighting the risk of burn patients for early-onset nosocomial infections. An extensive investigation identified the role of environmental reservoirs.
Differential astrometry with Gaia Abbas, U.; Bucciarelli, B.; Lattanzi, M. G. ...
Astronomy and astrophysics (Berlin),
08/2022, Letnik:
664
Journal Article
Recenzirano
Odprti dostop
Aims.
In this paper, we develop a differential astrometric framework that is appropriate for a scanning space satellite such as
Gaia.
We apply it to the first of the GAREQ fields – the
Gaia
...Relativistic Experiment on Jupiter’s quadrupole – which is the fruit of dedicated efforts within the
Gala
project focused on measuring the relativistic deflection of light close to Jupiter’s limb. This provides a preliminary assessment of the following: a) the observability of the relativistic deflection of light close to Jupiter and b)
Gaia’s
astrometric capabilities under extremely difficult conditions such as those around a bright extended object.
Methods.
Inputs to our differential astrometric model are the charge-coupled device (CCD) transit times as measured by the intermediate data update (IDU) system, transformed to field angles via astrometric global iterative solution (AGIS) geometric calibrations, and the commanded or nominal spacecraft attitude. Actual attitude rates, including medium and high-frequency effects, were estimated from successive CCD pair observations and used to transfer the field angles onto intermediate tangent planes, finally anchored to a common reference frame by fitting a six-parameter model to a set of suitable reference stars. The best-fit parameters provide the target star’s deflection as a time-varying systematic effect. To illustrate the model, we analyzed
Gaia
astrometric measurements after their calibration through the latest cyclic early data release EDR3/DR3 processing of the GAREQ event in February 2017. We used observations of the closest bright target star successfully observed several times by
Gaia
in close proximity to Jupiter and surrounding reference stars brighter than
G
< 13 mag in transits leading up to the time of closest approach and on subsequent transits.
Results.
The relativistic deflection signal is detected with a signal-to-noise ratio (S/N) of 50 at closest approach by the target star. This signal is the combined effect due to Jupiter and the Sun, mainly dominated by Jupiter’s monopole, demonstrating Gala’s scientific performance under extreme observational conditions. It is an unprecedented detection for the following reasons: a) it is the closest ever to Jupiter’s limb (~7″) in the optical and b) the highest S/N at any wavelength. Finally, this work sets the stage for investigations into disentangling the relativistic quadrupole deflection due to Jupiter with future
Gaia
astrometric measurements.
Aim
To evaluate the influence of larger apical canal enlargement in curved canals using reciprocating systems subjected to various heat treatments.
Methodology
Ninety mandibular premolars with root ...curvatures ranging from 20° to 30° were selected and scanned by microcomputed tomography (micro‐CT) before and after root canal preparation with reciprocating systems (n = 30): Reciproc Blue (RB size 25, .08 taper and size 40, .06 taper; VDW, Munich, Germany), WaveOne Gold (WOG size 25, .07 taper and size 35, .06 taper; Dentsply Sirona, Ballaigues, Switzerland) and ProDesign R (PDR size 25, .06 taper and size 35, .05 taper; Easy Dental Equipment, Belo Horizonte, Brazil). Canal transportation, untouched areas, and apical and total root canal volumes were measured. Statistical analysis was performed with the nonparametric Kruskal–Wallis and Dunn's tests and a significance level set at 5%.
Results
The between‐group comparison revealed no significant difference in untouched areas, canal transportation, and apical root canal volume among the groups (P > 0.05). However, WOG size 35, .06 taper was associated with a significant increase in the percentage of total canal volume in comparison to the PDR size 35, .05 taper (P < 0.05). The within‐group comparison revealed a significant decrease in untouched areas, increase in apical and total root canal volume for all groups when using a larger instrument (P < 0.05). There was no significant difference in transportation among the groups and when a larger apical preparation was created (P > 0.05).
Conclusions
Larger apical enlargement of curved canals was associated with a decrease in untouched areas, an increase in root canal volume and maintenance of canal trajectory. In addition, all systems were safe and provided similar root canal shapes.
Aim
To evaluate the torsional properties of pathfinding nickel‐titanium (NiTi) rotary instruments manufactured from several NiTi alloys, ProGlider (M‐wire), Hyflex GPF (conventional NiTi Wire and ...controlled memory wire), Logic (conventional NiTi wire and controlled memory wire) and Mtwo (conventional NiTi wire).
Methodology
A total of 56 NiTi instruments from Glidepath rotary systems (n = 8) were used: Logic (size 25, .01 taper), Logic CM (size 25, .01 taper), ProGlider (size 16, .02 taper), Hyflex GPF (size 15, .01 taper), Hyflex GPF CM (size 15, .02 taper; size 20, .02 taper) and Mtwo (size 10, .04 taper). The torsion tests were performed based on ISO 3630‐1 (1992). Three millimetres of each instrument tip was clamped to a small load cell by a lever arm linked to the torsion axis. Data were analysed using a one‐way analysis of variance (anova) and Tukey test with a significance level at a = 5%.
Results
The Logic size 25, .01 taper had significantly higher torsional strength values (P < 0.05). The ProGlider was significantly different when compared with Hyflex GPF size 15, .01 taper and size 15, .02 taper (P < 0.05). The Logic CM size 25, .01 taper had significantly higher torsional strength than Hyflex GPF size 15, .01 taper and size 15, .02 taper (P < 0.05). No difference was found amongst Mtwo size 10, .04 taper and Hyflex GPF groups (size 15, .01 taper; size 15, .02 taper; size 20, .02 taper). In relation to the angle of rotation, Logic CM size 25, .01 taper and Hyflex GPF size 15, .01 taper had the highest angle values (P < 0.05). The ProGlider had the lowest angle values in comparison with all the groups (P < 0.05) followed by Mtwo size 10, .04 taper. The Logic size 25, .01 taper had significantly higher angle of rotation values than ProGlider and Mtwo size 10, .04 taper (P < 0.05).
Conclusion
The Logic size 25, .01 taper instrument made of conventional NiTi alloy had the highest torsional strength of all instruments tested. In addition, the ProGlider instrument manufactured from M‐Wire alloy had the lowest angle of rotation to fracture in comparison with the other instruments.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination has decreasing protection from acquiring any infection with emergence of new variants; however, vaccination continues to ...protect against progression to severe coronavirus disease 2019 (COVID-19). The impact of vaccination status on symptoms over time is less clear.
Within a randomized trial on early outpatient COVID-19 therapy testing metformin, ivermectin, and/or fluvoxamine, participants recorded symptoms daily for 14 days. Participants were given a paper symptom diary allowing them to circle the severity of 14 symptoms as none (0), mild (1), moderate (2), or severe (3). This is a secondary analysis of clinical trial data on symptom severity over time using generalized estimating equations comparing those unvaccinated, SARS-CoV-2 vaccinated with primary vaccine series only, or vaccine-boosted.
The parent clinical trial prospectively enrolled 1323 participants, of whom 1062 (80%) prospectively recorded some daily symptom data. Of these, 480 (45%) were unvaccinated, 530 (50%) were vaccinated with primary series only, and 52 (5%) vaccine-boosted. Overall symptom severity was least for the vaccine-boosted group and most severe for unvaccinated at baseline and over the 14 days (P < .001). Individual symptoms were least severe in the vaccine-boosted group including cough, chills, fever, nausea, fatigue, myalgia, headache, and diarrhea, as well as smell and taste abnormalities. Results were consistent over Delta and Omicron variant time periods.
SARS-CoV-2 vaccine-boosted participants had the least severe symptoms during COVID-19, which abated the quickest over time. Clinical Trial Registration. NCT04510194.
It remains largely unknown as to why some individuals experience substantial weight loss with obesity interventions, while others receiving these same interventions do not. Person-specific ...characteristics likely play a significant role in this heterogeneity in treatment response. The practice of precision medicine accounts for an individual’s genes, environment, and lifestyle when deciding upon treatment type and intensity in order to optimize benefit and minimize risk. In this review, we first discuss biopsychosocial determinants of obesity, as understanding the complexity of this disease is necessary for appreciating how difficult it is to develop individualized treatment plans. Next, we present literature on person-specific characteristics associated with, and predictive of, weight loss response to various obesity treatments including lifestyle modification, pharmacotherapy, metabolic and bariatric surgery, and medical devices. Finally, we discuss important gaps in our understanding of the causes of obesity in relation to the suboptimal treatment outcomes in certain patients, and offer solutions that may lead to the development of more effective and targeted obesity therapies.
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