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Instructor satisfaction with the blended technique
Instructors teaching the blended approach reported higher satisfaction levels, with 84% preferring this over the traditional 4-step technique. This mirrors the positive attitudes towards blended learning seen in other studies [The current study noted lower candidate satisfaction in the research group, possibly due to i...
PMC10644658
Duration of the teaching session
Contrary to reports of worsened performance with reduced face-to-face time [
PMC10644658
Limitations
Although a standardised checklist was used which closely resembled the long-used ETC assessment criteria for a pelvic binder application and found consensus of an expert ETC panel, it was not officially validated, nor evaluated for its reliability. Face validity of the checklist appeared high, as 96% of the candidates ...
PMC10644658
Conclusions
This multicentre, randomised controlled study evaluated the role of blended learning for teaching the application of a pelvic binder in the ETC, using a blended modification of the 4-step technique [Future research should focus on the role of blended learning for skills with different complexity as the effectiveness of...
PMC10644658
Acknowledgements
Trauma
This manuscript is based on a dissertation for Master in Medical Education at the University of Dundee. Many thanks go to the supervisor Bonnie Lynch, for her expert advice and great support and to Judy Scopes for her valuable review. We would also like to thank the European Trauma Course Organisation for supporting th...
PMC10644658
Author contributions
EB was responsible for the study conception, design, data collection, analysis and the first draft. AB helped with the data collection and reviewed the manuscript. KT helped with the production of online materials and reviewed the manuscript. All authors read and approved the final draft.
PMC10644658
Funding
Open Access funding enabled and organized by Projekt DEAL. Open access was funded by Universität Bielefeld.
PMC10644658
Availability of data and materials
All data and additional materials can be provided by the corresponding author upon reasonable request.
PMC10644658
Declarations
PMC10644658
Ethical approval and consent to participate
This study was approved by the Ethics Committee of the Schools of Medicine and Life Sciences Research of the University of Dundee (REC number 22/59, 28
PMC10644658
Consent for publication
All participants gave written consent for the study data to be published.
PMC10644658
Competing interests
EB was lead educator of the ETCO from 2019 to Jan 2023. AB is educational developer of the ETCO. KT is chairman of the ETCO.
PMC10644658
References
PMC10644658
1. Introduction
Type 2 Diabetes, T2D, CM, diabetes
TYPE 2 DIABETES, RECRUITMENT, DIABETES
In-person culinary medicine (CM) can improve health behaviors, but its translation to virtual platforms and impact on diabetes outcomes are not well described. We designed a pragmatic trial comparing the effectiveness of virtual CM (eCM) to Medical Nutrition Therapy on diabetes outcomes among patients with uncontrolled...
PMC10574259
2. Materials and Methods
PMC10574259
2.1. Study Setting
diabetes
DIABETES
The highest incidence of estimated diabetes prevalence in North Texas is concentrated in South Dallas and is likely exacerbated by food insecurity [
PMC10574259
2.2. Study Design
diabetes
DIABETES
We designed a pragmatic randomized controlled trial (RCT) to compare the effectiveness of hands-on, experiential cooking classes (culinary medicine intervention) and standard of care, clinic-based medical nutrition therapy for patients with uncontrolled diabetes. This study was approved by the UT Southwestern Medical C...
PMC10574259
2.3. Study Eligibility
Diabetes, diabetes
TYPE 2 DIABETES, DIABETES, DIABETES
Patients were identified from Parkland’s Type 2 Diabetes Registry, which captures patients using a combination of ICD codes and laboratory data. Those with an assigned primary care provider at the Parkland COPC clinic in South Dallas were eligible if they (1) had a primary care visit in the past 12 months, (2) were age...
PMC10574259
2.4. Recruitment Strategy
RECRUITMENT
Eligible patients were sent a study invitation letter and information sheet in their preferred language (English or Spanish). A research assistant followed up by phone to confirm eligibility and complete recruitment. Due to the shift to virtual classes, a screening question about internet access was added to the inclus...
PMC10574259
2.5. Participant Enrollment and Food Assistance
Participants were notified by phone of their study arm assignment and scheduled to meet with the study team to complete their enrollment process at an established South Dallas community organization with an on-site food pantry and kitchen suitable for culinary medicine classes. With written informed consent to release ...
PMC10574259
2.6. Development of Medical Nutrition Therapy Arm (MNT)
diabetes, Diabetes
DIABETES, DIABETES
We partnered with Parkland Clinical Nutrition to deliver the MNT intervention. Participants randomized to MNT were offered a series of six sessions based on the American Diabetes Association (ADA) recommended Medical Nutrition guidelines for diabetes education [
PMC10574259
2.7. Development of Electronic Culinary Medicine Arm (eCM)
Diabetes
DIABETES
In partnership with culinary medicine-trained clinicians (JA, MDS), our study team accessed the Diabetes and Carbohydrate training module from the Health Meets Food curriculum [
PMC10574259
2.8. Initial Study Launch Review
RECRUITMENT
After the study launch (November 2021), weekly team meetings to monitor progress identified recruitment difficulties and low initial attendance for the first English and Spanish eCM groups (0 and 2 participants, respectively). In January 2022, we paused the study to solicit team-based observational feedback based on ph...
PMC10574259
3. Results
PMC10574259
3.1. Study Recruitment and Enrollment Redesign
RECRUITMENT
Interview data and study team observational feedback on original elements of study design helped narrow and identify change opportunities and strategies (These challenges, combined with scheduling and coordination challenges for the study team, led us to implement an opt-in model for food assistance. This change negate...
PMC10574259
3.2. eCM Engagement and Redesign
Participants appreciated and reinforced the importance of reminders for eCM classes. Common reasons for non-attendance included family emergencies and internet connectivity issues. eCM participants highlighted a lack of familiarity with culinary medicine classes and suggested that the opportunity to invite and cook wit...
PMC10574259
3.3. Trial Recruitment Results
MAY, RECRUITMENT, RECRUITMENT
Recruitment occurred during three periods: November–December 2021, May–June 2022, and January–February 2023. The study team applied exclusion criteria during each recruitment period, as shown in
PMC10574259
3.4. Randomization and Baseline Characteristics
Participants providing verbal consent and completing the baseline survey were randomized 1:1 to a study arm (48 MNT and 52 eCM). Twenty-one (5 MNT and 16 eCM) were unable to be reached following randomization or did not pick up study supplies and were withdrawn by the study team prior to the first class, leaving 43 MNT...
PMC10574259
3.5. Participant Engagement
We described how many participants attended at least one class during the six-class intervention period and, more specifically, how many participants attended the first class. Overall, 75% of participants attended at least one class (59/79), and 70% of those attended the first class (55/79). Both metrics were higher in...
PMC10574259
4. Discussion
diabetes
RECRUITMENT, DIABETES
In this pragmatic trial designed to compare the effectiveness of eCM and MNT for patients with uncontrolled diabetes, we faced multiple challenges in recruiting and engaging underserved patients in virtual nutrition interventions. After pausing the study to critically evaluate operational processes and engage participa...
PMC10574259
5. Conclusions
RECRUITMENT
Recruitment and engagement of underserved populations in virtual culinary medicine and nutrition studies is challenging. Although our study team had substantial experience in the delivery of in-person culinary medicine and nutrition interventions, translating these experiences to virtual platforms presented an array of...
PMC10574259
Author Contributions
This study was conceptualized and designed by M.E.B., J.A., S.L.P., and M.D.S. Data analysis and interpretation was conducted by M.E.B., P.M.C., C.S.-M., V.C.M., and M.F.M. All authors participated in the drafting and revision of the manuscript. M.E.B. was responsible for funding acquisition. All authors have read and ...
PMC10574259
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Institutional Review Board of The University of Texas Southwestern Medical Center (STU2020-1244) on 4 February 2021, with the most recent approval on 27 December 2022. The trial is registered with clinicaltrials...
PMC10574259
Informed Consent Statement
Informed consent was obtained from all participants involved in the study.
PMC10574259
Data Availability Statement
The data are not publicly available due to the ongoing status of the study which is not de-identified at this time.
PMC10574259
Conflicts of Interest
S.L.P. declares consulting fees from Pfizer (unrelated to this work). M.E.B. declares research support from Boehringer Ingelheim (unrelated to this work). While the study design changes were disclosed and approved by the sponsor, the sponsor had no role in the design, execution, interpretation, or writing of the study.
PMC10574259
References
mistakes, allergies, Confusion, diabetes
RECRUITMENT, RECRUITMENT, ALLERGIES, EVENTS, DIABETES
Recruitment Flow Diagram, November 2021–February 2023.Participant Class Engagement Metrics After Re-Design by Study Arm and Preferred Language (Comparison of Study Arms with respect to the Role of the Facilitator, Setting, Requirements, Content, and Educational Approach.Original Design with Stakeholder Feedback and Des...
PMC10574259
Background
DISEASE, RESPIRATORY INSUFFICIENCY, INFLAMMATORY RESPONSE
Edited by: Gerardo Guillen, Center for Genetic Engineering and Biotechnology (CIGB), CubaReviewed by: Marko Lucijanic, Clinical Hospital Dubrava, Croatia; Massimiliano Bonifacio, University of Verona, Italy†These authors have contributed equally to this workThis article was submitted to Cytokines and Soluble Mediators ...
PMC10151807
Methods
respiratory insufficiency
RESPIRATORY INSUFFICIENCY
We designed a randomized phase II clinical trial to determine whether the combination of ruxolitinib (5 mg twice a day for 7 days followed by 10 mg BID for 7 days) plus simvastatin (40 mg once a day for 14 days), could reduce the incidence of respiratory insufficiency in COVID-19. 48 cytokines were correlated with clin...
PMC10151807
Participants
DISEASE, COVID-19 INFECTION
Patients admitted due to COVID-19 infection with mild disease.
PMC10151807
Results
death, CL-1
Up to 92 were included. Mean age was 64 ± 17, and 28 (30%) were female. 11 (22%) patients in the control arm and 6 (12%) in the experimental arm reached an OSCI grade of 5 or higher (p = 0.29). Unsupervised analysis of cytokines detected two clusters (CL-1 and CL-2). CL-1 presented a higher risk of clinical deteriorati...
PMC10151807
Conclusions
Ruxolitinib plus simvastatin did not impact the outcome of COVID-19. Cytokine profiling identified patients at risk of severe COVID-19 and predicted clinical deterioration.
PMC10151807
Trial registration
PMC10151807
Background
cancer
VIRUS, SARS-COV-2 INFECTION, CANCER, DISEASE, CYTOKINE STORM
COVID-19 remains an important health problem worldwide three years after its initial description (Cytokine storm due to SARS-CoV-2 infection is a critical step in mild and severe disease (Janus Kinase (JAK) are essential proteins involved in immune response and could play a role in the hyperinflammatory state in patien...
PMC10151807
Objectives
toxicity
DISEASE
The primary objective of this study was to compare the number of COVID19 patients who progressed to severe disease (defined as grade 5 or more of the OSCI) in the control vs the experimental arm.Secondary objectives were to compare ICU admission and length of stay, days of hospitalization, and mortality at 28 days, 6 m...
PMC10151807
Methods
We designed a randomized, single-center phase II clinical trial. Patients were allocated in a 1:1 ratio to the control or experimental arm.Randomization was stratified based on concurrent treatment with statins or strong CYP 340 inhibitors.
PMC10151807
Participants
DISEASE, COVID-19 INFECTION
Eligible cases were adult patients admitted to our institution due to COVID-19 infection. They must have presented with mild disease (defined as grade 3 or 4 in the WHO-Ordinal Scale for Clinical Improvement [WHO-OSCI]) and provided consent (The study was performed at the Hospital Universitario Sanchinarro, Madrid (Spa...
PMC10151807
Outcomes
respiratory insufficiency
DISEASE, RESPIRATORY INSUFFICIENCY
The primary objective was the percentage of patients progressing from mild (grade 3 or 4 in the OSCI) to severe (grade 5 or more) disease. Secondary objectives included days of hospitalization, days of admission in the intensive care unit (when required), survival at 28 days, 6 months and 12 months after study inclusio...
PMC10151807
Statistical methods
Quantitative variables are expressed as mean ± standard deviation when normally distributed and median (IQR) otherwise. Normality was tested using the Shapiro test. Categorical variables are expressed as absolute (relative, %) frequencies.Analysis of the primary objective was reported by treatment arm and performed in ...
PMC10151807
Cytokine analysis
BLOOD, VIRUS
Up to 444 blood samples from 92 patients were collected. 84 (91%) were participants of the Ruxo-Sim trial and 8 extra cases were included providing they met same eligibility criteria. Clinical information and patient demographics were obtained from the electronic medical records, and confidentiality was maintained by a...
PMC10151807
Cytokine characterization
25 µl of neat serum samples from patients were tested using Human Cytokine/Chemokine/Growth Factor Panel A 48 Plex Kit (ref. HCYTA-60K-PX48, Merck KGaA, Darmstadt, Germany) according to the manufacturer’s instructions (see
PMC10151807
Statistical and machine learning analysis
REGRESSION
Hierarchical consensus clustering based on the most variable cytokines resulted in two clusters of patients with distinct cytokine profiles. A logistic regression model was used to classify patients in CL-1 or CL-2 based on a two-cytokine ratio. This model was tested on the 81 patients with a cytokine characterization ...
PMC10151807
Results
PMC10151807
Participant flow
RECRUITMENT
100 patients were included in the trial (“intention to treat” population). Eight cases were deemed ineligible after randomization (six presented an OSCI grade greater than four, one was not a COVID patient, and one was included in a competing clinical trial). Thus, the “per protocol” population included 92 patients. (F...
PMC10151807
Baseline data
obesity, cancer, diabetes
OBESITY, CANCER, CARDIOVASCULAR DISEASE, DIABETES
Mean age was 64 (range 24-98) and 30% were female. Regarding the main clinical prognostic factors in COVID-19: 16% presented diabetes, 13% cardiovascular disease, 12% cancer and 9% obesity. No significant disbalance was observed between study arms regarding these variables (Demographics and basal clinical characteristi...
PMC10151807
Outcomes and analysis
toxicity
ADVERSE EVENTS, EVENT, SECONDARY
Regarding the primary objective of the study in the intention to treat population, 11 (22%) patients in the control arm and 6 (12%) in the experimental arm reached an OSCI grade of 5 or higher (p = 0.29).In the “per protocol” population numbers were smaller (p = 0.0002) with 4 (9%) and 7 (16%) in the control and experi...
PMC10151807
Cytokine analysis
respiratory deterioration, CL-1
Consensus clustering of the 61 patients who had a measurement on the first day from hospital admission, based on the 17 most variable cytokines, revealed two clusters in the data (Cytokine clustering and patient’s outcome of the study population. Orange: Cluster 1; purple: cluster 2. We used the MIP-1α/M-CSF model to c...
PMC10151807
Discussion
SARS-Cov-2 infection, death, multiorgan dysfunction, Hyperinflammation, RDS, ill, deaths, CL-1
RESPIRATORY FAILURE, DISEASE, COMPLICATION, RESPIRATORY DISTRESS SYNDROME, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME
We present the results of a single-center randomized phase II clinical trial with the combination of ruxolitinib and simvastatin for the treatment of COVID19. Up to 100 hospitalized patients were included and allocated in a 1:1 ratio to SOC or the experimental arm. Treatment was well tolerated but no differences were f...
PMC10151807
Data availability statement
The original contributions presented in the study are included in the article/
PMC10151807
Ethics statement
The studies involving human participants were reviewed and approved by the ethics committee at HM Hospitales and the Spanish National Agency for Drugs and Health Products (AEMPS). The patients/participants provided their written informed consent to participate in this study.
PMC10151807
Author contributions
Conception and design of study: JG-D, DM-U, KK, PV, AB, EN-V, CR, PN, PB, RM. Acquisition of data (laboratory or clinical): JG-D, DMU, KK, PV, AB, AD, JR-M, EC, RV, EN-V, MY, MO, MB, SR-L, MQ, MZ, CR, PN, PB, RM. Data analysis and/or interpretation: JG-D, DM-U, KK, PV, AB, EN-V, MZ, CR, PN, PB, RM. Drafting of manuscri...
PMC10151807
Acknowledgments
APICES SLP and ONCOPERSONAL SLP for their kind support.
PMC10151807
Conflict of interest
JR-M: Advisory boards and Consulting for BMS, Amgen, Novartis. Rainier, Janssen, Pierre-Fabre. Speaker honoraria from Roche, BMS, Novartis, MSD, Janssen, Pfizer, Astra-Zeneca. Travel, accommodations, expenses: Astellas, Novartis, Roche, BMS, Pfizer, MSD, Astra-Zeneca. Corporate-sponsored research: Astra- Zeneca, BMS, A...
PMC10151807
Publisher’s note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ...
PMC10151807
Supplementary material
The Supplementary Material for this article can be found online at: Click here for additional data file.Click here for additional data file.
PMC10151807
References
PMC10151807
Background
tic, tic suppression, voluntary tic suppression
TOURETTE SYNDROME IN CHILDREN
Comprehensive Behavioral Intervention for Tics (CBIT) is recommended as a first-line treatment for Tourette syndrome in children and adults. While there is strong evidence proving its efficacy, the mechanisms of reduction in tic severity during CBIT are still poorly understood. In a recent study, our group identified a...
PMC10755221
Methods
Thirty-two children with TS, aged 8 to 13 years old, participated in a randomized controlled trial of CBIT
PMC10755221
Results
vocal tic, tic
Functional connectivity during tic suppression did not change from baseline to endpoint. However, baseline tic suppression-related functional connectivity specifically predicted the decrease in vocal tic severity from baseline to endpoint in the CBIT group. Supplementary analyses revealed that the functional connectivi...
PMC10755221
Conclusions
vocal tic, tic, voluntary tic suppression, tics
This study revealed that functional connectivity during tic suppression at baseline predicted reduction in vocal tic severity. These results suggest probable overlap between the mechanisms of voluntary tic suppression and those of behavior therapy for tics.
PMC10755221
Keywords
PMC10755221
Introduction
tic, tic suppression, tic suppressibility, voluntary tic suppression, Tourette syndrome, tics
TOURETTE SYNDROME
Comprehensive Behavioral Intervention for Tics (CBIT) is recommended as a first-line treatment for Tourette syndrome (TS) in children and adults (Andrén et al., Recently, Essoe, Ramsey, Singer, Grados, and McGuire (Another process that may be linked with CBIT is voluntary tic suppression. Most people with TS can volunt...
PMC10755221
Methods
PMC10755221
Procedures
PMC10755221
Study design, randomization, and treatment
Full details pertaining to the structure of the RCT can be found in Morand-Beaulieu et al. (
PMC10755221
EEG recordings
Continuous EEG was recorded at a 250 Hz sampling rate from 128 electrodes (HydroCel Geodesic Sensor Net) referenced online to the vertex electrode (Cz). We used a Net Amps 200 amplifier and Net Station Acquisition software version 4.2.1 (EGI, Inc.) to monitor signal acquisition. The sensor net was soaked in a potassium...
PMC10755221
Experimental task
tics, tic
EEG was recorded during three 2-min tic suppression sessions during which children were asked to suppress all tics. They were also asked to keep their eyes open while looking at the computer screen. Recordings took place in a dimly-lit room.
PMC10755221
Outcome assessment
vocal tic
Changes in motor and vocal tic severity from baseline to endpoint were assessed by a blinded rater using the Yale Global Tic Severity Scale (Leckman et al.,
PMC10755221
EEG signal treatment
PMC10755221
EEG signal preprocessing
EEG recordings were preprocessed using the Maryland Analysis of Developmental EEG (MADE) pipeline (Debnath et al.,
PMC10755221
Source-based connectivity pipeline
BRAIN
Brain sources were reconstructed with minimum source imaging (wMNE) in Brainstorm (Tadel, Baillet, Mosher, Pantazis, & Leahy, The phase-locking value (PLV) was computed in Brainstorm and served as our measure of functional connectivity. The PLV reflects the absolute value of the mean phase difference between two signal...
PMC10755221
Statistical analyses
vocal tic, tic, reductions in motor and vocal tics
To assess whether functional connectivity during tic suppression changed from baseline to endpoint, we conducted a repeated-measures ANOVA with Functional connectivity as the dependent variable, and with the between-subjects factor Treatment (CBIT and TAU) and the within-subjects factor Time (baseline and endpoint). We...
PMC10755221
Results
vocal tic, tic, tic suppression
CORTEX
Results from the RCT have been published elsewhere (Morand-Beaulieu et al., Change in tic severity from baseline to endpointThe first objective of this study was to assess if functional connectivity increased from baseline to endpoint in the CBIT group relative to TAU. Our analyses revealed no main effect of Time [CBIT...
PMC10755221
Discussion
tic, vocal tic, tic suppression, voluntary tic suppression, tic suppressibility, tics, vocal tics
CORTEX, SUPPRESSION, BRAIN
In the current study, we wished to assess how functional connectivity associated with tic suppression was related to CBIT response. EEG was recorded during three 2-min tic suppression sessions at baseline and endpoint. Brain sources were then reconstructed. We assessed functional connectivity within a subnetwork involv...
PMC10755221
Supporting information
PMC10755221
Morand-Beaulieu et al. supplementary material
Morand-Beaulieu et al. supplementary material
PMC10755221
Acknowledgements
We thank all children who participated in this study, as well as their family.
PMC10755221
Supplementary material
The supplementary material for this article can be found at
PMC10755221
Financial support
DGS, Tourette syndrome
BRAIN, TOURETTE SYNDROME, TOURETTE
This project was supported by NIMH grant K01MH079130 to DGS. SMB was supported by a postdoctoral fellowship award from the Canadian Institutes of Health Research (MFE164627) and by the Clinical Research Training Scholarship in Tourette syndrome from the Tourette Association of America and the American Brain Foundation,...
PMC10755221
Ethical standards
The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008.
PMC10755221
References
PMC10755221
Purpose
This study was conducted to evaluate a smartphone-based online electronic logbook used to assess the clinical skills of nurse anesthesia students in Iran.
PMC10169697
Methods
This randomized controlled study was conducted after tool development at Ahvaz Jundishapur University of Medical Sciences in Ahvaz, Iran from January 2022 to December 2022. The online electronic logbook involved in this study was an Android-compatible application used to evaluate the clinical skills of nurse anesthesia...
PMC10169697
Results
A total of 39 students participated in the study. The mean satisfaction score of the intervention group was significantly higher than that of the control group (P=0.027). The mean score of learning outcomes was also significantly higher for the intervention than the control group (P=0.028).
PMC10169697
Conclusion
Smartphone technology can provide a platform for improving the evaluation of the clinical skills of nursing anesthesia students, leading to increased satisfaction and improved learning outcomes.
PMC10169697
Graphical abstract
PMC10169697
Introduction
PMC10169697
Background/rationale
Formative assessment of the clinical performance of nurse anesthesia students during training courses is an indispensable component of their education. This assessment promotes the quick diagnosis of weaknesses and strengths, correction of performance, and improvement of clinical competence [Today, the use of electroni...
PMC10169697
Objectives
The present study was conducted to design, implement, and evaluate a smartphone-based online electronic logbook (the AGAH app) to evaluate the clinical skills of nurse anesthesia students. We hypothesized that by providing quick access, online evaluation, and timely feedback, the design and implementation of the AGAH a...
PMC10169697
Methods
PMC10169697