bluuebunny/crossref_metadata_2025_split huggingface dataset:
Adaptive designs in critical care trials: a simulation study
Authors: Li W. , Cornelius V. , Finfer S. , Venkatesh B. , Billot L. 
Published: October 2023

Abstract
Background
Adaptive clinical trials are growing in popularity as they are more flexible, efficient and ethical than traditional fixed designs. However, notwithstanding their increased use in assessing treatments for COVID-19, their use in critical care trials remains limited. A better understanding of the relative benefits of various adaptive designs may increase their use and interpretation.

Methods
Using two large critical care trials (ADRENAL. ClinicalTrials.gov number, NCT01448109. Updated 12-12-2017; NICE-SUGAR. ClinicalTrials.gov number, NCT00220987. Updated 01-29-2009), we assessed the performance of three frequentist and two bayesian adaptive approaches. We retrospectively re-analysed the trials with one, two, four, and nine equally spaced interims. Using the original hypotheses, we conducted 10,000 simulations to derive error rates, probabilities of making an early correct and incorrect decision, expected sample size and treatment effect estimates under the null scenario (no treatment effect) and alternative scenario (a positive treatment effect). We used a logistic regression model with 90-day mortality as the outcome and the treatment arm as the covariate. The null hypothesis was tested using a two-sided significance level (α) at 0.05.

Results
Across all approaches, increasing the number of interims led to a decreased expected sample size. Under the null scenario, group sequential approaches provided good control of the type-I error rate; however, the type I error rate inflation was an issue for the Bayesian approaches. The Bayesian Predictive Probability and O’Brien-Fleming approaches showed the highest probability of correctly stopping the trials (around 95%). Under the alternative scenario, the Bayesian approaches showed the highest overall probability of correctly stopping the ADRENAL trial for efficacy (around 91%), whereas the Haybittle-Peto approach achieved the greatest power for the NICE-SUGAR trial. Treatment effect estimates became increasingly underestimated as the number of interims increased.

Conclusions
This study confirms the right adaptive design can reach the same conclusion as a fixed design with a much-reduced sample size. The efficiency gain associated with an increased number of interims is highly relevant to late-phase critical care trials with large sample sizes and short follow-up times. Systematically exploring adaptive methods at the trial design stage will aid the choice of the most appropriate method.
FEEDBACK trial - A randomised control trial to investigate the effect of personalised feedback and financial incentives on reducing the incidence of road crashes
Authors: Stevenson Mark , Mortimer Duncan , Meuleners Lynn , Harris Anthony , Senserrick Teresa , Thompson Jason , De Silva Anurika , Barrera-Jimenez Humberto , Streatfield Avita , Perera Maneesha 
Published: October 2023

Abstract
Background
Road crashes continue to pose a significant threat to global health. Young drivers aged between 18 and 25 are over-represented in road injury and fatality statistics, especially the first six months after obtaining their license. This study is the first multi-centre two-arm parallel-group individually randomised controlled trial (the FEEDBACK Trial) that will examine whether the delivery of personalised driver feedback plus financial incentives is superior to no feedback and no financial incentives in reducing motor vehicle crashes among young drivers (18 to 20 years) during the first year of provisional licensing.

Methods
A total of 3,610 young drivers on their provisional licence (P1, the first-year provisional licensing) will participate in the trial over 28 weeks, including a 4-week baseline, 20-week intervention and 4-week post-intervention period. The primary outcome of the study will be police-reported crashes over the 20-week intervention period and the 4-week post-intervention period. Secondary outcomes include driving behaviours such as speeding and harsh braking that contribute to road crashes, which will be attained weekly from mobile telematics delivered to a smartphone app.

Discussion
Assuming a positive finding associated with personalised driver feedback and financial incentives in reducing road crashes among young drivers, the study will provide important evidence to support policymakers in introducing the intervention(s) as a key strategy to mitigate the risks associated with the burden of road injury among this vulnerable population.

Trial registration
Registered under the Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12623000387628p on April 17, 2023.
Comparison of the physical activity levels between shift workers and non-shift workers in a large-scale cross-sectional study in Iran
Authors: Najafi Anahita , Safari-Faramani Roya , Selk-Ghaffari Maryam , Najafi Farid , Ghafouri Mohammad , Darbandi Mitra , Mahdaviani Behnaz , Nakhostin-Ansari Amin 
Published: October 2023

Abstract
Background
Shift work has been related to adverse health outcomes that can partially be attributed to physical inactivity. However, our knowledge of the influence of shift work on physical activity and sedentary behavior is inconclusive. Therefore, this study aimed to assess physical activity levels among shift and non-shift workers among a sample of Iranian adults.

Methods
Baseline data of the Ravansar Non-Communicable Disease (RaNCD) cohort study were used. All participants of RaNCD except those excluded due to unemployment or considerable disability were included in the study. We evaluated participants’ physical activity levels using the PERSIAN cohort questionnaire and examined its associations with being a shift worker.

Results
A total of 4695 participants with a mean age of 46.1 (SD = 7.74) were included in the study. In total, 1108 (23.6%) participants were shift workers, 1420 (30.2%) had insufficient physical activity levels, and 4283 (91.2%) were male. The prevalence of physical inactivity was significantly lower among shift workers compared to non-shift workers (21% vs. 33.1%, p < 0.001). Multiple backward stepwise binary logistic regression tests indicated that being a shift worker was significantly associated with a lower chance of having insufficient physical activity levels (OR = 0.77, 95% CI = 0.65–0.92, p = 0.003).

Conclusions
The prevalence of insufficient physical activity was higher among non-shift workers than shift workers in our study. By providing the factors associated with insufficient physical activity among the workers in a region of Iran, the current study findings might help policymakers target groups at higher risk of physical activity in Iran and design interventions to improve physical activity, especially among non-shift workers.
Long-term effects of air pollutants on respiratory and cardiovascular mortality in a port city along the Adriatic sea
Authors: Mei Federico , Renzi Matteo , Bonifazi Martina , Bonifazi Floriano , Pepe Nicola , D’Allura Alessio , Brusasca Giuseppe , Viegi Giovanni , Forastiere Francesco 
Published: October 2023

Abstract
Background
Shipping and port-related air pollution has a significant health impact on a global scale. The present study aimed to assess the mortality burden attributable to long-term exposure to ambient particulate matter (PM2.5, PM10) and nitrogen dioxide (NO2) in the city of Ancona (Italy), with one of the leading national commercial harbours.

Methods
Exposure to air pollutants was derived by dispersion models. The relationship between the long-term exposure of air pollution exposure and cause-specific mortality was evaluated by Poisson regression models, after adjustment for gender, age and socioeconomic status. Results are expressed as percent change of risk (and relative 95% confidence intervals) per 5 unit increases in the exposures. The health impact on the annual number of premature cause-specific deaths was also assessed.

Results
PM2.5 and NO2 annual concentrations were higher in the area close to the harbour than in the rest of the city. Positive associations between each pollutant and most of the mortality outcomes were observed, with estimates of up to 7.6% (95%CI 0.1, 15.6%) for 10 µg/m3 increase in NO2 and cardiovascular mortality and 15.3% (95%CI-1.1, 37.2%) for 10 µg/m3 increase PM2.5 and lung cancer. In the subpopulation living close to the harbour, there were excess risks of up to 13.5%, 24.1% and 37.9% for natural, cardiovascular and respiratory mortality. The number of annual premature deaths due to the excess of PM2.5 and NO2 exposure (having as a reference the 2021 World Health Organization Air Quality Guidelines) was 82 and 25, respectively.

Conclusions
Our study confirms the long-term health effects of PM and NO2 on mortality and reveals a higher mortality burden in areas close to shipping and port-related emissions. Estimating the source-specific health burdens is key to achieve a deeper understanding of the role of different emission sources, as well as to support effective and targeted mitigation strategies.
Receiver operating characteristic (ROC) to determine cut-off points of clinical and biomolecular markers to discriminate mortality in severe COVID-19 living at high altitude
Authors: Vélez-Páez Jorge Luis , Baldeón-Rojas Lucy , Cañadas Herrera Cristina , Montalvo Mario Patricio , Jara Fernando Esteban , Aguayo-Moscoso Santiago , Tercero-Martínez Wendy , Saltos Lenin , Jiménez-Alulima Glenda , Guerrero Verónica , Pérez-Galarza Jorge 
Published: October 2023

Abstract
Background
In 2020, Ecuador had one of the highest death rates because of COVID-19. The role of clinical and biomolecular markers in COVID disease prognosis, is still not well supported by available data. In order for these markers to have practical application in clinical decision-making regarding patient treatment and prognosis, it is necessary to know an optimal cut-off point, taking into consideration ethnic differences and geographic conditions.

Aim
To determine the value of clinical and biomolecular markers, to predict mortality of patients with severe COVID-19 living at high altitude.

Methods
In this study, receiver operating characteristic (ROC) curves, area under the curve (AUC) of ROC, sensitivity, specificity and likelihood ratios were calculated to determine levels of clinical and biomolecular markers that best differentiate survivors versus non-survivors in severe COVID subjects that live at a high altitude setting.

Results
Selected cut-off values for ferritin (≥ 1225 ng/dl, p = 0.026), IL-6 (≥ 11 pg/ml, p = 0.005) and NLR (≥ 22, p = 0.008) at 24 h, as well as PaFiO2 (≤ 164 mmHg, p = 0.015), NLR (≥ 16, p = p = 0.013) and SOFA (≥ 6, p = 0.031) at 72 h, appear to have good discriminating power to differentiate survivors versus non-survivors. Additionally, odds ratios for ferritin (OR = 3.38); IL-6 (OR = 17.07); PaFiO2 (OR = 4.61); NLR 24 h (OR = 4.95); NLR 72 h (OR = 4.46), and SOFA (OR = 3.77) indicate increased risk of mortality when cut-off points were taken into consideration.

Conclusions
We proposed a straightforward and understandable method to identify dichotomized levels of clinical and biomolecular markers that can discriminate between survivors and non-survivors patients with severe COVID-19 living at high altitudes.
The effect of generation change on the accuracy of full arch digital impressions
Authors: Schmalzl Judit , Róth Ivett , Borbély Judit , Hermann Péter , Vecsei Bálint 
Published: October 2023

Abstract
Purpose
This study is aimed to evaluate the effect of generation change on accuracy of IOSs on full-arch scans and the inter-operator reliability.

Methods
In this study, 6 different IOS were tested: 3Shape Trios 3 (20.1.2.), 3Shape Trios 4 (20.1.1.), Medit i500 (2.3.6.), Medit i700 (2.4.6.), Planmeca Emerald (6.0.1.) and Planmeca Emerald S (6.0.1.). Eighteen dental students, inexperienced in scanning, took part in this study as operators. Each operator made 10 digital impressions; altogether, 30 impressions were made by each scanner. The 30 STL files were imported to the Geomagic Control X program, where they were compared to a reference STL file; the surface point’s deviation of the full arch and the distance between the second molars’ distobuccal cusps were measured, the inter-operator reliability was also investigated.

Results
A significant increase in accuracy was found between Trios 3 and 4 in the case of both parameters and between Medit i500 and i700 in the case of full arch. There was no significant difference between Planmeca generations. In case of the inter-operator reliability no significant difference was detected.

Conclusion
Within this current study’s limitation, it can be concluded that surface digitalization’s accuracy can be modified with generation changes and that digital technology is less technique sensitive than traditional impression taking.
Improving computerized decision support system interventions: a qualitative study combining the theoretical domains framework with the GUIDES Checklist
Authors: Yamada Janet , Kouri Andrew , Simard Sarah Nicole , Lam Shin Cheung Jeffrey , Segovia Stephanie , Gupta Samir 
Published: October 2023

Abstract
Background
Computerized clinical decision support systems (CDSSs) can improve care by bridging knowledge to practice gaps. However, the real-world uptake of such systems in health care settings has been suboptimal. We sought to: (1) use the Theoretical Domains Framework (TDF) to identify determinants (barriers/enablers) of uptake of the Electronic Asthma Management System (eAMS) CDSS; (2) match identified TDF belief statements to elements in the Guideline Implementation with Decision Support (GUIDES) Checklist; and (3) explore the relationship between the TDF and GUIDES frameworks and the usefulness of this sequential approach for identifying opportunities to improve CDSS uptake.

Methods
In Phase 1, we conducted semistructured interviews with primary care physicians in Toronto, Canada regarding the uptake of the eAMS CDSS. Using content analysis, two coders independently analyzed interview transcripts guided by the TDF to generate themes representing barriers and enablers to CDSS uptake. In Phase 2, the same reviewers independently mapped each belief statement to a GUIDES domain and factor. We calculated the proportion of TDF belief statements that linked to each GUIDES domain and the proportion of TDF domains that linked to GUIDES factors (and vice-versa) and domains.

Results
We interviewed 10 participants before data saturation. In Phase 1, we identified 53 belief statements covering 12 TDF domains; 18 (34.0%) were barriers, and 35 (66.0%) were enablers. In Phase 2, 41 statements (77.4%) linked to at least one GUIDES factor, while 12 (22.6%) did not link to any specific factor. The GUIDES Context Domain was linked to the largest number of belief statements (19/53; 35.8%). Each TDF domain linked to one or more GUIDES factor, with 6 TDF domains linking to more than 1 factor and 8 TDF domains linking to more than 1 GUIDES domain.

Conclusions
The TDF provides unique insights into barriers and enablers to CDSS uptake, which can then be mapped to GUIDES domains and factors to identify required changes to CDSS context, content, and system. This can be followed by conventional mapping of TDF domains to behaviour change techniques to optimize CDSS implementation. This novel step-wise approach combines two established frameworks to optimize CDSS interventions, and requires prospective validation.
Development, implementation, and evaluation of neonatal thermoregulation decision support web application
Authors: Beykmirza Raziyeh , Mehrabani Elahe Rastkar , Hashemi Maryam , Shahri Maryam Mahdizade , Negarandeh Reza , Varzeshnejad Maryam 
Published: October 2023

Abstract
Objectives
Thermoregulation is important for all age groups, and in neonates, it is considered a crucial event to adapt to extrauterine life. Therefore, using systems that provide frequent reminders in different ways in the field of thermoregulation can help thermal stability in neonates. The present study aimed to develop, implement, and evaluate a neonatal thermoregulation decision support system (DSS) as a web application.

Methods
The present research was a multi-method study because it included the three phases of development, implementation, and evaluation of the neonatal thermoregulation decision support web application. In the system designing phase, the waterfall model is used. The second and third phases of the study, implementation, and evaluation, were conducted as a quasi-experimental study.

Results
The results of this study were presented in two parts: the developed web application, and the results of the evaluation of the web application. The results of the statistical tests revealed that the use of the web application had a positive and significant effect on both the adjustment of the temperature of the incubator (maintaining the neutral temperature) and the maintenance of the temperature of the neonate’s body (p = 0.000).

Conclusions
These results indicate that a nurse’s sensitization and guidance with a neonatal thermoregulation decision support system can help to effectively neonate thermoregulation and the nurse has brought the temperature care close to the standard care based on the conditions of each neonate.
Interpreting deep learning models for glioma survival classification using visualization and textual explanations
Authors: Osadebey Michael , Liu Qinghui , Fuster-Garcia Elies , Emblem Kyrre E. 
Published: October 2023

Abstract
Background
Saliency-based algorithms are able to explain the relationship between input image pixels and deep-learning model predictions. However, it may be difficult to assess the clinical value of the most important image features and the model predictions derived from the raw saliency map. This study proposes to enhance the interpretability of saliency-based deep learning model for survival classification of patients with gliomas, by extracting domain knowledge-based information from the raw saliency maps.

Materials and methods
Our study includes presurgical T1-weighted (pre- and post-contrast), T2-weighted and T2-FLAIR MRIs of 147 glioma patients from the BraTs 2020 challenge dataset aligned to the SRI 24 anatomical atlas. Each image exam includes a segmentation mask and the information of overall survival (OS) from time of diagnosis (in days). This dataset was divided into training ($$n=118$$

n
=
118

) and validation ($$n=29$$

n
=
29

) datasets. The extent of surgical resection for all patients was gross total resection. We categorized the data into 42 short (mean $$\mu =157$$

μ
=
157

days), 30 medium ($$\mu =369$$

μ
=
369

days), and 46 long ($$\mu =761$$

μ
=
761

days) survivors. A 3D convolutional neural network (CNN) trained on brain tumour MRI volumes classified all patients based on expected prognosis of either short-term, medium-term, or long-term survival. We extend the popular 2D Gradient-weighted Class Activation Mapping (Grad-CAM), for the generation of saliency map, to 3D and combined it with the anatomical atlas, to extract brain regions, brain volume and probability map that reveal domain knowledge-based information.

Results
For each OS class, a larger tumor volume was associated with a shorter OS. There were 10, 7 and 27 tumor locations in brain regions that uniquely associate with the short-term, medium-term, and long-term survival, respectively. Tumors located in the transverse temporal gyrus, fusiform, and palladium are associated with short, medium and long-term survival, respectively. The visual and textual information displayed during OS prediction highlights tumor location and the contribution of different brain regions to the prediction of OS. This algorithm design feature assists the physician in analyzing and understanding different model prediction stages.

Conclusions
Domain knowledge-based information extracted from the saliency map can enhance the interpretability of deep learning models. Our findings show that tumors overlapping eloquent brain regions are associated with short patient survival.
Effect of patient-centered and family-centered self-care education program on the quality of life of patients with multiple sclerosis: a quasi-experimental study
Authors: Rooddehghan Zahra , Nezhad Mozhgan Moghaddasi , Zakerimoghadam Masoumeh , Karimi Raoofeh 
Published: October 2023

Abstract
Background
Performing self-care behaviors education improves the quality of life of MS patients and reduces their fatigue. This study was conducted with the aim of comparing the effect of patient-centered and family-centered self-care training programs on the quality of life and fatigue of patients with multiple sclerosis.

Methods
This is a quasi-experimental study that was conducted on the MS patients referred to the Iranian MS Association. Sampling was done by convenience method from November 2017 to September 2018. To create a random sequence in the three groups, blocks of nine were used. The control group received no intervention but the intervention groups 1 and 2 received the desired training in the form of workshop with the difference that in the intervention group 2, the patient participated in the training sessions along with one of his/her family members. The phone call follow-up was continued for 8 weeks after the last session. The questionnaire of quality of life in patients with MS (MSQOL-54), fatigue scale (FIS) and demographic information form were used for data collection. The collected data was analyzed by SPSS-16 statistical software, using descriptive (Mean and Standard deviation) and statistical statistics (paired t-test, Analysis of variance and Bonferroni).

Result
A statistically significant difference in the mean scores of quality of life(53/16 ± 15/19 vs 56/03 ± 14/40 vs 52/48 ± 21/20)(P < 0.001) and fatigue(50/08 ± 3/28 vs 46/54 ± 28/69 vs 56/11 ± 27/93) (P < 0.001) was observed between both patient-centered and family-centered groups and the control group.

Conclusions
Considering the importance and role of the family and nurses in the care and education of patients with multiple sclerosis, it is possible to improve the quality of life and reduce their fatigue by providing self-care training packages to patients and their families.