title
stringlengths
1
1.19k
keywords
stringlengths
0
668
concept
stringlengths
0
909
paragraph
stringlengths
0
61.8k
PMID
stringlengths
10
11
Intervention
Children were randomized 1:1 to standard care management and a working memory cognitive training program (Cogmed software) for 8 weeks (25 sessions) (intervention) or to standard management (control).
PMC10485729
Main Outcomes and Measures
SECONDARY
The primary outcome was the visuospatial index score from the Wechsler Preschool and Primary Scale of Intelligence, 4th Edition. Secondary outcomes were working memory, intellectual functioning, executive and attention processes, language skills, behavior, quality of life, and schooling. Neurobehavioral assessments wer...
PMC10485729
Results
There were 169 children randomized, with a mean (SD) age of 5 years 11 months (2 months); 91 (54%) were female. Of the participants, 84 were in the intervention group (57 of whom [68%] completed at least 15 cognitive training sessions) and 85 were in the control group. The posttraining visuospatial index score was not ...
PMC10485729
Conclusions and Relevance
memory disorders
This randomized clinical trial found no lasting effect of a cognitive training program on visuospatial processing in children aged 5½ to 6 years with working memory disorders who were born very preterm. The findings suggest that this training has limited long-term benefits for improving executive function. Transient be...
PMC10485729
Trial Registration
ClinicalTrials.gov Identifier:
PMC10485729
Introduction
visual inhibition disorders, cognitive impairment
Children born very preterm may have neurobehavioral problems that impact school, family, social adjustments, and their adult lives.The EFs are high-level cognitive operations fundamental in learning and social adjustments.Specific computerized cognitive training programs supporting EFs have primarily focused on working...
PMC10485729
Methods
PMC10485729
Study Design
EPIREMED (A detailed description of the EPIREMED trial protocol has been previously published.
PMC10485729
Participants
Participants selected from the EPIPAGE 2 cohort
PMC10485729
Interventions
PMC10485729
Intervention Group
Two neuropsychologists trained in the computerized cognitive training program (developed for children aged 4-7 years) explained the process to the parent(s) or legal guardian(s) and provided WM and software information sheets. The professional scheduled and designed the structure of the sessions: 3 weekly 15-minute ses...
PMC10485729
Control Group
No rehabilitation program was conducted in the control group. The control group received customary care management with speech therapy and/or academic support for children experiencing academic difficulties.
PMC10485729
Outcomes
The primary outcome was the visuospatial index (VSI) score from the Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI-IV).
PMC10485729
Sample Size
A sample size of 64 participants per group (128 total) was selected to obtain 80% power to detect a mean (SD) difference of 7.5 (0.5) points on the VSI at 16 months after training between the 2 groups and was clinically significant compared with similar studies.
PMC10485729
Randomization
WM anomaly
A secure, computer-generated clinical research platform was used for participant randomization with a 1:1 allocation ratio. At the end of the initial visit, each child was randomly allocated to either the intervention or control group. This platform used a permuted block design stratified on the center and gemellarity:...
PMC10485729
Statistical Analysis
PMC10485729
Data Imputation
REGRESSION
Intention-to-treat analyses were done. To fortify the validity of the results and get the most accurate regression model estimates, a multiple imputation procedure was conducted before all analyses. The distribution of missing data are shown in eTable 6 in The imputation of multiple data sets was carried out using the ...
PMC10485729
Statistical Modeling of the Primary and Secondary Outcomes
±2
REGRESSION
To assess the effect of cognitive training on the outcomes at each time point (baseline and after finishing training at 6 months [±2 months] and 16 months [±2 months]), a mixed model for repeated measures was performed for each outcome. We systematically adjusted for confounding by including the following confounders i...
PMC10485729
Results
PMC10485729
Participants
Of the 3083 children in the EPIPAGE 2 cohort, 313 were eligible for the EPIREMED trial. The trial’s enrollment consisted of 169 children with a mean (SD) age of 5 years 11 months (2 months), mean (SD) FSIQ score of 88.5 (10.3), and mean (SD) WM score of 80.0 (5.3); 91 children (54%) were female, and 78 (46%) were male....
PMC10485729
Demographic and Clinical Characteristics of Participants at Birth and Randomization Baseline
Abbreviations: EPOPé, Obstetrical, Perinatal and Pediatric Epidemiology Research Team at the Center for Research on Epidemiology and Statistics Sorbonne Paris Cité; TFU, transfontanellar ultrasonography.Data are presented as the number of participants with data/total number (percentage) unless otherwise indicated.Highe...
PMC10485729
Neurodevelopmental Profile of Randomized Participants
Abbreviation: MABC-2, Movement Assessment Battery for Children, 2nd Edition.Effect size measures the size of the difference between the 2 groups. A positive value reflects a positive effect on the score and a negative value, a negative effect on the score in the intervention group. According to Cohen criteria, effect s...
PMC10485729
Outcomes
PMC10485729
Primary Outcome
There was no group difference in VSI score at a mean (SD) of 3.0 (1.8) months (difference, −0.6 points; 95% CI, −4.7 to 3.5 points) or 12.9 (2.6) months (difference, 0.1 points; 95% CI, −5.4 to 5.1 points) after finishing training, even after adjustment for both neurodevelopmental profile severity and multiple imputati...
PMC10485729
Treatment Group Differences at Inclusion and the Intermediate and Final Visits
REGRESSION
Results are adjusted for neurodevelopmental profile severity for 3 subtests of NEPSY, 2nd edition (auditory attention score, design fluency score, and inhibition score) and 1 subtest of the Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (processing speed index); the presence of an impairment in motor...
PMC10485729
Sensitivity Analysis Adjusted With Missing Data Imputations Restricted to 142 Children Who Completed at Least 15 Training Sessions
POSITIVE
Abbreviation: NA, not applicable.Group differences greater than or less than 0 reflect a higher or lower score in the intervention group, respectively.The Statistical Modeling of the Primary and Secondary Outcomes subsection of the Methods section gives the adjusted variables.Positive value reflects a positive effect o...
PMC10485729
Secondary Outcomes
At the intermediate point (mean [SD], 3.0 [1.8] months after finishing training), there was a positive effect of the cognitive training program on WM only (difference, 4.7 points; 95% CI, 1.2-8.1 points); even after adjustment and multiple imputation, this effect was not maintained long term (
PMC10485729
Discussion
’s behavior, WM impairment
In children born very preterm with WM impairment, a cognitive training program showed no medium-term or long-term effect on visuospatial skills. Activation of the WM was transient with no lasting retention and did not lead to any significant transfer near (other EFs, other cognitive functions) or far (concerning the ch...
PMC10485729
Limitations
This study has limitations. At 15 sessions, the sensitivity of our results improved, but our workforce’s power was reduced. The use of methods for imputing missing data preserved the statistical power used to estimate the sample size, and nonresponders were likely to have outliers. Therefore, the loss of these nonrespo...
PMC10485729
Conclusion
In this randomized clinical trial, there was no lasting effect of a cognitive training program on VSI scores in children aged 5½ to 6 years born very preterm, suggesting that it is challenging to improve EFs. Other studies also failed to find long-lasting effects, as reported in a previous meta-analyses.
PMC10485729
1. Introduction
NSCLC, tumor, death, non-small-cell lung cancer, Lung cancer, PD, primary lung tumor
DISEASE PROGRESSION, TUMOR, METASTASIS, DISEASE, LUNG CANCER, NSCLC, REGRESSION, PATHOLOGY
These authors contributed equally to this work.Health Canada approved pembrolizumab in the first-line setting for advanced non-small-cell lung cancer with PD-L1 ≥ 50% and no EGFR/ALK aberration. The keynote 024 trial showed 55% of such patients progress with pembrolizumab monotherapy. We propose that the combination of...
PMC10297400
2. Materials and Methods
PMC10297400
2.1. Patients
NSCLC, pembrolizumab, Tumor, cancer stage, hepatic and renal function, Cancer
TUMOR, MAY, NSCLC, ONCOLOGY, AUTOIMMUNE DISEASE, CANCER
We obtained approval from the institutional review board for this study. The review board waived the requirement for written informed consent for this study, as it is a retrospective study with minimal risk. Patients were identified using a retrospective data access request for NSCLC patients referred to the single cen...
PMC10297400
2.2. CT Scan Acquisition and Review
tumor, SD, Tumors, PD, primary lung tumor
DISEASE, TUMOR, METASTATIC DISEASE, TUMORS
The baseline and first FU CT scans were acquired according to the standard body scanning protocols at our institution. All CT scans used a GE Light Speed CT scanner (GE Healthcare, Milwaukee, WI, USA), with an intravenous iodinated contrast injection obtained at the portal venous phase for the chest, abdomen, and pelvi...
PMC10297400
2.3. Statistical Analysis
PD, death, primary lung tumor
REGRESSION, DISEASE PROGRESSION, DISEASE
The primary endpoint for this study was progressive disease (PD). The explanatory variables were baseline characteristics, including the primary lung tumor size and “number of involved organs”, from the CT and patient’s age, sex, smoking status and pack years, and ECOG.To illustrate the relationship between PD and the ...
PMC10297400
3. Results
PMC10297400
3.1. Summary of Patient’s Baseline Characteristics and Treatment Response at the 1st Follow-Up CT
PD
A total of 138 eligible patients (53% female) were included, with a median age of 73 years ranging from 61 to 91 years. ECOG ranged from 0 to 4, with 81/138 (59%) having an ECOG ≤ 1 and 53/138 (38%) with ECOG ≥ 2, while 4/138 (3%) had an unknown ECOG status. Most patient (92%) were current or ex-smokers (At first FU CT...
PMC10297400
3.2. Comparison of the Baseline Variables between Patients with PD vs. DC
Descriptive analyses of 138 patients are shown in
PMC10297400
3.4. Performance of the MV Logistic Regression Model in Classifying PD or DC
Ten patients (7% of 138) were excluded in this step due to missing data in either smoking or ECOG, and hence, the final model was conducted on 128 patients. The final MV logistic model demonstrated a good classification performance with an AUC of the ROC at 0.79 (95% CI: 0.71–0.84) (
PMC10297400
3.5. Individual Predicted “Risk of Progression” and Predicted “High- vs. Low-Risk of Progression” Groups
PD
An equation to calculate a patient’s predicted “risk of progression” derived from the above MV model was as follows:Then, the patients were classified into the “low-” or “high-risk of progression” group if the calculated risk value was lower or higher than the Youden or topleft cut-off. When using the Youden cut-off, 9...
PMC10297400
3.6. Survival (PFS and OS) of the Predicted “High- vs. Low-Risk of Progression” Groups
For PFS, the median follow-up time was 9 months (Q1–Q3: 4.3–14.8 months), and 56 were progression-free survivors. For OS, the median follow-up time was 19.2 months (Q1–Q3: 8.6–35.3 months), where 44 were survivors. The PFS and OS of the predicted “high- vs. low-risk of progression” groups were demonstrated by Kaplan–Me...
PMC10297400
4. Discussion
NSCLC, cancers, RET, cancer, lung cancer, PD, primary lung tumor
CANCERS, CANCER, DISEASE, LUNG CANCER, NSCLC, REGRESSION, DISEASES
The present results show, in advanced NSCLC patients who are eligible for the currently standard first-line pembrolizumab monotherapy, their baseline burden of disease estimated with CT using the “number of involved organs” and smoking history/pack years as independent predictors of an adverse response (i.e., progressi...
PMC10297400
Author Contributions
C.H.
Conceptualization, C.H., J.Z., S.L., C.M., B.M. and R.Y.; Methodology, C.H., Q.Y., J.Z., S.L., C.M., B.M. and R.Y.; Formal Analysis, Q.Y. and L.W.; Investigation, A.S., I.J., J.L., M.M., Y.W., B.M. and R.Y.; Resources, C.H. and B.M.; Data Curation: C.H., B.M. and R.Y.; Writing—original draft preparation, A.S., C.H., Q....
PMC10297400
Institutional Review Board Statement
We obtained approval from the institutional review board for this study (UBC/BCCA REB #H19-01597). The review board waived the requirement for written informed consent from subjects for this study, as it is a retrospective study with minimal risk.
PMC10297400
Informed Consent Statement
Not applicable.
PMC10297400
Data Availability Statement
The data generated or analyzed during the study are available from the corresponding author by request.
PMC10297400
Conflicts of Interest
Johnson and Johnson and Novartis
EMD
A.S. reports no competing interest. C.H. reports grants from AstraZeneca, EMD Serono, and Roche and receives honoraria from Abbvie, Amgen, Astra Zeneca, Bayer, BMS, Eisai, EMD Serono, Janssen, Jazz, Merck, Novartis, Pfizer, Roche and Takeda. Q.Y. reports no competing interests. J.Z. reports grants from Merck; grants an...
PMC10297400
Objectives
To prospectively compare the results of microvascular flap reconstruction of midface and scalp advanced oncologic defects using superficial temporal versus cervical as recipient vessels.
PMC10300290
Methods
GROUP B, COMPLICATIONS
This is a parallel group clinical trial with 1:1 allocation ratio of patients who underwent midface and scalp oncologic reconstruction with free tissue flap from April 2018 to April 2022 in a tertiary oncologic center. Two groups were analyzed: those in whom superficial temporal vessels were used as the recipient vesse...
PMC10300290
Results
GROUP B, COMPLICATION
On the basis of the different recipient vessels, 32 patients were randomized into 2 groups, and of these 27 patients completed the study: Group A with superficial temporal recipient vessels (n = 12) and Group B with cervical recipient vessels (n = 15). There were 18 male and 09 female patients with an average age of 53...
PMC10300290
Conclusion
COMPLICATIONS
In the group with superficial temporal recipient vessels, the postoperative rate of free flap complications was similar than the cervical recipient vessel group. Therefore the use of superficial temporal recipient vessels for midface and scalp oncologic reconstruction could be a reliable option.
PMC10300290
Keywords
PMC10300290
Introduction
thrombosis, head and neck surgeon, vasospasm
THROMBOSIS, VASOSPASM
Advanced oncologic defects of the midface and scalp are a significant challenge to the reconstructive head and neck surgeon, who must consider the need for midfacial projection, rehabilitation, and function restoration. Soft free tissue flaps, such as anterolateral thigh flaps, The superficial temporal vessels have been ...
PMC10300290
Methods
head and neck surgery, Cancer
GROUP B, COMPLICATIONS, CANCER
We performed a parallel group clinical trial in patients who underwent midface and scalp reconstruction with free tissue flaps in the department of head and neck surgery of the Brazilian National Cancer Institute from April 2018 to April 2022. This study was approved by the IRB of the Brazilian National Cancer Institut...
PMC10300290
Statistical analysis
non-melanoma advanced skin cancers
Sample-size estimation was performed using OpenEpi (openepi.com). In Brazil, the estimated incidence of non-melanoma advanced skin cancers that affect the midface and scalp and are eligible for surgery is 800 cases/year (see
PMC10300290
Results
thrombosis, squamous cell carcinoma of the left midface, venous thrombosis, microvascular vascular anastomosis obstruction
THROMBOSIS, ARTERIAL THROMBOSIS, GROUP B, MINOR, RECRUITMENT, COMPLICATION, VENOUS THROMBOSIS, COMPLICATIONS, ARTERIAL THROMBOSIS
Thirty-two patients were selected and randomized into two groups. Five patients were excluded from the study. The total study period was developed prospectively over 4 years (from April 2018 to April 2022) with the recruitment period occurring during the initial 45 months. The minimum follow-up of the patients was 3 mo...
PMC10300290
Discussion
head and neck reconstruction
SECONDARY, ADVANCED CANCER, COMPLICATIONS
Few articles have specifically compared the postoperative results based on the choice of the recipient vessels in midface and scalp microvascular reconstruction.The superficial temporal vessels are readily available, and their suitability as recipient vessels for microvascular free tissue flap in head and neck reconstr...
PMC10300290
Conclusion
SECONDARY, COMPLICATION
Midface and scalp advanced oncologic reconstruction using cervical or superficial temporal recipient vessels did not differ in terms of success and complication rates. Therefore, the use of superficial temporal recipient vessels may be a reasonable option, especially in a secondary reconstruction setting.
PMC10300290
Funding
The study had own financing.
PMC10300290
Conflicts of interest
The authors declare no conflicts of interest.
PMC10300290
References
PMC10300290
Supplementary data
The following are Supplementary data to this article:Supplementary material related to this article can be found, in the online version, at doi:
PMC10300290
Introduction
PMC10016654
Mental health and the COVID pandemic
Psychiatric
Mental health issues were already of concern for organisations before the COVID-19 pandemic. Adult Psychiatric Morbidity Survey 2014 conducted in a large and representative British sample has positioned the overall prevalence of mental health problems in adults over 16 years of age at 18.9%, an increase from 17.6% in 2...
PMC10016654
The concept of resilience
anxiety, adversity, traumatic, depression, multiple stressors
Many employees are able to deal with stressors individually. However, an accumulation of multiple stressors as well as an extended duration of exposure to stress could lead to a detrimental impact on the psychological and physical well-being of employees, as well as on their performance at work [The concept of resilien...
PMC10016654
Team resilience
Resilience is not a single trait, but, rather, a function supported by a whole range of resources that exist both at the individual level (psychological and physiological resources) and the level of the environment (community, team, organisation resources, etc.) [In recent years, research has started to focus on resili...
PMC10016654
SPARK Resilience programme
There is evidence that the psychological mechanisms of workplace resilience can be developed by means of structured training and workshops using a wide variety of techniques identified in the literature [A recent meta-analysis of data from 1,584 samples indicates small to moderate efficacy (Hedges’ One of the multiple ...
PMC10016654
SPARK Resilience in the workplace intervention protocol
ALBERT
The development of the SPARK model was informed by the original ABC model of Albert Ellis [
PMC10016654
The SPARK Resilience model.
Whilst the SPARK model can be used as a coaching tool in itself, its most important role is that of an organising framework that could help structure and introduce multiple strategies and tools aimed to enhance resilience. Each of the SPARK factors is used to introduce relevant resilience-enhancing strategies, enabling...
PMC10016654
The SPARK solutions model.
PMC10016654
SPARK Resilience in the workplace sessions and associated tools.
SESSION
The final three sessions are devoted to helping participants apply these skills in their workplace context. Session 6 helps the participants to select personally relevant techniques that can be used under pressure. It introduces KRAP, an inversed SPARK tool using the “Knowledge–Reaction–Affect–Perception” sequence base...
PMC10016654
Aim of the present study
The present study aimed to investigate the effectiveness of the SPARK Resilience Programme in an online (distance-based) setting using a mixed-method approach to inform the future adaptation of the program to a distance-based format.
PMC10016654
Methods
PMC10016654
Participants and procedure
The study used a two-group non-randomised controlled design with a pre-test and a post-test. The data were collected in April 2020. The participants were French-speaking volunteers who enrolled in the SPARK Resilience Programme. The intervention was delivered in a group coaching format via synchronous video conferencin...
PMC10016654
Resilience scale
EVENT
We used 7 items theoretically informed by the two-facet general definition of resilience as a combination of capacity for recovery (“I am able to adapt to change”, “I tend to bounce back from illness or difficulties”, “I can cope with any unexpected event”) and resistance (“Under pressure, I concentrate and think clear...
PMC10016654
Personal meaning scale
POSITIVE
This brief scale was validated as part of Positive Organisational Profile [
PMC10016654
Perceived Stress Scale (PSS) [
We used the 10-item version of this instrument (PSS-10) with a 5-point Likert response scale going from 1 “Never” to 5 “Very often”. We asked the participants to evaluate their experiences during the past week. Sample items: “…have you felt that you were unable to control the important things in your life?”, “…have you...
PMC10016654
Data analysis
PMC10016654
Quantitative analyses
To investigate the differences between the groups in the change from pre-test to post-test, we used univariate ANCOVA to compare the scores in the two groups at post-test, controlling for the pre-existing individual differences (i.e., pre-test scores) [
PMC10016654
Qualitative analyses
The answers to the three open-ended questions submitted by participants (from both the April and the June waves) were combined and analysed using thematic analysis [
PMC10016654
Results
PMC10016654
Quantitative findings
The descriptive statistics for both groups and the results of hypothesis tests are given in
PMC10016654
Descriptive statistics.
Note.* Student’s paired-samples t-test According to ANCOVA, the group differences in change from pre-test to post-test were statistically significant for all 6 dependent variables. The strongest effects were observed for meaning (The simple effects analyses using paired-samples Student’s t-test revealed a statistically...
PMC10016654
Qualitative data
The qualitative accounts were provided by 151 individuals from both groups who took part in the intervention either at Wave 1 or at Wave 2 (following the wait-list period). Based on coding, we identified six main themes: solution focus/action orientation, awareness of emotion-cognition interaction, growth after adversi...
PMC10016654
Awareness of emotion-cognition interactions
EVENTS, SAID
Developing an understanding of the SPARK model involves identifying the situation, perception, affect, reaction, and knowledge in application to real-life situations. This theme reflects participants’ experiences of being aware of the interaction between the way one interprets events and the subsequent associated emoti...
PMC10016654
Growth from adversity
adversity
EVENTS
This theme unites participants’ experiences of their capacity to grow following challenging and painful incidents by finding meaning and by making sense of what happened. This process involves redefining one’s identity and self-perception after life-shaking events, as well as discovering and relying on one’s strengths ...
PMC10016654
Emotion regulation strategies
This theme comprises the experiences of using emotion regulation strategies to deal with difficult emotions recounted by participants. Strategies to regulate emotions involved a variety of helpful actions, such as expressing gratitude, listening to music, meditating, making a pause in one’s work day, and looking at the...
PMC10016654
Mental health
anxiety
SAID
About half of the participants observed that their mental health was enhanced by SPARK resilience training. In particular, resilience and psychological resources appeared to have been strengthened, with participants expressing feeling stronger, more loving, and having more dignity and hope. For instance, one participan...
PMC10016654
Relationships and communication
Finally, the development of positive relationships and more effective communication with others emerged as one of the results. Some participants have experienced being more able to receive and welcome help from others, for example: “I have found people on my way on whom I could rely and I am now surrounded by a stable ...
PMC10016654
Discussion
depression, anxiety
Although the SPARK Resilience programme has been evaluated in quantitative studies using adolescent samples [The quantitative findings that we observed are in line with those obtained in previous studies. Pluess and colleagues [The effects that we observed in the present study are not only statistically significant but...
PMC10016654
Limitations
Obviously, the study is not without its limitations. The first limitation is its modest sample size. According to sensitivity analyses, the resulting sample has allowed to attain sufficient power (.80) for small to medium-sized effects of the intervention (ηSecond, the sample was not representative and heterogeneous wi...
PMC10016654
Conclusion
Psychological science tells us that resilience can be developed, with evidence pinpointing to multiple resources that can be built through deliberate coaching, training, and positive interventions. SPARK Resilience can be used as a brief coaching model, but also as a structured coaching approach to organise work with i...
PMC10016654
Supporting information
(XLSX)Click here for additional data file.
PMC10016654
References
PMC10016654
Subject terms
The aim of this study was to examine the effectiveness of a stress management educational intervention programme based on the Transactional Model of Stress and Coping (TMSC) among industrial workers. Participants were 106 employees of a power plant in Iran, randomly assigned into an intervention group and a control gro...
PMC10050170
Introduction
’
Employees are exposed to a range of physical and psychosocial risks at their workplaces according to occupationStress management is a poorly defined conceptThe conceptualisation of coping in the context of stress has for many years revolved around the work of Lazarus and Folkman. Their Transactional Model of Stress and...
PMC10050170
Method
The Scientific and Ethics Committee of Shiraz University of Medical Sciences approved the study protocol (IR.SUMS.REC.1399.372). The research was conducted in accordance with the Declaration of Helsinki, and all participants provided written informed consent.
PMC10050170
Study design and participants
psychiatric
This study used a randomized controlled trial (RCT) design with a 1:1 ratio. Participants were employees of a combined cycle power plant in Iran. The company had 211 employees at the time of the study, all employees worked one of two teams, each working rotating 12-h shifts. Inclusion criteria were having more than one...
PMC10050170
Measures
PMC10050170
Demographic information
Demographic variables—age, sex, marital status, education level, job tenure, and employment status—were assessed at baseline.
PMC10050170