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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 were performed at inclusion and after finishing training at 6 months (intermeditate assessment; secondary outcomes) and at 16 months (final assessment; primary outcome). | 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 different between groups 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). The working memory index score in the intervention group significantly improved from baseline at the intermediate time point (difference, 4.7 points; 95% CI, 1.2-8.1 points), but this improvement was not maintained at the final assessment. | 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 benefits seemed to be associated with the developmental state of executive functions. | 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 memory (WM) training with a cognitive training program (Cogmed) or a general approach to training all EFs (Brian; BrainGame).Finally, children born very preterm are at risk for global or local visual processing difficulties, which appear to be partly mediated by visual inhibition disorders.Our study assessed both the ability of a computerized cognitive training program for WM to improve long-term visuospatial abilities in children born very preterm and its effect on overall executive functions. If successful, this study could facilitate a preventative cognitive impairment strategy in children born very preterm. | 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 sessions for 8 weeks. Sessions were conducted at home or at the inclusion center.The child, accompanied by an adult, completed a series of interactive activities automatically adapted for each individual. After each session, the neuropsychologist checked the adherence and results online. The program calculated a performance score representing the difference between the maximum and starting levels and offered analysis of the child’s progress compared with their baseline. | 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: singleton or twin (ie, if 1 twin had a WM anomaly, only this child was selected for randomization; if both twins had a diminished WM, both were randomized to the same group to reduce contamination). Children randomized to the intervention group received cognitive training. | 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 chained equations algorithm. | 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 in the mixed regression model: neurodevelopmental profile severity (for 3 subtests of NEPSY, 2nd EditionAn additional sensitivity analysis using the previous mixed model was conducted for participants who completed at least 15 training sessions by recommendations of the cognitive training program to assess the conclusions’ robustness. When appropriate, 95% CIs were presented. The α level of significance was set at 5%; hence, 2-sided Another sensitivity analysis was conducted for participants who completed at least 20 or 25 cognitive training program sessions. Data were analyzed from February to December 2020 using IBM SPSS Statistics for Windows, version 20.0. The statistical analysis plan is available in | 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. Among these children, 84 were randomized to the intervention group and 85 to the control group. The retention rate at a mean (SD) of 3.0 (1.8) months was 91% and at a mean (SD) of 12.9 (2.6) months was 80% ( | 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.Higher socioprofessional status comprises 3 working categories: managerial, intermediate, and administrator. Lower socioprofessional status comprises 2 categories: domestic or sales employee.Mild was defined as 28 or more days of oxygen and spontaneous respiration-room air at 36 weeks; moderate, 28 or more days of oxygen and mechanical ventilation or continuous positive airway pressure or fraction of inspired oxygen greater than 21% at 36 weeks; and severe, 28 or more days of oxygen and mechanical ventilation or continuous positive airway pressure or fraction of inspired oxygen 30% at 36 weeks.At least 1 parent with a minimum of 1 year of university education. | 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 sizes could be categorized as small (0.2), medium (0.5), or large (≥0.8).Children who benefitted from any of the following school assistance: special needs teaching assistant, assistance by any other professional, technical aid, personalized educational plans for children with disabilities, and other types of support. Data were missing for 20 participants (12%).Children who, in the 12 months before inclusion in the study, were followed up at a specialist center (Early Medical-Social Action Centers and Medical Psychologic Centers of Early Childhood) or benefited from 1 or more medical consultations by the following professionals: psychologist, psychometrician, orthoptist, speech therapist, and/or physiotherapist. Data were missing for 21 participants (12%).The participants randomized to the intervention group completed a mean (SD) of 18.1 (9.1) training sessions. Among them, 57 children (68%) completed 15 or more sessions, 52 (62%) completed 20 or more sessions, and 43 (51%) completed 25 sessions, with mean (SD) progression index scores of 23.4 (6.4), 23.8 (6.3), and 24.0 (6.3), respectively. The workforce’s power was reduced to 32% at 15 sessions, 38% at 20 sessions, and 49% at 25 sessions (eTable 3 in | 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 imputation ( | 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 performance as assessed by the Movement Assessment Battery for Children, 2nd Edition (scores ≤5th percentile); and gestational age, birth weight, child’s sex, parents’ socioprofessional status, and parents’ educational level. Point estimates reflect regression coefficients from mixed-effects models with missing data imputations, and error bars represent 95% CIs. Group difference greater than 0 reflects a higher score in the intervention group, and less than 0 reflects a lower score. Language skills were assessed using the Communiquer, Lire et Écrire Pour Apprendre. | 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 on the score and a negative value, a negative effect on the score in the intervention group.Assessed using Communiquer, Lire et Écrire Pour Apprendre. | 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 child’s behavior, quality of life, or learning).This large study is, to our knowledge, the first multicenter computerized WM cognitive training study involving children aged 5 to 6 years born very preterm with a long-term effect evaluation. Among the few studies using the same cognitive training program in children born prematurely, the population size, conditions of the control group, waiting list or active group,Similarly, it should be noted that quality of adherence (progression index) is difficult to achieve. In our study, as in the IMPRINT study,Long-term outcome assessments were comprehensively extended to cognitively trained WM and nontrained functions, such as visuospatial skills. We consider the VSI as sound according to different criteria: (1) children born very preterm are particularly at risk of developing local or global processing difficulties mediated by the inhibition visual disordersFor preschool-aged children born very preterm whose entire neurological development is affected (cognitive, behavioral, and social components), | 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 nonresponders could underestimate variability and thus result in an artificially narrow CI for the cognitive training effect. Even if the randomization was homogeneous on the basic eligibility criteria, this would not reflect a potential flaw in the randomization process or a random allocation of severity. The groups born very preterm presented heterogeneity in the severity of their neurodevelopmental profile,At baseline, the intervention group had fewer special educational services. During the training, this frequency was not reported, although this might have influenced the outcome. The neuropsychological assessment was carried out by testers not blinded to the child’s assignment to either the intervention group or the control group; the tester could have given parents suggestions to improve the poor results in the control group, thereby reducing a potential effect of the intervention, or in other ways as if it were an expectancy bias that the intervention should work. However, we found no other options to ensure the feasibility of the study, and testers were asked to adhere to the test guidelines as much as possible. | 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 baseline CT and clinical factors can help identify those patients who may progress. In 138 eligible patients from our institution, we retrospectively collected their baseline variables, including baseline CT findings (primary lung tumor size and metastatic site), smoking pack years, performance status, tumor pathology, and demographics. The treatment response was assessed via RECIST 1.1 using the baseline and first follow-up CT. Associations between the baseline variables and progressive disease (PD) were tested by logistic regression analyses. The results showed 46/138 patients had PD. The baseline CT “number of involved organs” by metastasis and smoking pack years were independently associated with PD (Lung cancer remains the leading cancer-related death globally, with the 5-year survival at 22% [The KN024 trial demonstrated that pembrolizumab monotherapy improved the overall response rate (ORR) and overall and progression-free survival (OS and PFS) compared to platinum doublet chemotherapy (PDC) in the first-line setting for advanced NSCLC patients with a high PDL1 expression (i.e., ≥50%) and no EGFR/ALK aberration [The goal of this study was to identify, in advanced NSCLC patients with PD-L1 ≥ 50% and no EGFR/ALK aberration, which baseline features could predict a patient’s future disease progression assessed radiographically at the first follow-up CT. There have been no clinical radiologic studies that have specifically correlated the baseline CT disease features to the treatment response. We propose that the combination of a patient’s baseline CT findings and clinical factors, including smoking pack years, can predict the treatment response and can be used to guide first-line treatment decisions in this PD-L1 high cohort. | 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 center at British Columbia Cancer from 1 January 2015, to 31 May 2019. We consecutively recruited patients meeting the following eligibility criteria: males and females from all races and ethnic groups who received first-line monotherapy with pembrolizumab for stage IIIB or IV NSCLC without EGFR mutation or translocation of the ALK gene and with PD-L1 expression ≥50% (as determined by the Stand-of-Care IHC assay used at our institution). All had adequate hepatic and renal function. All must have had a baseline staging CT ≤ 6 weeks prior to starting treatment and the first follow-up (FU) CT within 9 to 12 weeks after treatment initiation for the response assessment. Patients were excluded if they received concurrent chemotherapy, any other form of immunotherapy, or radiation; had an active, known, or suspected autoimmune disease; or received long-term immunosuppressive therapy or systemic corticosteroids (requiring more than 10 mg prednisone/day or equivalent).The baseline demographic characteristics were collected, including age, sex, Eastern Cooperative Oncology Group performance status (ECOG), and smoking status and pack years (PY), where a light to never smoker was defined as a patient who had smoked fewer than 100 cigarettes. Tumor histologic subtype and cancer stage at presentation were also collected. | 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 pelvis, with the images reconstructed using a 2 or 2.5 mm slice thickness. Imaging of the brain included pre- and post-IV contrast scans from a CT and/or MRI. All follow-up scans were acquired using the same protocol.Two board-certified oncology radiologists, with 8 and 20 years of experience in tumor burden measurements/response assessments, performed the imaging analysis while blinded to the patient outcome data. Any question from the imaging analysis was resolved by the consensus of the two radiologists. For the baseline CT, the radiologists measured the largest dimension of the primary lung tumor, documented the sites of metastatic disease, and summed the total “number of involved organs” as an estimate of the disease burden (Next, the baseline and first FU CT were compared to assess the treatment response as per the Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.1) [According to RECIST V1.1, progressive disease (PD) was at least a 20% increase in the sum of the diameters of the target lesions (with the sum also demonstrating an absolute 5 mm increase in size). A complete response (CR) was the disappearance of all target lesions and reduction of pathological lymph nodes to a <10 mm short axis. A partial response (PR) was at least a 30% decrease in the sum of the diameters of the target lesions. A stable disease (SD) had neither sufficient shrinkage to qualify for PR nor was sufficient to qualify for PD. Patients were dichotomized into the “progressive disease, PD” group or “disease control, DC” group if they demonstrated CR, PR, or SD. | 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 baseline characteristics, we first compared the baseline characteristics between two response groups (PD vs. DC) using the Kruskal–Wallis test for continuous, and chi-square or Fisher’s exact test for categorical, variables.Then, the associations between the baseline characteristics and PD were examined using uni- and multivariate (MV) logistic regression analyses. To restrict the number of variables in the MV analysis, we considered only the variables that showed a trend of significant associationd with PD (Then, individual patient’s “risk of progression” was calculated using the best MV logistic model (patients were excluded from the MV model if there were missing data in any of the explanatory variables). Patients were separated into the “low-” or “high-risk of progression” group by comparing their calculated risk to the Youden or topleft cut-off (i.e., high- vs. low-risk was defined if the calculated risk was higher or lower than the Youden or topleft cut-off).The progression-free survival (PFS) and overall survival (OS) between the predicted high- vs. low-risk progression groups were compared by Kaplan–Meier plots using log-rank tests. PFS was defined as the time from starting pembrolizumab to the earliest CT date that showed disease progression or the latest available CT date for patients with no sign of progression. OS was defined as the time from starting pembrolizumab to death or the date of the last follow-up.All statistical analyses were performed with R software (Version 4.1.3. 2022-03-10. R: The R Project for Statistical Computing (r-project.org). All statistical tests were two-sided and considered significant with a | 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, 46/138 (33%) showed PD and 92/138 (67%) patients had DC, including 1 (1%) CR, 51 PR (37%), and 40 SD (29%). The objective response rate (ORR) was 38% (ORR = CR + PR/138). The baseline variables are summarized and compared between the PD and DC groups in | 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, 93% (38/41) of PD patients were accurately captured in the “high-risk of progression” group, indicating a high sensitivity of the Youden index (0.93), compared to 71% (29/41) when using the “topleft” cut-off. In contrast, using the topleft cut-off, 74% (64/87) of patients who achieved DC were accurately captured in the “low-risk of progression” group, indicating a high specificity (0.74) of the topleft cut-off, compared to 54% (47/87) when using the “Youden” cut-off (Two example cases showing consistency between the real-world responses and predicted risk of progression are shown in | 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–Meier plots ( | 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., progressive disease, PD) to this treatment. Those who have no smoking history and a higher burden of disease on the baseline CT are at an increased risk of PD. Although smoking is associated with the response to pembrolizumab, compared to smokers with >40 pack years, those with ≤40 pack years have a higher risk for developing PD. For these high risk of progression patients, physicians may consider offering chemotherapy immunotherapy, or immunotherapy combinations upfront to provide more effective early control of the disease.Studies have shown that some clinical parameters could facilitate response identification, such as age, gender, ECOG, and smoking status [From a clinical perspective, misclassifying patients belonging to the PD group (i.e., misclassifying a PD patient into the low-risk of progression group) is arguably more detrimental than misclassifying a DC patient. Therefore, we think the Youden cut-off may be preferred when using this MV prediction model to identify patients at a higher risk to progress, because the corresponding SN with the Youden cut-off is 0.93, which indicates that 93% of patients who are indeed in the PD group will be correctly predicted by the model as the “high-risk of progression group”, in contrast to only 71% if using the “topleft” cut-off.In the current study, we used the “number of involved organs” (by diseases) counted using the baseline CT as the surrogate for the “overall disease burden”, and its positive association with PD suggested a relationship between widespread disease (i.e., more organ involvement) and a poor response to pembrolizumab monotherapy. This measure is not precisely how RECIST 1.1 describes the “disease burden”, as it does not consider the size of each target lesion. However, the multivariate logistic regression showed that it was significantly associated with the response outcome, while the “size of the primary lung tumor” was not. In addition, although it may not be as accurate as RECIST that was commonly used in the trial, in clinical practice, the “number of involved organs” could easily be quantified during the radiological review without labor-intensive measurements for each lesion. We think “the number of involved organs” on a CT could be a simple, meaningful, and practical measures that have the potential to guide the selection of therapy in clinical practice, with the consideration of adding chemotherapy or another immunotherapy. To our knowledge, this has not been reported, and this CT measure may expand our knowledge of the clinicoradiological characteristics of the subsets of this high PD-L1 cohort.The impact of smoking history on the therapeutic response to immunotherapy has been reported, while there is limited data about the effect of pack years and the response in smokers. A recent meta-analysis supported that smoking history could be a simple index to guide the selection of potential responders to immunotherapy among NSCLC patients [Our study endpoint was the treatment response (i.e., PD vs. DC) rather than survival. We chose so, because treatment switching often relies on the response assessed radiographically at the FU CT in clinical practice, and it was the PD patients that we aimed to identify at the baseline before commencing treatment. In addition, we used the disease control (DC) rate (sum of CR, PR, or SD) to reflect the “response to treatment” [Since the discovery of a checkpoint blockade through the anti-PD-1- and anti-PD-L1-based immunotherapies and their successful application in cancers, including lung cancer, identifying which patients are most likely to respond remains a challenge [From a medical imaging perspective, artificial intelligence (AI) and the CT imaging radiomic analysis have demonstrated remarkable progress and are expected to identify wide applications in assessing treatment responses. Future studies using radiomics in this cohort may identify radiomic features that can provide added value to the current results and serve as a “digital biomarker” to predict the responses to immunotherapy in this cohort.The strength of our study is in having a homogeneous patient population (i.e., all patients had PDL1 > 50%, no EGFR and ALK aberrant, received upfront pembrolizumab monotherapy, and had baseline and subsequent CT scans to assess the responses), which enabled us to study this important question. Our study had several limitations. First, it was a retrospective study based at a single cancer center with a relatively small sample size, and most of the patients included were Caucasians. Whether these findings are applicable to other patient populations remains unknown. Secondly, except for EGFR and ALK, the mutation status of many targetable mutations that may impact benefit from ICI are unknown. There is evidence indicating ROS1, RET fusion, and MET exon 14 mutations could associate with an inadequate response to ICIs despite high PD-L1 expression [ | 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.Y., J.Z., B.M. and R.Y.; Writing—review and editing, A.S., C.H., Q.Y., J.Z., I.J., J.L., M.M., L.W., Y.W., S.L., C.M., B.M. and R.Y.; Supervision, B.M. and R.Y.; Project administration: B.M. and R.Y.; and Funding acquisition, R.Y. All authors have read and agreed to the published version of the manuscript. | 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 and personal fees from Johnson and Johnson and Novartis; and personal fees from Bristol Myers Squibb, AstraZeneca, GenePlus, Innovent, and Hengrui outside the submitted work. I.J., J.L., M.M., L.W., Y.W., S.L. and C.M. report no competing interests. B.M. receives honoraria and participates in advisory boards for Astra Zeneca, BMS, Merck, Roche, Jazz, Pfizer, Jansen, Roche, and Novartis. R.Y. reports no competing interests. | 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 vessels (Group A) and those in whom cervical vessels were used as the recipient vessels (Group B). Patient gender and age, cause and localization of the defect, flap choice for reconstruction, recipient vessels, intraoperative outcome, postoperative course, and complications were recorded and analyzed. A Fisher’s exact test was used to compare outcomes between the 2 groups. | 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 53.92 ± 17.49 years. The overall flap survival rate was 88.89%. The overall complication rate for vascular anastomosis was 14.81%. The total flap loss rate in patients with superficial temporal recipient vessels was higher than the complication rate in those with cervical recipient vessels but with no statistical significance (16.67% vs. 6.66%, | 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 shown to have comparable diameters to the cervical vessels, with increased proximity to defects in the midface and scalp. Yet, because of their variable diameter and tortuous anatomy, these vessels have been considered to be at risk for postoperative vasospasm and thrombosis, and its use has been restricted to selected cases. | 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 Institute and registered in an international clinical trials database (ClinicalTrials.gov identifier: NCT05749120). All participants signed an informed consent form. The following inclusion criteria were employed: (1) Patients eligible to subtotal, total, or extensive radical oncologic maxillectomy, or advanced scalp oncologic resection; (2) Patients with clinical conditions suitable for major surgery; (3) Complete medical records. Patients were randomized into two groups by the main author in blocks of four patients for each technique (one to one ratio) who were blinded to the intervention, namely Group A: the superficial temporal recipient vessels; and Group B: the cervical recipient vessels. Patient gender and age, cause and classification of the defect, flap choice for reconstruction, recipient vessels, postoperative course, and complications were recorded and analyzed. Patients who died within a period of less than 30 days of the surgical intervention or who missed follow-up for a period of less than 3 months were excluded. | 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 months, enough time to assess major and minor complications. The diagram describes the participants flow (Study design.Patients characteristics and type of free tissue flap.ALTF, Anterolateral Thigh Flap; RAF, (A) Pre-operative aspect of an advanced squamous cell carcinoma of the left midface. (B) The cervical recipient vessels: single asterisk demonstrates the microanastomosis of facial vein with the flap vein and double asterisk demonstrates the microanastomosis of facial artery with the flap artery. (C) The late post-operative aspect of an anterolateral thigh free flap inserted in the surgical site.(A) Per-operative aspect of an extended right orbit exenteration due an advanced cutaneous squamous cell carcinoma. (B) The superficial temporal recipient vessels demonstrate the microanastomosis of the superficial temporal vein with the flap vein (single asterisk) and the double asterisk demonstrates the microanastomosis of the superficial temporal artery with the flap artery. (C) The late post-operative aspect of an anterolateral thigh free flap inserted in the right midface.In Group B, the following recipient arteries were used: facial artery (n = 9), superior thyroid artery (n = 4), and lingual artery (n = 2). The recipient cervical veins used in this group were: facial vein (n = 11) and internal jugular vein (n = 4). Vein grafts were not used. All microanastomosis were performed in an end-to-end fashion except for four cases, in which the anastomosis with the internal jugular vein were performed using an end-to-side technique. Only one patient in Group B required early return to the operating room due to microvascular vascular anastomosis obstruction, with successful resolution. Arterial thrombosis developed in one patient in Group B on the 2nd postoperative day, with total flaps loss. Two patients in Group A suffered total flap loss: one due to venous thrombosis on the 3rd postoperative day, and one due to arterial thrombosis on the 5th postoperative day. Both patients underwent a late successful reconstruction with another free tissue flap. No other major complications occurred in this group.In the present series, the overall flap survival rate was 88.89% (24 of 27 flaps). All major complications involved microvascular thrombosis, with a complication rate of 14.81% (4 of 27 patients). Of the three patients who developed total flap loss, two were in Group A (16.67%) and one was in Group B (6.66%), not significant (Characteristics of the technical aspects and complications of free tissue flaps in both groups. | 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 reconstruction has been reported by numerous authors.Although there was no significant difference in the rate of total flap loss between the 2 groups in our series, the rate of complications was nevertheless higher in patients with superficial temporal recipient vessels than in those with cervical recipient vessels. It is important to emphasize that, of the 4 patients who had microvascular anastomosis complications, three were undergoing secondary free tissue flap reconstruction, due to previous total flap loss. In our series, the overall flap survival rate was 88.89%. These data are similar to other available series reporting above 90% of success in free flaps for advanced cases.Wang et al.Our study is not without limitations. First, selection bias could have been an issue, since the main author did patient allocation. Even though, we cannot completely exclude this systematic error, our statistical results indicate that groups were similar in each and every domain, so minimizing the effect of patient selection. Finally, sample size is not expressive, but proved adequate on statistical analysis. It is worth considering the rarity of such advanced cancers of the midface and scalp, even in reference centers, like ours, resulting in very large surgical defects and demanding very complex reconstructions. Our results should be validated in large multicenter studies. On the other hand, our study is the first randomized study in the field providing further support for the use of superficial temporal vessels in such difficult cases of midface and scalp advanced oncologic reconstruction. | 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 2007 [Mental health pressures have intensified since the beginning of 2020. Declared a global pandemic by the World Health Organization (WHO), COVID-19 led many countries to pronounce a state of emergency, issue restricted movement orders and, in most cases, impose lockdowns. Workwise, although some work patterns have intensified (especially in the healthcare sector: [Data from the UK Household Longitudinal Study based on nearly 9,000 British adults indicate that psychological distress increased among all employees from 20.1% at the 2017–2018 baseline to 31.8% in April 2020 with prevalence increasing similarly across all demographic groups over time. Furthermore, distress increased from 23.7% at baseline to 69.4% in April 2020 for those who were permanently laid off [ | 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 resilience was conceived about 40 years ago when researchers noticed that some people manage to adapt well to life despite the presence of high-risk circumstances (such as losing parents young, for example). This step was a positive divergence from the typical pathological models based on the assumption that early traumatic experiences undoubtedly result in negative life outcomes. However, the scientific research devoted to this phenomenon was scarce at the time and it is only in the past 20 years that the investigation of resilience has expanded considerably. A recent review revealed that the usage of the term ‘resilience’ in the academic literature has increased eightfold in the last two decades [Resilience is generally defined in functional terms, as the capacity for successful adaptation and/or growth in the face of significant adversity [Research indicates that higher levels of self-reported resilience are associated with lower levels of psychological distress, anxiety, and depression symptoms in various age groups and that these associations are stronger in individuals facing adversity [ | 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 resilience as a collective phenomenon, given that work is increasingly structured in and around teams. A team is defined as a group of interdependent persons who share the responsibility for a common outcome [Team resilience can be defined as a “Although team resilience is undoubtedly influenced by individual factors such as personal knowledge, skills, diversity and values, it tends to be more dependent on team social and process factors [ | 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 resilience intervention protocols established and tested in the last two decades is the SPARK Resilience Programme (RP), which was originally developed as a universal school-based resilience curriculum based on cognitive-behavioural therapy and positive psychology interventions [These findings showing the efficacy of the SPARK Resilience Programme in schools have led to the development of a new variant of the program aimed at employees and called | 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 participants to experiment with over twenty-five tools and practices issued from scientific sources [The intervention protocol (see the session themes listed in | 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 based on the premise that in stressful situations emotional regulation should precede cognitive reframing [Every session begins with a brief introduction and a voluntary review of homework from the previous session followed by a 5-minute inclusion exercise (e.g., a quiz, a question to share responses or a brief guided positive psychology intervention). Next, the topic of the daily session and associated strategies are introduced. Each session normally includes 1 to 3 small-group sessions with 3 to 6 participants per group taking 30 to 45 minutes altogether. At the end, a 15-minute mindfulness exercise appropriate to the session’s topic is performed. | 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 conferencing using Zoom software over eight 90-minute sessions spanning four weeks. The sessions included a combination of teaching, whole-group interactions, questioning, using voice and chat functionalities, quizzes, small virtual group discussions, peer coaching, guided mindfulness exercises, and non-mandatory homework. The SPARK sessions were conducted by two trainers with postgraduate degrees in psychology (MSc and PhD, respectively), background in positive and organizational psychology, and extensive experience in group facilitation and resilience work.The participants were recruited from among the individuals who had registered for a free pilot trial of the SPARK Resilience Programme for French-speaking adults scheduled to take place in April 2020. The training was advertised using mailing lists and positive psychology-themed websites in March. Although the advertisements mainly targeted working professionals, students were also allowed to register. Once it became clear that the number of potential participants would exceed the limitations imposed by the Zoom platform (The week before the April wave was due to start, all SPARK participants from both groups received an email invitation to take part in a research study of psychological factors and dynamics of resilience in the context of the COVID-19 pandemic. The study involved completing a set of online questionnaires twice, at a one-month interval. Those who opted to take part in the study received a link to the pre-test questionnaire immediately and another link to the post-test questionnaire one month later. Participation in the study was voluntary and was not a condition for participation in the SPARK programme itself. The trainers had no information about the study participation or the responses provided by specific individuals. To ensure a realistic representation of SPARK programme participants, the study did not use any specific exclusion criteria. The research was conducted in accordance with the Declaration of Helsinki. Informed consent in an electronic form was obtained from all participants. The study protocol was approved by the HSE University Research Ethics Committee.The number of questionnaires collected was 390 for the pre-test (177 in the intervention group and 213 in the control group) and 232 for the post-test (140 in the intervention group and 92 in the control group). For the present study, we used the data of participants who completed both the pre-test and the post-test and whose questionnaires could be matched based on the identifiers they provided. The resulting sample included 101 participants in the intervention group and 86 in the control group (three control group participants provided incomplete questionnaires; we report the effective sample size for each analysis).The participants were mostly female (87.1%) and ranged in age from 20 to 76 ( | 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 clearly”, “I am not easily discouraged by failures”, “I think of myself as a strong person”, “I am able to tolerate unpleasant feelings”). The participants were asked to evaluate the items using a 5-point Likert scale from 1 “Completely disagree” to 5 “Completely agree”. CFA has supported a theoretically expected single-factor structure (X | 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 felt difficulties were piling up so high that you could not overcome them?” | 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 significant (Analyses of potential moderators of the intervention effects using the data from the intervention group only have revealed some individual differences. Controlling for perceived stress at baseline, age has emerged as a negative predictor of perceived stress at post-test (The adherence to the intervention was fairly good: the intervention group participants reported attending, on average, 7.55 (The satisfaction survey was completed by 98 out of 101 intervention group participants. Parallel analysis [ | 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 adversity, emotion regulation strategies, mental health, and relationships and communication ( | 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 emotions, as well as of the mechanisms underlying this connection and of one’s own cognitive biases. It also refers to practicing cognitive flexibility, creating a distance from a difficult situation by reflecting on it and contextualising it. For instance, one of the participants described this distancing effect as follows: “I have learnt to accept uncertainty, to look at the glass half full compared to the glass half empty, and am now able to see how my own thoughts can impact the way I feel”, whilst another said: “What I thought was ‘failure’ may not be that much of a bad thing”. Other participants described how they could now link the different SPARK components, for instance, a stressful situation (“I had a burnout one year ago in my professional life”) with its perception (“I thought it was not possible to get away from this work overload of and being in conflict with my value”) and affect (“this state has affected me on all levels: emotional, psychological, physical and existential”). Similarly, some participants described using their understanding of resilience to work on their perceptions and modify their ways of looking at things. As one participant expressed it, “I now analyse my challenges through the filter of SPARK”. | 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 to rise from these situations. For instance, a participant whose colleague had suddenly decided to stop their professional work alliance embraced the situation this way: “Finally, this was a very beautiful opportunity to feel fully at my place professionally”. Another participant related the way she had discovered her strengths and found her life meaning: “My career as a humourist was born! I had found a true meaning to my life. I wrote a play that I then performed on stage!”. In addition to discovering strengths, the process of growth from adversity can bring other benefits: the very way one views their relationship with themselves, with others, and with the world can be changed as part of this personal transformation process. As one participant described it, “I am realising the importance of the changes that happened to my values, to my way of looking at the world and at others”. Another person shared their new-found awareness of their own values, those being “authenticity, self-realisation, personal and professional accomplishments and recognition”. | 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 glass as half full rather than half empty. Participants shared: “Practicing a mindfulness exercise that involved singing negative thoughts was a great discovery that I will use again in the future” and “I am now taking the time to notice the positive side of a situation every day”. Comments expressing the importance of positivity in dealing with difficult emotions were common. Emotional regulation strategies used by participants also involved disputation, de-catastrophising, reappraising, reframing, and using self-compassion: “if you fail, tell yourself that you were not in the best conditions to accomplish this task”. Naming and identifying emotions was also one of the strategies participants used to manage and soothe difficult emotions: “Reconnecting with emotions, even with the most unpleasant ones, is essential in allowing an optimal development, in adapting to different situations encountered, in acknowledging and responding to our psychological needs, in enjoying fully the experiences that we are living, in order to spend less time in the autopilot mode, and be more aware of our internal states. This leads to being able to respond in a relevant way to the demands of a situation instead of being in reaction mode”. In addition, practical and simple actions such as cooking, writing, savouring, learning new skills, physical activity, cultural activities, nature, praying, nutrition, health care, and satisfying basic needs, such as eating when hungry and sitting down when tired, were all mentioned as being helpful for participants. | 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 participant shared: “I was trying to get back up the slope, to take care of myself to regain some energy and dignity”. Another said: “I felt more able to resist circumstances and this has helped my anxiety”. Increased awareness of one’s perceptions, emotions and needs might lead to positive mental health changes. Several participants reported an improvement in their levels of emotional well-being. As one participant recounted, “Even with everything that is currently going on in the world, I feel more content and stable in myself”; another person expressed feeling “liberated” after a job interview that did not lead to the job; yet another participant stated: “I am proud for having acted upon my needs and not based on my father’s thoughts of what he considers as normal. Each of us has our own way of doing things, so I want to continue listening to myself.” In addition, participating in the SPARK training seems to have enhanced feelings of psychological safety and grounding for some, referred to by one participant as “a sense of internal security”. | 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 affective environment” or “I have received so much help and support from my father-in-law”. Reaching out to others was also common among participants, with some reporting having sought support from others in their group: “I felt the need to continue to exchange with [another participant’s name] who gave me advice when working in a small group”. Another participant shared: “Even though we did not know each other well, the intimacy developed in breakout rooms was simply incredible”. Participants reported developing more positive expectations towards others and being on the giving end of kindness and altruism: “I devote myself now to trying to help others by transmitting my experience, my learning and discoveries”, “I make myself available and listening to my close people, my clients, my friends”. Some participants have experienced relationships to be helpful and strengthened when confronting adverse situations. This was not limited to friends and family: supportive positive work relationships were also described. For instance, a participant expressed the following regarding her relationships with her colleagues after dealing together with a difficult manager: “Our relationships became more fluid, with more sharing, and a lot more trust between us”. | 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 also stronger in magnitude compared to the previous studies of the SPARK Resilience Programme with The findings concerning individual differences in the intervention outcomes suggest that SPARK resilience training was more effective at reducing stress and negative affect for older adults. (An investigation of the scatterplots suggested a linear association of the intervention effectiveness with age; unfortunately, the sample was too small to allow sufficient power for a statistical analysis of the differences across age groups). On the one hand, this finding could be explained by the fact that the health risks associated with the COVID-19 pandemic are vastly different across age groups, given that existing meta-analyses indicate stronger effects of resilience interventions in populations at higher risk [The data showing high participant adherence and satisfaction indicate that the intervention was extremely well received, corroborating the principal study outcomes. This result could also be explained by the pandemic context: after all, the study was conducted during the very early period of lockdown, which was first introduced in France on March 17. Based on data from a representative French sample, March and April 2020 were characterized by higher levels of negative affective experiences, such as anxiety, loneliness, boredom, and depression, compared to subsequent months (see the data visualisation tool presented by Leander and colleagues [The qualitative data extend the quantitative results by shedding light on the specific benefits and areas of improvement resulting from the SPARK intervention in the pandemic context. Some of the emerging themes, such as awareness of cognition-emotion interactions, development of the repertoire of emotion regulation strategies, as well as strengthened positive relationships, are generally consistent with the previous qualitative findings in an adolescent sample [ | 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 with respect to employment status and age. Also, the prevalence of female participants did not allow us to explore the gender differences in the intervention outcomes that have been reported earlier [Third, the lack of proper randomization resulted in non-equivalent groups. Nevertheless, the use of a pre-test/post-test research design has allowed us to control for baseline differences in psychological variables. Randomization would have meant withholding the possibility to obtain psychological support from some people who may have needed it most during the very beginning of the lockdown. This is why we opted to form the intervention group on a first-come first-served basis until the maximum size of the group the facilitators could accommodate was reached. In the end, all the study participants had the opportunity to benefit from the intervention.Fourth, at the time when the study was conceived, we were not aware of the existence of any validated French versions of brief instruments to measure resilience, such as the BRS-F [Finally, the absence of a placebo or an alternative intervention does not allow to rule out participant expectation effects and the absence of a passive control group did not allow for a longer-term follow-up to see if the intervention effects were sustainable. However, a different study design would be associated with additional ethical and organizational challenges too difficult to resolve quickly during an ongoing pandemic. Nevertheless, we believe that the findings constitute strong evidence in favour of important immediate effects of SPARK Resilience training in a challenging context. | 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 individuals, groups of employees or even teams. This approach is flexible enough to grow and develop in line with new research and practice discoveries.SPARK Resilience training already benefits from a substantial evidence base constituted not only by the scientific studies of the mechanisms and processes of resilience, but also by empirical validation under various conditions. The present study shows the efficacy of the program in a French adult sample during the very early stage of the COVID-19 pandemic, contributing to the body of knowledge showing how positive psychology can help people to remain efficacious and to stay well even under such unprecedented challenges. | 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 group. The intervention comprised active and participatory methods to enhance employees coping skills and it was delivered in six face-to-face sessions. Data was collected using the Ways of Coping Questionnaire, the Multidimensional Scale of Perceived Social Support, the Perceived Stress Scale, and the Spiritual Well-Being Scale at baseline and three months after the intervention. We found mean scores of distancing, self-controlling, seeking social support, escape-avoidance, planned problem-solving, positive reappraisal, total coping skills, perceived social support, and spiritual well-being significantly differed at follow-up compared to baseline in the intervention group, but not in the control group. There was also a significant difference in the mean score of perceived stress between the two groups. We conclude that the educational intervention based on the TMSC was effective in improving coping skills and reducing perceived stress. We suggest that interventions based on the TMSC model can be supportive in workplaces where job stress is common. | 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 Coping (TMSC) illustrates how stress and coping is a process based on changing cognitive appraisals of a given situation and one’s resourcesThere is evidence to suggest that educational health promotion programmes are effective interventions for stress management in the workplace. For example, a rational-emotive health education intervention used to coach technical college teachers’ in Nigeria, significantly decreased the stress of the intervention group compared to a control groupTo our knowledge, there remains a need to provide supportive stress interventions beyond the teaching profession, including employees working in large industrial power plants. To our knowledge, no study has assessed the effect of a transactional model-based education programme on stress management and coping skills of industrial workers. Therefore, the purpose of this study was to investigate the effect of a health promotion educational intervention based on the TMSC on stress management and coping skills among industrial workers in Iran. | 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 year of job tenure, no history of stress management education, and no history of psychiatric treatment, determined through participants’ self-report. Exclusion criteria included absence from two educational sessions, not attending the pre-test or post-test sessions, withdrawal from the study, and undergoing treatment by a psychiatrist due to mental illness during the intervention. 194 employees were eligible to participate, however some declined to participate leaving a consenting sample of 170 employees. A sample size calculation was calculated based on the effect size (0.58) provided by Faryabi et al.Data was collected at baseline, and three months after the 6-weeks educational intervention period had been completed. All participants completed the anonymous study questionnaires on the same day at baseline, and the same day at the follow-up, except for three participants in the intervention group who did not provide data at the three-month follow-up. This gave a final sample for data analysis of 103 participants. Figure Consort flow diagram of the study. 211 employees who participants worked one of two 12-hour shifts in an industrial plant were invited into the study. 170 gave informed consented. One shift was randomly allocated as the educational intervention group the other was the control group. From potential participants 53 participants were randomly allocated into each study group. Three participants dropped out of the Intervention Group before the three-months post-intervention follow-up which was on the same day for both groups. Thus, data was analysed from 50 participants in the Intervention group and compared with 53 participants in the control group. | PMC10050170 | |
Measures | PMC10050170 | |||
Demographic information | Demographic variables—age, sex, marital status, education level, job tenure, and employment status—were assessed at baseline. | PMC10050170 |
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