Impaired Physical Health Research Articles

Treating nightmares in posttraumatic stress disorder with dronabinol: study protocol of a multicenter randomized controlled study (THC PTSD-trial)

BackgroundDistressing nightmares are a core symptom of posttraumatic stress disorder (PTSD) and contribute to psychiatric comorbidity, impaired physical health and decreased social functioning. No specific pharmacological treatment for PTSD-related nightmares is yet approved. Preliminary clinical data indicate that cannabinoid agonists can improve nightmares and overall PTSD symptoms in patients with PTSD. The primary objective of the study is to examine the efficacy of oral dronabinol (BX-1) versus placebo in reducing nightmares in patients with PTSD. The secondary objectives of the study are to examine the efficacy of oral BX-1 in reducing other PTSD symptoms.MethodsThe study is designed as a multi-centric, double-blind, randomized (1:1), placebo-controlled, parallel group interventional trial. Eligible patients will be randomized to BX-1 or placebo, receiving a once-daily oral dose before bedtime for 10 weeks. Primary efficacy endpoint is the Clinician-Administered PTSD Scale (CAPS-IV) B2 score for the last week, measuring frequency and intensity of nightmares. Secondary efficacy endpoints are other disorder-specific symptoms in patients with PTSD. Further, tolerability and safety of dronabinol will be assessed.DiscussionThis randomized controlled trial will provide evidence whether treating patients with PTSD and nightmares with dronabinol is safe and efficacious.Trial registrationNCT04448808, EudraCT 2019–002211-25.

Changes in self-rated physical and mental health and life satisfaction associated with opioid and potentially inappropriate opioid prescribing in primary care older adults.

To examine changes in life satisfaction and physical and mental health associated with opioid and potentially inappropriate opioid prescribing (PIOP) among older adults. Secondary data analysis from the Étude sur la Santé des Aînés (ESA)-Services study. The sample consisted of 945 older adults recruited in primary care with available health survey information linked to administrative medical record data. The exposure of interest was categorized as no prescription, opioid prescription, and PIOP, defined using the Beers criteria. Outcomes were self-rated physical health, mental health, and life satisfaction measured at baseline and at a 3-year follow-up. Generalized estimating equations were used to examine 3-year changes in outcomes as a function of opioid prescribing. Analyses were adjusted for covariates relating to health, psychosocial, and sociodemographic factors as well as duration/frequency of opioid prescribing. Analyses were conducted in the overall sample and in non-cancer patients. The sample had an average age of 73.1 years; the majority was Canadian-born (96.3%) while females made up over half (55.4%) the sample. Compared to not receiving an opioid prescription, PIOP was associated with a deterioration in physical health (ORadjusted = 0.65; 95%CI = 0.49, 0.86), but not mental health and life satisfaction. In non-cancer patients, PIOP was associated with poorer physical health (ORadjusted = 0.59; 95%CI = 0.40, 0.87) and opioid prescribing was marginally associated with improved life satisfaction (ORadjusted = 1.58; 95%CI = 0.96, 2.60). PIOP was associated with a deterioration in physical health. Patient-centred chronic pain management and the effect on health and well-being require further study in older adults.

Impact of the Coronavirus Disease 2019 Pandemic on Leisure Screen Time and Eating Habits of Japanese High School Students: A Comparison between before and during the Pandemic.

This study aimed to determine whether adolescents' leisure screen time differed during the coronavirus disease 2019 (COVID-19) pandemic compared to before the pandemic, and to identify factors that affect leisure screen time among Japanese high school students. The Health Behavior in School Children questionnaire was used to investigate differences in eating habits and physical and mental health. The results showed that the leisure screen time of Japanese high school students was 2.6 h (SD = 1.4) before the pandemic, and 3.2 h (SD = 1.5) during the pandemic. The factors that increased leisure screen time were found to differ between boys and girls. No significant deterioration in physical and mental health was observed. The impact of the pandemic on eating habits differed in boys and girls. Boys reported "not feeling great about life" as a factor that increased leisure screen time during the pandemic, suggesting that negative emotions influenced the increase in leisure screen time. The pandemic had a significant impact on girls' leisure screen time. Longer screen time should be carefully monitored because it can lead to sleep disturbances, worsening of mental health, and obesity. Compared with before the pandemic, the health status of boys and girls changed little. Eating habits tended to improve for both boys and girls.

The associations between sport- and physical activity-related concussions and suicidality, suicide capability, and hopelessness among high school adolescents.

Concussions are associated with a variety of physical, cognitive, and mental health impairments. If sustained during adolescence, a time when the brain is undergoing development, the risk of long-term impairments becomes heightened. This is a notable subject for investigation as many concussions are sustained among adolescents during high school sports and other physical activities. We used data from the 2019 United States Youth Risk Behavior Survey to investigate the association between concussions and suicidality (i.e., suicide ideation, planning, and attempts), suicide capability (i.e., physical fighting and weapon carrying), and hopelessness, a risk factor for suicide. We utilized a cross-sectional design and used multivariate regression models and t tests for analysis. Participants were 1754 adolescent students who sustained a concussion during the prior year (54.61% male; M age = 15.94) and 9795 adolescent students who did not sustain a concussion during the prior year (47.27% male; M age = 15.95). Females were less likely (13.23%) than males (17.12%) to report at least one concussion in the past 12 months. Both male and female students who had experienced a concussion were more likely to report physical fighting, weapon carrying, and hopelessness. Male students with a concussion history were also more likely to report suicide attempts than male students without a concussion history. Findings indicate that concussions are associated with an increased risk of suicide attempts, suicide capability, and hopelessness among male adolescents and suicide capability and hopelessness among female adolescents. They further suggest a need for additional mental health support and safety policies for student-athletes and other at-risk adolescents.

Patient-Reported Outcomes in Myotonic Dystrophy Type 2: Correlations with Motor and Cognitive Endpoints (S7.007)

<h3>Objective:</h3> To characterize patient-reported outcomes (PROs) and evaluate relationships between PROs and clinical endpoints in patients with myotonic dystrophy type 2 (DM2). <h3>Background:</h3> Although muscle weakness is the key feature in DM2, two-thirds of patients report that impaired cognition is among the most disabling symptoms and affects their quality of life. PROs of physical and mental status are extremely limited in DM2 but could serve as measures for clinical trial development. <h3>Design/Methods:</h3> Ten individuals with DM2 and ten age and gender-matched controls were enrolled. All participants underwent brain MRIs and a comprehensive battery of cognitive and motor measures. Additionally, they completed PROs, including the 36-Item Short Form (SF-36), PRO Measurement Information System (PROMIS-10), Beck Depression and Anxiety Inventory (BDI and BAI), and Apathy Evaluation Scale (AES). Paired t-test and Spearman’s correlation were used to determine group differences and correlations between PROs and clinical endpoints. <h3>Results:</h3> Of 20 participants (60% female), mean age and education were similar between groups. Compared to controls, the DM2 group showed a significant difference in BAI, AES, and SF-36 physical functioning (PF) subscale (<i>p</i>=0.004–0.024) and impaired PROMIS-Global Physical (GPH) and Mental Health (GMH). We found a strong correlation between SF-36 (PF) and PROMIS-GPH with a 6-minute walk test and gait speed (<i>rho</i>=0.68–0.75, <i>p</i>=0.02–0.04). Moderate correlations were observed between 1) BDI and verbal fluency test; 2) BAI and processing speed; 3) AES and a test of executive function and cerebral white matter integrity. <h3>Conclusions:</h3> Our pilot study demonstrates that changes in mental and physical health status are of significance for DM2 patient’s quality of life. The relationships between PROs (BAI, BDI, and AES) and cognitive endpoints suggest brain involvement. PROs, as measured by SF-36 and PROMIS-10, are associated with motor endpoints. These results support the use of PROs as a tool to measure disease burden in DM2. <b>Disclosure:</b> Dr. Jain has nothing to disclose. Dr. Olszewski has nothing to disclose. Dr. Flashman has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Archives of Clinical Neuropsychology. The institution of Dr. Flashman has received research support from NIH/NINDS. The institution of Dr. Flashman has received research support from Michael J Fox Foundation. Mrs. Burgos-Aguilar has nothing to disclose. Dr. Duncan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BrainQ Technologies. Dr. Duncan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for University of Pittsburg Pepper Center. Dr. Duncan has stock in CareDirections. The institution of Dr. Duncan has received research support from PCORI. The institution of Dr. Duncan has received research support from NIA and NINDS. The institution of Dr. Duncan has received research support from AHRQ. Dr. Duncan has received intellectual property interests from a discovery or technology relating to health care. The institution of Dr. Nopoulos has received personal compensation in the range of $500-$4,999 for serving as a Consultant for norvartis. The institution of Dr. Puwanant has received research support from Muscular Dystrophy Association. The institution of Dr. Puwanant has received research support from NIH/NINDS. The institution of Dr. Puwanant has received research support from NIH/NINDS.

Calcaneal broadband ultrasound attenuation predicts physical capability: EPIC-Norfolk prospective population-based study

BackgroundCalcaneal ultrasound (broadband ultrasound attenuation – BUA), a marker of bone strength, may predict future physical capability and thus provide a strategy to identify individuals at risk of age-related deterioration of health. This study aims to determine if BUA can predict future physical capability among middle-aged and older adults. MethodsSummary performance scores (SPS), an objective quantification of physical capability, were devised using participants' measures of standing balance, gait speed and timed chair rises. Associations between BUA and SPS, measured at least six years apart, were investigated using univariable and multivariate sex-specific linear and logistic regression, adjusting for confounders. Results5893 participants were included. In men and women, for every five points lower BUA, there was a 0.2-point decrease in SPS. In women, BUA less than one standard deviation below the mean was associated with low physical capability (defined as SPS 3–6); fully adjusted odds ratio (OR) (95 % confidence interval (CI)) 1.35 (1.01–1.84). No association existed among men; OR (95 % CI) 0.84 (0.59–1.19). Significant risk factors for low physical capability in men with baseline low BUA were: older age [OR 5.77]; high BMI [OR 2.85]; lower social class [OR 1.59]; low physical activity [OR 1.64]. Risk factors among women were: older age [OR 5.54]; high BMI [OR 2.08]; lower education [OR 1.42], low physical activity [OR 1.27]; steroid use [OR 2.05]; and stroke [OR 2.74]. ConclusionBUA may predict future physical capability in older adults. With further validation, BUA could stratify individuals at risk of deterioration in physical health.

Work-related coping behaviour and experience patterns in university students: a review of 20 years of research.

Work-related coping behaviour and experience patterns (WCEP) is the conceptualisation of personal experience with occupational stress and of the typical behavioural responses for coping with such stress. The objective of this review, which is based on 69 references that used the WCEP inventory in university students, is to offer a comprehensive overview of the findings on WCEP and their correlates in the student population. The results of the published studies consistently show that female students, teacher education students (compared to medical students) and students who receive insufficient social and financial support are at greater risk for being assigned to work-related patterns that indicate vulnerability to burnout and occupational health issues. Moreover, students assigned to these patterns, especially to the resigned (burnout) pattern, are prone to manifest other negative characteristics, such as less adaptive personality traits and coping strategies, vulnerability to stress, lower quality motivation, lack of commitment to the chosen career and suitability for the profession, and impaired physical and mental health. In contrast, the most desirable correlates, such as adaptive personality traits, higher quality motivation, commitment to the chosen career, suitability for the profession, stress resistance, adaptive coping and better physical and mental health, were related to the healthy ambitious pattern. Nevertheless, further research is needed to analyse work-related coping behaviour and experience patterns beyond the German speaking population to increase the generalisability of the findings.

Abstract CT216: Response to first-line (1L) pembrolizumab (pembro) + chemotherapy (chemo) in non-small cell lung cancer (NSCLC) by blood tumor mutational burden (bTMB): the phase 2 KEYNOTE-782 trial

Abstract Background: 1L pembro + platinum-based chemo has shown clinical activity in metastatic NSCLC regardless of tissue tumor mutational burden (tTMB) status. bTMB assessed using circulating tumor DNA in plasma may be a surrogate for tTMB. The single-arm, phase 2 KEYNOTE-782 study (NCT03664024) evaluated the correlation of bTMB with efficacy of 1L pembro + chemo in nonsquamous NSCLC. Methods: Eligible patients (pts) had histologically or cytologically confirmed stage IV nonsquamous NSCLC with measurable disease per RECIST v1.1 and were not eligible for EGFR-, BRAF-, ROS1-, or ALK-directed therapy. Pts were not previously treated for advanced or metastatic disease, had an ECOG PS of 0 or 1, and had an evaluable biopsy sample for biomarker analysis. All pts received intravenous pembro 200 mg Q3W + platinum chemo doublet Q3W (pemetrexed 500 mg/m2 + 4 cycles of carboplatin AUC 5 mg/mL/min or cisplatin 75 mg/m2). The primary objective was to evaluate the association of baseline bTMB with ORR per RECIST v1.1 by investigator assessment. Secondary objectives were to determine safety and the association of baseline bTMB with PFS per RECIST v1.1 by investigator assessment and OS. A study-specific next-generation sequencing-based assay using a 1.9 Mb/654-gene cancer panel, which includes specific lung cancer-associated gene targets, was used to measure bTMB (continuous scale) in cell-free DNA extracted from baseline plasma samples. Paired white blood cell DNA sequencing was also performed to eliminate potential clonal hematopoiesis-derived somatic mutations. Database cutoff: November 5, 2021. Results: 117 pts were enrolled; median age was 64.0 years (range, 37-85), and the majority were male (60.7%), had an ECOG PS of 1 (69.2%), and no brain metastases at baseline (92.3%). Median time from first dose to data cutoff was 19.3 months (range, 1.0-35.5). ORR was 40.2% (95% CI, 31.2-49.6; 6 CRs, 41 PRs), median PFS was 7.2 months (95% CI, 5.6-9.8), and median OS was 18.1 months (95% CI, 13.5-25.6). Treatment-related adverse events (TRAEs) occurred in 113 pts (96.6%) and grade 3-5 TRAEs occurred in 56 (47.9%). Eight pts (6.8%) died due to a TRAE (febrile neutropenia and pneumonitis [n = 2 each], and septic shock, pulmonary sepsis, general physical health deterioration, and neutropenia [n = 1 each]). bTMB data were available for 101 pts. The area under the receiver operating curve for bTMB as a continuous variable to discriminate response was 0.47 (95% CI, 0.36-0.59). The posterior probabilities for a positive association of bTMB with PFS and OS were 16.8% and 7.8%, respectively. Conclusions: Baseline bTMB showed no evidence of an association with ORR, PFS, or OS in pts with nonsquamous NSCLC treated with 1L pembro + chemo. These findings indicate no clinical utility of bTMB in this patient population and treatment setting. No new safety signals were observed. Citation Format: Jair Bar, Emilio Esteban, Delvys Rodríguez-Abreu, Santiago Ponce Aix, Zsuzsanna Szalai, Enriqueta Felip, Maya Gottfried, Mariano Provencio Pulla, Andrew Robinson, Andrea Fülöp, Suman B. Rao, D. Ross Camidge, Giovanna Speranza, Steven M. Townson, Julie Kobie, Mark Ayers, Elisha J. Dettman, Robert McDaniel, Byoungsok Jung, David Burkhardt, Ruth Mauntz, Tibor Csőszi. Response to first-line (1L) pembrolizumab (pembro) + chemotherapy (chemo) in non-small cell lung cancer (NSCLC) by blood tumor mutational burden (bTMB): the phase 2 KEYNOTE-782 trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr CT216.

Examining Online Behaviors of Young Adults During the Covid-19 Pandemic Social Isolation Period with Regard to Life Satisfaction, Loneliness, and Hostility.

The Covid-19 pandemic exposed individuals to intense restrictions and social isolation, as well as the possibility of deterioration of physical health. In the pandemic period, the Internet has become the principal avenue for social interaction, leisure related activities, and school-work pursuits for most people and consequently problematic Internet use (PIU) has increased dramatically in this period. Modeling of PIU among university students - considered one of the most negatively affected groups at this time - along with PIU subconstructs as well as indicators of psychological well-being - life satisfaction, loneliness, and hostility - will be valuable in directing future studies. This study examined the effects of the psychological well-being indicators of life satisfaction, loneliness, and hostility on PIU constructs; the preference for online social interaction, Internet use for mood regulation, and deficient self-regulation of Internet use during the Covid-19 pandemic social isolation period. Participants were 418 undergraduate students from a public university (130 male and 288 female). Results revealed that young adults with low life satisfaction have been more likely to problematically use the Internet to regulate their mood during the Covid-19 pandemic. Hostility and loneliness between which there is a moderately strong direct relationship, were similarly related to deficiently self-regulated Internet use. Moreover, individuals experiencing feelings of loneliness are more likely to use the Internet problematically for online social interaction purposes, while those experiencing feelings of hostility are more likely to use it problematically for mood regulation purposes. Given the significant relationships between indicators of psychological well-being and PIU, higher education institutions should take measures to prevent PIU behaviors in their students in case they face potential periods of social isolation.

Objective and Subjective Stress among Grandparents Providing Assistive Regular Grandchild Care.

Research on stress and coping has differentiated the effects of objective stress and subjective perceptions of stress on psychological and physical health, including in old age. This study examined the moderating role of social support in the relationship between objective and subjective stress with depressive and somatic symptoms in the context of Israeli grandparents. This cross-sectional study involved 243 grandparents who provided at least 5 hours a week of assistive regular care to their grandchildren, divided into lower and higher support groups. The results show that the levels of depressive and somatic symptoms were higher in the lower support group. Social support moderated the association between the intensity of care and perceived stress. Social support moderated the association between subjective stress and somatic symptoms. To conclude, the combination of high subjective stress and lower social support constitutes a risk factor for impaired psychological and physical health.

Impairments among DSM-5 eating disorders: A systematic review and multilevel meta-analysis.

Previous research revealed that people who did not meet full DSM-IV criteria for anorexia nervosa (AN), bulimia nervosa (BN), or binge-eating disorder (BED) but met criteria for eating disorder not otherwise specified (EDNOS) display high levels of psychiatric and physical morbidity commensurate with full criteria eating disorders. The DSM-5 introduced significant changes to eating disorder diagnostic criteria, so the present study aimed to determine whether the revised diagnostic criteria better distinguish between full criteria eating disorders, and other specified feeding or eating disorder (OSFED) and unspecified feeding or eating disorder (UFED). We present a series of meta-analyses comparing eating pathology, general psychopathology, and physical health impairments among those with AN, BN, and BED, compared to those with OSFED or UFED (n=69 eligible studies). Results showed significantly more eating pathology in OSFED compared to AN, no difference in general psychopathology, and greater physical health impairments in AN. BN had greater eating pathology and general psychopathology than OSFED, but OSFED showed more physical health impairments. No differences were found between BN and purging disorder or low-frequency BN, or between BED and OSFED. Findings highlight the clinical severity of OSFED and suggest the DSM-5 criteria may not appropriately account for these presentations.

Quality of life indicators in children with non-traumatic and non-syncopal transient loss of consciousness and their families

Background. There are extremely limited research on the quality of life in children with non-traumatic and non-syncopal transient loss of consciousness (TLOC), which does not sufficiently reflect the impact of epilepsy, first unprovoked epileptic seizure or psychogenic TLOC on the parental quality of life and family functioning. The purpose was to provide a comparative analysis of quality of life in children with non-traumatic and non-syncopal TLOC, as well as to study the impact of these diseases on the family quality of life. Materials and methods. Twenty-two patients with epilepsy, 18 with first unprovoked epileptic seizure, and 18 with psychogenic TLOC aged 8–17 years were examined. The control group consisted of 40 apparently healthy children. Quality of life in children and their parents was assessed using the PedsQL™ 4.0 Generic Core Scales (child report, adolescent report, parent report), and the PedsQL™ 2.0 Family Impact Module (parent report). Results. Epilepsy and psychogenic TLOC have a negative impact on the quality of life of children. Epilepsy was accompanied by deterioration of physical (57.1 ± 5.2; 77.3 ± 4.8 points) and psychosocial health (60.7 ± 5.7; 76.3 ± 2.7 points), while psychogenic TLOC were characterized by only low physical health (55.0 ± 5.5; 77.3 ± 4.8 points) according to patient self-reports (p &lt; 0.01). The quality of life of children with epilepsy was influenced by age (r = –0.55; r = 0.007) and features of clinical manifestation of the epileptic seizure (r = –0.56; r = 0.007). The number of previous non-epileptic seizures had an impact on quality of life among patients with psychogenic TLOC (r = –0.60; r = 0.0008). The first unprovoked epileptic seizure was not accompanied by quality of life deterioration among children and parents. Only epilepsy was associated with a decrease in the quality of life of parents and family as a whole, mainly due to an increased anxiety (38.8 ± 4.5; 63.2 ± 4.0 points), a decrease in emotional functioning (47.5 ± 3.9; 66.9 ± 3.3 points), a lack of effective communication between family members (50.0 ± 4.8; 79.4 ± 2.9 points); p &lt; 0.01. Conclusions. The combined evaluation of quality of life in children and their parents helps better understand the impact of disease course peculiarities and treatment on the child’s and his family’s quality of life in order to provide timely medical and psychological assistance.

Mood and Emotions among Inmates after COVID-19 Pandemic

During imprisonment, inmates face many difficulties in adapting to life behind bars. The aim of the study was to find out (a) how challenging for inmates were the selected COVID-19 pandemic-related changes and stressors, (b) what moods and emotions are most commonly experienced by prisoners just after the difficult period of the COVID-19 pandemic, and (c) which of the selected factors determine the positive and negative mood of inmates. The research was conducted in July 2022 in six randomly selected Polish prisons. Prisoners (N = 250) were invited to participate. Comparative and regression analyses were carried out. Two scales measuring moods: the General Mood Scale and the Mood Scale (positive and negative), the Emotions Questionnaire by B. Wojciszke and W. Baryła, and a proprietary questionnaire were used. Sanitary restrictions implemented in prisons resulted in a moderate experience of discomfort among prisoners, mainly in terms of not being able to have direct contact with family and friends, limitation in their personal freedoms to do their jobs, self-development, and deterioration of mental and physical health. A depressed mood predominated among the prisoners, making them feel unhappy, discouraged, tense, and uptight. They reported dominant feelings of alienation, distress, anxiety, and worry at the time of the survey. The mood of inmates was changing from more positive to more negative; on average, it was described as moderate. Based on the regression coefficients, the significant predictors of inmates' positive mood were perceived happiness (for those who got sick with COVID-19 during their prison sentence) and joy, angst, and contentment (for the healthy ones). In the group of SARS-CoV-2-infected prisoners, unhappiness, age, concern, cheerfulness, and rage were found to be predictors of their negative mood. The feeling of joy appeared to be a significant predictor of negative mood for those inmates who had no personal experience with COVID-19. It is necessary to provide convicts with continuous psychological care and to monitor their mood. Such measures should be the foundation for restorative interventions.

LEARNING ABOUT CANNABIDIOL

Alzheimer’s Disease (AD) has different stages and different levels of mental and physical health impairment, which do not cause hospitalization. Thus, we present a manual of procedures for care at the patient’s home, where the caregiver’s role is very important. Physiotherapeutic intervention in patients with AD, linked to Medicine, should take place in a preventive way to the deficiencies that occur due to the lack of physical activities that progressively deteriorate the functional capacity; physiotherapy is indicated in the case of patients with AD, because early treatment has the preventive nature of complications and minimization of symptoms that accompany the pathology in people of advanced age. The general objective is to evaluate and analyze the perspectives in the medical treatment of AD, aiming at its quality of life.

THYROID FUNCTION ABNORMALITIES IN COVID-19 PATIENTS.

COVID-19 has a great physical and psychological impact on each group of society, including the deterioration in physical health, unapproachable health care facilities, psychological upset, stress, anxiety, depression, etc. The initiated immune response by COVID-19 leads to overt thyroid dysfunction by interfering the desiodases and thyroid transport proteins. The T3 level is inversely proportional to IL-6 with a modest decrease of TSH and T4. This cross - sectional, observational study was aimed to evaluate the thyroid prole abnormalities in patients with COVID-19 pneumonia and to nd out its relation to the severity of disease. Atotal of 100 COVID-19 patients were involved in the study. Adetailed history was collected. Thyroid function test, including TSH, TT3 and TT4, Procalcitonin and IL-6 were done for all the patients. The majority (36%) of the patients were in the age group of 48 to 57 years of age and male female ratio in COVID-19 group was 1.17:1. A signicant correlation was found between thyroid alteration with severity of disease. It was concluded that among patients diagnosed with COVID-19 had signicant thyroid alterations

Abstract P4-01-01: RIBANNA 5th interim analysis: Matched-pair analysis of progression-free survival (PFS) across treatment cohorts and comparison of frontline ribociclib + endocrine therapy PFS data from RIBANNA vs MONALEESA trials, in HR+, HER2– ABC

Abstract Background: Ribociclib (RIB) plus endocrine therapy (ET) has demonstrated a statistically significant survival benefit across the three phase 3 MONALEESA (ML) trials, irrespective of menopausal status, line of therapy, or combination partner. RIBANNA (CLEE011ADE03), a prospective, noninterventional study assessing the efficacy and safety of RIB + ET, or ET monotherapy or chemotherapy (CT) in first-line (1L) setting in pre-, peri- and postmenopausal patients (pts) with hormone receptor–positive (HR+), human epidermal growth factor receptor-2–negative (HER2–) advanced breast cancer (ABC) is ongoing in Germany since October 2017 to gain insights into real-world scenario. In the 5th interim analysis (IA) from RIBANNA, a matched-pair analysis of 1L PFS data from the three treatment cohorts and comparison of 1L PFS data on RIB + ET from RIBANNA versus (vs) ML trials will be performed. Methods: Pre-, peri- and postmenopausal women receiving RIB + ET, ET monotherapy, or CT as 1L treatments for HR+, HER2– ABC, in accordance with German treatment guidelines, were included. Propensity score matched (PSM) analysis of PFS data from the 3 treatment cohorts will be conducted to reduce the bias due to confounding variables. In addition to safety analyses, comparison of 1L PFS data on RIB + ET from RIBANNA vs ML trials will be performed. Results: By the cutoff date of the 4th IA (October 11, 2021), data were available for 2187 pts, including 1849 (83.0%), 193 (78.1%), and 145 (73.6%) pts from the RIB + ET, ET monotherapy, and CT cohorts in 1L setting, respectively (Table 1). Of these 2187 pts, 1111 postmenopausal pts received 1L RIB + letrozole; 357 postmenopausal pts received 1L RIB + fulvestrant, and 158 pre- and perimenopausal pts received 1L RIB + anastrazole/letrozole. The unadjusted Kaplan–Meïer estimate for median PFS was 31.7 months (95% confidence interval [CI], 28.5–36.2) in the RIB + ET cohort, 25.7 months (95% CI, 18.0–not reached) in the ET monotherapy cohort, and 15.3 months (95% CI, 9.5–17.5) in the CT cohort. The most frequent treatment-emergent adverse events (grade 3 or 4) in the RIB + ET and ET monotherapy cohorts were neutropenia (14.8% and 6.6%, respectively) while that in CT cohort was general physical health deterioration (9.1%). Conclusions: In RIBANNA, a diverse pt population is being analyzed in a real-world setting; treatment with RIB + ET has been observed to be well adopted. The 5th IA is planned in October 2022 and data will be presented in SABCS 2022, which will include PSM analysis to compare 1L PFS data across treatment cohorts as well as comparison of 1L PFS data on RIB + ET from RIBANNA vs ML trials. The safety profile of RIB was found to be similar to those observed in ML trials. Table 1. Patient demographics and baseline clinical characteristics from the 4th IA. Citation Format: Christian Jackisch, Cosima Brucker, Thomas Decker, Anne Engel, Peter A. Fasching, Thomas Göhler, Jan Janssen, Andreas Köhler, Kerstin Lüdtke-Heckenkamp, Diana Lüftner, Marion van Mackelenbergh, Frederik Marmé, Arnd Nusch, Beate Rautenberg, Toralf Reimer, Marcus Schmidt, Rudolf Weide, Pauline Wimberger, Christian Roos, Achim Wöckel. RIBANNA 5th interim analysis: Matched-pair analysis of progression-free survival (PFS) across treatment cohorts and comparison of frontline ribociclib + endocrine therapy PFS data from RIBANNA vs MONALEESA trials, in HR+, HER2– ABC [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-01-01.

Abstract PD18-05: MEN1611, a PI3K inhibitor, combined with trastuzumab ± fulvestrant for HER2+/PIK3CA mutant advanced or metastatic breast cancer: updated safety and efficacy results from the ongoing phase 1b study (B-PRECISE-01)

Abstract Background: MEN1611 (MEN) is an oral PI3K inhibitor active on the p110α mutant and wild type, β and γ isoforms, while sparing the δ. B-PRECISE-01 is an open-label, 2-arm, phase 1b study investigating MEN1611 in combination with trastuzumab ± fulvestrant in patients with HER2 positive/PIK3CA mutated metastatic breast cancer (MBC). No dose-limiting toxicities were observed during the dose-escalation step and MEN1611 48 mg BID was selected as the recommended phase 2 dose (RP2D) for cohort expansion (CE). Methods: Eligible patients had HER2+/PIK3CA-mutated MBC and were treated with at least 2 prior lines of anti-HER2-based therapy in the advanced/metastatic setting including trastuzumab. Patients received MEN1611 + trastuzumab (MEN+T); hormone receptor positive (HR+) postmenopausal women received M+ T + fulvestrant (MEN+T+F). Recruitment was closed in December 2021. Pooled safety and efficacy data from the two subpopulations of CE are presented herein. Results: As of June 2022, 62 female patients were treated: 56 of them with MEN1611 48 mg BID (25 MEN+T and 31 MEN+T+F). Median age 55.5 years (range 34-78), 21% premenopausal, ECOG PS 0-1: 95.2%. Median metastatic regimens 4; 71.0% had prior pertuzumab and 91.9% had prior T-DM1. Common treatment-emergent adverse events (TEAEs, ≥20%) were diarrhea 66.1%, nausea 45.2%, hyperglycemia 43.6%, anemia 35.5%, asthenia 29.0%, decreased appetite 27.4%, rash 25.8%, aspartate aminotransferase increased 22.6%, vomiting 22.6%, and pyrexia 22.6%. Common TEAEs with CTCAE grade ≥3 (≥10%) were hyperglycemia (22.6%) and diarrhea (11.3%). Most treatment-related AEs (TRAEs) were reversible and manageable by supportive care. TEAEs leading to permanent treatment discontinuation occurred in 9 patients (14.5%), the only TEAE occurring in more than one patient was lipase increased (3.2%). TEAEs caused temporary treatment interruptions in 32 patients (51.6%), the most common being hyperglycemia (21.0%) and diarrhea (9.7%). TEAEs leading to dose reduction occurred in 14 patients (22.6%), the most common being diarrhea (6.5%), hyperglycemia (3.2%) and stomatitis (3.2%). Serious TRAEs were experienced by 12 patients (19.4%): hyperglycemia 6 patients, diarrhea 3 patients, anemia, general physical health deterioration, generalized edema, lipase increased, ketoacidosis and pneumonitis (1 patient each). In the efficacy-evaluable population at the RP2D (n=41) 14 patients (34.1%) showed partial response (MEN+T 5/15, MEN+T+F 9/26), 1 patient (2.4%) had a complete response (MEN+T 1/15) and 23 patients (56.1%) had stable disease (MEN+T 6/15, MEN+T+F 17/26) as best response. At the RP2D, the median (95% CI) overall survival (OS) was 21.9 (11.9, NE) months and the median (95% CI) progression free survival (PFS) 5.6 (3.7, 7.2) months. In the MEN+T group, the median OS was 11.9 (5.7, NE) months and median PFS 3.9 (2.3, 6.7) months. In the MEN+T+F group the median OS was 21.9 (16.9, NE) months and median PFS 5.7 (3.7, 11.5) months. Five patients continue on treatment. Conclusions: Updated results from B-PRECISE-01 demonstrated that MEN1611 combined with trastuzumab ± fulvestrant continued to show a manageable safety profile with encouraging anti-tumor activity and duration of response in heavily pre-treated patients with HER2+/PIK3CA-mutated advanced or metastatic breast cancer. Citation Format: Martine Piccart, Audrey Hennequin, Manuel Ruiz Borrego, Santiago Escrivá-de-Romani, Anja Williams, Begoña Jiménez Rodríguez, Gianluca Del Conte, Sacha J. Howell, Michela Palleschi, Matteo Simonelli, Francois P. Duhoux, Diego Tosi, Bernard Doger de Speville Uribe, Yolanda Jerez Gilarranz, Pierfrancesco Tassone, Giuseppe Curigliano, Simon Waters, Philippe Aftimos, Hans Wildiers, Simona Scartoni, Bartomeu Piza Vallespir, Ram Charan Shankaraiah, Krzysztof Grzegorzewski, Nassir Habboubi. MEN1611, a PI3K inhibitor, combined with trastuzumab ± fulvestrant for HER2+/PIK3CA mutant advanced or metastatic breast cancer: updated safety and efficacy results from the ongoing phase 1b study (B-PRECISE-01) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD18-05.

Развивающая психолого-педагогическая программа «Познаю себя. Развиваюсь. Стремлюсь»

&lt;p&gt;The article presents the experience of conducting a developing psychological and pedagogical program under the general title &amp;ldquo;I&amp;rsquo;m knowing myself. I&amp;rsquo;m developing. I&amp;rsquo;m striving.", which includes five interrelated courses of extracurricular activities: &amp;ldquo;I&amp;rsquo;m knowing myself" (grades V&amp;ndash;VI), &amp;ldquo;Happy Teenager&amp;rdquo; (grade VII), &amp;ldquo;Psychology and Choosing a Profession&amp;rdquo; (grade VIII), &amp;ldquo;Fundamentals of Psychology&amp;rdquo; (grade IX), "Psychology of a high grade student" (grades X-XI), which provide for the phased implementation of all tasks based on the implementation of previous courses. The work programs of extracurricular activities courses determine the content of the work of psychologists with students aged 11&amp;ndash;18 in the following areas: psychoprophylaxis, psychodiagnostics, psychological counseling. At the same time, the ongoing diagnostic, correctional and developmental, consultative, educational procedures are correlated with the age of the students. The work program in each grade is designed for the one academic year (35 hours in grades V-VIII, X, 34 hours in grades IX and 17 hours in grades XI. The criteria for assessing the achievement of planned results included indicators of the success of the student&amp;rsquo;s activity, the implementation of activities without significant impairment of physical and mental health, satisfaction with their activities, their position, linking their personal plans and interests with this activity in the future.&lt;/p&gt;

Activities for Independent Living at Schools for Those with Physical Disabilities and Health Impairments

Activities for Independent Living at Schools for Those with Physical Disabilities and Health Impairments

CHALLENGES EXPERIENCED BY MOTHERS OF CHILDREN WITH CEREBRAL PALSY DURING THE MOVEMENT CONTROL ORDER (LOCKDOWN) IN MALAYSIA: A QUALITATIVE STUDY

Background and Purpose: Following the global coronavirus (COVID-19) outbreak and the recent spike in COVID-19 cases in Malaysia, the Malaysian government had imposed a Movement Control Order (MCO) on 16 March 2020 as a measure to curb the outbreak. Consequently, all non-essential affairs were suspended and operated fully on a work-from-home basis, when schools were temporarily closed, and citizens were urged to stay at home. Despite a high number of studies on the negative impacts of MCO to various sectors, there is a little concern noted for the potential impacts on vulnerable populations, including parents with special kids such as cerebral palsy (CP). The purpose of this qualitative study was to investigate the burdens and difficulties associated with the experience of caring for children with CP during the MCO&#x0D; &#x0D; Methodology: This study was designed as qualitative research. Twenty-six participants were selected using a purposive sampling method to involve in in-depth interviews. They were the parents who joined the Cerebral Palsy Support Group in Terengganu, Malaysia. The interview responses were thematically analyzed using a content analysis method.&#x0D; &#x0D; Findings: Four main themes were revealed from the thematic analysis, namely emotional distress, worry over postponement of therapy and medical consultation, burn out due to work from home, and conditions of the CP children themselves. The findings indicated that both mothers, either working or housewife, experienced depression and deterioration in physical health and psychosocial emotions.&#x0D; Contributions: Interventions in the forms of financial aids, guidance for CP children self-therapy at home, and emotional supports are urgently needed to ensure mothers and their CP children maintain their quality of life despite the MCO. &#x0D; &#x0D; Keywords: Movement control order, challenges, parents, cerebral palsy, financial distress, emotional distress.&#x0D; &#x0D; Cite as: Wan Abdul Ghapar, W. R. G., Ahmad, M. F., &amp; Yahya, N. (2023). Challenges experienced by mothers of children with cerebral palsy during the movement control order (lockdown) in Malaysia: A qualitative study. Journal of Nusantara Studies, 8(1), 246-269. http://dx.doi.org/10.24200/jonus.vol8iss1pp246-269