Trauma has been found to be highly prevalent and associated with many negative health and social outcomes (i.e., heart disease, higher suicide risk, high-risk behaviors) in the general population. Despite these associations, trauma detection is relatively rare in service-providing organizations. Trauma-informed care (TIC) is a proposed solution that encourages trauma detection, understanding the symptoms associated with trauma, and treating trauma while actively avoiding re-traumatization to the service user. Although research about TIC efficacy has been fairly limited, there are some promising potential benefits of the practice to the client, provider, and the population as a whole. For this study, we looked at service providers’ reported familiarity with TIC and implementation of TIC in their organization across seven timepoints. We found familiarity increased more than implementation, and we discuss potential reasons that may cause this discrepancy.

Adverse childhood experiences (ACEs) are traumatic events during a person’s early life that can influence their later mental health, physical health, and wellbeing. Internalizing symptoms such as anxiety and depression are common mental health outcomes associated with these events. Two factors, religiosity/spirituality (R/S) and mindfulness, are possible protecting factors to help lessen the effect of traumatic experiences on later mental health. This study examined whether R/S and mindfulness are protective factors in the relationship between ACEs and future internalizing symptoms. Further, this study examined whether the impact of R/S was influenced by an individual’s mindfulness (moderated moderation). Participants (N = 769, age M = 20.43, SD = 4.507) for this study were recruited through the SONA research platform at East Tennessee State University as a part of the REACH (Religion, Emotions, and Current Health) self-report survey. Results from the current study did not support either mindfulness or R/S as moderating factors for the relationship between ACEs and internalizing symptoms. However, exploratory mediation suggested mindfulness was a mediator for this relationship. This study, while it did not demonstrate the buffering capacity of study variables, provides information about the implications of ACEs in a Northeast Tennessee sample. Future research should examine new variables as potential protective factors for this relationship and more detailed information about the mediating effect of mindfulness.

Pregnancy is a unique developmental period in a woman’s life, characterized by numerous psychological, behavioural, and biological changes. How a biologically female woman experiences her pregnancy is impacted by her previous life experiences, including early experiences of adversity. In particular, maternal history of Adverse Childhood Experiences (ACEs) before age 18, has been shown to exert distal effects on mental health and behaviour in pregnancy. The current study explored the associations between ACEs and mental health symptoms in pregnancy via structural equation modelling within a sample of 330 Canadian women. This statistical approach permitted the use of a latent ACE variable comprised of abuse, neglect, and household dysfunction as indicator variables, as well as a latent mental health variable comprised of symptoms of depression, anxiety, and fear of childbirth. A direct effect emerged whereby maternal ACEs predicted mental health symptoms. This permitted subsequent testing of the following mediating pathways: sleep, health-risk behaviours, resilience, and social support. In the mediation analyses, further support emerged for the total indirect effect of maternal ACEs on mental health symptoms in pregnancy, once mediation pathways were added. In reviewing individual indirect pathways, sleep and social support mediated the association between ACEs and mental health symptoms in pregnancy. However, health risk behaviours and resilience did not. In addition, social support mediated the relationship between resilience and mental health symptoms in pregnancy. This study contributes to the existing research on maternal ACEs and their relationship with mental health symptoms during pregnancy. The concurrent testing of several pathways in the structural model served to characterize possible mechanisms through which early adversity relates to current mental health symptoms in pregnancy. Implications of these findings include identification of possible targets for intervention in pregnancy, in order to lessen the burden of ACEs on maternal mental health. / Graduate

There are millions of adult male offenders currently involved with U.S. corrections system, many of which report a wide range of mental health difficulties and a history of traumatic experiences. Mental health and trauma-related difficulties are important considerations in the treatment and rehabilitation of adult male offenders. The relationship between adverse childhood experiences (ACEs), attachment style, and PTSD symptoms were studied in a sample of adult male participants in a court-ordered diversion program. The sample consisted of 59 men, ranging in age from 19 to 68-years-old, who endorsed a history of at least one prior arrest. Data were collected during a psychoeducational group-therapy class offered at a post-arrest diversion program. Primary study measures included the use of the ACEs questionnaire, Attachment Style Questionnaire (ASQ-40), and the Posttraumatic Stress Disorder Checklist-5 (PCL-5). A priori hypotheses proposed, 1) there is a significant correlation among ACEs, ASQ subscales, and PTSD symptoms, and 2) insecure attachment subscales mediate the relationship between ACEs and PTSD symptoms. Correlation, regression, and mediation analyses evaluated the relationship among ACEs, ASQ subscales and PCL-5 scores. As predicted, ACEs and PTSD symptoms were negatively correlated with secure attachment and positively correlated with insecure attachment. Also as predicted, insecure attachment style (i.e. discomfort from closeness) mediated the relationship between ACEs and PTSD symptoms. Results suggested that the confidence and discomfort with closeness attachment scales shared a significant relationship between and ACEs and PTSD symptoms. These findings suggest that the relationship between ACEs, attachment style, and PTSD symptomatology can further inform conceptualizations and treatments oriented toward improving outcomes for adult male offenders and successful reintegration into their communities.

5 ABSTRACT Candidate: Lenka Polláková1 Supervisor: prof. RNDr. Jiří Vlček, CSc.1 Consultant: doc. MUDr. Tomáš Soukup, Ph.D.2 1 Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University 2 2nd Department of Internal Gastroenterology, University Hospital in Hradec Králové Title of the master thesis: Analysis of non-cardiac adverse event of glucocorticoid pulse therapy Intravenous glucocorticoid pulse therapy (PT GC) is effective in life threatening flares of rheumatic diseases. However, due to GC's pleiotropic effect, higher doses and additive nongenomic mechanism in pulse regimen, it is not free of complications (1). The aim of theoretical part was to describe from literature research the relevance of PT GC, its non- cardiac adverse events (AE) in rheumatic patients and their influencing factors. The aim of experimental part of the study was to analyze the occurrence of non-cardiac AE in real-life setting, analyze risk factors of potential adverse drug reactions (ADR) and its complications and analyze the risk minimalization management in real-life setting. Patients were administered 1000 mg methylprednisolone in 3 to 5 doses on alternating days. Analysis includes 277 rheumatic patients with 325 pulse therapy courses. Data were collected retrospectively from their...

Analysis of spontaneous adverse events reports of hypolipidemics Author: Anežka Škabradová Supervisor: PharmDr. Kateřina Malá, Ph.D. Consultant: PharmDr. Josef Malý, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Hypolipidemic drugs are widely used in today's medicine and their consumption is still rising. Besides all benefits, their usage includes also some risks that needs to be reconsidered regularly. Analysis of spontaneous adverse effects (AEs) reports contributes to a safer therapy by detecting especially serious and unexpected adverse drug reactions. Objective: The aim of this thesis was to analyse spontaneous adverse events reports of hypolipidemic drugs, which were sent to the State Institute for Drug Control (SÚKL) database in the period from June 2004 to October 2017. Methods: The data obtained from SÚKL during the above mentioned period was analysed using descriptive statistics. The frequency of occurrence of certain AEs, which were categorized according to MedDRA and distinguished by hypolipidemics, was analysed, as well as their severity and expectability. Part of the analysis was for example also by whom was the report submitted and which way they used to submit it. Results: Overall 290 reports were obtained,...

Background Efficacy and safety of treatments for hospitalized COVID-19 are uncertain. We systematically reviewed efficacy and safety of remdesivir for the treatment of COVID-19. Methods Studies evaluating remdesivir in adults with hospitalized COVID-19 were searched in several engines until August 21, 2020. Primary outcomes included all-cause mortality, clinical improvement or recovery, need for invasive ventilation, and serious adverse events (SAEs). Inverse variance random effects meta-analyses were performed. Results We included four randomized controlled trials (RCTs) (n = 2296) [two vs. placebo (n = 1299) and two comparing 5-day vs. 10-day regimens (n = 997)], and two case series (n = 88). Studies used intravenous remdesivir 200mg the first day and 100mg for four or nine more days. One RCT (n = 236) was stopped early due to AEs; the other three RCTs reported outcomes between 11 and 15 days. Time to recovery was decreased by 4 days with remdesivir vs. placebo in one RCT (n = 1063), and by 0.8 days with 5-days vs. 10-days of therapy in another RCT (n = 397). Clinical improvement was better for 5-days regimen vs. standard of care in one RCT (n = 600). Remdesivir did not decrease all-cause mortality (RR 0.71, 95% CI 0.39 to 1.28, I2 = 43%) and need for invasive ventilation (RR 0.57, 95%CI 0.23 to 1.42, I2 = 60%) vs. placebo at 14 days but had fewer SAEs; 5-day decreased need for invasive ventilation and SAEs vs. 10-day in one RCT (n = 397). No differences in all-cause mortality or SAEs were seen among 5-day, 10-day and standard of care. There were some concerns of bias to high risk of bias in RCTs. Heterogeneity between studies could be due to different severities of disease, days of therapy before outcome determination, and how ordinal data was analyzed. Conclusions There is paucity of adequately powered and fully reported RCTs evaluating effects of remdesivir in hospitalized COVID-19 patients. Until stronger evidence emerges, we cannot conclude that remdesivir is efficacious for treating COVID-19. / Revisión por pares

Analysis of spontaneous adverse events reports of antiepileptic drugs Author: Ivana Šoborová Supervisor: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Epilepsy is one of the most common neurological diseases, which occurs worldwide. Antiepileptic drugs (AED) suppress the onset of an epileptic seizure. Analysis of spontaneous adverse drug reactions (ADRs) analysis is important data source for generating the potential risks signals in pharmacotherapy. Objective: The aim of this work was to analyse spontaneous reports of ADRs from the Czech Central Database of ADRs of the State Institute for Drug Control (SÚKL) in the period from June 2004 to October 2017. The analyses of potential drug interactions of all medicinal products mentioned in the reports and the assessment of the reported ADRs expectability was the secondary goal. Methods: Retrospective analyses of the spontaneous ADR reports of antiepileptic drugs obtained from the SÚKL in the given period. Anonymized data was processed using the descriptive statistics in MS Excel. For example, the patient characteristics or seriousness and expectability of the ADRs were evaluated. The specific adverse drug reactions were divided according to the system...

Magister Pharmaceuticae - MPharm / Gestational diabetes mellitus (GDM) is a condition that affects pregnant women and is one of the most common complications related to pregnancy. According to the World health organisation (WHO), the usual window for diagnosing GDM is between 24 and 28 weeks of gestation and the primary aim of diagnosing gestational diabetes is to identify women and infants at risk of short- or longer-term adverse outcomes. Recent results from the hyperglycaemia and adverse pregnancy outcome (HAPO) study have suggested that even mild levels of hyperglycaemia can have adverse effects on foetal outcomes but there are uncertainties about the prevalence of these outcomes in GDM diagnosed according to the latest WHO 2013 guideline and/or IADPSG 2010 criteria in diverse populations. GDM prevalence has been studied by different researchers, but the prevalence of adverse foetal outcomes in GDM diagnosed based on the latest WHO 2013 guideline and/or IADPSG 2010 criteria have not yet been explored except for the data published by the HAPO study. Due to the lack of sufficient knowledge on foetal outcomes in GDM, this study was conducted to review the evidence on the prevalence of adverse foetal outcomes in GDM diagnosed according to WHO 2013 guideline and/or the IADPSG 2010 criteria. Different databases including PubMed, Science Direct, Google Scholar and CINAHL as well as bibliographic citations were searched using a well-formulated search strategy to find the relevant observational studies (prospective/retrospective cohort and case-control) using explicit inclusion and exclusion criteria. The following search terms were used, “gestational diabetes”, “pregnancy”, “adverse fetal outcomes” and “adverse foetal outcomes”. The findings of this study were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and the obtained data analysed using MetaXL ® version 5.3. This review was registered online on PROSPERO, the International prospective register of systematic reviews (registration number: CRD42020155061). Fifteen studies with 88,831 pregnant women (range: 83-25,543 participants) from 12 countries around the world were identified, with a wide variation in the prevalence of foetal outcomes in GDM using the stipulated criteria. These studies were unevenly distributed geographically as six of them were conducted in Asia, four in Europe, four in North America, one in Australia and none in Africa, Antarctica and South America. A meta-analysis found that the overall prevalence of foetal outcomes ranged from 1% (perinatal mortality) to 11% ( large for gestational age). The finding is limited due to the paucity of data on the prevalence of foetal outcomes in GDM. However, more studies using these criteria in low- and middle- income countries (LMICs) are needed by health care providers, to inform practice and allocate resources for control of GDM and its adverse foetal outcomes in diverse settings and ethnic groups, especially in LMICs.

Background: Root Cause Analysis (RCA) is a method of investigating adverse events (AEs). The purpose of RCA is to improve quality of care and patient safety through a retrospective, structured investigative process of an incident, resulting in recommendations to prevent the recurrence of medical errors. Aim: The aim of the study was to develop and validate a prototype questionnaire to establish whether the RCA model and processes employed at the research setting were perceived by the users to be acceptable, thorough and credible in terms of internationally established criteria. Methods: This is a validation study comprising four phases to meet the study objectives: 1) the development of a prototype questionnaire guided by a literature review; 2) assessing the validity of the content of the questionnaire by and numerical evaluation of the face validity thereof; 3) assessing the qualitative face validity cognitive interviews; and 4) reliability by test-retest. Results: Content validity assessment in Phase 2 resulted in removal of 1/36 (2.77%) question items and amendment of 7/36 (19.44%), resulting in 35 for the revised questionnaire. Analysis of data from the cognitive interviews resulted in amendment of 20/35 (57.14%) question items but no removal. Reliability of the final questionnaire achieved the predetermined ≥0.7 level of agreement. Conclusion: The questionnaire achieved a high content validity index and face validity was enhanced by cognitive interviews by providing qualitative data. The inter-rater coefficient indicated a high level of reliability. The tool was designed for a local private healthcare sector and this may limit its use.