Questionnaire-based study of COVID-19 vaccination induced headache: evidence of clusters of adverse events.

BACKGROUND: The adverse events (AEs) after a Coronavirus disease 2019 (Covid-19) Pfizer-Biotech mRNA vaccination present a medical and epidemiological issue of increasing interest. Headache is the most frequent neurological adverse effect and generally the third most common adverse event after a Covid-19 vaccination, but only a few studies focus on the link between headache and other AEs after vaccination. This study aims to investigate the correlation between headaches and Covid-19 vaccination, as well as the possible links between headaches and other AEs after Covid-19 vaccination, thereby helping the management of AEs and avoiding further occurrences. METHODS: This study is based on a published questionnaire survey of 1,402 healthcare workers. Our study focused on the 5 questions including 12 AEs and headaches extracted from the questionnaire post the first and second Covid-19 vaccination. The severity of the 12 AEs and headaches could be classified by the participants on a five-step scale: "Not at all", "Little", "Average", "Quite", and "Very" (abbreviated as "N", "L", "A", "Q", "V"). We used the Bowker test to study the comparison of headache severity, indicated on a 5-point Likert scale between the first and second vaccinations. We applied an ordinal logistic regression to the 5 categories with headache severity serving as the dependent variable and the ratings of the other 12 AEs serving as the independent variable to further explore to what extent the severity of the 12 AEs is associated with the severity of headaches. Receiver Operating Characteristic (ROC) analysis was conducted to evaluate the predictive value of the ratings of the 12 AEs to headache severity. RESULTS: We found that participants rated their headaches as more severe after the second vaccination, and participants who reported experiencing fatigue, flu-like symptoms, pain at the injection site, known tension-type headache, fever, dizziness/balance problems and known migraine are associated with headache symptoms. CONCLUSIONS: There are clusters of headache-associated AEs post Covid-19 vaccination. The association of various AEs with headaches may be due to similar causative mechanisms.

Dietary habits, traveling and the living situation potentially influence the susceptibility to SARS-CoV-2 infection: results from healthcare workers participating in the RisCoin Study.

PURPOSE: To explore occupational and non-occupational risk and protective factors for the coronavirus disease 2019 (COVID-19) in healthcare workers (HCWs). METHODS: Serum specimens and questionnaire data were obtained between October 7 and December 16, 2021 from COVID-19-vaccinated HCWs at a quaternary care hospital in Munich, Germany, and were analyzed in the RisCoin Study. RESULTS: Of 3,696 participants evaluated, 6.6% have had COVID-19 at least once. Multivariate logistic regression analysis identified working in patient care occupations (7.3% had COVID-19, 95% CI 6.4-8.3, Pr = 0.0002), especially as nurses, to be a potential occupation-related COVID-19 risk factor. Non-occupational factors significantly associated with high rates of the disease were contacts to COVID-19 cases in the community (12.8% had COVID-19, 95% CI 10.3-15.8, Pr < 0.0001), being obese (9.9% had COVID-19, 95% CI 7.1-13.5, Pr = 0.0014), and frequent traveling abroad (9.4% had COVID-19, 95% CI 7.1-12.3, Pr = 0.0088). On the contrary, receiving the basic COVID-19 immunization early during the pandemic (5.9% had COVID-19, 95% CI 5.1-6.8, Pr < 0.0001), regular smoking (3.6% had COVID-19, 95% CI 2.1-6.0, Pr = 0.0088), living with the elderly (3.0% had COVID-19, 95% CI 1.0-8.0, Pr = 0.0475), and frequent consumption of ready-to-eat meals (2.6% had COVID-19, 95% CI 1.1-5.4, Pr = 0.0045) were non-occupational factors potentially protecting study participants against COVID-19. CONCLUSION: The newly discovered associations between the living situation, traveling as well as dietary habits and altered COVID-19 risk can potentially help refine containment measures and, furthermore, contribute to new mechanistic insights that may aid the protection of risk groups and vulnerable individuals.

Mental health problems during the COVID-19 pandemic among residents of Jimma town: a cross-sectional study.

The COVID-19 pandemic presents an unprecedented challenge to community wellbeing and mental health. However, quantifiable information on the extent of mental health problems and associated factors due to the pandemic is still lacking in low-income countries. Thus, this study aimed to investigate the levels of depression, anxiety, and stress and their association with risk and resilience factors among residents of Jimma town in Southwestern Ethiopia. A community-based cross-sectional study was conducted between October 2021 and November 2021. Data were collected from 1196 adult Jimma town residents selected through multi-stage sampling. The following scales were used for the cross-sectional assessment of depressions, anxiety and stress and their associations: depression, anxiety, and stress-21(DASS-21), World Health Organization (WHO) wellbeing, University of California, Los Angeles Loneliness Scale (UCLA), Childhood trauma questionnaire, and brief resilience scales. A pre-tested, interviewer-completed questionnaire was used for data collection. Bivariate and multivariate logistic regression analyses were conducted to identify factors associated with depression, anxiety, and stress. Odds ratios consistent with 95% CI were used to report the presence of an association between risk and resilience factors and the outcome variable at a P-value < 0.05. Overall, 963 (80.53%) respondents had divergent DASS-21 score findings. Specifically, 27.68%, 31.52% and 21.32% experienced depression, anxiety, and stress respectively. Higher DASS-21 scores were associated with the presence of one or more COVID-19 risk factors for anyone close to the participants (AOR = 1.53, 95% CI 1.03-2.27), feelings of stress/burden (ß = 1.09, 95% CI 1.07-1.12), positive coping (ß = 1.044, 95% CI 1.01-1.07), loneliness (ß = 1.063, 95% CI 1.04-1.08), and childhood trauma (ß = 1.03, 95% CI 1.01-1.04). In contrast, lower DASS-21 scores were associated with beliefs about the necessity of solidarity-based behavior (ß = 0.94, 95% CI 0.90-0.98), resilience (ß = 0.92, 95% CI 0.87-0.97) and wellbeing (ß = 0.90, 95% CI 0.87-0.94). In the course of the COVID-19 pandemic in 2021, symptoms of depression, anxiety, and stress in the study community were prevalent, and associated with numerous risk and resilience factors. Although causality cannot be inferred, these findings underscore the importance of strengthening mental health services and may guide COVID-19 prevention and treatment strategies.

A prospective longitudinal cohort study on risk factors for COVID-19 vaccination failure (RisCoin): methods, procedures and characterization of the cohort.

The primary objective of the RisCoin study was to investigate the interplay of genetic, metabolic, and lifestyle factors as well as stress levels on influencing the humoral immune response after at least two COVID-19 vaccinations, primarily with mRNAs, and the risk of SARS-CoV-2 breakthrough infections during follow-up. Here, we describe the study design, procedures, and study population. RisCoin is a prospective, monocentric, longitudinal, observational cohort study. Between October and December 2021, 4515 participants with at least two COVID-19 vaccinations, primarily BNT162b2 and mRNA-1273, were enrolled at the LMU University Hospital of Munich, thereof > 4000 healthcare workers (HCW), 180 patients with inflammatory bowel disease under immunosuppression, and 119 patients with mental disorders. At enrollment, blood and saliva samples were collected to measure anti-SARS-CoV-2 antibodies, their neutralizing capacity against Omicron-BA.1, stress markers, metabolomics, and genetics. To ensure the confidential handling of sensitive data of study participants, we developed a data protection concept and a mobile application for two-way communication. The application allowed continuous data reporting, including breakthrough infections by the participants, despite irreversible anonymization. Up to 1500 participants attended follow-up visits every two to six months after enrollment. The study gathered comprehensive data and bio-samples of a large representative HCW cohort and two patient groups allowing analyses of complex interactions. Our data protection concept combined with the mobile application proves the feasibility of longitudinal assessment of anonymized participants. Our concept may serve as a blueprint for other studies handling sensitive data on HCW.

COVID-19 management at one of the largest hospitals in Germany: Concept, evaluation and adaptation.

CONTEXT: The LMU University Hospital is among the largest healthcare facilities in Germany. The measures implemented prior to and during the first pandemic wave of COVID-19, were evaluated in preparation of a second pandemic wave. This paper presents the pandemic management concept, evaluation and adaptation of LMU University Hospital. METHODS: Between July and September 2020 the disaster management team of LMU University Hospital conducted a mixed-method evaluation of the hospital's pandemic management. A workshop series based on the After Action Review working group format was organized to examine the management structure, decision-making processes, documentation, and crisis preparedness response for a second COVID-19 wave. Further, the satisfaction of employees with the hospital's COVID-19 management was examined through an anonymous survey. RESULTS: The workshop series highlighted a need for structural and operational adaptation of the COVID-19 management at LMU University Hospital. The results of the employee survey (N = 2182) provided positive feedback for the measures taken during the first pandemic wave. Specific actions were derived concerning the availability of personal protective equipment and emergency childcare services. A key outcome of both evaluation activities was the identified need for further improvement in communication between stakeholders. All changes were adopted prior to the second pandemic wave.

Are We Prepared for the Next Pandemic? Management, Systematic Evaluation and Lessons Learned from an In-Hospital COVID-19 Vaccination Centre for Healthcare Workers.

BACKGROUND: the organisation of a COVID-19 vaccination campaign for healthcare workers (HCWs) within a university hospital presents a challenge of a particularly large scale and urgency. Here, we evaluate the in-hospital vaccination process and centre for HCWs at LMU University Hospital in Munich, Germany. METHODS: We executed a mixed-method process evaluation of the vaccination centre at LMU University Hospital during the first COVID-19 vaccination campaign. In a programme monitoring, we continuously assessed the implementation of the centre's operational management including personnel resources. In evaluating the outreach to and satisfaction of the target group with the centre and process, we executed two anonymous surveys aimed at the HCWs vaccinated at the in-hospital centre (1) as well as centre staff members (2). RESULTS: staff numbers and process time per person were reduced several times during the first vaccination campaign. Lessons concerning appointment scheduling were learned. HCWs vaccinated at the in-hospital centre were satisfied with the process. A longer waiting time between admission and inoculation, perceived dissatisfying accessibility as well as an increased frequency of observed adverse events were linked to a reduced satisfaction. Comparatively subpar willingness to adhere to non-pharmaceutical measures was observed. Centre staff reported high satisfaction and a workload relatively equal to that of their regular jobs. Our outcomes provide references for the implementation of an in-hospital vaccination centre in similar settings.

COVID-19 Vaccination Intent, Barriers and Facilitators in Healthcare Workers: Insights from a Cross-Sectional Study on 2500 Employees at LMU University Hospital in Munich, Germany.

Considering the role of healthcare workers (HCW) in promoting vaccine uptake and previously recorded hesitancy among HCW, we aim to examine the COVID-19 vaccination intent and status of HCW through a cross-sectional anonymous online survey at LMU University Hospital in Munich. Data collection was informed by the Health Belief Model (HBM) and focused on vaccination intent, status and on potential factors affecting the decision-making process. In total, 2555 employees completed the questionnaire. Our data showed that an approving attitude towards recommended vaccines and having received an influenza vaccine in the previous winter were strongly associated with COVID-19 vaccination intent. Further, a positive COVID-19 vaccination status was associated with a higher likelihood of approving the extension of the validity of non-pharmaceutical interventions at the workplace. Our HBM-analysis demonstrated strong associations between the perceived benefits and barriers and COVID-19 vaccination intent. Unchanged or low perceived susceptibility and severity were associated with refusal or indecisiveness. Our findings highlight the factors associated with the decision regarding a COVID-19 vaccine and indicate a pattern-like behavior in the acceptance of novel vaccines by HCW. These insights can help inform the communication aims of vaccination campaigns among HCW within similar organizational contexts or in future outbreaks.

Dietary Supplementation Before, During and After Pregnancy: Results of the Cluster-Randomized GeliS Study.

Introduction The nutritional status of women before, during, and after pregnancy plays an important role in the health of mother and child. In addition to a balanced mixed diet, the increased need for folic acid and iodine should be met and ensured with supplements. The aim of this study was to assess dietary supplementation in the context of pregnancy and to investigate the effect of targeted counselling on supplementation behavior during and after pregnancy. Methods In the context of the "Gesund leben in der Schwangerschaft" (GeliS; "Healthy living in pregnancy") trial, women in the intervention group (IG) received four structured lifestyle counselling sessions during pregnancy as well as postpartum, during which they were informed about appropriate dietary supplementation. The women in the control group (CG) received routine prenatal care. The intake of dietary supplements was recorded at different points using a questionnaire. Results In total, 2099 women were included in the analysis. Prior to conception, 31.3% of the women in the IG and 31.4% of the women in the CG took folic acid supplements. Prenatally, about half of the women took folic acid (IG: 54.1%; CG: 52.0%) and iodine (IG: 50.2%; CG: 48.2%). Statistically significant differences between the groups with regard to supplementation behavior could not be observed, neither prior to inclusion in the study nor during the intervention. During pregnancy, 23.0% of all women took docosahexaenoic acid (DHA) supplements and 21.8% iron supplements. 49.4% of the women additionally took vitamin D supplements. A higher educational level (p < 0.001), advanced age (p < 0.001), primiparity (p < 0.001), and a vegetarian diet (p = 0.037) were all associated with a higher level of dietary supplementation. Conclusion The GeliS lifestyle counselling did not significantly improve the supplementation behavior of women during and after pregnancy. Women should be informed about adequate dietary supplementation early on within the scope of gynecological prenatal care.

[Evidence-based public health: perspectives and specific implementation factors]. / Evidenzbasierte Public Health: Perspektiven und spezifische Umsetzungsfaktoren.

An evidence-based approach is considered a central requirement in the public health system. Five general principles apply in evidence-based medicine as well as in evidence-based public health (EBPH). These comprise a systematic approach, transparency in relation to uncertainty, integration and participation, management of conflicts of interest, and a structured, reflective process. This article aims to promote a common understanding of what taking an evidence-based approach entails in the field of public health.We explored the international understanding of EBPH through systematic literature searches of definitions, concepts, and models regarding an evidence-based approach in public health. In this manner, 20 English sources and one German source were identified and examined using content analysis. Beyond the above-described general principles, characteristics of these perspectives are concerned with a population orientation, the underlying concept of evidence, disciplines, and stakeholder groups to be involved in the process, as well as relevant criteria and necessary competencies for implementing an evidence-based approach.Based on this, and taking into account methodological developments to address complexity, four specific implementation factors of EBPH can be derived. These include theory, interdisciplinarity, context-sensitivity, and complexity as well as general societal aspects.The practical implementation of EBPH requires human and financial resources as well as competencies - among others, for conducting systematic reviews of the effectiveness of measures, examining other relevant questions in a scientific manner, and establishing transparent processes to formulate recommendations.