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INTRODUCTION: Vaccinations are important for informal caregivers and their care recipients. Mental health problems are common among care givers. The aim of this study was to investigate vaccination readiness in informal caregivers and associations with mental health issues. Associations between vaccination readiness in informal caregivers and the vaccination status of their aged care recipients were examined. METHODS: Within the multicenter prospective registry study 'Bavarian ambulatory Covid-19 Monitor (BaCoM) ', informal caregivers were asked for symptoms of depression (PHQ-9), burden of caretaking (BSFC-s), psychological antecedents of vaccination readiness (5C model) and previous Covid-19 infections of their care recipients. The vaccination status against Covid-19, seasonal influenza and pneumococcal disease was determined via vaccination certificates. Data analysis was performed using ordinal regressions and Mann-Whitney-U tests. RESULTS: Data of n = 91 informal caregivers, associated with n = 84 care recipients were collected. Symptoms of depression were associated with reduced vaccination readiness (Calculation: p = 0.026, OR = 1.18), as well as the perceived burden of caretaking (Confidence: p = 0.006, OR = 0.88). A previous Covid-19 infection of the care recipients was associated with decreased vaccination readiness of informal caregivers (Median (Q1-Q3) Confidence: 5.0 (4.5-6.0) vs. 4.0 (3.0-5.0); Calculation: 5.0 (3.0-6.0) vs. 4.0 (1.0-5.0)). The vaccination status of the care recipients interrelated significantly with vaccination readiness of their informal caregivers (Confidence: p < 0.001; Complacency: p < 0.01; Constraints p < 0.05). No significant interrelations between vaccination readiness and the vaccination status against seasonal influenza or pneumococcal disease occurred. CONCLUSION: Mental health issues of informal caregivers seem to be associated with the actual vaccination status against Covid-19 in their care recipients. Target group specific counselling as well as an active involvement of informal caregivers in shared decision-making processes can be of relevance, but even more attention should be paid to the protection of mental health for informal caregivers. TRIAL REGISTRATION NUMBER: German Register of Clinical Studies DRKS 26039.
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Vacinas contra COVID-19 , COVID-19 , Cuidadores , Depressão , Saúde Mental , Vacinação , Humanos , COVID-19/prevenção & controle , COVID-19/epidemiologia , Cuidadores/psicologia , Masculino , Feminino , Estudos Transversais , Pessoa de Meia-Idade , Idoso , Vacinação/psicologia , Depressão/epidemiologia , Estudos Prospectivos , Vacinas contra COVID-19/administração & dosagem , SARS-CoV-2/imunologia , Adulto , Vacinas contra Influenza/administração & dosagem , Hesitação Vacinal/estatística & dados numéricos , Hesitação Vacinal/psicologia , Idoso de 80 Anos ou mais , Influenza Humana/prevenção & controle , Vacinas Pneumocócicas/administração & dosagem , Pandemias/prevenção & controle , Alemanha/epidemiologiaRESUMO
BACKGROUND: In Germany, general practitioners play a pivotal role in palliative care provision. Caring for patients with palliative care needs can be a burden for general practitioners, highlighting the importance of self-care and mental health support. This study aimed to explore the role of palliative care in general practitioners' daily work, the stressors they experience, their coping mechanisms, and the potential benefits of Advance Care Planning in this context. METHODS: An exploratory approach was employed, combining a short quantitative survey with qualitative interviews. The analysis was based on a structuring qualitative content analysis, following a deductive-inductive procedure and integrating the Stress-Strain Model and Lazarus' Transactional Model of Stress and Coping. We recruited eleven general practitioners to take part in the study. RESULTS: General practitioners viewed palliative care as integral to their practice but faced challenges such as time constraints and perceived expertise gaps. Societal taboos often hindered conversations on the topic of death. Most general practitioners waited for their patients to initiate the topic. Some general practitioners viewed aspects of palliative care as potentially distressing. They used problem-focused (avoiding negative stressors, structuring their daily schedules) and emotion-focused (discussions with colleagues) coping strategies. Still, general practitioners indicated a desire for specific psychological support options. Advance Care Planning, though relatively unfamiliar, was acknowledged as valuable for end-of-life conversations. CONCLUSIONS: Palliative care can be associated with negative psychological stress for general practitioners, often coming from external factors. Despite individual coping strategies in place, it is advisable to explore concepts for professional psychological relief. TRIAL REGISTRATION: Not registered.
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Adaptação Psicológica , Clínicos Gerais , Cuidados Paliativos , Pesquisa Qualitativa , Estresse Psicológico , Humanos , Clínicos Gerais/psicologia , Cuidados Paliativos/métodos , Cuidados Paliativos/psicologia , Cuidados Paliativos/normas , Masculino , Feminino , Pessoa de Meia-Idade , Estresse Psicológico/psicologia , Estresse Psicológico/terapia , Adulto , Alemanha , Inquéritos e Questionários , IdosoRESUMO
BACKGROUND: Multimorbidity is increasingly prevalent among ageing patients, leading to reduced daily functioning. To address the challenges posed by multimorbidity in older adults, a person- and context-centred approach is needed. This study aimed to develop a questionnaire as a self-assessment tool for older adults focusing on functioning in general practice based on the International Classification of Functioning, Disability and Health (ICF). METHODS: A mixed-methods approach was employed in the development and validation of the German EFA23 (Erfassung Funktionaler Gesundheit im Alter - 23 Fragen; Assessing Functional Health in Old Age - 23 questions) questionnaire. Based on an ICF subset developed in a preparatory phase and consensus study, questionnaire items were formulated and tested in a qualitative pretest, followed by a validation study. A workshop with general practitioners (GPs) was held to develop a supplementary manual for GPs on how to interpret the questionnaire results and discuss them with the patients. RESULTS: A total of 69 items were developed and tested in the qualitative pretest with 15 respondents, resulting in 37 items for the validation study. The validation study, involving 237 older adults, showed the presence of one significant principal component. It demonstrated good internal consistency (Cronbach's alpha = 0.967) and construct validity, showing positive correlations with established assessment tools. Descriptive statistics showed differences between the means of self-assessment by patients and an external GP assessment. The final EFA23 questionnaire consists of 23 items assessing limitations in functioning. CONCLUSIONS: The EFA23 questionnaire can be used as a valid self-assessment instrument to measure functioning in older adults, supporting a person- and context-centred approach in general practice.
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Medicina Geral , Vida Independente , Autoavaliação (Psicologia) , Humanos , Idoso , Feminino , Masculino , Inquéritos e Questionários , Idoso de 80 Anos ou mais , Reprodutibilidade dos Testes , Atividades Cotidianas , Avaliação Geriátrica/métodos , Psicometria/métodos , Multimorbidade , Pessoa de Meia-IdadeRESUMO
OBJECTIVES: Medical overuse exposes patients to unnecessary risks of harm. It is an open question whether and how patients perceive the concept of medical overuse, its causes and negative consequences. DESIGN: A qualitative study design, using elements of the Grounded Theory Approach by Strauss and Corbin. SETTING: Between May 2017 and January 2020, we recruited participants and conducted face-to-face interviews in the participants' homes. Data collection took place in Bavaria, Germany. PARTICIPANTS: We recruited 16 participants (female=8, male=8) with various characteristics for the study. We used different strategies such as flyers in supermarkets, pharmacies, participants spreading information about the study or local multipliers (snowball sampling). RESULTS: The participants mostly defined medical overuse as too much being done but understood the concept superficially. During the interviews, most participants could describe examples of medical overuse. They named a variety of direct and indirect drivers with economic factors suspected to be the main driver. As a consequence of medical overuse, participants named the physical and emotional harm (eg, side effects of medication). They found it difficult to formulate concrete solutions. In general, they saw themselves more in a passive role than being responsible for bringing about change and solutions themselves. Medical overuse is a 'problem of the others'. The participants emphasised that health education is important in reducing medical overuse. CONCLUSIONS: Medical overuse was little discussed among participants, although many participants reported experiences of too much medicine. Health education and strengthening the patients' self-responsibility can play a vital role in reducing medical overuse.
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Uso Excessivo dos Serviços de Saúde , Pesquisa Qualitativa , Humanos , Masculino , Feminino , Alemanha , Uso Excessivo dos Serviços de Saúde/prevenção & controle , Pessoa de Meia-Idade , Adulto , Idoso , Entrevistas como Assunto , Teoria Fundamentada , Atenção à SaúdeRESUMO
Many practicing physicians struggle to properly evaluate clinical research studies - they either simply do not know them, regard the reported findings as 'truth' since they were reported in a 'reputable' journal and blindly implement these interventions, or they disregard them as having little pragmatic impact or relevance to their daily clinical work. Three aspects for the latter are highlighted: study populations rarely reflect their practice population, the absolute average benefits on specific outcomes in most controlled studies, while statistically significant, are so small that they are pragmatically irrelevant, and overall mortality between the intervention and control groups are unaffected. These observations underscore the need to rethink our research approaches in the clinical context - moving from the predominant reductionist to an eco-systemic research approach will lead to knowledge better suited to clinical decision-making for an individual patient as it takes into account the complex interplay of multi-level variables that impact health outcomes in the real-world setting.
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Vaccinations against COVID-19 are of the utmost importance in long-term care facilities. During the pandemic, mental health issues increased significantly. This cross-sectional analysis aimed to assess the associations of depression and anxiety with health literacy in people in need of care and the association of depression and burnout with vaccination readiness against COVID-19 in health care workers (HCWs). Within our cross-sectional study, people in need of care were assessed for symptoms of depression (PHQ-9), anxiety (GAD-7), and health literacy (HLS-EU-Q16). Among HCWs, we assessed symptoms of depression (PHQ-9) and burnout (MBI-HSS), as well as psychological antecedents of vaccination (5C) to measure vaccination readiness against COVID-19. A multivariate regression analysis was performed. Symptoms of a major depression were significantly associated with reduced health literacy (p = 0.010) in people in need of care. Among HCWs, symptoms of depression and burnout reduced vaccination readiness against COVID-19 significantly. In particular, collective responsibility was reduced in HCWs suffering from burnout symptoms (p = 0.001). People in need of care and their HCWs could benefit from intensified target group-specific vaccination counseling. Additionally, more attention should be paid to the protection of mental health in long-term care facilities.
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BACKGROUND: Medical overuse is defined as health care services that exceed the individual needs of patients and when the potential harms of medical interventions exceed their benefits. It has impacts on patients as well as on health care resources. To address medical overuse, it is important to understand the knowledge and experiences of overuse on the side of patients. RESEARCH QUESTIONS: What is the citizens' understanding of overuse? How do they assess its relevance, causes, consequences and potential solutions? METHODS: A quantitative online survey was conducted. The participants were asked to state what they understand by medical overuse. Statements on causes, consequences and possible solutions were evaluated. Recruitment was carried out via a panel of a market research institute (Schlesinger Group). RESULTS: The survey was completed by 406 participants. In terms of age and gender, the sample corresponded to the distribution in the German population. The majority had never heard of medical overuse (58%). About 60% assumed that medical overuse means "too much medicine including overtreatment and overtesting". Medical overuse was mainly suspected for services not covered by the public health insurance system (56%), surgical interventions (45%) and medication prescriptions (37%). Reasons for medical overuse were seen in uncoordinated care and financial incentives, but also in the expectations of patients. The main problem with medical overuse was seen in rising health care costs, while harmful physical and mental consequences for patients were mentioned less often. In order to reduce medical overuse, little importance was attributed to a primary care based system or higher financial contribution of patients. Instead, stricter cost control on the side of physicians and better coordination between care providers were suggested as solutions. Differences in socio-demographic characteristics hardly showed any differences in response behavior. CONCLUSION: More than half of the respondents had never heard of medical overuse. Overuse was mainly associated with financial causes and consequences. It was not seen that overuse can be harmful for patients directly. The limited awareness of the problem of overuse probably is a barrier to tackling it effectively. Communicating the topic to the public might therefore be an effective start to mitigate medical overuse. TAKE HOME MESSAGE: Many citizens seem not to be familiar with the concept of medical overuse, especially not with the fact that it may directly cause harm to patients. Informing citizens about the harms of medical overuse might be helpful in mitigating it.
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Uso Excessivo dos Serviços de Saúde , Humanos , Alemanha , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Despite general practitioners' (GPs') key role in Germany`s primary health care, clinical research in general practice is scarce. Clinical research is mainly conducted at inpatient facilities, although their results are rarely transferable. German GPs have no extra time or funding for research, as well as limited research training. To support clinical research in German primary health care, practice-based research networks (PBRNs) are developed. As they will be based on an active involvement of GPs, we need more information on GPs` participation-readiness. The aim of this study was to explore facilitators and barriers to participation in the Bavarian Research Practice Network (BayFoNet) from the GPs`perspective before clinical trials will be performed. METHODS: We have performed semi-structured qualitative interviews with a purposive sample of 20 Bavarian GPs in 2022 under the application of the consolidated framework for implementation research (CFIR). Transcriptions were analysed according to Kuckartz` qualitative content analysis. The five domains of the CFIR framework served as initial deductive codes. RESULTS: N = 14 interviewees already agreed to participate in BayFoNet, whereas n = 6 interviewees opted not to participate in BayFoNet at the time of data collection. Main facilitators to conduct clinical research within BayFoNet were the motivation to contribute to evidence strength and quality in general practice, professional development and training of practice staff, as well as networking. Barriers for an active participation were bad experiences with previous clinical studies and lack of resources. CONCLUSIONS: PBRNS in Germany have to be promoted and the entire practice team has to be involved at an early stage of development. Professional training of general practice staff and a living network might enhance engagement. Participatory approaches could help to develop acceptable and feasible study designs. Furthermore, PBRNs should support patient recruitment and data collection in general practices and disseminate the results of their research projects regularly to maintain GPs` engagement. TRIAL REGISTRATION: DRKS00028805, NCT05667207.
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Medicina Geral , Clínicos Gerais , Humanos , Motivação , Atitude do Pessoal de Saúde , Medicina Geral/métodos , Pesquisa QualitativaRESUMO
BACKGROUND: The international study PRICOV-19 aims to assess the impact of the COVID-19 pandemic on the organisation of primary health care. The German part focuses on German general practitioners during the second wave of the COVID-19 pandemic. This paper addresses the following research questions: (1) How were changes in tasks on primary care and patient treatment perceived by GPs?, (2) What was the role of GPs during the pandemic, and how was their wellbeing?, (3) How did GPs perceive health policy measures?, and, (4) What influenced the attitudes of GPs on health policy measures? METHODS: This study pursues a multi-country cross-sectional design. Data collection took place throughout Germany from 01.02. to 28.02.2021 with a quantitative online questionnaire consisting of 53 items. The questionnaire was analysed through descriptive and inferential analyses using correlation and multiple regression models. RESULTS: The response rate was 20.4% (n = 349). The respondents were mainly GPs (59.6%) in single practices (62.5%) with a mean work experience of 15 to 20 years. GPs experienced a change in their work and practice organisation (80.3%). They felt a high responsibility (70.6%) and found their work has become more meaningful to them (76%). They also saw a lack of political support (75.2%) and that the measures taken by the government overburdened the daily practice (66.4%). Not many GPs were at risk of being distressed (53.4%) but rated the health policies rather negatively (60%). The multiple regression showed, the more GPs were exposed to risk of distress, the worse they assessed the government's measures. CONCLUSION: GPs perceived their work as relevant and felt confident they could fulfil their tasks, but noticed that health policy initially hardly supported the outpatient sector. Health policies should increase their competence in relation to primary care, ensure its needs and consider an active inclusion of GPs in preparedness plans.
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COVID-19 , Clínicos Gerais , Humanos , COVID-19/epidemiologia , Estudos Transversais , Pandemias , Inquéritos e Questionários , GovernoRESUMO
BACKGROUND: In the course of the SARS-CoV-2 pandemic, multiple vaccines were developed. Little was known about reactogenicity and safety in comparison to established vaccines, e.g. influenza, pneumococcus, or herpes zoster. Therefore, the present study aimed to compare self-reported side effects in persons vaccinated against SARS-CoV-2 with the incidence of side effects in persons receiving one of the established vaccines. METHODS: A longitudinal observational study was conducted over a total of 124 days using web-based surveys. Persons receiving either a vaccination against SARS-CoV-2 or one of the established vaccines (comparator group) were included. In the first questionnaire (short-term survey), 2 weeks after vaccination, mainly local and systemic complaints were evaluated. The long-term survey (42 days after vaccination) and follow-up survey (124 weeks after vaccination) focused on medical consultations for any reason. Multivariate analyses were conducted to determine the influence of the vaccine type (SARS-CoV-2 vs. comparator) and demographic factors. RESULTS: In total, data from 16,636 participants were included. Self-reported reactogenicity was lowest in the comparator group (53.2%) and highest in the ChAdOx1 group (85.3%). Local reactions were reported most frequently after mRNA-1273 (73.9%) and systemic reactions mainly after vector-based vaccines (79.8%). Almost all SARS-CoV-2 vaccines showed increased odds of reporting local or systemic reactions. Approximately equal proportions of participants reported medical consultations. None in the comparator group suspected a link to vaccination, while this was true for just over one in 10 in the mRNA-1273 group. The multivariate analysis showed that people with SARS-CoV-2 vaccination were not more likely to report medical consultations; patients who had received a regimen with at least one ChAdOx1 were even less likely to report medical consultations. Younger age, female gender and higher comorbidity were mostly associated with higher odds of medical consultations. CONCLUSION: The rate of adverse reactions after established vaccinations was roughly comparable to previous studies. Two weeks after vaccination, participants in the SARS-CoV-2 vaccination group reported more local and systemic local reactions than participants in the comparator group. In the further course, however, there were no higher odds of medical consultations in either of the two groups. Thus, altogether, we assume comparable safety. TRIAL REGISTRATION: DRKS-ID DRKS00025881 and DRKS-ID DRKS00025373.
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Vacinas contra COVID-19 , COVID-19 , Feminino , Humanos , Vacina de mRNA-1273 contra 2019-nCoV , Estudos de Coortes , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Medidas de Resultados Relatados pelo Paciente , SARS-CoV-2 , Vacinação/efeitos adversos , MasculinoRESUMO
BACKGROUND: In 2014 a new system for drug expenditures, the Wirkstoffvereinbarung (WSV, English: Active substance agreement) was implemented in Bavaria. In pre-defined indication groups, economic prescription of medications shall be enabled based on the selection, quantity, and proportion of an individual drug. Ambulatory care physicians receive quarterly trend reports on their prescribing behavior. This study examines physicians' perceptions of the WSV. METHODS: Qualitative interviews (n = 20) and seven focus groups (n = 36) were conducted with ambulatory care physicians (e.g. general practitioners, cardiologists, pulmonologists). The methodology followed Qualitative Content Analysis. RESULTS: Physicians generally accepted the necessity of prescribing economically. The majority of them rated the WSV positively and better than the previous system. As an improvement, they especially named timely feedback in form of easily understandable trend reports, encouraging self-reflection as well as allowing early control options. Problems perceived were drug discount contracts that were strongly criticized as leading to patients mixing up medications. Some perceived constraints of therapeutic freedom. CONCLUSIONS: The implementation of the WSV is mostly viewed positively by physicians. The restrictions of therapeutic freedom partially perceived might be met by improved information on the reasons why some drugs are rated as less economical than others. TRIAL REGISTRATION NUMBER: Main ID: DRKS00019820 (German Register of Clinical Studies and World Health Organization).
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Clínicos Gerais , Gastos em Saúde , Humanos , Pesquisa Qualitativa , Grupos Focais , Assistência AmbulatorialRESUMO
OBJECTIVES: Functioning of older adults needs to be adequately described before it can become the focus of care. The International Classification of Functioning, Disability and Health (ICF) provides a basis for describing functioning. As the ICF is too extensive for daily practice in primary care, there is a need for a reduced number of categories. The aim is to develop an ICF-subset for community-dwelling older adults aged 75 and above in primary care. DESIGN: The scientific basis for decision-making in our consensus study was laid by four preparatory studies, identifying potentially relevant ICF categories from four perspectives (research, patients', experts' and clinical perspective). The results of the preparatory phase were discussed by an international expert panel in a consensus study following the Nominal Group Technique (NGT). SETTING: An international 1-day online consensus conference. PARTICIPANTS: International experts (n=7) participated in the consensus conference, meeting the following criteria: extensive expertise in the field of the ICF and/or caring for older adults, and being fluent in English. RESULTS: Each preparatory study yielded a different number of categories with some overlaps but also differences. The expert panel decided to: (1) restrict the subset to second-level categories and reduce the number of categories from the preparatory phase, (2) limit the subset to the component activities and participation and (3) weight the patients' perspective as the most relevant one. CONCLUSIONS: By using consensus techniques and the NGT, the process led to 51 second-level ICF categories to describe the functioning of community-dwelling older adults. The decisions made in the consensus conference emphasised the importance of considering the individual life situation from a more holistic perspective and addressing functioning as a focus of care. Next, the 51 categories will contribute to the development of an ICF-based questionnaire.
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Vida Independente , Classificação Internacional de Funcionalidade, Incapacidade e Saúde , Humanos , Idoso , Consenso , Atenção Primária à SaúdeRESUMO
INTRODUCTION: General practitioners often criticise clinical trials for their poor applicability in primary care, which may at least partially explain why their engagement in primary care research remains limited. In order to enhance primary care research, the German government has funded six regional practice based research networks (PBRNs). Within the Bavarian PBRN (BayFoNet), two cluster-randomised pilot trials will be conducted. This paper presents the protocol of the process evaluation accompanying both trials, which aims to explore relevance, feasibility, acceptability and credibility of clinical research in primary care from the perspectives of BayFoNet researchers, general practitioners, and patients. METHODS AND ANALYSIS: The BayFoNet will be established by recruiting general practices (GPs) as prospective research collaborators in two cluster randomised pilot trials. Research teams will provide training in good clinical practice, and support practices in patient recruitment, data collection and documentation. Our process evaluation explores barriers and facilitators in the set up of the BayFoNet PBRN and both cluster randomised pilot trials, under the application of the consolidated framework for implementation research and the theoretical domains framework. In a mixed-methods concept, we will use qualitative and quantitative approaches to evaluate both pilot cluster-randomised trials as well as the BayFoNet itself: focus groups with researchers, semi-structured interviews with general practitioners and questionnaires for patients participating in the pilot cluster-randomised trials at three different time points. ETHICS AND DISSEMINATION: Research ethical approval for this study was granted by the Ethics Committee of the Medical Department, Ludwig-Maximilians-University Munich (AZ 21-1135). Results will be published in international peer-reviewed journals and summaries will be provided to the funders of the study as well as other PBRNs, GP teams and patients. TRIAL REGISTRATION NUMBERS: DRKS00028805, NCT05667207.
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Documentação , Projetos de Pesquisa , Humanos , Estudos Prospectivos , Coleta de Dados , Comissão de ÉticaRESUMO
We understand clinical quality governance (CQG) as quality management in the clinical domain. In 2020, presumably due to the coronavirus pandemic, more patients requested to be vaccinated against influenza as compared to previous years so that it became apparent that there would be a shortage for high-risk patients. To meet the problem, we started a CQG process. This article is explicitly not a research article but an exemplary description of a CQG process intended as a stimulus and for discussion. We initiated the following process: (1) evaluation of the present state, (2) patients who already had requested a vaccination were prioritized and vaccinated first, and (3) contacting via telephone and vaccination of high-risk patients not on the list. We chose patients with chronic obstructive pulmonary disease (COPD) older than 60 years as an indicator for the group of highest priority. In the beginning only 3 (8%) of our 38 patients with COPD were vaccinated against influenza. After prioritization and vaccination of the high-risk collective in the list of those who had requested to be vaccinated, 25 (66%) of our 38 patients with COPD were vaccinated. After a phone call of high-risk patients not on the list, 28 (74%) patients were vaccinated. This represents an increase of vaccination coverage from 8% to 74% which is close to the rate recommended by the World Health Organization (WHO). In times of a pandemic, family physicians occasionally have to deal with a scarcity of resources and have to develop strategies for fair resource allocation. Not only in this context is CQG worth the effort. The generation of list queries could be improved by the providers of electronic patient records.
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BACKGROUND: Since the beginning of the COVID-19 vaccination campaigns, recommendations regarding the vaccination have been very dynamic. Although the safety and efficacy of different vaccines have been analysed, data were scarce for vaccine regimens combining different vaccines. We therefore aimed to evaluate and compare the perceived reactogenicity and need for medical consultation after the most frequently applied homologous and heterologous COVID-19 vaccination regimens. METHODS: In an observational cohort study, reactogenicity and safety were assessed within a maximum follow-up time of 124 days using web-based surveys. Reactogenicity was assessed for different vaccination regimens 2 weeks after a vaccination (short-term survey). The following surveys, long-term and follow-up surveys, focused on the utilisation of medical services, including those that were not suspected to be vaccine-related. RESULTS: Data of 17,269 participants were analysed. The least local reactions were seen after a ChAdOx1 - ChAdOx1 regimen (32.6%, 95% CI [28.2, 37.2]) and the most after the first dose with mRNA-1273 (73.9%, 95% CI [70.5, 77.2]). Systemic reactions were least frequent in participants with a BNT162b2 booster after a homologous primary immunisation with ChAdOx1 (42.9%, 95% CI [32.1, 54.1]) and most frequent after a ChAdOx1 - mRNA-1273 (85.5%, 95% CI [82.9, 87.8]) and mRNA-1273/mRNA-1273 regimen (85.1%, 95% CI [83.2, 87.0]). In the short-term survey, the most common consequences were medication intake and sick leave (after local reactions 0% to 9.9%; after systemic reactions 4.5% to 37.9%). In the long-term and follow-up surveys, between 8.2 and 30.9% of participants reported consulting a doctor and between 0% and 5.4% seeking hospital care. The regression analyses 124 days after the first and after the third dose showed that the odds for reporting medical consultation were comparable between the vaccination regimens. CONCLUSIONS: Our analysis revealed differences in reactogenicity between the COVID-19 vaccines and vaccination regimens in Germany. The lowest reactogenicity as reported by participants was seen with BNT162b2, especially in homologous vaccination regimens. However, in all vaccination regimens reactogenicity rarely led to medical consultations. Small differences in seeking any medical consultation after 6 weeks diminished during the follow-up period. In the end, none of the vaccination regimens was associated with a higher risk for medical consultation. TRIAL REGISTRATION: DRKS DRKS00025881 ( https://drks.de/search/de/trial/DRKS00025373 ). Registered on 14 October 2021. DRKS DRKS00025373 ( https://drks.de/search/de/trial/DRKS00025881 ). Registered on 21 May 2021. Registered retrospectively.
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Vacinas contra COVID-19 , COVID-19 , Humanos , Vacinas contra COVID-19/efeitos adversos , Vacina BNT162 , Vacina de mRNA-1273 contra 2019-nCoV , Estudos Retrospectivos , COVID-19/prevenção & controle , Vacinação/efeitos adversos , ImunizaçãoRESUMO
BACKGROUND AND OBJECTIVES: The first wave of the COVID-19 pandemic (Mar-Apr 2020) posed significant challenges for primary care. The goal of this study was to analyse the burden of the crisis situation as experienced by the general practitioners (GPs) at its beginning and over the course of the pandemic and to identify factors predictive of the sense of being overburdened. METHODS: In this cross-sectional study, a total of 6300 randomly selected GPs in four federal states of Germany were contacted per post in order to survey changes in health care they provided and their psychological burden in the context of the pandemic between August and October 2020. RESULTS: The response rate was 23%; 46% of the participants were female. At the beginning of the pandemic, 40% of the participants experienced a high or a very high level of being overburdened; later on, it was only 10%. With increasing numbers of COVID patients, the sense of being overburdened increased, as also their perceived capability to care for COVID patients. Predictors of a sense of being overburdened were, among others, a high level of psychological stress, excessive organising efforts, poor capability to care for COVID patients, and scarce supply of protective equipment. CONCLUSION: Despite a sense of being overburdened initially, GPs felt increasingly capable of caring for COVID patients. To help GPs in future crisis situations like this pandemic, organization of care should be simplified to the extent possible so that they can focus on patient care.
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COVID-19 , Clínicos Gerais , Humanos , Feminino , Masculino , COVID-19/epidemiologia , Estudos Transversais , Alemanha/epidemiologia , PandemiasRESUMO
INTRODUCTION: People in need of care or support are severely affected by the COVID-19 pandemic. We lack valid data of long-term assessments. We present a register study to detect the physical and psychosocial impact of the COVID-19 pandemic on people in need of care or support in Bavaria, Germany. To describe the persons' life conditions comprehensively, we assess the perspectives and needs of the respective care teams too. Results will serve as evidence-based source to manage the pandemic and long-term prevention strategies. METHODS AND ANALYSIS: The 'Bavarian ambulatory COVID-19 Monitor' is a multicentre registry including a purposive sample of up to 1000 patient-participants across three study sites in Bavaria. The study group consists of 600 people in need of care with a positive SARS-CoV-2 PCR test. Control group 1 comprises 200 people in need of care with a negative SARS-CoV-2 PCR test, while control group 2 comprises 200 people with a positive SARS-CoV-2 PCR test but are not in need of care. We assess the clinical course of infection, psychosocial aspects and care needs using validated measures. Follow-up is every 6 months for up to 3 years. Additionally, we assess up to 400 people linked to these patient-participants (caregivers, general practitioners (GPs)) for their health and needs. Main analyses are stratified by level of care I-V (I=minor/V=most severe impairment of independence), inpatient/outpatient care setting, sex and age. We use descriptive and inferential statistics to analyse cross-sectional data and changes over time. In qualitative interviews with 60 stakeholders (people in need of care, caregivers, GPs, politicians), we explore interface problems of different functional logics, of everyday and professional perspectives. ETHICS AND DISSEMINATION: The Institutional Review Board of the University Hospital LMU Munich (#20-860) and the study sites (Universities of Wurzburg and Erlangen) approved the protocol. We disseminate the results by peer-reviewed publications, international conferences, governmental reports, etc.