Addressing psychosocial needs in patients with Long-COVID (PsyLoCo-Study): study protocol of a pilot-study of a specialized modular intervention.

Introduction: After an acute infection with the corona virus 10-20% of those affected suffer from ongoing or new symptoms. A causal therapy for the phenomenon known as Long/Post-COVID is still lacking and specific therapies addressing psychosocial needs of these patients are imperatively needed. The aim of the PsyLoCo-study is developing and piloting a psychotherapeutic manual, which addresses Long/Post-COVID-related psychosocial needs and supports in coping with persistent bodily symptoms as well as depressive or anxiety symptoms. Methods and analysis: This pilot trial implements a multi-centre, 2-arm (N=120; allocation ratio: 1:1), parallel group, randomised controlled design. The pilot trial is designed to test the feasibility and estimate the effect of 1) a 12-session psychotherapeutic intervention compared to 2) a wait-list control condition on psychosocial needs as well as bodily and affective symptoms in patients suffering from Long/Post-COVID. The intervention uses an integrative, manualized, psychotherapeutic approach. The primary study outcome is health-related quality of life. Outcome variables will be assessed at three timepoints, pre-intervention (t1), post-intervention (t2) and three months after completed intervention (t3). To determine the primary outcome, changes from t1 to t2 are examined. The analysis will be used for the planning of the RCT to test the efficacy of the developed intervention. Discussion: The pilot study will evaluate a 12-session treatment manual for Long/Post-COVID sufferers and the therapy components it contains. The analysis will provide insights into the extent to which psychotherapeutic treatment approaches improve the symptoms of Long/Post-COVID sufferers. The treatment manual is designed to be carried out by psychotherapists as well as people with basic training in psychotherapeutic techniques. This approach was chosen to enable a larger number of practitioners to provide therapeutic support for Long/Post-COVID patients. After completion of the pilot study, it is planned to follow up with a randomized controlled study and to develop a treatment guideline for general practitioners and interested specialists. Trial registration: The pilot trial has been registered with the German Clinical Trials Register (Deutsches Register Klinischer Studien; Trial-ID: DRKS00030866; URL: https://drks.de/search/de/trial/DRKS00030866) on March 7, 2023.

German primary care data collection projects: a scoping review.

BACKGROUND: The widespread use of electronic health records (EHRs) has led to a growing number of large routine primary care data collection projects globally, making these records a valuable resource for health services and epidemiological and clinical research. This scoping review aims to comprehensively assess and compare strengths and limitations of all German primary care data collection projects and relevant research publications that extract data directly from practice management systems (PMS). METHODS: A literature search was conducted in the electronic databases in May 2021 and in June 2022. The search string included terms related to general practice, routine data, and Germany. The retrieved studies were classified as applied studies and methodological studies, and categorised by type of research, subject area, sample of publications, disease category, or main medication analysed. RESULTS: A total of 962 references were identified, with 241 studies included from six German projects in which databases are populated by EHRs from PMS. The projects exhibited significant heterogeneity in terms of size, data collection methods, and variables collected. The majority of the applied studies (n = 205, 85%) originated from one database with a primary focus on pharmacoepidemiological topics (n = 127, 52%) including prescription patterns (n = 68, 28%) and studies about treatment outcomes, compliance, and treatment effectiveness (n = 34, 14%). Epidemiological studies (n = 77, 32%) mainly focused on incidence and prevalence studies (n = 41, 17%) and risk and comorbidity analysis studies (n = 31, 12%). Only 10% (n = 23) of studies were in the field of health services research, such as hospitalisation. CONCLUSION: The development and durability of primary care data collection projects in Germany is hindered by insufficient public funding, technical issues of data extraction, and strict data protection regulations. There is a need for further research and collaboration to improve the usability of EHRs for health services and research.

Comparison between In-Hospital and Out-of-Hospital Acute Myocardial Infarctions: Results from the Regional Myocardial Infarction Registry of Saxony-Anhalt (RHESA) Study.

AIMS: Risk factors and outcomes of in-hospital ST elevation myocardial infraction (STEMI) are well explored. Recent findings show that non-ST elevation myocardial infarction (NSTEMI) accounts for the majority of in-hospital infarctions (IHMIs). Our aim was to identify differences between IHMI and out-of-hospital myocardial infraction (OHMI) in terms of risk factors, treatment and outcomes, including both STEMI and NSTEMI. METHODS: We analyzed the Regional Myocardial Infarction Registry of Saxony-Anhalt dataset. Patient characteristics, treatments and outcomes were compared between IHMI and OHMI. The association between clinical outcomes and myocardial infarction type was assessed using generalized additive models. RESULTS: Overall, 11.4% of the included myocardial infractions were IHMI, and the majority were NSTEMI. Patients with IHMI were older and had more comorbidities than those with OHMI. Compared to OHMI, in-hospital myocardial infarction was associated with higher odds of 30-day mortality (OR = 1.85, 95% CI 1.32-2.59) and complications (OR = 2.36, 95 % CI 1.84-3.01). CONCLUSIONS: We provided insights on the full spectrum of IHMI, in both of its classifications. The proportion of IHMI was one ninth of all AMI cases treated in the hospital. Previously reported differences in the baseline characteristics and treatments, as well as worse clinical outcomes, in in-hospital STEMI compared to out-of-hospital STEMI persist even when including NSTEMI cases.

Anxiety, depressive symptoms, and distress over the course of the war in Ukraine in three federal states in Germany.

Introduction: The Russian invasion of Ukraine and the resulting consequences are in the center of political discussions, media, and likely individual thinking of the population in Germany. Yet, the impact of this prolonged exposure on mental health is not known hitherto. Methods: Using the population based cohort study DigiHero from three federal states (Saxony-Anhalt, Saxony, and Bavaria), we assessed anxiety levels (GAD-7), depressive symptoms (PHQ-9), and distress (modified PDI) in the first weeks of war and 6 months later. Results: Of those 19,432, who responded in the first weeks of war, 13,934 (71.1%) responded also 6 months later. While anxiety and emotional distress decreased during the 6 months, their average scores were still elevated, and a substantial fraction of respondents displayed clinically relevant sequelae. Persons from low-income households were especially affected, specifically by fears related to the personal financial situation. Those who reacted with a particularly strong fear in the beginning of war were more likely to have persistent clinically relevant symptoms of depression and anxiety also 6 months later. Discussion: The Russian invasion of Ukraine is accompanied by continuing impairment of mental health in the German population. Fears surrounding the personal financial situation are a strong determinant.

Mental health in Germany in the first weeks of the Russo-Ukrainian war.

BACKGROUND: In the connected world, although societies are not directly involved in a military conflict, they are exposed to media reports of violence. AIMS: We assessed the effects of such exposures on mental health in Germany during the military conflict in Ukraine. METHOD: We used the German population-based cohort for digital health research, DigiHero, launching a survey on the eighth day of the Russo-Ukrainian war. Of the 27 509 cohort participants from the general population, 19 444 (70.7%) responded within 17 days. We measured mental health and fear of the impact of war compared with other fears (natural disasters or health-related). RESULTS: In a subsample of 4441 participants assessed twice, anxiety in the population (measured by the Generalised Anxiety Disorder-7 screener) was higher in the first weeks of war than during the strongest COVID-19 restrictions. Anxiety was elevated across the whole age spectrum, and the mean was above the cut-off for mild anxiety. Over 95% of participants expressed various degrees of fear of the impact of war, whereas the percentage for other investigated fears was 0.47-0.82. A one-point difference in the fear of the impact of war was associated with a 2.5 point (95% CI 2.42-2.58) increase in anxiety (11.9% of the maximum anxiety score). For emotional distress, the increase was 0.67 points (0.66-0.68) (16.75% of the maximum score). CONCLUSIONS: The population in Germany reacted to the Russo-Ukrainian war with substantial distress, exceeding reactions during the strongest restrictions in the COVID-19 pandemic. Fear of the impact of war was associated with worse mental health.

Involvement in maternal care by migrants and ethnic minorities: a narrative review.

BACKGROUND: Guidelines for improving the quality of maternal health services emphasise women's involvement in care. However, evidence about migrant and ethnic minorities' preferences for participation in maternal care remains unsystematised. Understanding these populations' experiences with and preferred forms of involvement in care provision is crucial for imbuing policies and guidelines with sensitivity to diversity and for implementing people-centred care. This paper presents a narrative synthesis of empirical studies of involvement in maternal health care by migrants and ethnic minorities based on four key dimensions: information, communication, expression of preferences and decision-making. METHODS: Studies indexed in PubMed and Scopus published until December 2019 were searched. Original quantitative, qualitative and mixed methods studies written in English and reporting on migrant and ethnic minority involvement in maternal care were included. Backward reference tracking was carried out. Three researchers conducted full-text review of selected publications. RESULTS: In total, 22 studies met the inclusion criteria. The majority of studies were comparative and addressed only one or two dimensions of involvement, with an emphasis on the information and communication dimensions. Compared to natives, migrants and ethnic minorities were more likely to (1) lack access to adequate information as a result of health care staff's limited time, knowledge and misconceptions about women's needs and preferences; (2) report suboptimal communication with care staff caused by language barriers and inadequate interpreting services; (3) be offered fewer opportunities to express preferences and to have preferences be taken less into account; and (4) be less involved in decisions about their care due to difficulties in understanding information, socio-cultural beliefs and previous experiences with care provision less attuned with playing an active role in decision-making and care staff detracting attitudes. CONCLUSION: Constraints to adequate and inclusive involvement in maternal care can hinder access to quality care and result in severe negative health outcomes for migrant and ethnic minority women. More research is needed into how to tailor the dimensions of involvement to migrant and ethnic minorities' needs and preferences, followed by provision of the resources necessary for effective implementation (e.g. sufficient time for consultations, optimal interpreter systems, health care staff training).