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Abstract Objective The COVID-19 pandemic has had significant health and socioeconomic impacts worldwide. Extensive measures, including contact restrictions, were implemented to control the spread of the virus. This study aims to examine the factors that influenced private and professional contact behaviour during the COVID-19 pandemic. Results We used baseline data (January–April 2021) from the SeMaCo study (Serologische Untersuchungen bei Blutspendern des Großraums Magdeburg auf Antikörper gegen SARS-CoV-2), a longitudinal, regional cohort study assessing COVID-19 seroprevalence in blood donors from Magdeburg and surrounding areas in Germany. In the blood donor cohort (n = 2,195), there was a general reduction in private contacts (by 78.9%) and professional contacts (by 54.4%) after March 18, 2020. Individuals with higher education reduced both private (by 84.1%) and professional (by 70.1%) contacts more than those with lower education levels (private contacts 59.5%; professional contacts 37%). Younger age groups (18–30 years) reduced private contacts more frequently (by 85.4%) than older individuals (61–83 years, by 68.6%) and demonstrated a higher likelihood of private contact reduction compared to older age groups (51–60 years: odds ratio (OR) 0.45 [95% [CI] 0.32–0.65]; 61–83 years: OR 0.33 [95% [CI] 0.22–0.48]).

BackgroundHigh suicide rates in older adults are a relevant public health concern. Social isolation or widowhood as well as physical decline play a crucial role for suicidality in older adulthood. Previous evidence suggested that demoralization is an important risk factor for suicide. Whether demoralization is a relevant phenomenon in older adulthood which possibly could account for high suicide rates remains unclear.MethodsDemoralization Scale II (DS-II) scores assessed in a survey of the German general population were investigated with respect to older adults (aged ≥ 65 years). DS-II scores were compared between older (≥ 65 years) and younger (< 65 years) adulthood and between young-old (65–74y), middle-old (75–84y), and old-old (85+y) individuals. We tested the impact of sociodemographic factors on DS-II scores within older adults.ResultsThe sample comprised N = 545 adults ≥ 65 years and N = 1922 adults < 65 years. DS-II scores increased in older compared to younger adults (F(1,2465) = 6.1; p = 0.013; d = 0.09) and further from young-old to old-old (Mdiff = 2.7; 95% CI 0.45, 5.46; p = 0.034). One-fourth of individuals ≥ 65 years and almost half of old-old individuals reported DS-II scores above the cut-off > 5. Living with a partner protected from demoralization in old-old individuals.DiscussionThis study provides first evidence for an increased rate of demoralization in very old adults, in particular women, which is partly related to partnership status. We suggest that demoralization is considered as a crucial entity in older adulthood which can be missed by standard psychological screenings.

BackgroundIn 2017, a reform of the German outpatient psychotherapy guideline was carried out, aiming to reduce waiting times and facilitate low-threshold access. This study analyzes the extent to which the implementation of the two new service elements ‘psychotherapeutic consultation times’ and ‘acute short-term psychotherapeutic interventions’ improved psychotherapeutic care for patients with mental disorders and chronic physical conditions (cMPs), for patients with mental disorders without chronic physical conditions (MnoP), and elderly patients.MethodsIn a quantitative secondary analysis, we analyzed health insurance data of patients with psychotherapy billing codes obtained from the National Association of Statutory Health Insurance Physicians (KBV) for the years 2015-2019, evaluating descriptive statistical parameters for specific patient groups and care services.ResultsBetween 2015 and 2019, the number of mentally ill receiving psychotherapy at least once in the corresponding year increased by 30.7%. Among these, the proportion of cMPs-patients increased from 26.8% to 28.2% (+1.4%), while that of MnoP-patients decreased from 68.3% to 66.4% (-1.9%). The number of elderly people receiving treatment also increased.ConclusionSince increases and decreases in the percentage shares occur evenly over the years investigated, it is questionable whether the reform in 2017 has had a direct influence on these changes.Study registrationID DRKS00020344, URL: https://www.bfarm.de/DE/Das-BfArM/Aufgaben/Deutsches-Register-Klinischer-Studien/_node.html.

Abstract Background Demoralization is a clinically relevant syndrome in chronic diseases. The demoralization scale (DS-II) was recently developed as an economic screening tool in clinical populations. Main aim of this study was to provide normative data of DS-II scores in the general population. Methods We developed a new German version, the DS-II Münster, and tested internal consistency as well as the previously proposed two-factor structure with confirmatory factor analyses. The DS-II was applied in a household survey of the general population. Associations between DS-II scores and age, gender and other sociodemographic variables were explored. Results The final sample consisted of N = 2471 participants (mean age = 49.8 years, range: 18–96; 50.1% men, 49.8% women). The DS-II Münster showed nearly excellent internal consistency. The model fit indices of the two-factor structure were not superior to those of the one-factor model. Mean scores of the DS-II were as follows. Total score: M = 3.76 (SD = 5.56), Meaning and Purpose subscale: M = 1.65 (SD = 2.77), Distress and Coping Ability subscale: M = 2.11 (SD = 3.02). DS-II scores were increased in women with an effect size of Cohen’s d = 0.19. An age-related increase was specifically found for the Meaning and Purpose subscale (d = 0.21). Conclusions The study provides normative values of the DS-II with respect to age and gender in the general population to facilitate interpretation of DS-II scores in clinical samples. A DS-II total score > 5 is suggested as a cut-off value. The findings further our understanding of significant symptom burden that was previously suggested in young patients with cancer.

BACKGROUND Adoptive transfer of EBV-specific T cells can restore specific immunity in immunocompromised patients with EBV-associated complications.METHODS We provide results of a personalized T cell manufacturing program evaluating donor, patient, T cell product, and outcome data. Patient-tailored clinical-grade EBV-specific cytotoxic T lymphocyte (EBV-CTL) products from stem cell donors (SCDs), related third-party donors (TPDs), or unrelated TPDs from the allogeneic T cell donor registry (alloCELL) at Hannover Medical School were manufactured by immunomagnetic selection using a CliniMACS Plus or Prodigy device and the EBV PepTivators EBNA-1 and Select. Consecutive manufacturing processes were evaluated, and patient outcome and side effects were retrieved by retrospective chart analysis.RESULTS Forty clinical-grade EBV-CTL products from SCDs, related TPDs, or unrelated TPDs were generated for 37 patients with refractory EBV infections or EBV-associated malignancies with and without a history of transplantation, within 5 days (median) after donor identification. Thirty-four patients received 1–14 EBV-CTL products (fresh and cryopreserved). EBV-CTL transfer led to a complete response in 20 of 29 patients who were evaluated for clinical response. No infusion-related toxicity was reported. EBV-specific T cells in patients’ blood were detectable in 16 of 18 monitored patients (89%) after transfer, and their presence correlated with clinical response.CONCLUSION Personalized clinical-grade manufacture of EBV-CTL products via immunomagnetic selection from SCDs, related TPDs, or unrelated TPDs in a timely manner is feasible. Overall, EBV-CTLs were clinically effective and well tolerated. Our data suggest EBV-CTL transfer as a promising therapeutic approach for immunocompromised patients with refractory EBV-associated diseases beyond HSCT, as well as patients with preexisting organ dysfunction.TRIAL REGISTRATION Not applicable.FUNDING This study was funded in part by the German Research Foundation (DFG, 158989968/SFB 900), the Deutsche Kinderkrebsstiftung (DKS 2013.09), Wilhelm-Sander-Stiftung (reference 2015.097.1), Ellen-Schmidt-Program of Hannover Medical School, and German Federal Ministry of Education and Research (reference 01EO0802).

Purpose The SeMaCo study (Serologische Untersuchungen bei Blutspendern des Großraums Magdeburg auf Antikörper gegen SARS-CoV-2), a prospective, longitudinal cohort study with four survey phases spanning 3–5 months each over a period of 22 months, extends the spectrum of seroepidemiological studies in Germany. We present here a careful characterisation of the initial survey phase of the cohort to provide baseline data on infection incidence and obtained from questionnaires, focussing in particular on the attitude towards COVID-19 vaccinations, the vaccination success and the vaccination acceptance.Participants A total of 2195 individual blood donors from the donor pool of the blood donation service of the University Hospital Magdeburg were enrolled in the initial survey phase from 20 January 2021 to 30 April 2021. 2138 participants gave sociodemographic/contact data (51.7% male, mean age 44 years) and 2082 participants answered the vaccination questionnaire.Findings to date Out of 2195 participants with antibody results, 1909 (87.0%) were antibody negative. The remaining 286 subjects (13.0%) were either antibody-positive and vaccinated (160/286; 55.9%) or antibody-positive without vaccination information (17/286; 5.9%) or antibody-positive and unvaccinated (109/286; 38.1%). The latter result reflects the rate of true or highly probable SARS-CoV-2 infections in our initial study cohort.Future plans The study primarily aims to measure the prevalence and long-term kinetics of IgG-antibodies against SARS-CoV-2. Including the baseline, the study foresees four survey periods of 3–4 months each. At each visit, we will assess the blood donors’ attitude towards vaccination, the antibody response following vaccination and/or infection, as well as undesired vaccination effects. We aim to test the same participants during the survey periods by repeated invitations for blood donation to ensure a long-term (follow-up) in as many study participants as possible. After the four survey phases, a longitudinal data set will be created that reflects the course of the antibody levels/frequencies as well as the infection and vaccination incidence.Trial registration number DRKS00023263.

Abstract Background In individuals suffering from a rare disease the diagnostic process and the confirmation of a final diagnosis often extends over many years. Factors contributing to delayed diagnosis include health care professionals' limited knowledge of rare diseases and frequent (co-)occurrence of mental disorders that may complicate and delay the diagnostic process. The ZSE-DUO study aims to assess the benefits of a combination of a physician focusing on somatic aspects with a mental health expert working side by side as a tandem in the diagnostic process. Study design This multi-center, prospective controlled study has a two-phase cohort design. Methods Two cohorts of 682 patients each are sequentially recruited from 11 university-based German Centers for Rare Diseases (CRD): the standard care cohort (control, somatic expertise only) and the innovative care cohort (experimental, combined somatic and mental health expertise). Individuals aged 12 years and older presenting with symptoms and signs which are not explained by current diagnoses will be included. Data will be collected prior to the first visit to the CRD’s outpatient clinic (T0), at the first visit (T1) and 12 months thereafter (T2). Outcomes Primary outcome is the percentage of patients with one or more confirmed diagnoses covering the symptomatic spectrum presented. Sample size is calculated to detect a 10 percent increase from 30% in standard care to 40% in the innovative dual expert cohort. Secondary outcomes are (a) time to diagnosis/diagnoses explaining the symptomatology; (b) proportion of patients successfully referred from CRD to standard care; (c) costs of diagnosis including incremental cost effectiveness ratios; (d) predictive value of screening instruments administered at T0 to identify patients with mental disorders; (e) patients’ quality of life and evaluation of care; and f) physicians’ satisfaction with the innovative care approach. Conclusions This is the first multi-center study to investigate the effects of a mental health specialist working in tandem with a somatic expert physician in CRDs. If this innovative approach proves successful, it will be made available on a larger scale nationally and promoted internationally. In the best case, ZSE-DUO can significantly shorten the time to diagnosis for a suspected rare disease. Trial registration ClinicalTrials.gov; Identifier: NCT03563677; First posted: June 20, 2018, https://clinicaltrials.gov/ct2/show/NCT03563677 .

Abstract Background Access to outpatient mental healthcare can be challenging for patients. In Germany, a national structural reform was implemented in 2017 to accelerate and enhance access to outpatient psychotherapy and reduce waiting times. During the first phase of the study ‘Evaluation of a structural reform of the outpatient psychotherapy guideline (ES-RiP)’ and embedded into a process evaluation, the implementation was to be evaluated through assessing general practitioners’ (GPs) and psychotherapists’ (PTs) perspectives regarding utilization of provided new measures, and perceived potential for optimization. Particular focus was on patients with a comorbidity of mental disorders and chronic physical conditions (cMPs). Methods This exploratory cross-sectional qualitative study used on-site and online focus group discussions and semi-structured telephone interviews with GPs and outpatient PTs. Generated data were analyzed using thematic framework analysis. Descriptive statistics were used to analyze participant characteristics collected via a socio-demographic questionnaire. Results Perspectives on the structural reform were heterogenous. GPs and PTs considered the component of timely initial psychotherapeutic assessment consultations beneficial. GPs disapproved of their deficits in detailed information about the structural reform and exchange with outpatient PTs. Improvement suggestions included structured short information exchange and joint quality circles. The overall number of available outpatient PTs in rural areas was perceived as insufficient. For patients with cMPs, GPs saw patient barriers for therapy access and continuity in low intrinsic motivation, physical impediments and older age. PTs also saw patient challenges regarding low intrinsic motivation and keeping scheduled appointments. They considered post-reform administrative efforts to be high and reported that the regulations (conformity) lead to planning difficulties and financial losses. Reform elements were tailored to fit in with PTs key therapy areas. Stronger networking and joint lectures were suggested as remedy for the currently still limited exchange with GPs. Unlike the GPs, PTs emphasized that accepting patients into psychotherapeutic treatment was independent of a possibly present chronic physical disease. Conclusions The findings contribute to understanding the integration of the delivered structural reform into daily care processes and provide an indication about reached targets and potential improvements. Further phases of the ES-RiP study can build on the findings and broaden insights. Trial registration Registration-ID DRKS00020344 (DRKS German Register of Clinical Trials.

Introduction In 2017, in Germany, a structural reform of the outpatient psychotherapy guideline took place, aiming to reduce waiting times, to facilitate flexible low-threshold access (eg, general reachability by phone) and to lower access barriers for specific patient groups. The reform included new service elements, such as the implementation of additional psychotherapeutic consultations, acute short-term psychotherapeutic interventions and relapse prophylaxis as well as the promotion of group therapies, the facilitation of psychotherapists’ availability, and the installation of appointment service centres. The ES-RiP project aims to thoroughly evaluate the effects of the reform with a special focus on patients with a comorbidity of mental disorders and chronic physical conditions (cMPs) compared with patients with a mental disorder but no long-term physical condition (MnoP). The project aims to evaluate (a) the extent to which the reform goals were achieved in the large group of patients with cMPs compared with MnoP, (b) the barriers that might hinder the implementation of the new guideline and (c) the procedures required for further developing and improving outpatient psychotherapy.Methods and analysis A mixed-methods design (quantitative, qualitative) along with a multilevel approach (patients, service providers, payers) triangulating several data sources (primary and secondary data) will be applied to evaluate the reform from different perspectives.Ethics and dissemination Ethical approval was obtained from the coordinating committee as well as one local ethics committee, Justus Liebig University Giessen and Marburg – Faculty of Medicine (approval number: AZ 107/20) and Heidelberg (approval number: S-466/2020). The results of this study will be disseminated through expert panels, conference presentations and publications in peer-reviewed journals.Trial registration number DRKS00020344.

Abstract Background Adoptive transfer of virus-specific T cells (VSTs) represents a prophylactic and curative approach for opportunistic viral infections and reactivations after transplantation. However, inadequate frequencies of circulating memory VSTs in the T-cell donor’s peripheral blood often result in insufficient enrichment efficiency and purity of the final T-cell product, limiting the effectiveness of this approach. Methods This pilot study was designed as a cross-over trial and compared the effect of a single bout (30 min) of high-intensity interval training (HIT) with that of 30 min of continuous exercise (CONT) on the frequency and function of circulating donor VSTs. To this end, we used established immunoassays to examine the donors’ cellular immune status, in particular, with respect to the frequency and specific characteristics of VSTs restricted against Cytomegalovirus (CMV)-, Epstein–Barr-Virus (EBV)- and Adenovirus (AdV)-derived antigens. T-cell function, phenotype, activation and proliferation were examined at different time points before and after exercise to identify the most suitable time for T-cell donation. The clinical applicability was determined by small-scale T-cell enrichment using interferon- (IFN-) γ cytokine secretion assay and virus-derived overlapping peptide pools. Results HIT proved to be the most effective exercise program with up to fivefold higher VST response. In general, donors with a moderate fitness level had higher starting and post-exercise frequencies of VSTs than highly fit donors, who showed significantly lower post-exercise increases in VST frequencies. Both exercise programs boosted the number of VSTs against less immunodominant antigens, specifically CMV (IE-1), EBV (EBNA-1) and AdV (Hexon, Penton), compared to VSTs against immunodominant antigens with higher memory T-cell frequencies. Conclusion This study demonstrates that exercise before T-cell donation has a beneficial effect on the donor’s cellular immunity with respect to the proportion of circulating functionally active VSTs. We conclude that a single bout of HIT exercise 24 h before T-cell donation can significantly improve manufacturing of clinically applicable VSTs. This simple and economical adjuvant treatment proved to be especially efficient in enhancing virus-specific memory T cells with low precursor frequencies.

SARS-CoV-2 serosurveillance is important to adapt infection control measures and estimate the degree of underreporting. Blood donor samples can be used as a proxy for the healthy adult population. In a repeated cross-sectional study from April 2020 to April 2021, September 2021, and April/May 2022, 13 blood establishments collected 134,510 anonymised specimens from blood donors in 28 study regions across Germany. These were tested for antibodies against the SARS-CoV-2 spike protein and nucleocapsid, including neutralising capacity. Seroprevalence was adjusted for test performance and sampling and weighted for demographic differences between the sample and the general population. Seroprevalence estimates were compared to notified COVID-19 cases. The overall adjusted SARS-CoV-2 seroprevalence remained below 2% until December 2020 and increased to 18.1% in April 2021, 89.4% in September 2021, and to 100% in April/May 2022. Neutralising capacity was found in 74% of all positive specimens until April 2021 and in 98% in April/May 2022. Our serosurveillance allowed for repeated estimations of underreporting from the early stage of the pandemic onwards. Underreporting ranged between factors 5.1 and 1.1 in the first two waves of the pandemic and remained well below 2 afterwards, indicating an adequate test strategy and notification system in Germany.

Introduction: Serologic studies are crucial for clarifying the regional dynamics of the SARS-CoV-2 coronavirus pandemic as well as the success of a vaccination campaign against COVID-19. We describe a cohort study investigating the seroprevalence of antibodies against SARS-CoV-2 in Magdeburg (Saxony-Anhalt, Germany). Protocol and study design: The SeMaCo study (Serologische Untersuchungen bei Blutspendern des Großraums Magdeburg auf Antikörper gegen SARS-CoV-2) is a longitudinal, regional cohort study to assess the seroprevalence of COVID-19 in blood donors from Magdeburg (Capital of Saxony-Anhalt) and surrounding areas. We consider blood donors as a surrogate for the healthy, working-age population of Saxony-Anhalt. The study primarily aims to measure the prevalence and kinetics of IgG antibodies against SARS-CoV-2 in first time and repeat blood donors over a period of 21 months. The study explores four survey periods of three to four months each (January–April 21, July–October 21, February–April 22, July–October 22). At each visit, we will assess the attitude towards vaccination, the antibody response following vaccination, as well as undesired vaccination effects. Furthermore, we will collect data on occupational activities, housing conditions and the frequency of family and other social contacts. Discussion: The SeMaCo study extends the spectrum of seroepidemiological investigations in Germany. A longitudinal observation with repeated testing and serial interviews can provide a more accurate view on the dynamics of COVID-19 prevalence and spread than repeated cross-sectional studies. Based on interim results from similar studies, we expect a seroprevalence of SARS-CoV-2 antibodies below 5% in the first survey period. SeMaCo will influence policy decisions and preventative measures.