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Abstract Background Studies estimate that at least 7.5% of adults are affected by long-term symptoms such as fatigue or cognitive impairment after the acute phase of COVID-19. COVID-19 vaccination may reduce the risk of long COVID. Rehabilitation can have a positive impact on recovery. This study aims to present the experiences of people with long COVID with COVID-19 vaccination and rehabilitation. Such research is important because perceptions of these measures can impact healthcare utilization and health status. Methods 48 adults with long COVID participated in this qualitative study, 25 of them in one-on-one interviews and 23 in focus groups. Participants were recruited via calls for participation on the websites and social media channels of two university hospitals and with the help of respondents’ networks. The conversations were audio-recorded, transcribed, and analyzed using qualitative content analysis. Subsequently, the results were compared, interpreted, and discussed by scientific literature. Results 35 study participants reported that they had received a COVID-19 vaccination and 16 of them stated that they had utilized a rehabilitation service. These participants had varying experiences with COVID-19 vaccination and rehabilitation. Nine of them stated that they developed long COVID despite vaccination before COVID-19. Ten participants reported vaccine reactions, and two participants reported severe side effects. Two participants reported persistent deterioration of their long COVID symptoms after vaccination. This led to uncertainty about the safety, benefits, and handling of COVID-19 vaccination. However, most participants perceived the vaccine as effective regarding milder COVID-19 sequelae. Four participants felt their rehabilitation was helpful and four participants felt it was unhelpful. Two persons found the combination of inpatient rehabilitation and rehabilitation sport helpful. Conclusions Several implications can be derived from this study: (1) researchers should explore the effects of COVID-19 vaccination on long COVID symptoms; (2) vaccination campaigns should be more responsive to the perspectives of people with long COVID on vaccination; (3) care planners should build rehabilitation facilities specialized in long COVID; (4) rehabilitation providers should train their professionals regarding long COVID and develop rehabilitation programs tailored to different clinical pictures. Trial registration German register for clinical trials DRKS00026007, 09 September 2021.

Objectives: This study aims to investigate the impact of gender and parental tasks on social participation, health-related quality of life (hrQoL), and mental health in persons with long COVID. Methods: A mixed-methods approach was followed including a cross-sectional web-based survey and semi-structured interviews. Multivariable linear regressions were used to quantify the effect of gender and parenting tasks on social participation, hrQoL, and mental health. Qualitative data from interviews with participants experiencing long COVID symptoms was analyzed using content analysis. Results: Data from 920 participants in the quantitative study and 25 participants in the qualitative study was analyzed. Parenting tasks were associated with increased impairments in family and domestic responsibilities in persons with long COVID compared to lower impairments in persons without long COVID ( P = .02). The qualitative data indicate that coping with long COVID and pursuing parenting tasks limit participants’ ability to perform leisure activities and attend social gatherings. In long COVID, men had higher anxiety symptoms than women, and in those without long COVID, the opposite was observed ( P

BackgroundPost–COVID-19 syndrome (PCS; also known as “long COVID”) is a relatively novel disease comprising physical, psychological, and cognitive complaints persisting several weeks to months after acute infection with SARS-CoV-2. Approximately 10% of patients with COVID-19 are affected by long-term symptoms. However, effective treatment strategies are lacking. The ErgoLoCo (Occupational Therapy [Ergotherapie] for Long COVID) study was designed to develop and evaluate a novel occupational therapy (OT) concept of online delivery of therapy for long COVID. ObjectiveThe primary study objective is to assess the feasibility of the online OT intervention in PCS. Secondary aims include the evaluation of online OT concerning cognitive problems, occupational performance, and social participation. MethodsThis randomized controlled interventional pilot study involves parallel mixed methods process analyses and a realist evaluation approach. A total of 80 clients with PCS aged at least 16 years will be recruited into two interventional groups. The control cohort (watch and wait) comprises 80 clients with long COVID. Treatment is provided through teletherapy (n=40) or delivery of prerecorded videos (n=40) using the same standardized OT concept twice weekly over 12 weeks. Analyses of quantitative questionnaires and qualitative interviews based on the theoretical framework of acceptability will be performed to assess feasibility. Focus group meetings will be used to assess how acceptable and helpful the intervention was to the participating occupational therapists. Standardized tests will be used to assess the initial efficacy of the intervention on neurocognitive performance; limitations in mobility, self-care, and everyday activities; pain; disabilities; quality of life (QoL); social participation; and anxiety and depression in PCS, and the possible effects of online OT on these complaints. ResultsThe German Ministry of Education and Research provided funding for this research in March 2022. Data collection took place from October 2022 to August 31, 2023. Data analysis will be completed by the end of April 2024. We anticipate publishing the results in the fall of 2024. ConclusionsDespite the enormous clinical need, effective and scalable treatment options for OT clients who have PCS remain scarce. The ErgoLoCo study will assess whether online-delivered OT is a feasible treatment approach in PCS. Furthermore, this study will assess the effect of the intervention on cognitive symptoms, QoL, and occupational performance and participation in everyday life. Particular emphasis will be placed on the experiences of clients and occupational therapists with digitally delivered OT. This study will pave the way for novel and effective treatment strategies in PCS. Trial RegistrationGerman Clinical Trial Registry DRKS00029990; https://drks.de/search/de/trial/DRKS00029990 International Registered Report Identifier (IRRID)PRR1-10.2196/50230

Abstract Background Many people experience long-term symptoms such as fatigue, cognitive problems, or shortness of breath after an acute infection with COVID-19. This emerging syndrome, known as long COVID, is new and complex in many aspects. This study aims to collect the experiences of people with long COVID with ambulatory healthcare structures. Methods Four focus groups were conducted with a total of 23 adults with long COVID in June and July 2022. These discussions were audio-recorded, subsequently transcribed, and analyzed using the qualitative content analysis of Mayring and Kuckartz. Results Fourteen out of 19 participants who had a primary care encounter regarding their long COVID symptoms did not perceive it as helpful. Many respondents reported that their general practitioners did not take their long COVID symptoms seriously and did not refer them to specialists or made therapeutic recommendations. However, some participants reported that they were prescribed non-pharmaceutical therapies (e.g., group meetings supported by psychotherapists, occupational therapy, etc.) that improved their condition. 14 of 23 respondents perceived care barriers such as providers’ lack of awareness of long COVID, poor access to specialists, a lack of specialized care (e.g., long COVID clinics), or high bureaucratic hurdles for specific healthcare services. To improve medical care, participants suggested campaigns to raise awareness of long COVID among healthcare providers and the general population, increase research and government investments regarding the development of treatment structures for long COVID, expanding existing therapeutic services, and establishing one-stop shops for integrated specialist healthcare for people with long COVID. Conclusions Several implications for healthcare professionals and policymakers can be derived from this study: (1) general practitioners should take the symptoms of long COVID seriously, assume a care coordinating role, make referrals, and establish contact with long COVID clinics; (2) care planners should focus on developing interprofessional evidence-based care and treatment approaches for long COVID; (3) existing care structures such as long COVID outpatient clinics should be expanded. The overarching goal must be to develop consistent guidelines for long COVID diagnosis, care, and treatment. Trial registration The study is registered in the German register for clinical trials (DRKS00026007, first registration on 09/09/2021).

Abstract Background In pediatric medical emergencies, paramedics and emergency physicians must often rely on the information of third parties, often caregivers, to gather information. Failing to obtain relevant information may lead to misinterpretation of symptoms and subsequent errors in decision making and clinical treatment. Thus, children and/or caregivers with limited proficiency of the locally spoken language may be at risk for medical errors. This study analyzes logs of rescue missions to determine whether paramedics could obtain essential information from German-speaking and foreign-language children and their caregivers. Methods We conducted a secondary data analysis based on retrospective data on pediatric patients of four emergency medical services (EMS) stations in Northern Germany. We defined language discordance with communication difficulties as main exposure. We used documentation quality as outcome defined as existing information on (a) pre-existing conditions, (b) current medication, and (c) events prior to the medical emergency. Statistical analyses include descriptive statistics, simple regression and multivariable regression. As multivariable regression model, a logistic regression was applied with documentation quality as dependent variable and language discordance with communication difficulties as independent variable adjusted for age, sex and Glasgow Coma Scale (GCS). Results Data from 1,430 pediatric rescue missions were analyzed with 3.1% (n = 45) having a language discordance with communication difficulties. Patients in the pediatric foreign-language group were younger compared to German-speaking patients. Thorough documentation was more frequent in German-speaking patients than in patients in the foreign-language group. Pre-existing conditions and events prior to the medical emergency were considerably more often documented in German-speaking than for foreign-language patients. Documentation of medication did not differ between these groups. The adjustment of sex, age and GCS in the multivariable analysis did not change the results. Conclusion Language barriers are hindering paramedics to obtain relevant information in pediatric pre-hospital emergencies. This jeopardizes the safe provision of paramedic care to children who themselves or their caregivers are not fluent in German language. Further research should focus on feasible ways to overcome language barriers in pre-hospital emergencies. Trial registration This is a retrospective secondary data analysis of a study that was registered at the German Clinical Trials Register (No. DRKS00016719), 08/02/2019.

Purpose: This study aims to examine the health-related Quality of Life (hrQoL) and social participation in participants with Long COVID compared to participants without symptoms after COVID-19 and participants with no prior SARS-CoV-2 infection. Methods: A cross-sectional online survey was conducted in Germany. The non-random sample consists of participants 18 years or older. Participants were divided in three groups: Lg COVID with a prior SARS-CoV-2 infection and new or persistent symptoms 28 days after infection, ExCOVID with a prior SARS-CoV-2 infection and without new or persistent symptoms after 28 days, and NoCOVID when participants had no prior SARS-CoV-2 infection. EQ-5D-3L was used as hrQoL measure and the Index for the Assessment of Health Impairments (IMET) to reflect social participation. Descriptive and inferential statistics were performed. Results: A total of 3188 participants were included in the analysis (1421 Lg COVID, 260 ExCOVID, 1507 NoCOVID). Lg COVID was associated with the lowest EQ-5D-3L index values (p

BackgroundA future shortage of physicians, especially in general practice, will result in an increasing workload for health care providers as a whole. Therefore, it is important to optimize patient-encounter processes to increase time efficiency related to visits. Utilizing digital tools to record patients’ medical histories prior to a consultation offers great potential to achieve this goal. The collected information can be stored into the practice’s electronic medical record, allowing for the general practitioner to review structured information of the patients’ complaints and related medical history beforehand, thereby saving time during the encounter. However, the low usability of new digital developments in this setting often hinders implementation. ObjectiveThe aim of this study was to evaluate the usability of an app designed for medical history taking in general practice to capture the patients’ perspective. MethodsBetween November 2021 and January 2022, we recruited 406 patients with acute complaints in one out-of-hour urgent care and seven general practice clinics. These study participants used the app during their waiting time and subsequently assessed its usability by completing the System Usability Scale (SUS), a robust and well-established 10-question survey measuring the perceived usability of products and technologies. Additionally, we collected general participant information, including age, sex, media usage, health literacy, and native language. Descriptive and inferential statistics were applied to identify patient characteristics associated with low or high SUS scores. ResultsWe analyzed data from 397 patients (56.7% female, 43.3% male). The mean total SUS score was 77.8 points; 54.4% (216/397) of participants had SUS scores of 80 points or higher, indicating high usability of the app. In a multiple linear regression predicting SUS score, male sex and higher age (65 years or older) were significantly negatively associated with the SUS score. Conversely, a higher health literacy score and German as the native language were significantly positively associated with the SUS score. ConclusionsUsability testing based on the SUS anticipates successful implementation of the app. However, not all patients will easily adapt to utilizing the app, as exemplified by the participants of older age in this study who reported lower perceived usability. Further research should examine these groups of people, identify the exact problems in operating such an app, and provide targeted solutions. Trial RegistrationGerman Clinical Trials Register World Health Organization Trial Registration Data Set DRKS00026659; https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00026659

ABSTRACTObjective The COVID-19 pandemic has affected how people go about their daily lives, often in various and substantial ways. This study aims to prospectively evaluate the changes in social participation during the COVID-19 pandemic in persons with a high risk for a severe COVID-19 course in Germany.Methods A paper-pencil-based survey was conducted starting at March 2021. Participants filled out questionnaires at four time points based on their COVID-19 vaccination status: before COVID-19 vaccination, one month, six months and twelve months after COVID-19 vaccination. Social participation measures included the Pandemic Social Participation Questionnaire (PSP-Q) and the Index for measuring participation restrictions (IMET). Repeated measures ANOVA and paired t-test were used to test for changes between time-points. Repeated measures correlation was used to assess the relationship between social participation and local COVID-19 incidences.Results Data from 245 participants was analyzed before and one month after COVID-19 vaccination. In addition, data from 156 participants was analyzed at time points one, six and twelve months after COVID-19. PSP-Q and IMET scores changed significantly after participants received a COVID-19 vaccination. Between one month and twelve months after vaccination, social participation improved significantly measured by PSP-Q. Social participation was negatively correlated with regional COVID-19 incidences before and after COVID-19 vaccination. Social participation was positively correlated with COVID-19 incidences between one month and twelve months after COVID-19 vaccination.Conclusions Social participation improved in persons with a high risk for a severe COVID-19 course during the pandemic. The local COVID-19 incidence showed a negative association with social participation only until the fall of 2021 when it was used as the sole metric to regulate COVID-19 protective measures. Although our data describes the trends in social participation, further studies are needed to identify the influencing factors for the observed increase in social participation.

Abstract Background In out-of-hours urgent care practices in Germany, physicians of different specialties care for a large number of patients, most of all unknown to them, resulting in a high workload and challenging diagnostic decision-making. As there is no common patient file, physicians have no information about patients’ previous conditions or received treatments. In this setting, a digital tool for medical history taking could improve the quality of medical care. This study aims to implement and evaluate a software application (app) that takes a structured symptom-oriented medical history from patients in urgent care settings. Methods We conduct a time-cluster-randomized trial in two out-of-hours urgent care practices in Germany for 12 consecutive months. Each week during the study defines a cluster. We will compare participants with (intervention group) and without app use (control group) prior to consultation and provision of the self-reported information for the physician. We expect the app to improve diagnostic accuracy (primary outcome), reduce physicians’ perceived diagnostic uncertainty, and increase patients’ satisfaction and the satisfaction with communication of both physician and patient (secondary outcomes). Discussion While similar tools have only been subject to small-scale pilot studies surveying feasibility and usability, the present study uses a rigorous study design to measure outcomes that are directly associated with the quality of delivered care. Trial registration The study was registered at the German Clinical Trials Register (No. DRKS00026659 registered Nov 03 2021. World Health Organization Trial Registration Data Set, https://trialsearch.who.int/Trial2.aspx? TrialID = DRKS00026659.

Background and aims: The COVID-19 pandemic has a major impact on many areas of life, including many people's job situations. Not everyone is affected in the same way - people with chronic conditions may experience increased mental stress and social problems. In this study, we focus on immunocompromised people (ICP), who are at high risk for a severe course of COVID-19. Our aim was to investigate the level of social participation during the pandemic, focusing on how ICPs perceive changes in their working lives. Methods: We applied a mixed-methods concurrent triangulation design with qualitative interviews (N = 13) and a quantitative cross-sectional survey with N = 179 participants. This approach allowed us to gain deep insights into the experience of occupational-social participation. Results: Qualitative results show that working from home during the COVID-19 pandemic was seen as a relief by many, as medical necessities could be integrated more easily into everyday life. Understanding and consideration of their professional social network were essential for all respondents. Our interview data hint at an influence of the family situation (e.g., having children) and the relationship of the ICP to coworkers on the perception of changes to their work environment. The quantitative results indicate an interaction between mental health and employment status on social participation, with employment reducing the negative impact of poorer mental health on social participation after adjusting for sociodemographic variables. Conclusions: Our results indicate changes necessary to integrate people with chronic conditions into working life, even under pandemic conditions. This includes the possibility of flexible working hours and compliance with hygiene measures at the workplace.

Abstract Background Providing medical care to newly arrived migrants presents multiple challenges. A major challenge is a lack of a common language in the absence of language interpretation services. We examine the multilingualism of German physicians and clinical psychotherapists providing ambulatory care. Methods We retrieved publicly available data from the Associations of Statutory Health Insurance Physicians provider registry of three German federal states (Lower Saxony, Saarland, Bavaria). We selected and grouped relevant practice-based disciplines. We used descriptive statistics to analyze the provider’s multilingualism among different disciplines. Results 69.6% of ambulatory providers offer consultations only in German. 15.5% of providers reported offering consultations in one additional non-German language, and 14.9% in two or more additional languages. Most common additional languages were English (28.6%) and French (9.9%). 1.4% of providers reported offering consultation in at least one language of the Middle Eastern region (Arabic, Dari, Hebrew, Kurdish, Pashtu, Farsi, and Turkish). There were differences in the offered languages between the medical disciplines with the highest mean rates found for gynecologists and obstetricians, urologists, and general surgeons. Psychotherapeutic disciplines offered consultation in other languages significantly less often. Conclusion Our study suggests a significant numeric mismatch in the number of providers offering consultations in the languages of people seeking protection in Germany. The resulting language barriers are compromising equitable access and quality of care.

Abstract Background With the help of digital tools patients’ medical histories can be collected quickly and transferred into their electronic medical records. This information can facilitate treatment planning, reduce documentation work, and improve care. However, it is still unclear whether the information collected from patients in this way is reliable. In this study, we assess the accuracy of the information collected by patients using an app for medical history taking by comparing it with the information collected in a face-to-face medical interview. We also study the app’s usability from the patients’ point of view and analysing usage data. Methods We developed a software application (app) for symptom-oriented medical history taking specialized for general practice. Medical history taking will take place involving patients with acute somatic or psychological complaints (1) using the app and (2) verbally with trained study staff. To assess the perceived usability, patients will complete a questionnaire for the System Usability Scale. We will collect sociodemographic data, information about media use and health literacy, and app usage data. Discussion Digital tools offer the opportunity to improve patient care. However, it is not self-evident that the medical history taken by digital tools corresponds to the medical history that would be taken in an interview. If simply due to a design flaw patients answer questions about signs and symptoms that indicate possible serious underlying conditions ‘wrong’, this could have severe consequences. By additionally assessing the app’s usability as perceived by a diverse group of patients, potential weaknesses in content, design and navigation can be identified and subsequently improved. This is essential in order to ensure that the app meets the need of different groups of patients. Trial registration German Clinical Trials Register DRKS00026659 , registered Nov 03 2021. World Health Organization Trial Registration Data Set, https://trialsearch.who.int/Trial2.aspx? TrialID = DRKS00026659.

Abstract Background The influence of immunosuppressive therapy on immunogenicity after COVID-19 vaccination remains unclear. This study surveys patients who receive immunosuppressive therapy about whether or not they paused their immunosuppressive medication while receiving SARS-CoV-2 vaccination. Methods In this prospective observational study, immunosuppressed participants were asked by phone and email about their medication before and during vaccination and who—if anyone—advised them to pause their medication. In addition, a baseline paper-based questionnaire contributes general characteristics regarding age, gender, immunosuppressive medication(s) and the chronic disease(s) requiring immunosuppressive therapy. Results Of 207 surveyed participants, 59 persons (28.5%) paused their immunosuppressive medication before/during vaccination. Persons with rheumatic conditions and women were significantly more likely to pause immunosuppressive therapy than others. Over half of those who paused their medication reported receiving a recommendation from their specialist and 22.0% (13 of 59) decided to pause medication themselves without consulting a physician in advance. Conclusions Besides lack of evidence, many immunosuppressed individuals and their treating physicians choose to pause medication before COVID-19 vaccination and accepting the risk of worsening their underlying disease. Trial registration: DRKS00023972, registered 12/30/2020.

BackgroundCommunication across language barriers is a particular challenge for health care providers. In emergency medical services, interpreters are mostly not available on rescue scenes, which jeopardizes safe and high-quality medical care. In a cocreative process together with paramedics and software designers, we developed a fixed-phrase translation app with 600 phrases and 18 supported languages that supports paramedics when providing care to foreign-language patients. This paper reports on the results of a pilot study to evaluate the app’s effect on paramedic-patient communication. ObjectiveThis study aims to gain insights into the efficacy and feasibility of a multilingual app that helps paramedics to communicate with patients who are not proficient in the local language. MethodsA 3-armed nonrandomized interventional pilot study was conducted in 4 rescue stations in the German Federal State of Lower Saxony: 3 rural areas and 1 in urban environment. The intervention group comprised rescue missions with patients with limited German language proficiency (LGP) with whom the app was used; control group 1 comprised LGP patients without app usage; and control group 2 consisted of rescue missions with German-speaking patients. For each rescue operation with LGP patients, paramedics filled out questionnaires about the communications with patients. From standardized Rescue Service Case Protocols, we extracted information on patient demographics (age and sex), clinical aspects (preliminary diagnosis and Glasgow Coma Scale), and rescue operation characteristics (time spent on emergency scene and additional dispatch of emergency physicians). The primary outcome was the paramedics’ perceived quality of communication with LGP patients. The secondary outcome was the ability to obtain necessary information from patients and the ability to provide important information to patients. A linear regression model was applied to assess the impact of the app on perceived communication, controlling demographic factors, and severity of illness. ResultsA total of 22 LGP patients were recruited into the intervention group and 122 into control group 1. The control group 2 included 27,212 German-speaking patients. LGP patients were more than 2 decades younger than German-speaking patients. App usage among LGP patients was associated with higher perceived overall quality of communication (0.7 points on a 5-point Likert scale, P=.03). Applying a linear regression model controlling for age, sex, and Glasgow Coma Scale, the quality of communication was associated with an increase of 0.9 points (95% CI 0.2-1.6, P=.01). Compared to either German-speaking patients or LGP patients, paramedics spent 6-7 minutes longer on an emergency scene when the app was used (P=.24). ConclusionsThe use of the app suggests a relevant improvement in communication with patients with limited proficiency in the locally spoken language in paramedic care. The small sample size and the lack of randomization reduce the generalizability of the findings. Trial RegistrationGerman Clinical Trials Register DRKS00016719; https://drks.de/search/de/trial/DRKS00016719

Abstract Background Immunocompromised people (ICP) and elderly individuals (older than 80 years) are at increased risk for severe coronavirus infections. To protect against serious infection with SARS-CoV-2, ICP are taking precautions that may include a reduction of social contacts and participation in activities which they normally enjoy. Furthermore, for these people, there is an uncertainty regarding the effectiveness of the vaccination. The COVID-19 Contact (CoCo) Immune study strives to characterize the immune response to COVID-19 vaccination in immunocompromised, elderly people, and patients with hematological or oncological diseases. The study uses blood-based screenings to monitor the humoral and cellular immune response in these groups after vaccination. Questionnaires and qualitative interviews are used to describe the level of social participation. Methods The CoCo Immune Study is a mixed methods prospective, longitudinal, observational study at two large university hospitals in Northern Germany. Starting in March 2021, it monitors anti-SARS-CoV-2 immune responses and collects information on social participation in more than 600 participants, at least 18 years old. Inclusion criteria and subcohorts: Participants with (1) regularly intake of immunosuppressive medication (ICP-cohort) or (2) age ≥ 80 years (80 + -cohort). Additionally, patients with current or former (3) myeloid, (4) lymphatic disease or (5) solid tumor under checkpoint inhibition (3–5: HO-cohort). Exclusion criteria: (1) refusal to give informed consent, (2) contraindication to blood testing, (3) inability to declare consent. Participants complete a questionnaire at four different time points: prior to full vaccination, and 1, 6 and 12 months after completed vaccination. In addition, participants draw blood samples themselves or through a local health care provider and send them with their questionnaires per post at the respective time points after vaccination. Patients of the HO cohort dispense additional blood samples at week 3 to 12 and at month 6 to 9 after 2nd vaccination to gain additional knowledge in B and T cell responses. Selected participants are invited to qualitative interviews about social participation. Discussion This observational study is designed to gain insight into the immune response of people with weakened immune systems and to find out how social participation is affected after COVID-19 vaccination. Trial registration: This study was registered with German Clinical Trial Registry (registration number: DRKS00023972) on 30th December 2020.

Background/aimsThe COVID-19 pandemic situation poses new challenges for research. Ethical issues might arise if especially vulnerable individuals for severe COVID-19 course expose themselves because of participation in studies to a higher risk of infection for study purposes. How is the feasibility and acceptance of self-organized blood sample collections to measure anti-SARS-CoV-2 Spike IgG antibodies in persons with a high risk for a severe COVID-19 disease progression?MethodsPersons with a high risk for a severe COVID-19 disease progression (immunocompromised, oncology patients or over 80 years old) were recruited between January and September 2021 to send in blood samples (at least 500 μl) 1 month and 6 months after second COVID-19 vaccination. Participants were given the choice of drawing capillary or venous blood themselves or having blood drawn by health professionals belonging to either the study's own research team or the personnel found in local practices or clinics. Participants were surveyed via a telephone interview in December 2021 and January 2022 about their choice of blood sampling methods and influence of blood collection choice upon study participation.ResultsData from 360 participants was collected via telephone follow-up. First blood samples were collected by the participants themselves (35.8%), local practices or clinics (31.9%) and the research team (22.5%). Second blood samples were mostly collected in local practices or clinics (35.6%) followed by participants themselves (25.9%) and the research team (11.5%). Blood samples were not collected in 2.5% and 19.1% of persons during first and second blood draw, respectively. Only 2% of blood samples did not reach the laboratory or were not analyzable. About one-fourth (26%) of participants stated that they would not have participated in the study if it would have been required to travel to the university hospital to give their blood sample.ConclusionsParticipants were able to self-organize blood collection, making use of several different blood sample methods. Nearly all blood samples were analyzable when self-collected and sent in by post. One-fourth of the participants would not have participated in the study if required to give their blood sample in the study location.Trial registrationGerman Clinical Trial Registry, DRKS00021152.

IntroductionThe coronavirus disease 2019 (COVID-19) pandemic impacted how people perform their daily lives in manifold and sometimes massive ways. Particularly, individuals who are at high risk for a severe disease progression, like immunocompromised people, may have experienced drastic changes in social participation during the pandemic. A COVID-19 basic vaccination may have changed the safety behavior of immunocompromised individuals in terms of infection risk and thereby influence social participation and mental wellbeing.MethodsThis study aims to investigate self-perceived social participation at baseline before and at follow-up 1 and 6 months after basic vaccination. Beginning in March 2021, 274 immunocompromised persons 18 years or older were enrolled in the COVID-19 Contact Immune study (CoCo study) in Lower Saxony, Germany. Measurements were performed at three time points regarding social participation [Index for the Assessment of Health Impairments (IMET)], mental health [Patient Health Questionnaire-4 (PHQ-4)], subjective health status (five-point Likert-scale) and quality of life (five-point Likert-scale).ResultsIn total, 126 participants were included in the final analysis. About 60% of the participants showed increasing social participation over time. The greatest increase in social participation was observed within the first month after basic vaccination (p < 0.001). During the following 5 months, social participation remained stable. The domains “social activities,” “recreation and leisure” and “close personal relationships” were responsible for the overall change in social participation. No association was found between social participation and mental health, sociodemographic or medical factors (except hypertension).DiscussionIt is unclear why social participation increased after basic vaccination. Perceived vaccine efficacy and a feeling of being protected by the vaccine may have caused relaxed social distancing behaviors. Reducing safety behaviors may, however, increase the risk of a COVID-19 infection for immunocompromised individuals. Further investigations are needed to explore the health-related consequences of more social participation among immunocompromised persons.

BackgroundWith population-wide vaccination availability, the global COVID-19 pandemic entered a new phase. Despite vaccination status, some people who were infected with SARS-CoV-2 experience long-term symptoms. ObjectiveIn this study, we aim to characterize the long-term effects of SARS-CoV-2 infection and the pandemic. We also aim to build symptom clusters and determine risk factors for developing long COVID symptoms. Furthermore, we assess social participation and health-related quality of life in patients with long COVID and in the general population during a global pandemic. MethodsWith a mixed-methods, web-based approach, we aim to recruit 2000 people in Germany who are older than 18 years and can provide informed consent. In the quantitative arm of the study, we identify symptoms of and predictive factors for long COVID manifestations with cluster analysis and assess social participation during the pandemic with standardized questionnaires. The qualitative arm of the study uses individual interviews and focus group discussions to better understand the illness experience of persons who experience long COVID. ResultsRecruitment started in September 2021. Up until July 2022, we recruited approximately 4500 participants via our web-based database. ConclusionsThis study aims to build an innovative, patient-centered, web-based research platform appropriate for the pandemic by minimizing physical contact between study personnel and participants. All study activities are designed to better understand the long COVID syndrome, social participation during the pandemic, and the illness experiences of persons affected by long COVID. Trial RegistrationGerman Clinical Trial Registry DRKS00026007; https://tinyurl.com/yh282fkt International Registered Report Identifier (IRRID)DERR1-10.2196/38718

Immunocompromised persons are at an increased risk for a severe SARS-CoV-2 infection and their safety behaviors may influence their social participation. Vaccinated persons have a lower incidence of infection and severe disease when infected compared to non-vaccinated persons. Therefore, their behavior may change and their social participation may increase after a complete vaccination. The aim of this study was to explore social participation of immunocompromised persons before and after complete COVID-19 vaccination. Between March and September 2021, 274 immunocompromised participants were recruited. Survey data were collected at baseline and follow-up from 194 participants including the Index for the Assessment of Health Impairments [IMET], Patient Health Questionnaire-4 [PHQ-4], subjective health status and quality of life. At baseline, participants were not yet completely vaccinated. Complete vaccination was achieved prior to the follow-up questionnaire. IMET scores decreased significantly at follow-up, indicating a higher social participation after complete vaccination. PHQ-4, subjective health status and quality of life did not differ between baseline and follow-up. There were no significant differences across sociodemographic factors. Significant PHQ-4 differences were observed regarding the population size of the participants' home community. Social participation of immunocompromised persons in our study increased after COVID-19 vaccination. Therefore, social participation should be explored further, especially with regards to the impact of vaccination on groups with a high health risk.

Tinnitus, vertigo and dizziness are symptoms commonly reported among Long and Post COVID patients, however the severity of these symptoms has not been assessed in large trials. Therefore, in this study a large cohort of Long COVID patients was surveyed about the presence and severity of tinnitus and vertigo or dizziness symptoms. The online survey was completed by a German cohort of 1,082 adult Long COVID patients after a mean period of 43.2 weeks ± 23.4 weeks after infection. Eighty percent were not fully vaccinated (at least two vaccinations) at the time of their first COVID symptoms and 9.8% were hospitalized in the course of their acute SARS-CoV-2 infection. At the time of the survey, 60% of patients reported the presence of vertigo or dizziness with a mean severity of 4.6 ± 2.7 on a scale of 1 (least severe) to 10 (most severe) and 30% complained of tinnitus with a mean severity of 4.8 ± 3.0. Approximately one fifth of the participants with tinnitus and vertigo or dizziness, rated their symptoms to be severe. The data shown in this study confirms that tinnitus and vertigo or dizziness are common symptoms in Long COVID patients and demonstrates, that a compelling number of patients rate their symptoms as severe. The self-reported severity highlights the need for Long COVID clinics to address these symptoms effectively. We suggest a multidisciplinary diagnostic and therapeutic approach to prevent further morbidity and socioeconomic burden for Long COVID patients suffering from severe vertigo, dizziness or tinnitus.

Background:Restrictions to contain the COVID-19 pandemic affect the social participation of people worldwide. Especially those at high risk for a severe disease tend to abstain from social gatherings. While there are a few questionnaires to measure social participation in elderly or chronic patients, a valid survey instrument that includes pandemic-related social participation is needed.MethodsWe developed a social participation questionnaire that aims to assess pandemic-related restrictions in social participation. Items were developed using a theory and literature-based approach and then compiled in a discursive process involving experts and lay people. This was followed by the validation of the questionnaire through a cross-sectional survey on 431 individuals. Items with low item-total correlations and low factor loadings using exploratory factor analysis [EFA] were excluded. Using EFA on the remaining items, the factor structure was retrieved and tested with a confirmatory factor analysis [CFA]. Internal consistency was assessed with Chronbachs α.ResultsInitially, 27 items were developed which were used for validation. 13 items were excluded due to low item-total correlations and factors loadings. EFA of the remaining 14 items revealed three factors which were identified as domains “active social participation,” “wellbeing,” and “restrictions”. CFA showed an acceptable model fit using the three-dimensional structure. Chronbachs α of 0.81 and McDonalds Ω of 0.87 indicate good internal consistency. Correlation analysis showed an association between the developed questionnaire and previously-established participation and mental health scales.ConclusionThis study suggests that our 14 item questionnaire is of high reliability and validity and can be used to measure social participation during a pandemic.

Food conditions are changing due to anthropogenic activities and natural sources and thus, many species are exposed to new challenges. Animals might cope with altered quantitative and qualitative composition [i.e. variable protein, nitrogen (N) and energy content] of food by exhibiting trophic and digestive plasticity. We examined experimentally whether tadpoles of the common frog (Rana temporaria) exhibit phenotypic plasticity of the oral apparatus and intestinal morphology when raised on a diet of either low (i.e. Spirulina algae) or high protein, N and energy content (i.e. Daphnia pulex). Whereas intestinal morphology was highly plastic, oral morphology did not respond plastically to different chemical compositions of food. Tadpoles that were fed food with low protein and N content and low-energy density developed significantly longer guts and a larger larval stomachs than tadpoles raised on high protein, N and an energetically dense diet, and developed a different intestinal surface morphology. Body sizes of the treatment groups were similar, indicating that tadpoles fully compensated for low protein, N and energy diet by developing longer intestines. The ability of a species, R. temporaria, to respond plastically to environmental variation indicates that this species might have the potential to cope with new conditions during climate change.

We consider large random matrices with a general slowly decaying correlation among its entries. We prove universality of the local eigenvalue statistics and optimal local laws for the resolvent away from the spectral edges, generalizing the recent result of Ajanki et al. [‘Stability of the matrix Dyson equation and random matrices with correlations’, Probab. Theory Related Fields173(1–2) (2019), 293–373] to allow slow correlation decay and arbitrary expectation. The main novel tool is a systematic diagrammatic control of a multivariate cumulant expansion.