[Immunosuppressed people's beliefs, expectations, and experiences with COVID-19 vaccinations : Results of a longitudinal study]. / Impfeinstellung, Erwartungen und Impferfahrung von Immunsupprimierten bei COVID-19-Impfungen : Ergebnisse einer Längsschnittstudie.

BACKGROUND: Immunocompromised people are less likely to be vaccinated, despite an increased benefit of many vaccinations in terms of benefit-risk assessment, including the vaccines against SARS CoV-2 (COVID-19). Attitudes, expectations, and experiences with previous vaccinations influence the decision to get vaccinated. OBJECTIVE: To explore the attitudes of immunocompromised people towards vaccinations in general and COVID-19 vaccination in particular and their experiences with COVID-19 vaccinations. MATERIAL AND METHODS: As part of the CoCo Immune study, immunocompromised participants were surveyed in the spring and summer of 2021 (1 November 2021-7 September 2021) using questionnaires. Initially, they were asked about their expectations concerning a COVID-19 vaccination and followed up about their experience after COVID-19 vaccination. In addition, sociodemographic data, general attitudes toward vaccinations and experiences with previous vaccinations were collected. Analysis was performed using descriptive and bivariate statistics. RESULTS: The 243 participants mostly approved vaccinations and expected the COVID-19 vaccination to be effective and well-tolerated. Women were more concerned about the safety of vaccinations and were more often worried about side effects. Older persons felt better informed than younger persons. Participants who reported subjective side effects of previous vaccinations were more skeptical about vaccinations as well as the government institutions that recommend vaccinations. They less often agreed with the statement "in retrospect, the COVID-19 vaccination has been harmless for me so far". DISCUSSION: The participants mostly expressed a positive attitude and anticipation towards COVID-19 vaccinations; however, the age and sex differences found suggest that there are different information needs which should be addressed when educating individuals about vaccinations or designing vaccination campaigns.

Immunogenicity of COVID-19 Vaccination in Melanoma Patients under Immune Checkpoint Blockade.

BACKGROUND: Immunogenicity of SARS-CoV-2 vaccines is modestly impaired in cancer patients due to a generally weakened immune system. Immune checkpoint inhibitors (ICI) are expected to enhance immune response. This has already been described to be the case in influenza vaccines, and first data about COVID-19 vaccines show a trend in this direction. AIM: We aimed to investigate the immune response of patients with melanoma under ICI therapy after COVID-19 vaccination. PATIENTS AND METHODS: In the Skin Cancer Center Hanover (Germany), we recruited 60 patients with advanced melanoma who either received ICI therapy during or before the vaccination period. Serological blood analysis was performed using quantitative ELISA for Anti-SARS-CoV-2 spike protein 1 IgG antibodies. RESULTS: We did not observe an enhanced humoral immune response in patients under active or past ICI therapy after COVID-19 vaccination. Nevertheless, there is a tendency of higher antibody levels when ICI therapy was received within the last 6 months before vaccination. Subgroup analysis revealed that patients in our study population under ongoing targeted therapy during vaccination period had significantly higher median antibody levels than patients without any active antitumor treatment. CONCLUSION: Melanoma patients under ICI therapy show comparable antibody response after SARS-CoV-2 vaccination to healthy health care professionals. This finding is independent of the timing of ICI therapy.

SARS-CoV-2-specific immune responses in elderly and immunosuppressed participants and patients with hematologic disease or checkpoint inhibition in solid tumors: study protocol of the prospective, observational CoCo immune study.

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.

Association of long COVID with health-related Quality of Life and Social Participation in Germany: Finding from an online-based cross-sectional survey.

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 < 0.001), Visual Analogue Scale (VAS) scores (p < 0.001), and IMET (p < 0.001) scores followed by NoCOVID and ExCOVID. After adjusting for sociodemographic and medical conditions in a multivariable model Long COVID was still associated with lower hrQoL compared to NoCOVID (p < 0.001). About 10% of Lg COVID participants showed no health impairments in all EQ-5D dimensions while 51.1% of NoCOVID and 60% of ExCOVID participants showed no health impairments. Conclusion: This study highlights the impairments of persons with Long COVID on hrQoL and social participation compared to individuals without Long COVID in Germany. Trial registration: German Clinical Trial Registry, DRKS00026007.

Parenting and Gender as Impact Factors for Social Participation, Quality of Life, and Mental Health in Long COVID.

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 < .001). In the qualitative study, participants expressed feelings of dejection and pessimism about their future private, occupational, and health situations. No differences between the genders could be observed. CONCLUSIONS: Long COVID is associated with impairments in family and domestic responsibilities in individuals who have parenting tasks. Among participants with long COVID, anxiety symptoms are higher in men than women.

Feasibility of self-organized blood sample collection in adults for study purposes in a primary care setting.

BACKGROUND/AIMS: The 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? METHODS: Persons 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. RESULTS: Data 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. CONCLUSIONS: Participants 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 REGISTRATION: German Clinical Trial Registry, DRKS00021152.

[Social participation and melanoma during the COVID-19 pandemic]. / Soziale Teilhabe und Hautkrebs während der COVID-19-Pandemie.

BACKGROUND: Measures used to contain the spread of coronavirus disease 2019 (COVID-19) have impaired the social participation of many people. Especially people with chronic or oncologic conditions were affected. In this observational study, we aimed to assess social participation in melanoma patients with immune checkpoint therapy. Therefore, we investigated social participation in a very specific group and consider this a basis for further studies in a growing collective of long-term survivors in an era of infectious diseases. MATERIALS AND METHODS: Cross-sectional assessment via the index to measure social participation and health associated quality of life ("Index zur Messung von Einschränkungen der Teilhabe", IMET). Results are compared with published norm data. RESULTS: In all, 47 melanoma patients (mean age 58.5 years, standard deviation 13.2) were included: 18 patients had advanced melanoma stage III and received adjuvant Immunotherapy, while 29 patients were treated because of metastatic melanoma (stage IV). Results of the IMET showed no significant impairments in social participation when regarding the total score and when being compared to prepandemic norm data. Female patients did have significantly impaired participation. CONCLUSION: The endpoints health-related quality of life and social participation are important in long-term survivors with melanoma. During the pandemic, women of our collective were especially at risk for impairment of social participation. Differences between pandemic and disease-specific influences on social participation cannot be derived from our data. Nevertheless, this study will be part of growing and necessary research on long-term cancer survivors diseases.

Social participation during the COVID-19 pandemic in persons with a high risk for a severe course of COVID-19 - results of a longitudinal, multi-center observational study in Germany.

Objective: 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.

Social participation and mental health of immunocompromised individuals before and after COVID-19 vaccination-Results of a longitudinal observational study over three time points.

Introduction: The 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. Methods: This 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). Results: In 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). Discussion: It 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.

Who is pausing immunosuppressive medication for COVID-19 vaccination? Results of an exploratory observational trial.

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.

Development and Validation of a Questionnaire to Assess Social Participation of High Risk-Adults in Germany During the COVID-19 Pandemic.

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. Methods: We 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. Results: Initially, 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. Conclusion: This study suggests that our 14 item questionnaire is of high reliability and validity and can be used to measure social participation during a pandemic.

Effects of Pre-Existing Mental Conditions on Fatigue and Psychological Symptoms Post-COVID-19.

BACKGROUND: Patients who are post-COVID-19 will require more treatment soon. Therefore, it is important to understand the root cause of their psychological and somatic conditions. Previous studies showed contradictory results on the influence of pre-existing mental conditions. The present study examines the influence of these pre-existing conditions and their pre-treatment on the severity of post-COVID-19 symptoms. METHODS: This analysis employs questionnaire data from a large study sample in Germany. Overall, 801 participants were included. All participants rated their health status on a scale from 0 to 100. Fatigue, depression, and anxiety were measured using the FAS, PHQ-9, and GAD-7 scales. RESULTS: All pre-pandemic values showed no significant differences between the groups. The current health status was rated similarly by the recovered patients (µ = 80.5 ± 17.0) and the control group (µ = 81.2 ± 18.0) but significantly worse by acutely infected (µ = 59.0 ± 21.5) and post-COVID-19 patients (µ = 54.2 ± 21.1). Fatigue, depression, and anxiety were similar for recovered patients and the control group. By contrast, there were significant differences between the control and the post-COVID-19 groups concerning fatigue (45.9% vs. 93.1%), depression (19.3% vs. 53.8%), and anxiety (19.3% vs. 22.3%). CONCLUSION: Fatigue and psychological conditions of post-COVID-19 patients are not associated with pre-existing conditions.

Long-term Consequences of COVID-19 and the Pandemic: Protocol for a Web-Based, Longitudinal Observational Study (DEFEAT).

BACKGROUND: With 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. OBJECTIVE: In 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. METHODS: With 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. RESULTS: Recruitment started in September 2021. Up until July 2022, we recruited approximately 4500 participants via our web-based database. CONCLUSIONS: This 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 REGISTRATION: German Clinical Trial Registry DRKS00026007; https://tinyurl.com/yh282fkt. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38718.

The Impact of COVID-19 Vaccination on the Social Participation of Immunocompromised Persons - Results of a Multicenter Observational Study.

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.

Self-reported Tinnitus and Vertigo or Dizziness in a Cohort of Adult Long COVID Patients.

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.