Using Heart Rate Variability to Assess Nurses' Stress During the COVID-19 Pandemic.

OBJECTIVE: This study aimed to assess subjective and objective parameters of stress among nurses during the COVID-19 pandemic and to examine the recovery effect of a day off. METHODS: In this prospective observational trial, we measured heart rate variability (using a wearable device) and perceived stress levels on 3 working days and 1 day off. We obtained the following data using an online questionnaire: working conditions, COVID-19-related problems, depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), effort-reward imbalance, and work-family conflict in a sample of German nurses (N = 41). RESULTS: When comparing working days with a day off, we observed a significant difference for physical load (Cohen's d = 0.798, P < .001), mental load (Cohen's d = 0.660, P = .001), emotional exhaustion (Cohen's d = 0.945, P < .001), and overburdening (Cohen's d = 0.585, P = .002) with higher scores on working days. Regarding heart rate variability, we did not find a difference. Correlational analyses revealed a significant association between being afraid to get infected with COVID-19 and lower heart rate variability (r = -0.336, P = .045) and between being afraid to infect relatives and lower heart rate variability (r = -0.442, P = .007). Furthermore, a higher total sum score of work-family conflict was significantly associated with lower heart rate variability (r = -0.424, P = .01). CONCLUSION: As heart rate variability observations were different from those regarding subjectively perceived stress, further studies are needed to evaluate and differentiate the influence of work stress and other types of stress on heart rate variability.

Psycho-Oncological Self-Help Groups in Bavaria: The Current Situation and Suggestions for Improvement.

BACKGROUND: Self-help groups (SHGs) are an important cornerstone of the German health care system. Especially collaborations of SHGs with cancer centers enable active patient involvement in cancer care. We investigated the current situation and unmet needs of Bavarian SHGs in order to point out possible options of action. METHODS: We conducted a cross-sectional study with Bavarian psycho-oncological SHGs. Via e-mail, an online survey was sent to 150 SHGs registered at the BZKF (Bavarian Cancer Research Center). We assessed activities and needs of the SHGs as well as the nature of collaborations with cancer centers. We focused on adaptations during the COVID-19 pandemic and the inclusion of migrants. RESULTS: 46 (33.66%) SHGs participated, while 39 (84.78%) completed the questionnaire. During the COVID-19 pandemic, 50% of the SHGs reported less meetings. 22.7% changed to online meetings or other formats (43.2%). 20.9% of the SHGs had regular meetings with the cancer center, and 23.1% with the psycho-oncology. 51.2% evaluated the psycho-oncological services as neutral to dissatisfying due to lack of information, availability, and long waiting times. The SHGs indicated needs concerning interventions (coping strategies, digital applications, etc.), information, and better communication. Efforts for overcoming inequalities seemed rare: only 13.6% of the SHGs and 16.2% of the cancer centers had services for migrants. CONCLUSIONS: This study gave an overview of current activities and needs of Bavarian SHGs. The implementation of patient guides, comprehensive information material, and low-threshold psycho-oncological services should be objectives in future care to increase patient satisfaction. The needs for services for migrants should be investigated in more detail.

Working conditions and mental health of migrants and refugees in Europe considering cultural origin- a systematic review.

BACKGROUND: Migrants and refugees/asylum seekers, as a large part of the European work force, are often confronted with unfavorable working conditions in the host country. Main aim of this systematic review was to compare the association of these working conditions with mental health between migrants and refugees/asylum seekers due to their diverse migration experiences and cultural origins, and between different European host countries. METHODS: Systematic search for eligible primary studies was conducted in three electronic databases (PubMed/MEDLINE, PsycINFO and CINAHL) using quantitative study designs written in English, German, French, Italian, Polish, Spanish or Turkish and published from January 1, 2016 to October 27, 2022. Primary health outcomes were diagnosed psychiatric and psychological disorders, suicide and suicide attempts, psychiatric and psychological symptoms, and perceived distress. Secondary health outcomes were more general concepts of mental health such as well-being, life satisfaction and quality of life. Two reviewers independently completed screening, data extraction and the methodological quality assessment of primary studies using the Newcastle-Ottawa-Scale. Descriptive summary of primary studies on working conditions and their relationship with mental health were conducted, comparing migrants and refugees/asylum seekers, migrants and refugees/asylum seekers of different cultural backgrounds (collectivistic and individualistic) and migrants and refugees/asylum seekers living in different host countries. RESULTS: Inclusion criteria were met by 19 primary studies. Voluntary migrants are more likely to experience overqualification in the host country than refugees. In all examined host countries, migrants and refugees suffer from unfavorable working conditions, with migrants from collectivistic countries being slightly at risk compared to migrants from individualistic countries. Most unfavorable working conditions are related to poor mental health, regardless of migrant status, cultural origin or host country. CONCLUSIONS: Although the results should be interpreted with caution due to the small number of studies, it is evident that to maintain both the mental health and labor force of migrants and refugees/asylum seekers, their working conditions in host countries should be controlled and improved. Special attention should be paid to specific subgroups such as migrants from collectivistic societies. ETHICS AND DISSEMINATION: This systematic review is excluded from ethical approval because it used previously approved published data from primary studies. TRIAL REGISTRATION NUMBER: CRD42021244840.

Development and validation of a questionnaire for measuring team cohesion: the Erlangen Team Cohesion at Work Scale (ETC).

BACKGROUND: Team cohesion is a crucial factor when it comes to job satisfaction and turnovers. However, in Germany, economic measures for team cohesion are scarce. The aim of this study was to develop and validate an economic self-report questionnaire for measuring team cohesion in a work setting in health care. METHODS: The questionnaire was developed in a stepwise procedure. After item analysis, exploratory factor analysis was conducted to assess factor structure. Reliability was tested via internal consistency. To assess convergent and divergent validity, we applied the Copenhagen Psychosocial Questionnaire (COPSOQ), the Perceived Cohesion Scale (PCS), the ENRICHD Social Support Inventory (ESSI), the Effort-Reward Imbalance Scale (ERI) and the Patient Health Questionnaire (PHQ-4), respectively. RESULTS: The pilot version was tested in a sample of n = 126 adult nurses. Item analysis resulted in a total of 13 items for the final version. Exploratory factor analysis indicated a two-factor structure. Internal consistency for the two subscales was good, with α = 0.88 and α = 0.84, respectively. Convergent validity with the subscales of COPSOQ and PCS was moderate to high (r =.26- r =.64). For divergent validity, correlations with the ESSI were low (r =.01- r = -.09). We further found significant correlations with depression symptoms (r=-.22- r=-.37), as well as reward (ERI) (r =.41 -r =.47) and effort (ERI) (r=-.20 - r = -.24). CONCLUSIONS: We developed and validated the Erlangen Team Cohesion at Work Scale (ETC), a self-report measure for team cohesion with very good psychometric properties. Due to its economic deployment, it is suitable for measuring team cohesion in work settings, especially in health care.

Cognitive impairments and mental health of patients with post-COVID-19: A cross-sectional study.

BACKGROUND: Persistent cognitive complaints belong to the most frequent symptoms after COVID-19. This study explored the neuropsychological profile, mental health and risk factors for cognitive impairment in post-COVID-19 patients. METHODS: The patients were recruited consecutively in the Post COVID Center of the University Hospital of Erlangen between 12/2022 and 05/2023. They underwent an extensive neuropsychological assessment including the Verbal Learning Memory Test (VLMT), the digit span backwards from the Wechsler Memory Scale-Revised (WMS-R), the Trail Making Test (TMT) Part A and B, the d2 Test of Attention and the Regensburger Verbal Fluency Test (RWT). For each cognitive domain we calculated the frequency of age-adjusted scores below the measure-specific norms. Depressive symptoms were measured with the Patient-Health-Questionnaire-9 (PHQ-9). Logistic regression analyses were computed. RESULTS: In 110 patients (mean age: 42.5 ± 11.9 years; 68.2% women), the most frequent cognitive deficits were observed for verbal fluency, working speed, delayed recall and attention. In almost every cognitive domain high education levels were associated with a decreased risk for cognitive impairment. Higher age was a risk factor for working speed and delayed recall and a protective factor for verbal fluency. Clinically relevant depressive symptoms were associated with an elevated risk for an impairment regarding some cognitive functions. CONCLUSION: Cognitive dysfunctions were common among the post-COVID-19 patients. Differentiated exploration of cognitive impairments is crucial for a proper characterization of the post-COVID syndrome. In future research parameters of cognitive impairment should be correlated to alterations in biological markers of the disease like markers of immunological and microcirculation change.

Relationship between working conditions and mental health of migrants and refugees/asylum seekers vs. natives in Europe: a systematic review.

OBJECTIVE: Migrants and refugees/asylum seekers make up a significant proportion of the European workforce. They often suffer from poor working conditions, which might impact mental health. The main objective of this systematic review was to summarize and analyze existing research on working conditions of migrants and refugees/asylum seekers in European host countries and compare them to those of natives. Furthermore, the relationship between working conditions and mental health of migrants/refugees/asylum seekers and natives will be compared. METHODS: Three electronic databases (PubMed/MEDLINE, PsycInfo and CINAHL) were systematically searched for eligible articles using quantitative study designs written in English, German, French, Italian, Polish, Spanish or Turkish and published from January 1, 2016 to October 27, 2022. Primary health outcomes were diagnosed psychiatric and psychological disorders, suicide (attempts), psychiatric and psychological symptoms, and perceived distress. Secondary health outcomes were more general concepts of mental health such as well-being, life satisfaction and quality of life. Screening, data extraction and the methodological quality assessment of primary studies by using the Newcastle-Ottawa Scale were done independently by two reviewers. The results of the primary studies were summarized descriptively. Migrants and refugees/asylum seekers were compared with natives in terms of the association between working conditions and mental health. RESULTS: Migrants and refugees often face disadvantages at work concerning organizational (low-skilled work, overqualification, fixed-term contracts, shift work, lower reward levels) and social conditions (discrimination experiences) in contrast to natives. Most unfavorable working conditions are associated with worse mental health for migrants as well as for natives. CONCLUSIONS: Even if the results are to be taken with caution, it is necessary to control and improve the working conditions of migrants and refugees/asylum seekers and adapt them to those of the native population to maintain their mental health and thus their labor force.

Quality of Life and Sense of Coherence in Cancer Patients of German, Turkish and Polish Origin-A Cross-Sectional Study.

BACKGROUND: Due to a variety of symptoms and side-effects of cancer treatment, quality of life can be considerably impaired in cancer patients. Especially, cancer patients with a migration background seem to be at risk. The objective of our study is to investigate the quality of life and sense of coherence in adult cancer patients of German, Turkish and Polish origin. METHODS: We assessed sociodemographic, migration-specific and cancer-related parameters. Quality of life was measured via the EORTC QLQ-C30, sense of coherence was measured with the SOC-13. RESULTS: We included 227 patients in the study (59.5% native Germans, 40.5% with migration background). Native Germans did not differ in quality of life compared to all migrants. However, more nausea and vomiting (NV) and higher appetite loss (AP) was found in Turkish migrants compared to Polish migrants and native Germans. For sense of coherence, we observed significantly higher scores for native Germans compared to all migrants. Turkish migrants had significantly lower scores compared to native Germans. CONCLUSIONS: A Turkish migration background seems to play an important role in the perception of symptoms, especially of nausea and vomiting and appetite loss. Culture-specific aspects should be considered in cancer care.

Acute stress responses of autonomous nervous system, HPA axis, and inflammatory system in posttraumatic stress disorder.

Posttraumatic stress disorder (PTSD) does not only have direct consequences for well-being, but it also comes with a significant risk for severe somatic health consequences. A number of previous studies have pointed to alterations in stress systems in traumatized persons, as well as the inflammatory system, which might be important links in the pathway between trauma, PTSD, and health consequences. The aim of this study was to investigate acute stress responses in PTSD patients compared with healthy controls. Twenty-seven PTSD patients and 15 controls were exposed to the Trier Social Stress Test (TSST), and we measured salivary cortisol, salivary alpha-amylase (sAA), plasma interleukin-6 (IL-6), as well as heart rate and heart rate variability (HRV) at different time points before, during and after the stress test. Results revealed similar stress responses between patients and controls, but lower baseline cortisol levels and higher IL-6 baseline levels in PTSD patients. Increases in sAA stress responses were significantly lower in patients, while sAA concentrations were higher in the PTSD group during intervention. HRV was markedly decreased in patients and showed a significantly blunted acute stress response with a slower recovery after TSST. These results confirm previous findings of marked stress system dysregulations in PTSD and add to the literature on acute stress reactivity in PTSD which appears to show stress system-specific changes. Overall, these results have implications for our understanding of potential risk and resilience factors in the response to trauma.

Return to work after cancer: Improved mental health in working cancer survivors.

OBJECTIVE: Aim of the study was to compare working and non-working patients over a period of 12 months regarding socio-demographic, cancer-specific and mental health parameters. METHODS: This study was conducted as part of a Germany-wide longitudinal survey among 1398 patients in 13 national Comprehensive Cancer Centers. The sample used for analysis consisted of n = 430 cancer patients younger than 65 years (age M = 52.4 years, SD = 8.1; 67.0% females). Socio-demographic, cancer-specific and mental health parameters (Depression: Patient Health Questionnaire, Anxiety: Generalized Anxiety Disorder Scale, Distress: Distress Thermometer) were assessed at baseline during hospitalization and at 12 months follow-up. RESULTS: 73.7% of all patients (n = 317) have returned to work after one year. While working and non-working patients did not differ in socio-demographic parameters, there were significant differences in the presence of metastases, tumor and treatment status. Mixed analysis of variances revealed significant interactions between working status and time for depression (p = 0.009), anxiety (p = 0.003) and distress (p = 0.007). Non-working patients reported higher levels of depression, anxiety and distress than working patients over time. A logistic regression showed significant associations between lower depression (p = 0.019), lower distress (p = 0.033) and the absence of a tumor (p = 0.015) with working status. CONCLUSIONS: The majority of cancer survivors returned to work. Non-working patients had higher levels of depression, anxiety and distress than working patients. After controlling for cancer-specific factors, mental health parameters were still independently associated with working status. Return to work can thus be associated with an improved mental health in cancer survivors. In order to establish causality, further research is necessary.

[Vaccination willingness against COVID-19 among healthcare workers in Germany : Results from a University Medicine Network survey between November 2020 and January 2021]. / Bereitschaft zur COVID-19-Impfung unter Beschäftigten im Gesundheitswesen in Deutschland : Befragungsergebnisse aus dem Netzwerk Universitätsmedizin (NUM), November 2020 bis Januar 2021.

BACKGROUND: The COVID-19 pandemic is a continuing burden on society and the health system. The vaccination willingness among healthcare workers is of particular interest, as these groups play a key role in the pandemic response. OBJECTIVES: The present study investigated how the willingness of healthcare workers in Germany to get vaccinated depends on sociodemographic, occupational, and COVID-19-specific characteristics, as well as mental health. METHODS: Between November 2020 and January 2021, 6217 employees in the German healthcare system were questioned about their vaccination willingness, sociodemographic, occupational, COVID-19-specific, and psychosocial characteristics using the online VOICE survey within the framework of the University Medicine Network (NUM). RESULTS: The vaccination willingness of the sample group was 65.3%. A higher vaccination willingness was associated with male gender; age > 40 years; having no children or no migration background; not working in direct patient care; belonging to a COVID-19 risk group or professional group of physicians and psychologists in comparison with nursing staff; feeling sufficiently informed about COVID-19 and protected by the measures of the national or local authorities and the employer; fear of infection; and lack of signs of depression. Physicians showed the highest willingness to get vaccinated. CONCLUSIONS: During the study period, an overall moderate vaccination willingness against COVID-19 in the health sector was described. Information about the disease and vaccination, especially for younger people, females, and non-physicians, adequate protective measures and prevention of depressive symptoms could increase the vaccination willingness.

The influence of patient-related factors on the frequency and duration of psycho-oncological sessions in a university cancer center.

OBJECTIVE: The present study aimed at identifying factors that are associated with the frequency and duration of psycho-oncological sessions. DESIGN: In a retrospective single-center study, data of all patients who made use of the psycho-oncological service (POS) at the University Hospital Erlangen from April 2017 - March 2018 were registered. SAMPLE: Over the course of one year, N = 1601 patients made use of the POS. METHODS: In the hospital's digital documentation system, relevant data such as frequency of sessions, duration of sessions, gender, age, family status, preexisting mental disorder, prior psychotherapy, cancer entity (type of cancer) and treatment modality were recorded. Socio-demographic and clinical parameters were analyzed to predict frequency and duration of the psycho-oncology sessions. FINDINGS: Regression analyses revealed that among POS users, women, younger patients, patients with a longer hospital stay and those with a preexisting mental disorder attended significantly more sessions than other patients (p < .001). Patients with skin cancer had significantly fewer POS sessions than those with a hematological diagnosis. Also, patients who had undergone surgery had significantly fewer sessions than patients with pharmacological treatment. Younger age and a longer hospital stay significantly predicted longer sessions (p < .001). In the regression model, patients with brain tumors and lung cancer had significantly longer sessions than patients with skin cancer. IMPLICATIONS: With the identification of specific risk groups that require more and longer sessions, we can provide the basis for more patient-tailored intervention approaches and better scheduling according to the patients' needs. However, our results also suggest that the frequency and duration of POS sessions also depend on illness- and treatment-related criteria, e.g. the length of the hospital stay.

A Taxonomy for Psycho-Oncological Intervention Techniques in an Acute Care Hospital in Germany.

BACKGROUND: Due to the establishment of a nationwide certification system for cancer centers in Germany, the availability of psycho-oncological services for cancer patients has increased substantially. However, little is known about the specific intervention techniques that are applied during sessions in an acute care hospital, since a standardized taxonomy is lacking. With this study, we aimed at the investigation of psycho-oncological intervention techniques and the development of a comprehensive and structured taxonomy thereof. METHODS: In a stepwise procedure, a team of psycho-oncologists generated a data pool of interventions and definitions that were tested in clinical practice during a pilot phase. After an adaptation of intervention techniques, interrater reliability (IRR) was attained by rating 10 previously recorded psycho-oncological sessions. A classification of interventions into superordinate categories was performed, supported by cluster analysis. RESULTS: Between April and June 2017, 980 psycho-oncological sessions took place. The experts agreed on a total number of 22 intervention techniques. An IRR of 89% for 2 independent psycho-oncological raters was reached. The 22 techniques were classified into 5 superordinate categories. DISCUSSION/CONCLUSION: We developed a comprehensive and structured taxonomy of psycho-oncological intervention techniques in an acute care hospital that provides a standardized basis for systematic research and applied care. We expect our work to be continuously subjected to further development: future research should evaluate and expand our taxonomy to other contexts and care settings.

Interleukin-6 secretion upon acute psychosocial stress as a potential predictor of psychotherapy outcome in posttraumatic stress disorder.

Posttraumatic stress disorder (PTSD) is a severe mental disorder that can develop after a traumatic event. PTSD has been reported to be associated with activation of the innate immune system, as measured by increased levels of pro-inflammatory cytokines. While it is well known that PTSD patients display increased levels of interleukin 6 (IL-6) when compared with healthy controls, the relationship between cytokine secretion and treatment outcome has been hardly investigated yet. The aim of this study was to assess the potential association of inflammatory activation and therapy outcome in PTSD. Before therapeutic intervention, we applied the Trier Social Stress Test (TSST) as a method to elicit psychosocial stress and an acute inflammatory response. IL-6 levels were measured in blood plasma of PTSD patients at different time points before and after the TSST. Severity of depressive, trauma-related, and somatic symptoms was assessed before and 8 weeks after trauma-focused treatment in a multimodal day clinic setting. We showed that high reactivity of IL-6 to psychosocial stress at the beginning of the therapy was associated with a negative therapy outcome in PTSD, especially regarding depressive symptoms. This study suggests plasma IL-6 reactivity as a potential molecular marker to predict treatment outcome in PTSD.

Social Support and Optimism as Protective Factors for Mental Health among 7765 Healthcare Workers in Germany during the COVID-19 Pandemic: Results of the VOICE Study.

BACKGROUND: The COVID-19 pandemic is impacting mental health worldwide, particularly among healthcare workers (HCWs). Risk and protective factors for depression and generalized anxiety in healthcare workers need to be identified to protect their health and ability to work. Social support and optimism are known protective psychosocial resources, but have not been adequately studied in the context of the COVID-19 pandemic among healthcare workers in Germany. METHODS: Within the first wave of the VOICE study (n = 7765), a longitudinal web-based survey study among healthcare workers in Germany, we assessed symptoms of depression (PHQ-2) and generalized anxiety (GAD-2), social support (ENRICHD Social Support Inventory; ESSI), and generalized optimism as well as sociodemographic, occupational, and COVID-19 related variables. Multiple linear regression analyses were conducted to examine associations between the constructs. RESULTS: The analyses revealed that higher levels of social support and optimism were associated with lower levels of depression and generalized anxiety. They showed a higher association with depression and generalized anxiety than demographic or occupational risk factors such as female gender and direct contact with infected individuals. CONCLUSION: Psychosocial resources such as social support and optimism appear to contribute to successful coping with the COVID-19 pandemic and should be considered in future studies.

Prospective single-centre clinical observational study on electronically monitored medication non-adherence, its psychosocial risk factors and lifestyle behaviours after heart transplantation: a study protocol.

INTRODUCTION: In heart transplant recipients (HTRs), non-adherence (NA) to immunosuppressive (IS) medication and to recommended lifestyle behaviours are a common phenomenon and associated with higher risk of allograft rejection, organ loss and mortality. Risk factors for NA are highly diverse and still insufficiently researched. Precise measures of NA and an accurate understanding of its aetiology are of undisputable importance to detect patients at risk and intervene accordingly. The aim of this study is to assess the accuracy and concordance of different measures for NA as well as to determine potential risk factors. METHODS AND ANALYSIS: This is a single-centre prospective observational trial. HTRs who are at least aged 18 are no less than 6 months post-transplant and receive tacrolimus (Prograf or Advagraf), cyclosporine (Sandimmun) or everolimus (Certican) as their prescribed IS medication are eligible for participation. We only include patients during the phase of medication implementation. At study enrolment, we assess depression, health-related quality of life, self-efficacy, social support, attachment, experiences and attitudes towards IS medication, emotional responses after transplantation, satisfaction with information about IS medication and perceptions and beliefs about medications. We further ask patients to rate their lifestyle behaviours concerning alcohol, smoking, diet, physical activity, sun protection and appointment keeping via questionnaires. Three different measurement methods for NA are applied at T0: self-reports, physician's estimates and IS trough levels. NA is monitored prospectively using an electronic multicompartment pillbox (MEMS, VAICA) over a 3-month period. Meanwhile, participants receive phone calls every second week to obtain additional self-reports, resulting in a total of seven measurement points. ETHICS AND DISSEMINATION: The study was approved by the Clinical Ethics Committee of the University Hospital Erlangen (Friedrich-Alexander-University, Erlangen-Nürnberg). Written informed consent is attained from all participants. The results of this study will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: DRKS00020496.

Optimization of Electronically Monitored Non-Adherence in Highly Adherent Renal Transplant Recipients by Reducing the Dosing Frequency - A Prospective Single-Center Observational Study.

BACKGROUND: Non-adherence (NA) after renal transplantation poses a major risk for allograft rejection, graft loss, and patient mortality. Yet, there is still ambiguity about its etiology and its possible relationships with patient-related factors. In order to prevent poor outcomes after transplantation, it is crucial to gain a more refined understanding of potential determinants, to identify patients at risk, and to intervene accordingly. The objective of this study was to assess potential risk factors of NA by prospectively applying electronic monitoring. MATERIALS AND METHODS: This was a single-center prospective observational study. Prior to study initiation, sociodemographic, biomedical, and psychosocial variables (depression, health-related quality of life, self-efficacy, social support, attachment, experiences and attitudes towards immunosuppressive medication, emotional responses after organ transplantation, satisfaction with information about immunosuppressive medication, and perceptions and beliefs about medications) were assessed. Thereafter, immunosuppressive adherence behavior was measured prospectively via electronic monitoring (EM, VAICA©) during a 3-month period to receive the percentage frequency of Taking and Timing Adherence (±2h, ±30min) for each patient. Focus of this study was the phase of medication implementation. RESULTS: A total of 78 patients participated in our study (mean age 55.28, 56% male). We found rates of 99.39% for Taking Adherence, 98.34% for Timing Adherence ±2h, and 93.34% for Timing Adherence ±30min, respectively.  Multiple regression analyses revealed that the type of medication could significantly predict Taking Adherence. Patients receiving Advagraf© (once daily) depicted better Taking Adherence than patients receiving Prograf© (twice daily) (p=0.04). No associations were found for Timing Adherence (±2h, ±30min). Sociodemographic, biomedical, or psychosocial variables were not found to be associated with adherence behavior. DISCUSSION: In highly adherent populations, only a few factors can be altered to improve adherence. Changing the immunosuppressive regimen from twice-daily to once-daily could be an option for optimizing adherence. However, risk factors for NA could be different in a less adherent population.

Accuracy and concordance of measurement methods to assess non-adherence after renal transplantation - a prospective study.

BACKGROUND: Non-adherence (NA) to immunosuppressants (IS) among renal transplant recipients (RTRs) is associated with higher risk of allograft rejection, graft loss, and mortality. A precise measurement of NA is indispensable, although its prevalence differs greatly depending on the respective measurement methods. The objective of this study was to assess the accuracy and concordance of different measurement methods of NA in patients after renal transplantation. DESIGN AND METHODS: This was a single-center prospective observational study. At baseline (T0), NA was measured via physicians' estimates (PE), self-reports (SR), and tacrolimus trough level variability (CV%) in 78 RTRs. A Visual Analogue Scale (VAS, 0-100%) was applied both for SR and PE. In addition, we used BAASIS© for SR and a 5-point Likert scale for PE. NA was measured prospectively via electronic monitoring (EM, VAICA©) during a three month period. Meanwhile, all participants received phone calls in a two week interval (T1-T6) during which SRs were given. RESULTS: Seventy-eight RTRs participated in our study. At t0, NA rates of 6.4%, 28.6%, and 15.4% were found for PE, SR, and CV%, respectively. No correlation was found between these methods. During the study, the percentages of self-reported and electronically monitored adherence remained high, with a minimum mean of 91.2% for the strictest adherence measure (Timing Adherence ±30 min). Our results revealed a moderate to high association between SR and EM. In contrast to PE and CV%, SR significantly predicted electronically monitored adherence. Overall, a decreasing effect of electronically monitored adherence was found for both taking and timing adherence (±2 h, ±30 min) over the course of the study. DISCUSSION: The moderate to high concordance of SR and EM suggests that both methods measure NA equally accurately. SR seems to be a method that can adequately depict electronically monitored NA and may represent a good and economical instrument to assess NA in clinical practice. The increased adherence at the beginning of the study and its subsequent decrease suggests an intervention effect. Surveillance of IS intake via EM with intermittent phone calls could improve adherence on a short-term basis. To establish long-term effects, further research is necessary.

Psychosocial impact of prognostic genetic testing in uveal melanoma patients: a controlled prospective clinical observational study.

BACKGROUND: The risk of metastases in uveal melanoma can accurately be estimated through genetic analysis of the tumor. A growing number of patients decide to receive information on their prognosis, although this can be extremely burdensome. Studies on the psychosocial impact of testing are sparse. The objective of this study was to examine traits of patients opting for prognostication, to investigate its psychosocial impact and the use of psycho-oncological services over time. We further examined characteristics of patients utilizing these services and risk factors of prolonged psychological distress. DESIGN AND METHODS: This study is a non-randomized controlled prospective clinical observational trial. Patients availing for prognostication formed the test group, while those who opted out constituted the observational group. The psychosocial impact of genetic testing was assessed with the following variables: resilience, social support, fear of tumor progression, depression, general distress, health-related quality of life, estimation of the perceived risk, and the utilization of psycho-oncological interventions. Data were assessed at five different time points over a period of 12 months. We applied binary logistic regression analysis, multiple linear regressions and a mixed model. RESULTS: Of 175 patients, 63 decided to obtain prognostic information. Treatment method (enucleation > brachytherapy), lower social support and higher general distress could significantly predict patient's choice for prognostic testing. After result announcement, perceived risk of metastases was significantly increased in patients with poor prognosis, while it decreased in those with good prognosis. Overall, a significant decrease over time appeared concerning fear of progression, general distress, depression and anxiety. Mental quality of life increased over time. The utilization of psycho-oncological interventions increased significantly after prognostication; however, this was equivalent in the test and observational groups. Female sex, higher general distress and higher anxiety predicted greater use of psycho-oncological interventions. DISCUSSION: Availing of prognostic testing is not associated with poorer subsequent psychological well-being. It rather may help to alleviate distress and promote a more realistic risk perception. However, psychological support should be available to all patients, independent of prognosis and treatment, especially considering that patients with low social support and high distress increasingly opt for prognostication.