Psychological burden in patients with angina and unobstructed coronary arteries-underestimated, underexplored, undertreated.

Patients with angina and unobstructed coronary arteries (ANOCA) are frequently encountered in clinical practice. These cases represent a diagnostic and therapeutic challenge and are often characterized by a long patient journey until a diagnosis of coronary vasomotor disorders is established. Moreover, the unsatisfactory management of such patients leads to insecurity, ongoing symptoms, and psychological sequelae such as anxiety or depression. Currently, the psychological burden in patients with ANOCA is underestimated, underexplored, and undertreated. This review gives a new perspective on the pathophysiology of coronary vasomotor disorders including psychological risk factors and calls for comprehensive care by interdisciplinary ANOCA clinics.

Participative development and evaluation of a communication skills-training program for oncologists-patient perspectives on training content and teaching methods.

BACKGROUND: Using the 6-step approach to curriculum development for medical education, we developed a communication skills training (CST) curriculum for oncology and evaluated this curriculum from the perspective of cancer patients. METHODS: We conducted a qualitative interview study with cancer patients, collecting data using semi-structured face-to-face or telephone interviews with a short standardized survey. We fully transcribed the audiotaped interviews and conducted the content analysis using MAXQDA 2020. We analyzed the quantitative sociodemographic data descriptively. RESULTS: A total of 22 cancer patients participated, having a mean age of 60.6 (SD, 13.2) years and being predominantly female (55%). The patients believed that the CST curriculum addressed important aspects of patient-centered communication in cancer care. They emphasized the importance of physicians acquiring communication skills to establish a trusting relationship between doctor and patient, show empathy, inform patients, and involve them in treatment decisions. The patients had some doubts concerning the usefulness of strict protocols or checklists (e.g., they feared that protocol adherence might disturb the conversation flow). DISCUSSION: Although it was a challenge for some participants to take the perspective of a trainer and comment on the CST content and teaching methods, the patients provided a valuable perspective that can help overcome blind spots in CST concepts.

Com-On Questionnaire: Development and validation of a questionnaire for evaluating communication skills of oncologists.

OBJECTIVE: The present study aimed to develop and validate an instrument for assessing the communication skills of oncology physicians from a patient's point of view. METHODS: A first draft of the questionnaire was compiled based on skills reflecting good physician-patient communication identified in the literature. The questionnaire was critically revised by experts to ensure the validity of its contents. The revised questionnaire was completed by a sample of 153 cancer patients. The questionnaire was developed in German and later translated into English. RESULTS: After analysis using classical test theory and an exploratory factor analysis, four different factors could be extracted. These factors were labelled setting, patient-centeredness, empathy and consulting competencies. Unsuitable items were eliminated within the analysis. All remaining items hold an appropriate degree of selectivity, item difficulty and reliability/consistency. CONCLUSION: A novel questionnaire for evaluating communication skills of physicians was developed. It contains 36 items and is named 'Com-On Questionnaire: Questionnaire for the Evaluation of Physician's Communication Skills in Oncology'. PRACTICE IMPLICATIONS: The questionnaire is suitable for measuring both the strengths and deficits within the physician-patient communication in oncology from the patients' perspective.

Psychological factors and the uptake of preventative measures in BRCA1/2 pathogenic variant carriers: results of a prospective cohort study.

BACKGROUND: Women carrying BRCA1/2 pathogenic variants are exposed to elevated risks of developing breast cancer (BC) and are faced by a complex decision-making process on preventative measures, i.e., risk-reducing mastectomy (RRM), and intensified breast surveillance (IBS). In this prospective cohort study we investigated the effect of anxiety, personality factors and coping styles on the decision-making process on risk management options in women with pathogenic variants in BRCA1/2. METHODS: Breast cancer unaffected and affected women with a pathogenic variant in the BRCA1 or BRCA2 gene were psychologically evaluated immediately before (T0), 6 to 8 weeks (T1) and 6 to 8 months (T2) after the disclosure of their genetic test results. Uptake of RRM and IBS was assessed at T2. Psychological data were gathered using questionnaires on risk perception, personality factors, coping styles, decisional conflict, depression and anxiety, including the Hospital Anxiety and Depression Scale (HADS). We performed tests on statistical significance and fitted a logistic regression based on significance level. RESULTS: A total of 98 women were included in the analysis. Baseline anxiety levels in women opting for RRM were high but decreased over time, while they increased in women opting for intensified breast surveillance (IBS). Elevated levels of anxiety after genetic test result disclosure (T1) were associated with the decision to undergo RRM (p < 0.01; OR = 1.2, 95% CI = 1.05-1.42), while personal BC history and personality factors seemed to be less relevant. CONCLUSIONS: Considering psychosocial factors influencing the decision-making process of women with pathogenic variants in BRCA1/2 may help improving their genetic and psychological counselling. When opting for IBS they may profit from additional medical and psychological counselling. TRIAL REGISTRATION: Retrospectively registered at the German Clinical Trials Register under DRKS00027566 on January 13, 2022.

Nurse-led decision coaching by specialized nurses for healthy BRCA1/2 gene mutation carriers - adaptation and pilot testing of a curriculum for nurses: a qualitative study.

BACKGROUND: Women with BRCA1/2 mutations are at high risk to develop breast and ovarian cancer. To support these women to participate in shared decision-making, structured nurse-led decision coaching combined with an evidence-based decision aid may be employed. In preparation of the interprofessional randomized controlled trial to evaluate a decision coaching program to support preventive decisions of healthy female BRCA 1/2 gene mutation carriers (EDCP-BRCA), we adapted and piloted an existing training program for specialized nurses and included elements from an existing physician communication training. METHODS: The training was adapted according to the six-step-approach for medical curriculum development. The educational design is based on experience- and problem-based learning. Subsequently, we conducted a qualitative pilot study. Nurses were recruited from six German centers for familial breast and ovarian cancer. The acceptability and feasibility were assessed by structured class observations, field notes and participants' feedback. Data were analyzed using qualitative content analysis. The training was revised according to the results. Due to the COVID-19 pandemic, the patient intervention was adapted as a virtual coaching and a brief additional training for nurses was added. RESULTS: The training consists of two modules (2 + 1 day) that teach competences in evidence-based medicine and patient information, (risk) communication and decision coaching. One pilot test was conducted with six nurses of which three were specialized and experienced in patient counselling. A final set of eight main categories was derived from the data: framework conditions; interaction; schedule, transparency of goals, content, methods, materials and practical relevance and feasibility. Overall, the training was feasible and comprehensible. Decision coaching materials were awkward to handle and decision coaching role plays were set too short. Therefore, materials will be sent out in advance and the training was extended. CONCLUSIONS: Specialized nurses are rarely available and nurse-led counselling is not routinely implemented in the centers of familial breast and ovarian cancer. However, training of less qualified nurses seems feasible. Decision coaching in a virtual format seems to be a promising approach. Further research is needed to evaluate its feasibility, acceptability and effectiveness. TRIAL REGISTRATION: The main trial is registered under DRKS-ID: DRKS00015527 .

Prediction of survival on the waiting list for heart transplantation and of posttransplant nonadherence-Results of a prospective longitudinal study.

BACKGROUND: Only a few previous studies have focused on the interaction between pretransplant psychological variables, survival on the waiting list, and adherence to therapy after heart transplantation (HTx). METHODS: This work combined two studies: Study 1 monitored survival of patients on a HTx waiting list (n = 50) and study 2 examined barriers to adherence after HTx (subgroup of n = 20). All patients were evaluated immediately after listing for HTx (T0). Those in study 2 were also evaluated immediately after HTx (T1) and after 6 months (T2). Psychosocial functioning was measured by the Transplant Evaluation Rating Scale (TERS), and depression and anxiety by Patient Health Questionnaire and Hospital Anxiety and Depression Scale. Barriers to immunosuppressive adherence post-HTx were measured by the Medication Experience Scale for Immunosuppressants (MESI). RESULTS: According to the TERS classification of Rothenhäusler et al, patients were divided into three groups in study 1. Compared with inconspicuous patients (n = 23) and risk patients (n = 21), high-risk patients (n = 6) demonstrated a higher mortality (log-rank test of trend, P = 0.002). In study 2, there was a strong correlation between the TERS (T0) and the MESI (T2) (r = 0.84, P = 0.001). CONCLUSIONS: The TERS may serve as a predictor of survival on the waiting list. There is need for further longitudinal data with larger sample sizes.

Somatic and sociodemographic predictors of depression outcome among depressed patients with coronary artery disease - a secondary analysis of the SPIRR-CAD study.

BACKGROUND: Depressive symptoms are common in patients with coronary artery disease (CAD) and are associated with an unfavourable outcome. Establishing prognostic patient profiles prior to the beginning of mental health care may facilitate higher efficacy of targeted interventions. The aim of the current study was to identify sociodemographic and somatic predictors of depression outcome among depressed patients with CAD. METHODS: Based on the dataset of the multicentre SPIRR-CAD randomised controlled trial (n = 570 patients with CAD and ≥ 8 points on the Hospital Anxiety and Depression Scale (HADS)), 141 potential sociodemographic and somatic predictors of the change in the HADS-D depression score from baseline to 18-month-follow-up were derived in two different ways. We screened for univariable association with response, using either analysis of (co)variance or logistic regression, respectively, both adjusted for baseline HADS-D value and treatment group. To guard against overfitting, multivariable association was evaluated by a linear or binomial (generalised) linear model with lasso regularisation, a machine learning approach. Outcome measures were the change in continuous HADS-D depression scores, as well as three established binary criteria. The Charlson Comorbidity Index (CCI) was calculated to assess possible influences of comorbidities on our results and was also entered in our machine learning approach. RESULTS: Higher age (p = 0.002), unknown previous myocardial infarction (p = 0.013), and a higher heart rate variability during numeracy tests (p = .020) were univariably associated with a favourable depression outcome, whereas hyperuricemia (p ≤ 0.003), higher triglycerides (p = 0.014), NYHA class III (p ≤ 0.028), state after resuscitation (p ≤ 0.042), intake of thyroid hormones (p = 0.007), antidiabetic drugs (p = 0.015), analgesic drugs (p = 0.027), beta blockers (p = 0.035), uric acid drugs (p ≤ 0.039), and anticholinergic drugs (p = 0.045) were associated with an adverse effect on the HADS-D depression score. In all analyses, no significant differences between study arms could be found and physical comorbidities also had no significant influence on our results. CONCLUSION: Our findings may contribute to identification of somatic and sociodemographic predictors of depression outcome in patients with CAD. The unexpected effects of specific medication require further clarification and further research is needed to establish a causal association between depression outcome and our predictors. TRIAL REGISTRATION: www.clinicaltrials.gov NCT00705965 (registered 27th of June, 2008). www.isrctn.com ISRCTN76240576 (registered 27th of March, 2008).

[Comorbid Mental Disorders in Gastroenterology and Hepatology: Prevalence and Psychosocial Needs in Tertiary Care]. / Psychische Komorbidität in der Gastroenterologie und Hepatologie: Prävalenz und psychosozialer Versorgungsbedarf in der Tertiärversorgung.

BACKGROUND: In the field of gastroenterology and hepatology, associations and interactions with comorbid mental disorders are often described, but there is currently a lack of methodologically high-quality studies on prevalence and the need for care. The aim of the study was to take account of this shortcoming. METHODS: Prospective, monocentric, cross-sectional study of a representative sample of inpatients at a university hospital. A total of 308 participants were examined for the presence of 8 frequent psychological syndromes with a validated questionnaire (PHQ-D). In addition, 63 participants were examined for the presence of mental disorders according to ICD-10 with a diagnostic interview (SKID-I) that covers a wider range of diagnoses. The need for psychosocial care was raised from the perspective of internal medicine practitioners and psychosomatic experts. RESULTS: The prevalence for at least 1 mental syndrome in the questionnaire sample (PHQ-D excl. PHQ-15) was 39.6%, in 23.8% of whom more than one syndrome was present. The most frequent were depressive and anxiety syndromes. There were significant differences in the various subgroups (sex, type and severity of the somatic disease). The 4-week prevalence for any mental disorder in the interview sample (SKID-I) was 52.4%. Affective and somatoform disorders as well as adaptation disorders were dominant. The need for psychosocial care was reported in 23.1% by the practitioners and in 30.2% by the experts. CONCLUSIONS: Patients with gastroenterological-hepatological tertiary care have a high prevalence of treatment-related psychological syndromes or disorders. In comparison with the reference data of the Robert Koch Institute on the 12-month prevalence of mental disorders among the general population in Germany, the proportion of current mental disorders is almost twice as high (52.7 vs. 27.1%, p<0.001). To cover the need for care, the provision of psychosomatic liaison services and the strengthening of psychosomatic basic care in gastroenterology/hepatology should be established.

Investigation of the physical and psychosocial outcomes after living kidney donation - a multicenter cohort study (SoLKiD - Safety of Living Kidney Donors).

BACKGROUND: Over the last years, living kidney donation (LKD) has been established for patients with endstage renal failure as an alternative to post mortem donation, which is limited by organ scarcity and long lasting waiting periods. From an ethical perspective, the increase in LKD requires that donors' physical, psychological, and social harm has to be minimized as much as possible and the risk should not exceed the generally expected consequences of nephrectomy. Despite of numerous, mainly retrospective studies about the postoperative outcome of LKD over the last years from different countries, it becomes apparent that there is a lack of comprehensive prospective multicenter research in this field worldwide. Therefore, the main aim of the study is to examine the physical and psychosocial outcome of living kidney donors in a prospective design before and after transplantation in an interdisciplinary approach (surgery, nephrology, psychosocial medicine). METHODS/DESIGN: The goal of the study is to investigate such aspects as the impact of gender- and age-specific factors on LKD outcome, donor outcome in correlation to the health status of the recipient, the medical and psychosocial risk of a healthy subject undergoing the LKD procedure. The study is carried out as a nationwide multicenter study. All adult living kidney donors with sufficient knowledge in the German, Russian, or Turkish language, informed consent, and place of residence in Germany are included. In a naturalistic design (cohort study), clinical data and self-report measures (questionnaires) of 320 donors are collected before and 8 weeks, 6 and 12 months after donation. Primary outcome parameters are the kidney function (estimated GFR) and the quality of life (SF-36) of the donor. Secondary outcome parameters are data about physical (e.g., wound healing, blood pressure) and psychosocial (fatigue, depression, anxiety, somatization) outcome after donation. DISCUSSION: Previous studies on the postoperative outcome of living kidney donors have methodological limitations and/or were carried out in countries with different healthcare systems, e.g. United States, Norway, Canada, United Kingdom. Thus, results cannot be generalized and are not particularly applicable to the risks of mainly caucasian living kidney donors in the German healthcare system. The study design overcomes these disadvantages in that it provides a prospective multicenter design. TRIAL REGISTRATION: German Clinical Trials Register DRKS00006552 (22 September 2014).

[Adherence to Immunosuppressive Medication Following Organ Transplantation]. / Immunsuppressiva-Adhärenz nach Transplantation.

Organ transplantation is the best and to some extent only option for many patients with chronic organ failure. Usually after successful transplantation patients experience a significant improvement of their condition. Nevertheless, they are not cured but still chronically ill. Living with an organ transplant requires consequent immunosuppression intake, regular physician visits and following the recommendations regarding infection prevention. These factors are important to secure a long transplant survival. Especially non-adherence to immunosuppressants is known as a risk factor for transplant rejection. There are several reasons for non-adherent behavior. However identifying the individual motivations is crucial for addressing them correctly. The aim of this article is to give an overview of factors influencing adherence, to introduce options to assess adherence and to present ways to improve adherence. Randomized-controlled intervention studies are presented and on that basis recommendations for clinical practice are derived.

[Psychosocial Evaluation of Transplant Patients - Recommendations for the Guidelines for Organ Transplantation]. / Psychosoziale Evaluation von Transplantationspatienten ­ Empfehlungen für die Richtlinien zur Organtransplantation.

For the last few years, the German Medical Association's guidelines for transplant medicine have been subject to an extensive revision process. The present contribution presents recommendations regarding the psychosocial evaluation of patients prior to organ transplantation, which were developed by experts from the Psychology/Psychosomatics committee of the German Transplant Society with the aim to incorporate the recommendations into the guidelines. The main objective is to establish a mandatory psychosocial evaluation for all patients prior to their admission to the transplant waiting list. Contents, potential contraindications, and the procedure of the evaluation are described. Furthermore, the qualification deemed necessary for the examiners is addressed in detail. Finally, the future need for action is determined.

Patient-reported non-adherence and immunosuppressant trough levels are associated with rejection after renal transplantation.

BACKGROUND: Different measures of non-adherence to immunosuppressant (IS) medication have been found to be associated with rejection episodes after successful transplantation. The aim of the current study was to investigate whether graft rejection after renal transplantation is associated with patient-reported IS medication non-adherence and IS trough level variables (IS trough level variability and percentage of sub-therapeutic IS trough levels). METHODS: Patient-reported non-adherence, IS trough level variability, percentage of sub-therapeutic IS trough levels, and acute biopsy-proven late allograft rejections were assessed in 267 adult renal transplant recipients who were ≥12 months post-transplantation. RESULTS: The rate of rejection was 13.5%. IS trough level variability, percentage of sub-therapeutic IS trough levels as well as patient-reported non-adherence were all significantly and positively associated with rejection, but not with each other. Logistic regression analyses revealed that only the percentage of sub-therapeutic IS trough levels and age at transplantation remained significantly associated with rejection. CONCLUSIONS: Particularly, the percentage of sub-therapeutic IS trough levels is associated with acute rejections after kidney transplantation whereas IS trough level variability and patient-reported non-adherence seem to be of subordinate importance. Patient-reported non-adherence and IS trough level variables were not correlated; thus, non-adherence should always be measured in a multi-methodological approach. Further research concerning the best combination of non-adherence measures is needed.

Up to a Third of Renal Transplant Recipients Have Deficiencies in Cognitive Functioning.

INTRODUCTION: Kidney transplantation is beneficial in improving cognitive abilities in patients with chronic kidney disease; however, there is still uncertainty concerning which cognitive domains benefit and to what extent. AIM: In the present study, cognitive functioning of renal transplant recipients was compared to normative data. Sociodemographic and clinical parameters that were associated with low cognitive performance were identified. DESIGN: A total of 109 renal transplant recipients (63% men) participated in the study, with a mean age of 51.8 (standard deviation [SD] = 14.2) years. The cognitive test battery consisted of measurements assessing memory, attention, executive function, reproductive, and deductive ability. RESULTS: In all tests, participants showed mean scores ranging within 1 SD of the population means. However, except for tests measuring memory, the percentage of participants scoring more than 1 SD below normed means was higher than expected in a normal distribution of performance. In certain tests, up to a third of the participants scored below average. Participants with continuous low performance (11%) showed higher age, poorer education, a longer time since transplantation, higher serum levels of urea and creatinine, and were more likely to have a deceased donor allograft. DISCUSSION: Altough cognitive performance in renal transplant recipients matches normative data and confirms former findings, the amount of patients scoring more than 1 SD below average suggests that there are a considerable number of patients whose cognitive performance in certain domains lies below those of the general population. The identified sociodemographic and biochemical factors might be helpful to identify renal transplant recipients at risk.

[Results of a Representative Survey on the Psychosocial Evaluation Before Living Donor Kidney Transplantation in Germany]. / Ergebnisse einer repräsentativen Befragung zur Durchführung der psychosozialen Begutachtung vor Lebendnierenspende in Deutschland.

Aim Since there is no consensus about how to perform the predonation psychosocial evaluation of living kidney donor candidates, this is conducted differently in German transplant centers. Thus, the goal of the study was to learn more about how psychosocial evaluations are currently conducted in German transplant centers. Methods The psychosocial evaluators of the 38 transplant centers performing kidney transplantations in 2015 were contacted and asked to participate in an anonymous online survey. Results Psychosocial evaluators from 28 (75%) transplant centers responded. In only 30 (4%) of the evaluations contraindications for donation were reported. In most centers the psychosocial evaluation was performed after the completion of all medical tests. The evaluations were realized after only short waiting periods and were reported to be time-consuming. Financial reimbursement was mainly realized by internal cost allocation. In most centers the evaluators used semi-structured interviews. Still, there was limited consensus about structure and content of the psychosocial evaluation. Conclusion Standardization of the psychosocial evaluation process could be helpful to enable comparisons between transplant centers and to achieve equal opportunities for the potential living kidney donors and recipients.

Altruistic nondirected kidney donation: attitudes, characteristics and ethical implications.

PURPOSE OF REVIEW: Altruistic nondirected kidney donation involves a person donating one of their kidneys to an unknown recipient. The donor's mental health and motives are frequently questioned. We want to highlight this topic and also encourage discussions about ethical implications. RECENT FINDINGS: The main topics are the mental health of altruistic nondirected kidney donors and the general attitude towards the practice of this form of donation as well as the willingness of the public to donate this way. Soliciting organ donation via social networks or financial support is debated extensively in the media. SUMMARY: There is a lack of studies on altruistic nondirected kidney donation. Most studies focus on related donors. Studies with larger samples should be performed on altruistic nondirected kidney donors to learn more about their motives and assess their mental health.

Prevalence and Modifiable Determinants of Non-Adherence in Adult Kidney Transplant Recipients in a German Sample.

OBJECTIVES: The aim of this cross-sectional study was to investigate the prevalence and the modifiable determinants of non-adherence in adult kidney transplant patients in follow-up care. METHODS: In 74 patients at least six months post-transplant, self-reported adherence (Basel Assessment of Adherence to ImmunosuppressiveMedications Scale, BAASIS©), subjective experience and attitudes after transplantation (Medication Experience Scale for Immunosuppressants, MESI), and depression and anxiety (Hospital Anxiety and Depression Scale,HADSD) were assessed. RESULTS: Non-adherence to any of the four BAASIS© items was 24.3%. For the sub-dimensions: dose taking, drug holidays, timing deviation more than two hours from prescribed time, and dose reduction, the non-adherence levelswere 9.5%, 0%,17.6% and 2.7%, respectively. Marital status, negative beliefs towards immunosuppressants, and prominent anxiety and depression were associated with non-adherence. CONCLUSIONS: Screening for adherence and its indicators is of substantial importance in communication with renal transplant recipients. After detecting non-adherence, supportive interventions can be offered to the patients.

Resilience and quality of life in 161 living kidney donors before nephrectomy and in the aftermath of donation: a naturalistic single center study.

BACKGROUND: Due to the shortage of cadaveric organs, living kidney donation has begun to serve as the most crucial organ pool. Transplant centers have a legitimate interest in expanding the pool of donors. A psychosocial evaluation is established in transplantation centers to prevent donors from possible emotional harm in the aftermath of donation. We explored if the resilience questionnaire is an appropriate measure of the mental stability. To standardize procedures of psychosocial evaluation and to optimize donor recruitment, we present our evaluation protocol and analyze the causes of exclusion from donation. METHOD: In a naturalistic design, we compared resilience and quality of life in eligible and excluded donors at the time point of donation. Potential living kidney donors (N = 161) participated in the obligatory psychosomatic evaluation. Quality of life (World Health Organization Quality of Life, WHOQOL-Bref) and resilience (Resilience Scale, RS-12) were measured. Three months after nephrectomy donors quality of life was screened in a follow-up. RESULTS: In the evaluation interview donors were classified as eligible (n = 142) or excluded (n = 12). Nonrelated donors (n = 3) were excluded from donation significantly more often (p < .011). Eligible donors (M = 78.42, SD = 10.19) had higher values for resilience than excluded donors (M = 72.7, SD = 8.18, p < .04), who showed values comparable to the norm. In all domains of quality of life, eligible donors had significantly higher values than healthy normals (p < .001). After donation health-related quality of life decreased, but was comparable to the norm. A regression analysis showed that resilience was a significant predictor for all dimensions of quality of life before donation (R(2) = 10.2-24.6 %). Post-donation quality of life was significantly correlated with pre-donation resilience scores (p < .05). CONCLUSIONS: The resilience score predicts high mental quality of life before and after donation. Therefor it can be implemented as a self-rating instrument to further objectify donor's mental stability. Despite the stressful life event of donation, donor candidates presented high resilience and high levels of quality of life. Therefor our findings support health care providers` intentions to improve living donation. In the group of excluded donors nonrelated persons were overrepresented. Guidelines for the admission of nonrelated donors are currently unclear and need to be optimized.

Adherence with immunosuppression in heart transplant recipients.

PURPOSE OF REVIEW: Nonadherence is a major problem in heart transplantation (htx) and a challenge for clinical practice and research. In heart transplant recipients, nonadherence could cause chronic rejection of the transplanted heart followed by difficult clinical course and/or death of the patient. RECENT FINDINGS: Main topics are the relationship between psychological aspects and adherence, risk factors and prediction of nonadherence, strategies for improving adherence like single-dose immunosuppressant therapy and follow-up studies. SUMMARY: There is a lack of behavioral intervention studies. So-called targeted interventions should be defined for clinical practice and research with randomized controlled studies.

Feasibility of an interval, inspiration-triggered nocturnal odorant application by a novel device: a patient-blinded, randomised crossover, pilot trial on mood and sleep quality of depressed female inpatients.

It has been suggested that certain odorants positively affect mood, but this has not yet been scientifically tested in humans. The aim of the current study was to demonstrate the feasibility of a new odorant applicator and to assess the effects of nocturnal intermittent rose odorant application on mood, and quality of sleep and dreams in depressed female inpatients. We hypothesised that mood as primary outcome will improve. Twenty-seven normosmic, 18- to 49-year-old female, depressed inpatients were investigated in a randomised, placebo-controlled, crossover study. Exclusion criteria were rhinitis, hyp- or anosmia. During sleep, an interval-controlled, inspiration-triggered applicator added rose concentrate to the inspirated air. There were three consecutive nights of each odorant and placebo application and a wash-out phase. Patients completed standardised questionnaires on mood, dreams, and sleep quality. Four patients dropped out (n = 1: non-compliance in filling in the questionnaires, n = 3: intolerance of nasal tube). Otherwise, this novel odorant applicator was well tolerated. Application of the odorant showed no significant mood differences between rose and placebo, however, some subdomains of sleep quality and mood showed a positive trend towards improvement by rose application. The feasibility of this new device and of nasal tubes could be shown. Odorant application is well tolerated. It may have a positive influence on quality of mood and sleep in depressed patients. A longer application phase is planned to obtain convincing evidence for our hypothesis.

Study protocol OKRA: orientation compass for the preparing, delivering and following up on breaking bad news conversations in paediatric oncology.

INTRODUCTION: In paediatric oncology, 'breaking bad news'-BBN-like cancer diagnosis is perceived as particularly challenging. Enabling a trialogue between children with their relatives and health professionals requires profound communication skills. Lacking the skills, experience or adequate support tools might result in negative consequences for both paediatric oncologists as BBN transmitters and BBN receivers as children with cancer and their relatives.In contrast to oncology for adults, multiperspective studies that explore BBN experience and specific support needs are rare, especially in Germany. Systematically developed and practically piloted support instruments, which address the specific needs of paediatric oncology, are missing. OBJECTIVE: To systematically design and mature in practice an orientation compass for preparing, delivering and following up on BBN conversations in paediatric oncology-so-called Orientierungskompass zur Übermittlung schwerwiegender Nachrichten in der Kinderonkologie (OKRA). METHODS AND ANALYSIS: OKRA is based on a QUAL-quant mixed study design, comprising two phases. Four groups will contribute (1) experts through personal experience (representatives for children receiving BBN and their parents), (2) medical care providers and representatives of national medical societies, (3) ambulant psychosocial/psychological support providers and (4) researchers. In phase 1, multiperspective knowledge is generated through a participatory group Delphi that involves in-depth interviews, focus group discussions and questionnaires. This process culminates in formulating theses for a high-quality BBN process (output phase 1). In phase 2, based on the theses, a pilot orientation compass is designed. Through iterative cycles with the participatory action research method, this instrument will be piloted in three paediatric oncological settings and consequently optimised. ETHICS AND DISSEMINATION: OKRA was approved on 19 September 2023 by the ethics committee of the Medical Faculty of the University of Cologne (No. 23-1187). After project completion, the OKRA compass will be distributed to multidisciplinary paediatric oncology teams throughout Germany. TRIAL REGISTRATION NUMBER: DRKS00031691.