To Remind or Not to Remind During Recruitment? An Analysis of an Online Panel in Germany.

Objective: To explore the role of reminders in recruiting and maintaining participation in an online panel. Methods: 50,045 individuals from five German federal states were invited by regular mail to participate in the online study "Health-Related Beliefs and Healthcare Experiences in Germany." Those who did not respond to the first attempt received a postal reminder. Comparisons of sociodemographic characteristics and responses were made between first-attempt respondents and those who enrolled after the second letter. Results: After the initial letter, 2,216 (4.4%, 95%CI: 4.3%-4.6%) registered for the study; after a reminder 1,130 (2.5%, 2.3%-2.6% of those reminded) enrolled. Minor sociodemographic differences were observed between the groups and the content of the responses did not differ. Second-attempt respondents were less likely to participate in subsequent questionnaires: 67.3% of first-attempt vs. 43.3% of second-attempt respondents participated in their fourth survey. Recruitment costs were 79% higher for second-attempt respondents. Conclusion: While reminders increased the number of participants, lower cost-effectiveness and higher attrition of second-attempt respondents support the use of single invitation only for studies with a similar design to ours when the overall participation is low.

Prioritization and resource allocation in the context of the COVID-19 pandemic. Recommendations for colorectal and pancreatic cancer in Germany.

In the context of the COVID-19 pandemic, there has been a scarcity of resources with various effects on the care of cancer patients. This paper provides an English summary of a German guideline on prioritization and resource allocation for colorectal and pancreatic cancer in the context of the pandemic. Based on a selective literature review as well as empirical and ethical analyses, the research team of the CancerCOVID Consortium drafted recommendations for prioritizing diagnostic and treatment measures for both entities. The final version of the guideline received consent from the executive boards of nine societies of the Association of Scientific Medical Societies in Germany (AWMF), 20 further professional organizations and 22 other experts from various disciplines as well as patient representatives. The guiding principle for the prioritization of decisions is the minimization of harm. Prioritization decisions to fulfill this overall goal should be guided by 1. the urgency relevant to avoid or reduce harm; 2. the likelihood of success of the diagnostic or therapeutic measure advised; and 3. the availability of alternative treatment options. In the event of a relevant risk of harm as a result of prioritization, these decisions should be made by means of a team approach. Gender, age, disability, ethnicity, origin and other social characteristics, such as social or insurance status, as well as the vehemence of a patient's treatment request and SARS-CoV-2 vaccination status should not be used as prioritization criteria. The guideline provides concrete recommendations for 1. diagnostic procedures, 2. surgical procedures for cancer, and 3. systemic treatment and radiotherapy in patients with colorectal or pancreatic cancer within the context of the German healthcare system.

Terminological Confusion About Sedation in Palliative Care: Results of an International Online Vignette Survey.

Background: Terminological problems concerning sedation in palliative care and consequences for research and clinical decision making have been reported frequently. Objectives: To gather data on the application of definitions of sedation practices in palliative care to clinical cases and to analyze implications for high-quality definitions. Design: We conducted an online survey with a convenience sample of international experts involved in the development of guidelines on sedation in palliative care and members of the European Association for Palliative Care (EAPC). Participants were asked to apply four published definitions to four case vignettes. Data were analyzed using descriptive statistics. Results: A total of 32 experts and 271 EAPC members completed the survey. The definitions were applied correctly in n = 2200/4848 cases (45.4%). The mean number of correct applications of the definitions (4 points max.) was 2.2 ± 1.14 for the definition of the SedPall study group, 1.8 ± 1.03 for the EAPC definition, 1.7 ± 0.98 for the definition of the Norwegian Medical Association, and 1.6 ± 1.01 for the definition of the Japanese Society of Palliative Medicine. The rate of correct applications for the 16 vignette-definition pairs varied between 70/303 (23.1%) and 227/303 (74.9%). The content of definitions and vignettes together with free-text comments explains participants' decisions and misunderstandings. Conclusions: Definitions of sedation in palliative care are frequently incorrectly applied to clinical case scenarios under simplified conditions. This suggests that clinical communication and research might be negatively influenced by misunderstandings and inconsistent labeling or reporting of data. Clinical Trial Registration Number: DRKS00015047.

From book to bedside? A critical perspective on the debate about "translational bioethics".

The concept of "translational bioethics" has received considerable attention in recent years. Most publications draw an analogy to translational medicine and describe bioethical research that aims at implementing and evaluating ethical interventions. However, current accounts of translational bioethics are often rather vague and seem to differ with regard to conceptual and methodological assumptions. It is not clear and scarcely analyzed what exactly "translation" in the field of bioethics means, in particular regarding goals and processes so that it is justified to appeal to translational medicine. In this article, we thus explore possible analogies and disanalogies between translational medicine and translational bioethics to establish whether the often occurring reference to concepts of translational medicine in the field of bioethics can be justified by substantial analogies. We will first provide an account of different models of translational medicine. In a second step, we will propose an analytic definition that explicitly articulates the essential characteristics of "translational research" irrespective of the research field (i.e., biomedicine, bioethics). Subsequently, we will explore whether and in how far general characteristics and phases of translational research in medicine can be applied to translational research in bioethics. Based on our analyses, we will come to the skeptical conclusion that at present there are considerable conceptual disanalogies and unsolved conceptual problems that disallow using "translational bioethics" in a meaningful analogy to respective accounts in biomedicine. Nevertheless, we will demonstrate that some insights gained by the conceptual accounts of translational medicine can contribute to advance current research activities in bioethics.

What is an "early palliative care" intervention? A scoping review of controlled studies in oncology.

INTRODUCTION: Early palliative care (EPC) has been advocated to improve cancer patients' health. However, EPC differs with regard to its elements and target groups. It is not known which parts of EPC contribute to effectiveness for which patient group. This scoping review provides a structured analysis of EPC interventions and outcome measures. DESIGN: We searched EMBASE, MEDLINE, CINAHL, and CENTRAL up to February 2022. We included randomized controlled trials (RCT), nonrandomized trials, cohort studies (CS), and controlled before-after studies of EPC in adult patients in English, Dutch, and German language. Interventions had to be self-labeled as EPC. Screening and data extraction were performed by two raters. A structured analysis incorporating the TIDieR checklist was performed to describe the elements of the interventions. RESULTS: We screened 2651 articles, resulting in 40 articles being included: 34 studies were RCT and six studies were CS with a mean sample size of 208 patients. Patients with pancreatic (n = 10) and lung cancer (n = 9) were most often included. Studies reported different reference points for the onset of EPC such as time after diagnosis of incurable cancer (n = 18) or prognosis (n = 9). Thirteen studies provided information about elements of EPC and eight studies about the control intervention. Most frequent elements of EPC were symptom management (n = 28), case management (n = 16), and advance care planning (ACP; n = 15). Most frequently reported outcome measures were health-related quality of life (n = 26), symptom intensity (n = 6), resource use, and the patient's mood (n = 4 each). CONCLUSION: The elicited heterogeneity of ECP in combination with deficits of reporting are considerable barriers that should be addressed to further develop effective EPC interventions for different groups of cancer patients.

Expert-approved best practice recommendations on the use of sedative drugs and intentional sedation in specialist palliative care (SedPall).

BACKGROUND: The use of sedative drugs and intentional sedation in end-of-life care is associated with clinical, ethical and legal challenges. In view of these and of the issue's great importance to patients undergoing intolerable suffering, we conducted a project titled SedPall ("From anxiolysis to deep continuous sedation - Development of recommendations for sedation in palliative care") with the purpose of developing best practice recommendations on the use of sedative drugs and intentional sedation in specialist palliative care and obtaining feedback and approval from experts in this area. DESIGN: Our stepwise approach entailed drafting the recommendations, obtaining expert feedback, conducting a single-round Delphi study, and convening a consensus conference. As an interdisciplinary group, we created a set of best practice recommendations based on previously published guidance and empirical and normative analysis, and drawing on feedback from experts, including patient representatives and of public involvement participants. We set the required agreement rate for approval at the single-round Delphi and the consensus conference at ≥80%. RESULTS: Ten experts commented on the recommendations' first draft. The Delphi panel comprised 50 experts and patient and public involvement participants, while 46 participants attended the consensus conference. In total, the participants in these stages of the process approved 66 recommendations, covering the topics "indications", "intent/purpose [of sedation]", "decision-making", "information and consent", "medication and type of sedation", "monitoring", "management of fluids and nutrition", "continuing other measures", "support for relatives", and "team support". The recommendations include suggestions on terminology and comments on legal issues. CONCLUSION: Further research will be required for evaluating the feasibility of the recommendations' implementation and their effectiveness. The recommendations and the suggested terminology may serve as a resource for healthcare professionals in Germany on the use of sedative drugs and intentional sedation in specialist palliative care and may contribute to discussion on the topic at an international level. TRIAL REGISTRATION: DRKS00015047 (German Clinical Trials Register).

Cocreation of Assistive Technologies for Patients With Long COVID: Qualitative Analysis of a Literature Review on the Challenges of Patient Involvement in Health and Nursing Sciences.

BACKGROUND: Digital assistive technologies have the potential to address the pressing need for adequate therapy options for patients with long COVID (also known as post-COVID-19 condition) by enabling the implementation of individual and independent rehabilitation programs. However, the involvement of the target patient group is necessary to develop digital devices that are closely aligned to the needs of this particular patient group. OBJECTIVE: Participatory design approaches, such as cocreation, may be a solution for achieving usability and user acceptance. However, there are currently no set methods for implementing cocreative development processes incorporating patients. This study addresses the following research questions: what are the tasks and challenges associated with the involvement of patient groups? What lessons can be learned regarding the adequate involvement of patients with long COVID? METHODS: First, a literature review based on a 3-stage snowball process was conducted to identify the tasks and challenges emerging in the context of the cocreation of digital assistive devices and services with patient groups. Second, a qualitative analysis was conducted in an attempt to extract relevant findings and criteria from the identified studies. Third, using the method of theory adaptation, this paper presents recommendations for the further development of the existing concepts of cocreation in relation to patients with long COVID. RESULTS: The challenges of an active involvement of patients in cocreative development in health care include hierarchical barriers and differences in the levels of specific knowledge between professionals and patients. In the case of long COVID, patients themselves are still inexperienced in dealing with their symptoms and are hardly organized into established groups. This amplifies general hurdles and leads to questions of group identity, power structure, and knowledge creation, which are not sufficiently addressed by the current methods of cocreation. CONCLUSIONS: The adaptation of transdisciplinary methods to cocreative development approaches focusing on collaborative and inclusive communication can address the recurring challenges of actively integrating patients with long COVID into development processes.

[Pre-existing Mental Disorders and Depressiveness in the Second Wave of the SARS-CoV-2-Pandemic - The Role of Pandemic-Associated Stressors]. / Psychische Vorerkrankungen und Depressivität in der 2. Welle der SARS-CoV-2-Pandemie in Deutschland ­ Die Rolle pandemieassoziierter Stressoren.

The second wave of the SARS-CoV-2 pandemic was characterized by drastic restrictions. From previous pandemics as well as from the first wave, it is known that especially individuals with a history of mental disorders may be highly vulnerable to develop poor mental health. Therefore, this paper examines the association of prior mental disorders (PMD) and depressiveness in the 2nd pandemic wave, considering general stress, perceived isolation, perception of political measures to curb the pandemic, fears regarding consequences of the pandemic and changes in the employment and income situation. A cross-sectional analysis was conducted with data of 812 participants of the health related beliefs and health care experiences in Germany study (HeReCa). The association between PMD and depressiveness was studied by means of weighted (for education and age) logistic regression, adjusted for the named variables as well as sociodemographic characteristics. Individuals with PMD displayed substantially more often higher depressiveness than individuals without PMD (OR: 25.1; 95% CI: 11.0-57.3). This association decreased partially by accounting for higher general stress and stress from isolation. Lack of partnership, low income, and male sex were associated with higher depressiveness, but only marginally changed the association of PMD and depressiveness. Overall, during the pandemic, persons with PMD were more likely to develop higher depressiveness than persons without. It is strongly advised to provide care for mental illness in pandemic times, which can be completed by E-Mental-Health or professional support for coping with stress.

Effects of the Pandemic on the Care of Patients With Colorectal Cancer.

BACKGROUND: During the COVID-19 pandemic, there was a decrease in the rates of diagnosis and treatment of cancer. However, only a few detailed analyses have been made to date regarding the effect of the pandemic on the care of cancer patients in Germany. Such studies are needed as the basis for well-founded recommendations on health-care delivery priorities during pandemics and other, comparable situations of crisis. METHODS: This review is based on publications that were retrieved by a selective search of the literature for controlled studies from Germany on the effects of the pandemic on colonoscopies, first diagnoses of colorectal cancer (CRC), surgical procedures for CRC, and CRC-related mortality. RESULTS: Compared to 2019, the rate of screening colonoscopies performed by physicians in private practice was 1.6% higher in 2020 and 4.3% higher in 2021. On the other hand, the rate of diagnostic colonoscopies in the inpatient setting was 15,7% lower in 2020, while that of therapeutic colonoscopies was 11.7% lower. According to the data evaluated here, first diagnoses of CRC were 2.1% less common in January to September in 2020 than they had been in 2019; according to routine data collected by the statutory health insurance provider GRK, surgery for CRC was 10% less common in 2020 than in 2019. With regard to mortality, sufficient data from Germany were lacking to draw definite conclusions. International modeling data suggest an increase in mortality due to decreased colorectal screening rates during the pandemic that may at least be partially compensated for by intensified screening strategies following the pandemic. CONCLUSION: Three years after the onset of the COVID-19 pandemic, there is still only a limited evidence base for an evaluation of the effects of the pandemic on medical care and on the outcomes of patients with CRC in Germany. The implementation of central data and research infrastructures will be necessary for further study of the long-term effects of this pandemic, as well as to enable optimal preparedness for future crisis situations.

[Comprehension and Perspectives of the Need for Medical Rehabilitation - Results of a German Online Survey]. / Verständnis und Bedürfnis medizinischer Rehabilitation in der Bevölkerung ­ Ergebnisse einer Online-Befragung.

BACKGROUND: In Germany, medical rehabilitation usually requires an application of the persons in need. Therefore, these persons have to understand what rehabilitation is and in what case they need this type of health care service. In addition to people with health problems, their close persons (e. g. family members) should also have rehabilitation-related knowledge. Since there is only limited data on the perspective towards medical rehabilitation services, a survey was conducted. METHOD: In September 2020, we invited 2,401 registered participants (age: 18-79 years) of a population-based online panel study to participate in an online survey. The cross-sectional survey asked about the understanding of need, subjective information as well as attitudes and expectations towards medical rehabilitation services. We analysed the data descriptively, taking into account the participants' rehabilitation experience and health impairment. In a subgroup analysis, the potential factors influencing the subjective need for rehabilitation were tested using logistic regression. RESULTS: Data from 1,464 persons (Ø age: 52.5±14.5 years; 55% non-male) were analysed, 44% of the participants considered themselves to be "rather well" or "very well" informed about medical rehabilitation. The majority associated a need for rehabilitation with the access requirements related to service providers. In case of an emerging need for rehabilitation, family doctors would be the first point of contact. The participants mainly had function-oriented expectations of rehabilitation services and a majority prefer inpatient rehabilitation if necessary. Among 383 persons with long lasting and pronounced health-related impairment, the concrete individual need for rehabilitation was associated by a higher subjective degree of impairment as well as their own previous rehabilitation experience and rehabilitation experience in their personal social environment. CONCLUSION: Despite an overall good understanding of the need for rehabilitation, different rehabilitation views were found in certain population groups. In order to improve the general understanding of rehabilitation in the public and particularly in close persons, adequate dissemination of low-threshold, population-based rehabilitation information is recommended.

Efficacy of Three Numerical Presentation Formats on Lay People's Comprehension and Risk Perception of Fact Boxes-A Randomized Controlled Pilot Study.

(1) Background: Fact boxes present the benefits and harms of medical interventions in the form of tables. Some studies suggest that people with a lower level of education could profit more from graphic presentations. The objective of the study was to compare three different formats in fact boxes with regard to verbatim and gist knowledge in general and according to the educational background. (2) Methods: In May 2020, recruitment started for this randomized controlled trial. Participants were given one out of three presentation formats: natural frequencies, percentages, and graphic. We used Limesurvey® to assess comprehension/risk perception as the primary outcome. The Kruskal-Wallis test and the Mann-Whitney U test were used in addition to descriptive analyses. (3) Results: A total of 227 people took part in the study. Results of the groups were nearly identical in relation to the primary outcome verbatim knowledge, likewise in gist knowledge. However, participants with lower educational qualifications differed from participants with higher educational qualifications in terms of verbatim knowledge in the group percentages. (4) Conclusions: The results indicate that all three forms of presentation are suitable for conveying the content. Further research should take the individual preferences regarding the format into account.

Public information needs and preferences on COVID-19: a cross-sectional study.

BACKGROUND: Right from the beginning of the SARS-CoV-2 pandemic the general public faced the challenge to find reliable and understandable information in the overwhelming flood of information. To enhance informed decision-making, evidence-based information should be provided. Aim was to explore the general public's information needs and preferences on COVID-19 as well as the barriers to accessing evidence-based information. METHODS: We performed a cross-sectional study. Nine hundred twenty-seven panel members were invited to an online survey (12/2020-02/2021). The HeReCa-online-panel is installed at the Martin Luther University Halle-Wittenberg to assess regularly the general public's view on health issues in five regions in Germany. The survey was set up in LimeSurvey, with nine items, multiple-choice and open-ended questions that allowed to gather qualitative data. Quantitative data were analysed descriptively and a content analysis was carried out to categorise the qualitative data. RESULTS: Six hundred thirty-six panel members provided data; mean age 52 years, 56.2% female, and 64.9% with higher education qualifications. Asked about relevant topics related to COVID-19, most participants selected vaccination (63.8%), infection control (52%), and long-term effects (47.8%). The following 11 categories were derived from the qualitative analysis representing the topics of interest: vaccination, infection control, long-term effects, therapies, test methods, mental health, symptoms, structures for pandemic control, infrastructure in health care, research. Participants preferred traditional media (TV 70.6%; radio 58.5%; newspaper 32.7%) to social media, but also used the internet as sources of information, becoming aware of new information on websites (28.5%) or via email/newsletter (20.1%). The knowledge question (Which European country is most affected by the SARS-CoV-2 pandemic?) was correctly answered by 7.5% of participants. The Robert Koch Institute (93.7%) and the World Health Organization (78%) were well known, while other organisations providing health information were rarely known (< 10%). Barriers to accessing trustworthy information were lack of time (30.7%), little experience (23.1%), uncertainty about how to get access (22.2%), complexity and difficulties in understanding (23.9%), and a lack of target group orientation (15,3%). CONCLUSIONS: There are extensive information needs regarding various aspects on COVID-19 among the general population. In addition, target-specific dissemination strategies are still needed to reach different groups.

Sedation in Palliative Care­a Clinically Oriented Overview of Guidelines and Treatment Recommendations

BACKGROUND: The appropriate provision of sedation as a last resort for the relief of suffering in palliative care is dealt with variably in actual practice. This article is intended as an overview of practically relevant information found in treatment recommendations and guidelines. METHODS: A systematic literature search was conducted in the PubMed, Scopus, and Google Scholar databases, and a manual search was carried out online. Recommendations that were not available in either German or English, or that were specific to pediatric practice, were excluded. Publication quality was assessed with the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II). The recommendations in the documents were qualitatively evaluated. RESULTS: 29 publications (11 journal articles, 18 other) of varying quality according to AGREE II were included. All recommendations and guidelines were essentially based on expert consensus. The common indications for sedation are otherwise intractable delirium, dyspnea, and pain, in patients with a life expectancy of no more than two weeks. Existential distress is a controversial indication. The drug of first choice is midazolam. As the sedating effect of opioids is hard to predict, they should not be used as sedatives. The risks of sedation include respiratory and circulatory depression, as well as the loss of communicative ability, control, and autonomy. It is generally recommended that the patient's symptom burden and depth of sedation should be monitored; clinical and technically supported monitoring are recommended in some publications as well, depending on the situation. CONCLUSION: There is a broad consensus in favor of sedation to relieve suffering in the last days and hours of life. Recommendations vary for patients with a longer life expectancy and for those with existential distress, and with respect to monitoring.

Mental burden and moral distress among oncologists and oncology nurses in Germany during the third wave of the COVID-19 pandemic: a cross-sectional survey.

PURPOSE: There is evidence for mental burden and moral distress among healthcare workers during the pandemic. However, there is scarcity of analyses regarding possible correlations of mental burden and moral distress in this context. This study provides data to quantify mental burden and possible associations with moral distress among physicians and nurses working in oncology in Germany. METHODS: We conducted a cross-sectional online survey with physicians and nurses working in oncology in Germany between March and July 2021. Next to sociodemographic characteristics and working conditions, mental burden and moral distress were assessed using standardized instruments. Binary multivariate logistic regression using the enter method was performed in order to explore the relationship between mental burden and moral distress. RESULTS: 121 physicians and 125 nurses were included in the study. Prevalence of clinically relevant depressive symptoms, anxiety, somatic symptoms, burnout symptoms and moral distress was 19.2, 14.5, 12.7, 46.0 and 34.7% in physicians and 41.4, 24.0, 46.8, 46.6 and 60.0% in nurses respectively. Mental burden was significantly associated with moral distress, being female/diverse, younger age < 40 and increase in workload. Nurses who felt sufficiently protected from COVID-19 reported significantly less moral distress. CONCLUSION: To improve pandemic resilience, there is a need to ensure safe working environment including psychosocial support. Further evidence on risk and protective factors for moral distress is needed to be able to develop and implement strategies to protect healthcare workers within and beyond the pandemic.

General practice in the German Democratic Republic (1949-1990) : A discipline between threat and professionalization.

BACKGROUND: In the 1950s the socialist health policy in East Germany did not follow a clear-cut course with regard to outpatient medical care. Whilst state-run policlinics gradually took the place of doctors in private practice, the required qualifications of physicians working in outpatient care remained unclear. After preparatory lobbying by committed physicians from the outpatient sector, the 1960 Weimar Health Conference finally paved the way for the preservation and professionalization of general practice in East Germany. AIM: The article analyzes the formation of general practice as a specialty in East Germany between 1945 and 1990. We scrutinize the status of general practitioners and their field in the socialist health system as well as the foundation of their medical society. Our paper aims to contribute to a broader history of general practice in Germany. METHODS: We draw on literature from that time, unpublished archival material, and interviews with contemporary witnesses. RESULTS: After the establishment of standards for specialist training in the early 1960s, general practice was introduced as a field of specialty in 1967. By this, East Germany had a compulsory specialist training in general practice much earlier than West Germany. In 1971, a specialist society for general practice was founded in East Germany. However, institutionalization at the medical faculties was still lacking. Meanwhile, the nationalization of outpatient care continued. In the years that followed, primary medical care was increasingly provided in policlinics. In 1989, of 40,000 physicians in the GDR, only about 340 were still practicing in their own offices. CONCLUSION: Within the nationalized GDR health system a committed group of physicians, under difficult political circumstances, pushed for professionalization of general practice and its recognition as a field of specialty. When general medicine was recognized as a specialty in 1967, this happened earlier than in other countries and constituted an important milestone.

Evaluating requests for physician-assisted suicide. A survey among German oncologists.

BACKGROUND: Cancer patients form a notable proportion of requestors for physician-assisted suicide (PAS). This manuscript provides data on German oncologists' views concerning due criteria for the assessment of requests for PAS and quality assurance. METHODS: The German Society of Haematology and Medical Oncology (DGHO) has conducted a survey among its members to elicit data about practices and views on regulating PAS in March 2021. Descriptive analysis and bivariate logistic regression of quantitative data on socio-demographic and other determinants possibly associated with respondents' views on PAS as well as content analysis of qualitative data were performed. RESULTS: About 57.1% (n = 425) of respondents (n = 745) indicated that they had been asked for information about PAS by patients. Information about palliative (92.7%; n = 651) and psychological care options (85.6%; n = 598) was deemed most important in cases of requests for PAS. More than half of the respondents (57.6%; n = 429) were in favour of a formal expert assessment of decisional capacity and about 33.4% (n = 249) favoured a time span of 14 days between the counselling and prescription of a lethal drug. There was no association between participants who received more requests and a preference for disclosing publicly their willingness to assist with suicide. A majority of respondents requested measures of quality assurance (71.3%; n = 531). CONCLUSION: According to respondents' views, the regulation of PAS will require diligent procedures regarding the assessment of decisional capacity and counselling. The findings suggest that the development of adequate and feasible criteria to assess the quality of practices is an important task.

German physicians' perceptions and views on complementary medicine in pediatric oncology: a qualitative study.

Complementary and alternative medicine (CAM) use in children with cancer has a high prevalence. If (parents of) patients bring up the topic of CAM, pediatric oncologists (POs) face considerable challenges regarding knowledge and professional behavior. In this study, we explore German POs' understanding of CAM and related attitudes as well as challenges and strategies related to CAM discussions by means of semi-structured interviews analyzed according to principles of qualitative thematic analysis with parents of children with cancer. We could conduct 14 interviews prior to theoretical saturation. The interviews had a duration of 15-82 min (M = 30.8, SD = 18.2). Professional experience in pediatric oncology was between 0.5 and 26 years (M = 13.8, SD = 7.6). Main themes identified were a heterogeneous understanding and evaluation of CAM, partly influenced by personal experiences and individual views on plausibility; the perception that CAM discussions are a possible tool for supporting parents and their children and acknowledgement of limitations regarding implementation of CAM discussions; and uncertainty and different views regarding professional duties and tasks when being confronted with CAM as a PO. Our interdisciplinary interpretation of findings with experts from (pediatric) oncology, psychology, and ethics suggests that there is need for development of a consensus on the minimal professional standards regarding addressing CAM in pediatric oncology.

Effectiveness of a complex regional advance care planning intervention to improve care consistency with care preferences: study protocol for a multi-center, cluster-randomized controlled trial focusing on nursing home residents (BEVOR trial).

BACKGROUND: According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents. METHODS: This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications. DISCUSSION: This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020.