Stephan Nadolny

Background: People with intellectual disabilities have a higher prevalence of certain chronic diseases and higher avoidable mortality. Some of these diseases or their exacerbation could be avoided through disease prevention and health promotion interventions, as people with intellectual disabilities have high rates of unhealthy eating habits, stress, lower levels of mobility and similar addictive behaviours to the general population. At the same time, they face significant barriers to accessing preventive healthcare interventions.Objective: To test the effectiveness of an advanced practice nurse-led case management and prevention intervention for people with intellectual disabilities on health status after 12 months.Design: Two-arm parallel randomised-controlled trial with waiting list.Setting(s): Community setting in an urban area of Hamburg, Germany.Participants: 214 adults with an ICD-10 diagnosis F70-79 and a care level below 4 according to German Social Code XI, who were not at the end-of-life.Methods: The intervention consisted of case management, social space analysis, prevention planning and counselling in four outreach home visits on the topics of addiction, mobility, nutrition and stress. The control group received usual care. Participants were allocated using permuted block randomisation. The primary outcome was health status (WHODAS, 0-100) at 12 months (t2). Secondary outcomes were health status at 6 months (t1), resilience (RS-11, 7-77) and health-related quality of life (EQ5D, 0-100) at t1 and t2. Lower scores indicate better health status and higher scores better resilience and quality of life. Raters and analysts were blinded. Analyses were performed with ANCOVAs and Bonferroni correction to α= 0.025 and 97.5% confidence intervals (CI).Results: We randomised 107 participants to each group. For the primary outcome health status at t2 (n=167), the mean difference (MD) was -4.38 (CI: -8.13 to -0.62, ή²= 0.041). For the secondary outcome of health status at t1, the MD was -1.06 (CI: -3.51 to 5.62, ή²= 0.002). For resilience, the MD was +0.51 (CI: -3.11 to 2.10, ή²= 0.001) at t1 and +2.70 (CI: -5.78 to 0.39 ή²=0.022) at t2. For health-related quality of life, a MD of +0.72 (CI: -5.88 to 7.32, ή²=0.000) at t1 and -1.19 (CI: -8.71 to 6.33 ή²= 0.001) at t2 were measured.Conclusions: Overall, a nurse-led intervention focusing on prevention and case management can lead to a statistically significant change in health after 12 months, but not for the secondary outcomes. The current literature on minimal clinically important differences indicates that the effect is also clinically important.

Background: Decisional capacity is an important requirement for assisted suicide, which has been legalized in an increasing number of countries. While several instruments have been developed over the past few decades to assess the capacity to consent to treatment, little is known about their applicability to assessing capacity in the context of requests for assisted suicide. Methods: Systematic review of instruments assessing decisional capacity published up to March 2024. Data concerning criteria for determining decisional capacity, psychometric properties, and other aspects were extracted from all instruments included. Selected instruments were analyzed regarding their applicability to requests for assisted suicide. Results: We identified 23 instruments assessing the capacity to consent to treatment. There is considerable heterogeneity regarding the criteria utilized for assessing decisional capacity and their operationalization. Next to more cognitive abilities, some instruments directly incorporated emotions and values. Five instruments were assessed for applicability to requests for assisted suicide. The framing of decisional capacity within the context of disease and treatment options frequently limits the application of instruments to assess decisional capacity in the context of requests for assisted suicide. Conclusions: No instrument could be identified that could be applied to assessing decisional capacity in the context of requests for assisted suicide without any limitations or without necessitating adjustments. Further normative and empirical work is required for developing an instrument that could be applicable in this context.

Background: Community pharmacy practice is rarely considered in ethical research, although various ethical conflicts are known for this setting. Data on the actual frequency and perceived burden of ethical conflicts occurring in the community pharmacy setting are required. Aim: The survey aimed at investigating the frequency and perceived burden of ethical conflicts, reasons for the perceived burden and influences on decision-making in ethical conflicts in German community pharmacists. Method: An online survey was conducted among community pharmacists. It contained 15 ethical conflicts in which the ethically required action conflicts with another principle (e.g. law). Basing on these conflicting principles, 12 considerations relevant for decision-making were defined (e.g. solidarity principle). Participants were asked to rate the ethical conflicts in terms of frequency and perceived burden and to rate the influence on decision-making for the considerations. Results were analysed descriptively. Results: Five hundred and thirty-five questionnaires were evaluated. The participant’s median age was 39 (min–max: 20–78) years, 378 (71%) were female. Seven of the 15 predefined ethical conflicts were rated as occurring predominantly at least once a week. “Generic drug is not most suitable” was rated as the most frequent. Three ethical conflicts were rated mainly with a (very) strong burden. “Concerns for an unborn child” was rated as the most burdensome. Three of the 12 predefined decision-making considerations: pharmaceutical knowledge, legal requirements and personal values were rated primarily as having a very strong influence on decision-making. Conclusion: Pharmacists in community pharmacies are frequently affected by burdensome ethical conflicts in patient care situations.

Background: Medical students and doctors face various challenges in clinical practice. Some of these challenges are related to ethical issues. Therefore, teaching ethics respectively building moral competences has become an integral part of the medical curriculum in Germany and many other countries. To date, there is little evidence on moral competence of medical students. Methods: Self-administered survey among medical students from one German medical school in the first (cohort 1) and fifth semester (cohort 2) in the winter term 2019/20 (T0). Both cohorts received the same questionnaire one year later in winter term 2020/21 (T1). Assessment was performed with Lind’s Moral Competence Test. We performed convenience sampling. We analyzed the data with descriptive statistics and C-Scores as a measure of moral competence (higher scores = higher competence, ≥ 30 points = high competence). Results: A total of 613 students participated in the study (response rate 67.5%, n = 288 with data on both time points). 69.6% of the participants were female, the mean age was 21.3 years. Mean C-Score for both cohorts for T0 (first and fifth semester) is 32.5 ± 18.0 and for T1 (third and seventh semester) is 30.4 ± 17.9. Overall, 6.6% (T0) and 6.7% (T1) of respondents showed some but very low moral competence. 3.3% (T0) and 3.0% (T1) showed no moral competence. Additionally, students without prior experience in the healthcare system scored 3.0 points higher. Conclusions: Improvement of assessment of moral competence as well effective interventions are particular needed for supporting those students which have been identified to demonstrate little moral competences.

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.

Zusammenfassung: Hintergrund: Advance Care Planning (ACP) wird auch in Deutschland zunehmend praktiziert. Aus klinisch-ethischer Perspektive bietet ACP eine Möglichkeit, Vorausverfügungen zu konkretisieren und auf diese Weise die Entscheidungsfindung bei fehlender Selbstbestimmungsfähigkeit von Patient:innen zu unterstützen. Während es für Gesprächsangebote im Sinne des ACP in Pflegeeinrichtungen und Einrichtungen der Eingliederungshilfe seit 2015 Finanzierungsmöglichkeiten gibt und erste Studien zu Angeboten veröffentlich wurden, fehlt es in Deutschland bisher an publizierten Evaluationsstudien zu ACP-Angeboten im Krankenhaus. Intervention und Methoden: Im vorliegenden Beitrag erfolgt die strukturierte Darstellung von ACP als ein Element des klinisch-ethischen Unterstützungsangebotes am Universitätsklinikum Halle (Saale) (UKH). Es erfolgte eine quantitative Inhaltsanalyse der schriftlichen Dokumentation von durchgeführten ACP-Gesprächsprozessen für den Zeitraum der Pilotphase von 01/2020 bis 08/2021 (20 Monate). Ergebnisse: Im Zeitraum wurden 93 ACP-Gespräche angefragt. Mit 79 Patient:innen konnten 110 Gespräche geführt werden. 46 % der Anfragen kamen von Palliative Care betreuten Patient:innen. Im Durchschnitt dauerten die Beratungen 45 min. Der Gesprächsprozess zur Erstellung einer Patientenverfügung benötigte durchschnittlich 122 min und 2,5 Gespräche. Bei 23 % der Patient:innen endete der ACP-Prozess nach dem Erstgespräch. Die Inhalte der ACP-Prozesse tangierten verschiedene Bereiche anderer Professionen im Krankenhaus, insbesondere die Entscheidungsfindung über aktuelle Diagnostik und Therapie zwischen Ärzt:innen und Patient:innen. Diskussion: Die Einführung eines ACP-Angebotes im Krankenhaus zeigt neben einer Vielzahl an Chancen auch Herausforderungen auf, welche es im gemeinsamen Diskurs zu bewältigen gilt. Bei der Einbettung eines ACP-Angebots im Krankenhaus müssen die Besonderheiten der Klinik und insbesondere die Abgrenzung von ACP zu anderen Arbeitsfeldern der Ethikberatung, wie beispielsweise die Ethikfallberatung, bedacht werden.

Background: Adults with intellectual disabilities have a higher prevalence of unhealthy eating habits, stress, low levels of mobility, and comparable drug consumption as the general population. Consequently, they suffer from several chronic diseases earlier and more often, but there are fewer prevention and health promotion services including this population. The goal of this study is to determine if an advanced practice nursing approach in the community with home visits is an effective way to improve the health status of adults with intellectual disabilities. Methods: We will conduct a randomized-controlled trial with waiting list design in Hamburg, Germany. Inclusion criteria are diagnosis ICD F70-F79 and exclusion criteria are care level > 3 according to the German Social Code XI or being at the end-of-life. Participants will be block randomized. The intervention consists of advanced practice nurses performing case management, social space analysis, prevention planning, and counseling through four outreach home visits on nutrition, mobility, addiction, and stress. Comparison is usual care. The primary outcome is health status (WHODAS) after 12 months. Secondary outcomes are health-related quality of life (EQ-5D) and resilience (RS-11) after 6 and 12 months. The calculated sample size is 256 with an estimated dropout of 30%. Raters and analysts will be blinded. Analysis will be performed using ANCOVAs. Discussion: By providing case management and utilizing their nursing expertise, advanced practice nurses will provide valuable input and guidance on prevention and health promotion for people with intellectual disabilities. They will close the gap between health and social care, which is prominent in Germany, through cooperation between the existing care sectors. The findings will be disseminated in peer-reviewed journals and presented at national and international conferences. Trial registration: German Clinical Trials Register, DRKS00028771, registered 4 July 2022, Universal Trial Number: U1111-1277–0595.

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.

In their national follow-up study on ethics consultation (EC) in the U.S., Fox et al. (2022) report the worrying finding of a decline in efforts to evaluate ECs. Compared to the findings of Fox et ...