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Background: The decision aid "Entscheidungshilfe Prostatakrebs" is available online free of charge since June 2016. It is designed to support patients with their treatment decision-making and to lighten the burden on their treating urologists. This study evaluates usage data from the first 3 months.Materials and Methods: The ICHOM standard set was applied to allow a personalised presentation and to collect relevant data for subsequent counselling. Additionally, personal preferences and psychological burden were assessed amongst others. We collected anonymous data. A multivariate model evaluated predictors for high user satisfaction.Results: From June through August 2016 a total of 319 patients used the decision aid, showing a continuous monthly increase in the number of users. There were n = 219 (68.7%) complete questionnaires. Median age was 66.1 ± 8.0 years. The oncological risk was low in 30.3%, intermediate in 43.6% and high in 26.1%. A majority of 57.5% used the decision aid together with their partner, 35.1% alone and 5.5% with their children. In all, 54.8% were "very satisfied" and 32.0% were "satisfied" with the decision aid for a total satisfaction rate of about 87%. The only predictors of total satisfaction were the usage mode and reported distress level.Conclusions: As shown by the continuously increasing number of users this decision aid is becoming well established in German urology. Patients' overall ratings are very positive. The majority of patients use the decision aid with their partner. This represents a significant advantage of a multimedia approach compared to print media. [ABSTRACT FROM AUTHOR]

Due to the Embryo Protection Act, creation of supernumerary embryos, as well as egg and embryo donation, is prohibited in Germany. Human stem cell research is regulated through the Act on stem cells that came into force in 2002. A cross-sectional survey of 101 IVF couples (n = 202) in two fertility centres, and representative samples of healthcare professionals and ethicists (n = 879), was carried out, and their attitudes towards embryonic stem cell research and donation of gametes and embryos compared. A clear majority of IVF couples favoured legalization of egg and embryo donation and embryonic stem cell research for various purposes. The willingness of couples to donate was related to purpose and to other independent influences. The majority of physicians voted for legalization of embryonic stem cell production from surplus embryos. Most human geneticists and obstetricians approved egg, but not embryo, donation to other couples. Ethicists and midwives were opposed to every kind of donation and research on surplus embryos. The IVF couples surveyed have positive attitudes towards donation and research using surplus embryos, whereas the healthcare professionals and ethicists and predominantly sceptical about most research activities destroying human embryos. This difference should be considered carefully in legal and ethical discussions on reprogenetics. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the nationwide online decision aid 'Entscheidungshilfe Prostatakrebs' (established in 2016, >11.000 users and 60 new users/week) for patients with non-metastatic prostate cancer (PCa), from the perspective of patients and urologists., Patients and Methods: To provide personalised information, the tool collects most of the International Consortium for Health Outcomes Measurement standard set, personal preferences, psychological features, and a validated rating of the tool. To evaluate urologists' opinions, we developed a structured two-page questionnaire. All data were collected anonymously., Results: From June 2016 to December 2020, 11 290 patients used the PCa decision aid. Their median (interquartile range [IQR]) age was 67 (61-72) years. The median (IQR) time from initial diagnosis to using the tool was 4 (3-7) weeks. In all, 87.7% of users reported high satisfaction. In a multivariable model, predictors for considering observation were higher knowledge, using the decision aid alone, lower oncological risk, normal erectile function, and respective personal preferences. Of 194 urologists, 91 (47%) had implemented the decision aid in their clinical practice. The urologists' mean (SD) satisfaction score (1 'very good'; 6 'unsatisfactory') with it was 1.45 (0.55), and 92% recommended it. Half of the urologists reported time savings., Conclusion: Patients and urologists report a very high level of acceptance and satisfaction with this online tool. It offers advantages in shared decision-making and time efficiency. The usage of the decision aid might improve the adoption of active surveillance and watchful waiting when indicated., (© 2024 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.)

We describe the development of ACP in Switzerland during the last decade in the German- and French-speaking cantons and on the national level. In 2013, a revision of the Swiss civil law came into force, declaring advance directives (ADs) as binding. Since then, ACP has been researched and implemented primarily by universities and university hospitals. Despite the foundation of the national association "ACP Swiss" in 2020, several national initiatives, and a roadmap for a national implementation, many challenges and barriers still remain. There is, however, reasonable hope to implement high-quality ACP throughout Switzerland within the next ten years., (Copyright © 2023. Published by Elsevier GmbH.)

The National Cancer Plan emphasises the importance of medical communication and calls for its integration into medical education and training. In this context, the Milestone Communication Approach meets the communicative challenges in dealing with lung cancer patients. Interprofessional tandems, consisting of doctors and nurses, conduct structured conversations at defined moments with patients and their relatives. The concept aims at shared decision making, continuity in the care of lung cancer patients and the early integration of palliative care. During the symposium on the Heidelberg Milestone Communication in January 2020, recommendations on the care situation of lung cancer patients in advanced stages were developed. In addition, the further adaptability of HeiMeKOM to other settings and hospitals and to other diseases was discussed as well as the possibility of implementing such a concept in standard care. This article presents the experiences, best practice examples and recommendations discussed during the symposium in order to enable their extrapolation to other similarly oriented projects. The long-term goal is to transfer the milestone concept to other hospital, primarily certified lung cancer centers, and to ensure permanent funding. For further dissemination of the concept and, above all, to have it established in standard care, health policy awareness and support are required in addition to the integration of the concept in competence catalogues of continuing medical and nursing education., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

The Swiss healthcare system is highly decentralized, making implementation of shared decision making (SDM) and patient and public involvement (PPI) quite slow; nonetheless, change is happening. SDM is now a core communication competency for medical school graduates, as reflected by a dedicated station on the federal exam, and is endorsed by several national societies. Multiple local initiatives are contributing to international best practices, local implementation, and increased capacity. PPI is also gaining momentum, most notably in research, with the development of a national platform for clinical research and inclusion of patients in the evaluation committees for funding. The challenge now is going from example projects by motivated early adopters in academia to making SDM and PPI standard practice., (Copyright © 2022. Published by Elsevier GmbH.)

Background: Extracorporeal life support (ECLS) provides support to patients with cardiopulmonary failure refractory to conventional therapy. While ECLS is potentially life-saving, it is associated with severe complications; decision making to initiate ECLS must, therefore, carefully consider which patients ECLS potentially benefits despite its consequences., Objective: To answer 2 questions: First, which medically relevant patient factors influence decisions to initiate ECLS? Second, what are factors relevant to decisions to withdraw a running ECLS treatment?, Methods: We conducted a factorial survey among 420 physicians from 111 hospitals in Switzerland and Germany. The study included 2 scenarios: 1 explored willingness to initiate ECLS, and 1 explored willingness to withdraw a running ECLS treatment. Each participant responded to 5 different vignettes for each scenario. Vignettes were analyzed using mixed-effects regression models with random intercepts., Results: Factors in the vignettes such as patients' age, treatment costs, therapeutic goal, comorbidities, and neurological outcome significantly influenced the decision to initiate ECLS. When it came to the decision to withdraw ECLS, patients' age, days on ECLS, criteria for discontinuation, condition of the patient, comorbidities, and neurological outcome were significant factors. In both scenarios, patients' age and neurological outcome were the most influential factors., Conclusions: This study provided insights into physicians' decision making processes about ECLS initiation and withdrawal. Patients' age and neurological status were the strongest factors influencing decisions regarding initiation of ECLS as well as for ECLS withdrawal. The findings may contribute to a more refined understanding of complex decision making for ECLS.

Objectives: The OPTION scale ("observing patient involvement in decision making") assesses the extent to which clinicians involve patients in decisions across a range of situations in clinical practice. It so far just covers physician behavior. We intended to modify the scoring of the OPTION scale to incorporate active patient behavior in consultations., Methods: Modification was done on scoring level, attempting a dyadic, relationship-centred approach in that high ratings can be evoked also by the behaviour of active patients. The German version of the OPTION scale was compared with a modified version by analysing video recordings of primary care consultations dealing with cardiovascular prevention. Fifteen general practitioners provided 40 videotaped consultations. Videos were analysed by two rater pairs and two experts in shared decision making (SDM)., Results: Reliability measures of the modified version were lower than those of the original scale. Significant associations of the dichotomised scale with the expert SDM rating as well as with physicians' expertise in SDM were only found for the modified OPTION scale. Receiver Operating Characteristic (ROC) analyses confirmed a valid differentiation between the presence of SDM (yes/no) on total score level, even though the cut-off point was quite low. Standard deviations of the single items in the modified version were higher compared to the original OPTION scale, while the means of total scores were similar., Conclusions: The original OPTION scale is physician-centered and neglects the activity and a possible self-involvement of the patient. Our modified instruction was able to capture the dyadic element partially. The development of a separate dyadic instrument might be more promising.

Computerised log files are important for analysing user behaviour in health informatics to gain insight into processes that lead to suboptimal user patterns. This is important for software training programmes or for changes to improve usability. Technical user behaviour regarding decision aids has not so far been thoroughly investigated with log files. The aim of our study was to examine more detailed user interactions of primary-care physicians and their patients with arriba-lib, our multimodular electronic library of decision aids used during consultations, on the basis of log data. We analysed 184 consultation log files from 28 primary-care physicians. The average consultation time of our modules was about 8 min. Two-thirds of the consultation time were spent in the history information part of the programme. In this part, mainly bar charts were used to display risk information. Our electronic library of decision aids does not generate specific user behaviour based on physician characteristics such as age, gender, years in practice, or prior experience with decision aids. This supports the widespread use of our e-library in the primary-care sector and probably beyond.

Objective: To examine the psychometric properties of the German version of the 'observing patient involvement' scale (OPTION) by analysing video recordings of primary care consultations dealing with counselling in cardiovascular prevention., Design: Cross-sectional assessment of physician-patient interaction by two rater pairs and two experts in shared decision making (SDM)., Setting: Primary care., Participants: Fifteen general practitioners provided 40 videographed consultations., Measurements: Video ratings using the OPTION instrument., Results: Mean differences on item level between the four raters were quite large. Most items were skewed towards minimal levels of shared decision making. Measures of inter-rater association showed low to moderate associations on item level and high associations on total score level. Cronbach-α of the whole scale based on the data of all four raters is 0.90 and therefore on a high level. An oblique factor analysis revealed two factors, but both factors were highly correlated so we can confirm a one-dimensional structure of the instrument. ROC analyses between the rater total scores and dichotomized expert ratings (SDM yes/no) revealed a good discriminability of the OPTION total score. Physicians with more expertise in shared decision making received higher OPTION ratings., Conclusions: The German version of the OPTION scale is reliable at total score level. Some items need further revision in the direction of more concrete, observable behaviour. We were only able to perform a quasi-validation of the scale. Validity issues need further research efforts., (© 2011 Blackwell Publishing Ltd.)

Background: Evidence on the effectiveness of educational interventions on prescribing behaviour modification in prevention of cardiovascular disease is still insufficient. We evaluated the effects of a brief educational intervention on prescription of hydroxymethylglutaryl-CoA reductase inhibitors (statins), inhibitors of platelet aggregation (IPA), and antihypertensive agents (AH)., Design: Cluster randomised controlled trial with continuous medical education (CME) groups of general practitioners (GPs)., Methods: Prescription of statins, IPA, and AH were verified prior to study start (BL), immediately after index consultation (IC), and at follow-up after 6 months (FU). Prescription in patients at high risk (>15% risk of a cardiovascular event in 10 years, based on the Framingham equation) and no prescription in low-risk patients (≤ 15%) were considered appropriate., Results: An intervention effect on prescribing could only be found for IPA. Generally, changes in prescription over time were all directed towards higher prescription rates and persisted to FU, independent of risk status and group allocation., Conclusions: The active implementation of a brief evidence-based educational intervention on global risk in CVD did not lead directly to risk-adjusted changes in prescription. Investigations on an extended time scale would capture whether decision support of this kind would improve prescribing risk-adjusted sustainably.

Background: Decision aids based on the philosophy of shared decision making are designed to help patients make informed choices among diagnostic or treatment options by delivering evidence-based information on options and outcomes. A patient decision aid can be regarded as a complex intervention because it consists of several presumably relevant components. Decision aids have rarely been field tested to assess patients' and physicians' attitudes towards them. It is also unclear what effect decision aids have on the adherence to chosen options., Methods: The electronic library of decision aids (arriba-lib) to be used within the clinical encounter has a modular structure and contains evidence-based decision aids for the following topics: cardiovascular prevention, atrial fibrillation, coronary heart disease, oral antidiabetics, conventional and intensified insulin therapy, and unipolar depression. We conducted an evaluation study in which 29 primary care physicians included 192 patients. After the consultation, patients filled in questionnaires and were interviewed via telephone two months later. We used generalised estimation equations to measure associations within patient variables and traditional crosstab analyses., Results: Patients were highly satisfied with arriba-lib and the process of shared decision making. Two-thirds of patients reached in the telephone interview wanted to be counselled again with arriba-lib. There was a high congruence between preferred and perceived decision making. Of those patients reached in the telephone interview, 80.7% said that they implemented the decision, independent of gender and education. Elderly patients were more likely to say that they implemented the decision., Conclusions: Shared decision making with our multi-modular electronic library of decision aids (arriba-lib) was accepted by a high number of patients. It has positive associations to general aspects of decision making in patients. It can be used for patient groups with a wide range of individual characteristics.

Objective: To assess the feasibility and outcome of measuring the theory of planned behaviour (TPB) in patients receiving routine counselling versus counselling with a decision aid (DA) during primary care consultation on cardiovascular risk prevention., Methods: A DA was developed, based on models of shared decision-making (SDM) and the TPB. We evaluated the impact of the intervention in a randomized controlled trial. Main outcomes were previously reported. To assess the intermediate social cognitive processes and our theoretical framework, we evaluated the impact of the intervention on a TPB scale., Results: The TPB scale showed satisfactory measurement properties. Factor analysis (main component analysis, confirmatory model) could mostly replicate the assumptions of the model. 44% of variance of the behavioural intention to adhere to the decision after counselling was explained in linear regression models. Of the TPB components, only attitude towards the decision and moral norm were significantly more positive in the intervention. No difference was found with regard to intention to adhere to the decision. High risk resulted in higher values of the TPB components in both groups., Conclusion: Most DAs are developed and tested without explicitly referring to a theoretical model of psychosocial processes. The TPB may serve as a useful theoretical framework., Practice Implications: Trials on DAs demonstrate positive effects on psychological outcomes of patients without leading to better objective health results. Our study might contribute to an explanation: DAs might not cause stronger adherence to decisions even though one's attitude towards the decision becomes more positive., (Copyright 2009 Elsevier Ireland Ltd. All rights reserved.)

Background: Up to now it has not been systematically investigated in which kind of clinical situations a consultation style based on shared decision making (SDM) is preferred by patients and physicians. We suggest the factorial survey design to address this problem.This method, which so far has hardly been used in health service research, allows to vary relevant factors describing clinical situations as variables systematically in an experimental random design and to investigate their importance in large samples., Methods/design: To identify situational factors for the survey we first performed a literature search which was followed by a qualitative interview study with patients, physicians and health care experts. As a result, 7 factors (e.g. "Reason for consultation" and "Number of therapeutic options") with 2 to 3 levels (e.g. "One therapeutic option" and "More than one therapeutic option") will be included in the study. For the survey the factor levels will be randomly combined to short stories describing different treatment situations.A randomized sample of all possible short stories will be given to at least 300 subjects (100 GPs, 100 patients and 100 members of self-help groups) who will be asked to rate how the decision should be made. Main outcome measure is the preference for participation in the decision making process in the given clinical situation.Data analysis will estimate the effects of the factors on the rating and also examine differences between groups., Discussion: The results will reveal the effects of situational variations on participation preferences. Thus, our findings will contribute to the understanding of normative values in the medical decision making process and will improve future implementation of SDM and decision aids.

The legal status of stem cell research in Germany has most recently been debated at the highest political level. Stakeholders have argued referring to the situation of stem cell researchers in past debates; however, a survey of the views and attitudes of German stem cell researchers is currently being performed by the University of Marburg also involving a team at Exeter University. Here, we present some of the first findings from this study on the basis of 14 qualitative interviews and 117 responses to the quantitative survey. The data suggest that the motives for engaging in particular areas of research are multilayered. Respondents take a critical view towards the way in which research on human embryonic stem cells has been regulated. The majority of interviewees rejected a change in legislation involving the amendment of the cut-off date for the import of human embryonic stem cells lines. Also, the recent changes in the German regulation of stem cell research that, among other changes, include a change of the cut off date for the production of lines which could become used in the country from January 2002 to May 2007 appear not to be received as a satisfactory solution of the constraints experienced by science through the law in Germany.

The physician-patient relationship is of fundamental importance not only for individual patients but for the health care system in general and thus also for bioethical reflections. We give an overview on current research and analyses regarding the physician-patient relationship. A comprehensive ethical analysis takes conditions (historical and societal influences, norms and principles), the action itself and its consequences on the individual level (patient, physician) and societal level (health care system) into consideration. At present, two models of the physician-patient relationship are predominantly discussed, especially in terms of care ethics: evidence-based patient choice and shared decision making. These forms of relationships seem to be promising for several reasons, but might not fit all situations, and suitable for all preferences of patients and physicians in the same way. We conclude with a summary of the current debate and point out some of its shortcomings.

Objective: Due to a lack of valid German instruments measuring shared decision-making (SDM), a theory-driven questionnaire (SDM-Q) to measure the process of SDM was developed and validated., Methods: As a theoretical basis steps of the SDM process were defined in an expert panel. Item formulation was then conducted according to the Delphi method. For the first validation on a mixed sample Rasch analysis was used to eliminate items not fitting the construct thus receiving a unidimensional scale., Results: After eliminating 4 items the remaining 11 form a unidimensional scale with an acceptable reliability for person measures (0.77) and very good reliability for item difficulties (0.95). Analysis of subgroups revealed a different use of items in different conditions. Furthermore the scale showed high ceiling effects., Conclusion: A new theory-driven instrument to measure the process of SDM has been developed and validated by use of a rigorous method revealing first promising results. Yet the ceiling effects require the addition of more discriminating items, and the different use of items in different conditions demands an in depth analysis., Practice Implications: While the concept of SDM is constantly receiving more attention in medical practice, its valid and reliable measurement remains challenging.

We present results from our 'bioethical field studies', which explore and compare the views of experts, patients and the general public on the beginning of human life and the status of the preimplantation embryo in Germany. Using a qualitative and quantitative multi-method approach, we found crucial differences in the categorization of the beginning of human life within the expert group (representative samples of human geneticists n=104, ethicists n=168, midwives n=294, obstetricians n=147, paediatricians n=166), and between expert and lay samples (IVF couples n=108, high genetic risk couples n=324, general population n=1017). The majority of lay respondents as well as paediatricians and obstetricians chose nidation, the moment when the implantation of the fertilized egg into the uterus takes place, as the crucial boundary that marks the beginning of human life, whereas the majority of (female) human geneticists, ethicists and midwives voted for conception as the decisive point in time. The views of all groups on the status of the preimplantation embryo differed from the assumptions underlying German legislation (Embryo Protection Act). Religiousness and religious affiliation, gender, attitudes towards disabled people, post-material values and a present desire for a child were identified as independent factors influencing attitudes towards the preimplantation embryo in the population sample. The results are discussed within a broader philosophical and social science perspective of constructivism versus essentialism, proposing a truly interdisciplinary approach to such bioethical core issues as new reproductive technologies and the status of the preimplantation embryo.

Unlabelled: Definition of problem:, Background: Reproductive Biomedicine and new reproductive technologies (ART) belong to the fields of medicine that initiated most of the discussion on enhancement and desire fulfilling medicine in bioethics during the last years. One of the crucial questions to be answered is the definition of the right to procreate/right for a genetically related child. Closely connected are controversial opinions in regard to the definition of sterility as a disease/illness, or a mere fate, or malfunction, which does not have to be medically cured. Arguments: After a cursory description of the national and international debate, we introduce some results of our 'bioethical field studies', exploring and comparing the views of experts (human geneticists, ethicists, pediatricians, obstetricians and midwifes) and couples/patients (IVF couples, high genetic risk couples and couples with no known risk for an inherited disease or infertility problem) on sterility, the right to procreate, possibilities and appropriate limits of IVF in Germany., Conclusion: According to the WHO, sterility has to be defined as an illness, if the respective couples have a desire for a child. IVF can be a means for a cure. Since 2004, Germany does no longer supply a thoroughly insurer financed IVF treatment. Our surveys indicate that this change, though supported by many experts, is hard to accept for couples concerned. Only obstetricians share the WHO's view that sterility should count as an illness. Many ethicists see a proclaimed human right to procreate as merely negative right, although many support free IVF treatment for poor couples. We challenge the expert majority view on the basis of the capability approach (Amartya Sen) and functional liberalism (Herlinde Pauer Studer) and with a view to the international state of the art in IVF. The desire to have children cannot be reduced to a non-authoritative preference whose fulfillment is optional, but has to be conceptualized as a normative need that ought to be met.

The regulation of reproductive medicine technologies differs significantly among Western industrialized countries. In Germany, preimplantation genetic diagnosis (PGD) is prohibited due to the Embryo Protection Act, which came into force in 1991. In the last 5 years, this prohibition has been vigorously debated. In the present studies, which are part of the German research programme on ethical implications of the Human Genome Project, representative surveys were undertaken to assess the attitudes on PGD in the general population (n = 1017), five relevant expert groups (n = 879), high genetic risk couples (n = 324) and couples undergoing IVF (n = 108). All groups surveyed clearly favoured allowing PGD in Germany. Compared with the results of recently conducted population surveys in the UK and the USA, where PGD is already carried out, public approval of PGD does not differ significantly. The influence of restrictive biopolitics on the apparently liberal public opinion towards new reproductive technology seems to be marginal according to the present data, which should carefully be considered in the ongoing legislation process on human reproduction.

This article gives an overview about the ethical dispute on preimplantation genetic diagnosis (PGD), its legal status and its practical usage in Europe. We provide a detailed description of the situation in Germany wherein prenatal diagnosis is routinely applied, but PGD is prohibited on the basis of the internationally unique embryo protection act (EPA) that was put into force in 1991. Both PGD and stem cell research were vigorously debated in Germany during the last four years. As regards the PGD debate specifically, the voices of the ones directly affected were not adequately taken into consideration. We describe the predominant lines of argumentation in this debate and some essential results of our "bioethical field study" of opinions on and usage of PGD in Germany and their implications for the German legislation and ethical theory.