Online decision aid for patients with prostate cancer evaluated by 11 290 patients and 91 urologists in Germany.

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.

Genomic newborn screening: Are we entering a new era of screening?

Population newborn screening (NBS) for phenylketonuria began in the United States in 1963. In the 1990s electrospray ionization mass spectrometry permitted an array of pathognomonic metabolites to be identified simultaneously, enabling up to 60 disorders to be recognized with a single test. In response, differing approaches to the assessment of the harms and benefits of screening have resulted in variable screening panels worldwide. Thirty years on and another screening revolution has emerged with the potential for first line genomic testing extending the range of screening conditions recognized after birth to many hundreds. At the annual SSIEM conference in 2022 in Freiburg, Germany, an interactive plenary discussion on genomic screening strategies and their challenges and opportunities was conducted. The Genomics England Research project proposes the use of Whole Genome Sequencing to offer extended NBS to 100 000 babies for defined conditions with a clear benefit for the child. The European Organization for Rare Diseases seeks to include "actionable" conditions considering also other types of benefits. Hopkins Van Mil, a private UK research institute, determined the views of citizens and revealed as a precondition that families are provided with adequate information, qualified support, and that autonomy and data are protected. From an ethical standpoint, the benefits ascribed to screening and early treatment need to be considered in relation to asymptomatic, phenotypically mild or late-onset presentations, where presymptomatic treatment may not be required. The different perspectives and arguments demonstrate the unique burden of responsibility on those proposing new and far-reaching developments in NBS programs and the need to carefully consider both harms and benefits.

Shared decision making and advance care planning: a systematic literature review and novel decision-making model.

BACKGROUND AND AIMS: Shared decision making (SDM) and advance care planning (ACP) are important evidence and ethics based concepts that can be translated in communication tools to aid the treatment decision-making process. Although both have been recommended in the care of patients with risks of complications, they have not yet been described as two components of one single process. In this paper we aim to (1) assess how SDM and ACP is being applied, choosing patients with aortic stenosis with high and moderate treatment complication risks such as bleeding or stroke as an example, and (2) propose a model to best combine the two concepts and integrate them in the care process. METHODS: In order to assess how SDM and ACP is applied in usual care, we have performed a systematic literature review. The included studies have been analysed by means of thematic analysis as well as abductive reasoning to determine which SDM and ACP steps are applied as well as to propose a model of combining the two concepts into one process. RESULTS: The search in Medline, Cinahl, Embase, Scopus, Web of science, Psychinfo and Cochrane revealed 15 studies. Eleven describe various steps of SDM while four studies discuss the documentation of goals of care. Based on the review results and existing evidence we propose a model that combines SDM and ACP in one process for a complete patient informed choice. CONCLUSION: To be able to make informed choices about immediate and future care, patients should be engaged in both SDM and ACP decision-making processes. This allows for an iterative process in which each important decision-maker can share their expertise and concerns regarding the care planning and advance care planning. This would help to better structure and prioritize information while creating a trustful and respectful relationship between the participants. PROSPERO 2019. CRD42019124575.

Inequitable Access to Transplants: Adults With Impaired Decision-Making Capacity.

Inequitable access to deceased donor organs for transplantation has received considerable scrutiny in recent years. Emerging evidence suggests patients with impaired decision-making capacity (IDC) face inequitable access to transplantation. The "Ethical and Legal Issues" working group of the European Society of Transplantation undertook an expert consensus process. Literature relating to transplantation in patients with IDC was examined and collated to investigate whether IDC is associated with inferior transplant outcomes and the legitimacy of this healthcare inequality was examined. Even though the available evidence of inferior transplant outcomes in these patients is limited, the working group concluded that access to transplantation in patients with IDC may be inequitable. Consequently, we argue that IDC should not in and of itself be considered as a barrier to either registration on the transplant waiting list or allocation of an organ. Strategies for non-discrimination should focus on ensuring eligibility is based upon sound evidence and outcomes without reference to non-medical criteria. Recommendations to support policy makers and healthcare providers to reduce unintended inequity and inadvertent discrimination are set out. We call upon transplant centres and national bodies to include data on decision-making capacity in routine reporting schedules in order to improve the evidence base upon which organ policy decisions are made going forward.

AI support for ethical decision-making around resuscitation: proceed with care.

Artificial intelligence (AI) systems are increasingly being used in healthcare, thanks to the high level of performance that these systems have proven to deliver. So far, clinical applications have focused on diagnosis and on prediction of outcomes. It is less clear in what way AI can or should support complex clinical decisions that crucially depend on patient preferences. In this paper, we focus on the ethical questions arising from the design, development and deployment of AI systems to support decision-making around cardiopulmonary resuscitation and the determination of a patient's Do Not Attempt to Resuscitate status (also known as code status). The COVID-19 pandemic has made us keenly aware of the difficulties physicians encounter when they have to act quickly in stressful situations without knowing what their patient would have wanted. We discuss the results of an interview study conducted with healthcare professionals in a university hospital aimed at understanding the status quo of resuscitation decision processes while exploring a potential role for AI systems in decision-making around code status. Our data suggest that (1) current practices are fraught with challenges such as insufficient knowledge regarding patient preferences, time pressure and personal bias guiding care considerations and (2) there is considerable openness among clinicians to consider the use of AI-based decision support. We suggest a model for how AI can contribute to improve decision-making around resuscitation and propose a set of ethically relevant preconditions-conceptual, methodological and procedural-that need to be considered in further development and implementation efforts.

[Heidelberg Milestones Communication (HeiMeKOM) - Experiences, Best Practice Examples and Recommendations from the Final Symposium on January 30 and 31 in 2020]. / Heidelberger Meilenstein Kommunikation (HeiMeKOM) ­ Erfahrungen, Best Practice Beispiele und Empfehlungen aus dem Abschluss-Symposium am 30./31. Januar 2020.

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.

[Shared Decision-Making as a Genuine Interprofessional Endeavor]. / Shared Decision-Making als genuin interprofessionelle Aufgabe.

Shared Decision-Making as a Genuine Interprofessional Endeavor Abstract. In parallel with the growing complexity of decision-making processes, also the complexity of communication increases. This phenomenon requires adapted communication skills from all professions involved in the treatment of the patient. Consequently, the process of shared decision-making (SDM) also requires the continuous and active involvement of all the professions involved in the care process. Like the concept of interprofessional collaboration (IP), also SDM pursues the goal of creating the best possible framework conditions for the clinical context (in this case, treatment that is "tailored" to the person and agreed with him or her on the basis of his or her preferences and values). The numerous positive effects of both SDM and IP make the integration of both approaches in clinical practice not only an ethical necessity, but also a prerequisite for optimal treatment quality. The specific structure of SDM helps not only in a dyadic decision-making situation between physician and patient. It also encourages the interprofessional team to move away from an individualistic view of a single best solution to a more interprofessional team approach, which benefits both the patient and all the involved caregivers.

Advance Care Planning for People with Dementia: The Role of General Practitioners.

General practitioners (GPs) play a key role in the timely diagnosis of dementia and also in advance care planning (ACP). They often have known patients and their families for decades and are familiar with their values and treatment preferences; they are, therefore, in a position to initiate the ACP process even before the appearance of the first symptoms of dementia and certainly following disclosure of the diagnosis. To do so, they should recognise whether patients are receptive to an ACP consultation or whether they might reject it for personal, social or cultural reasons. Under no circumstances should the patient or their family be coerced into making these provisions. In most countries, the current framework does not provide enough time and money for GPs to carry out actual ACP consultations completely on their own. There is evidence that specially trained health professionals are able to more effectively discuss treatment goals and limits of life-prolonging measures than GPs who are well acquainted with their patients. Consequently, we suggest that it will be the GPs' task to seize the right moment for starting an ACP process, to raise awareness of patients and their relatives about ACP, to test the patient's decision-making capacity and, finally, to involve appropriately trained healthcare professionals in the actual ACP consultation process. Care should be taken that these professionals delivering time-intensive ACP consultations are not only able to reflect on the patient's values but are also familiar with the course of the disease, the expected complications and the decisions that can be anticipated. The GP will ensure an active exchange with the ACP professional and should have access to the documentation drawn up in the ACP consultation process (treatment plan and advance directive including instructions for medical emergencies) as soon as possible. GPs as coordinators of healthcare provision should document appropriately all specialists involved in the care and ensure that treatment decisions are implemented in accordance with the patient's preferences for future care or the presumed will of the patient.

Extending the Concept of Advance Care Planning to the Perinatal Period.

Easier access to prenatal diagnostic procedures led to its widespread use as a screening measure. Hence, today it is more common for life-limiting illnesses to be diagnosed during fetal life. The concept of Advance Care Planning (ACP) provides a framework for caregivers, families and their multidisciplinary teams to anticipate and plan ahead for potential future medical decisions so that the affected children are reliably treated according to their parents' individual values and wishes. In the perinatal context, ACP also has the potential to tackle the needs of unborn or newborn children with life-limiting illnesses and their families better, avoid unnecessary and burdensome measures and focus upon goals that are valuable and meaningful to both child and family.

Potentially inappropriate liver transplantation in the era of the "sickest first" policy - A search for the upper limits.

Liver transplantation has emerged as a highly efficient treatment for a variety of acute and chronic liver diseases. However, organ shortage is becoming an increasing problem globally, limiting the applicability of liver transplantation. In addition, potential recipients are becoming sicker, thereby increasing the risk of losing the graft during transplantation or in the initial postoperative period after liver transplantation (three months). This trend is challenging the model for end-stage liver disease allocation system, where the sickest candidates are prioritised and no delisting criteria are given. The weighting of the deontological demand for "equity", trying to save every patient, regardless of the overall utility; and "efficiency", rooted in utilitarianism, trying to save as many patients as possible and increase the overall quality of life of patients facing the same problem, has to be reconsidered. In this article we are aiming to overcome the widespread concept of futility in liver transplantation, providing a definition of potentially inappropriate liver transplantation and giving guidance on situations where it is best not to proceed with liver transplantation, to decrease the mortality rate in the first three months after transplantation. We propose "absolute" and "relative" conditions, where early post-transplant mortality is highly probable, which are not usually captured in risk scores predicting post-transplant survival. Withholding liver transplantation for listed patients in cases where liver transplant is not deemed clearly futile, but is potentially inappropriate, is a far-reaching decision. Until now, this decision had to be discussed extensively on an individual basis, applying explicit communication and conflict resolution processes, since the model for end-stage liver disease score and most international allocation systems do not include explicit delisting criteria to support a fair delisting process. More work is needed to better identify cases where transplantation is potentially inappropriate and to integrate and discuss these delisting criteria in allocation systems, following a societal debate on what we owe to all liver transplant candidates.

Low Level of Vegetative State After Traumatic Brain Injury in a Swiss Academic Hospital.

BACKGROUND: No standards exist regarding decision making for comatose patients, especially concerning life-saving treatments. The aim of this retrospective, single-center study was to analyze outcomes and the decision-making process at the end of life (EOL) in patients with traumatic brain injury (TBI) in a Swiss academic tertiary care hospital. METHODS: Consecutive admissions to the surgical intensive care unit (ICU) with stays of at least 48 hours between January 1, 2012 and June 30, 2015 in patients with moderate to severe TBI and with fatality within 6 months after trauma were included. Descriptive statistics were used. RESULTS: Of 994 ICU admissions with TBI in the study period, 182 had an initial Glasgow Coma Scale <13 and a length of stay in the ICU >48 hours. For 174 of them, a 6-month outcome assessment based on the Glasgow Outcome Scale (GOS) was available: 43.1% (36.0%-50.5%) had favorable outcomes (GOS 4 or 5), 28.7% (22.5%-35.9%) a severe disability (GOS 3), 0.6% (0%-3.2%) a vegetative state (GOS 2), and 27.6% (21.5%-34.7%) died (GOS 1). Among the GOS 1 individuals, 45 patients had a complete dataset (73% men; median age, 67 years; interquartile range, 43-79 years). Life-prolonging therapies were limited in 95.6% (85.2%-99.2%) of the cases after interdisciplinary prognostication and involvement of the surrogate decision maker (SDM) to respect the patient's documented or presumed will. In 97.7% (87.9%-99.9%) of the cases, a next of kin was the SDM and was involved in the EOL decision and process in 100% (96.3%-100.0%) of the cases. Written advance directives (ADs) were available for 14.0% (6.6%-27.3%) of the patients, and 34.9% (22.4%-49.8%) of the patients had shared their EOL will with relatives before trauma. In the other cases, each patient's presumed will was acknowledged after a meeting with the SDM and was binding for the EOL decision. CONCLUSIONS: At our institution, the majority of deaths after TBI follow a decision to limit life-prolonging therapies. The frequency of patients in vegetative state 6 months after TBI is lower than expected; this could be due to the high prevalence of limitation of life-prolonging therapies. EOL decision making follows a standardized process, based on patients' will documented in the ADs or on preferences assumed by the SDM. The prevalence of ADs was low and should be encouraged.

Revealing and acknowledging value judgments in health technology assessment.

BACKGROUND: Although value issues are increasingly addressed in health technology assessment (HTA) reports, HTA is still seen as a scientific endeavor and sometimes contrasted with value judgments, which are considered arbitrary and unscientific. This article aims at illustrating how numerous value judgments are at play in the HTA process, and why it is important to acknowledge and address value judgments. METHODS: A panel of experts involved in HTA, including ethicists, scrutinized the HTA process with regard to implicit value judgments. It was analyzed whether these value judgments undermine the accountability of HTA results. The final results were obtained after several rounds of deliberation. RESULTS: Value judgments are identified before the assessment when identifying and selecting health technologies to assess, and as part of assessment. They are at play in the processes of deciding on how to select, frame, present, summarize or synthesize information in systematic reviews. Also, in economic analysis, value judgments are ubiquitous. Addressing the ethical, legal, and social issues of a given health technology involves moral, legal, and social value judgments by definition. So do the appraisal and the decision-making process. CONCLUSIONS: HTA by and large is a process of value judgments. However, the preponderance of value judgments does not render HTA biased or flawed. On the contrary they are basic elements of the HTA process. Acknowledging and explicitly addressing value judgments may improve the accountability of HTA.

Systematic review of attitudes toward donation after cardiac death among healthcare providers and the general public.

OBJECTIVE: Organ donation after cardiac death (DCD) is one promising possibility of combating the organ shortage, but it raises ethical issues that differ from those raised in donation after brain death (DBD). Also, DCD may be perceived differently than DBD by medical staff and the public. The aim of this article is to systematically review empirical studies on attitudes of medical personnel and the public toward DCD and to discuss the findings from an ethical perspective. Our study was conducted in accordance with a seven-step approach for systematic reviews of empirical studies in bioethics. DATA SOURCES: The authors chose PubMed, EMBASE, CINAHL, PSYCINFO, and PSYNDEX, thus attempting to cover biomedical, sociological and ethical articles on the subject. STUDY SELECTION: A search algorithm using controlled vocabulary of the respective databases (where applicable) was created, and criteria for the relevance assessment of the articles were established. Article quality was assessed using the Critical Appraisal Skills Programme tool. DATA EXTRACTION AND SYNTHESIS: The authors took an integrative approach to the data, combining it for further analysis. Qualitative data were synthesized by means of thematic analysis, and a spectrum of relevant themes was identified. Then the authors extracted the quantitative data that corresponded with the identified themes. Quantitative data on common subjects were juxtaposed and presented later. CONCLUSIONS: Identified themes were the levels of support for DBD vs. DCD, attitudes toward postmortem measures without previous consent, lack of knowledge about DCD, concerns about the Dead Donor Rule, the potential for conflict of interest, making donation happen, and the call for standardized DCD protocols. All of these issues are of ethical relevance and merit further discussion. We conclude that deep-rooted concerns about DCD exist among medical personnel and the general public. These need to be taken seriously in order to maintain or foster trust in the transplantation system.

Evaluating an implementation strategy in cardiovascular prevention to improve prescribing of statins in Germany: an intention to treat analysis.

BACKGROUND: The prescription of statins is an evidence-based treatment to reduce the risk of cardiovascular events in patients with elevated cardiovascular risk or with a cardiovascular disorder (CVD). In spite of this, many of these patients do not receive statins. METHODS: We evaluated the impact of a brief educational intervention in cardiovascular prevention in primary care physicians' prescribing behaviour regarding statins beyond their participation in a randomised controlled trial (RCT). For this, prescribing data of all patients > 35 years who were counselled before and after the study period were analysed (each n > 75,000). Outcome measure was prescription of Hydroxymethylglutaryl-CoA Reductase Inhibitors (statins) corresponding to patients' overall risk for CVD. Appropriateness of prescribing was examined according to different risk groups based on the Anatomical Therapeutic Chemical Classification System (ATC codes). RESULTS: There was no consistent association between group allocation and statin prescription controlling for risk status in each risk group before and after study participation. However, we found a change to more significant drug configurations predicting the prescription of statins in the intervention group, which can be regarded as a small intervention effect. CONCLUSION: Our results suggest that an active implementation of a brief evidence-based educational intervention does not lead to prescription modifications in everyday practice. Physician's prescribing behaviour is affected by an established health care system, which is not easy to change. TRIAL REGISTRATION: ISRCTN71348772.

Advance Care Planning in Switzerland: Chances and challenges of delivering high-quality ACP in a small high-income, multilingual, federally organized country.

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.

Reliability and validity of the German version of the OPTION scale.

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.

Arriba-lib: evaluation of an electronic library of decision aids in primary care physicians.

BACKGROUND: The successful implementation of decision aids in clinical practice initially depends on how clinicians perceive them. Relatively little is known about the acceptance of decision aids by physicians and factors influencing the implementation of decision aids from their point of view. Our electronic library of decision aids (arriba-lib) is to be used within the encounter and has a modular structure containing 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. The aim of our study was to evaluate the acceptance of arriba-lib in primary care physicians. METHODS: We conducted an evaluation study in which 29 primary care physicians included 192 patients. The physician questionnaire contained information on which module was used, how extensive steps of the shared decision making process were discussed, who made the decision, and a subjective appraisal of consultation length. We used generalised estimation equations to measure associations within patient variables and traditional crosstab analyses. RESULTS: Only a minority of consultations (8.9%) was considered to be unacceptably extended. In 90.6% of consultations, physicians said that a decision could be made. A shared decision was perceived by physicians in 57.1% of consultations. Physicians said that a decision was more likely to be made when therapeutic options were discussed "detailed". Prior experience with decision aids was not a critical variable for implementation within our sample of primary care physicians. CONCLUSIONS: Our study showed that it might be feasible to apply our electronic library of decision aids (arriba-lib) in the primary care context. Evidence-based decision aids offer support for physicians in the management of medical information. Future studies should monitor the long-term adoption of arriba-lib in primary care physicians.

Supportive needs of informal caregivers of people with amyotrophic lateral sclerosis in Switzerland: a qualitative study.

OBJECTIVE: This study explores the supportive needs of informal caregivers of people with amyotrophic lateral sclerosis (ALS) in Switzerland. METHOD: We conducted semi-structured interviews with nine informal caregivers currently providing care to a person with ALS, 14 bereaved informal caregivers, and 13 healthcare professionals. Interviews were recorded on digital audio and analysed using an inductive thematic analysis within a realist framework. RESULT: Informal caregivers discussed five themes of support needs relating to being overburdened by administrative demand, in contact with healthcare providers, home support, especially during the terminal phase, and having or lacking social support. Healthcare professionals discussed three themes of support needs of informal caregivers which related to the general institutional support for informal caregivers, their own work as caring for informal caregivers, and the challenges in healthcare for families with ALS they encountered. SIGNIFICANCE OF RESULTS: Informal caregiving for people with ALS can be demanding. This study provides evidence for improvements in supporting informal caregivers. It shows administrative needs of informal caregivers, stresses their needs regarding advance care planning early in the context of ALS, and underlines the importance of social support, be it in peer-groups or community care.