Stimulating Preconception Care Uptake by Women With a Vulnerable Health Status Through a Mobile Health App (Pregnant Faster): Pilot Feasibility Study.

BACKGROUND: A low socioeconomic status is associated with a vulnerable health status (VHS) through the accumulation of health-related risk factors, such as poor lifestyle behaviors (eg, inadequate nutrition, chronic stress, and impaired health literacy). For pregnant women, a VHS translates into a high incidence of adverse pregnancy outcomes and therefore pregnancy-related inequity. We hypothesize that stimulating adequate pregnancy preparation, targeting lifestyle behaviors and preconception care (PCC) uptake, can reduce these inequities and improve the pregnancy outcomes of women with a VHS. A nudge is a behavioral intervention aimed at making healthy choices easier and more attractive and may therefore be a feasible way to stimulate engagement in pregnancy preparation and PCC uptake, especially in women with a VHS. To support adequate pregnancy preparation, we designed a mobile health (mHealth) app, Pregnant Faster, that fits the preferences of women with a VHS and uses nudging to encourage PCC consultation visits and engagement in education on healthy lifestyle behaviors. OBJECTIVE: This study aimed to test the feasibility of Pregnant Faster by determining usability and user satisfaction, the number of visited PCC consultations, and the course of practical study conduction. METHODS: Women aged 18-45 years, with low-to-intermediate educational attainment, who were trying to become pregnant within 12 months were included in this open cohort. Recruitment took place through social media, health care professionals, and distribution of flyers and posters from September 2021 until June 2022. Participants used Pregnant Faster daily for 4 weeks, earning coins by reading blogs on pregnancy preparation, filling out a daily questionnaire on healthy lifestyle choices, and registering for a PCC consultation with a midwife. Earned coins could be spent on rewards, such as fruit, mascara, and baby products. Evaluation took place through the mHealth App Usability Questionnaire (MAUQ), an additional interview or questionnaire, and assessment of overall study conduction. RESULTS: Due to limited inclusions, the inclusion criterion "living in a deprived neighborhood" was dropped. This resulted in the inclusion of 47 women, of whom 39 (83%) completed the intervention. In total, 16 (41%) of 39 participants visited a PCC consultation, with their main motivation being obtaining personalized information. The majority of participants agreed with 16 (88.9%) of 18 statements of the MAUQ, indicating high user satisfaction. The mean rating was 7.7 (SD 1.0) out of 10. Points of improvement included recruitment of the target group, simplification of the log-in system, and automation of manual tasks. CONCLUSIONS: Nudging women through Pregnant Faster to stimulate pregnancy preparation and PCC uptake has proven feasible, but the inclusion criteria must be revised. A substantial number of PCC consultations were conducted, and this study will therefore be continued with an open cohort of 400 women, aiming to establish the (cost-)effectiveness of an updated version, named Pregnant Faster 2. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/45293.

Exploring health and disease concepts in healthcare practice: an empirical philosophy of medicine study.

In line with recent proposals for experimental philosophy and philosophy of science in practice, we propose that the philosophy of medicine could benefit from incorporating empirical research, just as bioethics has. In this paper, we therefore take first steps towards the development of an empirical philosophy of medicine, that includes investigating practical and moral dimensions. This qualitative study gives insight into the views and experiences of a group of various medical professionals and patient representatives regarding the conceptualization of health and disease concepts in practice and the possible problems that surround them. This includes clinical, epistemological, and ethical issues. We have conducted qualitative interviews with a broad range of participants (n = 17), working in various health-related disciplines, fields and organizations. From the interviews, we highlight several different practical functions of definitions of health and disease. Furthermore, we discuss 5 types of problematic situations that emerged from the interviews and analyze the underlying conceptual issues. By providing theoretical frameworks and conceptual tools, and by suggesting conceptual changes or adaptations, philosophers might be able to help solve some of these problems. This empirical-philosophical study contributes to a more pragmatic way of understanding the relevance of conceptualizing health and disease by connecting the participants' views and experiences to the theoretical debate. Going back and forth between theory and practice will likely result in a more complex but hopefully also better and more fruitful understanding of health and disease concepts.

Improving shared decision-making about cancer treatment through design-based data-driven decision-support tools and redesigning care paths: an overview of the 4D PICTURE project.

Background: Patients with cancer often have to make complex decisions about treatment, with the options varying in risk profiles and effects on survival and quality of life. Moreover, inefficient care paths make it hard for patients to participate in shared decision-making. Data-driven decision-support tools have the potential to empower patients, support personalized care, improve health outcomes and promote health equity. However, decision-support tools currently seldom consider quality of life or individual preferences, and their use in clinical practice remains limited, partly because they are not well integrated in patients' care paths. Aim and objectives: The central aim of the 4D PICTURE project is to redesign patients' care paths and develop and integrate evidence-based decision-support tools to improve decision-making processes in cancer care delivery. This article presents an overview of this international, interdisciplinary project. Design methods and analysis: In co-creation with patients and other stakeholders, we will develop data-driven decision-support tools for patients with breast cancer, prostate cancer and melanoma. We will support treatment decisions by using large, high-quality datasets with state-of-the-art prognostic algorithms. We will further develop a conversation tool, the Metaphor Menu, using text mining combined with citizen science techniques and linguistics, incorporating large datasets of patient experiences, values and preferences. We will further develop a promising methodology, MetroMapping, to redesign care paths. We will evaluate MetroMapping and these integrated decision-support tools, and ensure their sustainability using the Nonadoption, Abandonment, Scale-Up, Spread, and Sustainability (NASSS) framework. We will explore the generalizability of MetroMapping and the decision-support tools for other types of cancer and across other EU member states. Ethics: Through an embedded ethics approach, we will address social and ethical issues. Discussion: Improved care paths integrating comprehensive decision-support tools have the potential to empower patients, their significant others and healthcare providers in decision-making and improve outcomes. This project will strengthen health care at the system level by improving its resilience and efficiency.

Improving the cancer patient journey and respecting personal preferences: an overview of the 4D PICTURE project The 4D PICTURE project aims to help cancer patients, their families and healthcare providers better undertstand their options. It supports their treatment and care choices, at each stage of disease, by drawing on large amounts of evidence from different types of European data. The project involves experts from many different specialist areas who are based in nine European countries. The overall aim is to improve the cancer patient journey and ensure personal preferences are respected.

Stimulating the Uptake of Preconception Care by Women With a Vulnerable Health Status Through mHealth App-Based Nudging (Pregnant Faster): Cocreation Design and Protocol for a Cohort Study.

BACKGROUND: Women with a low socioeconomic status often have a vulnerable health status due to an accumulation of health-deteriorating factors such as poor lifestyle behaviors, including inadequate nutrition, mental stressors, and impaired health literacy and agency, which puts them at an unnecessary high risk of adverse pregnancy outcomes. Adequately preparing for pregnancy through preconception care (PCC) uptake and lifestyle improvement can improve these outcomes. We hypothesize that nudging is a successful way of encouraging engagement in PCC. A nudge is a behavioral intervention that changes choice behavior through influencing incentives. The mobile health (mHealth) app-based loyalty program Pregnant Faster aims to reward women in an ethically justified way and nudges to engage in pregnancy preparation by visiting a PCC consultation. OBJECTIVE: Here, we first describe the process of the cocreation of the mHealth app Pregnant Faster that aims to increase engagement in pregnancy preparation by women with a vulnerable health status. Second, we describe the cohort study design to assess the feasibility of Pregnant Faster. METHODS: The content of the app is based on the eHealth lifestyle coaching program Smarter Pregnancy, which has proven to be effective in ameliorating preconceptional lifestyle behaviors (folic acid, vegetables, fruits, smoking, and alcohol) and an interview study pertaining to the preferences of the target group with regard to an mHealth app stimulating PCC uptake. For moral guidance on the design, an ethical framework was developed based on the bioethical principles of Beauchamp and Childress. The app was further developed through iterative cocreation with the target group and health care providers. For 4 weeks, participants will engage with Pregnant Faster, during which opportunities will arise to earn coins such as reading informative blogs and registering for a PCC consultation. Coins can be spent on small fun rewards, such as folic acid, fruits, and mascara. Pregnant Faster's feasibility will be tested in a study including 40 women aged 18 to 45 years, who are preconceptional or <8 weeks pregnant, with a low educational level, and living in a deprived neighborhood. The latter 2 factors will serve as a proxy of a low socioeconomic status. Recruitment will take place through flyers, social media, and health care practices. After finalization, participants will evaluate the app through the "mHealth App Usability Questionnaire" and additional interviews or questionnaires. RESULTS: Results are expected to be published by December 2023. CONCLUSIONS: Pregnant Faster has been designed through iterative cocreation with the target group and health care professionals. With the designed study, we will test Pregnant Faster's feasibility. If overall user satisfaction and PCC uptake is achieved, the app will be further developed and the cohort will be continued with an additional 400 inclusions to establish effectiveness. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45293.

Preclinical Disease or Risk Factor? Alzheimer's Disease as a Case Study of Changing Conceptualizations of Disease.

Alzheimer's Disease (AD) provides an excellent case study to investigate emerging conceptions of health, disease, pre-disease, and risk. Two scientific working groups have recently reconceptualized AD and created a new category of asymptomatic biomarker positive persons, who are either said to have preclinical AD, or to be at risk for AD. This article examines how prominent theories of health and disease would classify this condition: healthy or diseased? Next, the notion of being "at risk"-a state somewhere in-between health and disease-is considered from various angles. It is concluded that medical-scientific developments urge us to let go of dichotomous ways of understanding disease, that the notion of "risk," conceptualized as an increased chance of getting a symptomatic disease, might be a useful addition to our conceptual framework, and that we should pay more attention to the practical usefulness and implications of the ways in which we draw lines and define concepts.

Towards machine learning for moral choice analysis in health economics: A literature review and research agenda.

BACKGROUND: Discrete choice models (DCMs) for moral choice analysis will likely lead to erroneous model outcomes and misguided policy recommendations, as only some characteristics of moral decision-making are considered. Machine learning (ML) is recently gaining interest in the field of discrete choice modelling. This paper explores the potential of combining DCMs and ML to study moral decision-making more accurately and better inform policy decisions in healthcare. METHODS: An interdisciplinary literature search across four databases - PubMed, Scopus, Web of Science, and Arxiv - was conducted to gather papers. Based on the Preferred Reporting Items for Systematic and Meta-analyses (PRISMA) guideline, studies were screened for eligibility on inclusion criteria and extracted attributes from eligible papers. Of the 6285 articles, we included 277 studies. RESULTS: DCMs have shortcomings in studying moral decision-making. Whilst the DCMs' mathematical elegance and behavioural appeal hold clear interpretations, the models do not account for the 'moral' cost and benefit in an individual's utility calculation. The literature showed that ML obtains higher predictive power, model flexibility, and ability to handle large and unstructured datasets. Combining the strengths of ML methods with DCMs has the potential for studying moral decision-making. CONCLUSIONS: By providing a research agenda, this paper highlights that ML has clear potential to i) find and deepen the utility specification of DCMs, and ii) enrich the insights extracted from DCMs by considering the intrapersonal determinants of moral decision-making.

Ethics of access to newly approved expensive medical treatments: multi-stakeholder dialogues in a publicly funded healthcare system.

Background: Due to rising healthcare expenditures, countries with publicly funded healthcare systems face challenges when providing newly approved expensive anti-cancer treatments to all eligible patients. In the Netherlands in 2015, the so-called Coverage Lock (CL), was introduced to help safeguard the sustainability of the healthcare system. Since then, newly approved treatments are no longer automatically reimbursed. Previous work has shown that as policies for access to CL treatments are lacking, patient access to non-reimbursed treatments is limited and variable, which raises ethical issues. The ethics of access were discussed in a series of multi-stakeholder dialogues in the Netherlands. Methods: Three dialogues were held in early 2023 and included physicians, health insurers, hospital executives, policymakers, patients, citizens, and representatives of pharmaceutical companies, patient and professional organizations. In advance, participants had received an 'argument scheme' featuring three models: 1) access based on third-party payment (e.g., by pharmaceutical companies, health insurers or hospitals) 2) access based on out-of-pocket payments by patients 3) no access to CL treatments. During the dialogues, participants were asked to discuss the merits of the ethical arguments for and against these models together, and ultimately to weigh them. The discussions were audio-taped, transcribed, coded, and thematically analyzed. Results: Generally, most stakeholders were in favour of allowing access-at least when treatments are clearly beneficial-to treatments in the CL. When discussing third-party payment, stakeholders favoured payment by pharmaceutical companies over payment by health insurers or hospitals, not wanting to usurp collective funds while cost-effectiveness assessments are still pending. Largely, stakeholders were not in favour of out-of-pocket payments, emphasizing solidarity and equal access as important pillars of the Dutch healthcare system. Recurrent themes included the conflict between individual and collective interests, shifting attitudes, withholding access as a means to put pressure on the system, and the importance of transparency about access to CL-treatments. Conclusion: Policies for access to non-reimbursed treatments should address stakeholders' concerns regarding transparency, equal access and solidarity, and loss of potential health benefits for patients. Multi-stakeholder dialogues are an important tool to help inform policy-making on access to newly approved (too) expensive treatments in countries facing challenges to the sustainability of healthcare systems.

Early-Phase Clinical Trials of Bio-Artificial Organ Technology: A Systematic Review of Ethical Issues.

Regenerative medicine has emerged as a novel alternative solution to organ failure which circumvents the issue of organ shortage. In preclinical research settings bio-artificial organs are being developed. It is anticipated that eventually it will be possible to launch first-in-human transplantation trials to test safety and efficacy in human recipients. In early-phase transplantation trials, however, research participants could be exposed to serious risks, such as toxicity, infections and tumorigenesis. So far, there is no ethical guidance for the safe and responsible design and conduct of early-phase clinical trials of bio-artificial organs. Therefore, research ethics review committees will need to look to related adjacent fields of research, including for example cell-based therapy, for guidance. In this systematic review, we examined the literature on early-phase clinical trials in these adjacent fields and undertook a thematic analysis of relevant ethical points to consider for early-phase clinical trials of transplantable bio-artificial organs. Six themes were identified: cell source, risk-benefit assessment, patient selection, trial design, informed consent, and oversight and accountability. Further empirical research is needed to provide insight in patient perspectives, as this may serve as valuable input in determining the conditions for ethically responsible and acceptable early clinical development of bio-artificial organs.

Ethical Frameworks for Disclosure of Alzheimer Disease Biomarkers to Research Participants: Conflicting Norms and a Nuanced Policy.

More and more frequently, clinical trials for Alzheimer disease (AD) are targeting cognitively unimpaired individuals who are at increased risk of developing the disease. It is not always clear whether AD biomarker information should be disclosed to research participants: on the one hand, research participants may be interested in learning this information because of its perceived utility, but on the other hand, learning this information may be harmful, as there are very few effective preventive or therapeutic options available for AD. In this article, we bring together three separate sets of ethical guidance literature: on the return of individual research results, on an individual's right to access personal data, and on transparent enrollment into clinical trials. Based on these literatures, we suggest policies for the disclosure of AD biomarker test results in longitudinal observational cohort studies, clinical trials, and hybrid research projects, such as the European Prevention of Alzheimer's Dementia (EPAD) project, in which we served as an ethics team. We also present and critically discuss recommendations for disclosure of AD biomarkers in practice. We underscore that, as long as the clinical validity of AD biomarkers remains limited, there are good reasons to avoid actively disclosing them to cognitively unimpaired research participants.

Physicians' Perspectives on Ethical Issues Regarding Expensive Anti-Cancer Treatments: A Qualitative Study.

BACKGROUND: When anti-cancer treatments have been given market authorization, but are not (yet) reimbursed within a healthcare system, physicians are confronted with ethical dilemmas. Arranging access through other channels, e.g., hospital budgets or out-of-pocket payments by patients, may benefit patients, but leads to unequal access. Until now, little is known about the perspectives of physicians on access to non-reimbursed treatments. This interview study maps the experiences and moral views of Dutch oncologists and hematologists. METHODS: A diverse sample of oncologists and hematologists (n = 22) were interviewed. Interviews were analyzed thematically using Nvivo 12 qualitative data software. RESULTS: This study reveals stark differences between physicians' experiences and moral views on access to anti-cancer treatments that are not (yet) reimbursed: some physicians try to arrange other ways of access and some physicians do not. Some physicians inform patients about anti-cancer treatments that are not yet reimbursed, while others wait for reimbursement. Some physicians have principled moral objections to out-of-pocket payment, while others do not. CONCLUSION: Oncologists and hematologists in the Netherlands differ greatly in their perspectives on access to expensive anti-cancer treatments that are not (yet) reimbursed. As a result, they may act differently when confronted with dilemmas in the consultation room. Physicians working in different healthcare systems may face similar dilemmas.

Preferences of women with a vulnerable health status towards nudging for adequate pregnancy preparation as investment in health of future generations: a qualitative study.

BACKGROUND: Women with a vulnerable health status, as determined by a low socioeconomic status and poor lifestyle behaviours, are at risk for adverse pregnancy outcomes. Offering tailored preconception lifestyle care can significantly help to improve pregnancy outcomes. We hypothesize that so-called 'nudges' can be a successful way of increasing the uptake of preconception lifestyle care. A nudge is a behavioural intervention that supports healthy choices by making them easier to choose. Nudging, however, raises many moral questions. Effectiveness and respect for autonomy are, among other criteria, required for a nudge to be morally permissible. In general, the target group knows best what they find permissible and what would motivate them to change their lifestyle. Therefore, this study - conducted in women with a vulnerable health status - aimed to identify their preferences towards a nudge, provided via a mobile application that aims to help them adopt healthy lifestyle behaviours by offering rewards.  METHODS: We conducted semi-structured interviews with twelve women with a vulnerable health status. A framework approach was used to analyse the data. A thematic content analysis was conducted on five themes: (1) "Usefulness of an app as an integral information source", (2) "Permissibility and effects of offering rewards", (3) "Preferences regarding content", (4) "Preferences regarding type of rewards and system of allocation", and (5) "Barriers". RESULTS: Of the 12 participants, 11 deemed an app as integral information source concerning the preconception period useful. None of the participants objected to being nudged i.e., being rewarded for healthy behaviour. All participants stated that they would like the app to contain information on healthy nutrition and 8 participants wanted to know how to get pregnant quickly. Furthermore, participants stated that the freedom to choose the timing and content of the reward would increase the probability of successful behavioural change, and having to pay or contact a healthcare provider to access the app may prevent women using the app. CONCLUSIONS: These insights into the preferences of women with a vulnerable health status towards nudging will inform the design of an effective app-based nudge. This may help to improve prepregnancy health as investment in health of current and future generations.

Should Doctors Offer Biomarker Testing to Those Afraid to Develop Alzheimer's Dementia? : Applying the Method of Reflective Equilibrium for a Clinical Dilemma.

An increasing number of people seek medical attention for mild cognitive symptoms at older age, worried that they might develop Alzheimer's disease. Some clinical practice guidelines suggest offering biomarker testing in such cases, using a brain scan or a lumbar puncture, to improve diagnostic certainty about Alzheimer's disease and enable an earlier diagnosis. Critics, on the other hand, point out that there is no effective Alzheimer treatment available and argue that biomarker tests lack clinical validity. The debate on the ethical desirability of biomarker testing is currently polarized; advocates and opponents tend to focus on their own line of arguments. In this paper, we show how the method of reflective equilibrium (RE) can be used to systematically weigh the relevant arguments on both sides of the debate to decide whether to offer Alzheimer biomarker testing. In the tradition of RE, we reflect upon these arguments in light of their coherence with other argumentative elements, including relevant facts (e.g. on the clinical validity of the test), ethical principles, and theories on societal ideals or relevant concepts, such as autonomy. Our stance in the debate therefore rests upon previously set out in-depth arguments and reflects a wide societal perspective.

Ethical Issues of Digital Twins for Personalized Health Care Service: Preliminary Mapping Study.

BACKGROUND: The concept of digital twins has great potential for transforming the existing health care system by making it more personalized. As a convergence of health care, artificial intelligence, and information and communication technologies, personalized health care services that are developed under the concept of digital twins raise a myriad of ethical issues. Although some of the ethical issues are known to researchers working on digital health and personalized medicine, currently, there is no comprehensive review that maps the major ethical risks of digital twins for personalized health care services. OBJECTIVE: This study aims to fill the research gap by identifying the major ethical risks of digital twins for personalized health care services. We first propose a working definition for digital twins for personalized health care services to facilitate future discussions on the ethical issues related to these emerging digital health services. We then develop a process-oriented ethical map to identify the major ethical risks in each of the different data processing phases. METHODS: We resorted to the literature on eHealth, personalized medicine, precision medicine, and information engineering to identify potential issues and developed a process-oriented ethical map to structure the inquiry in a more systematic way. The ethical map allows us to see how each of the major ethical concerns emerges during the process of transforming raw data into valuable information. Developers of a digital twin for personalized health care service may use this map to identify ethical risks during the development stage in a more systematic way and can proactively address them. RESULTS: This paper provides a working definition of digital twins for personalized health care services by identifying 3 features that distinguish the new application from other eHealth services. On the basis of the working definition, this paper further layouts 10 major operational problems and the corresponding ethical risks. CONCLUSIONS: It is challenging to address all the major ethical risks that a digital twin for a personalized health care service might encounter proactively without a conceptual map at hand. The process-oriented ethical map we propose here can assist the developers of digital twins for personalized health care services in analyzing ethical risks in a more systematic manner.

Diversity of interpretations of the concept "patient-centered care for breast cancer patients"; a scoping review of current literature.

RATIONALE, AIMS AND OBJECTIVES: Patient-centered care is considered a vital component of good quality care for breast cancer patients. Nevertheless, the implementation of this valuable concept in clinical practice appears to be difficult. The goal of this study is to bridge the gap between theoretical elaboration of "patient-centered care" and clinical practice. To that purpose, a scoping analysis was performed of the application of the term "patient-centered care in breast cancer treatment" in present-day literature. METHOD: For data-extraction, a literature search was performed extracting references that were published in 2018 and included the terms "patient-centered care" and "breast cancer". The articles were systematically traced for answers to the following three questions: "What is patient-centered care?", "Why perform patient-centered care?", and "How to realize patient-centered care?". For the content analysis, these answers were coded and assembled into meaningful clusters until separate themes arose which concur with various interpretations of the term "patient-centered care". RESULTS: A total of 60 publications were retained for analysis. Traced answers to the three questions "what", "why", and "how" varied considerably in recent literature concerning breast cancer treatment. Despite the inconsistent use of the term "patient-centered care," we did not find any critical consideration about the nature of the concept, regardless of the applied interpretation. Interventions that are supposed to contribute to the heterogeneous concept of patient-centered care as such, seem to be judged desirable, virtually without empirical justification. CONCLUSIONS: We propose, contrary to previous efforts to define "patient-centered care" more accurately, to embrace the heterogeneity of the concept and apply "patient-centered care" as an umbrella-term for all healthcare that intends to contribute to the acknowledgement of the person in the patient. For the justification of measures to realize patient-centered care for breast cancer patients, instead of a mere contribution to the abstract concept, we insist on the demonstration of desirable real-world effects.

Health and disease as practical concepts: exploring function in context-specific definitions.

Despite the longstanding debate on definitions of health and disease concepts, and the multitude of accounts that have been developed, no consensus has been reached. This is problematic, as the way we define health and disease has far-reaching practical consequences. In recent contributions it is proposed to view health and disease as practical- and plural concepts. Instead of searching for a general definition, it is proposed to stipulate context-specific definitions. However, it is not clear how this should be realized. In this paper, we review recent contributions to the debate, and examine the importance of context-specific definitions. In particular, we explore the usefulness of analyzing the relation between the practical function of a definition and the context it is deployed in. We demonstrate that the variety of functions that health and disease concepts need to serve makes the formulation of monistic definitions not only problematic but also undesirable. We conclude that the analysis of the practical function in relation to the context is key when formulating context-specific definitions for health and disease. At last, we discuss challenges for the pluralist stance and make recommendations for future research.

Informed Decision-Making and Capabilities in Population-based Cancer Screening.

Informed decision-making (IDM) is considered an important ethical and legal requirement for population-based screening. Governments offering such screening have a duty to enable invitees to make informed decisions regarding participation. Various views exist on how to define and measure IDM in different screening programmes. In this paper we first address the question which components should be part of IDM in the context of cancer screening. Departing from two diverging interpretations of the value of autonomy-as a right and as an ideal-we describe how this value is operationalized in the practice of informed consent in medicine and translate this to IDM in population-based cancer screening. Next, we specify components of IDM, which is voluntariness and the requirements of disclosure and understanding. We argue that whereas disclosure should contain all information considered relevant in order to enable authentic IDM, understanding of basic information is sufficient for a valid IDM. In the second part of the paper we apply the capability approach in order to argue for the responsibility of the government to warrant equal and real opportunities for invitees for IDM. We argue that additional conditions beyond mere provision of information are needed in order to do so.

Views on Early Diagnosis of Alzheimer's Disease Among Dutch Physicians: A Qualitative Interview Study.

BACKGROUND: Hope for future treatments to prevent or slow down dementia motivates researchers to strive for ever-earlier diagnoses of Alzheimer's disease (AD) based on biomarkers, even before symptoms occur. But is a biomarker-based early diagnosis desirable in clinical practice? OBJECTIVE: This study explores the ethical considerations that shape current clinical practice regarding early AD diagnostics and the use of biomarkers. METHODS: In this qualitative study, Dutch physicians were interviewed. Topics included physicians' views concerning early AD diagnosis in persons with no or mild cognitive impairment, physicians' considerations regarding current and expected future practices of early AD diagnosis, the use of biomarkers, and the use of the concepts preclinical and prodromal AD. We analyzed the transcripts using directed content analysis. RESULTS: 15 general practitioners, neurologists, and geriatricians in the Netherlands were interviewed. Most of them interpreted an early AD diagnosis with an early diagnosis of dementia. We identified six clusters of considerations sometimes in favor but most often against pursuing an early AD diagnosis in people with no or mild cognitive impairment that influence physicians' diagnostic decision-making: preferences and characteristics of persons, test characteristics, impact on care, type of setting, disease concepts, and issues on a societal level. CONCLUSION: The discussion concerning an early AD diagnosis based on biomarkers which is widely held in the scientific field, has not entered clinical practice structurally. A biomarker-based early diagnosis does not fit within Dutch physicians' views on what good care for people with no, subjective, or mild cognitive impairment should entail.