Tanja Krones

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.

Effective continuing professional development for translating shared decision making in primary care: A study protocol

BackgroundShared decision making (SDM) is a process by which a healthcare choice is made jointly by the healthcare professional and the patient. SDM is the essential element of patient-centered care, a core concept of primary care. However, SDM is seldom translated into primary practice. Continuing professional development (CPD) is the principal means by which healthcare professionals continue to gain, improve, and broaden the knowledge and skills required for patient-centered care. Our international collaboration seeks to improve the knowledge base of CPD that targets translating SDM into the clinical practice of primary care in diverse healthcare systems.MethodsFunded by the Canadian Institutes of Health Research (CIHR), our project is to form an international, interdisciplinary research team composed of health services researchers, physicians, nurses, psychologists, dietitians, CPD decision makers and others who will study how CPD causes SDM to be practiced in primary care. We will perform an environmental scan to create an inventory of CPD programs and related activities for translating SDM into clinical practice. These programs will be critically assessed and compared according to their strengths and limitations. We will use the empirical data that results from the environmental scan and the critical appraisal to identify knowledge gaps and generate a research agenda during a two-day workshop to be held in Quebec City. We will ask CPD stakeholders to validate these knowledge gaps and the research agenda.DiscussionThis project will analyse existing CPD programs and related activities for translating SDM into the practice of primary care. Because this international collaboration will develop and identify various factors influencing SDM, the project could shed new light on how SDM is implemented in primary care.

Shared decision making development in Switzerland: room for improvement!

In Switzerland there is a strong movement at a national policy level towards strengthening patient rights and patient involvement in health care decisions. Yet, there is no national programme promoting shared decision making. First decision support tools (prenatal diagnosis and screening) for the counselling process have been developed and implemented. Although Swiss doctors acknowledge that shared decision making is important, hierarchical structures and asymmetric physician-patient relationships are still prevailing. The last years have seen some promising activities regarding the training of medical students and the development of patient support programmes. Swiss direct democracy and the habit of consensual decision making and citizen involvement in general may provide a fertile ground for SDM development in the primary care setting.

Arriba: effects of an educational intervention on prescribing behaviour in prevention of CVD in general practice

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.

How can continuing professional development better promote shared decision-making? Perspectives from an international collaboration

BackgroundShared decision-making is not widely implemented in healthcare. We aimed to set a research agenda about promoting shared decision-making through continuing professional development.MethodsThirty-six participants met for two days.ResultsParticipants suggested ways to improve an environmental scan that had inventoried 53 shared decision-making training programs from 14 countries. Their proposed research agenda included reaching an international consensus on shared decision-making competencies and creating a framework for accrediting continuing professional development initiatives in shared decision-making.ConclusionsVariability in shared decision-making training programs showcases the need for quality assurance frameworks.

Compulsory Treatment in Chronic Anorexia Nervosa by All Means? Searching for a Middle Ground Between a Curative and a Palliative Approach

Geppert (2015) has argued that mental disorders like anorexia nervosa (AN) do not fulfill the classic criteria for futility. We agree with her central thesis that “the contention that an ‘end-stage...

Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: A systematic literature review

BackgroundAn effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identified serious ethical issues associated with this intervention. Our objective was to systematically review these aspects by means of a literature analysis.MethodsWe chose the reflexive Socratic approach as the review method using Hofmanns question list, conducted a comprehensive literature search in biomedical, psychological and ethics bibliographic databases and screened the resulting hits in a 2-step selection process. Relevant arguments were assembled from the included articles, and were assessed and assigned to the question list. Hofmanns questions were addressed by synthesizing these arguments.ResultsOf the identified 879 documents 102 included arguments related to one or more questions from Hofmanns question list. The most important ethical issues were the implementation of ASCT in clinical practice on the basis of phase-II trials in the 1990s and the publication of falsified data in the first randomized controlled trials (Bezwoda fraud), which caused significant negative effects on recruiting patients for further clinical trials and the doctor-patient relationship. Recent meta-analyses report a marginal effect in prolonging disease-free survival, accompanied by severe harms, including death. ASCT in breast cancer remains a stigmatized technology. Reported health-related-quality-of-life data are often at high risk of bias in favor of the survivors. Furthermore little attention has been paid to those patients who were dying.ConclusionsThe questions were addressed in different degrees of completeness. All arguments were assignable to the questions. The central ethical dimensions of ASCT could be discussed by reviewing the published literature.

Resolving Some, But Not All Informed Consent Issues in DCDD--the Swiss Experiences.

engagement, I think it is unlikely that communicating the details of cDCDD practice to the public will enhance the ethical acceptability of this OD/T practice in a meaningful way. The conceptual and procedural complexity of cDCDD is such that it would be difficult for an average member of the public to sustain sufficient knowledge of the practice over time to constructively inform her or his potential future role as a direct or indirect decision maker. Although, as I have suggested, disclosing accessible information at the time of the signing of an organ donor declaration could be helpful, I think that the important, detailed, informed-choice work of Consent Elements III and IV is optimally situated in real, potential-donation circumstances after the decision to withdraw life-sustaining treatment has been made. Despite my reservation about the utility of enhanced public education about cDCDD, I do believe that core stakeholders, including members of the general public, family members of organ donors, and past critical care receivers, should be directly engaged as collaborative deliberators in the development of policies that guide the practice of cDCDD within health care organizations. &

Das neue Gendiagnostikgesetz. Implikationen für die Beratung von Schwangeren zur vorgeburtlichen Diagnostik

Ohne Zusammenfassung Die Stellungnahme wurde von der Arbeitsgruppe „Reproduktionsmedizin und Embryonenschutz“ in der Akademie fur Ethik in der Medizin e. V. (AEM) erarbeitet. Mitglieder der Arbeitsgruppe waren: Dr. med. Gisela Bockenheimer-Lucius, Senckenbergisches Institut fur Geschichte und Ethik der Medizin, Universitat Frankfurt/Main; Richter am Landgericht Dr. Urs Peter Bocher, Landgericht Frankfurt am Main; Prof. Dr. med. Wolfram Henn, Institut fur Humangenetik, Universitat Homburg/Saar; Prof. Dr. Uwe Korner, Charite – Universitatsmedizin Berlin, Institut fur Geschichte der Medizin; Prof. Dr. Hartmut Kres, Abt. fur Sozialethik, Evang.-Theol. Fakultat, Universitat Bonn; PD Dr. med. Dipl.Soz. Tanja Krones, Klinische Ethik, Universitatsspital Zurich; Prof. Dr. Hans-Wilhelm Michelmann, Frauenklinik, Universitat Gottingen; Priv.-Doz. Dr. med. Christian Netzer M.A. (Phil.), Institut fur Humangenetik, Universitatsklinikum zu Koln; Dr. med. Dagmar Schmitz, Ethiek Instituut, Universiteit Utrecht; Dr. Petra Thorn, Dipl. Sozialarbeiterin, Dipl. Sozialtherapeutin, Familientherapeutin DGSF, Morfelden; Dr. Christa Wewetzer, Dipl.-Biol., Zentrum fur Gesundheitsethik, Hannover. Arbeitsgruppen in der AEM sind offene Foren fur den Austausch unterschiedlicher Standpunkte und Positionen. Der Inhalt der von ihnen veroffentlichten Beitrage wird allein von den genannten Autorinnen und Autoren verantwortet. Er reprasentiert nicht notwendigerweise die Meinung der AEM oder ihrer Organe.

Einzelthemen der Angewandten Ethik: Medizinische Ethik und ihr Umfeld

Als elementare Naturerfahrungen stehen Gesundheit und Krankheit nicht nur in einem gesellschaftlich-kulturellen Bedeutungszusammenhang, sondern unterliegen subjektiven Wahrnehmungs- und Verstehensweisen sowie individuellen Sinngebungen. Ihr anthropologischer und geisteswissenschaftlicher Charakter lasst sie zu einem zentralen Thema der Philosophie werden. Vorstellungen von der Natur des Menschen, seiner Stellung in der Welt und der Verbindung von Korper und Geist haben zu allen Zeiten das medizinische Handeln beeinflusst und den Umgang der Gesellschaft mit kranken Menschen gepragt. Gegenwartig erweitert der Strukturwandel der Medizin nicht nur das medizinische Handlungsspektrum, sondern fordert vielfach auch unsere ethische Intuition (z. B. durch Hirngewebstransplantation, neurobionische Eingriffe, PID, lebensverlangernde Masnahmen am Lebensende — etwa durch kunstliche Ernahrung mittels PEG) heraus. Gesellschaftliche Debatten uber die Grenzen medizinischen Handelns und gesundheitspolitische Entscheidungen lassen eine Prazisierung der Begriffe ›Gesundheit‹ und ›Krankheit‹ notwendig erscheinen.