Marcel Mertz

The full spectrum of ethical issues in dementia care: systematic qualitative review

BACKGROUND Integrating ethical issues in dementia-specific training material, clinical guidelines and national strategy plans requires an unbiased awareness of all the relevant ethical issues. AIMS To determine systematically and transparently the full spectrum of ethical issues in clinical dementia care. METHOD We conducted a systematic review in Medline (restricted to English and German literature published between 2000 and 2011) and Google books (with no restrictions). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in clinical dementia care. RESULTS The literature review retrieved 92 references that together mentioned a spectrum of 56 ethical issues in clinical dementia care. The spectrum was structured into seven major categories that consist of first- and second-order categories for ethical issues. CONCLUSIONS The systematically derived spectrum of ethical issues in clinical dementia care presented in this paper can be used as training material for healthcare professionals, students and the public for raising awareness and understanding of the complexity of ethical issues in dementia care. It can also be used to identify ethical issues that should be addressed in dementia-specific training programmes, national strategy plans and clinical practice guidelines. Further research should evaluate whether this new genre of systematic reviews can be applied to the identification of ethical issues in other cognitive and somatic diseases. Also, the practical challenges in addressing ethical issues in training material, guidelines and policies need to be evaluated.

Research across the disciplines: a road map for quality criteria in empirical ethics research

BackgroundResearch in the field of Empirical Ethics (EE) uses a broad variety of empirical methodologies, such as surveys, interviews and observation, developed in disciplines such as sociology, anthropology, and psychology. Whereas these empirical disciplines see themselves as purely descriptive, EE also aims at normative reflection. Currently there is literature about the quality of empirical research in ethics, but little or no reflection on specific methodological aspects that must be considered when conducting interdisciplinary empirical ethics. Furthermore, poor methodology in an EE study results in misleading ethical analyses, evaluations or recommendations. This not only deprives the study of scientific and social value, but also risks ethical misjudgement.DiscussionWhile empirical and normative-ethical research projects have quality criteria in their own right, we focus on the specific quality criteria for EE research. We develop a tentative list of quality criteria – a “road map” – tailored to interdisciplinary research in EE, to guide assessments of research quality. These quality criteria fall into the categories of primary research question, theoretical framework and methods, relevance, interdisciplinary research practice and research ethics and scientific ethos.SummaryEE research is an important and innovative development in bioethics. However, a lack of standards has led to concerns about and even rejection of EE by various scholars. Our suggested orientation list of criteria, presented in the form of reflective questions, cannot be considered definitive, but serves as a tool to provoke systematic reflection during the planning and composition of an EE research study. These criteria need to be tested in different EE research settings and further refined.

Klinische Ethik als Partnerschaft – oder wie eine ethische Leitlinie für den patientengerechten Einsatz von Ressourcen entwickelt und implementiert werden kann

ZusammenfassungEthische Leitlinien für die klinische Praxis erfreuen sich zunehmender Beliebtheit. Damit klinisch-ethische Leitlinien aber überhaupt erfolgreich wirksam werden können, ist noch Pionierarbeit zu leisten. Solche Leitlinien müssen wissenschaftlich stärker fundiert und ihre praktische Anwendbarkeit muss verbessert werden. In dieser Arbeit werden die ersten Schritte des Projekts METAP zur methodischen Entwicklung und praktischen Implementierung einer Leitlinie für eine patientengerechte Versorgung am Krankenbett beschrieben und zur Diskussion gestellt. Das Projekt orientiert sich methodisch an der Entwicklung medizinischer Leitlinien und generiert damit eine forschungs- und konsensgestützte Leitlinie, die systematischer Evaluation und Modifikation unterliegt und Rechenschaft über ihre wissenschaftliche Fundierung gibt. Zusätzlich zur Leitlinie bietet das Projekt in der Form eines Handbuchs ein Entscheidungsfindungsverfahren an, welches unter anderem deliberative Aspekte unterstützt. Das Handbuch konzentriert sich auf ethische Fragen der Mikroallokation und liefert darüber hinaus Informationen über empirische, ethische und rechtliche Grundlagen für Therapieentscheidungen. Anhand eines Eskalationsmodells können unterschiedliche Instrumente nach Bedarf als ethische Lösungsstrategien eingesetzt werden, von der Kurzfassung im Kitteltaschenformat („Leporello“) mit den wichtigsten Fakten, weiterführenden Texten und Empfehlungen mit normativen und prozeduralen Hinweisen, über stationsinterne Lösungsversuche bis hin zum Ethikkonsil. Klinische Partner sind von Beginn an aktiv in den Entwicklungsprozess eingebunden und verbessern so die Praxistauglichkeit und Akzeptanz sowie die Ausrichtung des Instrumentariums an den tatsächlichen Bedürfnissen. Dieses partnerschaftliche, partizipative Vorgehen scheint eine wichtige Voraussetzung dafür zu sein, dass METAP in der Klinik Fuß fassen konnte.AbstractDefinition of the problem Recently, ethical guidelines for clinical practice have gained increased popularity, but in order to become useful they require more pioneer’s work. Clinical-ethical guidelines need to be based on a scientific foundation and their practicability must be improved. We present and put to discussion the initial steps of the METAP Project about the development and practical implementation of a clinical-ethical guideline dedicated to a fair resource-allocation at the bedside. Arguments With its methodological orientation, the project represents a guideline which is based on both research and consensus-building, undergoing systematic evaluation and modification. In addition to the guideline, the project comes with a manual (a tool kit) including a procedural instrument for making decisions supporting deliberative aspects. It focuses on issues of micro-allocation; furthermore, it provides empirical, ethical and legal basics for making fair treatment decisions that should help to prevent overtreatment, undertreatment or discrimination in patient care. We propose an Escalation Model with various instruments serving as problem solving strategies that correspond to the respective needs; these instruments include a pocket-summary (“Leporello”) with the most important facts; further reading material; normative and procedural recommendations; ward-specific strategies, and also the option of clinical ethics consultation. Conclusion Clinical partners have been actively involved in the developmental process from the beginning and contributed to the practical applicability, acceptance and a valid need-orientation of the whole tool kit. This partnership and the participatory approach seem to have helped METAP to gain a foothold in the clinic.

Systematic and transparent inclusion of ethical issues and recommendations in clinical practice guidelines: a six-step approach.

BackgroundClinical practice guidelines (CPGs), a core tool to foster medical professionalism, differ widely in whether and how they address disease-specific ethical issues (DSEIs), and current manuals for CPG development are silent on this issue. The implementation of an explicit method faces two core challenges: first, it adds further complexity to CPG development and requires human and financial resources. Second, in contrast to the in-depth treatment of ethical issues that is standard in bioethics, the inclusion of DSEIs in CPGs need to be more pragmatic, reductive, and simplistic, but without rendering the resulting recommendations useless or insufficiently justified. This paper outlines a six-step approach, EthicsGuide, for the systematic and transparent inclusion of ethical issues and recommendations in CPGs.MethodsThe development of EthicsGuide is based on (a) methodological standards in evidence-based CPG development, (b) principles of bioethics, (c) research findings on how DSEIs are currently addressed in CPGs, and (d) findings from two proof-of-concept analyses of the EthicsGuide approach.ResultsThe six steps are 1) determine the DSEI spectrum and the need for ethical recommendations; 2) develop statements on which to base ethical recommendations; 3) categorize, classify, condense, and paraphrase the statements; 4) write recommendations in a standard form; 5) validate and justify recommendations, making any necessary modifications; and 6) address consent. All six steps necessarily come into play when including DSEIs in CPGs.ConclusionsIf DSEIs are not explicitly addressed, they are unavoidably dealt with implicitly. We believe that as ethicists gain greater involvement in decision-making about health, personal rights, or economic issues, they should make their methods transparent and replicable by other researchers; and as ethical issues become more widely reflected in CPGs, CPG developers have to learn how to address them in a methodologically adequate way. The approach proposed should serve as a basis for further discussion on how to reach these goals. It breaks open the black box of what ethicists implicitly do when they develop recommendations. Further, interdisciplinary discussion and pilot tests are needed to explore the minimal requirements that guarantee a simplified procedure which is still acceptable and does not become mere window dressing.

Standards of practice in empirical bioethics research: towards a consensus.

BackgroundThis paper reports the process and outcome of a consensus finding project, which began with a meeting at the Brocher Foundation in May 2015. The project sought to generate and reach consensus on standards of practice for Empirical Bioethics research. The project involved 16 academics from 5 different European Countries, with a range of disciplinary backgrounds.MethodsThe consensus process used a modified Delphi approach.ResultsConsensus was reached on 15 standards of practice, organised into 6 domains of research practice (Aims, Questions, Integration, Conduct of Empirical Work, Conduct of Normative Work; Training & Expertise).ConclusionsThrough articulating these standards we outline a position that encourages responses, and through those responses we will be able to identify points of agreement and contestation that will drive the conversation forward. In that vein, we would encourage researchers, funders and journals to engage with what we have proposed, and respond to us, so that our community of practice of empirical bioethics research can develop and evolve further.

The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review.

Background When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. Aim To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. Method A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. Results The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. Conclusions The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure.

Did we describe what you meant? Findings and methodological discussion of an empirical validation study for a systematic review of reasons.

BackgroundThe systematic review of reasons is a new way to obtain comprehensive information about specific ethical topics. One such review was carried out for the question of why post-trial access to trial drugs should or need not be provided. The objective of this study was to empirically validate this review using an author check method. The article also reports on methodological challenges faced by our study.MethodsWe emailed a questionnaire to the 64 corresponding authors of those papers that were assessed in the review of reasons on post-trial access. The questionnaire consisted of all quotations (“reason mentions”) that were identified by the review to represent a reason in a given author’s publication, together with a set of codings for the quotations. The authors were asked to rate the correctness of the codings.ResultsWe received 19 responses, from which only 13 were completed questionnaires. In total, 98 quotations and their related codes in the 13 questionnaires were checked by the addressees. For 77 quotations (79%), all codings were deemed correct, for 21 quotations (21%), some codings were deemed to need correction. Most corrections were minor and did not imply a complete misunderstanding of the citation.ConclusionsThis first attempt to validate a review of reasons leads to four crucial methodological questions relevant to the future conduct of such validation studies: 1) How can a description of a reason be deemed incorrect? 2) Do the limited findings of this author check study enable us to determine whether the core results of the analysed SRR are valid? 3) Why did the majority of surveyed authors refrain from commenting on our understanding of their reasoning? 4) How can the method for validating reviews of reasons be improved?

Comment on: Ethical dilemmas in antibiotic treatment

Sir, Leibovici et al. are addressing very important issues regarding the ethical dilemma in antimicrobial stewardship, such as the central question: whether we could and should value benefits in the distant future for unidentified patients as more important than benefits in the near future for an identified patient. However, some aspects in the argumentation by Leibovici et al. are problematic: (i) overlapping use of two ethical frameworks, i.e. utilitarianism and principlism; (ii) justifying the use of cost-effectiveness studies by only one ethical framework; and (iii) other ethical solutions to deal with this dilemma exist. (i) Generally, the use of different theoretical frameworks in approaching an ethical dilemma is to be encouraged because different frameworks may result in different solutions. But, importantly, one has to resolve inconsistencies that arise from using different frameworks. The two ethical approaches used by Leibovici et al. are principlism and utilitarianism. Principlism is based on the four moral principles of autonomy, beneficence, non-maleficence and justice. In contrast, the single goal of utilitarianism is to maximize ‘total utility’. The weakness in this article lies in emphasizing cost-effectiveness studies as a tool justified solely by utilitarianism while simultaneously relying on a principlistic framework. However, these two frameworks are mutually exclusive, because utilitarianism only allows one moral principle: maximizing total utility. On the other hand, principlism does not allow one of its four principles to become absolute. Thus, if cost-effectiveness studies are used as a normative instrument justified by utilitarianism, this conflicts with this tenet of principlism. When using cost-effectiveness as an operationalization of utilitarianism, respect for patient autonomy and justice is no longer a concern, as long as violations of patient autonomy and justice do not lead to a heavy loss of overall utility. The reason for this is that, in contrast to principlism, respect for autonomy and justice have no intrinsic value in utilitarianism. There are multiple theories of utilitarianism, however, and some modern versions of preference utilitarianism, e.g. the theory of Gesang, take secondary preferences, such as moral preferences, into account. If, for example, many persons wish to live in a healthcare system that always respects patient autonomy and demands informed consent, the current practice of antimicrobial stewardship would lead to a severe loss of utility, rendering the practice immoral from a utilitarian point of view. Thus, the concept of utility in utilitarianism is broader than just medical benefit. (ii) Leibovici et al. note that ‘The inclusion of costeffectiveness together with the most quoted principles of bioethics looks strange.’ While it is easier to argue for costeffectiveness within a utilitarian framework, cost-effectiveness as a means to solve an ethical dilemma can be supported by principlism as well. In fact, Beauchamp and Childress discuss cost-effectiveness as part of the principle of beneficence. What they point out, though, is that such quantitative methods may only function as auxiliary means in ethical decision-making and must not become a surrogate for decision-making. The important difference is that all four principles have to be specified and balanced. Moreover, if using principlism, the exception to the rule that Leibovici et al. introduced in the case of lifethreatening scenarios would not have to be an exception. It would be just a specification of the principle of non-maleficence, which very likely would have gained enough weight in principlistic balancing to be morally preferred to all other courses of action. So, the same result might have been possible in the argumentation without mixing conflicting ethical approaches. (iii) One could further ask if there is no possibility of reconciling the duties of non-maleficence or beneficence for unidentified patients with the duty of respect for autonomy for the actual patient. We suggest three considerations. First, analogously to tacit consent when being treated in a teaching hospital (possibly by junior doctors and residents) someone treated with antibiotics tacitly consents to non-maximum empirical treatment, as long as there is no life-threatening situation. Secondly, informed patients might accept non-maximal empirical coverage because of ethical reasoning. Thirdly, one could consider that nowadays, respect for patient autonomy already does not include the duty to do everything that a patient wishes. Specific broad-spectrum antibiotics might, as Leibovici et al. suggest, be regarded as a ‘scarce’ resource when being used for empirical treatment, and thus, these antibiotics would represent a treatment restricted to those needing it most, e.g. in transplantation. In summary, restricting universal coverage in empirical treatment can be justified within various ethical frameworks. Cost-effectiveness analysis as a measure to solve the ethical dilemma can be used in a utilitarianistic or principlistic ethical framework. In order to assess the dilemma in the patient– doctor relationship, empirical studies should be conducted addressing what patients would accept in terms of non-maximal Letters to the Editor

Beyond integrating social sciences: Reflecting on the place of life sciences in empirical bioethics methodologies

Empirical bioethics is commonly understood as integrating empirical research with normative-ethical research in order to address an ethical issue. Methodological analyses in empirical bioethics mainly focus on the integration of socio-empirical sciences (e.g. sociology or psychology) and normative ethics. But while there are numerous multidisciplinary research projects combining life sciences and normative ethics, there is few explicit methodological reflection on how to integrate both fields, or about the goals and rationales of such interdisciplinary cooperation. In this paper we will review some drivers for the tendency of empirical bioethics methodologies to focus on the collaboration of normative ethics with particularly social sciences. Subsequently, we argue that the ends of empirical bioethics, not the empirical methods, are decisive for the question of which empirical disciplines can contribute to empirical bioethics in a meaningful way. Using already existing types of research integration as a springboard, five possible types of research which encompass life sciences and normative analysis will illustrate how such cooperation can be conceptualized from a methodological perspective within empirical bioethics. We will conclude with a reflection on the limitations and challenges of empirical bioethics research that integrates life sciences.

EMPIRISCHE GRUNDLAGEN DER ÜBER-, UNTER- UND UNGLEICHVERSORGUNG

Die Zuteilung medizinischer und pflegerischer Leistungen am Krankenbett (Mikroallokation) steht im Spannungsfeld zwischen Kostendruck mit dem Risiko fur Benachteiligung und High-Tec Therapie mit dem Risiko fur Uberversorgung. Benachteiligung wie auch Uberversorgung werfen ethische Fragen auf.