[Medical Necessity: A Notoriously Fuzzy and Therefore Dispensable Concept?] / Medizinische Notwendigkeit: Ein entbehrlicher, da notorisch unscharfer Begriff?

The concept of a 'medical necessity' (medN) of interventions is used as a dichotomous attribute with steering and orientating function in various contexts without, however, being precisely defined. We see this lack as a virtue if medN is understood as the dynamic result of transparent, trustworthy, and coherent deliberative procedures on both facts and norms. We suggest using the medN concept relative to health care systems, but independent of economic aspects.

[Medical Methods: What Makes them Necessary? Part I: Medical Methods, medical Necessity and its Main Criteria]. / Medizinische Behandlungsmethoden: Was macht sie medizinisch notwendig? Teil I: Medizinische Methoden, medizinische Notwendigkeit und ihre Hauptkriterien.

OBJECTIVES: "Medical necessity" (MedN) is a fuzzy term. Our project aims at concretising the concept between medical ethics, social law, and social medicine to support health care regulation, primarily within Germany's statutory health insurance system. In a previous publication we identified MedN as a tripartite predicate: A specific clinical condition requires a specific medical intervention to reach a specific medical goal. Our two-part text searches for and discusses criteria to classify medical methods as generally medically necessary (medn), provided a non-trivial clinical condition and a relevant, legitimate, and reachable goal actually exist. In this paper we present the first part of our results. METHODS: Based on an extensive ethical, sociolegal and sociomedical body of literature, and starting with an non-controversial case vignette (thrombolysis in acute stroke), we generally followed a critical reconstructive approach. First we defined the term "medical method". In several interdisciplinary rounds, we then collected and discussed criteria from three sources: methods to develop clinical practice guidelines as compendia of indication rules, the National Model of Prioritisation in Swedish Health Care, and the HTA Core Model of the European Network for Health Technology Assessment as an instrument of political counselling. RESULTS: We identified general clinical efficacy and benefit as the 2 main "medical" criteria of MedN. As a third - epistemic - criterion, the corresponding bodies of evidence are always to be considered. Since clinical and prioritising guidelines grade their recommendations, the question arises whether MedN should be conceptualised as a dichotomous or finer graded predicate. In accord with German social law we advocate for the binary form. Further discussions focused on multifactorial MedN-configurations, the range of the term, and the variability of evidence requirements. CONCLUSIONS: No matter how the content of MedN is conceptualised, it seems impossible to include its criteria in an algorithm. So deliberative effort is indispensable at any stage of developing a programme to classify medical methods as medically necessary.

[Medical Methods: What Makes them Medically Necessary? Part II: Further Criteria, Overuse, Moving Thresholds, and Grey Zones]. / Medizinische Behandlungsmethoden: Was macht sie medizinisch notwendig? Teil II: Weitere Kriterien, Übermaßverbot, wandernde Grenzen und Grauzonen.

OBJECTIVES: "Medical necessity" (MedN) is a fuzzy term. Our project aims at concretising the concept between medical ethics, social law, and social medicine to support health care regulation, primarily within Germany's statutory health insurance system. In Part I, we identified efficacy, (net)benefit, and the corresponding bodies of evidence as obligatory criteria of MedN. This is the second part suggesting and discussing further criteria. METHODS: See Part I RESULTS: (Part II): As further MedN-criteria we critically assessed a method's effectiveness and acceptance in routine care, its potential beneficiaries, theoretical fundament, cost, and being without alternative as well as patients' self-responsibility, cooperation, and preferences. Since MedN has both lower and upper bounds, we had to consider certain cases of mis- and overuse, due for instance to "indication creep" or "disease mongering". CONCLUSIONS: The additional criteria neither establish MedN (when met singly or together) nor exclude it (when not met). If MedN is rejected in view of the 3 obligatory criteria then further information does not overturn the verdict. If a method is already assessed as being medn then further criteria do not make it "more or less necessary". Though we advocated for a binary MedN-concept (Part I) we are nonetheless convinced that not all medical methods deemed medn are equally medically relevant. Respective differences within the range of MedN could be assessed by techniques to prioritise medical conditions, methods, and aims.

[The Münsteraner Memorandum on Alternative Practitioners - Analysis and evaluation of critical commentaries]. / Münsteraner Memorandum Heilpraktiker ­ Analyse und Bewertung kritischer Kommentare.

With its "Münsteraner Memorandum on Alternative Practitioners" the author collective "Münsteraner Kreis" has recently criticized current German double standards for physicians versus alternative practitioners with regard to minimal competency and to quality assurance. The authors' main goal was to attract attention to the problem and to provide systematic arguments in favor of a healthcare system that is serving patients' needs more appropriately. Reactions to the Memorandum were numerous, divergent in their evaluations, often constructive, and frequently emotionally heated. Here, we collect, analyse and evaluate only the critical voices in order to sharpen the positions presented in the Memorandum, upgrade them if necessary, and identify areas in need of further research. For greater clarity, we standardize the objections, sort them into categories, subject them to theoretical and empirical plausibility analysis, and discuss their significance for the positions we have adopted.

[Placebo Nocebo Ethics in Communicating with Patients How Anaesthesiologists Should Handle the Psychosomatic Dimension of Briefing]. / Placebo-Nocebo-Ethik für die Patientenkommunikation.

The briefing of patients is part of the daily routine of clinical anaesthesiologists and a central element for justification of medical treatment. It is increasingly apparent that such conversations can significantly affect the success of treatment by eliciting placebo and nocebo effects. Placebo effects are psychosocially caused clinical improvements, mediated by neurobiological mechanisms, which would be omitted in the case of hidden application. Nocebo effects are deteriorations, caused by the same mechanism. Anesthesiologists can make use of the knowledge about placebo and nocebo effects to increase positive impact on the outcome of treatment and to reduce negative effects at the same time. To do so legitimately, physicians have to balance the respect for patients' autonomy, the benevolence, and the non-maleficence for their patients. Patient's autonomy remains the supreme principle of the briefing about treatment and is institutionalized by the informed consent paradigm. Positive and negative expectations are to be handled by patient-oriented communication, but hard paternalistic deceptions and omissions are ethically unjustifiable. We will examine the practical strategies that could be used to deal with the imminent conflict between profound information and optimising placebo and nocebo responses. One key stone of these strategies is the pilot model. It helps to shape briefings as individually required and to promote the wellbeing and autonomy of our patients at the very same time.

[CAM products as therapeutic placebos: theoretical and bioethical reflections]. / CAM-Präparate als therapeutische Placebos: wissenschaftstheoretische und medizinethische Überlegungen.

In Germany as well as in many other countries the project of 'integrating' CAM interventions into conventional medicine is currently underway. It is a highly contested endeavour. One backdoor of justifying CAM interventions - even if, according to the scientific standards of conventional medicine, they have been proved to lack specific effectiveness - is their use as therapeutic placebos. In this paper we will first discuss general critical considerations regarding deceptive placebo use and then argue that in the specific case of CAM interventions used as placebos general ethical reservations are reinforced by the fact that their use is prone to promote a non- or antiscientific attitude among physicians and patients, which we consider highly problematic.

[The concept of complementary and alternative medicine from the perspective of the philosophy of science and bioethics]. / Komplementär- und Alternativmedizin: der Begriff im Licht wissenschaftstheoretischer und -ethischer Überlegungen.

Decisions about therapeutic interventions to be made by physicians, patients, and healthcare purchasers essentially depend on their classification in a credible context of justification, especially in a world dominated by contradicting experts. To some extent, this framing is done by sorting terms and their undertones, including the case of so-called CAM measures. In this paper, the authors reflect on ways to deal with the term CAM and the underlying supply-side approaches to healthcare from a primarily science-oriented perspective.

[Stakeholder participation in priority setting - a consideration of the normative status of quantitative and qualitative methods]. / Stakeholderpartizipation und Priorisierung - eine Betrachtung des normativen Status quantitativer und qualitativer Methoden.

Priority setting in medicine is generally regarded as an appropriate means for preparing just allocation of medical resources. By involving the general public or affected stakeholders in priority setting, advocates hope to legitimise this process and increase the acceptability of future decisions on resource allocation. Here, we differentiate between two ideal-typical methods of stakeholder involvement: 1) qualitative and 2) quantitative ones. We argue that the level of information of participants is important to the quality of the outcome of participatory events. Qualitative methods aim at fostering deliberative discussions among well-informed stakeholders. By contrast, quantitative methods usually do not have the capacity to ensure or, at least, control the level of information that participants use to guide their decisions. Hence, we conclude that in the context of priority setting qualitative and especially deliberative methods are preferable to quantitative approaches.

[Rationing health care by thresholds for clinical benefit and its acceptance by the German population]. / Leistungsbeschränkungen in der Medizin nach Maßgabe von Nutzen-Schwellen: Akzeptanz in der deutschen Bevölkerung?

Fair rationing in publicly accessible health care has become a subject of current international debate. One suggestion is to cut reimbursement for any medical intervention below some threshold of small clinical benefit. One can further differentiate between thresholds of small expectable clinical benefit as such and thresholds of low chances for clinical success. Public acceptance of both types of thresholds has been tested in a population survey. Results are presented and discussed in this paper. (As supplied by publisher).