Completed dissertations

Institute of History, Ethics and Philosophy of Medicine

Doctoral candidate

Hannes Kahrass

Title of the dissertation

Dealing with ethical-normative information in the context of evidence-based health care - Systematic reviews and status quo analyses using the example of clinical guidelines and editorial guidelines

Abstract

Background: Evidence-based healthcare aims at informed decisions. This means that in addition to the wishes, preferences and concerns of the individuals concerned, scientific evidence should also be taken into account in the decision-making process. As decisions in healthcare often also include ethical aspects, ethical-normative information - in the same way as descriptive-statistical information - should be systematically compiled and made transparent. However, there are currently no established standards for this and it is unclear how this lack affects the consideration of ethical issues in medical guidelines in practice.

The 'best available scientific evidence' is essentially obtained from specialist publications. It is therefore crucial that all relevant information for further use is reported. To ensure this, a number of guidelines and measures have been developed, such as the Declaration of Helsinki and Reporting Guidelines, which also take into account subject protection and scientific quality. Editors are in a central position, but it is unclear to what extent they support orientation and compliance with the above-mentioned guidelines and measures.

Aim: To 1) conduct systematic reviews on ethical issues in health care ("dementia" and "chronic renal failure"), 2) assess the consideration of ethical issues in medical guidelines, and 3) analyze the references to key requirements and measures for subject protection, scientific quality and full reporting in editorial guidelines.

Methods: Systematic reviews on ethical issues in the care of people with dementia and chronic insufficiency will be conducted. The procedure is based on the "classical" methods for reviews, as described in the Cochrane Handbook, among others. The methodology is adapted to the object of investigation ("ethical issues") using elements of qualitative research, in particular Mayring's summarizing content analysis. The theoretical background for the understanding of ethics is the principles model by Beauchamp and Childress. The range of dementia topics developed serves as the basis for a status quo analysis of the consideration of ethical topics in twelve medical care guidelines.

The content of editorial guidelines is analyzed on the basis of the following topics: 1) references to institutions that define specific guidelines, 2) reporting guidelines such as CONSORT, STARD, STROBE, MOOSE and PRISMA and 3) measures and instruments for the protection of test subjects and for ensuring scientific quality such as informed consent, the ethics vote, study registration and the regulation of conflicts of interest. The results are analyzed and presented quantitatively and qualitatively.

Results: The "classical" approach for systematic reviews, slightly adapted and supplemented by qualitative methods, is suitable for the development of comprehensive qualitative spectra of ethical topics. We identified 31 ethical issues for dementia and 27 for chronic insufficiency. Of the guidelines analyzed, none is ethics-free, but there are large differences, particularly in terms of a) the number of mentions (20% to 77%), b) recommendations given (10% to 71%) and c) supplementary and further information (0% to 76%).

A minority of 123 publishers refer to reporting guidelines in the editorial guidelines (8% on average). More than half of them mention relevant institutions in this context (42% on average) and measures that work towards scientific quality and the protection of persons (58% on average). Significantly fewer editorial guidelines specify their information, e.g. 11% request the registration number from the study register and 6% ask for details on informed consent.

Discussion: Systematic approaches to researching ethical and normative information should be used to a greater extent in order to create a reliable basis for evidence-based healthcare. The heterogeneity observed in the consideration of ethical issues in medical guidelines can only be explained to a limited extent by the different healthcare contexts. Although questions and challenges remain unresolved, minimum standards can and should be implemented in the development of decision-making principles in healthcare.

Publishers should use their influential position to draw more attention to recognized guidelines and measures to ensure and increase scientific quality, the protection of test subjects and the publication of all relevant information. To this end, the editorial guidelines should be expanded and concretized.