Background : researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to the trial drug (...) and the uses of such reasons. Data sources: databases in science/medicine, law and ethics, thesis databases, bibliographies, research ethics books and included publications’ notes/bibliographies. Publication selection: a publication was included if it included a reason as above. See article for detailed inclusion conditions. Data extraction and analysis: two reviewers extracted and analyzed data on publications and reasons. Results: of 2060 publications identified, 75 were included. These mentioned reasons based on morality, legality, interests/incentives, or practicality, comprising 36 broad (235 narrow) types of reason. None of the included publications, which included informal reviews and reports by official bodies, mentioned more than 22 broad (59 narrow) types. For many reasons, publications differed about the reason’s interpretation, implications and/or persuasiveness. Publications differed also regarding costs, feasibility and legality of PTA. Limitations: reason types could be applied differently. The quality of reasons was not measured. Conclusion: this review captured a greater variety of reasons and of their uses than any included publication. Decisions based on informal reviews or sub-sets of literature are likely to be biased. Research is needed on PTA ethics, costs, feasibility and legality and on assessing the quality of reason-based literature. (shrink)

Although rationing of scarce health-care resources is inevitable in clinical practice, there is still limited and scattered information about how physicians perceive and execute this bedside rationing (BSR) and how it can be performed in an ethically fair way. This review gives a systematic overview on physicians’ perspectives on influences, strategies, and consequences of health-care rationing. Relevant references as identified by systematically screening major electronic databases and manuscript references were synthesized by thematic analysis. Retrieved studies focused on themes that fell (...) under three major headings: (i) conditions and influences of BSR, (ii) strategies of BSR, and (iii) consequences of BSR. The range of themes indicates that physicians’ rationing behavior is highly variable, strongly influenced by context-related factors, and consists mainly of implicit rationing strategies. Torn between patient advocacy and the obligation to contain costs, physicians experience various role conflicts. The development of explicit rationing strategies seems necessary to avoid arbitrary BSR and allow a fair allocation of health-care resources. (shrink)

Background While there are many guidelines on how to make ethical decisions at the end of life, there is little evidence regarding the quality of this sort of ethical guidelines. Objectives First, this study aims to demonstrate the conceptual transferability of the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument for the quality assessment of ethical guidelines. Second, it aims to illustrate the status quo of the quality of guidelines on end-of-life decision-making by using the AGREE instrument in a (...) first practice test. Method The transferability of the AGREE instrument on the quality assessment of ethical guidelines is demonstrated by conceptual analysis. Guidelines on end-of-life decisions in medicine are identified through a systematic search in MEDLINE (from June 1999 to June 2009). The quality of all included guidelines was assessed with a slightly modified AGREE instrument. Results Of 103 guidelines identified, 34 were included as relevant. The majority of the guidelines analysed in this study were assessed as qualitatively insufficient in five out of six AGREE quality domains. A few guidelines demonstrated, however, that a high level of quality in accordance with the AGREE requirements is possible. Conclusion This review concludes that the quality of many ethical guidelines should and can be improved in all quality domains specified by the AGREE instrument. Furthermore, conceptual analysis indicates that a slightly modified AGREE instrument is transferable to the comprehensive evaluation of the quality of ethical guidelines. Nevertheless, future research is needed to improve the assessment of the presentation of the guidelines' normative basis. (shrink)

Background: Publications and discussions of survey research in empirical bioethics have steadily increased over the past two decades. However, findings often differ among studies with similar research questions. As a consequence, ethical reasoning that considers only parts of the existing literature and does not apply systematic reviews tends to be biased. To date, we lack a systematic review (SR) methodology that takes into account the specific conceptual and practical challenges of empirical bioethics. Methods: The steps of systematically reviewing empirical findings (...) in bioethics are presented and critically discussed. In particular, (a) the limitations of traditional SR methodologies in the field of empirical bioethics are critically discussed, and (b) conceptual and practical recommendations for SRs in empirical bioethics that are (c) based on the authors’ review experiences in healthcare ethics are presented. Results: A 7-step approach for SRs of empirical bioethics is proposed: (1) careful definition of review question; (2) selection of relevant databases; (3) application of ancillary search strategies; (4) development of search algorithms; (5) relevance assessment of the retrieved references; (6) quality assessment of included studies; and (7) data analysis and presentation. Conceptual and practical challenges arise because of various peculiarities in reviewing empirical bioethics literature and can lead to biased results if they are not taken into account. Conclusions: If suitably adapted to the peculiarities of the field, SRs of empirical bioethics provide transparent information for ethical reasoning and decision-making that is less biased than single studies. (shrink)

Most contributions to the current debate about the consideration and application of empirical information in ethics scholarship deal with epistemological issues such as the role and the meaning of empirical research in ethical reasoning. Despite the increased publication of empirical data in ethics literature we still lack systematic analyses and conceptual frameworks that would help us to understand the rarely discussed methodological and practical problems in appraising empirical research. This paper demonstrates the need for critical appraisal and its crucial methodological (...) role in the application of empirical information in ethical reasoning. Furthermore, it systematically examines the criteria and the appropriate appraisal of empirical research and the associated challenges by highlighting current problems in empirical ethics literature. These problems reveal the following challenges for a critical and responsible consideration of empirical information in ethical reasoning: (i) training in the basic skills of locating and communicating empirical data from the relevant studies; (ii) training in basic knowledge of how to critically appraise empirical (qualitative and quantitative) research and its results; (iii) determination of quality standards for empirical ethics research; (iv) adequate reporting of the methodology and results of empirical ethics research in scientific journals. (shrink)