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Moral case deliberation is one form of clinical ethics support, and there seems to be different ways of facilitating thedialogue. This paper aimed to explore the personal experiences of Swedish facilitators of their role in moral casedeliberations. Being a facilitator was understood through the metaphor of sailing: against the wind or with it. Therole was likened to a sailor’s set of skills: to promote security and well-being of the crew, to help crew navigate theirmoral reflections, to sail a course into the wind against homogeneity, to accommodate the crew’s needs and just sail withthe wind, and to steer towards a harbour with authority and expertise. Balancing the disparate roles of being accom-modative and challenging may create a free space for emotions and ideas, including self-reflection and consideration ofmoral demands. This research opens the question of whether all these skills can be taught through systematic training orwhether facilitators need to possess the characteristics of being therapeutic, pedagogical, provocative, sensitive andauthoritarian.

This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are available, how they are constructed and their goals in supporting healthcare personnel in clinical practice. This study engages in an integrative literature review. We searched for peer-reviewed academic articles written in English between 2000 and 2016 using specific Mesh terms and manual keywords in CINAHL, MEDLINE and Psych INFO databases. In total, 54 articles worldwide described clinical ethics support approaches that include clinical ethics consultation, clinical ethics committees, moral case deliberation, ethics rounds, ethics discussion groups, and ethics reflection groups. Clinical ethics consultation and clinical ethics committees have various roles and functions in different coun-tries. They can provide healthcare personnel with advice and recommendations regarding the best course of action. Moral case deliberation, ethics rounds, ethics discussion groups and ethics reflection groups support the idea that group reflection increases insight into ethical issues. Clinical ethics support in the form of a ‘‘bot-tom-up’’ perspective might give healthcare personnel opportunities to think and reflect more than a ‘‘top-down’’ perspective. A ‘‘bottom-up’’ approach leaves the healthcare personnel with the moral responsibility for their choice of action in clinical practice, while a ‘‘top-down’’ approach risks removing such moral responsibility.

Background

There is increasing interest in involving patient preferences for benefits and risks in regulatory decision making. Therefore, it is essential to identify patient perspectives regarding the value of patient preference information (PPI).

Objectives

The aim of this study was to explore how patients with rheumatoid arthritis (RA) value the use of PPI in regulatory decision making regarding medical products.

Methods

Regulators and patients with RA were interviewed to gather initial insights into opinions on the use of PPI in regulatory decisions regarding medical products. The interviews were used to draft and validate the interview guide for focus groups with patients with RA. Participants were purposively sampled in collaboration with the Swedish Rheumatism Association in Stockholm and Uppsala. Each focus group consisted of three to six patients (18 in total). All interviews were audio-recorded, transcribed verbatim, and analysed using content analysis.

Results

According to the participants, PPI could lead to regulators considering patients’ needs, lifestyles and well-being when making decisions. PPI was important in all stages of the medical product lifecycle. Participants reported that, when participating in a preference study, it is important to be well-informed about the use of the study and the development, components, administration, and risks related to the medical products.

Conclusions

Patients thought PPI could be valuable to consider in regulatory decisions. It is essential for patients to be well-informed when asked for their preferences. Research on information materials to inform patients in preference studies is needed to increase the value of PPI in regulatory decision making.

<h1>Background</h1><p>Patient preference (PP) information is not effectively integrated in decision-making throughout the medical product lifecycle (MPLC), despite having the potential to improve patients’ healthcare options. A first step requires an understanding of existing processes and decision-points to know how to incorporate PP information in order to improve patient-centric decision-making.</p><h1>Objectives</h1><p>The aims were to: 1) identify the decision-making processes and decision-points throughout the MPLC for industry, regulatory authorities, and reimbursement/HTA, and 2) determine which decision-points can potentially include PP information.</p><h1>Methods</h1><p>A scoping literature review was conducted using five scientific databases. Semi-structured interviews were conducted with representatives from seven European countries and the US, including industry (n = 24), regulatory authorities (n = 23), reimbursement/HTA (n = 23). Finally, validation meetings with key stakeholders (n = 11) were conducted.</p><h1>Results</h1><p>Six critical decision-points were identified for <em>industry decision-making,</em> three for <em>regulatory decision-making</em>, and six for <em>reimbursement/HTA decision-making.</em> Stakeholder groups agreed that PP information is not systematically integrated, either as obligatory information or pre-set criteria, but would benefit all the listed decision-points in the future.</p><h1>Conclusion</h1><p>Currently, PP information is not considered as obligatory information to submit for any of the MPLC decision-points. However, PP information is considered an important component by most stakeholders to inform future decision-making across the MPLC. The integration of PP information into 15 identified decision-points needs continued discussion and collaboration between stakeholders.</p>