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Importance: Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use.Objective: To develop international, consensus-based, PRO-specific ethical guidelines for clinical research.Evidence Review: The PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network's guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance.Findings: Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans.Conclusions and Relevance: The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare. [ABSTRACT FROM AUTHOR]

Background: Withdrawal of treatment is a common practice in intensive care units when treatment is considered futile. Compassion is an important aspect of care; however, it has not been explored much within the context of treatment withdrawal in intensive care units. Objectives: The aim was to examine how concepts of compassion are framed, utilised and communicated by intensive care nurses in the context of treatment withdrawal. Design: The study employed a qualitative approach conducting secondary analysis of an original data set. In the primary study, 13 nurses were recruited from three intensive care units within a large hospital in United Kingdom. Deductive framework analysis was used to analyse the data in relation to compassionate care. Ethical considerations: The primary study was approved by the local Research Ethics Committee and the hospital's Research and Development services. Findings: Compassionate care was mostly directed to the patient's family and was demonstrated through care and emotional support to the family. It was predominantly expressed through attempts to maintain the patient's dignity by controlling symptoms, maintaining patient cleanliness and removing technical apparatus. Conclusion: This study's findings provide insight about compassionate care during treatment withdrawal which could help to understand and develop further clinicians' roles. Prioritising the family over the patient raised concerns among nurses, who motivated by compassion, may feel justified in taking measures that are in the interests of the family rather than the patient. Further work is needed to explore the ethics of this. [ABSTRACT FROM AUTHOR]

Research exploring parents' experiences of having offspring with autism spectrum disorder (ASD) currently underrepresents fathers. This study aimed to develop an understanding of the experience of fathers, with a view to facilitating improved support. Eight fathers participated in semi-structured interviews exploring their experiences of fathering children with ASD. Fathers described their experiences as a path towards acceptance, with independence and integration for their offspring being key goals. Fathers saw themselves as advocates fighting obstructive services to access appropriate care. The value placed on formal and informal support varied, although the need for personalised support was emphasised. Enabling fathers to see their experiences as a journey, whilst engaging them on the important topics of independence and integration, may improve their experience. [ABSTRACT FROM AUTHOR]

Conditional and directed deceased organ donations occur when donors (or often their next of kin) attempt to influence the allocation of their donated organs. This can include asking that the organs are given to or withheld from certain types of people, or that they are given to specified individuals. Donations of these types have raised ethical concerns, and have been prohibited in many countries, including the UK. In this article we report the findings from a qualitative study involving interviews with potential donors (n = 20), potential recipients (n = 9) and transplant staff (n = 11), and use these results as a springboard for further ethical commentary. We argue that although participants favoured unconditional donation, this preference was grounded in a false distinction between 'medical' and 'non-medical' allocation criteria. Although there are good reasons to maintain organ allocation based primarily upon the existing 'medical' criteria, it may be premature to reject all other potential criteria as being unacceptable. Part of participants' justification for allocating organs using 'medical' criteria was to make the best use of available organs and avoid wasting their potential benefit, but this can also justify accepting conditional donations in some circumstances. We draw a distinction between two types of waste - absolute and relative - and argue that accepting conditional donations may offer a balance between these forms of waste. [ABSTRACT FROM AUTHOR]

Postpartum Psychosis (PP) is a severe and debilitating psychiatric illness with acute onset in the days following childbirth. Recovering from an episode can be a long and difficult process. The aim of this study was to gain an understanding of the difficulties faced by recovering women and to inform the planning of post-discharge information and support services. A study was designed collaboratively by service user and academic researchers. Women with experience of PP were trained in qualitative research methodology. Service user researchers (SURs) led in-depth interviews into women's experiences of recovery. PP is a life-changing experience that challenges women's sense of personal and social identity. Recovery themes are organised around ruminating and rationalising, rebuilding social confidence, gaining appropriate health service support, the facilitation of family functioning, obtaining appropriate information, and understanding that recovery will take time. Women suffering from PP must be adequately supported following discharge from psychiatric hospital if we are to address maternal suicide rates. We describe a successful collaboration between academics and service users exploring the needs of women and their families. [ABSTRACT FROM AUTHOR]

In this article we distinguish between philosophical bioethics (PB), descriptive policy orientated bioethics (DPOB) and normative policy oriented bioethics (NPOB). We argue that finding an appropriate methodology for combining empirical data and moral theory depends on what the aims of the research endeavour are, and that, for the most part, this combination is only required for NPOB. After briefly discussing the debate around the is/ought problem, and suggesting that both sides of this debate are misunderstanding one another (i.e. one side treats it as a conceptual problem, whilst the other treats it as an empirical claim), we outline and defend a methodological approach to NPOB based on work we have carried out on a project exploring the normative foundations of paternal rights and responsibilities. We suggest that given the prominent role already played by moral intuition in moral theory, one appropriate way to integrate empirical data and philosophical bioethics is to utilize empirically gathered lay intuition as the foundation for ethical reasoning in NPOB. The method we propose involves a modification of a long-established tradition on non-intervention in qualitative data gathering, combined with a form of reflective equilibrium where the demands of theory and data are given equal weight and a pragmatic compromise reached. [ABSTRACT FROM AUTHOR]