Mirtazapine to alleviate severe breathlessness in patients with COPD or interstitial lung diseases (BETTER-B): an international, multicentre, double-blind, randomised, placebo-controlled, phase 3 mixed-method trial.

Background: Breathlessness frequently becomes severe among people with respiratory disease. Mirtazapine, a widely used antidepressant, has shown promise in the modulation of respiratory sensation and the response to it, as well as reducing feelings of panic, which often accompanies breathlessness. We aimed to determine the effectiveness of mirtazapine to alleviate severe persisting breathlessness.

Treating Mycoplasma genitalium (in pregnancy): a social and reproductive justice concern.

Antimicrobial Resistance is a threat to individual and to population health and to future generations, requiring "collective sacrifices" in order to preserve antibiotic efficacy. 'Who should make the sacrifices?' and 'Who will most likely make them?' are ethical concerns posited as potentially manageable through Antimicrobial Stewardship. Antimicrobial stewardship almost inevitably involves a form of clinical cost-benefit analysis that assesses the possible effects of antibiotics to treat a diagnosed infection in a particular patient.

Medicine in the marketplace: clinician and patient views on commercial influences on assisted reproductive technology.

Research Question: What are the views and experiences of patient and expert stakeholders on the positive and negative impacts of commercial influences on the provision of assisted reproductive technology (ART) services, and what are their suggestions for governance reforms?

Design: Semi-structured interviews were conducted with 31 ART industry experts from across Australia and New Zealand and 25 patients undergoing ART from metropolitan and regional Australia, between September 2020 and September 2021. Data were analysed using thematic analysis.

Results: Expert and patient participants considered that commercial forces influence the provision of ART in a number of positive ways - increasing sustainability, ensuring consistency in standards and providing patients with greater choice.

Crafting representations of rare disease: collage as qualitative inquiry.

Background: Collage is a modality of expression which involves repurposing and juxtaposing fragments. Our aim was to explore both how and what collage, as an arts-based research method, might contribute to enlivening understandings of the experiences of families affected by rare conditions.

Methods: During 10 weeks of collaging workshops participants created artistic representations of their experiences.

The ethical challenges of personalized digital health.

Personalized digital health systems (pHealth) bring together in sharp juxtaposition very different yet hopefully complementary moral principles in the shared objectives of optimizing health care and the health status of individual citizens while maximizing the application of robust clinical evidence through harnessing powerful and often complex modern data-handling technologies. Principles brought together include respecting the confidentiality of the patient-clinician relationship, the need for controlled information sharing in teamwork and shared care, benefitting from healthcare knowledge obtained from real-world population-level outcomes, and the recognition of different cultures and care settings. This paper outlines the clinical process as enhanced through digital health, reports on the examination of the new issues raised by the computerization of health data, outlines initiatives and policies to balance the harnessing of innovation with control of adverse effects, and emphasizes the importance of the context of use and citizen and user acceptance.

Ethical preparedness and developments in genomic healthcare.

Considerations of the notion of preparedness have come to the fore in the recent pandemic, highlighting a need to be better prepared to deal with sudden, unexpected and unwanted events. However, the concept of preparedness is also important in relation to planned for and desired interventions resulting from healthcare innovations. We describe ethical preparedness as a necessary component for the successful delivery of novel healthcare innovations, and use recent advances in genomic healthcare as an example.

Spiritual, religious, and existential concerns of children and young people with life-limiting and life-threatening conditions: A qualitative interview study.

Background: Despite being a core domain of palliative care, primary data on spiritual and existential concerns has rarely been collected among children with life-limiting and life-threatening conditions and their families. Existing evidence has tended to focus on the religious aspects among children with cancer.

Aim: To identify the spiritual needs of children with life-limiting and life-threatening conditions.

Achieving child-centred care for children and young people with life-limiting and life-threatening conditions-a qualitative interview study.

Unlabelled: This study aims to identify the symptoms, concerns, and care priorities of children with life-limiting conditions and their families. A semi-structured qualitative interview study was conducted, seeking perspectives from multiple stakeholders on symptoms, other concerns, and care priorities of children and young people with life limiting and life-threatening conditions and their families. Participants were recruited from six hospitals and three children's hospices in the UK.

"I wanna live and not think about the future" what place for advance care planning for people living with severe multiple sclerosis and their families? A qualitative study.

Background: Little is known about how people with multiple sclerosis (MS) and their families comprehend advance care planning (ACP) and its relevance in their lives.

Aim: To explore under what situations, with whom, how, and why do people with MS and their families engage in ACP.

Methods: We conducted a qualitative study comprising interviews with people living with MS and their families followed by an ethical discussion group with five health professionals representing specialties working with people affected by MS and their families.

Writing the worlds of genomic medicine: experiences of using participatory-writing to understand life with rare conditions.

The diagnostic and treatment possibilities made possible by the development and subsequent mainstreaming of clinical genomics services have the potential to profoundly change the experiences of families affected by rare genetic conditions. Understanding the potentials of genomic medicine requires that we consider the perspectives of those who engage with such services; there are substantial social implications involved. There are increasing calls to think more creatively, and draw on more participatory approaches, in evoking rich accounts of lived experience.

Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study.

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice.

COVID-19: Impact on Pediatric Palliative Care.

Context: Children and young people with life-limiting or life-threatening conditions and their families are potentially vulnerable during COVID-19 lockdowns due to pre-existing high clinical support needs and social participation limitations.

Objectives: To explore the impact of the COVID-19 pandemic and lockdowns on this population.

Methods: Sub-analysis of an emergent COVID-19 related theme from a larger semi-structured interview study investigating priority pediatric palliative care outcomes.

Imagining genomic medicine futures in primary care: General practitioners' views on mainstreaming genomics in the National Health Service.

Genomic medicine has captured the imaginations of policymakers and medical scientists keen to harness its health and economic potentials. In 2012, the UK government launched the 100,000 Genomes Project to sequence the genomes of British National Health Service (NHS) patients, laying the ground for mainstreaming genomic medicine in the NHS and developing the UK's genomics industry. However, the recent research and reports from national bodies monitoring genomic medicine's roll-out suggest both ethical and practical challenges for health-care professionals.

A realist review of advance care planning for people with multiple sclerosis and their families.

Background: Advance care planning (ACP) is reported to improve the quality of outcomes of care among those with life-limiting conditions. However, uptake is low among people living with multiple sclerosis (MS) and little is known about why or how people with MS engage in this process of decision-making.

Aims: To develop and refine an initial theory on engagement in ACP for people with MS and to identify ways to improve its uptake for those who desire it.

Towards a national genomics medicine service: the challenges facing clinical-research hybrid practices and the case of the 100 000 genomes project.

Clinical practice and research are governed by distinct rules and regulations and have different approaches to, for example, consent and providing results. However, genomics is an example of where research and clinical practice have become codependent. The 100 000 genomes project (100kGP) is a hybrid venture where a person can obtain a clinical investigation only if he or she agrees to also participate in ongoing research-including research by industry and commercial companies.

Genomics England's implementation of its public engagement strategy: Blurred boundaries between engagement for the United Kingdom's 100,000 Genomes project and the need for public support.

The United Kingdom's 100,000 Genomes Project has the aim of sequencing 100,000 genomes from National Health Service patients such that whole genome sequencing becomes routine clinical practice. It also has a research-focused goal to provide data for scientific discovery. Genomics England is the limited company established by the Department of Health to deliver the project.

The UK's 100,000 Genomes Project: manifesting policymakers' expectations.

The UK's 100,000 Genomes Project has the aim of sequencing 100,000 genomes from UK National Health Service (NHS) patients while concomitantly transforming clinical care such that whole genome sequencing becomes routine clinical practice in the UK. Policymakers claim that the project will revolutionize NHS care. We wished to explore the 100,000 Genomes Project, and in particular, the extent to which policymaker claims have helped or hindered the work of those associated with Genomics England - the company established by the Department of Health to deliver the project.

Public trust and 'ethics review' as a commodity: the case of Genomics England Limited and the UK's 100,000 genomes project.

The UK Chief Medical Officer's 2016 Annual Report, Generation Genome, focused on a vision to fully integrate genomics into all aspects of the UK's National Health Service (NHS). This process of integration, which has now already begun, raises a wide range of social and ethical concerns, many of which were discussed in the final Chapter of the report. This paper explores how the UK's 100,000 Genomes Project (100 kGP)-the catalyst for Generation Genome, and for bringing genomics into the NHS-is negotiating these ethical concerns.

Healthcare professionals' and patients' perspectives on consent to clinical genetic testing: moving towards a more relational approach.

Background: This paper proposes a refocusing of consent for clinical genetic testing, moving away from an emphasis on autonomy and information provision, towards an emphasis on the virtues of healthcare professionals seeking consent, and the relationships they construct with their patients.

Methods: We draw on focus groups with UK healthcare professionals working in the field of clinical genetics, as well as in-depth interviews with patients who have sought genetic testing in the UK's National Health Service (data collected 2013-2015). We explore two aspects of consent: first, how healthcare professionals consider the act of 'consenting' patients; and second how these professional accounts, along with the accounts of patients, deepen our understanding of the consent process.

Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.

Background: Maximizing comprehension is a major challenge for informed consent processes in low-literacy and resource-limited settings. Application of rapid qualitative assessments to improve the informed consent process is increasingly considered useful. This study assessed the effects of Rapid Ethical Assessment (REA) on comprehension, retention and quality of the informed consent process.