Search

Objectives: Patients with advanced illness and their family caregivers can be mutually supportive. However, what facilitates and/or restricts supportive relationships between patients and family caregivers in palliative care remains unclear. We aimed to identify key barriers to and facilitators of supportive relationships between people with advanced illness and family caregivers in specialist palliative care., Methods: A qualitative study using grounded theory methodology was conducted. Semistructured interviews were undertaken with 15 patients with advanced illness and 21 family caregivers purposively and theoretically sampled from a large regional specialist palliative care service. Verbatim transcripts were analysed in line with grounded theory coding procedures., Results: Mutual support was underpinned by mutual concern and understanding. Facilitators of supportive relationships included patients and family caregivers already having a close relationship, caregivers assuming caregiving duties by choice, caregivers feeling competent in a caregiving role, patients valuing caregiver efforts, availability of respite for the caregiver and direct support from healthcare professionals to help both patients and caregivers adjust to advanced illness. Barriers to supportive relationships included absence of support from the wider family, prior mutual conflict between the patient and caregiver, caregivers feeling constrained in their caregiving role and patient and caregiver distress induced by mutual loss., Conclusions: Multiple factors at both a micro (eg, relationship based) and mesolevel (eg, assistance from services) impact patient and family caregiver ability to support one another in specialist palliative care. Supportive relationships between patients and family caregivers are mediated by feelings pertaining to both control and loss., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: An ageing prison population with complex health needs combined with punitive sentencing practices means palliative care for incarcerated individuals is increasingly important. However, there is limited evidence regarding the models of care delivery in high-income countries, and their associated challenges and benefits., Aim: To develop a typology of models of palliative care provision for incarcerated individuals, synthesise evidence of their outcomes and describe facilitators of and challenges in delivering different models of palliative and end-of-life care in prisons., Design: Scoping review following Arksey and O'Malley, with narrative synthesis. The protocol was registered prospectively (reviewregistry1260)., Data Sources: MEDLINE, EMBASE, CINAHL, PsycINFO, the Social Sciences Citation Index and grey literature were searched on 15th March 2023. The Mixed Methods Appraisal Tool (MMAT) was used for quality appraisal., Results: A total of 16,865 records were screened; 22 peer-reviewed articles and 18 grey literature sources met the inclusion criteria. Three models were identified: Embedded Hospice, Outsourcing Care and Community Collaboration. The Embedded Hospice model shows potential benefits for patients and prisons. Outsourcing Care may miss opportunities for comprehensive care. Collaborative Care relies on proactive prison-community relationships that could be formalised for improvement. Psychosocial and bereavement needs of those dying in prison and their caregivers lack sufficient documentation., Conclusion: Further research is needed to evaluate prison hospice costs and examine how prison hospices impact compassionate release usage. Beyond the USA, policies might formalise care pathways and recognise best practices. Further investigation to address psychosocial needs of people in prison with life-limiting illnesses and post-death bereavement support is required., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objectives: ' Early' specialist palliative care (SPC) has been shown to improve outcomes for patients with advanced cancer, yet patients are often referred late. 'Enhanced supportive care' (ESC) aims to facilitate earlier integrated supportive care for those with incurable cancer. This study aimed to explore clinicians' understanding of ESC/SPC delivery through description of current service provision., Methods: This national cross-sectional survey of 53 cancer centres had two parts. Part 1: Service details, was directed to lead ESC/SPC nurses or consultants about service configuration, and Part 2: Clinician understanding, targeting conceptual understanding of service aims including ESC/SPC teams and oncology consultants (n=262 surveys). Multiple-choice questions explored service provision, referral triggers and evidence of integration with oncology, with free-text responses. Quantitative results were analysed with Fischer's exact test. Qualitative free text was line-by-line coded by two authors independently to derive themes., Results: 56% (30/53) of SPC and ESC teams and 14% (14/100) of oncologists responded. Those involved in ESC self-reported greater integration with oncology compared with non-ESC teams, for example, joint case discussions (64.3%, 9/14 vs 23.1%, 3/13, p=0.05), and timelier patient referral ((>6 months before death vs <6 months) (10/14 vs 4/13, p=0.06)). Qualitative themes described ambiguity in definitions of supportive and palliative terms and a perception of timelier identification of patients when ESC was involved., Conclusion: Providers of ESC perceive greater integration with oncology and potentially timelier referral for patients compared with teams not delivering ESC. Terminology around SPC and ESC remains uncertain across England., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Decision-making in palliative care usually involves both patients and family caregivers. However, how concordance and discordance in decision-making manifest and function between patients and family caregivers in palliative care is not well understood., Objectives: To identify key factors and/or processes which underpin concordance and/or discordance between patients and family caregivers with respect to their preferences for and decisions about palliative care; and ascertain how patients and family caregivers manage discordance in decision-making in palliative care., Methods: A systematic review and narrative synthesis of original studies published in full between January 2000 and June 2021 was conducted using the following databases: Embase; Medline; CINAHL; AMED; Web of Science; PsycINFO; PsycARTICLES; and Social Sciences Full Text., Results: After full-text review, 39 studies were included in the synthesis. Studies focused primarily on end-of-life care and on patient and family caregiver preferences for patient care. We found that discordance between patients and family caregivers in palliative care can manifest in relational conflict and can result from a lack of awareness of and communication about each other's preferences for care. Patients' advancing illness and impending death together with open dialogue about future care including advance care planning can foster consensus between patients and family caregivers., Conclusions: Patients and family caregivers in palliative care can accommodate each other's preferences for care. Further research is needed to fully understand how patients and family caregivers move towards consensus in the context of advancing illness., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The COVID-19 pandemic has been a devastating and enduring mass-bereavement event, with uniquely difficult sets of circumstances experienced by people bereaved at this time. However, little is known about the long-term consequences of these experiences, including the prevalence of Prolonged Grief Disorder (PGD) and other conditions in pandemic-bereaved populations., Methods: A longitudinal survey of people bereaved in the UK between 16 March 2020 and 2 January 2021, with data collected at baseline ( n  = 711), c. 8 ( n  = 383), 13 ( n  = 295), and 25 ( n  = 185) months post-bereavement. Using measures of Prolonged Grief Disorder (PGD) (Traumatic Grief Inventory), grief vulnerability (Adult Attitude to Grief Scale), and social support (Inventory of Social Support), this analysis examines how participant characteristics, characteristics of the deceased and pandemic-related circumstances (e.g., restricted visiting, social isolation, social support) are associated with grief outcomes, with a focus on symptoms of PGD., Results: At baseline, 628 (88.6%) of participants were female, with a mean age of 49.5 (SD 12.9). 311 (43.8%) deaths were from confirmed/suspected COVID-19. Sample demographics were relatively stable across time points. 34.6% of participants met the cut-off for indicated PGD at c. 13 months bereaved and 28.6% at final follow-up. Social isolation and loneliness in early bereavement and lack of social support over time strongly contributed to higher levels of prolonged grief symptoms, while feeling well supported by healthcare professionals following the death was associated with reduced levels of prolonged grief symptoms. Characteristics of the deceased most strongly associated with lower levels of prolonged grief symptoms, were a more distant relationship (e.g., death of a grandparent), an expected death and death occurring in a care-home. Participant characteristics associated with higher levels of prolonged grief symptoms included low level of formal education and existence of medical conditions., Conclusion: Results suggest higher than expected levels of PGD compared with pre-pandemic times, with important implications for bereavement policy, provision and practice now (e.g., strengthening of social and specialist support) and in preparedness for future pandemics and mass-bereavement events (e.g., guidance on infection control measures and rapid support responses)., Competing Interests: AP declared a potential financial interest relating to lobbying by the Childhood Bereavement Network and National Bereavement Alliance for additional financial support for the bereavement sector. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Harrop, Medeiros Mirra, Goss, Longo, Byrne, Farnell, Seddon, Penny, Machin, Sivell and Selman.)

Background: Good Grief Festival was originally planned as a face-to-face festival about grief and bereavement. Due to COVID-19, it was held online over 3 days in October 2020., Objective: To evaluate the festival's reach and impact., Design: Pre/post evaluation., Methods: Pre-festival online surveys assessed reasons for attending and attitudes to bereavement across four items (fear of saying the wrong thing, avoiding talking to someone bereaved, knowing what to do if someone bereaved was struggling, knowing how to help). Post-festival online surveys evaluated audience experiences and the four attitude items. Free-text responses, analysed using thematic analysis, generated suggestions for improvement and general comments., Results: Between 5003 and 6438 people attended, with most attending two to five events. Pre-festival survey participants ( n  = 3785) were mostly women (91%) and White (91%). About 9% were from Black or minoritised ethnic communities. About 14% were age ⩾65 years, 16% age ⩽34 years. Around 75% were members of the public, teachers, students or 'other'; 25% academics, clinicians or bereavement counsellors. A third had been bereaved in the last year; 6% had never been bereaved. People attended to learn about grief/bereavement (77%), be inspired (52%) and feel part of a community (49%). Post-festival participants ( n  = 685) reported feeling part of a community (68%), learning about grief/bereavement (68%) and being inspired (66%). 89% rated the festival as excellent/very good and 75% agreed that they felt more confident talking about grief after attending. Higher ratings and confidence were associated with attending more events. Post-festival attitudes were improved across all four items ( p  < 0.001). Attendees appreciated the festival, particularly valuing the online format, opportunities for connection during lockdown and the diversity and quality of speakers. Suggestions included improving registration, more interactive events and less content., Conclusion: Good Grief Festival successfully reached a large public audience, with benefit in engagement, confidence and community-building. Evaluation was critical in shaping future events. Findings suggest festivals of this nature can play a central role in increasing death- and grief-literacy within a public health approach., Competing Interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: LES conceived of Good Grief Festival and led the funding application. AM, LD and LES designed the festival. AM was paid through the grant funding to deliver the festival., (© The Author(s), 2023.)

Background: Voluntary and community sector bereavement services are central to bereavement support in the UK., Aim: To determine service providers' perspectives on access to their support before and during the COVID-19 pandemic., Design: Mixed methods study using an explanatory sequential design: (1) Cross-sectional online survey of UK bereavement services; (2) Qualitative interviews with staff and volunteers at selected services., Settings/participants: 147 services participated in the survey; 24 interviews were conducted across 14 services., Results: 67.3% of services reported there were groups with unmet needs not accessing their services before the pandemic; most frequently people from minoritised ethnic communities (49%), sexual minority groups (26.5%), deprived areas (24.5%) and men (23.8%). Compared with before the pandemic, 3.4% of services were seeing more people from minoritised ethnic groups, while 6.1% were seeing fewer. 25.2% of services did not collect ethnicity data. Qualitative findings demonstrated the disproportionate impact of the pandemic on minoritised ethnic communities, including disruption to care/mourning practices, and the need for culturally appropriate support. During the pandemic outreach activities were sometimes deprioritised; however, increased collaboration was also reported. Online provision improved access but excluded some. Positive interventions to increase equity included collecting client demographic data; improving outreach, language accessibility and staff representation; supporting other professionals to provide bereavement support; local collaboration and co-production., Conclusions: Service providers report inequities in access to bereavement support. Attention needs to be paid to identifying, assessing and meeting unmet needs for appropriate bereavement support. Identified positive interventions can inform service provision and research.

We identified factors associated with higher levels of grief and support needs among 711 people bereaved during the COVID-19 pandemic in the UK (deaths 16 March 2020-2 January 2021). An online survey assessed grief using the Adult Attitude to Grief (AAG) scale, which calculates an overall index of vulnerability (IOV) (range 0-36), and practical and emotional support needs in 13 domains. Participants' mean age was 49.5 (SD 12.9); 628 (88.6%) female. Mean age of deceased 72.2 (SD 16.1). 311 (43.8%) deaths were from confirmed/suspected COVID-19. High overall levels of grief and support needs were observed; 28.2% exhibited severe vulnerability (index of vulnerability ≥24). Grief and support needs were higher for close relationships with the deceased (vs. more distant) and reported social isolation and loneliness ( p < 0.001), and lower when age of deceased was above 40-50. Other associated factors were place of death and health professional support post-death ( p < 0.05)., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: During the COVID-19 pandemic, many children and young people have experienced the death of close family members, whilst also facing unprecedented disruption to their lives. This study aimed to investigate the experiences and support needs of bereaved children and young people from the perspective of their parents and guardians., Methods: We analysed cross-sectional qualitative free-text data from a survey of adults bereaved in the UK during the pandemic. Participants were recruited via media, social media, national associations and community/charitable organisations. Thematic analysis was conducted on free text data collected from parent/guardian participants in response to a survey question on the bereavement experiences and support needs of their children., Results: Free-text data from 104 parent/guardian participants was included. Three main themes were identified: the pandemic-related challenges and struggles experienced by children and young people; family support and coping; and support from schools and services. Pandemic-challenges include the impacts of being separated from the relative prior to their death, isolation from peers and other family members, and disruption to daily routines and wider support networks. Examples were given of effective family coping and communication, but also of difficulties relating to parental grief and children's existing mental health problems. Schools and bereavement organisations' provision of specialist support was valued, but there was evidence of unmet need, with some participants reporting a lack of access to specialist grief or mental health support., Conclusion: Children and young people have faced additional strains and challenges associated with pandemic bereavement. We recommend resources and initiatives that facilitate supportive communication within family and school settings, adequate resourcing of school and community-based specialist bereavement/mental health services, and increased information and signposting to the support that is available., (© 2022. The Author(s).)

The evaluation of public engagement health festivals is of growing importance, but there has been no synthesis of its practice to date. We conducted a systematic review of evidence from the evaluation of health-related public engagement festivals published since 2000 to inform future evaluation. Primary study quality was assessed using the Mixed Methods Appraisal Tool. Extracted data were integrated using narrative synthesis, with evaluation methods compared with the Queen Mary University of London public engagement evaluation toolkit. 407 database records were screened; eight studies of varied methodological quality met the inclusion criteria. Evaluations frequently used questionnaires to collect mixed-methods data. Higher quality studies had specific evaluation aims, used a wider variety of evaluation methods and had independent evaluation teams. Evaluation sample profiles were often gender-biased and not ethnically representative. Patient involvement in event delivery supported learning and engagement. These findings and recommendations can help improve future evaluations. (Research Registry ID reviewregistry1021)., Competing Interests: The authors have declared that no competing interests exist.

Those who are bereaved during the current COVID-19 pandemic are subject to restrictions on funeral sizes and practices. We conducted a rapid review synthesising the quantitative and qualitative evidence regarding the effect of funeral practices on bereaved relatives' mental health and bereavement outcomes. Searches of MEDLINE, PsycINFO, KSR Evidence, and COVID-related resources were conducted. 805 records were screened; 17 studies of variable quality were included. Current evidence regarding the effect of funeral practices on bereaved relatives' mental health and bereavement outcomes is inconclusive. Five observational studies found benefits from funeral participation while six did not. However, qualitative research provides additional insight: the benefit of after-death rituals including funerals depends on the ability of the bereaved to shape those rituals and say goodbye in a way which is meaningful for them. Findings highlight the important role of funeral officiants during the pandemic. Research is needed to better understand the experiences and sequalae of grief and bereavement during COVID-19.

Background: The COVID-19 pandemic has been a devastating, mass bereavement event characterised by high levels of disruption to end-of-life, grieving and coping processes. Quantitative evidence is emerging on the effects of the pandemic on grief outcomes, but rich qualitative evidence on the lived experiences of people bereaved during these times is lacking., Methods: We analysed qualitative data from two independent UK-wide online surveys to describe the experiences of 881 people bereaved during the pandemic. We analysed the data in two phases, conducting an inductive thematic analysis and then applying Stroebe and Schut's Dual Process Model (DPM) and concepts of loss-oriented and restoration-oriented coping (1999; 2010) as an analytic lens to further contextualise and interpret the data., Results: We identified six main themes: troubled deaths; mourning, memorialisation and death administration; mass bereavement, the media and the ongoing threat of the pandemic; grieving and coping; work and employment; and support from the health and social care system. Examples of loss-oriented stressors included being unable to visit and say goodbye at the end of life and restricted funeral and memorialisation practices. Associated reactions were feelings of guilt, anger, and problems accepting the death and beginning to grieve. Examples of restoration-oriented stressors and reactions were severely curtailed support-systems and social/recreational activities, which impacted people's ability to cope., Conclusion: Study results demonstrate the exceptionally difficult sets of experiences associated with pandemic bereavement, and the utility of the DPM for conceptualising these additional challenges and their impacts on grieving. Our analysis builds and expands on previous use of the DPM in explicating the impact of the pandemic on bereavement. We make recommendations for statutory, private and third sector organisations for improving the experiences of people bereaved during and following this and future pandemics., Competing Interests: Conflict of interest statement: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s), 2022.)

Background: Experiences of end-of-life care and early bereavement during the COVID-19 pandemic are poorly understood., Aim: To identify clinical and demographic risk factors for sub-optimal end-of-life care and pandemic-related challenges prior to death and in early bereavement, to inform clinical practice, policy and bereavement support., Design: Online national survey of adults bereaved in the UK (deaths between 16 March 2020 and 2 January 2021), recruited via media, social media, national associations and organisations., Setting/participants: 711 participants, mean age 49.5 (SD 12.9, range 18-90). 628 (88.6%) were female. Mean age of the deceased was 72.2 (SD 16.1, range miscarriage to 102 years). 311 (43.8%) deaths were from confirmed/suspected COVID-19., Results: Deaths in hospital/care home increased the likelihood of poorer experiences at the end of life; for example, being unable to visit or say goodbye as wanted ( p  < 0.001). COVID-19 was also associated with worse experiences before and after death; for example, feeling unsupported by healthcare professionals ( p  < 0.001), social isolation/loneliness (OR = 0.439; 95% CI: 0.261-0.739), and limited contact with relatives/friends (OR = 0.465; 95% CI: 0.254-0.852). Expected deaths were associated with a higher likelihood of positive end-of-life care experiences. The deceased being a partner or child also increased the likelihood of positive experiences, however being a bereaved partner strongly increased odds of social isolation/loneliness, for example, OR = 0.092 (95% CI: 0.028-0.297) partner versus distant family member., Conclusions: Four clear risk factors were found for poorer end-of-life care and pandemic-related challenges in bereavement: place, cause and expectedness of death, and relationship to the deceased.

Introduction: In 2020 England moved to an opt-out deceased donation law. We aimed to investigate the views of a mixed stakeholder group comprising people with kidney disease, family members and healthcare practitioners towards the change in legislation. We investigated the expected impacts of the new legislation on deceased-donor and living-donor transplantation, and views on media campaigns regarding the law change., Methods: We undertook in-depth qualitative interviews with people with kidney disease (n = 13), their family members (n = 4) and healthcare practitioners (n = 15). Purposive sampling was used to ensure diversity for patients and healthcare practitioners. Family members were recruited through snowball sampling and posters. Interviews were audio-recorded and transcribed verbatim. Transcripts were analysed using thematic analysis., Results: Three themes with six subthemes were identified: (i) Expectations of impact (Hopeful patients; Cautious healthcare professionals), (ii) Living-donor transplantation (Divergent views; Unchanged clinical recommendations), (iii) Media campaigns (Single message; Highlighting recipient benefits). Patients expected the law change would result in more deceased-donor transplant opportunities., Conclusions: Clinicians should ensure patients and families are aware of the current evidence regarding the impact of opt-out consent: expectations of an increased likelihood of receiving a deceased-donor transplant are not currently supported by the evidence. This may help to prevent a decline in living-donor transplantation seen in other countries with similar legislation. Media campaigns should include a focus on the impact of organ receipt., Patient or Public Contribution: Two patient representatives from the Kidney Disease Health Integration Team, Primrose Granville and Soumeya Bouacida, contributed to the content and design of the study documents., (© 2021 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

Introduction: People dying in Britain spend, on average, 3 weeks of their last year of life in hospital. Hospital discharge presents an opportunity for secondary care clinicians to communicate to general practitioners (GPs) which patients may have a poor prognosis. This would allow GPs to prioritise these patients for Advance Care Planning.The objective of this study is to produce a critical overview of research on the communication of poor prognosis between secondary and primary care through a systematic review and narrative synthesis., Methods and Analysis: We will search Medline, EMBASE, CINAHL and the Social Sciences Citation Index for all study types, published since 1 January 2000, and conduct reference-mining of systematic reviews and publications. Study quality will be assessed using the Mixed-Methods Appraisal Tool; a narrative synthesis will be undertaken to integrate and summarise findings., Ethics and Dissemination: Approval by research ethics committee is not required since the review only includes published and publicly accessible data. Review findings will inform a qualitative study of the sharing of poor prognosis at hospital discharge. We will publish our findings in a peer-reviewed journal as per Preferred Reporting for Systematic review and Meta-analysis (PRISMA) 2020 guidance., Prospero Registration: CRD42021236087., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: The COVID-19 pandemic is a mass bereavement event which has profoundly disrupted grief experiences. Understanding support needs and access to support among people bereaved at this time is crucial to ensuring appropriate bereavement support infrastructure., Aim: To investigate grief experiences, support needs and use of formal and informal bereavement support among people bereaved during the pandemic., Design: Baseline results from a longitudinal survey. Support needs and experiences of accessing support are reported using descriptive statistics and thematic analysis of free-text data., Setting/participants: 711 adults bereaved in the UK between March and December 2020, recruited via media, social media, national associations and community/charitable organisations., Results: High-level needs for emotional support were identified. Most participants had not sought support from bereavement services (59%, n = 422) or their General-Practitioner (60%, n = 428). Of participants who had sought such support, over half experienced difficulties accessing bereavement services (56%, n = 149)/General-Practitioner support (52%, n = 135). About 51% reported high/severe vulnerability in grief; among these, 74% were not accessing bereavement or mental-health services. Barriers included limited availability, lack of appropriate support, discomfort asking for help and not knowing how to access services. About 39% ( n = 279) experienced difficulties getting support from family/friends, including relational challenges, little face-to-face contact and disrupted collective mourning. The perceived uniqueness of pandemic bereavement and wider societal strains exacerbated their isolation., Conclusions: People bereaved during the pandemic have high levels of support needs alongside difficulties accessing support. We recommend increased provision and tailoring of bereavement services, improved information on support options and social/educational initiatives to bolster informal support and ameliorate isolation.

Background: While patient and public involvement (PPI) in clinical trials is beneficial and mandated by some funders, formal guidance on how to implement PPI is limited and challenges have been reported. We aimed to investigate how PPI is approached within a UK Clinical Trials Unit (CTU)'s portfolio of randomised controlled trials, perceived barriers to/facilitators of its successful implementation, and perspectives on the CTU's role in PPI., Methods: A mixed-methods study design, involving (1) an online survey of 26 trial managers (TMs) and (2) Interviews with Trial Management Group members and public contributors from 8 case-study trials. Quantitative survey data were summarised using descriptive statistics and interview transcripts analysed thematically. Two public contributors advised throughout and are co-authors., Results: (1) 21 TMs completed the survey; (2) 19 in-depth interviews were conducted with public contributors (n=8), TMs (n=5), chief investigators (n=3), PPI coordinators (n=2) and a researcher. 15/21 TMs surveyed reported that a public contributor was on the trial team, and 5 used another PPI method. 12/21 TMs reported that public contributors were paid (range £10-50/h). 5 TMs reported that training was provided for public contributors and few staff members had received any formal PPI training. The most commonly reported tasks undertaken by public contributors were the review of participant-facing materials/study documents and advising on recruitment/retention strategies. Public contributors wanted and valued feedback on changes made due to their input, but it was not always provided. Barriers to successful PPI included recruitment challenges, group dynamics, maintaining professional boundaries, negative attitudes to PPI amongst some researchers, a lack of continuity of trial staff, and the academic environment. Successful PPI required early and explicit planning, sharing of power and ownership of the trial with public contributors, building and maintaining relationships, and joint understanding and clarity about expectations/roles. CTUs have an important role to play in supporting recruitment, signposting and coordinating PPI., Conclusions: While highly valuable, PPI in trials is currently variable. PPI representatives are recruited informally, may not be provided with any training and are paid inconsistently across trials. Study findings can help optimise PPI in trials and ensure researchers and public contributors are adequately supported., (© 2021. The Author(s).)

Background: Despite its ubiquity in academic research, the phrase 'ethical challenge(s)' appears to lack an agreed definition. A lack of a definition risks introducing confusion or avoidable bias. Conceptual clarity is a key component of research, both theoretical and empirical. Using a rapid review methodology, we sought to review definitions of 'ethical challenge(s)' and closely related terms as used in current healthcare research literature., Methods: Rapid review to identify peer-reviewed reports examining 'ethical challenge(s)' in any context, extracting data on definitions of 'ethical challenge(s)' in use, and synonymous use of closely related terms in the general manuscript text. Data were analysed using content analysis. Four databases (MEDLINE, Philosopher's Index, EMBASE, CINAHL) were searched from April 2016 to April 2021., Results: 393 records were screened, with 72 studies eligible and included: 53 empirical studies, 17 structured reviews and 2 review protocols. 12/72 (17%) contained an explicit definition of 'ethical challenge(s), two of which were shared, resulting in 11 unique definitions. Within these 11 definitions, four approaches were identified: definition through concepts; reference to moral conflict, moral uncertainty or difficult choices; definition by participants; and challenges linked to emotional or moral distress. Each definition contained one or more of these approaches, but none contained all four. 68/72 (94%) included studies used terms closely related to synonymously refer to 'ethical challenge(s)' within their manuscript text, with 32 different terms identified and between one and eight different terms mentioned per study., Conclusions: Only 12/72 studies contained an explicit definition of 'ethical challenge(s)', with significant variety in scope and complexity. This variation risks confusion and biasing data analysis and results, reducing confidence in research findings. Further work on establishing acceptable definitional content is needed to inform future bioethics research., (© 2021. The Author(s).)

Background: News media create a sense-making narrative, shaping, reflecting and enforcing cultural ideas and experiences. Reportage of COVID-related death and bereavement illuminates public perceptions of, and responses to, the COVID-19 pandemic., Aim: We aimed to explore British newspaper representations of 'saying goodbye' before and after a COVID-related death and consider clinical implications., Design: Document analysis of UK online newspaper articles published during 2 week-long periods in March-April 2020., Data Sources: The seven most-read online newspapers were searched: The Guardian, The Daily Mail, The Telegraph, The Mirror, The Sun, The Times and The Metro. Fifty-five articles discussed bereavement after a human death from COVID-19, published during 18/03-24/03/2020 (the UK's transition into lockdown) or 08/04-14/04/2020 (the UK peak of the pandemic's first wave)., Results: The act of 'saying goodbye' (before, during and after death) was central to media representations of COVID bereavement, represented as inherently important and profoundly disrupted. Bedside access was portrayed as restricted, variable and uncertain, with families begging or bargaining for contact. Video-link goodbyes were described with ambivalence. Patients were portrayed as 'dying alone' regardless of clinician presence. Funerals were portrayed as travesties and grieving alone as unnatural. Articles focused on what was forbidden and offered little practical guidance., Conclusion: Newspapers portrayed COVID-19 as disruptive to rituals of 'saying goodbye' before, during and after death. Adaptations were presented as insufficient attempts to ameliorate tragic situations. More nuanced and supportive reporting is recommended. Clinicians and other professionals supporting the bereaved can play an important role in offering alternative narratives.

Background: To inform clinical practice and policy, it is essential to understand the lived experience of health and social care policies, including restricted visitation policies towards the end of life., Aim: To explore the views and experiences of Twitter social media users who reported that a relative, friend or acquaintance died of COVID-19 without a family member/friend present., Design: Qualitative content analysis of English-language tweets., Data Sources: Twitter data collected 7-20th April 2020. A bespoke software system harvested selected publicly-available tweets from the Twitter application programming interface. After filtering we hand-screened tweets to include only those referring to a relative, friend or acquaintance who died alone of COVID-19. Data were analysed using thematic content analysis., Results: 9328 tweets were hand-screened; 196 were included. Twitter users expressed sadness, despair, hopelessness and anger about their experience and loss. Saying goodbye via video-conferencing technology was viewed ambivalently. Clinicians' presence during a death was little consolation. Anger, frustration and blame were directed at governments' inaction/policies or the public. The sadness of not being able to say goodbye as wished was compounded by lack of social support and disrupted after-death rituals. Users expressed a sense of political neglect/mistreatment alongside calls for action. They also used the platform to reinforce public health messages, express condolences and pay tribute., Conclusion: Twitter was used for collective mourning and support and to promote public health messaging. End-of-life care providers should facilitate and optimise contact with loved ones, even when strict visitation policies are necessary, and provide proactive bereavement support.

A living-donor kidney transplant (LDKT) is one of the best treatments for kidney failure. The UK's LDKT activity falls behind that of many other countries, and there is evidence of socioeconomic inequity in access. We aimed to develop a UK-specific multicomponent intervention to support eligible individuals to access a LDKT. The intervention was designed to support those who are socioeconomically-deprived and currently disadvantaged, by targeting mediators of inequity identified in earlier work. We identified three existing interventions in the literature which target these mediators: a) the Norway model (healthcare practitioners contact patients' family with information about kidney donation), b) a home education model, and c) a Transplant candidate advocate model. We undertook intervention development using the Person-Based Approach (PBA). We performed in-depth qualitative interviews with people with advanced kidney disease (n = 13), their family members (n = 4), and renal and transplant healthcare practitioners (n = 15), analysed using thematic analysis. We investigated participant views on each proposed intervention component. We drafted intervention resources and revised these in light of comments from qualitative 'think-aloud' interviews. Four general themes were identified: i) Perceived cultural and societal norms; ii) Influence of family on decision-making; iii) Resource limitation, and iv) Evidence of effectiveness. For each intervention discussed, we identified three themes: for the Norway model: i) Overcoming communication barriers and assumptions; ii) Request from an official third party, and iii) Risk of coercion; for the home education model: i) Intragroup dynamics; ii) Avoidance of hospital, and iii) Burdens on participants; and for the transplant candidate advocates model: i) Vested interest of advocates; ii) Time commitment, and iii) Risk of misinformation. We used these results to develop a multicomponent intervention which comprises components from existing interventions that have been adapted to increase acceptability and engagement in a UK population. This will be evaluated in a future randomised controlled trial., Competing Interests: The authors have declared that no competing interests exist.

The COVID-19 pandemic has been followed intensely by the global news media, with deaths and bereavement a major focus. The media reflect and reinforce cultural conventions and sense-making, offering a lens which shapes personal experiences and attitudes. How COVID-19 bereavement is reported therefore has important societal implications. We aimed to explore the reportage and portrayal of COVID-19 related bereavement in the top seven most-read British online newspapers during two week-long periods in March and April 2020. We conducted a qualitative document analysis of all articles that described grief or bereavement after a death from COVID-19. Analysis of 55 articles was informed by critical discourse analysis and Terror Management Theory, which describes a psychological conflict arising between the realisation that death is inevitable and largely unpredictable and the human need for self-preservation. We identified three main narratives: (1) fear of an uncontrollable, unknown new virus and its uncertain consequences-associated with sensationalist language and a sense of helplessness and confusion; (2) managing uncertainty and fear via prediction of the future and calls for behaviour change, associated with use of war metaphors; and (3) mourning and loss narratives that paid respect to the deceased and gave voice to grief, associated with euphemistic or glorifying language ('passed away', 'heroes'). Accounts of death and grief were largely homogenous, with bereavement due to COVID-19 presented as a series of tragedies, and there was limited practical advice about what to do if a loved one became seriously ill or died. Reporting reflected the tension between focusing on existential threat and the need to retreat from or attempt to control that threat. While the impact of this reporting on the public is unknown, a more nuanced approach is recommended to better support those bereaved by COVID-19., Competing Interests: The authors have declared that no competing interests exist.

Background: Parents commonly ask about food allergy tests, to find a cause for their child's eczema, yet the value of routine testing is uncertain., Objective: To determine whether a clinical trial comparing test-guided dietary advice versus usual care, for the management of eczema, is feasible., Methods: Children (>3 months and <5 years) with mild-to-severe eczema, recruited via primary care, were individually randomized (1:1) to intervention or usual care. Intervention participants underwent structured allergy history and skin prick tests (SPT) with dietary advice for cow's milk, hen's egg, wheat, peanut, cashew and codfish. All participants were followed up for 24 weeks. A sample of doctors and parents was interviewed. Registration ISRCTN15397185., Results: From 1059 invitation letters sent to carers of potentially eligible children, 84 were randomized (42 per group) with mean age of 32.4 months (SD 13.9) and POEM of 8.7 (4.8). Of the 42, 6 (14%) intervention participants were advised to exclude one or more foods, most commonly egg, peanut or milk. By participant, 1/6 had an oral food challenge (negative); 3/6 were told to exclude until review in allergy clinic; and 6/6 advised a home dietary trial (exclusion and reintroduction of food over 4-6 weeks) - with 1/6 partially completing it. Participant retention (four withdrawals) and data completeness (74%-100%) were acceptable and contamination low (two usual care participants had allergy tests). There were three minor SPT-related adverse events. During follow-up, 12 intervention and 8 usual care participants had minor, unrelated adverse events plus one unrelated hospital admission., Conclusions: It is possible to recruit, randomize and retain children with eczema from primary care into a trial of food allergy screening and to collect the outcomes of interest. Changes to recruitment and inclusion criteria are needed in a definitive trial, to ensure inclusion of younger children from more diverse backgrounds., (© 2021 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd.)

Background: Ethical issues arise daily in the delivery of palliative care. Despite much (largely theoretical) literature, evidence from specialist palliative care practitioners about day-to-day ethical challenges has not previously been synthesised. This evidence is crucial to inform education and adequately support staff., Aim: To synthesise the evidence regarding the ethical challenges which specialist palliative care practitioners encounter during clinical practice., Design: Systematic review with narrative synthesis (PROSPERO registration CRD42018105365). Quality was dual-assessed using the Mixed-Methods Appraisal Tool. Tabulation, textural description, concept mapping and thematic synthesis were used to develop and present the narrative., Data Sources: Seven databases (MEDLINE, Philosopher's Index, EMBASE, PsycINFO, LILACS, Web of Science and CINAHL) were searched from inception to December 2019 without language limits. Eligible papers reported original research using inductive methods to describe practitioner-reported ethical challenges., Results: A total of 8074 records were screened. Thirteen studies from nine countries were included. Challenges were organised into six themes: application of ethical principles; delivering clinical care; working with families; engaging with institutional structures and values; navigating societal values and expectations; philosophy of palliative care. Challenges related to specific scenarios/contexts rather than the application of general ethical principles, and occurred at all levels (bedside, institution, society, policy)., Conclusion: Palliative care practitioners encounter a broad range of contextual ethical challenges, many of which are not represented in palliative care ethics training resources, for example, navigating institutional policies, resource allocation and inter-professional conflict. Findings have implications for supporting ethical practice and training practitioners. The lack of low- and middle- income country data needs addressing.

Aims: To inform and guide patient-centred care for men with lower urinary tract symptoms (LUTS), by providing in-depth qualitative evidence regarding men's perspectives on treatment decision-making for LUTS., Methods: An interview study of men recruited from 26 English urology departments. Purposive sampling captured surgical/nonsurgical treatment decisions, and diversity in demographics and symptom burden, in men who had urodynamics and those who did not. After diagnostic assessments, men were interviewed either pre-treatment or after LUTS surgery. Thematic analysis was conducted. Participants' descriptions of how LUTS treatment decisions were made were categorised as patient-led, doctor-led, or shared., Results: A total of 41 men participated (25 pre-treatment, 16 post-surgery), ages 52-89. Twenty out of 41 described the treatment decision as shared with their consultant, 14 as doctor-led, and seven as patient-led. There was no obvious association between treatment decision-making style and patients' satisfaction with either clinicians' role in their decision or their treatment decision. Incomplete or rushed discussions and misperceptions of LUTS and its treatment were reported, indicating a risk of suboptimal decision-making support by clinicians. As well as clinician opinion, men's treatment decision-making was influenced by the results of urological assessments, comparing current symptoms with possible side-effects of surgery, and others' experiences and opinions., Conclusions: Men with LUTS report and prefer different kinds of decision-making support from their clinicians, who must tailor their input to patients' preferences and needs. Patients' treatment decision-making involves multiple factors and can be challenging, and areas of inadequate clinician support were identified. Recommendations for patient-centred consultations about LUTS treatment are presented., (© 2020 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals LLC.)

Background: The global COVID-19 pandemic has left health and social care systems facing the challenge of supporting large numbers of bereaved people in difficult and unprecedented social conditions. Previous reviews have not comprehensively synthesised the evidence on the response of health and social care systems to mass bereavement events., Aim: To synthesise the evidence regarding system-level responses to mass bereavement events, including natural and human-made disasters as well as pandemics, to inform service provision and policy during the COVID-19 pandemic and beyond., Design: A rapid systematic review was conducted, with narrative synthesis. The review protocol was registered prospectively (www.crd.york.ac.uk/prospero, CRD 42020180723)., Data Sources: MEDLINE, Global Health, PsycINFO and Scopus databases were searched for studies published between 2000 and 2020. Reference lists were screened for further relevant publications, and citation tracking was performed., Results: Six studies were included reporting on system responses to mass bereavement following human-made and natural disasters, involving a range of individual and group-based support initiatives. Positive impacts were reported, but study quality was generally low and reliant on data from retrospective evaluation designs. Key features of service delivery were identified: a proactive outreach approach, centrally organised but locally delivered interventions, event-specific professional competencies and an emphasis on psycho-educational content., Conclusion: Despite the limitations in the quantity and quality of the evidence base, consistent messages are identified for bereavement support provision during the pandemic. High quality primary studies are needed to ensure service improvement in the current crisis and to guide future disaster response efforts.

Background: Lower urinary tract symptoms (LUTS) in men may indicate bladder outlet obstruction (BOO) or weakness, known as detrusor underactivity (DU). Severe bothersome LUTS are a common indication for surgery. The diagnostic tests may include urodynamics (UDS) to confirm whether BOO or DU is the cause, potentially reducing the number of people receiving (inappropriate) surgery., Objectives: The primary objective was to determine whether a care pathway including UDS is no worse for symptom outcome than one in which it is omitted, at 18 months after randomisation. Rates of surgery was the key secondary outcome., Design: This was a pragmatic, multicentre, two-arm (unblinded) randomised controlled trial, incorporating a health economic analysis and qualitative research., Setting: Urology departments of 26 NHS hospitals in England., Participants: Men (aged ≥ 18 years) seeking further treatment, potentially including surgery, for bothersome LUTS. Exclusion criteria were as follows: unable to pass urine without a catheter, having a relevant neurological disease, currently undergoing treatment for prostate or bladder cancer, previously had prostate surgery, not medically fit for surgery and/or unwilling to be randomised., Interventions: Men were randomised to a care pathway based on non-invasive routine tests (control) or routine care plus invasive UDS (intervention arm)., Main Outcome Measures: The primary outcome was International Prostate Symptom Score (IPSS) at 18 months after randomisation and the key secondary outcome was rates of surgery. Additional secondary outcomes included adverse events (AEs), quality of life, urinary and sexual symptoms, UDS satisfaction, maximum urinary flow rate and cost-effectiveness., Results: A total of 820 men were randomised (UDS, 427; routine care, 393). Sixty-seven men withdrew before 18 months and 11 died (unrelated to trial procedures). UDS was non-inferior to routine care for IPSS 18 months after randomisation, with a confidence interval (CI) within the margin of 1 point (-0.33, 95% CI -1.47 to 0.80). A lower surgery rate in the UDS arm was not found (38% and 36% for UDS and routine care, respectively), with overall rates lower than expected. AEs were similar between the arms at 43-44%. There were more cases of acute urinary retention in the routine care arm. Patient-reported outcomes for LUTS improved in both arms and satisfaction with UDS was high in men who received it. UDS was more expensive than routine care. From a secondary care perspective, UDS cost an additional £216 over an 18-month time horizon. Quality-adjusted life-years (QALYs) were similar, with a QALY difference of 0.006 in favour of UDS over 18 months. It was established that UDS was acceptable to patients, and valued by both patients and clinicians for its perceived additional insight into the cause and probable best treatment of LUTS., Limitations: The trial met its predefined recruitment target, but surgery rates were lower than anticipated., Conclusions: Inclusion of UDS in the diagnostic tests results in a symptom outcome that is non-inferior to a routine care pathway, but does not affect surgical rates for treating BOO. Results do not support the routine use of UDS in men undergoing investigation of LUTS., Future Work: Focus should be placed on indications for selective utilisation of UDS in individual cases and long-term outcomes of diagnosis and therapy., Trial Registration: Current Controlled Trials ISRCTN56164274., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 42. See the NIHR Journals Library website for further project information., Competing Interests: Outside this work, Paul Abrams reports grants and personal fees for being a consultant and speaker for Astellas Pharma Inc. (Tokyo, Japan), and personal fees for being a consultant for Ipsen (Paris, France) and a speaker for Pfizer Inc. (New York City, NY, USA) and Sun Pharmaceutical Industries Ltd (Mumbai, India). He also reports personal fees from Pierre Fabre S.A. (Paris, France) and Coloplast Ltd (Peterborough, UK). Christopher Chapple reports being an author for Allergan plc (Dublin, Ireland) and Astellas Pharma; being an investigator for scientific studies/trials with Astellas Pharma and Ipsen; being a patent holder with Symimetics; receiving personal fees as a consultant/advisor for Astellas Pharma, Bayer Schering Pharma GmbH (Berlin, Germany), Ferring Pharmaceuticals (Saint-Prex, Switzerland), Galvani Bioelectronics (GlaxoSmithKline; Stevenage, UK), Pierre Fabre, Symimetics, TARIS Biomedical Inc. (Lexington, MA, USA), and Urovant Sciences (Irvine, CA, USA); and receiving personal fees as a meeting participant/speaker for Astellas Pharma and Pfizer. J Athene Lane was a member of the Clinical Trials Unit funded by the National Institute for Health Research during the conduct of this trial. Marcus J Drake reports being on associated advisory boards and has received grants, personal fees and non-financial support from Allergan, Astellas Pharma and Ferring Pharmaceuticals. He has also received personal fees from Pfizer.

Deaths due to COVID-19 are associated with risk factors which can lead to prolonged grief disorder, post-traumatic stress, and other poor bereavement outcomes among relatives, as well as moral injury and distress in frontline staff. Here we review relevant research evidence and provide evidence-based recommendations and resources for hospital clinicians to mitigate poor bereavement outcomes and support staff. For relatives, bereavement risk factors include dying in an intensive care unit, severe breathlessness, patient isolation or restricted access, significant patient and family emotional distress, and disruption to relatives' social support networks. Recommendations include advance care planning; proactive, sensitive, and regular communication with family members alongside accurate information provision; enabling family members to say goodbye in person where possible; supporting virtual communication; providing excellent symptom management and emotional and spiritual support; and providing and/or sign-posting to bereavement services. To mitigate effects of this emotionally challenging work on staff, we recommend an organizational and systemic approach which includes access to informal and professional support., (Copyright © 2020 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Trial oversight is important for trial governance and conduct. Patients and/or lay members of the public are increasingly included in trial oversight committees, influenced by international patient and public involvement (PPI) initiatives to improve the quality and relevance of research. However, there is a lack of guidance on how to undertake PPI in trial oversight and tokenistic PPI remains an issue. This paper explores how PPI functions in existing trial oversight committees and provides recommendations to optimise PPI in future trials. This was part of a larger study investigating the role and function of oversight committees in trials facing challenges., Methods: Using an ethnographic study design, we observed oversight meetings of eight UK trials and conducted semi-structured interviews with members of their trial steering committees (TSCs) and trial management groups (TMGs) including public contributors, trial sponsors and funders. Thematic analysis of data was undertaken, with findings integrated to provide a multi-perspective account of how PPI functions in trial oversight., Results: Eight TSC and six TMG meetings from eight trials were observed, and 66 semi-structured interviews conducted with 52 purposively sampled oversight group members, including three public contributors. PPI was reported as beneficial in trial oversight, with public members contributing a patient voice and fulfilling a patient advocacy role. However, public contributors were not always active at oversight meetings and were sometimes felt to have a tokenistic role, with trialists reporting a lack of understanding of how to undertake PPI in trial oversight. To optimise PPI in trial oversight, the following areas were highlighted: the importance of planning effective strategies to recruit public contributors; considering the level of oversight and stage(s) of trial to include PPI; support for public contributors by the trial team between and during oversight meetings., Conclusions: We present evidence-based recommendations to inform future PPI in trial oversight. Consideration should be given at trial design stage on how to recruit and involve public contributors within trial oversight, as well as support and mentorship for both public contributors and trialists (in how to undertake PPI effectively). Findings from this study further strengthen the evidence base on facilitating meaningful PPI within clinical trials.

Background: Although compassionate care is considered a cornerstone of quality palliative care, there is a paucity of valid and reliable measures to study, assess, and evaluate how patients experience compassion/compassionate care in their care., Objective: The aim was to develop a patient-reported compassion measure for use in research and clinical practice with established content-related validity evidence for the items, question stems, and response scale., Methods: Content validation for an initial 109 items was conducted through a two-round modified Delphi technique, followed by cognitive interviews with patients. A panel of international Subject Matter Experts (SMEs) and a Patient Advisory Group (PAG) assessed the items for their relevancy to their associated domain of compassion, yielding an Item-level Content Validity Index (I-CVI), which was used to determine content modifications. The SMEs and the PAG also provided narrative feedback on the clarity, flow, and wording of the instructions, questions, and response scale, with items being modified accordingly. Cognitive interviews were conducted with 16 patients to further assess the clarity, comprehensibility, and readability of each item within the revised item pool., Results: The first round of the Delphi review produced an overall CVI of 72% among SMEs and 80% among the PAG for the 109 items. Delphi panelists then reviewed a revised measure containing 84 items, generating an overall CVI of 84% for SMEs and 86% for the PAG. Sixty-eight items underwent further testing via cognitive interviews with patients, resulting in an additional 14 items being removed., Conclusions: Having established this initial validity evidence, further testing to assess internal consistency, test-retest reliability, factor structure, and relationships to other variables is required to produce the first valid, reliable, and clinically informed patient-reported measure of compassion.

Background: Increasing numbers of older adults are living with kidney disease. For those with comorbidities, conservative management of end-stage kidney disease is a viable option: dialysis may afford limited or no survival benefit, and perceived burdens may outweigh benefits. Conservative management focuses on: maintaining remaining kidney function; symptom management; and quality of life. Common symptoms in conservatively managed kidney disease include: fatigue; anorexia; nausea and vomiting; pain and pruritis. Chronic disease is associated with biographical disruption and a loss of sense of self. Coping strategies are shaped by illness perceptions, but little is known of illness perceptions of people living with conservatively managed kidney disease. This study aimed to explore the experience, impact and understanding of conservatively managed end-stage kidney disease among older adults., Methods: Secondary analysis of qualitative interviews analysed using thematic analysis. Twenty people with conservatively managed end-stage kidney disease were recruited from 3 UK renal units: median age was 82 (range, 69-95); 9 women, 11 men., Results: Participants described the invisibility and intangibility of kidney disease, and challenges in attributing symptoms to the disease. They described a spectre-like presence, sapping their energy and holding them down. For some, it was hard to differentiate symptoms of the illness from characteristics of aging, resulting in challenges in illness attribution, and disconnectedness from the illness., Conclusions: Participants described challenges in attributing their symptoms to kidney disease which negatively impacted upon their wellbeing, and ability to accept an adjusted sense of self. Understanding these challenges is critical in the management conditions such as end-stage kidney disease where prognosis may be poor, and where an increase in symptom distress may suggest a marked deterioration in their condition, or a change in phase of illness. Clinical services need to recognize the illness experience (alongside more symptom led approaches), including the invisibility, intangibility, and disconnectedness, and address this through specific interventions focused on improving clinical assessment, communication and education, alongside peer and professional support.

Objective: To explore generalist palliative care providers' experiences of emotional labour when undertaking conversations around palliative and end-of-life care with patients and families, to inform supportive strategies., Methods: Semi-structured interviews conducted with generalist staff (those providing 'primary' or 'general' palliative care, not palliative care specialists) who had attended a communication workshop. Sampling was purposive (by gender, profession, experience). Data were analysed using a framework approach; a sample of transcripts were double-coded for rigour. Data collection and analysis were informed by theories of emotional labour, coping, and communication., Results: Four ambulance staff, three nurses, two speech and language therapists, and one therapy assistant were interviewed. Five themes emerged: emotions experienced; emotion 'display rules'; emotion management; support needs; and perceived impact of emotional labour. Participants reported balancing 'human' and 'professional' expressions of emotion. Support needs included time for emotion management, workplace cultures that normalise emotional experiences, formal emotional support, and palliative and end-of-life care skills training., Conclusion: Diverse strategies to support the emotional needs of generalist staff are crucial to ensure high-quality end-of-life care and communication, and to support staff well-being., Practice Implications: Both formal and informal support is required, alongside skills training, to enable a supportive workplace culture and individual development., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: Older people with advanced kidney disease require information and support from clinicians when deciding whether to have dialysis or conservative (non-dialysis) care. There is evidence that communication practices, information provision and treatment rates vary widely across renal units. However, experiences of communicating with clinicians among patients receiving conservative care are poorly understood. This evidence is essential to ensure support is patient-centred and equitable. Our aim was to explore views and experiences of communication, information provision and treatment decision-making among older patients receiving conservative care., Methods: In-depth qualitative interviews were conducted with patients with stage 5 chronic kidney disease from three UK renal units. Purposive sampling captured variation in age, co-morbidity and functional status. Interviews were analysed thematically., Results: 20 patients were interviewed (11 were men; median age 82 (range 69-95)). Participants described positive experiences of communicating with clinicians and receiving information, but also negative experiences involving insensitivity, rushing or ambiguity. Participants reported clinicians omitting/avoiding conversations regarding diagnosis and prognosis, and described what helped and hindered good communication and support. They wanted information about their treatment options and illness, but expressed ambivalence about knowing details of disease progression. Clinicians' views and recommendations regarding treatment influenced patients' decision-making., Conclusions: Older patients report variable quality in communication with clinicians and gaps in the information received. Uncertainty about the disease trajectory and patients' ambivalence regarding information makes communication particularly challenging for clinicians. Tailoring information to patient preferences and conveying it clearly and sensitively is critical. Renal clinicians require support and training to ensure decision-making support for older patients is patient-centred. Future research should examine how clinicians' communication practices influence treatment decision-making.

Background: Low participation in clinical trials is a major challenge to advancing clinical Alzheimer's disease (AD) research and care. Factors influencing recruitment to AD trials are not fully understood., Objective: To identify barriers to, and facilitators of, recruitment in a UK multi-center, secondary care AD trial (Reducing pathology in Alzheimer's Disease through Angiotensin TaRgeting (RADAR) trial) and implications for improving recruitment to AD trials., Methods: Semi-structured qualitative telephone interviews with a purposive sample of 17 trial site staff explored the RADAR trial recruitment pathway and views and experiences of recruitment. Interviews were analyzed thematically., Results: Diagnostic and care pathways hindered identifying patients with mild-moderate AD, with a lack of up-to-date patient records and data access problems affecting screening. Research is not routinely embedded in AD care but facilitated recruitment when it was. Clinicians' and patients' favorable view of the trial purpose facilitated recruitment, although the complexity of participant information sheets and requirement for study companion created challenges., Conclusion: These findings have important implications for the design of future AD trials and for planning how to best interface with clinical commitments to ensure sufficient and timely recruitment. Challenges to AD trial recruitment can occur at care pathway, clinician, and patient and companion levels. Recruitment can be facilitated by: improving diagnostic processes and systems for recording and sharing patient information, embedding research into routine patient care, collaborating with a range of services to identify and approach eligible patients, training and engaging trial staff, and providing patients with clear and concise study information.

Aims: To capture in-depth qualitative evidence regarding attitudes to and experiences of urodynamic testing among men with lower urinary tract symptoms (LUTS) at each end of the clinical pathway., Methods: Semi-structured interview study conducted within the Urodynamics for Prostate Surgery: Randomized Evaluation of Assessment Methods (UPSTREAM) trial, which randomized men to a care pathway including urodynamics or routine non-invasive tests from 26 secondary care urology sites across England. Men were interviewed after assessments but prior to treatment, or after surgery for LUTS. Men were purposively sampled to include those who had urodynamics and those who did not, and diversity in demographic characteristics and symptom burden. Interviews were analyzed using inductive thematic analysis., Results: Forty-one men participated (25 pre-treatment, 16 post-surgery), ages 52-89. The 16 men who had not previously experienced urodynamics said they would accept the test in their assessment, but some were apprehensive or wanted more information. The 25 men who had experienced urodynamics all found it acceptable, though some reported pain, infection, or embarrassment. Embarrassment was minimized by informing patients what the procedure would be like, and ensuring privacy. Urodynamics was valued for its perceived diagnostic insight. Information deficits were reported before, during, and after the test. How and when results were explained and the adequacy of explanations varied., Conclusions: Urodynamics is acceptable to men with LUTS and generally well-tolerated. To ensure patients are prepared and informed, good communication before and during the procedure is essential. Privacy should be prioritized, and test results discussed promptly and in sufficient detail. Staff require training and guidance in these areas., (© 2017 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals, Inc.)

Background: Cutaneous T-cell lymphomas (CTCL) are rare cancers, which can be difficult to diagnose, are incurable and adversely affect quality of life, particularly in advanced disease. Families often provide care, but little is known about their experiences or needs while caring for their relative with advanced disease or in bereavement., Objectives: To explore the experiences of bereaved family caregivers of patients with CTCL., Methods: Single, semi-structured qualitative interviews were conducted with bereaved family caregivers of patients with CTCL recruited via a supra-regional CTCL clinic. Transcribed interviews were analysed thematically, focusing on advanced disease, the approach of death and bereavement., Results: Fifteen carers of 11 deceased patients participated. Experiences clustered under four themes: (1) complexity of care and medical intervention; (2) caregiver roles in advanced CTCL; (3) person-centred vs. organization-centred care in advanced CTCL and (4) knowing and not knowing: reflections on dying, death and bereavement. Caregivers often had vivid recollections of the challenges of caring for their relative with advanced CTCL and some took on quasi-professional roles as a result. Advanced disease made high demands on both organizational flexibility and family resources. For many caregivers, seeing disease progression was a prolonged and profoundly traumatic experience. The extent to which they were prepared for their relative's death and supported in bereavement was highly variable. Sub-themes within each theme provide more detail about caregiver experiences., Conclusions: Family caregivers should be considered part of the wider healthcare team, acknowledging their multiple roles and the challenges they encounter in looking after their relative with CTCL as the disease progresses. Their experiences highlight the importance of organizational flexibility and of good communication between healthcare providers in advanced CTCL., (© 2018 British Association of Dermatologists.)

Context: Advance care planning (ACP) can improve end-of-life outcomes, but low uptake indicates it is less acceptable to patients of some cultural backgrounds., Objectives: The objectives of this study were to explore how cultural factors influence ACP for patients with progressive, incurable disease and how ACP might be made cross-culturally appropriate., Method: We conducted a systematic literature review using narrative synthesis. Protocol was registered prospectively (PROSPERO CRD42017060441). Key words and subject headings of six databases (AMED, PsycINFO, Embase, Ovid MEDLINE, CINAHL, and Cochrane) were searched without time restrictions. Eligible studies reported original research published in full that included adult participants with progressive, incurable disease or their formal or informal caregivers. Study quality was assessed using the Mixed Methods Appraisal Tool., Results: Eight hundred and eighteen studies were screened. Twenty-seven were included: 20 quantitative, four qualitative, and three mixed methods. Most (20/30) studies were conducted in the U.S., where nonwhite ethnicity was associated with lower acceptability of formal, documented ACP processes. Cultural factors affecting ACP acceptability included religiosity, trust in the health care system, patient and clinician comfort discussing death, and patient attitudes regarding decision-making. Informal, communication-focused approaches to ACP appear more cross-culturally acceptable than formal processes. Clinician education in cultural competence is recommended. Study limitations included use of unvalidated tools and convenience samples and lack of reflexivity., Conclusion: Many interconnected cultural factors influence the acceptability of ACP in progressive, incurable disease, although specific mechanisms remain unclear. A communication-focused approach to ACP may better meet the needs of culturally diverse populations., (Copyright © 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Patient empowerment, defined as 'a process through which people gain greater control over decisions and actions affecting their health' (World Health Organization) is a key theme within global health and social care strategies. The benefits of incorporating empowerment strategies in care are well documented, but little is known about their application or impact for patients with advanced, life-limiting illness(s)., Aim: To identify and synthesise the international evidence on patient empowerment for adults with advanced, life-limiting illness(s)., Design: Systematic review (PROSPERO no. 46113) with critical interpretive synthesis methodology., Data Sources: Five databases (MEDLINE, Embase, CINHAL, PsycINFO and Cochrane) were searched from inception to March 2018. Grey literature and reference list/citation searches of included papers were undertaken., Inclusion Criteria: empirical research involving patients with advanced life-limiting illness including descriptions of, or references to, patient empowerment within the study results., Results: In all, 13 papers met inclusion criteria. Two qualitative studies explored patient empowerment as a study objective. Six papers evaluated interventions, referencing patient empowerment as an incidental outcome. The following themes were identified from the interpretive synthesis: self-identity, personalised knowledge in theory and practice, negotiating personal and healthcare relationships, acknowledgement of terminal illness, and navigating continued losses., Conclusion: There are features of empowerment, for patients with advanced life-limiting illness distinct to those of other patient groups. Greater efforts should be made to progress the empowerment of patients nearing the end of their lives. We propose that the identified themes may provide a useful starting point to guide the assessment of existing or planned services and inform future research.

Objectives: Evidence-based communication skills training for health and social care professionals is essential to improve the care of seriously ill patients and their families. We aimed to evaluate the self-reported impact of 'Difficult Conversations', a multidisciplinary half-day interactive workshop, and gain feedback to inform future development and evaluation., Methods: Service evaluation using questionnaire data collected before and immediately after workshops from February 2015 to August 2016 regarding participant self-assessed confidence, knowledge and skills. Qualitative free-text comments provided feedback about the workshop and were subjected to content analysis., Results: Of 886 workshop participants, 655 completed baseline questionnaires and 714 postworkshop questionnaires; 550 were matched pairs. Participants were qualified or trainee general practitioners (34%), community nurses and care coordinators (32%), social care professionals (7%), care home staff (6%), advanced practice/specialist nurses (5%), care workers (5%) and allied health professionals (3%). All groups demonstrated significant increases in mean self-assessed confidence (2.46, 95% CI 2.41 to 2.51; to 3.20, 95% CI 3.17 to 3.24; P<0.001), knowledge (2.22, 95% CI 2.17 to 2.27; to 3.18, 95% CI 3.14 to 3.22; P<0.001) and skills (2.37, 95% CI 2.32 to 2.42; to 3.09, 95% CI 3.05 to 3.12; P<0.001). Qualitative findings showed participants valued role play, the communication framework acronym and opportunities for discussion. They commended workshop facilitators' skills, the safe atmosphere and interprofessional learning. Suggested improvements included more prepared role play and greater coverage of the taught topics., Conclusions: 'Difficult Conversations' workshops were associated with improvements in participants' self-assessed confidence, knowledge, and skills. Our findings identify workshop characteristics that are acceptable to multidisciplinary trainees. Further testing is warranted to determine effectiveness and accurately identify workshop components leading to change., Competing Interests: Competing interests: LJB, LES, NG, KB and JK declare no competing interests. JN and CM-S developed the ‘Difficult Conversations’ workshop and have a small proportion of their time paid by the Social Enterprise Difficult Conversations., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: A new model of care is required to meet the changing needs of people living with HIV (PLWH), particularly in low and middle-income countries, where prevalence is highest. We evaluated a palliative care intervention for PLWH in Mombasa, Kenya. Although we found no effect on pain (primary outcome), there was a positive effect on mental health (secondary outcome) in the intervention group. To inform replication and implementation, we have determined the active ingredients of the intervention and their mechanisms of action., Methods: We conducted a randomised controlled trial (RCT) with qualitative exit interviews in HIV clinic attenders. The intervention was delivered over 5 months, with a minimum of 7 clinical contacts. Longitudinal quantitative data on components of care received were analysed using area under the curve and logistic regression. Qualitative data were analysed using inductive and deductive thematic analysis., Results: Quantitative data analysis identified that intervention patients received more weak opioid, laxatives, discussion about spiritual worries, emotional support from staff for themselves and their families, time to talk about worries, discussion about future and planning ahead. Qualitative data analysis found that patients reported that having time to talk, appropriate pain medication and effective health education was of therapeutic value for their psychological well-being. Integration of mixed method findings suggest that positive effect in quantitative measures of mental health and well-being are attributable to the active ingredients of: appropriate medication, effective health education and counselling, and having time to talk in clinical encounters. Mechanisms of action include symptom relief, improved understanding of illness and treatment, and support focused on articulated concerns., Conclusions: Routine care must provide opportunities and means for existing clinical staff to make routine appointments more person-centred. This approach enabled staff to identify and manage multidimensional problems and provide tailored health education and counselling., Trial Registration: ClinicalTrials.gov ( NCT01608802 ). Registered 12th May 2012.

Background: Spiritual distress is prevalent in advanced disease, but often neglected, resulting in unnecessary suffering. Evidence to inform spiritual care practices in palliative care is limited., Aim: To explore spiritual care needs, experiences, preferences and research priorities in an international sample of patients with life-limiting disease and family caregivers., Design: Focus group study., Setting/participants: Separate patient and caregiver focus groups were conducted at 11 sites in South Africa, Kenya, South Korea, the United States, Canada, the United Kingdom, Belgium, Finland and Poland. Discussions were transcribed, translated into English and analysed thematically., Results: A total of 74 patients participated: median age 62 years; 53 had cancer; 48 were women. In total, 71 caregivers participated: median age 61 years; 56 were women. Two-thirds of participants were Christian. Five themes are described: patients' and caregivers' spiritual concerns, understanding of spirituality and its role in illness, views and experiences of spiritual care, preferences regarding spiritual care, and research priorities. Participants reported wide-ranging spiritual concerns spanning existential, psychological, religious and social domains. Spirituality supported coping, but could also result in framing illness as punishment. Participants emphasised the need for staff competence in spiritual care. Spiritual care was reportedly lacking, primarily due to staff members' de-prioritisation and lack of time. Patients' research priorities included understanding the qualities of human connectedness and fostering these skills in staff. Caregivers' priorities included staff training, assessment, studying impact, and caregiver's spiritual care needs., Conclusion: To meet patient and caregiver preferences, healthcare providers should be able to address their spiritual concerns. Findings should inform patient- and caregiver-centred spiritual care provision, education and research.

Background: Anti-hypertensives that modify the renin angiotensin system may reduce Alzheimer's disease (AD) pathology and reduce the rate of disease progression., Objective: To conduct a phase II, two arm, double-blind, placebo-controlled, randomized trial of losartan to test the efficacy of Reducing pathology in Alzheimer's Disease through Angiotensin TaRgeting (RADAR)., Methods: Men and women aged at least 55 years with mild-to-moderate AD will be randomly allocated 100 mg encapsulated generic losartan or placebo once daily for 12 months after successful completion of a 2-week open-label phase and 2-week placebo washout to establish drug tolerability. 228 participants will provide at least 182 subjects with final assessments to provide 84% power to detect a 25% difference in atrophy rate (therapeutic benefit) change over 12 months at an alpha level of 0.05. We will use intention-to-treat analysis, estimating between-group differences in outcomes derived from appropriate (linear or logistic) multivariable regression models adjusting for minimization variables., Results: The primary outcome will be rate of whole brain atrophy as a surrogate measure of disease progression. Secondary outcomes will include changes to 1) white matter hyperintensity volume and cerebral blood flow; 2) performance on a standard series of assessments of memory, cognitive function, activities of daily living, and quality of life. Major assessments (for all outcomes) and relevant safety monitoring of blood pressure and bloods will be at baseline and 12 months. Additional cognitive assessment will also be conducted at 6 months along with safety blood pressure and blood monitoring. Monitoring of blood pressure, bloods, and self-reported side effects will occur during the open-label phase and during the majority of the post-randomization dispensing visits., Conclusion: This study will identify whether losartan is efficacious in the treatment of AD and whether definitive Phase III trials are warranted.

Background: The oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder and sponsor. We aimed to examine how the relationships between these stakeholders affect the trial oversight process and its rigour, to inform future revision of Good Clinical Practice guidelines., Methods: Using an ethnographic study design, we observed the oversight processes of eight trials and conducted semi-structured interviews with members of the trials' TSCs and TMGs, plus other relevant informants, including sponsors and funders of trials. Data were analysed thematically, and findings triangulated and integrated to give a multi-perspective account of current oversight practices in the UK., Results: Eight TSC and six TMG meetings from eight trials were observed and audio-recorded, and 66 semi-structured interviews conducted with 52 purposively sampled key informants. Five themes are presented: (1) Collaboration within the TMG and role of the CTU; (2) Collaboration and conflict between oversight committees; (3) Priorities; (4) Communication between trial oversight groups and (5) Power and accountability. There was evidence of collaborative relationships, based on mutual respect, between CTUs, TMGs and TSCs, but also evidence of conflict. Relationships between trial oversight committees were influenced by stakeholders' priorities, both organisational and individual. Good communication following specific, recognised routes played a central role in ensuring that relationships were productive and trial oversight efficient. Participants described the possession of power over trials as a shifting political landscape, and there was lack of clarity regarding the roles and accountability of each committee, the sponsor and funder. Stakeholders' perceptions of their own power over a trial, and the power of others, influenced relationships between those involved in trial oversight., Conclusions: Recent developments in trial design and conduct have been accompanied by changes in roles and relationships between trial oversight groups. Recognising and respecting the value of differing priorities among those involved in running trials is key to successful relationships between committees, funders and sponsors. Clarity regarding appropriate lines of communication, roles and accountability is needed. We present 10 evidence-based recommendations to inform updates to international trial guidance, particularly the Medical Research Council guidelines.

Background: Over half of all deaths in Europe occur in hospital, a location associated with many complaints. Initiatives to improve inpatient end-of-life care are therefore a priority. In England, over 78,000 volunteers provide a potentially cost-effective resource to hospitals. Many work with people who are dying and their families, yet little is known about their training in end-of-life care., Aims: To explore hospital volunteers' end-of-life care training needs and learning preferences, and the acceptability of training evaluation methods., Design: Qualitative focus groups., Setting/participants: Volunteers from a large teaching hospital were purposively sampled., Results: Five focus groups were conducted with 25 hospital volunteers (aged 19-80 years). Four themes emerged as follows: preparation for the volunteering role, training needs, training preferences and evaluation preferences. Many described encounters with patients with life-threatening illness and their families. Perceived training needs in end-of-life care included communication skills, grief and bereavement, spiritual diversity, common symptoms, and self-care. Volunteers valued learning from peers and end-of-life care specialists using interactive teaching methods including real-case examples and role plays. A chance to 'refresh' training at a later date was suggested to enhance learning. Evaluation through self-reports or observations were acceptable, but ratings by patients, families and staff were thought to be pragmatically unsuitable owing to sporadic contact with each., Conclusion: Gaps in end-of-life care training for hospital volunteers indicate scope to maximise on this resource. This evidence will inform development of training and evaluations which could better enable volunteers to make positive, cost-effective contributions to end-of-life care in hospitals.

Context: End-of-life care (EoLC) communication skills training for generalist palliative care providers is recommended in policy guidance globally. Although many training programs now exist, there has been no comprehensive evidence synthesis to inform future training delivery and evaluation., Objectives: To identify and appraise how EoLC communication skills training interventions for generalist palliative care providers are developed, delivered, evaluated, and reported., Methods: Systematic review. Ten electronic databases (inception to December 2015) and five relevant journals (January 2004 to December 2015) were searched. Studies testing the effectiveness of EoLC communication skills training for generalists were included. Two independent authors assessed study quality. Descriptive statistics and narrative synthesis are used to summarize the findings., Results: From 11,441 unique records, 170 reports were identified (157 published, 13 unpublished), representing 160 evaluation studies of 153 training interventions. Of published papers, eight were of low quality, 108 medium, and 41 high. Few interventions were developed with service user involvement (n = 7), and most were taught using a mixture of didactics (n = 123), reflection and discussion (n = 105), and role play (n = 86). Evaluation designs were weak: <30% were controlled, <15% randomized participants. Over half (n = 85) relied on staff self-reported outcomes to assess effectiveness, and 49% did not cite psychometrically validated measures. Key information (e.g., training duration, participant flow) was poorly reported., Conclusions: Despite a proliferation of EoLC communication skills training interventions in the literature, evidence is limited by poor reporting and weak methodology. Based on our findings, we present a CONSORT statement supplement to improve future reporting and encourage more rigorous testing., (Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.)

Context: As most end-of-life care is provided by health care providers who are generalists rather than specialists in palliative care, effective communication skills training for generalists is essential., Objectives: To determine the effect of communication training interventions for generalist palliative care providers on patient-reported outcomes and trainee behaviors., Methods: Systematic review from searches of 10 databases to December 2015 (MEDLINE, EMBASE, PsycINFO, ERIC, CINAHL, CENTRAL, Web of Science, ICTRP, CORDIS, and OpenGrey) plus hand searching. Randomized controlled trials of training interventions intended to enhance generalists' communication skills in end-of-life care were included. Two authors independently assessed eligibility after screening, extracted data, and graded quality. Data were pooled for meta-analysis using a random-effects model. PRISMA guidelines were followed., Results: Nineteen of 11,441 articles were eligible, representing 14 trials. Eleven were included in meta-analyses (patients n = 3144, trainees n = 791). Meta-analysis showed no effect on patient outcomes (standardized mean difference [SMD] = 0.10, 95% CI -0.05 to 0.24) and high levels of heterogeneity (chi-square = 21.32, degrees of freedom [df] = 7, P = 0.003; I 2  = 67%). The effect on trainee behaviors in simulated interactions (SMD = 0.50, 95% CI 0.19-0.81) was greater than in real patient interactions (SMD = 0.21, 95% CI -0.01 to 0.43) with moderate heterogeneity (chi-square = 8.90, df = 5, P = 0.11; I 2  = 44%; chi-square = 5.96, df = 3, P = 0.11; I 2  = 50%, respectively). Two interventions with medium effects on showing empathy in real patient interactions included personalized feedback on recorded interactions., Conclusions: The effect of communication skills training for generalists on patient-reported outcomes remains unclear. Training can improve clinicians' ability to show empathy and discuss emotions, at least in simulated consultations. Personalized feedback on recorded patient interactions may be beneficial., Registration Number: CRD42014014777., (Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.)