Correction: Supported: Supporting, enabling, and sustaining homecare workers to deliver end-of-life care: A qualitative study protocol.

[This corrects the article DOI: 10.1371/journal.pone.0291525.].

Qualified and motivated, but limited by specialty-specific barriers: a national survey of UK Palliative Medicine consultants research experience.

OBJECTIVES: Providing high-quality safe palliative care requires high-quality clinically driven research. Little is known about how to optimise clinical research capacity in this field.To understand interest and capacity to conduct clinical research in palliative medicine and identify key facilitators and barriers, by surveying palliative medicine consultants and academic trainees. METHODS: National online survey exploring experience in conducting research, including facilitators and barriers. Sent to all current UK palliative medicine consultants, and previous/current academic trainees. Descriptive statistics are reported with framework analysis of free text responses. RESULTS: 195 surveys were submitted including 15 respondents with Integrated Academic Training (IAT) experience. 78% (n=140/180) of consultants were interested in conducting research. Despite this enthusiasm, 83% had no allocated time within their job plan. 88% of those who undertook IAT would recommend IAT, but 60% reported difficulty transitioning from academic trainee to research active consultant.Barriers to research included; insufficient research culture and integration, with small teams working in a mixture of National Health Service (NHS) and non-NHS settings, leading to isolated, silo working. Even those who had undertaken IAT, felt a 'cliff edge' in opportunities after completing IAT. Filling service gaps was routinely prioritised over research activity. CONCLUSION: Palliative medicine consultants, including those who have completed academic training want to conduct research but overwhelming barriers limit activity. A palliative care-specific strategy that permeates different palliative care settings, promotes interspecialty collaboration and improves the current infrastructure for palliative care research to maximise gains from IAT and embed a research culture are suggested.

Supported: Supporting, enabling, and sustaining homecare workers to deliver end-of-life care: A qualitative study protocol.

BACKGROUND: Homecare workers provide essential care at home for people at end-of-life but are often poorly trained and supported. AIM: To explore the experiences and needs of homecare workers and the views of homecare clients and carers, and other community-based health and social care staff about the homecare worker role, including identification of good practice. METHODS: In this qualitative exploratory study, we will conduct 150 semi-structured interviews with homecare workers within three geographic English localities chosen for maximum socio-demographic variation. Eligible participants will be consenting adults providing care services (workers [n = 45], managers [n = 15] community practitioners [n = 30]), receiving care (clients thought to be in the last 6 months of life [n = 30], family carers [n = 15], or commissioners of homecare services supporting end-of-life care [n = 15]. Interviews may adopt a Pictor-guided or standard semi-structured approach according to their preference. Managers and commissioners can contribute to an online focus group if preferred. A range of recruitment strategies will be used, including through homecare agencies, local authorities, local NHS services, charities, voluntary sector groups and social media. Interviews and focus groups will be recorded, transcribed, anonymised, and analysed adopting a case-based approach for each geographic area within-case and then comparison across cases using reflexive thematic analysis. The design and analysis will be informed by Bronfenbrenner's Adapted Ecological Systems theory. This study is registered on the Research Registry (No.8613). CONTRIBUTION: We will provide evidence on ways to improve the experiences and address the needs of homecare workers in relation to caring for people nearing end-of-life. It will offer insight into good practice around supporting homecare workers including responding to their training and development needs. Findings will inform subsequent stages of an evaluation-phase study of a training resource for homecare workers.

Applying the community readiness model to identify and address inequity in end-of-life care in South Asian communities.

BACKGROUND: Individuals from minoritised ethnic backgrounds are less likely than individuals from the dominant ethnic group to access palliative care services and to have documented Advance Care Plans. They are more likely to be admitted to hospital in the last months of life. AIM: To use the Community Readiness Model to identify the barriers that influence how South Asian communities access and use two new palliative care services. DESIGN: The Community Readiness Model is a validated tool that measures the readiness of a community. Key stakeholders were asked to: (i) complete a questionnaire to assess South Asian communities' readiness to engage in advance care planning and, (ii) attend a focus group to explore their views on the communities' understandings of palliative and end-of-life care. SETTING/PARTICIPANTS: Ten key stakeholders who held a variety of occupations within palliative and end-of-life care services were recruited from the community. FINDINGS: The South Asian communities were found to be at the 'pre-planning' stage of readiness, despite initiatives to improve awareness. The readiness of the health system was found to be limited, with a narrow medical focus during advance care planning, poor integration of voluntary and community services and limited understanding of what people consider a 'good' death. CONCLUSIONS: The Community Readiness Model allowed insight into the South Asian communities' awareness of and readiness (to use) palliative care services. Using the Community Readiness Model before service implementation allowed steps to be taken to avoid widening inequities in access and use of new services.

Researching minoritised communities in palliative care: An agenda for change.

BACKGROUND: Palliative care access, experiences and outcomes of care disadvantage those from ethnically diverse, Indigenous, First nation and First people communities. Research into this field of inquiry raises unique theoretical, methodological, and moral issues. Without the critical reflection of methods of study and reporting of findings, researchers may inadvertently compromise their contribution to reducing injustices and perpetuating racism. AIM: To examine key evidence of the place of minoritised communities in palliative care research to devise recommendations that improve the precision and rigour of research and reporting of findings. METHODS: Narrative review of articles identified from PubMed, CINAHL and Google Scholar for 10 years augmented with supplementary searches. RESULTS: We identified and appraised 109 relevant articles. Four main themes were identified (i) Lack of precision when working with a difference; (ii) 'black box epidemiology' and its presence in palliative care research; (iii) the inclusion of minoritised communities in palliative care research; and (iv) the potential to cause harm. All stymie opportunities to 'level up' health experiences and outcomes across the palliative care spectrum. CONCLUSIONS: Based on the findings of this review palliative care research must reflect on and justify the classification of minoritised communities, explore and understand intersectionality, optimise data quality, decolonise research teams and methods, and focus on reducing inequities to level up end-of-life care experiences and outcomes. Palliative care research must be forthright in explicitly indentifying instances of structural and systemic racism in palliative care research and engaging in non-judgemental debate on changes required.

Development of guidelines to reduce, handle and report missing data in palliative care trials: A multi-stakeholder modified nominal group technique.

BACKGROUND: Missing data can introduce bias and reduce the power, precision and generalisability of study findings. Guidelines on how to address missing data are limited in scope and detail, and poorly implemented. AIM: To develop guidelines on how best to (i) reduce, (ii) handle and (iii) report missing data in palliative care clinical trials. DESIGN: Modified nominal group technique. SETTING/PARTICIPANTS: Patient and public research partners, palliative care clinicians, trialists, methodologists and statisticians attended a 1-day workshop, following which a multi-stakeholder development group drafted the guidelines. RESULTS: Seven main recommendations for reducing missing data, nine for handling missing data and twelve for reporting missing data were developed. The top five recommendations were: (i) train all research staff on missing data, (ii) prepare for missing data at the trial design stage, (iii) address missing data in the statistical analysis plan, (iv) collect the reasons for missing data and (v) report descriptive statistics comparing the baseline characteristics of those with missing and observed data. Reducing missing data, preparing for missing data and understanding the reasons for missing data were greater priorities for stakeholders than how to deal with missing data once they had occurred. CONCLUSION: Comprehensive guidelines on how to address missing data were developed by stakeholders involved in palliative care trials. Implementation of the guidelines will require endorsement of research funders and research journals.

Specialist palliative care services response to ethnic minority groups with COVID-19: equal but inequitable-an observational study.

OBJECTIVES: To develop insights into response of palliative care services caring for people from ethnic minority groups during COVID-19. METHODS: Cross-sectional online survey of UK palliative care services response to COVID-19. Quantitative data were summarised descriptively and χ2 tests used to explore relationships between categorical variables. Free text comments were analysed using reflexive thematic analysis. RESULTS: 277 UK services responded. 168 included hospice teams (76% of all UK hospice teams). Services supporting those from ethnic minority groups were more likely to include hospital (p<0.001) and less likely to include hospice (p<0.001) or home care teams (p=0.008). 34% (93/277) of services had cared for patients with COVID-19 or families from ethnic minority groups. 66% (61/93) of these services stated no difference in how they supported or reached these groups during the pandemic.Three themes demonstrated impact of policy introduced during the pandemic, including: disproportionate adverse impact of restricted visiting, compounded communication challenges and unmet religious and faith needs. One theme demonstrated mistrust of services by ethnic minority groups, and the final theme demonstrated a focus on equal and individualised care. CONCLUSIONS: Policies introduced during the COVID-19 pandemic may have adversely impacted those from ethnic minority groups making these at-risk populations even more vulnerable. The palliative care response may have been equal but inequitable. During the para-COVID-19 period, systemic steps, including equality impact assessments, are urgently needed.

Performance status and trial site-level factors are associated with missing data in palliative care trials: An individual participant-level data analysis of 10 phase 3 trials.

BACKGROUND: Missing data compromise the internal and external validity of trial findings, however there is limited evidence on how best to reduce missing data in palliative care trials. AIM: To assess the association between participant and site level factors and missing data in palliative care trials. DESIGN AND SETTING: Individual participant-level data analysis of 10 phase 3 palliative care trials using multi-level cross-classified models. RESULTS: Participants with missing data at the previous time-point and poorer performance status were more likely to have missing data for the primary outcome and quality of life outcomes, at the primary follow-up point and end of follow-up. At the end of follow-up, the number of site randomisations and number of study site personnel were significantly associated with missing data. Trial duration and the number of research personnel explained most of the variance at the trial and site-level respectively, except for the primary outcome where the amount of data requested was most important at the trial-level. Variance at the trial level was more substantial than at the site level across models and considerable variance remained unexplained for all models except quality of life at the end of follow-up. CONCLUSION: Participants with a poorer performance status are at higher risk of missing data in palliative care trials and require additional support to provide complete data. Performance status is a potential auxiliary variable for missing data imputation models. Reducing trial variability should be prioritised and further factors need to be identified and explored to explain the residual variance.

Intention-to-Treat Analyses for Randomized Controlled Trials in Hospice/Palliative Care: The Case for Analyses to be of People Exposed to the Intervention.

CONTEXT: Minimizing bias in randomized controlled trials (RCTs) includes intention-to-treat analyses. Hospice/palliative care RCTs are constrained by high attrition unpredictable when consenting, including withdrawals between randomization and first exposure to the intervention. Such withdrawals may systematically bias findings away from the new intervention being evaluated if they are considered nonresponders. OBJECTIVES: This study aimed to quantify the impact within intention-to-treat principles. METHODS: A theoretical model was developed to assess the impact of withdrawals between randomization and first exposure on study power and effect sizes. Ten reported hospice/palliative care studies had power recalculated accounting for such withdrawal. RESULTS: In the theoretical model, when 5% of withdrawals occurred between randomization and first exposure to the intervention, change in power was demonstrated in binary outcomes (2.0%-2.2%), continuous outcomes (0.8%-2.0%), and time-to-event outcomes (1.6%-2.0%), and odds ratios were changed by 0.06-0.17. Greater power loss was observed with larger effect sizes. Withdrawal rates were 0.9%-10% in the 10 reported RCTs, corresponding to power losses of 0.1%-2.2%. For studies with binary outcomes, withdrawal rates were 0.3%-1.2% changing odds ratios by 0.01-0.22. CONCLUSION: If blinding is maintained and all interventions are available simultaneously, our model suggests that excluding data from withdrawals between randomization and first exposure to the intervention minimizes one bias. This is the safety population as defined by the International Committee on Harmonization. When planning for future trials, minimizing the time between randomization and first exposure to the intervention will minimize the problem. Power should be calculated on people who receive the intervention.

A feasibility, randomised controlled trial of a complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF): study protocol.

INTRODUCTION: Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive lung disease that causes breathlessness and cough that worsen over time, limiting daily activities and negatively impacting quality of life. Although treatments are now available that slow the rate of lung function decline, trials of these treatments have failed to show improvement in symptoms or quality of life. There is an immediate unmet need for evidenced-based interventions that improve patients' symptom burden and make a difference to everyday living. This study aims to assess the feasibility of conducting a definitive randomised controlled trial of a holistic, complex breathlessness intervention in people with IPF. METHODS AND ANALYSIS: The trial is a two-centre, randomised controlled feasibility trial of a complex breathlessness intervention compared with usual care in patients with IPF. 50 participants will be recruited from secondary care IPF clinics and randomised 1:1 to either start the intervention within 1 week of randomisation (fast-track group) or to receive usual care for 8 weeks before receiving the intervention (wait-list group). Participants will remain in the study for a total of 16 weeks. Outcome measures will be feasibility outcomes, including recruitment, retention, acceptability and fidelity of the intervention. Clinical outcomes will be measured to inform outcome selection and sample size calculation for a definitive trial. ETHICS AND DISSEMINATION: Yorkshire and The Humber - Bradford Leeds Research Ethics Committee approved the study protocol (REC 18/YH/0147). Results of the main trial and all secondary end-points will be submitted for publication in a peer-reviewed journal.

Palliative care triggers in progressive neurodegenerative conditions: An evaluation using a multi-centre retrospective case record review and principal component analysis.

BACKGROUND: The use of specific triggers has been suggested to help identify patients with progressive neurological disease who would benefit from palliative care. AIM: This study aimed to improve the evidence base for the use of triggers for patients with progressive neurological disease. DESIGN: An evaluation of palliative care services was undertaken using a retrospective case note review of the timing and presence of triggers in the last 2 years of life. SETTING/PARTICIPANTS: A total of 12 specialist palliative care units across the United Kingdom provided data from 300 patients: mean patient age 70 years, 50% male, diagnoses included motor neurone disease 58%, Parkinson's disease 17% and Parkinson's Plus syndromes 12%. RESULTS: There was a high burden of triggers - 17 in the last 2 years of life and 10 in the last 6 months of life. The most frequent triggers were deteriorating physical function, complex symptoms and dysphagia. Four factors were found to explain 64% of the total variance: Factor 1 - Deterioration in physical function, dysphagia, significant complex symptoms and pain; Factor 2 - Weight loss and respiratory symptoms; Factor 3 - Recurrent infections and cognitive decline; Factor 4 - Aspiration pneumonia. Cox regression analyses found different triggers were associated with survival from diagnosis versus survival from referral to palliative care. Different triggers were also associated with survival for different neurological conditions. CONCLUSION: This study demonstrates that there is a high burden of triggers in the last months and years of life and that these could potentially be reduced to fewer components. Prospective studies assessing which triggers are useful for different conditions are now required.

One evidence base; three stories: do opioids relieve chronic breathlessness?

The efficacy of low-dose systemic opioids for chronic breathlessness was questioned by the recent Cochrane review by Barnes et al We examined the reasons for this conflicting finding and re-evaluated the efficacy of systemic opioids. Compared with previous meta-analyses, Barnes et al reported a smaller effect and lower precision, but did not account for matched data of crossover trials (11/12 included trials) and added a risk-of-bias criterion (sample size). When re-analysed to account for crossover data, opioids decreased breathlessness (standardised mean differences -0.32; -0.18 to -0.47; I2=44.8%) representing a clinically meaningful reduction of 0.8 points (0-10 numerical rating scale), consistent across meta-analyses.

Quality of missing data reporting and handling in palliative care trials demonstrates that further development of the CONSORT statement is required: a systematic review.

OBJECTIVES: Assess (i) the quality of reporting and handling of missing data (MD) in palliative care trials, (ii) whether there are differences in the reporting of criteria specified by the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement compared with those not specified, and (iii) the association of the reporting of MD with journal impact factor and CONSORT endorsement status. STUDY DESIGN AND SETTING: Systematic review of palliative care randomized controlled trials. CENTRAL, MEDLINE, and EMBASE (2009-2014) were searched. RESULTS: One hundred and eight trials (15,560 participants) were included. MD was incompletely reported and not handled in accordance with current guidance. Reporting criteria specified by the CONSORT statement were better reported than those not specified (participant flow, 69%; number of participants not included in the primary outcome analysis, 94%; and the reason for MD, 71%). However, MD in items contributing to scale summaries (10%) and secondary outcomes (9%) were poorly reported, so the proportion of MD stated is likely to be an underestimate. The reason for MD provided was unclear for 54% of participants and only 16% of trials with MD reported a MD sensitivity analysis. The odds of reporting most of the MD and other risk of bias reporting criteria were increased as the journal impact factor increased and in journals that endorsed the CONSORT statement. CONCLUSION: Further development of the CONSORT MD reporting guidance is likely to improve the quality of reporting. Reporting recommendations are provided.

Missing data in randomized controlled trials testing palliative interventions pose a significant risk of bias and loss of power: a systematic review and meta-analyses.

OBJECTIVES: To assess the risk posed by missing data (MD) to the power and validity of trials evaluating palliative interventions. STUDY DESIGN AND SETTING: A systematic review of MD in published randomized controlled trials (RCTs) of palliative interventions in participants with life-limiting illnesses was conducted, and random-effects meta-analyses and metaregression were performed. CENTRAL, MEDLINE, and EMBASE (2009-2014) were searched with no language restrictions. RESULTS: One hundred and eight RCTs representing 15,560 patients were included. The weighted estimate for MD at the primary endpoint was 23.1% (95% confidence interval [CI] 19.3, 27.4). Larger MD proportions were associated with increasing numbers of questions/tests requested (odds ratio [OR], 1.19; 95% CI 1.05, 1.35) and with longer study duration (OR, 1.09; 95% CI 1.02, 1.17). Meta-analysis found evidence of differential rates of MD between trial arms, which varied in direction (OR, 1.04; 95% CI 0.90, 1.20; I(2) 35.9, P = 0.001). Despite randomization, MD in the intervention arms (vs. control) were more likely to be attributed to disease progression unrelated to the intervention (OR, 1.31; 95% CI 1.02, 1.69). This was not the case for MD due to death (OR, 0.92; 95% CI 0.78, 1.08). CONCLUSION: The overall proportion and differential rates and reasons for MD reduce the power and potentially introduce bias to palliative care trials.

Patient and health care professional decision-making to commence and withdraw from renal dialysis: a systematic review of qualitative research.

BACKGROUND AND OBJECTIVE: To ensure that decisions to start and stop dialysis in ESRD are shared, the factors that affect patients and health care professionals in making such decisions must be understood. This systematic review sought to explore how and why different factors mediate the choices about dialysis treatment. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: MEDLINE, Embase, CINAHL, and PsychINFO were searched for qualitative studies of factors that affect patients' or health care professionals' decisions to commence or withdraw from dialysis. A thematic synthesis was conducted. RESULTS: Of 494 articles screened, 12 studies (conducted from 1985 to 2014) were included. These involved 206 patients (most receiving hemodialysis) and 64 health care professionals (age ranges: patients, 26-93 years; professionals, 26-61 years). For commencing dialysis, patients based their choice on "gut instinct," as well as deliberating over the effect of treatment on quality of life and survival. How individuals coped with decision-making was influential: Some tried to take control of the problem of progressive renal failure, whereas others focused on controlling their emotions. Health care professionals weighed biomedical factors and were led by an instinct to prolong life. Both patients and health care professionals described feeling powerless. With regard to dialysis withdrawal, only after prolonged periods on dialysis were the realities of life on dialysis fully appreciated and past choices questioned. By this stage, however, patients were physically dependent on treatment. As was seen with commencing dialysis, individuals coped with treatment withdrawal in a problem- or emotion-controlling way. Families struggled to differentiate between choosing versus allowing death. Health care teams avoided and queried discussions regarding dialysis withdrawal. Patients, however, missed the dialogue they experienced during predialysis education. CONCLUSIONS: Decision-making in ESRD is complex and dynamic and evolves over time and toward death. The factors at work are multifaceted and operate differently for patients and health professionals. More training and research on open communication and shared decision-making are needed.

A systematic review of strategies used to increase recruitment of people with cancer or organ failure into clinical trials: implications for palliative care research.

CONTEXT: The challenges of palliative care clinical trial recruitment are well documented. OBJECTIVES: The aim of the study was to review tested strategies to improve recruitment to trials of people with a range of conditions who may access palliative care services but are not explicitly stated to be "palliative." METHODS: This was a systematic review with narrative description. The Cochrane, Embase, PubMed, PsycINFO, and CINAHL electronic databases were searched (English; January 2002 to February 2014) for quasi-experimental and randomized controlled trials (RCTs) testing the effect of recruitment strategies on accrual to clinical trials of people with organ failure and cancer. Titles, abstracts, and retrieved articles were screened by two researchers and categorized by recruitment challenge: 1) patients with reduced cognition, 2) those requiring emergency treatment, and 3) willingness of patients and clinical staff to contribute to trials. RESULTS: Of 549 articles identified, 15 were included. Thirteen reported RCTs and two papers reported three quasi-experimental studies. Five were cluster RCTs of recruiting sites/institutions. One was a randomized cluster, crossover, feasibility study. Seven studies recruited patients with cancer. Others included patients with dementia, stroke, cardiovascular disease, diabetes, frail elderly, and bereaved carers. Some interventions improved recruitment: memory aid, contact before arrival, cluster consent, "opt out" consent. Others either reduced recruitment (formal mental capacity assessment) or made no difference (advance research directive; a variety of educational, supportive, and advertising interventions). CONCLUSION: Successful strategies from other disciplines could be considered by palliative care researchers. Tailored, efficient, evidence-based strategies must be developed, acknowledging that strategies with face validity are not necessarily the most effective.