Should end-of-life patients be enrolled as participants in clinical research? A best-fit framework synthesis.

AIM: To identify and appraise evidence about ethical concerns regarding conducting medical research with end-of-life patients. DESIGN: A best-fit framework synthesis of the literature regarding ethical issues in research involving adult patients at the end of life was conducted. DATA SOURCES: Five databases were searched (Cumulative Index to Nursing and Allied Health Literature, Web of Science, Embase, MEDLINE, and PsychINFO) between January 2000-August 2019. REVIEW METHODS: Data were synthesized and categorized according to the moral positions described by Foster. RESULTS: In all, 18 papers that met the inclusion criteria were included in this review. These papers provided rich knowledge not only about various ethical objections to researching the end of life but also about the social, moral, and clinical requirements to perform rigorous studies on clinical interventions in this field. CONCLUSIONS: Research on people at end of life is not an unsolvable ethical dilemma between providing the best possible care and enhancing new therapies. It is important to find a balance between the moral duties of providing care and achieving research outcomes that are rigorous and meaningful for service users. IMPACT: Research ethics committees can be challenged by the evaluation of human research. This review provides up-to-date evidence on key challenges and ethical considerations about researching with end-of-life patients. SUMMARY STATEMENT: This study is a review of relevant evidence and key ethical challenges and issues around palliative and end-of-life research. Our findings provided important recommendations for clinicians, research, and ethics committee members when evaluating clinical research with people at their end of life.

Are the MORECare guidelines on reporting of attrition in palliative care research populations appropriate? A systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Palliative care trials have higher rates of attrition. The MORECare guidance recommends applying classifications of attrition to report attrition to help interpret trial results. The guidance separates attrition into three categories: attrition due to death, illness or at random. The aim of our study is to apply the MORECare classifications on reported attrition rates in trials. METHODS: A systematic review was conducted and attrition classifications retrospectively applied. Four databases, EMBASE; Medline, CINHAL and PsychINFO, were searched for randomised controlled trials of palliative care populations from 01.01.2010 to 08.10.2016. This systematic review is part of a larger review looking at recruitment to randomised controlled trials in palliative care, from January 1990 to early October 2016. We ran random-effect models with and without moderators and descriptive statistics to calculate rates of missing data. RESULTS: One hundred nineteen trials showed a total attrition of 29% (95% CI 28 to 30%). We applied the MORECare classifications of attrition to the 91 papers that contained sufficient information. The main reason for attrition was attrition due to death with a weighted mean of 31.6% (SD 27.4) of attrition cases. Attrition due to illness was cited as the reason for 17.6% (SD 24.5) of participants. In 50.8% (SD 26.5) of cases, the attrition was at random. We did not observe significant differences in missing data between total attrition in non-cancer patients (26%; 95% CI 18-34%) and cancer patients (24%; 95% CI 20-29%). There was significantly more missing data in outpatients (29%; 95% CI 22-36%) than inpatients (16%; 95% CI 10-23%). We noted increased attrition in trials with longer durations. CONCLUSION: Reporting the cause of attrition is useful in helping to understand trial results. Prospective reporting using the MORECare classifications should improve our understanding of future trials.

What are the main symptoms and concerns reported by patients with advanced chronic heart failure?-a secondary analysis of the Palliative care Outcome Scale (POS) and Integrated Palliative care Outcome Scale (IPOS).

There is a lack of valid disease-specific patient-reported outcome measures (PROMs) for detecting symptoms and concerns in patients with advanced chronic heart failure (CHF). The Palliative care Outcome Scale (POS) and Integrated Palliative care Outcome Scale (IPOS) are specifically developed to capture the main symptoms and concerns of people severely affected by advanced disease. The aim of this study was to determine whether POS and IPOS captures the main symptoms and concerns self-reported by patients with advanced CHF. A secondary analysis of existing POS/IPOS data collected in three longitudinal studies was conducted. POS and IPOS start with an open-ended question for patients to report their main problems and concerns, followed by subsequent closed questions on a range of symptoms and other concerns. Descriptive statistics were used to report the results. The 102 participants from the three datasets had median age 81 years (SD ±9.84 years); 62% male; 87% white. A total of 107 concerns were reported in the first, open POS/IPOS question seeking the patient's main concerns. Of these, 83 (77%) were reflected in the subsequent IPOS/POS closed questions. The high correspondence between the free-text responses and the closed questions indicates that most issues are captured by the POS/IPOS items. In conclusion, the generic versions of POS and IPOS do capture the main problems and concerns of patients with advanced CHF. Minor adaptations and further psychometric validation of POS and IPOS are needed in this population.

Family members' experiences of assisted dying: A systematic literature review with thematic synthesis.

BACKGROUND: Families' experiences of assisted dying are under-investigated and families are rarely considered in clinical guidelines concerning assisted dying. AIM: To systematically review family experiences of assisted dying. DESIGN: A systematic literature review using thematic synthesis. DATA SOURCES: MEDLINE, Embase, CINAHL, AMED (Allied and Complementary Medicine) and PsycINFO databases (January 1992 to February 2019). Studies investigating families' experiences on the practice of legalised assisted dying were included. We excluded studies prior to legalisation within the jurisdiction, secondary data analysis and opinion papers. RESULTS: Nineteen articles met the inclusion criteria. Publications were derived from four countries: The Netherlands, United States (Oregon, Washington and Vermont), Canada and Switzerland. Dutch studies predominately investigated family involvement in euthanasia, while Swiss and American studies only reported on assisted suicide. Eleven studies had a qualitative design, using predominately in-depth interviews; seven were retrospective surveys. Five analytical themes represented families' experiences in assisted dying: (1) context of the decision, (2) grounding the decision, (3) cognitive and emotional work, (4) experiencing the final farewell and (5) grief and bereavement. The results showed that families can be very involved in supporting patients seeking assisted dying, where open communication is maintained. Family involvement appeared to be influenced by the type of legislation in their country and the families' perception of the social acceptability of assisted dying. CONCLUSION: Our data confirm that families across all jurisdictions are involved in assisted suicide decision and enactment. Family needs are under-researched, and clinical guidelines should incorporate recommendations about how to consider family needs and how to provide them with evidence-based tailored interventions.

Using the 'Social Marketing Mix Framework' to explore recruitment barriers and facilitators in palliative care randomised controlled trials? A narrative synthesis review.

BACKGROUND: Effective recruitment to randomised controlled trials is critically important for a robust, trustworthy evidence base in palliative care. Many trials fail to achieve recruitment targets, but the reasons for this are poorly understood. Understanding barriers and facilitators is a critical step in designing optimal recruitment strategies. AIM: To identify, explore and synthesise knowledge about recruitment barriers and facilitators in palliative care trials using the '6 Ps' of the 'Social Marketing Mix Framework'. DESIGN: A systematic review with narrative synthesis. DATA SOURCES: Medline, CINAHL, PsycINFO and Embase databases (from January 1990 to early October 2016) were searched. Papers included the following: interventional and qualitative studies addressing recruitment, palliative care randomised controlled trial papers or reports containing narrative observations about the barriers, facilitators or strategies to increase recruitment. RESULTS: A total of 48 papers met the inclusion criteria. Uninterested participants (Product), burden of illness (Price) and 'identifying eligible participants' were barriers. Careful messaging and the use of scripts/role play (Promotion) were recommended. The need for intensive resources and gatekeeping by professionals were barriers while having research staff on-site and lead clinician support (Working with Partners) was advocated. Most evidence is based on researchers' own reports of experiences of recruiting to trials rather than independent evaluation. CONCLUSION: The 'Social Marketing Mix Framework' can help guide researchers when planning and implementing their recruitment strategy but suggested strategies need to be tested within embedded clinical trials. The findings of this review are applicable to all palliative care research and not just randomised controlled trials.