Palliative care research raises a host of ethical concerns. Obtaining informed consent from seriously ill patients and their families is often perceived as an additional burden. Alternative approaches to traditional written informed consent reflects the changing nature of modern trial design, embracing real-world effectiveness and pragmatic clinical trials with those who are seriously ill. Ethicists, clinical investigators, and regulatory bodies have acknowledged the challenges to rigorous, meaningful, and generalizable research across diverse patient populations in real-world settings. The purpose of this paper is to describe how these clinical trial designs have driven innovation in methods for achieving informed consent, with a focus on palliative care research. In this paper, we describe, and provide examples of consent waivers and three types of alternative approaches to consent, including broadcast notification, and integrated and targeted consent. We also present our experiences in an ongoing palliative care clinical trial, specifically using broadcast notification. Working with participants and regulatory oversight organizations, investigators can address the limits of traditional written informed consent and adopt innovative consent models to advance the science of palliative care. Research is now needed to determine the impact of these differing consent models on clinical trial recruitment, enrollment, and retention, as well as participants' informed understanding of their research participation using such models.
BACKGROUND: Clinical cancer research trials may offer little or no direct clinical benefit to participants where a cure is no longer possible. As such, the decision-making and consent process for patient participation is often challenging.
AIM: To gain understanding of how patients make decisions regarding clinical trial participation, from the perspective of both the patient and healthcare professionals involved.
METHODS: In-depth, face to face interviews using a grounded theory approach. This study was conducted in a regional Cancer Centre in the United Kingdom. Of the 36 interviews, 16 were conducted with patients with cancer that had non-curative intent and 18 with healthcare professionals involved in the consent process.
RESULTS: 'Nothing to lose' was identified as the core category that underpinned all other data within the study. This highlighted the desperation articulated by participants, who asserted trial participation was the 'only hope in the room'. The decision regarding participation was taken within a 'trusting relationship' that was important to both patients and professionals. Both were united in their 'fight against cancer'. These two categories are critical in understanding the decision-making/consent process and are supported by other themes presented in the theoretical model.
CONCLUSION: This study presents an important insight into the complex and ethically contentious situation of consent in clinical trials that have non-curative intent. It confirms that patients with limited options trust their doctor and frequently hold unrealistic hopes for personal benefit. It highlights a need for further research to develop a more robust and context appropriate consent process.
CONTEXT: Although high quality research with patients and family members is needed to improve palliative care, difficulties in recruitment are often reported.
OBJECTIVES: The present article analyses the authors` experiences in recruiting participants of two types of dyads for the study 'Dy@EoL - Interaction at the end of life in dyads of parents and adult children'. Recruitment challenges and factors found to improve recruitment are examined.
METHODS: Between February 2018 and November 2019, the research team cooperated with diverse inpatient and ambulatory palliative and hospice care providers to recruit both dyads. Cooperation strategies and adaptations were protocolled. Data on (non-)participation were recorded and analysed using descriptive statistics.
RESULTS: The recruitment rate was 34.6% (dyad 1, terminally ill adult children with parents: 36.4%; dyad 2, terminally ill parents with adult children: 33.9%). In total, 82.2% of participants were recruited from inpatient settings. The research team has applied various strategies, such as public outreach activities and the extension of recruitment partners. The study protocol was adapted at an early stage to include single participants. Of all patients, 47.7% participated without their dyad partner. The main reason to exclude their family member was the patients' wish to protect them from extra burden.
CONCLUSION: The recruitment was more successful in inpatient than in ambulatory settings. The extension of recruitment partners was beneficial to recruit participants from ambulatory contexts. The inclusion of single participants was conducive as a great number of patients participated without their dyad partner. Sharing the obtained experiences can be helpful for future research planning.
BACKGROUND: Public involvement is increasingly considered a prerequisite for high-quality research. However, involvement in palliative care is impeded by limited evidence on the best approaches for populations affected by life-limiting illness.
AIM: To evaluate a strategy for public involvement in palliative care and rehabilitation research, to identify successful approaches and areas for improvement.
DESIGN: Co-produced qualitative evaluation using focus groups and interviews. Thematic analysis undertaken by research team comprising public contributors and researchers.
SETTING/PARTICIPANTS: Researchers and public members from a palliative care and rehabilitation research institute, UK.
RESULTS: Seven public members and 19 researchers participated. Building and maintaining relationships, taking a flexible approach and finding the 'right' people were important for successful public involvement. Relationship building created a safe environment for discussing sensitive topics, although public members felt greater consideration of emotional support was needed. Flexibility supported involvement alongside unpredictable circumstances of chronic and life-limiting illness, and was facilitated by responsive communication, and opportunities for in-person and virtual involvement at a project- and institution-level. However, more opportunities for two-way feedback throughout projects was suggested. Finding the 'right' people was crucial given the diverse population served by palliative care, and participants suggested more care needed to be taken to identify public members with experience relevant to specific projects.
CONCLUSION: Within palliative care research, it is important for involvement to focus on building and maintaining relationships, working flexibly, and identifying those with relevant experience. Taking a strategic approach and developing adequate infrastructure and networks can facilitate public involvement within this field.
OBJECTIVE: Although stakeholders' participation in healthcare is increasingly recommended, bereaved parents are often excluded for perceived potential risks to them. The objective of this study is to describe the ongoing involvement and the perspectives of bereaved parents engaged in different types of activities in Neonatal Intensive Care Units and providers who work with them.
DESIGN/METHODS: Mixed methods convergent analysis.
SETTING: Canadian paediatric tertiary care university hospital.
PARTICIPANTS: All bereaved members of the resource parents group (n=8) and most providers who work with them (n=16) answered a satisfaction/needs questionnaires.
RESULTS: Since 2011, eight bereaved parents were involved in a large number of activities mostly related to palliative care (research, education or clinical care initiatives). Three engaged in peer-to-peer support activities while the others preferred activities outside of clinical units and/or without direct interactions with other families. All of them reported that their participation had positive impacts, but two parents also reported a reactivation of traumatic experiences during a medical simulation activity. All participants expressed a desire for further collaboration. Motivation to contribute gravitated around two central themes: helping others and helping themselves. Many wanted to give back, help other families, improve the system and meet with providers who had cared for their child. All stated that this kind of involvement empowered them and gave meaning to their experiences. Providers and researchers all reported positive experiences, mainly due to the unique perspectives of bereaved parents who took part in their projects.
CONCLUSIONS: With careful recruitment and supervision, some bereaved parents can become resource parents involved in different types of activities. It is important to understand the positive impacts this type of engagement can have on their healing process and to control the risks related to their participation. Research is needed to develop pertinent tools and measures to evaluate the outcomes and impacts of their participation.
Background: Involving adults lacking capacity (ALC) in research on end of life care (EoLC) or serious illness is important, but often omitted. We aimed to develop evidence-based guidance on how best to include individuals with impaired capacity nearing the end of life in research, by identifying the challenges and solutions for processes of consent across the capacity spectrum.
Methods: Methods Of Researching End of Life Care_Capacity (MORECare_C) furthers the MORECare statement on research evaluating EoLC. We used simultaneous methods of systematic review and transparent expert consultation (TEC). The systematic review involved four electronic databases searches. The eligibility criteria identified studies involving adults with serious illness and impaired capacity, and methods for recruitment in research, implementing the research methods, and exploring public attitudes. The TEC involved stakeholder consultation to discuss and generate recommendations, and a Delphi survey and an expert ‘think-tank’ to explore consensus. We narratively synthesised the literature mapping processes of consent with recruitment outcomes, solutions, and challenges. We explored recommendation consensus using descriptive statistics. Synthesis of all the findings informed the guidance statement.
Results: Of the 5539 articles identified, 91 met eligibility. The studies encompassed people with dementia (27%) and in palliative care (18%). Seventy-five percent used observational designs. Studies on research methods (37 studies) focused on processes of proxy decision-making, advance consent, and deferred consent. Studies implementing research methods (30 studies) demonstrated the role of family members as both proxy decision-makers and supporting decision-making for the person with impaired capacity. The TEC involved 43 participants who generated 29 recommendations, with consensus that indicated. Key areas were the timeliness of the consent process and maximising an individual’s decisional capacity. The think-tank (n = 19) refined equivocal recommendations including supporting proxy decision-makers, training practitioners, and incorporating legislative frameworks.
Conclusions: The MORECare_C statement details 20 solutions to recruit ALC nearing the EoL in research. The statement provides much needed guidance to enrol individuals with serious illness in research. Key is involving family members early and designing study procedures to accommodate variable and changeable levels of capacity. The statement demonstrates the ethical imperative and processes of recruiting adults across the capacity spectrum in varying populations and settings.
BACKGROUND: Research with persons with dementia is important to better understand the causes of dementia and to develop more effective diagnostics, therapies, and preventive measures. Advance Research Directives (ARDs) have been suggested as a possible solution to include persons with dementia in research in an ethically sound way. Little is known about how people, especially those affected by cognitive impairment, understand and regard the use of ARDs, as empirical studies are mainly conducted with healthy, non-cognitively impaired, participants.
METHODS: This qualitative study, a sub-study of a larger study on the evaluation of ARDs in the context of dementia research in Germany, consists of semi-structured in-depth interviews with 24 persons with cognitive impairment.
RESULTS: Our results indicate that most participants consider ARDs a valuable tool for allowing them to make their own decisions. Many would prefer to draft an ARD when they are still healthy or soon after the diagnosis of cognitive impairment. Participants suggested that the completion of ARDs can be advanced with the provision of practical support and increased dissemination of information on ARDs in society.
CONCLUSION: Persons with subjective or mild cognitive impairment (SCI/MCI) suggested several motivating factors and concerns for completing an ARD. Clinicians need to be trained to accommodate patients' needs for sufficient and adequate information. Furthermore, a standardised, partly pre-formulated template could be helpful for drafting an ARD. As such tested templates are currently not yet available, this addresses the urgent need for more translational and implementation research for the use of ARDs.
Introduction: The transplant waiting list exceeds the number of organs available. One means of increasing the organ pool is to broaden potential donors to include those with chronic diseases.
Research Questions: The study tested the effectiveness of using peer mentors to encourage individuals on dialysis to enroll on an organ donor registry.
Design: Dialysis units were pair-matched by size and racial composition and then randomized to one of 2 interventions: meetings with a peer mentor (experimental intervention) or organ donation mailings (control). Peer mentors were trained to discuss organ donation with individuals on dialysis during in-person meetings at dialysis units. The primary outcome was verified registration in the state’s donor registry.
Results: After adjusting for age, gender, race, income, and education and accounting for correlation within the dialysis center, there was a significant intervention effect. Among individuals in the intervention group, the odds of enrolling (verified) on the donor registry were 2.52 times higher than those in the control group.
Discussion: The use of peer mentors to discuss donating organs after death with individuals on dialysis can increase enrollment on a donor registry. Dispelling myths about chronic illness and donation can counter widely held misconceptions and help persons make an informed choice about end-of-life decisions and present an opportunity to increase the number of organs and tissues available for transplant.
Objective: To engage young adults (18–35 years of age) with life-limiting neuromuscular conditions, their parents, and health and community providers in the development of a public health approach to palliative care. A public health approach protects and improves health and wellness, maximises the quality of life when health cannot be restored and improves the quality, scope and accessibility of age-appropriate care and services.
Methods: Group concept mapping (GCM) was used to determine the most important priorities for these young adults. GCM involves three district phases: (1) brainstorming ideas, (2) sorting and rating ideas based on level of importance and (3) analysing and interpreting concepts maps. Online software was used to collect information for phases 1 and 2 and develop concept maps. In phase 3, a face-to-face workshop, participants analysed and interpreted the concept maps. The combination of online and face-to-face research activities offered the needed flexibility for participants to determine when and how to participate in this research.
Results: Through this three-phase patient engagement strategy, participants generated 64 recommendations for change and determined that improvements to programming, improvements to funding and creating a continuum of care were their most important priorities. Five subthemes of these three priorities and development of the concept map are also discussed.
Conclusion: This research demonstrates the unique perspectives and experiences of these young adults and offers recommendations to improve services to enhance their health and well-being. Further, these young adults were integral in the development of recommendations for system changes to match their unique developmental needs.
End-of-life (EOL) HIV cure-related research provides a novel approach to studying HIV reservoirs. The Last Gift is a rapid autopsy research study at the University of California San Diego that enrolls terminally ill people living with HIV (PLWHIV) with a desire to contribute to HIV cure-related research. We conducted in-depth baseline and follow-up interviews with Last Gift study participants. We analyzed interview data applying conventional content analysis. Since summer 2017, 13 participants have been enrolled (n = 11 males and 2 females; aged 45–89 years) and 8 participants interviewed. Terminal illnesses included cancers, heart diseases, and neurodegenerative illnesses. Our analysis revealed five key themes: (1) The Last Gift study has tremendous meaning for participants at the end of their life. (2) HIV-specific altruism was a primary motivator to join the Last Gift study, nested within the context of community, scientific advancement, and moral obligation. (3) Participants did not expect physical benefits yet they perceived emotional/psychological, financial, and societal/scientific benefits. (4) There were minimal participant-perceived risks and concerns. (5) Last Gift participants expressed immense gratitude toward study staff. The Last Gift study provides a framework for ethical HIV cure-related research at EOL and highlighted participants' perspectives, motivations, and experiences. Knowing how PLWHIV understand and experience such studies will remain critical to designing ethical, fully informed HIV cure research protocols that are acceptable to PLWHIV.
BACKGROUND/OBJECTIVES: To determine the feasibility of conducting a cluster randomized controlled trial providing individualized feedback reports to increase advance care planning (ACP) engagement in the primary care setting.
DESIGN: Pilot cluster randomized controlled trial.
SETTING: Two primary care practices selected for geographic colocation.
PARTICIPANTS: Adults aged 55 years and older.
INTERVENTION: Brief assessment of readiness to engage in (stage of change for) three ACP behaviors (healthcare agent assignment, communication with agent about quality vs quantity of life, and living will completion) generating an individualized feedback report, plus a stage-matched brochure.
MEASURES: Patient recruitment and retention, intervention delivery, baseline characteristics, and stage of change movement.
RESULTS: Recruitment rates differed by practice. Several baseline sociodemographic characteristics differed between the 38 intervention and 41 control participants, including employment status, education, and communication with healthcare agent. Feedback was successfully delivered to all intervention participants, and over 90% of participants completed a 2-month follow-up. More intervention participants demonstrated progression in readiness than did control participants, without testing for statistical significance.
CONCLUSIONS: This pilot demonstrates opportunities and challenges of performing a clustered randomized controlled trial in primary care practices. Differences in the two practice populations highlight the challenges of matching sites. There was a signal for behavior change in the intervention group.
CONTEXT: Few studies have examined how clinicians assess decision-making capacity for research in the last weeks of life.
OBJECTIVE: We examined the decision-making capacity for participation in a research study and its association with clinician impression and delirium among cancer patients with days to weeks of life expectancy.
METHODS: Patients admitted to our Palliative and Supportive Care Unit (PSCU) were approached for a prospective observational study. We assessed for their decision-making capacity based on clinical impression of physician and nurse, Memorial Delirium Assessment Scale (MDAS) and the MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR).
RESULTS: Among the 206 patients, 131 patients (64%) did not require MacCAT-CR assessment because they were overtly delirious or unresponsive; 37 (18%) patients were alert but did not complete the MacCAT-CR assessment for other reasons and 38 patients (18%) completed the MacCAT-CR assessment. Among these 38 patients, 5 (13%) were incapable and had normal albeit significantly higher MDAS scores compared to those who were capable (1.8 vs. 4.2, P=0.002). Compared against MacCAT-CR and MDAS, the overall agreement with capacity assessment with a clinician was 88% (95% CI 82-93%) for physicians and 90% (95% CI 82-94%) for nurses. The area-under the receiver-operating characteristics curve was 0.93 (95% CI 0.88-0.96) for physicians and 0.94 (95% CI 0.89-0.97) for nurses, suggesting high discrimination.
CONCLUSION: A majority of patients in the PSCU lacked decision-making capacity for participation in clinical research. Clinician impression had high accuracy. Few patients with normal MDAS were found to be incapable with MacCAT-CR assessment.
BACKGROUND/OBJECTIVES: A patient-directed, online program (PREPARE for Your Care [PREPARE]; prepareforyourcare.org) has been shown to increase advance care planning (ACP) documentation. However, the mechanisms underlying PREPARE are unknown. Our objectives were to compare the efficacy of PREPARE plus an easy-to-read advance directive (AD) vs an AD alone to increase active patient participation in ACP discussions during clinic visits and to examine effects of active patient participation on ACP documentation.
DESIGN: Audio recordings of postintervention primary care visits from two randomized trials (2013-2016).
SETTING: Seven primary care clinics at a veterans affair and safety-net hospital in San Francisco, CA.
PARTICIPANTS: English- and Spanis-speaking adults, aged 55 years and older, with two or more chronic/serious conditions.
INTERVENTION: PREPARE plus an easy-to-read AD or an AD alone.
MEASUREMENTS: The primary outcome was the number of active patient participation utterances about ACP (eg, asking questions, stating preferences) measured by the validated Active Patient Participation Coding Scheme. We examined differences in utterances by study arm using mixed effects negative binomial models and utterances as a mediator of PREPARE's effect on documentation using adjusted logistic regression. Models were adjusted for health literacy, prior care planning, and clinician.
RESULTS: Among 393 participants, the mean (SD) age was 66 (8.1) years, 120 (30.5%) had limited health literacy, and 99 (25.2%) were Spanish speaking. PREPARE plus the AD resulted in 41% more active patient participation in ACP discussions compared with the AD alone (mean [SD] = 10.1 [16.8] vs 6.6 [13.4] utterances; incidence rate ratio = 1.41; 95% confidence interval = 1.00-1.98). For every additional utterance, participants had 15% higher odds of ACP documentation, and active patient participation accounted for 16% of PREPARE's effect on documentation.
CONCLUSIONS: The PREPARE program and easy-to-read AD empowered patients to actively participate in ACP discussions during clinical visits more than the AD alone. Increased activation was associated with increased ACP documentation. Therefore, PREPARE may mitigate barriers to ACP among English- and Spanish-speaking older adults.
TRIAL REGISTRATION: ClinicalTrials.gov identifiers: “Improving Advance Care Planning by Preparing Diverse Seniors for Decision Making (PREPARE)” NCT01990235 and “Preparing Spanish-Speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)” NCT02072941.
Fathers are under-represented in pediatric palliative care research despite frequently playing a key role in the lives of their children. The purpose of this study was to identify factors that affected paternal study invitation and participation. A secondary mixed-methods evaluation design guided examination of interview and focus group data as well as field notes from a qualitative study that examined the experiences and support needs of fathers of children with a life-limiting illness. Facilitators of paternal participation in the study consisted of: fathers' desire to gain from study participation either for themselves or others, perception of the study's importance, sense of appreciation for the study's focus on fathers and an established relationship with recruiting health care providers. Barriers to study participation included: recruiting health care providers' appraisal of fathers' lack of well-being, bereaved fathers' self-reported poor coping and the inability to locate and contact fathers, particularly after a child's death. Strategies for improving the engagement of fathers into research entailed: educating recruitment personnel, designing "father-focused" studies, communicating the value of the research to recruitment personnel and potential participants, and ensuring that child health records are accurate and include fathers' contact information.
Community participation is a frequently mentioned theme in palliative care projects. Yet most of the projects claiming to be community-led have only minimal participation from the community, usually in the form of resource mobilization. Achieving higher levels of participation, the process of involving community collectives as partners in running, and later taking responsibility to sustain and own the program, is more complex and more difficult to achieve. Common barriers include lack of the mandatory preparatory work to understand the social and political dynamics of the community, facilitators’ values and agenda assuming the dominant role in the project, unwillingness on the part of facilitators to give up control and problems with the ‘political process’ that should go with capacity building. Another issue is that community mobilization, being a dynamic cascading process, does not yield to conventional methods of evaluation.
OBJECTIVES: In non-gynecologic cancers, clinical trial participation has been associated with aggressive care at the end of life. The objective of this investigation was to examine how trial participation affects end of life outcomes in patients with ovarian cancer.
METHODS: In a retrospective review of women diagnosed with ovarian cancer at our institution between January 2010 and December 2015, we collected variables identified by the National Quality Forum as measures of aggressive end of life care including chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, or death in the acute care setting. Trials investigating medications but not surgical interventions were included. The primary outcome of this study was the association between trial participation and the National Quality Forum measures of aggressive end of life care in ovarian cancer decedents. Data were analyzed with univariable and multivariable parametric and non-parametric testing, and time to event outcomes were analyzed using the Kaplan-Meier method and Cox's proportional hazard models.
RESULTS: Among 391 women treated for ovarian cancer, 62 patients (16%) participated in a clinical trial. Patients enrolled in clinical trials were more likely to have chemotherapy administered within 14 days of death; however, no association was found with other metrics of aggressive care at the end of life including the initiation of a new chemotherapy regimen in the last 30 days of life, ICU admissions, and death in an acute care setting. Among patients with recurrent ovarian cancer, median overall survival for trial participants was 57 months compared with only 31 months in non-trial participants (p<0.001).
CONCLUSIONS: In patients with ovarian cancer, clinical trial enrollment is associated with chemotherapy administration within 14 days of death, but not other measures of aggressive care at the end of life. Given the importance of clinical trial participation in improving care for women with ovarian cancer, this study suggests that concerns regarding aggressive care prior to death should not limit clinical trial participation.
INTRODUCTION: Minimising bias in randomised controlled trials (RCTs) includes intention-to-treat (ITT) analyses. Hospice/palliative care RCTs are constrained by high attrition unpredictable when consenting, including withdrawals between randomisation and first exposure to the intervention. Such withdrawals may systematically bias findings away from the new intervention being evaluated if they are considered non-responders. This study aimed to quantify this impact within ITT principles.
METHODS: A theoretical model was developed to assess the impact of withdrawals between randomisation and first exposure on i) study power and ii) 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 randomisation 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 ten 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.
DISCUSSION: If blinding is maintained and all interventions are available simultaneously, our model suggests that excluding data from withdrawals between randomisation and first exposure to the intervention minimises one bias. This is the safety population as defined by the International Committee on Harmonisation. When planning for future trials, minimising the time between randomisation and first exposure to the intervention will minimise the problem. Power should be calculated on people who receive the intervention.
Background: There are significant policy imperatives to involve consumers at the outset of and throughout research. How best to achieve this in an authentic and meaningful way is elusive, particularly within the palliative care population.
Aim: To determine how best to engage people with palliative care needs and their families in co-designing a qualitative study to better understand how to improve care of the dying in the acute care setting.
Methods: A case study design informed this work, informed by pre-determined research questions that focused on consumers advising on participant experience within the research, rather than research methodology per se.
Findings: Eleven consumers contributed across five panel meetings. Analysis of documented feedback led to four key areas of protocol change: Getting the language in the recruitment materials and information and consent forms right; Developing a feasible and acceptable recruitment strategy; Opportunities to more clearly articulate the explicit value of this research for patients and families; Support strategies for participants.
Discussion: Authentic consumer engagement requires time and effort; however, the outcomes are well worth the invested time and energy. Key foci outlined within this case study to enhance authenticity included: collaboration; preferencing the consumer voice; adequate preparation to support consumer engagement; and openness to all feedback provided.
Conclusion: Co-designing research with consumers enabled the outcome to be feasible for implementation, without any modifications required. Ensuring relevance and consumer-centredness for the expanding palliative care evidence base is essential and can only be achieved through meaningful partnerships with consumer representatives.
BACKGROUND: Family meetings in palliative care can enhance communication with family members and identify unmet needs. However, the patient's voice may not be heard.
METHODS: This pre and post-test quality improvement project was conducted from 2013-2014 and investigated a patient-centered family meeting, which is a different approach to palliative care family meetings, to determine its feasibility and acceptability for patients, family and the palliative care team. Newly admitted patients to an Australian in-patient specialist palliative care unit were invited to ask anyone they wished to join them in a meeting with the palliative care team and to identify issues they wished to discuss. Consenting inpatients were interviewed shortly after admission; participated in a family meeting and re-interviewed 2-3 days after the meeting. Family members provided feedback at the end of the meeting. A focus group was held with staff for feedback on this new approach for family meetings. Meetings were observed, documented and thematically analyzed.
RESULTS: Thirty-one newly admitted patients were approached to participate in a family meeting. Eighty-four percent had family meetings and the majority (96%) was attended by the patient. Thematic analysis revealed 69% of patient-centered meetings raised end-of-life concerns and 54% were "family-focused".
CONCLUSIONS: Patient-centered family meetings in palliative care were shown to be feasible and acceptable for staff, patients and family members. Many patients and families spontaneously shared end-of-life concerns. A patient-centered approach to family meetings that includes active patient involvement may provide additional and valued opportunities for patients and families to: express mutual concerns, deliver messages of comfort and appreciation, and prepare for death. Further investigation of this approach, including families' bereavement outcomes, is warranted.
BACKGROUND: Research is needed to improve care and diminish suffering for children with life-limiting illnesses and their parents. However, there are doubts about whether it is possible to conduct paediatric end of life research safely and ethically, as it may unduly burden or inadvertently harm participants.
AIM: To compare and evaluate responses from participants to the assessments of burdens and benefits that were conducted at two timepoints during a phenomenological study that investigated parents' experiences of having a child with life-limiting cancer participate in a Phase I clinical trial.
DISCUSSION: Parents reported that participating in the study was beneficial and resulted in minimal burden or distress. The assessment of benefits and burdens at the first timepoint appeared sufficient to understand participants' experiences.
CONCLUSION: This study adds to the evidence that research may be safely and effectively conducted with parents of children who are deceased or have life-limiting illnesses. Further research is needed to evaluate the most effective timing of assessments of the burdens and benefits of their participation in research.
IMPLICATIONS FOR PRACTICE: It is important when conducting research with people with life-limiting illnesses or their family members to assess the burdens and benefits of their participation, to understand their experiences and assist in its conduct.