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.
Spirituality could be understood as a personal belief, a relation with sacred, divine experience, a sense of purpose and meaning towards life, authenticity and connectedness. It is a continually evolving, highly complex, contextual, subjective, and sensitive construct. A continuous development is seen around understanding about spirituality and spiritual concepts, such as spiritual experiences, spiritual pain and spiritual distress, especially among patients and families at the end of life. The concepts, values, attitudes, and beliefs around spirituality, spiritual needs and expressions vary among different individuals, cultures, and religions. There is a dearth of literature around spirituality, especially among Muslim patients and families at the end of life. The complexities around the concept of spirituality in the literature raise several ethical and methodological concerns for a novice researcher while planning and conducting a study on spirituality during end-of-life care in a hospice setting, especially among a Muslim population. This paper aims to share some of the methodological and ethical challenges that can be faced by qualitative researchers while conducting research around spirituality and end-of-life care in an Islamic/Muslim context. Major challenges include defining the term spirituality, spirituality and culture, communication, power relations, language and translation, recruitment and selection of the participants, emotional distress, and reflexivity and reciprocity. Having an in-depth understanding of these challenges can guide researchers to address these issues adequately in their spirituality research in a Muslim context.
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: Early referral of cancer patients for palliative care significantly improves the quality of life. It is not clear which patients can benefit from an early referral, and when the referral should occur. A Delphi Panel study proposed 11 major criteria for an outpatient palliative care referral.
Objective: To operationalize major Delphi criteria in a cohort of lung cancer patients, using a prospective approach, by linking health administrative data.
Design: Population-based observational cohort study.
Setting/Subjects: The study population comprised 38,851 cases of lung cancer in the Ontario Cancer Registry, diagnosed from January 1, 2012, to December 31, 2016.
Measurements: We operationalized 6 of the 11 major criteria (4 diagnosis or prognosis based and 2 symptom based). Patients were considered eligible (index event) for palliative care if they qualified for any criterion. Among eligible patients, we identified those who received palliative care.
Results: Twenty-eight thousand one hundred sixty-four patients were eligible for palliative care by qualifying for either the diagnosis- or prognosis-based criteria (n = 21,036, 76.5%), or for symptom-based criteria (n = 7128, 23.5%). A total of 23,199 (82.4%) patients received palliative care. The median time from palliative care eligibility to the receipt of first palliative care or death or maximum study follow-up was 56 days (range = 17–348).
Conclusions: We operationalized six major criteria that identified the majority of lung cancer patients who were eligible for palliative care. Most eligible patients received the palliative care before death. Future research is warranted to test these criteria in other cancer populations.
Background: Palliative care-related postdoctoral training opportunities are critical to increase the quantity and quality of palliative care research.
Objective: To describe the history, activities, challenges, and future goals of the National Postdoctoral Palliative Care Research Training Collaborative.
Design: National web-based survey of participating program leaders.
Measurements: Information about participating programs, trainees, challenges faced, and future goals.
Results: Nine participating programs at academic institutions across the United States focus on diverse aspects of palliative care research. The majority of 73 current and former fellows are female (75%) and white (84%). In total, 38% of fellows (n = 28) have MD backgrounds, of whom less than half (n = 12) completed hospice and palliative medicine fellowships. An additional 38% of fellows (n = 28) have nursing PhD backgrounds and 23% (n = 17) have other diverse types of PhD backgrounds. Key challenges relate to recruiting diverse trainees, fostering a shared identity, effectively advocating for trainees, and securing funding. Future goals include expanding efforts to engage clinician and nonclinician scientists, fostering the pipeline of palliative care researchers through expanded mentorship of predoctoral and clinical trainees, increasing the number of postdoctoral palliative care training programs, and expanding funding support for career development grants.
Conclusion: The National Postdoctoral Palliative Care Research Training Collaborative fills an important role in creating a community for palliative care research trainees and developing strategies to address shared challenges.
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.
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: There has been a call for palliative care (PC) published research to support the impact and need for more specialty PC services.
OBJECTIVE: The purpose of this study was to characterize research in PC over a 15-year period in 3 PC journals published in the United States.
DESIGN: The authors reviewed every issue of the Journal of Pain and Symptom Management, Journal of Palliative Medicine, and American Journal of Hospice and Palliative Medicine from 2004 through 2018. Studies included were original articles and brief reports. Study type (qualitative, quantitative), author (first and last), gender, and professional degree of the author (first and last) were recorded.
RESULTS: A total of 4881 articles were included in this study. The proportion of quantitative papers significantly increased across 3 time points from 63% to 67% to 78%. The proportion of women first authors increased across all 3 time points (54%, 2004-2008; 57%, 2009-2013; 60%, 2014-2018), and the proportion of women last authors increased across all time points (38%, 2004-2008; 44%, 2009-2013; 46%, 2014-2018). More than 40% of authors were physicians.
CONCLUSIONS: Published PC studies are increasingly quantitative in design. Gender authorship is female dominant for the first authors and increasingly equal across genders for the last authors.
The translation of evidence-based interventions into routine hospice care is impeded by numerous barriers, including a disconnect between research priorities and clinical care. To inform the development of a more practice-informed agenda for hospice intervention research, our team conducted a qualitative descriptive study, posing the following research questions: 1) How do hospice staff members describe their most significant work-related challenges? and 2) What regulatory changes do hospice staff members report would most improve hospice care? To answer these research questions, we interviewed 22 hospice staff members and then conducted a template analysis of the interview content. In doing so, we identified themes that described challenges in 5 key areas: time, documentation, professional roles, recruitment and retention, and burn-out. In addition, we identified a perceived need among hospice staff members for more regulatory flexibility and clarity. Based on our findings, we conclude that a practice-informed agenda for hospice intervention research includes the development and testing of interventions that increase efficiency, explicitly speak to the humanity of hospice care, and elevate the roles of all members of the interdisciplinary team.
Coronavirus disease 2019 has created unprecedented challenges for amyotrophic lateral sclerosis (ALS) clinical care and research in the United States. Traditional evaluations for making an ALS diagnosis, measuring progression, and planning interventions rely on in-person visits that may now be unsafe or impossible. Evidence- and experience-based treatment options, such as multidisciplinary team care, feeding tubes, wheelchairs, home health, and hospice, have become more difficult to obtain and in some places are unavailable. In addition, the pandemic has impacted ALS clinical trials by impairing the ability to obtain measurements for trial eligibility, to monitor safety and efficacy outcomes, and to dispense study drug, as these also often rely on in-person visits. We review opportunities for overcoming some of these challenges through telemedicine and novel measurements. These can reoptimize ALS care and research in the current setting and during future events that may limit travel and face-to-face interactions.
Ce numéro de la revue est consacré à la philosophie de terrain définie comme rapport entre réalité et pensée et comme spécificité de l’activité philosophique. Sont abordés la revendication contemporaine d’une philosophie impliquée, une philosophie de terrain en lien avec la pensée canguilhémienne des normes individuelles, l’accompagnement de la fin de vie ou encore la recherche en éthique clinique.
BACKGROUND: Evaluation of palliative care services is crucial in order to ensure high quality care and to plan future services in light of growing demand. There is also an acknowledgement of the need to better understand patient experiences as part of the paradigm shift from paternalistic professional and passive patient to a more collaborative partnership. However, while clinical decision-making is well-developed, the science of the delivery of care is relatively novel for most clinicians. We therefore introduce the Trajectory Touchpoint Technique (TTT), a systematic methodology designed using service delivery models and theories, for capturing the voices of palliative care service users.
METHODS: We used design science research as our overarching methodology to build our Trajectory Touchpoint Technique. We also incorporated a range of kernel theories and service design models from the wider social sciences. We developed and tested our Trajectory Touchpoint Technique with palliative care patients and their families (n = 239) in collaboration with different hospices and hospital-based palliative care providers (n = 8).
RESULTS: The Trajectory Touchpoint Technique is user-friendly, enables systematic data collection and analysis, and incorporates all tangible and intangible dimensions of palliative care important to the service user. These dimensions often go beyond clinical care to encompass wider aspects that are important to the people who use the service. Our collaborating organisations have already begun to make changes to their service delivery based on our results.
CONCLUSIONS: The Trajectory Touchpoint Technique overcomes several limitations of other palliative care evaluation methods, while being more comprehensive. The new technique incorporates physical, psychosocial, and spiritual aspects of palliative care, and is user-friendly for inpatients, outpatients, families, and the bereaved. The new technique has been tested with people who have a range of illnesses, in a variety of locations, among people with learning disabilities and low levels of literacy, and with children as well as adults. The Trajectory Touchpoint Technique has already uncovered many previously unrecognised opportunities for service improvement, demonstrating its ability to shape palliative care services to better meet the needs of patients and their families.
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.
Conducting palliative care research can be personally and professionally challenging. While limitations in funding and training opportunities are well-described, a less recognized barrier to successful palliative care research is creating a sustainable and resilient team. In this special report, we describe the experience and lessons-learned in a single palliative care research lab. In the first few years of the program, 75% of staff quit, citing burnout and the emotional tolls of their work. To address our sustainability, we translated resilience theory to practice. First, we identified and operationalized shared mission and values. Next, we conducted a resilience resource needs assessment for both individual team-members and the larger team as a whole, and created a workshop based curriculum to address unmet personal and professional support needs. Finally, we changed our leadership approach to foster psychological safety and shared mission. Since then, no team-member has left and the program has thrived. As the demand for rigorous palliative care research grows, we hope this report will provide perspective and ideas to other established and emerging palliative care research programs.
Mixed methods research has been increasingly recognized as a useful approach for describing and explaining complex issues in palliative care and end-of-life research. However, little is known about the use of this methodology in the field and the ways in which mixed methods studies have been reported. The purpose of this methodological review was to examine the characteristics, methodological features and reporting quality of mixed methods articles published in palliative care research. The authors screened all articles published in eight journals specialized in palliative care between January 2014 and April 2019. Those that reported a mixed methods study (n = 159) were included. The Good Reporting of a Mixed Methods Study (GRAMMS) criteria were used to assess reporting quality. Findings showed that 57.9% of the identified studies used a convergent design and 82.4% mentioned complementarity as their main purpose for using a mixed methods approach. The reporting quality of the articles generally showed a need for improvement as authors usually did not describe the type of mixed methods design used and provided little detail on the integration of quantitative and qualitative methods. Based on the findings, recommendations are made to improve the quality of reporting of mixed methods articles in palliative care.
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.
A growing number of people living with HIV/AIDS are participating in HIV cure-related research at the end of life (EOL). Due to the novelty of EOL HIV cure-related research, there is a need to understand how their next-of-kin (NOK) perceive such research. We conducted in-depth interviews with NOK of the Last Gift study participants at the University of California, San Diego. The Last Gift study occurs in the context of the EOL and involves a full body donation. NOK completed two interviews: (1) shortly after the participants' enrollment in the study and (2) following death. We applied thematic analysis to analyze qualitative data. NOK included seven individuals (five males and two females), including two spouses, one ex-partner, one sister, a grandmother/grandfather, and a close friend. Thematic analysis revealed five key themes: (1) NOK viewed the Last Gift program in a positive light and had an accurate overall understanding of the study; (2) NOK identified factors that motivated participants to donate their body to science; (3) NOK identified benefits of the Last Gift program for both the donors and themselves; (4) NOK did not perceive any physical risks or decisional regrets of study but wanted to minimize psychosocial impacts and ensure the dignity of participants at all times; and (5) NOK noted elements that remained essential to the successful implementation of EOL HIV cure-related research, such as early involvement and clear communication. Our study uniquely contributes to increased understanding and knowledge of what is important from the point of view of supportive NOK to ensure successful implementation of EOL HIV cure-related research. More research will be needed to understand perspectives of less supportive NOK.
Overcoming barriers in hospice and palliative care research is a multifaceted challenge for researchers conducting intervention studies. The complexity and variations of these barriers are abundant and serious in nature and can threaten the success of intervention research for the hospice and palliative care patient population. This article explores how challenges and barriers to intervention research can be mitigated by nurses caring for patients in hospice and palliative care settings.
Background: Little is known about strategies for enrolling patients in home-based palliative care (HBPC) programs, despite the need to conduct effectiveness studies of this emerging industry.
Purpose: We used medical claims data from Accountable Care Organizations in California to identify patients for a randomized controlled trial of HBPC. We report outcomes from this strategy and the implications for future research.
Results: Claims data identified 1,357 patients. Research assistants could not reach 986 patients (72.7%), usually because the phone calls went unanswered (38.5%) and many patients’ phone numbers were missing or incorrect (16.3%). Of 371 patients reached, 163 opted out. Of 208 patients screened, 177 were ineligible for the trial. Just 10 patients were enrolled.
Recommendations: Our findings suggest that medical claims data may not be useful for engaging patients potentially eligible for palliative care research trials. We recommend that alternative identification and recruitment strategies be considered.
In 2010, forgoing curative therapies were removed as a hospice eligibility criterion for children through section 2302 of the Patient Protection and Affordable Care Act called Concurrent Care for Children. Given that concurrent care is a federally mandated option for children and their families, no review of the science has been conducted. The purpose of this study was to systematically collect the evidence on concurrent hospice care, critically appraise the evidence, and identify areas for future nursing research. Of the 186 articles identified for review, 14 met the inclusion and exclusion criteria. Studies in this review described concurrent hospice care from a variety of perspectives: policy, legal, and ethics. However, only 1 article evaluated the impact of concurrent hospice care on outcomes, whereas several studies explained clinical and state-level implementation. There is a need for further studies that move beyond conceptualization and generate baseline and outcomes data. Understanding the effectiveness of concurrent hospice care might provide important information for future nursing research. The approaches used to disseminate and implement concurrent hospice care at state, provider, and family levels should be explored.