Revised European Association for Palliative Care (EAPC) recommended framework on palliative sedation: An international Delphi study.

BACKGROUND: The European Association for Palliative Care (EAPC) acknowledges palliative sedation as an important, broadly accepted intervention for patients with life-limiting disease experiencing refractory symptoms. The EAPC therefore developed 2009 a framework on palliative sedation. A revision was needed due to new evidence from literature, ongoing debate and criticism of methodology, terminology and applicability. AIM: To provide evidence- and consensus-based guidance on palliative sedation for healthcare professionals involved in end-of-life care, for medical associations and health policy decision-makers. DESIGN: Revision between June 2020 and September 2022 of the 2009 framework using a literature update and a Delphi procedure. SETTING: European. PARTICIPANTS: International experts on palliative sedation (identified through literature search and nomination by national palliative care associations) and a European patient organisation. RESULTS: A framework with 42 statements for which high or very high level of consensus was reached. Terminology is defined more precisely with the terms suffering used to encompass distressing physical and psychological symptoms as well as existential suffering and refractory to describe the untreatable (healthcare professionals) and intolerable (patient) nature of the suffering. The principle of proportionality is introduced in the definition of palliative sedation. No specific period of remaining life expectancy is defined, based on the principles of refractoriness of suffering, proportionality and independent decision-making for hydration. Patient autonomy is emphasised. A stepwise pharmacological approach and a guidance on hydration decision-making are provided. CONCLUSIONS: This is the first framework on palliative sedation using a strict consensus methodology. It should serve as comprehensive and soundly developed information for healthcare professionals.

Report on palliative sedation medication usage: a survey of palliative care experts in Eight European countries.

BACKGROUND: The practice of palliative sedation continues to raise ethical questions among people, which in turn leads to its varied acceptance and practice across regions. As part of the Palliative Sedation European Union (EU) project, the aim of the present study was to determine the perceptions of palliative care experts regarding the practice of palliative sedation in eight European countries (The Netherlands, Belgium, Germany, UK, Italy, Spain, Hungary, and Romania). METHODS: A specifically designed survey, including questions on the most frequently used medications for palliative sedation, their availability per countries and settings, and the barriers and facilitators to the appropriate practice of palliative sedation was sent to expert clinicians involved and knowledgeable in palliative care in the indicated countries. A purposive sampling strategy was used to select at least 18 participating clinicians per consortium country. Descriptive statistical analysis was conducted on the survey data. RESULTS: Of the 208 expert clinicians invited to participate, 124 participants completed the survey. Midazolam was perceived to be the most frequently used benzodiazepine in all eight countries. 86% and 89% of expert clinicians in Germany and Italy, respectively, perceived midazolam was used "almost always", while in Hungary and Romania only about 50% or less of the respondents perceived this. Levomepromazine was the neuroleptic most frequently perceived to be used for palliative sedation in the Netherlands, Spain, Germany, and the United Kingdom. Between 38- 86% of all eight countries´ expert clinicians believed that opioid medications were "almost always" used during palliative sedation. The perceived use of IV hydration and artificial nutrition "almost always" was generally low, while the country where both IV hydration and artificial nutrition were considered to be "very often" given by a third of the expert clinicians, was in Hungary, with 36% and 27%, respectively. CONCLUSIONS: Our study provides insight about the differences in the perceived practice of medication during palliative sedation between eight European countries. In countries where palliative care services have been established longer perceptions regarding medication use during palliative sedation were more in line with the recommended European guidelines than in Central and Eastern European countries like Romania and Hungary.

Patient values in patient-provider communication about participation in early phase clinical cancer trials: a qualitative analysis before and after implementation of an online value clarification tool intervention.

BACKGROUND: Patients with advanced cancer who no longer have standard treatment options available may decide to participate in early phase clinical trials (i.e. experimental treatments with uncertain outcomes). Shared decision-making (SDM) models help to understand considerations that influence patients' decision. Discussion of patient values is essential to SDM, but such communication is often limited in this context and may require new interventions. The OnVaCT intervention, consisting of a preparatory online value clarification tool (OnVaCT) for patients and communication training for oncologists, was previously developed to support SDM. This study aimed to qualitatively explore associations between patient values that are discussed between patients and oncologists during consultations about potential participation in early phase clinical trials before and after implementation of the OnVaCT intervention. METHODS: This study is part of a prospective multicentre nonrandomized controlled clinical trial and had a between-subjects design: pre-intervention patients received usual care, while post-intervention patients additionally received the OnVaCT. Oncologists participated in the communication training between study phases. Patients' initial consultation on potential early phase clinical trial participation was recorded and transcribed verbatim. Applying a directed approach, two independent coders analysed the transcripts using an initial codebook based on previous studies. Steps of continuous evaluation and revision were repeated until data saturation was reached. RESULTS: Data saturation was reached after 32 patient-oncologist consultations (i.e. 17 pre-intervention and 15 post-intervention). The analysis revealed the values: hope, perseverance, quality or quantity of life, risk tolerance, trust in the healthcare system/professionals, autonomy, social adherence, altruism, corporeality, acceptance of one's fate, and humanity. Patients in the pre-intervention phase tended to express values briefly and spontaneously. Oncologists acknowledged the importance of patients' values, but generally only gave 'contrasting' examples of why some accept and others refuse to participate in trials. In the post-intervention phase, many oncologists referred to the OnVaCT and/or asked follow-up questions, while patients used longer phrases that combined multiple values, sometimes clearly indicating their weighing. CONCLUSIONS: While all values were recognized in both study phases, our results have highlighted the different communication patterns around patient values in SDM for potential early phase clinical trial participation before and after implementation of the OnVaCT intervention. This study therefore provides a first (qualitative) indication that the OnVaCT intervention may support patients and oncologists in discussing their values. TRIAL REGISTRATION: Netherlands Trial Registry: NL7335, registered on July 17, 2018.

Regulations on palliative sedation: an international survey across eight European countries.

BACKGROUND: Palliative sedation is a commonly accepted medical practice. This study aims to clarify how palliative sedation is regulated in various countries and whether this may impact its practice. METHODS: An online survey requesting regulations on palliative sedation was conducted in Belgium, Germany, Hungary, Italy, The Netherlands, Spain, Romania and the UK. Purposive sampling strategy was used to identify clinicians from different medical fields and legal experts for each country. Regulations were analyzed using the principles of the European Association for Palliative Care Framework on palliative sedation. Country reports describing how palliative sedation is regulated were elaborated. RESULTS: One hundred and thirty-nine out of 223 (62%) participants identified 31 laws and other regulations affecting palliative sedation. In Spain, 12 regional laws recognize palliative sedation as a right of the patient at the end of life when there are refractory symptoms. In Italy, the law of informed consent and advance directives specifically recognizes the doctor can use deep sedation when there are refractory symptoms. There are also general medical laws that, while not explicitly referring to palliative sedation, regulate sedation-related principles: the obligation of doctors to honour advance directives, informed consent, the decision-making process and the obligation to document the whole process. In Germany, the Netherlands and the UK, palliative sedation is also regulated through professional guidelines that are binding as good practice with legal significance. CONCLUSIONS: Palliative sedation is considered in the general law of medical practice, in laws regarding the patient's autonomy, and through professional guidelines.

The clinical practice of palliative sedation in patients dying from COVID-19: a retrospective chart review.

BACKGROUND: Clinical experts experienced challenges in the practice of palliative sedation (PS) during the COVID-19 pandemic. Rapid deterioration in patients' situation was observed while the indications for starting PS seemed to differ compared to other terminal patients. It is unclear to which extent clinical trajectories of PS differ for these COVID patients compared to regular clinical practice of PS. OBJECTIVES: To describe the clinical practice of PS in patients with COVID versus non-COVID patients. METHODS: A retrospective analysis of data from a Dutch tertiary medical centre was performed. Charts of adult patients who died with PS during hospitalisation between March '20 and January '21 were included. RESULTS: During the study period, 73 patients received PS and of those 25 (34%) had a COVID infection. Refractory dyspnoea was reported as primary indication for starting PS in 84% of patients with COVID compared to 33% in the other group (p < 0.001). Median duration of PS was significantly shorter in the COVID group (5.8 vs. 17.1 h, p < 0.01). No differences were found for starting dosages, but median hourly dose of midazolam was higher in the COVID group (4.2 mg/hr vs. 2.4 mg/hr, p < 0.001). Time interval between start PS and first medication adjustments seemed to be shorter in COVID patients (1.5 vs. 2.9 h, p = 0.08). CONCLUSION: PS in COVID patients is characterized by rapid clinical deterioration in all phases of the trajectory. What is manifested by earlier dose adjustments and higher hourly doses of midazolam. Timely evaluation of efficacy is recommended in those patients.

Monitoring the clinical practice of palliative sedation (PALSED) in patients with advanced cancer: an international, multicentre, non-experimental prospective observational study protocol.

BACKGROUND: Palliative sedation involves the intentional lowering of consciousness at the end of life. It can be initiated to relieve a patient's burden caused by refractory symptoms at the end of life. The impact of palliative sedation needs to be clinically monitored to adjust the proper dose and regimen of sedative medication to ensure that patients are at ease and comfortable at the end of their lives. Although there is consensus among health care professionals and within guidelines that efficacy of palliative sedation needs to be closely monitored, there is no agreement about how, when, and by whom, this monitoring should be performed. The aim of this study is to evaluate the effects of palliative sedation by measuring the discomfort levels and sedation/agitation levels of the patients at regular timepoints. In addition, the clinical trajectories of those patients receiving palliative sedation will be monitored and recorded. METHODS: The study is an international prospective non-experimental observational multicentre study. Patients are recruited from in-patient palliative care settings in Belgium, Germany, Italy, Spain and the Netherlands. Adult patients with advanced cancer are monitored by using proxy observations of discomfort (DS-DAT) and depth of sedation/agitation levels (RASS-PAL) during palliative sedation. After the palliative sedation period, the care for the specific participant case is evaluated by one of the attending health care professionals and one relative via a questionnaire. DISCUSSION: This study will be the first international prospective multicenter study evaluating the clinical practice of palliative sedation including observations of discomfort levels and levels of sedation. It will provide valuable information about the practice of palliative sedation in European countries in terminally ill cancer patients. Results from this study will facilitate the formulation of recommendations for clinical practice on how to improve monitoring and comfort in patients receiving palliative sedation. TRIAL REGISTRATION: This study is registered at Clinicaltrials.gov since January 22, 2021, registration number: NCT04719702.

Core values of patients with advanced cancer considering participation in an early-phase clinical trial: a qualitative study.

OBJECTIVE: This article identifies the core values that play a role in patients' decision-making process about participation in early-phase clinical cancer trials. METHODS: Face-to-face, semi-structured serial interviews (n = 22) were performed with thirteen patients with advanced cancer recruited in two Dutch specialized cancer centers. In a cyclic qualitative analysis process, open and axial coding of the interviews finally led to an overview of the values that are woven into patients' common language about cancer and clinical trials. RESULTS: Six core values were described, namely, acceptance creates room for reconsideration of values, reconciliation with one's fate, hope, autonomy, body preservation, and altruism. Previously found values in advanced cancer, such as acceptance, hope, autonomy, and altruism, were further qualified. Reconciliation with one's fate and body preservation were highlighted as new insights for early-phase clinical cancer trial literature. CONCLUSIONS: This article furthers the understanding of core values that play a role in the lives and decision-making of patients with advanced cancer who explore participation in early-phase clinical cancer trials. These values do not necessarily have to be compatible with one another, making tragic choices necessary. Understanding the role of core values can contribute to professional sensitivity regarding what motivates patients' emotions, thoughts, and decisions and help patients reflect on and give words to their values and preferences. It supports mutual understanding and dialog from which patients can make decisions according to their perspectives on a good life for themselves and their fellows in the context of participation in an early-phase clinical cancer trial.

How to measure the effects and potential adverse events of palliative sedation? An integrative review.

BACKGROUND: Palliative sedation is the monitored use of medications intended to relieve refractory suffering. The assessment of palliative sedation has been focused on the assess of the level of consciousness but a more comprehensive approach to assessment is needed. AIM: To understand how the potential effects and possible adverse events of palliative sedation in Palliative Care patients are measured. DESIGN: Integrative review of most recent empirical research. DATA SOURCES: Cochrane Library, Embase, Medline, PubMed, and CINAHL were searched (2010-2020) using the terms sedation, palliative care, terminal care, assessment. Limits included studies in English and adults. Inclusion criteria were: scientific assessment papers, effects and complications of palliative sedation; patients with incurable illness. RESULTS: Out of 588 titles, 26 fulfilled inclusion criteria. The Discomfort Scale-Dementia of Alzheimer Type and Patient Comfort Score were used to assess comfort. The Richmond Agitation-Sedation Scale and The Ramsay Sedation Scale are the most used to measure its effect. Refractory symptoms were assessed through multi-symptom or specific scales; except for psychological or existential distress. Delirium was assessed using the Memorial Delirium Assessment Scale and pain through the Critical Care Pain Observation Tool. The use of technical approaches to monitor effects is upcoming. There is lack of measurement of possible adverse events and variability in timing measurement. CONCLUSIONS: There are palliative care validated instruments to assess the sedation effect but this review shows the need for a more standardized approach when assessing it. Instruments should be used within an experienced and trained expert, providing a holistic assessment.

Ethical and research governance approval across Europe: Experiences from three European palliative care studies.

BACKGROUND: Research requires high-quality ethical and governance scrutiny and approval. However, when research is conducted across different countries, this can cause challenges due to the differing ethico-legal framework requirements of ethical boards. There is no specific guidance for research which does not involve non-medicinal products. AIM: To describe and address differences in ethical and research governance procedures applied by research ethics committees for non-pharmaceutical palliative care studies including adult participants in collaborative European studies. DESIGN: An online survey analysed using descriptive statistics. SETTING/PARTICIPANTS: Eighteen principal investigators in 11 countries conducting one of three European-funded studies. RESULTS: There was variation in practice including whether ethical approval was required. The time to gain full approvals differed with the United Kingdom having governance procedures that took the longest time. Written consent was not required in all countries nor were data safety monitoring committees for trials. There were additional differences in relation to other data management issues. CONCLUSION: Researchers need to take the differences in research approval procedures into account when planning studies. Future research is needed to establish European-wide recommendations for policy and practice that dovetail ethical procedures and enhance transnational research collaborations.

Living and dying with incurable cancer: a qualitative study on older patients' life values and healthcare professionals' responsivity.

BACKGROUND: In ageing Western societies, many older persons live with and die from cancer. Despite that present-day healthcare aims to be patient-centered, scientific literature has little knowledge to offer about how cancer and its treatment impact older persons' various outlooks on life and underlying life values. Therefore, the aims of this paper are to: 1) describe outlooks on life and life values of older people (≥ 70) living with incurable cancer; 2) elicit how healthcare professionals react and respond to these. METHODS: Semi-structured qualitative interviews with 12 older persons with advanced cancer and two group interviews with healthcare professionals were held and followed by an analysis with a grounded theory approach. RESULTS: Several themes and subthemes emerged from the patient interview study: a) handling incurable cancer (the anticipatory outlook on "a reduced life", hope and, coping with an unpredictable disease) b) being supported by others ("being there", leaving a legacy, and having reliable healthcare professionals) and; c) making end-of-life choices (anticipatory fears, and place of death). The group interviews explained how healthcare professionals respond to the abovementioned themes in palliative care practice. Some barriers for (open) communication were expressed too by the latter, e.g., lack of continuity of care and advance care planning, and patients' humble attitudes. CONCLUSIONS: Older adults living with incurable cancer showed particular outlooks on life and life values regarding advanced cancer and the accompanying last phase of life. This paper could support healthcare professionals and patients in jointly exploring and formulating these outlooks and values in the light of treatment plans.

Palliative care for patients with substance use disorder and multiple problems: a qualitative study on experiences of healthcare professionals, volunteers and experts-by-experience.

BACKGROUND: There is little information about how healthcare professionals feel about providing palliative care for patients with a substance use disorder (SUD). Therefore, this study aims to explore: 1) the problems and needs experienced by healthcare professionals, volunteers and experts-by-experience (HCP/VE) during their work with patients with SUD in a palliative care trajectory and; 2) to make suggestions for improvements using the quality of care model by Donabedian (Structure, Process, Outcome). METHODS: A qualitative study was conducted, consisting of six focus group interviews which consisted of HCP/VE working with patients with SUD in a palliative care phase. At the end of the focus group interviews, participants structured and summarized their experiences within a Strengths, Weaknesses, Opportunities and Threats (SWOT) framework. Interview transcripts (other than the SWOT) were analysed by the researchers following procedures from the Grounded Theory Approach ('Grounded Theory Lite'). SWOT-findings were not subjected to in-depth analysis. RESULTS: HCP/VE stated that within the Structure of care, care networks are fragmented and HCP/VE often lack knowledge about patients' multiplicity of problems and the time to unravel these. Communication with this patient group appears limited. The actual care-giving Process requires HCP/VE a lot of creativity and time spent seeking for cooperation with other caregivers and appropriate care settings. The latter is often hindered by stigma. Since no formalized knowledge is available, care-delivery is often exclusively experience-based. Pain-medication is often ineffective due to active substance use. Finally, several Outcomes were brought forward: Firstly, a palliative care phase is often identified only at a late stage. Secondly, education and a (mobile) team of expertise are desired. Thirdly, care for the caregivers themselves is often de-prioritized. CONCLUSIONS: Better integration and collaboration between the different professionals with extensive experience in addiction, palliative and general curative care is imperative to assure good palliative care for patients with SUD. Currently, the resources for this care appear to be insufficient. Development of an educational program and social mapping may be the first steps in improving palliative care for patients with severe SUD.

Disseminating research findings using a massive online open course for maximising impact and developing recommendations for practice.

BACKGROUND: Developing recommendations for how we deliver healthcare is often left to leading experts in a field. Findings from the Integrated Palliative Care in cancer and chronic conditions (InSup-C) study, which aimed to identify best practice in integrated palliative care in cancer, chronic obstructive pulmonary disease (COPD) and heart failure, led to recommendations developed through an expert consultation process. We also wanted to develop these recommendations further with participants who were largely clinicians and members of the public. METHODS: Results from the InSup-C study were disseminated through a three-week massive open online course (MOOC) which ran in 2016, 2017 and 2019. The first course helped develop the final recommendations, which were ranked by MOOC participants in the subsequent courses. MOOC participants were predominantly clinicians, but also academics and members of the public. They rated how important each recommendation was on a 9 point scale (9 most important). Descriptive statistics were used to analyse the ratings. The results were compared to findings from the consultation. RESULTS: Five hundred fifteen completed the last part of the course where the recommendations were ranked, of which 195 (38%) completed the ratings. The top recommendations related to: need to expand palliative care to non-malignant conditions; palliative care needs to include different dimensions of care including physical, psychological and spiritual; policies and regulations assessments should be made regularly; palliative care integration should be mandatory; and there should be greater availability of medicines. These differed compared to the top ranked recommendations by the consultation panel in relation to the importance of leadership and policy making. This may indicate that clinicians are more focused on daily care rather than the (inter) national agenda. CONCLUSIONS: Whilst both sets of recommendations are important, our study shows that we need to include the views of clinicians and the public rather than rely upon leading expert opinion alone. To keep recommendations fresh we need both the input of clinicians, the public and experts. When disseminating findings, MOOCs offer a useful way to gain greater reach with clinicians and the public, and importantly could be a vehicle to validate recommendations made by leading expert panels.

Recommendations on priorities for integrated palliative care: transparent expert consultation with international leaders for the InSuP-C project.

BACKGROUND: The World Health Organisation (WHO) endorses integrated palliative care which has a significant impact on quality of life and satisfaction with care. Effective integration between hospices, palliative care services, hospitals and primary care services are required to support patients with palliative care needs. Studies have indicated that little is known about which aspects are regarded as most important and should be priorities for international implementation. The Integrated Palliative Care in cancer and chronic conditions (InSup-C) project, aimed to investigate integrated practices in Europe and to formulate requirements for effective palliative care integration. It aimed to develop recommendations, and to agree priorities, for integrated palliative care linked to the InSuP-C project. METHODS: Transparent expert consultation was adopted at the approach used. Data were collected in two phases: 1) international transparent expert consultation using face-to-face roundtable discussions at a one day workshop in Brussels, and 2) via subsequent online cross-sectional survey where items were rated to indicate degree of agreement on their importance and ranked to indicate priority for implementation. Workshop discussions used content analysis to develop a list of 23 recommendations, which formed the survey questionnaire. Survey analysis used descriptive statistics and qualitative content analysis of open responses. RESULTS: Thirty-six international experts in palliative care and cancer care, including senior clinicians, researchers, leaders of relevant international organisations and funders, were invited to a face-to-face workshop. Data were collected from 33 (19 men, 14 women), 3 declined. They mostly came from European countries (31), USA (1) and Australia (1). Twenty one of them also completed the subsequent online survey (response rate 63%). We generated 23 written statements that were grouped into the organisational constructs: macro (10), meso (6) and micro (7) levels of integration of palliative care. Highest priority recommendations refer to education, leadership and policy-making, medium priority recommendations focused on funding and relationship-building, and lower priority recommendations related to improving systems and infrastructure. CONCLUSIONS: Our findings suggest that amongst a group of international experts there was overall good agreement on the importance of recommendations for integrated palliative care. Understanding expert's priorities is important and can guide practice, policymaking and future research.

Palliative care for people with substance use disorder and multiple problems: a qualitative study on experiences of patients and proxies.

BACKGROUND: Systematic research into palliative care (PC) for people with substance use disorder (SUD) and multiple problems is scarce. The existing literature shows problems in the organizational structure of this care, e.g., lack of clear care pathways. Furthermore, negative attitudes of healthcare professionals (HCPs) and stigmatization surrounding SUD, and patients' care-avoidance and non-disclosure of substance use are hindering factors in providing timely and person-centered PC. Furthermore, the experiences and needs of patients and proxies themselves are unknown. Therefore, this study aims to explore which problems and needs patients with SUD and multiple problems, and their proxies, experience in a PC phase. METHODS: Data-collection of this qualitative study consisted of semi-structured interviews with patients with SUD and multiple problems in a PC phase, and their proxies, about their experiences in PC and their well-being. Interviews were inductively analyzed. RESULTS: Nine patients and three proxies were included. Six patients suffered from COPD, one patient from cirrhosis of the liver and two patients from both. Seven patients stayed in a nursing home and two had a room in either a social care service (hostel) or an assisted living home where medical care was provided. Five themes were identified: 1) healthcare delivery (including HCPs behaviour and values); 2) end-of-life (EOL) preferences (mostly concerning only the individual patient and the 'here-and-the-now'); 3) multidimensional problems; 4) coping (active and passive) and; 5) closed communication. Proxies' experiences with healthcare differed. Emotionally, they were all burdened by their histories with the patients. CONCLUSIONS: This study shows that talking about and anticipating on PC with this patient-group appears hard due to patients' closed and avoiding communication. Furthermore, some of patients' EOL-preferences and needs, and coping-strategies, seem to differ from the more generally-accepted ideas and practices. Therefore, educating HCPs in communicating with this patient-group, is needed.

Realizing better doctor-patient dialogue about choices in palliative care and early phase clinical trial participation: towards an online value clarification tool (OnVaCT).

BACKGROUND: Patients with advanced cancer for whom standard systemic treatment is no longer available may be offered participation in early phase clinical trials. In the decision making process, both medical-technical information and patient values and preferences are important. Since patients report decisional conflict after deciding on participation in these trials, improving the decision making process is essential. We aim to develop and evaluate an Online Value Clarification Tool (OnVaCT) to assist patients in clarifying their values around this end-of-life decision. This improved sharing of values is hypothesized to support medical oncologists in tailoring their information to individual patients' needs and, consequently, to support patients in taking decisions in line with their values and reduce decisional conflict. METHODS: In the first part, patients' values and preferences and medical oncologists' views hereupon will be explored in interviews and focus groups to build a first prototype OnVaCT using digital communication (serious gaming). Next, we will test feasibility during think aloud sessions, to deliver a ready-to-implement OnVaCT. In the second part, the OnVaCT, with accompanied training module, will be evaluated in a pre-test (12-18 months before implementation) post-test (12-18 months after implementation) study in three major Dutch cancer centres. We will include 276 patients (> 18 years) with advanced cancer for whom standard systemic therapy is no longer available, and who are referred for participation in early phase clinical trials. The first consultation will be recorded to analyse patient-physician communication regarding the discussion of patients' values and the decision making process. Three weeks afterwards, decisional conflict will be measured. DISCUSSION: This project aims to support the discussion of patient values when considering participation in early phase clinical trials. By including patients before their first appointment with the medical oncologist and recording that consultation, we are able to link decisional conflict to the decision making process, e.g. the communication during consultation. The study faces challenges such as timely including patients within the short period between referral and first consultation. Furthermore, with new treatments being developed rapidly, molecular stratification may affect the patient populations included in the pre-test and post-test periods. TRIAL REGISTRATION: Netherlands Trial Registry number: NTR7551 (prospective; July 17, 2018).

"Never at ease" - family carers within integrated palliative care: a multinational, mixed method study.

BACKGROUND: Family carers manage a wide range of responsibilities in the lives and care of patients receiving palliative care. They fulfil multiple roles and perform activities within different settings. This has immediate consequences on family carers' every-day lives. According to literature, family carers in palliative care are both part of the formal and informal care network, but also persons in need of support. This article aims to investigate 1) burdens and rewards associated with family caregiving and 2) what family carers find helpful in their contact with professionals from integrated palliative care initiatives (IPC-i) and other services. METHODS: Family carers looking after patients with cancer, chronic obstructive pulmonary disease or chronic heart failure were purposefully recruited at 22 IPC-i in Belgium, Germany, Hungary, the Netherlands and the United Kingdom in the course of the project "Patient-centred palliative care pathways in advanced cancer and chronic disease" (InSup-C). Semi-structured interviews (n = 156) and 87 quantitative questionnaires (CRA, POS, CANHELP Lite) were conducted with family carers. Interviews were analysed with transnationally agreed thematic codes (MAXQDA or NVivo). Statistical tests (SPSS) were carried out in accordance with the characteristic value of the items and distributions. RESULTS: On average, quantitative data showed moderate burden, but the qualitative findings indicated that this burden might be underrated. There is some evidence that IPC-i with well-developed professional care networks and communication systems relieved family carers' burden by direct and indirect interventions; e.g. provision of night shift nurses or psychological support. Needs of family carers were similar in all participating countries. However, in all countries IPC-i mostly offered one-off events for family carers, lacking systematic or institutionalised support structures. CONCLUSIONS: Data suggest that, most IPC-i did not pay enough attention to the needs of most family carers, and did not offer proactive care and access to supportive resources to them (e.g. training, respite care, access to resources). We recommend recognizing family carers as part of the 'unit of care' and partner in caregiving, to improve their knowledge about, and access to, and the support available.

The effect of weekly specialist palliative care teleconsultations in patients with advanced cancer -a randomized clinical trial.

BACKGROUND: Teleconsultation seems to be a promising intervention for providing palliative care to home-dwelling patients; however, its effect on clinically relevant outcome measures remains largely unexplored. Therefore, the purpose of this study was to determine whether weekly teleconsultations from a hospital-based specialist palliative care consultation team (SPCT) improved patient-experienced symptom burden compared to "care as usual". Secondary objectives were to determine the effects of these teleconsultations on unmet palliative care needs, continuity of care, hospital admissions, satisfaction with teleconsultations, and the burden experienced by informal caregivers. METHODS: Seventy-four home-dwelling patients diagnosed with advanced cancer were recruited from outpatient clinics of a tertiary university hospital and from regional home care organizations between May 2011 and January 2015. Participants were randomized to receive weekly, prescheduled teleconsultations with an SPCT-member (intervention group), or to receive "care as usual" (control group), for a period of 12 weeks. The primary outcome of this study was: patient-experienced symptom burden indicated by the following: (1) Total Distress Score (defined as the sum of all nine subscales of the Edmonton Symptom Assessment System) and (2) the Hospital Anxiety and Depression Scale. Mixed models were used to test for differences between the two groups. RESULTS: The Total Distress Score became significantly higher in the intervention group than in the control group, reaching significance at week 12 (adjusted difference at week 12: 6.90 points, 95% CI, 0.17 to 13.63; P = 0.04). The adjusted anxiety scores were higher in the intervention group than in the control group (estimate effect: 1.40; 95% CI, 0.14 to 2.55; P = 0.03). No difference was found between the groups in adjusted depression scores (estimate effect: 0.30; 95% CI, -1.39 to 1.99; P = 0.73) or in secondary outcome measures. CONCLUSIONS: Adding weekly teleconsultations to usual palliative care leads to worse reported symptom scores among home-dwelling patients with advanced cancer. Possible explanations for these findings include excess attention on symptoms and (potential) suffering, the supply-driven care model for teleconsultations used in this trial, and the already high level of specialist palliative care provided to the control group in this study. TRIAL REGISTRATION: "The Netherlands National Trial Register", NTR2817 , prospectively registered: March 21, 2011.

Funding models in palliative care: Lessons from international experience.

BACKGROUND: Funding models influence provision and development of palliative care services. As palliative care integrates into mainstream health care provision, opportunities to develop funding mechanisms arise. However, little has been reported on what funding models exist or how we can learn from them. AIM: To assess national models and methods for financing and reimbursing palliative care. DESIGN: Initial literature scoping yielded limited evidence on the subject as national policy documents are difficult to identify, access and interpret. We undertook expert consultations to appraise national models of palliative care financing in England, Germany, Hungary, Republic of Ireland, New Zealand, The Netherlands, Norway, Poland, Spain, Sweden, Switzerland, the United States and Wales. These represent different levels of service development and a variety of funding mechanisms. RESULTS: Funding mechanisms reflect country-specific context and local variations in care provision. Patterns emerging include the following: Provider payment is rarely linked to population need and often perpetuates existing inequitable patterns in service provision. Funding is frequently characterised as a mixed system of charitable, public and private payers. The basis on which providers are paid for services rarely reflects individual care input or patient needs. CONCLUSION: Funding mechanisms need to be well understood and used with caution to ensure best practice and minimise perverse incentives. Before we can conduct cross-national comparisons of costs and impact of palliative care, we need to understand the funding and policy context for palliative care in each country of interest.

How continuity of care is experienced within the context of integrated palliative care: A qualitative study with patients and family caregivers in five European countries.

BACKGROUND: Patients with advanced diseases often experience deficient continuity of care. Although integrated palliative care promotes continuity of care, it is not clear how it can be optimized to improve continuity of care experiences. AIM: To examine how relational, informational and management continuity of care are experienced by patients with advanced diseases and their family caregivers receiving care from several integrated palliative care initiatives in five European countries. DESIGN: We adopted a longitudinal qualitative study design including two interviews (interval 3 months) with patients and family caregivers focusing on how health care professionals responded to their needs. Interviews were audio-recorded and transcribed verbatim. Analysis involved a two-step qualitative content approach. SETTING/PARTICIPANTS: A total of 22 integrated palliative care initiatives (established local palliative care collaborations) were selected in Belgium, Germany, Hungary, the Netherlands and the United Kingdom. We recruited 152 patients (63% cancer, 24% chronic obstructive pulmonary disease, 13% heart failure; life expectancy <1 year; mean age 68 years, 56% female) and 92 family caregivers (mean age 61 years, 66% female). RESULTS: Trusted relationships with a small number of key health care professionals to receive tailored care and easily access help were essential. Relational continuity was often deficient, especially with general practitioners. Although informational and management continuity was often lacking in care provision, collaborative integrated palliative care initiatives were related to consistent and coherent care. CONCLUSION: Patients and family caregivers most likely experience continuity of care by having a small number of trusted health care professionals who are available, provide multidisciplinary care and regularly transfer information to all health care professionals involved. Optimizing continuity of care requires further integration of integrated palliative care initiatives with other health care professionals involved in the patients' care networks.

Enhancing integrated palliative care: what models are appropriate? A cross-case analysis.

BACKGROUND: Effective integration between hospices, palliative care services and other local health care services to support patients with palliative care needs is an important international priority. A previous model suggests that integration involves a cumulative stepped process of engagement with other organisations labelled as 'support, supplant or supplement', but the extent to which this model currently applies in the United Kingdom is unknown. We aimed to investigate accounts of hospice integration with local health care providers, using the framework provided by the model, to determine how service users and healthcare professionals perceived palliative care services and the extent of integration experienced. METHODS: Longitudinal organisational case study methods were employed using qualitative serial interviews (interval 3 months) with patients and family carers focusing on how services responded to their needs; and group interviews with health professionals. Data were audio-recorded, transcribed verbatim, and analysed by qualitative content analysis and combined across data sources. RESULTS: The study focused on four hospices in northern England, including 34 patients (diagnosis: 17 cancer, 10 COPD, 7 heart failure), 65% female, mean age 66 (range 44-89), 13 family carers of these patients (48% partners), and 23 health care professionals. While some care fell short of expectations, all patients reported high levels of satisfaction and valued continuity of care and efficient information sharing. All hospices supported and supplemented local providers, with three hospices also supplanting local provision by providing in-patient facilities. CONCLUSION: UK hospices predominantly operate in ways that support and supplement other providers. In addition, some also supplant local services, taking over direct responsibility and funding in-patient care. They all contributed to integration with local services, with greater blurring of boundaries than defined by the original model. Integrated care offers the necessary flexibility to respond to changes in patient needs, however, constraints from funding drivers and a lack of clear responsibilities in the UK can result in shortfalls in optimal service delivery. Integrating hospice care with local healthcare services can help to address demographic changes, predominantly more frail older people, and disease factors, including the needs of those with non-malignant conditions. This model, tested in the UK, could serve as an example for other countries.