Sexual satisfaction and its predictors in patients with advanced cancer and their family caregivers in six European countries: Baseline data from the DIAdIC study.

OBJECTIVE: To identify predictors of sexual satisfaction in patients with advanced cancer and their family caregivers. METHODS: Cross-sectional study using baseline survey data from a randomized controlled trial in six European countries. Patients with advanced cancer and their family caregiver completed measures on sexual satisfaction (one item from Functional Assessment of Cancer Therapy - General questionnaire for patients and Caregiver Quality of Life Index-Cancer scale for family caregivers) and health-related characteristics. Multivariable linear regressions were performed for all predictors (identified based on literature) with sexual satisfaction as dependent variable. RESULTS: The sample comprised 431 patient-family caregiver dyads. Patients with prostate or gynecological cancer reported lower sexual satisfaction (respectively B = -0.267 95% CI: -1.674, -0.594 and B = -0.196, 95% CI -2.103, -0.452). Higher emotional (B = 0.278, 95% CI 0.024, 0.057) physical (B = 0.305, 95% CI 0.012, 0.025) and social functioning (B = 0.151, 95% CI 0.001, 0.013), global health (B = 0.356, 95% CI 0.007, 0.013) and social wellbeing (B = 0.161, 95% CI 0.013, 0.082) among patients were associated with higher sexual satisfaction. Among family caregivers, sexual satisfaction was lower with increased age (B = -0.142, 95% CI -0.022, -0.004). Higher emotional functioning (B = 0.027, 95% CI 0.011, 0.043) and quality of life (B = 0.165, 95% CI -0.165, 0.716) were associated with higher sexual satisfaction in family caregivers. CONCLUSIONS: The results underscore that sexual wellbeing of patients and family caregivers is related to health related factors in physical, emotional, and social domains. Patients and family caregivers could benefit from a dyadic approach to address sexual wellbeing.

Relatives' Experiences of Being Involved in Assisted Dying: A Qualitative Study.

Recent literature demonstrates an interdependence between relatives and healthcare providers throughout euthanasia processes. Yet, current guidelines and literature scarcely specify the interactions between healthcare providers and bereaved relatives. The aim of this work consisted of providing an insight into bereaved relatives' experiences (1) of being involved in euthanasia processes and (2) of their interactions with healthcare providers before, during, and after the euthanasia. The research process was guided by the principles of constructivist grounded theory. Nineteen Dutch-speaking bereaved relatives of oncological patients, who received euthanasia at home or in a hospital less than 24 months ago, participated via semi-structured interviews. These interviews were conducted between May 2021 and June 2022. Due to the intensity of euthanasia processes, relatives wanted to be involved as early as possible, in order to receive time, space, and access to professionals' support whilst preparing themselves for the upcoming loss of a family member with cancer. Being at peace with the euthanasia request facilitated taking a supportive attitude, subsequently aiding in achieving a serene atmosphere. A serene atmosphere facilitated relatives' grief process because it helped them in creating and preserving good memories. Relatives appreciated support from healthcare providers, as long as overinvolvement on their part was not occurring. This study advocates for a relational approach in the context of euthanasia and provides useful complements to the existing euthanasia guidelines.

A self-management psychoeducational eHealth program to support and empower people with advanced cancer and their family caregivers: Development using the scrum methodology.

Background: eHealth programs could be a flexible and scalable resource to support and empower people with advanced cancer and their family caregivers. A face-to-face intervention that has demonstrated effectiveness is the "FOCUS" program, developed and tested in the USA. Recently the FOCUS program was translated and adapted to the European context as part of an international study in six European countries, resulting in the "FOCUS+" program. FOCUS+ served as the basis for development of the web-based iFOCUS program. Objective: We aim to (1) describe the development process of the iFOCUS program, (2) outline the challenges we encountered and how they were overcome, and (3) present findings regarding the acceptability and usability of iFOCUS. Methods: We used the four phased agile Scrum methodology to develop iFOCUS and applied set timeframes of rapid program development and evaluation (sprints). Five teams were involved in the development i.e. a core development group, a web development team, an international consortium, audio-visual experts, and potential end-users. Results: Development followed seven steps, integrated across the four phases of Scrum: (1) concept design, (2) development of mock-ups, (3) Feedback from the international consortium, (4) technical development of iFOCUS, (5) creating versions for the six participating countries, (6) preliminary testing of iFOCUS and (7) implementing the final version in a randomized controlled trial. User testing included 42 participants (twenty patient-family caregiver dyads and two bereaved family caregivers) who reviewed the iFOCUS program. Users found the iFOCUS program to be acceptable and usable. Feedback mainly focused on text size and fonts. Minor changes to the content, tailoring, and program flow were required. During development we encountered program specific and general challenges. Using the Scrum methodology facilitated iterative development to address these issues. For some challenges, such as tailoring, we had to make pragmatic choices due to time and resource limitations. Conclusions/discussion: The development of a tailored, self-managed psychoeducational eHealth program for people with advanced cancer and their family caregivers is an intense process and requires pragmatic choices. By keeping the emphasis on the target population during development, no specific remarks pertaining to advanced cancer were identified. Some challenges we encountered are common to eHealth development, others were related to program specific requirements. Using the Scrum methodology allows teams to efficiently collaborate during program development and increases the flexibility of the development process. Interpersonal contact between research staff and potential end-users is recommended during and after the development of eHealth programs.

Characteristics and outcomes of peer consultations for assisted dying request assessments: Cross-sectional survey study among attending physicians.

Background: In most jurisdictions where assisted dying practices are legal, attending physicians must consult another practitioner to assess the patient's eligibility. Consequently, in some jurisdictions, they can rely on the expertise of trained assisted dying consultants (trained consultants). However, these peer consultations remain under-researched. We examined the characteristics and outcomes of peer consultations to assess an assisted dying request with trained consultants, and explored how these characteristics influence the performance of assisted dying. Methods: We conducted a cross-sectional survey in 2019-2020 in Belgium among attending physicians who had consulted a trained consultant for an assisted dying request assessment (N = 904). Results: The valid response rate was 56% (502/903). The vast majority of attending physicians (92%) who had consulted a trained consultant were general practitioners. In more than half of the consultations (57%), the patient was diagnosed with cancer. In 66%, the patient was aged 70 or older. Reported as the patients' most important reasons to request assisted dying: suffering without prospect of improving in 49% of the consultations, loss of dignity in 11%, pain in 9%, and tiredness of life in 9%. In the vast majority of consultations (85%), the attending physician consulted the trained consultant because of the expertise, and in nearly half of the consultations (46%) because of the independence. In more than nine out of ten consultations (91%), the consultant gave a positive advice: i.e., substantive requirements for assisted dying were met. Eight out of ten consultations were followed by assisted dying. The likelihood of assisted dying was higher in consultations in which loss of dignity, loss of independence in daily living, or general weakness or tiredness were reasons for the request. Conclusion: Our findings indicate that the peer consultation practice with trained consultants is most often embedded in a primary care setting. Moreover, our study corroborates previous research in that assisted dying is performed relatively less frequently in patients with cancer and more often in patients with general deterioration. Our findings suggest that attending physicians hold peer consultations with trained consultants to endorse their own decision-making and to request additional support.

Systematic translation and adaptation of the FOCUS program, a USA-based supportive intervention for persons with cancer and their family caregivers, for use in six European countries.

PURPOSE: Having advanced cancer presents many challenges for patients and family caregivers. The FOCUS program is a psychoeducational nurse-led intervention, developed in the USA, to support dyads of patients with cancer and their family caregivers to live with the illness. The program includes a conversation manual and information resources for dyads. We aimed to develop a version of the program for dyads facing advanced cancer in six European countries. METHOD: The Participatory and Iterative Process Framework for Language Adaptation (PIPFLA) was used to guide the translation of the program to the local contexts of Belgium, Denmark, Ireland, Italy, the Netherlands, and the UK. In several rounds, potential program users (e.g., nurses, clinicians, patients, family caregivers) and researchers from all six countries reviewed program materials and advised on adaptations. RESULTS: The PIPFLA process resulted in one European version of the program in different languages (FOCUS +). The FOCUS + conversation manual is uniform across all countries. The main adaptations included additional attention to both family caregiver and patient needs; more emphasis on self-management, advance care planning, and shared responsibilities; discussing the dyad's outlook rather than optimism; addressing the role of nurses as educational rather than therapeutic; and more suggestions to refer dyads to health care professionals for specific care needs. The information resources for dyads were adapted to fit with local contexts. CONCLUSION: The PIPFLA methodology is an efficient and effective framework to thoroughly translate and culturally adapt a complex USA-based program for use in six European countries in collaboration with end users.

Assisted dying request assessments by trained consultants: changes in practice and quality - Repeated cross-sectional surveys (2008-2019).

OBJECTIVES: To study changes in the peer consultation practice of assessing assisted dying requests and its quality among trained 'Life End Information Forum' (LEIF) consultants in Belgium between 2008 and 2019. METHODS: Cross-sectional surveys conducted in 2008 (N=132) and 2019 (N=527) among all registered LEIF consultants. RESULTS: The response rate was 75% in 2008 and 57% in 2019. In 2019 compared with 2008, more LEIF consultants were significantly less than 40 years old (25%/10%, p=0.006) and at least 60 years old (34%/20%, p=0.006). In their activities regarding assessments of assisted dying requests over 12 months, we found a significant increase in the number of patients who did not meet the substantive requirements for assisted dying in 2019 compared with 2008 (1-4 patients: 41.1 %/58.8%, p=0.020). In their most recent assessments of an assisted dying request, LEIF consultants in 2019 made significantly more assessments of patients aged 80 years or older than in 2008 (31%/9%, p<0.001), and significantly fewer assessments for patients with cancer (53%/70%, p=0.034). Regarding adherence to quality criteria for consultation, LEIF consultants discussed unbearable suffering (87%/65%, p=0.003) and alternative treatments (palliative: 48 %/13%, p<0.001; curative: 28%/5%, p=0.002) significantly more often with the attending physician. CONCLUSIONS: Changes in peer consultation practice and its quality among LEIF consultants likely reflect changes in assisted dying practice in general, as well as changes in LEIF consultations on more complex cases for which LEIF consultants' expertise is required.

Physicians' Experiences and Perceptions of Environmental Factors Affecting Their Practices of Continuous Deep Sedation until Death: A Secondary Qualitative Analysis of an Interview Study.

As previous research has paid little attention to environmental factors affecting the practice of continuous deep sedation until death (CDS), we aimed to explore these using physicians' experiences and perceptions. We performed an interpretative thematic analysis of primary data from a qualitative interview study conducted from February to May 2019 in Belgium with 47 physicians. Structural factors were identified: the lack of professional and/or technical support in monitoring sedated patients; the use of guidelines in team contexts; the time constraints for treating individual patients and work pressure; the structural knowledge gap in medical education; the legal context for assisted dying; and the lack of a clear legal context for CDS. Cultural factors were identified: the moral reservations of care teams and/or institutions towards CDS; the presence of a palliative care culture within care teams and institutions; the culture of fear of making clinical errors regarding CDS among a group of physicians; the professional stigma of performing assisted dying among some of the physician population; the different understandings of CDS in medical and policy fields; and the societal taboo around suffering at the end of life and natural death. To conclude, improving CDS practice requires a whole-system approach considering environmental factors.

The added value of palliative day care centres: A full-population cross-sectional survey among clients and their family caregivers in Flanders, Belgium.

In addition to palliative care delivery at home or in hospital, palliative day care centres occupy an in-between position in palliative care. In palliative day care centres, multidisciplinary teams provide holistic care and support for people with (chronic) life-limiting conditions, or clients, in a homely surrounding, allowing them to remain living at home while attending a specialist palliative care service. This study aims to evaluate palliative day care centres from a user perspective. We conducted a full-population cross-sectional survey of clients (N = 86) and their family caregivers (N = 63) in all five palliative day care centres in Flanders, Belgium from January until December 2019. We used validated instruments supplemented with self-developed items to measure participants' reasons for use, support provided, unmet support needs and added value to other (palliative) care services across palliative care domains, i.e., physical, psychological, social and spiritual care. Response rate was 77% for clients and 81% for family caregivers. The most often indicated reasons for use were that the client needs social contacts (clients: 73%, caregivers: 65%), to enable the client to live at home as long as possible (resp. 58%, 55%) and to reduce the family caregiver's mental burden (resp. 42%, 65%). Three out of four family caregivers felt better able to combine daily activities with caring for the client (77%) and felt better able to perform their family care-giving tasks (77%) because the client attends the palliative day care centre. Thirty-six per cent of clients had received support for social needs exclusively in the palliative day care centre and not from any professionals outside palliative day care. Palliative day care centres seem to be of added value for those care domains to which often less attention is paid in other settings, particularly social and emotional support, both for clients and family caregivers.

Effectiveness of a nurse-delivered (FOCUS+) and a web-based (iFOCUS) psychoeducational intervention for people with advanced cancer and their family caregivers (DIAdIC): study protocol for an international randomized controlled trial.

BACKGROUND: Worldwide, millions of people with advanced cancer and their family caregivers are experiencing physical and psychological distress. Psychosocial support and education can reduce distress and prevent avoidable healthcare resource use. To date, we lack knowledge from large-scale studies on which interventions generate positive outcomes for people with cancer and their informal caregivers' quality of life. This protocol describes the DIAdIC study that will evaluate the effectiveness of two psychosocial and educational interventions aimed at improving patient-family caregiver dyads' emotional functioning and self-efficacy. METHODS: We will conduct an international multicenter three-arm randomized controlled trial in Belgium, Denmark, Ireland, Italy, The Netherlands, and the United Kingdom. In each country, 156 dyads (936 in total) of people with advanced cancer and their family caregiver will be randomized to one of the study arms: 1) a nurse-led face-to-face intervention (FOCUS+), 2) a web-based intervention (iFOCUS) or 3) a control group (care as usual). The two interventions offer tailored psychoeducational support for patient-family caregiver dyads. The nurse-led face-to-face intervention consists of two home visits and one online video session and the web-based intervention is completed independently by the patient-family caregiver dyad in four online sessions. The interventions are based on the FOCUS intervention, developed in the USA, that addresses five core components: family involvement, optimistic outlook, coping effectiveness, uncertainty reduction, and symptom management. The FOCUS intervention will be adapted to the European context. The primary outcomes are emotional functioning and self-efficacy of the patient and the family caregiver, respectively. The secondary outcomes are quality of life, benefits of illness, coping, dyadic communication, and ways of giving support of the patient and family caregiver. DISCUSSION: DIAdIC aims to develop cost-effective interventions that integrate principles of early palliative care into standard care. The cross-country setup in six European countries allows for comparison of effectiveness of the interventions in different healthcare systems across Europe. By focusing on empowerment of the person with cancer and their family caregiver, the results of this RCT can contribute to the search for cost-effective novel interventions that can relieve constraints on professional healthcare. TRIAL REGISTRATION: Registration on ClinicalTrials.gov on 12/11/2020, identifier NCT04626349 . DATE AND VERSION IDENTIFIER: 20211209_DIAdIC_Protocol_Article.

Control Measures for Continuous Deep Sedation Until Death: A Framing Analysis of the Views of Physicians.

Physicians have been subject to increasing external control to improve their medical practice, and scholars have theorized extensively about their opposition to such control. However, little empirical attention has been paid to the views and reasoning that lie behind this opposition. An in-depth understanding is necessary for enhancing the effectiveness and efficiency of external controls, and continuous deep sedation until death (CDS) is an interesting case in this regard. This study aims to explore how physicians frame control measures for CDS. We conducted 47 semi-structured interviews with Belgian physicians in 2019. A qualitative framing analysis was performed to analyze their views and reasoning. This study reveals that physicians approach CDS practice and control measures with different emphases. Controlling by mechanisms of professional self-regulation and state governance are put forward as appropriate means to improve CDS practice. Policymakers should take into consideration physicians' frames to develop sound control measures.

Commonalities and differences in legal euthanasia and physician-assisted suicide in three countries: a population-level comparison.

OBJECTIVES: To describe and compare euthanasia and physician-assisted suicide (EAS) practice in Flanders, Belgium (BE), the Netherlands (NL) and Switzerland (CH). METHODS: Mortality follow-back surveys among attending physicians of a random sample of death certificates. RESULTS: We studied 349 EAS deaths in BE (4.6% of all deaths), 851 in NL (4.6% of all deaths) and 65 in CH (1.4% of all deaths). People who died by EAS were mostly aged 65 or older (BE: 81%, NL: 77% and CH: 71%) and were mostly diagnosed with cancer (BE: 57% and NL: 66%). Home was the most common place of death in NL (79%), while in BE and CH, more variation was found regarding to place of death. The decision to perform EAS was more frequently discussed with a colleague physician in BE (93%) and NL (90%) than in CH (60%). CONCLUSIONS: EAS practice characteristics vary considerably in the studied countries with legal EAS. In addition to the legal context, cultural factors as well as the manner in which legislation is implemented play a role in how EAS legislation translates into practice.

How accurately is euthanasia reported on death certificates in a country with legal euthanasia: a population-based study.

BACKGROUND: Death certificates are the main source of information on the incidence of the direct and underlying causes of death, but may be unsuitable for monitoring the practice of medical assistance in dying, e.g. euthanasia, due to possible underreporting. This study examines the accuracy of certification of euthanasia. METHODS: Mortality follow-back survey using a random sample of death certificates (N = 6871). For all cases identified as euthanasia we checked whether euthanasia was reported as a cause of death on the death certificate. We used multivariable logistic regression analysis to evaluate whether reporting varied according to patient and decision-making characteristics. RESULTS: Through the death certificates, 0.7% of all deaths were identified as euthanasia, compared with 4.6% through the mortality follow-back survey. Only 16.2% of the cases identified from the survey were reported on the death certificate. Euthanasia was more likely to be reported on the death certificate where death was from cancer (14% covered), neurological diseases (22%) and stroke (28%) than from cardiovascular disease (7%). Even when the recommended drugs were used or the physician self-labelled the end-of-life decision as euthanasia, euthanasia was only reported on the death certificate in 24% of cases. CONCLUSIONS: Death certificates substantially underestimate the frequency of euthanasia as a cause of death in Belgium. Mortality follow-back studies are essential complementary instruments to examine and monitor the practice of euthanasia more accurately. Death certificate forms may need to be modified and clear guidelines provided to physicians about recording euthanasia to ensure more accurate certification.

Involvement of palliative care in euthanasia practice in a context of legalized euthanasia: A population-based mortality follow-back study.

BACKGROUND: In the international debate about assisted dying, it is commonly stated that euthanasia is incompatible with palliative care. In Belgium, where euthanasia was legalized in 2002, the Federation for Palliative Care Flanders has endorsed the viewpoint that euthanasia can be embedded in palliative care. AIM: To examine the involvement of palliative care services in euthanasia practice in a context of legalized euthanasia. DESIGN: Population-based mortality follow-back survey. SETTING/PARTICIPANTS: Physicians attending a random sample of 6871 deaths in Flanders, Belgium, in 2013. RESULTS: People requesting euthanasia were more likely to have received palliative care (70.9%) than other people dying non-suddenly (45.2%) (odds ratio = 2.1 (95% confidence interval, 1.5-2.9)). The most frequently indicated reasons for non-referral to a palliative care service in those requesting euthanasia were that existing care already sufficiently addressed the patient's palliative and supportive care needs (56.5%) and that the patient did not want to be referred (26.1%). The likelihood of a request being granted did not differ between cases with or without palliative care involvement. Palliative care professionals were involved in the decision-making process and/or performance of euthanasia in 59.8% of all euthanasia deaths; this involvement was higher in hospitals (76.0%) than at home (47.0%) or in nursing homes (49.5%). CONCLUSION: In Flanders, in a context of legalized euthanasia, euthanasia and palliative care do not seem to be contradictory practices. A substantial proportion of people who make a euthanasia request are seen by palliative care services, and for a majority of these, the request is granted.

Euthanasia in Belgium: trends in reported cases between 2003 and 2013.

BACKGROUND: In 2002, the Belgian Act on Euthanasia came into effect, regulating the intentional ending of life by a physician at the patient's explicit request. We undertook this study to describe trends in officially reported euthanasia cases in Belgium with regard to patients' sociodemographic and clinical profiles, as well as decision-making and performance characteristics. METHODS: We used the database of all euthanasia cases reported to the Federal Control and Evaluation Committee on Euthanasia in Belgium between Jan. 1, 2003, and Dec. 31, 2013 (n = 8752). The committee collected these data with a standardized registration form. We analyzed trends in patient, decision-making and performance characteristics using a χ2 technique. We also compared and analyzed trends for cases reported in Dutch and in French. RESULTS: The number of reported euthanasia cases increased every year, from 235 (0.2% of all deaths) in 2003 to 1807 (1.7% of all deaths) in 2013. The rate of euthanasia increased significantly among those aged 80 years or older, those who died in a nursing home, those with a disease other than cancer and those not expected to die in the near future (p < 0.001 for all increases). Reported cases in 2013 most often concerned those with cancer (68.7%) and those under 80 years (65.0%). Palliative care teams were increasingly often consulted about euthanasia requests, beyond the legal requirements to do so (p < 0.001). Among cases reported in Dutch, the proportion in which the person was expected to die in the foreseeable future decreased from 93.9% in 2003 to 84.1% in 2013, and palliative care teams were increasingly consulted about the euthanasia request (from 34.0% in 2003 to 42.6% in 2013). These trends were not significant for cases reported in French. INTERPRETATION: Since legalization of euthanasia in Belgium, the number of reported cases has increased each year. Most of those receiving euthanasia were younger than 80 years and were dying of cancer. Given the increases observed among non-terminally ill and older patients, this analysis shows the importance of detailed monitoring of developments in euthanasia practice.

Increased Risk of Burnout for Physicians and Nurses Involved in a Patient Safety Incident.

BACKGROUND: Human errors occur everywhere, including in health care. Not only the patient, but also the involved health professional is affected (ie, the "second victim"). OBJECTIVES: To investigate the prevalence of health care professionals being personally involved in a patient safety incident (PSI), as well as the relationship of involvement and degree of harm with problematic medication use, excessive alcohol consumption, risk of burnout, work-home interference (WHI), and turnover intentions. RESEARCH DESIGN: Multilevel path analyses were conducted to analyze cross-sectional survey data from 37 Belgian hospitals. SUBJECTS: A total of 5788 nurses (79.4%) and physicians (20.6%) in 26 acute and 11 psychiatric hospitals were included. MEASURES: "Involvement in a patient safety incident during the prior 6 months," "degree of harm," and 5 outcomes were measured using self-report scales. RESULTS: Nine percent of the total sample had been involved in a PSI during the prior 6 months. Involvement in a PSI was related to a greater risk of burnout (ß=0.40, OR=2.07), to problematic medication use (ß=0.33, OR=1.84), to greater WHI (ß=0.24), and to more turnover intentions (ß=0.22). Harm to the patient was a predictor of problematic medication use (ß=0.14, OR=1.56), risk of burnout (ß=0.16, OR=1.62), and WHI (ß=0.19). CONCLUSIONS: Second victims experience significant negative outcomes in the aftermath of a PSI. An appropriate organizational response should be provided to mitigate the negative effects.