Legalisation of euthanasia and assisted suicide: advanced cancer patient opinions - cross-sectional multicentre study.

OBJECTIVES: The French government voted a new law in February 2016 called the Claeys-Leonetti Law, which established the right to deep and continuous sedation, confirmed the ban on euthanasia and ruled out physician-assisted suicide. The aim of this work was to gather the opinion of patients on continuous sedation and the legalisation of medical assistance in dying and to explore determinants associated with favourable and unfavourable opinions. METHODS: This was a French national prospective multicentre study between 2016 and 2020. RESULTS: 331 patients with incurable cancer suffering from locally advanced or metastatic cancer in 14 palliative care units were interviewed. 48.6% of participants expressed a favourable opinion about physician-assisted suicide and 27.2% an unfavourable opinion about its legalisation. Regarding euthanasia, 52% of patients were in favour of its legalisation. In univariate analysis, the only factor determining opinion was belief in God. CONCLUSIONS: While most healthy French people are in favour of legalising euthanasia, only half of palliative care patients expressed this opinion. Medical palliative care specialists were largely opposed to euthanasia. The only determining factor identified was a cultural factor that was independent of the other studied variables. This common factor was found in other studies conducted on cohorts from other countries. This study contributes to the knowledge and thinking about the impact of patients' personal beliefs and values regarding their opinions about euthanasia and assisted suicide. TRIAL REGISTRATION NUMBER: NCT03664856.

Withholding or withdrawing life-sustaining treatments in the COVID-19 pandemic: adherence to legal standards.

OBJECTIVES: In France, when the patient is unable to express his wishes, the decision to withhold or withdraw life-sustaining treatment (WWLST) is made following a collegial procedure described by a law. The aim of our study was to assess how closely this WWLST decision-making procedure in end of life patients was maintained during the COVID-19 pandemic. METHODS: This retrospective observational multicentre study compared the rate of non-compliance with WWLST decision-making procedures during the pandemic period from March to June 2020 with control period in 2019, in Clermont-Ferrand and Lyon Hospitals. Secondary objectives were to determine the factors associated with non-compliance. RESULTS: In 430 deceased patients included (176 in 2019 and 254 in 2020), the rate of non-compliance was 61.4% in 2019 and 59.1% in 2020 (p=0.63). In multivariable analysis, non-compliance was associated with immunosuppression status (OR 1.69, 95% CI (1.12 to 2.54), p=0.01) but was lower in intensive care unit (OR 0.54, 95% CI (0.36 to 0.82), p=0.003) and when the patient had visits from relatives (OR 0.41, 95% CI (0.22 to 0.75), p=0.004). CONCLUSION: In France, more than half of WWLST decisions do not comply with the law. The COVID-19 pandemic did not increase this non-compliance rate. Further studies are needed for a better understanding of the mechanisms underlying non-compliance with WWLST decision-making procedure. TRIAL REGISTRATION NUMBER: NCT04452487.

Validation of a French version of the Breakthrough Pain Assessment Tool in cancer patients: Factorial structure, reliability and responsiveness.

OBJECTIVE: Breakthrough cancer pain should be properly assessed for better-personalized treatment plan. The Breakthrough Pain Assessment Tool is a 14-item tool validated in English developed for this purpose; no French version is currently available and validated. This study aimed to translate it in French and assess the psychometric properties of a French version of the Breakthrough Pain Assessment Tool (BAT-FR). METHODS: First, translation and cross-cultural adaptation of the 14 items (9 ordinal and 5 nominal) of the original BAT tool in French language was made. Second, assessments of validity (convergent, divergent and discriminant validity), factorial structure (exploratory factor analysis) and test-retest reliability of the 9 ordinal items were done with data of 130 adult cancer patients suffering from breakthrough pain in a hospital-academic palliative care center. Test-retest reliability and responsiveness of total and dimension scores derived from these 9 items were also assessed. Acceptability of the 14 items was also assessed on the 130 patients. RESULTS: The 14 items had good content and face validity. Convergent and divergent validity, discriminant validity and test-retest reliability of the ordinal items were acceptable. Test-retest reliability and responsiveness of total and dimensions derived from ordinal items were also acceptable. The factorial structure of the ordinal items had two dimensions similar to the original version: "1-pain severity and impact" and "2-pain duration and medication". Items 2 and 8 had a low contribution to the dimension 1 they were assigned and item 14 clearly changed of dimension compared with the original tool. The acceptability of the 14 items was good. CONCLUSION: The BAT-FR has shown acceptable validity, reliability and responsiveness supporting its use for assessing breakthrough cancer pain in French-speaking populations. Its structure needs nevertheless further confirmation.

Legalised active assistance in dying: palliative care stakeholders' national e-consultation.

OBJECTIVES: There is a growing debate surrounding the legalisation of medical assistance in dying (MAID). MAID is currently prohibited by the French law; however, the debate has recently been reinvigorated in France. This study aims to collect opinions of palliative care stakeholders (PCS) regarding the legalisation of MAID and to identify the factors associated with their opinions. METHODS: We performed a transversal survey between 26 June 2021 and 25 July 2021, on PCS who were on the French national scientific society for palliative care. Participants were invited by email. RESULTS: 1439 PCS took part and expressed an opinion about the legalisation of MAID. 1053 (69.7%) were against the legalisation of MAID. When forced to choose which option should be privileged if the law had to change, 3.7% favoured euthanasia, 10.1% favoured assisted suicide with provision of lethal drug by a professional, 27.5% favoured assisted suicide with prescription of a lethal drug and 29.5% favoured assisted suicide with provision of a lethal drug by an association. The opinion regarding legalisation of MAID was statistically different depending on the participant profession (p<0.001) and when comparing clinical and non-clinical positions (p<0.001). A quarter of participants (26.7%) believe that legalising MAID might lead them to change their current position. CONCLUSIONS: Overall, French palliative care professionals are against a modification of the current legal framework for legalising MAID but some might change their current position if a law was voted. This might destabilise the PCS demography that is already worrying.

Methadone and neuropathic cancer pain subcomponents: a prospective cohort pilot study.

Forty per cent of cancer pain associate neuropathic and nociceptive pain simultaneously, and refractory pain affects 15% of cancer pain. Methadone is an effective opioid in treating nociceptive pain and could have an effect on neuropathic pain. Uncertainty remains on its effects on the different subcomponents of neuropathic pain. OBJECTIVES: To identify which subcomponents of neuropathic cancer pain are addressed using methadone. METHODS: An observational prospective cohort study of palliative care inpatients after rotation for refractory neuropathic cancer pain. Pain intensity was assessed weekly for 28 days, using a Visual Analogue Scale (VAS) and the Neuropathic Pain Symptom Inventory (NPSI). RESULTS: Forty-eight patients were included and 17 completed the 28 days follow-up. VAS pain rating decreased by at least 20 mm in 47% of patients and the pain intensity was significantly lower at day 28 with 53% of patients with a VAS inferior to 4 (p<0.001). The pressure/squeezing component (NPSI score) decreased by more than 2 points in 50% of patients.A linear regression showed allodynia and pressure/squeezing were responsible for the largest part of the overall alleviation of pain (p=0.01). CONCLUSIONS: Methadone could significantly improve neuropathic pain through a targeted effect of allodynia and its pressure/squeezing component.

Deep continuous patient-requested sedation until death: a multicentric study.

OBJECTIVES: In 2016, a new law was adopted in France granting patients the right, under specific conditions, to continuous deep sedation until death (CDSUD). The goal of this study was to measure the frequency of requests for CDSUD from patients in palliative care. METHODS: The data collected from the medical records of patients in palliative care units (PCU) or followed by palliative care support teams (PCST) in the Rhône-Alpes area, who died after CDSUD, focused on the patient's characteristics, the drugs used (and compliance with regulatory processes). RESULTS: All 12 PCU and 12 of the 24 PCST were included. Among the 8500 patients followed, 42 (0.5%) requested CDSUD until death. The patients were: 65.7 (SD=13.7) years old, highly educated (69%), had cancer (81%), refractory symptoms (98%) and mostly psychoexistential distress (69%). The request was rejected for 2 (5%) patients and delayed for 31 (74%) patients. After a delay of a mean 8 days, 13 (31%) patients were granted CDSUD. The drug used was midazolam at 115 mg/24 hours (15-480), during a mean of 3 days. PCUs used lower dosages than PCSTs (83 vs 147), with significantly lower initial doses (39 mg vs 132 mg, p=0.01). A life-threatening condition was recorded in 13 cases (31%) and a collegial decision was taken in 25 cases (60%). CONCLUSION: This study highlights the low rate of request and the even lower rate of CDSUD in specialised palliative care. However, the sedation for psychoexistential distress and the lack of procedure records raise ethical questions.

Palliative care from the perspective of cancer physicians: a qualitative semistructured interviews study.

OBJECTIVE: Integrated palliative care for populations with cancer is now highly recommended. However, numerous physicians working in cancer care are still reluctant to refer patients to specialist palliative care teams. This study explores their perceptions of palliative care and factors influencing reasons to refer to specialist palliative care. METHODS: We used a qualitative methodology based on semistructured interviews with physicians working in cancer care, in two tertiary hospitals and one comprehensive cancer centre with access to a specialist palliative care team. Forty-six physicians were invited and 18 interviews were performed until data saturation. Participants were mainly men, licensed in cancer care, 37.9 years old on average and had 13 years of professional experience. The length of interviews was on average 34 min (SD=3). Analysis was performed accordingly with the thematic analysis. RESULTS: The data analysis found four themes: symptom management as a trigger, psychosocial support, mediation provided by interventions, and the association with terminal care or death. Palliative care integrated interventions were mainly perceived as holistic approaches that offered symptom management expertise and time. They were valued for helping in consolidating decision-making from a different or external perspective, or an 'outside look'. Several barriers were identified, often due to the confusion between terminal care and palliative care. This was further highlighted by the avoidance of the words 'palliative care', which were associated with death. CONCLUSIONS: National policies for promoting palliative care seemed to have failed in switching oncologists' perception of palliative care, which they still consider as terminal care.

What is the effectiveness and safety of mirtazapine versus escitalopram in alleviating cancer-associated poly-symptomatology (the MIR-P study)? A mixed-method randomized controlled trial protocol.

BACKGROUND: Advanced cancer patients often experience multiple symptoms at a same time. This might lead to polypharmacy and increase adverse events representing major threats to the quality of health care, especially in palliative care situations. Mirtazapine, an antidepressant agent, has been suggested as a potential relevant drug to alleviate multiple cancer-related symptoms at a same time. Therefore, the present study aims to assess the effectiveness of mirtazapine in alleviating multiple symptoms at a same time in advanced cancer patients suffering from a major depressive episode compared to a group receiving escitalopram, another antidepressant agent. METHODS: Multicentre, prospective, randomized, controlled trial in 12 palliative care services in France. The study will be based on a mixed-method methodology using parallel groups, of oral mirtazapine compared with oral escitalopram, with a 56 day follow-up. The primary outcome will be an improvement of the Global health Status (issued from the EORTC-QLQ-C30) on day 56. 418 participants will be clinically followed-up on day 7 and 56 and will have a telephonic assessment on days 14 and 28. A sub-sample of participants will be invited to take part in semi-structured qualitative interviews at baseline and day 56. For the qualitative part, purposeful sampling will be used. DISCUSSION: This study will provide evidence for the pharmaceutics management of poly-symptomatology in advanced cancer patients. This could lead to important changes in the management of those patients by using a single molecule to alleviate multiple symptoms at a same time, potentially improving medication adherence, symptoms' control, and reducing the risk of medications adverse events. TRIAL REGISTRATION: Trial registration: NCT04763135 . Registered 18 March 2021.

Haematologists and palliative care: a multicentric qualitative study.

OBJECTIVES: Early palliative care leads to meaningful improvements in physical and psychosocial symptoms, as well as quality of life, in patients with advanced cancer. Patients with haematological malignancies, despite a high level of distress, continue to have less access to palliative care services. The aim of this study was to identify haematologists' perceptions of palliative care, as well as barriers to patient referral. METHODS: We used a qualitative grounded theory methodology. Twenty-four medical haematologists involved in clinical practice from two French centres in Lyon-the Lyon Sud University Hospital and the Léon Bérard Cancer Center-were included. The interview guide questions aimed to establish the clinical situations which triggered referral to palliative care and how participants perceived palliative care. RESULTS: Data saturation was reached after 14 interviews. The data analysis highlighted four themes. The aim of palliative care was clearly identified as alleviating severe suffering. Palliative care was identified as a separate specialty, and respondents expressed the need for collaboration. Early intervention was perceived as beneficial to avoid certain situations such as hospitalisation or emergency department visits at the end of life. The main barrier to palliative care referral remained the negative connotations associated with the term 'palliative', which was overwhelmingly associated with the end of life. SIGNIFICANCE OF RESULTS: Our results suggest that the principal barrier to palliative care referral is the term 'palliative care'; haematologists would prefer 'supportive care' instead.

Art therapy and social function in palliative care patients: a mixed-method pilot study.

OBJECTIVES: To evaluate the influence of art therapy in reducing palliative symptoms, on social availability and on perceptions of aesthetics in hospitalised palliative care patients. The secondary objective was to evaluate its influence on bereaved families. METHODS: A mixed-method quasi-experimental before and after study comprising a follow-up postal survey of bereaved families. All patients who were keen to have art therapy sessions were eligible. We used patient-reported outcome scales 5 min before and after the session. The Edmonton Symptom Assessment Scale has been used for pain, anxiety, well-being, fatigue and depression. Ten-point visual analogue scales were used for social availability, lack of desire and wishes, and perceptions of aesthetics based on the Beautiful-Well-Good model. A postal survey was sent to bereaved families. Correlations and data mining analyses were performed. RESULTS: In all, 24 patients were recruited for a total of 53 art therapy sessions analysed. Seven families completed the survey. Art therapy significantly reduced the assessed symptoms and overall symptom distress by 54.4% (p <0.001, d = 1.08). It also decreased the feeling of social unavailability (-59%, d = 0.67) and the lack of desire and wishes (-60%, d=0.86). The analysis of the family questionnaires indicates the positive effects regarding support, artwork and feelings during illness and grief. CONCLUSION: Our results suggest an overall improvement in the symptoms experienced and social functioning of palliative patients. Based on our findings, we propose a model for the potential mechanism of action of art therapy.

Knowledge and use of prognostic scales by oncologists and palliative care physicians in adult patients with advanced cancer: A national survey (ONCOPRONO study).

BACKGROUND: Prognostic scales exist to estimate patient survival in advanced cancer. However, there are no studies evaluating their use and practice. The objective of this study was to evaluate in a nationwide study the proportion of oncologists and palliative care physicians who had knowledge of these scales. METHODS: A descriptive, national, cross-sectional study was conducted via an online questionnaire to oncologists and palliative care physicians across France. RESULTS: Palliative care physicians had better knowledge of the scales than oncologists (42.3% (n = 74) vs. 27.8% (n = 33), p = 0.015). The Palliative Performance Status (PPS) and Pronopall Scale were the best-known (51.4% (n = 55) and 65.4% (n = 70), respectively) and the most widely used (35% (n = 28) and 60% (n = 48), respectively). Improved training in the use of these scales was requested by 85.4% (n = 251) of participants, while 72.8% (n = 214) reported that they did not use them at all. Limited training and lack of consensus on which scale to use were cited as the main obstacles to use. CONCLUSION: This is the first national study on the use of prognostic scales in advanced cancer. Our findings highlight a need to improve training in these scales and to reach a consensus on scale selection.

Nursing home hospital transfers in the terminally ill: night shift nurses matter!

BACKGROUND: French demographic projection expects an increasing number of older, dependent patients in the next few years. A large proportion of this population lives in nursing homes and their transfer to hospitals at the end of life is an ongoing issue. OBJECTIVE: This study explored the factors influencing the transfer of patients living in nursing homes to hospital at the end of life. DESIGN: We used a mixed-methods questionnaire developed by an expert group and assessing different characteristics of the nursing homes. PARTICIPANTS: All the nursing homes in the Rhône-Alpes area (n=680) were surveyed. RESULTS: We obtained 466 (68%) answers. We found that a palliative care programme was present in 336 (72%) nursing homes. The majority had a coordinating physician 428 (82%) and a mean number of 6 nurses for 83 beds, with 83 (18%) having a night shift nurse. There was a mean number of 19 deaths per nursing home during the recorded year. The main cause of death was dementia (41%), cancer-related death (13%). Death occurred mostly in the nursing home (14 74%). Night shift nurse attendance was significantly associated with the place of death: 27 deaths occurred in nursing homes with a night shift nurse versus 12 in those without one (p<0001). CONCLUSIONS: The location of the death of frail elderly patients is a major health issue that needs to be addressed. Our results suggests that the presence of a night shift nurse decreases the number of emergency transfers and deaths in the hospital.

Quality of end-of-life care in the emergency department.

OBJECTIVE: To assess appropriateness of end-of-life treatments provided to actively dying patients attending the emergency department of a primary care hospital. METHODS: Retrospective cohort study of patients who died in the emergency department of a French primary care hospital between January 2014 and January 2017. The deceased were identified through the admissions register. Then, electronic medical records were screened for bio-demographic data, data relative to decisions to withhold or withdraw treatments, to diagnosis and to the care provided. Patients were clustered into two categories, actively dying or non-actively dying, using clinical opinion based on their medical records. Appropriateness of care was appraised following French guidelines. RESULTS: One hundred and forty-six deaths were recorded. Actively dying patients mostly suffered from vascular conditions (29.4%). When compared to the overall sample, they were more likely to have decisions to withhold or withdraw treatments (OR = 5.3 [1.56; 20.7], p-value = 0.003), to have strong opioids (OR = 5.32 [2.1; 13.9], p-value <0.0001), hypnotics (OR = 2.6 [0.95; 8.39], p-value = 0.05), and scopolamine (OR = 2.5 [1.1; 6.13], p-value = 0.03). Moreover, they were less likely to have unbeneficial treatments in terminal conditions, such as resuscitation care (OR = 0.06 [0.001; 0.52], p = 0.002) and antibiotics (OR = 0.42 [0.19; 0.92], p-value = 0.022). There were no differences in rate of hydration, venous access and use of tracheal aspirations. CONCLUSIONS: Overall, actively dying patients were appropriately supported. However, several issues regarding hydration management, drug administration routes, and broncho-pulmonary secretions management remain to be addressed.

Transcultural Validation of the French Version of the Modified Edmonton Symptom Assessment Scale: The ESAS12-F.

Background: Cancer-related physical symptoms can decrease patients' overall quality of life and are often underdiagnosed. The Edmonton Symptom Assessment Scale (ESAS) is widely used in palliative care for cancer patients to easily assess cancer patients' symptoms. It has been often modified, adding symptoms and explanations, and translated into many languages. The European Association of Palliative Care research team developed a database, which included the modified 12-item ESAS-r as the symptom assessment tool. Objectives: The purpose of this study was to achieve the translation and cross-cultural validation in French of the 12-item ESAS-r, the ESAS12-F. Design: A French version of the ESAS-r was developed using a standardized forward and backward translation method. Patients completed the ESAS12-F and provided feedback on the translation. Setting/Subjects: Forty-five patients with advanced cancer, followed by the palliative care team from the Lyon Sud University Hospital in France, were recruited. Results: Eighty-nine percent of patients considered the ESAS easy to understand. They highlighted some concerns more about the tool itself than the translation: the time line "now," the difficulty to quantify a symptom in a numerical evaluation. Some items (sleep and appetite) needed to be reread and for some others (digestive and psychological symptoms, and well-being) to be reordered in the questionnaire. Conclusion: The ESAS12-F is well accepted and easy to use for the cancer patients. The next step is to carry out a psychometric validation of the definitive version of the ESAS12-F.

Physician's perception leading to the transfer of a dying nursing home resident to an emergency department: A French qualitative study.

AIM: The aim of the present study was to find out physicians' perceptions about the transfer of dying nursing home residents to emergency departments. METHOD: This qualitative study used semi-structured interviews, and data were analyzed using qualitative methods. Participants were medical directors of nursing homes who were informed by e-mail and included when they agreed to take part in our study. RESULTS: We interviewed 12 medical directors until data saturation. The following themes emerged: (i) related to the resident - difficulties in identifying the end of life, refractory symptoms and lack of knowledge of the resident's wishes; (ii) related to the family - denial of the end of life/fear of death, lack of confidence in the nursing home and conflict among family members; (iii) related to the nursing staff - fear of death, lack of communication, lack of training, lack of staff (especially of nurses during the nightshift) and use of temporary employees; and (iv) related to the physicians - lack of anticipation of the end of life situation, difficulty in accessing some drugs, inadequate working hours in the nursing home, conflicting medical opinions of the GP and medical director, and lack of training on palliative care issues. CONCLUSIONS: These results suggest many ways of reducing the transfer of dying residents to emergency departments through palliative care training, and communication about advance care planning. Geriatr Gerontol Int 2019; 19: 249-253.

[Improving the quality of cancer pain management in palliative care unit: Targeted clinical audit]. / Qualité de la prise en charge de la douleur du cancer en unité de soins palliatifs : audit clinique ciblé.

Goal This study aims to assess the quality of the cancer pain management in Palliative care unit. METHOD: The method used was the targeted clinical audit. The audit grid was built according to the recommendations of the pilot Committee, and tested until the final version with 19 items was obtained. In this retrospective study, 60 consecutive patients were studied on 2 periods of time. The first one (T1) shows the gap between the patient's chart and the expected standard, and proposes corrective measures. The second one (T2) re-assesses, using the same items list, the efficacy of these measures. RESULTS: After the corrective measures, the patients' medical record documentation was significantly improved at T2 for: neuropathic pain assessment improved, from 3% (T1) to 67% (T2) (P<0.001), so did pain assessment during the titration, from 6.7% (T1) to 90% (T2) (P<0.001). The overdoses symptoms assessment improved from 17% at T1 to 93% at T2, (P=0.002) and breakthrough pain evaluation improved from 3% at T1 to 73% at T2, (P<0.001). The pain reassessment after the rescue doses improved from 10% at T1 to 73% at T2 (P<0.001). The other points improved but not significantly. CONCLUSION: The quality of the pain cancer management was improved during the audit, but some points (patient education and in patient medical record documentation) can be improved. We need to continue to implement the improvement measures in our unit.