Sophie Pennec

Joëlle Gaymu

Efi Markou

Amandine Stephan

Géraldine Vivier

Elisabeth Morand

Marie Bailly

Danielle

Martyna Wojcik

End-of-Life Surveys in the French Overseas Departments DATA COLLECTION PROTOCOL

Keywords: End of life, palliative care, place of death, euthanasia, medical decisions, sedation, limiting and stopping treatment, surveys, French Overseas fin de vie, enquête, décisions médicales, soins palliatifs, lieux de décès, limitation et arrêt de traitement, sédation, euthanasie, prise en soins, Départements d'Outre-Mer

This project is the first to provide scientists, the health authorities and the public with objective data on end-oflife conditions in the French overseas departments. It shows the impact of the overseas departments' sociodemographic and cultural particularities

Background

A number of changes regarding the end of life have occurred in recent decades, notably legislative changes. This stage of life, which usually comes at an advanced age, is now largely medicalised and institutionalised. This research project in the French overseas departments follows on from a study conducted in metropolitan France in 2010 on the circumstances in which people spend their last months of life. From the metropolitan France study, the researchers were able to assess the implementation of the 2005 Leonetti Law, improve understanding of residential transitions prior to death, the role of carers, and people's wishes as to where they want to die. Endof-life circumstances in the overseas departments are not known. And yet the population is ageing fast, people commonly die at home, the organisation of family life is changing fast, the share of poverty is higher and there are fewer residential aged care facilities. These factors all shape end-of-life conditions in different ways, so it will be useful to acquire more data about the situation in these departments.

Aims

The purpose of this research is to give an overview of end-of-life conditions in the French overseas departments (Martinique, Guadeloupe, French Guiana and La Réunion). The aim is to see in what ways they differ from those pertaining in metropolitan France and document what public policy changes would be needed to meet these departments' particular needs.

The first research strand explores possible inequalities in medical care at this stage of life between the four overseas departments and metropolitan France: do the same individual or general situations receive the same medical care everywhere?

A second strand focuses on implementation of the two laws that grant rights to end-of-life patients in France: the law of [START_REF] Riou | When Physicians Report Having Used Medical Drugs to Deliberately End a Patient's Life: Findings of the "End-of-Life in France[END_REF] April 2005 and that of 16 February 2016. It compares medical practice with the provisions of the legislation and describes how much patients and their families know about these laws and their application.

The third strand considers the more sociological aspects regarding family and social context at this stage of life, how patient care and support is organised and who is involved. Patients' families were asked about their perceptions and expectations, with a view to improving quality of life for caregivers and hence also for people in their last stage of life.

Method

The data had to be gathered, as there were none in existence. We conducted a quantitative survey among physicians, using the broad lines of the protocol designed for metropolitan France but adapting it to local particularities to achieve a proper measure of different indicators for all topics under study and in particular medical decisions at end-of-life. We also conducted a qualitative survey in La Réunion to shed light on the context for ageing in the overseas departments and the proportion of home deaths. This comprised a series of semidirective interviews with decedents' relatives and two focus groups, providing new information about (a) people's knowledge of the law and (b) the strengths and weaknesses of end-of-life care at home.

Funding:

This research was supported by the Caisse nationale de solidarité pour l'autonomie (CNSA), as part of the call for projects launched by IReSP (project IReSP-17-Hand8-16); by the Fondation de France as part of the call for project "Soigner, soulager, accompagner (2017)" and by the Institut national d'études démographiques (INED).

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I. GENERAL SCIENTIFIC BACKGROUND TO THE RESEARCH PROJECT

The purpose of this research is to give an overview of end-of-life conditions in Martinique, Guadeloupe, French Guiana and La Réunion, France's historical overseas departments 1 . It sets out to show how sociodemographic, cultural and public health differences between departments affect patterns of end-of-life care and may create inequalities in treatment of the terminally ill. It suggests how public policy needs to change to meet the particular needs of these departments.

This project follows on from research conducted in metropolitan France in 2010 and in other countries, mainly in Europe. In the mid-1990s surveys were conducted in the Netherlands and Belgium to find out more about physicians' decision-making in end-of-life situations. That work enabled the authorities, healthcare professionals and citizens of those countries to conduct a society-wide debate based on exact, reliable information [START_REF] Van Der | End-of-life decision-making in six european countries : descriptive study[END_REF][START_REF] Houttekier | Place of Death of Older Persons with Dementia. A Study in Five European Countries[END_REF][START_REF] Klinkenberg | The last 3 months of life: care, transitions and the place of death of older people[END_REF][START_REF] Abarshi | Transitions between care settings at the end of life in The Netherlands: results from a nationwide study[END_REF][START_REF] Higginson | Time to get it right: are preferences for place of death more stable than we think?[END_REF][START_REF] Klinkenberg | The last 3 months of life: care, transitions and the place of death of older people[END_REF][START_REF] Chambaere | A post-mortem survey on end-of-life decisions using a representative sample of death certificates in Flanders, Belgium : research protocol[END_REF][START_REF] Chambaere | Forgoing artificial nutrition or hydration at the end of life: a large cross-sectional survey in Belgium[END_REF][START_REF] Chambaere | Characteristics of Belgian "life-ending acts without explicit patient request": a large-scale death certificate survey revisited[END_REF][START_REF] Cohen | Cultural differences affecting euthanasia practice in Belgium: one law but different attitudes and practices in Flanders and Wallonia[END_REF][START_REF] Evans | End-of-Life Decisions: A Cross-National Study of Treatment Preference Discussions and Surrogate Decision-Maker Appointments[END_REF][START_REF] Fournier | Quelle utilité des directives anticipées pour les médecins ?[END_REF][START_REF] Hunt | VOICES Redesign and testing to inform -a National End of Life Survey[END_REF][START_REF] Papavasiliou | Physician-reported practices on continuous deep sedation until death: A descriptive and comparative study[END_REF][START_REF] Weitzen | Factors associated with site of death: a national study of where people die[END_REF]. There had been very little research on the subject in France. The 2010 Fin de Vie en France (End of Life in metropolitan France) study filled the gap and provided an accurate picture of end-of-life decisions, whatever the individual characteristics of the deceased or their place of death. It was an important step forward and provided an assessment of the implementation of the Leonetti Law five years after it came into force [START_REF] Pennec | Trajectories of care home residents during the last month of life: the case of France[END_REF][START_REF] Pennec | End-of-life medical decisions in France: a death certificate follow-up survey 5 years after the 2005 Act of Parliament on Patient's Rights and End of life[END_REF][START_REF] Pennec | Le dernier mois de l'existence : les lieux de la fin de vie et de la mort en France[END_REF][START_REF] Pennec | Fin de vie au domicile en France métropolitaine en 2010 : à partir d'une étude nationale en population générale[END_REF][START_REF] Pennec | Les lieux de décès des personnes de 80 ans et plus en France[END_REF][START_REF] Pennec | Physician-assisted deaths in France: results from a nation-wide survey. Les décès médicalement assistés en France: résultats d'une enquête nationale[END_REF][START_REF] Riou | When Physicians Report Having Used Medical Drugs to Deliberately End a Patient's Life: Findings of the "End-of-Life in France[END_REF][START_REF] Pennec | Les décisions médicales en fin de vie en France[END_REF]. More broadly, that survey also gave a description of end-of-life circumstances (residential transitions, carers, the patient's desired place of death, etc.). The analyses added to our understanding of the end-of-life process, the limitations of home care and the reasons why people are taken into hospital at this stage of life.

The present project aims to acquire the same information about France's overseas departments and show how far their particular demographic, social, historical, cultural and religious characteristics affect the unfolding of a person's last stage of life. End-of-life circumstances differ in a number of ways between these four departments and metropolitan France. Although life expectancy is the same as in other French departments (except for French Guiana, where it is three years shorter), mortality rates are higher at younger ages [START_REF] Crouzet | L'espérance de vie sans incapacité dans les départements d'Outre-mer[END_REF]. As a result, fewer people die after the age of 60 than in metropolitan France -50% fewer in French Guiana and 73% fewer in Guadeloupe.

In addition, fewer people die in institutions in the Caribbean and La Réunion: more people die at home (over 40% compared to 25% in metropolitan France in 2015), so fewer die in hospital (fewer than 50%, compared to over 60% in metropolitan France). Even fewer die in care homes (fewer than 5% compared to 13% in metropolitan France) [START_REF] Breton | Les Dom face aux défis du vieillissement et des migrations: Nouvelles réalités démographiques et nouveaux enjeux sociaux[END_REF][START_REF] Beaugendre | Lieux de vie de la famille et solidarités intergénérationnelles aux Antilles et à La Réunion[END_REF][START_REF] Breton | Les départements d'Outre-Mer face aux défis du vieillissement démographique et des migrations[END_REF][START_REF] Beaugendre | Faire famille à distance » chez les natifs des Antilles et de La Réunion[END_REF]. In French Guiana, only 3% die in care homes, and more die in hospital than in metropolitan France.

Another aim will focus more specifically on the implementation of the provisions of the law of 22 April 2005 on the rights of the sick and the end of life, called the "Leonetti law" [START_REF] Legleye | Surveying end-of-life medical decisions in France: evaluation of an innovative mixed-mode data collection strategy[END_REF], and that of 2 February 2016, the "Leonetti-Claeys law", which created new rights for sick people at the end of life [START_REF] Insee | Les décès en 2015. p[END_REF]. On the one hand, it will be necessary to compare medical practices with legislative provisions and, on the other hand, to describe the level of knowledge that families and patients have of the provisions regarding the patents' rights and their application.

III. ORGANISATION

SCIENTIFIC COMMITTEE

The project's scientific committee was made up of members of the Conseil national de l'ordre des Médecins (the French medical board, Dr Jean-Marie Faroudja) and people from the End-of-Life Group at the Free University of Brussels (Joachim Cohen), CépiDc (the Inserm Centre for cause of death epidemiology-Grégoire Rey).

PARTNERSHIPS

The research team managed the project for all data collection. Other operators involved in the survey are:

-ARS La Réunion (the regional health agency: Florence Caliez, head of data and health surveys department; Gilberte Hachim and Florence Payet, technicians) and the Centre d'épidémiologie sur les causes médicales de Décès (CepiDc-Inserm, centre for the epidemiology of medical causes of death) for selecting the sample; -A service provider acting as 'trusted third party' for the management and digitisation of the questionnaires: Centre Hospitalier Régional Universitaire (university hospital), Besançon -Medical data department: Marie-Pierre Pequignot, head of department; Muriel Chatey, Sophie Folley, Laurence Tillati, technicians and Maryline Laurent, IT; -A printing and dispatch provider who printed and dispatched the documents and personalised letters (Merico-Paragon, chosen by tender); -A telephone survey provider to make reminder calls to physicians (Kantar, chosen by tender).

IV. REGULATORY ASPECTS

The methodology of both the project's data collecting strands (the quantitative survey and the semi-directive interviews and focus groups) were approved by the Comité d'expertise pour les recherches, les études et les évaluations dans le domaine de la santé (CEREES, expert committee for health-related research, surveys and evaluations) in March 2018 and by the Commission nationale de l'informatique et des libertés (CNIL, the French data protection authority) in May 2018 (Cnil -DR-2018-102).

V. EXPLORATORY MISSION

In 2012 we conducted an exploratory mission in La Réunion to establish the feasibility of gathering the data and the acceptability of the research topic. The idea was to discuss with the various institutions that might be involved in the study, such as the Agence Régionale de Santé (ARS, regional health agency) and the medical authorities (Conseil de l'ordre des Médecins, the national medical council; Union Régionale des personnels de santé de la Réunion, the Réunion health personnel union; the president of the hospital's medical committee). Because religion is an important factor in Réunion's multicultural society, we also approached the religious authorities. Discussions showed that there was no a priori reticence to the survey, so a protocol was then drawn up.

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VI. METHODOLOGY

The data needed to meet all the goals of the research had never been gathered. To collect it, we used a mixed method. A quantitative survey among physicians was conducted, broadly on the lines of the protocol used in metropolitan France [START_REF] Insee | Les décès en 2015. p[END_REF] but adapting it to local particularities so as to obtain a good measure of incidences. We also designed a qualitative survey to shed light on the particularities of the situation regarding ageing in the overseas departments and especially the proportion of people dying at home. A series of semi-directive interviews with decedents' relatives and two focus groups with healthcare professionals in La Réunion provided new information about people's knowledge of the law and the strengths and weaknesses of end-of-life care in the home.

QUANTITATIVE DATA COLLECTION

The quantitative survey had two challenges to overcome for the sake of territorial continuity in statistical data gathering operations. Our data gathering arrangements had to be suited to the real situation in these departments, but the methodology and questionnaire had to be sufficiently close to the one used in metropolitan France to make comparisons feasible. A presentation of the protocol for the metropolitan France survey can be found in Legleye et al. [START_REF] Insee | Les décès en 2015. p[END_REF]. Starting from a sample of death certificates, the survey was conducted among the physicians who had issued the certificates. It was a retrospective survey: a self-administered questionnaire asked the physicians about the end-of-life circumstances of the person concerned by each certificate. So the survey concerned two populations: the decedents and the physicians who certified their deaths. This procedure gave us data about the causes and individual characteristics of deaths wherever they occurred -at home, in hospital, in a nursing home or even in the street.

The survey on end-of-life circumstances in the overseas departments (Fin de vie -DOM) used the same broad topics as the metropolitan France survey. It addressed end-of-life care and the application of the current end-oflife legislation (laws of 2005 and 2016). Some questions were altered to ensure respondents' anonymity in such a small territory (for example, the physicians' specialities were grouped into only two categories rather than the ten in the metropolitan France survey). Other questions were added, notably about religion and sedation. Lastly, the survey enabled us to analyse in greater detail the family environment and the family's role in patient care at this stage of life. It also improved the information gathering, notably as regards residential transitions and the medical reasons for such moves (usually from home to hospital).

The data was gathered in two phases:

-First, data about the death was taken from the death certificates (characteristics of the deceased, name and address of the certifying physician); -Then the physicians were asked to complete a questionnaire about the end of life of patients whose certificate they had signed. They were given enough information (including the name of the deceased) for them to identify the patient. A paper questionnaire was used, as this was the form most physicians had preferred in the metropolitan France survey (72% of replies on paper vs. 28% online). To ensure the physicians' anonymity, the questionnaire was self-administered, and their replies were collected by a 'postal voting' protocol involving a trusted third party.

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PHASE ONE: DATA COLLECTION FROM DEATH CERTIFICATES SAMPLE OF DEATHS

In order to have enough responses for a detailed analysis of each overseas department and given the 40% response rate in the metropolitan France survey [START_REF] Insee | Les décès en 2015. p[END_REF], all the deaths in one year were included2 . Only persons aged 18 and over were included. The number of child deaths would have been too small to allow quantitative analysis, and the survey protocol and questionnaire would have needed adjusting to address the particularities of care for dying children and the legal aspects involved.

Taking the mortality figures for 2018 [31], the survey covered about 927 deaths in French Guiana, 3280 in Martinique, 3195 in Guadeloupe and 5044 in La Réunion, making a total of 12,446 deaths.

The survey covered deaths from March 2020 to February 2021.

To avoid too long a time between the death and the physician's receipt of the questionnaire, and to spread our requests among physicians who often sign death certificates, we divided the data collection into three waves of four months of deaths.

-Wave 1: deaths from March to June 2020 -Wave 2: deaths from July to October 2020 -Wave 3: deaths from November 2020 to February 2021.

BUILDING UP THE "PHYSICIANS/DECEDENTS" FILE Before we could contact the physicians who had certified deaths and invite them to fill in the questionnaire for the decedents concerned, we had to take information from the death certificate: the date of birth, date of death, sex, place of death, and the name and address of the certifying physician (from their stamp on the certificate).

The death certificates were processed by the regional health agencies or CépiDc-Inserm, depending on the type of certificate (paper or online) and where they were collected.

Electronic certificates are sent directly to CépiDc-Inserm. We could therefore obtain electronic death certificates from CépiDc-Inserm very soon after the death and did not have to manually input the data on them.

Paper certificates are signed by the physician and delivered to the municipality, which sends them to INSEE and the local ARS. These make a number of checks and procedures, add a supervision sheet and send the certificates to CépiDc-Inserm in monthly batches.

For the paper certificates, we had to manually input the data needed for the survey, e.g. the contact details of the certifying physician. It was preferable to gather information directly from the ARSs for paper certificates because it minimised the time lag between the death and the dispatch of a questionnaire to the physician. However, this option was only possible for La Réunion thanks to a partnership with the Réunion ARS, which had their staff input the death certificate data.

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Figure1: Transmission of deaths certificates

Source: Simplified version of the process described in [START_REF] Rey | les données des certificats de décès en France: processus de production et principaux types d'analyse[END_REF] For Martinique, Guadeloupe and French Guiana, death certificates were input by INED on CépiDc-Inserm's premises. This significantly increased the time between the death and the dispatch of the questionnaire to the certifying physician, given the unavoidable time lag between the death and the information reaching CépiDc-Inserm.

The fact that the local ARS was inputting the La Réunion data gave a three-month advance on the data for Martinique, Guadeloupe and French Guiana, which was input by CépiDc. We could thus contact the certifying physicians in La Réunion three months earlier than in the other overseas departments.

Because the death certificate data was acquired in two different ways, we adjusted the initial protocol and divided the data collection into four periods (see calendar below).

We built a database associating death with their certifying physicians. For this, information from all the death certificates were entered in an application that INED's surveys department had developed especially for this survey. This data input operation was overseen by the medical inspector at the La Réunion ARS and the CépiDc director. The data entered were the patient's dates of birth and death, their sex, place of death, commune of residence and of death, and an indicator of 'violent death' and transfer to a forensic medicine unit. For the physicians, the necessary information for contacting them was entered: full name and professional address when they certified the death.

When the certifying physician could not be identified (rubber stamp absent or illegible), the municipality of the place of death was contacted to try to obtain the missing information. Sometimes it can be more legible on the burial/cremation authorization form.

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The data entered (indirectly nominative for the patient, nominative for the physician) were sent to INED's surveys and polls department, either by entering it via a secure internet link or by uploading files to a secure server.

From the second data collection period, this file was matched with the public death records (available from a government website, data.gouv.fr) so as to add the first and last names of the patients so that their physicians could identify them. This information is often useful for finding a patient's hospital file.

The resulting file was then processed to match each death certificate with the physician concerned. These matched death/physician pairs constituted our sample. We removed from the sample all deaths certified by forensic pathologists, ARS-funded certification networks that we had identified, and physicians for whom we could find no contact details. These seemed often to have been medical interns or temporary physicians.

Given the large number of physicians who had signed multiple death certificates within the same period, we decided to send no more than four questionnaires to any one physician, to avoid overburdening them. We made an exception for hospital unit heads and supervising physicians at care homes and retirement homes. These physicians had not only certified some deaths in person but were also named if we could not identify the actual certifying physician in their establishment (name absent or illegible). They could then pass the questionnaires on to the physicians concerned.

The file of death/physician pairs was entered into the tracking tool developed and managed by INED's surveys department to manage and monitor the data collection. Data extracts (containing only the necessary information) were sent via secure server to the survey service providers tasked with dispatching the questionnaires and reminders (postal and phone).

PHASE TWO: COLLECTING DATA FROM PHYSICIANS

THE PHYSICIAN CONTACT LETTER

The data collection followed a similar protocol to that used in metropolitan France but was split between the four survey periods.

Each physician asked to take part in the survey was sent the following, by post:

a presentation brochure (appendix 2.1) -a letter describing the aim of the survey (Appendix 2.2), giving practical information for participating and explaining the data processing procedures a presentation of the care taken to ensure respondent anonymity, and legal information such as the physician's right of access to their information under the Law of If the physician had made out the death certificate for a person who was not in their care, they could send INED's package on to the colleague who had cared for the patient at the end of their life. Or they could send us the regular physician's contact details or any other information (regular physician not known, deceased unknown, etc.), using the prepaid envelope and the transfer coupon at the bottom of the patient identification sheet. The End of life in French overseas departments -data collection protocol 13/62 information on the transfer coupons was entered in the tracking tool so that the data collection material could be sent to the regular physician and the physician initially contacted would be troubled no further for this death.

From the second wave, emails were sent to physicians who had certified deaths during that wave, to let them know that they would soon be receiving a letter by post for the new survey wave. Email addresses were obtained during the first telephone reminder.

THE REMINDERS

At intervals of about six weeks, one or two reminder letters were sent to physicians who had not yet responded, enclosing the same documents as the first time (Appendixes 2.6). The design and content of the letter was changed, to make it less likely that the recipient would hastily discard it.

For each collection period, after two months of field work, telephone reminders were made by a call centre provider. The purpose of these was to present the survey to physicians who had neither responded nor explicitly refused to take part and encourage them to participate. No questionnaires were filled in by telephone during these calls.

In the fourth and last data collection period, reminder calls were made both to physicians who had certified deaths in this period and physicians who had never responded or only partially responded at any previous period.

Phase Three: detailed recording and anonymisation of questionnaire responses

To ensure anonymity, we used a two-envelope system such as is used in postal voting: a plain envelope containing the questionnaire inside a (prepaid) envelope identifying the death/physician pair. The prepaid envelope was sent to an institution independent of the survey promoter. This 'trusted third party' was the medical data department of Besançon university hospital (see appendix 6.3: Procedure to ensure anonymity).

The trusted third party opened the prepaid envelope with the identification number on it and removed the blank envelope containing the questionnaire. They listed the identification numbers received each day and sent the list to INED by FTP server. INED updated its tracking interface with this data. The blank envelopes were collected in a 'voting box'

Phase Four: inputting the questionnaires

The questionnaire responses were entered by the trusted third party to whom the prepaid envelopes had been addressed, via an internet interface developed in Limesurvey and run by INED's surveys department). Once there were enough questionnaires in the voting box to ensure complete anonymity, the blank envelopes containing the questionnaires were opened. The third party had been supplied with sheets of labels with which to number the questionnaires and so avoid duplication. No link exists between death identification numbers on the prepaid envelopes and the questionnaire number, as described on the "survey procedure, medical confidentiality and anonymity" sheet (appendix 2.6)

End of life in French overseas departments -data collection protocol 14/62 CALENDAR To shorten the time between the physician filling in the death certificate and being asked to take part in the survey, and to smooth requests across the year for physicians certifying more than one death, we divided the fieldwork into three waves of four months of deaths. As the La Réunion data, input by ARS, reached us faster than the data entered manually at CépiDc, collection was divided between four periods, as follows: In La Réunion, in addition to the project's quantitative strand, semi-directive interviews were held with recentlybereaved relatives and two focus groups of healthcare professionals (carer networks, voluntary carers and palliative care teams or networks). The aim was to shed fresh light and provide new information on end-of-life care, especially for those who die at home. The qualitative approach was based on existing studies by Southampton University [START_REF] Hunt | VOICES Redesign and testing to informe -a National End of Life survey[END_REF] and INTEGRATE project by the End-of-Life group at Vrije Universiteit Brussel.

Period of data collection Wave of deaths

[www.endoflifegroup.be].

For the sake of anonymity, we did not link these interviews with the quantitative questionnaires filled in by physicians.

INTERVIEWS WITH DECEDENTS' RELATIVES FINDING PEOPLE TO INTERVIEW

The search for those who had cared for a dying relative at home was mainly conducted by the sociology professor at the La Réunion IRTS (the regional social workers' institute). She asked the various services and professionals involved with patients and their families -i.e. Hospital at Home (HAD)services, mobile palliative care teams, independent nurses, etc. The IRTS students helped with the recruiting, meeting some services, support groups, etc. and using the snowball approach to find people who had cared for a loved one.

TRAINING THE STUDENT INTERVIEWERS

The eight students who joined the project were in their third (and final) year of various courses at the IRTS, e.g. social work, special education or social engineering diploma courses. They were tasked with interviewing people who had cared for a dying relative at home, transcribing these interviews and translating them from Creole to French where necessary. Their involvement was voluntary, but participation went towards their training (and in some cases was assessed), and they were paid for post-data-collecting tasks. Although all were training for social work occupations, they were in different training programmes and varied somewhat in their previous experience of qualitative surveys (with a research angle).

All had attended the seminars about the project as a whole and the findings of the 2010 quantitative survey in metropolitan France. For the La Réunion qualitative strand, their training included several presentation stages which progressively gave them a grasp of the project. It started in December, when the project was discussed and formalised with an initial session about the recruitment process of future interviewees; a one-day session in January focused on how to conduct an interview (a combination of guiding and actively listening; the interviewer's posture; taking ownership of goals and topic-based secondary goals; the question of triggering; taking and using notes; reminder techniques and examples; ending an interview). There were practical exercises including a half-day collective assessment around the first contacts made, using recordings of the first interviews (two at this stage). The training also included some instruction on the students' other tasks (transcription and anonymisation of the interviews) and information on the legal, practical and logistical aspects of the survey (interviewees' rights, commitment to confidentiality, equipment, secure entry and processing of the data, etc.).

SAMPLE:

About 40 semi-directive interviews with bereaved relatives were envisaged. The interviews took place between March and June 2019. The interviewers (social workers in training) were particularly alerted to the ethical aspects of this kind of survey. For this reason, interview of the relative had to take place at least 6 months after the death of person (ideally between to 6 and 18 months). They were asked not to interview anyone they knew personally or with whom they were liable to have some relationship in the future. Interviewees were given an information leaflet about the survey, featuring the phone number of a bereavement helpline (Appendix 3.1 and interviewer's contact sheet, appendix 3.2)).

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The topics raised in the interviews with relatives were:

 The person's role in the last stage of life of the person they cared for, how long it lasted, coordination with others involved (formal and informal carers), their role in decisions about where the patient spent the last phase of their life and where they died, and their role in end-of-life medical decisions;

 Perceptions and representations of their caregiving, their expectations, and proposals for improving end-of-life care;

 Knowledge of the law on the end of life: trusted third party, refusing treatment, palliative care, continuous sedation until death in some cases;

 Etc.
The interview guide is appended (Appendix 3.3).

FOCUS GROUPS

Two focus groups were formed in La Réunion, bringing together medical personnel, relatives and other carers.

The topics addressed include the links between professional and non-professional carers; between carers and the family in caregiving, the need of psychological support for carers. The difficulties encountered and the possible ways to improve matters locally or in public policy are among the topics discussed.

Some of the topics addressed came from information gathered in the first interviews with relatives.

ANALYSIS OF DATA

The quantitative dataset is weighted and standardised by sex, age, place of death, period of data collection and FOD to account for territorial disparity in response rate and to maximise representativeness of deaths [START_REF] Legleye | Surveying end-of-life medical decisions in France: evaluation of an innovative mixed-mode data collection strategy[END_REF].

To conduct the studies, descriptive analysis methods will be applied to the quantitative data: percentages, bivariate analysis with Pearson chi-square tests, multivariate analysis, etc. Logistic regression models gave the adjusted effects of socio-medical profiles on the variables of interest. Optimal matching will be used to analyse patients' residential transitions in the last month of life. SAS and R statistical software will be used for the analysis.

The semi-directive interviews and focus groups will be analysed by traditional methods: transcription, analysis by category/theme. The triangulation with other sources will serve to enrich the analyses by crossing the different data and insights provided by doctors (quantitative survey), relatives (individual qualitative interviews), and professionals of home end of life support (focus groups). These methods will be coupled, when appropriate, with text analysis (Iramuteq software). The questionnaire addresses -How the last phase of life unfolds in general terms; -The availability of palliative care; -End-of-life medical decisions: withholding of treatment, continuation or withdrawal of active care, pain treatment, sedation; -The conditions in which these decisions are taken; -Implementation of provisions in advance directives, consultation with trusted third party.

End of life in

What will the survey be used for?

This survey is in no way intended to assess professional practice. The survey results will provide information about patterns of end-of-life care in the overseas departments. They will also provide a better understanding of the application of the Leonetti Law of 22 April 2005 on the rights of the dying, notably how widely it is known and applied, and the Claeys-Leonetti Law of 14 February 2016, which granted new rights to the dying. The survey will also enable comparison between end-of-life circumstances in the overseas departments and those in metropolitan France.

Who are the survey partners?

The Institut national d'études démographiques (INED, the French institute for demographic studies) is conducting this survey with CépiDc (a branch of Inserm, Institut national de la santé et de la recherche médicale the French institute of health and medical research) and some regional health agencies (ARSs). It is supported by the Conseil national de l'ordre des Médecins (French medical council). It has been funded by subsidies obtained by tender from the Caisse nationale de solidarité pour l'autonomie (CNSA, national solidarity fund for autonomy), the Fondation de France and INED.

How will the survey unfold?

In order to have a large enough sample for reliable statistical analysis, the survey will cover all deaths of persons aged 18 and over occurring between March 2020 and February 2021. It will take place in three waves to reduce the time lag between the deaths and the completion of the questionnaires.

How were you selected to take part in the survey?

For every death occurring between March 2020 and February 2021, we recorded the name and address of the physician who certified the death (but without having access to the cause of death, as that is a medical secret). You are receiving one or more questionnaires because you have certified at least one death in the period concerned, or because the certifying physician has named you as the physician who cared for the patient at the End of life in French overseas departments -data collection protocol 23/62 end of their life. When only the unit is identifiable from the death certificate, the questionnaire is sent to the unit head, asking them to pass it on to the colleague concerned.

What death are you being asked about?

We are giving you the characteristics of a person whose death you certified or whom you cared for at the end of their life: dates of birth and death, age, sex, place and commune of death and home commune. You should be able to identify the patient from this information. The name of the deceased is not given because we only have access to anonymised death certificates. If you certified several deaths in the period concerned, you may be asked about more than one. You may also be asked to participate in more than one wave of the survey.

How to respond to the survey

A self-administered questionnaire is sent out by post, using a similar method to postal voting: once you have filled in the questionnaire, please put it in the blank envelope and put the blank envelope in the prepaid envelope.

Will my responses be anonymous?

The survey methodology ensures medical secrecy and strict anonymity for both the physician and the deceased person.

It was approved by the Comité d'expertise pour les recherches, les études et les évaluations dans le domaine de la santé (CEREES, expert committee for health-related research, surveys and evaluations) in March 2018 and by the Commission nationale de l'informatique et des libertés (CNIL, the French data protection authority) (Cnil -DR-2018-102, May 2018).

What is INED?

The Institut national d'études démographiques is a public research body that studies population issues in France and elsewhere. It looks at major demographic trends in fertility, mortality and migration and their determinants. Its research on health and mortality addresses a number of aspects including causes of death, social inequality in health, disability, ageing and dependence, place of death and experience of death.

INED is also tasked with informing the public on population issues. It disseminates the results of its research throughout France and internationally, publishing books, a journal (Population) and a monthly news sheet (Population & Societies).

The research team for this study is multi-disciplinary and includes researchers from INED, the Besançon university hospital, the Robert Debré hospital (Paris) and the University of Strasbourg. The research protocol was designed, and the data collected, with the help on INED's surveys and polls department.

How to respond

The procedure for returning questionnaires ensures that your responses will be anonymous. We use the same double envelope method as is used for postal voting. You put a blank envelope containing the questionnaire into a prepaid envelope with the identifier of the death.

Your dispatch is received by a 'trusted third party', an independent institution with proven experience in processing confidential data. This institution separates the two envelopes and stores the blank envelopes.

-It gives SES-INED the identifier on the prepaid envelope so that they will not approach you again for the same case.

-When the trusted third party has received enough blank envelopes, they open them and enter the data from the questionnaires in a secure application. This way, the body tasked with receiving your questionnaire has no way of accessing your name, and SES-INED has no way of connecting your name with the responses on the questionnaire.

5.

As regards the analysis and publication of the results, the questioning was designed to be statistically relevant but sufficiently general to ensure the anonymity of the deceased and the physicians taking part in the survey.

End of life in French overseas departments -data collection protocol 32/62

APPENDIX 2.6 -THE SURVEY QUESTIONNAIRE

For reasons of space, the initial French version of the questionnaire is available in a clickable PDF. b. One week before death (J-7)

Some questions about you

 1  2  3  8  9 c. One month (J-30)  1  2  3  8  9 d. Two months (J-60)  1  2  3  8  9
8.1 What was their usual place of residence before they were hospitalised? The patient was not in the terminal phase  2

  1 Own home   2 Retirement/convalescent
There were still medical prospects for lessening the suffering or symptoms  3

The request had not been carefully thought out  4

The request was influenced by a third party  5

The patient retracted their request  6

The partner or family were against it  7

Because of principled objections to euthanasia  8

To

That is the end of the questionnaire Thank you very much for your cooperation

Wave 1 :

 1 deaths from March to June 2020 Wave 2: deaths from July to October 2020 Wave 3: deaths from November 2020 to February 2021.

  End of life in French overseas departments -data collection protocol 54/62 APPENDIX 3-DOCUMENTS CONNECTED WITH THE QUALITATIVE SURVEY

  The quantitative data was gathered by the INED surveys department. This department, staffed by some twenty engineers and technicians, has extensive experience of conducting surveys on subjects or populations considered 'sensitive'. It was involved in the Endof-Life survey in mainland France. Statisticians from INED's statistical methods department helped analyse the data.INED's IT department and survey department were responsible for the storage of anonymised questionnaire responses.

Qualitative data collection (interviews) involved the research team, INED's surveys department, and the Institut Régional du Travail Social (regional social work institute) in La Réunion.

2 How old are you?

		End of life in French overseas departments -data collection protocol
		 1 Under 40
		 2 40 to 49
		 3 50 to 59
		 4 60 or over
	1.3 You are:
		 1 a general practitioner
		 2 a specialist
	1.4 Working in what context?
		(Several replies possible)
		 1 Independent practice
		 2 Hospital, clinic, medical welfare structure, care home or retirement home
		 3 Mixed structure
		 8 Other. Give details
	1.5 Have you received training in end-of-life care?
		 1 Yes, initial training
		 2 Yes, in-practice training
		 3 No
		33/62

1.1 You are:

  1 A man  2 A woman 1.

Questions about the decedent For the purposes of statistical representativeness, please answer these questions about the decedent whose characteristics were sent to you with this questionnaire. 2.1 Sex of the deceased:

	 1 Man
	 2 Woman
	2.2 Their age group:
	 1 Under 40
	 2 40 to 59
	 3 60 to 69
	 4 70 to 79
	 5 80 to 89
	 6 90 or over
	2.3 Period of the death:
	 1 March to June 2020
	 2 July to October 2020
	 3 After October 2020
	2.4

Place of residence of the deceased

			End of life in French overseas departments -data collection protocol
	2.6 Who did the deceased live with?
		(Several answers possible)
		 1 No one
		 2 Partner
		 3 One or more children
		 4 Other person/people. Give details
		 8 Other (e.g. in retirement home). Give details
		 9 I don't know
	2.7 Department/Region of death:
		 1 Guadeloupe
		 2 French Guiana
		 3 Martinique
		 4 La Réunion
	2.8 Place of death:
		 1 At home
		 2 Hospital or private clinic
		 3 Retirement/convalescent home, care home, geriatric unit
		 4 Street or public place
		 8 Other
	3.	Main cause of death:
		 1 Cancer
		 2 Cardiovascular disease
		 3 Neurological or cerebrovascular disease
		 4 Infectious disease
		
				Yes	No	I don't know
		a.	Partner	 1	 2	 9
		b. overseas department as the deceased Child or children living in the same	 1	 2	 9
		c. overseas department as the deceased Child of children not living in the same	 1	 2	 9
		d.	Brother(s) / sister(s)	 1	 2	 9
		e.	Others	 1	 2	 9
						34/62

:  1 Rural commune  2 Town  9 I don't know 2.5 To your knowledge, what family did they have? (Check a box on each line) 5 Respiratory system disease (other than cancer)  6 Digestive system disease (other than cancer)   7 Mental or psychiatric disorder   8 Violent death, other causes 4.

Was the patient suffering from dementia or a neuro-cognitive disorder at the time of death?

		End of life in French overseas departments -data collection protocol End of life in French overseas departments -data collection protocol
	5.	Was the death sudden and entirely unexpected?
		 1 Yes
		 2 No
		 9 I don't know
	6.	How long had the patient been in your care?
	  1 They were not my patient (I only certified the death)
		 2 Less than a week
		 3 Less than a year
		 4 A year or more
	7.	Do you think you can provide some information about this patient's end of life?
	 1 Yes → Go to question 8
	 2 No
		If you answered "No" to 7→ End of questionnaire
		Thank you for your cooperation.
		 1 No
		 2 Yes, mild cognitive impairment
		 3 Yes, severe cognitive impairment
		 9 I don't know
		35/62 36/62

Place of death, care and treatment 8. Where was the patient staying at the time of their death and in the preceding weeks?

				Retirement
		At home	Hospital (public or private)	home, care home, geriatric	Other place	I don't know
				unit
	a. Day of death	1	2	3	8	9

(Check one box per line)

Did the patient's partner and/or family express a wish as to where the patient should die?

  The death happened sooner than expected   2 The family was against it  3 The health care professionals were against it  4 The professional caregivers were against it  5 The patient was living alone   6 Care was too complicated or burdensome to be performed at home  

		End of life in French overseas departments -data collection protocol
	9.	Did the patient express a preference for their place of death?
	   9.1 Where did they want to die?  1 Yes  2 No  9 I don't know   1 At home   2 In hospital or a clinic   3 Retirement/convalescent home, care home, geriatric unit   8 Other place. Give details 9.2 Did they die where they wanted to die?   1 Yes   2 No 9.2.1 If the patient did not die in the preferred place, why was this? (Several answers possible)  1 Yes   2 No   3 The patient had no partner or family   9 I don't know   1  10.1
		home, care home, geriatric unit
		 8 Other place
		 9 I don't know
		37/62

8 Other reason. Give details ..................................................................................................................   9 I don't know End of life in French overseas departments -data collection protocol 38/62 10.

Where did the partner and/or family want the patient to die?

  The death happened sooner than expected   2 The patient was against it  3 The health care professionals were against it  4 The professional caregivers were against it  5 The patient was living alone   6 The care was too complex or burdensome   8 Other. Give details

	End of life in French overseas departments -data collection protocol
	  1 At home
	  2 In hospital or a clinic
	  3 In a retirement/convalescent home, care home or geriatric unit
	  8 Other. Give details
	10.2 Were the wishes of the partner and/or family carried out?
	  1 Yes
	  2 No
	10.2.1 If the patient did not die in the place chosen
	by their partner and/or family,
	why was this?
	(Several answers possible)
	  1   9 I don't know
	39/62

11. Had the patient appointed a trusted third party?

  (The trusted third party within the meaning of the Law of 2 February 2016 is the person named by the patient as their spokesperson if they are no longer able to make decisions for themselves)  1 Yes  2 No  3 Was not able to (e.g. unconscious)  9 I don't know

11.1 Was the trusted third party

	 1 the patient's partner
	 2 their father or mother
	 3 a brother or sister
	 4 One of their children or descendants
	 5 another member of the family
	 6 a friend
	 7 their regular physician
	 8 Someone else. Give details
	 9 I don't know
	11.2

Was the trusted third party involved in discussions about medical decisions in the terminal stage?

		End of life in French overseas departments -data collection protocol
	  1 Yes
	 2 No
	 9 I don't know
	11.2.1	Why?
	(Several answers possible)
	  1 Death happened too quickly
	  8 Other reason. Give details
	  9 I don't know
		40/62

12. Were other friends or relatives involved in discussions about decisions in the terminal stage?

		End of life in French overseas departments -data collection protocol
	 14.	 1 Yes. Give details  2 No
		 9 I don't know
	13. Had the patient drawn up an advance directive?
		(An advance directive is a document drawn up by an adult, in which they put down their wishes regarding end-of-life
	issues, notably concerning the continuation, withdrawal or limitation of treatments)
		 1 Yes
		 2 No
		 9 I don't know
		13.1 Was the patient's advance directive complied
		with in decisions taken in the terminal stage?
		  1 Yes
		  2 No
		  9 I don't know
		13.1.1 Why?
		(Several answers possible)
		 1 Death occurred too quickly
		 2 The wishes expressed in the directives
		were not appropriate to the situation
		 8 Other reason. Give details
		…………………………………………………………………..
		…………………………………………………………………..
		 9 I don't know
		41/62

Were the following people involved in care of the patient in the last month of their life?

		(Check one box per line)
			Yes	No		I don't know
		a.	Regular physician	 1	 2	 9
		b.	Pain control or palliative care specialists	 1	 2	 9
		c. (other than psychiatry) Physician in another speciality	 1	 2	 9
		d.	Psychiatrist or psychologist	 1	 2	 9
		e.	Nurse, nursing assistant	 1	 2	 9
		f.	Physiotherapist	 1	 2	 9
		g.	Social worker	 1	 2	 9
	15. Did the patient receive palliative treatment?
		(symptom relief, pain control)?
		 1 Yes
		 2 No
		 9 I don't know
		15.1

How long before the death was this treatment begun?

	  1 Several hours
	  2 Several days
	  3 Several weeks
	 4 Several months
	  9 I don't know
	15.2 Who administered the palliative care?
	(Several answers possible)
	  1 the usual caregivers
	  2 palliative care specialists (palliative care unit, mobile team or network)
	16.

What was the purpose of treatment given in the last week of life?

	End of life in French overseas departments -data collection protocol
	17.
	 Exclusively curative
	 Exclusively palliative
	 Curative and palliative
	 No treatment
	42/62

At the moment of death, was the patient receiving any treatment that affects vigilance or awareness?

  Yes, continuously until death  2 Yes, but it was stopped a few hours before death  3 Yes, but it was stopped a few days before death  4 Yes, but it was stopped a few weeks before death 

			End of life in French overseas departments -data collection protocol
	18. Did the patient receive artificial hydration?
	 Yes  No  I don't know  1 5 No 17.1 What drugs were used? (Several answers possible)  9 I don't know
	  1   2 19. Did the patient receive artificial nutrition? Morphine or other opiate Midazolam or other benzodiazepine
	  8  1 Yes, continuously until death Other class or classes of drug. Give details
	 2 Yes, but it was stopped a few hours before death
	 3 Yes, but it was stopped a few days before death 17.2 How long before the death was this treatment begun?   1  4 Yes, but it was stopped a few weeks before death Several hours   2  5 No Several days   3 Several weeks  9 I don't know
	20.	17.3 The treatment was administered to produce
		  1	conscious sedation
		  2	deep sedation
		17.4 Was the treatment affecting vigilance or awareness administered
		  1	continuously
		  2	intermittently
		17.5 Was the treatment affecting vigilance or awareness administered
		(Several answers possible)
		  1	knowing that it would not hasten death
		  2	knowing that it might hasten death
		  3	without concern for whether it might hasten death
		  4	with the explicit intention of hastening death
		  5	to put an end to what you perceived as a situation the patient found unbearable
		  6	for another purpose. Give details
		  9	I don't know
			43/62

In your view, to what extent (on a scale of 0 to 10) did the patient display the following symptoms in the last 24 hours before death (despite treatment if any)?

					End of life in French overseas departments -data collection protocol
	End-of-
	(For each symptom, check the column that matches your assessment)
		0	1	2	3	4	5	6	7	8	9	10
	No pain	0 1 2 3 4 5 6 7 8 9 10 Worst pain imaginable
	No nausea or digestive problems	0 1 2 3 4 5 6 7 8 9 10 Severe digestive problems
	No fatigue	0 1 2 3 4 5 6 7 8 9 10 Severe fatigue
	No respiratory difficulty	0 1 2 3 4 5 6 7 8 9 10 Severe respiratory difficulty
	No depression, anxiety or unease	0 1 2 3 4 5 6 7 8 9 10	Severe anxiety or depression, or deep unease
	No confusion	0 1 2 3 4 5 6 7 8 9 10 Severe confusion
	No difficulty moving about	0 1 2 3 4 5 6 7 8 9 10 Confined to bed
												44/62

life decisions taken by yourself or another physician 21. As regards this patient, did you primarily decide to do everything possible to prevent death?

	 1 Yes
	 2 No
	21.1 What treatment(s) did you administer?
	(Several answers possible)
	  1 Artificial hydration
	  2 Artificial nutrition
	  3 Artificial respiration
	  4 Catecholamines
	  5 Blood product transfusion
	  6 Dialysis
	  7 Oral chemotherapy, hormone therapy
	 8 Other specific anti-cancer treatment
	  9 Surgery
	  88 Other treatment. Give details
	22.

As regards this patient, did you decide to withhold a treatment liable to prolong their life?  1 Yes  2 No 22.1 What treatment or treatments were withheld?

	(Several answers possible)
	  1 Artificial hydration
	  2 Artificial nutrition
	  3 Artificial respiration
	  4 Catecholamines
	  5 Blood product transfusion
	  6 Dialysis
	  7 Oral chemotherapy, hormone therapy
	 8 Other specific anti-cancer treatment
	  9 Surgery
	 

88 Other treatment. Give details 22.2 Did you consider the fact that this decision might hasten death?

	  1 Yes
	  2

No 22.3 Was it your conscious intention to hasten death?

	  1 Yes
	  2

No 22.4 Do you think that this decision did hasten death?

	End of life in French overseas departments -data collection protocol
	  1 Yes
	  2 No
	  9 I don't know
	45/62

23. As regards this patient, did you decide to withdraw a treatment liable to prolong life?

		 1 Yes
		 2 No
	23.1 What treatments were withdrawn?
		(Several answers possible)
		  1 Artificial hydration
		  2 Artificial nutrition
		  3 Artificial respiration
		  4 Catecholamines
		  5 Blood product transfusion
		  6 Dialysis
		  7 Oral chemotherapy, hormone therapy
		 8 Other specific anti-cancer treatment
		  9 Surgery
		  88 Other treatment. Give details
	23.2

Did you consider the fact that this decision might hasten death?

	  1 Yes
	  2

No 23.3 Was it your conscious intention to hasten death?

	  1 Yes
	  2

No 23.4 Do you think this decision did hasten death?

	End of life in French overseas departments -data collection protocol
	  1 Yes
	  2 No
	  9 I don't know
	46/62

24. As regards this patient, did you decide to intensify treatment of pain and/or symptoms by means of one or more drugs?

	 1 Yes
	 2 No
	24.1	What drugs were used?
	(Several answers possible)
	  1 Morphine or other opiate
	  2 Benzodiazepine
	  8 Other class of drugs. Give details
	24.2	Did you consider the fact that this decision might hasten death?
	  1 Yes
	  2 No
	24.3	Was it your conscious intention to hasten death?
	  1 Yes
	  2 No
	24.4	Do you think this decision did hasten death?
	  1 Yes
	  2 No
	  9 I don't know
	25.

As regards this patient, did you decide to apply continuous deep sedation until death?

			End of life in French overseas departments -data collection protocol
	26.
		 1 Yes
		 2 No
		25.1	How long was it administered for?
		  1 several hours
		  2 several days
		  3 several weeks
		25.2	Why was it applied?
		  1 Because of a stubborn symptom
		  2 Because it had been decided to withdraw lifesaving treatment
		  8 Other reason. Give details
			47/62

As regards this patient, did you decide to use one or more drugs to deliberately end life?

	 Yes
	 No
	 I don't know
	26.1	What drug did you use?
	(Several answers possible)
	  1 Barbiturate
	  2 Benzodiazepine
	  3 Pethidine -chlorpromazine -promethazine
	  4 Morphine or other opiate
	  5 Neuroleptic
	  6 Myorelaxant (curare)
	  7 Potassium
	  8 Other drug. Give details
	26.2	Who administered the drug(s)?
	(Several answers possible)
	  1 You or another physician
	  2 A nurse
	  3 The patient themselves
	  8

Someone else 26.2.1 Were you or another physician present when it was administered?  1 Yes  2 No If you answered No to all the questions 21 to 26 → Go to question 35

	End of life in French overseas departments -data collection protocol
	48/62

The last medical act mentioned NB: questions 27 to 34 concern the last act mentioned, i.e. your last "Yes" in response to questions 21 to 26. 27. Did you (or a colleague) discuss with the patient the decision taken for the last act mentioned?  1 Yes 27.1 During this discussion, did you find the patient able to assess their situation?

			 1 Yes
			 2 No
			 9 I don't know
		27.2

During the discussion, did you find the patient capable of making their own decisions?

			 1 Yes
			 2 No
			 9 I express no opinion
	 2 No

28. Why was the decision taken for the last act mentioned not discussed with the patient?

		End of life in French overseas departments -data collection protocol
	29.
	(Several answers possible)
	 	 1 As a doctor, I do not think I have to raise this question with a patient
	 	 2 I did not feel able to raise this question
	 	 3 I did not know what would be the best attitude to take
	 	 4 The patient was unconscious or barely conscious
	 	 5 The patient had dementia
	 	 6 The patient exhibited mental deficiency
	 	 7 The patient exhibited a psychiatric disorder
	 	 8 The last act was clearly the best for the patient
	 	 9 A discussion would have done the patient more harm than good
	 	 10 The patient saw themselves as being in better health than they were
	 	 88 Other reason. Give details
	 	 99 I don't know
	 9 I don't know
		49/62

Was the decision over this last act taken at the patient's explicit request?

	 Yes
	 No
	 I don't know
	29.1	Was that request repeated?
	  1 Yes
	  2 No
	  9 I don't know
	30.

Did you (or a colleague) discuss the decision about the last medical act with anyone else before it was

	carried out?
	(Several answers possible)
	 1 Yes, with one or more other physicians
	 2 Yes, with the nursing team
	 3 Yes, with the patient's partner and/or family
	 4 Yes, with the trusted third party
	 5 Yes, with other persons
	 6 Yes, as part of a collegial process
	 7 No
	 9 I don't know
	30.1	What was the purpose of the discussion?
		(Several answers possible)
		 1 to inform
		 2 to get another opinion
		 3 to make a joint decision
	30.2

Were the views expressed in the discussion (with the patient or anyone else) entered in the patient's file?

	  1 Yes
	  2 No
	  9 I don't know
	30.3

Were the beliefs or religion of the patient or their family considered in the discussions (with the patient or anyone else) and decision-making?   1

  Yes   2 No   9 I don't know End of life in French overseas departments -data collection protocol 50/62

31. What were the reasons for the last act mentioned?

  The patient's persistent pain despite analgesic treatment  2The patient's uncontrollable symptoms (acute asphyxia, cataclysmic haemorrhage)  3

	(Several answers possible)
	 1
		The patient's mental distress
	 4	No prospect of improvement
	 5	Not wanting to pointlessly prolong life
	 6	The patient's wish or request
	 7	The wish or request of the patient's partner, family or trusted third party
	 8	Other reason
	32. What

expression do you think best describes the last act mentioned? (Give only one answer)  1

  Treatment of symptoms  2 Decision to withhold or withdraw treatment  3 Continuous deep sedation until death  4 Euthanasia ("deliberate action by a third party that ends a person's life, with the intention of putting an end to a situation considered unbearable" -Comité consultatif national d'éthique (national consultative ethics committee))  5Medical aid in dying (when a physician supplies the patient with a substance that they take themselves)  6 Assisted suicide (when a third party deliberately ends the life of someone who cannot kill themselves and asks to be killed)  8 Other. Give details End of life in French overseas departments -data collection protocol 51/62

33. Did the patient at any time express the wish to hasten death?

  Orally from the patient   2 From the patient's advance directive (written or otherwise, e.g. audio recording)   3 From a relative of the patient   4 From the nursing team   5 Another way The pain or symptoms were stubborn  2 The patient had a constant fear of death  3 The patient felt a sense of indignity  8 Other

	 Yes, explicitly
	 Yes, but not explicitly
	 No
	 I don't know
	33.1	How did you learn of this wish?
	  1 34. Did the patient explicitly request euthanasia?
	 Yes
	 No
	34.1	Why?
	(Several answers possible)
	 1 34.2	Was their request complied with?
	  1 Yes
	  2 No
		34.2.1	Why?
		(Several answers possible)
		 1

Companionship and support 35. For each of the following people, check the box that matches their pattern of care for the patient in the

  comply with the law  88 Other reason

			End of life in French overseas departments -data collection protocol
	last month before death:
		(Check one box per line)
						Unable to get
						involved (e.g.
	People	Daily	Occasionally Not involved	reasons of	I don't know
						health, distance,
						no partner)
	a.	Partner	 1	 2	 3	 4	 9
	b.	Children	 1	 2	 3	 4	 9
	c.	Brothers/sisters	 1	 2	 3	 4	 9
	d.	Other family members	 1	 2	 3	 4	 9
	e.	Friends, neighbours	 1	 2	 3	 4	 9
	f.	Volunteer befriender	 1	 2	 3	 4	 9
	g.	Representative of a religion (e.g.	 1	 2	 3	 4	 9
		almoner, minister, priest, rabbi,
		imam)
	36.
		
							52/62

Did the patient receive any visits in the last week before death?

  brothers, sisters  4 other family members  5 friends, neighbours  6 volunteer befrienders  7 a representative of a religion (e.g. almoner, minister, priest, rabbi, imam)  8 someone else End of life in French overseas departments -data collection protocol 53/62

	 1 Yes
	 2 No
	 9 I don't know
	36.1	By whom?
	(Several answers possible)
	 1 partner
	 2 children
	 3

37. Who was present at the patient's death?

	(Several answers possible)
	 1	You, another physician, or another health care professional
	 2	Their partner
	 3	Children
	 4	Brothers, sisters
	 5	Other family members
	 6	Friend(s), neighbour(s)
	 7	Someone else (e.g. professional carer, volunteer)
	 8	Nobody was there
	 9	I don't know
	38. Was support by a psychologist provided?
	(Several answers possible)
	 1	Yes, for the patient
	 2	Yes, for the family
	 3	Yes, for the nursing staff
	 4	No
	 9	I don't know
	 8	N.a.: death came quickly
	39.

In your opinion, did the conditions of the patient's death meet their expectations?

	 1	Yes
	 2	No
	 9	I express no opinion
	40. Today,

do you think the conditions in which this death unfolded were

	 1	very decent
	 2	fairly decent
	 3	rather bad
	 4	very bad
	 9	I express no opinion
	41.

To what extent did you yourself find this death a distressing experience? 0

 1  2  3  4  5  6  7  8  9  10  (not at all) (very much)

Mayotte is not included in the research owing to the poor quality of its civil registry data (deaths are significantly under-recorded).

For the metropolitan France survey, we had a sample of 14,999 deaths occurring in December 2009. Questionnaires were sent out for 14,080 of them (sometimes the certifying physician could not be found; we limited the number of questionnaires per physician; etc.). We received 5217 responses.

The resulting file was used for data collection and destroyed once collection was finished.

organising data collection and the various mailings was tasked by SES-INED. They allocated an identifier to each physician-decedent. You will receive a questionnaire (with the necessary for returning it) for each death certificate you signed in the period covered by the survey.

Survey on the last stage of life in the overseas departments 2020-2021

What is the purpose of the survey?

The purpose of the survey is to provide an overview of end-of-life circumstances in the overseas departments. It follows on from a survey conducted in metropolitan France in 2010.

Information about INED and its research can be found online at: http://www.ined.fr

If you need more information

We will be happy to answer your questions or receive your comments, by phone or email:

Tel: 33 (0) The research was designed by a multidisciplinary team of researchers from INED, CHRU of Besançon, the University of Strasbourg and AP-HP, in collaboration with the CépiDc of Inserm and some regional health agencies.

To have a sufficiently large sample for robust statistical analysis, the survey covers all deaths of 18-year-olds from March 2020 to February 2021.

To reduce the time between the occurrence of each death and the completion of the questionnaire associated with it, the collection will take place in 3 successive waves. We are beginning the first wave, dealing with deaths occurring mainly from March to June 2020.

You have received this letter because you or one of your staff has certified one or more deaths or because you monitored the end of life of certain people who died during these 4 months.

In this envelope, you will find information to identify the deceased persons and how to respond to this survey. The survey methodology strictly guarantees both your anonymity and that of the deceased, and medical confidentiality.

It will take about twenty minutes to answer this questionnaire, and only a few minutes if the death was sudden.

Your answer is important for the quality of the results and their statistical representativeness. As a reminder, the procedure used for the investigation fully guarantees the confidentiality of your answers, your anonymity as well as that of the deceased.

The main results of this survey will be available when they are published on https://fdv.site.ined.fr. To ensure anonymity, we use the same procedure as with postal voting: -a plain envelope in which to put the completed questionnaire. There must be nothing on it to identify you, such as a professional stamp; -a prepaid envelope in which to put the envelope containing the completed questionnaire. Do not include the coupon with your name on it.

IF YOU ARE NOT THE PHYSICIAN WHO CARED FOR THIS PATIENT BEFORE THEIR DEATH

If you know the physician, you can pass this letter on to them together with all the survey documents, and/or tell us their name and contact details so that we can send them the papers.

Please send us the transfer coupon in the enclosed prepaid envelope; if a reminder is needed, we can send it directly to your colleague. Project title: End of life in the French overseas departments -qualitative survey of family members

Aim of the research project

The purpose of this research was to give an overview of end-of-life conditions in Martinique, Guadeloupe, French Guiana and La Réunion, France's four overseas departments. The aim was to find out in what ways they differ from those in metropolitan France and what changes to public policy would be needed to meet the particular needs of these departments.

The project was based on three complementary data collections:

-A quantitative survey of physicians. This followed on from the one carried out in metropolitan France in 2010. It set out to describe the circumstances of people's last stage of life (medical decisions, residential transitions before the death, caregivers, patients' wishes regarding place of death, etc.). -Interviews with carers involved in end-of-life care, both voluntary (e.g. from non-profit bodies or religious organisations) and professional (members of palliative care teams, nurses and home care workers). -An interview survey of family members or friends who have cared for an elderly person in the last stage of their life. This is the survey you are responding to.

These interviews address various topics. We will ask about the practical aspects of the caregiving: the roles of different people, the choice of place for the caregiving, medical decisions, knowledge of the law on end-of-life medical decisions and how it was applied, etc. We will also ask about your perceptions (causes of satisfaction, difficulties, expectations, ideas for improvements etc.) This survey on the strengths and weaknesses of end-of-life care in the home will enable us to make innovative proposals for ways of supporting caregivers and families to improve the quality of life for someone dying at home, which is what most people hope for.

A summary of the main results of each of the publications resulting from the survey will be available to everyone on the INED website (www.fdv.ined.fr), as will the full publication where possible.

For further information, contact the survey staff:

 By email: fdv@ined.fr;  By telephone: 01 56 06 20 43

End of life in French overseas departments -data collection protocol 57/62

Your rights

Voluntary participation and right of withdrawal

Your participation in this research is voluntary. You can refuse to take part, or you can withdraw your participation at any moment with no need to give reasons. You have a perfect right to not want to discuss some subjects and the interviewer will respect your wishes.

You can withdraw from the survey at any time during or after the interview.

In this case, the data collected will be destroyed if you explicitly ask for that.

Support for respondents

After the interview, if you feel the need for support or someone to talk to, you can phone the 'Caring for the dying' helpline run by the Centre national des soins palliatifs et de la fin de vie, 08 11 020 300 from 10am to 1pm and 2pm to 5pm (metropolitan France time).

Confidentiality

Anything you say will be treated in the strictest confidence. Interviewers pledge not to divulge any information you give them. The recordings are anonymised, meaning that nobody will have access to your name to any personal information: the data files and transcriptions are stored on a safe computer and deleted from all other mediums.

Ethical aspects and regulations

In compliance with regulations, the survey methodology was approved by the Comité d'expertise pour les recherches, les études et les évaluations dans le domaine de la santé (CEREES) in March 2018 and by the Commission nationale de l'informatique et des libertés (CNIL) (CNIL -DR-2018-102, May 2018).

APPENDIX 3.2 -INTERVIEWERS' CONTACT SHEET

Instructions for FDV-DOM-quali interviewers

Interviewer-respondent contact sheet Hello,

Presentation

"My name is ... and I am an interviewer for a government-funded research team (from INED...). We are studying end-of-life conditions in the overseas departments. The aim is to produce an overview of the conditions in which people are cared for in their last stage of life and gain a better understanding of how their care is organised between the different people involved -medical staff, family members and friends, etc.

As part of this work we want to talk to people who have cared for a dying relative or friend, to record their testimony and experiences. We are also gathering information from doctors, health care professionals and volunteers who care for the terminally ill. But we think it is very important to also record the experience of the End of life in French overseas departments -data collection protocol 58/62 family, who play an essential part and whose viewpoint complements the others. Your testimony will enable us to pinpoint the strengths and weaknesses of home care and suggest ways for local and national decision-makers to make improvements.

Interview conditions

In practice, the interview will be a conversation, a free discussion, at your home or any other place of your choosing.

Everyone's participation is entirely voluntary and if there are issues you do not want to talk about you can just let me know. Interview length varies from person to person but is about an hour on average. The conversation is usually recorded so as to be faithfully transcribed and analysed afterwards. But you can refuse to have your responses recorded. In any case your anonymity is ensured because names and other identifying information are not kept.

I am personally pledged to respect the confidentiality of anything you tell me. Do you agree to talk to me about the subject and share your experience with me? Do you have any questions?

Additional information for interviewers

The research project's more precise goals

The purpose of this research is to give an overview of end-of-life conditions in Martinique, Guadeloupe, French Guiana and La Réunion, France's overseas departments. The aim is to see in what ways they differ from those pertaining in metropolitan France and what public policy changes would be needed to meet these departments' particular needs.

The project is based on three complementary data collections:

-A quantitative survey of physicians. This followed on from the one carried out in metropolitan France in 2010, to describe the circumstances of people's last stage of life (medical decisions, residential transition before the death, caregivers, patients' wishes regarding place of death, etc.). -Interviews with carers involved in end-of-life care, both voluntary (e.g. from non-profit bodies or religious organisations) and professional (members of palliative care teams, nurses and home care workers). -An interview survey of family members or friends who had cared for an older person in the last stage of their life.

Topics addressed in the interview

The practical aspects of caregiving will be addressed, i.e. the roles of the various parties involved, the choice of place for the caregiving, medical decisions, knowledge of the law on end-of-life medical decisions and how it was applied, etc. We will also ask about perceptions (causes of satisfaction, difficulties, expectations, ideas for improvements etc.) This survey on the strengths and weaknesses of home care for the terminally ill may enable us to make innovative suggestions for ways of supporting caregivers and families to improve the quality of life for someone dying at home, which is what most people hope for.

Ethical and regulatory aspects of the project

Confidentiality/Anonymity:

The interview recordings are stored on a safe computer and the interviewers undertake to delete them from their recording devices. The files are anonymised, meaning that nobody will have access to the respondents' names. When the survey results are analysed and published, it will not be possible to identify the respondents.

In compliance with the law, the interviewers pledge not to divulge the information gathered. The service providers that transcribe the interviews will only have access to the anonymised recordings during their mission. They will be under an obligation to destroy all files they may have in their possession.

The recordings and transcriptions will be stored on a safe server at INED, accessible only to the research team.

Once the study is finished, they will be archived anonymously.

Compliance with ethical regulations

In line with the regulations (the Jardé act), the survey methodology was approved by the Comité de protection des personnes (an ethical review board) on march 2018, by CEREES (expert committee for health-related research, surveys and evaluations) and by the CNIL (the French data protection authority) (CNIL -DR-2018-102, May 2018).

End of life in French overseas departments -data collection protocol 60/62

Right of withdrawal

The respondent can exercise their right of withdrawal at any time.

In that case, the data recorded can be destroyed at their explicit request.

Support for respondents

Because of the issues addressed, the interviewer must mention that a partnership has ben set up with the Caring for the Dying helpline run by the national palliative care and end of life centre, and that if the respondent feels the need for support or someone to talk to, they can dial 0811020 300 from 10am to 1pm and 2pm to 5pm (metropolitan France time).

Use of participants' information and data

The survey analysis results will be published through the usual channels for science research (journal articles, conference papers etc.).

A summary of the main findings of each publication based on the survey (and the publication itself whenever possible) will be available to the public, and especially the survey participants, on the project website: www.fdv.ined.fr.

Contacts

For further information, contact the survey staff:

Proposed interview guide Presentation

As I told you on the phone, we at INED are making a study of care for older people at the end of their lives.

Of course, everything said in the interview will remain absolutely confidential. If we ask your permission to record it, it is to facilitate our work and avoid any errors in the note-taking. You are free to refuse that permission. In any case, your anonymity is strictly protected because names and other identifying information are not kept.

Do you have any questions about the interview process?

Starting question:

Could you tell us about the circumstances in which you lost your partner/husband/father/mother/other person?

Elicit the type of illness, how it developed, how long it lasted, the care that was needed, etc.

home care and hospitalisation:

-Did your partner/father/mother/other person stay at home throughout? Was that their wish? Was it your wish? Did you talk about it with them? With your family and friends?

If the person was hospitalised (once or more than once): -Can you tell me how that went? Who decided? (role of physician, patient's participation, family etc.)

Elicit the reasons and duration of hospital stay, why and how the patient came home again.

-During the hospital stay, how did you find the care provided for your partner/father/mother/other person? What were your relations with the medical staff? What did your partner/father/mother/other person think of it?

Relations with others involved in the home care:

-How did it go with other family members and friends? -Did you get any psychological help from other people or the community? [find out whether some people unexpectedly offered help or support].

The legal provisions

-How was the medical care your loved one received in their last months/week of life?

-Do you know whether it was decided to withhold some treatments, withdraw treatments or treat them with powerful painkillers such as morphine? Did your loved one receive palliative care (meaning treatment to alleviate pain and improve the comfort of a dying patient)?

-Did the physician talk to you about any medical decisions that had to be taken? If so, which?

-Did your loved one take part in that decision process? What part did you play in it? Do you think you were fully informed and listened to?

Ask whether the decedent had made their wishes known as regards their end-of-life care, whether they had named a trusted third party or drawn up a living will, and if so, whether the trusted third party was involved in the decision and whether the living will was taken into account.

-Have you heard of the Leonetti and Claeys-Leonetti laws on patients' rights at the end of life?

-If so, from what information sources? (knowledge in general or knowledge acquired because of the situation with your loved one)? In your opinion, what improvement has it brought? Did you or your loved one make use of any of their provisions (advance directives, appointing a trusted third party, involvement in medical decisions)?

[If not, explain that these laws enable a patient, or their family if they are unable to express themselves, to tell doctors what they want in terms of end-of-life medical treatment]; -These laws don't ring a bell for you? Or: -You had never heard of them? -Do you think everything possible was done to respect the wishes of your loved one?

General perceptions

-What do you feel about your experience and your role during the last months or weeks of your loved one's life?

If a sense of personal fulfilment is mentioned, inquire further: was it about fulfilling one's role, feeling useful, closeness with the patient, fulfilling their wishes etc.? Or explore: Did you have a sense of personal fulfilment?

Look into the difficulties and the feeling of helplessness (duration of the loved one's illness, how it developed, difficulty of the care required, lack of help from other people, relations with other people involved, etc.) or ask: Were there moments or situations when you felt particularly helpless? If so, what were they?

-What advice or suggestions would you give to help families in this kind of situation?

-Are there any other points you would like to raise?