Design and financing
This is a prospective cohort study. So far, data has been collected at 2 points. The first part of the study was organized between 2015 and 2016, and the second part was organized between 2020 and 2021. Prior to the second part, the study design was a cross-sectional design. The design of cohort beaun in the second part. This is why we submitted the protocol study at this time. At its launch, the EVAL-PLH study was supported by the PREPS (Research program on the performance of the healthcare system, Directorate General for the Organization of Care, 2013) and the National Institute of Health and Research. Medical (INSERM, 2013).
The study is registered in the ClinicalTrials.gov database (Trial registration: NCT02400528; registered 2015-03-27). Sponsorship was represented by Assistance Publique, Hôpitaux de Marseille, France; its role was to check the relevance of ethical and legal considerations. All the methods were carried out in accordance with the French directives and regulations in force. The research was approved by the French ethics committee (name: Sud Méditerranée V Personal Protection Committee; postal address: CHU·HOPITAL DE CIMIEZ, Nice, France; website: https://www.cpp-sud- mediterranee-v.fr/; date of approval: 20/10/2014; reference number: 2014-A00953-44; registration number: 14.041). All experiments were performed in accordance with current guidelines and regulations. The research was carried out in accordance with the Declaration of Helsinki. A written consent form was obtained from each participant and/or their legal guardians.
Settings
The EVAL-PLH cohort was set up on 03/01/2015 and concerned people with severe multiple disabilities cared for in the following centres: four rehabilitation centres, eight accommodation facilities (Study, Education and Care Association for Persons with Multiple Disabilities (CESAP)), and a specialized pediatric/neurological service of a university hospital (Neurpediatrics Service, UPMC, Hôpital Trousseau, Assistance Publique Hôpitaux de Paris, France). The four rehabilitation centers receive hospitalized patients requiring significant medical care over long periods (several days, months, or even years) through standard hospital stays (specialized rehabilitation centres). Residential facilities receive inpatients and outpatients requiring less intensive medical care. The specialized paediatrics/neurology service receives children with their families who are cared for and cared for at home. These families, supported by human assistance (nurses, physiotherapists, etc.) and technical assistance (wheelchair, specific bed, and other devices) at home, benefit from an annual follow-up at the hospital.
Populations
Three different populations were eligible: (1) people with severe multiple disabilities; (2) family carers of included persons; and (3) institutional caregivers of included individuals.
The selection criteria were as follows:
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People with severe polyhandicap are defined as people with both motor impairment (tetraparesis, hemiparesis, paraparesis, extrapyramidal syndrome, cerebellar syndrome, neuromuscular disorders) and profound intellectual impairment (intelligence quotient
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Family carers of included persons over the age of 18; were the reference person contacted for all medical, administrative and social questions; and agreed to participate. Parents, siblings and other family members were eligible. In the second wave, due to the low participation rate (
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Institutional carers of included persons over the age of 18; be the institutional referring caregiver for at least one patient included in the cohort; and agreed to participate (the institutional referent caregiver was appointed by the healthcare team for each patient with multiple disabilities; he was the resource person who had to coordinate the various issues concerning the patient, such as care, family contact, administrative and social). problems).
The exclusion criteria for people with multiple disabilities were age at inclusion
General procedure
The initiation of each wave of the cohort study is based on the collaboration between a specialist in neuropediatrics (Pr Thierry Billette de Villemeur) and a specialist in epidemiology (Pr Pascal Auquier). A steering committee made up of a doctor treating people with severe multiple disabilities (Dr Marie-Christine Rousseau), an epidemiologist (Dr Karine Baumstarck) and psychologists (Tanguy Leroy, Lionel Dany) carried out the investigation. This committee is in charge of the general organization of the study: coordination, regulatory issues, search for solutions in the event of malfunction. All study partners (doctors and scientific, administrative and logistical actors) make up the EVAL-PLH group [see Additional file 1. The EVAL-PLH group]. Data was collected from the first 2 assessments. The first wave was organized between 2015 and 2016, the second wave was organized between 2020 and 2021, and the third wave is planned for 2025-2026.
Each wave is organized according to the following stages:
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Persons with multiple disabilities: The list of eligible patients is drawn up by a dedicated clinical research assistant in each center and checked by the patients’ referring physicians. Clinical data was collected from medical records. The list of eligible patients is updated with each wave (declaration of deceased persons, identification of new cases and investigation of patients who change centres). The data is collected by a doctor (permanent or not) of the center. The doctor has experience of people with multiple disabilities and is encouraged to question the healthcare team in charge of the person.
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Family caregivers: A maximum of 2 family referents are systematically identified for each person included. Contact details are updated as much as possible. A survey booklet is mailed to each family referent. To optimize participation, a prepaid return envelope addressed to the coordination team is attached to the mail. In the event of non-response, a reminder system is provided.
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Institutional caregivers: The members of the steering committee hold meetings with the institutional caregivers of each center to explain the objectives and methods of the study. A self-survey booklet is given to each referring caregiver who volunteers to participate. No details are given concerning the place where they had to fill in the booklet (at the hospital or not). To optimize participation, a reminder system is provided.
Data gathering
Various data sources are used. An additional details file shows this in more detail [see Additional file 2, Data collection details]
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For people with multiple disabilities, data is collected from the medical file: sociodemography, severity and stability, associated disabilities, comorbidities, neurodevelopmental patterns, medical devices, rehabilitation procedures and medical treatments.
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For family carers, the data is compiled in a booklet including the following elements: socio-demographic data, nature of their relationship with the person with multiple disabilities, marital status, number of children, level of education, professional status, financial situation, presence of person with multiple disabilities at home, personal health data (chronic illnesses; use of health resources), psycho-behavioural data (anxiety, mood disorders, coping, quality of life, burden) and specific information on the social environment and satisfaction with health care.
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For institutional caregivers, the data is collected in a booklet including the following elements: socio-demographic data, marital status, number of children, level of education, financial situation, concept of disabled person living at home, personal health data, situation professional (job categories, work schedule, experience in disability care) and psycho-behavioral data (anxiety, mood disorders, coping, quality of life, burn-out).
Data quality, data monitoring and statistical aspects
Data quality is ensured by the clinical research assistant dedicated to the study (AB). The data entry plan and the data monitoring plan have been validated by the operational committee (including the clinical research assistant (AB), the statistician (IH), the referent epidemiologist (KB), and the doctor experienced in multiple disabilities (RCM)). The promoter (Assistance Publique des Hôpitaux de Marseille) carried out a test audit at the end of the 1st wave including the number of participants and the collection of consent. The second audit test is planned for 2022 for the second wave. No independent audit was planned. The database is stored securely in the dedicated department of the sponsor (Department of Epidemiology, Service of Epidemiology and Health Economics, Assistance Publique des Hôpitaux de Marseille, France. Pr Pascal Auquier (PA) is responsible for the department and of the referent epidemiologist for EVAL-PLH is Dr Karine Baumstarck (KB) Database security and confidentiality are based on the appropriate French directive (the French National Commission for Data Protection (CNIL) has published a new reference concerning the processing of data in health research to adapt the existing framework to the European General Data Protection Regulation (GDPR) (1) Cross-sectional study of populations (people with multiple disabilities, family caregivers and institutional caregivers) assessed at the 2nd wave: description of tive data and identification of determinants (health, psycho-behavioral profiles, quality of life); and (2) Study longitudinal for people assessed in the first 2 waves: analyzes of the evolution over time of clinical data, psycho-behavioral data, quality of life, identification of predictors and description of care pathways. The SAP is available upon reasonable request.
Ethical approval and consent to participate
All methods were performed in accordance with relevant French guidelines and French regulations. The research was approved by the French ethics committee (name: Sud Méditerranée V Personal Protection Committee; postal address: CHU·HOPITAL DE CIMIEZ, Nice, France; website: https://www.cpp-sud- mediterranee-v.fr/; date of approval: 20/10/2014; reference number: 2014-A00953-44; registration number: 14.041). All experiments were performed in accordance with current guidelines and regulations. The research was carried out in accordance with the Declaration of Helsinki. A written consent form was obtained from each participant and/or their legal guardians.
Consent to publication
A written consent form was obtained from each participant and/or their legal guardians.
