ITMO public health
Last update : 09/28/2015 | Version : 1 | ID : 73183
| General | |
| Identification | |
| Detailed name | Longitunal study on patients with locked-in syndrome: quality of life and evolution over a 6-year period |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Disability/handicap Neurology Rare diseases |
| Pathology (details) | locked-in syndrome |
| Health determinants |
Social and psychosocial factors Others (specify) |
| Others (details) | Quality of life |
| Keywords | Locked-in-syndrome; quality of life; Anamnestic Comparative Self-Assessment; determinants |
| Scientific investigator(s) (Contact) | |
| Name of the director | Rousseau |
| Surname | Marie-Christine |
| Phone | + 33 (0)6 70 90 30 90 |
| marie-christine.rousseau@ssl.aphp.fr | |
| Unit | Médecine Physique et Réadaptation |
| Organization | AP-HP |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Public |
| Details | APHP |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | AP-HP |
| Organisation status |
Public |
| Presence of scientific or steering committees |
No |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A population file |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | This study was performed with the active collaboration of the French Association of Locked-in syndrome (ALIS) |
| Database objective | |
| Main objective | We performed a survey of a population of LIS patients to describe the course of the QoL of LIS patients over a 6-year period and to determine the potential predictive factors of QoL changes over time. |
| Inclusion criteria | The inclusion criteria were the following: adult patients, patients with LIS diagnoses according to the description of Plum and Posner [17] (i.e., complete or near-total loss of motor function, preservation of eye movements, anarthria, and preserved consciousness and intellectual function), and patients who agreed to participate. The exclusion criteria were the following: minors, and patients with major motor recuperation. |
| Population type | |
| Age |
Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2007 |
| Date of last collection (YYYY or MM/YYYY) | 2013 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | Questionnaires were sent to 197 patients in 2007, the same questionnaire was sent again in 2013 to the 67 patients who responded in 2007. |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Declarative data |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | sociodemographic data, including gender, age, living status, marital status, children, educational level, income, and religious status; type of LIS (total, classical, or partial), disease duration, etiology, physical/handicap status (gastrostomy, tracheotomy, urinary probe, pain, wheelchair use), communication ability, psychological status (presence of anxiety/depression and suicidal thoughts), self-reported QoL as assessed with the Anamnestic Comparative Self-Assessment (ACSA), French Reintegration to Normal Living Index (RNLI) (participation in recreational and social activities and movement in the community), end-of-life issues, i.e., the wish to be reanimated and willing for euthanasia. |
| Presence of a biobank |
No |
| Health parameters studied |
Quality of life/health perception |
| Quality of life/perceived health (detail) | Self-reported QoL as assessed with the Anamnestic Comparative Self-Assessment (ACSA), which provides an overall global assessment of the quality of life. |
| Procedures | |
| Participant monitoring |
Yes |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Other information | Rousseau MC., Baumstarck K., Alessandrini M., Blandin V., Billette de Villemeur T., Auquier P. Quality of life in patients with locked-in syndrome: evolution over a 6-year period. Orphanet Journal of rare Diseases ; 2015 : 10(1):88. |
| Access | |
| Presence of document that lists variables and coding procedures |
No |
| Terms of data access (charter for data provision, format of data, availability delay) | This study was performed with the active collaboration of the French Association of Locked-in syndrome (ALIS), a non-profit association that was created in 1997 to help and support LIS patients and their families. The contact information of the LIS patients was provided by the ALIS, questionnaires were sent by ALIS to LIS patients in 2007 and in 2013, then the patients completed the self-report questionnaires. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
| ABOUT | CATALOG | RESOURCES | USEFUL LINKS |
This site complies with the HONcode standard for trustworthy health information: |
8 rue de la Croix Jarry 75013 Paris Phone : +33 1 44 23 67 47 |
Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05
