The surveillance depends on:
1. The declarative data of the Nutrinautes (in the health questionnaires and the dedicated website)
The means used in the collection of data concerning health events that occur during the follow up period of the NutriNet-Santé study and the validation of such events on medical basis, are well explained in the side document one can download from the site. However, the validation of diseases, which are the judgment criteria for the NutriNet-Santé study, requires a direct access to complementary medical documents enabling independent specialists to make a clear and precise diagnosis and to classify such diseases according to the International Classification of Diseases (ICD) of the WHO.
For this purpose, the team in charge of setting up the NutriNet-Santé study would like to collect, from the participants at the study and on a voluntary basis, precise and documented information on health events (principal and secondary judgment criteria) occurring during the 10-year follow up period. Such collection guarantees a maximum level of data security and confidentiality in the study of health-nutrition relationships.
2. The surveillance of the Nutrinautes health using medico-administrative database
Surveillance of mortality and causes of death
Data on the vital status and causes of death will be obtained following the procedure described in decree 98-37 that authorises the access to the RNIPP and the database of CépiDc-INSERM. Such procedure is simple and efficient (except for the non-French, born abroad persons who are hard to trace).
Surveillance of health events
Health events will be retrospectively evaluated at year 3, 5 and 10 of the study; this evaluation is largely based on the existent medico-administrative databases (whenever available for the research team) and on the scientific and technical management board of cohorts and big epidemiological trails (Plastico project).
- For health events, the access to the national information system of Health Insurance (SNIIR-AM in French) can provide an access to individual medical data which are structured and coded in a standardised way. This system comprises data on the expenditures of all Health Insurance regimes; by geographical zone, by nature of expenditures, by category of professionals who are in charge of these expenditures and by sector (professional or enterprise).
- The reimbursement database of the Health Insurance service provides useful information on medical prescriptions only that it doesn’t comprise information on the nature of the treated illnesses, and evidently it does not provide information on over-the-counter medications and the non reimbursed benefits.
- Chronic diseases database (ALD in French) regroups all affiliates who are exonerated from co-payment with agreement of the medical service of Health Insurance that codes the exonerated illnesses according to the International classification of diseases (ICD10).
- Database of programme of medical information systems of hospitals (PMSI in French) comprises, for each hospital admission, information on the principal diagnosis, associated diagnoses, age, sex and the most expensive diagnostic or therapeutic actions. The diagnoses are coded according to the ICD10, and the actions according to the common classification of medical acts (CCAM in French).
Database of the National Insurance Fund for retirement and old ages (Cnav in French)
The study has obtained a State Council decree regarding the automated treatment of personal data within the NutriNet-Santé study (n°2013-175 from 26/02/2013)
Aiming at the creation of a comprehensive health status database without creating an extra burden for participants, we have applied for access to the national SNIIRAM database (Système national d’information inter régimes de l’assurance maladie) with the explicit consent from each participant. Thus, we would like to ask each participant whether he/she would be willing to provide their social security number (NIR) via a secure interface and in observance of all applicable laws. This information will be collected solely for the purpose of collecting data on healthcare expenditures, medication use, and health services use, which will complete our health status database. This data collection will be carried out by staff researchers in charge of the study. The acquisition of a State Council decree was deemed necessary given the legislative restrictions regarding access to the NIR.
For that purpose, we initially obtained permission from the Health Data Institute (Institut des Données de Santé, IDS), in observance of the National Social Security Code. Following a meeting with Pr Hercberg and a deliberation, the IDS granted its approval in September 2010. Next, approval was obtained from the CCTIRS on 17/11/2011 (file n°11.675) regarding «the supplementary collection of NIR from volunteers participating in the NutriNet-Santé study, which will permit access to personal data stored in SNIIRAM.» Next, approval was obtained from the National Health Insurance Council (Conseil de la Caisse nationale de l’assurance maladie des travailleurs salariés, CNAMTS) on 25/09/2012. The CNIL also provided its approval (Deliberation n°2012-260, permitn°12013236 from 19/07/2012, JO from 28/02/2013) with an order from the State Council regarding the treatment of personal data for health research purposes within the NutriNet-Santé study.
The State Council has announced the Decree on 26/02/2013 (n°2013-175) regarding the automated treatment of personal data within the NutriNet-Santé study. It authorizes the collection of the NIR from participants who have consented to providing that information, and the respective link with national SNIIRAM medical database.