Before you publish
The results of work carried out using Constances data made available as part of a project must be made public, in the form of scientific publications, presentations, reports, theses or dissertations, etc.
Before finalizing your manuscript
Before finalizing the manuscript, ensure compliance with the “Dissemination of research results” guidelines outlined in the Constances cohort access charter.
In particular, the names of at least two members of the Constances team (the project referent and the Constances principal investigator) must appear as co-authors. Any scientific output must clearly state that the research was conducted using the Constances cohort, the mention that the research was carried out within the Constances cohort must be made in any scientific production: the word “Constances” must appear in the title or at least in the abstract, and the DOI: doi.org/10.13143/inserm_constances must be included in the “Methods” section of the manuscript.
Whenever possible, Constances publications should be published in Open Access and archived on the HAL platform.
Information to be included in the manuscript
A STROBE Statement is available.
Constances Cohort description text
The Constances cohort was designed as a random sample of French adults aged 18 to 69 years at the time of inclusion. Approximately 220,000 volunteers were enrolled between 2012 and 2019. At baseline, selected participants were invited to complete self-administered questionnaires and to attend a Health examination center for a comprehensive medical check-up. A biobank containing blood and urine samples was also created. Participants follow-up includes an annual self-administered questionnaire (paper or internet), a medical examination every four years, and yearly linkage with national medico-administrative databases. Virtually none of the participants are permanently lost to follow-up, as they are passively monitored in these national databases on an ongoing basis.
Data collected from participants include their demographic characteristics, socio-economic status, life events, behaviors, and occupational attributes. In addition to questionnaires and health examinations, medical and social data are obtained through linkage with French national medico-administrative databases, including the National health data system (Système national des données de santé, SNDS). Overall, available health data cover a wide range of topics, including self-reported health scales, clinical and paraclinical examinations, occupational and residential environments, prevalent and incident diseases, chronic conditions, hospitalizations, work absences, disabilities, healthcare use, and mortality (including causes of death).
For descriptive studies presenting population prevalence or incidence estimates, and to address non-participation at inclusion and attrition during longitudinal follow-up, a representative random cohort of 440,000 non-participants was created. This cohort is linked to the same national administrative databases as the participants, allowing for follow-up of similar same socio-economic and health data. It enables the analysis of personal, socioeconomic, and health factors associated with participation, and supports the development of statistical weighting techniques to estimate population-weighted prevalence or incidence of various health indicators in the general French population.
Regulatory and ethical approvals
The authors certify that all procedures performed in the study complied with the ethical standards of the relevant national and institutional committees on human experimentation and with the 1975 Declaration of Helsinki, as revised in 2008. All procedures were approved by the Institutional review board (IRB) of the National institute of health and medical research (Inserm) (Opinions No. 01-011 and No. 21-842), and authorized by the French data protection authority (Commission nationale de l’informatique et des libertés, CNIL) (Authorization No. 910486). The biobank received a favorable opinion from the Research ethics committee (Comité de protection des personnes) (CPP Sud Est I, Opinions No. 2018-32) and was authorized by the CNIL (Authorization No. DR-2-2018-137). All volunteers signed written informed consent for their participation in the Constances cohort, and when applicable, for inclusion in the biobank (ethical approvals, authorizations, and consent procedures are available under the “Rights and data protection” section of the Constances website).
Funding
The Constances cohort is supported and funded by the French national health insurance fund (Caisse nationale d’assurance maladie, CNAM). Constances is recognized as a “National infrastructure in biology and health” and receives funding from the French national research agency (grant ANR-11-INBS-0002). The cohort is also marginally funded by private sector companies, notably from the healthcare industry, within the framework of public-private partnerships. None of these funding sources played any role in the study design, data collection and analysis, or the decision to publish the findings.
Acknowledgements
The authors thank the team of the Epidemiological Population Cohorts Unit in France (UMS 011 – Inserm, Universités Paris Cité, Paris Saclay, Versailles Saint-Quentin), which designed and manages the Constances cohort. They also acknowledge the French national health insurance fund (Caisse nationale d’assurance maladie, CNAM) and its Health examination centers for collecting a large part of the data, as well as the French national old-age insurance fund (Caisse nationale d’assurance vieillesse, CNAV) for their contribution to the establishment of the cohort, and ClinSearch for performing data quality control.
Data access and availability
The data used in this study are not publicly available. Access can be granted upon approval of a research proposal by the Constances cohort international scientific committee and provided the project meets the legal requirements set by the French data protection authority (Commission nationale de l’informatique et des libertés, CNIL) under the General data protection regulation (GDPR). The use of cohort data is governed by the Constances cohort access charter. The data access procedure is available on the Constances cohort website (https://www.constances.fr/, “Scientific area” / “Access to Constances”).
References that can be included in References section of manuscript
- Zins M, Goldberg M, and the CONSTANCES team. The French CONSTANCES population-based cohort: design, inclusion and follow-up. Eur J Epidemiology. 2015 Dec, 30(12):1317-1328. doi: 10.1007/s10654-015-0096-4. [General presentation of the cohort]
- Goldberg M, Carton M, Descatha A, Leclerc A, Roquelaure Y, Santin G, Zins M; CONSTANCES team. CONSTANCES: a general prospective population-based cohort for occupational and environmental epidemiology – Cohort profile. Occup Environ Med. 2017 Jan, 74(1):66-71. doi: 10.1136/oemed-2016-103678. [Focusing on the environment and occupational hazards]
- Henny J, Nadif R, Le Got S, Lemonnier S, Ozguler A, Ruiz F, Beaumont K, Brault D, Sandt E, Goldberg M, Zins M. The CONSTANCES Cohort Biobank: An Open Tool for Research in Epidemiology and Prevention of Diseases. Front Public Health. 2020 Dec, 8:605133. doi: 10.3389/fpubh.2020.605133. [Biobank presentation]
- Ruiz F, Goldberg M, Lemonnier S, Ozguler A, Boos E, Brigand A, Giraud V, Perez T, Roche N, Zins M. High quality standards for a large-scale prospective population based observational cohort: Constances. BMC Public Health 2016 Aug, 16(1):877. doi:10.1186/s12889-016-3439-5. [Health exam data]
- Santin G, Herquelot E, Guéguen A, Carton M, Cyr D, Genreau M, Goldberg S, Gourmelen J, Hourani I, Ozguler A, Pascal P, Ribet C, Salem E, Goldberg M, Zins M. Estimation de prévalences dans Constances : premières explorations. Bull Epidémiol Hebd. 2016;35-36:622-9. [Weighting data]