Presented by Prof. Antoine Flahault, MD, PhD, Dean of EHESP French School of Public Health (Ecole de Hautes Etudes en Santé Publique), and President-Elect of the Association of the Schools of Public Health of the European Region (ASPHER) and Dr Fabrice Carrat, senior lecturer, hospital physician at University Pierre and Marie Curie (Paris) and researcher in the Inserm UMR-S 707 unit.
In the context of the emerging pandemic influenza, it is urgent to setup a multicenter international cohort project, involving each WHO member state, proposing them to document, assess and follow-up at an individual level the coming pandemic influenza in a standardized way, from a representative samples of at least 1000 households in each country. This should start as early as possible and last at least until the end of 2010.
The 1st research seminar was hosted by the EHESP in Rennes, 11 May 2009
Download the minutes (pdf, 356 ko)
Questions and Objectives
To assess health and social impact of the pandemic influenza in a representative sample of households at a global level.
- How the dynamic of the pandemic evolves within households, in each country, at a regional and global level? How many waves, when and of what amplitude? A real time electronic reporting from each national study coordinator could be of help and may contribute to the monitoring of the pandemic at a global level.
- What will be attack rates in each sample of the participating countries, and at a regional and global level?
- What is the proportion of asymptomatic or paucisymptomatic infections?
- What is the observed case-mix, the percentage of severe cases, the description of the natural history of the disease and underlying conditions, complications, and deaths if any?
- What is the use of antivirals, antibiotics, vaccines and other drugs? Questions on their field accessibility, compliance and efficacy.
- What is the use of protective masks, hand wash?
- What are the trends regarding viral mutation, co-circulation, potential for mismatching in case of the use of a vaccine, identification of antiviral resistance emergence?
- What is the role of co-infections with other infectious agents, such as plasmodium, HIV, dengue fever, or any documented agents?
- What is the risk perception level and its trends with time in each country sample?
- What is the level of knowledge, attitudes and behaviors in these various population and their trends with time?
- What is the economic burden of the pandemic on the participating households, in terms of direct (drugs, vaccines, hospitalization,…) and indirect costs of the disease, (days of sickness leaves, loss of income,…)?
- What is the impact of seasons and climate variability on the epidemic dynamics?
- Other questions and objectives to be discussed within the International Scientific Committee
Methods
A cohort followed up to 2 years from a representative sample of at least 1000 households in country.
A standardized core protocol shared by all participating countries,
- including a set of variable to be regularly measured within the cohort and according to a standardized questionnaire translated in each appropriate language, and administered by trained interviewers supervised by a national study coordinator;
- including a set of biologic samples to be collected with a standardized protocol of storage and analyses;
- following each national regulations in terms of confidentiality and ethics, with the declared willingness of sharing on a real time basis all collected core data, with the respect of each participating country ownership of data and sample collection.
Study coordination
Principal Investigator (proposal)
Fabrice Carrat, EHESP-Inserm-UPMC, Paris, France
Steering Committee (proposal)
To be suggested by WHO
Scientific Advisory Board
to be suggested by WHO, EHESP, LSHTM, ASPHER and all other proposed stakeholders
Agenda
Decision by WHO
ASAP (before May, 15th)
Search for partners
before May 31st and writing of the core study protocol.
Kickoff meeting
26-27 June 2009
Les Pensières, Annecy, Conference Center founded by Fondation Mérieux
Start of the inclusions
ASAP mid July for the first ready countries? South hemisphere should be the priority.
Funding
Each participating member state should fund its own national study and is asked to co-fund the coordination of the study. Technical, scientific and logistic assistance is provided by the PI and Steering Committee on request.
PI and Steering Committee are funded for study coordination, data and sample collection, storage, shipment, analysis, and distribution.
