Wanted: 1,000s of households for H1N1 study - May 12, 2009
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Posted for Declan Butler
French scientists this week proposed an international scheme to monitor closely how the new H1N1 swine flu associated strain behaves in the population. The proposal was presented a meeting of flu scientists in Rennes yesterday by Antoine Flahault, dean of the French School of Public Health, which is based in Rennes and Paris.
The proposal suggests creating within three months a system to track the impact of the new flu strain in a standardized way in 1,000 households in as many countries as possible, with surveillance continuing until at least the end of 2010. It suggests the World Health Organization might be one appropriate coordinator.
Under the proposal, the network would report in almost real time basic epidemiological variables such as the proportion of the cohort infected, ill, and asymptomatic, as well as clinical data on case severity and symptoms. The network would also look at such things as local antiviral availability, and precautions being taken.
It is too soon to say if the project has legs. Participating states would be asked to fund their own 1,000 household studies, but Flahault says he's confident he can easily find core funding for running the network.
Nature quickly ran the idea past one top US epidemiologist. Here's what he had to say:
I like the idea that we should be setting up some systematic way to harvest the experience of watching a pandemic unfold in real time. Whether this is a realistic or desirable study design needs some serious reflection and discussion. Perhaps there are more efficient and feasible alternatives.It also seems to me that the fact of keeping this cohort under observation will affect the outcomes of some of these variables. So my first take is that starting some kind of system to collect information, including biological samples from around the world, is a good idea, but whether this proposal is the one to implement I am less sure.
"Nothing is currently fixed," says Flahault, adding that he is flagging the idea, but open to considering and participating in alternative flavours of the same basic idea, while moving ahead on his own proposal. Flahault admits to being unsure about how much country buy-in the proposal will get.
"It is absolutely crucial and necessary to launch [such a project], he says, however, "We need to document precisely what is the status in 1,000 families in Mali, Bolivia, Laos, UK, France, Siberia, Bulgaria, USA, and so on. 1,000 families is probably enough if we estimate an attack rate around 30%."
Comments
WHO-CoPanFlu: WHO international multicenter project « Cohorts for Pandemic Influenza »
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).
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.
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 to WHO and may contribute to the monitoring of the pandemic at a global level.
- What will be attack rates in each sample of the participating member state, 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 each member state.
A standardized core protocol shared by all participating member states,
- 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 member state 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, ASPHER and all other proposed stakeholders
Agenda
Decision by WHO: ASAP (before May, 15th)
Search for partner: before May 31st and reactive writing of the study core protocol.
Kickoff meeting: First week of June 2009
Start of the inclusions: ASAP, mid June for the first ready countries? South hemisphere should be the priority.
Funding
Each participating member state should fund its own national study and are 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.
Posted by: FLAHAULT Antoine, MD, PhD | May 13, 2009 07:38 AM