- How many respiratory samples should be taken by each sentinel?
This may vary, but based on experience from the British Columbia Centre for Disease Control (BCCDC), it is anticipated that an average of one to two specimens a week (25 in total) may be submitted per sentinel physician over the course of the study period. In the national collaboration between British Columbia, Alberta, Ontario and Quebec, we are aiming for a total of 3,000 respiratory specimens as part of this study.
- When should I start taking samples from patients presenting with symptoms of influenza-like illness this year?
Once you receive the information package and testing kits, you can start submitting samples right away.
- Which patients are eligible for the vaccine effectiveness study?
Any patient who is a resident of Ontario, who presents in your practice with symptoms of ILI (as per the FluWatch definition) within one week of first ILI symptom onset.
You should collect respiratory specimens (nasopharyngeal or nasal preferred) using the test kits for influenza testing.
You will be notified if specimen collection for the purpose of this study will change. Please note that it is important that you collect respiratory specimens from all patients who are residents of Ontario and who are presenting within seven days of ILI onset, whether they received the influenza vaccine or not.
- Should I submit study samples to the laboratory to which I usually send respiratory specimens?
For the purpose of the study, you are required to ship the respiratory specimens associated by the completed Laboratory requisition form only to Toronto Public Health Laboratory by Purolator.
- Will I be compensated for my time?
Your time, effort and participation is much appreciated. Participating sentinels will be compensated $10 for each sample submitted with a completed study requisition. Reimbursement will be made at the end of the study period.
- Has this study received ethics approval and if so, what special ethics requirements are there?
This study methodology has been reviewed by ethics boards in each participating province as well as the Health Canada ethics board every year that it has been conducted since 2004. This means that separate ethics review and approval has been granted in each of British Columbia, Alberta, Ontario and Quebec, as well as by the Health Canada ethics board (five separate reviews). For the 2010-11 season, an application for ethics renewal will be submitted. As part of the study, sentinel physicians are required to inform their eligible patients and elicit verbal consent to participate through specimen collection and questionnaire completion. A verbal consent script has been drafted by study investigators for this purpose.
- Who else is participating in this study?
In each participating province, a team of epidemiologists and laboratory investigators has been established. These investigators have been working collaboratively for several years and Ontario investigators and sentinel physicians will again join that team of provincial investigators this season.
- How will vaccine effectiveness be derived?
Vaccine effectiveness against laboratory confirmed influenza is calculated in this study based on a case control design. Using the laboratory results (both positive and negative for influenza) and the answers to the simple questions accompanying the laboratory requisition, vaccine status is compared to those with and without influenza. The study is predicated on the understanding that not everyone with influenza-like illness will have influenza. Those who test negative become the controls.
- Where will this analysis be done nationally, and how will confidentiality be preserved?
Since 2004, an overall vaccine effectiveness result has been derived for all participating provinces combined nationally through statistical analysis at the BC Centre for Disease Control (BCCDC).
Data from Quebec, Ontario and Alberta that is shared with the BCCDC in deriving this combined estimate does not include any personal identifiers and conditions as specified by ethics boards. Absolutely no personal identifying information will be transmitted. Only the influenza test result and relevant epidemiologic information provided on the requisition are shared for the sole purpose of deriving an aggregate vaccine effectiveness result. At each level, all data is stored in a secure and locked facility. Dr. Danuta Skowronski, principal investigator, is located at the BCCDC.
- Do I need special equipment for the study?
Testing kits will be provided to all sentinels. We recommend that specimens be shipped as soon as they are collected; however since this may not be possible, specimens are to be maintained at a temperature of 4°C until transported to the lab. Fridges used to store specimens should also have a freezer compartment to store the ice packs needed for specimen transport to the laboratory.
- Where can I get more information about what else is circulating in my area?
Please refer to the Laboratory Surveillance Report that can be found at: http://oahpp.ca/h1n1
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