Influenza Research in 2008-2009 continued

A Difficult Influenza Season


The study began in February 2009, accepting patients who presented at the hospital site fitting all inclusion criteria, including a positive influenza quick test, and willing to participate in the study.  Unfortunately, a number of factors contributed to a very low patient yield over the 2 month course of the study.


The first problem was an interesting one that deserves more discussion in and of itself at another place and time.  The incidence of positive influenza infection within the ILI patient population was incredibly low, less than 20% in the Portland region.  When contacting the CDC and Oregon State Public Health, what became clear very quickly was that in addition to the influenza season being very mild to begin with, the likelihood of the illness being influenza and not other upper respiratory infections was very low, and in fact lower than anywhere else in the country for this flu season.  In other words, Portland was the worst location to run a flu study in the whole country, with rates of influenza as compared to overall ILI a fraction of that seen in other areas of the US.


Reinforcing this problem was our resource limitations.  Our budget, which was around $50,000, quickly ran out, despite many people working on a completely voluntary basis to support the study.  Because of our limited funds, we were unable to run the study at multiple sites in different areas of the country, which may well have helped us side-step the first problem of low incidence.  Ideally, the study would be run at several locations simultaneously throughout the country, both to ensure a higher influx of flu-positive patients, but also to test the ability of the questionnaire tool to be effectively applied in different health care settings.  


A third factor was undoubtedly the global financial crisis that had hit a couple of months earlier.  By the time our study was in full swing, financial panic had hit the world in general and the US in particular, and one of the ways we noted this was that the overall number of patients seeking attention was diminished.  In other words, it is probably that many who had fallen ill were more likely to stay home, rather than see a health care provider or physician.  In fact, the urgent care center where we were running the study noted a decided diminishment of patients complaining of ILI during this particular season.


As a result of these issues, we were able to confirm our methodology, documents, patient interview, and follow-up protocol, but were unfortunately unable to reach our needed goal of patient numbers to assess the remedy itself.  So while we were seeing patients outside the study who were responding nicely to the remedy, in Portland the numbers coming into this site were insignificant.  What is interesting, however, is that there were a significant number of patients who presented to the study and fit the influenza inclusion criteria, as well as the genus epidemicus questionnaire, but who tested negative on the quick-flu test nonetheless.  The implication of this finding alone is that while many patients may have some other respiratory illness and not the actual influenza virus, they may still present with the genus epidemicus symptom picture, and thus be expected to have a positive outcome from taking that remedy.  This phenomenon speaks to the roles of co-evolution and epigenetic change in seasonal/endemic/epidemic illnesses like influenza, RSV, and/or Strep.   


One of the tools assessed in this pilot study is which laboratory test to use to confirm that the patient being seen has influenza, as opposed to another ILI.  Ideally, we would have used viral culture, the gold-standard in influenza testing, to confirm diagnoses, but we did not have the resources to do so.  In addition, in a true pandemic situation it is likely that a quick test would be used due to the time and resource constraints that would be in place.  It turned out that the kit we used indicated that only around 10% of the patients coming to see us with ILI actually tested positive for the flu, and therefore only those individuals were included. Because this percentage was very similar to what the CDC was finding in the site area, however, we felt it confirmed the soundness of our patient inclusion methodology, and reconfirmed the need to run multi-center studies in the future.


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