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thank you Dan, Terry,

The researchers asked 228 Hutterite colonies (with 70-120 residents) and 48 colonies were enrolled. Interestingly, 20 Hutterite colonies were not eligible because they did not vaccinate. I think these 20 nonvaccinated colonies would be good for an unvaccinated group.

Dan mentions secondary outcomes, indeed I think I am guilty of focusing on a secondary outcome and looked whether overall the intranasal or injected flu vaccine was effective - as far as I understand the article's statistical language, it appears not? 

The authors themselves kept to the primary outcome. But that is, I think, where the impression/deception is created, by stating, that intranasal  "LAIV does not provide better community protection against influenza than (injected) IIV." The way it is put in words, to me, gives the impression that both provide protection against influenza, when it doesnt?

Which is also the questionable? headline in the BMJ :
"Intranasal flu vaccine provides similar protection to injected flu vaccine, finds study"
http://www.bmj.com/content/354/bmj.i4481






On Thu, Aug 18, 2016 at 2:45 PM, Mayer, Dan <[log in to unmask]> wrote:

 

Dan Mayer, MD, FAAEM, FACEP
Professor Emeritus of Emergency Medicine
Albany Medical College
Albany, NY, USA

Hi all,

 

Not having read the articles and basing my (lack of) knowledge on what was presented in the thread, I would suggest that the primary purpose of the study was to compare LAIV and IIV, which were no different in this community.  Also, the study found (not primary outcome) that the rates of influenza were the same in unvaccinated members (children only?) of the same community.  This certainly can be an example of "herd immunity".  I think I'm using the right word to describe this.  The children are immune and they don't bring "influenza" home to the other members of their families, who will show a similarly low rate of infection.

 

Is this a unique community?  Are there some differences between their "lifestyles" those of other communities?  This looks at the external validity of the results, which must be taken into consideration before using the results.

 

Glad that we are discussing this thread as it shows the intricacies of study interpretation especially when dealing with secondary outcome, that are so often heralded as the main (reportable) outcome.

 

Best wishes


Dan

 

 

From: Evidence based health (EBH) [EVIDENCE-BASED-HEALTH@JISCMAIL.AC.UK] on behalf of Wouter Havinga [[log in to unmask]]
Sent: Thursday, August 18, 2016 7:12 AM
To: EVIDENCE-BASED-HEALTH@JISCMAIL.AC.UK
Subject: Re: [EXTERNAL] Acceptable? BMJ & Ann Intern Med. misleading use of words - influenza vaccine study

I think the BMJ news article is correct in saying "There was no significant difference in confirmed rates of infection with influenza A or B between the non-vaccinated people living in the same communities as the vaccinated children (1.03 (0.85 to 1.24))" 
because in the "Discussion" of the original article it says "The relative attack rates between the groups in vaccinated children and nonvaccinated persons were consistent with findings of the overall effect"

In other words, as I understand it, one can just as well give sugar water but the authors imply "community protection" with their use of words, that both flushots work: 
"Our results suggest that vaccinating children with LAIV does not confer better community protection against influencza than IIV"

I find this misleading, but considered acceptable to the Canadian Institutes of health Research (grant 123266), Public Health Agency of Canada, and Canadian Institutes of health Research Influenza Research network and Annals of Internal Medicine and BMJ?



On Wed, Aug 17, 2016 at 7:48 PM, Shaneyfelt, Terry <[log in to unmask]> wrote:
The BMJ news article appears to have it wrong by my reading. Here is the Annals results you mention as being misleading: "  "For the primary outcome, we found no significant difference between LAIV and IIV (pooled HR, 1.03 [95% CI, 0.85 to 1.24]) (Table 2)." The study mentions nothing about unvaccinated in the main results related to his HR.

Don’t get your flu shot if you don’t want it.

-----Original Message-----
From: Evidence based health (EBH) [mailto:EVIDENCE-BASED-HEALTH@JISCMAIL.AC.UK] On Behalf Of Wouter Havinga
Sent: Wednesday, August 17, 2016 5:17 AM
To: EVIDENCE-BASED-HEALTH@JISCMAIL.AC.UK
Subject: [EXTERNAL] Acceptable? BMJ & Ann Intern Med. misleading use of words - influenza vaccine study

I can imagine the outcry from the EBM community if the study treatment was a herbal lollypop but when the topic is the "flu shot" people remain silent?

This is the headline in the BMJ :
"Intranasal flu vaccine provides similar protection to injected flu vaccine, finds study"
http://www.bmj.com/content/354/bmj.i4481

However, the BMJ news article continues with:
"There was no significant difference in confirmed rates of infection with influenza A or B between the non-vaccinated people living in the same communities as the vaccinated children (1.03 (0.85 to 1.24))."

The title of the original research in Annals of Internal Medicine says:
"Live Attenuated Versus Inactivated Influenza Vaccine in Hutterite Children: A Cluster Randomized Blinded Trial" http://annals.org/article.aspx?articleid=2543271
This original article doesn't even mention in their abstract that there was no significant difference between the vaccinated and non-vaccinated.

To me these are clear examples of misleading use of words.

How should the (EBM) community respond to this, in view of overdiagnosis and use of study money to make misleading claims and what about, as such, abusing the study population's trust (or did the Hutterite participants receive money to be complicit?)

Dr Wouter Havinga, locum GP, NHS, UK
GMC 3578256

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