A Press Release!

Please excuse my exuberance. This is my first, ever, press release thanks to FirstEditionDesignPublishing.com! It feels good to get this done, and I thank Thea Tlsty and Philippe Gascard for their insights and hard work while working on the DCIS Dilemmas eBook. Click on the image for the full press release.

DCIS Dilemmas eBook - Press Release

Now on to 2016 – Happy New Year!

Full-Fledged Flu

‘Tis the season, folks. Fancy the opportunity to find flu facts while falling onto the sofa. I fear I may have infected a few as I felt the forceful signs form within. Of course, my bout came from fellow flyers during my fortnight of travel. For those flummoxed by my fanciful alliteration, I have an excuse – I’m under the influence of influenza. The Flu I.Q. widget is an interactive quiz to test your flu knowledge.

First, some flu facts, according to the US Center for Disease Control and Prevention (CDC):

  • Flu cases start in October/November, usually peak in February and can last until May.
  • Flu vaccines kick in about 2 weeks after you get them, so now is the time!
  • Flu strains (types) differ each year, hence the call for yearly flu vaccines.
  • Almost everyone over 6 months old should get a vaccine. That means you, since you can read.
  • The flu is caused by a virus, so antibiotics DON’T work!
  • People who are at higher risk of flu complications should get antiviral drugs once they have the flu.
    • This includes: kids under age 2, adults over age 65, pregnant women, people with some medical conditions, or those who are hospitalized with the flu.
  • Check out “What You Should Know About the 2015-2016 Influenza Season.”

Vaccines: To Take or Not To Take

The Flu I.Q. widget is an interactive quiz to test your flu knowledge.Some people refuse to take the flu vaccine, due to mistaken beliefs, irrational fears, or stubbornness. Suzanne Koven puts it this way in her STAT article:

[Blaming flu vaccines] is “like blaming umbrellas for the rain.”

Suzanne Koven, A doctor’s explanation of why so many patients say no to flu shots

Did I get a flu vaccine this year? No, too busy. Do I wish I had? Yes, so I could get all the things done I’m thinking about while having the flu!

More information about vaccines is listed hereYou can stay up to date on Twitter with @CDCFlu. Good information is also available here.

Here’s wishing you a happy, and HEALTHY holiday!

All content © 2015 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.

When Clinical Trials Don’t Match Their Data

dart off-centerClinical trials (research studies in people) can help find better treatment, care and prevention for patients. When done well, they answer important questions posed in the protocol (study plan) before the trial starts. Unfortunately, those answers are often not published. Some also don’t have the right study designs, which means the studies won’t tell us what we truly want to know.

The Problem?

…”the international Cochrane Collaboration commonly exclude from evidence 50% to 75% of published studies…”

– Soumerai, Starr, and Majumdar, The Health Care Blog

Why? They don’t meet the basic research design standards that Cochrane relies on to produce reliable results. 1/2 to 3/4 of our clinical trials? Big problem! But it’s only one of the issues.

Why Does This Happen?

Many misalignments help foster these problems. In their article, Soumerai et al show how clinical trialists start with errors that get multiplied as they gather steam, especially when those who will profit spin stories that get picked up by the news media.

“We will show how single, flawed studies, combined with widespread news media attention and advocacy by special interests, can lead to ineffective or unsafe policies.”

– Soumerai, Starr, and Majumdar

John Ioannidis at Stanford has written about this for years, and was recently interviewed by Gary Schwitzer from HealthNewsReview.org (podcast available). John published a seminal paper in 2005 called “Why Most Published Research Findings Are False.” Sorry to say that 10 years later, it is still true and will be until incentives change.

The COMPARE Project has taken on a simple (but not easy) goal – to find out which clinical trials reported on the outcomes (endpoints) that they stated in the protocol (study plan). As of 12/10/2015, the 58 trials they checked had these depressing results:

  • 8 trials (14%) reported the stated outcomes and they didn’t add later outcomes.
    That means they did what they said they would do. Thank you.
  • In the 50 trials (86%) that did NOT report on the stated outcomes,
    • They did NOT report on 306 of the original outcomes.
    • They added 304 different outcomes after they saw the data.
Photo credit: stevendepolo via Foter.com / CC BY

Photo credit: stevendepolo via Foter.com / CC BY

That’s like waiting until everyone turns over their cards before you decide how you want to play! There can be valid reasons for some, but certainly not all, of these changes. Retraction Watch has a good post about this.

To follow up, Ben Goldacre and his team send letters to journals who published the trial results to alert them to errors so they can issue a correction.

…”we entrust journals with an incredibly important job, a huge portion of the knowledge management in medicine and science.  We should be able to expect that journals routinely police something as unambiguous as outcome switching, during the peer review and editing process. Where there are slip-ups, we should be able to expect that those errors are corrected swiftly.”

– Ben Goldacre

Why Does This Matter?

Patients rely on doctors for accurate information that can be used to make critical decisions. Physicians also want this, and often base their decisions that treatments off of these clinical trials. If the evidence isn’t real, it could actually lead to wrong decisions that might actually create harm to patients. And no one wants that, do they?

What are publishers doing about this?

The COMPARE Project is relatively recent, so maybe it just takes publishers longer than expected to publish the team’s letters and then issue corrections. Right?

Old letters in string - deskI mean, it only makes sense that such esteemed journals as the Journal of the American Medical Association (JAMA), The Lancet, the Annals of Internal Medicine (Annals), and the British Medical Journal (BMJ) would take this seriously and correct errors quickly. And they would commit to checking something simple like this for each clinical trial BEFORE it is published. Right?

Millions of patients who count on the accuracy of their publications certainly hope so.

All content © 2015 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.