Inside the World of Medical Evidence

Inside the World of Medical Evidence

Joan Young


Agenda

My Background What is medical evidence and why does it matter Five-part process, illustrated Future of medical evidence Take-home questions


Background Co-investigator of a clinical survey Participated in medical research projects leading to 3 journal articles Part of a team that developed medical practice guidelines Testified at an FDA drug hearing Wrote two journal articles based on my experiences Wrote a chapter for a medical textbook Became a member of the American Society of Hematology Associate editor of the International Journal of User-Driven Healthcare Reviewed research protocols for the National Institutes of Health Reviewed and wrote hundreds of medical research articles for the

public Worked for several pharmaceutical companies


One Definition

“…the use of mathematical estimates of the risk of benefit and harm, derived from high-quality research on population samples, to inform clinical decision-making in the diagnosis, investigation or management of individual patients."

Greenhalgh, Trisha. How To Read a Paper: The Basics of Evidence-Based Medicine. Wiley-Blackwell, fourth edition, 2010, p. 1.


Why do we care?

FDA approvals are based on medical evidence Practice guidelines are based on medical evidence Medical recommendations are based on medical evidence Medical evidence is used to justify medical opinions Evidence-based medicine is the gold standard for classically trained

physicians


http://www.emeraldinsight.com/content_images/fig/2400370406003.png

Levels of Evidence


Process

Researchers Decide and do research Write an article about the research Publish the research

Physicians/Patients Find the research Apply the research


Researchers - Decide and do research

Grant opportunities Promotion opportunities Professional visibility/acceptance Faculty/Academic direction Industry directive/incentive Personal interest



“In fact, the four labs that tested Tritan [plastic containing BPA] for the peer-reviewed paper in the Elsevier journal received funding from Eastman that was not publicly disclosed. Also not reported by Eastman's marketing materials or the paper: The lead author of the study, who analyzed the data from the four labs, was paid by Eastman for that work.”

Begley S. “Insight: Science for hire - Trial over plastic exposes disclosure deficit.” Reuters. Jul 18, 2013

http://www.reuters.com/article/2013/07/18/us-science-eastmanchemical-insight-idUSBRE96H05020130718



My experience


Researchers – Write an article about the research

“An analysis of nearly 600 registered clinical trials published online October 29 in BMJ has shown that 29% remained unpublished 5 years after completion, that no results were available in ClinicalTrials.gov for three fourths of those unpublished trials, and that industry-funded trials were nearly twice as likely to go unreported as studies that had not received industry funding.”

Kelly JC. “Randomized Clinical Trials: 1 in 3 Not Reported.: Medscape Medical News. Oct 29, 2013 http://www.medscape.com/viewarticle/813447


Researchers - Write an article about the research

My experience


Researchers – Publish the research

“…emphasizing that research is considered especially important if it is published in one of a few historically influential journals — Cell, Nature, Science— could be a laudable attempt to get scientists to think ambitiously about their research goals. But it can also result in excessive pressure to publish big claims, leading to problems of irreproducibility, for example.”

“The maze of impact metrics.” Nature. Oct 21 2013 http://www.nature.com/news/the-maze-of-impact-metrics-1.13952?WT.ec_id=NATURE-20131017


Researchers – Publish the research

My experience


Physician/patients – Find the research

Pubmed - www.pubmed.comMedscape - www.medscape.comGreen Med Info - www.greenmedinfo.comNEJM Journal Watch - www.jwatch.orgClinical Trials - www.clinicaltrials.govGovernment agencies – FDA/NIEHS/NIH institutesMedical Journal Indexes


Physician/patients – Find the research

My experience


Physicians/Patients - Apply the research

“Among 357 recommendations in 17 guidelines issued between 2005 and 2011, 121 (34%) combined a strong recommendation with low-quality evidence…the authors found 33 instances in which no compelling justification for a strong-recommendation/low-evidence guideline existed. In a second study, researchers reviewed 169 guidelines on prostate, lung, breast, and colorectal cancer published between 2005 and 2010…On average, guidelines fulfilled only 2.75 of the 8 standards.”

Brett AS. “Clinical Practice Guidelines Require Scrutiny for Quality.” Journal Watch. Sep 26 2013. http://www.jwatch.org/na32275/2013/09/26/clinical-practice-guidelines-require-scrutiny-quality


Physician/patients – Apply the research“Scientists reviewed each issue of The New England Journal of Medicine from 2001 through 2010 and found 363 studies examining an established clinical practice. In 146 of them, the currently used drug or procedure was found to be either no better, or even worse, than the one previously used…More than 40 percent of established practices studied were found to be ineffective or harmful, 38 percent beneficial, and the remaining 22 percent unknown.”Bakalar N. “Medical Procedures May Be Useless, or Worse.” New York Times. 2013 jul 26 http://well.blogs.nytimes.com/2013/07/26/medical-procedures-may-be-useless-or-worse/

Vinay Prasad, MD et al. “A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices.” Mayo Clin Proc. 2013 August;88(8):790-798. http://download.journals.elsevierhealth.com/pdfs/journals/0025-196/PIIS0025619613004059.pdf


Physicians/patients – Apply the research

“This demand for evidence to draw conclusions and inferences is often a trap that many of us fall into. Not always. Don't we know of so [many examples of medical evidence] that are sitting on the shelf and yet have not led to or been implemented in the form of progressive changes in policy? The road from generating evidence through research to improving human situation in the form of reducing injustice or inequity is so long. “ MD in India


Physician/patients – Apply the research

My experience


Future of Medical Evidence

Comparative effectiveness Personalized medicine Publish all results Open access publishing More targeted clinical trials Sunshine laws Patient education


Take-home Questions

What kind of study is it?Who funded the study?Who wrote it?What are the other studies on the subject, including those in the past?Do the authors have a financial incentive/disincentive?What does the package insert say?Does the informed consent include everything?Did you get a second opinion?


Medical Evidence Crusaders

Dr. John IoannidisFreedman D. “Lies, Damned Lies, and Medical Science.” Atlantic Magazine. Nov. 2010. http://www.theatlantic.com/magazine/archive/2010/11/lies-damned-lies-and-medical-science/8269/

Bob Goldacre (UK)Book: Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients www.badscience.nethttp://www.ted.com/talks/ben_goldacre_battling_bad_science.html


Book - Wish by Spirit : A journey of recovery and healing from an autoimmune blood disease

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Inside the World of Medical Evidence

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