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Home/Legal & Regulatory and Reimbursement/Trust, Science and Evidence Raised at AMA Meeting
Legal & Regulatory and Reimbursement

Trust, Science and Evidence Raised at AMA Meeting

November 25, 2019 5 min read Premium comments

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Trust, Science and Evidence Raised at AMA Meeting
Source: American Medical Association
#americanmedicalassociation#patriceaharris#pvalue#researchquality

In her speech to attending members of the American Medical Association (AMA) interim meeting in San Diego Saturday, November 16, 2019, AMA President Patrice A. Harris, M.D., M.A. raised the issue of science and evidence quality and its effect on trust between patient and physician.

This is not the first time that the science and evidence bell has been rung.

Two members of the National Institutes of Health (NIH) (Collins and Tabak, director and principal deputy director, respectively), wrote in their 2014 Nature paper[1] that the issue of clinical study irreproducibility is a growing problem and documented 12 such cases.

In 2015, the Center for Open Science sponsored an open, registered empirical study of reproducibility called the Reproducibility Project (led by Brian Nosek).[2] Two hundred seventy researchers from around the world collaborated to attempt to replicate 100 empirical studies from three top psychology journals.

Of the original studies, 97% reported significant results (p<.05) while in the replication studies reported significant results in only 36% of the cases.

John Ioannidis, professor of medicine and of Health Research and Policy at Stanford University School of Medicine and a professor of statistics wrote in his seminal paper “Why Most Published Research Findings are False”[3]:

“Several methodologists have pointed out[4] [5] [6] that the high rate of nonreplication (lack of confirmation) of research discoveries is a consequence of the convenient, yet ill-founded strategy of claiming conclusive research findings solely on the basis of a single study assessed by formal statistical significance, typically for a p-value less than 0.05.”

“Research is not most appropriately represented and summarized by p-values, but, unfortunately, there is a widespread notion that medical research articles should be interpreted based only on p-values.”

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On March 7, 2016, the American Statistical Association (ASA), the world’s largest community of statisticians and the oldest continuously operating professional science society in the United States, released its first statistical practice guidance document in history. The paper titled “American Statistical Association Releases Statement on Statistical Significance and P-Values”[7], cautioned that scientific journal editors were becoming overly dependent on p-value as a gatekeeper for whether research is publishable.

Said Jessica Utts, ASA President: “This apparent editorial bias leads to the ‘file-drawer effect,’ in which research with statistically significant outcomes are much more likely to get published, while other work that might well be just as important scientifically is never seen in print. It also leads to practices called by such names as ‘p-hacking’ and ‘data dredging’ that emphasize the search for small p-values over other statistical and scientific reasoning.”

AMA President Harris on Trust

On November 16, 2019, the AMA President Patrice A. Harris told her 217,000 physician colleagues:

“The late Stephen Covey, author of ‘The 7 habits of highly effective people’, called trust ‘the glue of life…’ and ‘…the foundational principle that holds all relationships.’

And every preschooler’s best friend, Mr. Rogers, testified before Congress ‘One of the first things a child learns in a healthy family is trust.’

I see the significance of those words in my practice as a child and adolescent psychiatrist.

I imagine I’m not alone and everyone in this room can attest to the importance of trust in our relationships, in our daily lives, and in our interactions with our patients. And yet, unfortunately, we find ourselves today in an era of distrust.

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Three in four Americans say they have lost trust in the federal government. Two in three say we’re losing trust in one another. From advertising and government to media and technology – trust in our American institutions seems near an all-time low.

But do you know who people still trust – and continue to hold in high esteem? Us…their doctors. Physicians are routinely ranked among the most trusted professions.

How have we maintained that level of trust when we see it slipping away in other areas of society? Because of the values of our profession, and our aspirations to meet the three dimensions of trust…competency, honesty and compassion.”

AMA President Harris on Reinforcing Science and Evidence

After laying the foundation of trust, AMA President Harris then pivoted in her speech to explain how science and evidence are two key pillars that sustain trust between physician and patient and how the AMA is fighting to keep science and evidence at the center of every healthcare interaction:

“We are…urging leading social media and technology companies to ensure their platforms only promote accurate, timely and scientifically sound information.

Our patients’ trust requires us to do no less.

In the last six months, Dr. Aletha Maybank and her team have built a strong foundation for the Center for Health Equity, to ensure that health equity is imbedded into the DNA of our organization and is foundational to all our work.

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The evidence tells us that prior authorization delays access to necessary care and may lead to life-threatening emergencies.

That’s why the AMA has activated a grassroots campaign – and is advocating for prior authorization reforms in Congress, through the regulatory process, and in legislatures across the U.S.

If insurance companies believe they’re more qualified than physicians to decide what patients need, let us be very clear…that’s a fight we are willing to have, and we will not back down.

The AMA is a force for honesty and truth-telling in the assault on physicians’ freedom of speech.

That’s why we fought back when the administration imposed a ‘gag rule’ on physicians under Title X, preventing us from having evidence-based conversations with our patients and recommending appropriate referrals for care.

We fought back when lawmakers in North Dakota passed a law requiring physicians to tell our patients that medical abortion may be ‘reversable,’ a patently false claim.

Will patients trust us if we are not thorough in our counseling? Or if we are forced to give false or misleading information?

No, they will not.

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The patient-physician relationship is the cornerstone of health care…and the trust in this relationship depends on open and honest conversations about all of our patient’s health care options.”

Medicine Rises or Falls According to the Predictive Value of its Advice

All medical advice is an explicit or implicit prediction. Every office visit, pharmaceutical, biologic, surgical or non-surgical intervention, device, Band-Aid, catheter or salve brings to each patient an inherent predictive value—yes, as it is more commonly referred to—a P-Value.

Further, every one of the products employed in the treatment process or, increasingly, treatment related software comes to market by way of FDA review, clearance, approval or license—which function to establish a base level of efficacy and safety predictability.

As AMA President so aptly stated in her speech last week, “We believe we can improve care for ALL of our 300-plus million fellow Americans…and stand as leaders in health care across the globe. We can do this because people trust us…and because we will always strive to be worthy of their trust.”

Trust, in short, based on accurate and reproducible science and evidence.


[1] Collins, Tabak, NIH Plans to Enhance Reproducibility, Nature. 2014 Jan 30; 505(7485): 612-613

[2] Open Science Collaboration (2015). “Estimating the reproducibility of Psychological Science”. Science. 349 (6251): aac4716. doi:10.1126/science.aac4716. PMID 26315443.

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[3] Ioannidis JPA (2005) Why most published research findings are false. PLOS Med 2(8): e124.

[4] Sterne JA, Davey Smith G. Sifting the evidence—What’s wrong with significance tests. BMJ. 2001;322:226–231.

[5] Wacholder S, Chanock S, Garcia-Closas M, Elghormli L, Rothman N. Assessing the probability that a positive report is false: An approach for molecular epidemiology studies. J Natl Cancer Inst. 2004;96:434–442.

[6] Risch NJ. Searching for genetic determinants in the new millennium. Nature. 2000;405:847–856

[7] http://www.amstat.org/asa/files/pdfs/P-ValueStatement.pdf

React:

Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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