Future of Health CareMedical Decision-MakingResearch
September 11, 2019

Fixing Clinical Science Requires a Moonshot

“We chose to go to the moon” President John Kennedy’s statement instigated a monumental marshaling of resources to achieve a remarkable goal. Those famous words also established a powerful metaphor for aiming high. We need an equally monumental shift in purpose and commitment of resources for how we conduct clinical science. Nothing less than our nation’s health is at stake. In my view, there are only three possible ways research efforts might proceed: First, the conduct of research might not change, but continue to rely on observational studies and non-generalizable randomized trials (RTs). If so, populations of subjects included in…
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Future of Health CareMedical Decision-MakingResearch
August 21, 2019

AI May Be the Future, But It’s Not (Yet) the Future of Clinical Research

Good medical practice depends on good clinical research. Without rigorous, replicable, reliable research findings, we cannot trust that our medical decisions are based on truth. To put it bluntly, flawed research leads to bad medicine. It’s essential that we get it right. In this series, I have argued for a more rigorous approach. The present model of clinical research is expensive, slow, studies insufficient populations of subjects—making generalizability difficult— and lacks power to examine important variations in clinical and personal characteristics of individuals. In my biased view, study design determines if research is being done. Without an appropriate design, we…
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Future of Health CarePopulation HealthResearch
May 29, 2019

Here’s One Way to Do Better Science

Clinical research with randomized trials (RTs), as opposed to basic or bench research, is the science of comparison. RTs ask a fundamental question: Is “x” better than “y”? They do more than observe how treatments work; they also require methods that control the research environment. Finding an independent contribution of one action over another demands random, stratified populations in order to find truthful differences, as medical care advances on these differences. But the way that patients are typically recruited for RTs can undercut the validity of the study’s findings. I propose we take a different approach, one I call “Gallup…
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Future of Health CareMedical Decision-MakingResearch
April 24, 2019

If Not Now, It’s Too Late: More Clinical Science Pitfalls and a Path to Improvement

Let’s review three major vulnerabilities with how randomized trials (RTs) are conducted, as discussed so far in this series. Critically appraising a research study involves determining the “internal and external” validity. Internal validity deals with the conduct of the study, per se. External validity deals with whether the study’s findings can be generalized to others in the population. Here’s what can go wrong: Populations being studied in RTs are too often convenience samples of patients/subjects rather than random or systematic samples of subjects. This diminishes our ability to externalize findings from the RT to the population at large. This is…
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Future of Health CareMedical Decision-MakingResearch
March 6, 2019

If Not Now, It’s Too Late: Clinical Science Is Futile If We Study the Wrong Population

In 1936, the Literary Digest, a respected national magazine, undertook a public opinion poll. Who would win the race between Republican Alfred Landon, governor of Kansas, and Democratic incumbent Franklin D. Roosevelt? Mock ballots were mailed to 10 million Americans. About 2.4 million responded—one of the largest survey samples ever created. Their prediction? Landon would carry the day. They were wrong—by a landslide for FDR. That’s because respondents were biased toward Landon and did not accurately represent the distribution of presidential preferences across all voters. Notably, George Gallop accurately predicted FDR’s victory using a smaller representative sample of about 50,000…
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Consumers & PatientsFuture of Health CareMedical Decision-MakingResearch
February 13, 2019

If Not Now, It’s Too Late: Clinical Science Needs Fixing

In 1967, the year I graduated from high school, my family’s television required “rabbit ear” antennae with perched aluminum foil. Our farming family had little time to watch TV, but when we did, the ritual included a side trip to reset the antennae’s angle to ensure good reception. Today, I watch a clear picture on myriad devices, no antennae needed. In the 1980s, my trips to a library to find medical literature were few. A single trip to the library would take hours and net only a small number of papers. Now, I obtain articles on any topic in a…
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Future of Health CarePatient EmpowermentResearch
August 9, 2017

How to Recognize “Fake” Medical News — And Why It Matters

Is coffee good for you? A recent headline suggested that people who drink coffee live longer. Sounds great to me. I drink a lot of coffee, so maybe I will be immortal. But, wait, another report links coffee to cancer. Dang. Estrogens were once touted as a life saving elixir for women of elegant ages, until these hormone supplements were linked to increased cancer risk. Wine will either add to your life expectancy or increase chances of breast cancer. But if you are married and have cancer, your outcome is better; you live longer (and can drink more wine?). Eggs…
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Future of Health CareMedical Decision-MakingPatient Empowerment
July 26, 2017

It’s Not What We Don’t Know That Hurts Us: It‘s What We “Know” That Isn’t So

Making a decision is a—or really—“the” fundamental activity of life. The decisions we make, the consequences of those decisions, our feelings about the consequences, our interpretation of whether we made a good or bad decision based on those consequences, in total, form the basis of our life’s experiences, and, often, how we decide the next time. My children used to say, “Duh,” to my muttering an obvious observance like, “It sure is hot today,” because the temperature just hit 100 degrees. The opening sentence of this blog may seem so obvious that it may trigger a similar response. Making a…
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Future of Health CarePerformance Improvement
January 31, 2017

The Dirty Little Secret About Performance Measurement Data

“The data just hooks up.” That was an opening remark from a competitor applauding his company’s scoring system for physician quality. He went on to explain how this data produced reliable scores on quality. The idea that data hooks up and produces a true scoring system for quality is a fantasy. Not only is data itself flawed, but it doesn’t always tell the exact truth. Treating data casually amounts to an off-hand dismissal of the complexity and inherent biases of performance measurement. But here’s the kicker: we need to measure performance, anyway. In fact, it’s more critical than ever to…
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Registry ScienceResearch
November 15, 2016

Bedside Viewpoint: Why Watson Will Never Know Enough to Replace Your Physician

Every conversation with a patient is an exercise in big data analysis. Your patient’s appearance, changes in mood and expression, and eye contact are data points. The illness narrative is rich in semiotics: pacing, timing, nuances of speech and dialect are influenced by context, background and insight, which, in turn, reflect religion, education, literacy, numeracy, life experiences and peer input. To all this, add personality traits such as recalcitrance, acceptance and personal philosophies. Taking a history generates a wealth of data. Mix in physical findings of variable reliability, laboratory markers of variable specificity, imaging bits and bytes, and you have…
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