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 CareResearch
July 17, 2019

How the Stock Market Models a Path to Better Research.

The better clinical research is, the better medical care will be. It is so crucial to the future of best medical care that I have highlighted deficiencies of the present conduct of randomized trials (RTs) in previous articles to suggest ways to improve. A system of better research must accommodate studies on any intervention aimed to improve care, including interventions such as a change in practice, any quality or safety plan, or an economic principle such as fee-for-service versus capitation—not just studies of new drugs. In my last article, I coined the term “Gallup Research Medicine” as a model to…
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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
April 3, 2019

If Not Now, It’s Too Late: Simple Randomization Can Lead to False Inferences 
About Treatment Decisions

Medical decisions are best made on the basis of clinical science. Accurate research, shared between physician and patient, enables the patient to make an informed choice about risks and outcomes of treatment options. That’s how it should work, in theory. But in practice, even with the best shared medical decision-making, far too much clinical research employs faulty methodologies that limit the relevance of findings. This must change. In a recent blog post, I suggested that clinical science can improve by choosing more representative groups of people for study. Many clinical studies use convenience samples of patients rather than samples chosen…
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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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Consumers & PatientsMedical Decision-MakingValue-Based Health Care
December 12, 2018

Conflict of Interest in Medical Practice Is Hardwired: Unless We Acknowledge It, Nothing Will Change

In philosophy class, we were asked to choose which of two children falling out of a boat, unable to swim, should we save. Kant believed all people share the same moral equivalency, and a choice cannot be made to save one or the other based on morality. They must be treated the same. This question was paired with a second question forcing a choice between sacrificing one to save others, or many to save one. Tough moral questions. However, both questions were moot if the one being saved or sacrificed was your child. No matter what moral principle studied, whether…
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Consumers & PatientsFuture of Health CareMedical Decision-MakingResearchValue-Based Health Care
October 17, 2018

Wise Patients Really Can Make Medical Decisions

“The numbers in this blog are hard to believe. Why is the medical profession recommending shingles vaccine? It is one thing to say that patients should be their own advocates. But why would medical professionals recommend a vaccine to their patient that has such a paltry risk/benefit outcome? After all, we go to doctors because we presume that they know more about medical conditions, prevention and treatment than we do. If they don’t, what’s the point?” A wise patient reading my blog on the shingles vaccine made the above comments. The adjective “wise” has been defined as “able to make good judgments.”…
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Consumers & PatientsMedical Decision-MakingResearch
August 8, 2018

Why Randomized Clinical Trials Are Essential to Informed Medical Decisions

I am not a card-carrying philosopher, although I did study philosophy as my undergraduate major. What I enjoyed most was epistemology, the theory of knowledge. We debated, hotly, from the standpoints of social interaction and humanism, “What is knowledge? What constitutes knowing?” But such philosophical debates are not relevant in medical care. Medicine is not a philosophical province. By that I mean that when we are ill, we are philosophically the same; debating differences is a waste of time. We have equal value; have the same rights to the same efforts and same actions to get us better. The essential…
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