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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Consumers & PatientsFuture of Health CareValue-Based Health CareWomen and Health Care
May 15, 2019

How Providers Must Improve Value in Women’s Health

Writing the Roji Health Intelligence® series on gender disparities and other women’s health issues has been a revelation. As a woman who has worked in so many parts of the health care industry, I was already aware of basic gender disparities, risk levels, incidence of disease, and economic issues that are predominant among women. Most women in health care have had their knowledge and judgment doubted as both patients and professionals. Women everywhere encounter the economic barriers associated with affordable health care, some much worse than others, and every woman who is a mother struggles with balancing the interests of…
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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-MakingPopulation HealthValue-Based Health CareWomen and Health Care
March 28, 2019

Women with Autoimmune Diseases Fight Uphill Battle on Every Health Care Front

Our articles on women’s health care issues have focused on areas that must change in order to provide better quality and outcomes, to lower costs, to advance treatment, and to treat women respectfully and equitably as patients and providers. We have demonstrated how women have been sidelined from getting the right health care because of two key systemic obstacles that must be addressed: Cultural bias that prevents accurate clinical assessment of symptoms and diagnosis, adoption or use of protocols relative to women’s biology, and effective health care therapies, and Inadequate basic science and clinical research that will illuminate sex-differentiated biology…
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Future of Health CareResearchWomen and Health Care
March 20, 2019

At the Heart of Gender Disparities in Health Care is Women’s Pain

Pain is a key symptom of injury or disease, and managing acute pain is usually one of the first services provided to patients. But if the patient in pain is a woman, the provider may require more convincing. Providers doubt that women’s pain is real and underestimate the level of pain for women. Substantial evidence shows that providers report higher levels of pain for men than for women. Gender stereotypes are so strong that in a recent pediatric study, participants evaluating a child’s pain reported higher levels when told that the child was a boy and lower if told it…
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ACOsFuture of Health CarePopulation HealthValue-Based Health CareWomen and Health Care
March 13, 2019

Women’s Health Research Needs an Infusion: How Health Systems and ACOs Should Help Correct Gender Disparities

Women receive health care that is below par, and the consequences are unnecessary morbidity and death. It is fact, not fiction—borne out by significant data that reveal disparities across many major conditions—that inattention to women’s unique symptoms, risk factors, disease biology and treatment effects are causing harm to women. Despite the reality, a poor body of research exists to point women’s health in the right direction. Value-Based Health Care (VBHC) assumes that we can measure providers’ delivery of health care against clinical standards. What if we don’t even know how half the population exhibits disease or responds to therapies? At…
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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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