EPtalk by Dr. Jayne 1/9/25

The hot topic around the virtual water cooler this week was the push to use real-world evidence (RWE) while caring for patients. This topic has become more relevant as increasing number of clinicians have access to RWE while caring for patients.

This kind of data can have particular strengths, including demonstrating how medications and other treatments actually work with real patient populations versus those found in clinical trials. It can also be used for post-marketing surveillance of new drugs and treatments.

However, there can be challenges depending on how clinicians are looking at the data. For example, if you’re looking at how clinicians are treating certain types of patients, one has to still understand why they might be choosing those therapies and whether those patterns are consistent with the evidence from rigorous clinical trials.

If you don’t take that into consideration, there can be a slippery slope where “everyone’s doing it, I should too” overrules graded recommendations. Depending on how data is sourced, there’s the potential for RWE to function as an echo chamber.

For example, if a large health system is pulling RWE data from their EHR, it’s going to be influenced by the formularies that are in place at its facilities. One might not see more appropriate treatment patterns that better match conventional evidence because the majority of drugs that are being prescribed for a given condition are done so in order to achieve formulary compliance and to avoid prior authorizations or additional work.

The consensus among physicians in the discussion was that real-world evidence has its place, but it shouldn’t overshadow the recommendations that are gleaned from robust clinical trials or gathered through expert consensus.

Mr. H. mentioned it earlier this week, but I would be remiss if I didn’t include my own mention of the Lown Institute’s 2024 Shkreli Awards, recognizing “the worst examples of profiteering and dysfunction in healthcare.” The list is named after so-called pharma bro Martin Shkreli. If you’re not familiar with his exploits, I would recommend spending a minute or two with your favorite search engine.

There have been a number of terrible individuals and organizations in healthcare over the last several decades. I might have reconsidered my career choices had I known how bad it could be. My academic advisor had a sweet job lined up for me in the world of publication, and although I’m sure it would have been interesting, I can’t imagine it would have been as much of a thrill ride as healthcare has been.

For people who are new to the industry, I would encourage you to look at previous iterations of the Awards. Many of you are inspired and altruistic, and previous lists will provide some clues about things to watch out for.

This year’s list includes a medical school that failed to notify the next of kin before selling the body parts of the deceased, inappropriate procedures to “treat” infant tongue ties, exorbitant air ambulance bills, the focus on profits of private equity hospitals, and insurance companies behaving badly. Although it only ranked fourth on the list of 10, my personal pick for the worst of the worst is an oncologist who recommended unnecessary cancer treatment for patients. Let me know if you have other callouts for folks that should have made the list but didn’t.

Speaking of tacky behavior, I recently received a so-called “grateful patient” solicitation from an organization where I recently received care. The problem is that the care I received was not in keeping with the standard of care and left me confused, concerned, and a witness to a HIPAA violation. I reported these issues to the provider at the time of care and was asked to reflect them in my patient survey when I received it. I did that and have had exactly zero contact from the institution. Let’s see if attaching a summary of my recent visit to the grateful patient response card inspires anyone there to reach out.

I admit that I fall victim to clickbait-style headlines as much as the next person, so this one caught my attention: “Hospital at home needs an ‘Uber app,’ Mayo Clinic leader says.” The piece features comments from Michael Maniaci MD, chief clinical officer of advanced care at home for the organization. He notes that Mayo Clinic can’t scale beyond its current volume of 30-35 patients per day due to lack of coordination for staffing, supply, and other patient needs. He states, “Imagine an Uber app where the car chassis, the tires, the fuel, the engine, and the driver all show up separately. You have the tubing coming from someplace, prescription medication coming from another place, the nurse coming from one place, the DME and the pump coming from another place — and they all have to show up at the same time.”

Sounds a bit like what healthcare organizations have been doing in other developed countries for years, minus the “we need an app” bit. I have a medical school classmate who worked for an organization in Germany that provided care to patients in their homes. It sent out a fully equipped medical vehicle that was stocked with almost everything you could receive from a high-acuity urgent care or freestanding emergency department. Another classmate who worked in the United Kingdom was partnered with public health nurses who rounded on patients and provided care beyond what we consider typical nursing care in the US.

For these models to be successful, you need a certain degree of vertical integration that we don’t typically have in our fragmented healthcare system. When your insurance contracts with a home care agency that isn’t affiliated with the hospital from which you were just discharged, there will be disconnects. I’m not convinced that an app is the answer, and would instead put my money on concepts that align all facets of care with the patient and their outcomes rather than aligning with profit motives or passing the buck to other agencies.

Another article that caught my eye this week was a viewpoint piece in the Journal of the American Medical Association that addressed health privacy and the use of synthetic data. Although this approach can help mitigate issues with insufficient private health data, it introduces additional challenges due to the fact that healthcare is a complicated and highly regulated environment. The authors note difficulties in creating data points that accurately represent rare conditions or highly complex clinical presentations such as scenarios that take place in the intensive care unit. There is also the risk of bias with synthetic data particularly when it is used at scale.

They go on to state the need for standards to generate and evaluate synthetic data. I woud be interested to hear from readers who are involved in organizational use of synthetic data and the approaches that are being taken to ensure that the promise is fulfilled.

Shortly after many people around the world rang in the New Year with a cocktail, US Surgeon General Vivek Murthy released a recommendation that alcohol products receive a warning label that advises consumers of the increased cancer risk associated with alcohol consumption. This would literally require an act of Congress. As we head towards HIMSS and another year of conferences, it will be interesting to see if health-forward organizations continue hosting alcohol-laden happy hours in their booths or if they use it as an opportunity to trim budgets as well as to promote health.

Will you reduce or eliminate alcohol consumption based on these recommendations? Whether yes or no, what’s your favorite beverage pick for 2025? Leave a comment or email me.

Email Dr. Jayne.