The “Gold Standard” of Randomized Clinical Trials “Has Its Own Issues”

(p. R2) . . ., closely held Epic Systems Corp., maker of one of the most widely used electronic health record systems, searched a segment of its database in the spring of 2020 to find that routine breast, colon and cervical cancer screenings in the U.S. had each dropped by more than 85% during the first weeks of the Covid-19 pandemic. The report helped spur efforts to persuade people to make up for missed screenings.

But researchers have a much more ambitious vision for this data: to help guide how doctors treat individual patients in real time.

“The evidence from real-world data is a different and exciting new path,” says Jackie Gerhart, a physician who works with the informatics team at Epic. “You can get a lot of outcomes information from medical records that can help change care for individual patients.”

. . .

To be sure, patient records are observational, and thus subject to confounders and other shortcomings that can undercut their reliability in pointing to treatment options.

But the gold standard has its own issues. Randomized clinical trials, which control for differences in patient health status and other variables, are the preferred evidence to inform patient care. Yet such trials generally exclude an especially common group of patients—those with multiple ailments. Moreover, the elderly, children, women, minority groups and people who live far from medical research centers have long been underrepresented in such studies.

As a result, the highest-quality evidence that medicine produces doesn’t apply to most patients doctors see in daily practice. “There are so many clinical situations where the evidence that is needed does not exist,” says Nigam Shah, professor of medicine and biomedical data science at Stanford University Medical School.

Researchers have believed for at least a half-century that data in patient medical records could help fill the gaps.

. . .

The struggles of International Business Machines Corp.’s Watson raises [a] . . . yellow flag. It had ambitions to develop a tool for cancer doctors that would mine patient health records and thousands of pages of research from the peer-reviewed medical literature for treatment advice. But it hit walls, including accuracy and the complexity of combining data from electronic health records, billing claims and published research to provide a cohesive product. Doctors who used the service rarely changed treatment plans. IBM says it discontinued Watson for Oncology at the end of 2020.

For the full story, see:

Ron Winslow. “Mining the Gold in Patient Records.” The Wall Street Journal (Thursday, December 9, 2021): R2.

(Note: ellipses, and bracketed word, added.)

(Note: the online version of the story has the date December 3, 2021, and has the title “Medical Records Data Offers Doctors Hope of Better Patient Care.” In a couple of passages there are a few extra words in the online version, which is the version quoted above.)

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