“Don’t rush to use unverified digital health products”

The Covid-19 pandemic has driven the era of digital health forward, but the medical community should have a critical perspective to verify the potential and actual effect of digital health, an expert said.

Harlan Krumholz, director of the Center for Outcomes Research and Evaluation (CORE) at Yale University, discussed the role of the medical community in the introduction of digital health products during the session “Next Normal & Digital Healthcare in the Post-COVID-19 Era ”at Korea Healthcare. Congress 2021, hosted by the Korean Hospital Association on Thursday.

Harlan Krumholz, director of the Center for Outcomes Research and Evaluation (CORE) at Yale University, said doctors should not rush to use digital health products at Korea Healthcare Congress 2021 on Thursday. (Credit: KHC 2021 online session video clip)

Quoting a Korean idiom, “don’t drink kimchi soup first,” Krumholz said doctors shouldn’t change treatment methods in a hurry until they can see digital products prove their ability. to improve treatment.

“Digital health technologies are certainly necessary, but just having the technologies does not guarantee improved outcomes of clinical intervention,” he said.

With increasing interest in digital health in the wake of Covid-19, the US government has revised its policies to promote telehealth. The FDA developed the criteria for evaluating software as a medical device (SaMD).

However, not all digital health products are subject to regulation or verification, and insufficient data for verification makes it difficult to confirm the effect of digital health products, Krumholz said.

Data used for analysis and clinical validation is not being disclosed, whether regulated or not, he continued. Even if the data is controlled, essential information such as whether the clinical trial was conducted on all populations is often missing, he said.

Krumholz predicted that publication bias, only to publish results that show a favorable conclusion, would occur more frequently in the digital health industry.

A five-year investigation found that a study supported by the U.S. National Institutes of Health omitted a third of the results due to publication bias, he said.

Clinical studies testing products remotely may encounter the problem of participants leaving the designated site in the middle of the study. If researchers pull results from the few remaining participants at the end of the trial, there is a risk that the results will be biased.

Even when doctors directly encourage patients to participate in clinical trials, about half of them only use the product for about a month, Krumholz said. “We should improve the criteria so that we can examine and evaluate the product under real conditions,” he said.

Krumholz proposed to create an innovative ecosystem that forces digital health companies to be responsible for the effect of their products. He said the starting point would be to ask a basic question about what the patient is getting from using the product.

“If physicians are swayed by the rise of digital health products and market trends, they might choose a product that is unnecessary or even harmful. They should approach this issue in a fundamental way, ”Krumholz said. When evaluating the product, physicians should consider whether the patient’s life has improved, whether the survival rate, quality of life and cost of care have improved, whether the patient has had the opportunity to ” achieve their health goals and if the patient’s preferences and values ​​have been respected. , he added.

He also called for caution against unexpected side effects from digital health products.

He said every intervention should assess the possibility of causing unexpected side effects. There is always a possibility of erroneous results on a modified system, even with good intentions.

“Physicians should focus not only on the expected benefits, but also on the potential for harm. The damage may be greater than the expected benefit, ”he said.

Finally, he said the medical community should be rewarding the best treatment outcomes, not the salesperson, in an age of big digital health promise. “The medical community must take a critical look at the entire product life cycle and demand proof,” he added.

Maria J. Book