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The pandemic has multiplied the number of apps that take care of our health, but a study by four CERGAS scholars shows that there's still a long way to go in terms of design and clinical trials

The number of digital therapeutics apps (those intended to deliver treatment) in app stores increased 400% over the pandemic, and other forms of mobile health (m-health) also experienced dramatic growth.

However, a literature review by four scholars from CERGAS, the Centre for Research on Health and Social Care Management at SDA Bocconi School of Management, published in npj Digital Medicine, a Nature Portfolio journal, highlights a number of weaknesses that need to be corrected to achieve the goal of truly effective and safe m-health.

Analyzing 69 randomized controlled trials on apps for chronic diseases such as diabetes, cardiovascular disease, chronic respiratory disease and cancer, the authors note, first of all, that the design of clinical trials is extremely conventional. "This is problematic because conventional clinical trials involve very long timescales and scarce possibility of adaptation, while medical apps, like any other IT product, are subject to frequent updates and new releases," says Rosanna Tarricone, one of the authors, who has been active in research on medical apps for years, as part of the European research project COMED.

Furthermore, the quality of the trials is not particularly good, due to a limited average sample size and short follow-ups.

Designers, according to the authors, should also remedy the lack of physicians and patients involved in the app design phase. "Their feedback," say the authors, "would in fact be essential if we want user-friendly apps capable of establishing themselves in the market."

Finally, the results of clinical trials are, for the most part, inconclusive. That is, in few cases they demonstrate the effectiveness of apps in a statistically significant way.

"With the quantitative explosion due to the pandemic," Professor Tarricone concludes, "the time is definitely ripe to carefully analyze the quantity and quality of clinical evidence supporting medical apps, which, like drugs, should only be marketed after being tested in a proper way."

To achieve this goal, we need more physician and end-user engagement, more flexible clinical trials, more representative samples, and longer follow-up times.

Maria Cucciniello, Francesco Petracca, Oriana Ciani, and Rosanna Tarricone. "Development Features and Study Characteristics of Mobile Health Apps in the Management of Chronic Conditions: A Systematic Review of Randomised Trials". npj Digital Medicine, 4, 144 (2021). DOI: https://doi.org/10.1038/s41746-021-00517-1

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