A tool developed by researchers questions the clinical relevance and quality of the majority of e-health applications. According to them, the majority would not have been validated by scientific studies.
- Marketing health applications without providing proof of their effectiveness is not illegal but represents a potential risk for patients.
- The applications evaluated by this study were all French.
In 2020, every day, 250 new applications in the field of e-health were put online, i.e. 90,000 in the year.
Downloaded by many users on their smartphone or tablet to help them exercise more, eat healthily, adopt a healthier lifestyle… they have experienced a big boom with the Covid-19 pandemic. For example, in March 2021, 40.6 million French people have logged into a health site or application.
Unknown quality
But it turns out that “thea large majority (e-health applications) have not been clinically validated, their quality is unknown and the user does not know if they are effective and safe” says a scientific team from the National Institute of e-health in a study published in the Journal of Medical Internet Research.
To reach this conclusion, the researchers created and tested a scoring tool – based on 26 questions developed in particular on the evaluation criteria of the High Authority for Health (HAS) and the recommendations of the European Society of Medical Oncology – out of 68 online health solutions designed to monitor diseases such as cancer, heart disease and chronic pain.
More specifically, 30% of them were related to taking medication and reducing the toxicity of treatment, 23% concerned early detection of the disease, 16% decision support, 12% prevention, 6% direct therapeutic indications, 2% patient triage and 2% emergency department overload. Oncology applications (22%) and general health solutions (23%) were the most represented.
“We built the rating tool with patient associations and eHealth experts and submitted it to the creators of e-health applications, who evaluated their applications, say the scientists. After fulfilling the evaluation criteria, their applications received an overall score and 4 categories of subscores”.
These criteria evaluated the type of solution and domain, the size of the population targeted by the solution, the level of clinical evaluation and information about the supplier.
No study
According to this study, before being marketed, only 21% of them were the subject of randomized studies (where two groups are compared, one with a treatment and the other without), corresponding to a good level of reliability to demonstrate their effectiveness from a scientific point of view.
15% of the apps have been evaluated with real-life health data where we observe a group of patients with this tool but we do not compare them with the results of patients who do not have this tool.
And, above all, 64% of the applications have not been the subject of any clinical study. “Added to this, the questionnaire revealed that the publishers of these applications often did not have medical skills or did not include a scientific board.“, indicates Professor Fabrice Denis, president of the National Institute of e-health and co-author of the study.
Security issue
However, faulty applications represent a risk for patients: “there is a real issue of security and trust“, sorry Professor Fabrice Denis. “If the algorithms of these applications are not validated and the alerts are not triggered in time, this may represent a risk for the patient. We are talking about the toxicity of a drug, complications of diseases, infections or errors of orientationBe careful, therefore, not to trust e-health applications too much and always prefer the advice of a health professional in case of doubt.