What do evidence based digital health technologies really mean?
In our previous blog posts, we have emphasised the importance of validating and evaluating digital health technologies (DHT) to ensure their safety and effectiveness. But what do we mean by “evidence-based” and what standards as well as regulations exist in the health care industry that help demonstrate the value but also increase the adoption of DHT? And what do we in Triumf do to ensure our health app for children is the highest quality possible?
DHT have the potential to provide a cost-effective, scalable option by which to empower patients and allow a more convenient care, whilst reducing the number of appointments and reaching people who live in rural areas (National Institute for Health and Care Excellence, 2019). However, given their rapid development, DHT may lack robust, high-quality evidence of their effectiveness, compared to drugs or devices (NICE, 2019). That, in turn, creates scepticism and hesitation in stakeholders when adopting new DHT (NICE, 2019).
To address the lack of objective, transparent, and standards-based guidance regarding developing and assessing DHTs, NICE released a framework that can be used to evaluate DHTs. The first step in the guidelines identifies the classification of the DHT based on its function to identify the level of potential harm that the solutions can cause. Based on the categorisation tier, different kind of evidence is expected, including acceptability with users, reliable information content, ongoing data collection to show value, demonstrating effectiveness, and more.
Triumf health app for children can be classified into evidence tier 3a: DHTs for preventative behaviour change, or which allow self-management of a diagnosed condition. Our health game aims to prevent and help manage mental health issues that can emerge when a child is diagnosed with a chronic condition, such as cancer or diabetes. Additionally, our digital health solution delivers behaviour change techniques that prompt children to living healthier lives. On the other hand, Triumf mobile game conforms to the World Health Organization’s classification of digital health interventions category “targeted for clients” (1.1.2 Transmit targeted health information to client(s) based on health status or demographics; World Health Organization, 2018).
As you may be aware, our solution has been designed with end-users and care teams from the start to ensure acceptability with users. The content and information within the game is based on validated psychological theories and put together by psychologists and research experts. We also run ongoing data collection within patient groups to show ongoing value. Read about our latest testing session with diabetic patients here. Importantly, we are very proud to have finished the first clinical trials last year within pediatric cancer patients, showing positive impact of our game on their quality of life. In addition to this, we are working together with ORCHA who are reviewing health apps, to improve the safety of our solution. Our solution will be available on their platform shortly. We have also entered the Health Tech Connect platform that supports the development and adoption of health technologies to receive expert evaluation.
To meet tier 3a standards, the best evidence practice is carrying out a high-quality intervention study that includes a comparison group showing improvements in outcomes such as patient-reported outcomes including symptom severity or quality of life, healthy behaviours, physiological measures, etc. That said, we are so excited to kick off randomised control trials in three international hospitals in Autumn time, in Singapore and Finland. This is a huge learning opportunity for us but also a source of credibility as we can directly compare the results between the intervention group (receives treatment) and control group.
NICE guidelines provide a valuable tool for us to navigate through the evidence-based digital health market. It is good to see that we are already on the right track but of course there’s still a lot to do and improve to guarantee that our health app has the best possible impact on children.