Integrating the Patient Voice Part 3: The Importance of Clinical Trials for mHealth Digital Tools
We continue our series on Integrating the Patient Voice by focusing on how we can formalize the patient voice through clinical trials.
The healthcare landscape is at an important junction right now --- trying to balance the traditional modes of healthcare delivery and the rapidly expanding, largely untested waters of mHealth digital tools. The market is continuously being introduced to the “next best” mHealth tool --- so much so that the US Telemedicine market is expected to exceed $64 billion by 2025.(1) But at the end of the day --- relative to the learning curve, costs, and time to implementation, do these digital tools provide actual value and benefit to the patients? The tenants of medicine are founded on evidence-based practices. Interventions that have been shown to effectively improve patient outcomes are often proven in randomized controlled trials.
So, where is the evidence for the added benefit and value of the mHealth digital tool explosion? In a niche market that promises so much, where does the evidence lie? How are patients, providers, hospital systems supposed to distinguish between tools that have proven benefit versus those that have devoted millions of dollars to their marketing plan?
Photo by Dan Dimmock on Unsplash
Here lies the critical value of randomized controlled trials (RCTs)! So, what exactly is an RCT? Let’s think of this in its most popularized application -> drug/medication testing. In this scenario, a basic RCT is a study in which people are allocated at random to receive one of two interventions. One of these interventions is the standard of comparison or control, often called a placebo. This could be a "sugar pill" or no intervention at all. While the other group receives the drug/medication of study. Several outcomes measures are then collected as the patients are followed over a period of time. An RCT is considered the gold standard of research as well as the introduction of safe and effective therapeutic interventions. With that being said, we also understand how it is likely more difficult to identify study variables and outcome parameters for the mHealth digital tool RCTs compared to those utilized for drug clinical trials.
At STREAMD, we strongly believe in the value of prospective randomized controlled trial. We knew it would be difficult, but here is our attempt to provide evidenced-based research on our chatbot in patients undergoing total knee or total hip replacements, published in the Journal of Bone & Joint Surgery! We believe so much in providing evidence-based data for mHealth digital tools, that we are currently embarking in other similar prospective RCTs as well. Patients, providers, and hospital systems deserve to understand the therapeutic benefits and value that these digital tools can provide, and the first step towards this, is providing high-quality evidence-based results.