The promise of reduced readmissions and improved health outcomes in patients achieved through the continuous mHealth-powered patient-provider connection is what drives the mobile healthcare market. The increasing wave of attracted investments is expected to boost the market up to $102.35B by 2023.
But forecasts alone cannot keep the interest in healthcare app development in the long run. Clinical stakeholders, payers, and consumers altogether need tangible results from mHealth to prove its efficiency and highlight priority areas to focus on. Here’s where it gets complicated.
Scarce evidence of mHealth efficiency
In a recent overview, scientists from the Centre for Research in Evidence-Based Practice at Bond University in Queensland, Australia, concluded that there is not enough evidence to decide whether providers should recommend the currently available mHealth apps to their patients.
The team inspected 4 databases from 2008 onwards and the Journal of Medical Internet Research to identify only 6 systematic reviews with 23 randomized controlled trials (RCTs) evaluating 22 standalone healthcare apps, mostly targeting obesity, mental health, and diabetes. Meanwhile, the mHealth Economics 2017 study states that major app stores feature around 325,000 unique health apps.
So, in ten years, only 22 were apps evaluated, but that’s not all.
According to the researchers, “most trials were pilots with small sample size and of short duration. Risk of bias of the included reviews and trials was high.” The overview also states that “the overall low quality of the evidence of effectiveness greatly limits the prescribability of health apps. mHealth apps need to be evaluated by more robust RCTs that report between-group differences before becoming prescribable.”
The possible harm of under-researched healthcare apps
This lack of proven credibility lowers the chances of mobile health apps to become full-fledged care delivery tools used in clinical settings and in patients’ homes. Instead, mHealth will be either perceived as a huge market of novelty toys or even a harmful technology.
Non-studied apps: good, bad, or evil
One of the recent studies discovered that the use of fitness trackers and calorie-counting apps can exacerbate eating disorders, increasing eating concerns and triggering dietary restraints.
Even NHS-accredited apps claiming to help patients with such conditions as bipolar disorder, bulimia nervosa, and post-traumatic stress disorder (PTSD) were found to be of questionable efficiency. These apps had no scientifically reviewed data to prove they are indeed helping patients with depression or anxiety caused by mental health disorders.
Another research, also touching upon the currently available apps for mental health, concluded that there is a significant gap between app vendors, the scientific community, and clinical stakeholders. This lack of collaboration in the creation of apps that claim to relieve the symptoms of complex psychological conditions harms every party involved. Without solid proofs of efficiency, the resulting product can’t be openly suggested to anyone who may need it, so the user base won’t grow as fast as it could, providers won’t get improvements in patients’ health results, and patients won’t be able to use reliable mobile self-management tools.
On top of that, even when the study is conducted, an app still can go under fire.
The Case of Natural Cycle App Causing Unwanted Pregnancies
Natural Cycles is the mobile app for non-hormonal and non-intrusive female birth control using algorithms that determine a woman’s fertility status. The app analyzes a user’s basal body temperature in combination with cycle length, sperm survival, ovulation day, length of follicular and luteal phases, and then suggests on red and green days for having unprotected sex.
Natural Cycles’ creators claim that this app’s efficiency is comparable with traditional birth control methods, proving it with the largest study of natural birth control methods – 22,785 women, 29 years old in average, 224,563 menstrual cycles. The study has shown that the app is 93% effective for contraception with a Pearl Index of 7.0, meaning that during one year, only 7 out of 100 women will get pregnant due to any possible reason while using the Natural Cycles.
In January 2018, over 37 unwanted pregnancies among the Natural Cycles’ users at a major Swedish hospital. The app’s co-founder Elina Berglund initiated an internal investigation to find out that the algorithm’s efficacy rate stayed within the declared 93%.
She commented on the case to Business Insider Nordic: “It’s very much in line with what we expected. It’s not fun at all to see that there are unwanted pregnancies, but then again, there is no contraceptive today that is 100 percent safe.” Still, the app creators also admit the need for more research following their largest study of natural birth control methods.
This case got a loud public outcry because the efficiency of a birth control app is quite easy to track, and the cost of failing is obvious too. Natural Cycles’ developers made ambitious claims to help women avoid unwanted pregnancies, but the product turned out not to be perfect for everybody, what a surprise. The app creators made everything in their power to ensure credibility – they have put science in the center of their product, researched its efficiency, and also presented results to create trust in gaining their user base.
Now, let’s think again about all those thousands of applications that enter the market with zero proven research put into their creation, but claim to assist patients with complex medical conditions, exercising, physical rehabilitation, nutrition control, etc. The cause-and-effect relationship may not be as evident compared to birth control, but it exists and should be researched properly to ensure patient safety.
The roadmap to proven mobile health expertise
Basically, if we won’t be able to find out which apps really bring value to patients and providers, all new mHealth applications will be the waste of time and effort on ineffective or even harmful products. To avoid it, the first step should be establishing collaboration between clinical stakeholders, developers, and the scientific community.
As Bond University researchers noted, app development researchers should also share information and their findings with each other in order to “reduce research waste and prevent re-invention of wheels.”
In the future, we expect more systematic reviews, pre-release studies, and independent researches with larger user bases and focus groups. Upon the release, patient feedbacks should be gathered to avoid negative influence and ensure positive health outcomes. If these steps are taken, we can hope to see mobile health become an integral part of the care delivery cycle.
Inga Shugalo is a Healthcare Industry Analyst at Itransition, a custom software development company headquartered in Denver, Colorado. She focuses on healthcare IT, highlighting the industry challenges and technology solutions that tackle them. Inga’s articles explore diagnostic potential of healthcare IoT, opportunities of precision medicine, robotics and VR in healthcare and more.
