Align Clinical CRO, ZappRx, SAP, And More: News From January 2019
By John D. Halamka
January 28, 2019
In a previous blog post, I shared an excerpt from the new book that Paul Cerrato and I just completed, The Transformative Power of Mobile Medicine. Here is a second excerpt from Chapter 3, “Exploring the Strengths and Weaknesses of Mobile Health Apps.”
Even patients who are fully engaged in their own care still need access to medical apps they can trust. The IQVIA Institute for Human Data Science has performed a detailed analysis of the clinical evidence supporting mobile health apps, rating their maturity and relative quality. Its rating scale places a single observational study near the bottom of the scale, progressing upwards through multiple observational studies, a single randomized controlled trial, multiple RCTs, a single meta-analysis, and several meta-analyses. Using this methodology, it organized mobile apps into several categories. In the category called “Potential disappointments—more study required” are apps for exercise, pain management, dermatology, autism, schizophrenia, multiple sclerosis, and autism. In the category called “Candidates for [clinical] Adoption” were mobile apps for weight management, asthma, COPD, congestive heart failure, stroke, arthritis, cancer, PTSD, insomnia, smoking cessation, stress management, cardiac rehabilitation, and hypertension. The most important category listed in the IQVIA analysis, which it considered candidates for inclusion in clinical guidelines, were diabetes, depression, and anxiety.
IQVIA has also generated of list of “Top rated apps” for 2017, taking into account their top clinical rating and the fact that they are free and publicly available. Top rated apps in the free list includes Runkeeper by FitnessKeeper, Inc, Headspace, for stress management, Kwit, for smoking cessation, My Spiritual Toolkit, an AA 12 step program, mySugr, for diabetes management, and SmartBP for hypertension. In the top clinical rating list are Omada, for diabetes prevention, BlusStar Diabetes by WellDoc, Kardia by AliveCor, for atrial fibrillation and dysrhythmias, MoovCare for cancer patients, AiCure for medication management, and Walgreens medication refill app.
The UK’s National Institute for Health and Care Excellence (NICE), has also made real progress in evaluating mobile health apps. One of its missions is to provide guidelines for the use of health technologies within the NHS. NICE reviews data on drugs, medical devices, diagnostic techniques, surgical procedures, and health promotion activities, basing its recommendations on clinical evidence that demonstrates these treatments and activities are effectives, and on economic evidence that shows they are cost effective.
The Institute has evaluated numerous mHealth services, with very detailed reviews of each service or mobile app. Among the apps that have been studied: GDm-Health, which is intended for women with gestational diabetes, AliveCor Health Monitor and AliveECG app for monitoring cardiac function, Sleepio, for adults with sleeping problems, VitalPAC, for assessing vital signs in hospital patients, LATITUDE NXT Patient Management System, which allows clinicians to monitor cardiac devices at home, and numerous others.
To illustrate the depth and thoroughness of the NICE reviews, consider its analysis of GDm-Health. The review explains the app’s purpose, which is to download data from a patient’s blood glucose meter and send it to a secure website where it can be monitored by clinicians. The web site also lets clinicians send text messages to patients to help them manage their condition. But NICE does not stop there. It also evaluates the app’s clinical effectiveness, user benefits, and the impact that its use would have on costs and resources. It then puts the mobile app into the context of NICE’s guideline for gestational diabetes, explains several of the app’s features in detail, and goes into an extensive discussion of the evidence supporting the app, including summaries of each of the clinical trials that support its use, the key outcomes, and its strengths and limitations.