Only about 20 randomized clinical trials involving mHealth tools or services have been conducted in the United States since 2008 under the auspices of the National Institutes for Health. And more than half of them have failed to document clear evidence of improved outcomes.
Francis Collins, MD, the NIH's director, delivered the message to attendess at the 2012 mHealth Summit in his closing keynote on Dec. 5. Collins pointed out that the lack of trial-based evidence is hindering acceptance of the technology by a healthcare industry that could really use these tools.
Dr. Collins also noted that controlled trials often are diffiicult to design in the real world by saying,
"The mHealth field is evolving so rapidly that oftentimes the technology used in trials is outdated by the time the trials are completed. For that reason, he said, the scientific and healthcare communities have to work together to fine-tune the process, producing viable results in a timely manner.
The alternative? Forge ahead with mHealth without evidence that mHealth is improving healthcare."
This viewpoint may be highly biased as to the cohort and demographics of such a study. Presently there are thousands of mobile apps in development, most stimulated by public perception and enthusiasm from the HIT community. The feeding frenzy for profit is dynamic with the federal stimulus packages.
Many vendors in mHealth would argue differently. Hopefully some of them will comment here.
[See also: New bill would create FDA mHealth office.]
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