In this issue of JAMA Cardiology, Scragg et al1 present the results from a large, simple trial evaluating the effect of monthly high-dose vitamin D supplementation on cardiovascular outcomes. Using a randomized, double-blind, placebo-controlled trial design of more than 5000 participants recruited from a community of family practices of approximately 50 000 adults, the investigators showed that high-dose vitamin D supplementation given monthly did not improve the incidence of cardiovascular disease or death compared with placebo. While a verdict on use of vitamin D supplementation for cardiovascular prevention awaits results of other ongoing trials, this trial does not support there being a net benefit from a monthly high-dose administration of vitamin D.
What makes this trial interesting and important is 2-fold. First, answering common, everyday questions such as whether vitamin supplementation that can be readily accessible and easily implemented may have a profound public health impact. Second, the design of the study takes advantage of routine health care. Participants were recruited from existing family practices in the community at a relatively high rate of participation. The study drug was mailed directly to participants, and follow-up was seamless as participants encountered the health system, with data generated at every hospital stay.
Moving forward and in the spirit of the learning health care system, we need to more regularly consider how to routinely embed trials into health care and persons’ daily lives as did Scragg et al.1 The systems and technology are emerging in which people can be randomized at their convenience in their home; have their study interventions delivered directly to them, perhaps even by services such as Uber or Amazon; and donate their data as part of routine clinical care. National health systems worldwide are taking advantage of the integration of care, electronic health records, and the understanding that evidence generation from simple interventions may lead to great public health improvement. Ongoing examples from the National Institutes of Health Health Care Systems Research Collaboratory, which has a series of large embedded health system trials, and the Patient-Centered Outcomes Research Insitute–funded the National Patient-Centered Clinical Research Network (PCORnet) demonstrate the power of integrating research with clinical practice.2,3 In this fashion, optimization of health interventions with people studied within health systems may become a marker of success and quality as systems strive to improve the health of their surrounding communities.
Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Hernandez AF, Harrington RA, O'Donnell CJ. Integrating Research With Clinical PracticeKeeping It Simple. JAMA Cardiol. Published online April 05, 2017. doi:10.1001/jamacardio.2017.0216