Our study utilized a retrospective, cross-sectional design to evaluate the prevalence of cardiometabolic risk factors in the "real-world" physician practice setting, and the subsequent impact of these risk factors on BP control.
The FDA knows that in the real world physicians are unlikely to widely prescribe a new drug that comes to market with a black-box warning.
In the real world, physicians must collect and report suspected adverse events to medications already on the market according to established guidelines for adverse event reporting and their own professional discretion.
However, in real-world practice, physicians may use different treatment regimens.
The eight-week time period was selected based on the timing of incident nausea/vomiting in clinical trials [8, 18, 19] as well as anecdotal information from the real-world experiences of physicians prescribing cinacalcet.
Nevertheless, this study provides real-world evidence of physicians' perceptions and clinical practice patterns that cannot be determined in a randomized, controlled trial.
Unlike randomized controlled trials, where patients are required to be 'persistent' with their therapy, real-world patients and physicians do not follow a stringent protocol and, therefore, any differences in patients' persistence with their insulin treatment can translate into differences in clinical and economic outcomes 17.
The annual effect of scribes in a real-world clinic on physician productivity and revenue has not been evaluated.
Our study design enabled us to assess the co-occurrence of cardiometabolic risk factors in a large hypertensive study population representing a "real-world" setting among physician practices across the US, and to estimate the impact of specific overlapping risk factors on BP control.
Such interventions should take into account real-world power differentials between physicians and other health professions.
Since our intervention was delivered in a real-world setting for family physicians, effectiveness is more appropriate.
