BLOG - More Than a Measurement:
What’s “Clinically Validated” Got to Do with It?
Volume I, Issue VIII
In November of last year, the American Heart Association (AHA), redefined high blood pressure: the new parameters now reflect hypertension to be a reading of 130 over 80, down from 140 over 90.
This change means that almost half – 46 percent – of all U.S. adults are now considered hypertensive.
“The America Medical Association (AMA) is committed to having 80 percent of patients with their hypertension under control—that’s part of the target in the Target: BP campaign,” said Raymond R. Townsend, MD, a nephrologist, is director of the Hypertension Program at the Hospital of the University of Pennsylvania. “Let’s use a validated device that we’ve checked in that patient—so we can trust the readings—and then treat the patient’s home blood pressures rather than the 20 or 30 points higher that it is in the office setting.”
For people currently living with hypertension, measuring blood pressure will become a critical part of their daily routine. But what if you experience what most people do and your home readings are different from those your doctor takes? How do you ensure your own monitor is accurate?
ABOUT CLINICALLY VALIDATED
The term “clinical validation” is one you’ll frequently read on blood pressure monitor packaging to ensure accuracy of results. But “clinically validated” can mean a number of different things – and not all monitors are created equal. How do you tell the real deal from the also-rans? Read on!
To ensure your device is actually clinically validated, it needs three factors (that can be easily checked on manufacturer websites):
- It used modern protocols for testing procedure. Various protocols have been published to assess automated devices against the industry’s gold standard: two well-trained nurses with a mercury sphygmomanometer and stethoscope. While there are many different protocols out there (including the International Protocol of the European Society of Hypertension and the protocol of the British Hypertension Society), the most current protocol to evaluate the accuracy of a blood pressure device against the gold standard of a trained healthcare practitioner is ISO 81060-2. This is the protocol currently endorsed by the FDA.
- It used an independent validation of accuracy. The market today for blood pressure monitors places a strong emphasis on independently validating the device accuracy and generating a study that is peer-reviewed for neutrality of conclusions.
- It was published in a peer-reviewed journal. Following the independent validation, the full report of the validation study describing the process and results should be published in a peer-reviewed journal. This adds credibility to the validation study because the Journal would not include the report in its publication without the medical peers of the author(s) having found the techniques and quality of the outcome to be sound.
Now that you know your monitor is accurate, make sure you don’t cause “operator error” by not using the right procedure for taking your blood pressure! For a refresher on that topic, see our guidelines for taking accurate blood pressure readings.
And for those of you who can’t get enough of this clinical validation topic, please feel free to review our special reports on the subject for healthcare practitioners!
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