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New hypertension guidelines would add 15.6 million new diagnoses

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Preprint strategy assures rapid sharing of relevant research

This study addressing hypertension guideline changes is unique because it was initially published on a public preprint server.

Preprints are common in some scientific areas, but uncommon in major medical journals. They allow investigators to share research, quickly and openly, for critique and feedback before standard peer review and publication.

In the case of this study, researchers analyzed the public health implications of the anticipated changes to the 2017 ACC/AHA hypertension guidelines in two nationally representative data sets from the United States and China.

The authors quickly finalized their manuscript right after the revised hypertension guidelines were released. They chose the preprint approach because they realized their research would be immediately relevant to the discussion that followed, first author Rohan Khera, MD, recounted on BMJ Blogs.

“The traditional approach of submitting to a medical journal would mean being out of the public eye for several months,” Dr. Khera said in his post. “The preprint platform offered us an excellent opportunity of ensuring early dissemination of our research study in its entirety, while we sought its evaluation by peer reviewers and the refinement by a medical journal.”

The manuscript was submitted via a Web-based system and was publicly available 2 hours later on the same day the guidelines were published. The researchers received comments and suggestions on the preprint, some of which were incorporated into the final manuscript they submitted for peer review.

Then the manuscript went through the usual iterative peer review process; however, the preprint was still available online to guide other investigators and limit duplication of effort, Dr. Khera said in his blog post.

That contrasts with another recent experience in which Dr. Khera and his colleagues performed work that “failed to inform” ongoing policy discussions, and other research efforts, while they waited for eventual publication.

“We hope that more journals will accept the benefits of science that is publicly available while journal editors and peer reviewers carry out their critical role of improving both the quality and the impact of these scientific contributions,” Dr. Khera wrote.

Rohan Khera, MD, a cardiology fellow at the University of Texas (Dallas) Southwestern Medical Center in, wrote about his experience with preprints for BMJ Blogs . Dr. Khera had no conflicts of interest to disclose.



A new analysis estimates that adopting the 2017 ACC/AHA hypertension guidelines would add 15.6 million Americans to the ranks of the hypertensives, and half of those would be candidates for treatment.

Similar increases would occur in other countries, according to study authors, who analyzed two large datasets from the United States and China.

Dr. Harlan M. Krumholz is director of Yale New Haven Health System

Dr. Harlan M. Krumholz

That happened by resetting the definition of adult hypertension from the long-standing threshold of 140/90 mm Hg to a blood pressure at or above 130/80 mm Hg, meaning more than half of people aged 45-75 years in both countries would be classified as having hypertension, according to the researchers, led by Harlan M. Krumholz, MD, of the Center for Outcomes Research and Evaluation at Yale–New Haven (Conn.) Hospital and the section of cardiovascular medicine at Yale

An additional 7.5 million Americans would be recommended for treatment under the new lower treatment thresholds, with a correspondingly large increase in the Chinese population, according to results published in the BMJ.

The guideline changes are “not firmly rooted in evidence” and could have health policy implications that include strain on public health programs, Dr. Krumholz and his colleagues said in their report on the study.

“The change occurs at a time when both countries have substantial numbers of people who are not aware of having hypertension, and who have hypertension that is not controlled, even according to the previous standards,” they wrote.

The analysis by Dr. Krumholz and his colleagues was based on the two most recent cycles of the U.S. National Health and Nutrition Examination Survey (NHANES), representing 2013-2014 and 2015-2016 periods, as well as the China Health and Retirement Longitudinal Study (CHARLS) in 2011-2012.

Under the new ACC/AHA guidelines, they found, 70.1 million Americans aged 45-65 years would be classified as hypertensive, representing 63% of that age group. That’s a 27% relative increase over the 55.3 million individuals, or 49.7%, with hypertension as defined in the JNC-8 guidelines.

In addition, 15.6 million persons would be classified as eligible for treatment but not receiving it, up from 8.1 million under the JNC-8 guidance.

Previous estimates projected a far greater jump in new hypertension classifications, including one that used data from the National Health and Nutrition Examination Survey, antihypertensive clinical trials, and population-based cohort studies. That study estimated that 31 million people would newly carry the label (JAMA Cardiol. 2018 May 23; doi: 10.1001/jamacardio.2018.1240.)

In the current analysis, in China, 267 million aged 45-65 years (55% of that age group) would be classified with hypertension under the ACC/AHA guidelines, a relative increase of 45% over the JNC-8 guidelines, while the number of candidates for treatment would be 129 million, up from 74.5 million under the earlier guidelines.

Dr. Krumholz noted that the ACC/AHA guideline changes were prompted by results from the SPRINT trial. However, the improvements in outcomes seen in SPRINT, which included patients at high risk for cardiovascular events but without diabetes, have not been observed in individuals at low or intermediate risk, or in those with diabetes, they said.

“Expanding the pool of patients who merit treatment to include those at low risk could potentially render public health programs less efficient and viable,” they wrote in a discussion of health policy implications.

The new guidelines also put millions at risk of the “psychological morbidity” that comes with the label of a chronic disease, and at risk for more adverse events caused by inappropriate use of drug therapy, they added.

Dr. Krumholz reported research agreements from Medtronic and from Johnson and Johnson (Janssen) through Yale University, and a grant from the Food and Drug Administration and Medtronic. He reported other disclosures related to UnitedHealth, the IBM Watson Health Life Sciences Board, Element Science, Aetna, and Hugo, a personal health information platform he founded. First author Rohan Khera, MD, reported support from the National Institutes of Health.

SOURCE: Khera R et al. BMJ. 2018 Jul 11;362:k2357

This article was updated 7/19/18.

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