For more than 30 years, the National Health, Lung, and Blood Institute (NHLBI) has released blood pressure (JNC I – 1976), cholesterol (NCEP ATP I – 1988), and obesity (1998) treatment guidelines.  These guidelines have had an enormous impact on ambulatory care pharmacy practice because they are considered the standard of care, influence collaborative practice agreements, and are used by payers and accreditation bodies to set performance metrics.  In June, Gary Gibbons, the director of NHLBI, and Michael Lauer, director of NHLBI’s Division of Cardiovascular Sciences stated that there is a pending decision on whether the guidelines will continue to be formulated under NHLBI’s leadership or if they will become a product of other organizations.1 These organizations have not been named yet, but speculations have been made that the American Heart Association (AHA) and the American College of Cardiology (ACC) may be involved.2 According to Gibbons, NHLBI will be allowed to continue to serve its unique leadership role, and ensure that practice guidelines are published in a public domain in a timely manner.1

The decision to “outsource” the NHLBI guidelines is an attempt to align with the Institute of Medicine (IOM) recommendations made in 2011 that established standards for generating systemic evidence reviews and developing clinical practice guidelines.  The standards include:

  • Assembling expert teams with the capacity to manage bias, conflicts of interest, and stakeholder input,
  • Identifying pressing clinical needs while developing an optimal analytic framework,
  • Developing and following rigorous protocols that cover the search and assessment of evidence, as well as its synthesis, and
  • Preparing structured, user-friendly peer-reviewed final reports.

Five guideline products are expected to be released in the coming months: cholesterol, blood pressure, risk assessment, lifestyle interventions, and obesity.2 The National Cholesterol Education Program (NCEP) Adult Treatment Panel 3 (ATP3) full report was last updated in 20025, the Joint National Commission 7 (JNC7) full report was last updated in 20046, and the Obesity Guidelines full report was last updated in 1998.7 All of these guidelines were released by the NHLBI, with input from other member-driven organizations.  Currently, the final drafts of the ATP4 and JNC8 guidelines have gone through a federal review, expert review, and advisory council. HHS clearance is pending, and partnership formation is ongoing.8

These influential NHLBI guidelines have been repeatedly delayed and are woefully outdated.   Whether “outsourcing” the guidelines will improve the efficiency of the guideline development process or their quality remains to be seen.  

 

References
1.  Gibbons GH. NHLBI adopts new collaborative partnership model for clinical practice guidelines development. NIH. 2013. Accessed July 23, 2013.
2.  Wood S. NIH says AT 4, JNC 8 guidance out “in a matter of months” (with a twist).Heartwire. 2013. Accessed July 23, 2013.
3.  Gibbons GH, Shurin SB, Mensah GA, Lauer MS. Refocusing the agenda on cardiovascular guidelines: An announcement from the National Heart, Lung, and Blood Institute. J Am Coll Cardiol. 2013. Accessed July 23, 2013.
4.  National Academy of Sciences. Institute of Medicine report on Finding What Works in Health Care: Standards for Systematic Reviews. Accessed July 23, 2013.
5.  Grundy SM, et al. Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). NIH. 2002; Publication No. 02-5215.
6.  Chobanian AV, et al. and the National High Blood Pressure Education Program Coordinating Committee. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. NIH. 2004;Publication No. 04-5230.
7.  Pi-Sunyer FX, et al. and the NHLBI Obesity Education Initiative Expert Panel. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. NIH. 1998;Publication No. 98-4083.
8.  Systematic Evidence Reviews in Development. National Institutes of Health, NHLBI. Last updated June 2013. Accessed July 23, 2013.