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June 20, 2013

NIH - NHLBI Discontinues Guidelines Program Passes Work off to Associations

Over the years, we have written about the important role clinical practice guidelines play in physician care and treatment of patients. In fact, many continuing medical education (CME) programs have improved physician adherence to certain guidelines, which has led to better diagnosis and treatment of certain diseases (for example antibiotic guidelines in hospitals and hypertension guidelines).

For example, in 1977, the National Heart, Lung, and Blood Institute (NHLBI) issued the first of a number of clinical practice guidelines that would emerge from the National Blood Pressure Education Program, as well as from other similar efforts like the National Cholesterol Education Program. The NHLBI guidelines have covered a variety of topics, including, but not limited to, cholesterol, blood pressure, asthma, and von Willebrand Disease. "Over the years, these groundbreaking health education initiatives have promoted marked increases in the public's awareness of cardiovascular disease risk factors and contributed to the major reductions in coronary heart disease mortality observed during this period."

The use and creation of guidelines has continued to grow over the years, and more than 2,500 now can be found in the archives of the Agency for Healthcare Research and Quality's (AHRQ) National Guideline Clearinghouse. The last guidelines were published from 1997-2003 with ground breaking reports such as ATP3 and JNC6. In 2007 NHLBI Began the process of convening the panels of experts to revise the guidelines on high blood cholesterol, high blood pressure, and overweight/obesity in adults and develop new reports on cardiovascular risk assessment and lifestyle modification.

However, various concerns were raised about the reliability of certain guidelines and the processes involved in their development.  In response to these concerns, the Institute of Medicine (IOM) issued a new set of standards for clinical practice guidelines in March 2011 intended to enhance the quality of guidelines being produced. 

Consequently, a recent development regarding guidelines creation occurred yesterday, when the NHLBI issued a statement announcing that it will "refocus" its health education agenda to its "core mission of knowledge generation and synthesis by supporting and producing rigorous systematic reviews that can then be used by other collaborating organizations to generate guideline products that serve the public interest."

The NHLBI has decided that "the five integrated cardiovascular guideline products will be published as evidentiary reviews, and that the Institute will subsequently collaborate with other organizations to prepare and issue the related clinical practice guidelines." The decision was made at a public meeting with the NHLBI Advisory Council (NHLBAC).

While the detailed elements of the new NHLBI model remain to be further refined, the Institute said its "overall framework is well aligned with the IOM approach," and outlined "six operating principles" that will govern the new framework:

    1. Before taking on new evidence syntheses, the NHLBI will consult closely with external stakeholders to identify high-priority needs with compelling relevance to the NHLBI mission and the health of the nation.
    2. Once those needs are identified, the NHLBI will work with external stakeholders to determine which critical questions are most crucial for their ability to generate guidelines that are reliable, robust, credible, relatively easy to implement and likely to promote significant improvements in public health.
    3. In supporting and generating evidence syntheses, the NHLBI will pay careful attention to the evolving standards on systematic reviews promulgated by the IOM and other credible sources (citing an IOM report on Standards for Systematic Reviews) (see below for more)

    4. In enabling partner organizations to generate their own guideline products, the NHLBI will continue to abide by the highest standards for developing trustworthy clinical practice guidelines and continue to adapt as best practices and the landscape of stakeholders evolve.(citing an IOM Report on Clinical Practice Guidelines)

    5. The NHLBI will implement a process for internal evaluation and continuous improvement in line with our commitment to results-based accountability and stewardship of public resources.
    6. The syntheses will identify evidence gaps which can guide research investments in areas of importance to public health.

Below is a summary of NHLBI's reasoning for making this decision and some historical background on their previous guideline activities. The Institute noted that while the "time has come for a change in [its] practice of generating clinical guidelines," it will "remain steadfastly committed" to generating "rigorous systematic evidentiary reviews in support of the highest quality clinical practice guidelines worthy of the public trust." They maintained that the "new collaborative partnership model of guideline development will enable the NHLBI to 'recruit knowledge and science in the service of national strength' as envisioned by President Franklin Roosevelt 73 years ago.

Background

For more than sixty-five years, the NHLBI core mission has been, and continues to be, the generation and dissemination of knowledge and science with the goal of securing a healthy nation. On July 26, 1972, Elliot Richardson, the Secretary of the US Department of Health, Education, and Welfare (now HHS), announced the establishment of a "National Hypertension Program." The program planned a four-step approach to include (1) agreement on standards and conditions for treatment, (2) education of health workers, (3) public dissemination of information, and (4) research on the impact of the program on health care delivery.

Richardson appointed two committees: (1), the "Hypertension Information and Education Advisory Committee," which focused on the knowledge of hypertension and the communication of that knowledge, and (2), an "Interagency Working Group" to focus on exchange of information and coordination with the professional community.

After NHLBI created the initial guidelines noted above, "the landscapes surrounding the management of blood pressure and cholesterol disorders, as well as the landscape of clinical practice guidelines," underwent profound changes. "Many more effective strategies are available for clinicians and patients to choose from, and orders of magnitude more clinical evidence information is available. The advent of the internet and the proliferation of mass media outlets provide the lay public with direct-to-consumer access to a plethora of health information."

Clinical research sophistication has grown, as the "mega-trial" has gone from being the exception to the norm. During this period the number and scope of governmental entities engaged in providing guidance on clinical practice has also changed substantially.

NHLBI also noted that "numerous organizations outside government have developed expertise and experience in developing guidelines. Indeed, a special working group of the NHLBAC has noted that nearly all NIH Institutes and Centers have elected to limit engagement in guideline development to efforts involving close collaboration with professional societies or other external groups. "In recent history, the NHLBI has been the lone exception to this general NIH practice," the statement explains.

Discussion

Part of the explanation for NHLBI's discontinuation of guideline making is tied to the fact that the number "of available guidelines provided by a variety of sources has literally exploded." However, "serious questions and controversies have arisen about how guidelines should be developed, implemented, and evaluated," and "[c]ritics have aptly noted that it is not a given that clinical practice guidelines benefit patients."

Frequently, guideline "developers have been criticized for failing to adequately control for conflicts of interest, for issuing guidelines of variable quality, and for issuing contradictory guidelines that leave clinicians feeling confused and vulnerable. Despite these allegations, NHLBI correctly maintained that "the development of clinical practice guidelines leads to invaluable benefits for patients and clinicians:

  • improved outcomes due to better deployment of evidence-based strategies,
  • improved consistency of care,
  • empowering information for patients,
  • improved public policy through attention drawn to areas of importance to public health,
  • assistance to clinicians who aim to keep their practices up-to-date,
  • guidance for quality improvement activities; and
  • help researchers and research funders identify important research gaps and set the stage for the iterative process of new knowledge generation and advances in patient care.

NHLBI also noted the "debate about who should be in the driver's seat." (i.e., writing the guidelines. "Primary care generalists, specialists, and government agencies may each have limitations which impede their effectiveness in leading the development of guidelines." These concerns have led many organizations to actively reach out to many stakeholders, as was the case in a cardiovascular guideline on risk assessment that. NHLBI emphasized that multiple stakeholders working together collaboratively should write guidelines, rather than one entity, because "there is a much greater likelihood of high-quality products, products that reflect diverse perspectives, philosophies, and expertise."

NHLBI then went on to cite the two IOM reports (noted above) addressing clinical guidelines and the recommendations and analysis they helped provide in general and to the Institute. The Institute noted IOM's distinction in creating two reports: one on standards for systematic reviews and the other on development of trustworthy guidelines. With respect to the former, NHLBI noted that standards for systematic reviews, which NHLBI will be continuing, include:

  1. assembling expert teams with the capacity to manage bias, conflicts of interest, and stakeholder input;
  2. identifying pressing clinical needs while developing an optimal analytic framework;
  3. developing and following rigorous protocols that cover the search and assessment of evidence, as well as its synthesis; and
  4. preparing structured, user-friendly peer-reviewed final reports

The Institute noted that the "standards on guidelines include a similar focus on transparency, management of conflict of interest, team composition, effective articulation of recommendations, external review, and updating." IOM stated that, "Clinical Practice Guideline developers should use systematic reviews that meet standards, [and should interact with] the systematic review team regarding the scope, approach, and output of both processes."

Conclusion

NHLBI's decision demonstrates an interesting point: even the most cutting edge scientists who are constantly analyzing new scientific and medical information and data are sometimes not able to keep up with the pace or have enough resources to synthesize this kind of information to create new information that physicians can act on to improve patient care. This point is the very heart of why continuing medical education (CME) is so critical for America's healthcare system.

CME provides an additional resource for physicians who do not have the time or resources to learn about clinical practice guidelines, the systematic reviews that helped shape such guidelines, or the reasoning behind the recommendations. Further, CME can help physicians walk through these guidelines in a way they can explain to their patients and if necessary to other colleagues.

Ultimately, with the NHLBI leaving the guideline writing industry, it will be incumbent upon professional medical associations and physician organizations to continue the research, collaboration, and analysis necessary to inform physicians in all fields and specialties about new treatments, discoveries and breakthroughs through clinical practice guidelines. This task, however, may be difficult for some organizations and groups given the tremendous task this amounts to and the incredible financial and resource burden imposed on groups—particularly if they are going to comply with IOM recommendations.

Nevertheless, it is promising to see that NHLBI will continue to focus on creating sound systematic reviews for researchers and groups to use as evidence for guidelines. Hopefully, NHLBI and future guideline writers will include CME stakeholders in this new process because CME may be the ultimate conduit from which physicians learn about such recommendations.

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