The organization previously known as Institute of Medicine (IOM), now known as The National Academy of Medicine (NAM), released standards for systematic reviews in March of 2011. Since its release, these 2011 IOM Standards (now 2011 NAM Standards) have been the bar in which many organizations and guideline developers operate by when creating guidelines.

While it’s not the only grading system that exists for guidelines, it is the most thoroughly adopted. Let’s look closer for those of you who may not be familiar with what the NAM Standards are or what they do.

Who is the National Academy of Medicine?

The National Academy of Medicine was founded as the Institute of Medicine in 1970 operating under the 1863 Congressional charter of the National Academies of Sciences. The National Academies, which include organizations for sciences and engineering along with medicine are private, nonprofit organizations. They operate outside of the government and have the shared goal of providing objective advice on matters of science, technology and health. The 2011 Standards are only one small piece of a very large organization.

How Were the Standards Developed?

Through the Medicare Improvement for Patients and Providers Act of 2008, Congress directed the National Academy of Medicine to develop standards for clinical practice guidelines and the initiative was sponsored by the Department of Health and Human Services (HHS).

To complete this task, The National Academy of Medicine formed two committees to assess relevant evidence and consider expert guidance. The committees worked in tandem to identify what standards were critical for producing scientifically valid, transparent, and reproducible results that could be turned into recommendations.

Why Are The 2011 NAM Standards So Important?

Prior to the development of these standards, healthcare professionals expressed concern over an influx of competing recommendations between guidelines. While people expect clinical practice guidelines to provide an accurate and fair account of the benefits and harms of various treatments, that wasn’t always the case with what they got and many guidelines published before these standards were rife with unreliable information, conflicts of interests, or skewed data.

What Are the Standards?

While a complete list can be found under Clinical Practice Guidelines We Can Trust on the National Academies website, we’ve provided a summary of each standard below.

Standard 1: Establishing Transparency

Summary – The development and funding process should be transparent, detailed, and publicly accessible.

Standard 2: Management of Conflict of Interest

Summary – Individuals hoping to be part of the Guideline Development Group (GDG) must declare all possible conflicts of interests (COI). While individuals with COI may still make up a minority portion of the group, it is recommended all COI are clearly exposed, stated, and group members may not participate in areas that may be affected by their COI.

Standard 3: Guideline Development Group Composition

Summary – The composition of the GDG should contain multi-disciplinary members with a variety of experts.

Standard 4: Clinical Practice Guideline-Systematic Review Intersection

Summary – Developers should use systematic reviews that meet the NAM Standards for Systematic Reviews of Comparative Effectiveness Research.

Standard 5: Establishing Evidence Foundations for and Rating Strength

Summary – Each recommendation should have a clear description of benefits/harms; a summary of available evidence; an explanation of the part played by values, opinions, and clinical experience; a confidence rating level; a rating of strength; and an explanation of any differences of opinions.

Standard 6: Articulation of Recommendations

Summary – Recommendations should be in a standard form detailing precise action and under what circumstances it should be performed.

Standard 7: External Review

Summary – External reviews should be anonymous and be made up of a full spectrum of stakeholders, organizations, agencies, patients and public representatives. A drafter of the guideline should be made available for public comment.

Standard 8: Updating

Summary – The guideline should include a proposed date for future review and literature should be monitored regularly to identify new, potentially relevant evidence. The guideline should be updated when the new evidence suggests the need.

Are There Drawbacks of the Standards?

While these standards are widely considered the ‘gold standard’ for clinical practice guideline development and systematic reviews, nothing is perfect. The standards can be hard to implement fully for many organizations. Guideline developers that are limited in resources (monetary and otherwise) may find it difficult to be able to meet the threshold for the standards.

Alternatively, some conditions or areas don’t have enough clinical data to be able to support a guideline that meets the standards; however, that doesn’t mean that the guideline contains unimportant information.

What’s in Store for the Future?

With the landscape of guideline development always changing, it would make sense that guideline grading systems, like the 2011 NAM Standards, would also evolve. Many key players in the guideline space have spoken out in favor of a reform, or of adopting standards that leave room for exceptions for specific circumstances.

We want to know, how does your organization handle developing guidelines within standards, like the one mentioned in our blog? Let us know below in the comments!