Determining Extent Adherence to the IOM Standards in NGC
The following information describes the Institute of Medicine (IOM) standards for trustworthy guidelines and the National Guideline Clearinghouse's (NGC's) planned activities related to the standards.
The IOM Standards and Why They Were Issued
In 2008, the U.S. Congress requested that the Secretary of the Department of Health and Human Services (DHHS) contract with the Institute of Medicine (IOM) to identify "the best methods used in developing clinical practice guidelines in order to ensure that organizations developing such guidelines have information on approaches that are objective, scientifically valid, and consistent."1 The resulting report, Clinical Practice Guidelines We Can Trust 2, was published in March 2011 and provided eight standards for clinical practice guidelines to guide the process of developing trustworthy guidelines. In summary, the IOM recommended that guidelines should:
- Be based on a systematic review of the existing evidence
- Be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups
- Consider important patient subgroups and patient preferences, as appropriate
- Be based on an explicit and transparent process that minimizes distortions, biases, and conflicts of interest
- Provide a clear explanation of the logical relationships between alternative care options and health outcomes, and provide ratings of both the quality of evidence and the strength of recommendations
- Be reconsidered and revised as appropriate when important new evidence warrants modification of recommendations.2
IOM Recommendation for NGC: Indicating Extent Adherence
The 2011 IOM report on trustworthy guidelines included the following recommendation:
"The Agency for Healthcare Research and Quality should…require the National Guideline Clearinghouse (NGC) to provide a clear indication of the extent to which clinical practice guidelines (CPGs) submitted adhere to the standards for trustworthiness."2
The Agency for Healthcare Research and Quality (AHRQ) is currently exploring options to determine whether and how best to meet the above recommendation. If any changes to NGC result from this exploration, they will be phased in over the next several years, and AHRQ will provide opportunities to engage stakeholders, including the NGC/NQMC Editorial Board, guideline developers, and NGC users in that effort.
NGC's Steps and Timeline
The first step has already taken place, namely the revision of NGC's Inclusion Criteria to meet the IOM's updated definition of CPGs.
"Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options."2
The revised inclusion criteria were posted to the NGC Web site in June 2013 and became effective in June 2014. Guidelines submitted after June 1, 2014, must meet the 2013 (revised) inclusion criteria to be accepted into NGC.
The second step is an NGC team exploration of a two-phased process. The first phase is to develop an approach to determine the extent to which guidelines that meet NGC's revised inclusion criteria adhere to the IOM standards for developing trustworthy CPGs. Work is underway to develop and pilot test a tool that the NGC team will use to determine the extent to which CPGs adhere to elements of these specific IOM standards: 1.1 (Establishing transparency), 2.2 (Management of conflict of interest), 3.1 and 3.2 (Guideline development group composition), 4.1 (Clinical practice guideline–systematic review intersection), 5.1 (Establishing evidence foundations for and rating strength of recommendations), 6.1 (Articulation of recommendations), 7.1 (External review), and 8.1 (Updating). The second phase is to develop a meaningful display of the results of the determination on the NGC Web site. Movement from phase 1 to phase 2 is not automatic and will be a decision made by AHRQ with input from the NGC/NQMC Editorial Board, guideline developers, and NGC users.
When the exploration is complete and the decision is made to finalize the process, NGC summaries will add determinations of the extent to which all new and updated guidelines accepted under the 2013 (revised) criteria adhere to the IOM standards. If the decision is made to implement these changes, we anticipate that the process of determining and posting the extent adherence of guidelines against the IOM standards will begin in the latter half of 2015.
Your Input Is Welcomed!
We invite you to send your comments and suggestions on the proposed approach to determining the extent adherence to the IOM Standards for trustworthy guidelines to firstname.lastname@example.org. Comments will be acknowledged but will not be published. We look forward to hearing from you.
- Medicare Improvements for Patients and Providers Act, Public Law 110-275, 110th Cong. (July 15, 2008).
- Institute of Medicine. Graham R, Mancher M, Wolman DM, Greenfield S, Steinberg E, editor(s). Clinical practice guidelines we can trust. Washington (DC): National Academies Press; 2011. 2p. Also available: http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust/Standards.aspx .