Third Edition of AAO-HNSF Guideline Development Manual Published
Third Edition of AAO-HNSF Guideline Development Manual Published This month, the American Academy of Otolaryngology—Head and Neck Surgery Foundation (AAO-HNSF) publishes its newest guideline development manual “Clinical Practice Guideline Development, 3rd Edition: A Quality-Driven Approach for Translating Evidence into Action” in Otolaryngology–Head and Neck Surgery. The latest manual reflects our continued efforts to refine our guideline development processes so we remain at the forefront of the field. The new manual is authored by Richard M. Rosenfeld, MD, MPH, AAO-HNSF senior consultant for Quality and Guidelines; Richard Shiffman, MD, MCIS, associate director, Yale Center for Medical Informatics; and Peter Robertson, MPA, AAO-HNSF senior manager of Research and Quality Improvement. Several areas within the manual are highlighted below, reflecting recent changes to the guideline development process. Standards for Guideline Development In March 2011, the Institute of Medicine (IOM) published “Clinical Practice Guidelines We Can Trust,” which revised the Institute’s definition of clinical practice guidelines and outlined a set of eight standards for trustworthy guidelines.1 The Guidelines International Network also outlined standards for guideline development; both sets of standards are summarized in the table on the next page.2 While there has not been universal acceptance of the standards, they do represent an initial set of best practices for developers who have begun to assess the degree to which their processes comply. “Clinical Practice Guidelines (CPGs)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.”1 Action Statement Profiles Action statement profiles, previously known as evidence statement profiles,3 support each of the guidelines’ key action statements and outline all key decisions made by the guideline development group. To promote the importance of the information conveyed in the action statement profile, the profiles now immediately follow each key action statement. Each profile outlines the aggregate evidence quality, level of confidence in the evidence, benefits, risks, harms and costs, benefit-harm assessment, value judgments, intentional vagueness, role of patient preferences, exemptions, policy level, and differences of opinion. As recommended by the IOM, we added “level of confidence” and “differences in opinion” to our action statement profiles. The level of confidence relates to quantity, consistency, precision, and generality of the aggregate evidence, which is distinct from evidence level. It is possible to have “low” confidence in evidence from randomized trials if the trials are inconsistent, have design flaws, and relate poorly to the guideline’s target population. Conversely, it is possible to have “high” confidence in observational studies if they are consistent, well-designed, and applicable to patients covered by the guideline. Differences of opinion among guideline development group members can occur with any component of the action statement profile. Mechanisms for resolving disagreements should be specified early in the development process, such as a member vote with a specified threshold for approval (e.g., 50 percent, 70 percent). Any differences of opinion are rated as “minor” or “major” with an explanation of what occurred and how it was resolved. Public Comment Independent external review of a guideline is a critical aspect of development. To build off our previous external review process (the guideline was reviewed by 30 to 40 individual reviewers), each guideline is now made available for a two-week period of public comment. The public comment follows the external review, with the final guideline draft being posted to the AAO-HNSF website. The comment period is publicized via member communication, press releases, and direct solicitation to pertinent organizations, such as consumer advocacy groups. For more information about when guidelines are available for public comment, visit www.entnet.org/guidelines. As with the external review, all comments are reviewed and addressed by the guideline development panel and the draft is further refined, where appropriate. Updating Guidelines Guidelines should be viewed as living documents, so that the guidelines’ recommendations will continue to be assessed for their relevancy and the document will be updated when appropriate. The third edition of the guideline development manual further outlines the AAO-HNSF guideline update process. At a minimum, AAO-HNSF guidelines will be updated five years after publication. An early update may take place if there are significant changes in the clinical evidence, there are changes in available interventions, there are changes in the importance or value of outcomes, there is a shift in the balance of benefits versus harms, or there are changes in the resources available for healthcare. The update follows a similar process to guideline development: convening a guideline update group, reviewing the original guidelines recommendations, performing update literature searches, and determining the extent of the guideline update. The AAO-HNSF has identified three different levels of guideline update: Reaffirmation, if no significant changes are required. The guideline update group prepares a brief statement for publication stating how the group reached its decision and the duration of the reaffirmation. Note: guidelines may be reaffirmed only once. Minor update, if revisions are required to the key action statements, but they do not substantially change the conclusions or recommendations. Major update, if revisions that substantively change recommendations or the inclusion of new key action statements are required. The AAO-HNSF’s 2006 clinical practice guideline on acute otitis externa is the first to undergo an update. The guideline update is expected to be published in the summer of 2013.4 Learn More The third edition of the guideline development manual is available to AAO-HNS members and the public as a supplement to the journal Otolaryngology–Head and Neck Surgery, visit http://oto.sagepub.com. To find out more about the AAO-HNSF guideline development activities, including copies of previously published guidelines, products under development, and how to participate in guideline public comment, visit http://www.entnet.org/guidelines. References Institute of Medicine (U.S.). Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Clinical practice guidelines we can trust. Washington, DC: National Academies Press; 2011. Qaseem A, Forland F, Macbeth F, Ollenschlager G, Phillips S, van der Wees P. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med. Apr 3, 2012;156(7): 525-531. Rosenfeld RM, Shiffman RN. Clinical practice guideline development manual: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg. Jun 2009; 140(6 Suppl 1):S1-43. Rosenfeld RM, Brown L, Cannon CR, et al. Clinical practice guideline: acute otitis externa. Otolaryngol Head Neck Surg. Apr 2006; 134(4 Suppl):S4-23. B
Third Edition of AAO-HNSF Guideline Development Manual Published
This month, the American Academy of Otolaryngology—Head and Neck Surgery Foundation (AAO-HNSF) publishes its newest guideline development manual “Clinical Practice Guideline Development, 3rd Edition: A Quality-Driven Approach for Translating Evidence into Action” in Otolaryngology–Head and Neck Surgery. The latest manual reflects our continued efforts to refine our guideline development processes so we remain at the forefront of the field. The new manual is authored by Richard M. Rosenfeld, MD, MPH, AAO-HNSF senior consultant for Quality and Guidelines; Richard Shiffman, MD, MCIS, associate director, Yale Center for Medical Informatics; and Peter Robertson, MPA, AAO-HNSF senior manager of Research and Quality Improvement.
Several areas within the manual are highlighted below, reflecting recent changes to the guideline development process.
Standards for Guideline Development
In March 2011, the Institute of Medicine (IOM) published “Clinical Practice Guidelines We Can Trust,” which revised the Institute’s definition of clinical practice guidelines and outlined a set of eight standards for trustworthy guidelines.1 The Guidelines International Network also outlined standards for guideline development; both sets of standards are summarized in the table on the next page.2 While there has not been universal acceptance of the standards, they do represent an initial set of best practices for developers who have begun to assess the degree to which their processes comply.
“Clinical Practice Guidelines (CPGs)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.”1
Action Statement Profiles
Action statement profiles, previously known as evidence statement profiles,3 support each of the guidelines’ key action statements and outline all key decisions made by the guideline development group. To promote the importance of the information conveyed in the action statement profile, the profiles now immediately follow each key action statement. Each profile outlines the aggregate evidence quality, level of confidence in the evidence, benefits, risks, harms and costs, benefit-harm assessment, value judgments, intentional vagueness, role of patient preferences, exemptions, policy level, and differences of opinion.
As recommended by the IOM, we added “level of confidence” and “differences in opinion” to our action statement profiles. The level of confidence relates to quantity, consistency, precision, and generality of the aggregate evidence, which is distinct from evidence level. It is possible to have “low” confidence in evidence from randomized trials if the trials are inconsistent, have design flaws, and relate poorly to the guideline’s target population. Conversely, it is possible to have “high” confidence in observational studies if they are consistent, well-designed, and applicable to patients covered by the guideline.
Differences of opinion among guideline development group members can occur with any component of the action statement profile. Mechanisms for resolving disagreements should be specified early in the development process, such as a member vote with a specified threshold for approval (e.g., 50 percent, 70 percent). Any differences of opinion are rated as “minor” or “major” with an explanation of what occurred and how it was resolved.
Public Comment
Independent external review of a guideline is a critical aspect of development. To build off our previous external review process (the guideline was reviewed by 30 to 40 individual reviewers), each guideline is now made available for a two-week period of public comment. The public comment follows the external review, with the final guideline draft being posted to the AAO-HNSF website. The comment period is publicized via member communication, press releases, and direct solicitation to pertinent organizations, such as consumer advocacy groups. For more information about when guidelines are available for public comment, visit www.entnet.org/guidelines.
As with the external review, all comments are reviewed and addressed by the guideline development panel and the draft is further refined, where appropriate.
Updating Guidelines
Guidelines should be viewed as living documents, so that the guidelines’ recommendations will continue to be assessed for their relevancy and the document will be updated when appropriate. The third edition of the guideline development manual further outlines the AAO-HNSF guideline update process. At a minimum, AAO-HNSF guidelines will be updated five years after publication. An early update may take place if there are significant changes in the clinical evidence, there are changes in available interventions, there are changes in the importance or value of outcomes, there is a shift in the balance of benefits versus harms, or there are changes in the resources available for healthcare.
The update follows a similar process to guideline development: convening a guideline update group, reviewing the original guidelines recommendations, performing update literature searches, and determining the extent of the guideline update. The AAO-HNSF has identified three different levels of guideline update:
- Reaffirmation, if no significant changes are required. The guideline update group prepares a brief statement for publication stating how the group reached its decision and the duration of the reaffirmation. Note: guidelines may be reaffirmed only once.
- Minor update, if revisions are required to the key action statements, but they do not substantially change the conclusions or recommendations.
- Major update, if revisions that substantively change recommendations or the inclusion of new key action statements are required.
The AAO-HNSF’s 2006 clinical practice guideline on acute otitis externa is the first to undergo an update. The guideline update is expected to be published in the summer of 2013.4
Learn More
The third edition of the guideline development manual is available to AAO-HNS members and the public as a supplement to the journal Otolaryngology–Head and Neck Surgery, visit http://oto.sagepub.com.
To find out more about the AAO-HNSF guideline development activities, including copies of previously published guidelines, products under development, and how to participate in guideline public comment, visit http://www.entnet.org/guidelines.
References
- Institute of Medicine (U.S.). Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Clinical practice guidelines we can trust. Washington, DC: National Academies Press; 2011.
- Qaseem A, Forland F, Macbeth F, Ollenschlager G, Phillips S, van der Wees P. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med. Apr 3, 2012;156(7): 525-531.
- Rosenfeld RM, Shiffman RN. Clinical practice guideline development manual: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg. Jun 2009; 140(6 Suppl 1):S1-43.
- Rosenfeld RM, Brown L, Cannon CR, et al. Clinical practice guideline: acute otitis externa. Otolaryngol Head Neck Surg. Apr 2006; 134(4 Suppl):S4-23. B