Commentary
Updating Clinical Practice Guidelines: How Do We Stay Current? Richard K. Gurgel, MD1
No sponsorships or competing interests have been disclosed for this article.
Abstract Clinical practice guidelines (CPGs) are created to address quality improvement opportunities for all clinicians, optimize patient care, promote effective diagnosis and therapy, and reduce harmful or unnecessary variations in patient care. Tremendous resources are invested in creating CPGs we can trust. Once a guideline is created, however, how is it maintained to reflect the most up-to-date clinical evidence? This article reviews protocols for reviewing and maintaining CPGs with particular attention to the protocols established by the American Academy of Otolaryngology—Head and Neck Surgery. Keywords clinical practice guidelines, evidence-based medicine, methodology, systematic review, updating Received January 6, 2015; revised January 7, 2015; accepted January 29, 2015.
Background The US Institute of Medicine (IOM) defines clinical practice guidelines (CPGs) as ‘‘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(p4) The American Academy of Otolaryngology—Head and Neck Surgery (AAOHNS) has created 13 clinical practice guidelines. These guidelines are created to address quality improvement opportunities for all clinicians, optimize patient care, promote effective diagnosis and therapy, and reduce harmful or unnecessary variations in patient care.2 The AAO-HNS process for guideline development is based on an established and transparent process that considers levels of evidence, harm-benefit balance, and expert consensus to resolve gaps in evidence.3 Tremendous resources are devoted to the creation of these guidelines. After the guideline is created, however, how does the AAOHNS maintain the guideline to ensure that recommendations are up to date? This article reviews the processes by which guidelines are maintained as well as offers some recommendations for future maintenance.
Otolaryngology– Head and Neck Surgery 1–3 Ó American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599815573735 http://otojournal.org
When to Update? In a study by Shekelle et al,4 which evaluated how quickly CPGs become outdated, the authors reported that 50% of guidelines were outdated in 5.8 years (95% confidence interval [CI], 5.0-6.6 years). This finding underscores the fact that medical knowledge is constantly growing. The rate of growth, however, is variable for different disease processes. As such, it is difficult to strictly proscribe how much time should elapse before a CPG is updated. An ideal approach to updating CPGs would be to update continuously as new, high-level evidence emerges (ie, using a ‘‘near real-time’’ approach).5 Such an approach, however, is impractical given the substantial resources necessary to maintain CPGs. The IOM has recommended that ‘‘the CPG publication date, date of evidence review, and proposed date for future CPG review should be documented in the CPG; literature should be monitored regularly and the CPG updated when new evidence suggests a need for modification.’’1(p137) The Guidelines International Network (GIN) recommends, ‘‘A guideline should include an expiration date and/or describe the process that the GDG will use to update the recommendations.’’2(p526) Protocols for updating CPGs have not always been specifically delineated. Burgers et al6 reported that of CPGs reviewed from 18 guideline programs, 9 lacked formal procedures for keeping their guidelines up to date. In a systematic review of 35 methodological handbooks on how guidelines should be created and maintained, Vernooij et al7 found that 40% recommended updates every 2 to 3 years, 23% for every 4 to 5 years, and almost 30% did not indicate a recommended time frame. The study by Vernooij et al concluded that available guidance from such handbooks is of overall poor quality and that CPG developers should provide more explicit and rigorous guidance to the update process. Despite the difficulty in finding a balance between too long vs too short time periods between CPG updates, it is reasonable to establish predetermined protocols on how much time should elapse before a CPG is updated. The 1
Division of Otolaryngology, University of Utah, Salt Lake City, Utah, USA
Corresponding Author: Richard K. Gurgel, Division of Otolaryngology–Head and Neck Surgery, University of Utah Hospitals, 50 N. Medical Dr, Salt Lake City, UT, 84132, USA. Email: [email protected]
Downloaded from oto.sagepub.com at SUNY STONY BROOK on March 12, 2015
2
Otolaryngology–Head and Neck Surgery
Figure 1. Flowchart of how clinical practice guidelines are formally reviewed and updated. KAS, key action statement. *Guidelines can be updated before 5 years if there is new evidence to trigger an earlier update and change a KAS. Adapted from Rosenfeld et al.3
AAO-HNS has adopted the policy of creating a formal CGP update at a minimum of 5 years after publication.3 A CPG may be updated sooner than the 5-year automatic review. A CPG could be updated sooner than 5 years when there are3,8 Changes in evidence that bear on the existing benefits and harms of interventions Changes in outcomes considered important Changes in available interventions Changes in evidence that current practice is optimal Changes in values placed on outcomes Changes in resources available for health care To date, the AAO-HNS has produced 13 CPGs. Of those, there has been an official update published for acute otitis externa.9 Five updates are in development or the development queue, including adult sinusitis, otitis media with effusion, cerumen impaction, benign paroxysmal positional vertigo, and hoarseness.
How to Update? The process of updating an AAO-HNS CPG is similar to its creation, although on a smaller scale (see Figure 1). A guideline update group is formed consisting of a chair, assistant chair, a methodology consultant, consumers, and content experts.3 Prior to formal review, an executive summary of the original CPG is sent to 5 to 10 external reviewers who are tasked to create a summary grid for each key action statement. For each statement, the external reviews suggest a disposition of ‘‘keep as is,’’‘‘keep but modify,’’ or ‘‘discard.’’ This group of external reviewers also identifies new evidence for quality improvement from which new actions statements could be created. A new literature search is also conducted by an information specialist to identify new high-grade studies pertaining to the
CPG topic. The update group then convenes to review the CPG, suggestions from external reviewers, and new evidence based on the literature search. The group decides whether the CPG needs minor or major updates or if it can be reaffirmed as it currently exists. This type of focused review has been reported to be equally effective as more comprehensive literature searches.8,10,11 The update is disseminated in similar fashion to the original GPG: via the AAO-HNS website, official journal, presentations at the AAO-HNS annual meeting, monthly bulletin, and press releases.
Summary The creation of CPGs we can trust is dictated by strict protocols for evaluating the available literature. Maintaining CPGs is also ideally guided by similar protocols that are established to ensure the incorporation of new knowledge within a predetermined timeframe. The AAO-HNS has such protocols in place and has implemented these practices in the maintenance of its own protocols. Acknowledgment I am grateful to Drs Richard Rosenfeld and Seth Schwartz for their critical review and suggestions for this manuscript. I also thank Lorraine Nnacheta and Stephanie Jones at the AAO-HNS for their help with this manuscript and the CPG process.
Author Contributions Richard K. Gurgel, conception/design manuscript.
Disclosures Competing interests: None. Sponsorships: None. Funding source: None.
Downloaded from oto.sagepub.com at SUNY STONY BROOK on March 12, 2015
Gurgel
3
References 1. Graham R, Mancher M, Miller Wolman D, et al. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011. 2. Qaseem A, Forland F, Macbeth F, et al. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med. 2012;156:525-531. 3. Rosenfeld RM, Shiffman RN, Robertson P, et al. Clinical Practice Guideline Development Manual, Third Edition: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg. 2013;148:S1-S55. 4. Shekelle PG, Ortiz E, Rhodes S, et al. Validity of the Agency for Healthcare Research and Quality clinical practice guidelines: how quickly do guidelines become outdated? JAMA. 2001;286:1461-1467. 5. Lyratzopoulos G, Barnes S, Stegenga H, et al. Updating clinical practice recommendations: is it worthwhile and when? Int J Technol Assess Health Care. 2012;28:29-35.
6. Burgers JS, Grol R, Klazinga NS, et al. Towards evidencebased clinical practice: an international survey of 18 clinical guideline programs. Int J Qual Health Care. 2003;15:31-45. 7. Vernooij RW, Sanabria AJ, Sola I, et al. Guidance for updating clinical practice guidelines: a systematic review of methodological handbooks. Implement Sci. 2014;9:3. 8. Shekelle P, Eccles MP, Grimshaw JM, et al. When should clinical guidelines be updated? BMJ. 2001;323:155-157. 9. Rosenfeld RM, Schwartz SR, Cannon CR, et al. Clinical practice guideline: acute otitis externa. Otolaryngol Head Neck Surg. 2014;150:S1-S24. 10. Gartlehner G, West SL, Lohr KN, et al. Assessing the need to update prevention guidelines: a comparison of two methods. Int J Qual Health Care. 2004;16:399-406. 11. Becker M, Neugebauer EA, Eikermann M. Partial updating of clinical practice guidelines often makes more sense than full updating: a systematic review on methods and the development of an updating procedure. J Clin Epidemiol. 2014;67:33-45.
Downloaded from oto.sagepub.com at SUNY STONY BROOK on March 12, 2015
Updating Clinical Practice Guidelines: How Do We Stay Current? Richard K. Gurgel, MD1
No sponsorships or competing interests have been disclosed for this article.
Abstract Clinical practice guidelines (CPGs) are created to address quality improvement opportunities for all clinicians, optimize patient care, promote effective diagnosis and therapy, and reduce harmful or unnecessary variations in patient care. Tremendous resources are invested in creating CPGs we can trust. Once a guideline is created, however, how is it maintained to reflect the most up-to-date clinical evidence? This article reviews protocols for reviewing and maintaining CPGs with particular attention to the protocols established by the American Academy of Otolaryngology—Head and Neck Surgery. Keywords clinical practice guidelines, evidence-based medicine, methodology, systematic review, updating Received January 6, 2015; revised January 7, 2015; accepted January 29, 2015.
Background The US Institute of Medicine (IOM) defines clinical practice guidelines (CPGs) as ‘‘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(p4) The American Academy of Otolaryngology—Head and Neck Surgery (AAOHNS) has created 13 clinical practice guidelines. These guidelines are created to address quality improvement opportunities for all clinicians, optimize patient care, promote effective diagnosis and therapy, and reduce harmful or unnecessary variations in patient care.2 The AAO-HNS process for guideline development is based on an established and transparent process that considers levels of evidence, harm-benefit balance, and expert consensus to resolve gaps in evidence.3 Tremendous resources are devoted to the creation of these guidelines. After the guideline is created, however, how does the AAOHNS maintain the guideline to ensure that recommendations are up to date? This article reviews the processes by which guidelines are maintained as well as offers some recommendations for future maintenance.
Otolaryngology– Head and Neck Surgery 1–3 Ó American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599815573735 http://otojournal.org
When to Update? In a study by Shekelle et al,4 which evaluated how quickly CPGs become outdated, the authors reported that 50% of guidelines were outdated in 5.8 years (95% confidence interval [CI], 5.0-6.6 years). This finding underscores the fact that medical knowledge is constantly growing. The rate of growth, however, is variable for different disease processes. As such, it is difficult to strictly proscribe how much time should elapse before a CPG is updated. An ideal approach to updating CPGs would be to update continuously as new, high-level evidence emerges (ie, using a ‘‘near real-time’’ approach).5 Such an approach, however, is impractical given the substantial resources necessary to maintain CPGs. The IOM has recommended that ‘‘the CPG publication date, date of evidence review, and proposed date for future CPG review should be documented in the CPG; literature should be monitored regularly and the CPG updated when new evidence suggests a need for modification.’’1(p137) The Guidelines International Network (GIN) recommends, ‘‘A guideline should include an expiration date and/or describe the process that the GDG will use to update the recommendations.’’2(p526) Protocols for updating CPGs have not always been specifically delineated. Burgers et al6 reported that of CPGs reviewed from 18 guideline programs, 9 lacked formal procedures for keeping their guidelines up to date. In a systematic review of 35 methodological handbooks on how guidelines should be created and maintained, Vernooij et al7 found that 40% recommended updates every 2 to 3 years, 23% for every 4 to 5 years, and almost 30% did not indicate a recommended time frame. The study by Vernooij et al concluded that available guidance from such handbooks is of overall poor quality and that CPG developers should provide more explicit and rigorous guidance to the update process. Despite the difficulty in finding a balance between too long vs too short time periods between CPG updates, it is reasonable to establish predetermined protocols on how much time should elapse before a CPG is updated. The 1
Division of Otolaryngology, University of Utah, Salt Lake City, Utah, USA
Corresponding Author: Richard K. Gurgel, Division of Otolaryngology–Head and Neck Surgery, University of Utah Hospitals, 50 N. Medical Dr, Salt Lake City, UT, 84132, USA. Email: [email protected]
Downloaded from oto.sagepub.com at SUNY STONY BROOK on March 12, 2015
2
Otolaryngology–Head and Neck Surgery
Figure 1. Flowchart of how clinical practice guidelines are formally reviewed and updated. KAS, key action statement. *Guidelines can be updated before 5 years if there is new evidence to trigger an earlier update and change a KAS. Adapted from Rosenfeld et al.3
AAO-HNS has adopted the policy of creating a formal CGP update at a minimum of 5 years after publication.3 A CPG may be updated sooner than the 5-year automatic review. A CPG could be updated sooner than 5 years when there are3,8 Changes in evidence that bear on the existing benefits and harms of interventions Changes in outcomes considered important Changes in available interventions Changes in evidence that current practice is optimal Changes in values placed on outcomes Changes in resources available for health care To date, the AAO-HNS has produced 13 CPGs. Of those, there has been an official update published for acute otitis externa.9 Five updates are in development or the development queue, including adult sinusitis, otitis media with effusion, cerumen impaction, benign paroxysmal positional vertigo, and hoarseness.
How to Update? The process of updating an AAO-HNS CPG is similar to its creation, although on a smaller scale (see Figure 1). A guideline update group is formed consisting of a chair, assistant chair, a methodology consultant, consumers, and content experts.3 Prior to formal review, an executive summary of the original CPG is sent to 5 to 10 external reviewers who are tasked to create a summary grid for each key action statement. For each statement, the external reviews suggest a disposition of ‘‘keep as is,’’‘‘keep but modify,’’ or ‘‘discard.’’ This group of external reviewers also identifies new evidence for quality improvement from which new actions statements could be created. A new literature search is also conducted by an information specialist to identify new high-grade studies pertaining to the
CPG topic. The update group then convenes to review the CPG, suggestions from external reviewers, and new evidence based on the literature search. The group decides whether the CPG needs minor or major updates or if it can be reaffirmed as it currently exists. This type of focused review has been reported to be equally effective as more comprehensive literature searches.8,10,11 The update is disseminated in similar fashion to the original GPG: via the AAO-HNS website, official journal, presentations at the AAO-HNS annual meeting, monthly bulletin, and press releases.
Summary The creation of CPGs we can trust is dictated by strict protocols for evaluating the available literature. Maintaining CPGs is also ideally guided by similar protocols that are established to ensure the incorporation of new knowledge within a predetermined timeframe. The AAO-HNS has such protocols in place and has implemented these practices in the maintenance of its own protocols. Acknowledgment I am grateful to Drs Richard Rosenfeld and Seth Schwartz for their critical review and suggestions for this manuscript. I also thank Lorraine Nnacheta and Stephanie Jones at the AAO-HNS for their help with this manuscript and the CPG process.
Author Contributions Richard K. Gurgel, conception/design manuscript.
Disclosures Competing interests: None. Sponsorships: None. Funding source: None.
Downloaded from oto.sagepub.com at SUNY STONY BROOK on March 12, 2015
Gurgel
3
References 1. Graham R, Mancher M, Miller Wolman D, et al. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011. 2. Qaseem A, Forland F, Macbeth F, et al. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med. 2012;156:525-531. 3. Rosenfeld RM, Shiffman RN, Robertson P, et al. Clinical Practice Guideline Development Manual, Third Edition: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg. 2013;148:S1-S55. 4. Shekelle PG, Ortiz E, Rhodes S, et al. Validity of the Agency for Healthcare Research and Quality clinical practice guidelines: how quickly do guidelines become outdated? JAMA. 2001;286:1461-1467. 5. Lyratzopoulos G, Barnes S, Stegenga H, et al. Updating clinical practice recommendations: is it worthwhile and when? Int J Technol Assess Health Care. 2012;28:29-35.
6. Burgers JS, Grol R, Klazinga NS, et al. Towards evidencebased clinical practice: an international survey of 18 clinical guideline programs. Int J Qual Health Care. 2003;15:31-45. 7. Vernooij RW, Sanabria AJ, Sola I, et al. Guidance for updating clinical practice guidelines: a systematic review of methodological handbooks. Implement Sci. 2014;9:3. 8. Shekelle P, Eccles MP, Grimshaw JM, et al. When should clinical guidelines be updated? BMJ. 2001;323:155-157. 9. Rosenfeld RM, Schwartz SR, Cannon CR, et al. Clinical practice guideline: acute otitis externa. Otolaryngol Head Neck Surg. 2014;150:S1-S24. 10. Gartlehner G, West SL, Lohr KN, et al. Assessing the need to update prevention guidelines: a comparison of two methods. Int J Qual Health Care. 2004;16:399-406. 11. Becker M, Neugebauer EA, Eikermann M. Partial updating of clinical practice guidelines often makes more sense than full updating: a systematic review on methods and the development of an updating procedure. J Clin Epidemiol. 2014;67:33-45.
Downloaded from oto.sagepub.com at SUNY STONY BROOK on March 12, 2015
