The Development of Clinical Guidelines by the American Gastroenterological Association
Article Outline
- Current AGA Process for Development of Medical Position Statements
- The US Preventive Services Task Force Recommendation Grading System
- The Grading of Recommendations Assessment, Development and Evaluation System
- Looking to the Future
- References
- Copyright
Included in this issue of Gastroenterology is a medical position statement and technical review (TR) on the diagnosis and management of colorectal neoplasia in inflammatory bowel disease by Farraye et al.1 The American Gastroenterological Association (AGA) Institute Clinical Practice and Quality Management Committee (CPQMC) is charged with developing evidence-based, clinical practice guidelines. We take this opportunity to report on the mechanisms and challenges of the current AGA process for development of position statements, and to offer insight into procedures for their future development.
Current AGA Process for Development of Medical Position Statements
The aim of evidence-based medicine is to improve the quality of health care by integrating the best research evidence with clinical expertise and patient values.2, 3 Evidence-based clinical guidelines are sets of recommendations intended to assist health care providers and patients in selecting the best management for common clinical situations while accounting for patient-specific circumstances. Beyond the goals of optimal, patient-centered care and improved outcomes, guidelines can reduce practice variability, identify gaps in evidence, enhance efficiency of resource use, and facilitate development of outcome and performance measures.
The AGA understands the importance of a rigorous scientific vetting for its guidelines and has published a procedure manual outlining the process.4 The CPQMC chooses a topic by consensus discussion and votes after reviewing a list of potential topics derived from member recommendations. One or 2 topics per year are budgeted. The CPQMC Committee Chair, with support of AGA staff, then contacts the Clinical Counsel Chair and requests counsel's input for authorship and external reviewers. Authors are selected and write a TR. The initial draft of the TR is reviewed by 2–3 content experts and the CPQMC. The revised TR is then used to draft a medical position statement, a summary of the TR aimed at practicing physicians. Both documents are reviewed and revised during a panel meeting composed of content experts, practicing gastroenterologists, other specialists (surgeon, pathologist, etc), a patient representative, and AGA staff. After final consensus is reached, both documents are again reviewed by the CPQMC. Based on the committee's vote, a recommendation is submitted to the AGA Institute Governing Board, which provides final approval. When approval is granted, the guideline is published in Gastroenterology and is also posted on the AGA website.
Even when developed with the best intention, clinical practice guidelines can be flawed. Grol6 described 4 major problems with practice guidelines: (1) many guidelines are of low quality; (2) in many cases, the primary literature is too incomplete to develop evidence-based guidelines; (3) most guidelines are developed for the “textbook” patient; and (4) guidelines are often developed without consideration of whether their implementation would be acceptable to patients, physicians, or health care systems. One approach toward addressing these shortcomings has been to improve the methodology by which recommendations are generated, thereby improving transparency and reducing bias.
The US Preventive Services Task Force Recommendation Grading System
The AGA procedure manual,4 released in 2007, endorsed the 2003 version of the US Preventive Services Task Force (USPSTF) system to grade strength of recommendations.5 In that version, there are 5 grading classifications (A, B, C, D, and I) reflecting (a) the magnitude of net benefit (benefits minus harms) and (b) the quality of evidence (good, fair, or poor). In May 2007, the USPSTF changed its methods and grade definitions. The new grade definitions integrate (a) the magnitude of net benefit and (b) the level of certainty regarding the net benefit. A grade of A or B means that the USPSTF recommends the service. A grade of C or D means that the USPSTF recommends against routinely providing the service. A grade of I means that current evidence is insufficient to assess the balance of benefits and harms of the service.
The Grading of Recommendations Assessment, Development and Evaluation System
The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system (available: http://www.gradeworkinggroup.org/index.htm) has been adopted by several national and international societies and was constructed to address the shortcomings of existing grading systems.7, 8 GRADE separates quality of evidence from the strength of recommendation to ensure that the magnitude of benefits and harms is assessed as rigorously as the efficacy of interventions. With regard to strength of recommendations, GRADE has 2 categories: strong and weak (Table 1). Strong recommendations are meant to signify interventions that should be received by most individuals with a particular condition, and can be adopted as policy in most circumstances. Weak recommendations require individualized scrutiny of the evidence, and policy making would require substantial debate and involvement from multiple stakeholders. The classification requires consideration of 4 factors: quality of evidence, uncertainty about the balance between desirable and undesirable effects, variability in values and preferences, and uncertainty about whether the intervention represents a wise use of resources. Of importance to our current health care debate is that interventions receiving a strong recommendation may be targets for development of performance measures.
Table 1. GRADE: Recommendation Strength and Evidence Quality
| Clinical implication | Policy implication | |
|---|---|---|
| Strength of Recommendation | ||
 Strong | “Do it” or “Don't do it.” | Adherence to this recommendation could be used as a quality or performance measure. |
| Weak | “Probably do it” or “Probably don't do it.” | Recommendation not suitable for quality or performance measure. |
| Quality of Evidence | Definition | |
| High | Further research is very unlikely to change the estimate of effect. | |
| Moderate | Further research is likely to have an important impact and may change the estimate of effect. | |
| Low | Further research is very likely to have an important impact and is likely to change the estimate of effect. | |
| Very low | Any estimate of effect is uncertain. | |
Quality of evidence is assessed on a 4-point scale: high, moderate, low, and very low. Instead of being classified strictly on the basis of study design (ie, randomized, controlled clinical trials automatically receiving “high” quality marks) these levels reflect the likelihood that further research would change our confidence in the estimate of a particular intervention's beneficial effect. Five factors that determine quality include study limitations, inconsistency of results between studies, indirectness (generalizability) of results, imprecision, and publication bias. For this reason, randomized, controlled clinical trials that have methodologic flaws may be downgraded, whereas well-done observational studies that have large effect sizes (ie, relative risk >2–5 or <0.5–0.2) may receive upgrading.
Looking to the Future
As the field of guideline development has evolved, the AGA and CPQMC recognized the need to reconsider our approach to developing guidelines. The AGA and CPQMC are currently reviewing the resources needed to produce high-quality clinical guidelines that are relevant to our constituency. In the coming years, we anticipate a transition from the USPSTF system to the GRADE system for AGA guidelines. This shift is based on several factors, including the transparency of the GRADE system and its efficient process for updating guidelines. The CPQMC will continue to review our existing guidelines to identify new guidelines that need to be developed and old guidelines that need to be retired or revised. A forthcoming guideline addresses the management of Barrett's esophagus. With the development of the AGA's Digestive Health Outcome Registry, diseases demonstrated to have significant variability in practice patterns or outcomes will be targets for future position papers and educational efforts. Given the time and resources needed to generate a new guideline, topics that have the greatest impact on patient care will be of high priority. Position statements of the AGA will support the Institute of Medicine's 6 aims that health care should be safe, timely, effective, efficient, equitable, and patient centered. At times, the AGA may endorse guidelines developed by other professional organizations, but only if the AGA has been involved as a co-author and the guideline has gone through the same rigorous review and vetting as happens with AGA guidelines. Recommendations from AGA members for topics of future guidelines can be forwarded to the CPQMC via the AGA website at http://www.gastro.org/wmspage.cfm?parm1=4453.
References
- AGA technical review on the diagnosis and management of colorectal neoplasia in inflammatory bowel disease. Gastroenterology. 2010;138:746–774
- . Evidence based medicine: what it is and what it isn't. BMJ. 1996;312:71–72
- . Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academies Press; 2001;
- The AGA Institute practice recommendations development manual (A guidebook to assist individuals who write, evaluate and/or use AGA Institute Practice Recommendations). Bethesda, MD: AGA Institute Clinical Practice and Quality Management Committee; 2007;
- US Preventive Services Task Force ratings: strength of recommendations and quality of evidence. Guide to clinical preventive services, 3rd ed. Periodic updates. Rockville, MD: Agency for Healthcare Research and Quality; 2000–2003;
- . Improving the quality of medical care: building bridges among professional pride, payer profit, and patient satisfaction. JAMA. 2001;286:2578–2585
- GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336:924–926
- How strong is the evidence?. Am J Gastroenterol. 2008;103:1334–1338
PII: S0016-5085(09)02189-1
doi:10.1053/j.gastro.2009.12.028
© 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.
Refers to erratum:
- Correction , 08 February 2010
