- Email: [email protected]
SMFM adopts GRADE (Grading of Recommendations Assessment, Development, and Evaluation) for clinical guidelines
Editorials
www.AJOG .org
SMFM adopts GRADE (Grading of Recommendations Assessment, Development, and Evaluation) for clinical guidelines Society for Maternal-Fetal Medicine (SMFM); Suneet P. Chauhan, MD; Sean C. Blackwell, MD
I
n this edition of the journal, the Society for Maternal-Fetal Medicine (SMFM) has published its latest clinical guideline regarding fetal blood sampling.1 Up to this point, SMFM had been using an evidence grading system outlined by the US Preventive Services Task Force that classified recommendations level A (based on good and consistent scientific evidence), level B (based on limited or inconsistence scientific evidence), and level C (based on expert opinion or consensus). After careful consideration and consultation with experts in the field, the SMFM Publications Committee has adopted Grading of Recommendations Assessment, Development, and Evaluation (GRADE) for grading scientific evidence and practice recommendations for SMFM clinical guidelines (Table 1).2 This decision to adopt GRADE was multifactorial: the desire to achieve a singular classification system to improve consistency with other organizations creating guidelines and to address some of the limitations of previous classification systems. This will ultimately benefit clinicians, policy-makers, and patients. Similar to the process for the previously used classification system, GRADE starts with formulating a question in the format of population, intervention, comparison, and outcome.2-17 Once the relevant studies are summarized, GRADE provides explicit criteria for rating the quality of evidence that include study design, risk of bias, imprecision, inconsistency, indirectness, and magnitude of effect. Eventually, the quality of the evidence is categorized as one of the following: high (grade A), moderate (grade B), or low (grade C). Once the evidence is graded, recommendations are made, characterizing them as either strong (grade 1) or weak (grade 2) (Tables 2 and 3). Similar to any situation when a new process or approach is undertaken, it is expected there will be a learning curve with GRADE for both the SMFM Publications Committee and those interpreting the guidelines. We believe that in the long term the adoption of GRADE benefits clinicians and policy-makers and From the Society for Maternal-Fetal Medicine Publications Committee, Eastern Virginia Medical School, Norfolk, VA (Dr Chauhan); UT Health-University of Texas Medical School at Houston, Houston, TX (Dr Blackwell). The authors report no conflict of interest. Reprints are not available from the authors. 0002-9378/free ª 2013 Mosby, Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2013.07.012
See related article, page 170
thus leads to improvement in the quality of care for our patients. For additional information and resources regarding GRADE, please see http://www.gradeworkinggroup.org. REFERENCES 1. Society for Maternal-Fetal Medicine; Berry SM, Stone J, Norton M, Johnson M, Berghella V. SMFM Clinical Guideline: fetal blood sampling. Am J Obstet Gynecol 2013;209:170-80. 2. Guyatt GH, Oxman AD, Vist G, et al; for the GRADE Working Group. Rating quality of evidence and strength of recommendations GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6. 3. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines, 2: framing the question and deciding on important outcomes. J Clin Epidemiol 2011;64:395-400. 4. Balshem H, Helfand M, Schünemann HJ, et al. GRADE guidelines, 3: rating the quality of evidence. J Clin Epidemiol 2011;64:401-6. 5. Guyatt GH, Oxman AD, Vist G, et al. GRADE guidelines, 4: rating the quality of evidenceestudy limitations (risk of bias). J Clin Epidemiol 2001;64:407-15. 6. Guyatt GH, Oxman AD, Montori V, et al. GRADE guidelines, 5: rating the quality of evidenceepublication bias. J Clin Epidemiol 2011;64: 1277-82. 7. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines, 6: rating the quality of evidenceeimprecision. J Clin Epidemiol 2011;64:1283-93. 8. Guyatt GH, Oxman AD, Kunz R, et al; GRADE Working Group. GRADE guidelines, 7: rating the quality of evidenceeinconsistency. J Clin Epidemiol 2011;64:1294-302. 9. Guyatt GH, Oxman AD, Kunz R, et al; GRADE Working Group. GRADE guidelines, 8: rating the quality of evidenceeindirectness. J Clin Epidemiol 2011;64:1303-10. 10. Guyatt GH, Oxman AD, Sultan S, et al; GRADE Working Group. GRADE guidelines, 9: rating up the quality of evidence. J Clin Epidemiol 2011;64:1311-6. 11. Bruneti M, Shemilt I, Pregno S, et al. GRADE guidelines, 10: considering resource use and rating the quality of economic evidence. J Clin Epidemiol 2013;66:140-50. 12. Guyatt G, Oxman AD, Sultan S, et al. GRADE guidelines, 11: making an overall rating of confidence in effect estimates for a single outcome and for all outcomes. J Clin Epidemiol 2013;66:151-7. 13. Guyatt GH, Oxman AD, Santesso N, et al. GRADE guidelines, 12: preparing summary of findings tablesebinary outcomes. J Clin Epidemiol 2013;66:158-72. 14. Guyatt GH, Thorlund K, Oxman AD, et al. GRADE guidelines, 13: preparing summary of findings tables and evidence profilesecontinuous outcomes. J Clin Epidemiol 2013;66:173-83. 15. Andrews J, Guyatt G, Oxman AD, et al. GRADE guidelines, 14: going from evidence to recommendations; the significance and presentation of recommendations. J Clin Epidemiol 2013;66:719-25. 16. Andrews JC, Schünemann HJ, Oxman AD, et al. GRADE guidelines, 15: going from evidence to recommendationedeterminants of a recommendation’s direction and strength. J Clin Epidemiol 2013;66:726-35. 17. UpToDate, grading guide. Available at: http://www.uptodate.com/ home/grading-guide#GradingRecommendations. Accessed March 8, 2013. SEPTEMBER 2013 American Journal of Obstetrics & Gynecology
163
GRADE recommendations2,17 Grade of recommendation
Quality of supporting evidence
Implications
Benefits clearly outweigh risks and burdens, or vice versa
Consistent evidence from well-performed randomized, controlled trials or overwhelming evidence of some other form; further research is unlikely to change our confidence in estimate of benefit and risks
Strong recommendations, can apply to most patients in most circumstances without reservation; clinicians should follow strong recommendation unless clear and compelling rationale for alternative approach is present
1B Strong recommendation, moderate-quality evidence
Benefits clearly outweigh risks and burdens, or vice versa
Evidence from randomized, controlled trials with important limitations (inconsistent results, methodological flaws, indirect or imprecise), or very strong evidence of some other research design; further research (if performed) is likely to have impact on our confidence in estimate of benefit and risks and may change estimate
Strong recommendation and applies to most patients; clinicians should follow strong recommendation unless clear and compelling rationale for alternative approach is present
1C Strong recommendation, low-quality evidence
Benefits appear to outweigh risks and burdens, or vice versa
Evidence from observational studies, unsystematic clinical experience, or randomized, controlled trials with serious flaws; any estimate of effect is uncertain
Strong recommendation, and applies to most patients; some of evidence base supporting recommendation is, however, of low quality
2A Weak recommendation, high-quality evidence
Benefits closely balanced with risks and burdens
Consistent evidence from well-performed randomized, controlled trials or overwhelming evidence of some other form; further research is unlikely to change our confidence in estimate of benefit and risks
Weak recommendation, best action may differ depending on circumstances or patients or societal values
2B Weak recommendation, moderate-quality evidence
Benefits closely balanced with risks and burdens; some uncertainly in estimates of benefits, risks, and burdens
Evidence from randomized, controlled trials with important limitations (inconsistent results, methodological flaws, indirect or imprecise), or very strong evidence of some other research design; further research (if performed) is likely to have impact on our confidence in estimate of benefit and risks and may change estimate
Weak recommendation, alternative approaches likely to be better for some patients under some circumstances
2C Weak recommendation, low-quality evidence
Uncertainty in estimates of benefits, risks, and burdens; benefits may be closely balanced with risks and burdens
Evidence from observational studies, unsystematic clinical experience, or randomized, controlled trials with serious flaws; any estimate of effect is uncertain
Very weak recommendation; other alternatives may be equally reasonable
Best practice
Recommendation in which either: (i) there is enormous amount of indirect evidence that clearly justifies strong recommendatione direct evidence would be challenging, and inefficient use of time and resources, to bring together and carefully summarize; or (ii) recommendation to contrary would be unethical
GRADE, Grading of Recommendations Assessment, Development and Evaluation. Adapted from UpToDate.17 SMFM. SMFM adopts GRADE. Am J Obstet Gynecol 2013.
www.AJOG.org
Clarity of risk/benefit
1A Strong recommendation, high-quality evidence
Editorials
164 American Journal of Obstetrics & Gynecology SEPTEMBER 2013
TABLE 1
www.AJOG.org
TABLE 2
Editorials TABLE 3
Quality of evidence
Strength of recommendation
Quality
Description
Strength
Description
High-A
Consistent evidence from well-performed randomized, controlled trials or overwhelming evidence of some other form; further research is unlikely to change our confidence in estimate of benefit and risks
1. Strong
Benefits clearly outweigh risks and burdens, or vice versa
2. Weak
Benefits closely balanced with risks and burdens
Moderate-B
Evidence from randomized, controlled trials with important limitations (inconsistent results, methodological flaws, indirect or imprecise), or very strong evidence of some other research design; further research (if performed) is likely to have impact on our confidence in estimate of benefit and risks and may change estimate
Low-C
Evidence from observational studies, unsystematic clinical experience, or randomized, controlled trials with serious flaws; any estimate of effect is uncertain
SMFM. SMFM adopts GRADE. Am J Obstet Gynecol 2013.
SMFM. SMFM adopts GRADE. Am J Obstet Gynecol 2013.
SEPTEMBER 2013 American Journal of Obstetrics & Gynecology
165
www.AJOG .org
SMFM adopts GRADE (Grading of Recommendations Assessment, Development, and Evaluation) for clinical guidelines Society for Maternal-Fetal Medicine (SMFM); Suneet P. Chauhan, MD; Sean C. Blackwell, MD
I
n this edition of the journal, the Society for Maternal-Fetal Medicine (SMFM) has published its latest clinical guideline regarding fetal blood sampling.1 Up to this point, SMFM had been using an evidence grading system outlined by the US Preventive Services Task Force that classified recommendations level A (based on good and consistent scientific evidence), level B (based on limited or inconsistence scientific evidence), and level C (based on expert opinion or consensus). After careful consideration and consultation with experts in the field, the SMFM Publications Committee has adopted Grading of Recommendations Assessment, Development, and Evaluation (GRADE) for grading scientific evidence and practice recommendations for SMFM clinical guidelines (Table 1).2 This decision to adopt GRADE was multifactorial: the desire to achieve a singular classification system to improve consistency with other organizations creating guidelines and to address some of the limitations of previous classification systems. This will ultimately benefit clinicians, policy-makers, and patients. Similar to the process for the previously used classification system, GRADE starts with formulating a question in the format of population, intervention, comparison, and outcome.2-17 Once the relevant studies are summarized, GRADE provides explicit criteria for rating the quality of evidence that include study design, risk of bias, imprecision, inconsistency, indirectness, and magnitude of effect. Eventually, the quality of the evidence is categorized as one of the following: high (grade A), moderate (grade B), or low (grade C). Once the evidence is graded, recommendations are made, characterizing them as either strong (grade 1) or weak (grade 2) (Tables 2 and 3). Similar to any situation when a new process or approach is undertaken, it is expected there will be a learning curve with GRADE for both the SMFM Publications Committee and those interpreting the guidelines. We believe that in the long term the adoption of GRADE benefits clinicians and policy-makers and From the Society for Maternal-Fetal Medicine Publications Committee, Eastern Virginia Medical School, Norfolk, VA (Dr Chauhan); UT Health-University of Texas Medical School at Houston, Houston, TX (Dr Blackwell). The authors report no conflict of interest. Reprints are not available from the authors. 0002-9378/free ª 2013 Mosby, Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2013.07.012
See related article, page 170
thus leads to improvement in the quality of care for our patients. For additional information and resources regarding GRADE, please see http://www.gradeworkinggroup.org. REFERENCES 1. Society for Maternal-Fetal Medicine; Berry SM, Stone J, Norton M, Johnson M, Berghella V. SMFM Clinical Guideline: fetal blood sampling. Am J Obstet Gynecol 2013;209:170-80. 2. Guyatt GH, Oxman AD, Vist G, et al; for the GRADE Working Group. Rating quality of evidence and strength of recommendations GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6. 3. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines, 2: framing the question and deciding on important outcomes. J Clin Epidemiol 2011;64:395-400. 4. Balshem H, Helfand M, Schünemann HJ, et al. GRADE guidelines, 3: rating the quality of evidence. J Clin Epidemiol 2011;64:401-6. 5. Guyatt GH, Oxman AD, Vist G, et al. GRADE guidelines, 4: rating the quality of evidenceestudy limitations (risk of bias). J Clin Epidemiol 2001;64:407-15. 6. Guyatt GH, Oxman AD, Montori V, et al. GRADE guidelines, 5: rating the quality of evidenceepublication bias. J Clin Epidemiol 2011;64: 1277-82. 7. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines, 6: rating the quality of evidenceeimprecision. J Clin Epidemiol 2011;64:1283-93. 8. Guyatt GH, Oxman AD, Kunz R, et al; GRADE Working Group. GRADE guidelines, 7: rating the quality of evidenceeinconsistency. J Clin Epidemiol 2011;64:1294-302. 9. Guyatt GH, Oxman AD, Kunz R, et al; GRADE Working Group. GRADE guidelines, 8: rating the quality of evidenceeindirectness. J Clin Epidemiol 2011;64:1303-10. 10. Guyatt GH, Oxman AD, Sultan S, et al; GRADE Working Group. GRADE guidelines, 9: rating up the quality of evidence. J Clin Epidemiol 2011;64:1311-6. 11. Bruneti M, Shemilt I, Pregno S, et al. GRADE guidelines, 10: considering resource use and rating the quality of economic evidence. J Clin Epidemiol 2013;66:140-50. 12. Guyatt G, Oxman AD, Sultan S, et al. GRADE guidelines, 11: making an overall rating of confidence in effect estimates for a single outcome and for all outcomes. J Clin Epidemiol 2013;66:151-7. 13. Guyatt GH, Oxman AD, Santesso N, et al. GRADE guidelines, 12: preparing summary of findings tablesebinary outcomes. J Clin Epidemiol 2013;66:158-72. 14. Guyatt GH, Thorlund K, Oxman AD, et al. GRADE guidelines, 13: preparing summary of findings tables and evidence profilesecontinuous outcomes. J Clin Epidemiol 2013;66:173-83. 15. Andrews J, Guyatt G, Oxman AD, et al. GRADE guidelines, 14: going from evidence to recommendations; the significance and presentation of recommendations. J Clin Epidemiol 2013;66:719-25. 16. Andrews JC, Schünemann HJ, Oxman AD, et al. GRADE guidelines, 15: going from evidence to recommendationedeterminants of a recommendation’s direction and strength. J Clin Epidemiol 2013;66:726-35. 17. UpToDate, grading guide. Available at: http://www.uptodate.com/ home/grading-guide#GradingRecommendations. Accessed March 8, 2013. SEPTEMBER 2013 American Journal of Obstetrics & Gynecology
163
GRADE recommendations2,17 Grade of recommendation
Quality of supporting evidence
Implications
Benefits clearly outweigh risks and burdens, or vice versa
Consistent evidence from well-performed randomized, controlled trials or overwhelming evidence of some other form; further research is unlikely to change our confidence in estimate of benefit and risks
Strong recommendations, can apply to most patients in most circumstances without reservation; clinicians should follow strong recommendation unless clear and compelling rationale for alternative approach is present
1B Strong recommendation, moderate-quality evidence
Benefits clearly outweigh risks and burdens, or vice versa
Evidence from randomized, controlled trials with important limitations (inconsistent results, methodological flaws, indirect or imprecise), or very strong evidence of some other research design; further research (if performed) is likely to have impact on our confidence in estimate of benefit and risks and may change estimate
Strong recommendation and applies to most patients; clinicians should follow strong recommendation unless clear and compelling rationale for alternative approach is present
1C Strong recommendation, low-quality evidence
Benefits appear to outweigh risks and burdens, or vice versa
Evidence from observational studies, unsystematic clinical experience, or randomized, controlled trials with serious flaws; any estimate of effect is uncertain
Strong recommendation, and applies to most patients; some of evidence base supporting recommendation is, however, of low quality
2A Weak recommendation, high-quality evidence
Benefits closely balanced with risks and burdens
Consistent evidence from well-performed randomized, controlled trials or overwhelming evidence of some other form; further research is unlikely to change our confidence in estimate of benefit and risks
Weak recommendation, best action may differ depending on circumstances or patients or societal values
2B Weak recommendation, moderate-quality evidence
Benefits closely balanced with risks and burdens; some uncertainly in estimates of benefits, risks, and burdens
Evidence from randomized, controlled trials with important limitations (inconsistent results, methodological flaws, indirect or imprecise), or very strong evidence of some other research design; further research (if performed) is likely to have impact on our confidence in estimate of benefit and risks and may change estimate
Weak recommendation, alternative approaches likely to be better for some patients under some circumstances
2C Weak recommendation, low-quality evidence
Uncertainty in estimates of benefits, risks, and burdens; benefits may be closely balanced with risks and burdens
Evidence from observational studies, unsystematic clinical experience, or randomized, controlled trials with serious flaws; any estimate of effect is uncertain
Very weak recommendation; other alternatives may be equally reasonable
Best practice
Recommendation in which either: (i) there is enormous amount of indirect evidence that clearly justifies strong recommendatione direct evidence would be challenging, and inefficient use of time and resources, to bring together and carefully summarize; or (ii) recommendation to contrary would be unethical
GRADE, Grading of Recommendations Assessment, Development and Evaluation. Adapted from UpToDate.17 SMFM. SMFM adopts GRADE. Am J Obstet Gynecol 2013.
www.AJOG.org
Clarity of risk/benefit
1A Strong recommendation, high-quality evidence
Editorials
164 American Journal of Obstetrics & Gynecology SEPTEMBER 2013
TABLE 1
www.AJOG.org
TABLE 2
Editorials TABLE 3
Quality of evidence
Strength of recommendation
Quality
Description
Strength
Description
High-A
Consistent evidence from well-performed randomized, controlled trials or overwhelming evidence of some other form; further research is unlikely to change our confidence in estimate of benefit and risks
1. Strong
Benefits clearly outweigh risks and burdens, or vice versa
2. Weak
Benefits closely balanced with risks and burdens
Moderate-B
Evidence from randomized, controlled trials with important limitations (inconsistent results, methodological flaws, indirect or imprecise), or very strong evidence of some other research design; further research (if performed) is likely to have impact on our confidence in estimate of benefit and risks and may change estimate
Low-C
Evidence from observational studies, unsystematic clinical experience, or randomized, controlled trials with serious flaws; any estimate of effect is uncertain
SMFM. SMFM adopts GRADE. Am J Obstet Gynecol 2013.
SMFM. SMFM adopts GRADE. Am J Obstet Gynecol 2013.
SEPTEMBER 2013 American Journal of Obstetrics & Gynecology
165