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SMFM adopts GRADE (Grading of Recommendations Assessment, Development, and Evaluation) for clinical guidelines

      See related article, page 170
      In this edition of the journal, the Society for Maternal-Fetal Medicine (SMFM) has published its latest clinical guideline regarding fetal blood sampling.
      • Berry S.M.
      • Stone J.
      • Norton M.
      • Johnson M.
      • Berghella V.
      Society for Maternal-Fetal Medicine
      SMFM Clinical Guideline: fetal blood sampling.
      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).
      • Guyatt G.H.
      • Oxman A.D.
      • 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.
      Table 1GRADE recommendations
      • Guyatt G.H.
      • Oxman A.D.
      • 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.

      UpToDate, grading guide. Available at: http://www.uptodate.com/home/grading-guide#GradingRecommendations. Accessed March 8, 2013.

      Grade of recommendationClarity of risk/benefitQuality of supporting evidenceImplications
      1A

      Strong recommendation, high-quality evidence
      Benefits clearly outweigh risks and burdens, or vice versaConsistent 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 risksStrong 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 versaEvidence 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 estimateStrong 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 versaEvidence from observational studies, unsystematic clinical experience, or randomized, controlled trials with serious flaws; any estimate of effect is uncertainStrong 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 burdensConsistent 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 risksWeak 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 burdensEvidence 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 estimateWeak 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 burdensEvidence from observational studies, unsystematic clinical experience, or randomized, controlled trials with serious flaws; any estimate of effect is uncertainVery weak recommendation; other alternatives may be equally reasonable
      Best practiceRecommendation in which either: (i) there is enormous amount of indirect evidence that clearly justifies strong recommendation–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.

      UpToDate, grading guide. Available at: http://www.uptodate.com/home/grading-guide#GradingRecommendations. Accessed March 8, 2013.

      SMFM. SMFM adopts GRADE. Am J Obstet Gynecol 2013.
      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.
      • Guyatt G.H.
      • Oxman A.D.
      • 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.
      • Guyatt G.H.
      • Oxman A.D.
      • Kunz R.
      • et al.
      GRADE guidelines, 2: framing the question and deciding on important outcomes.
      • Balshem H.
      • Helfand M.
      • Schünemann H.J.
      • et al.
      GRADE guidelines, 3: rating the quality of evidence.
      • Guyatt G.H.
      • Oxman A.D.
      • Vist G.
      • et al.
      GRADE guidelines, 4: rating the quality of evidence–study limitations (risk of bias).
      • Guyatt G.H.
      • Oxman A.D.
      • Montori V.
      • et al.
      GRADE guidelines, 5: rating the quality of evidence–publication bias.
      • Guyatt G.H.
      • Oxman A.D.
      • Kunz R.
      • et al.
      GRADE guidelines, 6: rating the quality of evidence–imprecision.
      • Guyatt G.H.
      • Oxman A.D.
      • Kunz R.
      • et al.
      GRADE Working Group
      GRADE guidelines, 7: rating the quality of evidence–inconsistency.
      • Guyatt G.H.
      • Oxman A.D.
      • Kunz R.
      • et al.
      GRADE Working Group
      GRADE guidelines, 8: rating the quality of evidence–indirectness.
      • Guyatt G.H.
      • Oxman A.D.
      • Sultan S.
      • et al.
      GRADE Working Group
      GRADE guidelines, 9: rating up the quality of evidence.
      • Bruneti M.
      • Shemilt I.
      • Pregno S.
      • et al.
      GRADE guidelines, 10: considering resource use and rating the quality of economic evidence.
      • Guyatt G.
      • Oxman A.D.
      • Sultan S.
      • et al.
      GRADE guidelines, 11: making an overall rating of confidence in effect estimates for a single outcome and for all outcomes.
      • Guyatt G.H.
      • Oxman A.D.
      • Santesso N.
      • et al.
      GRADE guidelines, 12: preparing summary of findings tables–binary outcomes.
      • Guyatt G.H.
      • Thorlund K.
      • Oxman A.D.
      • et al.
      GRADE guidelines, 13: preparing summary of findings tables and evidence profiles–continuous outcomes.
      • Andrews J.
      • Guyatt G.
      • Oxman A.D.
      • et al.
      GRADE guidelines, 14: going from evidence to recommendations; the significance and presentation of recommendations.
      • Andrews J.C.
      • Schünemann H.J.
      • Oxman A.D.
      • et al.
      GRADE guidelines, 15: going from evidence to recommendation–determinants of a recommendation's direction and strength.

      UpToDate, grading guide. Available at: http://www.uptodate.com/home/grading-guide#GradingRecommendations. Accessed March 8, 2013.

      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).
      Table 2Quality of evidence
      QualityDescription
      High-AConsistent 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
      Moderate-BEvidence 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-CEvidence 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.
      Table 3Strength of recommendation
      StrengthDescription
      1. StrongBenefits clearly outweigh risks and burdens, or vice versa
      2. WeakBenefits closely balanced with risks and burdens
      SMFM. SMFM adopts GRADE. Am J Obstet Gynecol 2013.
      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 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.

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      1. UpToDate, grading guide. Available at: http://www.uptodate.com/home/grading-guide#GradingRecommendations. Accessed March 8, 2013.

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