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. 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 ).
Table 1
GRADE recommendations
| Grade of recommendation | Clarity of risk/benefit | Quality of supporting evidence | Implications |
|---|---|---|---|
| 1A Strong recommendation, high-quality evidence | 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 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.
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