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In this edition of the journal, the Society for Maternal-Fetal Medicine (SMFM) has published its latest clinical guideline regarding fetal blood sampling.
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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
Table 1GRADE recommendations
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UpToDate, grading guide. Available at: http://www.uptodate.com/home/grading-guide#GradingRecommendations. Accessed March 8, 2013.
| 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.
Adapted from UpToDate.
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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.
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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).UpToDate, grading guide. Available at: http://www.uptodate.com/home/grading-guide#GradingRecommendations. Accessed March 8, 2013.
Table 2Quality of evidence
| Quality | 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 |
| 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.
Table 3Strength of recommendation
| Strength | Description |
|---|---|
| 1. Strong | Benefits clearly outweigh risks and burdens, or vice versa |
| 2. Weak | Benefits 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.
References
- SMFM Clinical Guideline: fetal blood sampling.Am J Obstet Gynecol. 2013; 209 (170-80)
- Rating quality of evidence and strength of recommendations GRADE: an emerging consensus on rating quality of evidence and strength of recommendations.BMJ. 2008; 336: 924-926
- GRADE guidelines, 2: framing the question and deciding on important outcomes.J Clin Epidemiol. 2011; 64: 395-400
- GRADE guidelines, 3: rating the quality of evidence.J Clin Epidemiol. 2011; 64: 401-406
- GRADE guidelines, 4: rating the quality of evidence–study limitations (risk of bias).J Clin Epidemiol. 2001; 64: 407-415
- GRADE guidelines, 5: rating the quality of evidence–publication bias.J Clin Epidemiol. 2011; 64: 1277-1282
- GRADE guidelines, 6: rating the quality of evidence–imprecision.J Clin Epidemiol. 2011; 64: 1283-1293
- GRADE guidelines, 7: rating the quality of evidence–inconsistency.J Clin Epidemiol. 2011; 64: 1294-1302
- GRADE guidelines, 8: rating the quality of evidence–indirectness.J Clin Epidemiol. 2011; 64: 1303-1310
- GRADE guidelines, 9: rating up the quality of evidence.J Clin Epidemiol. 2011; 64: 1311-1316
- GRADE guidelines, 10: considering resource use and rating the quality of economic evidence.J Clin Epidemiol. 2013; 66: 140-150
- 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: 151-157
- GRADE guidelines, 12: preparing summary of findings tables–binary outcomes.J Clin Epidemiol. 2013; 66: 158-172
- GRADE guidelines, 13: preparing summary of findings tables and evidence profiles–continuous outcomes.J Clin Epidemiol. 2013; 66: 173-183
- GRADE guidelines, 14: going from evidence to recommendations; the significance and presentation of recommendations.J Clin Epidemiol. 2013; 66: 719-725
- GRADE guidelines, 15: going from evidence to recommendation–determinants of a recommendation's direction and strength.J Clin Epidemiol. 2013; 66: 726-735
UpToDate, grading guide. Available at: http://www.uptodate.com/home/grading-guide#GradingRecommendations. Accessed March 8, 2013.
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- Fetal blood samplingAmerican Journal of Obstetrics & GynecologyVol. 209Issue 3
