The conundrum of guidelines, recommendations, and strength of recommendation
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American Society of Regional Anesthesia/European Society of Regional Anesthesia
Grading of Recommendations, Assessment, Development and Evaluations
To the Editor,
Showing statements of evidence
Statements of evidence
Evidence obtained from meta-analysis of RCTs
Evidence obtained from at least 1 RCT
Evidence obtained from at least 1 well-designed controlled study without randomization
Evidence obtained from at least 1 other type of well-designed quasi-experimental study
Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies, and case reports
Evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities
Showing statement of evidence and grade of recommendations
Grades of recommendations
Requires at least 1 prospective RCT as part of a body of literature of overall good quality and consistency addressing the specific recommendation (evidence levels Ia and Ib)
Requires the availability of well conducted clinical studies, but no prospective, randomized clinical trials on the topic of recommendation (evidence levels IIa, IIb, III)
Requires evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities.
Indicates an absence of directly applicable clinical studies of good quality (evidence level IV)
These recommendations are made after a detailed review of the advantages and disadvantages of a particular modality for a given clinical situation or an intervention. Recommendations also depend on the clinical question under evaluation and the most appropriate study suitable for finding an answer to that question. The recommendation is low if the type of study used to find the answer is not appropriate. These recommendations are usually graded based on current evidence along with rating the quality of evidence from which the information is gathered. Level of evidence is described as high (high confidence that the evidence reflects the true effect), moderate (moderate confidence that the evidence reflects the true effect), low (low confidence that the evidence reflects the true effect), insufficient, or very low (evidence either is unavailable or does not permit a conclusion) (Definition of levels of evidence (LoE) and overall strength of evidence (SoE) 2015).
The recommendations should be easy to understand, generated from unbiased, robust evidence, and practical to use and implement. Confounding factors, publication bias, and inappropriate study designs all lead to misinterpretation of pooled data, thereby leading to the formulation of practical guidelines which are not only based on low-quality evidence but also lead to the implementation of scientifically incorrect guidelines.
The grading system usually used to have several flaws like the confusion between the strength of recommendations and quality of evidence leading to misinterpretation, lack of transparent judgments, and difficulty to implement on occasions. To overcome these issues and to have a comprehensive, unbiased evidence-based recommendation, GRADE (Grading of Recommendations, Assessment, Development and Evaluations) system was introduced. GRADE system is used to derive recommendations for systematic reviews and guidelines. GRADE differs from other tools because it separates the quality of evidence and strength of recommendation, quality of evidence is assessed for each outcome, observational studies can be upgraded if they meet certain criteria, and language used is simple and not confusing to clinicians implementing guidelines (Goldet and Howick 2013).
The GRADE approach rates the quality of evidence by analyzing the study design, i.e., randomized trials, case-control studies, cohort studies, and observational studies. Based on the study design, GRADE either rates down the quality of evidence (by analyzing 5 reasons: limitations in study design, inconsistent results, indirect evidence, imprecision, and publication bias) or rates up the quality of evidence (by analyzing 3 reasons: large magnitude of effect, dose-response gradient, and less confounding factors (Zhang et al. 2018).
Showing GRADE ranking
What it implies?
Confident that the effect in the study reflects the actual effect.
Quite confident that the effect in the study is close to the true effect, but it is also possible it is substantially different.
True effect may differ significantly from the estimate.
True effect is likely to be substantially different from the estimated effect.
GRADE system is used by many societies to draft guidelines and recommendations; the recent one is that of Missair et al.’s “Impact of perioperative pain management on cancer recurrence: an ASRA/ESRA (American Society of Regional Anesthesia/European Society of Regional Anesthesia) special article” in Regional Anesthesia and Pain Medicine Journal (Missair et al. 2019).
To conclude, clinicians should know and understand the methodology used for drafting guidelines and recommendations. GRADE system is used by many researchers and guideline makers which describe the quality and strength of recommendation. The ease of using the GRADE system and the simple language used in describing the details are possibly the reasons why the system is preferred.
ASN contributed to the concepts, design, literature review, manuscript preparation, and image permission and design. SD contributed to the manuscript review, final draft, and literature review. Both authors read and approved the final manuscript.
Ethics approval and consent to participate
Consent for publication
The authors declare that they have no competing interests.
- Definition of levels of evidence (LoE) and overall strength of evidence (SoE). Global Spine J. 2015;5:262Google Scholar
- United States Department of Health and Human Services Agency for Health Care Policy and Research. Acute pain management: operative or procedures and trauma. The Agency 1993; Clinical Practice Guideline No. 1; No. 92–0023-0107Google Scholar
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