HCV Guidance
From www.HCVGuidance.org on February 26, 2021


Table 2. Rating System Used to Rate Level of Evidence and Strength of Recommendation

Recommendations are based on scientific evidence and expert opinion. Each recommended statement includes a Roman numeral (I, II, or III) representing the level of the evidence that supports the recommendation and a letter (A, B, or C) representing the strength of the recommendation.
 

Class

I Evidence and/or general agreement that a given diagnostic evaluation, procedure, or treatment is beneficial, useful, and effective.
II Conflicting evidence and/or a divergence of opinion about the usefulness and efficacy of a diagnostic evaluation, procedure, or treatment.
IIa Weight of evidence and/or opinion is in favor of usefulness and efficacy.
IIb Usefulness and efficacy are less well established by evidence and/or opinion.
III Conditions for which there is evidence and/or general agreement that a diagnostic evaluation, procedure, or treatment is not useful and effective or if it in some cases may be harmful.

 

Level

A Data derived from multiple randomized clinical trials, meta-analyses, or equivalent.
B Data derived from a single randomized trial, nonrandomized studies, or equivalent.
C Consensus opinion of experts, case studies, or standard of care.


Adapted from the American College of Cardiology and the American Heart Association Practice Guidelines (AHA, 2011); (Shiffman, 2003).

In some situations, such as for interferon-sparing HCV treatments, randomized clinical trials with an existing standard-of-care arm cannot ethically or practicably be conducted. The US Food and Drug Administration (FDA) has suggested alternative study designs, including historical controls or immediate versus deferred placebo-controlled trials. For additional examples and definitions see FDA link: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/ UCM225333.pdf. In those instances for which there was a single predetermined, FDA-approved equivalency established, panel members considered the evidence as equivalent to a randomized controlled trial for levels A or B.

Last update: 
November 6, 2019

Related References

American College of Cardiology Foundation and American Heart Association, Inc. Methodology manual and policies from the ACCF/AHA task force on practice guidelines, Accessed June 13, 2019.; 2010.

Shiffman RN, Shekelle P, Overhage JM, Slutsky J, Grimshaw J, Deshpande AM. Standardized reporting of clinical practice guidelines: a proposal from the Conference on Guideline Standardization. Ann Intern Med. 2003;139(6):493-498.



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