Best Practices in Liver Biopsy Histologic Assessment for Nonalcoholic Steatohepatitis Clinical Trials: Expert Opinion

Table 1

Grading framework.

	Definition
Category grade
Class I	There is agreement of the proposed procedure is beneficial, useful, and effective
Class II	Conflicting evidence and/or divergence of opinion about the usefulness/efficacy of the procedure
Class IIa	Weight of evidence/opinion is in favor of usefulness
Class IIb	Usefulness is less well established by evidence/opinion
Class III	Evidence and/or general agreement that a procedure is not useful/effective, and in some cases, it may be harmful
Quality of evidence
Level A	Data derived from multiple randomized, clinical trials or meta-analysis
Level B	Data derived from a single randomized, clinical trials or meta-analysis or nonrandomized studies
Level C	Based on opinion of experts, case-studies, or standard of care