Fibrosis stage improvement in nonalcoholic steatohepatitis: A systematic review of placebo treated participants in randomized controlled trials

Roskilly, Anna; Taylor, Elliot; Jones, Roberta; Rowe, IA

doi:10.1016/s0168-8278(18)31418-1

Cited by 1 publication

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“…According to recently published systematic reviews, histologic outcomes have been reported in 37 randomised, placebo‐controlled trials of adult patients with NASH (Table S1). Of these trials, 30 used the NAS system for assessing disease activity and fibrosis.…”

Section: Methodsmentioning

confidence: 99%

Standardising the interpretation of liver biopsies in non‐alcoholic fatty liver disease clinical trials

Pai¹,

Kleiner²,

Hart³

et al. 2019

Aliment Pharmacol Ther

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Summary Background There is substantial variation in how histologic definitions and scoring systems of non‐alcoholic fatty liver disease (NAFLD) are operationalised. Aim To develop a consensus‐based framework for standardising histologic assessment of liver biopsies in clinical trials of NAFLD. Methods An expert panel of 14 liver pathologists and three hepatologists was assembled. Using modified RAND/University of California Los Angeles appropriateness methodology, 130 items derived from literature review and expert opinion were rated by each panel member on a 1‐9 scale. Disagreement was defined as ≥5 ratings in the lowest (1‐3) and highest (7‐9) categories. Items were classified as inappropriate (median 1‐3.5 without disagreement), uncertain (median 3.5‐6.5 or any median with disagreement) or appropriate (median 6.5‐9 without disagreement). Survey results were discussed as a group before voting. Results Current measures of disease activity and fibrosis may not fully capture important features of non‐alcoholic steatohepatitis (NASH). Alternative methods to evaluate ballooning degeneration are needed. Panellists were uncertain whether portal inflammation, degree of steatosis and Mallory‐Denk bodies are important measures of disease activity. Furthermore, it was felt that current staging systems do not capture the full spectrum of fibrosis in NASH. A consensus definition and sub‐stages for bridging fibrosis are needed. The severity of perisinusoidal fibrosis should be captured at all stages. Lastly, a method to evaluate features of fibrosis regression should be developed. Conclusion The operating properties of the modifications proposed should be evaluated prospectively to determine reliability and responsiveness.

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Section: Methodsmentioning

confidence: 99%