TY - JOUR
T1 - Liver biopsy in the real world—reporting, expert concordance and correlation with a pragmatic clinical diagnosis
AU - TARGET-NASH Investigators
AU - Kim, Hannah P.
AU - Idowu, Michael O.
AU - Mospan, Andrea R.
AU - Allmon, Andrew G.
AU - Roden, Michael
AU - Newsome, Philip
AU - Lok, Anna S.
AU - Thuluvath, Paul J.
AU - Taunk, Jawahar
AU - Fried, Michael W.
AU - Sanyal, Arun J.
AU - Barritt, A. Sidney
AU - Abdelmalek, Manal
AU - Aguilar, Humberto
AU - Ahmed, Aijaz
AU - Allen, Alina
AU - Barlow, Sarah
AU - Barritt, Sid
AU - Bernstein, David
AU - Bhamidimarri, Kaylan
AU - Billings, Liana
AU - Brown, Kyle
AU - Brown, Robert
AU - Corbin, Karen
AU - Cusi, Kenneth
AU - deLemos, Andrew
AU - Emerick, Karan
AU - Firpi-Morell, Roberto
AU - Ghali, Maged Adel
AU - Henry, Zachary
AU - Jackson, Whitney
AU - Janardhan, Sujit
AU - Kabbany, Mohammad
AU - Kemmer, Nyingi
AU - Koch, David
AU - Kupec, Justin
AU - Landis, Charles
AU - Lawrence, Mary Katherine
AU - Levy, Cynthia
AU - Lidofsky, Steven
AU - Lok, Anna
AU - Luketic, Velimir
AU - Martinez, Enrique
AU - McClain, Craig
AU - McKiernan, Patrick
AU - Mitchell, Ellen
AU - Noureddin, Mazen
AU - Palle, Sirish
AU - Pham, Yen
AU - Pound, David
N1 - Publisher Copyright:
© 2021 John Wiley & Sons Ltd
PY - 2021/12
Y1 - 2021/12
N2 - Background: Patients with non-alcoholic steatohepatitis (NASH) and fibrosis stage ≥2 comprise a target population for pharmacotherapy. Liver biopsy, the reference standard for identifying this population, requires complete and accurate assessment of steatohepatitis and fibrosis. Aims. To investigate the completeness of real-world NASH-related pathology reports, assess concordance between site pathologists and central expert interpretation of the histologic elements of NASH, and determine concordance between biopsy-diagnosed NASH and a pragmatic clinical definition of NASH. Methods: Liver pathology reports from 222 patients across 38 TARGET-NASH sites were analysed for documentation of the histologic features of NASH. Biopsy slides were over-read by a blinded central expert pathologist. Concordance of histologic scores and interpretation was assessed. Histologic concordance with a clinical definition of NASH was determined. TARGET-NASH clinically defined NASH: elevated ALT, hepatic steatosis on biopsy or imaging and ≥1 of the following: BMI ≥30 kg/m2, type 2 diabetes mellitus and dyslipidaemia. Results: Documentation of steatosis, lobular inflammation, portal inflammation and ballooning were missing from 21%, 35%, 46% and 40% of reports, respectively. There was slight-to-fair concordance (weighted kappa 0.01-0.35) between site and central pathologists for inflammatory features, and moderate concordance (weighted kappa 0.56-0.57) for fibrosis staging. Clinical definition of NASH was 75%-91% concordant (94%-95% sensitive) with biopsy-diagnosed NASH. Conclusions: There is substantial variability in reporting and grading NASH and fibrosis staging in clinical practice. This heterogeneity may adversely impact patient assessment and translation of practice guidelines into reality. The TARGET-NASH pragmatic clinical definition may serve as a valuable tool to accurately identify NASH patients in clinical practice.
AB - Background: Patients with non-alcoholic steatohepatitis (NASH) and fibrosis stage ≥2 comprise a target population for pharmacotherapy. Liver biopsy, the reference standard for identifying this population, requires complete and accurate assessment of steatohepatitis and fibrosis. Aims. To investigate the completeness of real-world NASH-related pathology reports, assess concordance between site pathologists and central expert interpretation of the histologic elements of NASH, and determine concordance between biopsy-diagnosed NASH and a pragmatic clinical definition of NASH. Methods: Liver pathology reports from 222 patients across 38 TARGET-NASH sites were analysed for documentation of the histologic features of NASH. Biopsy slides were over-read by a blinded central expert pathologist. Concordance of histologic scores and interpretation was assessed. Histologic concordance with a clinical definition of NASH was determined. TARGET-NASH clinically defined NASH: elevated ALT, hepatic steatosis on biopsy or imaging and ≥1 of the following: BMI ≥30 kg/m2, type 2 diabetes mellitus and dyslipidaemia. Results: Documentation of steatosis, lobular inflammation, portal inflammation and ballooning were missing from 21%, 35%, 46% and 40% of reports, respectively. There was slight-to-fair concordance (weighted kappa 0.01-0.35) between site and central pathologists for inflammatory features, and moderate concordance (weighted kappa 0.56-0.57) for fibrosis staging. Clinical definition of NASH was 75%-91% concordant (94%-95% sensitive) with biopsy-diagnosed NASH. Conclusions: There is substantial variability in reporting and grading NASH and fibrosis staging in clinical practice. This heterogeneity may adversely impact patient assessment and translation of practice guidelines into reality. The TARGET-NASH pragmatic clinical definition may serve as a valuable tool to accurately identify NASH patients in clinical practice.
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U2 - 10.1111/apt.16674
DO - 10.1111/apt.16674
M3 - Article
C2 - 34694013
AN - SCOPUS:85121118259
SN - 0269-2813
VL - 54
SP - 1472
EP - 1480
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
IS - 11-12
ER -