Reviewer's report
Title:FibroSURE as a Noninvasive Marker of Liver Fibrosis and Inflammation in
Chronic Hepatitis B
Version:2Date:23 April 2014
Reviewer: Stevan Gonzalez
Reviewer's report:
The investigators of this study evaluated the performance of FibroSURE as a
marker of fibrosis and inflammation in patients with chronic HBV. The
development of accurate noninvasive markers of hepatic fibrosis is clinically
relevant and has importance in clinical decision-making, particularly as it applies
to initiating antiviral therapy in patients with chronic HBV. Although several
studies have previously assessed noninvasive markers in HBV, the authors note
that data evaluating the role of the commercially available FibroSURE test are
limited. This is a well-written manuscript; however, there are several limitations
that should be addressed.
Major compulsory revisions:
1. How were patients selected to be included in this study? It appears that these
were not consecutive patients as the 45 individuals were selected over a long
period of time (7 years). This raises questions regarding selection bias and
should be explicitly noted in the Methods section.
2. Table 1 should provide a more complete picture of this study population,
including HBeAg status. Ranges should be given for ALT, AST, and HBV DNA
levels. An ideal HBV population in which a noninvasive test would be useful are
those with normal ALT levels – what proportion of patients had normal ALT or
less than 2x ULN ALT?
Minor essential revisions:
1. The authors do point out in the discussion that a major limitation is the small
size of this study. However an additional factor that should also be pointed out is
the heterogenous population that was included: 12/45 were co-infected with HIV
and 10/45 were on antiviral therapy with a mix of different antiviral agents. The
authors found that their cohort of HIV-positive patients were more likely to have
advanced fibrosis, be on antiviral therapy, and have elevated ALT levels.
Additionally, only a very small proportion of this study population actually had
advanced inflammation and fibrosis (n=7). This raises statistical concerns when
considering the observed trend in FibroSURE scores noted in Figures 1a/1b.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I declare that I have no competing interests.
Reviewer's report
Title:FibroSURE as a Noninvasive Marker of Liver Fibrosis and Inflammation in
Chronic Hepatitis B
Version:2Date:23 April 2014
Reviewer: Stevan Gonzalez
Reviewer's report:
The investigators of this study evaluated the performance of FibroSURE as a
marker of fibrosis and inflammation in patients with chronic HBV. The
development of accurate noninvasive markers of hepatic fibrosis is clinically
relevant and has importance in clinical decision-making, particularly as it applies
to initiating antiviral therapy in patients with chronic HBV. Although several
studies have previously assessed noninvasive markers in HBV, the authors note
that data evaluating the role of the commercially available FibroSURE test are
limited. This is a well-written manuscript; however, there are several limitations
that should be addressed.
Major compulsory revisions:
1. How were patients selected to be included in this study? It appears that these
were not consecutive patients as the 45 individuals were selected over a long
period of time (7 years). This raises questions regarding selection bias and
should be explicitly noted in the Methods section.
2. Table 1 should provide a more complete picture of this study population,
including HBeAg status. Ranges should be given for ALT, AST, and HBV DNA
levels. An ideal HBV population in which a noninvasive test would be useful are
those with normal ALT levels – what proportion of patients had normal ALT or
less than 2x ULN ALT?
Minor essential revisions:
1. The authors do point out in the discussion that a major limitation is the small
size of this study. However an additional factor that should also be pointed out is
the heterogenous population that was included: 12/45 were co-infected with HIV
and 10/45 were on antiviral therapy with a mix of different antiviral agents. The
authors found that their cohort of HIV-positive patients were more likely to have
advanced fibrosis, be on antiviral therapy, and have elevated ALT levels.
Additionally, only a very small proportion of this study population actually had
advanced inflammation and fibrosis (n=7). This raises statistical concerns when
considering the observed trend in FibroSURE scores noted in Figures 1a/1b.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I declare that I have no competing interests.
Please review this paper.
user
Reviewer's report
Title:FibroSURE as a Noninvasive Marker of Liver Fibrosis and Inflammation in
Chronic Hepatitis B
Version:2Date:23 April 2014
Reviewer: Stevan Gonzalez
Reviewer's report:
The investigators of this study evaluated the performance of FibroSURE as a
marker of fibrosis and inflammation in patients with chronic HBV. The
development of accurate noninvasive markers of hepatic fibrosis is clinically
relevant and has importance in clinical decision-making, particularly as it applies
to initiating antiviral therapy in patients with chronic HBV. Although several
studies have previously assessed noninvasive markers in HBV, the authors note
that data evaluating the role of the commercially available FibroSURE test are
limited. This is a well-written manuscript; however, there are several limitations
that should be addressed.
Major compulsory revisions:
1. How were patients selected to be included in this study? It appears that these
were not consecutive patients as the 45 individuals were selected over a long
period of time (7 years). This raises questions regarding selection bias and
should be explicitly noted in the Methods section.
2. Table 1 should provide a more complete picture of this study population,
including HBeAg status. Ranges should be given for ALT, AST, and HBV DNA
levels. An ideal HBV population in which a noninvasive test would be useful are
those with normal ALT levels – what proportion of patients had normal ALT or
less than 2x ULN ALT?
Minor essential revisions:
1. The authors do point out in the discussion that a major limitation is the small
size of this study. However an additional factor that should also be pointed out is
the heterogenous population that was included: 12/45 were co-infected with HIV
and 10/45 were on antiviral therapy with a mix of different antiviral agents. The
authors found that their cohort of HIV-positive patients were more likely to have
advanced fibrosis, be on antiviral therapy, and have elevated ALT levels.
Additionally, only a very small proportion of this study population actually had
advanced inflammation and fibrosis (n=7). This raises statistical concerns when
considering the observed trend in FibroSURE scores noted in Figures 1a/1b.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I declare that I have no competing interests.
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