Reviewer ’s report  
 
Title:  Health -Related Quality of Life in patients with chronic hepatitis C receiving Sofosbuvir -
Based Treatment, with and without Interferon: a prospective observational study in Egypt  
 
Version: 0 Date: 24 Nov 2016 
 
Reviewer:  Masako  Shomura  
 
Reviewer’s report:  
 
Reviewer's comment  
 
In the manuscript entitled "Health -Related Quality of Life in patients with chronic hepatitis C 
receiving Sofosbuvir -Based Treatment, with and without Interferon: a prospective observational 
study in Egypt", t he authors present the findings of patient reported outcomes in chronic HCV 
patients receiving Sofosbuvir -based treatment.  
 
The data collected in this study contribute to our understanding of possible care for clinicians to 
HCV patients receiving Sofosbuvi r-based treatment, the manuscript could be considered for 
publication following revisions.  
 
1. P3 Background Line5 -6, Ref 1 was not the study of epidemiology in HCV. If Ref 1 was 
not related to the epidemiology of HCV. Please reconsider and delete this Ref . 
 
2. You focused health related quality of life(HRQOL) at the title and the purpose in this 
study. However, P3 Line26, you mentioned "the terms of HRQOL and patients reported 
outcomes (PROs) have been interchangeably. It looks like confusing the terms of HRQOL and 
PROs. You need to define the terms of HRQOL and PROs in this study. Those terms have the 
different meanings; you should use separately. Moreover, you need to explain the importance of 
HRQOL and previous studies about HRQOL in CHC patients.  
 
3. Some terms of abbreviations were not consistent. Please check and reconsider.  
 
Ex: P3 Line34 chronic hepatitis C (CHC)   P5 Line22 chronic HCV  
 
4. P5 Line44 (Figure1) I could not find out Figure 1 in your manuscript. Please add Figure 
1. 
 
5. P5 from Line 40, you mentioned about sampling and inclusion criteria of this study. 
Please explain clearly and separately sampling method and inclusion criteria.  
 
6. P6 Line15 -22 You explained protocol of HCV therapy. I wonder interferon = Peg IFN or 
not. No1 regimen usual ly use for genotype 1 or 4 HCV, and No2 regimen use for genotype 2 or 3 
HCV. How have you decided the application of those tow regimens? Moreover, you should 
include genotype of HCV in Table 1.  
7. P6 Questionnaires and data collection You have used four PROs instruments, not 
HRQOL. If you claim PROs include HRQOL, you should define what part of instrument contain 
HRQOL component.  
 
8. P9 Line6 Why numbers of participants at T2 decreased? You should mention that reason.  
 
9. All of your tables are busy lines. In the usual manuscript, researcher use smallest 
numbers of vertical lines. Please recheck and reconsider.  
 
10. Usually, the numbers of the value under decimal point are consistent throughout the 
manuscript. In your ma nuscript, the numbers of the value under decimal point were inconsistent. 
Please recheck and reconsider.  
 
11. P9 Comparison between males and females.  Why did you focus on only baseline gender 
differences? If gender have strong effect to RPOs or HRQOL, yo u should claim the importance 
of gender to RPOs or HRQOL at the background.  
 
12. P9 Line50 etc.  You focused without PegIFN (dual) vs with PegIFN (triple). Thus you 
should explain without vs with IFN throughout the manuscript, including Table 3 and 4.  
 
13. When you have use repeated ANOVA to only 36 patients, if you did not make sure the 
normal distribution. Friedman method and Wilcoxon paired t test are better choice as statistical 
methods. Please recheck and reconsider.  
 
14. At the discussion, PROs and HR QOL remain to use confusingly. Thus, I felt hard to 
understand the main results of this study. Please recheck and reconsider.  
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
No 
 
Are you able to assess any statistics in the manuscript or would you recommend an 
additional stat istical review?  
If an additional statistical review is recommended, please specify what aspects require further 
assessment in your comments to the editors.  
I recommend additional statistical review  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Needs some language corrections before being publi shed 
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an 
organisation that may in any way gain or lose financially from the publication of this 
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose 
financially from the publication of thi s manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the 
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
If you can answer no to all of the  above, write 'I declare that I have no competing interests' 
below. If your reply is yes to any, please give details below.  
 
I declare that I have no competing interests.  
 
I agree to the open peer review policy of the journal. I understand that my name will  be included 
on my report to the authors and, if the manuscript is accepted for publication, my named report 
including any attachments I upload will be posted on the website along with the authors' 
responses. I agree for my report to be made available unde r an Open Access Creative Commons 
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments 
which I do not wish to be included in my named report can be included as  confidential comments 
to the editors, which will not be published . 
 
I agree to the open peer review policy of the journal  
Reviewer ’s report  
 
Title:  Health -Related Quality of Life in patients with chronic hepatitis C receiving Sofosbuvir -
Based Treatment, with and without Interferon: a prospective observational study in Egypt  
 
Version: 0 Date: 24 Nov 2016 
 
Reviewer:  Masako  Shomura  
 
Reviewer’s report:  
 
Reviewer's comment  
 
In the manuscript entitled "Health -Related Quality of Life in patients with chronic hepatitis C 
receiving Sofosbuvir -Based Treatment, with and without Interferon: a prospective observational 
study in Egypt", t he authors present the findings of patient reported outcomes in chronic HCV 
patients receiving Sofosbuvir -based treatment.  
 
The data collected in this study contribute to our understanding of possible care for clinicians to 
HCV patients receiving Sofosbuvi r-based treatment, the manuscript could be considered for 
publication following revisions.  
 
1. P3 Background Line5 -6, Ref 1 was not the study of epidemiology in HCV. If Ref 1 was 
not related to the epidemiology of HCV. Please reconsider and delete this Ref . 
 
2. You focused health related quality of life(HRQOL) at the title and the purpose in this 
study. However, P3 Line26, you mentioned "the terms of HRQOL and patients reported 
outcomes (PROs) have been interchangeably. It looks like confusing the terms of HRQOL and 
PROs. You need to define the terms of HRQOL and PROs in this study. Those terms have the 
different meanings; you should use separately. Moreover, you need to explain the importance of 
HRQOL and previous studies about HRQOL in CHC patients.  
 
3. Some terms of abbreviations were not consistent. Please check and reconsider.  
 
Ex: P3 Line34 chronic hepatitis C (CHC)   P5 Line22 chronic HCV  
 
4. P5 Line44 (Figure1) I could not find out Figure 1 in your manuscript. Please add Figure 
1. 
 
5. P5 from Line 40, you mentioned about sampling and inclusion criteria of this study. 
Please explain clearly and separately sampling method and inclusion criteria.  
 
6. P6 Line15 -22 You explained protocol of HCV therapy. I wonder interferon = Peg IFN or 
not. No1 regimen usual ly use for genotype 1 or 4 HCV, and No2 regimen use for genotype 2 or 3 
HCV. How have you decided the application of those tow regimens? Moreover, you should 
include genotype of HCV in Table 1.  
7. P6 Questionnaires and data collection You have used four PROs instruments, not 
HRQOL. If you claim PROs include HRQOL, you should define what part of instrument contain 
HRQOL component.  
 
8. P9 Line6 Why numbers of participants at T2 decreased? You should mention that reason.  
 
9. All of your tables are busy lines. In the usual manuscript, researcher use smallest 
numbers of vertical lines. Please recheck and reconsider.  
 
10. Usually, the numbers of the value under decimal point are consistent throughout the 
manuscript. In your ma nuscript, the numbers of the value under decimal point were inconsistent. 
Please recheck and reconsider.  
 
11. P9 Comparison between males and females.  Why did you focus on only baseline gender 
differences? If gender have strong effect to RPOs or HRQOL, yo u should claim the importance 
of gender to RPOs or HRQOL at the background.  
 
12. P9 Line50 etc.  You focused without PegIFN (dual) vs with PegIFN (triple). Thus you 
should explain without vs with IFN throughout the manuscript, including Table 3 and 4.  
 
13. When you have use repeated ANOVA to only 36 patients, if you did not make sure the 
normal distribution. Friedman method and Wilcoxon paired t test are better choice as statistical 
methods. Please recheck and reconsider.  
 
14. At the discussion, PROs and HR QOL remain to use confusingly. Thus, I felt hard to 
understand the main results of this study. Please recheck and reconsider.  
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
No 
 
Are you able to assess any statistics in the manuscript or would you recommend an 
additional stat istical review?  
If an additional statistical review is recommended, please specify what aspects require further 
assessment in your comments to the editors.  
I recommend additional statistical review  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Needs some language corrections before being publi shed 
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an 
organisation that may in any way gain or lose financially from the publication of this 
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose 
financially from the publication of thi s manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the 
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
If you can answer no to all of the  above, write 'I declare that I have no competing interests' 
below. If your reply is yes to any, please give details below.  
 
I declare that I have no competing interests.  
 
I agree to the open peer review policy of the journal. I understand that my name will  be included 
on my report to the authors and, if the manuscript is accepted for publication, my named report 
including any attachments I upload will be posted on the website along with the authors' 
responses. I agree for my report to be made available unde r an Open Access Creative Commons 
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments 
which I do not wish to be included in my named report can be included as  confidential comments 
to the editors, which will not be published . 
 
I agree to the open peer review policy of the journal  
Please review this paper.
user
Reviewer ’s report  
 
Title:  Health -Related Quality of Life in patients with chronic hepatitis C receiving Sofosbuvir -
Based Treatment, with and without Interferon: a prospective observational study in Egypt  
 
Version: 0 Date: 24 Nov 2016 
 
Reviewer:  Masako  Shomura  
 
Reviewer’s report:  
 
Reviewer's comment  
 
In the manuscript entitled "Health -Related Quality of Life in patients with chronic hepatitis C 
receiving Sofosbuvir -Based Treatment, with and without Interferon: a prospective observational 
study in Egypt", t he authors present the findings of patient reported outcomes in chronic HCV 
patients receiving Sofosbuvir -based treatment.  
 
The data collected in this study contribute to our understanding of possible care for clinicians to 
HCV patients receiving Sofosbuvi r-based treatment, the manuscript could be considered for 
publication following revisions.  
 
1. P3 Background Line5 -6, Ref 1 was not the study of epidemiology in HCV. If Ref 1 was 
not related to the epidemiology of HCV. Please reconsider and delete this Ref . 
 
2. You focused health related quality of life(HRQOL) at the title and the purpose in this 
study. However, P3 Line26, you mentioned "the terms of HRQOL and patients reported 
outcomes (PROs) have been interchangeably. It looks like confusing the terms of HRQOL and 
PROs. You need to define the terms of HRQOL and PROs in this study. Those terms have the 
different meanings; you should use separately. Moreover, you need to explain the importance of 
HRQOL and previous studies about HRQOL in CHC patients.  
 
3. Some terms of abbreviations were not consistent. Please check and reconsider.  
 
Ex: P3 Line34 chronic hepatitis C (CHC)   P5 Line22 chronic HCV  
 
4. P5 Line44 (Figure1) I could not find out Figure 1 in your manuscript. Please add Figure 
1. 
 
5. P5 from Line 40, you mentioned about sampling and inclusion criteria of this study. 
Please explain clearly and separately sampling method and inclusion criteria.  
 
6. P6 Line15 -22 You explained protocol of HCV therapy. I wonder interferon = Peg IFN or 
not. No1 regimen usual ly use for genotype 1 or 4 HCV, and No2 regimen use for genotype 2 or 3 
HCV. How have you decided the application of those tow regimens? Moreover, you should 
include genotype of HCV in Table 1.  
7. P6 Questionnaires and data collection You have used four PROs instruments, not 
HRQOL. If you claim PROs include HRQOL, you should define what part of instrument contain 
HRQOL component.  
 
8. P9 Line6 Why numbers of participants at T2 decreased? You should mention that reason.  
 
9. All of your tables are busy lines. In the usual manuscript, researcher use smallest 
numbers of vertical lines. Please recheck and reconsider.  
 
10. Usually, the numbers of the value under decimal point are consistent throughout the 
manuscript. In your ma nuscript, the numbers of the value under decimal point were inconsistent. 
Please recheck and reconsider.  
 
11. P9 Comparison between males and females.  Why did you focus on only baseline gender 
differences? If gender have strong effect to RPOs or HRQOL, yo u should claim the importance 
of gender to RPOs or HRQOL at the background.  
 
12. P9 Line50 etc.  You focused without PegIFN (dual) vs with PegIFN (triple). Thus you 
should explain without vs with IFN throughout the manuscript, including Table 3 and 4.  
 
13. When you have use repeated ANOVA to only 36 patients, if you did not make sure the 
normal distribution. Friedman method and Wilcoxon paired t test are better choice as statistical 
methods. Please recheck and reconsider.  
 
14. At the discussion, PROs and HR QOL remain to use confusingly. Thus, I felt hard to 
understand the main results of this study. Please recheck and reconsider.  
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
No 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
No 
 
Are you able to assess any statistics in the manuscript or would you recommend an 
additional stat istical review?  
If an additional statistical review is recommended, please specify what aspects require further 
assessment in your comments to the editors.  
I recommend additional statistical review  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Needs some language corrections before being publi shed 
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an 
organisation that may in any way gain or lose financially from the publication of this 
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose 
financially from the publication of thi s manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the 
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
If you can answer no to all of the  above, write 'I declare that I have no competing interests' 
below. If your reply is yes to any, please give details below.  
 
I declare that I have no competing interests.  
 
I agree to the open peer review policy of the journal. I understand that my name will  be included 
on my report to the authors and, if the manuscript is accepted for publication, my named report 
including any attachments I upload will be posted on the website along with the authors' 
responses. I agree for my report to be made available unde r an Open Access Creative Commons 
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understand that any comments 
which I do not wish to be included in my named report can be included as  confidential comments 
to the editors, which will not be published . 
 
I agree to the open peer review policy of the journal  
assistant