Reviewer’s report
Title: 
The LUCID study: Living with Ulcerative Colitis; Identifying the
socioeconomic burden in Europe
Version: 
0 
Date: 
26 Mar 2021
Reviewer's report:
In this paper, the authors aimed to study annual costs of living with UC from a
societal perspective, and the effects of some PROMS on UC.
the study is interesting, but needs additional explanations on some major points.
MAIN COMMENTS.
Introduction.
The introduction is well-written, but I have some comments on the content. I
would suggest to report information on medications in a fair way. This means
that the specific mention of Tofacitinib should be deleted.
In the same meaning, reference 2 already included recommendations on Tofa, as
well as the reference 12. Therefore, this last should be deleted from the reference
list, unless all papers on other treatments are fairly considered separately too.
References 18 and 19 are focused on healthcare costs, which I don't understand
the link with your paragraph.
I did not understand what was meant by "active UC". UC is a chronic disease,
and the impact on patients life is largely due to the chronic component, that
cannot disconnect active and remission phases. PLease explain.
Assessing the impact - as compared to the effect - of UC on the factors
mentioned would have asked for another study design than a cross-sectional one.
Please update this term on page 6.
Methods.
Please refer to the STROBE checklist for observational studies when describing
the methods, including paragraphs ordering. An non-interventional study is
observational.
Overall, the description of the methods is largerly unordered - therefore difficult
to follow.
Some examples where more explanation is needed.:
- I did not found a clear definition of the index date. 
- How did you include patients in ARM2? what was the time lag considered
between the moderate or severe UC status and the remission obtained? this
means that your observation period started before 12 months? Were moderate-
severe episodes the first experienced by patients or any other?
- It is not clear how did patients agree their data to be collected for the study. Did
they sign an ICF - if yes, how did you manage ICFs in all local languages? If
only those that understood English were selected, means a clear study bias.
- How were detailed information on costs collected? Could you give an example
(for example related to direct costs - for example regarding use of infliximab -
and how you handled differences by countries)
- statistical details are missing regarding analyses performed to answer study
objectives. Here the paragraph only refers on how data on costs were built.
Results.
- lines 14-15 and 42 (page 11): some kind of same information is reported, but
95% patient response rate first is attributed to Spain, second to Romania. Please
check your results.
- up to 12% (10%) of UC patients had strictures or fistulas. Does this mean that
diagnosis of UC was not ascertained the same in each country? or may have
changed to CD. PLease comment.
- differences according to countries are sometimes based on very low numbers,
which is a clear limit to generalisation of the results for those countries.
Publons Reviewer Recognition
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registered for such service or help editors to identify candidate reviewers. Please
find the details of processing in Publons’ privacy policy
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Yes
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 this 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 have no competing interests
Reviewer Publication Consent.
 I agree for my report to be made available
under an Open Access Creative Commons CC-BY License (
http://creativecommons.org/licenses/by/4.0
) if this manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the
editorial office before completing the review.
If you wish, you can include your
name in your published report. Please note you must decide whether to include
your name at the start of the process and confirm this decision whenever
prompted. If you change your decision later, we will not be able to publish your
name.
I agree to the terms of the CC-BY 4.0 license; please 
do not
 publish my name
with my report. (default)
Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
No
Are the methods sufficiently described to allow the study to be repeated?
No
Is the use of statistics and treatment of uncertainties appropriate?
No
Is the presentation of the work clear?
No
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes
Reviewer’s report
Title: 
The LUCID study: Living with Ulcerative Colitis; Identifying the
socioeconomic burden in Europe
Version: 
0 
Date: 
26 Mar 2021
Reviewer's report:
In this paper, the authors aimed to study annual costs of living with UC from a
societal perspective, and the effects of some PROMS on UC.
the study is interesting, but needs additional explanations on some major points.
MAIN COMMENTS.
Introduction.
The introduction is well-written, but I have some comments on the content. I
would suggest to report information on medications in a fair way. This means
that the specific mention of Tofacitinib should be deleted.
In the same meaning, reference 2 already included recommendations on Tofa, as
well as the reference 12. Therefore, this last should be deleted from the reference
list, unless all papers on other treatments are fairly considered separately too.
References 18 and 19 are focused on healthcare costs, which I don't understand
the link with your paragraph.
I did not understand what was meant by "active UC". UC is a chronic disease,
and the impact on patients life is largely due to the chronic component, that
cannot disconnect active and remission phases. PLease explain.
Assessing the impact - as compared to the effect - of UC on the factors
mentioned would have asked for another study design than a cross-sectional one.
Please update this term on page 6.
Methods.
Please refer to the STROBE checklist for observational studies when describing
the methods, including paragraphs ordering. An non-interventional study is
observational.
Overall, the description of the methods is largerly unordered - therefore difficult
to follow.
Some examples where more explanation is needed.:
- I did not found a clear definition of the index date. 
- How did you include patients in ARM2? what was the time lag considered
between the moderate or severe UC status and the remission obtained? this
means that your observation period started before 12 months? Were moderate-
severe episodes the first experienced by patients or any other?
- It is not clear how did patients agree their data to be collected for the study. Did
they sign an ICF - if yes, how did you manage ICFs in all local languages? If
only those that understood English were selected, means a clear study bias.
- How were detailed information on costs collected? Could you give an example
(for example related to direct costs - for example regarding use of infliximab -
and how you handled differences by countries)
- statistical details are missing regarding analyses performed to answer study
objectives. Here the paragraph only refers on how data on costs were built.
Results.
- lines 14-15 and 42 (page 11): some kind of same information is reported, but
95% patient response rate first is attributed to Spain, second to Romania. Please
check your results.
- up to 12% (10%) of UC patients had strictures or fistulas. Does this mean that
diagnosis of UC was not ascertained the same in each country? or may have
changed to CD. PLease comment.
- differences according to countries are sometimes based on very low numbers,
which is a clear limit to generalisation of the results for those countries.
Publons Reviewer Recognition
. Springer Nature can send verification of this
review directly to Publons (a subsidiary of Clarivate Analytics). If you would
like to take advantage of this service, please click on the “Yes” option below.
Your name, email address, title of the reviewed manuscript, name of the journal,
and date of your review submission (the “Review Data”) will then be transmitted
to Publons after the final decision on the manuscript has been made. If you have
already registered at Publons, they will notify you of the receipt of this review
and update your profile 
as per your settings and their policy. If you are not
registered with Publons, you will receive an email from them asking you to
register in order for them to be able to recognize your review on your new
profile page. Publons may use the Review Data to generate derivative metadata
for the benefit of Publons and you as a reviewer, carefully considering the
sensitivity of such information. For example, Publons may verify your record as
a reviewer by updating your profile published on its webservice if you have
registered for such service or help editors to identify candidate reviewers. Please
find the details of processing in Publons’ privacy policy
https://publons.com/about/terms
Yes
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 this 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 have no competing interests
Reviewer Publication Consent.
 I agree for my report to be made available
under an Open Access Creative Commons CC-BY License (
http://creativecommons.org/licenses/by/4.0
) if this manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the
editorial office before completing the review.
If you wish, you can include your
name in your published report. Please note you must decide whether to include
your name at the start of the process and confirm this decision whenever
prompted. If you change your decision later, we will not be able to publish your
name.
I agree to the terms of the CC-BY 4.0 license; please 
do not
 publish my name
with my report. (default)
Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
No
Are the methods sufficiently described to allow the study to be repeated?
No
Is the use of statistics and treatment of uncertainties appropriate?
No
Is the presentation of the work clear?
No
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes
Please review this paper.
user
Reviewer’s report
Title: 
The LUCID study: Living with Ulcerative Colitis; Identifying the
socioeconomic burden in Europe
Version: 
0 
Date: 
26 Mar 2021
Reviewer's report:
In this paper, the authors aimed to study annual costs of living with UC from a
societal perspective, and the effects of some PROMS on UC.
the study is interesting, but needs additional explanations on some major points.
MAIN COMMENTS.
Introduction.
The introduction is well-written, but I have some comments on the content. I
would suggest to report information on medications in a fair way. This means
that the specific mention of Tofacitinib should be deleted.
In the same meaning, reference 2 already included recommendations on Tofa, as
well as the reference 12. Therefore, this last should be deleted from the reference
list, unless all papers on other treatments are fairly considered separately too.
References 18 and 19 are focused on healthcare costs, which I don't understand
the link with your paragraph.
I did not understand what was meant by "active UC". UC is a chronic disease,
and the impact on patients life is largely due to the chronic component, that
cannot disconnect active and remission phases. PLease explain.
Assessing the impact - as compared to the effect - of UC on the factors
mentioned would have asked for another study design than a cross-sectional one.
Please update this term on page 6.
Methods.
Please refer to the STROBE checklist for observational studies when describing
the methods, including paragraphs ordering. An non-interventional study is
observational.
Overall, the description of the methods is largerly unordered - therefore difficult
to follow.
Some examples where more explanation is needed.:
- I did not found a clear definition of the index date. 
- How did you include patients in ARM2? what was the time lag considered
between the moderate or severe UC status and the remission obtained? this
means that your observation period started before 12 months? Were moderate-
severe episodes the first experienced by patients or any other?
- It is not clear how did patients agree their data to be collected for the study. Did
they sign an ICF - if yes, how did you manage ICFs in all local languages? If
only those that understood English were selected, means a clear study bias.
- How were detailed information on costs collected? Could you give an example
(for example related to direct costs - for example regarding use of infliximab -
and how you handled differences by countries)
- statistical details are missing regarding analyses performed to answer study
objectives. Here the paragraph only refers on how data on costs were built.
Results.
- lines 14-15 and 42 (page 11): some kind of same information is reported, but
95% patient response rate first is attributed to Spain, second to Romania. Please
check your results.
- up to 12% (10%) of UC patients had strictures or fistulas. Does this mean that
diagnosis of UC was not ascertained the same in each country? or may have
changed to CD. PLease comment.
- differences according to countries are sometimes based on very low numbers,
which is a clear limit to generalisation of the results for those countries.
Publons Reviewer Recognition
. Springer Nature can send verification of this
review directly to Publons (a subsidiary of Clarivate Analytics). If you would
like to take advantage of this service, please click on the “Yes” option below.
Your name, email address, title of the reviewed manuscript, name of the journal,
and date of your review submission (the “Review Data”) will then be transmitted
to Publons after the final decision on the manuscript has been made. If you have
already registered at Publons, they will notify you of the receipt of this review
and update your profile 
as per your settings and their policy. If you are not
registered with Publons, you will receive an email from them asking you to
register in order for them to be able to recognize your review on your new
profile page. Publons may use the Review Data to generate derivative metadata
for the benefit of Publons and you as a reviewer, carefully considering the
sensitivity of such information. For example, Publons may verify your record as
a reviewer by updating your profile published on its webservice if you have
registered for such service or help editors to identify candidate reviewers. Please
find the details of processing in Publons’ privacy policy
https://publons.com/about/terms
Yes
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 this 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 have no competing interests
Reviewer Publication Consent.
 I agree for my report to be made available
under an Open Access Creative Commons CC-BY License (
http://creativecommons.org/licenses/by/4.0
) if this manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the
editorial office before completing the review.
If you wish, you can include your
name in your published report. Please note you must decide whether to include
your name at the start of the process and confirm this decision whenever
prompted. If you change your decision later, we will not be able to publish your
name.
I agree to the terms of the CC-BY 4.0 license; please 
do not
 publish my name
with my report. (default)
Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
No
Are the methods sufficiently described to allow the study to be repeated?
No
Is the use of statistics and treatment of uncertainties appropriate?
No
Is the presentation of the work clear?
No
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes
assistant