Reviewer ’s report  
 
Title: The association between disease activity and patient -reported outcomes in patients with 
moderate -to-severe ulcerative colitis in the United States and Europe  
 
Version: 0 Date: 06 Oct 2019  
 
Reviewer: Peter Hasselblatt  
 
Reviewer's report:  
 
In their present manuscript entitled "The association between disease activity and patient -
reported outcomes in patients with moderate -to-severe ulcerative colitis in the United States and 
Europe" Armuzzi and colleagues report on their finding s on associations between disease 
activity and health -related quality of life (HRQoL) in UC patients. Briefly they performed a 
retrospective survey in approx. 1300 UC patients in the US and Europe which received either 
steroids, immunomodulators or biologi cals and were asked to fill the EQ -5D, SIBDQ 
questionnaires and to provide information about work productivity. These data were correlated 
with their physician's estimate of disease activity (either "deep remission", "remission" or "active 
disease"). The a uthors demonstrate that "active disease" resulted in reduced quality of life and 
impaired work productivity.  
 
These findings confirm well established and previously published correlations between patient 
reported outcomes, quality of life and disease activ ity in UC, which are adequately 
acknowledged in the manuscript. A major advantage of this study is the relatively large patient 
cohort. However, the presented data lack novelty and the amount of data presented is rather 
limited. Other drawbacks are the ret rospective study design and the insufficient characterization 
of disease activity: The authors claim in the title, that they examined "associations between 
disease activity….. in patients with moderate -to-severe ulcerative colitis….". Severity of disease 
was not really measured in this study, so it is difficult to judge whether patients were indeed 
"moderate to severely active"? Disease activity should have been better controlled and 
quantified. In the present form, objective measures of inflammation (calpr otectin or similar) are 
lacking and endoscopy was not mandatory. Therefore the assessment of patients being in "deep 
remission" (clinical and endoscopic remission) or "remission" (clinical remission and no 
endoscopic remission or no endoscopy at all) is ra ther arbitrary (e.g. the authors need to state the 
percentage of patients with endoscopies available more clearly). The same limitations apply to 
patients with "active disease", which very likely encompass a large spectrum of disease 
activities.  
 
In conclu sion the manuscript confirms well established associations between disease activity and 
HRQoL. The amount of data is rather limited and disease activity poorly defined which limits 
this reviewers' enthusiasm for this manuscript.  
 
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 requ ired in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manus cript or would you recommend an 
additional statistical review?  
If an additional statistical review is recommended, please speci fy what aspects require further 
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the qua lity of language in the manuscript:  
 
Acceptable  
 
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 salar y 
from an organisation that may in any way gain or lose financial ly from the 
publication of this manuscript, either now or in the future?  
 
2.  Do you hold any stocks or shares in an organisation t hat may in any way gain or 
lose financially from the publicati on 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 decla re 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 understan d that my name will be included 
on my repor t to the authors and, if the manuscript is accepted f or 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 under an Open Access Creativ e 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 in cluded 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: The association between disease activity and patient -reported outcomes in patients with 
moderate -to-severe ulcerative colitis in the United States and Europe  
 
Version: 0 Date: 06 Oct 2019  
 
Reviewer: Peter Hasselblatt  
 
Reviewer's report:  
 
In their present manuscript entitled "The association between disease activity and patient -
reported outcomes in patients with moderate -to-severe ulcerative colitis in the United States and 
Europe" Armuzzi and colleagues report on their finding s on associations between disease 
activity and health -related quality of life (HRQoL) in UC patients. Briefly they performed a 
retrospective survey in approx. 1300 UC patients in the US and Europe which received either 
steroids, immunomodulators or biologi cals and were asked to fill the EQ -5D, SIBDQ 
questionnaires and to provide information about work productivity. These data were correlated 
with their physician's estimate of disease activity (either "deep remission", "remission" or "active 
disease"). The a uthors demonstrate that "active disease" resulted in reduced quality of life and 
impaired work productivity.  
 
These findings confirm well established and previously published correlations between patient 
reported outcomes, quality of life and disease activ ity in UC, which are adequately 
acknowledged in the manuscript. A major advantage of this study is the relatively large patient 
cohort. However, the presented data lack novelty and the amount of data presented is rather 
limited. Other drawbacks are the ret rospective study design and the insufficient characterization 
of disease activity: The authors claim in the title, that they examined "associations between 
disease activity….. in patients with moderate -to-severe ulcerative colitis….". Severity of disease 
was not really measured in this study, so it is difficult to judge whether patients were indeed 
"moderate to severely active"? Disease activity should have been better controlled and 
quantified. In the present form, objective measures of inflammation (calpr otectin or similar) are 
lacking and endoscopy was not mandatory. Therefore the assessment of patients being in "deep 
remission" (clinical and endoscopic remission) or "remission" (clinical remission and no 
endoscopic remission or no endoscopy at all) is ra ther arbitrary (e.g. the authors need to state the 
percentage of patients with endoscopies available more clearly). The same limitations apply to 
patients with "active disease", which very likely encompass a large spectrum of disease 
activities.  
 
In conclu sion the manuscript confirms well established associations between disease activity and 
HRQoL. The amount of data is rather limited and disease activity poorly defined which limits 
this reviewers' enthusiasm for this manuscript.  
 
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 requ ired in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manus cript or would you recommend an 
additional statistical review?  
If an additional statistical review is recommended, please speci fy what aspects require further 
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the qua lity of language in the manuscript:  
 
Acceptable  
 
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 salar y 
from an organisation that may in any way gain or lose financial ly from the 
publication of this manuscript, either now or in the future?  
 
2.  Do you hold any stocks or shares in an organisation t hat may in any way gain or 
lose financially from the publicati on 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 decla re 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 understan d that my name will be included 
on my repor t to the authors and, if the manuscript is accepted f or 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 under an Open Access Creativ e 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 in cluded 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: The association between disease activity and patient -reported outcomes in patients with 
moderate -to-severe ulcerative colitis in the United States and Europe  
 
Version: 0 Date: 06 Oct 2019  
 
Reviewer: Peter Hasselblatt  
 
Reviewer's report:  
 
In their present manuscript entitled "The association between disease activity and patient -
reported outcomes in patients with moderate -to-severe ulcerative colitis in the United States and 
Europe" Armuzzi and colleagues report on their finding s on associations between disease 
activity and health -related quality of life (HRQoL) in UC patients. Briefly they performed a 
retrospective survey in approx. 1300 UC patients in the US and Europe which received either 
steroids, immunomodulators or biologi cals and were asked to fill the EQ -5D, SIBDQ 
questionnaires and to provide information about work productivity. These data were correlated 
with their physician's estimate of disease activity (either "deep remission", "remission" or "active 
disease"). The a uthors demonstrate that "active disease" resulted in reduced quality of life and 
impaired work productivity.  
 
These findings confirm well established and previously published correlations between patient 
reported outcomes, quality of life and disease activ ity in UC, which are adequately 
acknowledged in the manuscript. A major advantage of this study is the relatively large patient 
cohort. However, the presented data lack novelty and the amount of data presented is rather 
limited. Other drawbacks are the ret rospective study design and the insufficient characterization 
of disease activity: The authors claim in the title, that they examined "associations between 
disease activity….. in patients with moderate -to-severe ulcerative colitis….". Severity of disease 
was not really measured in this study, so it is difficult to judge whether patients were indeed 
"moderate to severely active"? Disease activity should have been better controlled and 
quantified. In the present form, objective measures of inflammation (calpr otectin or similar) are 
lacking and endoscopy was not mandatory. Therefore the assessment of patients being in "deep 
remission" (clinical and endoscopic remission) or "remission" (clinical remission and no 
endoscopic remission or no endoscopy at all) is ra ther arbitrary (e.g. the authors need to state the 
percentage of patients with endoscopies available more clearly). The same limitations apply to 
patients with "active disease", which very likely encompass a large spectrum of disease 
activities.  
 
In conclu sion the manuscript confirms well established associations between disease activity and 
HRQoL. The amount of data is rather limited and disease activity poorly defined which limits 
this reviewers' enthusiasm for this manuscript.  
 
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 requ ired in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Yes 
 
Are you able to assess any statistics in the manus cript or would you recommend an 
additional statistical review?  
If an additional statistical review is recommended, please speci fy what aspects require further 
assessment in your comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the qua lity of language in the manuscript:  
 
Acceptable  
 
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 salar y 
from an organisation that may in any way gain or lose financial ly from the 
publication of this manuscript, either now or in the future?  
 
2.  Do you hold any stocks or shares in an organisation t hat may in any way gain or 
lose financially from the publicati on 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 decla re 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 understan d that my name will be included 
on my repor t to the authors and, if the manuscript is accepted f or 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 under an Open Access Creativ e 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 in cluded as confidential comments 
to the editors, which will not be published.  
 
I agree to the open peer review policy of the journal  
assistant