Reviewer ’s report  
 
Title: Protocol of a multicentric prospective cohort study for  the VALIDation of the IBD -Disk 
instrument for assessing disability in Inflammatory Bowel Diseases: the VALIDate study.  
 
Version: 1 Date: 16 Dec 2019  
 
Reviewer: Valerie Pittet  
 
Reviewer's report:  
This paper refers to a protocol describing a 3 -centers study conducted with the goal to val idate 
the IBD -Disk tool. The IBD -Disk tool is a short version of a previous questionnaire developed to 
assess the disability of patients with IBD (the IBD -DI) that showed difficulties for use in routine 
clinical practice. The IBD -DI needs indeed to be admi nistered by a healthcare professional and 
therefore is probably easier to use in clinical trials.  
 
The protocol is well detailed. This is a very interesting study, on a tool that seems promising for 
its ease of use in clinical practice.  
I have some comments.  
 
Abstract and discussion: why did the author mention that this study is "the first study designed to 
validate the IBD Disk"? Should that means that other studies will need to be planned to validate 
the same tool? I would suggest delet ing the term "first" in these sentences.  
 
Background.  
PROs have not only been developed because of an increasing attention to the patient well -being - 
which is probably and overall achievement when treating patients. Other additional, but 
important reasons  could also be the increased willingness to let patients participate in their own 
health, and the increased attention given to communication with patients, as well as 
developments in patient -centered care. This should be better highlighted.  
 
Methods.  
Page  9: the physician will collect patient's oral non -opposition. Why non -opposition rather than 
consent? Please explain.  
It is not quite clear to me why the validation means finding a good correlation with IBD -DI 
(knowing that there were some limitations with  the tool), but not with, for example, other 
psychosomatic or quality of life questionnaires. Please explain.  
 
To test the intraobserver reliability, it is planned to include a sample of 70 patients. Where did 
you get this number? Why not 100 patients? Ple ase explain.  
 
List of variables. The disease duration would be collected twice (at inclusion and FU visit), as 
well as the age at diagnosis. Why this duplicate collection of the same data (also knowing that 
age at diagnosis should not vary within 12 months , unless the diagnosis is not confirmed).  
 
Analyzes.  
Page 12: "a comprehensive descriptive analysis will allow to present the clinical and 
sociodemographic characteristics of IBD patients in France". As far as I understood, this is a 
study conducted in onl y 3 clinical centers, not across the country. Please replace "in France" with 
"in our study".  
The summary table may include means (+/ -SD) or medians (IQR), depending on the distribution 
of the variables. Please update.  
"Headcounts" may be replaced by "Numb ers". 
 
Discussion.  
The authors mentioned that studies analyzing the gaps between doctors and patients perspectives 
have so far focused on UC, which is not true (ex Vaucher et al, Scand J Gastroenterol. 2016). 
Please correct.  
Page 14: "we will also collect the date of the FU visit for each patient". I suppose should be 
replace by "we will also plan".  
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your c omments to the authors.  
 
Yes 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
Unable to assess  
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in yo ur 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 y our comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Needs some language corrections before being published  
 
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, f ees, funding, or salary from an 
organisation that may in any way gain or lose financially from the publi cation 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 publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you curr ently 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 understan d that my name will be included 
on my report to the authors and, if the manuscript is accepted for publication, my named repo rt 
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 Creative Commons 
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understan d 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: Protocol of a multicentric prospective cohort study for  the VALIDation of the IBD -Disk 
instrument for assessing disability in Inflammatory Bowel Diseases: the VALIDate study.  
 
Version: 1 Date: 16 Dec 2019  
 
Reviewer: Valerie Pittet  
 
Reviewer's report:  
This paper refers to a protocol describing a 3 -centers study conducted with the goal to val idate 
the IBD -Disk tool. The IBD -Disk tool is a short version of a previous questionnaire developed to 
assess the disability of patients with IBD (the IBD -DI) that showed difficulties for use in routine 
clinical practice. The IBD -DI needs indeed to be admi nistered by a healthcare professional and 
therefore is probably easier to use in clinical trials.  
 
The protocol is well detailed. This is a very interesting study, on a tool that seems promising for 
its ease of use in clinical practice.  
I have some comments.  
 
Abstract and discussion: why did the author mention that this study is "the first study designed to 
validate the IBD Disk"? Should that means that other studies will need to be planned to validate 
the same tool? I would suggest delet ing the term "first" in these sentences.  
 
Background.  
PROs have not only been developed because of an increasing attention to the patient well -being - 
which is probably and overall achievement when treating patients. Other additional, but 
important reasons  could also be the increased willingness to let patients participate in their own 
health, and the increased attention given to communication with patients, as well as 
developments in patient -centered care. This should be better highlighted.  
 
Methods.  
Page  9: the physician will collect patient's oral non -opposition. Why non -opposition rather than 
consent? Please explain.  
It is not quite clear to me why the validation means finding a good correlation with IBD -DI 
(knowing that there were some limitations with  the tool), but not with, for example, other 
psychosomatic or quality of life questionnaires. Please explain.  
 
To test the intraobserver reliability, it is planned to include a sample of 70 patients. Where did 
you get this number? Why not 100 patients? Ple ase explain.  
 
List of variables. The disease duration would be collected twice (at inclusion and FU visit), as 
well as the age at diagnosis. Why this duplicate collection of the same data (also knowing that 
age at diagnosis should not vary within 12 months , unless the diagnosis is not confirmed).  
 
Analyzes.  
Page 12: "a comprehensive descriptive analysis will allow to present the clinical and 
sociodemographic characteristics of IBD patients in France". As far as I understood, this is a 
study conducted in onl y 3 clinical centers, not across the country. Please replace "in France" with 
"in our study".  
The summary table may include means (+/ -SD) or medians (IQR), depending on the distribution 
of the variables. Please update.  
"Headcounts" may be replaced by "Numb ers". 
 
Discussion.  
The authors mentioned that studies analyzing the gaps between doctors and patients perspectives 
have so far focused on UC, which is not true (ex Vaucher et al, Scand J Gastroenterol. 2016). 
Please correct.  
Page 14: "we will also collect the date of the FU visit for each patient". I suppose should be 
replace by "we will also plan".  
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your c omments to the authors.  
 
Yes 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
Unable to assess  
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in yo ur 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 y our comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Needs some language corrections before being published  
 
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, f ees, funding, or salary from an 
organisation that may in any way gain or lose financially from the publi cation 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 publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you curr ently 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 understan d that my name will be included 
on my report to the authors and, if the manuscript is accepted for publication, my named repo rt 
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 Creative Commons 
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understan d 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: Protocol of a multicentric prospective cohort study for  the VALIDation of the IBD -Disk 
instrument for assessing disability in Inflammatory Bowel Diseases: the VALIDate study.  
 
Version: 1 Date: 16 Dec 2019  
 
Reviewer: Valerie Pittet  
 
Reviewer's report:  
This paper refers to a protocol describing a 3 -centers study conducted with the goal to val idate 
the IBD -Disk tool. The IBD -Disk tool is a short version of a previous questionnaire developed to 
assess the disability of patients with IBD (the IBD -DI) that showed difficulties for use in routine 
clinical practice. The IBD -DI needs indeed to be admi nistered by a healthcare professional and 
therefore is probably easier to use in clinical trials.  
 
The protocol is well detailed. This is a very interesting study, on a tool that seems promising for 
its ease of use in clinical practice.  
I have some comments.  
 
Abstract and discussion: why did the author mention that this study is "the first study designed to 
validate the IBD Disk"? Should that means that other studies will need to be planned to validate 
the same tool? I would suggest delet ing the term "first" in these sentences.  
 
Background.  
PROs have not only been developed because of an increasing attention to the patient well -being - 
which is probably and overall achievement when treating patients. Other additional, but 
important reasons  could also be the increased willingness to let patients participate in their own 
health, and the increased attention given to communication with patients, as well as 
developments in patient -centered care. This should be better highlighted.  
 
Methods.  
Page  9: the physician will collect patient's oral non -opposition. Why non -opposition rather than 
consent? Please explain.  
It is not quite clear to me why the validation means finding a good correlation with IBD -DI 
(knowing that there were some limitations with  the tool), but not with, for example, other 
psychosomatic or quality of life questionnaires. Please explain.  
 
To test the intraobserver reliability, it is planned to include a sample of 70 patients. Where did 
you get this number? Why not 100 patients? Ple ase explain.  
 
List of variables. The disease duration would be collected twice (at inclusion and FU visit), as 
well as the age at diagnosis. Why this duplicate collection of the same data (also knowing that 
age at diagnosis should not vary within 12 months , unless the diagnosis is not confirmed).  
 
Analyzes.  
Page 12: "a comprehensive descriptive analysis will allow to present the clinical and 
sociodemographic characteristics of IBD patients in France". As far as I understood, this is a 
study conducted in onl y 3 clinical centers, not across the country. Please replace "in France" with 
"in our study".  
The summary table may include means (+/ -SD) or medians (IQR), depending on the distribution 
of the variables. Please update.  
"Headcounts" may be replaced by "Numb ers". 
 
Discussion.  
The authors mentioned that studies analyzing the gaps between doctors and patients perspectives 
have so far focused on UC, which is not true (ex Vaucher et al, Scand J Gastroenterol. 2016). 
Please correct.  
Page 14: "we will also collect the date of the FU visit for each patient". I suppose should be 
replace by "we will also plan".  
 
 
Are the methods appropriate and well described?  
If not, please specify what is required in your c omments to the authors.  
 
Yes 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
Unable to assess  
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in yo ur 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 y our comments to the editors.  
 
I am able to assess the statistics  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Needs some language corrections before being published  
 
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, f ees, funding, or salary from an 
organisation that may in any way gain or lose financially from the publi cation 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 publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you curr ently 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 understan d that my name will be included 
on my report to the authors and, if the manuscript is accepted for publication, my named repo rt 
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 Creative Commons 
CC-BY license ( http://creativecommons.org/licenses/by/4.0/ ). I understan d 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