Review for 10.1186/s12876-015-0390-3 (2015)

Reviewer ’s report  
 
Title: An Open -Label Prospective Randomized Multicenter Study of Intensive versus Weekly  
Granulocyte and Monocyte Apheresi s in Active Crohn's Disease  
 
Version: 0 Date: 14 Sep 2015  
 
Reviewer: Askin  Erdogan  
 
Reviewe r's report:  
Dear Editor,  
I have revised the paper "An Open -Label Prospective Randomized Multicenter Study of 
Intensive versus Weekly Granulocyte and Monocyte Apheresis in Active Crohn's Disease" and I 
have some suggestions regard ing the paper as listed below.  
 
Yours sincerely,  
 
Methods  
1. Ethical consideration subtitle: Please put ® after Adacolumn.  
2. Statistical analysis subtitle: Please state which version of SA is used for analysis.  
3. Statistical analysis subtitle: With appro ximately 5% withdrawal, a total of 100 patients had 
to be included in each arm. However, when the patient number in each arm reached around 
50, an interim analysis was done, which showed similar remission rates in the two arms. 
Did authors look how many pa tients were needed to reach a statistical significant difference 
between treatment groups?  
 
Results  
1. Subtitle "Patient randomization and demography": The authors state that; a total of 104 
patients met the study inclusion criteria and were randomized to the weekly GMA arm (n = 
49) or to the intensive GMA arm (n = 55). Five patients in the weekly GMA could not be 
included in the efficacy analysis, two had not reached CDAI score ≥200 at screening, one 
patient was not available for GMA therapy and the remain ing two patients were found to 
have received GMA prior to assignment. Additionally, one patient who was assigned to the 
intensive GMA arm had received weekly GMA, this patient was included in the weekly 
GMA arm during the analysis of the treatment outcome.  My understanding from the 
"patients subtitle under methods section" that these reasons should be in the exclusion 
criteria. So actually 104 did not meet the inclusion criteria.  
2. Changes in leucocyte count, and inflammation markers subtitle: Please give the p value here 
as well (Likewise, CRP level had decreased from 1.90 mg/dL to 0.80 mg/dL.)  
Discussion  
1. Please give the limitations of study; such as study being open -label in the discussion section.  
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.  
 
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 manuscript or would you recommend an  
additional statistical review?  
If an additional statistical review is recommended, please specify 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 quality of language in the manuscr ipt: 
 
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, fundin g, 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 f rom 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 o rganization 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 tha t 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 upl oad 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 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