Reviewer's report
Title:Treatment of Children and Adolescents with Ulcerative Colitis by
Adsorptive Depletion of Myeloid Lineage Leucocytes as Monotherapy or in
Combination with Low Dose Prednisolone After Failure of First-line Medications
Version: 2Date:31 May 2013
Reviewer: Jennifer deBruyn
Reviewer's report:
Discretional Revisions: None
Minor Essential Revisions
1. In the Abstract: Background paragraph, the authors indicate that “these
medications in children and adolescent may adversely affect the patients’ growth
and development.” This is only supported in the literature for corticosteroids and
therefore these statements require revision.
2. The Abstract should contain a statement of the objective of the study.
3. The Abstract: Methods section should contain statement of the setting and
time period of the study.
4. Abstract: Results paragraph: please clarify what is meant by “initial GMA
sessions.”
5. Abstract: Conclusions: The final statement about “most young UC patients
may respond to GMA and be spared from pharmacologics” is inappropriate as all
24 subjects were given 5-aminosalicylate treatment and 5 subjects required
prednisolone.
6. Methods: Treatment design and efficacy assessment: Please describe the
tapering schedule for prednisolone.
Minor issues not for publication
1. Abstract:Methods paragraph: remove, “an” before “11 sessions.”
2. Abstract:Methods paragraph: correct prednisolone dose to “mg/kg/day”.
3. Introduction: 1st paragraph: remove comma after “factors.”
4. Introduction: 1st paragraph: remove comma after “children.”
5. Introduction: last paragraph: correct grammar in the sentence of “the present
article reports was on the efficacy and safety ...”
6. Methods: GMA procedures: correct spelling of “venipuncture.”
7. Methods: Statistics: correct spelling of “analyses.”
Major Compulsory Revisions
1. The authors describe that “GMA with Adacolumn is an established and
officially approved extracorporeal treatment intervention for patients with active
IBD” in the METHODS section. The authors should clarify the context and setting
of this statement as it is not an established and officially approved treatment
worldwide.
2. Methods: Treatment design and efficacy assessment: Clinical activity index
and disease activity index: Neither index is commonly used in contemporary
studies. I am also unable to find the source for how these indices were
developed and subsequently validated. This makes it difficult for readers to
interpret the results of the study. Therefore, I recommend including the indices as
supplementary tables and also identifying references that describe their
development and validation.
3. Methods: Treatment design and efficacy assessment: The authors report that
assessments were done within one week post last session. The results section
should indicate the follow-up time for each patient (perhaps in table format).
4. Methods: Treatment design and efficacy assessment: Did all patients continue
on salicylate therapy. The details of this should be included. Also, the dose by
mg/kg should be included to ensure that patients were treated with an adequate
dose of salicylate therapy.
5. Methods: Treatment design and efficacy assessment: The authors should
clarify the dates of enrolment. Were there only 24 patients with UC assessed at
the unit between 2000 and 2012. This seems like a very low number and also
does not make sense in light of the duration of treatment in the “Results:
Maintenance of remission” paragraph.
6. Figures 2 & 3: The x-axis should include a temporal component (ie, weeks) as
it is unclear from the manuscript the varying lengths of follow-up time.
7. Results: subgroup analyses: Did the authors evaluate for any other predictors
of response aside from CAI and DAI scores? For example, what about gender,
age, duration of disease, disease extent, or laboratory parameters?
8. Results: treatment safety: What about the risk of infection given that
granulocytes and monocytes are depleted? Were patients screened to rule out
infection risk prior to commencement? (ie, stool studies for culture, Clostridium
difficile)
9. Table 1: It would be helpful to include age, weight, baseline medication dose
by mg/kg, and also to categorize the patients by treatment.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
'I declare that I have no competing interests'
Reviewer's report
Title:Treatment of Children and Adolescents with Ulcerative Colitis by
Adsorptive Depletion of Myeloid Lineage Leucocytes as Monotherapy or in
Combination with Low Dose Prednisolone After Failure of First-line Medications
Version: 2Date:31 May 2013
Reviewer: Jennifer deBruyn
Reviewer's report:
Discretional Revisions: None
Minor Essential Revisions
1. In the Abstract: Background paragraph, the authors indicate that “these
medications in children and adolescent may adversely affect the patients’ growth
and development.” This is only supported in the literature for corticosteroids and
therefore these statements require revision.
2. The Abstract should contain a statement of the objective of the study.
3. The Abstract: Methods section should contain statement of the setting and
time period of the study.
4. Abstract: Results paragraph: please clarify what is meant by “initial GMA
sessions.”
5. Abstract: Conclusions: The final statement about “most young UC patients
may respond to GMA and be spared from pharmacologics” is inappropriate as all
24 subjects were given 5-aminosalicylate treatment and 5 subjects required
prednisolone.
6. Methods: Treatment design and efficacy assessment: Please describe the
tapering schedule for prednisolone.
Minor issues not for publication
1. Abstract:Methods paragraph: remove, “an” before “11 sessions.”
2. Abstract:Methods paragraph: correct prednisolone dose to “mg/kg/day”.
3. Introduction: 1st paragraph: remove comma after “factors.”
4. Introduction: 1st paragraph: remove comma after “children.”
5. Introduction: last paragraph: correct grammar in the sentence of “the present
article reports was on the efficacy and safety ...”
6. Methods: GMA procedures: correct spelling of “venipuncture.”
7. Methods: Statistics: correct spelling of “analyses.”
Major Compulsory Revisions
1. The authors describe that “GMA with Adacolumn is an established and
officially approved extracorporeal treatment intervention for patients with active
IBD” in the METHODS section. The authors should clarify the context and setting
of this statement as it is not an established and officially approved treatment
worldwide.
2. Methods: Treatment design and efficacy assessment: Clinical activity index
and disease activity index: Neither index is commonly used in contemporary
studies. I am also unable to find the source for how these indices were
developed and subsequently validated. This makes it difficult for readers to
interpret the results of the study. Therefore, I recommend including the indices as
supplementary tables and also identifying references that describe their
development and validation.
3. Methods: Treatment design and efficacy assessment: The authors report that
assessments were done within one week post last session. The results section
should indicate the follow-up time for each patient (perhaps in table format).
4. Methods: Treatment design and efficacy assessment: Did all patients continue
on salicylate therapy. The details of this should be included. Also, the dose by
mg/kg should be included to ensure that patients were treated with an adequate
dose of salicylate therapy.
5. Methods: Treatment design and efficacy assessment: The authors should
clarify the dates of enrolment. Were there only 24 patients with UC assessed at
the unit between 2000 and 2012. This seems like a very low number and also
does not make sense in light of the duration of treatment in the “Results:
Maintenance of remission” paragraph.
6. Figures 2 & 3: The x-axis should include a temporal component (ie, weeks) as
it is unclear from the manuscript the varying lengths of follow-up time.
7. Results: subgroup analyses: Did the authors evaluate for any other predictors
of response aside from CAI and DAI scores? For example, what about gender,
age, duration of disease, disease extent, or laboratory parameters?
8. Results: treatment safety: What about the risk of infection given that
granulocytes and monocytes are depleted? Were patients screened to rule out
infection risk prior to commencement? (ie, stool studies for culture, Clostridium
difficile)
9. Table 1: It would be helpful to include age, weight, baseline medication dose
by mg/kg, and also to categorize the patients by treatment.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
'I declare that I have no competing interests'
Please review this paper.
user
Reviewer's report
Title:Treatment of Children and Adolescents with Ulcerative Colitis by
Adsorptive Depletion of Myeloid Lineage Leucocytes as Monotherapy or in
Combination with Low Dose Prednisolone After Failure of First-line Medications
Version: 2Date:31 May 2013
Reviewer: Jennifer deBruyn
Reviewer's report:
Discretional Revisions: None
Minor Essential Revisions
1. In the Abstract: Background paragraph, the authors indicate that “these
medications in children and adolescent may adversely affect the patients’ growth
and development.” This is only supported in the literature for corticosteroids and
therefore these statements require revision.
2. The Abstract should contain a statement of the objective of the study.
3. The Abstract: Methods section should contain statement of the setting and
time period of the study.
4. Abstract: Results paragraph: please clarify what is meant by “initial GMA
sessions.”
5. Abstract: Conclusions: The final statement about “most young UC patients
may respond to GMA and be spared from pharmacologics” is inappropriate as all
24 subjects were given 5-aminosalicylate treatment and 5 subjects required
prednisolone.
6. Methods: Treatment design and efficacy assessment: Please describe the
tapering schedule for prednisolone.
Minor issues not for publication
1. Abstract:Methods paragraph: remove, “an” before “11 sessions.”
2. Abstract:Methods paragraph: correct prednisolone dose to “mg/kg/day”.
3. Introduction: 1st paragraph: remove comma after “factors.”
4. Introduction: 1st paragraph: remove comma after “children.”
5. Introduction: last paragraph: correct grammar in the sentence of “the present
article reports was on the efficacy and safety ...”
6. Methods: GMA procedures: correct spelling of “venipuncture.”
7. Methods: Statistics: correct spelling of “analyses.”
Major Compulsory Revisions
1. The authors describe that “GMA with Adacolumn is an established and
officially approved extracorporeal treatment intervention for patients with active
IBD” in the METHODS section. The authors should clarify the context and setting
of this statement as it is not an established and officially approved treatment
worldwide.
2. Methods: Treatment design and efficacy assessment: Clinical activity index
and disease activity index: Neither index is commonly used in contemporary
studies. I am also unable to find the source for how these indices were
developed and subsequently validated. This makes it difficult for readers to
interpret the results of the study. Therefore, I recommend including the indices as
supplementary tables and also identifying references that describe their
development and validation.
3. Methods: Treatment design and efficacy assessment: The authors report that
assessments were done within one week post last session. The results section
should indicate the follow-up time for each patient (perhaps in table format).
4. Methods: Treatment design and efficacy assessment: Did all patients continue
on salicylate therapy. The details of this should be included. Also, the dose by
mg/kg should be included to ensure that patients were treated with an adequate
dose of salicylate therapy.
5. Methods: Treatment design and efficacy assessment: The authors should
clarify the dates of enrolment. Were there only 24 patients with UC assessed at
the unit between 2000 and 2012. This seems like a very low number and also
does not make sense in light of the duration of treatment in the “Results:
Maintenance of remission” paragraph.
6. Figures 2 & 3: The x-axis should include a temporal component (ie, weeks) as
it is unclear from the manuscript the varying lengths of follow-up time.
7. Results: subgroup analyses: Did the authors evaluate for any other predictors
of response aside from CAI and DAI scores? For example, what about gender,
age, duration of disease, disease extent, or laboratory parameters?
8. Results: treatment safety: What about the risk of infection given that
granulocytes and monocytes are depleted? Were patients screened to rule out
infection risk prior to commencement? (ie, stool studies for culture, Clostridium
difficile)
9. Table 1: It would be helpful to include age, weight, baseline medication dose
by mg/kg, and also to categorize the patients by treatment.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
'I declare that I have no competing interests'
assistant