Reviewer's report
Title:Effects of omeprazole on symptoms and quality of life in Japanese patients
with reflux esophagitis: Final results of OMAREE, a large-scale clinical
experience investigation
Version: 1Date:26 September 2010
Reviewer: Mattijs E Numans
Reviewer's report:
Although potentially interesting essentially this is a more or less classically
organized post-marketing survey of the use of omeprazole among patients with
RE in Japan. The interesting parts are that it investigates QOL as a primary
endpoint and that the study population is relatively large. The major flaws
however are, that it is uncontrolled, biased by indication (e.g. differences in
complaint characteristics between comparison groups) and that the authors do
not discuss these flaws adequately.
1. Is the question posed by the authors well defined?
Yes it is presented as a study describing and surveying symptoms and QOL.
2. Are the methods appropriate and well described?
Yes as long as you accept that this is a descriptive study, not comparing efficacy
of omepr with other drugs
3. Are the data sound?
It is unclear how many patients were excluded and for what reasons, so the
relation of the study population and the population "at risk" cannot be defined.
Apart from that the data presented seem sound.
4. Does the manuscript adhere to the relevant standards for reporting and data
deposition?
As long as you accept this is an uncontrolled study
5. Are the discussion and conclusions well balanced and adequately supported
by the data?
No, this study does not allow to conclude that omeprazole is better than other
drugs
6. Are limitations of the work clearly stated?
No, see above
7. Do the authors clearly acknowledge any work upon which they are building,
both published and unpublished?
No, they are refering to controlled trials that cannot be compared with the basis
of this study.
8. Do the title and abstract accurately convey what has been found?
Again, this is an uncontrolled study.
9. Is the writing acceptable?
The English is reasonably well.
Level of interest: An article of limited interest
Quality of written English: Acceptable
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:Effects of omeprazole on symptoms and quality of life in Japanese patients
with reflux esophagitis: Final results of OMAREE, a large-scale clinical
experience investigation
Version: 1Date:26 September 2010
Reviewer: Mattijs E Numans
Reviewer's report:
Although potentially interesting essentially this is a more or less classically
organized post-marketing survey of the use of omeprazole among patients with
RE in Japan. The interesting parts are that it investigates QOL as a primary
endpoint and that the study population is relatively large. The major flaws
however are, that it is uncontrolled, biased by indication (e.g. differences in
complaint characteristics between comparison groups) and that the authors do
not discuss these flaws adequately.
1. Is the question posed by the authors well defined?
Yes it is presented as a study describing and surveying symptoms and QOL.
2. Are the methods appropriate and well described?
Yes as long as you accept that this is a descriptive study, not comparing efficacy
of omepr with other drugs
3. Are the data sound?
It is unclear how many patients were excluded and for what reasons, so the
relation of the study population and the population "at risk" cannot be defined.
Apart from that the data presented seem sound.
4. Does the manuscript adhere to the relevant standards for reporting and data
deposition?
As long as you accept this is an uncontrolled study
5. Are the discussion and conclusions well balanced and adequately supported
by the data?
No, this study does not allow to conclude that omeprazole is better than other
drugs
6. Are limitations of the work clearly stated?
No, see above
7. Do the authors clearly acknowledge any work upon which they are building,
both published and unpublished?
No, they are refering to controlled trials that cannot be compared with the basis
of this study.
8. Do the title and abstract accurately convey what has been found?
Again, this is an uncontrolled study.
9. Is the writing acceptable?
The English is reasonably well.
Level of interest: An article of limited interest
Quality of written English: Acceptable
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:Effects of omeprazole on symptoms and quality of life in Japanese patients
with reflux esophagitis: Final results of OMAREE, a large-scale clinical
experience investigation
Version: 1Date:26 September 2010
Reviewer: Mattijs E Numans
Reviewer's report:
Although potentially interesting essentially this is a more or less classically
organized post-marketing survey of the use of omeprazole among patients with
RE in Japan. The interesting parts are that it investigates QOL as a primary
endpoint and that the study population is relatively large. The major flaws
however are, that it is uncontrolled, biased by indication (e.g. differences in
complaint characteristics between comparison groups) and that the authors do
not discuss these flaws adequately.
1. Is the question posed by the authors well defined?
Yes it is presented as a study describing and surveying symptoms and QOL.
2. Are the methods appropriate and well described?
Yes as long as you accept that this is a descriptive study, not comparing efficacy
of omepr with other drugs
3. Are the data sound?
It is unclear how many patients were excluded and for what reasons, so the
relation of the study population and the population "at risk" cannot be defined.
Apart from that the data presented seem sound.
4. Does the manuscript adhere to the relevant standards for reporting and data
deposition?
As long as you accept this is an uncontrolled study
5. Are the discussion and conclusions well balanced and adequately supported
by the data?
No, this study does not allow to conclude that omeprazole is better than other
drugs
6. Are limitations of the work clearly stated?
No, see above
7. Do the authors clearly acknowledge any work upon which they are building,
both published and unpublished?
No, they are refering to controlled trials that cannot be compared with the basis
of this study.
8. Do the title and abstract accurately convey what has been found?
Again, this is an uncontrolled study.
9. Is the writing acceptable?
The English is reasonably well.
Level of interest: An article of limited interest
Quality of written English: Acceptable
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