PONE-D-19-31034

Community based reference interval of selected clinical chemistry parameters among apparently healthy Adolescents in Tigrai, Ethiopia

PLOS ONE

Dear Mr Belay,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration by two reviewers, we believe that the manuscript has merit but could be improved significantly. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Specifically, as noted by Reviewer 1, more details are needed in terms of the analysis used, the socio-demographics of the participants, and the exclusion criteria used for participants. A clearer discussion section which emphasizes the main conclusions of the study would also be helpful. Please address both sets of reviewer comments and resubmit a revised version of your manuscript by Feb 02 2020 11:59PM.

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Colin Johnson, Ph.D.

Academic Editor

PLOS ONE

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2. We noticed you have some minor occurrence(s) of overlapping text with the following previous publication(s), which needs to be addressed:

https://doi.org/10.11613/BM.2016.001

https://doi.org/10.1371/journal.pone.0201782

https://doi.org/10.1016/j.cca.2019.01.001

https://doi.org/10.3109/10408363.2013.786673

https://doi.org/10.1016/j.clinbiochem.2009.06.025

https://en.wikipedia.org/wiki/Mekelle

In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the Methods section. Further consideration is dependent on these concerns being addressed.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Partly

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: I Don't Know

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: No

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: No

Reviewer #2: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Daniel Asmelash (Questions/Comments/Suggestions)

1. The title the authors worked with is interesting and sensible for African region. However, Thorough proof reading needed

2. Justify the research gap of this study, particularly why you focus on this specific age group?

3. Representativeness of the study? Does study done only on Mekelle city will infer for the whole Tigray region? Are you inferring for the general population of Tigray region?

4. What new thing your study added from the study by Molla Abebe et. al (https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0201782)

5. Socio-demographic Characteristics of the study participants lacks depth, it needs more information

6. On the Data Collection and Laboratory analysis section of the manuscript you didn’t include laboratory methods analysis for each analyte?

7. On the data analysis why, you choose Mann Whitney U test non– parametric analysis?

8. I didn’t see what type of laboratory tests was done for your exclusion criteria and the number of study participants excluded by your exclusion criteria mainly Based on laboratory findings?

9. Abreviations should be clearly mentioned on the tables

10. The Discussion needs more clarification on the possible reasons of the findings.

Reviewer #2: Thank you for the opportunity to review this manuscript titled “Community based reference interval of selected clinical chemistry parameters among apparently healthy Adolescents in Tigrai, Ethiopia”.

• There are several grammatic errors across the text.

• The authors need to reference several statements throughout the text (unfortunately there are no line numbers), e.g. first sentence in the introduction section, first sentence of paragraph 3 in the introduction section, 4th paragraph etc… several other places throughout the text.

• The authors claim in the last paragraph of the introduction section that “The results of this study, therefore, will be used as reference values in the future evidence informed practices. Patients will get better service as their result will be interpreted based on the locally established value; physicians will have better tool in their patient management process and medical laboratory professionals will have confidence especially flagged result based on RIs established elsewhere are a common challenge. Moreover, this study would serve as baseline information for further studies in the area.” Who will use these “locally established” reference intervals? How do the authors justify that their reference intervals are appropriate for the intended setting? Is a sample size of 344 enough to represent a population of 310,436 people?

• How was certainty determined for the exclusion criteria?

• How did the authors determine that the participants of the study were representative of the local population? The same criticism against the international guidelines can apply to the ‘locally established’ reference intervals.

• The tables are overwhelming. The authors need to provide a narrative description of the key messages captured in each of the tables. Additionally, based on the statistical methods described in the text and the results in the tables, the authors actually only compared local measurements with international guidelines, instead of establishing new reference intervals. There is a mismatch between the aim of the study, the methods described, and the results presented (which mostly in tables). It is unclear what the study intended to do and what was done.

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Reviewer #1: Yes: Daniel Asmelash

Reviewer #2: No

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Attachments

Attachment

Submitted filename: Reviewer(Daniel Asmelash) Comments.docx

Community based reference interval of selected clinical chemistry parameters among apparently healthy Adolescents in Mekelle City, Tigrai, Northern Ethiopia

PONE-D-19-31034R1

Dear Dr. Belay,

We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements.

Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication.

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With kind regards,

Colin Johnson, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: No

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: (No Response)

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Daniel Asmelash Gebretensae