Transfer Alert

This paper was transferred from another journal. As a result, its full editorial history (including decision letters, peer reviews and author responses) may not be present.

Dear Dr Luangasanatip,

Thank you very much for submitting your manuscript "Implementation of Field Detection Devices in Medicine Quality Screening in Lao PDR – A Cost-Effectiveness Analysis" for consideration at PLOS Neglected Tropical Diseases. As with all papers reviewed by the journal, your manuscript was reviewed by members of the editorial board and by several independent reviewers. In light of the reviews (below this email), we would like to invite the resubmission of a significantly-revised version that takes into account the reviewers' comments.

We cannot make any decision about publication until we have seen the revised manuscript and your response to the reviewers' comments. Your revised manuscript is also likely to be sent to reviewers for further evaluation.

When you are ready to resubmit, please upload the following:

[1] A letter containing a detailed list of your responses to the review comments and a description of the changes you have made in the manuscript. Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out.

[2] Two versions of the revised manuscript: one with either highlights or tracked changes denoting where the text has been changed; the other a clean version (uploaded as the manuscript file).

Important additional instructions are given below your reviewer comments.

Please prepare and submit your revised manuscript within 60 days. If you anticipate any delay, please let us know the expected resubmission date by replying to this email. Please note that revised manuscripts received after the 60-day due date may require evaluation and peer review similar to newly submitted manuscripts.

Thank you again for your submission. We hope that our editorial process has been constructive so far, and we welcome your feedback at any time. Please don't hesitate to contact us if you have any questions or comments.

Sincerely,

Vahid Yazdi-Feyzabadi, PhD

Deputy Editor

PLOS Neglected Tropical Diseases

Vahid Yazdi-Feyzabadi

Deputy Editor

PLOS Neglected Tropical Diseases

***********************

Reviewer's Responses to Questions

Key Review Criteria Required for Acceptance?

As you describe the new analyses required for acceptance, please consider the following:

Methods

-Are the objectives of the study clearly articulated with a clear testable hypothesis stated?

-Is the study design appropriate to address the stated objectives?

-Is the population clearly described and appropriate for the hypothesis being tested?

-Is the sample size sufficient to ensure adequate power to address the hypothesis being tested?

-Were correct statistical analysis used to support conclusions?

-Are there concerns about ethical or regulatory requirements being met?

Reviewer #1: First, I think that te paper needs to more clearly present the objectives of the study rather than only saying that they are evaluating the cost-effectiveness of introducing the screening devices. They should state what the testable hypothesis is for the study, the perspective of the study, and the target audience. Also, since the study focused on testing of ACTs, it appears to be focused on antimalarials rather than other types of drugs. In that case, the title of the study should be changed to reflect the focus on antimalarials as opposed to all medicines. Iis not clear whether the findings can be generalized to other types of medicines.

It would also be helpful to describe the prevalence and incidence of malaria in Lao PDR what interventions are currently being implemented against malaria, etc.

The study design is described but focuses largely on the assumptions of the decision analysis and effectiveness of the screening devices. It requires more detail on data collection and costing methods. It is unclear whether actual data collection was conducted in Lao PDR and, if so, who conducted the analysis. Also, it does not include a description of the cost categories and costing methods used. It does not appear that capital costs were depreciated as would be expected. Also, the total costs of introducing the devices is not described, i.e. implementation costs as well as the costs of the devices, are not presented except in Table 7. It would be good to see a table with total costs as well as proportions spent on each cost category since delivery costs are important in making decisions on introduction of a new technology.

I found Table 1 difficult to interpret. It would help to explain this table in more detail - e.g. what device fail and device pass means. This information is in the decision analytic model but should also be stated in the table.

Reviewer #2: Yes, the methods used, the statistical analysis and data presentation is well indicated. The study met its objectives with sufficient sample size.

Reviewer #3: Use Strategies instead of overview heading.

In the parameter inputs section of the methods, it is better to include subtitles such as probabilities, costs and consequences, which in each section, how to calculate each item is explained in detail.

Given that the measure of outcome is DALY averted in this study and the main parameters of DALY such as YLL and disability weight are assumed and there is no specific source or reference for them. Therefore, the results cannot be trusted.

The perspective of cost calculating, time horizon and discount rate are not mentioned in the method.

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Results

-Does the analysis presented match the analysis plan?

-Are the results clearly and completely presented?

-Are the figures (Tables, Images) of sufficient quality for clarity?

Reviewer #1: The analysis presented matches the analysis plan to some extent. However, as noted above, it does not provide sufficient information on the costs of implementation and only presents this information in the budget impact. This information should be presented in the general results section for the two scenarios and some charts developed with the shares of total costs for each cost category with and without the costs of the devices

Reviewer #2: Yes

Reviewer #3: The ACER column in Tables 4 and 5 should be changed to ICER because ACER is calculated for a strategy while the numbers in this column are incremental cost/ incremental effect for a strategy compare with baseline.

Probability sensitivity analysis(PSA) should be performed according to its importance in policy decisions

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Conclusions

-Are the conclusions supported by the data presented?

-Are the limitations of analysis clearly described?

-Do the authors discuss how these data can be helpful to advance our understanding of the topic under study?

-Is public health relevance addressed?

Reviewer #1: In the discussion section, it would be helpful to compare the findings with other studies in the literature if there are any. Also, it would be good to compare the delivery costs with and without the cost of devices with current expenditures on ACT screening if this information is available.

Reviewer #2: Discussion is poorly written.

Reviewer #3: (No Response)

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Editorial and Data Presentation Modifications?

Use this section for editorial suggestions as well as relatively minor modifications of existing data that would enhance clarity. If the only modifications needed are minor and/or editorial, you may wish to recommend “Minor Revision” or “Accept”.

Reviewer #1: (No Response)

Reviewer #2: Minor revision

Reviewer #3: (No Response)

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Summary and General Comments

Use this section to provide overall comments, discuss strengths/weaknesses of the study, novelty, significance, general execution and scholarship. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. If requesting major revision, please articulate the new experiments that are needed.

Reviewer #1: The paper discusses the cost-effectiveness of of portable screening devices to assess the quality of medicines in Lao PDR. The paper indicates that insufficient screening of medicine quality is being conducted, particularly to assess substandard medicines. However, the paper needs to improve its situation analysis, presentation of methods and results, as well as discuss other literature on the subject. It is unclear whether the study is focusing on antimalarials rather than all medicines, the title does not seem to match the content, and the costing methods are not well-described and presented.

Reviewer #2: The authors sought to determine the Cost-Effectiveness of Field Detection Devices in Medicine Quality Screening in Lao PDR. Indeed, Substandard and falsified medicines pose a significant threat to the health system nowadays.

The authors did an outstanding work which add knowledge to the scientific community.

The methods used, the statistical analysis and data presentation is well indicated. The English write-up was also good.

It is a breakthrough to assess the cost-effectiveness of intervention methods to mitigate the impact of SF ACTs.

Listed below are minor comments:

• Your study focused on market surveillance among pharmacies in Laos. The study could have been more plausible if it is multi-centered including various facilities to draw better concluding remarks.

• You have tested about 6 different devices to evaluate cost-effectiveness; however, device specific conclusions were not made lastly.

• The discussion is poorly written; It looks simply a repetition of your methodology and result part. Moreover, it states facts and I didn’t see comparisons with other similar studies. Suggestion: better to mention a portion of your result, compare with other similar (may not be exactly same) reports, then draw justification.

Reviewer #3: In the abstract, instead of the analysis scenario, it is better to emphasize the type of costs that have been calculated and the outcome measurement index.

Depending on the type of economic evaluation study (cost utility analysis), it is better to use the term outcome or effect instead of benefit in all parts of the manuscript.

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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: No

Reviewer #2: Yes: Melaku Ashagrie Belete

Reviewer #3: Yes: Reza Goudarzi

Figure Files:

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email us at figures@plos.org.

Data Requirements:

Please note that, as a condition of publication, PLOS' data policy requires that you make available all data used to draw the conclusions outlined in your manuscript. Data must be deposited in an appropriate repository, included within the body of the manuscript, or uploaded as supporting information. This includes all numerical values that were used to generate graphs, histograms etc.. For an example see here: http://www.plosbiology.org/article/info%3Adoi%2F10.1371%2Fjournal.pbio.1001908#s5.

Reproducibility:

To enhance the reproducibility of your results, PLOS recommends that you deposit laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. For instructions see https://journals.plos.org/plosntds/s/submission-guidelines#loc-methods

Attachments

Attachment

Submitted filename: Reviewer report .docx

Dear Dr Luangasanatip,

Thank you very much for submitting your manuscript "Implementation of Field Detection Devices for Antimalarial Quality Screening in Lao PDR – A Cost-Effectiveness Analysis" for consideration at PLOS Neglected Tropical Diseases. As with all papers reviewed by the journal, your manuscript was reviewed by members of the editorial board and by several independent reviewers. The reviewers appreciated the attention to an important topic. Based on the reviews, we are likely to accept this manuscript for publication, providing that you modify the manuscript according to the review recommendations.

Please prepare and submit your revised manuscript within 10 days. If you anticipate any delay, please let us know the expected resubmission date by replying to this email.

When you are ready to resubmit, please upload the following:

[1] A letter containing a detailed list of your responses to all review comments, and a description of the changes you have made in the manuscript.

Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out

[2] Two versions of the revised manuscript: one with either highlights or tracked changes denoting where the text has been changed; the other a clean version (uploaded as the manuscript file).

Important additional instructions are given below your reviewer comments.

Thank you again for your submission to our journal. We hope that our editorial process has been constructive so far, and we welcome your feedback at any time. Please don't hesitate to contact us if you have any questions or comments.

Sincerely,

Vahid Yazdi-Feyzabadi, PhD

Deputy Editor

PLOS Neglected Tropical Diseases

Vahid Yazdi-Feyzabadi

Deputy Editor

PLOS Neglected Tropical Diseases

***********************

Reviewer's Responses to Questions

Key Review Criteria Required for Acceptance?

As you describe the new analyses required for acceptance, please consider the following:

Methods

-Are the objectives of the study clearly articulated with a clear testable hypothesis stated?

-Is the study design appropriate to address the stated objectives?

-Is the population clearly described and appropriate for the hypothesis being tested?

-Is the sample size sufficient to ensure adequate power to address the hypothesis being tested?

-Were correct statistical analysis used to support conclusions?

-Are there concerns about ethical or regulatory requirements being met?

Reviewer #1: The objectives of the study are clearly stated. The study design seems appropriate. In general, the methods seem appropriate. I question, though, why the study authors did not use discounting for their capital costs. In a cost-effectiveness study, it is recommended to estimate economic costs rather than financial costs and the capital costs should be discounted. So, I suggest that the authors should discount the capital costs.

Reviewer #3: (No Response)

--------------------

Results

-Does the analysis presented match the analysis plan?

-Are the results clearly and completely presented?

-Are the figures (Tables, Images) of sufficient quality for clarity?

Reviewer #1: (No Response)

Reviewer #3: (No Response)

--------------------

Conclusions

-Are the conclusions supported by the data presented?

-Are the limitations of analysis clearly described?

-Do the authors discuss how these data can be helpful to advance our understanding of the topic under study?

-Is public health relevance addressed?

Reviewer #1: I have some comments about the conclusions. First, for the budget impact analysis, I don't think it makes sense to say that donor support to purchase some of the devices would be required since that would not be supporting sustainability. Instead, it would be better to say what the most affordable options are, given the available budget.

It seems obvious that cost-effectiveness is not an 'inherent' feature of the devices since cost-effectiveness will vary with the probability of SF, the costs, and effectiveness. So I would reword that sentence.

I also think that it would be useful to discuss whether there are any other uses of the devices that would increase their cost-effectiveness.

Reviewer #3: (No Response)

--------------------

Editorial and Data Presentation Modifications?

Use this section for editorial suggestions as well as relatively minor modifications of existing data that would enhance clarity. If the only modifications needed are minor and/or editorial, you may wish to recommend “Minor Revision” or “Accept”.

Reviewer #1: I see that the authors added a paragraph on malaria incidence to the paper. However, I think that it should be in the introduction section rather than the methods section. Also, they should say 'incidence' rather than 'incidences.' I also think that they should add a sentence on the burden of malaria illness compared to other diseases and why it would be important to ensure that ACTs are of high quality and not SF.

The phrasing of some sentences is awkward. In several places, it would be preferable to use the term 'introducing' rather than 'implementing. - e.g. pg. 5, line 123.

Reviewer #3: (No Response)

--------------------

Summary and General Comments

Use this section to provide overall comments, discuss strengths/weaknesses of the study, novelty, significance, general execution and scholarship. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. If requesting major revision, please articulate the new experiments that are needed.

Reviewer #1: In general, the revised paper has improved.

Reviewer #3: (No Response)

--------------------

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: No

Reviewer #3: Yes: Reza Goudarzi

Figure Files:

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email us at figures@plos.org.

Data Requirements:

Please note that, as a condition of publication, PLOS' data policy requires that you make available all data used to draw the conclusions outlined in your manuscript. Data must be deposited in an appropriate repository, included within the body of the manuscript, or uploaded as supporting information. This includes all numerical values that were used to generate graphs, histograms etc.. For an example see here: http://www.plosbiology.org/article/info%3Adoi%2F10.1371%2Fjournal.pbio.1001908#s5.

Reproducibility:

To enhance the reproducibility of your results, we recommend that you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. Additionally, PLOS ONE offers an option to publish peer-reviewed clinical study protocols. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols

References

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article's retracted status in the References list and also include a citation and full reference for the retraction notice.

Dear Dr Luangasanatip,

Thank you very much for submitting your manuscript "Implementation of Field Detection Devices for Antimalarial Quality Screening in Lao PDR – A Cost-Effectiveness Analysis" for consideration at PLOS Neglected Tropical Diseases. As with all papers reviewed by the journal, your manuscript was reviewed by members of the editorial board and by several independent reviewers. The reviewers appreciated the attention to an important topic. Based on the reviews, we are likely to accept this manuscript for publication, providing that you modify the manuscript according to the review recommendations.

Please prepare and submit your revised manuscript within 7 days. If you anticipate any delay, please let us know the expected resubmission date by replying to this email.

When you are ready to resubmit, please upload the following:

[1] A letter containing a detailed list of your responses to all review comments, and a description of the changes you have made in the manuscript.

Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out

[2] Two versions of the revised manuscript: one with either highlights or tracked changes denoting where the text has been changed; the other a clean version (uploaded as the manuscript file).

Important additional instructions are given below your reviewer comments.

Thank you again for your submission to our journal. We hope that our editorial process has been constructive so far, and we welcome your feedback at any time. Please don't hesitate to contact us if you have any questions or comments.

Sincerely,

Vahid Yazdi-Feyzabadi, PhD

Deputy Editor

PLOS Neglected Tropical Diseases

Vahid Yazdi-Feyzabadi

Deputy Editor

PLOS Neglected Tropical Diseases

***********************

Figure Files:

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email us at figures@plos.org.

Data Requirements:

Please note that, as a condition of publication, PLOS' data policy requires that you make available all data used to draw the conclusions outlined in your manuscript. Data must be deposited in an appropriate repository, included within the body of the manuscript, or uploaded as supporting information. This includes all numerical values that were used to generate graphs, histograms etc.. For an example see here: http://www.plosbiology.org/article/info%3Adoi%2F10.1371%2Fjournal.pbio.1001908#s5.

Reproducibility:

To enhance the reproducibility of your results, we recommend that you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. Additionally, PLOS ONE offers an option to publish peer-reviewed clinical study protocols. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols

References

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article's retracted status in the References list and also include a citation and full reference for the retraction notice.

Dear Dr Luangasanatip,

Thank you very much for submitting your manuscript "Implementation of Field Detection Devices for Antimalarial Quality Screening in Lao PDR – A Cost-Effectiveness Analysis" for consideration at PLOS Neglected Tropical Diseases. As with all papers reviewed by the journal, your manuscript was reviewed by members of the editorial board and by several independent reviewers. The reviewers appreciated the attention to an important topic. Based on the reviews, we are likely to accept this manuscript for publication, providing that you modify the manuscript according to the review recommendations.

We did receive no response or any required change for below comments in last review.

Please kindly response to these comments and amend based on the reviewer comments.

1. I see that the authors added a paragraph on malaria incidence to the paper. However, I think that it should be in the introduction section rather than the methods section. Also, they should say 'incidence' rather than 'incidences.' I also think that they should add a sentence on the burden of malaria illness compared to other diseases and why it would be important to ensure that ACTs are of high quality and not SF.

2. The phrasing of some sentences is awkward. In several places, it would be preferable to use the term 'introducing' rather than 'implementing. - e.g. pg. 5, line 123.

Editor's Comments to Author

Please prepare and submit your revised manuscript within 30 days. If you anticipate any delay, please let us know the expected resubmission date by replying to this email.

When you are ready to resubmit, please upload the following:

[1] A letter containing a detailed list of your responses to all review comments, and a description of the changes you have made in the manuscript.

Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out

[2] Two versions of the revised manuscript: one with either highlights or tracked changes denoting where the text has been changed; the other a clean version (uploaded as the manuscript file).

Important additional instructions are given below your reviewer comments.

Thank you again for your submission to our journal. We hope that our editorial process has been constructive so far, and we welcome your feedback at any time. Please don't hesitate to contact us if you have any questions or comments.

Sincerely,

Vahid Yazdi-Feyzabadi, PhD

Deputy Editor

PLOS Neglected Tropical Diseases

Vahid Yazdi-Feyzabadi

Deputy Editor

PLOS Neglected Tropical Diseases

***********************

We did receive no response or required change to below comments in last review.

Please kindly response to these comments and amend based on the reviewer comments.

I see that the authors added a paragraph on malaria incidence to the paper. However, I think that it should be in the introduction section rather than the methods section. Also, they should say 'incidence' rather than 'incidences.' I also think that they should add a sentence on the burden of malaria illness compared to other diseases and why it would be important to ensure that ACTs are of high quality and not SF.

The phrasing of some sentences is awkward. In several places, it would be preferable to use the term 'introducing' rather than 'implementing. - e.g. pg. 5, line 123.

Editor's Comments to Author

Figure Files:

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email us at figures@plos.org.

Data Requirements:

Please note that, as a condition of publication, PLOS' data policy requires that you make available all data used to draw the conclusions outlined in your manuscript. Data must be deposited in an appropriate repository, included within the body of the manuscript, or uploaded as supporting information. This includes all numerical values that were used to generate graphs, histograms etc.. For an example see here: http://www.plosbiology.org/article/info%3Adoi%2F10.1371%2Fjournal.pbio.1001908#s5.

Reproducibility:

To enhance the reproducibility of your results, we recommend that you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. Additionally, PLOS ONE offers an option to publish peer-reviewed clinical study protocols. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols

References

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article's retracted status in the References list and also include a citation and full reference for the retraction notice.

Dear Dr Luangasanatip,

We are pleased to inform you that your manuscript 'Implementation of Field Detection Devices for Antimalarial Quality Screening in Lao PDR – A Cost-Effectiveness Analysis' has been provisionally accepted for publication in PLOS Neglected Tropical Diseases.

Before your manuscript can be formally accepted you will need to complete some formatting changes, which you will receive in a follow up email. A member of our team will be in touch with a set of requests.

Please note that your manuscript will not be scheduled for publication until you have made the required changes, so a swift response is appreciated.

IMPORTANT: The editorial review process is now complete. PLOS will only permit corrections to spelling, formatting or significant scientific errors from this point onwards. Requests for major changes, or any which affect the scientific understanding of your work, will cause delays to the publication date of your manuscript.

Should you, your institution's press office or the journal office choose to press release your paper, you will automatically be opted out of early publication. We ask that you notify us now if you or your institution is planning to press release the article. All press must be co-ordinated with PLOS.

Thank you again for supporting Open Access publishing; we are looking forward to publishing your work in PLOS Neglected Tropical Diseases.

Best regards,

Vahid Yazdi-Feyzabadi, PhD

Deputy Editor

PLOS Neglected Tropical Diseases

Vahid Yazdi-Feyzabadi

Deputy Editor

PLOS Neglected Tropical Diseases

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