PONE-D-20-12484

Assessment of effectiveness of DAMaN : A malaria intervention program initiated by Government of Odisha, India

PLOS ONE

Dear Dr. Ranjit,

Thank you for submitting your manuscript for review to PLoS ONE. After careful consideration, we feel that your manuscript will likely be suitable for publication if the authors revise it to address specific points raised by the reviewer.  According to reviewers, there are some specific areas where further improvements would be of substantial benefit to the readers, including sample size calculation. Additionally, the authors should clarify about critical variables that may impact malaria control, such as the annual variation in rainfall and the fluctuation of vector density.

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Luzia Helena Carvalho, Ph.D.

Academic Editor

PLOS ONE

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2.  Please include additional information regarding the survey or questionnaire used in the study and ensure that you have provided sufficient details that others could replicate the analyses. For instance, if you developed a questionnaire as part of this study and it is not under a copyright more restrictive than CC-BY, please include a copy, in both the original language and English, as Supporting Information."

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Reviewer #1: Yes

Reviewer #2: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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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Reviewer #1: Yes

Reviewer #2: Yes

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

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(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: PONE-D-20-12484

Title: Assessment of effectiveness of DAMaN: A malaria intervention program initiated by Government of Odisha, India

Article Type: Registered Report Protocol

General Comments: This study aims to assess the impact of a special programme launched in Odisha state of India to flush out asymptomatic malaria by biannual mass surveillance programme and of the mass distribution of long lasting insecticide nets (LLINs) on overall malaria incidence in the state. For the same, authors’ have proposed to divide malarious districts in to three strata based on 2016 malaria data (figure 1).

Specific Comments:

1. Figure 2 suggests that two districts are already selected from each of the three strata. Selection of the study districts in each stratum should be unbiased for which, the districts in each stratum may be listed from higher to lower API and then divided further in two subgroups of almost equal number of districts, one districts from upper half and one from the lower half in each zone may be selected. Sample size should be calculated based on lowest prevalence. This sample size may be applied to higher prevalence district in each of the zones for uniformity. Since prevalence of malaria has shown significant reduction in the years 2018 and 2019 in Odisha, sample size calculation should be based on current prevalence/incidence for representativeness and not based on 2016 data.

2. Introduction: Authors have stated ‘This initiative saw huge investment of public fund from the state government.’ How much per capita was invested, may be mentioned?

3. “At least 1 ml of intra- venous blood specimen will be collected for malaria and haemoglobin analysis and anthropometric measurements will be recorded from all the members of the sampled household present at the time of interview.”

Considering only two years of implementation of DAMaN, what is the rationale of taking anthropometric measurements? What difference DAMaN would have made in a short span to these features, is not understood? Hence this objective may be dropped and focus should be primarily on the epidemiological impact.

4. What definition of an asymptomatic case will be used? Will temperature be taken at the time of house visit?

5. Where is P. malariae in the whole scheme? This species has been reported from Odisha with decent prevalence in some districts as in previous studies. [The prevalence of P. malariae in Odisha, India by Pati et. al., Tropical Biomedicine 34(3): 607–614 (2017)]

6. The rationale for using three diagnostic methods may be clearly stated in view of Pfhrp-2 gene deletion which ranges from 5-10%; e.g. what is missed by RDT could be captured by microscopy and the PCR will capture low/sub-microscopic parasitaemia which the above two methods may miss detection.

7. On page 15, objective (d), Remove `prevalence’ to assess the outcome of maternal and child health.

8. On page 15, explain outcome assessment from MSAT? (Use Primary data/Generate data)

9. On page 16, Aim 3: Explain about stratification in detail in methodology.

10. On page 17, Sample size: Based on the calculated sample size, you should include 2228 household with pregnant women not household only.

11. On page 22, Statistical analysis: Anaemia should be defined separately for pregnant women, children and general population in a tabular form. It is not clear.

12. Authors will need to calculate sample size separately for LLIN usage (No. of Household) and child health outcome (<5 years)

Reviewer #2: Since 2017, the Indian National Vector-borne Disease Control Programme (NVBDCP) has implemented an intervention project (called DAMaN) to eliminate malaria in the hard-to-reach areas of high malaria-burden district of Odisha State, located on the south-eastern coast of the country.

Madhusmita Bal and colleagues are now proposing an evaluation study of the DAMaN project, in order to establish a continuous assessment of its effectiveness. This proposed DAMaN Assessment will provide evidence on the impact and outcome of intervention based on reduction in overall parasite load and reduction/interruption in transmission and changes in important key health indicators.

The strategies used in the DAMaN project to eliminate malaria in the target areas are not innovative. All of them were based on WHO guidelines for the elimination of malaria transmission. However, the evaluation methodology proposed by the authors of this manuscript brings a new tool to the malaria control and elimination strategies.

The rationale of this registered report protocol is clear, relevant and valid. The study protocol is well written and the methodology stated the authors hypotheses. The sample size was properly calculated. The strategies to analyse the results of the DAMaN Assessment study consider proposals for adequate, robust and well-characterized statistical models.

Despite the clarity of the study protocol submitted, it was not evident how the authors will analyse some variables provided for in the DAMaN Project. In the main objectives of the DAMaN Assessment the authors stated that they will estimate the mass screening and treatment (MSAT), vector control measures (LLIN and/or IRS) and community mobilization and participation. However, no detailed information was presented on how variables related to vector control measures (LLIN usage, for example) and community mobilization and participation will be measured to be included in the difference analysis models.

Da mesma forma, não está claro se os autores irão avaliar outras variáveis importantes na avaliação do controle da malária, tais como a variação anual da chuva e a flutuação da densidade vetorial na área estudada.

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Reviewer #1: No

Reviewer #2: No

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Assessment of effectiveness of DAMaN : A malaria intervention program initiated by Government of Odisha, India

PONE-D-20-12484R1

Dear Dr. Ranjit,

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

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Luzia Helena Carvalho, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #2: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #2: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Reviewer #2: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 #2: Yes

**********

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 #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #2: All my comments and questions made in the first revision of this manuscript were properly argumented or answered by the authors.

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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 #2: No