https://orcid.org/0000-0001-6961-3858
Peer Review History
| Original SubmissionMarch 17, 2021 |
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PONE-D-21-08640 Evaluating the impact of Bolsa Familia, Brazil’s conditional cash transfer programme, on maternal and child health: a study protocol PLOS ONE Dear Dr. Falcão, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. The present study protocol sits amid important research questions and production of quality evidence regarding a major social program and maternal and child outcomes. The rationale is also well stated. However, as consistently pointed out by the reviewers, there are several methodological aspects that need to be clarified, including steps for data management and availability, statistical procedures (also considering the huge sample size), and approaches for sensitivity analysis --all crucial for ensuring reproducibility. In addition, please note that more detail on the planned developments may be useful to highlight the need to register this study protocol, as opposed to bringing such information in the methodology section of derived original studies (for instance, by the same research group: https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003509). Please submit your revised manuscript by Dec 17 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript:
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If your ethics statement is written in any section besides the Methods, please delete it from any other section. 9. Please upload a new copy of Figure 1 as the detail is not clear. Please follow the link for more information: " ext-link-type="uri" xlink:type="simple">https://blogs.plos.org/plos/2019/06/looking-good-tips-for-creating-your-plos-figures-graphics/" " ext-link-type="uri" xlink:type="simple">https://blogs.plos.org/plos/2019/06/looking-good-tips-for-creating-your-plos-figures-graphics/" 10. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. [Note: HTML markup is below. Please do not edit.] 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 Reviewer #3: 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 #1: Yes Reviewer #2: Partly Reviewer #3: Partly ********** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: No Reviewer #2: No Reviewer #3: 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 #1: Yes Reviewer #2: No Reviewer #3: 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 #1: Yes Reviewer #2: Yes Reviewer #3: 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 #1: Review: Thank you for this informative paper on your proposed study protocol for exploring the impact of Brazil’s Bolsa Familia Program on maternal and child health outcomes. I appreciate the time you’ve put into describing your protocols and methods before undertaking a study, which is important for transparency in scientific research. Suggested revisions: 1. In the first paragraph of the ‘Background’ section (lines 53-57), I’m not sure if this sentence refers to Brazil, lower-middle-income/higher-middle-income countries, globally. Please clarify. 2. In the first paragraph of the ‘Methods’ section, could you briefly elaborate on the original purpose of the 100 Million Brazilian Cohort survey. 3. In the second paragraph of the ‘Methods’ section, I find the sentence on lines 97-98 unclear. Can you briefly explain the two stages? Is this unique to your study? Or is this standard procedure for linking surveys to government data? 4. The second paragraph of the ‘Methods’ section is generally a bit disjointed with the CIDACS acronym being defined at the end, CIDACS-RL being mentioned, then linkages, then an explanation of CIDACS-RL. It could be improved for the ease of comprehension. 5. Line 105, it would be helpful to general readers to briefly explain the purpose of TIDieR-PHP reporting guidelines and why you used them. 6. Line 167, is definition b) not covered by definition a)? If so, then definition b) is redundant. If not, please rephrase b) for better clarity. 7. Line 180, do you want a ‘2)’ before “…stratified…”? Is it not a second definition? 8. You’ve mentioned Regression Discontinuity Design (RDD) in your keywords. I see no reference to RDD analyses in the main text. How do you plan to use RDD with your data? What questions do you hope to answer? 9. Rationale for stratification/sub-analyses of samples post-2011 is not clearly laid out in the text. It is briefly explained under “iii) child malnutrition - study population”. But post-2011 sub-analyses are suggested before that without explanation (LGA, SGA and prematurity). I figure this is due to changes in the BFP, but this is not clearly laid out in the text. 10. Table 1: • In the text you refer to the Bolsa Familia Program, but in the table, it is the Family Grant Program. I suggest you use Bolsa Familia here for consistency. • Under relevant variables from SINASC, it says “month that started prenatal after 2011”. Do you mean prenatal classes? Prenatal vitamins? Please check this. • Are all the main variables you intend to use in your analyses listed in this table? It would be very important to know other health-related variable of the mothers (i.e. pre-existing diabetes or gestational diabetes; smoking; etc.) as these will be relevant confounders for prematurity, LGA and SGA analyses. 11. Table 3: There is an extra ‘e’ in front of “extremely preterm” in the outcomes column. 12. Figure 1: Resolution needs to be checked as it is barely readable at the moment. For further consideration: Your proposed rationale is reasonable, but have you considered how cash transfers that are conditional and preferentially paid to mothers may not increase purchasing power/ empowerment for all women. For example, the responsibility of getting children to school and to regular medical appointments for working mothers with partners may further entrench domestic/care work as women’s roles – potentially at the expense of paid employment, social networks, self-care, etc. Indeed, there appears to be a heterogeneous effect of CCT on women’s empowerment that may need further consideration in additional analyses: De Brauw, A., Gilligan, D. O., Hoddinott, J., Roy, S. (2014). The impact of Bolsa Família on women’s decision-making power. World Development, 59, 487-504. Reviewer #2: It is not clear to me that what the manuscript describes warrants a study protocol. The construction of the database itself has been published elsewhere by the same group. All aspects described in the section “Secondary objectives, study population, definition of exposure, and outcomes” are minor and would be well suited to methodology sections of different papers. The statistical methods are solid for natural experiment studies in public health. I firmly believe that the authors should expand the details of their methodological decisions and processes in a future submission and publish the product of this development as a supplemental file to their methodology. Nevertheless, if the authors decide to proceed with the submission, some key points should be addressed. Keeping in mind that reproducibility is one of the main pillars of study protocols at PLOS ONE, the authors should provide a comprehensive background of how the databases that compose the 100 Million Brazilian Cohort can be accessed for research purposes. If only governmental officials can access the data, the authors should consider another type of publication for this manuscript. Given the 100 Million Brazilian complexity, the author should also expand on how they plan to address bias in all three outcomes. A more thorough explanation should be provided concerning data cleaning decisions and the linkage process. Minor points to be addressed: Some aspects of the study population, exposure to PBF, and outcome should be standardized between sections. For example, picking either the “2004-2015” or “2004 to 2015” to declare year ranges. In the logic model, “Linkage to the place of birth” is not a product but a process and does not belong to this logic model. Reviewer #3: “Evaluating the Impact of Bolsa Familia, Brazil’s conditional cash transfer programme on, on maternal and child health: a study protocol,” submitted to PLOS ONE (PONE-08640) The protocol outlines a substantive analysis using various large administrative health and social program databases from Brazil to the so-called 100 million Brazilian cohort. It represents an ambitious research agenda (likely leading to multiple papers) that has potential to improve understanding of the influences of PBF. The authors make clear that despite its enormous size and importance, careful empirical assessment of the effect of PBF, particularly on child and maternal outcomes, is sparse. They identify an appropriate set of outcomes based on available data and the literature. There are likely to have sufficient power for even very small impacts and rare events such as maternal mortality (making it important to judge not only statistical impact but size of impact). The large sample sizes and observational nature of the data make the research design, i.e., arguments for assessing causal impact and not just associations, crucial. Main Comments: 1. One important reason there is not more evidence on PBF is the lack of a strong research design for assessing program impacts, as was done for example via randomization of Progresa in Mexico. Another challenge when examining impact at a national level, I believe, are the differences in program administration across municipalities played. The team proposes resolving identification of the causal effects of the intervention via propensity score matching techniques. This approach is preferable to simpler comparisons but still relies on key assumptions of non-confoundedness across treatment and comparison groups after matching. After controlling for the observed factors available, the assumption is that there are no unobserved differences in those taking up the treatment and those not taking it up. Central problem is that those who enter, despite observed characteristics, might be different – ie more likely to benefit or have unobserved wealth or something we do not observe. So, sign of bias is difficult to ascertain. If untreated are better off on other characteristics, for example, might be able to argue results are conservative or underestimates of beneficial program benefits. Unconfoundedness cannot be proven but the matching literature provides various approaches for assessing it in the articles cited and my expectation is many of these will be done in your analyses. 2. In practice, carrying out PS or other matching techniques on these large data sets will involve dozens if not hundreds of decisions regarding the specifics (on which variables, functional form, common support etc.) and possibly variations on those decisions to assess sensitivity. It could be useful to say a bit more about how this will be approached, including the specifics of the data for readers less familiar with it – for example specific variables/measures that are included or links to those descriptions or an appendix. 3. In their work (and related approaches), Imbens and coauthors develop other types of matching such as Nearest Neighbor (implemented in Stata using the command nnmatch). It may not be feasible with such large data sets to follow those approaches but a key aspect of them is allowing “exact” matching on certain types of characteristics. One that may be particularly important in this context is location – I noted mention of some subgroup analyses but think my suggestion here is a little different. Taking for example geographic location, to help ensure important elements like potential differences in municipality health systems are not leading to bias, a strategy of only matching treated cases with untreated in the same municipality can be used in the overall analysis. This permits an arguably better comparison than allowing geographic location, for example, to enter only via the combined propensity score. 4. Because PBF had an income cut-off, I did wonder whether there was any scope for an alternative approach to identification, related to regression discontinuity designs (RDD). I believe this could be done in conjunction with ps matching, but it would require availability of income measures (but these appear to be available). Or if not explicit, limiting comparison samples to those with incomes nearer to the cutoff, for example. 5. Administrative data match quality: I am unfamiliar with the various administrative data the study will use. It has been my experience in other settings, however, that combining administrative data across systems can be error ridden. To that end, greater support for the case that merging administrative records across the data sets is feasible and result in high quality (and high %) matches would strengthen confidence in the research design and the ultimate findings. Differences in quality of administrative match across the different data sets may influence findings in the three domains differently. It was unclear to me what the “similarity index” (page 3) approach was, but I presume on subsets of information (eg birth date, gender, location but not quite exact name spelling). A clear distinction in the final papers between the administrative matching across data sets and the ps matching procedures needs to be made. Characteristics of those matched and those not matched could shed light on potential biases. 6. Are there any statistical considerations relevant to having particularly large sample sizes? 7. It was unclear to me whether length of exposure (beyond pregnancy periods) for outcomes would be considered, but I may have missed this. ********** 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: No Reviewer #2: No Reviewer #3: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment 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. Registration is free. 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 PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. |
| Revision 1 |
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PONE-D-21-08640R1Evaluating the impact of Bolsa Familia, Brazil’s conditional cash transfer programme, on maternal and child health: a study protocolPLOS ONE Dear Dr. Falcão, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Apr 28 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript:
If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-emailutm_source=authorlettersutm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Bárbara Hatzlhoffer Lourenço, Ph.D. Academic Editor PLOS ONE Journal Requirements: 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. [Note: HTML markup is below. Please do not edit.] 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 Reviewer #3: 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 #1: Yes Reviewer #2: Yes Reviewer #3: Yes ********** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: 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 #1: Yes Reviewer #2: Yes Reviewer #3: 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 #1: Yes Reviewer #2: Yes Reviewer #3: 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 #1: Overall, the manuscript is much more clear. The authors have made important improvements. There are, however, a few remaining issues to be addressed: 1- Please check your acronyms. Sometimes you use PBF, and other times BFP. 2- Line 158-159: Why drop babies of less than 500g or born before 22 gestational weeks? I know they may be less likely to survive but could extreme prematurity and/or very low birthweight not be related to the socioeconomic standing of the mother? Is this not conditioning on the outcome? I understand the rationale for multiple births or congenital abnormalities as they are unlikely to be related to SES but related to birthweight and prematurity, but excluding the babies based on their likelihood of survival does not make sense to me. 3- On line 241, do you mean the parent's education or the child's? 4- Line 270: You say "quasi-experimental approaches". You should explain how your approaches are quasi-experimental (i.e. exogenous changes with the BF program and subsequent outcomes, or regression discontinuity designs around the cut points for BF eligibility). I'm not sure I would use this characterization here based on how your have described your proposed analyses. Reviewer #2: The authors addressed all the points raised. I believe that this work have the potential to improve methodological rigor in future researches exploring maternal and child health outcomes Reviewer #3: Thank you for the clarifications and revisions. In finalizing, I suggest you consider reconsidering words like "effect" and "impact" if you wish to be more careful around causal language (see you response to my first comment). In chart 1, column 1 it often says "access" but I believe you mean "assess" ********** 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: No Reviewer #2: No Reviewer #3: Yes: John A. Maluccio [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment 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. Registration is free. 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 PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. |
| Revision 2 |
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Evaluating the effect of Bolsa Familia, Brazil’s conditional cash transfer programme, on maternal and child health: a study protocol PONE-D-21-08640R2 Dear Dr. Falcão, 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. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Bárbara Hatzlhoffer Lourenço, Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: |
| Formally Accepted |
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PONE-D-21-08640R2 Evaluating the effect of Bolsa Familia, Brazil’s conditional cash transfer programme, on maternal and child health: a study protocol Dear Dr. Falcão: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Bárbara Hatzlhoffer Lourenço Academic Editor PLOS ONE |
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