PONE-D-24-25892PRECIS-2 used as an implementation science tool for global environmental health:

A cross-sectional evaluation of the Ecolectivos study protocol to reduce burning of household plastic waste in rural GuatemalaPLOS ONE

Dear Dr. Thompson,

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.

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Thank you for your valuable study.

I genuinely enjoyed reading your work, and I can see the thought and endeavour behind it. However, I believe that some of the comments will need more time to address. The idea is very good, and I appreciate your intention, but a bit more work will be needed.

I will list all comments along with my interpretation and suggestions for improvement:

1) Please double-check grammar (e.g. repetition and verb tense);

2) Please double-check refs (e.g. punctuation and formatting);

3) The Abstract is clear and well-structured, but certain refinements are needed:

- First, the transition between terms, specifically the connection between RCTs and the PRECIS-2 tool, is abrupt. The link between the efficacy of the tool and its application could be more clearly outlined. A simple addition explaining how the tool applies to RCTs and enhances their design in real-world contexts can resolve this. For example, ;

- The debate on "RCTs being underutilised" would be more suitable as an in-depth part of the Introduction rather than the Abstract;

- If the authors prefer to elaborate on RCTs to provide a stronger rationale, consider making a clear link between RCTs and the intervention. If the intention is to argue against other, this argument could be reframed within the Introduction;

- Please clarify the real-world application of the tool, including its background and the framework supporting its use;

- The Methods section could begin with an overview of the overall characteristics, followed by an introduction to the PRECIS-2 framework. This will refine readability while also adhering to the guidelines;

- Some parts of the Results section need explanation re. their importance to the findings;

- Please Work on a stronger conclusion debating the applications and implications for environmental health, for example;

- I understand that the debate on RCTs at the beggining of Introduction was provided in similar studies (e.g. 10.1136/bmj.h2147), but it may no be appropriate for a broader audience in this current form;

4) The authors report the ID (i.e. NCT05130632) but provided the STROBE checklist, also mentioned as observational. Although this isn't wrong, some concerns were noted:

- Neither the STROBE nor CONSORT guidelines appear to be adhered to in the ms. The - important - items based on the study design could be addressed to ensure compliance. I suggest a thorough check of the applicable guidelines (i.e. STROBE or CONSORT) and a careful revision of both the Abstract and the ms;

- Insufficient detail regarding the sample, design, and background, in both Abstract and text, making it unclear what the variables, outcomes, and implications are;

- In its conciseness, the Background section describes the intentions. There are interesting explanations re. the importance of RCTs over other designs (e.g. "This is especially relevant in community-based environmental studies"). This construction of argument is important for setting the tone for both the readers and a broader audience. However, despite the commendable attention to detail, the authors appear to be aware of the limitations in clearly defining their study.   In the Study Details section, the context, rationale, and gaps are somewhat overextended (e.g. "Household air pollution from solid fuel combustion is a major environmental risk factor in low- and middle-income countries, accounting for an estimated 2.6 million deaths annually (World Health Organization, 2018). The contribution of plastic waste incineration in household fires has not been quantified. This is problematic for countries like Guatemala, where 71% of households burn waste as a primary means of disposal (Government of the Republic of Guatemala, 2019)."). While informative, this introduction of the problem is not as clear as it could be. I highly suggest reshaping the Introduction to improve flow and readability, focusing on: a) background, b) rationale, c) main gaps in previous studies, d) the motivation behind this study, e) its significance, and f) the hypotheses and objectives;

- The refs. need to be refined and integrated more thoroughly throughout the text, as there are several statements without citations. For example, more information on the validity, reliability, subjectivity, or generalisation, especially re, the proposed RCT—could be strengthened with additional references (e.g. 10.1186/s13063-023-07313-0; 10.1016/j.jclinepi.2020.03.<wbr style="color: rgb(34, 34, 34); font-family: Arial, Helvetica, sans-serif; font-size: small;" />027);

- Please streamline the Method section, emphasising why specific aspects or markers are important. Currently, some details are repeated from other studies rather than focusing on improving the clarity of the hypotheses and objectives;

5) Both the Methods and Results sections lack the necessary detail, making it difficult to evaluate the manuscript in its current form. I'll list a few questions for the authors - especially based on the guidelines and necessity for refine scientific communication;

- Why not begin by describing a key aspect of your study—the sample?;

- Where are the power calculations or sample size determinations? This is *essential*. Additionally, consider addressing the differences in the invitee ratios;

- Please ensure adhering to the guidelines when reporting the data storage and handling;

- What are the confounding factors and possible intervening variables, and how were they managed? Consider response bias as a primary issue;

- Please include details on the psychometric properties of the tool, including the scoring and rating process;

- Was the tool validated?;

- Why is no mention of the specific tests, their assumptions, parameters and explanations? Although Mann-Whitney is mentioned, no explanation is provided. Please consider detailing all parameters, including effect sizes and CIs;

- A detailed section for the qualitative part it essential;

- Explain the modifications to the study?;

Overall, the Methods and Results sections need to be refined, particularly as they do not currently adhere to the relevant guidelines;

6) There seems to be a misunderstanding, as the Results section includes aspects that should belong in the Methods section;

- More detail on eligibility, analyses, and scoring methods are relevant;

- How the data were collected or measured, details of survey questions, and the scales used for evaluation could be provided in Methods;

- Correlations are also advisable - as well as potential regression analyses;

7) Based on this, it is difficult to fully assess the data without proper alignment with the guidelines;

8) The formative phase baseline recruitment, involving door-to-door approaches, was considered more explanatory due to the additional effort required, while recruitment for the main trial was viewed as pragmatic, with village-level randomisation and community-based approaches that aligned with usual community engagement. Please elaborate;

9) The authors should consider checking their data again. For example, in Tables:

10) There is the need to expand a few more demographics, specifically the ones that could serve as confounding factors as IQ, education or previous experiences. Also in Table 2, there are no descriptions of additional tests (e.g. chi-squared). Also check of how these influence the other variables;

- In Table 3, please expand including effects, CIs and check outliers. Considering the small sample, the IQRs can be double-checked;

- In Table 4, the first two domains exhibited significant results after correcting the data. Even without adjusting, the results for recruitment were also significant. I'd highly suggest the authors to double-check;

11) The dispersion of data (i.e. IQR) indicates both the possibility of influence of pre-existing knowledge, as that sample could be biased, i.e. if sample were larger, then probably outcomes would be different. This can be better observed;

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We look forward to receiving your revised manuscript.

Kind regards,

Thiago P. Fernandes, PhD

Academic Editor

PLOS ONE

Journal requirements: 1. When submitting your revision, we need you to address these additional requirements.Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Please amend either the title on the online submission form (via Edit Submission) or the title in the manuscript so that they are identical. 3. Your abstract cannot contain citations. Please only include citations in the body text of the manuscript, and ensure that they remain in ascending numerical order on first mention. 4. Please include a caption for figure 1. 5. Thank you for stating the following financial disclosure:  [The Ecolectivos Trial is supported by the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health under Award Number R01ES032009. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health].  Please state what role the funders took in the study.  If the funders had no role, please state: ""The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript."" If this statement is not correct you must amend it as needed. Please include this amended Role of Funder statement in your cover letter; we will change the online submission form on your behalf. 6. In the online submission form, you indicated that [The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.]. All PLOS journals now require all data underlying the findings described in their manuscript to be freely available to other researchers, either 1. In a public repository, 2. Within the manuscript itself, or 3. Uploaded as supplementary information.This policy applies to all data except where public deposition would breach compliance with the protocol approved by your research ethics board. If your data cannot be made publicly available for ethical or legal reasons (e.g., public availability would compromise patient privacy), please explain your reasons on resubmission and your exemption request will be escalated for approval.  7. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please move it to the Methods section and delete it from any other section. Please ensure that your ethics statement is included in your manuscript, as the ethics statement entered into the online submission form will not be published alongside your manuscript.  8. 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. 

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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: Yes

Reviewer #3: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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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: Yes

Reviewer #3: Yes

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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: Yes

Reviewer #2: Yes

Reviewer #3: 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: PONE-D-24-25892

"PRECIS-2 used as an implementation science tool for global environmental health: A cross-sectional evaluation of the Ecolectivos study protocol to reduce burning of household plastic waste in rural Guatemala"

This study evaluates the Ecolectivos research protocol, which aims to reduce plastic waste burning in rural Guatemalan communities, using the Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) framework. Researchers and study partners assessed the protocol across nine domains, finding that four domains were clearly pragmatic, four were mixed, and one was mainly explanatory. Results highlighting the study's practical aspects and contribute to the integration of implementation science in environmental health research. The manuscript is well-written and methods are very clear. Comments are below.

• I was excited to see a manuscript so clearly describing implementation science methodology in an environmental health context - I look forward to seeing future results from this project as it progresses. For readers (especially if only vaguely familiar), it could be helpful to define implementation science as a basic concept and further emphasize its importance in environmental health intervention work (in the introduction). Could just be a sentence or two.

[page 7, line ~107] “Theory and evidence-based behavior change research are necessary to guide these interventions.”

• Add citation? I see you have relevant references. Or would like to see citations here regarding relevant behavior change research concepts for readers looking for a basic overview if unfamiliar.

• Beyond this, a few citations supporting the importance and understanding of the community-engaged research umbrella (which includes participatory action research, CBPR) would strengthen the introduction. The work you are doing is very important, especially when considering it in an EJ context – you mention EJ once in the background. Unless you define EJ further and/or include explicit contextual EJ examples in the study community, I might consider removing the term EJ. However, there is an opportunity to further emphasize community-engagement (Minkler & Wallerstein, 2008) as this manuscript describes an important first step of a larger community-based implementation research plan.

[page 23 line ~473] “Other limitations were the requirement to be an English speaker, which means that some members of our Guatemalan team could not evaluate the study, and that the on-line survey only included short answer responses, which limited the richness of the data for qualitative analysis.”

• Could you add details about any future study steps that will address bilingual engagement with Spanish-speaking study team members, if at all? Will you access a translation service? Translator? Is there an opportunity to report back the results from this manuscript in Spanish to team members after the fact? If you are at all framing the overall study in an EJ context and/or using community-engaged approaches, this must be addressed.

• To consider: it would be interesting to see a brief section/paragraph reflecting on your partnership within Ecolectivos (Guatemalan team partners) thus far. Could be an opportunity to discuss the bullet point above.

Reviewer #2: Dear Author,

The paper is written in a very good quality of structure and clarity of the purpose of the study and interpretation of the findings. It is very important because it breakdown different domain of quasi experiments to measure its pragmatism or explanatory level. This could be a good evaluation step in developing action research protocols. I only have a few suggestions that might be considered to improve the paper.

1. the author could state her/his position as developer of the Ecolectivos protocols or outside parties of the Ecolectivos study? This could affect the interpretation of the findings by the author. and how the author address potential bias because of the role in Ecolectivos

2. It would be valuable for readers if the paper also present example of other intervention (as explained in the discussion section) and compare it similarity of different approach with Ecolectivos for each domain which might increase or reduce explanatory/pragmatic level.

3. I would like to see recommendations on what should be improved/important to be redesigned, or what domain actually the correct (expected) approach for being pragmatic or explanatory in this study or other environmental health intervention study?

Overall, the paper is very insightful in the field of intervention studies

Thank you

Reviewer #3: This manuscript outlines the use of the implementation science tool, PRECIS-2 to evaluate the RCT protocol of the Ecolectivos Study. This study aims to implement interventions to reduce plastic waste burning in rural Guatemala. This paper is a great example of using implementation science in environmental health settings and will hopefully move the field to be more rigorous in their implementation protocols!

The methods and results sections are straightforward and well laid out. I felt that there was some slight confusion in the introduction and conclusion around whether it was the Ecolectivos protocol or the PRECIS-2 tool itself that was being evaluated. In particular the last section of the abstract "Conclusion" makes it sound like the tool itself was being evaluated rather than used to evaluate the Ecolectivos protocol. I also recommend switching the order of the introduction to first introduce the Ecolectivos study and its goals and then move into the use of PRECIS-2 and implementation science tools to evaluate RCTs.

Minor comments:

Line 161 – how did you identify external participants as experts in their field?

Line 418-421 - had to read this sentence multiple times to understand the meaning - consider rewording.

Lines 421-430 feel out of place in the discussion and should be moved to the introduction as part of the description of the Ecolectivos study

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Reviewer #1: No

Reviewer #2: Yes: Ni Made Utami Dwipayanti

Reviewer #3: No

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PRECIS-2 used as an implementation science tool for global environmental health:

A cross-sectional evaluation of the Ecolectivos study protocol to reduce burning of household plastic waste in rural Guatemala

PONE-D-24-25892R1

Dear Dr. Thompson,

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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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,

Thiago P. Fernandes, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Thank you for your valuable submission.

Upon reassessment, the authors have addressed all remaining concerns.

The only notable issue is the overly lengthy presentation of the Abstract, which could be simplified to improve its flow and clarity for readers.

I strongly encourage the authors to check and correct this during typesetting, as the Abstract is often the only section readers engage with. A concise yet robust approach would be more effective than extending its length unnecessarily.

Wishing you success with your study.

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

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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: Yes

**********

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: No

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