PONE-D-22-20391Understanding Reproductive Health among Survivors of Paediatric and Young adults (URHSPY) Cancers in a low-income setting: a mixed method study protocolPLOS ONE

Dear Dr. Kayiira,

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 Nov 10 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:

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If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

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We look forward to receiving your revised manuscript.

Kind regards,

Callam Davidson

Editorial Office

PLOS ONE

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When submitting your revision, we need you to address these additional requirements.

1. 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 

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2. Thank you for stating the following financial disclosure: 

 "This study is funded by the North Pacific Global Health (NPGH) research fellow training consortium award to A.K, under the Fogarty International Centre and the National Institutes of Health [Grant # D43 TW009345] (https://www.fic.nih.gov/) and supported by the National Institutes of Health's National Centre for Advancing Translational Sciences [Grant # UL1 TR002494] (https://www.nih.gov/about-nih/what-we-do/nih-almanac/national-center-advancing-translational-sciences-ncats#:~:text=NCATS'%20mission%20is%20to%20catalyze,improving%20health%20through%20smart%20science.). The funding organisations did not have any role in the design of the study or writing the manuscript. They will not be involved in data collection, analysis, and interpretation of data."

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. 

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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?

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

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

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

Reviewer #1: No

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.

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: The authors present a study protocol of mixed methods study. The rationale for the study is clearly described. The results of this study will provide novel information about the reproductive health climate of young cancer patients living in Uganda.

Overall, the protocol manuscript would significantly benefit from editorial assistance for grammar and punctuation corrections in each paragraph. It is also repetitive in some sections. Here are some specific suggestions for revisions:

Abstract Methods: Please include the estimated sample size for both the survey and interview components.

Background: This section would benefit from a re-organization to concisely present the rationale for the study’s purpose. The first paragraph can be removed as it is not necessary to present the global cancer incidence. Suggestion to start the background section with the incidence of cancers in Uganda among young cancer survivors and the reproductive morbidity (consider merging current paragraph 2 and the note definition of reproductive morbidity).

Purpose statement: The specific objectives are repetitive with what is already stated in the paragraph – consider merging all this information into one paragraph.

Methods Survey Approach:

Setting: This paragraph is very long; suggestion to shorten the amount of detailed information on the Kyadondo County and its residents.

Eligibility Criteria: Suggestion to state the inclusion and exclusion criteria in sentence format versus a bulleted list. Please also include your rationale for only including cancer patients diagnosed from ages 0 to 25 years. The National Cancer Institute definition of adolescent and young adult cancer patient includes ages 15 to 39 years. Please explain why you are not including cancer patients aged 26 to 39 years.

Sampling: This section is not clear; please consider revising for clarity.

Recruitment strategy: Please explain how the message with the survey will be sent to potential subjects prior to the first call. Will information be mailed?

Survey data collection, management and analysis: The paragraphs describing the survey instruments and data collection are quite lengthy and somewhat repetitive. Consider revising to be more concise. For the data collection processes, please provide a rationale for making 10 attempts and up to 2 per day for the first contact.

Methods Qualitative Approach:

Setting: This paragraph is too long; suggestion to shorten the amount of detailed information in this paragraph.

Eligibility Criteria: Suggestion to state the inclusion and exclusion criteria in sentence format versus a bulleted list.

In-depth interview instruments: Please move the sentences describing the interview guides located in the “Data collection process” paragraph into this section to provide more details regarding the semi-structured interview questions.

Data collection process: This section can be shortened for better flow and clarity.

Qualitative data management and analysis: Please provide more details on how many individuals will be coding the qualitative transcripts and how consensus between coders will be reached.

Trustworthiness: Consider removing this section from the manuscript.

Discussion: Consider revising the last three paragraphs into one study strengths and limitations paragraph.

Reviewer #2: Thank you for inviting me to review such an interesting and thought-provoking research proposal. With the information provided by the authors, I believe there is enough justification for the study. Although the methodology appears appropriate, I still have some concerns. My first concern borders on the sampling method for the cross-sectional arm of the study - Will the authors recruit only the calculated sample size of 362 from the identified study population, or do they plan to recruit all consenting eligible survivors? If the former is the case, then the authors should calculate and adjust for non-response, define as well how they will select the sample population from the study population. My second concern relates to the questionnaire - was it adapted to the local population. Thirdly, is there any compensation for the participants for their time? Fourthly, the authors noted the possibility of adverse psychological effects by the study - How do they plan to monitor this? or do they have a plan for interim assessment of the magnitude of such psychological harm? Finally, the authors should be specific on how the study will influence policy and practice. RECOMMENDATION: Approved after addressing the concerns raised in the review.

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Reviewer #1: No

Reviewer #2: Yes: Ekwuazi Kingsley Emeka

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PONE-D-22-20391R1Understanding Reproductive Health among Survivors of Paediatric and Young adults (URHSPY) Cancers in Uganda: a mixed method study protocolPLOS ONE

Dear Dr. Kayiira,

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 Mar 17 2023 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:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

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-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Dorina Onoya

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.

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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 #3: Partly

**********

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 #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: Yes

Reviewer #3: No

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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 #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 #3: 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.

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: The authors response to reviewers comments was thorough and addressed the primary concerns to strengthen their study protocol manuscript. The results of this study will provide novel information about the reproductive health climate of pediatric and young adult cancer patients living in Uganda.

The revised manuscript is a significant improvement from the previous version. Since PLOS ONE does not copyedit accepted manuscripts, a suggestion is to conduct a thorough copy edit of the manuscript to correct for double words, spelling, grammar and punctuation throughout the manuscript. For example, in the Background section, first paragraph, fifth sentence, “Incidence” should not be capitalized and in the 6th sentence, “Nonetheless” is listed twice. Another example is in the Discussion section, second paragraph, second sentence, “CATI based surgery” should be “CATI based survey”.

Reviewer #3: General: The research resulting from studies done on this protocol will contribute with very valuable information regarding reproductive health. The protocol is fairly concise, I was not reviewer of the first version but have gone through all actions from previous reviewers. The responses appear adequate.

By having experience and expertise in qualitative methodology as additional reviewer my focus has caught some additional points that would benefit from being addressed. My biggest concern is that by reading your protocol you have neither convinced me that the study has a mixed methods design, nor that Grounded Theory is adequately planned to be used. It seems more like two different studies are planned, if not you need to better reflect why this is a mixed methods study and have data being generated will be analysed together and provide added value to each other. Grounded Theory is a complex method to use, and I cannot see that the objective or the description of the methodology is in line with how the method should be used. Some choices needs to be made regarding these issues, and then it must be described with consistency.

1. Keywords in abstract should be ordered alphabetically

2. Page 6 “Eligibility criteria”, I would suggest you to reconsider the age defining “young adults”, 18-39 would be more appropriate. See reference from The National cancer institute in the USA, They define young adults between 15-39, and from legal motives it may be simpler to include those from 18. “The national Cancer Institute. Adolescents and Young Adults with Cancer. Available online: https://www.cancer.gov/types/aya

3. Page 6 heading “Sample size”, incomplete sentence; In this study, the proportion of survivors that had or sired a pregnancy…”

4. Not convinced that what you are doing is Grounded Theory, a form of mixed methods: Yes, but the qualitative plan could more easily be understood if you would keep it o have a qualitative approach where interviews are planned to be analysed using a thematic method. If you choose to keep GT as the preferred method, it must be clear if you are supposed to develop theory, or study the processes in relation to the subject – which presently is NOT a part of the described objective and you are not presenting any adequate reference to the method of GT.

5. Page 10; “In depth interview instruments”: Preferably I would like to see you interview guide, the sample questions suggest that those being interviewed are supposed to be those that have suffered from cancer – but from the objective, they are supposed to be guardians – unclear, please revise. (For some reason i cannot access supplements)

6. Doing qualitative interviews without being a researcher trained in the methods is not suitable – especially when using GT, the interviewer must have training in GT in order to make interviews that follows the process of GT. And also the same if it is supposed to be narrative interviews analysed with thematic analysis

7. Similarly regarding the “mixed methods design”, here in the protocol it is ok, but in the resulting article you must argue how the data analysis and presentation will be done in line with how it is expected to be done in mixed design. No adequate reference for mixed methods designs is present.

a. My suggestion is that when you are panning to publish, that you separate it into two articles, since the mixed design is weak and the objectives of the two parts differentiate too much.

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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

Reviewer #3: Yes: Mats Jong

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[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.

Understanding Reproductive Health among Survivors of Paediatric and Young adults (URHSPY) Cancers in Uganda: a mixed method study protocol

PONE-D-22-20391R2

Dear Dr. Anthony Kayiira,

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,

Dorina Onoya

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

The revised manuscript has adequately addressed the reviewer's comments and recommendations. However, it is recommended that the authors conduct a final review to address any minor typographical errors. Additionally, there are a couple of abbreviations that should be spelled out. While it may not be necessary to go through another round of reviews, the authors should make sure to address these issues during the proofreading stage before publication.

Reviewers' comments: