PONE-D-23-32907The PROCAN-B Study Protocol: Early diagnosis of PROstate CANcer for Black men - a community-centred participatory approach in Scotland and the North-East of EnglandPLOS ONE

Dear Dr. Christie-de Jong,

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Mohammed Faruk

Academic Editor

PLOS ONE

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2. Thank you for stating the following financial disclosure: 

"Authors who received this award are: FC, JL, JE, MKo, JK, KR. This study is funded by Prostate Cancer Research https://www.prostate-cancer-research.org.uk/ 

Grant reference number: 6968"

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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4. 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 If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references.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 If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.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 #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: Partly

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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: 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 #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: 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.

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: Manuscript Feedback

Title: The PROCAN-B Study Protocol: Early diagnosis of PROstate CANcer for Black men - a

community-centred participatory approach in Scotland and the North-East of England.

Strengths.

This manuscript seeks to address a significant public health issue as prostate cancer is a leading

cause of death among men in the UK and disproportionately affects Black men.

This study seeks to design an intervention that is tailored to the needs and sensitivity of the

communities most impacted.

An attempt is made to engage the targeted communities for input in the design of the intervention.

Opportunities.

Framework.

A theoretical framework is provided: Integrated Screening Action Model. However, how this

framework informs the study design or other aspects of the study (Focus Group guide, refining

intervention testing, etc.) is not mentioned.

Sample Size/Recruitment.

Objective 1 – exploration of barriers. Sample group of N=13 for both sites is too small to give

diverse views from both communities.

Objective 2 – design of intervention. The sample size of 13 for both sites seem small to capture

diverse views, especially given the aim of designing an intervention that is culturally relevant to

each site.

Objective 6 – Same observation as for Objectives 1 &2 above

Objectives 4, 5, 7, 8, the sample size appear more reasonable.

Work Package 2.

Are the participants involved in this Work Package, the same 13 participants recruited for Work

Package 1? If so, how would you ensure some fresh perspectives are brought to the table in terms

of potential intervention ideas? How about having a mix of participants who were part of Work

Package 1 and some participants who were not?

Overall Feedback

Good proposal with the potential to garner some creative interventions that will be adapted by the

targeted communities.

Reviewer #2: The "PROCAN-B Study Protocol: Early Diagnosis of Prostate Cancer for Black Men - a community-centered Participatory Approach in Scotland and the North-East of England" aims to address the critical issue of health disparities in prostate cancer diagnosis among Black men through a community-centered, mixed methods research approach. While the protocol robustly outlines the involvement of the community via a Public Involvement and Community Engagement (PICE) group and integrates both qualitative and quantitative research methods, there are several areas where clarity and depth could be enhanced to improve the manuscript's strength and acceptability for publication. These areas include better integration of the mixed methods data, a more streamlined theoretical framework, detailed explanations of sample size justifications, and a more thorough discussion of ethical considerations and the intervention's specifics. Enhancing these aspects will provide clearer insights into the study's methodological rigor and potential impact. Additional comments below:

Based on the information provided from the sources, the PROCAN-B study protocol titled "The PROCAN-B Study Protocol: Early diagnosis of PROstate CANcer for Black men - a community-centered participatory approach in Scotland and the North-East of England" is a comprehensive approach designed to address disparities in prostate cancer diagnosis and treatment among Black men. The study employs a mixed methods design and emphasizes community participation and cultural tailoring of interventions, which are its significant strengths. However, for this study protocol to be enhanced and made more acceptable for publication in a peer-reviewed journal, the following areas could benefit from improvements or further clarity:

INTRODUCTION

• The introduction clearly states the problem and the target population, emphasizing the health disparity for prostate cancer in Black men in the UK. However, it could be enhanced by adding a concise review of the existing literature that highlights gaps the study aims to fill. Providing a brief overview of prior interventions and their limitations can strengthen the rationale for this study.

• Multiple theoretical frameworks are introduced (e.g., I-SAM, COM-B, socio-ecological model), but their interrelations and specific contributions to the research questions could be articulated more clearly to avoid conceptual overlap and confusion. I also think the whole protocol is too bloated with unnecessary use of frameworks without adequate justification of use.

• Additionally, articulating the theoretical framework that guides the study at the outset would lay a solid foundation for understanding the choice of methods and intervention design.

• While the socio-ecological conceptual framework is mentioned, its application to the study could be elaborated. How exactly does this framework guide the study's design and the development of interventions? A more detailed explanation would help in linking theoretical underpinnings directly to study actions and expected outcomes.

• Several abbreviations were not defined upon first use.

• Expanding on the rationale and benefits of using a participatory and community-centered approach for this specific population could solidify the study's methodological choice. Briefly discussing evidence that supports the effectiveness of such approaches in similar settings would strengthen the argument for adopting this strategy.

• There are mentions of the high incidence and mortality rates of prostate cancer among Black men, but we could benefit from more current or specific epidemiological data to underscore the urgency and scale of these disparities.

• The introduction asserts the importance of early diagnosis in closing health disparities but does not sufficiently address how early diagnosis can specifically mitigate these disparities. It could be beneficial to include evidence or theories suggesting that earlier diagnosis leads to better treatment outcomes and how these outcomes specifically impact the mortality and morbidity rates among Black men.

• There is mention of cultural and structural barriers; it would be strengthened by a deeper exploration of these factors. Discussing specific examples or past research findings that illustrate how these barriers manifest and affect health behaviors could provide more context and depth.

• The statement about the limited research in the UK on this topic is compelling but could be enhanced by a brief review of what has been done internationally and how this study's approach differs or builds on previous work.

METHODS

• The selection of study locations—Scotland and the North-East of England—raised questions about the demographic relevance, especially since areas like London and the West Midlands have a higher concentration of Black populations in the UK. The protocol mentions these regions are socioeconomically deprived with poor cancer outcomes, which might suggest a strategic focus on under-studied regions. However, for robustness and clarity, this choice warrants a more detailed justification.

• More specificity about the sampling strategy for focus groups, including how participants are identified and recruited, could enhance transparency and replicability. Detailing the inclusion and exclusion criteria would also fortify this section.

• The methods section should detail a specific integration strategy, such as a convergent design where both data types are collected simultaneously and analyzed separately, then merged to draw meta-inferences. This should include an explanation of how these inferences are synthesized to create comprehensive insights that neither method could achieve alone. Describing the analytical techniques, such as joint displays or narrative weaving, will further illustrate how data interrelate and support the study's conclusions.

• While the method for thematic analysis using NVivo is mentioned, the protocol could benefit from a more detailed description of the coding process, including how codes will be derived and how discrepancies between coders will be handled.

• The intervention's development is participatory, which is a strength. Yet, the description of how feedback from the community is systematically incorporated into the intervention development could be more explicit.

• The use of the Integrated Screening Action Model (I-SAM) is well-noted, but the manuscript could benefit from a more detailed explanation of how this model interacts with other theoretical frameworks mentioned, such as the COM-B model and the socio-ecological model. Clarifying how these models collectively inform the research questions, design, and expected outcomes could strengthen the theoretical basis.

o Also, while the I-SAM is intended to guide intervention development, specific examples of how its components (capability, opportunity, motivation) are operationalized within the study’s interventions would help in translating theory into practice more clearly.

• Each work package is aligned with specific objectives, but expanding on how these packages integrate with each other to achieve the overall study goals could clarify the step-by-step progression of the research.

o Also some sample sizes in the table do not match the descriptive texts.

• No detailed rationale for the chosen sample sizes in each work package. It's essential to clarify why specific numbers were selected and how they ensure statistical power or adequacy for meaningful analysis, especially considering the diversity and complexity of the population being studied.

• The protocol should specify whether the same participants are used across different WPs or if new participants are recruited for each phase.

o A clear flow diagram or a detailed description of participant progression through the study’s phases would aid in understanding how individuals move through the intervention, evaluation, and refinement stages

• More detail on the specific methods used in the evaluation phases (WP5 and WP8) and how findings from each phase feed into the next would underscore the iterative nature of the intervention development process.

• Pg 8: what does different ethnicities mean?

• How would findings from these areas be extrapolated or related to Black men in other UK regions?

• What exactly are the community engagement efforts that informed the choice of these locations. If local organizations or healthcare providers have existing relationships or have identified specific needs, these details would strengthen the rationale for site selection.

• Since this is a protocol, expected results should not be discussed, so it’s confusing why there are some results presented from some of the work packages.

DISCUSSION

• The protocol could pre-emptively address how it intends to interpret and disseminate the findings, especially in light of potential limitations. How does the study's design (including its participatory elements) impact the generalizability of the results to other settings or populations?

• What are the expected contributions to the literature, potential implications for practice and policy, and future research directions?

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Reviewer #1: No

Reviewer #2: No

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The PROCAN-B Study Protocol: Early diagnosis of PROstate CANcer for Black men - a community-centred participatory approach in Scotland and the North-East of England

PONE-D-23-32907R1

Dear Dr. Christie-de Jong,

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,

Mohammed Faruk

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

The article is now fully accepted for publication

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 #3: No

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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 #3: Partly

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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 #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 #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 #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 #3: While the revisions are extensive and address many of the prior concerns, several issues remain outstanding and warrant further attention:

1) Although the revised manuscript acknowledges the pilot nature of the study and aligns with typical sample sizes for similar research, it still lacks a detailed explanation of how the sample size ensures statistical power for meaningful analysis.

2) The manuscript references a sequential exploratory design and thematic analysis, but it does not adequately clarify how qualitative and quantitative findings will be integrated to provide comprehensive insights. The term "joined display" used in the revision should be corrected to "joint display." Additionally, the justification for employing a mixed methods approach remains unclear, and the study design does not convincingly demonstrate the characteristics of a true mixed methods study.

3) While the authors discuss the limited generalizability of the findings due to the study's design, they could provide a clearer articulation of how these results might inform broader applications or future research across other settings and populations.

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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 #3: No

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