Engagement and retention of Patient and Public Involvement (PPI) contributors in cancer clinical trials – a scoping review protocol

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Maintaining engagement and retaining PPI contributors throughout the clinical trial lifecycle can be challenging. Currently, there is limited understanding of effective engagement and retention strategies. Therefore, the aim of this scoping review is to identify the strategies and reported barriers to engaging and retaining PPI contributors in cancer clinical trials. Methods This scoping review will be conducted using the framework proposed by the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-analysis extension for scoping reviews (PRISMA-ScR), will be used to guide the reporting. Searches will be conducted of PubMed, Scopus, CINAHL, EMBASE, PsycINFO, and Web of Science supplemented by grey literature searches, from 2014 to October 2024. In collaboration with an experienced research librarian, a comprehensive PubMed search strategy was developed. Cancer clinical trial papers incorporating PPI at any stage of the trial process will be included. Before commencing full data charting, the data extraction form will be pilot tested. The data will be synthesised using a narrative synthesis approach, supplemented by descriptive statistics where appropriate. Conclusion This scoping review will comprehensively identify and map existing scientific literature on PPI in cancer clinical trials, providing evidence on strategies used to engage and retain PPI contributors. The findings will offer guidance to health professionals on effective approaches for involving and supporting PPI contributors in cancer trials. 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HRB Open Res 2025, 8 :18 ( https://doi.org/10.12688/hrbopenres.14041.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Engagement and retention of Patient and Public Involvement (PPI) contributors in cancer clinical trials – a scoping review protocol [version 1; peer review: 1 approved] Katarina Medved https://orcid.org/0009-0004-8097-6659 1,2 , Patricia Kearney https://orcid.org/0000-0001-9599-3540 1 , Alice Biggane 3 , Laia Raigal 4 , Johanna Pope https://orcid.org/0000-0002-1823-3254 5,6 , Frances Shiely https://orcid.org/0000-0003-0969-8321 1,2,7 Katarina Medved https://orcid.org/0009-0004-8097-6659 1,2 , Patricia Kearney https://orcid.org/0000-0001-9599-3540 1 , [...] Alice Biggane 3 , Laia Raigal 4 , Johanna Pope https://orcid.org/0000-0002-1823-3254 5,6 , Frances Shiely https://orcid.org/0000-0003-0969-8321 1,2,7 PUBLISHED 31 Jan 2025 Author details Author details 1 School of Public Health, University College Cork School of Public Health, Cork, County Cork, Ireland 2 HRB Trials Methodology Research Network, HRB Clinical Research Facility, Cork, County Cork, Ireland 3 Pfizer Ltd., Pfizer, Kent, UK 4 Cancer Research @UCC, University College Cork College of Medicine and Health, Cork, County Cork, Ireland 5 School of Nursing and Midwifery, University of Galway, Galway, County Galway, Ireland 6 Evidence Synthesis Ireland, University of Galway, Galway, County Galway, Ireland 7 TRAMS (Trials Research and Methodologies Unit), HRB Clinical Research Facility, Cork, County Cork, Ireland Katarina Medved Roles: Conceptualization, Investigation, Methodology, Project Administration, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Patricia Kearney Roles: Supervision, Writing – Review & Editing Alice Biggane Roles: Supervision, Writing – Review & Editing Laia Raigal Roles: Supervision, Writing – Review & Editing Johanna Pope Roles: Writing – Review & Editing Frances Shiely Roles: Conceptualization, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the HRB-TMRN gateway. Abstract Background Patient and Public Involvement (PPI) in research has gained increasing recognition as it has a potential to enhance research relevance, quality, ethical conduct and credibility of research. Maintaining engagement and retaining PPI contributors throughout the clinical trial lifecycle can be challenging. Currently, there is limited understanding of effective engagement and retention strategies. Therefore, the aim of this scoping review is to identify the strategies and reported barriers to engaging and retaining PPI contributors in cancer clinical trials. Methods This scoping review will be conducted using the framework proposed by the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-analysis extension for scoping reviews (PRISMA-ScR), will be used to guide the reporting. Searches will be conducted of PubMed, Scopus, CINAHL, EMBASE, PsycINFO, and Web of Science supplemented by grey literature searches, from 2014 to October 2024. In collaboration with an experienced research librarian, a comprehensive PubMed search strategy was developed. Cancer clinical trial papers incorporating PPI at any stage of the trial process will be included. Before commencing full data charting, the data extraction form will be pilot tested. The data will be synthesised using a narrative synthesis approach, supplemented by descriptive statistics where appropriate. Conclusion This scoping review will comprehensively identify and map existing scientific literature on PPI in cancer clinical trials, providing evidence on strategies used to engage and retain PPI contributors. The findings will offer guidance to health professionals on effective approaches for involving and supporting PPI contributors in cancer trials. READ ALL READ LESS Keywords patient and public involvement, PPI, cancer clinical trials, clinical trials, patient engagement Corresponding Author(s) Katarina Medved ( [email protected] ) Close Corresponding author: Katarina Medved Competing interests: No competing interests were disclosed. Grant information: Katarina Medved is a Health Research Board (HRB) Trials Methodology Research Network (TMRN) scholar. Copyright: © 2025 Medved K et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Medved K, Kearney P, Biggane A et al. Engagement and retention of Patient and Public Involvement (PPI) contributors in cancer clinical trials – a scoping review protocol [version 1; peer review: 1 approved] . HRB Open Res 2025, 8 :18 ( https://doi.org/10.12688/hrbopenres.14041.1 ) First published: 31 Jan 2025, 8 :18 ( https://doi.org/10.12688/hrbopenres.14041.1 ) Latest published: 31 Jan 2025, 8 :18 ( https://doi.org/10.12688/hrbopenres.14041.1 ) Background Patient and Public Involvement (PPI) is research done with or by patients and the public, not to, about or for them 1 . PPI involves a range of activities that allow patients and the public to contribute their perspectives, experiences, and insights into the design, delivery, and evaluation of health services 1 , 2 . The origins of PPI in healthcare decision-making can be traced back to the 1980s, when initiatives began to emerge to incorporate patient feedback into health services planning 2 , 3 . By the late 1990s and early 2000s, PPI had become formalised, particularly in the UK, where the establishment of INVOLVE in 1996 marked a significant milestone 4 . INVOLVE provided guidance and frameworks for incorporating patient perspectives into National Health Service (NHS) research 2 , 3 . The National Institute for Health Research (NIHR) made PPI a core requirement for funded research, further establishing its role in the research process 2 . In cancer research, PPI has evolved from minimal involvement to a more integrated approach, where patients actively contribute to shaping research agendas 5 , 6 . There has been a marked increase in PPI activities during the early stages of cancer research, reflecting the growing recognition of its value in informing research directions 5 – 7 . PPI offers numerous benefits, including enhanced relevance, quality, and credibility of research, which leads to more robust and applicable findings 8 , 9 . It also enhances the ethical conduct of research, ensuring that studies address real-world patient concerns and issues 4 . This involvement improves patient choice, self-care, and shared decision-making, crucial elements for patient satisfaction and better outcomes 10 . Another benefit is the innovation that PPI brings 7 , 11 , 12 . PPI contributes to the identification of relevant research questions and outcomes, which can significantly influence the effectiveness of clinical trials 11 , 13 . When patients are engaged in the research process, they can provide insights that help shape the study's objectives and methodologies, ensuring that the outcomes measured are meaningful to them 14 , 15 . PPI helps also ensures that research findings are communicated in a way that is accessible and meaningful to the broader public, leading to faster uptake of new treatments and practices 8 . Importance of engagement and retention Effective engagement and retention of PPI contributors is critical to ensuring their meaningful involvement throughout the clinical trial lifecycle 2 , 4 , 11 , 16 . We know that trials engaging only a small number of PPI contributors, leads to feelings of marginalisation and tokenism 8 , 17 . The sense of tokenism can result in contributors feeling that their input is neither valued nor impactful, discouraging their ongoing participation and retention 8 , 10 , 17 . Effective communication and regular feedback are shown to be crucial for retaining PPI contributors as they motivate them for further involvement and support their learning 4 , 16 , 18 . However, how effective communication might be conducted is unclear. Lack of recognition and compensation for the time and expertise of PPI contributors may act as a barrier to their retention 15 , 19 . Many contributors feel undervalued when their contributions are not adequately acknowledged or compensated 19 , 20 . Previous research has shown that PPI contributors who are involved in responsive and managerial roles, such as membership in Trial Management Groups (TMGs), tend to provide greater benefits to the trial compared to those in oversight roles, such as Trial Steering Committees 4 , 7 , 11 . Evidence suggests that when PPI contributors are part of decision-making processes, they develop a sense of ownership and relevance, which significantly enhances their engagement and motivation to contribute meaningfully throughout the trial 4 , 7 , 12 . Productive working relationships between researchers and PPI contributors have also been identified as crucial for effective engagement 13 , 16 , 18 , 21 . Strong partnerships foster mutual respect and understanding, which impacts how contributors perceive the value of their involvement 2 , 4 , 18 . Additionally, challenges persist in involving patients with lower education levels in trial development, highlighting the importance of understanding diverse perspectives in PPI activities 18 , 22 , 23 . While previous research has identified some strategies and barriers that affect the engagement and retention of PPI contributors in clinical trials, the underlying reasons remain poorly understood 13 , 20 , 21 , 24 . Currently, there are no well-established strategies for maintaining PPI involvement, and while training is recognised as essential for both researchers and contributors, the interest for such training remains limited, particularly among PPI contributors 13 , 25 , 26 . Feelings of tokenism and marginalisation among PPI contributors can discourage their ongoing participation 2 , 8 , 23 , but the precise mechanisms that lead to disengagement are not fully explored. Effective communication is highlighted as crucial for retention 4 , but there is a lack of understanding of how different communication strategies can be tailored to meet the diverse needs of contributors, especially those from marginalised backgrounds 10 , 23 . Compensation is recognised as vital for acknowledging the contributions of PPI members 2 , 19 , 21 . Understanding these gaps and strategies for engagement and retention strategies is essential for optimising PPI and realising its benefits 2 , 4 , 11 , 16 . While previous reviews have broadly covered the application and reporting of PPI in cancer research, they did not assess the specific methodologies used and challenges identified in engaging and retaining PPI contributors 5 , 6 . For the purpose of this scoping review, we will adopt the definition of PPI as "research done with or by patients and the public, not to, about, or for them 1 ." This definition includes the active, collaborative role of patients and the public in research. The engagement and involvement refer to the active and meaningful participation of patients, carers, and members of the public in the planning, design, conduct, and dissemination of cancer clinical trials. Objectives To determine the strategies used to engage and retain PPI contributors in cancer clinical trials To identify reported barriers to engagement and retention of PPI Contributors To describe the demographic characteristics of PPI contributors engaged in cancer clinical trials To provide guidance to health professionals on how to engage and retain PPI contributors in cancer trials Methods The scoping review will adhere to the guidelines and framework by the Joanna Briggs Institute (JBI), which represents the most recent framework for conducting scoping reviews 27 . Unlike other frameworks, the JBI framework offers a more structured and comprehensive methodological approach 28 – 30 . The framework consists of nine steps: 1. Defining and aligning the objectives and questions 2. Developing and aligning the inclusion criteria with the objectives and questions 3. Describing the planned approach to evidence searching, selection, data extraction and presentation of the evidence 4. Searching for the evidence 5. Selecting the evidence 6. Extracting the evidence 7. Analysis of the evidence 8. Presentation of the results 9. Summarising the evidence in relation to the purpose of the review, making conclusions and noting any implication of the findings The research question is: "What are the strategies used to engage and retain PPI contributors in cancer clinical trials?". Inclusion criteria According to the JBI methodological framework for scoping reviews 27 , the criteria for including and excluding studies in the review will be based on specific screening criteria related to population, concept, and context ( Table 1 ). Table 1. Population, concept, context criteria. Population (P) Individuals involved as PPI contributors in cancer clinical trials. Concept (C) Methods of engagement and retention—strategies used to actively engage and retain PPI contributors in cancer clinical trials. Context (C) Identification of key methods and factors that influence the engagement and retention of PPI contributors, including facilitators and barriers, in cancer clinical trials. The scoping review will include cancer clinical trial papers that include PPI at any stage of the trial process. Individuals involved as PPI contributors must be aged 18 years or older. Studies will be included if they are published in peer-reviewed journals, written in English, and published between January 2014 and October 2024. Exclusion criteria Quasi-randomised trials, clinical trial protocols, paediatrics trials, pre-clinical studies, Trials within Cohorts (TwiC). Search strategy The search will involve the electronic databases PubMed, Scopus, CINAHL, EMBASE, PsycINFO, and Web of Science supplemented by grey literature searches via Google Scholar, organizational websites, and conference proceedings. The targeted search strategy, developed in consultation with a librarian at Royal College of Surgeons Ireland, will be adapted for each database using the software Polyglot 31 . The search strategy will employ a combination of keywords and medical subject headings (MeSH) related to PPI (e.g., "PPI", "public involvement", "patient engagement"), cancer (e.g., "neoplasms", "cancer clinical trials"), and methods (e.g., "engagement strategies", "retention strategies"). In addition to the database search, we will search reference lists of all selected articles, which may contain additional studies relevant to the research topic. The "Similar Articles" feature on PubMed, which provides algorithmically generated suggestions based on the content of the currently viewed articles, will also be used. This comprehensive approach may find additional relevant studies that not identified by the initial search. Screening and study selection All identified citations from the database searches will be imported into Rayyan QCRI software for duplicate removal and screening. The screening process will involve two reviewers (KM and JP). Both reviewers will independently screen the titles and abstracts of the studies to identify potentially relevant articles. Studies that meet the inclusion criteria will proceed to full-text review. KM and JP will independently assess the full-text articles for eligibility based on predefined inclusion and exclusion criteria. If disagreement arises between reviewers regarding the eligibility of studies, a third reviewer FS will be consulted. Data extraction Before commencing the full data charting process, the data extraction form will be piloted using a sample of 10 studies. This step aims to refine and optimise the data to be extracted, ensuring alignment with the objectives of the scoping review. The data extraction will be conducted by one reviewer (KM), with a random sample (10%) of the studies being double-extracted and checked for consistency by a second reviewer (JP) to enhance reliability. If the agreement rate for the extracted data in the 10% sample is below 80%, an additional 10% validation sample will be extracted and reviewed. This process will be repeated until an agreement rate exceeding 80% is achieved. The data extraction process will collect information on study characteristics (author, year, country, study design), participant characteristics (e.g., number of participants, age, education level, and health conditions), and details of engagement and retention methods (e.g., strategies used, frequency, and duration). Data synthesis We will use a narrative synthesis approach to analyse the data, incorporating descriptive statistics where appropriate. Descriptive statistics will include frequencies and percentages of trial characteristics. A narrative summary will be developed to present the extracted data in alignment with the review's objectives. The narrative synthesis will follow the Guidance on the Conduct of Narrative Synthesis in Systematic Reviews 32 . Furthermore, the report will highlight any gaps identified in the existing literature. Presentation of findings The review findings will be reported in accordance with the PRISMA-ScR guidelines 33 . A PRISMA flow diagram will be created to provide a summary of the identification, screening, eligibility, and inclusion phases, and will include explanations for the exclusion of studies during the screening process. Summary tables will outline the characteristics of the included studies. Additional tables, figures, and narrative descriptions will be utilised to present data relevant to our research question. Ethics and consent Ethical approval and consent were not required. Data availability Underlying data No data are associated with this article. Faculty Opinions recommended References 1. Oxford BRC NIHR: A researcher’s guide to Patient and Public Involvement. 2017. Reference Source 2. Wilson P, Mathie E, Keenan J, et al. : ReseArch with Patient and Public invOlvement: a RealisT evaluation - the RAPPORT study. Health Services and Delivery Research. 2015; 3 (38): 1–176. PubMed Abstract | Publisher Full Text 3. 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PubMed Abstract | Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 31 Jan 2025 ADD YOUR COMMENT Comment Author details Author details 1 School of Public Health, University College Cork School of Public Health, Cork, County Cork, Ireland 2 HRB Trials Methodology Research Network, HRB Clinical Research Facility, Cork, County Cork, Ireland 3 Pfizer Ltd., Pfizer, Kent, UK 4 Cancer Research @UCC, University College Cork College of Medicine and Health, Cork, County Cork, Ireland 5 School of Nursing and Midwifery, University of Galway, Galway, County Galway, Ireland 6 Evidence Synthesis Ireland, University of Galway, Galway, County Galway, Ireland 7 TRAMS (Trials Research and Methodologies Unit), HRB Clinical Research Facility, Cork, County Cork, Ireland Katarina Medved Roles: Conceptualization, Investigation, Methodology, Project Administration, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Patricia Kearney Roles: Supervision, Writing – Review & Editing Alice Biggane Roles: Supervision, Writing – Review & Editing Laia Raigal Roles: Supervision, Writing – Review & Editing Johanna Pope Roles: Writing – Review & Editing Frances Shiely Roles: Conceptualization, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information Katarina Medved is a Health Research Board (HRB) Trials Methodology Research Network (TMRN) scholar. Article Versions (1) version 1 Published: 31 Jan 2025, 8:18 https://doi.org/10.12688/hrbopenres.14041.1 Copyright © 2025 Medved K et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics VIEWS $counts.viewCount downloads Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Medved K, Kearney P, Biggane A et al. Engagement and retention of Patient and Public Involvement (PPI) contributors in cancer clinical trials – a scoping review protocol [version 1; peer review: 1 approved] . HRB Open Res 2025, 8 :18 ( https://doi.org/10.12688/hrbopenres.14041.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 31 Jan 2025 Views 0 Cite How to cite this report: Boland V. Reviewer Report For: Engagement and retention of Patient and Public Involvement (PPI) contributors in cancer clinical trials – a scoping review protocol [version 1; peer review: 1 approved] . HRB Open Res 2025, 8 :18 ( https://doi.org/10.21956/hrbopenres.15415.r45751 ) The direct URL for this report is: https://hrbopenresearch.org/articles/8-18/v1#referee-response-45751 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 18 Feb 2025 Vanessa Boland , Trinity College Dublin, Dublin, Ireland Approved VIEWS 0 https://doi.org/10.21956/hrbopenres.15415.r45751 A well-written protocol is presented. The topic area is timely and worthy of investigation. The proposed methods and scoping review approach are logical. The background is concise and PPI in clinical trials is clearly defined. Add the benefit of ... Continue reading READ ALL A well-written protocol is presented. The topic area is timely and worthy of investigation. The proposed methods and scoping review approach are logical. The background is concise and PPI in clinical trials is clearly defined. Add the benefit of PPI in clinical trials specifically to convince funders and trial organizers. The knowledge gap is clear and the objectives are logical. An appropriate framework (JBI) is outlined. Caution in the addition of terms relating to methods - this has the potential to narrow your search. However, the selection of databases, citation checks, grey literature, and the addition of a librarian strengthens this review. An author consensus plan is proposed and a contingency plan is in place. A narrative synthesis is appropriate. Content analysis could also work well. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Cancer survivorship, PPI, mixed methods research, evidence synthesis, scoping review methodology. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Boland V. Reviewer Report For: Engagement and retention of Patient and Public Involvement (PPI) contributors in cancer clinical trials – a scoping review protocol [version 1; peer review: 1 approved] . HRB Open Res 2025, 8 :18 ( https://doi.org/10.21956/hrbopenres.15415.r45751 ) The direct URL for this report is: https://hrbopenresearch.org/articles/8-18/v1#referee-response-45751 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 31 Jan 2025 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 Version 1 31 Jan 25 read Vanessa Boland , Trinity College Dublin, Dublin, Ireland Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Boland V. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 18 Feb 2025 | for Version 1 Vanessa Boland , Trinity College Dublin, Dublin, Ireland 0 Views copyright © 2025 Boland V. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions A well-written protocol is presented. The topic area is timely and worthy of investigation. The proposed methods and scoping review approach are logical. The background is concise and PPI in clinical trials is clearly defined. Add the benefit of PPI in clinical trials specifically to convince funders and trial organizers. The knowledge gap is clear and the objectives are logical. An appropriate framework (JBI) is outlined. Caution in the addition of terms relating to methods - this has the potential to narrow your search. However, the selection of databases, citation checks, grey literature, and the addition of a librarian strengthens this review. An author consensus plan is proposed and a contingency plan is in place. A narrative synthesis is appropriate. Content analysis could also work well. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Cancer survivorship, PPI, mixed methods research, evidence synthesis, scoping review methodology. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Boland V. Peer Review Report For: Engagement and retention of Patient and Public Involvement (PPI) contributors in cancer clinical trials – a scoping review protocol [version 1; peer review: 1 approved] . HRB Open Res 2025, 8 :18 ( https://doi.org/10.21956/hrbopenres.15415.r45751) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/8-18/v1#referee-response-45751 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Adjust parameters to alter display View on desktop for interactive features Includes Interactive Elements View on desktop for interactive features Competing Interests Policy Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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