Review Reports - Patient-Centered Activities Performed by Clinical Research Nurses in Clinical Trials: A Scoping Review of Enacted Practice

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

The authors aim to examine how nurses apply their clinical research-based skills and job descriptions in for clinical researches in patient-centered activities. This study, which includes a literature review of major databases in the field, addresses a significant gap in the literature and will provide valuable insights for hospital administrators. However, the following points should be considered in the article.

Could the authors clarify why mapping enacted patient-centered activities represents a sufficiently distinct research contribution beyond the existing literature on CRN competencies, roles, and responsibilities?
Could the authors provide a more systematic comparison with previous CRN reviews, explicitly showing what was already known, what remained unknown, and what new evidence the present review adds?
Could the authors develop a stronger conceptual explanation of how organizational, regulatory, and professional-context differences may account for these variations, rather than primarily describing country-level differences?
How did the authors assess the potential impact of the restrictions on the completeness of the evidence base, particularly regarding countries where CRN terminology and professional frameworks differ from those used in English-language literature?
How can readers determine the relative evidential strength of these heterogeneous sources? Would incorporating at least a descriptive assessment of study design or methodological rigor strengthen the interpretation of the findings?
Could the authors provide a more structured cross-country synthesis distinguishing differences attributable to professional scope, regulatory systems, institutional organization, or study design?
Could the authors more clearly distinguish evidence-based implications from recommendations derived from the authors' interpretation, and explain how the identified activities could be translated into measurable competency or workforce-development outcomes?

Author Response

Thank you very much for taking the time to review this manuscript. Please find the detailed responses in the attachment, and the corresponding revisions and corrections marked in red in the resubmitted files.

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

The manuscript addresses a relevant and underexplored aspect of Clinical Research Nursing, and the supplementary materials provide useful information regarding the PCC framework, PRISMA-ScR reporting, and database search strategies. However, several methodological issues still require clarification.

Definition and operationalization of patient-centered activities. Although the manuscript provides a definition of patient-centered activities, the PCC framework and search strategies focus more broadly on CRN roles, activities, tasks, competencies, and skills. Please explain more clearly how potentially eligible activities were subsequently classified as patient-centered. This is particularly important because some included domains, such as specimen management and aspects of investigational product management, may involve technical activities without direct interaction with research participants. The process used to derive and code the eight domains should also be described in greater detail.
Integration of primary and secondary evidence. The review includes both primary empirical studies and secondary sources, including literature and scoping reviews. The Methods indicate that relevant findings from primary studies were also extracted from secondary sources. Please clarify how overlap between primary studies and reviews was identified and managed to avoid double counting of the same evidence. Consider distinguishing clearly between evidence derived directly from primary studies and evidence derived from secondary sources.
Eligibility criteria and protocol reporting. There is an inconsistency regarding language restrictions: the Abstract and Limitations refer to publications in English and Italian, whereas the Methods state that only English-language articles were eligible. Please clarify and correct this throughout the manuscript. In addition, please provide the OSF registration link or identifier and state whether there were any deviations from the registered protocol. The exclusion of studies conducted exclusively in pediatric and decentralized clinical trial settings should also be explicitly justified.
Study populations and participant denominator. Supplementary File 2 appropriately acknowledges the different titles used for nurses involved in clinical research. However, several included studies involved mixed professional populations. Please clarify how non-eligible professional groups were excluded from the synthesis and verify that the statement that “more than 1,800 participants” contributed to the review refers only to participants whose CRN-specific data were actually included.
Interpretation and presentation of the synthesis. Cross-country comparisons regarding CRN autonomy should be interpreted cautiously because the included studies are heterogeneous and cannot necessarily be considered representative of national practice. Statements should therefore refer to the contexts or studies included rather than to countries as a whole. In addition, Figure 3 represents the proportion of included sources reporting each domain rather than the actual frequency with which CRNs perform these activities. Please make this distinction explicit, describe how the percentages were calculated, and consider whether a bar chart or table would provide a clearer representation.

The full database search strategies are appropriately provided in Supplementary File 3. However, the grey-literature search remains insufficiently reproducible; please provide the search terms, dates, screening limits, and specific organisational websites searched.

Finally, the manuscript would benefit from careful English-language editing to address grammatical, syntactic, and punctuation issues throughout.

Overall, the review has potential value, but substantial methodological clarification and more cautious interpretation of the synthesized evidence are required.

Author Response

Author Response File: Author Response.pdf

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

Thank you for the careful revision of the manuscript and for the detailed responses to the comments raised in the previous review. The manuscript has substantially improved, and the methodological and interpretative concerns have been satisfactorily addressed.

In particular, the clarification of the operational definition of patient-centered activities, the eligibility criteria, the handling of CRN-specific data, the interpretation of differences across clinical research contexts, and the revised presentation of the findings have strengthened the manuscript.

The revised manuscript is clearer, methodologically more transparent, and appropriately cautious in the interpretation of the evidence. I consider the manuscript suitable for publication in its present form.