Mattia Bozzetti, Monica Guberti, Alessio Lo Cascio, Daniele Privitera, Catia Genna, Silvia Rodelli, Laura Turchini, Valeria Amatucci, Luciana Nicola Giordano, Vincenzina Mora, Daniele Napolitano, Rosario Caruso
{"title":"揭示临床研究护理的专业景观:数据挖掘方法的范围审查。","authors":"Mattia Bozzetti, Monica Guberti, Alessio Lo Cascio, Daniele Privitera, Catia Genna, Silvia Rodelli, Laura Turchini, Valeria Amatucci, Luciana Nicola Giordano, Vincenzina Mora, Daniele Napolitano, Rosario Caruso","doi":"10.3390/nursrep15080266","DOIUrl":null,"url":null,"abstract":"<p><p><b>Background/Objectives</b>: Clinical Research Nurses (CRNs) have emerged as pivotal actors in the conduct, coordination, and oversight of clinical trials globally. Over the past three decades, the role of the CRN has evolved in response to the increasing complexity of research protocols, ethical standards, and regulatory frameworks. Originating as task-oriented support figures, CRNs have progressively assumed broader responsibilities that include patient advocacy, protocol integrity, ethical vigilance, and interprofessional coordination. By mapping the global literature on CRNs, this review will examine how their role has been defined, implemented, and evaluated over the past three decades. <b>Methods</b>: A scoping review was conducted using JBI methodology and PRISMA-ScR guidelines. The search covered the peer-reviewed and gray literature from 1990 to 2024 across major databases. Data analysis combined traditional extraction with topic modeling, Multiple Correspondence Analysis, and k-means clustering to identify key themes. <b>Results</b>: From the 128 included studies, four major themes emerged: clinical trial management, role perception and team integration, professional competencies and development, and systemic barriers. Despite formal competency frameworks, CRNs face inconsistencies in role recognition, unstable contracts, and limited career pathways. Emotional strain and professional isolation are recurrent. Over time, their functions have evolved from task execution to broader responsibilities, including advocacy and ethical oversight. However, no studies reported patient-level outcomes, revealing a critical gap in the evidence base. <b>Conclusions</b>: CRNs play a vital but undervalued role in clinical research. Persistent structural challenges hinder their development and visibility. Enhancing institutional support and generating outcome-based evidence are necessary steps toward fully integrating CRNs into research infrastructures.</p>","PeriodicalId":40753,"journal":{"name":"Nursing Reports","volume":"15 8","pages":""},"PeriodicalIF":2.0000,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12388699/pdf/","citationCount":"0","resultStr":"{\"title\":\"Uncovering the Professional Landscape of Clinical Research Nursing: A Scoping Review with Data Mining Approach.\",\"authors\":\"Mattia Bozzetti, Monica Guberti, Alessio Lo Cascio, Daniele Privitera, Catia Genna, Silvia Rodelli, Laura Turchini, Valeria Amatucci, Luciana Nicola Giordano, Vincenzina Mora, Daniele Napolitano, Rosario Caruso\",\"doi\":\"10.3390/nursrep15080266\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Background/Objectives</b>: Clinical Research Nurses (CRNs) have emerged as pivotal actors in the conduct, coordination, and oversight of clinical trials globally. Over the past three decades, the role of the CRN has evolved in response to the increasing complexity of research protocols, ethical standards, and regulatory frameworks. Originating as task-oriented support figures, CRNs have progressively assumed broader responsibilities that include patient advocacy, protocol integrity, ethical vigilance, and interprofessional coordination. By mapping the global literature on CRNs, this review will examine how their role has been defined, implemented, and evaluated over the past three decades. <b>Methods</b>: A scoping review was conducted using JBI methodology and PRISMA-ScR guidelines. The search covered the peer-reviewed and gray literature from 1990 to 2024 across major databases. Data analysis combined traditional extraction with topic modeling, Multiple Correspondence Analysis, and k-means clustering to identify key themes. <b>Results</b>: From the 128 included studies, four major themes emerged: clinical trial management, role perception and team integration, professional competencies and development, and systemic barriers. Despite formal competency frameworks, CRNs face inconsistencies in role recognition, unstable contracts, and limited career pathways. Emotional strain and professional isolation are recurrent. Over time, their functions have evolved from task execution to broader responsibilities, including advocacy and ethical oversight. However, no studies reported patient-level outcomes, revealing a critical gap in the evidence base. <b>Conclusions</b>: CRNs play a vital but undervalued role in clinical research. Persistent structural challenges hinder their development and visibility. Enhancing institutional support and generating outcome-based evidence are necessary steps toward fully integrating CRNs into research infrastructures.</p>\",\"PeriodicalId\":40753,\"journal\":{\"name\":\"Nursing Reports\",\"volume\":\"15 8\",\"pages\":\"\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-07-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12388699/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Nursing Reports\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3390/nursrep15080266\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"NURSING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Nursing Reports","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3390/nursrep15080266","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"NURSING","Score":null,"Total":0}
Uncovering the Professional Landscape of Clinical Research Nursing: A Scoping Review with Data Mining Approach.
Background/Objectives: Clinical Research Nurses (CRNs) have emerged as pivotal actors in the conduct, coordination, and oversight of clinical trials globally. Over the past three decades, the role of the CRN has evolved in response to the increasing complexity of research protocols, ethical standards, and regulatory frameworks. Originating as task-oriented support figures, CRNs have progressively assumed broader responsibilities that include patient advocacy, protocol integrity, ethical vigilance, and interprofessional coordination. By mapping the global literature on CRNs, this review will examine how their role has been defined, implemented, and evaluated over the past three decades. Methods: A scoping review was conducted using JBI methodology and PRISMA-ScR guidelines. The search covered the peer-reviewed and gray literature from 1990 to 2024 across major databases. Data analysis combined traditional extraction with topic modeling, Multiple Correspondence Analysis, and k-means clustering to identify key themes. Results: From the 128 included studies, four major themes emerged: clinical trial management, role perception and team integration, professional competencies and development, and systemic barriers. Despite formal competency frameworks, CRNs face inconsistencies in role recognition, unstable contracts, and limited career pathways. Emotional strain and professional isolation are recurrent. Over time, their functions have evolved from task execution to broader responsibilities, including advocacy and ethical oversight. However, no studies reported patient-level outcomes, revealing a critical gap in the evidence base. Conclusions: CRNs play a vital but undervalued role in clinical research. Persistent structural challenges hinder their development and visibility. Enhancing institutional support and generating outcome-based evidence are necessary steps toward fully integrating CRNs into research infrastructures.
期刊介绍:
Nursing Reports is an open access, peer-reviewed, online-only journal that aims to influence the art and science of nursing by making rigorously conducted research accessible and understood to the full spectrum of practicing nurses, academics, educators and interested members of the public. The journal represents an exhilarating opportunity to make a unique and significant contribution to nursing and the wider community by addressing topics, theories and issues that concern the whole field of Nursing Science, including research, practice, policy and education. The primary intent of the journal is to present scientifically sound and influential empirical and theoretical studies, critical reviews and open debates to the global community of nurses. Short reports, opinions and insight into the plight of nurses the world-over will provide a voice for those of all cultures, governments and perspectives. The emphasis of Nursing Reports will be on ensuring that the highest quality of evidence and contribution is made available to the greatest number of nurses. Nursing Reports aims to make original, evidence-based, peer-reviewed research available to the global community of nurses and to interested members of the public. In addition, reviews of the literature, open debates on professional issues and short reports from around the world are invited to contribute to our vibrant and dynamic journal. All published work will adhere to the most stringent ethical standards and journalistic principles of fairness, worth and credibility. Our journal publishes Editorials, Original Articles, Review articles, Critical Debates, Short Reports from Around the Globe and Letters to the Editor.