介绍支持新生儿护士参与临床研究的资源©。

IF 1.5 4区医学 Q3 NURSING Journal of Perinatal & Neonatal Nursing Pub Date : 2024-09-23 DOI:10.1097/JPN.0000000000000857

Mary A Short

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引用次数: 0

摘要

目的：本文介绍了支持新生儿护士参与临床研究的资源©，以教育和支持护士参与研究设计和方案审查。该资源旨在促进护士与药物研究人员之间的合作，以推动新生儿疗法的开发：背景：新生儿仍然是治疗孤儿，没有得到药物开发界的充分服务。新生儿标示外用药对其安全性和有效性的评估产生了负面影响。虽然新生儿重症监护室护士的能力是精心设计临床试验所需的专业知识的范例，但护士在提供见解方面的经验可能有限：资源开发包括文献综述和多方利益相关者的可用性测试：结果：可用性测试表明，该资源内容全面，与制药和非制药研究相关。评审员认为资源提示有助于评估研究的可行性：研究发起人需要护士的参与，以提高可行性和灵活性，防止临床试验方案出现偏差。利用 "支持新生儿护士参与临床研究的资源©"可以加强研究教育，促进护士参与新生儿研究：该资源对护理行业、制药业和新疗法的发展都有影响。护士个人可从教育和研究参与框架中受益。通过研究合作提高知名度，使护理专业受益。制药业可从新生儿护理、家庭动态和新生儿重症监护室护理标准方面获得宝贵的见解。在研究开发过程中促进合作的资源是推进新生儿新疗法的重要一步。

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Introducing a Resource to Support Neonatal Nurse Engagement in Clinical Research©.

Purpose: This paper introduces the Resource to Support Neonatal Nurse Engagement in Clinical Research© to educate and support engagement of nurses in study design and protocol review. The resource serves to promote collaboration between nurses and pharmaceutical researchers to advance the development of neonatal therapies.

Background: Neonates remain therapeutic orphans, underserved by the drug development community. Off-label use of drugs in neonates negatively impacts the evaluation of their safety and efficacy. Although NICU nurses' competencies are examples of expertise needed for well-designed clinical trials, nurses may have limited experience in providing insights.

Methods: Resource development included a literature review and usability testing by multiple stakeholders.

Results: Usability testing indicated the resource was comprehensive and relevant to pharmaceutical and nonpharmaceutical studies. Reviewers commented resource prompts are beneficial in assessing study feasibility.

Conclusion: Sponsors of research need nurse engagement to improve feasibility and flexibility and prevent protocol deviations in clinical trials. Leveraging the "Resource to Support Neonatal Nurse Engagement in Clinical Research©" can enhance research education and foster engagement of nurses in neonatal research.

Implications for practice: The resource has implications for the nursing profession, the pharmaceutical industry, and the advancement of new therapies. Individual nurses benefit from education and a framework for research engagement. The profession benefits from enhanced visibility through research collaboration. The pharmaceutical industry gains valuable insights on neonatal care, family dynamics, and NICU standard of care. A resource to foster collaboration in the study development process is an important step for advancing new therapies for neonates.

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来源期刊

Journal of Perinatal & Neonatal Nursing 医学-妇产科学

CiteScore

1.60

自引率

7.70%

发文量

147

审稿时长

>12 weeks

期刊介绍： The Journal of Perinatal and Neonatal Nursing (JPNN) strives to advance the practice of evidence-based perinatal and neonatal nursing through peer-reviewed articles in a topic-oriented format. Each issue features scholarly manuscripts, continuing education options, and columns on expert opinions, legal and risk management, and education resources. The perinatal focus of JPNN centers around labor and delivery and intrapartum services specifically and overall perinatal services broadly. The neonatal focus emphasizes neonatal intensive care and includes the spectrum of neonatal and infant care outcomes. Featured articles for JPNN include evidence-based reviews, innovative clinical programs and projects, clinical updates and education and research-related articles appropriate for registered and advanced practice nurses. The primary objective of The Journal of Perinatal & Neonatal Nursing is to provide practicing nurses with useful information on perinatal and neonatal nursing. Each issue is PEER REVIEWED and will feature one topic, to be covered in depth. JPNN is a refereed journal. All manuscripts submitted for publication are peer reviewed by a minimum of three members of the editorial board. Manuscripts are evaluated on the basis of accuracy and relevance of content, fit with the journal purpose and upcoming issue topics, and writing style. Both clinical and research manuscripts applicable to perinatal and neonatal care are welcomed.