Effect of evidence-based nursing management of protocol compliance in anticancer drug clinical trial.

Rui Yang, Qionghua Gu, Fengzhen Chen, Yang Yang, Lingli Gu, Jian Zhang, Zhenqi Lu, Xiaoju Zhang

Abstract read

In one paragraph

Article in Asia-Pacific journal of oncology nursing, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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5 · Who and what money

Authors and funding

8 authors.

Rui YangDepartment of Nursing, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Fudan University EBN Center, A JBI Centre of Excellence, Shanghai, China.

Qionghua GuDepartment of Nursing, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Fudan University EBN Center, A JBI Centre of Excellence, Shanghai, China.

Fengzhen ChenDepartment of Nursing, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.

Yang YangDepartment of Nursing, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.

Lingli GuDepartment of Nursing, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.

Jian ZhangPhase I Clinical Trial Center, Fudan University Shanghai Cancer Center, Shanghai, China.

Zhenqi LuDepartment of Nursing, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.

Xiaoju ZhangDepartment of Nursing, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Fudan University EBN Center, A JBI Centre of Excellence, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: This study aimed to construct evidence-based anticancer drug clinical trial nursing management norms to ensure the safety and quality of clinical trial nursing. Methods: This before-after study was carried out to complete the evidence implementation in a cancer hospital in Shanghai, China. Seven review indicators were developed and reviewed in one phase I clinical trial center and two oncology wards. The corresponding evidence-based intervention program was formulated, and the completion rate of good clinical practice certification, protocol training, delegation of duties, qualification rate of administration, sampling and document recording in anticancer drug clinical trials before and after implementation were compared. Results: After implementation, the completion rate of protocol training, delegation of duties, and the qualification rate of document recording were significantly higher than those of the baseline review, whereas the completion rate of good clinical practice certification and the qualification rate of sampling did not significantly differ from those observed at the baseline review. There was no administration or infusion device-related protocol deviation during the baseline and post reviews. Conclusions: Anticancer drug clinical trial nursing management norms and relevant standard operating procedures were constructed. The results showed that the implementation of this intervention improved the standardization of nurse qualification procedures and the nursing original document recording in anticancer drug clinical trials, and nursing-related protocol deviation could be reduced to a certain extent.

Indexed as

Clinical trialEvidence-basedNurseNursing managementProtocol complianceProtocol deviation

Identifiers

PMID36105794

DOI10.1016/j.apjon.2022.100114

PMCPMC9465272

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LicenceCC BY-NC-ND

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.