Establishing an evaluation index system of nursing quality for clinical drug trials: A Delphi study

• Published in: Nursing open Vol. 10; no. 11; pp. 7266 - 7278
• Main Authors: Chen, Junyi, Zhou, Huiyu, Mai, Qingxiu, Chen, Shuping, Liu, Qingyin, Shi, Mengyun, Lin, Yunni, Yan, Lihong, Li, Meiyu, Ye, Suiwen, Yao, Herui
• Format: Journal Article
• Language: English
• Published: Hoboken John Wiley & Sons, Inc 01.11.2023; John Wiley and Sons Inc; Wiley
• Subjects: clinical drug trial; Clinical trials; Cooperation; Decision making; Delphi; Delphi method; Drug stores; Empirical Research Mixed Methods; Hospitals; Interviews; Literature reviews; Nurses; Nursing; nursing quality; Pharmacists; Qualitative research; Quality control; quality evaluation; Questionnaires; R&D; Research & development; Working groups; United States > US; China
• ISSN: 2054-1058; 2054-1058
• DOI: 10.1002/nop2.1979

AimsTo construct a quality evaluation index system for clinical drug trials nursing management and obtain the weight of all indicators.DesignA mixed-method research design with a quantitative component was used, primarily qualitative.MethodsThrough a literature review and semi-structured interview, an expert consultation questionnaire on the quality of nursing evaluation indicators for clinical drug trials was developed in April 2021. Eighteen experts in clinical drug trial nursing, medical, and pharmacy conducted 2 rounds of consultation according to the Delphi method to determine the indicators for evaluating the quality of clinical drug trial nursing. The weights of each indicator were determined using analytic hierarchical analysis.ResultsThe established quality evaluation system of clinical drug trial nursing mainly includes 3 first-level indicators, 12 second-level indicators, and 59 third-level indicators. The positive coefficients of the two rounds of expert consultation were 90%–100%, and the authority coefficients were 0.831 and 0.885, respectively; the coordination coefficients were 0.189 and 0.214, respectively. The consulting results and weight settings are reliable. The evaluation index system we constructed is in line with the characteristics of the clinical drug trial nursing profession, with clear index levels and strong clinical operability, which can provide a reference for the assessment, monitoring and improvement of nursing quality in clinical drug trials. It will also clarify how nurses contribute to subjects' safety.