title: How many research nurses for how many clinical trials in an oncology setting? Definition of the Nursing Time Required by Clinical Trial-Assessment Tool (NTRCT-AT).
abstract: Few resources are available to quantify clinical trial-associated workload, needed to guide staffing and budgetary planning. The aim of the study is to describe a tool to measure clinical trials nurses' workload expressed in time spent to complete core activities. Clinical trials nurses drew up a list of nursing core activities, integrating results from literature searches with personal experience. The final 30 core activities were timed for each research nurse by an outside observer during daily practice in May and June 2014. Average times spent by nurses for each activity were calculated. The "Nursing Time Required by Clinical Trial-Assessment Tool" was created as an electronic sheet that combines the average times per specified activities and mathematic functions to return the total estimated time required by a research nurse for each specific trial. The tool was tested retrospectively on 141 clinical trials. The increasing complexity of clinical research requires structured approaches to determine workforce requirements. This study provides a tool to describe the activities of a clinical trials nurse and to estimate the associated time required to deliver individual trials. The application of the proposed tool in clinical research practice could provide a consistent structure for clinical trials nursing workload estimation internationally.
authors.affiliation: Research Nurses Team, European Institute of Oncology, Milan, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Milani
authors.affiliation: Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, Milan, Italy.|Department of Oncology and Hemato-oncology, University of Milan, Milan, Italy.
authors.forename: Ketti
authors.initials: K
authors.lastname: Mazzocco
authors.affiliation: Research Nurses Team, European Institute of Oncology, Milan, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Stucchi
authors.affiliation: Nursing Office and Patients Care Service, European Institute of Oncology, Milan, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Magon
authors.affiliation: Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, Milan, Italy.|Department of Oncology and Hemato-oncology, University of Milan, Milan, Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Pravettoni
authors.affiliation: Research Nurses Team, European Institute of Oncology, Milan, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Passoni
authors.affiliation: Research Nurses Team, European Institute of Oncology, Milan, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Ciccarelli
authors.affiliation: Research Nurses Team, European Institute of Oncology, Milan, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Tonali
authors.affiliation: Research Nurses Team, European Institute of Oncology, Milan, Italy.
authors.forename: Teresa
authors.initials: T
authors.lastname: Profeta
authors.affiliation: University of Verona, Verona, Italy.
authors.forename: Luisa
authors.initials: L
authors.lastname: Saiani
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D008495:Medical Oncology; D015399:Nursing Research; D016526:Workload
keywords: clinical trial; nursing; research; time studies; workload