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.

Measuring Workload of Clinical Trials: Transcultural Adaptation and Validation to Portuguese Lanquage of Ontario Protocol Assessment Level (OPAL)

“…This load has increased both due to the need to achieve internationally recognized quality standards, and to the need to evaluate the costs generated in the carrying out of clinical studies and other spending on the part of the team involved in such studies [11][12][13]. The increasing complexity of treatments nowadays as found in clinical studies, their elevated cost, the emphasis on a more effective use of resources, the adherence to standards of good clinical practice, and the rise in demand for guaranteeing the quality of the data gathered, are all seen as the factors that increasingly generate workload in research centers [11,[14][15][16][17].…”

Infirmière de recherche clinique en oncologie : revue exploratoire

“…En outre, la même étude a également recensé que les critères d'inclusion/exclusion dans les essais oncologiques sont généralement plus complexes et peuvent nécessiter une formation avancée dans les différents tests utilisés pour la classification des maladies, la confirmation de l'admissibilité des participants et la formation liée à l'étude. Un manque de ressources et d'appui augmente le risque d'épuisement professionnel de l'IRC en oncologie et, par conséquent, a un impact sur la satisfaction et le maintien dans l'emploi (Good, Lubejko, Humphries et Medders, 2013;Lee et Jeong, 2018;Milani et al, 2017).…”

“…Les paramètres mesurant la charge de travail des IRC ont été définis dans le Wichita Community Clinical Oncology Program Protocol Acuity Tool (WPAT), le Nursing Time Required by Clinical Trial -Assessment Tool (NTC-TA) d'Italie, et la Resource-Based Relative Value Scale for Clinical Research Nurses' Workload (échelle RBRV) de Corée (Good, Lubejko, Humphries et Medders, 2013;Lee et Jeong, 2018;Milani et al, 2017). Bien que ces outils provenaient de différents pays où la conception et la réglementation du rôle et de la pratique de l'IRC en oncologie peuvent ne pas être uniformes, ces outils sont similaires en termes d'objectifs et d'indicateurs de mesure.…”

“…Le NTC-TA a été conçu sur la base d'un calcul des coefficients standards des activités de soins infirmiers. Pour déterminer le nombre total d'heures de travail nécessaires par étude, les coefficients standards évaluent les activités principales effectuées par l'IRC en oncologie et la complexité moyenne des phases de recherche (phases I, II et III) (Milani et al, 2017). Les activités principales des soins infirmiers ont été déterminées à partir de la revue et de l'analyse de la littérature, des avis d'experts et de la vérification des membres.…”

A Resource-Based Relative Value for Clinical Research Nurses’ Workload

“…CRNs' workload has been calculated by several methods, such as subjectively perceived work intensity, 9 average times spent to complete core activities, 10 and a direct method using objective workload assessment tools. [11][12][13] These are protocol complexity rating scales that assign scores for protocol complexity factors, and the total scores are the workload of the protocol.…”