Keywords

Nursing summary, Clinical trial, Research protocol

 

Authors

  1. Di Giulio, Paola R.N., M.Sc.
  2. Arrigo, Celestina R.N., M.Sc., Ph.D.
  3. Gall, Helen R.N.
  4. Molin, Clementine R.N.
  5. Nieweg, Rose R.N., M.Sc.
  6. Strohbucker, Barbara R.N.

Abstract

In order to improve the overall quality of clinical trials, the role of the nurse should be expanded. The minimum requirement to facilitate nurses' participation and the optimal implementation of a clinical research protocol is to provide access to the clinical protocol document itself. However, given the high workload in an oncology unit, there is often little time for the staff to read the entire document. In addition, clinical protocols do not often provide detailed practical instructions for delivering treatment, observing patients, managing toxicities, and treating complications. A nursing summary of the medical protocol is a document that provides a short and easy-to-read selection of protocol-relevant information. It enables nurses to safely and more easily implement the research protocol and improve the care of patients in clinical trials. Master nursing summaries can be prepared centrally be the group responsible for the research protocol, while the unit/wards involved in the research can customize or adapt it to local needs. The potential benefit of implementing nursing summaries is overall improvement of the quality of the study by (a) increasing the reliability of nursing care regarding patients' safety, (b) standardizing monitoring and care of patients, (c) standardizing preventive measures, (d) proposing similar management of complications related to experimental treatments. Moreover, discussing nursing summaries may help evaluate workload related to research, allowing for better planning and allocation of resources.