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

Abstract

Introduction: The increase number of clinical protocols with different requirements and specificities, the demand for the quality of the data according to the good clinical practices evidence the need of an instrument capable of measuring the workload of clinical protocols, and to assist the management of research centers. The object of study is the instrument entitled the Ontario Protocol Assessment Level, created for measuring the workload of the research coordinator, focusing on the complexity of clinical protocols in oncology. Aim: To perform a transcultural adaptation and validation of the instrument in terms of the Portuguese language. Method: This is a methodological research, whose chosen scenario was the clinical research center of the Brazilian National Cancer Institute, located in Rio de Janeiro. The subjects were the clinical research coordinators. The research was approved by the ethics committee, under protocol 070066-12.50000.5274. Results: A significantly high degree of agreement between intra- and inter-observers was established; the agreement of the committee of specialists (the golden standard) was considered to be excellent (ICC>0.949) in both research periods (1 and 2); this score demonstrates a high level of validation. The analytical process confirmed that the tool score did not overestimate nor underestimate the evaluation of the committee of specialists. Conclusion: The instrument was considered valid and reliable based on the statistical tests performed. It provides the support required to calculate the workload generated by clinical protocols.