Adaptação transcultural e validação para a língua portuguesa da ferramenta Ontario Protocol Assessment Level (OPAL)

Abstract

Clinical research in Brazil had a significant growth in recent years and concurrently the concern of professionals involved in the conduct of clinical studies about their qualification and the quality of the data generated by them. The increasing number of clinical protocols with different demand and specificities along the difficulty in measuring the workload generated by them causes a difficulty in sharing the protocols between the study coordinators, tending to impair the conduct of clinical studies, the accomplishment with regulatory and ethical requirements and generating quality data. In this perspective, this paper studied the Ontario protocol assessment level (OPAL) to measure the workload of the study coordinator focusing on the complexity of oncology clinical trials. The study coordinator is responsible for the management and operational support of the actions listed in the study protocols. Thus, the study aims to perform the cross-cultural adaptation of OPAL, a tool that measures the workload of the study coordinators based on the complexity of clinical research protocols and verify its validity in clinical research center of the National Cancer Institute (INCA). This is a methodological research and the cross-cultural adaptation process was based on Beaton et al (2002) methodology and involved the translation tool for English language and its validation in a clinical research center in Brazil. The scenario chosen to develop the study was INCA / HCIII in their laboratories and the subjects were the HCIII study coordinators. This research was approved by the IRB / INCA CAAE 070066-12.50000.5274. After the conclusion of cross-cultural adaptation, the tool was considered valid and reliable through statistical tests and meets our need to calculate the workload generated by clinical protocols. It is believed that the subjective evaluation that was previously taken by itself, is not capable of evaluating the workload of increasingly complex protocols, however we understand that it can be used in conjunction with the evaluation of the OPAL.