[Improving the specification quality of inclusion criteria of patients in chemotherapy clinical trials]

Abstract

Objectives: To assess the quality improvement of chemotherapy prescriptions for patients included in clinical trials (CT) analyzing whether the prescription is specified for patient participation, after having identified the major risks factors and the appropriate corrective measures are applied.

Methods: Retrospective study of omissions collected during 2006 and 2007. After collecting all the information, we analyzed the risks factors and introduced improvement measures (information to prescribers and the beginning of electronic prescription). The 2007 data were then evaluated. Variables analyzed: CT, number of prescriptions, principal investigator, prescriber, department, anti-neoplastic involved and pathology.

Results: Oncology and Haematology make up 57.1% of hospital trials. In 2006, 1625 chemotherapy prescriptions were received and there were 151 incorrect prescriptions (9.3%), and in 2007, 1858 prescriptions with 65 (3.5%) incorrect. In 2006, there was a higher frequency of incorrect prescriptions in Haematology (34.1%) and (Oncology (8.6%)). In 2007 Hematology had just 1.8% of omissions and in Oncology it decreased to 3.6%. As regards the pathology, the error rate has virtually disappeared in multiple myeloma prescriptions (34.1 to 2.2%) and decreased in breast cancer (10.8 to 4.4%). The non-fulfillment rate is higher when the prescriber is not the principal investigator.

Conclusions: The overall frequency of prescriptions with errors decreased significantly from 9.3% to 3.5%, with an extraordinary reduction in Haematology (34.1% to 1.8%) related to the multiple myeloma trials. The corrective measures implemented have proved to be useful in CT.