CHEMOTHERAPY ADMINISTRATION AND DATA-COLLECTION IN AN EORTC COLLABORATIVE GROUP - CAN WE TRUST THE RESULTS

As part of a phase II study of the EORTC Soft Tissue and Bone Sarcoma Group, 15 centres took part in a programme to evaluate the quality of treatment delivered and data collected. The centres were visited and f acilities for treatment and data management were reviewed. Source data in randomly selected patient hospital records were compared with info rmation which had previously been completed on case record forms and r eturned to the EORTC Data Centre. The review included 71% of the patie nts entered into the study and 76% of the treatment cycles. Chemothera py was prepared by nurses or clinicians in 58% and by pharmacists in 4 2% of the centres and was administered by specialist nurses in 67% of the hospitals. 8776 items were checked with source data. 3.4% were inc orrect, 0.2% were missing and 30% could not be verified as correct (ma inly related to the lack of recording of toxicity data in hospital rec ords). The mean doses of chemotherapy delivered and treatment interval s were those stipulated in the protocol but 21% of the cycles were del ayed for avoidable reasons. Several modifications to the procedures fo r running chemotherapy trials were suggested by this survey including the use of a systematic checklist for recording toxicity and chemother apy administration and the development of quality assurance programmes in other collaborative groups and single centres to ensure that publi shed results are credible.