title: The use of a systemic therapy checklist improves the quality of data acquisition and recording in multicentre trials. A study of the EORTC Soft Tissue and Bone Sarcoma Group.
abstract: The aim of this study was to verify whether the introduction of a systemic therapy checklist in the performance of multinational multicentre studies improves the quality of data acquisition and recording. We retrospectively analysed the results obtained through the use of this checklist in a study of the EORTC Soft Tissue and Bone Sarcoma Group. During the clinical trial, data were recorded in the hospital record with optional use of a predesigned EORTC Systemic Therapy Checklist. After completion of the study, 11 centres were monitored for the use of this checklist. Monitors were highly experienced medical oncologists. Items checked included all aspects of patient eligibility, drug administration, biochemical and haematological values, variables related to toxicities of treatment and response parameters. Data of 183 cycles given to 51 patients were checked. A total of 8983 items were checked. 91% of the data was reported correctly, 1% was missing and 6% was reported on the case record from (CRF) but could not be retrieved in the hospital record file. Compared with data obtained before the introduction of the checklist (68% correct, 4% incorrect, 0.1% missing and 28% on CRF but not in hospital files), these results show marked improvement generally. In centres where no Systemic Therapy Checklist was used, 85.9% of data were correct 2.8% incorrect, 0.7% missing and 10.6% only on CRF, which compares unfavourably with those where the Systemic Checklist was completely used (97.7% correct, 0.7% incorrect, 1% missing, 0.6% only on CRF). In addition the time required for data checking largely decreased by the use of the checklist-without this, a median of 3.5 cycles could be checked per hour, whilst if the checklist was used, this number increased to 6.5 cycles per hour. The use of a Systemic Therapy Checklist as an integral part of the hospital file for data recording in multicentre multinational trials is highly recommended and leads to a major improvement in data quality.
authors.affiliation: Department of Medical Oncology, Rotterdam Cancer Institute (Daniel den Hoed Kliniek), The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Verweij
authors.forename: O S
authors.initials: OS
authors.lastname: Nielsen
authors.forename: P
authors.initials: P
authors.lastname: Therasse
authors.forename: A T
authors.initials: AT
authors.lastname: van Oosterom
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001859:Bone Neoplasms / Q000188:drug therapy; D003625:Data Collection / Q000379:methods* / Q000592:standards; D004317:Doxorubicin / Q000008:administration & dosage; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D015337:Multicenter Studies as Topic / Q000379:methods* / Q000592:standards; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012509:Sarcoma / Q000188:drug therapy; D012983:Soft Tissue Neoplasms / Q000188:drug therapy
chemical_list: D004317:Doxorubicin; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D007069:Ifosfamide