Optimizing Data Collection

Abstract

Accurate data collection is essential for the validity in use of scientific data entered in databases (DB). From an earlier study we identified the difficult task in entering accurate data to local and international databases. We therefore decided to examine which tools we have available to collect the data. We frequently participate in requests from CIBMTR, EBMT, local DB and we enter patients into clinical research protocols, all tasks where data collection is necessary. The patient file is in a paper and an electronic version. The paper version is documents which either have not been converted nor been able to convert into an electronic version. Within the patient paper file there is already a document to list essential data for data registering, and since the electronic patient file has been implemented, the awareness of paper documents has declined. Currently some data are collected solely by the data managers (DM) and extracted from patient files at the hospital and from national patient registries. Some data, however, must be reviewed and interpreted by a physician in order to extract valid data. Therefore, it is necessary for the treating physician to have an overview of which data is essential to list in the patient file. The BMT unit is preparing for JACIE accreditation and according to standard B9.1: “The Clinical Program must furnish evidence of its own periodic data audits to determine if data are accurate for evaluation of patient outcomes” e.g. outcome analysis on day +100, +180 and annually. To optimize data collection to increase validity of data entered to CIBMTR, EBMT, DB and CRF's. To identify which data are to be collected and entered in CIBMTR, EBMT, DB and Clinical Research Files (CRF). To create an overview of which data are to be collected to DB and CRF's to ease the data collection at patient visits. We reviewed forms from the CIBMTR, EBMT and CRF's from the clinical research team and listed which essential data are needed on day +100, +180 and annually. We identified and reviewed existing paper documents in the patient paper file, which previously has been created to give an overview of which data to be collected and also to enter data on by the treating physician. By looking into our electronic patient file system, we discovered the possibility to create standard notes. The existing paper document is now changed to a schedule to give an overview of which data to be collected on day +100, +180 and annually. The schedule is put in the patient paper file and data collection is divided into: Data collected by treating physician and data collected by data manager. Within the electronic patient file we created standard notes. The physician can click on the relevant day of visit and view which data to be entered on the specific dates of patient visits. From here the DM can extract the data. To implement the new schedules and notes in the patient file, we had a meeting with the BMT-physicians.