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ELECTRONIC DATA CAPTURE AND USE OF INTERNET TECHNOLOGIES IN A DOUBLE- BLIND RANDOMISED INTERVENTION TRIAL

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ELECTRONIC DATA CAPTURE AND USE OF INTERNET TECHNOLOGIES IN A DOUBLE- BLIND RANDOMISED INTERVENTION TRIAL

D. Oberle

1

, H. Köhler, T. Richardsen

2

, D. Brasseur

3

, B. Koletzko

1

1

University Children’s Hospital, Munich, Germany,

22

R DE Software GmbH, Grünwald Germany,

3

Free University Brussels ULB Belgium

Introduction: The EU Childhood Obesity Programme, (http://www.childhood- obesity.org) is a multi-centre double-blind randomised clinical trial which is performed in 5 European countries (Germany, Belgium, Italy, Poland and Spain). In order to test the hypothesis that a high protein intake in early life is related to early markers of childhood obesity, a total of 1000 formula fed and 250 breast fed infants are being closely followed up for 2 years. The formula fed infants are either randomised to a high protein formula group or a low protein formula group. Managing a multi-centre clinical trial amongst other things requires efficient data collection, review and integration.

Methods: In comparison with traditional Data Capture (DC) where data is transcribed from paper records into a database, Electronic Data Capture (EDC) enables data to be recorded instantly on-site, using pre-configured software instead of the traditional paper form. EDC, therefore, eliminates the need for data transcription. Edit checks and validation can be applied immediately, eliminating errors that routinely create queries several months later in paper- based processes. In the EU Childhood Obesity Programme, EDC is used for remote data entry (RDE) which means that information entered on-site is transferred via the internet to a central database thus unifying the data of five clinical study centres.

Results: EDC for RDE was successfully implemented into the data management of the EU Childhood Obesity Programme. Extensive know-how is a prerequisite in the set up of an efficient and user-friendly RDE system. Performance is a limiting resource. In the EU Childhood Obesity Programme it became obvious that the total response time must not exceed 2 seconds, otherwise it is not possible to enter data directly into the EDC system in front of the study subject.

Two updates have been installed to improve the functionality and user- friendliness of the software since its first release in January 2003. Although the study is still ongoing, it can be foreseen that researchers will benefit from the main advantage of EDC: rapid data availability. The study parameters (small number of study centres, large quantity of recordable data and numerous visits with repeated or similar design) argue for an EDC system rather than an

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exclusively paper-based study since its use may substantially reduce project costs.

Conclusion: Considering the pros and cons of electronic data capture for remote data entry, in our study the advantages clearly outweigh the disadvantages. This methodology can therefore be recommended for the use in multi-centre clinical trials.

Keywords: Electronic data capture, remote data entry, randomized clinical trial

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