I Pawellek1, T Richardsen, D Oberle, V Grote, B Koletzko. 1. Department of Metabolic Diseases and Nutrition, Dr von Hauner Children's Hospital, University of Munich Medical Centre, Munich, Germany.
Abstract
BACKGROUND/ OBJECTIVE: The European Childhood Obesity Project is a multi-centre double-blind randomised clinical trial in five countries testing whether protein intake in early life is related to later obesity risk. We use electronic data capture (EDC) in this trial and report here on our experience with the method. SUBJECTS/ METHODS: Data capture for the first two study years was done with 10 notebooks, which were installed with the RDE (Remote Data Entry) programme Clindoc. RESULTS: We here exemplary report our experiences in 1 of the 11 study centres. A total of 205 of 760 visits (27.0%) were documented with interim paper-based case report forms, whereas 555 (73.0%) visits were recorded with electronic case report forms (eCRF). The need for after-trial plausibility checks of anthropometric data is significantly reduced in visits done by eCRF in comparison with visits done by paper-based CRFs (14.05% versus 35.61%). CONCLUSION:EDC reduces significantly the need for after-trial data checks but the planning and implementation process before starting the trial is more time-consuming.
RCT Entities:
BACKGROUND/ OBJECTIVE: The European Childhood Obesity Project is a multi-centre double-blind randomised clinical trial in five countries testing whether protein intake in early life is related to later obesity risk. We use electronic data capture (EDC) in this trial and report here on our experience with the method. SUBJECTS/ METHODS: Data capture for the first two study years was done with 10 notebooks, which were installed with the RDE (Remote Data Entry) programme Clindoc. RESULTS: We here exemplary report our experiences in 1 of the 11 study centres. A total of 205 of 760 visits (27.0%) were documented with interim paper-based case report forms, whereas 555 (73.0%) visits were recorded with electronic case report forms (eCRF). The need for after-trial plausibility checks of anthropometric data is significantly reduced in visits done by eCRF in comparison with visits done by paper-based CRFs (14.05% versus 35.61%). CONCLUSION: EDC reduces significantly the need for after-trial data checks but the planning and implementation process before starting the trial is more time-consuming.
Authors: Tobias Johannes Brix; Philipp Bruland; Saad Sarfraz; Jan Ernsting; Philipp Neuhaus; Michael Storck; Justin Doods; Sonja Ständer; Martin Dugas Journal: PLoS One Date: 2018-06-22 Impact factor: 3.240