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A streamlined data case report form will be used in data collection.
All entries were checked by a different person against source data (case report form, parent's questionnaire).
Additional file 1: Clinical Data Case Report Form Version 1.1 29.04.2013.
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To ensure accurate collection of the data, electronic case report form (eCRF) is made with range check for data values.
The site investigator compared the recorded data with the case report form of the individual patient and daily ED census to confirm that all data were consecutively collected.
Raw data from the case report form was cross-checked for completeness, cleaned and entered into a computerized database using Epi Data 3.1.
§Includes data from supplemental case report form not available for prior years.
Afterwards, the nurse translated the data to the case report form.
We report an analysis based on 1886 subjects whose complete data on the Case Report Form and on questionnaires were available.
Exclusion of patients with missing data reduced the case report form dataset to 3296 977%) and the diary dataset to 2560 (75%) (fig 1).
Extrapolated from 4-week patient-reported data and 3-month clinical case report form data aKruskal-Wallis test.
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