Completed questionnaires are transferred periodically from the participating screening centres to the study co-ordinating centre at the Imperial Cancer Research Fund Cancer Epidemiology Unit (CEU), Oxford, UK.
The questionnaire was placed in a specific message area, and data from the completed questionnaire were transferred directly to a database.
Data from the self-administered paper based patient questionnaire were transferred to the Clinical Research Organization Winicker Norimed GmbH, Nürnberg, Germany and entered into the electronic database.
All complaints listed by patients in their baseline questionnaire were transferred to their follow-up questionnaires by the study office personnel, which ensured that each baseline complaint was assessed at each subsequent follow-up.
Following the standards set up by the Euroqol organisation, the developers and owners of the EQ-5D instrument [ 22], the 5-items from the EQ-5D questionnaire were transferred into a single value between 0 (worst imaginable health status) and 1 (best imaginable health status) [ 23].
Data from the questionnaire are transferred automatically to a clinical database, where a summary report can be accessed by the surgeon prior to the patient's subsequent follow-up clinic visit.
