[Criteria] [Data capture] [Data items] [Work-plan]
Data capture
The evaluation requires three types of data. First, basic attributes recorded at baseline for all subjects. This includes family history, demographic and risk factor data. The second is the screening information for each screening episode for each subject. The third is the cancer data collected for those who develop breast cancer during the five-year study period. Subjects will be flagged with ONS, but in view of the potential delays in cancer registration, centres will be asked to notify the co-coordinator of all breast cancers among recruits as they arise.
The details of the data required are given in the tables following. It is understood that not all the data items specified (notably updates of menopausal factors at each screen) will be available for all subjects, but there should at least be willingness to aim at recording these.
It is also planned to develop a final ‘exit' questionnaire for all subjects at the end of their five years in the study. This will be the subject of a separate application for resources and will undergo ethical scrutiny before implementation.
Data will be accepted and processed by the study co-ordinator in whatever format is most convenient for each centre. *For subjects who have been screened before recruitment, screening histories, again in whatever form is most convenient for each centre, would be welcome*.
For the most part, it is anticipated that centres will supply baseline and screening data in digital rather than paper format. In terms of the cancers diagnosed, some centres may prefer to supply cancer details in confidence on paper, as the number of cancers per centre is likely to be small. Some centres newly instigating the surveillance programme for purposes of this evaluation or who have previously not kept computerised records may need extra assistance in terms of data retrieval. In such cases, a compact database can be supplied by the study co-ordinator. This will be a simple database set up solely for the purpose of gathering the data listed below, and will not have complex relational links or provide automated prompts for call, recall etc.
*.....* added since 08/05/2003 guidelines circulated