We handle BEST2 participants' data in line with the Data Protection Act (1998). The patient information sheet given to all participants, states that they may withdraw from the study at any time without reason and no further data or research will be collected once that participant has withdrawn. Participants can contact Cambridge University Hospitals NHS Foundation Trust Patient Advice and Liaison Service (PALS) on 01223 216 756 should they wish to withdraw from participation at any time. They can also contact the Research Nurse, Tara Nuckcheddy- Grant on 01223 763994 or firstname.lastname@example.org.
All BEST2 participants are encouraged to maintain contact with their trial nurse and inform them of any change to contact details as well as any significant health events. Based on patient consent, NHS registries are being used to supplement and confirm events reported by the BEST2 trial. Existing registries will be providing data on cancer incidence and mortality. Further data will also be collected via the Hospital Episode Statistics (HES) which utilises in-patient, out-patient and A&E data.
The process for receiving healthcare data will involve Cambridge University Hospitals NHS Foundation Trust sending a list of the cohorts NHS linkage information which will include NHS Number, surname, forename, date of birth, Post code, sex and a unique identifier. Once matched with HES and cancer registry records held by the NHS Health and Social Care Information Centre (HSCIC) they will send the data set back to the trial site at Cambridge University Hospitals NHS Foundation Trust who will update the cohort data. All identifiable variables will be removed from the data set before a de-identified version is sent to the trial's partner site and data controller at Queen Mary’s University of London Cancer Prevention Trials Unit for further processing on baseline and cancer variables. The data from any participants who have withdrawn from participation of the study will not be sent to the HSCIC (http://www.hscic.gov.uk/) for any data linkages.