OMACS
Research type
Research Study
Full title
Outcome monitoring after cardiac surgery
IRAS ID
137511
Contact name
Lucy Culliford
Contact email
Sponsor organisation
University Hospitals Bristol NHS Foundation Trust
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
We propose to collect consent from cardiac surgery patients to access their data collected in Hospital Episode Statistics (HES) and existing NHS databases. We are particularly interested in outcomes such as stroke or heart attacks that occur in the years after patients have had heart surgery. Patients will be contacted about the study approximately 3 months after their operation.
Participants will be asked to complete a short questionnaire, relevant to the surgery they have received or a quality of life questionnaire, 3 months and 12 months after their operation. All other participation will be passive (i.e. use of participant data). Participants may choose to receive an annual newsletter for 5 years. Potential participants will be given a choice of participating electronically or via post. For economic, convenience and environmental reasons we would like to encourage uptake of use of secure electronic methods to complete the questionnaire and receive the newsletter. Participants who participate electronically will be asked to consent online and provide an email address to receive reminders and (optional) newsletters electronically. Participants may take part via the postal system instead (freepost envelopes will be provided). Choosing to receive a newsletter by post will entail giving consent to their contact details being shared with a selected mailing company who will send the newsletter. The website and newsletter would contain a mechanism for updating their contact details and opting out of the study should they change their mind.
As part of the study we will randomise participants to receive the same information about the study in one of three different formats. We will compare study uptake rates by the format of information received. We will use this information to assess whether the presentation of the patient information leaflet affects response rates from potential participants.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
14/EM/1222
Date of REC Opinion
4 Dec 2014
REC opinion
Further Information Favourable Opinion