The (P)atient (R)eported (C)omplications study
Research type
Research Study
Full title
A feasibility study to evaluate if breast cancer patients, consented using digital consent, reliably provide accurate Patient Reported Complication (PRC) data using feedback questionnaires
IRAS ID
326998
Contact name
Lisa Sheehan
Contact email
Sponsor organisation
Portsmouth Hospitals University NHS Trust
Duration of Study in the UK
0 years, 5 months, 3 days
Research summary
At the time of consent, patients are informed of possible post-operative complications. It is often not known whether these complications actually occur, whether there are others which go unreported and the extent, both quantitatively and qualitatively, of the complications. Patient reported complication data, to our best knowledge has not been previously studied.
This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. In this case, consent is to be sought digitally; the digital consent form includes a procedure specific list of recognised complications but these might not reflect actual patient experience.
If PRC data collection is feasible and reliable, this technique could be scaled to create a consent feedback loop, enabling operative outcome data to be collected from all patients, to be be used to improve the consent process for subsequent patients.
Awareness of post-operative patient complications is important and it is an NHS requirement that complications are discussed within regular clinical governance (mortality/morbidity) audit departmental meetings. Currently this process relies on clinicians obtaining and reporting these complications. The move towards Patient Initiated Follow Up (PIFU) models may be leading to underreporting of problems. Potentially Patient Reported Complications would allow for a more comprehensive understanding of the benefits and consequences of the various surgical procedures. This in turn might help facilitate ‘shared decision making’ and allow treatment decisions to be tailored to the individual patients
REC name
London - Harrow Research Ethics Committee
REC reference
23/PR/1388
Date of REC Opinion
17 Jan 2024
REC opinion
Further Information Favourable Opinion