DATA ENTRY EXTENSION UNTIL 31ST MARCH 2017
Over 2,100 patients have now been entered into iBRA2. There are still a significant number of units with incomplete data entry on REDCap. Data entry had therefore been extended until the 31st March 17. After this data data entry will be locked. Please enter full datasets for all women having mastectomy with or without reconstruction between 1st July 2016 to 31st December 2016.
Please email firstname.lastname@example.org to confirm when your data set is complete.
Any collaborator that enters 20 or more complete datasets will be entered into a prize draw to be awarded £100 of Amazon vouchers.
iBRA-2 is a national multi centre prospective audit which aims to evaluate the impact of immediate breast reconstruction on the time to adjuvant therapy compared with mastectomy alone.
The aims of the study are to evaluate:
- The rate of post-operative complications
- The requirement of adjuvant chemotherapy / radiotherapy
- Which patients experience of a delay to / or omission of their adjuvant therapy as a result of post-operative complications
- The time to adjuvant therapy
-To identify risk factors to identify patients who may experience a delay / or omission of adjuvant therapy due to post operative complications
-Generate high quality data to inform patient and healthcare worker decision making
It is hoped that the study will create high-quality data that will help patients, surgeons and oncologists make more informed decisions about the type and timing of reconstructive surgery in the future.
The full study protocol can be seen here
For many women there can be great psychological benefit in having an immediate breast reconstruction at the same time as mastectomy, but the benefits of immediate reconstruction have to be weighed against a potential delay in being able to start adjuvant treatments (such as chemotherapy or radiotherapy) due to post operative complications. A delay in starting adjuvant therapy of 7-12 weeks has been shown to decrease key outcome indicators such as recurrence free survival and overall survival. It is therefore important to be able to demonstrate whether or not immediate breast reconstructions have the potential to delay the commencement of adjuvant treatments compared to mastectomy alone.
For a more detailed discussion of the need for this study and the evidence behind the effects of a delay to adjuvant treatments can be found in the study protocol
We aim to collect data for 6 months from 1st July 2016 to 31st December 2016. We would like to collect data on over 2000 patients.
All patients having a mastectomy for invasive cancer or DCIS with or without a breast reconstruction (of ANY type - implant-based, pedicle or free flap).
Patients having risk reducing surgery, patients not having a total mastectomy.
To get more information and to register for the study please email us at email@example.com
If you are a trainee at your hospital you will need to identify a Consultant Lead at your site. You will then have to register iBRA-2 with your local audit department. There may well be a specific form that they need you to fill in and they may want to see a copy of the study protocol.
We plan to collect anonymised data on all patients undergoing mastectomy with or without reconstruction in the study period time-frame. We will collect general health demographic data and co-morbidities, date and type of surgery, planned adjuvant treatment, complications in the first 6 weeks post operatively and time to commencement of chemotherapy / radiotherapy.
The study is being run as a collaborative project in the same manor as the iBRA study. All participants that submit 10 full datasets or more will be citable collaborators on all future publications regarding iBRA-2.
As with the iBRA-1 study, the online data collection site REDCap will be used to collect all the data. Login details will be provided when units register for the study. Data can either be collected straight onto the REDCap site - or documented on the paper forms and then transcribed - they collect the same information.
There will be a rolling programme of data QA whereby each unit will be asked to audit a randomly selected sample of 5% of their records. This should be performed by an independent collaborator ideally the lead Consultant for the unit. As per the study protocol if the data is <90% accurate that unit will be excluded from the analysis.
Anybody who collects 10 or more complete datasets will be eligible to cite themselves as a collaborator for all future iBRA-2 related publications.