Thank you all for your continued participation, the number of records on the online system continues to rise, with over 2600 operations so far, and the completeness of data is building. As the period for entering operations draws close we wanted to alert you to the closing procedures.
All centres should have now finished their primary two month data collection period. Each patient should be individually followed-up for a minimum of 30 days. The final deadline for checking and submitting all data to the website is 15th May 2015 for all centres. After this point the online system will be locked for analysis and you will be unable to access it.
Closing procedure and final checks of data prior to locking records
Please do use your 30 day follow ups as an opportunity to look back at your notes and enter any missing information.
We are aware that the purpose of the lock button on the online tool has not been clear and that some records have been locked before the 30 day follow up period has passed. In order that all data is captured we have decided to unlock all records to give each centre an opportunity to do a final check – in particular to confirm that there have been no 30-day complications – and then re-lock the records once complete. When you are sure that a patient’s record has been completed with all available data from the paper or electronic notes, you should lock the individual record to demonstrate that it is completed and valid, and therefore ready for analysis at the end of the audit.
BMI and Smoking fields
We are aware that some sites do not have information available for all patients on BMI and smoking. Where you have this information please enter it. Otherwise you will now be able to record ‘Not Known’ for Smoking Status. If you do not have the BMI you can now just add the weight and height or record “weight and height not known”.
Missing data and retrospective patient entry
We are keen that the audit shows a complete record of all cases over the study period. If you have not recorded cases straight on to the online form you can still enter these cases online as long as the operative details are completed by, or in direct conjunction with, a surgeon who was present during the operation itself. Please do go through your notes entering any missing data and to identify eligible patients that were missed initially. Again, the final deadline for submitting data is 15th May 2015.
Summary so far
We are thrilled that data on over 2600 operations has already been entered from around 270 hospitals across 37 countries in Europe and beyond. Particular congratulations to the following top 5 recruiting centres:
- Helsinki University Central Hospital, Finland - 44 patients
- Western General Hospital, Scotland, UK - 38 patients
- Akershus University Hospital, Norway - 38 patients
- Aarhus University Hospital, Denmark - 36 patients
- University Hospitals Leuven, Belgium - 34 patients
Some sites are yet to create any records but we are aware that a number of hospitals have made use of the offline data collection form before uploading the details online. We will be in touch over the coming weeks to see if these sites need any assistance with re-setting passwords.
We also need to confirm co-investigator details with each site. As stated in the study protocol each site can have up to a maximum of five co-investigators.
To confirm, the three things needed from each centre, in order to become confirmed co-investigators and thereby be co-authors on all publications:
- Verify that all individual patient’s records are fully complete and followed up to >30 days post-op, then lock each record.
- Complete the organisational survey on the online tool giving information about your unit.
- Confirm the individuals at your site who have undertaken the work (up to a maximum of 5, including the lead person).
With best wishes,
The ESCP Cohort Studies and Audits Committee
Thomas Pinkney (Chair), Sandra Vennix, Matteo Frasson, Baljit Singh, Oded Zmora, Alaa El-Hussuna, Nick Battersby, Aneel Bhangu, Sanjay Chaudhri