1. 22 MAY – 5 JUNE 2017
A South African national, multi-centre fourteen day evaluation of patient care and clinical outcomes for paediatric patients undergoing surgery

2. Context Previous SA / Africa studies on postoperative outcomes
SASOS published in SAMJ
ASOS in press
April SAPSOS Investigators

3. Context
Very little data on paediatric perioperative morbidity and mortality in SA
Prospectively collected data best
Hence SAPSOS
April SAPSOS Investigators

4. Identified as a national priority
April SAPSOS Investigators

5. Presentation Overview
Enrollment
How to become part of the study
Study process
How to recruit patients and manage the study
How to fill in the CRF’s
How to collect data
Data Entry
How to enter data
April SAPSOS Investigators

6. Enrollment Contact us to enroll Documentation
or or
Documentation
University Ethics has been completed by university lead investigator
NHRD registration has been completed by university lead investigator
Hospital site permission
To be obtained by hospital site investigator
Register as hospital site investigator
Use this link to register:
One Hospital lead investigator plus site investigators
April SAPSOS Investigators

7. Study Process Intraoperatively:
Fill out screening form first: All patients
Create a recruitment log
Recruit eligible patients
All patients <16 yrs (except obstetric)
Elective and emergency
Locals, Regionals and GA’s where a procedure is performed
Forms on clipboard attached to anaesthetic machine
Compete Intraoperative CRF
Return completed forms to lead investigator
Tips
Keep a clipboard in theatre with:
Screening forms
Intraoperative CRFs
Post-op CRFs
Study Definitions document
FAQs document
April SAPSOS Investigators

8. Designed to be simple tick the “best fit” response
Tips
Designed to be simple tick the “best fit” response
Use FAQs or definitions documents if you are unsure
Don’t forget patient name and hospital number on the bottom of the form
“Unique patient ID ” will not be necessary yet
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9. Study Process Postoperatively:
Keep blank postoperative CRFs in theatre / complex
Fill name and hospital number on the post-op CRF and place in patient's folder before leaving recovery room
Keep track of which ward patient is sent back to on recruitment log
Once patient is discharged, collect completed forms and return to lead investigator
Explanation of Outcome Definitions will be in the file
Tips
Fill in the name and hospital number on the post-op form in theatre, that way you wont forget and errors are reduced
Remind the surgical team the patient has been recruited
April SAPSOS Investigators

10. Provide surgical teams with a copy of Outcome definitions
Tips
To stop post-op forms getting lost:
Do daily checks in wards as patients will get discharged and the post-op form has not been completed or was sent to the records department
Provide surgical teams with a copy of Outcome definitions
The highest grade of complication is recorded
Don’t forget to tick “none” if no complications
Calculating days:
Day 1 is recruitment day
Prospectively collected data. Everyday go through the list to make sure patient does not have any of these complications if the condition worsened cross out the previous one and sign and mark the correct one. For complications that weren’t present on the final day of discharge tick none.
April SAPSOS Investigators

11. Study Process CC: ICU or Critical care admission
Critical Care CRF’s will be placed in a file in doctors’ office/specified location
Fill out CC CRF for each patient admitted to ICU
Also fill out post-op CRF once discharged from ICU
Return CC or post-op CRF to lead investigator
List of postop patients in that ward / ICU will be in the file / recruitment log
Place completed forms back into file
Explanation of Outcome Definitions will be in the file
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13. Data Entry
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14. Visit the website
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15. April 2017 SAPSOS Investigators