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 http://www.sapsos.co.za

Context Previous SA / Africa studies on postoperative outcomes SASOS published in SAMJ ASOS in press April 2017 SAPSOS Investigators

Context Very little data on paediatric perioperative morbidity and mortality in SA Prospectively collected data best Hence SAPSOS April 2017 SAPSOS Investigators

Identified as a national priority April 2017 SAPSOS Investigators

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 2017 SAPSOS Investigators

Enrollment Contact us to enroll Documentation dawid@ansa.org.za or lallipop@meb.co.za or alexandra@iafrica.com 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: https://redcap.ansa.org.za/surveys/?s=3738N3HC47 One Hospital lead investigator plus site investigators April 2017 SAPSOS Investigators

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 2017 SAPSOS Investigators

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 Page 2 Page 1 April 2017 SAPSOS Investigators

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 2017 SAPSOS Investigators

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 2017 SAPSOS Investigators

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 April 2017 SAPSOS Investigators

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Data Entry April 2017 SAPSOS Investigators

Visit the website www.sapsos.co.za April 2017 SAPSOS Investigators

April 2017 SAPSOS Investigators