1. TIPS FOR COMPLETING CRF’S October 30 2015

3. Antimicrobial Report Form 7  In iDataFax use the drop-down list to record the Antimicrobial Code. This will allow the name of the antimicrobial code to automatically be recorded. The antimicrobial name cannot be typed as this field is view only. October 30 2015

4. Culture Report Form 8  In iDataFax use the drop-down list to record the Organism Code. Ensure to capture all positive organisms and all positive gram stains. If one culture report indicates more than 3 organisms/gram stains, use more than 1 line. October 30 2015

5.  Record Specimen #’s for all positive cultures as well as all negative C-Diff cultures.

6.  When completing an Infection Outcome Form based upon a positive culture, report the event on the Study Day the culture specimen was collected from the patient.  (e.g., Sputum collected on Day 3, positive results received on Day 5, event should be entered on Day 3) October 30 2015

7. Record Post ICU C-Diff Testing, both negative and positive, on Form 14.1 and 14.2. October 30 2015 Forward copies of all positive culture reports, culture negative/gram stain positive reports and all positive or negative C-Diff Reports to the Methods Centre

8. October 30 2015

9. Daily Data Form 4.1 Question 2  When a value is not available, (i.e. Lab Work), code as missing (leaving blanks will prompt a query).  When only 1 value for Temperature or Leukocytes is available, record same value for both highest and lowest values. October 30 2015

10. Stool Classification Form 6.2 Question 1  When Bristol Type is not available, leave the Bristol Type box blank, check the “other” box, specifying “not documented”. October 30 2015

12.  When is a Respiratory Infection Outcome Form 9 required? o When a patient is being treated with antimicrobials for a respiratory infection or suspected respiratory infection at time of Randomization - Study Day 1 (This includes Pre-Randomization events).  Review Antimicrobial Report October 30 2015

13. o At any time the patient is being treated with antimicrobials for a suspected respiratory infection or a new/worsening respiratory infection while in the ICU.  Review Antimicrobial Report o When a physician suspects a respiratory infection while patient is in the ICU, even when culture negative.  Review Physician/RN Progress Notes October 30 2015

14. o Each time a new organism related to a respiratory infection is identified on a positive culture report.  Review Culture Report o When a chest x-ray indicates a new or worsening consolidation or infiltrate.  Review Chest X-Ray October 30 2015

15.  Timeframe for Clinical Pulmonary Infection Score (CPIS) – Form 9.1 Question 3 o Worst CPIS scores are determined by reviewing the data up to and including 48 hours prior the event.  i.e., CPIS data is collected on the day the Respiratory Infection was recorded and 48 hours prior.. October 30 2015

16. o When a patient has a suspected or treated respiratory infection on the day of randomization, worst CPIS scores are determined by reviewing data on Study Day 1 and up to 48 hours prior to randomization.  48 hours prior to event could include data from either the ER or Ward or ICU. Do not use data from other hospitals October 30 2015

17. o For new or worsening events post- randomization, worst CPIS scores are determined by reviewing data on the day the respiratory infection is recorded and including up to 48 hours prior event.  48 hours prior event suspected on Study Day 2 could include data from ER or Ward. Do not use data from other hospitals. October 30 2015

18. o To help determine the CPIS Score, a worksheet is available on the Respiratory Infection Outcome Form 9.2. This worksheet is optional not mandatory. October 30 2015

19.  Timeframe for SIRS Criteria – Form 9.1 Question 5 o SIRS Criteria data is obtained by reviewing 24 hours before to 24 hours after date of suspected infection. October 30 2015

20. o When a patient has a suspected or treated respiratory infection on the day of randomization, SIRS Criteria data is determined by reviewing data from up to 24 hours prior to randomization to 24 hours after Study Day 1.  24 hours prior to event could include data from either the ER or Ward or ICU. Do not use data from other hospitals. October 30 2015

21. o To help determine the SIRS Criteria, a worksheet is available on the Respiratory Infection Outcome Form 9.2. This worksheet is optional not mandatory. October 30 2015

22.  Was there at least 1 microorganism identified? – Form 9.1 Question 8 o Ensure to capture positive gram stains and/or positive cultures October 30 2015

23. Infection Outcome Forms Blood Stream Form 10 Intra-Abdominal Form 11 Urinary Tract Form 12 Skin and Soft Tissue Form 13 Other Form 20 October 30 2015

24.  When are Infection Outcome Forms required? o When a patient is being treated with antimicrobials for an infection at time of Randomization - Study Day 1 (This includes Pre-Randomization events).  Review Antimicrobial Report October 30 2015

25. o When a physician suspects an infection while patient is in the ICU, even when culture negative.  Review Physician/RN Progress Notes October 30 2015 o At any time the patient is being treated with antimicrobials for a suspected infection or a new/worsening infection while in the ICU.  Review Antimicrobial Report

26. o Each time a new organism related to an infection is identified on a positive culture report.  Review Culture Report October 30 2015

27. Clostridium Difficile Outcome Form 14 October 30 2015

28. When is a Clostridium Difficile (C-Diff) Outcome Form 14 and required? o When a patient is being treated with antimicrobials for a C-Diff Infection or suspected C-Diff infection at time of Randomization - Study Day 1 (This includes Pre-Randomization events).  Review Antimicrobial Report October 30 2015

29. o When a positive or negative C-Diff has been identified on a culture report while patient is in ICU or any time during the hospitalization.  Review Culture Report October 30 2015 o At any time the patient is being treated with antimicrobials for a suspected C-Diff infection or new C-Diff infection while in the ICU.  Review Antimicrobial Report

30. How to report a Negative Clostridium Difficile o Response to Question 1 will be No o Question 2 (Which test was this based upon?) will be answered accordingly o Questions 3 and 4 will be left blank ( Question 4 and 5 will be left blank on the Clostridium Difficile Post ICU Discharge Form 14.1) October 30 2015

31. SOURCE DOCUMENTS October 30 2015

32. ICU Admission Notes and ICU Discharge/Transfer/Notes Please forward ICU Admission Notes and ICU Discharge Notes/Death Summary to the Methods Centre either by fax 905-308-7223 or via email to zytaruk@mcmaster.ca or lsaunde@mcmaster.ca zytaruk@mcmaster.calsaunde@mcmaster.ca October 30 2015

33. What Source Documents are required when reporting Infections (please submit to Methods Centre either via fax 905-308- 7223 or via email to zytaruk@mcmaster.ca or lsaunde@mcmaster.ca) zytaruk@mcmaster.calsaunde@mcmaster.ca o All related Physician/RN Progress Notes o All related Radiology Reports o All related Laboratory Tests o All related Positive Culture Reports o When reporting Clostridium Difficile, include both positive and negative Culture Reports October 30 2015