Infection Adjudication on REDCAP Module 1 Version: Feb 1st, 2012

Infection Adjudication Based on the microbiology and antibiotic data entered, REDCAP will automatically trigger suspicions of newly acquired infections Suspicions MUST be adjudicated by Site Investigator or MD delegate REDCAP will generate a table that will guide and assist the Site Investigator/Research Coordinator through the various steps 2

3 CRS Manual p 22

Log in to REDCAP using assigned username and password Click on the “My Database” tab, select TOP-UP. Click on the “Infection Adjudication” link You will be directed to the following window showing the patients that require adjudication and how many suspicions of infection each have Click on the patient ID How to Start? 4

Adjudication Table: baseline, daily data Infection adjudication table will show up listing: baseline/outcome information at the top daily data elements, micro and antibiotics Suspicions of infection (Newly Acquired Infections) 5

Microbiology and Antibiotic Forms 7 Click on the antibiotic or organism names to view the corresponding antibiotic/microbiology forms Click to open a window with the Day 1 Antibiotic form for Metronidazole Click to open a window with the Day 3 Microbiology form for Escherichia s.p. - coli

Adjudication Table: suspicions of infection You will have 3 options to enter in the NEWLY ACQUIRED INFECTION column: a)This is a newly acquired infection b)This is not a newly acquired infection c)This is a previously adjudicated infection 8

a) Newly acquired infection 10 Pick this option if the clinical suspicion of infection is considered to be a newly acquired infection. Assign a Category of Infection, then the degree of certainty of the infection using the definition from CRF Appendix 9 For example, on study day 9 the patient is febrile, has an elevated WBC, CXR reveals a new infiltrate. An endotracheal aspirate specimen was sent for culture, S. aureus is identified. The infection should be adjudicated as follows: Click to open a window describing the categories and the degrees of certainty

b) NOT a newly acquired infection 11 Pick this option if the clinical suspicion of infection is not considered to be an infection. Assign the degree of certainty of the infection using CRF Appendix 10 For example, On study day 17 a blood culture indicates the presence of Staph Epidermis. There are no other clinical indicators of infection (i.e. SIRS). A repeat culture is negative. The initial positive culture is thought to be a contaminant. The infection should be adjudicated as follows: Click to open a window describing the degrees of certainty

c) Previously adjudicated infection 12 Pick this option if this clinical suspicion of infection is associated with an infection already adjudicated. Indicate the day and the suspicion # of the associated previously adjudicated infection. Infections that occur within the first 72 hrs of ICU admission are not to be considered newly acquired infections, however, these may be related to suspicions later.  If the suspicion of infection was due to an infection that occurred in the first 72 hours after ICU admission, select “Baseline Infection”.

c) Previously adjudicated infection 13 For example, on study day 19 the patient is febrile, has an elevated WBC and CXR reveals a new infiltrate. An endotracheal aspirate specimen was sent for culture, S. aureus is identified. On study day 20 an antibiotic was initiated to treat the S. aureus. The clinical suspicion triggered on study day 20 with the initiation of an antibiotic is related to a previously adjudicated infection.

How to clear responses? To change your response, click on the CLEAR RESPONSE 14 To change your response, click on the CLEAR RESPONSE

Infection ID #’s All suspicions of infection will be assigned unique infection identification number followed by the study day it was entered on Infection ID #s will never be repeated Infection identification numbers will be sequential unless a microbiology and/or antibiotic form was changed/added AFTER adjudications have been saved 15

Site: infection responses completed When done click SAVE & COMPLETED at bottom of page if you have completed ALL the infection adjudication for this chart SAVE if wish to return Both buttons will initiate data checks There will be a confirmation for either a “save” or a “save and complete” at the top of the table 16

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Stages of Data Entry: After initial adjudication After completion of the adjudication, the patient will be in stage 3. CRS Manual page 28

Site Initial Adjudication done: Stage 3 19 Stage 2 Complete initial site adjudication Stage 3 Complete 3 & 6 month follow-up Stage 4a Central adjudicator reviews each adjudication and either agrees or disagrees with each suspicion of infection Stage 4b Both adjudicators agree on all suspicions of infection Stage 5 Patient chart closed Investigators Confirmation Site adjudicator reviews each adjudication and either agrees or disagrees with centrals adjudicators changes If the site disagrees with any of the central changes or has made any changes If the central adjudicator agrees with all of the site adjudicators Central disagrees with at least one adjudication

3 & 6 month follow up Complete the 3 and 6 month follow-up forms and click on the bottom of the REDCap grid You will now be in stage 4a

3 & 6 month follow up done: Stage 4a 21 Stage 2 Complete initial site adjudication Stage 3 Complete 3 & 6 month follow-up Stage 4a Central adjudicator reviews each adjudication and either agrees or disagrees with each suspicion of infection Stage 4b Both adjudicators agree on all suspicions of infection Stage 5 Patient chart closed Investigators Confirmation Site adjudicator reviews each adjudication and either agrees or disagrees with centrals adjudicators changes If the site disagrees with any of the central changes or has made any changes If the central adjudicator agrees with all of the site adjudicators Central disagrees with at least one adjudication

Central Adjudicator At stage 4a, the central adjudicator will review each suspicion of infection and determine if s/he agrees or disagrees with the site’s suspicion of infections Central adjudicator is assigned by CERU

Site response to Central adjudication Every few weeks, an on adjudications requiring your attention (including those that have been centrally adjudicated) will be sent to you Log in using your USERNAME and PASSWORD

Site response to Central adjudication Centrally adjudicated patients will appear on the adjudication table as stage 4b If the Central adjudicator agreed with all the adjudications, stage 4b will be skipped and the patient file closes (stage 5) 4b = Initial central adjudication queries 4b = Subsequent central adjudication queries

Central Adjudication done: Stage 4b 25 Stage 2 Complete initial site adjudication Stage 3 Complete 3 & 6 month follow-up Stage 4a Central adjudicator reviews each adjudication and either agrees or disagrees with each suspicion of infection Stage 4b Both adjudicators agree on all suspicions of infection Stage 5 Patient chart closed Investigators Confirmation Site adjudicator reviews each adjudication and either agrees or disagrees with centrals adjudicators changes If the site disagrees with any of the central changes or has made any changes If the central adjudicator agrees with all of the site adjudicators Central disagrees with at least one adjudication

Stage 4b

NOTE: Sites responses removed All adjudications that the central adjudicator has disagreed to will automatically remove the sites response upon completion All adjudications that the central adjudicator agreed to will not be changed 27 This was removed because the Central Adjudicator disagreed with Infection ID #1 The sites response was not changed

Comments 28 Click to see your old response and an explanation why the central adjudicator disagreed in a new window The number in brackets indicates the number of comments that have been recorded Use the comments window to track the discussion and the changes to suspicion of infection Click to add additional comments

Site Response to Central adjudication The CENTRAL ADJUDICATOR RESPONSE column will show either as an agree or a disagree (with a new response and the reasoning why in the comments) You must re-adjudicate all adjudications that the central disagreed to You will have 2 options to enter in the NEWLY ACQUIRED INFECTION column: Agree OR Disagree 29

OPTION 1: Select this if you agree with the determination made by the Central. If so, the following options stay disabled – This is a newly acquired infection – This is not a newly acquired infection – This is a previously adjudicated infection 30 OPTION 2: Select this if you disagree with any aspect of the determination made by the central (such as the presence of infection, the category of infection and/or the degree of certainty). Re- adjudicate using the following options: – This is a newly acquired infection – This is not a newly acquired infection – This is a previously adjudicated infection Site Response to Central adjudication

31 If you disagree, you must save a comment explaining your reasoning. All adjudications that you disagree to will automatically remove the centrals response upon completion Site Response to Central adjudication

Incorrect Response 32 This will be removed because the you disagreed with Infection ID #1 You can not agree to a response that will be removed This will be also be removed because it refers to Infection ID #1 which will be removed Since the central response is automatically removed when you disagree (eg infection ID #1), any adjudication that refers to it (eg infection ID #2) will be removed as well An error will trigger if you try to agree with a response that will be removed

Correct Response 33 You must select disagree and select previous to your (site) response If infection ID # 2 is a previous infection to ID #1, you must disagree and select that the suspicion is a previous adjudicated to your response

Site: to complete final adjudication Once adjudication is done, press The status will go back to Stage 4a for the central adjudicator to review The central adjudicator will have the opportunity to agree/disagree to adjudications you disagreed with This process will continue between site and central adjudicator until there is consensus for all the adjudications Once both adjudicators agree on all the responses, adjudication will be complete and the patient will automatically be set to stage 5 34

Site/Central Adjudication done: Stage 5 35 Stage 2 Complete initial site adjudication Stage 3 Complete 3 & 6 month follow-up Stage 4a Central adjudicator reviews each adjudication and either agrees or disagrees with each suspicion of infection Stage 4b Both adjudicators agree on all suspicions of infection Stage 5 Patient chart closed Investigators Confirmation Site adjudicator reviews each adjudication and either agrees or disagrees with centrals adjudicators changes If the site disagrees with any of the central changes or has made any changes If the central adjudicator agrees with all of the site adjudicators Central disagrees with at least one adjudication

Site Investigator Remember the Site Investigator/MD delegate must determine the presence or absence of infection, the categories of infection and the degree of certainty Upon completion at stage 5, print the adjudication table (right click and print) and have the Site Investigator sign it for source verification purposes 36

Whenever the or the buttons are clicked, they will run data checks. There are 4 types of checks 1)Partial responses 2)Missing responses 3)Missing Explanation 37 Data Checks

1) Partial responses Check Partial responses can not be saved. – For example, the category of infection and the degree of certainty must be completed for newly acquired infections to be saved – This applies to both and 38

2) Missing responses check Missing responses can be saved only with – For example, infection ID # 1-4 has been completed but # 5 has not. You can save infections 1-4 with the button but you will not be allowed to choose until infection #5 has been filled out 39

3) Missing Explanation Check If you disagree with the central adjudicators response, you must write a reason in the comment box This applies to both and 40