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 ID: 160696
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Infection Adjudication on REDCAP Module
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Version: Feb 1st, 2012Slide2
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
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CRS Manual p 22Slide4
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?
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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)
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Microbiology and Antibiotic Forms
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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
. - coliSlide8
Adjudication Table: suspicions of infection
You will have 3 options to enter in the NEWLY ACQUIRED INFECTION column:
This is a newly acquired infectionThis is not a newly acquired infection
This is a previously adjudicated infection
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a) Newly acquired infection
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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 certaintySlide11
b)
NOT a newly acquired infection
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Pick this option if the clinical suspicion of infection is
no
t 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 certaintySlide12
c)
Previously adjudicated infection
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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”. Slide13
c)
Previously adjudicated infection
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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.Slide14
How to clear responses?
To change your response, click on the CLEAR RESPONSE
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To change your response, click on the CLEAR RESPONSE
To change your response, click on the CLEAR RESPONSESlide15
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 repeatedInfection identification numbers will be sequential unless a microbiology and/or antibiotic form was changed/added AFTER adjudications have been saved
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Site: infection responses completed
When done click SAVE & COMPLETED at bottom of page if you have completed ALL the infection adjudication for this chartSAVE if wish to return
Both buttons will initiate data checksThere will be a confirmation for either a “save” or a “save and complete” at the top of the table
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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 28Slide19
Site Initial Adjudication done: Stage 3
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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 adjudicationSlide20
3 & 6 month follow up
Complete the 3 and 6 month follow-up forms and click on the bottom of the REDCap
gridYou will now be in stage 4aSlide21
3 & 6 month follow up done: Stage 4a
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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 adjudicationSlide22
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 CERUSlide23
Site response to Central adjudication
Every
few weeks, an email on adjudications requiring your attention (including those that have been centrally adjudicated) will be sent to youLog in using your USERNAME and PASSWORDSlide24
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 queriesSlide25
Central Adjudication done: Stage 4b
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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 adjudicationSlide26
Stage 4bSlide27
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
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This
was
removed because the Central Adjudicator disagreed with Infection ID #1
The sites response
was not changedSlide28
Comments
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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 commentsSlide29
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 toYou will have 2 options to enter in the NEWLY ACQUIRED INFECTION column: Agree OR Disagree
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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
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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
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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
Slide32
Incorrect Response
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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 removedSlide33
Correct Response
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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 Slide34
Site: to complete final adjudication
Once adjudication is done, press
The status will go back to Stage 4a for the central adjudicator to reviewThe 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
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Site/Central Adjudication done: Stage 5
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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 adjudicationSlide36
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
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Whenever the or the buttons are clicked, they will run data checks.
There are 4 types of checksPartial responses
Missing responsesMissing Explanation
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Data ChecksSlide38
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 savedThis applies to both and
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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
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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
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