Transcript Year 2 Highlight Slides

MARC-35
Year 2 Highlights
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MARC-35 Sites: Year 2
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Inclusion Criteria Update
• Permanent address, phone, email, alternate
contact information, and primary care provider
for next year
• Some exceptions to “permanent” info:
– Legal guardians who are college students may be
enrolled
– Military personnel NOT expecting to be deployed in
the next 12 months may be enrolled
– Families planning to move locally in next 12
months may be enrolled
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Screening Form Updates
• Fill out for ALL children <1yr admitted
with bronchiolitis
• Record whether child was:
– Approached
– Missed (no attempt to approach)
– Known to be ineligible from the pre-screen
• If patient is missed, indicate reason
• If missed or ineligible, the form ends here
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Screening Form Updates
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Study ID Numbers
Patient
number
1 11 2 01
Site-specific 3
digit number
Study year the
child was
enrolled
(either 1 or 2)
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Chart Review Reminders
• Choose “not documented” when something is not written
in the medical record. Lack of documentation does not
imply adequate or normal – or inadequate or abnormal.
• Avoid making assumptions or inferences
• Pay attention to the timing that a particular question
refers to pre-admission vs. admission values
• “Initial vitals” on Intake Chart Review:
- First vitals from clinic (if clinic → hospital)
- First vitals from ED (if ED → hospital)
- First vitals from ED (if clinic → ED → hospital)
• Double-check your entries to avoid transcription errors
• Be aware of admission and discharge dates and times
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Specimen Enrollment Checklist
• After collecting specimens, a participant:
Is fully enrolled …
2. Did not fulfill enrollment requirements … or
3. Withdrew consent before end of enrollment
1.
• Status is reflective of enrollment
immediately after specimen collection
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Blood Collection Updates
• Blood collected for CBC
– Should be drawn into purple top tube prior to
collection of other blood
• Blood for research purposes (25OHD, IgE, etc.)
– Should be drawn into red top tubes
– May use discarded blood also in red top tubes to
meet minimum volume; if yes, must spin.
• Discarded blood not in red top tubes
– Should be transferred to crytotubes for -80 freezer
storage and shipped with blood from red top tubes
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Where to ship serum
and discarded blood if:
• Fully enrolled (Chronic & Acute cohort)
• Found ineligible *
• Did not fulfill enrollment requirements *
Withdrew during
index hospitalization
• Withdrew after index hospitalization *
MGH
* Unless otherwise specified by your site-specific consent form
Do NOT ship –
destroy specimens!
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Where to ship pellet if:
Fully enrolled
(Chronic & Acute
cohort) AND
consented to
genetic portion of
study
University of Arizona
• Fully enrolled (Chronic & Acute cohort)
but did NOT consent to genetic portion of
study
• Found ineligible *
• Did not fulfill enrollment requirements *
Withdrew during
index
hospitalization
• Withdrew after index hospitalization *
MGH
* Unless otherwise specified by your site-specific consent form
Do NOT ship –
destroy specimens!
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Where to ship NPA if:
• Found ineligible *
Fully enrolled
(Chronic & Acute
cohort)
Baylor
• Did not fulfill
enrollment
requirements *
Withdrew during
index hospitalization
• Withdrew after index
hospitalization *
MGH
* Unless otherwise specified by your site-specific consent form
Do NOT ship –
destroy specimens!
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Where to ship
index nasal swab if:
• Fully enrolled (Chronic & Acute cohort)
• Found ineligible*
• Did not fulfill enrollment requirements*
Withdrew during
index hospitalization
• Withdrew after index hospitalization*
MGH
* Unless otherwise specified by your site-specific consent form
Do NOT ship –
destroy specimens!
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Shipping Updates
• Review the updated biospecimen manuals
(blood, NPA, nasal swab)
• Remember:
– Index nasal swabs are shipped immediately
– Blood and NPA are shipped in batches when
instructed by EMNet
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Clearance Swab Updates
• The date that the clearance swab should
be taken should be written on the swab kit
• Emphasize with parents:
– The importance of the swabs
– How to use the swab kits
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Final Thoughts
• Please review the updated forms you were
provided as part of Amendment 3
– Some questions have subtle changes; you
should be aware of the changes before
conducting an interview
– We have incorporated all of the updates into
the REDCap forms
• The updated MOP contains all of the
refinements and clarifications made for
Year 2
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Questions?
• Always available by phone or email with
any questions
• Optional “Office Hours” telephone call will
be held:
Monday, 10/29/12
11am – 1pm ET
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