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Year 2 Highlights

MARC-35

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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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• 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

Screening Form Updates

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Screening Form Updates

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Study ID Numbers

111 201Study year the

child was enrolled

(either 1 or 2)

Site-specific 3 digit number

Patient number

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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:

1. Is fully enrolled …2. Did not fulfill enrollment requirements … or3. Withdrew consent before end of enrollment

• 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:

MGH

Withdrew during index hospitalization

• Fully enrolled (Chronic & Acute cohort)

• Found ineligible *

• Did not fulfill enrollment requirements *

• Withdrew after index hospitalization *

Do NOT ship – destroy specimens!

* Unless otherwise specified by your site-specific consent form

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Where to ship pellet if:

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 after index hospitalization *

Withdrew during index hospitalization

Fully enrolled (Chronic & Acute cohort) AND consented to genetic portion of study

Do NOT ship – destroy specimens!

MGH

* Unless otherwise specified by your site-specific consent form

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Where to ship NPA if:

Baylor

• Found ineligible *

• Did not fulfill enrollment requirements *

• Withdrew after index hospitalization *

Withdrew during index hospitalization

Fully enrolled (Chronic & Acute cohort)

Do NOT ship – destroy specimens!

MGH

* Unless otherwise specified by your site-specific consent form

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Where to ship index nasal swab if:

MGH

Withdrew during index hospitalization

• Fully enrolled (Chronic & Acute cohort)

• Found ineligible*

• Did not fulfill enrollment requirements*

• Withdrew after index hospitalization*

Do NOT ship – destroy specimens!

* Unless otherwise specified by your site-specific consent form

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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, 10/29/1211am – 1pm ET