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Year 2 Highlights

Year 2 Highlights. MARC-35. MARC-35 Sites: Year 2. 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

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Year 2 Highlights

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  1. Year 2 Highlights MARC-35

  2. MARC-35 Sites: Year 2

  3. 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

  4. 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

  5. Screening Form Updates

  6. 1 1 1 2 0 1 Study year the child was enrolled (either 1 or 2) Site-specific 3 digit number Study ID Numbers Patient number

  7. 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

  8. Specimen Enrollment Checklist • After collecting specimens, a participant: • Is fully enrolled … • Did not fulfill enrollment requirements … or • Withdrew consent before end of enrollment • Status is reflective of enrollment immediately after specimen collection

  9. 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

  10. Where to ship serum and discarded blood if: • Fully enrolled (Chronic & Acute cohort) • Found ineligible * • Did not fulfill enrollment requirements * • Withdrew after index hospitalization * Withdrew during index hospitalization Do NOT ship – destroy specimens! MGH * Unless otherwise specified by your site-specific consent form

  11. Where to ship pellet if: • 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 * Fully enrolled (Chronic & Acute cohort) AND consented to genetic portion of study Withdrew during index hospitalization Do NOT ship – destroy specimens! University of Arizona MGH * Unless otherwise specified by your site-specific consent form

  12. Where to ship NPA if: • Found ineligible * • Did not fulfill enrollment requirements * • Withdrew after index hospitalization * Fully enrolled (Chronic & Acute cohort) Withdrew during index hospitalization Do NOT ship – destroy specimens! Baylor MGH * Unless otherwise specified by your site-specific consent form

  13. Where to ship index nasal swab if: • Fully enrolled (Chronic & Acute cohort) • Found ineligible* • Did not fulfill enrollment requirements* • Withdrew after index hospitalization* Withdrew during index hospitalization Do NOT ship – destroy specimens! MGH * Unless otherwise specified by your site-specific consent form

  14. 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

  15. 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

  16. 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

  17. 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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