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MARC-35 Year 2 Highlights 1 MARC-35 Sites: Year 2 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 – 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 3 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 4 Screening Form Updates 5 Study ID Numbers Patient number 1 11 2 01 Site-specific 3 digit number Study year the child was enrolled (either 1 or 2) 6 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 7 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 8 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 9 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! 10 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! 11 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! 12 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! 13 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 14 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 15 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 16 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 17