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MARC-30: Bronchiolitis Carlos Camargo, MD, DrPH Ashley Sullivan, MPH (Project Director) Massachusetts General Hospital, Boston, MA Jonathan Mansbach, MD.

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Presentation on theme: "MARC-30: Bronchiolitis Carlos Camargo, MD, DrPH Ashley Sullivan, MPH (Project Director) Massachusetts General Hospital, Boston, MA Jonathan Mansbach, MD."— Presentation transcript:

1 MARC-30: Bronchiolitis Carlos Camargo, MD, DrPH Ashley Sullivan, MPH (Project Director) Massachusetts General Hospital, Boston, MA Jonathan Mansbach, MD Children’s Hospital, Boston, MA Tony Piedra, MD Baylor College of Medicine, Houston, TX

2 Slide 2 NIAID

3 Slide 3

4 Slide 4 Outline of Presentation Overview of MARC-30 Inclusion/exclusion criteria Forms and examples NPA specimen collection

5 Slide 5 Outline of Presentation Overview of MARC-30 Inclusion/exclusion criteria Forms and examples NPA specimen collection

6 Slide 6 Objectives To elucidate the role of multiple (versus single) pathogen infections in bronchiolitis Determine the utility of PCR-testing for an infectious etiology To create clinical rules to predict reliably those children who require CPAP or intubation To develop/test a hospital discharge guideline that encourages earlier, but safe, discharges and that fosters family-centered care

7 Slide 7 Overview 15 North American hospitals 2,250 patients age <2 years with bronchiolitis: Over the enrollment period (November to March), each site is expected to enroll, perform chart review and follow-up for at least 6-8 ward patients & 2-4 ICU patients each month # of ICU patients – minimum of 2 with a flexible cap of 4 per month

8 Slide 8 Hospitalized Child Consent Provider Form MC Form Registry Follow-up Form EMNet Coordinating Center (send all data + registry Excel file) Repeat Visit (no forms) Daily Inpatient Form(s) No Consent (Refusal; short admit) Visit Form (NPA)

9 Slide 9 TimeForm(s) Hospital VisitConsent Form Provider Form Visit Form or MC Form Daily Inpatient Form 1 week post-visitFollow-up Form Ongoing Excel Registry AprilRegistry Form Study Design

10 Slide 10 Outline of Presentation Overview of MARC-30 Inclusion/exclusion criteria Forms and examples NPA specimen collection

11 Slide 11 Physician diagnosis of bronchiolitis Age <2 years Parental ability to give informed consent Inclusion Criteria

12 Slide 12 Interviewed for bronchiolitis study during an earlier visit Parents do not agree to the collection of the NPA specimen or to possible future use of the specimen Patient transferred to your hospital >48 hours after the time of admission at another hospital Exclusion Criteria

13 Slide 13 Patients with insurmountable language barriers are excluded No interview, but complete Missed Case Form and include in registry Spanish translations as tools Language Barriers

14 Slide 14 Monthly enrollment goals: –8-11 ward patients –2-4 ICU patients If there are eligible subjects in both the hospital ward and ICU, enroll the ICU patient Subject Enrollment

15 Slide 15 Outline of Presentation Overview of MARC-30 Inclusion/exclusion criteria Forms and examples NPA specimen collection

16 Slide 16 Coding –1 = “yes” –0 = “no” –8 when Q does not apply –9 when response is missing When interviewing patients, please read questions as written Follow skip patterns carefully Completing Forms

17 Slide 17 MARC-30 Forms MC Form Follow-up Form Registry (Excel) Registry Form Letter to Parents and PCP Consent Form Visit Form Provider Form Daily Inpatient Form(s)

18 Slide 18 Obtain consent from parent/guardian ( All consent forms used should have the IRB stamp of approval) –If consent: Complete Provider Form and interview portion of Visit Form –If no consent: Complete Missed Case (MC) Form Parent must be interviewed within 18 hours of the patient’s arrival on the medical floor Consent Form

19 Slide 19 Complete Visit Form for all eligible patients –Ask the parent questions –Questions are chart review Visit Form

20 Slide 20 Q6-7 Ethnicity and Race Q31 Breastfeeding duration Q34 Two-part eczema question; please ask both questions Q46-47 Results of virology testing sent to PCP and parent Points of Interest

21 Slide 21 Ask for multiple follow-up phone numbers! Other Points of Interest (cont.)

22 Slide 22 Interview the primary physician caring for the patient and family to answer these questions. Timing of the questions –Pertussis questions - beginning of admission –Factors that affect the decision to discharge - before discharge (if possible) Provider Form

23 Slide 23 For Pertussis, children stratified into groups based on the probability of infection (clinical, probable, and possible) If the child has clinical or probable B. pertussis infection: –Interviewer will notify clinical team –Encourage team to send appropriate pertussis tests, begin treatment, and place the child on droplet precautions. Provider Form (cont.)

24 Slide 24 Completed daily Record hospital day number Example: The child is admitted on 2/15/08 at 11:10 and the form is completed on 2/16/08 at 08:35. Enter “1” as the hospital day number Official response to Q4-8 should be completed on final day’s form Daily Inpatient Form(s)

25 Slide 25 Vital sign trends Retractions (Q17) –Today? None –Compared to yesterday? ImprovedWorsenedStable Other Points of Interest

26 Slide 26 Used for otherwise eligible patients who are “missed” by study investigators Completed entirely by chart review ( e.g. the patient was missed, no consent obtained). Missed Case (MC) Form

27 Slide 27 Follow-up Form 10-minute follow-up phone call with parent 1 week after hospital discharge (i.e., 8 to 14 days after hospital visit) Try calling at least 5 times over at least 3 days Always record attempted calls on the Follow-up Form

28 Slide 28 Follow-up Form (1 Week) Be careful of skip pattern for Q7 Follow-up Form

29 Slide 29 Excel Registry Use an independent administrative source to complete the registry During the enrollment period, compile a list of all bronchiolitis visits for children <2 years in the MARC-30 Registry This includes missed/refused cases and repeat visits, even though they will not be interviewed for the study

30 Slide 30 Record the required information using the variable definitions given on the registry form (e.g. Sex: 1. Male 2. Female) Record 1 (yes) for all for forms that were completed, 0 (no) if not completed (e.g. if visit form completed, vform = 1) Excel Registry

31 Slide 31 3-digit site number then 3-digit patient number Please delete name Examples:

32 Slide 32 Please delete MRN

33 Slide 33 Make sure all forms are accounted for Record ICU Info

34 Slide 34 Missed cases are also recorded in the registry

35 Slide 35 Repeat Visits Fill in all info through discharge date and then enter in 8s in all other cells

36 Slide 36 Different than the actual registry (Excel worksheet) Describes how to code the Bronchiolitis Registry Please calculate questions “a-g” at bottom of form when study complete Registry Form

37 Slide 37 Data due the last day of the month following enrollment (all of these data are entered using web-based data entry) –Visit Form –Provider Form –Daily Inpatient Form –Follow-up Form –Missed Case Form Sending Data

38 Slide 38 Logging In How to Navigate Error Messages How to Save / Send Forms Web-Based Data Entry

39 Slide 39 Website/Logging In

40 Slide 40

41 Slide 41

42 Slide 42

43 Slide 43

44 Slide 44 Please be sure to enter information carefully and SAVE frequently After you submit the forms changes can NO longer be made. You will be able to view all of the forms even after submission. After Hitting “Submit”

45 Slide 45 ALL data are due at the end of April –Copy of IRB Approval Letter (as soon as available) –Copy of one blank, approved consent form –Please send the Excel Registry as an attachment; send the Registry Form via fax or mail Sending Data

46 Slide 46 Send materials to: Ashley Sullivan, MPH, MS Emergency Medicine Network Massachusetts General Hospital 326 Cambridge Street, Suite 410 Boston, MA Sending Data (cont.)

47 Slide 47 Outline of Presentation Overview of MARC-30 Inclusion/exclusion criteria Forms and examples NPA specimen collection

48 Slide 48 Overview All subjects enrolled in the study require the collection of a nasopharyngeal aspirate (NPA) specimen All specimens shipped to Baylor College of Medicine

49 Slide 49 Mucus trap Sterile container Three 5mL syringes One 10 mL cryovial Suction catheter (8 French tubing) Two normal saline bullets (5 mL NS solution; pH 7.0) Virus stabilizer (15% glycerol in Iscove’s media) Labels: Specimen NPA label, Visit Form NPA label Bio-hazardous ziploc bags NPA Collection Kit

50 Slide 50 Visit website (www.emnet-usa.org) for complete collection instructions (including the NPA collection video) and handling instructionswww.emnet-usa.org Reminders: –All NPA specimens will be collected through the nose, even for children intubated or on CPAP. –Load both 5 ml syringes with exactly 2 mL of normal saline –DO NOT start suctioning while catheter is going into the nostril –Remove catheter with a swirling motion –Rinse the suction catheter with saline solution –Label Mucus trap and Visit form –Write the NPA Sample ID number and collection date on the NPA Shipment List NPA Collection

51 Slide 51 NPA Labeling NPA Sample ID # will be pre-assigned and pre- printed on a NPA Sample Label. Write the collection date (mm/yr) and time (hh:mm) on the NPA Sample Label On specimen - 1 NPA Sample Label On visit form - 1 NPA Sample Label with the same ID number

52 Slide 52 Labeling the Visit Form: Sample Visit Form NPA Label Sample ID#: Date: _______ Time: ____ 12/01/09 05:23

53 Slide 53 NPA Shipment List (after NPA collection) : /01/09 11/02/09 11/04/09 11/05/09 05:23 22:56 18:05 03:

54 Slide 54 TimeStep(s) Hospital VisitCollection of NPA on ice <1 hour post-collectionStorage at 4ºC <24 hours post-collectionStorage at -80ºC Day of shipmentNPA Shipment List OngoingExcel Registry AprilRegistry Form NPA Specimen Timeline

55 Slide 55 NPA Storage Immediately following collection, the nasal specimen must be transported, on ice, to a 4ºC refrigerator Always transport the specimen on ice Specimen must be transferred to -80ºC freezer no later than 24 hours after it is collected

56 Slide 56 NPA Shipping Only lab personnel certified in preparing diagnostic shipments, according to the IATA guidelines, should package and ship the specimens!

57 Slide 57 NPA Shipment List (when packaging) : /01/09 11/02/09 11/04/09 11/05/09 11/06/09 11/07/09 05:23 22:56 18:05 03:31 10:19 16:15 23:59 00:01 07:36          0 1 1

58 Slide 58 Specimens must be shipped (overnight) to: Pedro A. Piedra, M.D. Attention: Alan Jewell Baylor College of Medicine Department of Molecular Virology and Microbiology Mail stop code: BCM 280, Room 248E One Baylor Plaza Houston, Texas Lab Tel: Only ship specimens Mon, Tue, or Wed! NPA Shipping (cont.)

59 Slide 59 Each site will receive: $125 per patient with completed Visit form and follow-up interview Sites will not be compensated for enrollment of subjects without Daily Inpatient Forms. If enrollment is complete, but one cannot reach the subject for follow-up, then sites will receive $75 per patient for their efforts Stipend Information

60 Slide 60 Investigators are encouraged to publish manuscripts using MARC-30 data EMNet staff members provide: –data management –statistical support –scientific input –editorial advice Check “Publications”www.emnet-usa.org Manuscripts by Site PIs

61 Slide 61 Manuscripts by Site PIs (cont.)

62 Slide 62 Detailed information on form completion can be found in the Manual of Procedures on the website: If you have any questions, please contact Conclusion

63 Slide 63 Questions?

64 Slide 64 Emergency Medicine Network Massachusetts General Hospital 326 Cambridge Street, Suite 410 Boston, MA P: F: Contact Info


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