Background: 1) Does your center have effective ways of collecting data from multiple sources to submit to multiple organizations?

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1 University of Michigan Best Practices Pam James, MS CCRP Administrative Manager, Data Management Bone Marrow Transplant, Hematologic Malignancies & NCCN Background: The data management team at the University of Michigan that supports the submission of CIBMTR data consists of four members. The team provides CIBMTR data for approximately patients per year. In addition to supporting the submission of CIBMTR data, the team also supports the BMT programs Long Term Follow-up protocol which aims to collect data about all patients transplanted at the University of Michigan, approx. 240 patients per year. The BMT program has appointed two physician liaisons to work closely with the data management team to provide guidance and support regarding how to most accurately collect data as well as improve the flow of communication between the physicians and data managers to address issues in patient documentation. 1) Does your center have effective ways of collecting data from multiple sources to submit to multiple organizations? a. At the University of Michigan, the Bone Marrow Transplant program has a Long Term Follow-up study which allows the program to collect specific data to support research protocol development, standard practice guidelines and translational research. To avoid duplicating efforts in collecting program specific data and CIBMTR data, both sets of data collection forms are reviewed and any duplicated data points are removed from program specific forms. All data is entered into our clinical trials management system, VELOS, so that the BMT program has access to data for both the Long Term Follow Up protocol and CIBMTR TED level data. We will soon begin utilizing the CIBMTR Data Back to Centers program to load TED data into VELOS eliminating the need for entry of TED data into both FormsNet and Velos. b. Data that is captured as part of the BMT program s Long Term Follow-up protocol and for CIBMTR is also used, when appropriate, to analyze outcomes for investigator initiated trials. Where patients have signed consents for the Long Term Follow-up trial and an investigator initiated therapeutic research trial, follow-up data is collected only once and used to support both protocols. 2) Have you overcome the frustration of different abstractors using different definitions, unclear/incomplete records, or tracking recipients that are lost-to-follow-up? a. In addition to the manuals provide by CIBMTR to complete the various forms, we have printed each research form and disease specific CIBMTR form to.pdf and added comment boxes providing clarification about where to find certain data points, how to

2 determined which dates to use and other tips to ensure forms are completed with the correct information from our patient records specific to how our center functions. (see attachment baseline.pdf for an example). Physicians specializing in each disease area reviewed the disease specific forms to ensure accuracy in their instruction. b. Physicians provide training sessions annually that address specific diseases as well as GVHD for the data management team c. We have a physician QA process for CIBMTR forms and other data collected for internal use. Questions that require a review by a physician due to vague or unclear information in the patient s chart, or that require a clinical opinion are flagged by the data manager and then sent out for QA by a physician. d. We are in the process of fine tuning the physician QA process such that two primary physicians will review only post-transplant complications and GVHD information to provide greater consistency. Other physicians will review disease specific information in their area of specialty. e. While patients are inpatient for treatment, we have one physician who provides continuity grading for Acute GVHD. That physician rounds once per week and reviews each patient s clinical course to provide organ staging and overall maximum grade. This reduces chances of differing opinions from physician to physician and provides consistency within the program to ensure all GVHD patients are identified and staged using the same criteria. f. Data Management Staff meet weekly in a project group to share best practices for accurate and efficient data collection, discuss questions and concerns and address any ongoing issues. g. The BMT program has appointed two physician liaisons to work closely with the data management team to provide guidance and support regarding how to most accurately collect data as well as improve the flow of communication between the physicians and data managers to address issues in patient documentation. 3) Have you found creative solutions to time management and prioritization issues? a. We found evidence in the literature to support the assertion that using dual screens to perform data abstraction and data entry would allow for up to 40% greater efficiency. We requested and were provided with dual monitors for most of our staff. This allows our team to have patients electronic medical records open on one screen while allowing FormsNet 2.0 to be open on the other. Copying and pasting data is faster as is transcription of data. Dual monitors have also improved accuracy.

3 b. We have structured our team of 4 people such that one person is responsible for registering and completing all new patients, one is responsible for day 100 forms, one is responsible for day 180 forms and one is responsible for yearly forms. These responsibilities rotate every two months so that each staff member has the opportunity to work on all form types. As staff members complete their assigned forms for the month, they work on completing yearly forms for patients who were transplanted 2 or more years earlier. This provides a clear delineation of responsibilities, the ability to self direct, and clarity around where to direct efforts once primary responsibilities are completed. c. Staff meet weekly in a project group meeting to update each other on their progress toward completing their responsibilities for the month creating transparency within the group and accountability among its members. 4) What tools or customized forms have you developed to more accurately and efficiently collect data? a. University of Michigan utilizes a tool called the Electronic Medical Record Search Engine to search our electronic medical record. This tool, which was developed by Dr. David Hanuer at the University of Michigan, allows staff to use bundles of search terms to search a patient s medical record for transplant complications, infections, GVHD information. Results are displayed in a manner that allows the data manager to see where specific complications were mentioned in the medical record and to link back to a specific note or lab to review it in further detail. EMERSE allows data managers to review a large volume of information very quickly when looking for specific data points. b. Data managers collect acute GVHD data on a weekly basis, in real time until patients reach day 100 using a program specific data collection form. Collecting the data in this fashion allows the data management team to query physicians for clarification while patients are still being seen in the clinic or inpatient setting and while the patient s case is still fresh in the minds of the clinical staff. Information is collected on the program s GVHD data collection form and can be referred to when it is time to report data to CIBMTR. At the time acute GVHD data is reported to CIBMTR, questions and clarifications are more likely to already be resolved due to the real time collection of data. c. The BMT program has appointed two physician liaisons to provide support to the data management team. The data management team meets with the physician liaisons bi-monthly to discuss issues with patient documentation, get clarification as to how to collect certain data points and prioritize data requests.

4 d. Staff meets weekly in a project group meeting to share best practices, discuss issues in documentation, share information learned that clarifies how to collect certain data points. e. Clarifications and information gathered via from physicians and from CIBMTR are stored in shared folders so all data management team members have access to the same information in a searchable format.

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6 CIBMTR Center Number: OMB No: Expiration Date: 10/31/10 CIBMTR Recipient ID: Infectious Disease Markers Sequence Number: Registry Use Only Non-NMDP Donor ID: OR Donor gender: Donor date of birth: 1 male 2 female Non-NMDP Cord Blood Unit ID: Month Day Year Date Received: Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is Public reporting burden for this collection of information, in combination with the HLA Typing Form 05 and HSCT Infusion Form 06, is estimated to average 1.5 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 10-33, Rockville, Maryland, 857. Today s Date: Month Day Year Date of HSCT for which this form is being completed: Month Day Year HSCT type: allogeneic, allogeneic, syngeneic (check only one) unrelated related (identical twin) Product type: marrow PBSC cord blood other product, (check only one) specify: This form must be completed for all non-nmdp allogeneic or syngeneic donors, or non-nmdp cord blood units. If the donor or cord blood unit was secured through the NMDP, then report IDMs on forms 24 and 50 for allogeneic donors or through CORD Link for cord blood units. 1. Who is being tested for IDMs? 1 donor IDM (marrow or PBSC) 2 maternal IDM (cord blood) 3 cord blood unit IDM Infectious Disease Marker (report final test results) Hepatitis B Virus (HBV) 2. HBsAg: (hepatitis B surface antigen) Anti HBc: (hepatitis B core antibody) (no confirmatory test available) Hepatitis C Virus (HCV) 6. Anti-HCV: (hepatitis C antibody) Test Date Month Day Year CIBMTR Form 04 v1.0 (1 3) July 07 Copyright 07 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. For internal use only: Document F00479 version 1.0 Replaces: n/a Mail this form to your designated campus (Milwaukee or Minneapolis). Retain the original at the transplant center.

7 CIBMTR Center Number: CIBMTR Recipient ID: Infectious Disease Marker (report final test results) Human T-Lymphotropic Virus 8. Anti-HTLV I / II: 9. Human Immunodeficiency Virus (HIV) 10. HIV-1 p24 antigen: not reported 4 not performed; HIV NAT testing performed (skip date) 12. Was FDA licensed NAT testing for HIV-1 / HCV performed? 1 yes 2 no Specify results: 13. HIV positive 2 negative 3 not reported 15. HCV 1 positive 2 negative 16. Test Date Month Day Year 17. Anti-HIV 1 and anti-hiv 2*: 18. (antibodies to Human Immunodeficiency Viruses) * Testing for both HIV antibodies is required. This testing may be performed as separate tests or done using a combined assay. 4 not reported Syphilis 19. STS:. Cytomegalovirus (CMV) 21. Anti-CMV: (IgG or Total) previously reported reactive, not tested (skip date) 4 testing not performed CIBMTR Form 04 v1.0 (2 3) July 07 Copyright 07 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. For internal use only: Document F00479 version 1.0 Replaces: n/a

8 CIBMTR Center Number: CIBMTR Recipient ID: Infectious Disease Marker (report final test results) West Nile Virus (WNV) 23. WNV-NAT testing: positive 2 negative 4 not applicable 25. Other infectious disease marker, specify (e.g., EBV): 1 yes 2 no 26. Specify date performed: 27. Specify test and method: Test Date Month Day Year 28. Specify test results: 29. Other infectious disease marker, specify (e.g., EBV): 1 yes 2 no 30. Specify date performed: 31. Specify test and method: 32. Specify test results: 33. Other infectious disease marker, specify (e.g., EBV): 1 yes 2 no 34. Specify date performed: 35. Specify test and method: 36. Specify test results: 37. Signed: Person completing form Please print name: Phone number: ( ) Fax number: ( ) address: CIBMTR Form 04 v1.0 (3 3) July 07 Copyright 07 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. For internal use only: Document F00479 version 1.0 Replaces: n/a

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12 SOC Acute GVHD Tracking- Post 100day Patient: Weight at iniation of steroids: Reg #: Date of Initiation of steroids: Txpt Date: Date of 1st GVHD scoring: Score of 1st GVHD scoring: Use Dr. Choi's CONT CARE note in CareWeb. If unavailable, use maximum organ staging to calculate overall grade for the week. Symptoms (date) Biopsy (date) Biopsy (Result) Skin Liver Gut-L Gut- U Week Skin Liver Gut Overall Grade Date + posttxp drug assessment Day + posttxp drug assessment Steroid Dose in Medrol Equivalents (mg/kg) Other GVHD Meds & # of ECP treatments (including prophylaxis) 15 4/16/1900 day /23/1900 day /30/1900 day /7/1900 day /14/1900 day /21/1900 day /28/1900 day /4/1900 day /11/1900 day /18/1900 day /28/1900 day +180 Notes: v.4.0 8/12/09