CTRD

1. CTRD /PHTS Coordinator Symposium April 9, 2008 Harvard Conference Center 1

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3. CTRD /PHTS Coordinator Symposium April 9, 2008 10:00 am � 12:30 pm 9:30 Check In 10:00 Welcome David C. Naftel, PhD 10:10 The Contribution of PHTS to Pediatric Heart Transplantation Elizabeth Blume, MD 10:30 The Contribution of CTRD to Adult Heart Transplantation David O. Taylor, MD 10:50 Predicting Major Events David C. Naftel, PhD 11:20 Compliance Post Transplant Connie White-Williams, MSN 11:30 It�s all about the data! Quality Control Rebekah Burder Nicole Kirklin Data Reports Margaret Foushee Susan Myers 11:45 You�re in Control!: Table Sessions 12:15 Coordinator Recognition 3

4. CTRD /PHTS Coordinator Symposium April 9, 2008 10:00 am � 12:30 pm 9:30 Check In 10:00 Welcome David C. Naftel, PhD 10:10 The Contribution of PHTS to Pediatric Heart Transplantation Elizabeth Blume, MD 10:30 The Contribution of CTRD to Adult Heart Transplantation David O. Taylor, MD 10:50 Predicting Major Events David C. Naftel, PhD 11:20 Compliance Post Transplant Connie White-Williams, MSN 11:30 It�s all about the data! Quality Control Rebekah Burder Nicole Kirklin Data Reports Margaret Foushee Susan Myers 11:45 You�re in Control!: Table Sessions 12:15 Coordinator Recognition 4

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6. Purpose of Coordinator Symposium The overall purpose of this meeting is to improve patient outcomes by collecting high quality data and conducting high quality analyses based on this data. We will accomplish this by: Providing each coordinator with a detailed report that will include a summary of data received and statistical summaries to assist them with the IRB process. Provide an opportunity to learn from other coordinators by sharing information and knowledge. Providing answers to questions the coordinator may have about data entry and submission. Thanking each coordinator for their hard work. 6

7. PHTS Purpose (established 1993) The purposes of the group are to establish and maintain an international, prospective, event driven database for heart transplantation, to use the database to encourage and stimulate basic and clinical research in the field of pediatric heart transplantation and to promote new therapeutic strategies. 7

8. Scientific Research Provide analysis of a large ongoing combined experience focusing on time-related outcomes (such as death, re-transplant, rejection, and infection) after transplantation and identification of associated risk factors. Institution Results Provide summaries, evaluation, and comparisons to participating institutions. Future Studies Provide the framework for data collection, entry, and analysis for prospective multi-institutional studies. 8

9. Standard Operating Procedure for a Research Study The following is a suggested schedule for research projects: Proposal Submission February Review of Proposal March Acceptance of Proposal April Detailed Plan of Work May Lead Investigator to UAB (optional) June Analysis of data July or August Abstract generation August 31 Abstract review by co-authors September 15 Abstract Submission September 20 Manuscript April (prior to ISHLT)

10. Standard Operating Procedure for a Research Study Manuscript The lead investigator is responsible for generating the manuscript. Under the precise direction of the lead investigator, the CTRD DCC will produce the �journal ready� figures and tables. The lead investigator is responsible for circulating the manuscript to co-authors and to the Research Committee. Ideally, the manuscript would be submitted to a journal at the same time of the ISHLT presentation (some scientific societies require this). The CTRD leadership strongly recommends that the manuscript be submitted at the time of presentation or very soon thereafter.

11. UAB PHTS and CTRD Personnel David Naftel, Program Director and Statistician Nicole Kirklin, Program Manager for CTRD Rebekah Burder, Program Manager for PHTS Margaret Foushee, Programmer and Statistician Susan Myers, Programmer and Statistician Rob Brown, Programmer and Statistician Aimee Rountree, Data Entry Tonya Rainey, Data Entry Sainath Kamath, Data Entry Chase Lenderman, Data Entry St. Louis Personnel Charlie Canter, Program Director Ken Schechtman, Statistician Jie Zheng, Statistician 11

12. CTRD /PHTS Coordinator Symposium April 9, 2008 10:00 am � 12:30 pm 9:30 Check In 10:00 Welcome David C. Naftel, PhD 10:10 The Contribution of PHTS to Pediatric Heart Transplantation Elizabeth Blume, MD 10:30 The Contribution of CTRD to Adult Heart Transplantation David O. Taylor, MD 10:50 Predicting Major Events David C. Naftel, PhD 11:20 Compliance Post Transplant Connie White-Williams, MSN 11:30 It�s all about the data! Quality Control Rebekah Burder Nicole Kirklin Data Reports Margaret Foushee Susan Myers 11:45 You�re in Control!: Table Sessions 12:15 Coordinator Recognition 12

13. Pediatric Heart Transplant StudyParticipating Centers � April, 2008 (33 Sites) 13

14. The Impact of High Risk Criteria on Mortality Following Heart Transplantation in Children Dr. Ryan Davies Pediatric Heart Transplantation: 14 Years of Improving Results Illustrated by Patient Specific Predictions Dr. David Naftel Serum Creatinine is a Limited Indicator of Renal Function in Pediatric Heart Transplantation Dr. Brian Feingold Outcomes of Pediatric Patients with Hypertrophic Cardiomyopathy Listed for Transplant Dr. Robert Gajarski Dilated Cardiomyopathy and Listing for Heart Transplantation Dr. Richard Kirk Outcomes of Children with Restrictive Cardiomyopathy Listed for Heart Transplant Dr. Steve Zangwill 14

15. Betsy Blume � President Anne Dipchand � Vice President Elfriede Pahl � Secretary Treasurer Karen Uzark� Non Physician Representative Daphne Hsu � Past President Robert Spicer � Member at Large Erik Edens � Member at Large Steve Zangwill � Member at Large 15

16. Betsy Blume (Chair) Anne Dipchand Elfriede Pahl Karen Uzark Daphne Hsu Robert Spicer Erik Edens Steve Zangwill David Naftel 16

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18. Anne Dipchand (Chair) Erik Edens Kirk Kanter Charlie Canter Bob Gajarski Steve Zangwill Kathy Ainley 18

19. Elfie Pahl (Chair) Juan Alejos Richard Chinnock Debbie Murphy 19

20. All pediatric patients under 18 years of age listed for primary heart transplantation are included in the study. The only exclusions are: Patients who are greater than 18 years of age at the time of listing. Patients who are transplanted at an institution but the institution provides no care after discharge and is not involved in the medical followup of the patient. This must be a planned circumstance and is related to rules imposed by an insurance provider. This is a rare occurrence and should be discussed with the PHTS center. Patients that in combination with their primary heart transplant also receive another organ (e.g. lung or kidney) 20

21. Pediatric Heart Transplant StudyPediatric Monograph 21

22. Pediatric Heart Transplant StudyPediatric Mechanical Circulatory Support

23. PHTS: 22 Articles with 284 Citations (through Dec. 2007) Outcome of listing for heart transplantation in infants younger than six months: Predictors of death and interval to transplantation Dr. Robert Morrow (41 citations, published 1997) Survival and risk factors for death after cardiac transplantation in infants � A multi-institutional study Dr. Charles Canter (33 citations, published 1997) Predicting Outcomes after listing for heart transplantation in children: Comparison of Kaplan-Meier and parametric competing risk analysis Dr. David McGiffin (29 citations, published 1995) Outcomes of Children Bridged to Heart Transplantation with Ventricular Assist Devices: A Multi-Institutional Study Dr. Elizabeth Blume (15 citations, published 2006) a Impact of PHTS Research on Heart Transplant Community

24. Impact of PHTS Research on Heart Transplant Clinical Practices Survival Improvement What has PHTS contributed? 24

25. Impact of PHTS Research on Heart Transplant Clinical Practices Rejection Improvement What has PHTS contributed? 25

26. Impact of PHTS Research on Heart Transplant Clinical Practices Infection Improvement What has PHTS contributed? 26

27. Impact of PHTS Research on Heart Transplant Clinical Practices Coronary Artery Disease Improvement What has PHTS contributed? 27

28. Impact of PHTS Research on Heart Transplant Clinical Practices Malignancy Improvement What has PHTS contributed? 28

29. Impact of PHTS Research on Heart Transplant Clinical Practices Listing Practices What has PHTS contributed? 29

30. Dr. Robert Jaquiss ECMO as a Bridge to Transplant: Outcomes of Listed Children Dr. Kristine Gulesarian Outcomes Following Listing and Transplantation for Neonates with Unoperated Non-HLHS Congenital Heart Disease Dr. Sujata Chakravarti Sudden Death following Pediatric Heart Transplantation 30

31. Impact of PHTS Research on Heart Transplant Community 31



34. PHTS Studies that require additional data collection 34


36. Infection and Rejection Risk Using Induction with Interleukin II Receptor Blockers vs. Anthithymocyte Globulin vs. No Induction: A Multi-Institutional Study Dr. Salpy Pamboukian Impact of Interaction of Donor Characteristics on Post-Transplant Survival. A Multi-Institutional Analysis Dr. Josef Stehlik 36

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38. David O. Taylor, MD Committee Chair Keith Aaronson, MD David Feldman, MD Marc Semigran, MD Stuart Russell, MD Research Committee is responsible for: Reviewing research proposals Determining suitability of studies to be performed Interfacing with UAB regarding timing and support available for studies Providing advice and guidance to the investigator Ensuring that the roles of investigator and co-investigator are clarified prior to initiation of study Providing oversight regarding data analysis and presentation Ensuring timely publication of the data CTRD Research Committee (2007 � 2008) 38

39. Howard Eisen, MD Committee Chair David C. Naftel, PhD Gregory Ewald, MD Adrian VanBakel, MD Mary Beth Hagan, MSN Database Committee is responsible for: Modifying database as data evolves Facilitating data collection and analyses Ensuring the quality of the data 39

40. Josef Stehlik, MD Committee Chair Neil Lewis, MD Si M. Pham, MD Guillermo Torre, MD Patricia Chang, MD Finance Committee is responsible for: Approval of funds to be received and disbursed Establishment of guidelines for expenses related to approved studies Provision of budgetary oversight of studies performed by the CTRD Supervision of efforts to receive funds to support the activities of CTRD 40

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42. CTRD Inclusion Criteria: Patients undergoing heart transplantation (with or without other simultaneous organ transplant) Patients 18 years of age or older at the time of transplant Patients undergoing re-transplantation if primary transplant occurred at your institution after your institution joined CTRD 42

43. CTRD Exclusion Criteria: Patients under the age of 18 at time of transplant. Patients undergoing re-transplantation if any of the previous transplants occurred at another institution (even if transplants occurred at another CTRD institution). Termination of Follow up: Any patient who has �transferred care� to another institution and �come back� to your institution. Once they leave CTRD, they cannot be followed any longer. 43

44. Cardiac Transplant Research DatabaseParticipating Centers 44

45. Impact of CTRD Research on Heart Transplant Community 45



48. CTRD: 22 Articles with 922 Citations (through Dec. 2007) Pre-transplantation Risk Factors for Death After Cardiac Transplantation: A Multi-Institutional Study, Dr. RC Bourge (176 citations, published 1993) Heart Transplant Coronary Artery Disease Detected by Coronary Angiography: A Multi-Institutional Study of Preoperative Donor and Recipient Risk Factors, Dr. MR Costanzo (172 citations, published 1998) Pre-transplantation Risk Factors for Acute Rejection after Heart Transplantation: A Multi-Institutional Study, Dr. JA Kobashigawa (66 citations, published 1993) Impact of CTRD Research on Heart Transplant Community 48

49. Impact of CTRD Research on Heart Transplant Clinical Practices Survival Improvement What has CTRD contributed? 49

50. Impact of CTRD Research on Heart Transplant Clinical Practices Rejection Improvement What has CTRD contributed? 50

51. Impact of CTRD Research on Heart Transplant Clinical Practices Infection Improvement What has CTRD contributed? 51

52. Impact of CTRD Research on Heart Transplant Clinical Practices Coronary Artery Disease Improvement What has CTRD contributed? 52

53. Impact of CTRD Research on Heart Transplant Clinical Practices Malignancy Improvement What has CTRD contributed? 53

54. Impact of CTRD Research on Heart Transplant Clinical Practices Listing Practices What has CTRD contributed? 54


56. Pediatric Heart Transplantation: 14 Years of Improving Results Illustrated by Patient Specific PredictionsDavid C Naftel, James K Kirklin, Daphne T Hsu, Elizabeth D Blume, Steve A Webber, William R Morrow, and Charles E Canter. Predicting Major Events 56

57. Purpose: A key issue in pediatric heart transplantation is whether results have improved with time. Assessment of the degree of improvement in pts with specific characteristics can estimate the era effect and produce patient specific survival predictions. Predicting Major Events 57

58. Methods and Materials: The Pediatric Heart Transplant Study began in 1993. Currently 30 sites submit data on transplanted patients. Parametric methods that model phases of risk and incorporate risk factors were used to analyze survival. The resultant hazard function and risk factor co-efficients were used to produce survival predictions according to specific risk factors. The effect of transplant date was explicitly modeled. Predicting Major Events 58

59. Results: Between 1993 and 2006, 2238 transplant patients were entered. Major risk factors for the early phase of risk were younger age (p=.02), female (p=.008), congenital heart disease (p<.001), any combination (p<.001) of VAD, IABP, ventilator and ECMO; for the constant phase of risk were older age (p<.001), African American (p<.001), previous sternotomy (p=.003), and recipient/donor gender mismatch (p=.02). Earlier year of transplant was a risk factor in both phases of risk (early: p=.002, constant: p=.03). The figure illustrates the predicted survival in 2 white male pts with male donors and no previous sternotomies: Patient A (13 yrs old) with non-congenital diagnosis. Patient B (1 yr) with congenital diagnosis. The predicted survival for these 2 patients if transplant in 1993 vs 2001 is illustrated. The difference in the two curves is an estimate of the improvement during this time frame. Predicting Major Events 59

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61. Conclusions: Pediatric heart transplantation continues to have improving results. Multivariable models can be used to predict survival for a specific patient. The predictions can also be used to portray the effect of date of operation. Predicting Major Events 61


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97. CTRD/PHTS Coordinator Study Process to make this happen 97


99. PHTS Timeline 99 2006 � Banner Year 2008 � Minor form revisions, move toward electronic data entry, 501�32006 � Banner Year 2008 � Minor form revisions, move toward electronic data entry, 501�3

100. 100 February and the beginning of March were our busiest months in the last year.February and the beginning of March were our busiest months in the last year.

101. 101 Please check the website for all ISHLT 2008 Material.Please check the website for all ISHLT 2008 Material.

102. All pediatric patients under 18 years of age listed for primary heart transplantation are included in the study. The only exclusions are: Patients who are greater than 18 years of age at the time of listing. Patients who are transplanted at an institution but the institution provides no care after discharge and is not involved in the medical followup of the patient. This must be a planned circumstance and is related to rules imposed by an insurance provider. This is a rare occurrence and should be discussed with the PHTS center. Patients that in combination with their primary heart transplant also receive another organ (e.g. lung or kidney) 102

103. 1st Quarter: January, February, March Due: April 30th 2nd Quarter: April, May, June Due: July 31st 3rd Quarter: July, August, September Due: October 31st 4th Quarter: October, November, December Due: January 31st 103 Reminder that 1st quarter data is due at the end of the month.Reminder that 1st quarter data is due at the end of the month.

104. PHTS Forms: Form # Name When to Submit Patient Listing Immediately after listing 1t Patient Transplant Immediately after transplant 2 Donor Immediately after transplant 3 Immunosuppression Submit at discharge 4 CAD and LV Function Assessment Immediately after the event 5 Rejection Immediately after the event 6 Infection Immediately after the event 7 Malignancy/Lymphoproliferative Immediately after the event 8 Status Report Immediately after clinic visit 9 Coronary Revascularization Immediately after the event 10 Death Immediately after the event Re-transplant Immediately after the event 104 Form 1 and 10 will only be filled out once. The other forms can be multiples.Form 1 and 10 will only be filled out once. The other forms can be multiples.

105. What do I submit on a listed patient? Form 1 (Listing) Only filled out once in patient lifetime Form 12 (Annual Followup) Form 10 (Death) You do NOT need to send in any other forms until patient is transplanted. What do I submit when a patient is retransplanted? Form 11 (Retransplant) Form 1t (Transplant) Form 2 (Donor) Form 3 (Immunosuppression) Any other events and follow up as needed. 105

106. CTRD Timeline 106

107. CTRD Websitewww.uab.edu/ctsresearch/ctrdUsername: coordinator Password: teige240 107

108. CTRD Website: Forms Pagewww.uab.edu/ctsresearch/ctrdUsername: coordinator Password: teige240 108

109. CTRD Data Collection Schedule: 109

110. CTRD Inclusion Criteria: Patients undergoing heart transplantation (with or without other simultaneous organ transplant) Patients 18 years of age or older at the time of transplant Patients undergoing re-transplantation if primary transplant occurred at your institution after your institution joined CTRD 110

111. CTRD Exclusion Criteria: Patients under the age of 18 at time of transplant. Patients undergoing re-transplantation if any of the previous transplants occurred at another institution (even if transplants occurred at another CTRD institution). Termination of Followup: Any patient who has �transferred care� to another institution and �come back� to your institution. Once they leave CTRD, they can not be followed any longer. 111

112. CTRD Forms: Form # Name When to Submit Initial Patient Entry (or re-transplant) Immediately after transplant Donor Immediately after transplant Immunosuppression and Hospital Discharge Submit at discharge CAD and LV Function Assessment Immediately after the event Rejection Immediately after the event Infection Immediately after the event Malignancy/Lymphoproliferative Disease Immediately after the event Status Report (3, 6, 12, 24 month) Immediately after follow-up visit Coronary Revascularization Immediately after the event Death Immediately after the event Re-transplant Immediately after the event Status Report (annual after 2nd year) Immediately after annual follow-up visit 112

113. Form 1: Question number 4a, multi-organ transplant. Please be sure to send us all your heart transplants with additional simultaneous organ transplants (lung, liver, kidney, pancreas, other). Form 3: Immunosuppression and Hospital Discharge. Always fill out Form 3. Form 8 and 12: Follow up. Send in a follow up form, even if the patient misses their annual follow up. This lets us know that you haven�t forgotten the form. If a patient has transferred care to another institution, let us know. When an annual is missed determine if the patient just missed the appointment, has died or has transferred care. UNOS needs to know, so just let us know also.

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116. General Data Entry Issues: Make sure that all forms submitted have vital information. This means a complete id (institution code, patient number, re-transplant code, and patient initials). Checking Boxes in forms: When it says to check only one box on the form, please only check one box. Form Correction: If you send in a corrected form, please mark at the top of the form that this is a correction and circle the data you are correcting. Patient Consent: Please make sure that you consent your patients pre-transplant. This is extremely important.

117. Of the 27 participating centers in the 2007 report, 15 require informed consent for entry of a patient�s data into CTRD. On the following plots, the effect of starting a program of consent on reported mortality is demonstrated. Of the 15 institutions, 8 had 2 years of CTRD data before and after the start of informed consent. For the non-consent institutions, a date was chosen that approximated the median time that consent programs started. Several of these dates were tried, and the results were the same. The effect of consenting patients varies widely. As can be seen on the plot for Institution �A�, there may be no effect at all. This probably reflects pretransplant consenting. On the other hand, as the plot for Institution �B� demonstrates, the effect of consent may be profound. This probably reflects post-transplant consenting of survivors. The last example (Institution C) reflects a change in the method of consenting to post-transplant, even though prior to the change consenting did not seem to affect reported mortality. Of the 27 participating centers in the 2007 report, 15 require informed consent for entry of a patient�s data into CTRD. On the following plots, the effect of starting a program of consent on reported mortality is demonstrated. Of the 15 institutions, 8 had 2 years of CTRD data before and after the start of informed consent. For the non-consent institutions, a date was chosen that approximated the median time that consent programs started. Several of these dates were tried, and the results were the same. The effect of consenting patients varies widely. As can be seen on the plot for Institution �A�, there may be no effect at all. This probably reflects pretransplant consenting. On the other hand, as the plot for Institution �B� demonstrates, the effect of consent may be profound. This probably reflects post-transplant consenting of survivors. The last example (Institution C) reflects a change in the method of consenting to post-transplant, even though prior to the change consenting did not seem to affect reported mortality.

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122. For questions regarding CTRD form completion, please contact: Nicole Kirklin, Program Manager Office: 205-975-7810 Fax: 205-975-0085 Email: nkirklin@uab.edu Connie White-Williams, RN, MSN Office: 205-975-8611 Fax: 205-975-9792 Email: cwwilli@uabmc.edu Rob Brown, Data Manager Office: 205-934-2553 Fax: 205-975-0085 Email: rnbrown@uab.edu 122

123. For questions regarding PHTS form completion, please contact: Rebekah Burder, Program Manager Office: 205-975-0086 Fax: 205-975-0085 Email: rburder@uab.edu Margaret Foushee, Data Manager Office: 205-996-5897 Fax: 205-975-0085 Email: mtresler@uab.edu Rob Brown, Data Manager Office: 205-934-2553 Fax: 205-975-0085 Email: rnbrown@uab.edu 123

124. It�s All About the Data: Survey Responses I have been a transplant coordinator for�. PHTS CTRD Less than one year 3 (11%) 1 (7%) One to five years 8 (29%) 1 (7%) Five to ten years 8 (29%) 5 (33%) More than ten years 8 (29%) 8 (53%) I have been submitting data for�. Less than one year 3 (11%) - One to five years 11 (41%) 8 (50%) Five to ten years 9 (33%) 6 (38%) More than ten years 4 (15%) 2 (13%) 124

125. It�s All About the Data: Survey Responses Typically, I find data by� PHTS CTRD UNOS Database 1 (4%) - Chart Review 14 (52%) 11 (69%) Both 10 (37%) 4 (25%) Institutional Database 2 (7%) 1 (6%) I prefer�. Electronic Entry 21 (78%) 12 (80%) Paper Forms 5 (18%) 3 (20%) Either 1 (4%) - 125

126. I fill out forms� PHTS CTRD as I see each patient 1 (4%) 2 (13%) as each event happens 9 (34%) 4 (25%) at the end of the quarter 8 (31%) 5 (31%) at the end of the year 6 (23%) 2 (13%) when I am able to 2 (8%) 3 (19%) I spend�.on data submission. Less than one hour per week 3 (13%) 2 (13%) One hour per week 12 (52%) 5 (31%) Two to five hours per week 6 (26%) 8 (50%) More than five hours per week 1 (4%) 1 (6%) 3-4 days at the end of the year 1 (4%) - It�s All About the Data: Survey Responses 126

127. It�s All About the Data: Survey Responses I spend�.on UNOS data submission. PHTS CTRD Less than one hour per week 4 (17%) - One hour per week 8 (33%) 1 (6%) Two to five hours per week 4 (17%) 6 (38%) More than five hours per week 1 (4%) 2 (13%) Quarterly 1 (4%) 2 (13%) Annually - - Not responsible for UNOS Data 6 (25%) 5 (31%) 127

128. It�s All About the Data: Survey Responses (PHTS) How do you benefit from PHTS? It helps me keep up with patients. It keeps up my interest in transplant care. Our data is more consistent because of PHTS. The publications are interesting. It is very educational. I have access to support and knowledge of other coordinators. There is no benefit. 128

129. It�s All About the Data: Survey Responses (CTRD) How do you benefit from CTRD ? Available pool of transplant data. It is an avenue to search data. I learn by reading abstracts/journal articles. Tracks data. Great networking opportunity. Available for query. Good place to keep and reference donor information for each recipient. Can pull data regarding our centers performance in comparison to others. Chart review helpful learning more about particular patients. Forms are quick access to data. The yearly forms are interesting. Unfortunately, we gain very little benefit. 129

130. It�s All About the Data: Survey Responses (PHTS) How does your hospital benefit from PHTS? It helped us build an institutional database. We share information with other hospitals to increase quality of care. It gives us access to up to date information and resources for patients. It helps us evaluate our program. It helps us track our trends. It helps us with research. It does not benefit. Projects are hung up in Alabama. 130

131. It�s All About the Data: Survey Responses (CTRD) How does your hospital benefit from CTRD? Helps for QM/PI initiatives and gives snapshot view of program. We feel this is the most respected database for transplant patients and appreciate receiving benchmark data back. Available for query. Patient care is improved with the availability of CTRD data and provides a useful tool for our center to review and use to make changes according to information results. Source to compare data/outcomes. The PI authors/co-authors multiple abstracts. None that I can see. Never has used the information. Again, very little. The prestige only. 131

132. It�s All About the Data: Survey Responses What PHTS changes would you like to see? I would like to see PHTS go electronic. I would like to have more coordinator studies. I would like better access to center-specific data. I would like easier access to data queries. I would like to meet more coordinators. What CTRD changes would you like to see? I would like to see CTRD go electronic. Take all the UNOS parameters off the CTRD forms as it is duplication. I would like easier access to data queries. 132

133. It�s All About the Data: Survey Responses Why won�t you be able to attend the meetings at ISHLT? We do not have the funding. 8 I typically go to AHA not ISHLT. 3 Travel? What travel? I�m chained to my desk! 6 Work schedule does not permit, not enough coordinators. 4 Hospital does not support coordinator travel 1 133

134. 134 What does a great institution do? Sends IRB approval notice before expiration date Pays dues Submits complete data Has timely data submission Has good response time to email Asks questions when in doubt

135. 135 What does a great DCC do? Has good response time to email Asks questions when in doubt Keeps in contact with coordinators and principal investigators Completes analyses in a timely manner Provides clear instructions for form completion via manuals (with frequent revisions and updates) and form reviews.

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137. 137 These forms are available online. These forms are available online.

138. To be included in the final research database you must have: 1. Current IRB 2. Current Dues 3. Complete Data a. Listings (PHTS only) b. Transplants (reconciled with UNOS) c. Followup and Events d. Year End data received by March 1st 138

139. What it takes to have analyzable data: 1. Timely submission from institution (critical for the DCC to stay on track for deadline) 2. Data are: a. Received and separated for entry b. Entered by form type c. Entered forms are printed daily d. Forms are checked by two people e. Data entry (DCC) errors are corrected f. Data entry (Institutional) errors are collected and sent back quarterly g. Quarterly corrections are received back from institution h. Corrections are entered i. Forms are filed 139


142. Dates of transplant: 01/01/1990 � 12/31/2006 Total number of transplants: 7352 Current # participating institutions: 27

143. To be included in the final research database you must have: 1. Current IRB 2. Current Dues 3. Complete Data a. Listings (PHTS only) b. Transplants (reconciled with UNOS) c. Follow-up and Events d. Year End data received by March 1st

144. Work closely with coordinators to ensure timely and complete data submission Ensure timely and accurate data entry Double check data entry in a timely manner Work with coordinators to correct errors found during this process Check number of transplants reported by institution against UNOS report

145. Beyond a Better Data Set Initial data entry and double checking are completed in a timely manner Quality Improvement processes for overall data set are completed on a quarterly basis Timely feedback to coordinators is maintained Reviews information previously shown After initial data entry and checking have been completed: adds significant importance to data submission guidelines Combines previous sporadic data checks to quarterly requests. Reviews information previously shown After initial data entry and checking have been completed: adds significant importance to data submission guidelines Combines previous sporadic data checks to quarterly requests.

146. Data Quality Improvement Obvious problems Missing values Dates Missing forms Not quite as obvious problems (You, too, may come to love data) Common sense Information collected two ways Clinical relevance Obvious problems Missing Values (age, gender, etc) Dates Events other than listing occur before transplant Missing forms Retransplant (Form 11) with no new transplant form Not as obvious You, too, may come to love data because this makes you think�.. Common sense (Can usually see graphically) Information collected two ways Clinical relevance Obvious problems Missing Values (age, gender, etc) Dates Events other than listing occur before transplant Missing forms Retransplant (Form 11) with no new transplant form Not as obvious You, too, may come to love data because this makes you think�.. Common sense (Can usually see graphically) Information collected two ways Clinical relevance

147. Data Quality Improvement Obvious problems Missing values Dates Missing forms Not quite as obvious problems Common sense Information collected two ways Clinical relevance Obvious problems Missing Values (age, gender, etc) Dates Events other than listing occur before transplant Missing forms Retransplant (Form 11) with no new transplant form Not as obvious Common sense (Can usually see graphically) Information collected two ways Clinical relevance Obvious problems Missing Values (age, gender, etc) Dates Events other than listing occur before transplant Missing forms Retransplant (Form 11) with no new transplant form Not as obvious Common sense (Can usually see graphically) Information collected two ways Clinical relevance


151. This example actually fits into several categories, because the higher donor ages would also raise a flag for clinical relevance, but I am going to use different topic to address that issues.This example actually fits into several categories, because the higher donor ages would also raise a flag for clinical relevance, but I am going to use different topic to address that issues.


156. PHTS Items in Your Packet Overall PHTS information Listing and transplant totals for 2007* and since inception Demographic information for IRB submission Center-specific information Patient-specific listings and transplants for 2007* Lists of patients with missing or questionable data (please return to the DCC) * Data entered and checked as of 04/01/2008

157. CTRD Items in Your Packet Overall CTRD information 2007 Annual Report Center-specific information Comparison of your institution�s total reported 2007 transplants* and the UNOS reported total Patient-specific transplants and follow-up from the last data set. This DOES NOT include 2007 transplants. * Data entered and checked as of 04/01/2008

158. Summary COORDINATOR�s timely submission of data impacts data QI process COORDINATOR�s timely corrections and clarifications impact quality of final data set While the DCC�s work is measured in part by the quality of the data, we recognize that the COORDINATOR is the real key to quality!

159. Things We Might Have in Common NOW Data are (somewhat ?) fun. AKA: This presentation about data was not nearly as painful as I thought it might be.

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161. You�re in Control! Table Sessions Questions to Consider 1. Any ideas for a coordinator initiated study? 2. Are there any significant data we are not capturing? 3. How can the website be improved? 4. Suggestions for a better/closer working relationship between the DCC and Coordinators 161


163. Coordinator Recognition: Quiz What year were the PHTS / CTRD forms last updated? CTRD 2005 PHTS 2005 � CTRD and PHTS forms should be sent in ___. Annually Whenever I have them finished Quarterly Monthly None of the above � What is the most important information you must put on each form (which is sometimes left blank)? The patient ID which consists of; Institution code, patient number, patient initials � CTRD form 3 should be completed and mailed in __ days post transplant OR after hospital discharge. 30 days � What is CTRD / PHTS form 5 used for? CTRD: Rejection PHTS: Rejection � Which forms are used to track patient follow up? CTRD: Form 8 (3, 6, 12, 24 months) and Form 12 (annual follow up > 2 yrs) PHTS: Form 8 and Form 12 � 163

164. Coordinator Recognition: Quiz True or False CTRD / PHTS collect only primary heart transplants. False, CTRD collects the following: heart and additional simultaneous organ transplant including lung, liver, kidney, other. PHTS: True � True or False CTRD does not collect multi organ transplants? False; CTRD collects heart/liver, heart/kidney, heart/lung, heart/pancreas, heart/other � True or False Coordinator meetings are mandatory for each CTRD / PHTS coordinator to attend True True or False It is ok to leave off the sex of the patient. False � What is question 7 of Form 8? CTRD: Current maintenance Immunosuppression PHTS: Medications � �Tiebreaker: How much was Paul McCartney ordered to pay Heather Mills in their recent divorce settlement? 48.6 Million 164

165. The End Take Home: 1. Fill out follow-up forms as they occur. 2. Call us if you have questions. 3. Our research is making a difference. 165

CTRD

CTRD

Presentation Transcript

CTRD 3700 8:00 – 8:50 9:00 – 9:50

CTRD 3700 8:00 – 8:50 9:00 – 9:50

CTRD 3700 8:00 – 8:50 9:00 – 9:50