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Based on the 2016 CIBMTR Summary Slides, infection is reported as the primary cause of death in up to 18% of patients receiving autologous and allogeneic transplantation. However, transplant clinicians recognize that infection accounts for significantly greater morbidity in our patients. This burden of infections and its correlation with post-transplant immune reconstitution is the focus of our committee’s efforts.
The Infection and Immune Reconstitution Committee faces unique challenges due to the complex interactions of multiple time-dependent co-variates as well as the complexities associated with reporting multiple (and often recurrent) infections caused by a diverse range of pathogens. The rates of post-transplant infections are also associated with a variety of factors, including graft type, donor-recipient mismatch, recipient age, and GVHD incidence. Furthermore, infections prior to the transplant impact transplant outcomes. Given the complexity of these factors, our analyses rely heavily on novel statistical techniques provided by our excellent Statistician, Min Chen, MS, and our Statistical Director, Soyoung Kim, PhD, with the assistance of Kwang Woo Ahn, PhD.
The committee recognizes that data collection for infections and immune reconstitution is complex and particularly demanding. In part, the significant effort required to document infection endpoints has contributed to under-reporting biases evident in prior analyses. Given this complexity, we greatly appreciate the time involved by all data managers to provide us with the high-quality data needed to understand and improve infection-related transplant outcomes. To streamline and improve the quality of infection-related data, the committee leadership formed a task force with the ASBMT Infectious Disease Special Interest Group to redesign data collection mechanisms.
In January 2017, the CIBMTR released revisions to Form 2100 for infection prophylaxis, revised organisms of interest for capture, and capture at limited sites of interest. Revisions to the Data Manager Manual to facilitate collection accompanied the release. Furthermore, revisions to the fungal forms (2046 / 2146) and new forms to obtain detail on CMV / Adenovirus / EBV / HHV-6 (2150), and upper respiratory viruses (2149) are anticipated for release later this year. These revisions, developed in collaboration with data managers, capture limited information about diagnosis, treatment, and response to therapy. These forms are triggered forms based upon the organism reported and accounting for the site of infection. While limited in scope, the data will provide investigators a more global picture of infection complications following transplant. Dr. Riches presented these forms at the Data Managers Meeting and to the committee at the 2017 BMT Tandem Meetings in Orlando.
The past academic year has been quite productive. In addition to the activities of forms revision, investigators published four manuscripts of study results. Four additional studies currently have five manuscripts in preparation of final results. While all studies to date have focused on infections, the committee desires to expand our efforts to study correlates of immune recovery, including lymphocyte subsets and immunoglobulin levels, especially as the quantity and quality of these data improve over time. The committee welcomes proposals to further investigate these issues.
View planned, in-progress and completed studies and publications on the Infection and Immune Reconstitution Working Committee webpage.
Consumer Advocacy Committee Representative
The main goal of Health Services and International Studies Working Committee (HSIS WC) is to help improve the practice of HCT through health services research at a global level. The HSIS WC is the result of the 2013 merger of the Health Policy / Psychosocial Issues WC and the International Studies WC. We bring together an enthusiastic and diverse group of BMT investigators worldwide, representing varied clinical and research backgrounds. Studies in this WC include population-based studies to understand better questions around disparities in access and outcomes of HCT, practice patterns in HCT, and impact of HCT related variables on outcomes other than survival, such as costs and health care utilization. To complete these studies, we not only query the CIBMTR Research Database, but we also link it to other large databases both nationally and internationally to get a true population-based perspective. In addition, our WC strives to ensure good quality registry data by understanding gaps in follow-up, lead efforts in the area of improving international data collection, and help improve outcomes reporting by the CIBMTR by studying the impact of social determinants on outcomes. Our WC gives international centers the opportunity to ask research questions regarding their populations.
In the last five years, our combined WC published 19 papers, and our current portfolio contains 10 active studies. The HSIS WC works closely with the CIBMTR Health Services Research Program operated by NMDP/Be The Match’s Patient and Health Professional Services department. The Health Services Research Program typically conducts investigator-initiated studies that require expertise and resources beyond those usually needed for CIBMTR studies. Currently, the HSIS WC and Health Services Research Program are partnering on a study, Safety and Cost-Effectiveness of Outpatient Autologous Stem Cell Transplantation: A Multicenter Retrospective Case-Control Study Using Propensity Score Matching.
If you have an idea for an innovative outcomes-related or international study, let us know. View planned, in-progress and completed studies and publications on the Health Services and International Studies Working Committee webpage.
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The BMT Tandem Meetings - the combined annual meetings of the CIBMTR and ASBMT - are North America’s largest international gathering of BMT clinicians and investigators, laboratory technicians, advanced practice professionals, transplant nurses, pharmacists, administrators, and clinical research associates since 1999.
Leading authorities from around the world will present the latest developments in blood and marrow transplantation February 21-25, 2018, during the BMT Tandem Meetings at the Salt Palace Convention Center in Salt Lake City, Utah. Along with state-of-the-art educational offerings, industry-supported satellite sessions and product theaters will broaden the spectrum of presentations. In addition to an outstanding scientific program, the 2018 meetings offer peripheral sessions for BMT pharmacists, center administrators, coordinators, investigators, medical directors, clinical research professionals / data managers, transplant nurses, and advanced practitioners.
The online registration, abstract, and housing site opens mid-August. The early registration and abstract deadline is October 3. After registering, take advantage of special conference guest room rates offered at several hotels in the BMT Tandem Meetings housing block near the Salt Palace Convention Center. Don’t forget to reserve your ticket to the Saturday evening Tandem Reception to end a memorable week with colleagues and friends!
Questions regarding support opportunities at the 2018 BMT Tandem Meetings may be directed to Sherry Fisher, Director of Advancement for the CIBMTR. For general information, email email@example.com.
We look forward to seeing you in Salt Lake City!
The CIBMTR Health Services Research Program includes Lih-Wen Mau, PhD Investigator / Supervisor; Tatenda Mupfudze, PhD-level Health Services Research Analyst; Christa Meyer and Jaime Preussler, MS-trained Analysts; and Ellen Denzen, MS, Senior Manager. Oversight is provided by Linda Burns, MD, Vice President and Senior Scientific Director, and Elizabeth Murphy, Vice President, Patient and Health Professional Services and Education and Training. The Program is located in Minneapolis at the National Marrow Donor Program/Be The Match Coordinating Center.
The Program’s vision is to conduct research that contributes knowledge to the transplant field and informs policy, clinical practice, and survivorship issues, while fostering a culture of learning, integrity, and excellence. The overarching goals are to identify and address barriers to access to HCT, improve practice of HCT, and demonstrate the value of cellular therapies (compared to other therapies) and survivorship care through research and dissemination of findings.Data sources are varied and include public and commercial administrative claims linked to the CIBMTR Research Database clinical outcomes, prospective assessments, survey research, and qualitative interviews. The Health Services Research Program currently has 11 studies in progress and has published 18 papers since its creation in 2006. Select studies include:
The Health Services Research Program collaborates closely with internal and external partners by contributing research design and methodology expertise, grant proposal analytic support, administrative support and data collection services. Examples of partners include the BMT CTN, RCI BMT, Survey Research Group and NMDP/Be The Match Payer Policy, independent investigators, ASBMT, ASH, and Oncology Nursing Society. Funding for studies is provided in part by PCORI, the National Comprehensive Cancer Network / Pfizer, NIH, HRSA, and others.
By Tiffany Hunt, MS, CCRP, and Emilie Love, CSPO
Over the past year, teams of experts worked to revise and develop CIBMTR data collection forms was to capture the newest and most relevant data. As a result, 10 revised forms were released in July:
The Disease Classification Form 2402 (formerly Pre-TED Disease Classification) and the ALL Disease Inserts are now used to capture data for cellular therapies. This change was made to ensure all necessary disease specific data are captured, reduce duplication across forms, and provide consistency in data reporting.
For more details on form changes and the form revision process, please contact Emilie Love or Tiffany Hunt .
BMT CTN Publications
There are 76 BMT CTN published articles, including 21 primary analyses. The following secondary analysis manuscripts were recently published, representing the tenth and fourth 0302 and 0402 publications, respectively!
About the BMT CTN
The CIBMTR shares administration of the BMT CTN Data and Coordinating Center with National Marrow Donor Program/Be The Match® and The Emmes Corporation®. Together, these three organizations support all BMT CTN activities. The BMT CTN Steering Committee is currently under the leadership of Chair Steve Devine, MD, Ohio State University. Rick Jones, MD, Johns Hopkins, is Chair-Elect and Helen Heslop, MD, Baylor College of Medicine, is Vice-Chair.
To get up-to-date information about BMT CTN studies, meetings, and news:facebook.com/bmtctntwitter.com/bmtctn (@BMTCTN)
For any questions about the HSR Program, contact Ellen Denzen, MS, Senior Manager, Health Services Research or visit the Health Services Research webpage.
Our SupportersThe CIBMTR is supported by Public Health Service Grant/Cooperative Agreement 5U24-CA076518 from the National Cancer Institute (NCI), the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID); a Grant/Cooperative Agreement 5U10HL069294 from NHLBI and NCI; a contract HHSH250201200016C with Health Resources and Services Administration (HRSA/DHHS); two Grants N00014-13-1-0039 and N00014-14-1-0028 from the Office of Naval Research; and grants from our corporate and private contributors.