2016 Health Services and International Studies Minutes and 2016-2017 Overview Plan
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Not for publication or presentation MINUTES AND OVERVIEW PLAN CIBMTR WORKING COMMITTEE FOR HEALTH SERVICES AND INTERNATIONAL STUDIES Honolulu, Hawaii Friday, February 19, 2016, 12:15 – 2:15 PM Co-Chair: Yoshiko Atsuta, MD, PhD, Japanese Data Center for Hematopoietic Cell Transplantation, Nagoya, Japan; Telephone: 81-52-719-1973; E-mail: y- [email protected] Co-Chair: Jignesh Dalal, MD; The Children's Mercy Hospitals and Clinics, Kansas City, MO; Telephone: 816-234-3265; E-mail: [email protected] Co-Chair: Theresa Hahn, PhD, Roswell Park Cancer Institute, Buffalo, NY; Telephone: 716-845-5819; E-mail: [email protected] Co-Chair: Nandita Khera, MD, Mayo Clinic Arizona, Phoenix, AZ; Telephone: 480-342-0195; Email: [email protected] Co-Chair: Carmen Sales-Bonfim, MD, Hospital de Clinicas – UFPR, Curitiba, Brazil; Telephone: 55-41-3360-1000; E-mail: [email protected] Scientific Wael Saber, MD, MS, CIBMTR Statistical Center; Director: Telephone: 414-805-0677; Email: [email protected] Statistical Ruta Brazauskas, PhD, CIBMTR Statistical Center; Director: Telephone: 414-955-8687; E-mail: [email protected] Statistician: Naya He, MPH, CIBMTR Statistical Center; Telephone: 414-805-0685; E-mail: [email protected] 1. Introduction a. Minutes and Overview Plan from February 2015 meeting b. Instructions for sign-in and voting The meeting was called to order at 12:15pm by Dr. Saber. Dr. Saber described the goals, expectations, and limitations of the committee, and he gave an introduction of the data were collected in CRF and TED database. He also explained the voting process, role of working committee members, rules of authorship and statistical hour allocation, and importance of the conference evaluations. Dr. Atsuta will be completing her 5-year term as co-Chair at the end of this month. On behalf of the committee, Dr. Saber thanked Dr. Atsuta for her leadership and service to the committee. 2. Accrual summary Due to the full agenda, the accrual summary of registration and research cases between 2008 and 2015 were not presented to the committee but were available as part of the Working Committee attachments. Not for publication or presentation 3. Presentations, published or submitted papers Dr. Atsuta briefly reviewed the six manuscripts published, submitted, and/or presented during the last year in the Health Service and International Studies Working Committee. a. HS11-01 N Khera, NS Majhail, R Brazauskas, Z Wang, N He, MD Aljurf, G Akpek, Y Atsuta, S Beattie, CN Bredeson, LJ Burns, JD Dalal, CO Freytes, V Gupta, Y Inamoto, HM Lazarus, CF LeMaistre, A Steinberg, D Szwajcer, JR Wingard, B Wirk, WA Wood, S Joffe, TE Hahn, FR Loberiza, C Anasetti, MM Horowitz, SJ Lee. Comparison of characteristics and outcomes of trial participants and nonparticipants: example of blood and marrow transplant clinical trials network 0201 Trial. Biology of Blood and Marrow Transplant. 2015 Oct;21(10):1815-22.doi: 10.1016 b. HS13-03 JM. Knight, JD Rizzo, BR. Logan, T Wang, JM.G. Arevalo, J Ma, SW. Cole .Low socioeconomic status, adverse gene expression profiles, and clinical outcomes in hematopoietic stem cell transplant recipients. Clinical Cancer Research 2015. 2016 Jan 1; 22(1):69-78.doi: 10.1158/1078-0432.CCR-15-1344. c. HS13-02 SD. Arnold, P Satwani, R Brazauskas, N He, Y Li, R Aplenc, Z Jin, M Hall, Y Atsuta, J Dalal, T Hahn, C Sales-Bonfim, N Khera, W Saber. A study of Predictors of clinical outcomes AND Healthcare utilization in children with sickle cell disease Undergoing Allogeneic hematopoietic cell transplantation. Oral presented at ASH meeting in Orlando, FL, December 2015. d. HS13-01 A El-Jawahri, Y-B Chen, R Brazauskas, N He, S Lee, J Knight, N Khera, T Hahn, J Dalal, C Bonflm, Y Atsuta, W Saber. Association of Pre-Transplant Depression with Clinical Outcomes and Resource Utilization after Allogeneic Hematopoietic Stem Cell Transplantation. Oral presented at ASH meeting in Orlando, FL, December 2015. Oral presentation at BMT Tandem Meetings in Honolulu, Hawaii, February 2016. Received a Best Abstract Award. e. IS09-02 R Kumar, F Kimura, K Woo Ahn, Z-H Hu, Y Kuwatsuka, J P. Klein, M Pasquini, K Miyamura, K Kato, A Yoshimi, Y Inamoto, T Ichinohe, W Allen Wood Jr, B Wirk, M Seftel, P Rowlings, D Marks, K R. Schultz, Vi Gupta, L Dedeken, B George, J-Y Cahn, J Szer, J Wook Lee, A Ho Yew Leng, A Fasth, T Hahn, N Khera, J Dalal, C Bonfim, M Aljurf, Y Atsuta, W Saber. Comparing Outcomes with Bone Marrow or Peripheral Blood Stem Cells as Graft Source for Matched Sibling Transplants in Severe Aplastic Anemia across Different Economic Regions. Accepted by BBMT 2016. f. IS13-01 J Kanda , R Brazauskas, Z-H Hu, Y Kuwatsuka, K Nagafuji, H Kanamori , Y Kanda, K Miyamura , M Murata ,T Fukuda , H Sakamaki, F Kimura, S Seo, M Aljurf , A Yoshimi, G Milone, W A Wood , C Ustun, S Hashimi, M Pasquini, C Bonfim, J Dalal, T Hahn, Y Atsuta, W Saber. GVHD after HLA-matched sibling BMT or PBSCT: Comparison of North American Caucasian and Japanese Populations. Accepted by BBMT 2015. Not for publication or presentation 4. Studies in progress a. HS07-02b Long term financial impact of allogeneic HCT on patient and family (K Pederson/N Majhail) Manuscript Preparation b. HS12-02 Rates of Transplantation in Urban vs Rural Patients: Are Rural Patients Less Likely to Receive an Allogeneic Transplant? (K Paulson/ M Seftel/ D Szwajcer) Analysis c. IS10-01 Outcomes of HCT for ALL: an international comparative analysis (W Wood) Data File Preparation d. HS13-01 The effect of pre-transplant depression on outcomes of stem cell transplantation for hematologic malignancies (A El-Jawahri/YB Chen) Manuscript Preparation e. HS13-02 Investigating inpatient health care utilization of matched sibling donor hematopoietic cell transplantation for children with sickle cell disease (S Arnold/ P Satwani) Manuscript Preparation f. HS14-01 Investigating clinical outcomes and inpatient health care resource utilization of hematopoietic cell transplantation for children with acute leukemia (S Arnold/ R Aplenc/M Pulsipher/P Satwani) Analysis g. HS15-01 Who is lost to follow-up in the Center for International Blood and Marrow Transplant Research (CIBMTR) registry? (D Buchbinder/ T Hahn/ K Ballen/ W Saber/ S Parsons) Protocol Development h. HS15-02 Impact of socioeconomic status on pediatric stem cell transplant outcomes (K Bona/ J Wolfe/ C Duncan/ L Lehmann) Protocol Development 5. Future/proposed studies a. PROP 1511-32 Community Disparity Score for Allogeneic and Autologous Transplantation(S Hong / N S Majhail ) Dr. Hong presented this proposal. The specific aim of this study is to examine different measures of healthcare disparities described in County Health Rankings to create and validate a Community Disparity Score for autologous and allogeneic HCTs. Dr. Majhail noted that the Community Health Score and Rankings is a publicly available data source. Dr. Hahn asked how to apply the community health score to the target population since it was updated yearly. Dr. Hong replied it depends on the variation of the scores. If there are a lot of variations she will look into each year. If not, she will use 2010’s data since it’s the median year of the study period. In responding to a participant questioning what is the population that this study looking at, Dr. Hong replied that this study will validate the disparity score using the data from patients who received transplant reported to the CIBMTR. Dr. Hong explained the disparity score will be used to describe the health care disparities and help each county to improve their health care disparity by using the disparity score. Dr. Atsuta noted concern on how to adjust the center effect. Dr. Hong replied it wasn’t in her analysis plan yet but will be considered. b. PROP 1511-06 Impact of economic status on severity of acute graft-versus-host disease and subsequent mortality(J Kanda/ Y Atsuta/ T Teshima) Dr. Kanda presented this proposal. The objectives of this study are analyze effect of economic index on incidence of grades 2 to 4 acute GVHD and analyze effect of economic index on NRM after development of grades 2 to 4 acute GVHD. Several meeting participants noted concern regarding the small sample size in the lower-middle income country which could bias the result. Some participants commented that in addition to income, biology plays an important part on the incidence of acute Not for publication or presentation GVHD. In responding to Dr.Bonfim questioning how to adjust the effect of stem cell source on acute GVHD, Dr. Kanda explained he will classify the stem cell source to three groups. One participant suggested looking at effect of economic index on acute GVHD by year to get more information. c. PROP 1511-18 Trends in utilization and outcomes of Autologous and Allogeneic Hematopoietic cell transplantation in racial and ethnic minorities (N Khera/ T Hahn/ S Ailawadhi / W Saber) Dr. Khera presented this proposal. The specific aims of the study are two-fold: 1. Describe changes in the utilization of autologous and allogeneic HCT for hematological malignancies (Auto in myeloma, lymphoma; Allo in AML, ALL and MDS/ MPD) among patients of different racial/ ethnic minority groups from 2000 to 2014. 2. Examine trends in outcomes following autologous and allogeneic HCT for hematological malignancies(Auto in myeloma, lymphoma; Allo in AML, ALL and MDS/ MPD) across different race and ethnicities from 2000 to 2014. One participant suggested separating race group by age since it’s found that minorities are increased in pediatric group. Dr. Khera responded positively to this idea. One participant noted that there is a similar study published in 2004 also looking at the association between race and HCT outcomes.