High Value Reports in HCT Status Update Feb 2016

Transcription

1 High Value Reports in HCT Status Update 2015 Feb

2 Highlights of SCTOD expectations Collect data (and specimens) ALL allogeneic HCTs with a U.S. recipient or donor Related donor-recipient repository Other cellular therapies Quality of life data Secure, efficient electronic data capture system Analyze data Center-specific outcomes for U.S. centers: related and unrelated donor transplants Perform analyses of optimal size for the adult donor registry and cord blood unit inventory Conduct and support other research using the data collected under the contract Disseminate data Within the Program To the scientific and medical community To patients, families and the public

3 Center Outcomes Report 2015

4 Center Outcomes Cycle and Timeline Continuous Data Collection, CPI, Data confirmation by centers Data File preparation Analysis and Review Draft Report Submitted HRSA review and approval Publication Centers and Website January - April May - August September 1 November Dec - January Center Volumes

5 What is the MAIN goal?! Provide an equitable, balanced, scientific performance measurement tool(s) that can be used by the profession to define and improve quality. While: Acknowledging limitations Avoiding misuse/misinterpretation Striving for continuous improvement Be a resource to support the HCT community

6 Center Outcomes Report Final study population Centers must have >90% overall f/u at 1 year 5 centers closed or became inactive 173 centers; 22,174 patients first allo HCT Primary outcome: One year survival Overall: 68.0% (72% REL, 65% UNR) Center outcomes report 2015 includes 3 full years of data: Unrelated and Related HCT

7 Center Outcomes Report year rolling time window Outcome: 1 year survival Multivariate analysis adjusts for risk factors Full data on HCT Comorbidity Index (Sorror, et al) Reports for 2015 sent to centers Dec 2015 Additional univariate descriptive reports for centers accompany report 2015 Reports available on web Dec Reports sent directly to payers Dec 2015

8 Center Outcomes Report What changed in ? Better discrimination of disease status for: CML, CLL and MDS Removal of case mix summary score Frequently misunderstood, misinterpreted, misused Removal of graft type as a co-variate from model Removed the conditioning intensity from the multivariate models in 2015 Previously included only for limited diseases Lymphoma, PCD, other chronic leukemia not CLL, solid tumors Minimize center-based factors Correlated with several other variables in model, including prior autohct, KPS, HCT-CI and age

9 How are we doing? 2015 Risk Adjusted Performance 16% 10% Above Expected As Expected Below Expected 74% N = 173 9

10 What about missing data? Incomplete follow-up compromises outcomes Require minimum of 90% (or more) completeness of follow-up at the center Censored data logistic regression model Special case: Incomplete follow-up but complete reporting of those deceased (easier) Incomplete data puts centers at risk! Example: HCT-CI data Missing data for covariates If adequate number, model missing as a category Small numbers of missing data can be imputed 10

11 Your commitment matters! We are all about data aquiring it accurately, completely, efficiently AND making maximal use of those same data The efforts of data professionals has made a substantial difference over time. For the 2016 report, substantially fewer queries to centers to prepare the data file are necessary. 11

12 Reporting Results

13 Reporting Results - Centers Detailed report that includes overview, methods, descriptive tables and Results of risk adjustment model: Odds ratios (95% CI s) for one year survival (>1 means better survival) For each center, we include a table with Number of tx Observed survival Predicted survival 95% prediction interval Current performance indication Historical performance Graphical representations can also be helpful

14 Reporting Results 14

15 Reporting Results

16 Reporting Results - Public Results are posted online annually in January and accessible through HRSA website Be the Match CIBMTR Public reports are text-based single center descriptions of outcome vs expected Formats changing to better represent the data and more understandable to public Reports are also provided to payers

17 17

18 TC Directory Patient Survival 18

19 Reformat Center Listing Mobile Device Optimized 19

20 Possible Redesign of Outcomes Display Symbols Below expected As expected Above expected Graphic Updated language 20

21 What is the center outcomes forum? Bi-annual meeting to discuss the center specific survival analysis for hematopoietic cell transplantation (HCT) the highest impact report produced for the Stem Cell Therapeutics Outcomes Database (SCTOD) 1-2 day meeting 2008, 2010, 2012, 2014 Invitees include: HCT centers/community, ASBMT Quality Outcomes Committee, biostatisticians, quality and reporting methodologists, patients, payers, National Institutes of Health/Office of Naval Research/Health Resources and Services Administration representatives Held in MKE, MSP with average costs < $50,000 Highly rated by attendees 21

22 What Progress have we made? Increasing utilization of high value data for the HCT community 22

23 Key Question 2: What reports can CIBMTR produce using existing data that will facilitate centers quality improvement efforts? Recommendations 23

24 CIBMTR Action on Reports for Centers Expand existing descriptive reports More data/variables: expanded HCT-CI and KPS, graft source, manipulation, gvhd prophylaxis, clinical trial participation Better views: Add pediatric only, high performing centers comparison columns to the existing columns for individual center and all US centers Additional descriptive outcomes Descriptive outcomes for acute and chronic GVHD in addition to 100d, 6mos, 1 year OS Better access to individual center dataset 24

25 CIBMTR Action on Reports for Centers Carefully consider whether descriptive benchmark reports can be useful Cohort of HCT recipients that has clearly defined disease and other risk factors with.. Sufficient numbers of patients at centers To provide meaningful QI information Better access to individual center datasets Discussion with ASBMT Quality Outcome Committee/FACT re other ways of analyzing data for centers to identify improvement opportunities 25

26 What can centers expect in Center Performance Analytics (CPA)? Selectable data dimensions include key variables for first allogeneic transplants facilitated in the U.S. in 2011, 2012 & 2013 Data is organized in category-specific tabs Predefined filters enable limited comparative analysis based on center size, patient population (adult, pediatric, both), center performance, and region Visualization of each center s data relative to other centers in data set for a selected dimensions Analyze center's own one-year observed survival rate Create your own query on data dimensions available in the data set Export filtered data in Excel file format Export the center's entire Center Specific data set Data refreshed annually 26

27 Selectable Dimensions in CPA Patient Disease Transplant Outcomes Age Group Gender HCT CI History of Malignancy KPS Category Score KPS Score Race Recipient CMV Status Broad Disease Disease stage ALL Philadelphia chromosome ALL T-cell lineage CLL & other chronic Leukemia stage NHL subtype HL Chemo sensitivity NHL Chemo Sensitivity Interval Between DX & TX Year of Transplant Product Type Donor Type/Graft Type/HLA Product Type Details BM or PBSC HLA Match Single Cord Blood HLA Match Conditioning Regimen Drugs TBI Prior Auto HCT BM or PB donor Age at Transplant BM or PB donor CMV status BM or PB donor Race/ethnicity Match BM or PB donor Parity BM or PB donor Sex BM or PB donor Sex Match One year Survival Probability Ad-hoc Query 27

28 Center Performance Analytics 28

29 Center Performance Analytics 29

30 Center Performance Analytics 30

31 Center Performance Analytics 31

32 Center Performance Analytics Query Tool 32

33 Center Performance Analytics -Query 33

34 Center Performance Analytics - Outcomes 34

35 CPA platform What s next? Together with DBtC, provides more useful data and analytics for centers Testing and initial launch expected in April Future iterations with additional relevant demographic data GVHD prophylaxis, graft manipulation, trials participation, etc Additional outcomes possible NOT adjusted Survival later than one year Acute and chronic GVHD Suggestions welcome 35

36 Survival Calculator 1 year 36

37 Where are we headed next? FACT/JACIE Standard B June 2015: Allogeneic requirements The clinical program should achieve..within or above the expected range when compared to national or international outcome data (CIBMTR, BSBMT, SBST) If not met.. Corrective Action Plan Future Standards 2018? Expectations? 37

38 Where am I? 38

39 Center Volumes Reporting 39

40 Center Volumes Report One utility/publication of data from SCTOD to the.gov website Current centers HCT volumes for posted online Anticipate data will be posted to Portal and.gov website by April 2016 Anticipate review process will begin Summer 2016

41 HRSA reports Cycle and Timeline Continuous Data Collection, CPI, Data confirmation by centers Data File preparation Center Review CIBMTR Portal HRSA Report - CIBMTR Review and approval Publication Website May - June July - September Oct - November December CVDR Data File preparation Analysis and Review Draft Report Submitted HRSA review and approval Publication Centers and Website January - April May - August September 1 November Dec - January Center Specific Survival Analysis

42 Center Volume report New Process Disease status updated to match Center Specific Survival Report Data Quality reports to identify data inconsistencies and missing data Proactive Center contact for: Form completeness Data Discrepancies Reduced turnaround time for center updates review 42

43 CVDR - New Process Introduced Exclusion Criteria Focused on 7 data discrepancies Improved data completeness and quality Focus on adding more criteria Follow-up questionnaire for centers who select the following: Data Incomplete/Incorrect - Do not publish data or Data Complete/Correct - Publish Allo Data and not Auto Data Will contain follow-up questions and corrective action plan 43

44 What is new with center volumes Recommendations from Public Available TF Make a more flexible query tool Make the.gov site more readily navigated Update the national survival data by disease section of the.gov website Improve the disease indexing and navigation for ease of patient use 44

45 Program Website

46 What is the value? Patients and their families strongly desire to understand what to expect from HCT They need an unbiased, reliable source of information about: Anticipated results of HCT (aggregate vs. individual) By disease and other relevant factors Centers with experience for the disease in question Centers performance 46

47 Disease survival data Aggregate survival data by disease is available on Additional variables Age Gender Race Cell source 47

48 U.S. Transplant Data by Center Report 48

49 Learn more at: OAForum/Pages/index.aspx Reports/USStats/Documents/CIBMTR_HCT_ Center_Survival_Report_Methodology.pdf 49