Center-specific Outcomes2010

Current StatusFuture Directions

SUM07_1.ppt

Under the Contract, SCTOD will- 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

Center-Specific Outcomes Analysis

Performed periodically by NMDP since 1994 Annually from 2002 - CIBMTR PhD support

Risk-adjusted analysis of one-year survival for unrelated donor transplants Includes all transplant centers Includes all transplant recipients over a five

year interval Adjusts for multiple known risk factors Presents 95% confidence interval for

predicted survivals at each center

What is the REAL goal?!

Provide an equitable, balanced, scientific performance measure and tool(s) that can be used by the profession to define and improve quality. While: Acknowledging limitations Avoiding misuse Striving for continuous improvement

HOW TO DO IT BEST ? Engage transplant community

ASBMT Quality Outcomes Committee Forum on Assessing Center-specific

outcomes – September 2008 Engage the public

CIBMTR Consumer Advocacy Committee Active research program into the processes

and resources that determine performance Quality Improvement

Continue annual assessment of center-specific outcomes Unrelated donor transplants Add related donor transplants in 2010

TOWARDS 2010

Developed report of recommendations from Forum, draft plan for reports

Presented draft plan at Tandem 2009 Incorporate feedback (April 2009) Presented draft plan to HRSA (May 2009) Published final plan (Sept 2009) Conduct analyses and report (July 2010) Repeat Forum every 2 years (Sept 2010)

Timeline 2010

January 2010 – Begin center notification Jan-April – Follow center submission May – July – Build center outcomes data file July – Close data set, finalize Aug – Analyze data, notify centers with

inadequate data for analysis Sep 2010

Discuss analysis, report, tools for centers and others, future planning

Timeline 2010

Sep 2010 – Finalize analysis Submit final report to HRSA

Oct - Nov – Provide individual center outcomes to centers Provide center characteristics and univariate

outcome data (tools) Collect centers’ “public” commentary

Dec or later – Post updated data on HRSA website New framework and appearance?

Changes for 2011Lessons Learned

Remind centers earlier Copy all communication on this topic to

center director Better integration with overlapping components

Center Volume Reports CPI trimester requirements Proactive communication regarding forms

based errors Review data completeness and notify earlier

Timeline 2011

Sep/Oct 2010 – Center Volume Report 2009 Confirm HCT for 2009

Sep 2010 – CPI reports for all allogeneic HCT now active 2009 HCT data included

Jan 2011 – CPI report issued First reminder to centers (re data 2005-

2009) for center outcomes reporting Jan – Mar 2011 – Monthly reminders and

reports on forms due

Timeline 2011

Apr 2011 – CPI report closes out HCT for 2009 and earlier for one year outcomes

Apr/May 2011 – Dataset assembly Notification of center director re exclusions

Jun 2011 – Analysis Jul 2011 – Reports and tools to centers Aug 2011 – Collect center commentary Sep 2011 – Report to HRSA Nov - Dec 2011 – Post/Publish on HRSA (.gov)

website Depends upon review cycle, effort to post

What’s New in 2010

Inclusion of HCT data 2004-2008 UNR 2004-2008, REL 2008

New data collection instruments TED, CRF or both

New data elements Comorbidity – HCT-CI Cytogenetics in AML Distance from center Income surrogate

What’s New in 2010

New modeling considerations: Combined related vs. unrelated

modeling Larger overall numbers Time window for analysis (3 or 5 yr) How and when to incorporate new

variables and new techniques?

Objectives for Forum

Review current year outcomes report Open, transparent DISCUSSION

Process Analysis Reporting

Solicit input and new ideas Risk Adjustment Quality Improvement

TOPICS FOR TODAY

Review of Analyses

Criteria for center and recipient inclusion in the analysis

Analytic methodology Differentiation of variables for analysis

versus investigatory consideration Overview of adjustment model and

significant factors Overview of results for centers

Statistical & Methodologic Issues

Do the models work similarly for related and unrelated HCT?

Can the time window of analysis be narrowed? 3 year vs. 5 year Model building versus outcomes

reporting What is the right p-value for risk

adjustment model building? Large dataset, is 0.05 too permissive?

Statistical & Methodologic Issues

Are small centers and large centers equally at risk for an adverse rating?

How and when should we introduce new variables? Sorror, Cytogenetics

Hot topics for discussion

Are there pediatric risk factors that should be considered?

Are the criteria for inclusion of centers appropriate How should they be described?

Are there other variables that should be considered for investigational data collection? Can we measure and use a proxy for

“late referrals”?

Is one year survival still the best outcome?

Review rationale for 1 year survival Discuss uses and limitations for 100 day

mortality Descriptive versus multivariate

modeling Resources

Can we adequately characterize “investigatory HCT”?

Roy Jones and Helen Heslop on behalf of the ASBMT Quality Outcome committee

Can we develop reproducible criteria? How should the information be used?

Descriptive for each center? Introduction into risk adjustment

models?

Striving for performance improvement – what data can help?

Review CIBMTR plans for additional data to provide to centers

What is the value of the ‘risk score’ in the current report?

Can and should a “risk budget” equation or tool be made available (Stiff) Will there be unintended

consequences?

Going Public?!?

How are the data currently displayed (Murphy) Review ideas for change in 2010 Discussion

What data is useful to the public, and is there data that may be unintentionally misleading?

How can payers use the data, and is there additional data that CIBMTR can provide?

Is there a minimum HCT number to be included on public website, as opposed to report to HRSA and center?

What should it look like?

Distribution of over and underperforming centers

157 Centers in analysis 14 centers under performing

1-20 4 21-50 1 Over 50 9

11 centers over performing 1-20 0 21-50 2 Over 50 9