Consensus Conference on Transplant Program Quality and Surveillance Arlington, VA February 13-15, 2012

Consensus Conference on Transplant Program Quality and Surveillance Co-Chairs Bertram Kasiske (SRTR) and Maureen McBride (OPTN/UNOS) Steering Committee Robert Gaston (AST)Dennis Irwin (Optum Health) Mitch Henry (ASTS)Nancy Metzler (OPTN-TAC) Thomas Hamilton/Karen Tritz (CMS)John Roberts (OPTN-MPSC) Danielle Cornell (ACOT)Alan Reed (OPTN-PAIS) Kenyon Murphy (Patient/Public)Stuart Sweet (OPTN-POC) Funding HRSA

What is the SRTR’s mandate? Who uses PSRs and why? Are there unintended consequences? What can we learn from others? What statistical methods should we use? How should we adjust for risk? What outcomes should we use? What data should we collect? Key Questions

SRTR Actions Following the Consensus Conference Forming an STAC Subcommittee to oversee PSR development activities. Developed a prioritized list of actions. Reviewed the recommendations with the STAC on 2/23. Consensus Conference: 2/13 - 2/15

Immediate Priorities 1)Produce an SRTR PSR Manual of Operations detailing the SRTR process for risk model development and oversight. 2)Explore using a 3-year cycle of model development with formal input and involvement from the OPTN committees.

3-year Model Building Cycle Year 1 Kidney Pancreas Year 2 Heart Lung Year 3 Liver / Intestine OPO Yield

Immediate Priorities 3)Continue to explore making the reports more accessible/friendly to the public. Full graphical PSR was provided to transplant programs in June 2012.

Current Summary Page

Graphical Summary Page

Immediate Priorities 4)Add funnel plots to the new graphical PSRs. To be included in the January 2013 PSRs.

Funnel plots

5)Add time trend data to the new graphical PSRs. 6)Provide more data on waiting list risk and outcomes. Targeted improved waiting list metrics for the January 2013 PSR. 7)Move forward with production of CUSUM charts to be included on the programs’ secure SRTR website. Possibly start with kidney and/or liver programs. Explore methods and production options during Q3 & Q4 of Immediate Priorities

Longer-Term Priorities 8)Study Bayesian Hierarchical Modeling Strategies. Explore as part of the first tasks for the STAC-PSR subcommittee.

Methods: Use of hierarchical models with (Bayesian) suggested performance criteria Christiansen CL, Morris CN. Ann Intern Med. 1997;127:764.

Longer-Term Priorities 9)Study setting missing data values to the least beneficial value when risk adjustment models are applied. 10)Study inclusion of short-term living donor outcomes in the PSRs. Possible inclusion in January 2013 PSR for liver and kidney donors. 11)Study Life-Years from Listing (LYFL) for inclusion in the PSRs.

12)Study using period analyses to estimate survival rather than the historical cohorts currently used. This will possibly enable estimates of long-term patient outcomes based on the most recent data available. Incorporated some into the upcoming SRTR/OPTN annual data report. 13)Study measures of center “aggressiveness” for inclusion in the PSRs. 14)Study inclusion of data regarding what future PSRs will look like given events already observed. Likely for the secure site only. Explore modifications to the Excel-based tools. Longer-Term Priorities

15)Study Balanced Score Card approaches, including the current CPM under study by MPSC and extensions of the CPM to include pre- and post- transplant metrics. 16)Continue to support the MPSC’s exploration of alternative flagging methodologies, possibly incorporating results from the Bayesian modeling. Longer-Term Priorities

17)Work with the OPTN to explore the concept of excluding patients from that PSR cohorts that are in approved clinical studies. Discussed at the March 2012 MPSC meeting; John Roberts and Alan Reed are working toward assembling a subcommittee of the MPSC to explore this idea. Longer-Term Priorities

18)Explore the potential of additional risk adjustment for: a.More detailed data on donor/organ risk, possibly including more data from DonorNet®. b.Socioeconomic status (SES) based on recipient ZIP code c.Ventricular Assist Devices d.Coronary heart disease, revascularizations (needs additional data collection by OPTN) e.Peripheral vascular disease, revascularizations, amputations (needs additional data collection by OPTN) f.More detailed data on diabetes (needs additional data collection by OPTN). Longer-Term Priorities

19)Study measures of organ function, e.g. acute rejections, eGFR, FEV1. 20)Study use of external data sources to estimate re- hospitalization or cause-specific post-transplant hospitalization rates, e.g., Medicare data. 21)Study inclusion of data-completeness indicators in the PSRs. 22)Study the possibility of including quality of life as an outcome (currently no data available to the SRTR). Longer-Term Priorities

Consensus Conference Manuscript