Karnofsky Performance Score and Its Use in Risk Adjustment of Transplant Outcomes in the United States

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Karnofsky Performance Score and Its Use in Risk Adjustment of Transplant Outcomes in the United States Jon J Snyder, PhD* Nicholas J Salkowski, PhD Kenneth E Lamb, PhD David A Zaun, MS Taqee A Khaled, BS Ajay K Israni, MD, MS Bertram L Kasiske, MD, FACP *Presenter

Disclosure All authors are employees of MMRF, the Scientific Registry of Transplant Recipients (SRTR) contractor. No conflicts of interest exist relevant to the current presentation. 2

Background The Organ Procurement and Transplantation Network requires reporting of Karnofsky Performance Status (KPS) at the time of transplant for adult recipients. KPS scores range from 0% (dead) to 100% (normal, no complaints, no evidence of disease) in 10% increments. Historically, these data have been used by the Scientific Registry of Transplant Recipients (SRTR) to risk-adjust centerspecific transplant outcomes. However, the consistency of how the KPS is applied by different transplant programs, a factor that may bias subsequent risk adjustment, has not been examined. 3

Karnofsky Performance Status Karnofsky Score Description 100 Normal no complaints; no evidence of disease. 90 Able to carry on normal activity; minor signs or symptoms of disease. 80 Normal activity with effort; some signs or symptoms of disease. 70 60 Cares for self; unable to carry on normal activity or to do active work. Requires occasional assistance, but is able to care for most of his personal needs. 50 Requires considerable assistance and frequent medical care. 40 Disabled; requires special care and assistance. 30 Severely disabled; hospital admission is indicated although death not imminent. 20 Very sick; hospital admission necessary; active supportive treatment necessary. 10 Moribund; fatal processes progressing rapidly. 4

Why does the SRTR care about KPS? Ideally, case mix adjusters should be measured consistently across centers in order for case mix adjustment to be equitable. Case Mix Scenario #1: #2: Risk adjusted outcomes will look better worse compared to unadjusted outcomes. Center? Outcomes 5

KPS in the Renal Disease Literature 6

Mean KPS by Kidney Program, Adult Kidney Recipients March 2008 September 2010 Mean (Std Err) KPS (Divided by 10) 10 9 8 7 6 5 4 3 2 1 HEMO Study: 80.6 ± 16.7 (SD) *Only programs with >10 transplants during the time period are displayed. Kidney Program 7

Mean KPS by Liver Program, Adult Liver Recipients March 2008 September 2010 Mean (Std Err) Karnofsky Score (divided by 10) 10 9 8 7 6 5 4 3 2 1 *Only programs with >10 transplants during the time period are displayed. Liver Program 8

Mean KPS by Lung Program, Adult Lung Recipients March 2008 September 2010 Mean (Std Err) Karnofsky Score (divided by 10) 10 9 8 7 6 5 4 3 2 1 Lung Program 9

Range of Mean KPS Across Programs Mean KPS for kidney transplant recipients (N=39521) was 82.0% (STD 13.9%); means varied across centers from a high of 99.2% to a low of 39.8%. Inter-center variation remained after adjustment of mean KPS for age, gender, race, and primary cause of kidney failure (adjusted range: 98.0%-38.6%). For adult liver programs, mean KPS ranged from 79.0% to 20.0%. For adult lung programs, mean KPS ranged from 77.9% to 33.1%. Range in Mean KPS Across Programs 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% *Excludes lowest outlier due to small N.

Use of Karnofsky Score in SRTR Risk Adjustment Models KPS has been historically been used to risk adjust centerspecific outcomes for the following models (14 models in total): Organ Age Group Donor Type Time Period Outcome Adult Peds DD LD 1 yr 3 yr Patient Graft Kidney X X X X X Liver X X X X X X X X X X X X X X X X Lung X X X X X X 11

Adjusted Effect of KPS on 1-Year Graft Survival 2.00 1.00 0.62 0.73 1.00 0.88 2.00 1.00 1.22 1.00 1.62 1.38 2.00 1.00 1.00 1.44 0.50 0.50 0.50 0.25 Kidney (DD) 0.25 Liver (DD) 0.25 Lung 12 = Rescaled estimates to allow comparison to the kidney figure.

Effect on Center Flagging (July 2011 PSR Release) Organ Age Group Time Period Outcome Flagged Adult Peds 1 yr 3 yr Patient Graft With KPS (# that would not be flagged if KPS removed) 13 Without KPS (# that would not be flagged if KPS added) Centers Affected Kidney X X X 9 (0) 11 (2) 2 X X X 17 (1) 17 (1) 2 Liver X X X 9 (1) 8 (0) 1 X X X 5 (1) 5 (1) 2 X X X 1 (0) 1 (0) 0 X X X 2 (0) 3 (1) 1 Lung X X X 5 (0) 5 (0) 0 X X X 5 (0) 5 (0) 0

HRSA Recommended Actions In 2011, HRSA recommended study of the use of KPS in risk adjustment models over concern of gaming. Data were reviewed by the SRTR Technical Advisory Committee in July of 2011 and recommendation was to remove KPS from kidney risk adjustment models due to concerns over the consistency of application of the KPS across programs. KPS remains in liver & lung adjustment models. SRTR continues discussions with OPTN/UNOS regarding education initiatives to determine whether KPS can be objectively applied across programs. 14

Conclusions These data reveal large variation in reported KPS across transplant programs, which is not attenuated by adjustment for recipient age, gender, race, and primary cause of disease. If the KPS is applied inconsistently across transplant programs, its use as a risk adjuster for center-specific outcomes may lead to biased results. Potential bias appears to effect only a few programs across organ types. Further study and education efforts may yield a more consistent measure of functional status that can be more reliably used in risk adjustment models. 15