A recent Institute of Medicine report highlighted the pressing need to control health care costs in the US without sacrificing quality of care. As the largest payer of health care costs, the Centers for Medicare and Medicaid Services (CMS) conducts comprehensive national efforts to monitor quality of care. However, these efforts focus on acute conditions for which cure rates are high and mortality low. For a broad range of increasingly prevalent 'advanced health conditions', such cancer and Alzheimer's disease, cure rates are low, short-term mortality is high and the focus of disease management is end-of-life (EOL) palliative care. Such care is expensive, however. In 2010 national cost of cancer care was estimated to be $125 billion. Despite these huge costs, there are no comprehensive national efforts to monitor quality of EOL care. A key barrier to these efforts is the lack of appropriate statistical methodology. To estimate hospital-specific readmission rates, CMS currently uses a logistic-Normal generalized linear mixed model (GLMM). However, this model ignores death as a truncating event. As such, na1? ve application of the current CMS approach for quality of EOL assessments for advanced health conditions is inappropriate, would likely lead to bias and could have a major impact on how hospitals are rewarded/penalized for excellent/poor quality of care. In the statistics literature, the study of a non-terminal event (e.g. readmission) that is subject to a terminal event (e.g. death) is known as the 'semi-competing risks'problem. Current national quality of care assessment efforts ignore the semi-competing risks problem. A major contributing factor is that clustered semi-competing risks data has not been considered in the statistical literature. Novel statistical methods for semi-competing risks data must, therefore, be developed and evaluated. We will develop a comprehensive, unified Bayesian analysis framework for semi-competing risks data. The proposed framework will permit researchers to take advantage of the numerous benefits afforded within the Bayesian paradigm. A crucial contribution will be the development of a novel Bayesian hierarchical models for repeated measures semi- competing data, where individuals are clustered within hospitals. Novel multivariate hospital-level measures that jointly accommodate non-terminal and terminal events over time will be developed, as will methods for estimation, inference, ranking and the identification of excellent/poor hospitals. Finally, using data on all Medicare enrollees from 2000-2010 and tumor data from SEER-Medicare, we will apply our methods to quality of EOL care for cancers of the pancreas, lung, colon and brain. The proposed work will immediately and substantially improve and expand the set of statistical tools use for EOL care quality assessments, as well as provide key epidemiological results on cancer care in the US. The methods will be broadly applicable to all advanced health conditions, beyond cancer, many of which directly affect large segments of an increasingly aging US population.

Public Health Relevance

Despite huge costs, there are currently no comprehensive national efforts to monitor quality of end-of-life care for advanced health conditions such as cancer. The proposed work will develop new statistical methods and software and provide new epidemiological results for quality of EOL cancer care in the US. The methods will be broadly applicable to all advanced health conditions, beyond cancer, such as Alzheimer's disease, many of which directly affect large segments of an increasingly aging US population.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project (R01)
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Special Emphasis Panel (ZRG1-HDM-T (02))
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Mariotto, Angela B
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Harvard University
Biostatistics & Other Math Sci
Schools of Public Health
United States
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Haneuse, Sebastien (2017) Commentary: Multiple Causes of Death: The Importance of Substantive Knowledge in the Big Data Era. Epidemiology 28:28-29
Lee, Kyu Ha; Rondeau, Virginie; Haneuse, Sebastien (2017) Accelerated failure time models for semi-competing risks data in the presence of complex censoring. Biometrics 73:1401-1412
Jiang, Fei; Haneuse, Sebastien (2017) A Semi-parametric Transformation Frailty Model for Semi-competing Risks Survival Data. Scand Stat Theory Appl 44:112-129
Haneuse, Sebastien; Lee, Kyu Ha (2016) Semi-Competing Risks Data Analysis: Accounting for Death as a Competing Risk When the Outcome of Interest Is Nonterminal. Circ Cardiovasc Qual Outcomes 9:322-31
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Jazi?, Ina; Schrag, Deborah; Sargent, Daniel J et al. (2016) Beyond Composite Endpoints Analysis: Semicompeting Risks as an Underutilized Framework for Cancer Research. J Natl Cancer Inst 108:
Lee, Kyu Ha; Haneuse, Sebastien; Schrag, Deborah et al. (2015) Bayesian Semi-parametric Analysis of Semi-competing Risks Data: Investigating Hospital Readmission after a Pancreatic Cancer Diagnosis. J R Stat Soc Ser C Appl Stat 64:253-273