Faculty Bibliography

BACKGROUND: Approximately half of veterans with low-risk prostate cancer receive guideline-discordant imaging. Our objective was to identify and describe (1) physician knowledge, attitudes, and practices related to the use of imaging to stage prostate cancer, (2) patient attitudes and behaviors related to use of imaging, and (3) to compare responses across three VA medical centers (VAMCs). METHODS: A qualitative approach was used to explore patient and provider knowledge and behaviors relating to the use of imaging. We conducted 39 semi-structured interviews total-including 22 interviews with patients with newly diagnosed with prostate cancer and 17 interviews with physicians caring for them-between September 2014 and July 2015 at three VAMCs representing a spectrum of inappropriate imaging rates. After core theoretical concepts were identified, the Theoretical Domains Framework (TDF) was selected to explore linkages between themes within the dataset and existing domains within the framework. Interviews were audio-recorded, transcribed verbatim, and then coded and analyzed using Nvivo software. RESULTS: Themes from patient interviews were categorized within four TDF domains. Patients reported little interest in staging as compared to disease treatment (goals), and many could not remember if they had imaging at all (knowledge). Patients tended to trust their doctor to make decisions about appropriate tests (beliefs about capabilities). Some patients expressed a minor concern for radiation exposure, but anxiety about cancer outcomes outweighed these fears (emotion). Themes from physician interviews were categorized within five TDF domains. Most physicians self-reported that they know and trust imaging guidelines (knowledge) yet some were still likely to follow their own intuition, whether due to clinical suspicion or years of experience (beliefs about capabilities). Additionally, physicians reported that medico-legal concerns, fear of missing associated diagnoses (beliefs about consequences), influence from colleagues who image frequently (social influences), and the facility where they practice influences rates of imaging (environmental context). CONCLUSIONS: Interviews with patients and physicians suggest that physicians are the primary (and in some cases only) decision-makers regarding staging imaging for prostate cancer. This finding suggests a physician-targeted intervention may be the most effective strategy to improve guideline-concordant prostate cancer imaging.

BACKGROUND: In response to 2012 guidance in which the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) stated the importance of patient-centric measures in regulatory benefit-risk assessments, the Medical Device Innovation Consortium (MDIC) initiated a project. The project was used to develop a framework to help the Food and Drug Administration (FDA) and industry sponsors understand how patient preferences regarding benefit and risk might be integrated into the review of innovative medical devices. METHODS: A public-private partnership of experts from medical device industry, government, academia and non-profits collaborated on development of the MDIC patient centered benefit-risk framework. RESULTS: The MDIC Framework examines what patient preference information is and the potential use and value of patient preference information in the regulatory process and across the product development life cycle. The MDIC Framework also includes a catalog of patient preference assessment methods and an agenda for future research to advance the field. CONCLUSIONS: This article discusses key concepts in patient preference assessment of particular importance for regulators and researchers that are addressed in the MDIC Framework for patient centered benefit-risk assessment as well as the unique public-private collaboration that led its development.

OBJECTIVE: The purpose of this article is to compare the effectiveness of a treatment algorithm for small renal tumors incorporating the nephrometry score, a renal tumor anatomy scoring system developed by urologists, with the current standard of uniformly recommended partial nephrectomy in patients with mild-to-moderate chronic kidney disease (CKD). MATERIALS AND METHODS: We developed a state-transition microsimulation model to project life expectancy (LE) in hypothetic patients with baseline mild or moderate CKD undergoing treatment of small renal masses. Our model incorporated the nephrometry score, which is predictive of postsurgical renal function loss. The two tested strategies were uniform treatment with partial nephrectomy and selective treatment based on nephrometry score and CKD stage, including percutaneous ablation for CKD stages 2 or 3a and intermediate-to-high nephrometry score or stage 3b CKD and any nephrometry score; otherwise, partial nephrectomy was assumed for other CKD stages and nephrometry scores. The model accounted for benign and malignant lesions, renal function decline, recurrence, and metastatic disease rates specific to each treatment, mortality by CKD stage, and comorbidities. Sensitivity analysis tested the stability of results when varying key parameters. RESULTS: Selective treatment with partial nephrectomy resulted in an average LE benefit of 0.48 year (95% interpercentile range, 0.42-0.54 year) in 65-year-old men and 0.37 year (95% interpercentile range, 0.30-0.43 year) in 65-year-old women relative to nondiscriminatory surgery, due to worsening CKD and cardiovascular mortality associated with partial nephrectomy. Model results were most sensitive to the rate of renal function decline and CKD-related mortality. CONCLUSION: Nephron-sparing treatment selection for small renal masses based on nephrometry score may improve LE in patients with mild or moderate CKD.

OBJECTIVE: To determine the frequency of appropriate and inappropriate prostate cancer imaging in an integrated health care system. DATA SOURCES/STUDY SETTING: Veterans Health Administration Central Cancer Registry linked to VA electronic medical records and Medicare claims (2004-2008). STUDY DESIGN: We performed a retrospective cohort study of VA patients diagnosed with prostate cancer (N = 45,084). Imaging (CT, MRI, bone scan, PET) use was assessed among patients with low-risk disease, for whom guidelines recommend against advanced imaging, and among high-risk patients for whom guidelines recommend it. PRINCIPAL FINDINGS: We found high rates of inappropriate imaging among men with low-risk prostate cancer (41 percent) and suboptimal rates of appropriate imaging among men with high-risk disease (70 percent). Veterans utilizing Medicare-reimbursed care had higher rates of inappropriate imaging [OR: 1.09 (1.03-1.16)] but not higher rates of appropriate imaging. Veterans treated in middle [OR: 0.51 (0.47-0.56)] and higher [OR: 0.50 (0.46-0.55)] volume medical centers were less likely to undergo inappropriate imaging without compromising appropriate imaging. CONCLUSIONS: Our results highlight the overutilization of imaging, even in an integrated health care system without financial incentives encouraging provision of health care services. Paradoxically, imaging remains underutilized among high-risk patients who could potentially benefit from it most.

Physicians engage in risk stratification as a normative part of their professional duties. Risk stratification has the potential to be beneficial in many ways, and implicit recognition of this potential benefit underlies its acceptance as a cornerstone of the medical profession. However, risk stratification also has the potential to be harmful. We argue that 'profiling' is a term that corresponds to risk stratification strategies in which there is concern that ethical harms exceed likely or proven benefits. In the case of risk stratification for health goals, this would occur most frequently if benefits were obtained by threats to justice, autonomy or privacy. We discuss implications of the potential overlap between risk stratification and profiling for researchers and for clinicians, and we consider whether there are salient characteristics that make a particular risk stratification algorithm more or less likely to overlap with profiling, such as whether the risk stratification algorithm is based on voluntary versus non-voluntary characteristics, based on causal versus non-causal characteristics, or based on signifiers of historical disadvantage. We also discuss the ethical challenges created when a risk stratification scheme helps all subgroups but some more than others, or when risk stratification harms some subgroups but benefits the aggregate group.

BACKGROUND: HIV infected (HIV+) individuals may be more susceptible to alcohol-related harm than uninfected individuals. METHODS: We analyzed data on HIV+ and uninfected individuals in the Veterans Aging Cohort Study (VACS) with an Alcohol Use Disorders Identification Test-Consumption AUDIT-C score from 2008 to 2012. We used Cox proportional hazards models to examine the association between alcohol exposure and mortality through July, 2014; and linear regression models to assess the association between alcohol exposure and physiologic injury based on VACS Index Scores. Models were adjusted for age, race/ethnicity, smoking, and hepatitis C infection. RESULTS: The sample included 18,145 HIV+ and 42,228 uninfected individuals. Among HIV+ individuals, 76% had undetectable HIV-1 RNA (<500copies/ml). The threshold for an association of alcohol use with mortality and physiologic injury differed by HIV status. Among HIV+ individuals, AUDIT-C score >/=4 (hazard ratio [HR] 1.25, 95% CI 1.09-1.44) and >/=30 drinks per month (HR, 1.30, 95% CI 1.14-1.50) were associated with increased risk of mortality. Among uninfected individuals, AUDIT-C score >/=5 (HR, 1.19, 95% CI 1.07-1.32) and >/=70 drinks per month (HR 1.13, 95% CI 1.00-1.28) were associated with increased risk. Similarly, AUDIT-C threshold scores of 5-7 were associated with physiologic injury among HIV+ individuals (beta 0.47, 95% CI 0.22, 0.73) and a score of 8 or more was associated with injury in uninfected (beta 0.29, 95% CI 0.16, 0.42) individuals. CONCLUSIONS: Despite antiretroviral therapy, HIV+ individuals experienced increased mortality and physiologic injury at lower levels of alcohol use compared with uninfected individuals. Alcohol consumption limits should be lower among HIV+ individuals.

The impact of HIV and its treatment on the effects of alcohol remain unclear. Blood alcohol concentrations have been noted to be higher in HIV infected individuals prior to antiretroviral initiation. Our goal was to compare number of drinks to "feel a buzz or high" among HIV infected and uninfected men, stratified by viral load (VL) suppression. Data includes 1478 HIV infected and 1170 uninfected men in the veterans aging cohort study who endorsed current drinking. Mean (SD) number of drinks to feel a buzz was 3.1 (1.7) overall. In multivariable analyses, HIV infected men reported a lower mean number of drinks to feel a buzz compared to uninfected men (coef = -14 for VL < 500; -34 for VL >/= 500; p