Affiliated Faculty, NYU Wagner; Assistant Professor, NYU Langone School of Medicine
Dr. Makarov specializes in the treatment of prostate cancer and benign prostatic hyperplasia (BPH), as well as bladder and kidney cancer. He has first-hand experience in the surgical and medical treatment of prostate cancer. In addition to his clinical expertise in urological oncology, Dr. Makarov is a highly regarded health services researcher. He received his undergraduate degree in economics from Yale University and his medical degree at the Johns Hopkins School of Medicine. He completed a surgical internship in the William S. Halsted Department of Surgery and a residency in urology at the James Buchanan Brady Urological Institute (both at Johns Hopkins). After completing his residency, Dr. Makarov continued on the faculty at Johns Hopkins as an Instructor in Urology. After this experience, Dr. Makarov completed a Masters in Health Sciences Research as a Robert Wood Johnson Foundation Clinical Scholar at Yale University School of Medicine. Dr. Makarov joined NYU Urology Associates in 2010.
The goal of Dr. Makarov's research is to improve the quality and efficiency of care administered to men with prostate cancer in the United States. His research interests focus on the use of tissue and serum biomarkers for the risk stratification of men with prostate cancer (especially those with low-volume, low-grade disease) as well as policy-relevant questions impacting the provision of cost-effective, high-quality care for patients with prostate cancer. He is an Assistant Professor of Urology at the NYU School of Medicine as well as Assistant Professor of Health Policy at the Robert F. Wagner School of Public Service. Cognizant that many of the problems in the US healthcare system derive more from the inefficient delivery of care rather than a lack of available science, Dr. Makarov is interested in examining regional variation in utilization, appropriateness, and cost among problematic healthcare systems. In the future, Dr. Makarov hopes to leverage the understanding gained from studying such systems as multiple natural experiments in order to design large scale interventions to improve care.
The surgical robot, a costly technology for treatment of prostate cancer with equivocal marginal benefit, rapidly diffused into clinical practice. We sought to evaluate the role of teaching in the early adoption phase of the surgical robot. Teaching hospitals were the primary early adopters: data from the Healthcare Cost and Utilization Project showed that surgical robots were acquired by 45.5% of major teaching, 18.0% of minor teaching and 8.0% of non-teaching hospitals during the early adoption phase. However, teaching hospital faculty produced little comparative effectiveness research: By 2008, only 24 published studies compared robotic prostatectomy outcomes to those of conventional techniques. Just ten of these studies (41.7%) were more than minimally powered, and only six (25%) involved cross-institutional collaborations. In adopting the surgical robot, teaching hospitals fulfilled their mission to innovate, but failed to generate corresponding scientific evidence.
Introduction: The rapid diffusion of the surgical robot has been controversial because of the technology’s high costs and its disputed marginal benefit. Some, however, have suggested that adoption of the robot may have improved care for patients with renal malignancy by facilitating partial nephrectomy, an underutilized, technically challenging procedure believed to be less morbid than radical nephrectomy. We sought to determine whether institutional acquisition of the robot was associated with increased utilization of partial nephrectomy.
Methods: We used all payer data from 7 states to identify 21,569 nephrectomies. These patient-level records were aggregated to the hospital-level then merged with the American Hospital Association Annual Survey and publicly available data on timing of robot acquisition. We used a multivariable difference-in-difference model to assess at the hospital-level whether robot acquisition was associated with an increase in the proportion of partial nephrectomy, adjusting for hospital nephrectomy volume, year of surgery, and several additional hospital-level factors.
Results: In the multivariable-adjusted differences-in-differences model, hospitals acquiring a robot between 2001 and 2004 performed a greater proportion of partial nephrectomy in both 2005 (29.9% increase) and 2008 (34.9% increase). Hospitals acquiring a robot between 2005 and 2008 also demonstrated a greater proportion of partial nephrectomy in 2008 (15.5% increase). In addition, hospital nephrectomy volume and urban location were also significantly associated with increased proportion of partial nephrectomy.
Conclusions: Hospital acquisition of the surgical robot is associated with greater proportion of partial nephrectomy, an underutilized, guideline-encouraged procedure. This is one of the few studies to suggest robot acquisition is associated with improvement in quality of patient care.
Background: The surgical robot has been widely adopted in the United States in spite of its high cost and controversy surrounding its benefit. Some have suggested that a “medical arms race” influences technology adoption. We wanted to determine whether a hospital would acquire a surgical robot if its nearest neighboring hospital already owned one.
Methods: We identified 554 hospitals performing radical prostatectomy from the Healthcare Cost and Utilization Project Statewide Inpatient Databases for seven states. We used publicly available data from the website of the surgical robot's sole manufacturer (Intuitive Surgical, Sunnyvale, CA) combined with data collected from the hospitals to ascertain the timing of robot acquisition during year 2001 to 2008. One hundred thirty four hospitals (24%) had acquired a surgical robot by the end of 2008. We geocoded the address of each hospital and determined a hospital's likelihood to acquire a surgical robot based on whether its nearest neighbor owned a surgical robot. We developed a Markov chain method to model the acquisition process spatially and temporally and quantified the “neighborhood effect” on the acquisition of the surgical robot while adjusting simultaneously for known confounders.
Results: After adjusting for hospital teaching status, surgical volume, urban status and number of hospital beds, the Markov chain analysis demonstrated that a hospital whose nearest neighbor had acquired a surgical robot had a higher likelihood itself acquiring a surgical robot (OR=1.71, 95% CI: 1.07–2.72, p=0.02).
Conclusion: There is a significant spatial and temporal association for hospitals acquiring surgical robots during the study period. Hospitals were more likely to acquire a surgical robot during the robot's early adoption phase if their nearest neighbor had already done so.
Arsenic (As) exposure has been associated with both urologic malignancy and renal dysfunction; however, its association with hematuria is unknown. We evaluated the association between drinking water As exposure and hematuria in 7843 men enrolled in the Health Effects of Arsenic Longitudinal Study (HEALS). Cross-sectional analysis of baseline data was conducted with As exposure assessed in both well water and urinary As measurements, while hematuria was measured using urine dipstick. Prospective analyses with Cox proportional regression models were based on urinary As and dipstick measurements obtained biannually since baseline up to six years. At baseline, urinary As was significantly related to prevalence of hematuria (P-trend < 0.01), with increasing quintiles of exposure corresponding with respective prevalence odds ratios of 1.00 (reference), 1.29 (95% CI: 1.04–1.59), 1.41 (95% CI: 1.15–1.74), 1.46 (95% CI: 1.19–1.79), and 1.56 (95% CI: 1.27–1.91). Compared to those with relatively little absolute urinary As change during follow-up (− 10.40 to 41.17 μg/l), hazard ratios for hematuria were 0.99 (95% CI: 0.80–1.22) and 0.80 (95% CI: 0.65–0.99) for those whose urinary As decreased by > 47.49 μg/l and 10.87 to 47.49 μg/l since last visit, respectively, and 1.17 (95% CI: 0.94–1.45) and 1.36 (95% CI: 1.10–1.66) for those with between-visit increases of 10.40 to 41.17 μg/l and > 41.17 μg/l, respectively. These data indicate a positive association of As exposure with both prevalence and incidence of dipstick hematuria. This exposure effect appears modifiable by relatively short-term changes in drinking water As.
Purpose: The prevalence of lower urinary tract symptoms increases with age and impairs quality of life. Radical prostatectomy has been shown to relieve lower urinary tract symptoms at short-term followup but the long-term effect of radical prostatectomy on lower urinary tract symptoms is unclear.
Materials and Methods: We performed a prospective cohort study of 1,788 men undergoing radical prostatectomy. The progression of scores from the self-administered AUASS (American Urological Association symptom score) preoperatively, and at 3, 6, 12, 24, 48, 60, 84, 96 and 120 months was analyzed using models controlling for preoperative AUASS, age, prostate specific antigen, pathological Gleason score and stage, nerve sparing, race and marital status. This model was also applied to patients stratified by baseline clinically significant (AUASS greater than 7) and insignificant (AUASS 7 or less) lower urinary tract symptoms.
Results: Men exhibited an immediate worsening of lower urinary tract symptoms that improved between 3 months and 2 years after radical prostatectomy. Overall the difference between mean AUASS at baseline and at 10 years was not statistically or clinically significant. Men with baseline clinically significant lower urinary tract symptoms experienced immediate improvements in lower urinary tract symptoms that lasted until 10 years after radical prostatectomy (13.5 vs 8.81, p <0.001). Men with baseline clinically insignificant lower urinary tract symptoms experienced a statistically significant but clinically insignificant increase in mean AUASS after 10 years (3.09 to 4.94, p <0.001). The percentage of men with clinically significant lower urinary tract symptoms decreased from baseline to 10 years after radical prostatectomy (p = 0.02).
Conclusions: Radical prostatectomy is the only treatment for prostate cancer shown to improve and prevent the development of lower urinary tract symptoms at long-term followup. This previously unrecognized long-term benefit argues in favor of the prostate as the primary contributor to male lower urinary tract symptoms.
Background: Recent debate about prostate-specific antigen (PSA)-based testing for prostate cancer screening among older men has rarely considered the cost of screening.
Methods: A population-based cohort of male Medicare beneficiaries aged 66 to 99 years, who had never been diagnosed with prostate cancer at the end of 2006 (n = 94,652), was assembled, and they were followed for 3 years to assess the cost of PSA screening and downstream procedures (biopsy, pathologic analysis, and hospitalization due to biopsy complications) at both the national and the hospital referral region (HRR) level.
Results: Approximately 51.2% of men received PSA screening tests during the 3-year period, with 2.9% undergoing biopsy. The annual expenditures on prostate cancer screening by the national fee-for-service Medicare program were $447 million in 2009 US dollars. The mean annual screening cost at the HRR level ranged from $17 to $62 per beneficiary. Downstream biopsy-related procedures accounted for 72% of the overall screening costs and varied significantly across regions. Compared with men residing in HRRs that were in the lowest quartile for screening expenditures, men living in the highest HRR quartile were significantly more likely to be diagnosed with prostate cancer of any stage (incidence rate ratio [IRR] = 1.20, 95% confidence interval [CI] = 1.07-1.35) and localized cancer (IRR = 1.30, 95% CI = 1.15-1.47). The IRR for regional/metastasized cancer was also elevated, although not statistically significant (IRR = 1.31, 95% CI = 0.81-2.11).
Conclusions: Medicare prostate cancer screening–related expenditures are substantial, vary considerably across regions, and are positively associated with rates of cancer diagnosis.
Background: Cancer continues to rise as a contributor to premature death in the developing world. Despite this, little is known about whether cancer outcomes are related to a country’s income level, and what aspects of national healthcare systems are associated with improved cancer outcomes.
Methods: The most recent estimates of cancer incidence and mortality were used to calculate mortality-to-incidence ratio (MIR) for the 85 countries with reliable data. Countries were categorized according to high-income (Gross Domestic Product (GDP) > $15,000) or middle/low-income (GDP < $15,000), and a multivariate linear regression model was used to determine the association between healthcare system indicators and cancer MIR. Indicators study included per capita GDP, overall total healthcare expenditure (THE), THE as a proportion of GDP, total external beam radiotherapy devices (TEBD) per capita, physician density, and the year 2000 WHO healthcare system rankings.
Results: Cancer MIR in high-income countries (0.47) was significantly lower than that of middle/low-income countries (0.64), with a p < 0.001. In high-income countries, GDP, health expenditure and TEBD showed significant inverse correlations with overall cancer MIR. A $3040 increase in GDP (p = 0.004), a $379 increase in THE (p < 0.001), or an increase of 0.59 TEBD per 100,000 population (p = 0.027) were all associated with a 0.01 decrease in cancer MIR. In middle/low-income countries, only WHO scores correlated with decreased cancer MIR (p = 0.022); 12 specific cancer types also showed similar significant correlations (p < 0.05) as overall cancer MIR.
Conclusions: The analysis of this study suggested that cancer MIR is greater in middle/low-income countries. Furthermore, the WHO healthcare score was associated with improved cancer outcomes in middle/low-income countries while absolute levels of financial resources and infrastructure played a more important role in high-income countries.
Objective: To examine public and media response to the United States Preventive Services Task Force's (USPSTF) draft (October 2011) and finalized (May 2012) recommendations against prostate-specific antigen (PSA) testing using Twitter, a popular social network with over 200 million active users.
Materials and Methods: We used a mixed methods design to analyze posts on Twitter, called “tweets.” Using the search term “prostate cancer,” we archived tweets in the 24 hour periods following the release of the USPSTF draft and finalized recommendations. We recorded tweet rate per hour and developed a coding system to assess type of user and sentiment expressed in tweets and linked articles.
Results: After the draft and finalized recommendations, 2042 and 5357 tweets focused on the USPSTF report, respectively. Tweet rate nearly doubled within two hours of both announcements. Fewer than 10% of tweets expressed an opinion about screening, and the majority of these were pro-screening during both periods. In contrast, anti-screening articles were tweeted more frequently in both draft and finalized study periods. From the draft to the finalized recommendations, the proportion of anti-screening tweets and anti-screening article links increased (p= 0.03 and p<0.01, respectively).
Conclusions: There was increased Twitter activity surrounding the USPSTF draft and finalized recommendations. The percentage of anti-screening tweets and articles appeared to increase, perhaps due to the interval public comment period. Despite this, most tweets did not express an opinion, suggesting a missed opportunity in this important arena for advocacy.
Objective: Previous studies addressing racial disparities in treatment for early-stage prostate cancer have focused on the etiology of undertreatment of black men. Our objective was to determine whether racial disparities are attributable to undertreatment, overtreatment, or both.
Methods: Using the SEER-Medicare dataset, we identified men 67–84 years-old diagnosed with localized prostate cancer from 1998 to 2007. We stratified men into clinical benefit groups using tumor aggressiveness and life expectancy. Low-benefit was defined as low-risk tumors and life expectancy < 10 years; high-benefit as moderate-risk tumors and life expectancy ≥ 10 years; all others were intermediate-benefit. Logistic regression modeled the association between race and treatment (radical prostatectomy or radiotherapy) across benefit groups.
Results: Of 68,817 men (9.8% black and 90.2% white), 56.2% of black and 66.3% of white men received treatment (adjusted odds ratio (OR) = 0.65; 95% CI, 0.62–0.69). The percent of low-, intermediate-, and high-benefit men who received treatment was 56.7%, 68.4%, and 79.6%, respectively (P = < 0.001). In the low-benefit group, 51.9% of black vs. 57.2% of white patients received treatment (OR = 0.74; 95% CI, 0.67–0.81) compared to 57.2% vs. 69.6% in the intermediate-benefit group (OR = 0.64; 95% CI, 0.59–0.70). Racial disparity was largest in the high-benefit group (64.2% of black vs. 81.4% of white patients received treatment; OR = 0.57; 95% CI, 0.48–0.68). The interaction between race and clinical benefit was significant (P < 0.001).
Conclusion: Racial disparities were largest among men most likely to benefit from treatment. However, a substantial proportion of both black and white men with a low clinical benefit received treatment, indicating a high level of overtreatment.
Purpose: Radical prostatectomy is a common treatment for organ confined prostate cancer and its use is increasing. We examined how the increased volume is being distributed and what hospital characteristics are associated with increasing volume.
Materials and Methods: We identified all men age 40 to less than 80 years who underwent radical prostatectomy for prostate cancer from 2000 to 2008 in the NIS (Nationwide Inpatient Sample) (586,429). Ownership of a surgical robot was determined using the 2007 AHA (American Hospital Association) Annual Survey. The association between hospital radical prostatectomy volume and hospital characteristics, including ownership of a robot, was explored using multivariate linear regression.
Results: From 2000 to 2008 there was a 74% increase in the number of radical prostatectomies performed (p = 0.05) along with a 19% decrease in the number of hospitals performing radical prostatectomy (p <0.001), resulting in an increase in annual hospital radical prostatectomy volume (p = 0.009). Several hospital variables were associated with greater radical prostatectomy volume including teaching status, urban location, large bed size and ownership of a robot in 2007. On multivariate analysis the year, teaching status, large bed size, urban location and presence of a robot were associated with higher hospital radical prostatectomy volume.
Conclusions: Use of radical prostatectomy increased significantly between 2000 and 2008, most notably after 2005. The increase in radical prostatectomy resulted in centralization to select hospitals, particularly those in the top radical prostatectomy volume quartile and those investing in robotic technology. Our findings support the hypothesis that hospitals with the greatest volume increases are specialty centers already performing a high volume of radical prostatectomy procedures.
Purpose: Intracorporeal injections have low use rates and high discontinuation rates. We examined factors associated with intracorporeal injection use, long-term satisfaction with intracorporeal injection and reasons for discontinuation in men treated with radical prostatectomy.
Materials and Methods: Between October 2000 and September 2003, 731 men who underwent open radical retropubic prostatectomy were enrolled in a prospective outcomes study. The 8-year followup evaluation included the UCLA-PCI, and a survey capturing intracorporeal injection use, satisfaction and reasons for discontinuation. Logistic regression was used to determine associations between intracorporeal injection use and preoperative variables.
Results: The 8-year self-assessment was completed by 368 (50.4%) men. Of these men 140 (38%) indicated prior or current intracorporeal injection use, with only 34 using intracorporeal injection at 8 years. Overall, 44% of the men were satisfied with intracorporeal injections. Reasons for discontinuation included dislike (47%), pain (33%), return of erection (19%), inefficacy (14%) and no partner (6%). Men trying intracorporeal injections had greater preoperative UCLA-PCI sexual function scores (75.2 vs 65.62, p = 0.00005) as well as greater decreases in this score at 3 months (p = 0.0002) and 2 years (p = 0.003). Higher preoperative sexual function scores were independently associated with the use of intracorporeal injections in a model adjusted for age, marital status, nerve sparing status and body mass index (OR 1.021, 95% CI 1.008–1.035).
Conclusions: Men pursuing intracorporeal injections have better baseline erectile function and experience greater deterioration in erectile function during the early postoperative period. Despite the high efficacy of injections, many men discontinue intracorporeal injections due to dislike or discomfort. Satisfaction rates for intracorporeal injections indicate their long-term role in restoring sexual function in men with post-prostatectomy erectile dysfunction.
Objective To assess the impact of the American Urological Association (AUA) guidelines advocating partial nephrectomy for T1 tumors guidelines on the likelihood of undergoing partial nephrectomy.
Materials and Methods We analyzed the Nationwide Inpatient Sample (NIS), a dataset encompassing 20% of all United States inpatient hospitalizations, from 2007 through 2010. Our dependent variable was receipt of radical vs partial nephrectomy (55.50, 55.51, 55.52, and 55.54 vs 55.4) for a renal mass (International Classification of Disease, 9th Revision [ICD-9] code 189.0). The independent variable of interest was time of surgery (before or after the establishment of AUA guidelines); covariates included a diagnosis of chronic kidney disease (CKD), overall comorbidity, age, race, gender, geographic region, income, and hospital characteristics. Bivariate and multivariable adjusted logistic regression was used to determine the association between receipt of partial nephrectomy and time of guideline establishment.
Results We identified 26,165 patients with renal tumors who underwent surgery. Before the guidelines, 4031 patients (27%) underwent partial nephrectomy compared to 3559 (32%) after. On multivariable analysis, undergoing surgery after the establishment of guidelines (odds ratio [OR] 1.20, 95% confidence interval [CI] 1.08-1.32, P <.01) was an independent predictor of partial nephrectomy. Other factors associated with partial nephrectomy were urban location, surgery at a teaching hospital, large hospital bed size, Northeast location, and Black race. Female gender and CKD were not associated with partial nephrectomy.
Conclusion Although adoption of partial nephrectomy increased after establishment of new guidelines on renal masses, partial nephrectomy remains an underutilized procedure. Future research must focus on barriers to adoption of partial nephrectomy and how to overcome them.
Background: Reducing inappropriate use of imaging to stage incident prostate cancer is a challenging problem highlighted recently as a Physician Quality Reporting System quality measure and by the American Society of Clinical Oncology and the American Urological Association in the Choosing Wisely campaign. Since 2000, the National Prostate Cancer Register (NPCR) of Sweden has led an effort to decrease national rates of inappropriate prostate cancer imaging by disseminating utilization data along with the latest imaging guidelines to urologists in Sweden. We sought to determine the temporal and regional effects of this effort on prostate cancer imaging rates.
Methods: We performed a retrospective cohort study among men diagnosed with prostate cancer from the NPCR from 1998 to 2009 (n = 99 879). We analyzed imaging use over time stratified by clinical risk category (low, intermediate, high) and geographic region. Generalized linear models with a logit link were used to test for time trend.
Results: Thirty-six percent of men underwent imaging within 6 months of prostate cancer diagnosis. Overall, imaging use decreased over time, particularly in the low-risk category, among whom the imaging rate decreased from 45% to 3% (P < .001), but also in the high-risk category, among whom the rate decreased from 63% to 47% (P < .001). Despite substantial regional variation, all regions experienced clinically and statistically (P < .001) significant decreases in prostate cancer imaging.
Conclusions: A Swedish effort to provide data on prostate cancer imaging use and imaging guidelines to clinicians was associated with a reduction in inappropriate imaging over a 10-year period, as well as slightly decreased appropriate imaging in high-risk patients. These results may inform current efforts to promote guideline-concordant imaging in the United States and internationally.
Purpose: The combination of sepsis and ureteral calculus is a urological emergency. Traditional teaching advocates urgent decompression with nephrostomy tube or ureteral stent placement, although published outcomes validating this treatment are lacking. National practice patterns for such scenarios are currently undefined. Using a retrospective study design, we defined the surgical decompression rate in patients admitted to the hospital with severe infection and ureteral calculi. We determined whether a mortality benefit is associated with this intervention.
Materials and Methods: Patient demographics and hospital characteristics were extracted from the 2007 to 2009 Nationwide Inpatient Sample. We identified 1,712 patients with ureteral calculi and sepsis. Multivariate logistic regression was performed to determine the association between mortality and surgical decompression.
Results: Of the patients 78% underwent surgical decompression. Mortality was higher in those not treated with surgical decompression (19.2% vs 8.82%, p <0.001). Lack of surgical decompression was independently associated with an increased OR of mortality even when adjusting for patient demographics, comorbidities and geographic region of treatment (OR 2.6, 95% CI 1.9–3.7).
Conclusions: Absent surgical decompression is associated with higher odds of mortality in patients with sepsis and ureteral calculi. Further research to determine predictors of surgical decompression is necessary to ensure that all patients have access to this life saving therapy.
Policy makers interested in containing health care costs are targeting regional variation in utilization, including the use of advanced imaging. However, bluntly decreasing utilization among the highest-utilization regions may have negative consequences. In a cross-sectional study of prostate cancer patients from 2004 to 2005, we found that regions with lower rates of inappropriate imaging also had lower rates of appropriate imaging. Similarly, regions with higher overall imaging rates tended to have not only higher rates of inappropriate imaging, but also higher rates of appropriate imaging. In fact, men with high-risk prostate cancer were more likely to receive appropriate imaging if they resided in areas with higher rates of inappropriate imaging. This “thermostat model” of regional health care utilization suggests that poorly designed policies aimed at reducing inappropriate imaging could limit access to appropriate imaging for high-risk patients. Health care organizations need clearly defined quality metrics and supportive systems to encourage appropriate treatment for patients and to ensure that cost containment does not occur at the expense of quality.
Purpose: To evaluate the influence of immortal time bias on observational cohort studies of postoperative radiotherapy (PORT) and the effectiveness of sequential landmark analysis to account for this bias.
Methods and Materials: First, we reviewed previous studies of the Surveillance, Epidemiology, and End Results (SEER) database to determine how frequently this bias was considered. Second, we used SEER to select three tumor types (glioblastoma multiforme, Stage IA–IVM0 gastric adenocarcinoma, and Stage II–III rectal carcinoma) for which prospective trials demonstrated an improvement in survival associated with PORT. For each tumor type, we calculated conditional survivals and adjusted hazard ratios of PORT vs. postoperative observation cohorts while restricting the sample at sequential monthly landmarks.
Results: Sixty-two percent of previous SEER publications evaluating PORT failed to use a landmark analysis. As expected, delivery of PORT for all three tumor types was associated with improved survival, with the largest associated benefit favoring PORT when all patients were included regardless of survival. Preselecting a cohort with a longer minimum survival sequentially diminished the apparent benefit of PORT.
Conclusions: Although the majority of previous SEER articles do not correct for it, immortal time bias leads to altered estimates of PORT effectiveness, which are very sensitive to landmark selection. We suggest the routine use of sequential landmark analysis to account for this bias.
Purpose: Intensity-modulated radiation therapy (IMRT) requires a high degree of expertise compared with standard radiation therapy (RT). We performed a retrospective cohort study of Medicare patients treated with IMRT compared with standard RT to assess outcomes in national practice.
Methods and Materials: Using the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER)–Medicare linked database, we identified patients treated with radiation for cancer of the head and neck from 2002 to 2005. We used multivariate Cox models to determine whether the receipt of IMRT was associated with differences in survival.
Results: We identified 1613 patients, 33.7% of whom received IMRT. IMRT was not associated with differences in survival: the 3-year overall survival was 50.5% for IMRT vs. 49.6% for standard RT (p = 0.47). The 3-year cancer-specific survival was 60.0% for IMRT vs. 58.8% (p = 0.45).
Conclusion: Despite its complexity and resource intensive nature, IMRT use seems to be as safe as standard RT in national community practice, because the use of IMRT did not have an adverse impact on survival.
Purpose: According to guidelines most men with incident prostate cancer do not require staging imaging. We determined the population level prevalence and correlates of appropriate and inappropriate imaging in this cohort.
Materials and Methods: We performed a cross-sectional study of men 66 to 85 years old who were diagnosed with prostate cancer in 2004 and 2005 from the SEER (Surveillance, Epidemiology and End Results)-Medicare database. Low risk (no prostate specific antigen greater than 10 ng/ml, Gleason score greater than 7 or clinical stage greater than T2) and high risk (1 or more of those features) groups were formed. Inappropriate imaging was defined as any imaging for men at low risk and appropriate imaging was defined as bone scan for men at high risk as well as pelvic imaging as appropriate. Logistic regression modeled imaging in each group.
Results: Of 18,491 men at low risk 45% received inappropriate imaging while only 66% of 10,562 at high risk received appropriate imaging. For patients at low risk inappropriate imaging was associated with increasing clinical stage (T2 vs T1 OR 1.35, 95% CI 1.27–1.44), higher Gleason score (7 vs less than 7 OR 1.80, 95% CI 1.69–1.92), increasing age and comorbidity as well as decreasing education. Appropriate imaging for men at high risk was associated with lower stage (T4, T3 and T2 vs T1 OR 0.63, 95% CI 0.48–0.82, OR 0.67, 95% CI 0.60–0.80 and OR 0.87, 95% CI 0.80–0.86) and with higher Gleason score (greater than 8 and 7 vs less than 7 OR 2.18, 95% CI 1.92–2.48 and 1.51, 95% CI 1.35–1.70, respectively) as well as with younger age, white race, higher income, lower stage and more comorbidity.
Conclusions: We found poor adherence to imaging guidelines for men with incident prostate cancer. Understanding the patterns by which clinicians use imaging for prostate cancer should guide educational efforts as well as research to suggest evidence-based guideline improvements.
Introduction: The successful treatment of prostate cancer depends on the accurate estimation of the risk of regional lymph node (LN) involvement. The Roach formula (RF) has been criticized as overestimating LN risk. A modification of the RF has been attempted by other investigators using simplified adjustment ratios: the Nguyen formula (NF).
Methods and Materials: The National Cancer Institute Surveillance, Epidemiology, and End Results database was investigated for patients treated in 2004 through 2006 for whom at least 10 LN were examined at radical prostatectomy, cT1c or cT2 disease, and prostate-specific antigen (PSA) <26 ng/ml (N = 2,930). The Yale formula (YF) was derived from half of the sample (n = 1,460), and validated in the other half (n = 1,470).
Results: We identified 2,930 patients. Only 4.6% of patients had LN+, and 72.6% had cT1c disease. Gleason (GS) 8–10 histology was found in 14.4% of patients. The YF for prediction of %LN+ risk is [GS – 5] × [PSA/3 + 1.5 × T], where T = 0, 1, and 2 for cT1c, cT2a, and cT2b/cT2c. Within each strata of predicted %LN+ risk, the actual %LN+ was closest to the YF. Using a >15% risk as an indicator of high-risk disease, the YF had increased sensitivity (39.0% vs. 13.6%) compared with the NF, without a significant reduction in specificity (94.9% vs. 98.8%). The NF was overly restrictive of the high-risk group, with only 2% of patients having a >15% risk of LN+ by that formula.
Conclusion: The YF performed better than the RF and NF and was best at differentiating patients at high risk for LN+ disease.
Objectives: To develop a ‘2010 Partin Nomogram’ with total prostate-specific antigen (tPSA) as a continuous biomarker, in light of the fact that the current 2007 Partin Tables restrict the application of tPSA as a non-continuous biomarker by creating ‘groups’ for risk stratification with tPSA levels (ng/mL) of 0–2.5, 2.6–4.0, 4.1–6.0, 6.1–10.0 and >10.0. • To use a ‘predictiveness curve’ to calculate the percentile risk of a patient among the cohort.
Patients and Methods: In all, 5730 and 1646 patients were treated with radical prostatectomy (without neoadjuvant therapy) between 2000 and 2005 at the Johns Hopkins Hospital (JHH) and University Clinic Hamburg-Eppendorf (UCHE), respectively. • Multinomial logistic regression analysis was performed to create a model for predicting the risk of the four non-ordered pathological stages, i.e. organ-confined disease (OC), extraprostatic extension (EPE), and seminal vesicle (SV+) and lymph node (LN+) involvement. • Patient-specific risk was modelled as a function of the B-spline basis of tPSA (with knots at the first, second and third quartiles), clinical stage (T1c, T2a, and T2b/T2c) and biopsy Gleason score (5–6, 3 + 4 = 7, 4 + 3 = 7, 8–10).
Results: The ‘2010 Partin Nomogram’ calculates patient-specific absolute risk for all four pathological outcomes (OC, EPE, SV+, LN+) given a patient’s preoperative clinical stage, tPSA and biopsy Gleason score. • While having similar performance in terms of calibration and discriminatory power, this new model provides a more accurate prediction of patients’ pathological stage than the 2007 Partin Tables model. • The use of ‘predictiveness curves’ has also made it possible to obtain the percentile risk of a patient among the cohort and to gauge the impact of risk thresholds for making decisions regarding radical prostatectomy.
Conclusion: The ‘2010 Partin Nomogram’ using tPSA as a continuous biomarker together with the corresponding ‘predictiveness curve’ will help clinicians and patients to make improved treatment decisions.
Objectives: To assess a novel application of the Prostate Health Index (phi) and biopsy tissue DNA content in benign-adjacent and cancer areas to predict which patients would eventually require treatment of prostate cancer in the Proactive Surveillance cohort.
Methods: We identified 71 men who had had serum and biopsy tissue from their diagnosis banked and available for the present study. Of the 71 patients, 39 had developed unfavorable biopsy findings and 32 had maintained favorable biopsy status during surveillance. The serum total prostate-specific antigen (tPSA), free PSA (fPSA) and [−2]proPSA were measured using the Beckman Coulter immunoassay. The DNA content measurements of Feulgen-stained biopsy sections were performed using the AutoCyte imaging system.
Results: The ratio of phi was significantly greater (37.23 ± 15.76 vs 30.60 ± 12.28; P = .03) in men who ultimately had unfavorable biopsy findings. The serum phi ratio (P = .003), [−2]proPSA/%fPSA (P = .004), biopsy tissue DNA content (ie, benign-adjacent excess of optical density, P = .019; and cancer area standard deviation of optical density, P = .002) were significant predictors of unfavorable biopsy conversion on Cox regression analysis. However, phi and [−2]proPSA/%fPSA showed a highly significant correlation (rho = 0.927, P < .0001) and no difference in accuracy (c-index, 0.6247 vs 0.6158; P = .704) for unfavorable biopsy conversion prediction. Furthermore, phi and [−2]proPSA/%fPSA remained significant (P = .047 and P = .036, respectively) in the multivariate models and, combined with the biopsy tissue DNA content, showed improvement in the predictive accuracy (c-index, 0.6908 and 0.6884, respectively) for unfavorable biopsy conversion.
Conclusions: The Prostate Health Index to proPSA/%fPSA, combined with biopsy tissue DNA content, improved the accuracy to about 70% to predict unfavorable biopsy conversion at the annual surveillance biopsy examination among men enrolled in an Active Surveillance program.
To examine the prevalence and content of robotic surgery information presented on websites of U.S. hospitals. We completed a systematic analysis of 400 randomly selected U.S. hospital websites in June of 2010. Data were collected on the presence and location of robotic surgery information on a hospital's website; use of images or text provided by the manufacturer; use of direct link to manufacturer website; statements of clinical superiority; statements of improved cancer outcome; mention of a comparison group for a statement; citation of supporting data and mention of specific risks. Forty-one percent of hospital websites described robotic surgery. Among these, 37% percent presented robotic surgery on their homepage, 73% used manufacturer-provided stock images or text, and 33% linked to a manufacturer website. Statements of clinical superiority were made on 86% of websites, with 32% describing improved cancer control, and 2% described a reference group. No hospital website mentioned risks. Materials provided by hospitals regarding the surgical robot overestimate benefits, largely ignore risks and are strongly influenced by the manufacturer.
Objectives: A PSA velocity (PSAV) >0.35 ng/ml/year approximately 10–15 years prior to diagnosis is associated with a greater risk of lethal prostate cancer. Some have recommended that a PSAV >0.35 ng/ml/year should prompt a prostate biopsy in men with a low serum PSA (<4 ng/ml) and benign DRE. However, less is known about the utility of this PSAV cutpoint for the prediction of treatment outcomes among men undergoing radical prostatectomy (RP).
Methods: Between 1992 and 2007, 339 men underwent RP at our institution with a preoperative PSA <4 ng/ml, benign DRE, and multiple preoperative PSA measurements. PSAV was calculated by linear regression analysis using all PSA values within 18 months prior to diagnosis. Kaplan–Meier survival analysis was performed, and biochemical progression rates were compared between PSAV strata using the log-rank test.
Results: The preoperative PSAV was >0.35 ng/ml/year in 124 (36.6%) of 339 men. Although there were no significant differences in clinico-pathological characteristics based upon PSAV, men with a PSAV >0.35 ng/ml/year were significantly more likely to experience biochemical progression after RP at a median follow-up of 4 years (P = 0.022).
Conclusions: In this low-risk population with a preoperative PSA <4 ng/ml and benign DRE, approximately 1/3 had a preoperative PSAV >0.35 ng/ml/year. Physicians should carefully monitor men with a preoperative PSA >0.35 ng/ml/year as they are at increased risk of biochemical progression following RP.
Objective: To assess the DNA content in benign-adjacent and cancer-tissue areas of a diagnostic biopsy, to predict which patients would subsequently develop an unfavourable biopsy necessitating treatment for prostate cancer in the expectant management (EM) programme.
Patients and Methods: Of 71 patients who had benign-adjacent and cancer-tissue areas of diagnostic biopsies available, 39 developed unfavourable biopsies (Gleason score ≥7, Gleason pattern 4/5, three or more cores positive for cancer, >50% of any core involved with cancer), while 32 maintained favourable biopsies on annual surveillance examination (median follow-up 3.7 years). DNA content was measured on Feulgen-stained biopsy sections using an automatic imaging system (AutoCyteTM, TriPath Imaging Inc, Burlington, NC, USA). Cox proportional-hazard regression and Kaplan-Meier plots were used to identify significant predictors for unfavourable biopsy conversion.
Results: Univariately, DNA content measurements i.e. an excess of optical density (OD) in the benign-adjacent tissuer area, and the sd of the OD in the cancer tissue were significant, with a hazard ratio and 95% confidence interval of 2.58 (1.17–5.68; P = 0.019) and 5.36 (1.89–15.24; P = 0.002), respectively, for predicting unfavourable biopsy conversion that required intervention. Also, several other DNA content measurements in benign-adjacent and cancer-tissue areas showed a trend to statistical significance. Further, benign-adjacent excess of OD (3.12, 1.4–6.95; P = 0.005) and cancer sd of OD (5.88, 2.06–16.82; P = 0.001) remained significant in the multivariate model to predict unfavourable biopsy conversion. Patients with benign-adjacent excess of OD > 25.0 and cancer sd of OD of >4.0 had the highest risk for unfavourable biopsy conversion (P < 0.001).
Conclusions: DNA content measurements in the benign-adjacent and cancer-tissue areas appear to be useful for predicting unfavourable biopsy conversion (a recommendation for intervention) on annual surveillance examinations in the EM programme.
Purpose: Few groups have examined satisfaction after prostate cancer treatment. We determined 1) predictors of satisfaction between 3 months and 2 years after open radical retropubic prostatectomy, and 2) whether these factors are time dependent.
Materials and Methods: This prospective cohort study included 1,542 men who underwent radical retropubic prostatectomy from October 2000 to July 2008. The primary outcome was satisfaction self-assessed at 3, 6, 12 and 24 months. We used multivariate logistic regression and repeated measures analysis to determine predictors of satisfaction, adjusting for demographic and clinical characteristics.
Results: Median followup was 24 months. About 93% of the men were satisfied. On multivariate analysis men were significantly less satisfied at 3 months when the urinary catheter was indwelling for 3 weeks or greater (OR 0.23, 95% CI 0.10–0.54), or they required intervention for anastomotic stricture (OR 0.23, 95% CI 0.11–0.49) or experienced 4-point or greater worsening in American Urological Association symptom score (OR 0.26, 95% CI 0.13–0.49). At 6 months worsening urinary function (OR 0.34, 95% CI 0.13–0.88) and biochemical failure (OR 0.15, 95% CI 0.05–0.43) were significantly associated with satisfaction. Worsening sexual function became significant at 12 and 24 months. These associations were confirmed on repeated measures analysis.
Conclusions: Most men were satisfied after radical retropubic prostatectomy. Satisfaction determinants showed a nonsignificant trend toward time dependence. Postoperative factors, such as the duration of indwelling Foley catheterization, were associated with short-term satisfaction while sexual and urinary function, and biochemical failure were associated with long-term satisfaction. Based on high satisfaction rates open radical retropubic prostatectomy is an excellent treatment for prostate cancer.
Purpose: Among men with biochemical progression after radical prostatectomy little is known about prostate specific antigen at the time of metastasis to bone in hormone naïve patients. This information would be useful in determining when to initiate androgen deprivation therapy.
Materials and Methods: From a large radical prostatectomy series we identified 193 hormone naïve men in whom bone metastases developed at a mean of 6 years postoperatively. We examined the prostate specific antigen distribution at bone scan conversion by time from radical prostatectomy to metastasis. ANOVA and linear regression were also used to examine the association of clinicopathological tumor features with prostate specific antigen at bone metastasis.
Results: Median prostate specific antigen was 31.9 ng/ml at the initial diagnosis of metastatic disease. Bone scan conversion occurred at a prostate specific antigen of less than 10, 10 to 100 and greater than 100 ng/ml in 50 (25.9%), 98 (50.8%) and 45 (23.3%) men, respectively. Lower prostate specific antigen at diagnosis, higher prostatectomy Gleason scores and shorter time to metastasis were associated with lower prostate specific antigen at bone metastasis, whereas prostate specific antigen at metastasis was not significantly associated with other clinicopathological features.
Conclusions: Prostate specific antigen at the time of bone scan detected metastasis is highly variable. Unlike the pretreatment setting when metastases are rare at a prostate specific antigen of less than 10 ng/ml, 25.9% of bone metastases after radical prostatectomy occurred at a prostate specific antigen of less than 10 ng/ml. Because metastasis may occur at a low prostate specific antigen, patients with biochemical progression managed expectantly need regular bone scans even if prostate specific antigen is low to detect metastasis before symptoms.
Purpose: Surgical treatment for prostate cancer represents a large national health care expenditure. We determined whether state level variation in the cost of radical prostatectomy exists and whether we could explain this variation by adjusting for covariates associated with cost.
Materials and Methods: Using the 2004 Healthcare Cost and Utilization Project National Inpatient Sample of 7,978,041 patients we identified 9,917 who were 40 years old or older with a diagnosis of prostate cancer who underwent radical prostatectomy without cystectomy. We used linear regression to examine state level regional variation in radical prostatectomy costs, controlling for the local area wage index, patient demographics, case mix and hospital characteristics.
Results: The mean ± SD unadjusted cost was $9,112 ± $4,434 (range $2,001 to $49,922). The unadjusted mean cost ranged from $12,490 in California to $4,650 in Utah, each significantly different from the mean of $8,903 in the median state, Washington (p <0.0001). After adjusting for all potential confounders total cost was highest in Colorado and lowest in New Jersey, which were significantly different from the median, Washington ($10,750 and $5,899, respectively, vs $8,641, p <0.0001). The model explained 85.9% of the variance with regional variation accounting for the greatest incremental proportion of variance (35.1%) and case mix variables accounting for an incremental 32.3%.
Conclusions: The total cost of radical prostatectomy varies significantly across states. Controlling for known total cost determinants did not completely explain these differences but altered ordinal cost relationships among states. Cost variation suggests inefficiencies in the health care market. Additional studies are needed to determine whether these variations in total cost translate into differences in quality or outcome and how they may be translated into useful policy measures.
Background: In adult inpatients with acute kidney injury (AKI), clinicians routinely order a renal ultrasonography (RUS) study. It is unclear how often this test provides clinically useful information.
Methods: Cross-sectional study, including derivation and validation samples, of 997 US adults admitted to Yale–New Haven Hospital from January 2005 to May 2009, who were diagnosed as having AKI and who underwent RUS to evaluate elevated creatinine level. Pregnant women, renal transplant recipients, and patients with recently diagnosed hydronephrosis (HN) were excluded. Demographic and clinical characteristics were abstracted from the medical records. A multivariable logistic regression model was developed to create risk strata for HN and HN requiring an intervention (HNRI); a separate sample was used for validation. The frequency of incidental findings on RUS was assessed for each stratum.
Results: In a derivation sample of 200 patients, 7 factors were found to be associated with HN: history of HN; recurrent urinary tract infections; diagnosis consistent with obstruction; nonblack race; and absence of the following: exposure to nephrotoxic medications, congestive heart failure, or prerenal AKI. Among 797 patients in the validation sample (mean age, 65.6 years), 10.6% had HN and 3.3% had HNRI. Of 223 patients in the low-risk group, 7 (3.1%) had HN and 1 (0.4%) had HNRI (223 patients needed to be screened to find 1 case of HNRI). In this group, there were 0 incidental findings on RUS unknown to the clinical team. In the higher-risk group, 15.7% had HN and 4.7% had HNRI.
Conclusion: In adult inpatients with AKI, specific factors can identify patients unlikely to have HN or HNRI on RUS.
Background: Procedures performed in the office offer potential cost savings. Recent analyses suggest, however, that a fee-for-service system may incentivize subscale operations and, thus, contribute to excessive spending. The authors of this report sought to characterize changes in the practice of office-based and hospital-based endoscopic bladder surgery after 2005 increases in Medicare reimbursement.
Methods: All office and hospital-based endoscopic surgeries that were performed in a faculty practice from 2002 through 2007 were identified using billing codes for procedures, diagnoses, and procedure locations and then analyzed using the chi-square test and logistic regression. Costs were estimated based on published Medicare reimbursements for office and hospital-based surgeries.
Results: In total, 1341 endoscopic bladder surgeries were performed, including 764 in the office and 577 in the hospital. After 2005, the odds ratio (OR) for office surgery occurring among all cystoscopies and for surgery occurring in the office versus the hospital was 2.01 (95% confidence interval [CI], 1.71-2.37) and 2.29 (95% CI, 1.83-2.87), respectively. Among all treated lesions that were associated with a diagnosis of bladder cancer and nonbladder cancer, the OR for a procedure occurring in the office versus the hospital was 1.36 (95% CI, 1.07-1.73) and 1.99 (95% CI, 1.52-2.60), respectively. The likelihood of repeat surgery on the same lesion increased after 2005 (OR, 2.86; 95% CI, 1.46-5.62), and the likelihood of an office surgery leading to a bladder cancer diagnosis at the next visit declined (OR, 0.29; 95% CI, 0.16-0.51). The overall estimated expenditure increased by 50%.
Conclusions: After 2005, more bladder lesions were identified and treated in the office. In a single group practice, office treatment of bladder cancer did not fully explain this new practice pattern, suggesting a lowered threshold for office intervention.
Purpose: The Partin tables are a nomogram that is widely used to discriminate prostate cancer pathological stages, given common preoperative clinical characteristics. The nomogram is based on patients undergoing radical prostatectomy at The Johns Hopkins Medical Institutions. We validated the Partin tables in a large, population based sample.
Materials and Methods: The National Cancer Institute Surveillance, Epidemiology and End Results database was used to identify patients treated from 2004 to 2005 who underwent radical prostatectomy. The 2007 Partin tables were used to estimate the prevalence of positive lymph nodes, seminal vesicle invasion, extraprostatic extension and organ confined disease in men with prostate cancer in the database using clinical stage, preoperative prostate specific antigen and Gleason score. The discriminative ability of the tables was explored by constructing ROC curves.
Results: We identified 11,185 men who underwent radical prostatectomy for prostate cancer in 2004 to 2005. The Partin tables discriminated well between patient groups at risk for positive lymph nodes and seminal vesicle invasion (AUC 0.77 and 0.74, respectively). The discrimination of extraprostatic extension and organ confined disease was more limited (AUC 0.62 and 0.68, respectively). The AUC for positive lymph nodes was 0.78 in white men, 0.73 in black men and 0.83 in Asian/Pacific Islander men (p = 0.17). The AUC for positive lymph nodes in men 61 years old or younger was 0.80 vs 0.74 in men older than 61 years (p = 0.03).
Conclusions: The Partin tables showed excellent discrimination for seminal vesicle invasion and positive lymph nodes. Discrimination of extraprostatic extension and organ confined disease was more limited. The Partin tables performed best in young men.