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New technology in urology: Balancing risk and reward [Editorial]

Makarov, Danil V
PMID: 21555101
ISSN: 1873-2496
CID: 132317

The association between diffusion of the surgical robot and radical prostatectomy rates

Makarov, Danil V; Yu, James B; Desai, Rani A; Penson, David F; Gross, Cary P
BACKGROUND: Despite its expense and controversy surrounding its benefit, the surgical robot has been widely adopted for the treatment of prostate cancer. OBJECTIVES: To determine the relationship between surgical robot acquisition and changes in volume of radical prostatectomy (RP) at the regional and hospital levels. RESEARCH DESIGN: Retrospective cohort study. SUBJECTS: Men undergoing RP for prostate cancer at nonfederal, community hospitals located in the states of Arizona, Florida, Maryland, North Carolina, New York, New Jersey, and Washington. MEASURES: Change in number of RPs at the regional and hospital levels before (2001) and after (2005) dissemination of the surgical robot. RESULTS: Combining data from the Healthcare Cost and Utilization Project State Inpatient Databases 2001 and 2005 with the 2005 American Hospital Association Survey and publicly available data on robot acquisition, we identified 554 hospitals in 71 hospital referral regions (HRR). The total RPs decreased from 14,801 to 14,420 during the study period. Thirty six (51%) HRRs had at least 1 hospital with a surgical robot by 2005; 67 (12%) hospitals acquired at least 1 surgical robot. Adjusted, clustered generalized estimating equations analysis demonstrated that HRRs with greater numbers of hospitals acquiring robots had higher increases in RPs than HRRs acquiring none (mean changes in RPs for HRRs with 9, 4, 3, 2, 1, and 0 are 414.9, 189.6, 106.6, 14.7, -11.3, and -41.2; P<0.0001). Hospitals acquiring surgical robots increased RPs by a mean of 29.1 per year, while those without robots experienced a mean change of -4.8, P<0.0001. CONCLUSIONS: Surgical robot acquisition is associated with increased numbers of RPs at the regional and hospital levels. Policy makers must recognize the intimate association between technology diffusion and procedure utilization when approving costly new medical devices with unproven benefit
PMID: 21368677
ISSN: 1537-1948
CID: 134222

ProPSA and diagnostic biopsy tissue DNA content combination improves accuracy to predict need for prostate cancer treatment among men enrolled in an active surveillance program

Isharwal, Sumit; Makarov, Danil V; Sokoll, Lori J; Landis, Patricia; Marlow, Cameron; Epstein, Jonathan I; Partin, Alan W; Carter, H Ballentine; Veltri, Robert W
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
PMCID:4696012
PMID: 21216447
ISSN: 1527-9995
CID: 137827

Significance of preoperative PSA velocity in men with low serum PSA and normal DRE

Makarov, Danil V; Loeb, Stacy; Magheli, Ahmed; Zhao, Kevin; Humphreys, Elizabeth; Gonzalgo, Mark L; Partin, Alan W; Han, Misop
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
PMCID:3034139
PMID: 21153643
ISSN: 1433-8726
CID: 121322

The Influence of Regional Radiation Oncologist and Urologist Capacities on Treatment Choice for Prostate Cancer [Meeting Abstract]

Aneja, S; Gross, C; Makarov, D; Roberts, K; Yu, JB
ISI:000296411701212
ISSN: 0360-3016
CID: 2792752

In response to Dr. Hayes and colleagues [Letter]

Yu J.B.; Makarov D.V.; Gross C.P.
EMBASE:2011150234
ISSN: 0360-3016
CID: 130352

Renal ultrasonography in the evaluation of acute kidney injury: developing a risk stratification framework

Licurse, Adam; Kim, Michael C; Dziura, James; Forman, Howard P; Formica, Richard N; Makarov, Danil V; Parikh, Chirag R; Gross, Cary P
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
PMID: 21098348
ISSN: 1538-3679
CID: 137828

Patient centered outcomes in prostate cancer treatment: predictors of satisfaction up to 2 years after open radical retropubic prostatectomy

Abraham, Nitya E; Makarov, Danil V; Laze, Juliana; Stefanovics, Elina; Desai, Rani; Lepor, Herbert
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
PMID: 20850836
ISSN: 1527-3792
CID: 113746

Prostate specific antigen at the initial diagnosis of metastasis to bone in patients after radical prostatectomy

Loeb, Stacy; Makarov, Danil V; Schaeffer, Edward M; Humphreys, Elizabeth B; Walsh, Patrick C
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 naive 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 naive 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
PMID: 20483148
ISSN: 1527-3792
CID: 111024

Regional variation in total cost per radical prostatectomy in the healthcare cost and utilization project nationwide inpatient sample database

Makarov, Danil V; Loeb, Stacy; Landman, Adam B; Nielsen, Matthew E; Gross, Cary P; Leslie, Douglas L; Penson, David F; Desai, Rani A
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
PMID: 20172559
ISSN: 1527-3792
CID: 111025