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Surgical Decompression is Associated with Decreased Mortality in Patients with Sepsis and Ureteral Calculi
Borofsky, Michael S; Walter, Dawn; Shah, Ojas; Goldfarb, David S; Mues, Adam C; Makarov, Danil V
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.
PMID: 23017519
ISSN: 0022-5347
CID: 210832
Centralization of Radical Prostatectomy in the United States
Anderson, Christopher B; Penson, David F; Ni, Shenghua; Makarov, Danil V; Barocas, Daniel A
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.
PMID: 23069384
ISSN: 0022-5347
CID: 210822
A new approach to understanding racial disparities in prostate cancer treatment
Presley, Carolyn J; Raldow, Ann C; Cramer, Laura D; Soulos, Pamela R; Long, Jessica B; Yu, James B; Makarov, Danil V; Gross, Cary P
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.
PMCID:3697868
PMID: 23828723
ISSN: 1879-4068
CID: 415172
Long-term satisfaction and predictors of use of intracorporeal injections for post-prostatectomy erectile dysfunction
Prabhu, Vinay; Alukal, Joseph P; Laze, Juliana; Makarov, Danil V; Lepor, Herbert
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.
PMCID:3661773
PMID: 23174252
ISSN: 0022-5347
CID: 202302
Current treatments and novel therapeutic targets for castration resistant prostate cancer with bone metastasis
Wei, Juncheng; Wang, Zhilin; Makarov, Danil; Li, Xin
Prostate cancer is a leading cause of cancer death in men in developed countries. While early stage disease can often be cured, many patients eventually develop castration resistant prostate cancer (CRPC). The majority of CRPC patients have bone metastases, which cause significant morbidity and mortality. Although there is no cure for prostate cancer metastatic to bone, several bone-targeted agents have been approved to prevent skeletal-related events (SREs). Among them, bisphosphonates were the first class of drugs investigated for prevention of SREs. Denosumab is a recently approved agent that binds to the receptor activator of nuclear factor-kappaB ligand (RANKL) as a humanized monoclonal antibody. Both agents target prostate cancer skeletal metastasis through the inhibition of bone resorption. Alpharadin is the first radiopharmaceutical agent that has significant overall survival benefit. It has benefits in pain palliation and SREs as well. Another newly approved drug is Abiraterone acetate, which decreases circulating levels of testosterone by targeting an enzyme expressed in the testis and the adrenal, as well as in prostate cancer tissues. This review outlines the clinical and preclinical data supporting the use of these and new agents in development for CRPC with bone metastasis.
PMCID:4219282
PMID: 25374898
ISSN: 2330-1910
CID: 1845322
Comparison of the Level of Evidence Supporting Practice Guidelines in Cancer Care Between Therapeutic Modalities [Meeting Abstract]
Buscariollo, D.; Lloyd, S.; Gross, C.; Makarov, D.; Yu, J.
ISI:000310542900111
ISSN: 0360-3016
CID: 204872
Immortal time bias: a frequently unrecognized threat to validity in the evaluation of postoperative radiotherapy
Park, Henry S; Gross, Cary P; Makarov, Danil V; Yu, James B
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.
PMID: 22342097
ISSN: 0360-3016
CID: 174184
Patterns of Care and Outcomes Associated With Intensity-Modulated Radiation Therapy Versus Conventional Radiation Therapy for Older Patients With Head-and-Neck Cancer
Yu, James B; Soulos, Pamela R; Sharma, Richa; Makarov, Danil V; Decker, Roy H; Smith, Benjamin D; Desai, Rani A; Cramer, Laura D; Gross, Cary P
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.
PMID: 22342095
ISSN: 0360-3016
CID: 166569
Appropriate and inappropriate imaging rates for prostate cancer go hand in hand by region, as if set by thermostat
Makarov, Danil V; Desai, Rani; Yu, James B; Sharma, Richa; Abraham, Nitya; Albertsen, Peter C; Krumholz, Harlan M; Penson, David F; Gross, Cary P
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.
PMID: 22492890
ISSN: 0278-2715
CID: 166690
The relationship between clinical benefit and receipt of curative therapy for prostate cancer
Raldow, Ann C; Presley, Carolyn J; Yu, James B; Sharma, Richa; Cramer, Laura D; Soulos, Pamela R; Long, Jessica B; Makarov, Danil V; Gross, Cary P
PMCID:3491889
PMID: 22371925
ISSN: 0003-9926
CID: 160251