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Biomedical subjects

David C Miller

Publications and source records attributed to David C Miller.

At least 19 recordsLinked to original sources

Volume-based referral for cancer surgery: informing the debate.

PURPOSE: Mounting evidence suggests a relationship between hospital volume and outcomes after major cancer surgery; however, the absolute benefits of volume-based referral on a national basis are unclear. PATIENTS AND METHODS: Data from the Nationwide Inpatient Sample were used to measure the likelihood of operative mortality and a prolonged length of stay (LOS) after six cancer surgeries (prostatectomy, cystectomy, esophagectomy, pancreatectomy, pneumonectomy, and liver resection) between 1993 and 2003. Using sampling weights, the adjusted likelihood of the outcomes was used to calculate the number of lives saved (or prolonged LOS avoided) in the United States. RESULTS: The magnitude of the volume-operative mortality effect varied from an adjusted odds ratio (OR) of 1.3 (95% CI, 0.8 to 2.3) for cystectomy to 4.9 (95% CI, 2.4 to 10.1) for pancreatectomy. After accounting for varying rates of procedure utilization, the lives saved per 100 surgeries regionalized ranged from 0.2 (95% CI, 0.12 to 0.24 lives saved) for prostatectomy to 9.2 (95% CI, 6.7 to 10.4 lives saved) for pancreatectomy. The volume-prolonged LOS effect varied from an adjusted OR of 0.9 (95% CI, 0.5 to 1.6) for liver resection to 4.8 (95% CI, 3.5 to 6.7) for prostatectomy. After accounting for procedure use, the number of prolonged hospitalizations avoided ranged from -1.7 (95% CI, -11.3 to 3.6 hospitalizations) to 14.3 (95% CI, 12.9 to 15.4 hospitalizations) per 100 surgeries regionalized for liver resection and prostatectomy, respectively. CONCLUSION: For patients undergoing major cancer surgery, the benefits of volume-based referral depend on the interplay between procedure utilization, the magnitude of effect, and the outcome chosen.

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Rising incidence of small renal masses: a need to reassess treatment effect.

The incidence of kidney cancer has been rising over the last two decades, especially in cases where the disease is localized. Although rates of renal surgery parallel this trend, mortality rates have continued to rise. To investigate the basis of this "treatment disconnect" (i.e., increased rates of treatment accompanied by increased mortality rates), we analyzed patient data from nine registries of the National Cancer Institute's Surveillance, Epidemiology, and End Results Program. We assembled a cohort of 34,503 kidney cancer patients and derived incidence, treatment, and mortality trends for kidney cancer, overall and as a function of tumor size. From 1983 to 2002, the overall age-adjusted incidence rate for kidney cancer rose from 7.1 to 10.8 cases per 100,000 US population; tumors < or = 4 cm in size accounted for most of the increase. Adjusted rates of renal surgery increased concurrently, most notably for tumors < or = 4 cm (0.9-3.6 surgeries per 100,000 US population). However, among kidney cancer patients, all-cause mortality per 100,000 US population increased from 1.5 deaths in 1983 to 6.5 deaths in 2002, with the greatest absolute increase noted for patients with lesions > 7 cm. Our results demonstrate that the rising incidence of kidney cancer is largely attributable to an increase in small renal masses that are presumably curable. The fact that increased detection and treatment of small tumors is not reducing mortality argues for a reassessment of the current treatment paradigm.

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Incidence of initial local therapy among men with lower-risk prostate cancer in the United States.

BACKGROUND: The frequently indolent nature of early-stage prostate cancer in older men and in men with low- or moderate-grade tumors and the demonstration that the survival benefits of radical prostatectomy are primarily among men younger than 65 years have led to concerns about prostate cancer overtreatment. METHODS: Using data from 13 Surveillance, Epidemiology, and End Results registries, we performed a retrospective cohort study of 71,602 men who were diagnosed with localized or regional prostate cancer between 2000 and 2002. We quantified the incidence of initial curative therapy (i.e., surgery or radiation therapy) among men with lower-risk cancers as defined by their limited likelihood of either dying from expectantly managed prostate cancer or achieving a survival benefit from local therapy. Stratified analyses and multinomial logistic regression models were used to quantify the absolute and relative rates of curative therapy among men in various age-grade strata. All statistical tests were two-sided. RESULTS: We identified 24,405 men with lower-risk prostate cancers and complete data for the first course of treatment. Initial curative therapy was undertaken in 13,537 of these men (55%); 81% of treated men received radiation therapy. The likelihood of curative therapy, relative to expectant management, varied statistically significantly among lower-risk age-grade strata (all P<.05). Assuming that initial expectant management is appropriate for all lower-risk cancers, 2564 men (10%) in this population-based sample were overtreated with radical prostatectomy and 10,973 (45%) with radiation therapy. CONCLUSIONS: These data quantify a target population for whom greater use of expectant approaches may reduce overtreatment and improve the quality of localized prostate cancer care.

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Risk factors for adverse outcomes after transurethral resection of bladder tumors.

BACKGROUND: Risk factors for adverse outcomes after transurethral resection of bladder tumors (TURBT) have not been identified to date. Such information would facilitate preoperative risk stratification and case-mix-adjusted outcome comparison, and lead to the development of processes of care directed at improving outcomes and ultimately the quality of care for bladder carcinoma patients. METHODS: The National Surgical Quality Improvement Program (NSQIP) is a prospective quality management initiative of 123 Veterans Affairs Medical Centers nationwide. Since 1991, a total of 21,515 TURBTs have been prospectively registered by the NSQIP; these cases compose the current study population. Using multivariable logistic regression, the authors determined the independent association between preoperative patient risk factors and perioperative elements of structure/process and morbidity, mortality, and prolonged length of stay (LOS) outcomes. RESULTS: The postoperative complication, 30-day, and 90-day mortality rates were 4.3%, 1.3%, and 3.3%, respectively. The median, 75th percentile, and 90th percentile for LOS among patients undergoing TURBT was 2 days, 3 days, and 8 days, respectively. Robust preoperative patient risk factors that were found to be uniformly associated with all adverse outcomes included the presence of disseminated disease (odds ratio [OR], 1.9-5.2) weight loss (OR, 1.8-3.8), low serum albumin (OR, 2.3-7.1), elevated serum creatinine (OR, 1.3-2.9), a dependent functional status (OR, 1.5-2.7), and emergent case status (OR, 1.8-3.1). Compared with models using preoperative patient factors alone, models including perioperative structure and process measures explained further variation in surgical outcomes (each likelihood ratio test, P < .0001). CONCLUSIONS: The findings of the current study highlight the fact that there are a wide array of patient risk factors that are associated with adverse outcomes after TURBT. Validation of those processes implemented to modify such elements can provide a basis for quality metrics in the context of TURBT.

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Racial disparities in resource utilization for cystectomy.

OBJECTIVES: To examine the association of race with mortality and resource use among patients requiring cystectomy for bladder cancer, given the known racial differences with regard to bladder cancer incidence and survival. METHODS: Using the Nationwide Inpatient Sample (a nationally representative data set), 22,088 patients who underwent cystectomy for bladder cancer from 1988 to 2000 were identified using the International Classification of Disease, Ninth Revision, codes. The outcomes included in-hospital mortality, length of stay (LOS), and discharge status. Multivariable models were developed to perform risk-adjusted analyses and identify factors associated with these outcomes. RESULTS: The overall mortality rate after cystectomy was 2.9%. Unadjusted analyses revealed significant racial differences with respect to in-hospital mortality, LOS, and discharge disposition. Whites had a mortality rate of 2.8% compared with 4.2% for blacks and 3.9% for Hispanics (P = 0.006). Whites had a prolonged LOS 24.9% of the time compared with 38.2% for blacks and 24.6% for Hispanics (P < 0.001). The rate at which whites were discharged to subacute care facilities was 9.9% compared with 11.2% for black patients and 7.7% for Hispanics (P < 0.001). After adjusting for confounding factors, blacks were more likely to experience in-hospital mortality and prolonged LOS (odds ratios 1.66 and 2.10, respectively) compared with whites, although no significant differences were observed for Hispanics. No significant racial differences were noted for discharge status after risk adjustment. CONCLUSIONS: Black patients undergoing cystectomy for bladder cancer had greater mortality and greater LOS than did white patients. Additional study using detailed clinical data is necessary to identify the underlying causes of these differences.

Black or African American↗

National utilization trends of partial nephrectomy for renal cell carcinoma: a case of underutilization?

OBJECTIVES: Partial nephrectomy is perceived to be more technically demanding than radical nephrectomy; concurrently, the increasing incidence of small renal tumors has suggested a greater role for nephron-sparing techniques. From a quality-of-care perspective, the underuse of partial nephrectomy may represent suboptimal delivery of healthcare. METHODS: A total of 66,621 subjects undergoing radical and partial nephrectomy for kidney cancer between 1988 and 2002 were identified from the Nationwide Inpatient Sample, a nationally representative data set of hospital discharges. Adjusted models were developed to identify clinical factors and structural measures independently associated with the use of partial nephrectomy. RESULTS: Overall, 7.5% of patients treated underwent partial nephrectomy. The utilization rates for partial nephrectomy ranged from 0.21 cases per 100,000 U.S. residents in 1988 to 1.6 cases per 100,000 U.S. residents in 2002. The percentage of patients with renal cell carcinoma treated with partial nephrectomy has increased more than threefold during the study interval (3.7% in 1988 to 1990 compared with 12.3% in 2000 to 2002, P <0.0001 for trend). Patients treated at urban (odds ratio 1.1), teaching (odds ratio 1.3), and high nephrectomy volume (odds ratio 2.5) hospitals were more likely to undergo partial nephrectomy (each, P <0.01). CONCLUSIONS: The national use of partial nephrectomy has increased but remains lower than expected in certain settings, suggesting underuse or selective referral. Subjects with kidney cancer are more likely to be treated with partial nephrectomy at teaching institutions with high surgical volumes. The practice patterns of physicians at institutions more commonly using partial nephrectomy may reflect a better quality of care, although additional work in delineating the disparate utilization rates is warranted.

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Cost trends for oncological renal surgery: support for a laparoscopic standard of care.

PURPOSE: There may be inherent costs associated with the cultivation of laparoscopic expertise. We compared the cost trends for laparoscopy during the development of our program with that of open surgery for renal neoplasms. MATERIALS AND METHODS: We retrospectively reviewed the records of 381 patients treated surgically for renal cortical neoplasms from 1998 to 2003. Demographic information and cancer specific data were recorded on each subject. Direct variable costs, which are directly traceable to the patient care service provided and vary with patient volume, were used to analyze cost. Temporal trends were assessed using multivariate models developed to determine smoothed mean costs by year. RESULTS: Although it was initially more expensive, by 2003 mean costs were lower for laparoscopic than for open radical nephrectomy ($5,157 vs $5,808). This reflected a significantly lower annual increase in direct variable costs for laparoscopy vs open surgery even after adjustment for patient age, sex, race and clinical stage (p = 0.013). Although a similar trend was observed when comparing nephron sparing procedures vs open surgery, this did not attain statistical significance. In addition to surgical technique, only higher clinical stage was independently associated with increased direct variable costs after adjustment for operative year (p <0.0001). CONCLUSIONS: Relative to their open counterparts the costs of laparoscopic treatment of renal cortical neoplasms have increased at a lower rate in the last 6 years. When considered in the context of the well established benefits of laparoscopy, our findings lend additional support in favor of laparoscopy as the standard of care.

Costs and Cost Analysis↗

Laparoscopy for renal cell carcinoma: diffusion versus regionalization?

PURPOSE: Recognizing the emergence of laparoscopy as a standard of care for surgical treatment in many patients with organ confined renal cell carcinoma, we explored the diffusion of this technology by examining temporal trends in the nationwide use of laparoscopic total and partial nephrectomy in patients with renal cell carcinoma. MATERIALS AND METHODS: Data from the Healthcare Cost and Utilization Project Nationwide Inpatient Sample were abstracted for 1991 through 2003. International Classification of Diseases-Ninth Revision, Clinical Modification 9 codes were used to identify patients undergoing open and laparoscopic total and partial nephrectomy for renal cell carcinoma. Using hospital sampling weights we calculated annual incidence rates for open and laparoscopic nephrectomy, thereby estimating the diffusion of laparoscopy. Bivariate and multivariate analyses were used to identify patient and hospital characteristics associated with the more frequent use of laparoscopic techniques. RESULTS: Data on 63,812 patients were abstracted from the Nationwide Inpatient Sample, yielding a weighted national estimate of 323,979 who underwent laparoscopic (4.9%) or open (95.1%) nephrectomy (total or partial) for renal cell carcinoma between 1991 and 2003. Although it is still infrequent, the use of laparoscopy has increased steadily since 1998 with a utilization peak in 2003 of 1.7 laparoscopic nephrectomies per 100,000 American population, representing 16% of all total and partial nephrectomies for renal cell carcinoma in 2003. Treatment year, overall hospital nephrectomy volume and teaching hospital status were the most robust determinants of increased laparoscopic use (each p <0.001). CONCLUSIONS: Although its use has increased progressively in the last decade, the dissemination of laparoscopy for renal cell carcinoma has been generally slow and limited in scope. The next step in this body of work is to identify specific technical, educational and policy interventions that will influence the diffusion of this alternative standard of care.

Carcinoma, Renal Cell↗

The effects of adjusting for case mix on mortality and length of stay following radical cystectomy.

PURPOSE: Prior studies evaluating quality of care following radical cystectomy have been constrained by the use of retrospective reviews of single institutional series and limited ability to examine risk factors in a comprehensive manner. Characterization of these factors could enhance preoperative patient counseling and facilitate perioperative management, thereby improving the quality of patient care. MATERIALS AND METHODS: The National Surgical Quality Improvement Project is a prospective quality management initiative at 123 Veterans Affairs Medical Centers nationwide. The project collects preoperative clinical and intraoperative data, and outcomes on a wide variety of surgical procedures from multiple surgical disciplines. Since 1991, 2,538 radical cystectomies have been captured by the National Surgical Quality Improvement Project. Modeling using logistic regression was performed to identify preoperative risk factors associated with mortality and prolonged length of stay (greater than 90th percentile) after radical cystectomy. RESULTS: The 30 and 90-day mortality rates following cystectomy were 2.9% and 6.8%, respectively, and median hospital stay was 11 days (90th percentile 30). Robust preoperative factors associated with mortality and prolonged length of stay that uniformly increased risk were older patient age (OR 1.2 to 1.4), American Society of Anesthesiologists class 3 or greater (OR 1.5 to 3.3), dependent functional status (OR 1.7 to 2.0) and low serum albumin (OR 2.1 to 12.0). CONCLUSIONS: A defined set of preoperative risk factors is independently associated with greater mortality and hospital stay following radical cystectomy. The breadth of these factors suggests that complex case mix adjustment is mandatory when comparing outcomes. Implementation of novel processes directed toward minimizing patient risk has the potential to improve outcomes following cystectomy.

Age Factors↗

Discharge practice patterns following cystectomy for bladder cancer: evidence for the shifting of the burden of care.

PURPOSE: Between 1985 and 2000 the incidence of bladder cancer in this country increased by 33%. Radical cystectomy is the primary treatment modality in patients with invasive disease. We characterized trends in cystectomy use and discharge practice patterns following cystectomy during a recent 13-year period. MATERIALS AND METHODS: The Nationwide Inpatient Sample comprises a 20% probability sample of hospital discharges in the United States each year. Patients who underwent cystectomy for bladder cancer from 1988 to 2000 were identified using International Classification of Disease, 9th Revision, Clinical Modification codes. Outcome variables included in-hospital mortality, length of stay and hospital discharge status. RESULTS: From 1988 to 2000 an estimated 119,491 patients underwent cystectomy for bladder cancer. Cystectomy rates decreased by 17% from 3.91/100,000 (1988 to 1990) to 3.25/100,000 (1997 to 2000), largely due to a decreasing number of partial cystectomies. In-hospital mortality decreased from 3.3% (1988 to 1990) to 2.5% (1997 to 2000) (p = 0.027). Similarly median length of stay decreased from 13 days (1988 to 1990) to 9 (1997 to 2000) (p <0.001). During the same period the percent of patients being discharged to subacute care facilities increased from 5.3% to 13.2% (p <0.001), as did the percent of patients requiring home health care services (24.1% to 38.7%, p <0.001). CONCLUSIONS: From 1988 to 2000 there was a decrease in the rate of cystectomies being performed for bladder cancer with a substantial decrease in partial cystectomy use. During this period short-term outcomes following cystectomy improved, while the use of subacute care facilities and home health services increased dramatically, underscoring a shift in the burden of care in this patient population.

Aftercare↗

Local anesthesia in transrectal prostate biopsy.

The administration of local anesthesia both topical and injectable before transrectal ultrasound-guided prostate biopsy is safe and efficacious. We describe our technique and review the relevant published data on this topic.

Anesthesia, Local↗

Surgical management of low-stage renal cell carcinoma: Technology does not supersede biology.

OBJECTIVES: To address the concern that laparoscopic radical nephrectomy (LRN) is being applied in cases of small renal masses in which nephron-sparing surgery (NSS) might be more appropriate. METHODS: From 1998 to 2003, 381 consecutive patients underwent 391 procedures at our institution for renal cell carcinoma, of which 336 were for organ-confined tumors. The temporal trends in the application of LRN and NSS were assessed relative to the clinical stage. RESULTS: During the transition from early (1998 to 2000) to late (2001 to 2003) experience with laparoscopy, the use of LRN among patients with Stage T1a (4 cm or smaller) lesions remained infrequent (21% and 20%, respectively). In contrast, LRN increased among patients with larger lesions during this same interval (Stage T1b, 36% versus 56%, P = 0.017 and Stage T2, 24% versus 41%, P = 0.056). Concurrently, the use of NSS (open surgical or laparoscopic partial nephrectomy) increased for both Stage T1a (25% and 31% versus 34% and 37%, P = 0.082) and T1b (8% and 6% versus 19% and 5%, P = 0.017) tumors. Multivariate analysis demonstrated that the use of both NSS and LRN increased significantly with time (P = 0.002 and P = 0.001, respectively). Neither NSS nor LRN were associated with a greater risk of perioperative complications relative to radical or open surgery (P >0.05 for both). CONCLUSIONS: During a 6-year period at our institution, most Stage T1a lesions were managed with NSS, and a significant increase occurred in the use of NSS for Stage T1b tumors, despite the concurrent increasing application of LRN. These findings suggest that oncologic, rather than technologic, concerns were determining our practice patterns.

Carcinoma, Renal Cell↗

Use of medications or devices for erectile dysfunction among long-term prostate cancer treatment survivors: potential influence of sexual motivation and/or indifference.

OBJECTIVES: To evaluate the potential association between sexual motivation and patterns of erectile dysfunction (ED) therapy among a large cohort of localized prostate cancer treatment survivors. METHODS: The use of medications and devices to improve erections and sexual health-related quality of life (HRQOL) were evaluated using a mailed Expanded Prostate Cancer Index Composite survey administered to 896 men 4 to 8 years after brachytherapy, three-dimensional conformal external beam radiotherapy (3D-CRT), or radical prostatectomy and 112 control men. The responding participants (73% of those surveyed) were classified by prostate cancer treatment, sexual motivation, and ED therapy use. Bivariate and multivariate analyses were used to identify the factors associated with ED therapy use and sexual HRQOL outcome. RESULTS: The quality of erections unassisted by medications or devices was not different among the treatment groups. Prostate cancer survivors used medications or devices for ED more commonly than did the control men (30% versus 13%; P <0.01). One half of the prostate cancer survivors with ED reported indifference regarding their ED (small to no sexual bother despite absent or poor unassisted erections). Conversely, among men who were bothered by poor erections, 48% of the brachytherapy, 61% of the 3D-CRT, and 23% of radical prostatectomy subjects had never tried commonly available medications or devices to improve their erections (P <0.01). The current use of at least one erection aid was an independent determinant of more favorable sexual HRQOL (P <0.01). CONCLUSIONS: Many men who are bothered by posttreatment ED reported never having tried medications or devices to improve their erections. The lack of ED therapy was more prevalent among patients with erectile concerns after brachytherapy or 3D-CRT than after radical prostatectomy, suggesting possible opportunities for improving sexual HRQOL among long-term survivors.

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Comparing performance of Morbidity and Mortality Conference and National Surgical Quality Improvement Program for detection of complications after urologic surgery.

OBJECTIVES: The detection of postoperative complications is a necessary quality-of-care endeavor. Despite its historical role, the Morbidity and Mortality (M&M) Conference depends on voluntary reporting and may be an insufficient mechanism for comprehensive complication surveillance. In response to this concern, we compared the concordance between complications voluntarily reported at the M&M Conference and those identified prospectively by the National Surgical Quality Improvement Program (NSQIP). METHODS: For a single calendar year (2004), we compiled a comprehensive list of complications that were either identified and voluntarily entered into our department's electronic M&M Conference database and/or identified prospectively (from an explicit sample of cases) by a trained research associate-based NSQIP protocol. For analytic purposes, we treated NSQIP as the reference standard for the detection of complications. We then determined the sensitivity of the M&M Conference for the identification of complications at a patient and event level. Logistic regression modeling was used to evaluate for an association between complication category (ie, organ system affected) and detection by the M&M Conference. RESULTS: The NSQIP detected 347 complications in 176 patients. Using this reference standard, the patient-level and event-level sensitivity of the M&M Conference was 25% (44 of 176) and 14% (47 of 347), respectively. The sensitivity of the M&M Conference varied by NSQIP complication category (P = 0.08). Circulatory events were 11 times more likely to be reported at the M&M Conference than urinary complications (odds ratio 11.3, 95% confidence interval 2.4 to 53.7). CONCLUSIONS: Compared with the NSQIP, the M&M Conference has a low (but variable) sensitivity for the detection of postoperative complications. Therefore, despite its limitations, the NSQIP may provide a better foundation for urologic quality improvement endeavors.

Adolescent↗

Use of nephrectomy at select medical centers--a case of follow the crowd?

PURPOSE: Regionalization of high risk surgical procedures to larger, teaching hospitals has been suggested as a means to improve the quality of care. We determined the extent to which the regionalization of nephrectomy has occurred and describe the potential causes and implications of any observed regionalization. MATERIALS AND METHODS: The Nationwide Inpatient Sample comprises a 20% sampling of hospital discharges in the United States yearly. Patients undergoing nephrectomy for kidney cancer between 1988 and 2002 were identified using International Classification of Disease, Ninth Revision, Clinical Modification codes. Regionalization was assessed using 6 structural hospital measures, including teaching status, urban location, discharge volume, nephrectomy volume, bed capacity and for-profit status. Adjusted models were developed to identify the significance of temporal trends in each regionalization measure. RESULTS: We identified 66,621 patients undergoing nephrectomy during the study period. Compared to procedures performed between 1988 and 1990 the likelihood of undergoing nephrectomy at teaching, high nephrectomy volume and high throughput (all diagnoses) hospitals increased by 2.0 (CI 1.9 to 2.2), 7.4 (CI 7.1 to 7.7) and 2.2 times (CI 2.1 to 2.2), respectively, in 2000 to 2002. Conversely nephrectomy was less likely to be performed at for-profit hospitals (OR 0.5, CI 0.5 to 0.6). Patients were more likely to undergo partial nephrectomy at teaching, high volume, high throughput, urban hospitals. CONCLUSIONS: Regionalization of nephrectomy to teaching and high volume (nephrectomy and all diagnoses) hospitals is currently under way. Although the implications are not entirely clear, this study provides further evidence for the crowding of complex surgical procedures into these institutions.

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