Facilitating biomedical researchers' interrogation of electronic health record data: Ideas from outside of biomedical informatics.

Electronic health records (EHR) are a vital data resource for research uses, including cohort identification, phenotyping, pharmacovigilance, and public health surveillance. To realize the promise of EHR data for accelerating clinical research, it is imperative to enable efficient and autonomous EHR data interrogation by end users such as biomedical researchers. This paper surveys state-of-art approaches and key methodological considerations to this purpose. We adapted a previously published conceptual framework for interactive information retrieval, which defines three entities: user, channel, and source, by elaborating on channels for query formulation in the context of facilitating end users to interrogate EHR data. We show the current progress in biomedical informatics mainly lies in support for query execution and information modeling, primarily due to emphases on infrastructure development for data integration and data access via self-service query tools, but has neglected user support needed during iteratively query formulation processes, which can be costly and error-prone. In contrast, the information science literature has offered elaborate theories and methods for user modeling and query formulation support. The two bodies of literature are complementary, implying opportunities for cross-disciplinary idea exchange. On this basis, we outline the directions for future informatics research to improve our understanding of user needs and requirements for facilitating autonomous interrogation of EHR data by biomedical researchers. We suggest that cross-disciplinary translational research between biomedical informatics and information science can benefit our research in facilitating efficient data access in life sciences.

Pathological confirmation of nerve-sparing types performed during robot-assisted radical prostatectomy (RARP).

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Incremental nerve-sparing techniques (NSTs) improve postoperative erectile function after robot-assisted radical prostatectomy (RARP). However, there are no studies to date that histologically confirm the surgeon intended NST. Thus, in the present study, we histologically confirmed that the surgeon performed the nerve preservation as his intended NSTs during RARP. Also, we found that there was more variability in fascia width outcome on the left side compared with the right. Therefore, when performing nerve preservation on the surgeon's non-dominant side, we need to pay more close attention. OBJECTIVES: To confirm that the surgeon achieved true intended histological nerve sparing during robot-assisted radical prostatectomy (RARP) by studying RP specimens. To aid the novice robotic surgeon to develop the skills of RARP. PATIENTS AND METHODS: Between June 2008 and May 2009, 122 consecutive patients underwent RARP by a single surgeon (K.K.B.). The degree of nerve sparing (wide resection [WR], interfascial nerve sparing [ITE-NS], intrafascial nerve sparing [ITR-NS]) on both sides was recorded. The posterior sectors of RP specimens from distal, mid, and proximal parts were evaluated. Fascia width (FW) of each position in RP specimens were compared across nerve-sparing types (NSTs). FW was recorded at 15 ° intervals (3-9 o'clock position), measured as the distance between the outermost prostate gland and surgical margin. The slides were reviewed by an experienced uropathologist who was 'blinded' to the NST. RESULTS: In all, 93 men were included. The overall mean (sd) FW was the greatest in the order of WR, ITE-NS, and ITR-NS, at 2.42 (1.62), 1.71 (1.40) and 1.16 (1.08) mm, respectively (P < 0.001). FW was statistically significantly correlated with the surgical technique used. When the surgeon intended to perform various levels of nerve sparing, these were reflected in the FW. Interestingly, the left-side FW showed more variability than the right side. We suspect that this was a result of the surgeon's right-hand dominance. Erectile function (EF) recovery rate according to NST was 88.9%, 77.3%, 65.6%, 56.3%, and 0% in bilateral ITR-NS, ITR-NS/ITE-NS, bilateral ITE-NS, ITE-NS/WR, and bilateral WR, respectively. To further validate and confirm these preliminary findings, additional studies involving multicentre cohorts would be required. CONCLUSIONS: The surgeon intended dissection and FW correlate, with ITR-NS providing the narrowest FW and the EF recovery rate was the highest in bilateral ITR-NS. There was more variability in FW outcome on the left side than the right. The novice robotic surgeon should consider this variability when performing RARP. It may have implications for technique improvement on nerve preservation for EF.

An Integrated Model for Patient Care and Clinical Trials (IMPACT) to support clinical research visit scheduling workflow for future learning health systems.

We describe a clinical research visit scheduling system that can potentially coordinate clinical research visits with patient care visits and increase efficiency at clinical sites where clinical and research activities occur simultaneously. Participatory Design methods were applied to support requirements engineering and to create this software called Integrated Model for Patient Care and Clinical Trials (IMPACT). Using a multi-user constraint satisfaction and resource optimization algorithm, IMPACT automatically synthesizes temporal availability of various research resources and recommends the optimal dates and times for pending research visits. We conducted scenario-based evaluations with 10 clinical research coordinators (CRCs) from diverse clinical research settings to assess the usefulness, feasibility, and user acceptance of IMPACT. We obtained qualitative feedback using semi-structured interviews with the CRCs. Most CRCs acknowledged the usefulness of IMPACT features. Support for collaboration within research teams and interoperability with electronic health records and clinical trial management systems were highly requested features. Overall, IMPACT received satisfactory user acceptance and proves to be potentially useful for a variety of clinical research settings. Our future work includes comparing the effectiveness of IMPACT with that of existing scheduling solutions on the market and conducting field tests to formally assess user adoption.

Inconsistent Surgical Implant Documentation: A Case Study in Total Knee and Hip Arthroplasty.

Value-based care initiatives require accurate quantification of resource utilization. This study explores hospital resource documentation performance for total knee and hip arthroplasty (TKA, THA) implants and how this may differ between hospitals. This retrospective study utilized the Premier discharge database, years 2006 to 2020. TKA/THA cases were categorized into 5 tiers based upon the completeness of implant component documentation: Platinum, Gold, Silver, Bronze, Poor. Correlation between TKA and THA documentation performance (per-hospital percentage of Platinum cases) was assessed. Logistic regression analyses measured the association between hospital characteristics (region, teaching status, bed size, urban/rural) and satisfactory documentation. TKA/THA implant documentation performance was compared to documentation for endovascular stent procedures. Individual hospitals tended to have very complete (Platinum) or very incomplete (Poor) documentation for both TKA and THA. TKA and THA documentation performance were correlated (correlation coefficient = .70). Teaching hospitals were less likely to have satisfactory documentation for both TKA (P = .002) and THA (P = .029). Documentation for endovascular stent procedures was superior compared to TKA/THA. Hospitals' TKA and THA-related implant documentation performance is generally either very proficient or very poor, in contrast with often well-documented endovascular stent procedures. Hospital characteristics, other than teaching status, do not appear to impact TKA/THA documentation completeness.

Comparison of biochemical failure definitions for predicting local cancer recurrence following cryoablation of the prostate.

BACKGROUND: Various definitions of biochemical failure (BF) have been used to predict cancer recurrence following prostate cryoablation. However to date, none of these definitions have been validated for this use. We have reviewed several definitions of BF to determine their accuracy in predicting biopsy-proven local recurrence following prostate cryoablation. METHODS: The Columbia University Urologic Oncology Database was queried for patients who underwent prostate cryoablation between 1994 and 2010, and who subsequently underwent surveillance biopsy due to clinical suspicion of prostate cancer recurrence. Serial postoperative prostate-specific antigen (PSA) results were used to determine BF according to various definitions of BF. Biopsy results were used to determine local recurrence. Sensitivity, specificity, positive and negative predictive value, and receiver operating characteristic (ROC) curve area were calculated for each of the BF definitions. RESULTS: A total of 110 patients met inclusion criteria for the study. These patients were treated with primary full-gland (n = 38), primary focal (n = 24), or salvage cryoablation (n = 48). On surveillance biopsy, 66 patients (60%) were found to have locally recurrent prostate cancer. The most accurate BF definition overall was PSA nadir plus 2 ng/ml (Phoenix definition), with sensitivity, specificity, and ROC curve area of 68%, 59%, and 0.64, respectively. CONCLUSIONS: Overall, the Phoenix definition best predicted local cancer recurrence following prostate cryoablation. These preliminary data may be useful for researchers evaluating the short-term efficacy of cryoablation, and for urologists assessing their patients for potential cancer recurrence.

Dysregulation of circulating microRNAs and prediction of aggressive prostate cancer.

BACKGROUND: It is becoming increasingly evident that microRNAs (miRNAs) are associated with the development and progression of prostate cancer (PCa). METHODS: We examined the hypothesis that plasma miRNA levels can differentiate patients by aggressiveness in 82 PCa patients. Taqman based quantitative RT-PCR assays were performed to measure copy number of target miRNAs. RESULTS: miR-20a was significantly overexpressed in plasma from patients with stage 3 tumors compared to stage 2 or below (P = 0.03). The expression levels for miR-20a and miR-21 were significantly increased in patients with high risk CAPRA scores (16,623 and 1,595 copies, respectively). Significantly increased miR-21 and miR-145 expression were observed for patients with intermediate or high risk D'Amico scores compared to patients with low risk scores (P = 0.047 and 0.011, respectively). The relapse rates for CAPRA scores ranged from 1.9% for low risk to 9.5% for intermediate risk and to 22.2% for high risk patients (P = 0.023). For D'Amico scores, the relapse rates ranged from 0.0% for low risk to 7.4% for intermediate risk and 17.6% for high risk patients (P = 0.039). Expression of miR-21 and miR-221 significantly differentiated patients with intermediate risk from those with low risk CAPRA scores (AUC = 0.801, P = 0.002). Four miRNAs (miR-20a, miR-21, miR-145, and miR-221) could also distinguish high versus low risk in PCa patients by D'Amico score with an AUC of 0.824. CONCLUSIONS: These preliminary data suggest that altered plasma miRNAs may be useful predictors to distinguish PCa patients with varied aggressiveness. Further larger studies to validate this promising finding are warranted.

A comparison of the outcomes of neoadjuvant and adjuvant chemotherapy for clinical T2-T4aN0-N2M0 bladder cancer.

BACKGROUND: Despite evidence supporting perioperative chemotherapy, few randomized studies compare neoadjuvant and adjuvant chemotherapy for bladder cancer. Consequently, the standard of care regarding the timing of chemotherapy for locally advanced bladder cancer remains controversial. We compared patient outcomes following neoadjuvant or adjuvant systemic chemotherapy for cT2-T4aN0-N2M0 bladder cancer. METHODS: In a retrospective review of a single institutional database from 1988 through 2009, we identified patients receiving neoadjuvant or adjuvant multiagent platinum-based systemic chemotherapy for locally advanced bladder cancer. Survival analysis was performed comparing disease-specific survival (DSS) and overall survival (OS). RESULTS: A total of 146 patients received systemic perioperative chemotherapy (73 neoadjuvant, 73 adjuvant). Of these, 84% (122/146) received cisplatin-based chemotherapy compared with carboplatin-based chemotherapy (24/146, 16.4%). Most patients receiving cisplatin-based chemotherapy were treated with methotrexate/vinblastine/adriamycin/cisplatin (79/122, 64.8%), whereas the remaining patients received gemcitabine/cisplatin (GC) (43/122, 35.2%). In multivariable analysis, there was no significant difference in DSS (P = .46) or OS (P = .76) between neoadjuvant or adjuvant chemotherapy groups. There was statistically significant improvement in DSS when patients received neoadjuvant GC rather than adjuvant GC (P = .049, hazard ratio, 10.6; 95% confidence interval, 1.01-112.2). CONCLUSION: In this study, there was no statistically significant difference in OS and DSS between patients receiving neoadjuvant versus adjuvant systemic platinum-based chemotherapy for locally advanced bladder cancer. In addition, there was no significant difference between neoadjuvant and adjuvant cisplatin- or carboplatin-based chemotherapy. Chemotherapy sequence relative to surgery appeared less important than whether or not a patient actually received perioperative chemotherapy.

Partial nephrectomy online: a preliminary evaluation of the quality of health information on the Internet.

UNLABELLED: What's known on the subject? and What does the study add? Patients are highly likely to access the Internet for health information, and studies have reported that inaccurate or low-quality information may alter patients' expectations and negatively impact informed decision-making. In a unique collaboration with the Health On the Internet (HON) Foundation, we evaluated the top 20 search results for the urology search term 'partial nephrectomy,' and identified the highest and lowest scoring criteria to increase awareness of areas of concern and improvement. OBJECTIVE: To further evaluate the quality of information available on the Internet with regard to the management of localized renal cancer, we evaluated websites providing information on 'partial nephrectomy' in conjunction with the Health On the Internet (HON) Foundation. Many patients now utilize the Internet as a resource to provide further information on disease, treatments and outcomes, and health information on the Internet is largely unregulated. Inaccurate information may contribute to unrealistic expectations and dissatisfied patients. PATIENTS AND METHODS: A google.com search identified the top 30 websites for the search term 'partial nephrectomy'. The HON Foundation evaluated each website according to the eight principles for Health on the Internet code of conduct (HONcode) certification and reported the overall frequency of certification, as well as individual website compliance with each of the principles. RESULTS: Overall, seven (23.3%) of 30 websites met the requirements of HONcode certification and an additional two (6.7%) websites were under review to maintain their certification based on updating their resources. The remaining 21 (70%) websites did not meet the standards for certification. The lowest performing criteria included proper citation of medical information and a clear distinction of advertising from editorial content. CONCLUSIONS: The low rate of HONcode compliance for these websites illustrates the poor quality of information that patients may encounter when researching options for nephron-sparing surgery, which may have a significant impact on patient decision-making and treatment choices. Physicians should be aware of the quality of Internet resources and how to best use these tools to help guide patients to websites with valid information.

Prognostic indicators for upper tract urothelial carcinoma after radical nephroureterectomy: the impact of lymphovascular invasion.

UNLABELLED: What's known on the subject? and What does the study add? In an array of urological and non-urological malignancies, lymphovascular invasion (LVI) is a pathological feature known to be associated with adverse outcomes for recurrence and survival. For some cancers, LVI has therefore been incorporated into American Joint Committee on Cancer TNM staging algorithms. This study presents an analysis of the impact of LVI in upper urinary tract urothelial carcinoma (UTUC) treated at our institution over a 20-year period. In addition to known associations with features of aggressive disease and overall survival, we were able to show that LVI-positive status upsets the TNM staging for UTUC. Namely, patients with superficial stage and LVI-positive disease have overall survival outcomes similar to those of patients with muscle-invasive LVI-negative carcinoma. Such evidence may support the addition of LVI to future TNM staging algorithms for UTUC. OBJECTIVE: To assess the impact of lymphovascular invasion (LVI) on the prognosis of patients with upper urinary tract urothelial cell carcinoma (UTUC) treated with radical nephroureterectomy (RNU). PATIENTS AND METHODS: The Columbia University Medical Center Urologic Oncology database was queried and 211 patients undergoing RNU for UTUC between 1990 and 2010 were identified. These cases were retrospectively reviewed, and the prognostic significance of relevant clinical and pathological variables was analysed using log-rank tests and Cox proportional hazards regression models. Actuarial survival curves were calculated using the Kaplan-Meier method. RESULTS: LVI was observed in 68 patients (32.2%). The proportion of LVI increased with advancing stage, high grade, positive margin status, concomitant carcinoma in situ, and lymph node metastases. The 5- and 10-year overall survival rates were 74.7% and 53.1% in the absence of LVI, and 35.7% and 28.6% in the presence of LVI, respectively. In multivariate analysis, age, race and LVI were independent predictors of overall survival. CONCLUSIONS: The presence of LVI on pathological review of RNU specimens was associated with worse overall survival in patients with UTUC. LVI status should be included in the pathological report for RNU specimens to help guide postoperative therapeutic options. With confirmation from large international studies, inclusion of LVI in the tumour-node-metastasis staging system for UTUC should be considered.

Tumour diameter and decreased preoperative estimated glomerular filtration rate are independently correlated in patients with renal cell carcinoma.

OBJECTIVE: To examine the relationship between tumour diameter and estimated GFR (eGFR) in patients with renal cell carcinoma (RCC). PATIENTS AND METHODS: In total, 1009 patients undergoing partial or radical nephrectomy for unilateral RCC were identified in the Columbia Urologic Database. eGFR was calculated using the modification of diet in renal disease equation using demographic data and preoperative serum creatinine values. Data on patient demographics, tumour characteristics, and comorbidities were analyzed using univariate and multivariate regression analysis. RESULTS: Mean (sd, range) tumour diameter was 5.29 (3.8, 0.3-29) cm. Mean (sd, range) eGFR was 75 (23.4, 3-173) mL/min per 1.73 m(2) . In multivariate regression analysis, tumour diameter independently predicted decreased preoperative eGFR (coefficient, -0.513; P= 0.008) when controlling for hypertension and race. Consistent with this, decreased preoperative eGFR independently predicted increased tumour diameter (coefficient, -0.013; P= 0.007) when controlling for race, histology and smoking status. CONCLUSION: Tumour diameter and decreased preoperative eGFR are independently correlated in patients with RCC.

Effect of delaying surgery on radical prostatectomy outcomes: a contemporary analysis.

UNLABELLED: Study Type - Therapy (case series). Level of Evidence 4. What's known on the subject? and What does the study add? For patients electing surgical treatment, the question of the effect of surgical delay on clinical outcomes in prostate cancer is controversial. In this study we examined the effect of delay from diagnosis to surgery on outcomes in men with localized prostate cancer and found no association between time to surgery and risk of biochemical recurrence, even for patients with longer delays and high-risk disease. Men with localized prostate cancer can be reassured that reasonable delays in treatment will not influence disease outcomes. OBJECTIVE: • To examine the effect of time from last positive biopsy to surgery on clinical outcomes in men with localized prostate cancer undergoing radical prostatectomy (RP). PATIENTS AND METHODS: • We conducted a retrospective review of 2739 men who underwent RP between 1990 and 2009 at our institution. • Clinical and pathological features were compared between men undergoing RP ≤ 60, 61-90 and >90 days from the time of prostate biopsy. • A Cox proportional hazards model was used to analyse the association between clinical features and surgical delay with biochemical progression. Biochemical recurrence (BCR)-free rates were assessed using the Kaplan-Meier method. RESULTS: • Of the 1568 men meeting the inclusion criteria, 1098 (70%), 303 (19.3%) and 167 (10.7%) had a delay of ≤ 60, 61-90 and >90 days, respectively, between biopsy and RP. A delay of >60 days was not associated with adverse pathological findings at surgery. • The 5-year survival rate was similar among the three groups (78-85%, P= 0.11). • In a multivariate Cox model, men with higher PSA levels, clinical stages, Gleason sums, and those of African-American race were all at higher risk for developing BCR. • A delay to surgery of >60 days was not associated with worse biochemical outcomes in a univariate and multivariate model. CONCLUSIONS: • A delay of >60 days is not associated with adverse pathological outcomes in men with localized prostate cancer, nor does it correlate with worse BCR-free survival. • Patients can be assured that delaying treatment while considering therapeutic options will not adversely affect their outcomes.

Vitamin D deficiency in the urological population: a single center analysis.

PURPOSE: Vitamin D has a well-known role in calcium metabolism and bone health. It may also help prevent a number of chronic diseases, including cardiovascular disease, diabetes and malignancies such as breast, colorectal and prostate cancer. To our knowledge the prevalence of vitamin D deficiency has never been reported in the general urological population. We evaluated the vitamin D status of this population at a large academic center. MATERIALS AND METHODS: We retrospectively reviewed the records of 3,763 male and female patients from a urology database at a single academic institution. Patients were identified whose levels of serum 25-hydroxyvitamin D were measured for the first time between 1997 and 2010. We determined the prevalence of normal--greater than 30, insufficient--20 to 29 and deficient--less than 20 ng/ml 25-hydroxyvitamin D. Logistic regression analysis was performed to identify risk factors for vitamin D deficiency. RESULTS: Overall 2,559 patients (68%) had suboptimal 25-hydroxyvitamin D (less than 30 ng/ml), of whom 1,331 (52%) were frankly deficient (less than 20 ng/ml) in the vitamin. Vitamin D deficiency was more common in patients younger than age 50 years (44.5%), black (53.2%) and Hispanic (41.6%) patients (p <0.001), and patients without an existing urological malignancy (35.4%, p <0.001). On multivariate analysis race, age, season and cancer diagnosis were independent predictors of vitamin D status. CONCLUSIONS: Vitamin D deficiency is extremely common in urological patients at a major urban medical center. Urologists should consider recommending appropriate supplementation during the initial assessment of all patients.

Gleason score concordance on biopsy-confirmed prostate cancer: is pathological re-evaluation necessary prior to radical prostatectomy?

OBJECTIVES: • Gleason sum from prostate biopsy (bGS) is an important tool in classifying severity of disease, ultimately influencing clinical management. • Commonly, pathology specimens are re-evaluated internally prior to surgery. • We evaluate agreement of bGS with prostatectomy Gleason sum (pGS) and the impact of re-grading on prediction of true underlying tumor architecture. MATERIALS AND METHODS: • Retrospective analysis of men who underwent robotic-assisted radical prostatectomy (RARP) by two surgeons from 2005-2009. Initial transrectal ultrasound (TRUS) biopsy demonstrated carcinoma at an outside lab. Specimens were re-evaluated by our GU pathologists prior to surgery. Biopsy data were correlated with pGS. • Kappa (κ) statistics for agreement and linear regression analyses were used for categorical variables. Coefficient of concordance was used for continuous variables. RESULTS: • 100 patients had 331 positive biopsies. Agreement (κ) for bGS between outside labs and our pathologists was 0.55 (p < 0.001). • Internal read was twice as likely to upgrade vs. downgrade outside bGS (23% vs. 11%). • When re-evaluation resulted in a change in bGS, agreement with pGS was κ= 0.29, vs. κ=-0.04 for agreement of initial (outside) bGS with pGS. • When no change was made to bGS, agreement with pGS was κ= 0.40 (p < 0.001). CONCLUSION: • Good reproducibility seen between outside labs and our institution on bGS. Internal pathology re-reads correlated better with pGS than original community bGS. When re-reads result in a change in bGS, there is a marked improvement in prediction of underlying tumor architecture confirming the value of re-evaluating all external biopsies prior to definitive surgery.

Impacting factors for recovery of erectile function within 1 year following robotic-assisted laparoscopic radical prostatectomy.

INTRODUCTION: Neurovascular bundle preservation generally results in good postoperative sexual function after radical prostatectomy. However, erectile function (EF) after radical prostatectomy is still a significant concern. The same surgical technique often results in different EF outcomes. AIM: We evaluated factors that correlate with recovery of EF within 1 year after robotic-assisted laparoscopic radical prostatectomy (RALP). METHODS: From January 2008 to May 2009, 145 consecutive patients underwent RALP by one surgeon. Patients were followed postoperatively at 3-month intervals and assessed for EF recovery, defined as an erection sufficient for penetrative intercourse with satisfaction. Baseline demographics, medical comorbidities, degree of nerve sparing, and perioperative and postoperative variables were recorded. Univariate and multivariate analyses were used to determine factors associated with EF recovery. MAIN OUTCOME MEASURES: Postoperative sexual outcomes were attained prospectively via our erectile state questionnaire. RESULTS: Complete follow-up EF data were available on 89 men. Within 1-year follow-up, 56 men (62.9%) recovered EF and 33 men (37.1%) did not. In univariate logistic regression analysis, race (black), diabetes mellitus, hyperlipidemia, and clinical T2 carcinoma of the prostate were associated with diminished EF. Higher-preoperative Sexual Health Inventory for Men score and incremental nerve sparing (enhanced lateral prostatic fascia sparing) were associated with higher odds of recovering potency. In multivariate analysis, hyperlipidemia was primary comorbidity associated with diminished EF, and bilateral nerve sparing with a minimum unilateral-enhanced status was the impacting factor for EF recovery within 1 year after surgery. CONCLUSIONS: Bilateral nerve preservation with a minimum unilateral-enhanced status is associated with improved recovery of EF, and hyperlipidemia is a significant negative predictive factor of postoperative EF recovery within 1 year following RALP. Therefore, it is important to control hyperlipidemia as well as to use the proper surgical technique in maximizing EF recovery within 1 year after radical prostatectomy.

Comparison of two core biopsy techniques before and after laparoscopic cryoablation of small renal cortical neoplasms.

INTRODUCTION: Cryoablation is an acceptable treatment option for small renal cortical neoplasms (RCN). Unlike extirpative interventions, intraoperative needle biopsy is the only pathologic data for ablated tumors. It is imperative that sampled tissue accurately captures pathology. We studied the optimal intraoperative needle core biopsy protocol for small RCN during laparoscopic renal cryoablation (LCA). METHODS: Patients with RCN<4cm underwent intraoperative biopsy during LCA. Four biopsy cores were taken per tumor, 2 before and 2 after LCA by using both a standard and modified technique. Standard technique: needle biopsy device was deployed after insertion into the renal tissue at a depth of 5mm. Modified technique: needle biopsy device was deployed 1mm outside of the renal tissue. Biopsies were examined and compared with reference standard pathology. Percentage agreement was calculated across biopsy types (standard vs. modified) and time points (pre- vs. postcryoablation). Logistic regression was used to identify factors impacting biopsy accuracy. RESULTS: Thirty patients with 33 RCNs underwent LCA. The mean patient age was 69.1±8.0yrs, and mean tumor size was 2.3±0.7cm. No significant bleeding resulted from biopsies. A definitive diagnosis was made in 31/33 RCNs (94.0%). Ten tumors (30.3%) were benign, 21 (63.7%) were malignant, and 2 (6.0%) were nondiagnostic. Biopsy length was significantly longer using the standard vs. modified technique with mean lengths of 9.3mm vs. 7.0mm, respectively (P=.02). Highest agreement was seen in preablation biopsies (90.3%). A significant association with agreement was seen for younger age (P=.05) and larger tumor size (P=.02). CONCLUSIONS: Younger age and larger tumor size were associated with improved accuracy. Preoperative sampling resulted in superior accuracy and the standard technique resulted in significantly longer cores. Use of preablation standard biopsy technique may result in the most accurate pathologic diagnosis for patients undergoing cryoablation for small RCNs.

Complete ileal neobladder intracorporeal construction with standard sutured technique and novel technology.

PURPOSE: We compared the surgical efficacy and efficiency of a completely suture based procedure with a novel entero-urethral anastomosis device and an EndoGIA stapler to create an ileal neobladder. MATERIALS AND METHODS: Two groups of 7 pigs each were survived for 8 weeks. In group 1 the neobladder was constructed using a U-shaped segment of ileum sealed with the stapler. The entero-urethral anastomosis was created with a novel sutureless anastomosis device. All other procedures were completed with standard intracorporeal suturing techniques. In group 2 animals completely intracorporeal sutured technique was used. Total procedure, and enteroenteric, ileal neobladder, uretero-enteric and entero-urethral anastomosis times were recorded. Cystograms done immediately postoperatively, at 2 weeks and at sacrifice to evaluate the newly constructed system were rated from 0-no leakage to 3-severe leakage. RESULTS: In group 1 vs 2 the overall procedure, and enteroenteric, ileal neobladder, uretero-enteric and entero-urethral anastomoses were completed in 285.3, 32.3, 58.8, 54.2 and 5.5 vs 350.1, 29.9, 139.1, 58.0 and 46.3 minutes, respectively. In groups 1 and 2 the average postoperative cystogram rating was 0.83 and 1.6, respectively (p = 0.63). At 2 weeks and at sacrifice cystograms showed no extravasation in either group. The overall surgical procedure, pouch creation and entero-urethral anastomosis were statistically briefer in group 1 (p = 0.036, 0.01 and 0.039, respectively). Average survival in groups 1 and 2 was 30 (range 4 to 56) and 41 days (range 1 to 56), respectively (p = 0.36). All animals had voiding complications within 1 week after ureteral and urethral catheters were removed. One neobladder ruptured in group 1. CONCLUSIONS: Combining stapled ileal neobladder construction and the entero-urethral anastomosis device significantly decreases operative time, pouch creation and urethral anastomoses.

Comparison of manual and computer assisted ultrasonic guidance for transparenchymal percutaneous renal needle placement.

PURPOSE: We evaluated a novel computer based guidance system for deploying needles into the renal parenchyma. We compared it to current standards, including a fixed needle guide and a freehand technique. MATERIALS AND METHODS: We performed an in vitro comparison followed by a porcine trial. The in vitro model consisted of a bath of ultrasound medium with suspended metallic targets. We compared the number of attempts and the time needed by the novel guide design with and without its software and a support arm vs the freehand approach. In the porcine model we tested the software guide with and without a support arm for targeting a 5 mm lesion embedded in the renal parenchyma. Impressions of difficulty, time, the number of attempts, needle tip visualization and needle tip divergence were documented. RESULTS: Compared to freehand targeting the software guide and support arm decreased the number of targeting attempts in the in vitro model from 4.8 to 1.6 (p <0.001) and decreased the time required from 31.8 to 11.4 seconds (p <0.001). In the porcine study needle tip visualization with the software and support arm received an average score of 1.3 vs 1.8 with the software guide alone (p = 0.04). Tip divergence received a score of 1.4 with the arm and 1.8 without it (p = 0.07). Overall contribution received a score of 1.4 with and without the support arm (p = 0.35). CONCLUSIONS: Computer assisted needle deployment decreased the time and number of attempts required to successfully target simulated parenchymal lesions and also decreased the subjective difficulty inherent in the standard freehand approach.

Pilot study evaluating ureteric physiological changes with a novel 'ribbon stent' design using electromyographic and giant magnetoresistive sensors.

OBJECTIVE: To test a novel 'ribbon stent' (RS) design using an extraluminal bipolar electromyographic (EMG) and giant magnetoresistive (GMR) sensor system to characterize ureteric responses. MATERIALS AND METHODS: In all, 11 female domestic pigs were divided into three groups to evaluate ureteric physiology: group 1 (two pigs) with an unstented ureter, group 2 (three) with a standard 6 F ureteric stent, and group 3 (six) with the RS. For all groups EMG/GMR evaluation was performed at baseline, immediately after stenting, and at 3 and 7 days after stenting. All pigs underwent standardized retrograde ureteropyelogram evaluation at these time points, and after the final evaluation the pigs were killed and the urinary tract was harvested for histopathological evaluation. RESULTS: One stent in group 3 could not be deployed due to a problem with ureteric access. For groups 1, 2 and 3 the ureteric peristaltic activity was 109, 63, 72 events/h at baseline (P = 0.49); 61, 70, and 66 events/h immediately after stenting (P = 0.97); 66, 0, 8 events/h at 3 days after stenting (P = 0.002); and 61, 12, 0 events/h at 7 days after stenting, respectively (P = 0.049). CONCLUSION: The RS was deployed easily and safely in the porcine model using a standard technique. As with a standard stent, there was significant ureteric dilation and decrease in peristalsis with the RS.

The EZ Trainer: validation of a portable and inexpensive simulator for training basic laparoscopic skills.

PURPOSE: We assessed the face and content validity of a new portable laparoscopic trainer, the EZ Trainer. MATERIALS AND METHODS: The portable, affordable EZ trainer system was conceived, designed and commissioned by academic surgeons from the departments of urology at our 2 institutions with the express purpose of advancing laparoscopic surgical training. A total of 42 participants, including general surgeons, obstetricians/gynecologists, urologists and industry representatives, assessed the face and the content validity of the trainer using a standard questionnaire. Participants were stratified into high (greater than 30 laparoscopic cases per year) and low (less than 30 cases per year) volume laparoscopists. RESULTS: Of the participants 96% rated the trainer as a realistic laparoscopic training format. Of high volume laparoscopists 81.5% rated the trainer as comfortable to use, 92.6% found that the trainer was a realistic practice format, 70.4% would purchase the trainer for personal use and 85.2% would recommend that the trainer be made available to surgical residents in their discipline. Of low volume laparoscopists 87% rated the trainer as comfortable to use, 93.3% found that the trainer was a realistic practice format, 73.3% would purchase the trainer for personal use and 80% would recommend that the trainer be made available to diverse surgical residents. CONCLUSIONS: The EZ trainer system has face and content validity as a portable laparoscopic trainer across a broad range of surgical disciplines.

An assessment of urologists' training and knowledge of energy-based surgical devices.

OBJECTIVE: To assess surgeons' training and current understanding of existing energy-based surgical instrumentation (ESI), we disseminated an online questionnaire to urology residents, fellows and attending urologists. SUBJECTS AND METHODS: A two part 24-question survey was disseminated to 1000 urology residents, fellows and attending physicians. The first part of the questionnaire assessed the respondents' demographics and education about ESI; the second part evaluated the respondent's knowledge of surgical energy methods and ESI, and was stratified into nine basic- and six advanced-knowledge questions. RESULTS: In all, 136 people (13.6%) viewed the survey and it was completed by 63 (6.3%). Respondents comprised 27 (43%) attending physicians, 14 (22%) minimally-invasive urology fellows and 22 (35%) urology residents. Among participants, 41 (64%) had received no formal didactic training on ESI, and a further 14% of respondents' didactic experience was limited to one lecture. Of the respondents, 70% said that monopolar energy was the mode most often used in surgery. Overall, the participants correctly answered 41% of the questions. Of the nine questions classified as 'basic' knowledge, respondents correctly answered 49%. Of the six questions classified as 'advanced' knowledge, 29% were answered correctly. The highest percentage score was obtained by the attending urologists, with a mean (range) score of 41 (29-86)%, followed by the fellows, with a mean score of 39.5 (29-57)%, and then the residents, at 34 (14-64)%. CONCLUSION: Despite widespread and growing use of ESI, there is currently minimal formal training on energy modes and current energy devices being provided to urological surgeons. Both practising and training urologists have a limited understanding of surgical energy modes and of existing ESI.