Can a trained non-physician provider perform transrectal ultrasound-guided prostatic biopsies as effectively as an experienced urologist?
ABSTRACT Study Type - Diagnostic (retrospective cohort) Level of Evidence 3a What's known on the subject? and What does the study add? PSA testing has resulted in a large number of patients being referred to urologists for investigation of potential prostate cancer. Despite limited evidence, non-physician providers now perform a number of routine urological procedures such as transrectal ultrasound-guided prostatic biopsies (TRUSP) in a bid to help relieve this increasing workload. In the largest series to date, we provide evidence that an adequately trained non-physician provider is able to perform TRUSP as effectively as an experienced urologist after an initial learning curve. OBJECTIVE: • To evaluate differences in cancer detection rates between a trained non-physician provider (NPP) and an experienced urologist performing transrectal ultrasound-guided prostatic biopsies (TRUSP) at a single UK institution. PATIENTS AND METHODS: • We retrospectively analysed a prospectively accrued database of patients (n = 440) referred for investigation of an abnormal digital rectal examination and/or a raised age-specific prostate-specific antigen (PSA) value undergoing first-time outpatient prostatic biopsies who were sequentially allocated to either an NPP or a physician-led TRUSP clinic. • Differences in overall and risk-stratified prostate cancer detection rates were evaluated according to TRUSP operator. • Continuous variables were analysed using Mann-Whitney U test whereas categorical variables were analysed using Pearson's chi-squared test. A multivariate binary logistic regression model was fitted for predictors of a positive biopsy. RESULTS: • In all, 57.3% (126/220) of patients who underwent physician-led TRUSP were diagnosed with prostate cancer compared with 52.7% (116/220) in the NPP-led clinic (P = 0.338). • Sub-group analysis revealed a lower cancer detection rate in men presenting with a low PSA level (<9.9 ng/mL) during the first 50 independent TRUSP procedures performed by the NPP (P = 0.014). This initial difference was lost with increasing case volume, suggesting the presence of a learning curve. • Multivariate logistic regression analysis revealed age (odds ratio (OR) 1.054, 95% confidence interval (95% CI) 1.025-1.084, P ≤ 0.001), presenting PSA level (OR 1.05, 95% CI 1.02-1.081, P = 0.001), prostatic volume (OR 0.969, 95% CI 0.958-0.981, P ≤ 0.001) and clinical stage (OR 1.538, 95% CI 1.046-2.261, P = 0.029) to be predictors of a positive prostatic biopsy outcome. • The choice of TRUSP operator was not predictive of a positive prostatic biopsy (OR 0.729, 95% CI 0.464-1.146, P = 0.171). CONCLUSION: • An adequately trained NPP is able to perform TRUSP as effectively as an experienced urologist after an initial learning curve of 50 cases.
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ABSTRACT: Purpose To evaluate whether core length impacts biopsy accuracy and Gleason score underestimation compared to radical prostatectomy (RP) specimens. Methods From 2010 to 2011, 8,928 cores were trans-rectal obtained from 744 consecutive patients (178 RP, 24 %), 557 by an experienced performer (>250/year) and 187 (25 %) by in-training urology residents. Prospectively analyzed variables were core length, age, prostate volume, free and total prostate-specific antigen (PSA), PSA density and free/total PSA ratio. Results Mean core length for Gleason upgrading on RP (42.7 %, n = 76) was 11.61 (±2.5, median 11.40) compared to 13.52 (±3.2, median 13.70), p n = 102). In multivariate analysis, for each unit of core length increment in millimeter, the Gleason upgrading risk decreased 89.9 %, p = 0.049 [odds ratio (OR) 0.10, 95 % confidence interval (CI) 0.01-0.99]. Biopsy positivity between experienced (35.5 %) and in-training performer (30.1 %) was not significantly different (p = 0.20), with comparable mean patient age (65.1 vs. 64.1), prostate volume (52.3 vs. 50.7) and median PSA (5.2 vs. 5.1), respectively. Denoting wider variability in terms of core length, in-training performers obtained significantly larger cores for positive biopsies (11.33 ± 3.42 vs. 10.83 ± 3.68), p = 0.043, compared to experienced performer (11.39 ± 3.36 vs. 11.37 ± 3.64), p = 0.30. In multivariate analysis, PSA density (OR 1.14, 95 % CI 1.02-1.28) and age (OR 1.04, 95 % CI 1.01-1.07) were significantly associated with biopsy positivity, p = 0.021 and p = 0.011, respectively. Conclusion While core length on trans-rectal biopsy independently affects Gleason upgrading on RP specimens, performer experience has minor impact on Gleason discordance or biopsy positivity due to a sharp learning curve.World Journal of Urology 08/2014; 33(6). DOI:10.1007/s00345-014-1371-9 · 3.42 Impact Factor
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ABSTRACT: CONTEXT: Prostate cancer (PCa) screening to detect early stage PCa has resulted in increased identification of small-volume, low-grade PCa, many of which meet criteria for clinically indolent disease. Nevertheless, there remains some degree of underdetection of high-risk PCa in substantial numbers of men despite current diagnostic strategies. OBJECTIVE: To discuss the contemporary role of prostate biopsy (PB), focusing on the indications, techniques, and limitations of current PB techniques and evolving techniques affecting patient care. EVIDENCE ACQUISITION: A comprehensive Medline search was performed using the medical subject heading search terms prostate cancer, detection, prostate biopsy, significant cancer, and diagnosis, with restriction to the English language. Emphasis was given to publications within the past 5 yr. EVIDENCE SYNTHESIS: Because abnormal digital rectal examination (DRE) and prostate-specific antigen (PSA) tests alone lack specificity for cancer, there is no universal indication for PB. This lack has inspired exploration for a cancer-specific biomarker and prediction tools such as risk calculators. Indication for biopsy should involve a balance between the underdiagnosis of high-risk cancers and the potential risks for the overdetection of clinically insignificant cancers as well as biopsy-related morbidity. Evidence supports the inclusion of laterally directed cores during transrectal ultrasound (TRUS) PB in addition to the traditional sextant pattern, which significantly improves cancer detection without a demonstrable increase in morbidity. These data indicate that such PB templates, typically 12 cores, represent the optimal template in initial PB. Optimised techniques and templates for repeat PB remain controversial. However, debate continues regarding indications, sampling number, and location as well as on the potential of modern image-guided approaches or three-dimensional (3D) mapping biopsy in this unique setting. Additional limitations of repeat PB techniques include associated procedural risks if general anaesthesia is required and inherent sampling errors of template-based techniques that are not targeted to the specific tumour site. CONCLUSIONS: Current data support the utility of extended PB templates for initial TRUS PB intended to detect clinically significant PCa. Repeat PB in the setting of prior negative PB on the grounds of clinical suspicion or for risk-stratified approaches to management of low risk PCa requires balancing overdetection of low-risk cancer with the potential to miss significant cancer. Several options, including modern image-guided targeting, biomarker development, transrectal saturation PB, and 3D template mapping PB, are changing the clinical paradigms for evaluation and management. Evidence to support adopting approaches other than the current established standards should be tested through appropriately designed prospective studies.European Urology 09/2012; 63(2). DOI:10.1016/j.eururo.2012.09.033 · 12.48 Impact Factor
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ABSTRACT: Introduction-objectives: A virtual-reality learning environment dedicated to prostate biopsies was designed to overcome the limitations of current classical teaching methods. The aim of this study was to validate reliability, face, content and construct of the simulator. Materials and methods: The simulator is composed of a) a laptop computer, b) a haptic device with a stylus that mimics the ultrasound probe, c) a clinical case database including three dimensional (3D) ultrasound volumes and patient data and d) a learning environment with a set of progressive exercises including a randomized 12-core biopsy procedure. Both visual (3D biopsy mapping) and numerical (score) feedback are given to the user. The simulator evaluation was conducted in an academic urology department on 7 experts and 14 novices who each performed a virtual biopsy procedure and completed a face and content validity questionnaire. Results: The overall realism of the biopsy procedure was rated at a median of 9/10 by non-experts (7.1-9.8). Experts rated the usefulness of the simulator for the initial training of urologists at 8.2/10 (7.9-8.3), but reported the range of motion and force feedback as significantly less realistic than novices (p=0.01 and 0.03 respectively). Pearson's r correlation coefficient between correctly placed biopsies on the right and left side of the prostate for each user was 0.79 (p<0.001). The 7 experts had a median score of 64% (59-73), and the 14 novices a median score of 52% (43-67), without reaching statistical significance (p=0,19). Conclusion: The newly designed virtual reality learning environment proved its versatility and its reliability, face and content were validated. Demonstrating the construct validity will require improvements to the realism and scoring system used.Journal of endourology / Endourological Society 10/2013; DOI:10.1089/end.2013.0454 · 2.10 Impact Factor