Evaluation of functional outcomes after a second focal high-intensity focused ultrasonography (HIFU) procedure in men with primary localized, non-metastatic prostate cancer: results from the HIFU Evaluation and Assessment of Treatment (HEAT) registry.

OBJECTIVES: To assess change in functional outcomes after a second focal high-intensity focused ultrasonography (HIFU) treatment compared with outcomes after one focal HIFU treatment. PATIENTS AND METHODS: In this multicentre study (2005-2016), 821 men underwent focal HIFU for localized non-metastatic prostate cancer. The patient-reported outcome measures of International Prostate Symptom Score (IPSS), pad usage and erectile function (EF) score were prospectively collected for up to 3 years. To be included in the study, completion of at least one follow-up questionnaire was required. The primary outcome was comparison of change in functional outcomes between baseline and follow-up after one focal HIFU procedure vs after a second focal HIFU procedure, using IPSS, Expanded Prostate Cancer Index Composite (EPIC) and International Index of Erectile Function (IIEF) questionnaires. RESULTS: Of 821 men, 654 underwent one focal HIFU procedure and 167 underwent a second focal HIFU procedure. A total of 355 (54.3%) men undergoing one focal HIFU procedure and 65 (38.9%) with a second focal HIFU procedure returned follow-up questionnaires, respectively. The mean age and prostate-specific antigen level were 66.4 and 65.6 years, and 7.9 and 8.4 ng/mL, respectively. After one focal HIFU treatment, the mean change in IPSS was -0.03 (P = 0.02) and in IIEF (EF score) it was -0.4 (P = 0.02) at 1-2 years, with no subsequent decline. Absolute rates of erectile dysfunction increased from 9.9% to 20.8% (P = 0.08), leak-free continence decreased from 77.9% to 72.8% (P = 0.06) and pad-free continence from 98.6% to 94.8% (P = 0.07) at 1-2 years, respectively. IPSS prior to second focal HIFU treatment compared to baseline IPSS prior to first focal HIFU treatment was lower by -1.3 (P = 0.02), but mean IPSS change was +1.4 at 1-2 years (P = 0.03) and +1.2 at 2-3 years (P = 0.003) after the second focal HIFU treatment. The mean change in EF score after the second focal HIFU treatment was -0.2 at 1-2 years (P = 0.60) and -0.5 at 2-3 years (P = 0.10), with 17.8% and 6.2% of men with new erectile dysfunction. The rate of new pad use was 1.8% at 1-2 years and 2.6% at 2-3 years. CONCLUSION: A second focal HIFU procedure causes minor detrimental effects on urinary function and EF. These data can be used to counsel patients with non-metastatic prostate cancer prior to considering HIFU therapy.

Training Modalities in Robot-assisted Urologic Surgery: A Systematic Review.

CONTEXT: Novel surgical techniques demand that surgical training adapts to the need for technical and nontechnical skills. OBJECTIVE: To identify training methods available for robot-assisted surgical (RAS) training in urology, evaluate their effectiveness in terms of validation, educational impact, acceptability, and cost effectiveness, and assess their effect on learning curves (LCs). EVIDENCE ACQUISITION: A systematic review following Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines searched Ovid Medline, Embase, PsycINFO, and the Cochrane Library. Results were screened to include appropriate studies. Quality was evaluated. Each method was evaluated, and conclusions were drawn regarding LCs. EVIDENCE SYNTHESIS: Of 359 records, 24 were included (521 participants). Training methods included dry-lab training (n=7), wet-lab training (n=7), mentored training (n=7), and nonstructured pathways (n=5). Dry-lab training demonstrated educational impact by reducing console time and was acceptable in a study; 100% of participants confirmed face validity. Wet-lab training principally uses human cadaveric material; effectiveness is well rated, although dry-lab training and observation were rated as equally useful. Mentored programmes combine lectures, tutorials, observation, simulation, and proctoring. Minifellowships were linked to greater practice of RAS 1 yr later. LCs vary according to experience. One study found that surgeons from robot-related fellowships demonstrated fewer positive surgical margins than surgeons from laparoscopic-related fellowships (24% vs 34.6%; p=0.05) and reduced time (132 vs 152min; p=0.0003). Five studies examined nonstructured training pathways (clinical practice). Experience correlated with fewer complications (p=0.007), improved continence (p=0.049), and reduced time (p=0.002). CONCLUSIONS: RAS training methods include dry and wet lab, mentored training, and nonstructured pathways. Limited available evidence suggests that they affect LCs differently and are rarely used alone. The different methods of training appear effective when combined. Their benefits must be explored to facilitate validated acceptable training with educational impact. PATIENT SUMMARY: Robot-assisted training encompasses several methods used in combination, but more evidence is required to gain the greatest benefit and formulate future training pathways.

Modular Training for Robot-Assisted Radical Prostatectomy: Where to Begin?

OBJECTIVE: Effective training is paramount for patient safety. Modular training entails advancing through surgical steps of increasing difficulty. This study aimed to construct a modular training pathway for use in robot-assisted radical prostatectomy (RARP). It aims to identify the sequence of procedural steps that are learnt before surgeons are able to perform a full procedure without an intervention from mentor. DESIGN: This is a multi-institutional, prospective, observational, longitudinal study. We used a validated training tool (RARP Score). Data regarding surgeons' stage of training and progress were collected for analysis. A modular training pathway was constructed with consensus on the level of difficulty and evaluation of individual steps. We identified and recorded the sequence of steps performed by fellows during their learning curves. SETTING AND PARTICIPANTS: We included 15 urology fellows from UK, Europe, and Australia. RESULTS: A total of 15 surgeons were assessed by mentors in 425 RARP cases over 8 months (range: 7-79) across 15 international centers. There were substantial differences in the sequence of RARP steps according to the chronology of the procedure, difficulty level, and the order in which surgeons actually learned steps. Steps were not attempted in chronological order. The greater the difficulty, the later the cohort first undertook the step (p = 0.021). The cohort undertook steps of difficulty level I at median case number 1. Steps of difficulty levels II, III, and IV showed more variation in median case number of the first attempt. We recommend that, in the operating theater, steps be learned in order of increasing difficulty. A new modular training route has been designed. This incorporates the steps of RARP with the following order of priority: difficulty level > median case number of first attempt > most frequently undertaken in surgical training. CONCLUSIONS: An evidence-based modular training pathway has been developed that facilitates a safe introduction to RARP for novice surgeons.

Structured and Modular Training Pathway for Robot-assisted Radical Prostatectomy (RARP): Validation of the RARP Assessment Score and Learning Curve Assessment.

BACKGROUND: Use of robot-assisted radical prostatectomy (RARP) for prostate cancer is increasing. Structured surgical training and objective assessment are critical for outcomes. OBJECTIVE: To develop and validate a modular training and assessment pathway via Healthcare Failure Mode and Effect Analysis (HFMEA) for trainees undertaking RARP and evaluate learning curves (LCs) for procedural steps. DESIGN, SETTING, AND PARTICIPANTS: This multi-institutional (Europe, Australia, and United States) observational prospective study used HFMEA to identify the high-risk steps of RARP. A specialist focus group enabled validation. Fifteen trainees who underwent European Association of Urology robotic surgery curriculum training performed RARP and were assessed by mentors using the tool developed. Results produced LCs for each step. A plateau above score 4 indicated competence. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We used a modular training and assessment tool (RARP Assessment Score) to evaluate technical skills. LCs were constructed. Multivariable Kruskal-Wallis, Mann-Whitney U, and κ coefficient analyses were used. RESULTS AND LIMITATIONS: Five surgeons were observed for 42 console hours to map steps of RARP. HFMEA identified 84 failure modes and 46 potential causes with a hazard score ≥8. Content validation created the RARP Assessment Score: 17 stages and 41 steps. The RARP Assessment Score was acceptable (56.67%), feasible (96.67%), and had educational impact (100%). Fifteen robotic surgery trainees were assessed for 8 mo. In 426 RARP cases (range: 4-79), all procedural steps were attempted by trainees. Trainees were assessed with the RARP Assessment Score by their expert mentors, and LCs for individual steps were plotted. LCs demonstrated plateaus for anterior bladder neck transection (16 cases), posterior bladder neck transection (18 cases), posterior dissection (9 cases), dissection of prostatic pedicle and seminal vesicles (15 cases), and anastomosis (17 cases). Other steps did not plateau during data collection. CONCLUSIONS: The RARP Assessment Score based on HFMEA methodology identified critical steps for focused RARP training and assessed surgeons. LCs demonstrate the experience necessary to reach a level of competence in technical skills to protect patients. PATIENT SUMMARY: We developed a safety and assessment tool to gauge the technical skills of surgeons performing robot-assisted radical prostatectomy. Improvement was monitored, and measures of progress can be used in future to guide mentors when training surgeons to operate safely.