Construct, content and face validity of the eoSim laparoscopic simulator on advanced suturing tasks

Background: The purpose of this study was to validate the eoSim, an affordable and mobile inanimate laparoscopic simulator with instrument tracking capabilities, regarding face, content and construct validity on complex suturing tasks. Methods: Participants recruited for this study were novices (no laparoscopic experience), target group for this training (surgical/gynaecologic/urologic residents, &gt; 10 basic and &lt; 20 advanced laparoscopic procedures) and experts (&gt; 20 advanced laparoscopic procedures). Each participant performed the intracorporeal suturing exercise (Task 1), an upside down needle transfer (Task 2, developed for this study) and an anastomosis needle transfer (Task 3). Following, the participants completed a questionnaire regarding their demographics and opinion on the eoSim in terms of realism, didactic value and usability. Measured outcome parameters were time, distance, percentage of instrument tip off-screen, working area, speed, acceleration and smoothness. Results: In total, 104 participants completed the study, of which 60 novices, 31 residents and 13 experts. Face and content validity results showed a mean positive opinion on realism (3.9 Task 1, 3.6 Task 2 and 3.7 Task 3), didactic value (4.0, 3.4 and 3.7, respectively) and usability (4.2. 3.7 and 4.0, respectively). There were no significant differences in these outcomes between the specified expertise groups. Construct validity results showed significant differences between experts, target group or novices for Task 1 in terms of time (means 339, 607 and 1224 s, respectively, p &lt; 0.001) and distance (means 8.1, 15.6 and 21.7 m, respectively, p &lt; 0.001). Task 2 showed significant differences between groups regarding time (p &lt; 0.001), distance (p 0.003), off-screen (p &lt; 0.001) and working area (p &lt; 0.001). Task 3 showed significant differences between groups, after subanalyses, on total number of stitches (p &lt; 0.001), time per stitch (p &lt; 0.001) and distance per stitch (p &lt; 0.001). Conclusions: The results of this study indicate that the eoSim is a potential meaningful and valuable simulator in the training of suturing tasks.</p

Competency assessment tool for laparoscopic suturing: Development and reliability evaluation

Background: Laparoscopic suturing can be technically challenging and requires extensive training to achieve competency. To date no specific and objective assessment method for laparoscopic suturing and knot tying is available that can guide training and monitor performance in these complex surgical skills. In this study we aimed to develop a laparoscopic suturing competency assessment tool (LS-CAT) and assess its inter-observer reliability. Methods: We developed a bespoke CAT tool for laparoscopic suturing through a structured, mixed methodology approach, overseen by a steering committee with experience in developing surgical assessment tools. A wide Delphi consultation with over twelve experts in laparoscopic surgery guided the development stages of the tool. Following, subjects with different levels of laparoscopic expertise were included to evaluate this tool, using a simulated laparoscopic suturing task which involved placing of two surgical knots. A research assistant video recorded and anonymised each performance. Two blinded expert surgeons assessed the anonymised videos using the developed LS-CAT. The LS-CAT scores of the two experts were compared to assess the inter-observer reliability. Lastly, we compared the subjects’ LS-CAT performance scores at the beginning and end of their learning curve. Results: This study evaluated a novel LS-CAT performance tool, comprising of four tasks. Thirty-six complete videos were analysed and evaluated with the LS-CAT, of which the scores demonstrated excellent inter-observer reliability. Cohen’s Kappa analysis revealed good to excellent levels of agreement for almost all tasks of both instrument handling and tissue handling (0.87; 0.77; 0.75; 0.86; 0.85, all with p &lt; 0.001). Subjects performed significantly better at the end of their learning curve compared to their first attempt for all LS-CAT items (all with p &lt; 0.001). Conclusions: We developed the LS-CAT, which is a laparoscopic suturing grading matrix, with excellent inter-rater reliability and to discriminate between experience levels. This LS-CAT has a potential for wider use to objectively assess laparoscopic suturing skills.</p

Construct, content and face validity of the eoSim laparoscopic simulator on advanced suturing tasks

Background: The purpose of this study was to validate the eoSim, an affordable and mobile inanimate laparoscopic simulator with instrument tracking capabilities, regarding face, content and construct validity on complex suturing tasks. Methods: Participants recruited for this study were novices (no laparoscopic experience), target group for this training (surgical/gynaecologic/urologic residents, &gt; 10 basic and &lt; 20 advanced laparoscopic procedures) and experts (&gt; 20 advanced laparoscopic procedures). Each participant performed the intracorporeal suturing exercise (Task 1), an upside down needle transfer (Task 2, developed for this study) and an anastomosis needle transfer (Task 3). Following, the participants completed a questionnaire regarding their demographics and opinion on the eoSim in terms of realism, didactic value and usability. Measured outcome parameters were time, distance, percentage of instrument tip off-screen, working area, speed, acceleration and smoothness. Results: In total, 104 participants completed the study, of which 60 novices, 31 residents and 13 experts. Face and content validity results showed a mean positive opinion on realism (3.9 Task 1, 3.6 Task 2 and 3.7 Task 3), didactic value (4.0, 3.4 and 3.7, respectively) and usability (4.2. 3.7 and 4.0, respectively). There were no significant differences in these outcomes between the specified expertise groups. Construct validity results showed significant differences between experts, target group or novices for Task 1 in terms of time (means 339, 607 and 1224 s, respectively, p &lt; 0.001) and distance (means 8.1, 15.6 and 21.7 m, respectively, p &lt; 0.001). Task 2 showed significant differences between groups regarding time (p &lt; 0.001), distance (p 0.003), off-screen (p &lt; 0.001) and working area (p &lt; 0.001). Task 3 showed significant differences between groups, after subanalyses, on total number of stitches (p &lt; 0.001), time per stitch (p &lt; 0.001) and distance per stitch (p &lt; 0.001). Conclusions: The results of this study indicate that the eoSim is a potential meaningful and valuable simulator in the training of suturing tasks.Applied Ergonomics and Desig

Prognostic factors for occult inguinal lymph node involvement in penile carcinoma and assessment of the high-risk EAU subgroup: A two-institution analysis of 342 clinically node-negative patients

Background: The European Association of Urology (EAU) guidelines advise an elective bilateral lymphadenectomy in clinically node-negative (cN0) patients with high-risk penile carcinoma (â¥pT2, G3, or lymphovascular invasion [LVI]). Objective: Our aim was to assess prognostic factors for occult metastasis and to determine whether current EAU guidelines accurately stratify patients at high risk. Design, setting, and participants: Data of 342 cN0 patients with histologically proven invasive penile squamous cell carcinoma who had undergone the current dynamic sentinel node biopsy (DSNB) protocol were analysed. A complete ipsilateral inguinal lymphadenectomy was only done if the sentinel node was tumour positive. Measurements: The presence of occult metastasis was established by preoperative ultrasound and tumour-positive fine-needle aspiration cytology, tumour-positive sentinel nodes, and groin metastases during follow-up after a negative DSNB procedure. Median follow-up was 31 mo. Results and limitations: Sixty-eight of 342 patients (20%) and 87 of 684 groins (13%) had occult nodal involvement including 6 patients (2%) with a groin metastasis after negative DSNB. Corpus spongiosum invasion, corpus cavernosum invasion, histologic grade, and LVI were each significant prognosticators for occult metastasis on univariate analysis. On multivariate analysis, grade (odds ratio [OR] : 3.3 for intermediate and 4.9 for poor, respectively) and LVI (OR: 2.2) remained predictive factors. In total, 245 patients (72%) were classified high risk according to EAU guidelines. Among them, the incidence of occult metastasis was 23% (57 of 245). A potential limitation of this study is the lack of external review. Conclusions: Histologic grade and LVI are independent prognostic factors for occult metastasis in penile carcinoma. Although both predictors are incorporated into the current EAU guidelines, the stratification of patients needing a lymph node dissection is inaccurate. Approximately 77% of high-risk patients (188 of 245) would have had a negative bilateral inguinal lymphadenectomy. For the time being, DSNB is considered a more suitable staging method than EAU risk stratification for an accurate determination of patients who require lymph node dissection. © 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.Link_to_subscribed_fulltex

Competency assessment tool for laparoscopic suturing: Development and reliability evaluation

Background: Laparoscopic suturing can be technically challenging and requires extensive training to achieve competency. To date no specific and objective assessment method for laparoscopic suturing and knot tying is available that can guide training and monitor performance in these complex surgical skills. In this study we aimed to develop a laparoscopic suturing competency assessment tool (LS-CAT) and assess its inter-observer reliability. Methods: We developed a bespoke CAT tool for laparoscopic suturing through a structured, mixed methodology approach, overseen by a steering committee with experience in developing surgical assessment tools. A wide Delphi consultation with over twelve experts in laparoscopic surgery guided the development stages of the tool. Following, subjects with different levels of laparoscopic expertise were included to evaluate this tool, using a simulated laparoscopic suturing task which involved placing of two surgical knots. A research assistant video recorded and anonymised each performance. Two blinded expert surgeons assessed the anonymised videos using the developed LS-CAT. The LS-CAT scores of the two experts were compared to assess the inter-observer reliability. Lastly, we compared the subjects’ LS-CAT performance scores at the beginning and end of their learning curve. Results: This study evaluated a novel LS-CAT performance tool, comprising of four tasks. Thirty-six complete videos were analysed and evaluated with the LS-CAT, of which the scores demonstrated excellent inter-observer reliability. Cohen’s Kappa analysis revealed good to excellent levels of agreement for almost all tasks of both instrument handling and tissue handling (0.87; 0.77; 0.75; 0.86; 0.85, all with p &lt; 0.001). Subjects performed significantly better at the end of their learning curve compared to their first attempt for all LS-CAT items (all with p &lt; 0.001). Conclusions: We developed the LS-CAT, which is a laparoscopic suturing grading matrix, with excellent inter-rater reliability and to discriminate between experience levels. This LS-CAT has a potential for wider use to objectively assess laparoscopic suturing skills.Applied Ergonomics and Desig

A Prospective Multicenter Comparison Study of Risk-adapted Ultrasound-directed and Magnetic Resonance Imaging–directed Diagnostic Pathways for Suspected Prostate Cancer in Biopsy-naïve Men

Background: European Association of Urology guidelines recommend a risk-adjusted biopsy strategy for early detection of prostate cancer in biopsy-naïve men. It remains unclear which strategy is most effective. Therefore, we evaluated two risk assessment pathways commonly used in clinical practice. Objective: To compare the diagnostic performance of a risk-based ultrasound (US)-directed pathway (Rotterdam Prostate Cancer Risk Calculator [RPCRC] #3; US volume assessment) and a magnetic resonance imaging (MRI)-directed pathway. Design, setting, and participants: This was a prospective multicenter study (MR-PROPER) with 1:1 allocation among 21 centers (US arm in 11 centers, MRI arm in ten). Biopsy-naïve men with suspicion of prostate cancer (age ≥50 yr, prostate-specific antigen 3.0–50 ng/ml, ± abnormal digital rectal examination) were included. Intervention: Biopsy-naïve men with elevated risk of prostate cancer, determined using RPCRC#3 in the US arm and Prostate Imaging Reporting and Data System scores of 3–5 in the MRI arm, underwent systematic biopsies (US arm) or targeted biopsies (MRI arm). Outcome measurements and statistical analysis: The primary outcome was the proportion of men with grade group (GG) ≥2 cancer. Secondary outcomes were the proportions of biopsies avoided and GG 1 cancers detected. Categorical (nonparametric) data were assessed using the Mann-Whitney U test and χ2 tests. Results and limitations: A total of 1965 men were included in the intention-to-treat population (US arm n = 950, MRI arm n = 1015). The US and MRI pathways detected GG ≥2 cancers equally well (235/950, 25% vs 239/1015, 24%; difference 1.2%, 95% confidence interval [CI] −2.6% to 5.0%; p = 0.5). The US pathway detected more GG 1 cancers than the MRI pathway (121/950, 13% vs 84/1015, 8.3%; difference 4.5%, 95% CI 1.8–7.2%; p < 0.01). The US pathway avoided fewer biopsies than the MRI pathway (403/950, 42% vs 559/1015, 55%; difference −13%, 95% CI −17% to −8.3%; p < 0.01). Among men with elevated risk, more GG ≥2 cancers were detected in the MRI group than in the US group (52% vs 43%; difference 9.2%, 95% CI 3.0–15%; p < 0.01). Conclusions: Risk-adapted US-directed and MRI-directed pathways detected GG ≥2 cancers equally well. The risk-adapted US-directed pathway performs well for prostate cancer diagnosis if prostate MRI capacity and expertise are not available. If prostate MRI availability is sufficient, risk assessment should preferably be performed using MRI, as this avoids more biopsies and detects fewer cases of GG 1 cancer. Patient summary: Among men with suspected prostate cancer, relevant cancers were equally well detected by risk-based pathways using either ultrasound or magnetic resonance imaging (MRI) to guide biopsy of the prostate. If prostate MRI availability is sufficient, risk assessment should be performed with MRI to reduce unnecessary biopsies and detect fewer irrelevant cancers