Inter-Rater Reliability of Proliferative Diabetic Retinopathy Assessment on Wide-Field OCT-Angiography and Fluorescein Angiography.

Purpose: To assess inter-rater reliability in the detection of proliferative diabetic retinopathy (PDR) changes using wide-field optical coherence tomography angiography (WF-OCTA) versus fluorescein angiography (FA). Methods: This retrospective, cross-sectional study included patients with severe nonproliferative and PDR. Images were acquired with 12 × 12 mm WF-OCTA and FA with a 55° lens. Images were cropped to represent the exact same field of view. Qualitative (detection of neovascularization at the disc [NVD] and elsewhere [NVE], enlarged foveal avascular zone [FAZ], vitreous hemorrhage [VH]) and quantitative analyses (FAZ area, horizontal, vertical, and maximum FAZ diameter) were performed by 2 masked graders using ImageJ. Inter-rater reliability was calculated using unweighted Cohen's kappa coefficient (κ) for qualitative analyses and intraclass correlation coefficients (ICC) for quantitative analyses. Results: Twenty-three eyes of 17 patients were included. Inter-rater reliability was higher for FA than for WF-OCTA in qualitative analyses: κ values were 0.65 and 0.78 for detection of extended FAZ, 0.83 and 1.0 for NVD, 0.78 and 1.0 for NVE, and 0.19 and 1 for VH for WF-OCTA and FA, respectively. In contrast, inter-rater reliability was higher for WF-OCTA than for FA in the quantitative analyses: ICC values were 0.94 and 0.76 for FAZ size, 0.92 and 0.79 for horizontal FAZ diameter, 0.82 and 0.72 for vertical FAZ diameter, and 0.88 and 0.82 for maximum FAZ diameter on WF-OCTA and FA, respectively. Conclusions: Inter-rater reliability of FA is superior to WF-OCTA for qualitative analyses whereas inter-rater reliability of WF-OCTA is superior to FA for quantitative analyses. Translational Relevance: The study highlights the specific merits of both imaging modalities in terms of reliability. FA should be preferred for qualitative parameters, whereas WF-OCTA should be preferred for quantitative parameters.

Development and validity evidence of an objective structured assessment of technical skills score for minimally invasive linear-stapled, hand-sewn intestinal anastomoses: the A-OSATS score.

INTRODUCTION: The aim of this study was to develop a reliable objective structured assessment of technical skills (OSATS) score for linear-stapled, hand-sewn closure of enterotomy intestinal anastomoses (A-OSATS). MATERIALS AND METHODS: The Delphi methodology was used to create a traditional and weighted A-OSATS score highlighting the more important steps for patient outcomes according to an international expert consensus. Minimally invasive novices, intermediates, and experts were asked to perform a minimally invasive linear-stapled intestinal anastomosis with hand-sewn closure of the enterotomy in a live animal model either laparoscopically or robot-assisted. Video recordings were scored by two blinded raters assessing intrarater and interrater reliability and discriminative abilities between novices (n = 8), intermediates (n = 24), and experts (n = 8). RESULTS: The Delphi process included 18 international experts and was successfully completed after 4 rounds. A total of 4 relevant main steps as well as 15 substeps were identified and a definition of each substep was provided. A maximum of 75 points could be reached in the unweighted A-OSATS score and 170 points in the weighted A-OSATS score respectively. A total of 41 anastomoses were evaluated. Excellent intrarater (r = 0.807-0.988, p < 0.001) and interrater (intraclass correlation coefficient = 0.923-0.924, p < 0.001) reliability was demonstrated. Both versions of the A-OSATS correlated well with the general OSATS and discriminated between novices, intermediates, and experts defined by their OSATS global rating scale. CONCLUSION: With the weighted and unweighted A-OSATS score, we propose a new reliable standard to assess the creation of minimally invasive linear-stapled, hand-sewn anastomoses based on an international expert consensus. Validity evidence in live animal models is provided in this study. Future research should focus on assessing whether the weighted A-OSATS exceeds the predictive capabilities of patient outcomes of the unweighted A-OSATS and provide further validity evidence on using the score on different anastomotic techniques in humans.

Direct Observation versus Endoscopic Video Recording-Based Rating with the Objective Structured Assessment of Technical Skills for Training of Laparoscopic Cholecystectomy.

PURPOSE: The validated Objective Structured Assessment of Technical Skills (OSATS) score is used for evaluating laparoscopic surgical performance. It consists of two subscores, a Global Rating Scale (GRS) and a Specific Technical Skills (STS) scale. The OSATS has accepted construct validity for direct observation ratings by experts to discriminate between trainees' levels of experience. Expert time is scarce. Endoscopic video recordings would facilitate assessment with the OSATS. We aimed to compare video OSATS with direct OSATS. METHODS: We included 79 participants with different levels of experience [58 medical students, 15 junior residents (novices), and 6 experts]. Performance of a cadaveric porcine laparoscopic cholecystectomy (LC) was evaluated with OSATS by blinded expert raters by direct observation and then as an endoscopic video recording. Operative time was recorded. RESULTS: Direct OSATS rating and video OSATS rating correlated significantly (x03C1; = 0.33, p = 0.005). Significant construct validity was found for direct OSATS in distinguishing between students or novices and experts. Students and novices were not different in direct OSATS or video OSATS. Mean operative times varied for students (73.4 ± 9.0 min), novices (65.2 ± 22.3 min), and experts (46.8 ± 19.9 min). Internal consistency was high between the GRS and STS subscores for both direct and video OSATS with Cronbach's α of 0.76 and 0.86, respectively. Video OSATS and operative time in combination was a better predictor of direct OSATS than each single parameter. CONCLUSION: Direct OSATS rating was better than endoscopic video rating for differentiating between students or novices and experts for LC and should remain the standard approach for the discrimination of experience levels. However, in the absence of experts for direct rating, video OSATS supplemented with operative time should be used instead of single parameters for predicting direct OSATS scores.

Virtual reality does not meet expectations in a pilot study on multimodal laparoscopic surgery training.

BACKGROUND: The purpose of the present study was to determine the value of virtual reality (VR) training for a multimodality training program of basic laparoscopic surgery. MATERIALS AND METHODS: Participants in a two-day multimodality training for laparoscopic surgery used box trainers, live animal training, and cadaveric training on the pulsating organ perfusion (POP) trainer in a structured and standardized training program. The participants were divided into two groups. The VR group (n = 13) also practiced with VR training during the program, whereas the control group (n = 14) did not use VR training. The training modalities were assessed using questionnaires with a five-point Likert scale after the program. Concerning VR training, members of the control group assessed their expectations, whereas the VR group assessed the actual experience of using it. Skills performance was evaluated with five standardized test tasks in a live porcine model before (pre-test) and after (post-test) the training program. Laparoscopic skills were measured by task completion time and a general performance score for each task. Baseline tests were compared with laparoscopic experience of all participants for construct validity of the skills test. RESULTS: The expected benefit from VR training of the control group was higher than the experienced benefit of the VR group. Box and POP training received better ratings from the VR group than from the control group for some purposes. Both groups improved their skill parameters significantly from pre-training to post-training tests [score +17 % (P < 0.01), time -29 % (P < 0.01)]. No significant difference was found between the two groups for laparoscopic skills improvement except for the score in the instrument coordination task. Construct validity of the skills test was significant for both time and score. CONCLUSIONS: At its current level of performance, VR training does not meet expectations. No additional benefit was observed from VR training in our multimodality training program.

To whom do the results of the multicenter, randomized, controlled INSECT trial (ISRCTN 24023541) apply?--assessment of external validity.

UNLABELLED: A response to Seiler et al: Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicenter randomized trial (INSECT: ISRCTN24023541). Ann Surg 2009, 249(4):576-582. BACKGROUND: Existing evidence suggests that the transfer of results of randomized controlled trials into clinical practice may be limited. Potential reasons can be attributed to aspects of external validity. The aim of this study is to investigate issues related to the external validity of the INSECT trial. METHODS: All participating surgical departments were categorized and the clinical and baseline characteristics of randomized patients were evaluated. In addition, demographic and clinical data of all screened and randomized patients at the Departments of Surgery in Heidelberg and Erlangen were analyzed. RESULTS: Twenty-five centers enrolled a total of 625 patients. These centers included eight primary, 11 secondary, and six tertiary care centers. The tertiary care centers enrolled the most patients (n = 237, 38%) followed by the primary care centers (n = 199, 32%) and the secondary care centers (n = 189 patients; 30%). The mean number and baseline data of randomized patients did not differ between the three types of care centers (p = 0.09). Overall, the treatment according to protocol was at least 92%. At the Department of Surgery, University of Heidelberg, 307 patients were screened and 60 out of 130 eligible patients were randomized. There were no differences in demographic and clinical baseline data between included and non-included patients. In Erlangen, 351 patients were screened and 57 out of 106 eligible patients randomized. CONCLUSIONS: Results of the INSECT trial are applicable to a broad spectrum of patients treated at different hospital levels.

LabMELD-based organ allocation increases total costs of liver transplantation: a single-center experience.

INTRODUCTION: In 2006, model for end-stage liver disease (MELD)-based allocation was implemented in the Eurotransplant (ET) region. Sick patients, who in general require more resources, are prioritized. In this analysis, the effect of MELD on costs for liver transplantation (LTx) was assessed. METHODS: Total costs for LTx before and after implementation of MELD were identified in 256 patients from January 2005-December 2007. Forty-nine patients (Re-LTx, HU listings, and 30-d mortality) were excluded from further analysis. The costs of LTx in 207 patients have been correlated with their corresponding labMELD; 84 and 123 LTx before and after implementation of MELD were compared, and patient survival was monitored. RESULTS: A positive correlation exists between labMELD and costs (r(2) = 0.28; p < 0.05). Only nominal correlation existed between the Child-Pugh classification and costs. The labMELD scores can be stratified into four groups (I: 6-10, II: 11-18, III: 19-24, and IV: >24), with an increase of €15.672 ± 2.233 between each group (p < 0.05). Recipients' labMELD at the time of LTx increased significantly in the MELD-based allocation system. Costs increased by €11.650/patient (p < 0.05), while median survival decreased from 1219 to 869 d (p < 0.05). CONCLUSION: LabMELD-based allocation increased total costs of LTx. In accordance with other studies, the sickest patients need the most resources.

LigaSure versus conventional dissection technique in pancreatoduodenectomy: a pilot study.

BACKGROUND: Pancreatic surgery requires extensive preparation and tissue dissection. Therefore, LigaSure (Valleylab, Boulder, CO) provides an alternative to conventional dissection techniques. The aim of the present study was to describe the feasibility, safety, and cost efficiency of LigaSure in pancreatoduodenectomy. METHODS: Seven patients underwent surgery with the Ligasure and 7 patients underwent surgery with conventional dissection techniques. The patients were investigated for surgical time, intraoperative blood loss, complications, mortality, duration of hospital stay, and surgery-related costs. RESULTS: Surgical time was 207 minutes in the LigaSure group and 255 minutes in the conventional group (P = .020). Intraoperative blood loss was 271 and 771 mL, respectively (P = .010). Other perioperative outcomes were comparable. The respective surgery-related costs averaged €4,125 and €4,931 (P = .023). CONCLUSIONS: The use of LigaSure in pancreatoduodenectomy seems to be feasible and safe. In addition, it might lead to a reduction in the surgery-related costs.