Search

Background: Recent developments in esophageal cancer treatment, including studies exploring active surveillance following chemoradiotherapy, have led to a need for clear terminology and definitions regarding different multimodal treatment options. Objective: The aim of this study was to reach worldwide consensus on the definitions and semantics of multimodal esophageal cancer treatment. Methods: In total, 72 experts working in the field of multimodal esophageal cancer treatment were invited to participate in this Delphi study. The study comprised three Delphi surveys sent out by email and one online meeting. Input for the Delphi survey consisted of terminology obtained from a systematic literature search. Participants were asked to respond to open questions and to indicate whether they agreed or disagreed with different statements. Consensus was reached when there was ≥75% agreement among respondents. Results: Forty-nine of 72 invited experts (68.1%) participated in the first online Delphi survey, 45 (62.5%) in the second survey, 21 (46.7%) of 45 in the online meeting, and 39 (86.7%) of 45 in the final survey. Consensus on neoadjuvant and definitive chemoradiotherapy with or without surgery was reached for 27 of 31 items (87%). No consensus was reached on follow-up after treatment with definitive chemoradiotherapy. Conclusion(s): Consensus was reached on most statements regarding terminology and definitions of multimodal esophageal cancer treatment. Implementing uniform criteria facilitates comparison of studies and promotes international research collaborations. [ABSTRACT FROM AUTHOR]

BackgroundChildren with autism spectrum disorder (ASD) have social deficits that affect social interactions, communication, and relationships with peers. Many existing interventions focus mainly on improving social skills in clinical settings. In addition to the direct instruction–based programs, activity-based programs could be of added value, especially to bridge the relational gap between children with ASD and their peers. ObjectiveThe aim of this study is to describe an iterative design process for the development of an escape room–based serious game as a boundary object. The purpose of the serious game is to facilitate direct communication between high-functioning children with ASD and their peers, for the development of social skills on the one hand and strengthening relationships with peers through a fun and engaging activity on the other hand. MethodsThis study is structured around the Design Research Framework to develop an escape room through an iterative-incremental process. With a pool of 37 children, including 23 children diagnosed with ASD (5 girls) and 14 children (7 girls) attending special primary education for other additional needs, 4 testing sessions around different prototypes were conducted. The beta prototype was subsequently reviewed by experts (n=12). During the design research process, we examined in small steps whether the developed prototypes are feasible and whether they have the potential to achieve the formulated goals of different stakeholders. ResultsBy testing various prototypes, several insights were found and used to improve the design. Insights were gained in finding a fitting and appealing theme for the children, composing the content, and addressing different constraints in applying the goals from the children’s and therapeutic perspectives. Eventually, a multiplayer virtual escape room, AScapeD, was developed. Three children can play the serious game in the same room on tablets. The first test shows that the game enacts equal cooperation and communication among the children. ConclusionsThis paper presents an iterative design process for AScapeD. AScapeD enacts equal cooperation and communication in a playful way between children with ASD and their peers. The conceptual structure of an escape room contributes to the natural emergence of communication and cooperation. The iterative design process has been beneficial for finding a constructive game structure to address all formulated goals, and it contributed to the design of a serious game as a boundary object that mediates the various objectives of different stakeholders. We present 5 lessons learned from the design process. The developed prototype is feasible and has the potential to achieve the goals of the serious game.

BackgroundChildren with autism spectrum disorder (ASD) often face difficulties in social situations and are often lagging in terms of social skills. Many interventions designed for children with ASD emphasize improving social skills. Although many interventions demonstrate that targeted social skills can be improved in clinical settings, developed social skills are not necessarily applied in children's daily lives at school, sometimes because classmates continue to show negative bias toward children with ASD. Children with ASD do not blame the difficult social situations they encounter on their lack of social skills; their main goal is to be accepted by peers. ObjectiveThis study aims to design a comic creator—It's me—that would create comics to serve as transformational boundary objects to facilitate and enact a horizontal interaction structure between high-functioning children with ASD and their peers, aiming to increase mutual understanding between children at school. MethodsThis research project and this study are structured around the Design Research Framework in order to develop the comic through an iterative-incremental process. Three test sessions, which included 13, 6, and 47 children, respectively, were initiated where the focus shifted in time from usability during the first two tests to the initial assessment of acceptance and feasibility in the third session. A stakeholder review, which included six experts, took place after the second test session. ResultsA digital comic creator, It's me, was produced within this study. Children can create their own personal comic by filling in a digital questionnaire. Based on concepts of peer support, psychoeducation, and horizontal interaction, It's me has a rigorous base of underlying concepts that have been translated into design. Based on the first test sessions, the comic has shown its potential to initiate personal conversations between children. Teachers are convinced that It's me can be of added value in their classrooms. ConclusionsIt's me aims to initiate more in-depth conversations between peers, which should lead to more mutual understanding and better relationships between children with ASD and their peers. The first test sessions showed that It's me has the potential to enact horizontal interaction and greater understanding among peers. It's me was designed as a boundary object, aiming to connect the objectives of different stakeholders, and to trigger reflection and transformation learning mechanisms. The applied design research approach might be of added value in the acceptance and adoption of the intervention because children, professionals, and teachers see added value in the tool, each from their own perspectives.

Background: This study evaluated the association of pathological tumour response (tumour regression grade, TRG) and a novel scoring system, combining both TRG and nodal status (TRG-ypN score; TRG1-ypN0, TRG>1-ypN0, TRG1-ypN+ and TRG>1-ypN+), with recurrence patterns and survival after multimodal treatment of oesophageal adenocarcinoma. Methods: This Dutch nationwide cohort study included patients treated with neoadjuvant chemoradiotherapy followed by oesophagectomy for distal oesophageal or gastro-oesophageal junctional adenocarcinoma between 2007 and 2016. The primary endpoint was the association of Mandard score and TRG-ypN score with recurrence patterns (rate, location, and time to recurrence). The secondary endpoint was overall survival. Results: Among 2746 inclusions, recurrence rates increased with higher Mandard scores (TRG1 30.6%, TRG2 44.9%, TRG3 52.9%, TRG4 61.4%, TRG5 58.2%; P < 0.001). Among patients with recurrent disease, the distribution (locoregional versus distant) was the same for the different TRG groups. Patients with TRG1 developed more brain recurrences (17.7 versus 9.8%; P = 0.001) and had a longer mean overall survival (44 versus 35 months; P < 0.001) than those with TRG>1. The TRG>1-ypN+ group had the highest recurrence rate (64.9%) and worst overall survival (mean 27 months). Compared with the TRG>1-ypN0 group, patients with TRG1-ypN+ had a higher risk of recurrence (51.9 versus 39.6%; P < 0.001) and worse mean overall survival (33 versus 41 months; P < 0.001). Conclusion: Improved tumour response to neoadjuvant therapy was associated with lower recurrence rates and higher overall survival rates. Among patients with recurrent disease, TRG1 was associated with a higher incidence of brain recurrence than TRG>1. Residual nodal disease influenced prognosis more negatively than residual disease at the primary tumour site. In this Dutch nationwide cohort study, improved tumour response to neoadjuvant therapy was associated with a lower recurrence rate and higher overall survival rate. Among patients with recurrent disease, tumour regression grade (TRG) 1 was associated with a higher incidence of brain recurrences than TRG greater than 1. Residual nodal disease influenced prognosis more negatively than residual disease at the primary tumour site. [ABSTRACT FROM AUTHOR]

Global rating scales (GRSs) such as the Objective Structured Assessment of Technical Skills (OSATS) and Global Operative Assessment of Laparoscopic Surgery (GOALS) are assessment methods for surgical procedures. The aim of this study was to establish construct validity of Procedure-Based Assessment (PBA) and to compare PBA with GRSs for laparoscopic cholecystectomy. OSATS and GOALS GRSs were compared with PBA in their ability to discriminate between levels of performance between trainees who can perform the procedure independently and those who cannot. Three groups were formed based on the number of procedures performed by the trainee: novice (1–10), intermediate (11–20) and experienced (>20). Differences between groups were assessed using the Kruskal–Wallis and Mann–Whitney U tests. Increasing experience correlated significantly with higher GRSs and PBA scores (all p <.001). Scores of novice and intermediate groups overlapped substantially on the OSATS (p =.1) and GOALS (p =.1), while the PBA discriminated between these groups (p =.03). The median score in the experienced group was higher with less dispersion for PBA (97.2[85.3–100]) compared to OSATS (82.1[60.7–100]) and GOALS (80[60–100]). For assessing skill level or the capability of performing a laparoscopic cholecystectomy independently, PBA has a higher discriminative ability compared to the GRSs. [ABSTRACT FROM AUTHOR]

Background: The Surgery As Needed for Oesophageal cancer (SANO) trial compares active surveillance with standard oesophagectomy for patients with a clinically complete response (cCR) to neoadjuvant chemoradiotherapy. The last patient with a clinically complete response is expected to be included in May 2021. The purpose of this update is to present all amendments to the SANO trial protocol as approved by the Institutional Research Board (IRB) before accrual is completed.Design: The SANO trial protocol has been published ( https://doi.org/10.1186/s12885-018-4034-1 ). In this ongoing, phase-III, non-inferiority, stepped-wedge, cluster randomised controlled trial, patients with cCR (i.e. after neoadjuvant chemoradiotherapy no evidence of residual disease in two consecutive clinical response evaluations [CREs]) undergo either active surveillance or standard oesophagectomy. In the active surveillance arm, CREs are repeated every 3 months in the first year, every 4 months in the second year, every 6 months in the third year, and yearly in the fourth and fifth year. In this arm, oesophagectomy is offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant metastases. The primary endpoint is overall survival.Update: Amendments to the study design involve the first cluster in the stepped-wedge design being partially randomised as well and continued accrual of patients at baseline until the predetermined number of patients with cCR is reached. Eligibility criteria have been amended, stating that patients who underwent endoscopic treatment prior to neoadjuvant chemoradiotherapy cannot be included and that patients who have highly suspected residual tumour without histological proof can be included. Amendments to the study procedures include that patients proceed to the second CRE if at the first CRE the outcome of the pathological assessment is uncertain and that patients with a non-passable stenosis at endoscopy are not considered cCR. The sample size was recalculated following new insights on response rates (34% instead of 50%) and survival (expected 2-year overall survival of 75% calculated from the moment of reaching cCR instead of 3-year overall survival of 67% calculated from diagnosis). This reduced the number of required patients with cCR from 264 to 224, but increased the required inclusions from 480 to approximately 740 patients at baseline.Conclusion: Substantial amendments were made prior to closure of enrolment of the SANO trial. These amendments do not affect the outcomes of the trial compared to the original protocol. The first results are expected late 2023. If active surveillance plus surgery as needed after neoadjuvant chemoradiotherapy for oesophageal cancer leads to non-inferior overall survival compared to standard oesophagectomy, active surveillance can be implemented as a standard of care. [ABSTRACT FROM AUTHOR]

Focuses on an investigation of whether articles accepted by the `Nederlands Tijdschrift voor Geneeskunde,' the Dutch Journal of Medicine, were improved after peer review and editing. Methods of the investigation; Findings; Interpretation of the findings.

Objective: To assess the incidence, natural course, and possible pathogenesis of dysphagia that is not caused by anastomotic stricture, after transhiatal oesophagectomy and gastric tube reconstruction. Design: Prospective study. Setting: District teaching hospital, The Netherlands. Subjects: 22 patients who had transhiatal oesophagectomy and gastric tube reconstruction for cancer. Main outcome measures: Incidence of dysphagia that is not caused by anastomotic stricture one week after operation, and presence of this functional dysphagia and correlation with vocal cord palsy at 4, 8, 12, and 16 weeks postoperatively. Results: The incidence of functional dysphagia was 7 out of 22 (32%); it was self-limiting in 5 out of 7 (71%) of the cases and associated with the incidence of vocal cord palsy (p = 0.0006). Conclusion: Functional dysphagia after transhiatal oesophagectomy occurs frequently, but is self-limiting in most patients. Injury to branches of the recurrent laryngeal nerve is a likely cause. [ABSTRACT FROM AUTHOR]

Background: Neoadjuvant chemoradiotherapy (nCRT) plus surgery is a standard treatment for locally advanced oesophageal cancer. With this treatment, 29% of patients have a pathologically complete response in the resection specimen. This provides the rationale for investigating an active surveillance approach. The aim of this study is to assess the (cost-)effectiveness of active surveillance vs. standard oesophagectomy after nCRT for oesophageal cancer.Methods: This is a phase-III multi-centre, stepped-wedge cluster randomised controlled trial. A total of 300 patients with clinically complete response (cCR, i.e. no local or disseminated disease proven by histology) after nCRT will be randomised to show non-inferiority of active surveillance to standard oesophagectomy (non-inferiority margin 15%, intra-correlation coefficient 0.02, power 80%, 2-sided α 0.05, 12% drop-out). Patients will undergo a first clinical response evaluation (CRE-I) 4-6 weeks after nCRT, consisting of endoscopy with bite-on-bite biopsies of the primary tumour site and other suspected lesions. Clinically complete responders will undergo a second CRE (CRE-II), 6-8 weeks after CRE-I. CRE-II will include 18F-FDG-PET-CT, followed by endoscopy with bite-on-bite biopsies and ultra-endosonography plus fine needle aspiration of suspected lymph nodes and/or PET- positive lesions. Patients with cCR at CRE-II will be assigned to oesophagectomy (first phase) or active surveillance (second phase of the study). The duration of the first phase is determined randomly over the 12 centres, i.e., stepped-wedge cluster design. Patients in the active surveillance arm will undergo diagnostic evaluations similar to CRE-II at 6/9/12/16/20/24/30/36/48 and 60 months after nCRT. In this arm, oesophagectomy will be offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant dissemination. The main study parameter is overall survival; secondary endpoints include percentage of patients who do not undergo surgery, quality of life, clinical irresectability (cT4b) rate, radical resection rate, postoperative complications, progression-free survival, distant dissemination rate, and cost-effectiveness. We hypothesise that active surveillance leads to non-inferior survival, improved quality of life and a reduction in costs, compared to standard oesophagectomy.Discussion: If active surveillance and surgery as needed after nCRT leads to non-inferior survival compared to standard oesophagectomy, this organ-sparing approach can be implemented as a standard of care. [ABSTRACT FROM AUTHOR]

BACKGROUND: Although the positive effects of playing video games on basic laparoscopic skills have been studied for several years, no games are actually used in surgical training. This article discusses the face validity of the first video game and custom-made hardware, which takes advantage of these effects. METHODS: Participants were recruited at the Chirurgendagen 2013 and the Society of American Gastrointestinal and Endoscopic Surgeons 2014 annual meeting. In total, 72 laparoscopic surgeons completed a demo of the game and filled in a questionnaire. RESULTS: On a 1-to-10 scale, the mean score for hardware realism was 7.2 and the mean score for usefulness as a training tool was 8.4. Participants did not mind the fact that the workspace does not look like an abdominal cavity, but do have some trouble with the absence of tactile feedback. CONCLUSION: We obtained face validity for both the hardware and the usefulness of Underground, a video game made for training basic laparoscopic skills. [ABSTRACT FROM AUTHOR]

BACKGROUND: Recently, there has been a growth in studies supporting the hypothesis that video games have positive effects on basic laparoscopic skills. This review discusses all studies directly related to these effects. DATA SOURCES: A search in the PubMed and EMBASE databases was performed using synonymous terms for video games and laparoscopy. All available articles concerning video games and their effects on skills on any laparoscopic simulator (box trainer, virtual reality, and animal models) were selected. CONCLUSIONS: Video game experience has been related to higher baseline laparoscopic skills in different studies. There is currently, however, no standardized method to assess video game experience, making it difficult to compare these studies. Several controlled experiments have, nevertheless, shown that video games cannot only be used to improve laparoscopic basic skills in surgical novices, but are also used as a temporary warming-up before laparoscopic surgery. [ABSTRACT FROM AUTHOR]

Background and study aims Variation between trainers in providing traditional gastrointestinal endoscopy training, in which residents learn endoscopy by doing under the supervision of endoscopy trainers, may cause differences in endoscopy competence between residents. In this study, we explored endoscopy trainers' views on the current status and desired future best practices regarding endoscopy training. Methods This mixed-methods study comprised quantitative survey data collected from 158 endoscopy trainers working in 26 gastroenterology teaching hospitals in the Netherlands and semi-structured interviews with 15 gastroenterology residency (associate) program directors (PDs). Survey data were analyzed using descriptive statistics and interview results with thematic analysis. Results There was considerable variability in endoscopy training practices between teaching hospitals in the structure of endoscopy supervision, criteria used to determine the level of supervision, and participation of trainers in endoscopy teaching courses. Interview participants agreed that an endoscopy training supervisor requires several teaching strategies, highlighting the importance of formal education in endoscopy teaching. Interview participants perceived self-regulated learning strategies as essential for residents to learn endoscopy effectively. The perceived main barriers to effective supervision were a lack of time and heavy workload. Participants expressed the desire for more standardization in endoscopy training programs between teaching hospitals. Conclusions Considerable variability in endoscopy training practices between gastroenterology teaching hospitals was identified. Formal education on endoscopy teaching, promotion of self-regulated learning, and standardization of endoscopy training programs and supervision practices have the potential to improve future endoscopy training., Competing Interests: Conflict of Interest The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).)

Introduction: Determining limb length in gastric bypass procedures is a crucial step to ensure significant weight loss without risking malnutrition. This study investigated the effect of ex vivo training on the skills needed to determine limb lengths., Materials and Methods: This was a single-center ex vivo training experiment in a teaching hospital in the Netherlands. We designed a training exercise with marked ropes in a laparoscopic trainer box. All ten surgical residents participated and practiced the skill of estimating limb length. Before and after the two-week period their results on a 150-centimeter limb length task were evaluated., Results: Before training, 10 surgical residents estimated 150 centimeters of small bowel with an absolute deviation of 21% [range 9-30]. After the training experiment, the residents measured with 8% [2-20] deviation ( P = .17). The 8 residents who trained sufficiently improved statistically significantly to an absolute deviation of 5% [2-17] ( P = .012). Over 70% of the participants felt their skills had improved., Conclusions: With sufficient training, surgical residents' skills in measuring small bowel length improved when tested in an ex vivo model. Residents became more confident in their laparoscopic measurement skills. This ex vivo training model is a alternative and addition to on-site training., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background and study aims  Training in endoscopy is a key objective of gastroenterology residency. There is currently no standardized or systematic training approach. This study evaluated and compared the current status of gastrointestinal endoscopy training programs in all teaching hospitals in the Netherlands from a resident perspective. Materials and methods  A national online survey with open and closed questions on gastrointestinal endoscopy training was administered to all gastroenterology residents (N = 180) in the eight educational regions in the Netherlands. Results  One hundred residents who had already started endoscopy training were included in the analyses. Sixty-five residents (65 %) were satisfied with their endoscopy training program. Participation in a preclinical endoscopy course was mandatory in seven of eight educational regions. Residents from the region without a mandatory endoscopy training course were significantly less likely to be satisfied with their endoscopy training program (32 %, P  = .011). Criteria used to determine the level of supervision differed greatly between teaching hospitals (e. g. assessed endoscopy competence, predefined period of time or number of procedures). Only 26 residents (26 %) reported uniformity in teaching methods and styles between different supervising gastroenterologists in their teaching hospital. Conclusions  Although most gastroenterology residents were satisfied with the endoscopy training program and endoscopy supervision in their teaching hospital, this study identified considerable local and regional variability. Future studies should be conducted to evaluate the trainers' perspective and trainers' behavior during endoscopy training sessions, which might eventually lead to the development of best practices regarding endoscopy training, including standardization of training programs and supervision methods., Competing Interests: Competing interests The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Objective: This study investigated the patterns, predictors, and survival of recurrent disease following esophageal cancer surgery., Background: Survival of recurrent esophageal cancer is usually poor, with limited prospects of remission., Methods: This nationwide cohort study included patients with distal esophageal and gastroesophageal junction adenocarcinoma and squamous cell carcinoma after curatively intended esophagectomy in 2007 to 2016 (follow-up until January 2020). Patients with distant metastases detected during surgery were excluded. Univariable and multivariable logistic regression were used to identify predictors of recurrent disease. Multivariable Cox regression was used to determine the association of recurrence site and treatment intent with postrecurrence survival., Results: Among 4626 patients, 45.1% developed recurrent disease a median of 11 months postoperative, of whom most had solely distant metastases (59.8%). Disease recurrences were most frequently hepatic (26.2%) or pulmonary (25.1%). Factors significantly associated with disease recurrence included young age (≤65 y), male sex, adenocarcinoma, open surgery, transthoracic esophagectomy, nonradical resection, higher T-stage, and tumor positive lymph nodes. Overall, median postrecurrence survival was 4 months [95% confidence interval (95% CI): 3.6-4.4]. After curatively intended recurrence treatment, median survival was 20 months (95% CI: 16.4-23.7). Survival was more favorable after locoregional compared with distant recurrence (hazard ratio: 0.74, 95% CI: 0.65-0.84)., Conclusions: This study provides important prognostic information assisting in the surveillance and counseling of patients after curatively intended esophageal cancer surgery. Nearly half the patients developed recurrent disease, with limited prospects of survival. The risk of recurrence was higher in patients with a higher tumor stage, nonradical resection and positive lymph node harvest., Competing Interests: M.D.P.L. received research grants from Galvani and Medtronic. G.A.P.N. reports consulting fees and research grants from Medtronic. C.R. has received research grants from Johnson&Johnson and Medtronic. M.I.v.B.H. reports research grants from Olympus and Stryker, in addition to consulting fees from Medtronic, Alesi Surgical, Johnson&Johnson, and Mylan. M.G.H.v.O. has received unrestricted research grants from Bayer, Lilly, Merck Serono, Nordic, Servier, and Roche. The remaining authors report no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Tumor ablation is often employed for unresectable colorectal liver metastases. However, no survival benefit has ever been demonstrated in prospective randomized studies. Here, we investigate the long-term benefits of such an aggressive approach., Methods: In this randomized phase II trial, 119 patients with unresectable colorectal liver metastases (n < 10 and no extrahepatic disease) received systemic treatment alone or systemic treatment plus aggressive local treatment by radiofrequency ablation ± resection. Previously, we reported that the primary end point (30-month overall survival [OS] > 38%) was met. We now report on long-term OS results. All statistical tests were two-sided. The analyses were according to intention to treat., Results: At a median follow up of 9.7 years, 92 of 119 (77.3%) patients had died: 39 of 60 (65.0%) in the combined modality arm and 53 of 59 (89.8%) in the systemic treatment arm. Almost all patients died of progressive disease (35 patients in the combined modality arm, 49 patients in the systemic treatment arm). There was a statistically significant difference in OS in favor of the combined modality arm (hazard ratio [HR] = 0.58, 95% confidence interval [CI] = 0.38 to 0.88, P = .01). Three-, five-, and eight-year OS were 56.9% (95% CI = 43.3% to 68.5%), 43.1% (95% CI = 30.3% to 55.3%), 35.9% (95% CI = 23.8% to 48.2%), respectively, in the combined modality arm and 55.2% (95% CI = 41.6% to 66.9%), 30.3% (95% CI = 19.0% to 42.4%), 8.9% (95% CI = 3.3% to 18.1%), respectively, in the systemic treatment arm. Median OS was 45.6 months (95% CI = 30.3 to 67.8 months) in the combined modality arm vs 40.5 months (95% CI = 27.5 to 47.7 months) in the systemic treatment arm., Conclusions: This phase II trial is the first randomized study demonstrating that aggressive local treatment can prolong OS in patients with unresectable colorectal liver metastases., (© The Author 2017. Published by Oxford University Press.)