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Introduction In the United Kingdom, work-based assessments (WBAs) including procedure-based assessments (PBAs), case-based discussions (CBDs), clinical evaluation exercises (CEXs), and direct observation of procedural skills (DOPS) have been used in Higher General Surgical Training Program (HGSTP) since the introduction of Modernising Medical Careers. Although the Intercollegiate Surgical Curriculum Project states that they should be used for the formative development of trainees using feedback and reflection, there is no study to look at the perception of their usefulness and barriers in using them, particularly in HGSTP. The aim of this study is to investigate trainer's and trainee's perception of their usefulness, barriers in using them, and way forward for their improvement in HGSTP. Methods This was a mixed method study. In phase I, after ethics committee approval, an online survey was sent to 83 trainers and 104 trainees, with a response rate of 33 and 37%, respectively, using Online Surveys (formerly Bristol Online Survey) from July 2018 to December 2018. After analysis of this result, in phase II, semistructured interviews were conducted with five trainees and five trainers who had volunteered to take part from phase I. Thematic analysis was performed to develop overarching themes. Results For professional formative development, 15% of the trainers and 53% of the trainees felt that WBAs had a low value. Among 4 WBAs—CEX, CBD, PBA, and DOPS—PBA was thought to be the most useful WBA by 52% trainers and 74% trainees.More trainers than trainees felt that it was being used as a formative tool (33 vs. 16%). The total number of WBAs thought to be required was between 20 and 40 per year, with 46% of the trainers and 53% of the trainees preferring these numbers.The thematic analysis generated four themes with subthemes in each: theme 1, “factors affecting usefulness,” including the mode of validation, trainer/trainee engagement, and time spent in validating; theme 2, “doubt on utility” due to doubt on validity and being used as a tick-box exercise; theme 3, “pitfalls/difficulties” due to lack of time to validate, late validation, e-mail rather than face-to-face validation, trainer and trainee behavior, variability in feedback given, and emphasis on number than quality; and theme 4, “improvement strategies.” Conclusions The WBAs are not being used in a way they are supposed to be used. The perception of educational impact (Kirkpatrick levels 1 and 2) by trainers was more optimistic than by trainees. Improvements can be made by giving/finding more time, trainer training, more face-to-face validation, and better trainer trainee interactions.

BACKGROUND: Despite improvements in multidisciplinary management, patients with biliary tract cancer have a poor outcome. Only 20% of patients are eligible for surgical resection with curative intent, with 5-year overall survival of less than 10% for all patients. To our knowledge, no studies have described a benefit of adjuvant therapy. We aimed to determine whether adjuvant capecitabine improved overall survival compared with observation following surgery for biliary tract cancer.METHODS: This randomised, controlled, multicentre, phase 3 study was done across 44 specialist hepatopancreatobiliary centres in the UK. Eligible patients were aged 18 years or older and had histologically confirmed cholangiocarcinoma or muscle-invasive gallbladder cancer who had undergone a macroscopically complete resection (which includes liver resection, pancreatic resection, or, less commonly, both) with curative intent, and an Eastern Cooperative Oncology Group performance status of less than 2. Patients who had not completely recovered from previous surgery or who had previous chemotherapy or radiotherapy for biliary tract cancer were also excluded. Patients were randomly assigned 1:1 to receive oral capecitabine (1250 mg/m 2 twice daily on days 1–14 of a 21-day cycle, for eight cycles) or observation commencing within 16 weeks of surgery. Treatment was not masked, and allocation concealment was achieved with a computerised minimisation algorithm that stratified patients by surgical centre, site of disease, resection status, and performance status. The primary outcome was overall survival. As prespecified, analyses were done by intention to treat and per protocol. This study is registered with EudraCT, number 2005-003318-13.FINDINGS: Between March 15, 2006, and Dec 4, 2014, 447 patients were enrolled; 223 patients with biliary tract cancer resected with curative intent were randomly assigned to the capecitabine group and 224 to the observation group. The data cutoff for this analysis was March 6, 2017. The median follow-up for all patients was 60 months (IQR 37–60). In the intention-to-treat analysis, median overall survival was 51·1 months (95% CI 34·6–59·1) in the capecitabine group compared with 36·4 months (29·7–44·5) in the observation group (adjusted hazard ratio [HR] 0·81, 95% CI 0·63–1·04; p=0·097). In a protocol-specified sensitivity analysis, adjusting for minimisation factors and nodal status, grade, and gender, the overall survival HR was 0·71 (95% CI 0·55–0·92; p=0·010). In the prespecified per-protocol analysis (210 patients in the capecitabine group and 220 in the observation group), median overall survival was 53 months (95% CI 40 to not reached) in the capecitabine group and 36 months (30–44) in the observation group (adjusted HR 0·75, 95% CI 0·58–0·97; p=0·028). In the intention-to-treat analysis, median recurrence-free survival was 24·4 months (95% CI 18·6–35·9) in the capecitabine group and 17·5 months (12·0–23·8) in the observation group. In the per-protocol analysis, median recurrence-free survival was 25·9 months (95% CI 19·8–46·3) in the capecitabine group and 17·4 months (12·0–23·7) in the observation group. Adverse events were measured in the capecitabine group only, and of the 213 patients who received at least one cycle, 94 (44%) had at least one grade 3 toxicity, the most frequent of which were hand-foot syndrome in 43 (20%) patients, diarrhoea in 16 (8%) patients, and fatigue in 16 (8%) patients. One (INTERPRETATION: Although this study did not meet its primary endpoint of improving overall survival in the intention-to-treat population, the prespecified sensitivity and per-protocol analyses suggest that capecitabine can improve overall survival in patients with resected biliary tract cancer when used as adjuvant chemotherapy following surgery and could be considered as standard of care. Furthermore, the safety profile is manageable, supporting the use of capecitabine in this setting.FUNDING: Cancer Research UK and Roche.

Context Pancreatic leak following pancreaticoduodenectomy has a major impact on postoperative mortality. However, it is not clear whether pancreatic leaks affect long term survival in patients with pancreatic ductal adenocarcinoma. Objective The aim of this study is to compare the long term outcome in patients who underwent pancreaticoduodenectomy, with and without postoperative pancreatic leak. Patients All 133 patients who underwent a pancreaticoduodenectomy at the HepatoPancreatoBiliary Unit, Addenbrooke’s Hospital, Cambridge, between June 2002 and June 2007 were identified from a prospectively held database. The study was restricted to 47 patients who had a confirmed diagnosis of pancreatic ductal adenocarcinoma. Setting Pancreatic leak was defined as drain fluid amylase more than three times the serum level for more than 3 days post operatively. Main outcome measure Long term survival of patients with and without leaks were compared using Kaplan-Meier curves and significance was measured using the log-rank test. Results Median follow-up was 30.8 months. The median actuarial survival of all ductal adenocarcinoma patients was 19 months. Pancreatic leaks occurred in 9 patients (19.1%). There were no significant differences in the overall survival or presence of recurrence between the two groups. Conclusions Pancreatic leak following pancreaticoduodenectomy does not appear to impact on long-term outcome of patients with pancreatic ductal adenocarcinoma. Image: Kaplan-Meier curve showing no significant difference in the overall survival following pancreaticoduodenectomy between 9 patients with pancreatic leaks and 38 patients without pancreatic leaks., JOP. Journal of the Pancreas, Vol 11, No 3 (2010): May - p. 199-298