The effect of tongue‐strengthening exercises on tongue strength and swallowing‐related parameters in chronic radiation‐associated dysphagia

Background Radiation-associated dysphagia (RAD) is highly prevalent in head and neck cancer (HNC) patients, with insufficient tongue strength (TS) as a characteristic of this disabling complication. The effects of tongue-strengthening exercises (TSE) on TS, swallowing, and quality of life (QoL) have not been studied in this population. Methods A prospective phase 2 study using an 8 weeks during TSE protocol was carried out in 15 patients with chronic RAD. Outcome parameters were maximal isometric pressure (MIP), TS during swallowing (Pswal), swallowing function, and QoL. All parameters were evaluated at baseline, after 4 and 8 weeks of training, and 4 weeks after the last training session. Results MIP increased significantly, without detraining effects. Pswal did not increase significantly, but relevant effect sizes were measured. Swallowing function ameliorated, but did not result in increased functional oral intake, self-reported outcome or QoL. Conclusion TSE in patients with RAD results in increased strength and swallowing function

Effect of tongue‐strengthening exercises on tongue strength and swallowing‐related parameters in chronic radiation‐associated dysphagia

Background Radiation-associated dysphagia (RAD) is highly prevalent in head and neck cancer (HNC) patients, with insufficient tongue strength (TS) as a characteristic of this disabling complication. The effects of tongue-strengthening exercises (TSE) on TS, swallowing, and quality of life (QoL) have not been studied in this population. Methods A prospective phase 2 study using an 8 weeks during TSE protocol was carried out in 15 patients with chronic RAD. Outcome parameters were maximal isometric pressure (MIP), TS during swallowing (Pswal), swallowing function, and QoL. All parameters were evaluated at baseline, after 4 and 8 weeks of training, and 4 weeks after the last training session. Results MIP increased significantly, without detraining effects. Pswal did not increase significantly, but relevant effect sizes were measured. Swallowing function ameliorated, but did not result in increased functional oral intake, self-reported outcome or QoL. Conclusion TSE in patients with RAD results in increased strength and swallowing function

Very late xerostomia, dysphagia, and neck fibrosis after head and neck radiotherapy

Background: Acute and late toxicity after intensity‐modulated radiotherapy (IMRT) for head and neck cancer (HNC) impacts on patient quality of life; yet, very late toxicity data remain scarce. This study assessed dysphagia, xerostomia, and neck fibrosis 3‐8 years after IMRT. Methods: A retrospective analysis using generalized estimated equations was performed on 60 patients with HNC treated with fractionated IMRT between 2000 and 2015 who had a follow‐up ≥8 years. Toxicity was scored using LENT‐SOMA scales. Results: A trend towards a nonlinear global time effect (P = .05) was noted for dysphagia with a decrease during the 5 years post‐treatment and an increase thereafter. A significant decrease in xerostomia (P = .001) and an increase in neck fibrosis (P = .04) was observed until 8 years. Conclusions: Dysphagia, xerostomia, and neck fibrosis do not appear stable over time and remain highly prevalent in the very late follow‐up. Our findings support the need for prospective trials investigating very late toxicity in patients with HNC

Local Recurrence After Transanal Total Mesorectal Excision for Rectal Cancer: A Multicenter Cohort Study

OBJECTIVE: This study aimed to determine local recurrence (LR) rate and pattern after transanal total mesorectal excision (TaTME) for rectal cancer. BACKGROUND: TaTME for mid- and low rectal cancer has known a rapid and worldwide adoption. Recently, concerns have been raised on the oncological safety in light of reported high LR rates with a multifocal pattern. METHODS: This was a multicenter observational cohort study in 6 tertiary referral centers. All consecutive TaTME cases for primary rectal adenocarcinoma from the first TaTME case in every center until December 2018 were included for analysis. Patients with benign tumors, malignancies other than adenocarcinoma and recurrent rectal cancer, as well as exenterative procedures, were excluded. The primary endpoint was 2-year LR rate. Secondary endpoints included patterns and treatment of LR and histopathological characteristics of the primary surgery. RESULTS: A total of 767 patients were identified and eligible for analysis. Resection margins were involved in 8% and optimal pathological outcome (clear margins, (nearly) complete specimen, no perforation) was achieved in 86% of patients. After a median follow-up of 25.5 months, 24 patients developed LR, with an actuarial cumulative 2-year LR rate of 3% (95% CI 2-5). In none of the patients, a multifocal pattern of LR was observed. Thirteen patients had isolated LR (without systemic disease) and 10/13 could be managed by salvage surgery of whom 8 were disease-free at the end of follow-up. CONCLUSIONS AND RELEVANCE: This study shows good loco regional control after TaTME in selected cases from tertiary referral centers and does not indicate an inherent oncological risk of the surgical technique

Local Recurrence After Transanal Total Mesorectal Excision for Rectal Cancer: A Multicenter Cohort Study.

OBJECTIVE: This study aimed to determine local recurrence (LR) rate and pattern after transanal total mesorectal excision (TaTME) for rectal cancer. BACKGROUND: TaTME for mid- and low rectal cancer has known a rapid and worldwide adoption. Recently, concerns have been raised on the oncological safety in light of reported high LR rates with a multifocal pattern. METHODS: This was a multicenter observational cohort study in 6 tertiary referral centers. All consecutive TaTME cases for primary rectal adenocarcinoma from the first TaTME case in every center until December 2018 were included for analysis. Patients with benign tumors, malignancies other than adenocarcinoma and recurrent rectal cancer, as well as exenterative procedures, were excluded. The primary endpoint was 2-year LR rate. Secondary endpoints included patterns and treatment of LR and histopathological characteristics of the primary surgery. RESULTS: A total of 767 patients were identified and eligible for analysis. Resection margins were involved in 8% and optimal pathological outcome (clear margins, (nearly) complete specimen, no perforation) was achieved in 86% of patients. After a median follow-up of 25.5 months, 24 patients developed LR, with an actuarial cumulative 2-year LR rate of 3% (95% CI 2-5). In none of the patients, a multifocal pattern of LR was observed. Thirteen patients had isolated LR (without systemic disease) and 10/13 could be managed by salvage surgery of whom 8 were disease-free at the end of follow-up. CONCLUSIONS AND RELEVANCE: This study shows good loco regional control after TaTME in selected cases from tertiary referral centers and does not indicate an inherent oncological risk of the surgical technique.status: Published onlin

Proceedings of the 4th World Conference on Research Integrity

CITATION: O’Brien, S. P., et al. 2016. Proceedings of the 4th World Conference on Research Integrity. Research Integrity and Peer Review, 1:9, doi:10.1186/s41073-016-0012-9.The original publication is available at https://researchintegrityjournal.biomedcentral.comThese Proceedings contain the abstracts of the presentations given at the 4th World Conference in concurrent sessions, partner symposia, and poster sessions. Also included are summaries of the discussions in three focus tracks, which allowed delegates to consider and work on questions about the roles of funders, institutions, and countries in improving research systems and strengthening research integrity. Videos of the plenary presentations are available at the conference website (www.wcri2015.org).https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-016-0012-

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)