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Background and study aims Credentialing, the process through which an institution assesses and validates an endoscopist’s qualifications to independently perform a procedure, can vary by region and country. Little is known about these inter-societal and geographic differences. We aimed to systematically characterize credentialing recommendations and requirements worldwide. Methods We conducted a systematic review of credentialing practices among gastrointestinal and endoscopy societies worldwide. An electronic search as well as hand-search of World Endoscopy Organization members’ websites was performed for credentialing documents. Abstracts were screened in duplicate and independently. Data were collected on procedures included in each document (e. g. colonoscopy, ERCP) and types of credentialing statements (procedural volume, key performance indicators (KPIs), and competency assessments). The primary objective was to qualitatively describe and compare the available credentialing recommendations and requirements from the included studies. Descriptive statistics were used to summarize data when appropriate. Results We screened 653 records and included 20 credentialing documents from 12 societies. Guidelines most commonly included credentialing statements for colonoscopy, esophagogastroduodenoscopy (EGD), and ERCP. For colonoscopy, minimum procedural volumes ranged from 150 to 275 and adenoma detection rate (ADR) from 20 % to 30%. For EGD, minimum procedural volumes ranged from 130 to 1000, and duodenal intubation rate of 95 % to 100%. For ERCP, minimum procedural volumes ranged from 100 to 300 with selective duct cannulation success rate of 80 % to 90 %. Guidelines also reported on flexible sigmoidoscopy, capsule endoscopy, and endoscopic ultrasound. Conclusions While some metrics such as ADR were relatively consistent among societies, there was substantial variation among societies with respect to procedural volume and KPI statements.

Background Propensity score matching (PSM), a statistical technique that estimates a treatment effect by accounting for predictor covariates, has been used to evaluate biologics for inflammatory bowel disease (IBD). Financial conflicts of interest are prevalent in the marketing of biologic medications. It is unclear whether this burden of conflicts is present among authors of PSM studies comparing IBD biologics and biosimilars. Objective This study was aimed to determine the prevalence of financial conflicts of interest among authors of PSM studies evaluating IBD biologics and biosimilars. Methods We conducted a systematic search for PSM studies comparing biologics and biosimilars in IBD treatment. We identified 21 eligible studies. Two independent authors extracted self-declared conflicts from the disclosures section. Each participating author was searched on the Centers for Medicare & Medicaid Services Open Payments to identify payment amounts and undisclosed conflicts. Primary outcome was the prevalence of author conflicts. Secondary analyses assessed for an association between conflict prevalence and reporting of positive outcomes. Results Among 283 authors, conflicts were present among 41.0% (116 of 283). Twenty-three per cent (27 of 116) of author conflicts involved undisclosed payments. Studies with positive outcomes were significantly more likely to include conflicted authors than neutral studies (relative risk = 2.34, 95% confidence interval: 1.71 to 3.21, P < 0.001). Conclusions Overall, we found a high burden of undisclosed conflicts among authors of PSM studies comparing IBD biologics and biosimilars. Given the importance of PSM studies as a means for biologic comparison and the potential for undue industry influence from these payments, authors should ensure greater transparency with reporting of industry relationships.

Background Assessment of mucosal visualization during esophagogastroduodenoscopy (EGD) can be improved with a standardized scoring system. To address this need, we created the Toronto Upper Gastrointestinal Cleaning Score (TUGCS). Methods We developed the TUGCS using Delphi methodology, whereby an international group of endoscopy experts iteratively rated their agreement with proposed TUGCS items and anchors on a 5-point Likert scale. After each Delphi round, we analyzed responses and refined the TUGCS using an 80 % agreement threshold for consensus. We used the intraclass correlation coefficient (ICC) to assess inter-rater and test–retest reliability. We assessed internal consistency with Cronbach’s alpha and item-total and inter-item correlations with Pearson’s correlation coefficient. We compared TUGCS ratings with an independent endoscopist’s global rating of mucosal visualization using Spearman’s ρ. Results We achieved consensus with 14 invited participants after three Delphi rounds. Inter-rater reliability was high at 0.79 (95 %CI 0.64–0.88). Test–retest reliability was excellent at 0.83 (95 %CI 0.77–0.87). Cronbach’s α was 0.81, item-total correlation range was 0.52–0.70, and inter-item correlation range was 0.38–0.74. There was a positive correlation between TUGCS ratings and a global rating of visualization (r = 0.41, P = 0.002). TUGCS ratings for EGDs with global ratings of excellent were significantly higher than those for EGDs with global ratings of fair (P = 0.01). Conclusion The TUGCS had strong evidence of validity in the clinical setting. The international group of assessors, broad variety of EGD indications, and minimal assessor training improves the potential for dissemination.

Background Assessment is necessary to ensure both attainment and maintenance of competency in gastrointestinal (GI) endoscopy, and this can be accomplished through self-assessment. We conducted a systematic review with meta-analysis to evaluate the accuracy of self-assessment among GI endoscopists. Methods This was an individual participant data meta-analysis of studies that investigated self-assessment of endoscopic competency. We performed a systematic search of the following databases: Ovid MEDLINE, Ovid EMBASE, Wiley Cochrane CENTRAL, and ProQuest Education Resources Information Center. We included studies if they were primary investigations of self-assessment accuracy in GI endoscopy that used statistical analyses to determine accuracy. We conducted a meta-analysis of studies using a limits of agreement (LoA) approach to meta-analysis of Bland–Altman studies. Results After removing duplicate entries, we screened 7138 records. After full-text review, we included 16 studies for qualitative analysis and three for meta-analysis. In the meta-analysis, we found that the LoA were wide (−41.0 % to 34.0 %) and beyond the clinically acceptable difference. Subgroup analyses found that both novice and intermediate endoscopists had wide LoA (−45.0 % to 35.1 % and −54.7 % to 46.5 %, respectively) and expert endoscopists had narrow LoA (−14.2 % to 21.4 %). Conclusions GI endoscopists are inaccurate in self-assessment of their endoscopic competency. Subgroup analyses demonstrated that novice and intermediate endoscopists were inaccurate, while expert endoscopists have accurate self-assessment. While we advise against the sole use of self-assessment among novice and intermediate endoscopists, expert endoscopists may wish to integrate it into their practice.

Background Clinical practice guidelines are evidence-based resources designed to inform clinical decision making. Often, superior evidence will support the inclusion of novel procedures and practices to replace older recommendations. Recommendation reversals occur when (a) superior quality evidence emerges to suggest the harm or non-beneficence of prior recommendations, and (b) that recommendation is not supplanted by a newer one. Aims The primary objective of this study was to describe the content, frequency and rationale for recommendation reversals in CPGs published by gastroenterological societies. Methods For this meta-epidemiologic study, we considered two criteria to define a recommendation reversal: (a) the more recent CPG makes a recommendation that contradicts a previously accepted practice; and (b) the prior recommendation is not replaced by any novel intervention. We searched CPGs published by 20 major GI societies from 1991- 2019. Guidelines were included if had at least two iterations with the same title and used a valid evidence rating system (such as GRADE). Explicit recommendations which reported definite levels of evidence and strength of recommendation were extracted. Results We identified 1022 clinical guidelines from GI societies over 28 years. 292 CPGs were included for data synthesis. 5985 explicit statements were extracted. 12 reversals were confirmed and are summarized in the Table. Six reversals (50.0%) occurred due to studies reporting non-beneficence and 3 (25.0%) occrred due to studies reporting harm. Three recommendations (25.0%) were reversed due to new clinical trials; 3 (25.0%) due to systematic reviews or meta-analyses; and 2 to conform with CPGs of other societies (16.7%). Conclusions We describe recommendation reversals made in gastroenterology CPGs, and the reasons thereof. Investigation of recommendation reversals allows for the identification of low-value medical practices. This reinforces the need for GI CPG committees to (1) iteratively review guidelines to re-evaluate recommendations made on low-quality evidence and; (2) refrain from making recommendations when evidence for the same is weak. Funding Agencies None

Background Assessment tools are essential for endoscopy training, being required to support feedback provision, optimize learner capabilities, and document competence. We aimed to evaluate the strength of validity evidence that supports the available colonoscopy direct observation assessment tools using the unified framework of validity. Methods We systematically searched five databases for studies investigating colonoscopy direct observation assessment tools from inception until 8 April 2020. We extracted data outlining validity evidence (content, response process, internal structure, relations to other variables, and consequences) from the five sources and graded the degree of evidence, with a maximum score of 15. We assessed educational utility using an Accreditation Council for Graduate Medical Education framework and methodological quality using the Medical Education Research Quality Instrument (MERSQI). Results From 10 841 records, we identified 27 studies representing 13 assessment tools (10 adult, 2 pediatric, 1 both). All tools assessed technical skills, while 10 each assessed cognitive and integrative skills. Validity evidence scores ranged from 1–15. The Assessment of Competency in Endoscopy (ACE) tool, the Direct Observation of Procedural Skills (DOPS) tool, and the Gastrointestinal Endoscopy Competency Assessment Tool (GiECAT) had the strongest validity evidence, with scores of 13, 15, and 14, respectively. Most tools were easy to use and interpret, and required minimal resources. MERSQI scores ranged from 9.5–11.5 (maximum score 14.5). Conclusions The ACE, DOPS, and GiECAT have strong validity evidence compared with other assessments. Future studies should identify barriers to widespread implementation and report on the use of these tools in credentialing examinations.

Conflicts of interest (COIs) in healthcare are increasingly discussed in the literature, yet these relationships continue to influence healthcare. Research has consistently shown that financial COIs shape prescribing practices, medical education and guideline recommendations. In 2009, the Institute of Medicine (IOM, now the National Academy of Medicine) published Conflicts of Interest in Medical Research, Practice, and Education—one of the most comprehensive reviews of empirical research on COIs in medicine. Ten years after publication of theIOM’s report, we review the current state of COIs within medicine. We also provide specific recommendations for enhancing scientific integrity in medical research, practice, education and editorial practices.

Changes to endoscopy service availability during the COVID-19 pandemic may have affected management of upper gastrointestinal bleeding (UGIB). The aim of this study was to describe the impact of the pandemic on UGIB outcomes in the Toronto area in Canada.We described all adults admitted to general medicine wards or intensive care units at six hospitals in Toronto and Mississauga, Canada, with UGIB during the first wave of the COVID-19 pandemic (March 1 to June 30, 2020) and compared them with a historical cohort (March 1 to June 30, 2018 and 2019). We compared clinical outcomes (in-hospital mortality, length of stay, 30-day readmission, intensive care utilization, receipt of endoscopy, persistent bleeding, receipt of second endoscopy, and need for angiographic or surgical intervention) using multivariable regression models, controlling for demographics, comorbidities, and severity of clinical presentation.There were 82.5 and 215.5 admissions per month for UGIB during the COVID-19 and control periods, respectively. There were no baseline differences between groups for demographic characteristics, comorbidities, or severity of bleeding. Patients in the COVID-19 group did not have significantly different unadjusted (3.9% vs 4.2%, P = 0.983) or adjusted mortality (adjusted odds ratio [OR] = 0.64, 95% confidence interval [CI] = 0.25-1.48, P = 0.322). Patients in COVID-19 group were less likely to receive endoscopy for UGIB in the unadjusted (61.8% vs 71.0%, P = 0.003) and adjusted (adjusted OR = 0.64, 95% CI = 0.49-0.84, P0.01) models. There were no differences between groups for other secondary outcomes.While patients admitted for UGIB during the first wave of the pandemic were less likely to receive endoscopy, this had no impact on mortality or any secondary outcomes.

Background An increasing focus on quality and safety in colonoscopy has led to broader implementation of competency-based educational systems that enable documentation of trainees’ achievement of the knowledge, skills, and attitudes needed for independent practice. The meaningful assessment of competence in colonoscopy is critical to this process. While there are many published tools that assess competence in performing colonoscopy, there is a wide range of underlying validity evidence. Tools with strong evidence of validity are required to support feedback provision, optimize learner capabilities, and document competence. Aims We aimed to evaluate the strength of validity evidence that supports available colonoscopy direct observation assessment tools using the unified framework of validity. Methods We systematically searched five databases for studies investigating colonoscopy direct observation assessment tools from inception until April 8, 2020. We extracted data outlining validity evidence from the five sources (content, response process, internal structure, relations to other variables, and consequences) and graded the degree of evidence, with a maximum score of 15. We assessed educational utility using an Accreditation Council for Graduate Medical Education framework and methodological quality using the Medical Education Research Quality Instrument (MERSQI). Results From 10,841 records, we identified 27 studies representing 13 assessment tools (10 adult, 2 pediatric, 1 both). All tools assessed technical skills, while 10 assessed cognitive and integrative skills. Validity evidence scores ranged from 1–15. The Assessment of Competency in Endoscopy (ACE) tool, the Direct Observation of Procedural Skills (DOPS) tool, and the Gastrointestinal Endoscopy Competency Assessment Tool (GiECAT) had the strongest validity evidence, with scores of 13, 15, and 14, respectively. Most tools were easy to use and interpret and required minimal resources. MERSQI scores ranged from 9.5–11.5 (maximum score 14.5). Conclusions The ACE, DOPS, and GiECAT have strong validity evidence compared to other assessments. Future studies should identify barriers to widespread implementation and report on use of these tools in credentialing purposes. Funding Agencies None

Background Editorial self-publication refers to the practice wherein editors publish research in journals to which they serve as editorial board members. The International Committee of Medical Journal Editors (ICMJE) has detailed recommendations against the practice of self-publication. There is evidence to suggest that editorial board membership may influence the decision to publish academic papers, which may contribute to publication bias. Despite this, there have been few attempts to characterize this practice in gastroenterology journals. Aims To determine the prevalence of original gastroenterology research articles published by editorial board members in their own journal. Methods We conducted a cross-sectional study to determine the prevalence of editorial board members publishing within their own journals. A list of the top 25 highest impact factor gastroenterology journals was created through InCites Journal reports. Journals were screened to determine eligibility based on whether their primary focus included gastroenterology research and whether archives with the names and affiliations of editorial board members were available. 10 journals were selected based on these criteria. For each journal, we extracted all original research articles published in 2019 using Web of Science (Clarivate Analytics ©). Articles classified as editorial material, meeting abstracts, reviews, and clinical practice guidelines were excluded. We cross-referenced the affiliations of all authors found in each publication with affiliations of editors disclosed on the journal website. For each editorial board member, we determined the number of publications within their own journal. Results We identified 844 editorial board members in the 10 journals included. Overall, 337 (39.9%) of the editors had a publication in their own journal, of which, 152 (18.0%) had more than one publication. Across all journals, the median number of editors with self-publication is 27 (IQR=20.3–49.8). The median number of editors with more than one self-publication is 16 (IQR=10.0–25.3). In total, 507 (60.1%) of all editors had no publications within their respective journals. Conclusions Despite recommendations against this practice, our results show a high number of research publications authored by editorial board members. These results demonstrate a potential risk for publication bias. However, this study was limited by the inability to investigate beyond the prevalence of self-publication. Furthermore, the explicit implications of our results remain unclear. Further research is required to evaluate factors such as disclosures and the review process associated with increased rates of self-publication as well as its impact on publication bias. Funding Agencies None

Background Upper gastrointestinal (GI) endoscopic procedures are aerosol-generating, increasing the risk of healthcare workers (HCW) contracting Coronavirus disease 2019 (COVID-19). Aims To present a polycarbonate box (EndoBox) designed for use in upper GI endoscopy and evaluate its impact on the contamination of endoscopy staff during simulated procedures. Methods Simulated gastroscopies were performed using an upper body simulator placed in left lateral decubitus (LLD) and supine positions. The endoscopist and assistant wore personal protective equipment. Droplet exposure was measured using fluorescent abiotic surrogate particles. Two blinded observers independently viewed images from each scenario to qualitatively evaluate contamination levels. The primary outcome was the level of HCW contamination by droplets generated from a simulated cough with and without the EndoBox on the upper body simulator. The endoscopist’s ergonomic behaviour was also assessed using the Rapid Upper Limb Assessment (RULA) tool. Results Without the EndoBox, there was a higher level of contamination on the endoscopist when the upper body simulator is in the LLD position. A higher level of contamination was observed on the assistant when the simulator is in supine position. With the EndoBox, the contamination levels on the endoscopy staff were lower in both LLD and supine scenarios. The endoscopist’s ergonomics were rated 2 to 3 on the RULA tool when using the EndoBox. Conclusions The EndoBox reduces macroscopic droplet contamination during simulated gastroscopy. The endoscopist’s risk of musculoskeletal injury remained in the low risk categories as assessed by the RULA tool. Another advantage of the EndoBox design is the arch extending from the bottom that allows for removal of the box without withdrawing the endoscope. This enables rapid access to the patient’s airway if they experience respiratory distress. This study was limited by an inability to assess microscopic contamination and contamination at the level of the port or buttons when suction is applied. Within these limitations, the EndoBox may be a useful adjunct to traditional personal protective equipment. Funding Agencies SMHA AFP COVID-Related Innovation Funds

Background Endoscopy programs are increasingly integrating simulation training. We conducted a systematic review to determine whether virtual reality (VR) simulation training can supplement and/or replace conventional patient-based endoscopy training for health professional trainees with limited or no prior endoscopic experience. Methods We searched medical, educational, and computer literature databases in July 2017 for trials that compared VR simulation training with no training, conventional training, another form of simulation training, or an alternative method of VR training. We screened, abstracted data, and performed quantitative analysis and quality assessment through Cochrane methodology. Results We included 18 trials with 3817 endoscopic procedures. VR training provided no advantage over no training or conventional training based on the primary outcome of composite score of competency. VR training was advantageous over no training based on independent procedure completion (relative risk [RR] = 1.62, 95 % confidence interval [CI] 1.15 – 2.26, moderate-quality evidence), overall rating of performance (mean difference [MD] 0.45, 95 %CI 0.15 – 0.75, very low-quality evidence), and mucosal visualization (MD 0.60, 95 %CI 0.20 – 1.00, very low-quality evidence). Compared with conventional training, VR training resulted in fewer independent procedure completions (RR = 0.45, 95 %CI 0.27 – 0.74, low-quality evidence). We found no differences between VR training and no training or conventional training for other outcomes. Based on qualitative analysis, we found no significant differences between VR training and other forms of simulation training. VR curricula based in educational theory provided benefit with respect to composite score of competency, compared with unstructured curricula. Conclusions VR simulation training is advantageous over no training and can supplement conventional endoscopy training. There is insufficient evidence that simulation training provides benefit over conventional training.

In gastrointestinal endoscopy, simulation-based training can help endoscopists acquire new skills and accelerate the learning curve. Simulation creates an ideal environment for trainees, where they can practice specific skills, perform cases at their own pace, and make mistakes with no risk to patients. Educators also benefit from the use of simulators, as they can structure training according to learner needs and focus solely on the trainee. Not all simulation-based training, however, is effective. To maximize benefits from this instructional modality, educators must be conscious of learners’ needs, the potential benefits of training, and associated costs. Simulation should be integrated into training in a manner that is grounded in educational theory and empirical data. In this review, we focus on four best practices in simulation-based education: deliberate practice with mastery learning, feedback and debriefing, contextual learning, and innovative educational strategies. For each topic, we provide definitions, supporting evidence, and practical tips for implementation.

Assessment is critical to support pediatric endoscopy training. Although trainee engagement in assessment is encouraged, the use of self-assessment and its accuracy among pediatric endoscopists is not well described. We aimed to determine the self-assessment accuracy of novice, intermediate, and experienced pediatric endoscopists.Novice (performed50 previous colonoscopies), intermediate (50-500), and experienced (1000) pediatric endoscopists from 3 North American academic teaching hospitals each performed a clinical colonoscopy. Endoscopists were assessed in real-time by 2 experienced endoscopists using the Gastrointestinal Endoscopy Competency Assessment Tool for Pediatric Colonoscopy (GiECATKIDS). In addition, participants self-assessed their performance using the same instrument. Self-assessment accuracy between the externally assessed and self-assessed scores was evaluated using absolute difference scores, intraclass correlation coefficients, and Bland-Altman analyses.Forty-seven endoscopists participated (21 novices, 16 intermediates, and 10 experienced). Overall, there was moderate agreement of externally assessed and self-assessed GiECATKIDS total scores with an intraclass correlation coefficient of 0.72 (95% confidence interval, 0.55-0.83). The absolute difference scores among the 3 groups were significantly different (P = 0.005), with experienced endoscopists demonstrating a more accurate self-assessment compared to novices (P = 0.003). Bland-Altman plots revealed that novice endoscopists' self-assessed scores tended to be higher than their externally assessed scores, indicating they overestimated their performance.We found that endoscopic experience was positively associated with self-assessment accuracy among pediatric endoscopists. Novices were inaccurate in assessing their endoscopic competence and were prone to overestimation of their performances. Our findings suggest novices may benefit from targeted interventions aimed at improving their insight and self-awareness.

Background Gastrointestinal (GI) symptoms are common among patients with common variable immunodeficiency disorder (CVID) yet remain poorly understood. Aims The aim of this study was to characterize the demographic, clinical, endoscopic and histologic features of patients with CVID and GI symptoms. Methods We conducted a retrospective observational study of all patients with CVID at a large Canadian tertiary care centre between January 2000 and May 2018. Results We included 95 patients with CVID. The mean age of patients at the time of CVID diagnosis was 38.2(±16.0). Fifty-three (56%) patients were female. Sixty-four (67%) patients had GI symptoms, with a mean age of onset for GI symptoms of 43.4(±15.1) years. The most common symptoms were bowel movement changes (n = 55 [58%]) and abdominal pain (n = 44 [46%]). Patients with GI symptoms were more likely to have anemia (n = 23 [36%] versus n = 3 [10%], P = 0.0129), iron deficiency (n = 16 [25%] versus n = 2 [7%], P = 0.0481), and have received GI antibiotics (n = 37 [58%] versus n = 0, P < 0.0001) and proton pump inhibitors for reflux (n = 24 [38%] versus n = 3 [10%], P = 0.0067). The most common GI infections were Giardia lamblia (n = 14 [15%]) and Clostridium difficile (n = 4 [4%]). Forty-three (45%) patients with GI symptoms underwent colonoscopy, esophagogastroduodenoscopy or both. The most common findings were inflammation, nodular lymphoid hyperplasia, reduced plasma cells and increased intraepithelial lymphocytes. Conclusions This is the largest study on CVID patients in a North American setting. The majority of patients experienced GI symptoms. Future studies should study response to treatment for GI disease among patients with CVID.

Background Recommendations in clinical practice guidelines (CPGs) may be reversed when evidence emerges to show they are futile or unsafe. In this study, we identified and characterized recommendation reversals in gastroenterology CPGs. Methods We searched CPGs published by 20 gastroenterology societies from January 1990 to December 2019. We included guidelines which had at least two iterations of the same topic. We defined reversals as when (a) the more recent iteration of a CPG recommends against a specific practice that was previously recommend in an earlier iteration of a CPG from the same body, and (b) the recommendation in the previous iteration of the CPG is not replaced by a new diagnostic or therapeutic recommendation in the more recent iteration of the CPG. The primary outcome was the number of recommendation reversals. Secondary outcomes included the strength of recommendations and quality of evidence cited for reversals. Results Twenty societies published 1022 CPGs from 1990 to 2019. Our sample for analysis included 129 unique CPGs. There were 11 recommendation reversals from 10 guidelines. New evidence was presented for 10 recommendation reversals. Meta-analyses were cited for two reversals, and randomized controlled trials (RCTs) for seven reversals. Recommendations were stronger after the reversal for three cases, weaker in two cases, and of similar strength in three cases. We were unable to compare recommendation strengths for three reversals. Conclusion Recommendation reversals in gastroenterology CPGs are uncommon but highlight low value or harmful practices.

BACKGROUND: The quality of case reports, which are often the first reported evidence for a disease, may be negatively affected by a rush to publication early in a pandemic. We aimed to determine the completeness of reporting (COR) for case reports published on coronavirus disease 2019 (COVID-19). METHODS: We conducted a systematic search of the PubMed database for all single-patient case reports of confirmed COVID-19 published from Jan. 1 to Apr. 24, 2020. All included case reports were assessed for adherence to the CARE (Case Report) 31-item checklist, which was used to create a composite COR score. The primary outcome was the mean COR score assessed by 2 independent raters. Secondary outcomes included whether there was a change in overall COR score with certain publication factors (e.g., publication date) and whether there was a linear relation between COR and citation count and between COR scores and social media attention. RESULTS: Our search identified 196 studies that were published in 114 unique journals. We found that the overall mean COR score was 54.4%. No one case report included all of the 31 CARE checklist items. There was no significant correlation between COR with either citation count or social media attention. INTERPRETATION: We found that the overall COR for case reports on COVID-19 was poor. We suggest that journals adopt common case-reporting standards to improve reporting quality.

Background Inflammatory Bowel Disease (IBD) studies have commonly relied on real-world evidence to evaluate different therapies. An emerging idea has been the use of propensity score matching as a statistical method to account for baseline characteristics in IBD patients. In retrospective studies, propensity score matching of patients helps reduce treatment assignment bias and mimic the effects of randomization. Recently, propensity-score matching has become an important tool in IBD studies comparing biologic therapeutics. Biologic medications are among the highest-grossing drugs worldwide, and their pharmaceutical producers make considerable payments to physicians to market them. In spite of this, there is a lack of evidence examining the role of undue industry influence among propensity-score matched comparative studies evaluating biologic therapeutics for IBD. Aims Given the documented association between IBD biologics and FCOI, we hypothesize a high burden of FCOI in propensity-score matched studies. The aim of this study was to evaluate the prevalence of disclosed & undisclosed financial conflicts of Interest (FCOI) in propensity-score matched comparison studies evaluating biologics for IBD. Methods We developed & ran a librarian-reviewed systematic search on EMBASE, MEDLINE, and Cochrane Library databases for all propensity-score matched retrospective studies comparing biologics for the treatment of IBD. Full-text retrieval & screening was performed on all studies in duplicate. 16 articles were identified. Industry payments to authors were only considered FCOI if they were made by a company producing a biologic that was included in the comparison study. Disclosed FCOI were identified by authors’ interests disclosures in full-texts. Any undisclosed FCOI among US authors were identified using the Centre for Medicare and Medicaid Services (CMS) Open Payments Database, which collects industry payments to physicians. Results Based on a preliminary analysis of 16 studies, there was at least one author with a relevant FCOI in 14 (88%) of the 16 studies. 14 studies (88%) had at least one disclosed FCOI, while 6 studies (37.5%) had at least one undisclosed FCOI. Among studies with disclosed FCOI, a mean of 40.2% (SD = 23.4%) of authors/study reported FCOI. Among studies with undisclosed FCOI, a mean of 18.8% (SD = 7.0%) of authors/study reported FCOI. The total dollar value of FCOIs was $1,974,328.3. The median conflict dollar value was $5,576.6 (IQR: $321.6 to $36,394.9). Conclusions We found a high burden of undisclosed FCOI (37.5%) among authors of propensity-score matched studies evaluating IBD biologics. Given the potential for undue industry influence stemming from such payments, authors should ensure better transparency with industry relationships. Funding Agencies None

Background Financial conflicts of interest (FCOIs) are widespread in inflammatory bowel disease (IBD) and may be particularly important in point-of-care (POC) resources, such as UpToDate, that are used to aid clinical decision making. In this study, we determined the prevalence of industry payments from companies making biologic medications for IBD to contributors of UpToDate articles on IBD. Methods This cross-sectional analysis included UpToDate articles that mention the use of biologic medications for IBD. We collected the names of the contributors (authors and editors) and their disclosures on UpToDate. We then searched for their names on the Center for Medicare and Medicaid Open Payments database and compared the payment information from 2013 to 2018 with UpToDate's disclosures. We presented data per episode, which describes one instance of participation by one person in one article, regardless of whether that person contributed to multiple articles. Results We identified 23 articles on the treatment of Crohn's disease and ulcerative colitis that mentioned the use of biologic medications, with 86 total episodes. Sixty-two (72%) episodes involved FCOIs. The median payment associated with each episode was $$55 (interquartile range = $44 to $145,241). Contributors did not fully disclose FCOIs in 41 (48%) episodes. Deputy editors, who are required to be free of FCOIs, in general did not have substantial episodes involving FCOI. Conclusions We found that UpToDate articles on inflammatory bowel disease involve substantial FCOI, many of which are not disclosed. The presence of these FCOIs may hamper trust in the objectivity of treatment recommendations.

Background Since 2008, the Canadian Institutes of Health Research (CIHR) has mandated that studies it funds either in whole or in part are required to publish their results as open access (OA) within 12 months of publication using either online repositories and/or OA journals. Yet, there is evidence that authors are poorly compliant with this mandate. Specifically, there has been an apparent decrease in OA publication after 2015, which coincides with a change in the OA policy during the same year. One particular policy change that may have contributed to this decline was lifting the requirement that authors deposit their article in an OA repository immediately upon publication. We investigated the proportion of OA compliance of CIHR-funded studies in the period before and after the policy change of 2015 with manual confirmation of both CIHR funding and OA status. Methods and findings We identified CIHR-funded studies published between the years 2014 to 2017 using a comprehensive search in the Web of Science (WoS). We took a stratified random sample from all four years (i.e. 2014 to 2017), with 250 studies from each year. Two authors independently reviewed the final full-text publications retrieved from the journal web page to determine to confirm CIHR funding, as indicated in the acknowledgements or elsewhere in the paper. For each study, we also collected bibliometric data that included citation count and Altmetric attention score Statistical analyses were conducted using two-tailed Fisher’s exact test with relative risk (RR). Among the 851 receiving CIHR funding published from 2014 to 2017, the percentage of CIHR-funded studies published as OA significantly decreased from 79.6% in 2014 to 70.3% in 2017 (RR = 0.88, 95% CI: 0.79–0.99, P = 0.028). When considering all four years, there was no significant difference in the percentage of CIHR-funded studies published as OA in both 2014 and 2015 compared to both 2016 and 2017 (RR = 0.97, 95% CI: 0.90–1.05, P = 0.493). Additionally, OA publications had significantly higher citation count (both in year of publication and in total) and higher attention scores (P Conclusions Overall, we found that there was a significant decrease in the proportion of CIHR funded studies published as OA from 2014 compared to 2017, though this difference did not persist when comparing both 2014–2015 to 2016–2017. The primary limitation was the reliance of self-reported data from authors on CIHR funding status. We posit that this decrease may be attributable to CIHR’s OA policy change in 2015. Further exploration is warranted to both validate these studies using a larger dataset and, if valid, investigate the effects of potential interventions to improve the OA compliance, such as use of a CIHR publication database, and reinstatement of a policy for authors to immediately submit their findings to OA repositories upon publication.

Background and study aim Endoscopic ultrasound (EUS) enables diagnostic evaluation and therapeutic interventions but is associated with adverse events. We conducted a population-based cohort study to determine the risk of adverse events for upper and lower EUS with and without fine-needle aspiration (FNA). Patients and methods All adults who underwent EUS and resided in Calgary in 2007–2013 were included. Endoscopy and provincial databases were used to identify EUS procedures, unplanned emergency department visits, and hospital admissions within 30 days of the procedures, which were then characterized through formal chart review. Adverse events were defined a priori and classified as definitely, possibly, or not related to EUS. The primary outcome was 30-day risk of adverse events classified as definitely or possibly related to EUS. Univariable and multivariable analyses were conducted with risk factors known to be associated with EUS adverse events. Results 2895 patients underwent 3552 EUS procedures: 3034 (85 %) upper EUS, of which 710 (23 %) included FNA, and 518 (15 %) lower EUS, of which 23 (4 %) involved FNA. Overall, 69 procedures (2 %) involved an adverse event that was either definitely or possibly related to EUS, with 33 (1 %) requiring hospitalization. None of the adverse events required intensive care or resulted in death. On multivariable analysis, only FNA was associated with increased risk of adverse events (odds ratio 6.43, 95 % confidence interval 3.92–10.55; P Conclusion Upper and lower EUS were generally safe but FNA substantially increased the risk of adverse events. EUS-related complications requiring hospitalization were rare.