Search

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 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 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 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 The coronavirus disease 2019 (COVID-19) pandemic has impacted endoscopy services and education worldwide. This study aimed to characterize the impact of COVID-19 on gastroenterology trainees in Canada. Methods An analysis of Canadian respondents from the international EndoTrain survey, open from April 11 to May 2 2020 and distributed by program directors, trainees, and national and international gastroenterology societies’ representatives, was completed. The survey included questions on monthly endoscopy volume, personal protective equipment availability, trainee well-being and educational resources. The primary outcome was change in procedural volume during the COVID-19 pandemic. Secondary outcomes included trainee’s professional and personal concerns, anxiety and burnout. Results Thirty-four Canadian trainees completed the survey. Per month, participants completed a median of 30 esophagogastroduodenoscopies (interquartile range 16 to 50) prior to the pandemic compared to 2 (0 to 10) during the pandemic, 20 (8 to 30) compared to 2 (0 to 5) colonoscopies and 3 (1 to 10) compared to 0 (0 to 3) upper gastrointestinal bleeding procedures. There was a significant decrease in procedural volumes between the pre-COVID-19 and COVID-19 time periods for all procedures (P < 0.001). Thirty (88%) trainees were concerned about personal COVID-19 exposure, 32 (94%) were concerned about achieving and/or maintaining clinical competence and 24 (71%) were concerned about prolongation of training time due to the pandemic. Twenty-six (79%) respondents experienced some degree of anxiety, and 10 (31%) experienced some degree of burnout. Conclusion The COVID-19 pandemic has substantially impacted gastroenterology trainees in Canada. As the pandemic eases, it important for gastrointestinal programs to adapt to maximize resident learning, maintain effective clinical care and ensure development of endoscopic competence.

BACKGROUND Industry payments can lead to financial conflicts of interest (FCOI) among authors of clinical practice guidelines (CPGs). Guidelines for inflammatory bowel disease (IBD) may be at particularly high risk. We determined the prevalence of FCOI in IBD CPGs produced by various gastroenterology societies. METHODS We conducted a cross-sectional analysis of FCOI disclosure among CPGs related to the management of IBD. We ascertained the prevalence and types of FCOI for each guideline and determined adherence to National Academy of Medicine (NAM) standards. FCOI disclosures were compared between societies producing CPGs. RESULTS We identified 11 relevant CPGs with 173 total authors. There were 117 (68%) authors who declared a payment. A total of 107 (62%) authors declared FCOI related to a medication recommended in the guideline. There was a significant difference (P < 0.001) between the proportion of authors with FCOI between countries or regions. Authors of US CPGs had a significantly lower FCOI prevalence (19%) compared with other societies. Authors of UK CPGs had a significantly lower FCOI prevalence (56%) compared with Canadian (84%) and European (94%) CPGs. Three (27%) guidelines adhered to both NAM standards. CONCLUSIONS A substantial portion of authors of IBD CPGs had FCOI. Our study found a significant difference in FCOI prevalence based on CPG sponsor nationality. Most CPGs for IBD did not adhere to NAM standards for FCOI disclosure.

Background Outcome switching is a well-described form of inconsistent reporting in randomized clinical trials (RCTs), wherein pre-specified primary and/or secondary outcomes are changed between trial registration and the publication of results without explanation. This is of particular concern, as the selective publication of results that are favorable will insert bias into the trial’s results and may cast doubt on the veracity of its findings. While it has been investigated in other disciplines, the prevalence of outcome switching has yet to be described among RCTs for inflammatory bowel disease (IBD). Aims To determine the prevalence of correctly reported pre-specified primary and secondary outcomes in published phase 3 interventional RCTs for IBD. Methods We identified all phase 3 interventional trials for IBD with published results using clinicaltrials.gov. We included all results with an associated publication that detailed the results of the trial. We excluded registrations if: only an abstract of the results was available; trial results were only published as a pooled analysis; multiple trial segments were reported collectively; or a publication of the results could not be identified through clinicaltrials.gov or a custom search. Two reviewers extracted all pre-specified primary and secondary outcomes for each trial using the clinical trial registration page that was dated before the commencement of the trial. These outcomes were compared to the outcomes reported in the corresponding journal articles. Any discrepancies were noted, and additional outcomes were extracted. Results We identified a total of 88 phase 3 interventional RCTs for IBD, of which 57 were matched to independent publications of their results. All trials pre-specified a primary outcome, and 50 (87.7%) pre-specified secondary outcomes. 10 (17.5%) of trials did not report some or all primary outcomes, and 19 (33.3%) trials had a change or alteration to the primary outcome. Of the trials that pre-specified secondary outcomes, 16 (28.1%) did not report all pre-specified secondary outcomes. 49 (86.0%) trials added 6 (IQR: 2–8) unspecified secondary outcomes on average. Conclusions Many phase 3 interventional RCTs in IBD either did not report some or all primary outcomes, or altered the primary outcome. Trials routinely reported additional outcomes that were not pre-specified and failed to note that they were added post hoc. Based on these results, we recommend improvements in the reporting of pre-specified outcomes and higher fidelity in order to maintain confidence in trial results. Funding Agencies None

Background Ghost-authorship involves the exclusion of individuals who have made substantial contributions to the article from the author byline. Previous studies have found that ghost-authorship is highly prevalent in industry-sponsored clinical trials. Its prevalence, however, has yet to be investigated in trials of biologics in the management of inflammatory bowel disease (IBD). Aims To determine the prevalence of ghost-authorship in IBD biologic industry-sponsored clinical randomized controlled trials (RCTs). Methods Biologic medications indicated for ulcerative colitis (UC) or for Crohn’s disease (CD) were identified using the Food and Drug Agency (FDA) database. We identified the clinical trials on clinicaltrials.gov corresponding to the data presented at the time of FDA approval. Specifically, we included the first publication for each trial to report study results for our analysis. Two authors independently identified the presence of ghost-authorship, which we defined as the exclusion on the author byline of the included RCT publication of any individuals who assisted in the writing of the trial manuscript and/or performed the data analyses. Results We identified a total of 28 relevant RCTs on biologic medications (10 for UC and 18 for CD), which were matched to 20 publications. We found ghost-authorship in 70% of publications (n=14); 40% (n=8) involved manuscript and protocol writing assistance from sponsor staff; 35% (n=7) involved medical writers from external companies; 15% (n=3) involved both sponsor staff and medical writers assisting in manuscript writing; and 20% (n=4) involved individuals performing data analysis or interpretation. Conclusions We found that ghost-authorship in industry-sponsored IBD biologic clinical trials has a moderately high prevalence, with the most common being manuscript or protocol writing assistance. A lack of transparency regarding sponsor-affiliated and/or external contributors may negatively affect the trust placed in medical research. One limitation is that data was only extracted from publications. Further evidence on ghost-authorship may be found in study protocols and registrations, which will be investigated in the future. Funding Agencies None

BACKGROUND: Patients with common variable immunodeficiency (CVID) disorder are reported to have a significant burden of infectious and inflammatory gastrointestinal (GI) diseases. Currently, the clinical, endoscopic, and histopathologic characteristics of GI disease among CVID patients is not well described. AIMS: This study aims to characterize the clinical, endoscopic, and histopathologic profile of GI pathology in a large cohort of CVID patients from a tertiary care centre. METHODS: We included all CVID patients at St. Michael’s Hospital from January 1, 2000 to May 31, 2018. For each patient, we collected the age of CVID diagnosis, and age of onset of gastrointestinal symptoms. We collected the following clinical data at the time of onset of gastrointestinal symptoms: presence of abdominal pain, bowel movement changes, weight loss, nausea/vomiting, and bloating, history of gastrointestinal disease such as IBD or coeliac disease, treatments offered for GI symptoms, and gastrointestinal infections. We also collected endoscopic, histopathologic, and laboratory data, including immunoglobulin trough levels, at the date nearest to the onset of gastrointestinal symptoms, within three months. We used descriptive statistics to characterize patients with CVID, and compared patients with and without gastrointestinal symptoms using non-parametric tests for continuous variables and Fisher’s exact test for categorical variables. 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 anaemia (n=23 [36%] vs. n=3 [10%], p

BACKGROUND: Simulation-based training (SBT) curricula for training novices in gastrointestinal (GI) endoscopy have been shown to be effective. Gamification, the application of principles from games such as competition and rewards, has been used to enhance procedural learning in healthcare. There are no known applications of gamification for training of GI endoscopy, however. AIMS: To evaluate a SBT curriculum using gamification for novice endoscopists on the performance of simulated colonoscopies, compared to a conventional SBT curriculum. METHODS: Twenty-one novice endoscopists (completed 0.05). For the CLIC, there was a significant difference between the two groups immediately after training for intrinsic load, as the GIC demonstrated a significantly lower load (P=0.04). There were no other significant differences between the two groups for cognitive load. CONCLUSIONS: We found that a SBT curriculum using gamification for colonoscopy was associated with a significantly lower intrinsic load after training. A lower instrinsic load indicates that participants in the GIC group found that the task of colonoscopy was not as difficult as their counterparts in the CTC group. Although we did not find a difference with respect to colonoscopic performance, these findings represent an interim analysis. The completion of this study will likely yield important insight into further improvements of endoscopic training. FUNDING AGENCIES: None