Patient and Public Involvement in Inflammatory Bowel Disease Research-A Scoping Review.

Background: Interest in patient and public involvement in research has grown. Medical, health, and social care research has demonstrated several benefits of patient and public engagement, such as empowering user input and reducing attrition rates in clinical trials. To date, no study has reviewed patient engagement in inflammatory bowel disease (IBD). We aimed to describe the benefits, challenges, and best practices of patient engagement in IBD research. Methods: We performed a systematic search on MEDLINE, EMBASE, and Cochrane for all clinical IBD research studies in which patients were involved in the research process (1946- 2023). Patient input was considered in: (1) study design, (2) study execution, (3) research dissemination, and/or (4) other domains not specified here. Two authors independently screened and extracted data on type of engaged person(s), format of engagement, author-reported benefits, recommendations, and challenges. For each study, we reported the level of patient engagement and study adherence to standardized reporting guidelines. Results: After screening 9,355 articles, we included 51 for final analysis. IBD patients were most frequently engaged in study design. Patient engagement in IBD research improved recruitment rates and promoted the creation of user-friendly quality-of-life tools. Selection bias and recruitment difficulties were common challenges in the application of patient engagement. Authors recommended continuous patient involvement to address emerging priorities and cognitive interviewing to improve questionnaire clarity. Conclusions: Patient engagement represents an important step in promoting patient-centred care. According to study authors, implementing cognitive interviewing techniques, continuous patient involvement, and standardized reporting guidelines may improve future iterations of engagement in IBD.

Relative Efficacies of Interventions to Improve the Quality of Screening-Related Colonoscopy: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.

BACKGROUND & AIMS: Significant variability exists in colonoscopy quality indicators, including adenoma detection rate (ADR). We synthesized evidence from randomized trials in a network meta-analysis on interventions to improve colonoscopy quality. METHODS: We included trials from database inceptions to September 25, 2023, of patients undergoing screening-related colonoscopy and presented efficacies of interventions within domains (periprocedural parameters, endoscopist-directed interventions, intraprocedural techniques, endoscopic technologies, distal attachment devices, and additive substances) compared to standard colonoscopy. The primary outcome was ADR. We used a Bayesian random-effects model using Markov-chain Monte Carlo simulation, with 10,000 burn-ins and 100,000 iterations. We calculated odds ratios with 95% credible intervals and present surface under the cumulative ranking (SUCRA) curves. RESULTS: We included 124 trials evaluating 37 interventions for the primary outcome. Nine interventions resulted in statistically significant improvements in ADR compared to standard colonoscopy (9-minute withdrawal time, dual observation, water exchange, iScan, linked color imaging, computer-aided detection, Endocuff, Endocuff Vision, and oral methylene blue). Dual observation (SUCRA, 0.84) and water exchange (SUCRA, 0.78) ranked highest among intraprocedural techniques; iScan (SUCRA, 0.95), linked color imaging (SUCRA, 0.85), and computer-aided detection (SUCRA, 0.78) among endoscopic technologies; WingCap (SUCRA, 0.87) and Endocuff (SUCRA, 0.85) among distal attachment devices and oral methylene blue (SUCRA, 0.94) among additive substances. No interventions improved detection of advanced adenomas, and only narrow-band imaging improved detection of serrated lesions (odds ratio, 2.94; 95% credible interval, 1.46-6.25). CONCLUSIONS: Several interventions are effective in improving adenoma detection and overall colonoscopy quality, many of which are cost-free. These results can inform endoscopists, unit managers, and endoscopy societies on relative efficacies.

Interobserver Reliability of the Paris Classification for Superficial Gastrointestinal Tract Neoplasms: A Systematic Review.

Background and study aims: The Paris classification characterizes the morphology of superficial gastrointestinal tract neoplasms. This system has been shown to predict the risk of submucosal invasion in certain subtypes of lesions. There is limited data that assesses its agreement amongst endoscopists. We performed a systematic review to summarize the available literature on the interobserver reliability (IOR) of the Paris classification. Methods: We conducted a search through December 2020 for studies reporting IOR of the Paris classification. Studies were included if they quantitatively evaluated the IOR of the Paris classification with at least five participating endoscopists. Two authors independently screened studies and abstracted data using an a priori-designed data collection form. Evaluation of study quality and risk of bias was performed using an adapted version of the Guidelines for Reporting Reliability and Agreement Studies. Results: Of the 1,541 studies retrieved, 5 were included in the review. All studies were observational cohort studies published between 2014 and 2020. The IOR of the Paris classification was moderate amongst all four studies evaluating colorectal neoplasms (range, κ = 0.42 to κ = 0.54) and substantial in one study that evaluated gastric neoplasms (κw = 0.65). An educational intervention was conducted by three studies with variable methodology and no significant change in IOR. Conclusions: IOR of the Paris classification is moderate for superficial colonic neoplasms. Further study is needed to determine the reliability of this system for superficial gastric lesions. Standardized training programs are required to investigate the impact of educational intervention on the Paris classification amongst endoscopists.

Global trends in training and credentialing guidelines for gastrointestinal endoscopy: a systematic review.

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.

Validity evidence for observational ERCP competency assessment tools: a systematic review.

BACKGROUND : Assessment of competence in endoscopic retrograde cholangiopancreatography (ERCP) is critical for supporting learning and documenting attainment of skill. Validity evidence supporting ERCP observational assessment tools has not been systematically evaluated. METHODS : We conducted a systematic search using electronic databases and hand-searching from inception until August 2021 for studies evaluating observational assessment tools of ERCP performance. We used a unified validity framework to characterize validity evidence from five sources: content, response process, internal structure, relations to other variables, and consequences. Each domain was assigned a score of 0-3 (maximum score 15). We assessed educational utility and methodological quality using the Accreditation Council for Graduate Medical Education framework and the Medical Education Research Quality Instrument, respectively. RESULTS : From 2769 records, we included 17 studies evaluating 7 assessment tools. Five tools were studied for clinical ERCP, one for simulated ERCP, and one for simulated and clinical ERCP. Validity evidence scores ranged from 2 to 12. The Bethesda ERCP Skills Assessment Tool (BESAT), ERCP Direct Observation of Procedural Skills Tool (ERCP DOPS), and The Endoscopic Ultrasound (EUS) and ERCP Skills Assessment Tool (TEESAT) had the strongest validity evidence, with scores of 10, 12, and 11, respectively. Regarding educational utility, most tools were easy to use and interpret, and required minimal additional resources. Overall methodological quality (maximum score 13.5) was strong, with scores ranging from 10 to 12.5. CONCLUSIONS : The BESAT, ERCP DOPS, and TEESAT had strong validity evidence compared with other assessments. Integrating tools into training may help drive learners' development and support competency decision making.

The Toronto Upper Gastrointestinal Cleaning Score: a prospective validation study.

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.

Accuracy of self-assessment in gastrointestinal endoscopy: a systematic review and meta-analysis.

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.

Interventions to improve the quality of screening-related colonoscopy: protocol for a systematic review and network meta-analysis of randomised controlled trials.

INTRODUCTION: Colonoscopy quality can vary depending on endoscopist-related factors. Quality indicators, such as adenoma detection rate (ADR), have been adopted to reduce variations in care. Several interventions aim to improve ADR, but these fall into several domains that have traditionally been difficult to compare. We will conduct a systematic review and network meta-analysis of randomised controlled trials evaluating the efficacies of interventions to improve colonoscopy quality and report our findings according to clinically relevant interventional domains. METHODS AND ANALYSIS: We will search MEDLINE (Ovid), PubMed, EMBASE, CINAHL, Web of Science, Scopus and Evidence-Based Medicine from inception to September 2022. Four reviewers will screen for eligibility and abstract data in parallel, with two accordant entries establishing agreement and with any discrepancies resolved by consensus. The primary outcome will be ADR. Two authors will independently conduct risk of bias assessments. The analyses of the network will be conducted under a Bayesian random-effects model using Markov-chain Monte-Carlo simulation, with 10 000 burn-ins and 100 000 iterations. We will calculate the ORs and corresponding 95% credible intervals of network estimates with a consistency model. We will report the impact of specific interventions within each domain against standard colonoscopy. We will perform a Bayesian random-effects pairwise meta-analysis to assess heterogeneity based on the I2 statistic. We will assess the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework for network meta-analyses. ETHICS AND DISSEMINATION: Our study does not require research ethics approval given the lack of patient-specific data being collected. The results will be disseminated at national and international gastroenterology conferences and peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42021291814.

Financial Conflicts of Interest in Propensity Score-Matched Studies Evaluating Biologics and Biosimilars for Inflammatory Bowel Disease.

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.

Educational interventions to improve ergonomics in gastrointestinal endoscopy: a systematic review.

Background and study aims Endoscopists are at high risk of musculoskeletal pain and injuries (MSPI). Recently, ergonomics has emerged as an area of interest to reduce and prevent the incidence of MSPI in endoscopy. The aim of this systematic review was to determine educational interventions using ergonomic strategies that target reduction of endoscopist MSPI from gastrointestinal endoscopy. Methods In December 2020, we conducted a systematic search in MEDLINE, EMBASE, PsycINFO, Web of Science, Scopus, the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews for articles published from inception to December 16, 2020. Studies were included if they investigated educational interventions aimed at changing knowledge and/or behaviors related to ergonomics in gastrointestinal endoscopy. After screening and full-text review, we extracted data on study design, participants, type of training, and assessment of primary outcomes. We evaluated study quality with the Medical Education Research Study Quality Instrument (MERSQI). Results Of the initial 575 records identified in the search, five met inclusion criteria for qualitative synthesis. We found that most studies (n = 4/5, 80 %) were single-arm interventional studies that were conducted in simulated and/or clinical settings. The most common types of interventions were didactic sessions and/or videos (n = 4/5, 80%). Two (40 %) studies used both standardized assessment studies and formal statistical analyses. The mean MERSQI score was 9.7. Conclusions There is emerging literature demonstrating the effectiveness of interventions to improve ergonomics in gastrointestinal endoscopy.

Recommendation Reversals in Gastroenterology Clinical Practice Guidelines.

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.

Outcomes for upper gastrointestinal bleeding during the first wave of the COVID-19 pandemic in the Toronto area.

BACKGROUND AND AIM: 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. METHODS: 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. RESULTS: 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, P < 0.01) models. There were no differences between groups for other secondary outcomes. CONCLUSIONS: 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.

Self-assessment of Competence in Endoscopy: Challenges and Insights.

BACKGROUND: Endoscopists use self-assessment to monitor the development and maintenance of their skills. The accuracy of these self-assessments, which reflects how closely one's own rating corresponds to an external rating, is unclear. METHODS: In this narrative review, we critically examine the current literature on self-assessment in gastrointestinal endoscopy with the aim of informing training and practice and identifying opportunities to improve the methodological rigor of future studies. RESULTS: In the seven included studies, the evidence regarding self-assessment accuracy was mixed. When stratified by experience level, however, novice endoscopists were least accurate in their self-assessments and tended to overestimate their performance. Studies examining the utility of video-based interventions using observation of expert benchmark performances show promise as a mechanism to improve self-assessment accuracy among novices. CONCLUSIONS: Based on the results of this review, we highlight problematic areas, identify opportunities to improve the methodological rigor of future studies on endoscopic self-assessment and outline potential avenues for further exploration.

Do authors of research funded by the Canadian Institutes of Health Research comply with its open access mandate?: A meta-epidemiologic study.

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<0.05). 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.

COVID-19 and Canadian Gastroenterology Trainees.

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.

Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings.

INTRODUCTION: The United States Food and Drug Administration (FDA) Gastrointestinal Drug Advisory Committee (GIDAC) is involved in gastrointestinal drug application reviews. Characteristics and conflicts of interest (COI) in GIDAC meetings are not well described. This study analyzed FDA GIDAC meetings and characteristics that predict recommendations. METHODS: In this cross-sectional study, all publicly available GIDAC meetings where proposed medications were voted on were included. Data were collected regarding indications, medication sponsor, primary efficacy studies, and voting member characteristics (e.g. committee membership, COI). Univariate analyses were conducted at per-meeting and per-vote levels to assess for predictors of committee recommendation and individual votes respectively. RESULTS: Thirty-four meetings with 476 individual votes from 1998-2018 were included. Twenty-three (68%) proposals were recommended for approval and 25 (74%) received FDA approval. Most proposals involved >1 primary study (n = 27, 79%). At least one voting member had a COI in 24 (71%) of 34 meetings. Twelve (35%) meetings had at least one sponsor COI. Among 476 individual votes, 74 (15.5%) involved a COI, with 33 (6.9%) sponsor COI. COI decreased significantly over time, with fewer COI in 2006-2010, 2011-2015, and 2016-2020 compared to 1996-2000 and 2001-2005 (p<0.01). There were no significant associations between pre-defined predictors, including COI, and committee level recommendations or individual votes (p>0.05 for all univariate analyses). CONCLUSIONS: The GIDAC reviewed 34 proposals from 1998-2018. The majority were recommended for approval and later approved by the FDA, highlighting the GIDAC's prominence in the regulatory process. COI are present among GIDAC panelists but decreasing over time and not associated with recommendations.

Financial Conflicts of Interest in Clinical Practice Guidelines: A Systematic Review.

OBJECTIVE: To systematically evaluate the prevalence of disclosed and undisclosed financial conflicts of interest (FCOI) among clinical practice guidelines (CPGs). METHODS: In this systematic review, we ascertained the prevalence and types of FCOI for CPGs from January 1, 1980, to March 3, 2019. The primary outcome was the prevalence of FCOI among authors of CPGs. FCOI disclosures were compared between medical subspecialties and societies producing CPGs. RESULTS: Among the 37 studies including 14,764 total guideline authors, 45% had at least one FCOI. The prevalence of FCOI per study ranged from 6% to 100%. More authors had FCOI involving general payments (39%) compared with research payments (29%). Oncology, neurology, and gastroenterology had the highest prevalence of FCOI compared with other medical specialties. Among the 8 studies that included the monetary values in US dollars of FCOI, average payments per author ranged from $578 to $242,300. Among the 10 studies that included data on undisclosed FCOI, 32% of authors had undisclosed industry payments. CONCLUSION: There are numerous FCOI among authors of CPGs, many of which are undisclosed. Our study found a significant difference in FCOI prevalence based on types of FCOI and CPG sponsor society. Additional research is required to quantify the implications of FCOI on clinical judgment and patient care.

Factors Associated with Poor Quality of Life in a Canadian Cohort of Patients with Inflammatory Bowel Disease: A Cross-sectional Study.

BACKGROUND: Health-related quality of life (QoL) is often adversely affected in patients with inflammatory bowel disease (IBD). We aimed to identify factors associated with poor QoL among Canadian patients with IBD in clinical remission. METHODS: We enrolled patients at a single academic tertiary care center with inactive IBD. All eligible patients completed a series of questionnaires that included questions on demographics, disease activity, anxiety, depression and the presence of irritable bowel syndrome (IBS) symptoms. Stool sample for fecal calprotectin (FC) was also collected to assess for subclinical inflammation. The primary outcome measure was QoL assessed by the short inflammatory bowel disease questionnaire (SIBDQ), with planned subgroup comparisons for fatigue, anxiety, depression and IBS symptoms. RESULTS: Ninety-three patients were eligible for inclusion in this study. The median SIBDQ scores were lower in patients with anxiety (P < 0.001), depression (P = 0.004), IBS symptoms (P < 0.001) and fatigue (P = 0.018). Elevated FC in patients in clinical remission did not impact QoL. These findings were consistent on multivariate linear regression. CONCLUSIONS: Anxiety, depression, fatigue and IBS symptoms are all independently associated with lower QoL in patients with inactive IBD. Clinicians are encouraged to screen for these important factors as they may detrimentally impact QoL in IBD patients even in clinical remission.

Completeness of reporting for COVID-19 case reports, January to April 2020: a meta-epidemiologic study.

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.

Conflicts of Interest in Inflammatory Bowel Disease Articles on UpToDate.

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.