Assessing the repercussions of COVID-19 pandemic on symptoms, disease management, and emotional well-being in patients with inflammatory bowel disease: a multi-site survey study.

BACKGROUND: Coronavirus disease 2019 (COVID-19) pandemic has created numerous challenges in provision of safe and effective care for patients with Inflammatory Bowel Disease (IBD). In this study, we surveyed patients with IBD to highlight the impact of the pandemic on their IBD symptoms, management, and well-being. METHODS: A multi-site survey was administered to patients with IBD. We evaluated patient's symptoms, medications changes, seeking medical attention, eating behaviors, sleep patterns, stress, self-reported anxiety and depression. The survey also measured emotional impact of the pandemic using the validated Pandemic Emotional Impact Scale (PEIS) and resilience using the Brief Resilience Scale (BRS). Logistic, ordinal, and linear regression models were utilized to perform sensitivity analyses. RESULTS: The response rate to the survey was 61%. Of 391 surveyed patients, 21.1% reported worsened gastrointestinal symptoms, 17.5% reported changing biologic medication infusion schedule, 18.7% reported changing medication regimen, 43.6% attended at least one telemedicine visit with their gastroenterologist, 16.5% reported a less healthy diet, 40.5% reported worsening sleep, 63.7% reported more stress, and 65.3% reported feeling more vulnerable than before the pandemic. Women and participants with self-reported anxiety and depression were more likely to have worse symptoms, psychological well-being and daily functioning. Increased PEIS scores and decreased BRS scores were associated with worse outcomes. CONCLUSIONS: COVID-19 pandemic has impacted symptoms, disease management and well-being for patient with IBD, more prominently in patients who suffer from anxiety and depression. Utilizing PEIS and BRS scores as screening tools could help better tailor outreach and follow-up to support these patients.

A Comprehensive Literature Review and Expert Consensus Statement on Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease.

Therapeutic drug monitoring (TDM) of biologics is a rapidly evolving field. We aimed to provide a consensus statement regarding the clinical utility of TDM for biologics in inflammatory bowel disease (IBD). A modified Delphi method was applied to develop consensus statements. A comprehensive literature review was performed regarding TDM of biologic therapies in IBD, and 45 statements were subsequently formulated on the potential application of TDM in IBD. The statements, along with literature, were then presented to a panel of 10 gastroenterologists with expertise in IBD and TDM who anonymously rated them on a scale of 1-10 (1 = strongly disagree and 10 = strongly agree). An expert consensus development meeting was held virtually to review, discuss, refine, and reformulate statements that did not meet criteria for agreement or that were ambiguous. During the meeting, additional statements were proposed. Panelists then confidentially revoted, and statements rated ≥7 by 80% or more of the participants were accepted. During the virtual meeting, 8 statements were reworded, 7 new statements were proposed, and 19 statements were rerated. Consensus was finally reached in 48/49 statements. The panel agreed that reactive TDM should be used for all biologics for both primary nonresponse and secondary loss of response. It was recommended that treatment discontinuation should not be considered for infliximab or adalimumab until a drug concentration of at least 10-15 µg/mL was achieved. Consensus was also achieved regarding the utility of proactive TDM for anti-tumor necrosis factor therapy. It was recommended to perform proactive TDM after induction and at least once during maintenance. Consensus was achieved in most cases regarding the utility of TDM of biologics in IBD, specifically for reactive and proactive TDM of anti-tumor necrosis factors.

Adverse effects of COVID-19 pandemic on a multicenter randomized controlled trial.

OBJECTIVE: Describe the effects of the COVID-19 pandemic on subject enrollment in a multicenter randomized controlled trial. STUDY DESIGN: We assessed the number of eligible infants approached and consented for enrollment over five separate epochs including baseline, peak pandemic, and gradual but incomplete recovery. RESULT: The pandemic had a major effect on ability to approach parents for consent. Parents approached dropped from 95.4% baseline to 13.1% in the peak pandemic epoch and has not recovered to baseline even in the just-completed post-pandemic epoch (84.9%). Despite the decrease in subjects approached, there was no significant change in the overall consent rate for the study CONCLUSION: The pandemic has significantly limited ability to approach parents of eligible infants for consent, with only partial recovery. Opportunities for interactions of investigators and study coordinators with parents continue to present challenges limiting full recovery.

Patients' perspectives on marijuana use for inflammatory bowel disease: a multicenter survey.

Background: As marijuana use is rising among patients with inflammatory bowel disease (IBD), so is interest in its potential use as a therapeutic agent. We sought to survey IBD patients regarding marijuana use, self-reported impact on IBD symptoms, and perceptions of safety. Methods: A multicenter anonymous survey was administered to patients with IBD between October 2020 and June 2021. The 70-question survey collected demographic variables, clinical variables, attitudes about marijuana, and perceptions of its safety and efficacy in IBD. Participants were classified by their marijuana use: "rarely/never," "current," and "former". Percentage and chi-square tests were used to compare categorical variables between the 3 groups, and means and 2-group ANOVA were used for continuous variables. Results: Of 181 patients surveyed, 166 were eligible for the study. Of these, 70 (42.2%) participants were rare/never marijuana users, 44 (26.5%) were current users, and 52 (31.3%) were former users. Fifty-three percent thought marijuana would help with IBD inflammation and 80% thought it would help with IBD pain. Over 70% of patients from all groups thought marijuana had a low-to-moderate risk of harm, and 69.6% of the participants who never or rarely used marijuana thought marijuana was addictive, compared to 20.5% of the current users and 44% of the former marijuana users. Conclusions: While many patients thought marijuana use helps with IBD-related pain and inflammation, many expressed concerns about addiction to marijuana and a possible risk of harm. Further studies are needed to examine the benefit and harm of marijuana in IBD.