Patient Perspective on Safety of Elective Gastrointestinal Endoscopy During the COVID-19 Pandemic.

BACKGROUND: Patients' perception regarding the risks of COVID-19 infection with gastrointestinal (GI) and the preventive measures taken in GI endoscopy units to mitigate infection risk remains unclear. We aimed to assess patients' perception regarding risks of COVID-19 with GI endoscopy and the changes in the endoscopy unit as a result of the ongoing pandemic. METHODS: Outpatients undergoing GI endoscopy at our institution were categorized into those scheduled to undergo GI endoscopy (preprocedure) and those who had recently undergone GI endoscopy during the pandemic (postprocedure). Two separate but similar survey instruments were designed. Patients were asked to respond on a 5-point Likert scale. Responses were stratified as "low," "neutral," and "high" for analysis. RESULTS: A total of 150 and 355 respondents completed the preprocedure and postprocedure surveys, with a combined response rate of 82.5%. Non-white ethnicity was associated with reporting a "high" level of concern for endoscopy related COVID-19 exposure in both the preprocedure (OR 4.09, 95% CI 1.54-10.82) and postprocedure cohorts (OR 2.11, 95% CI 1.04-4.29). 42% of patients in the preprocedure cohort and 11.8% in the postprocedure cohort reported their level of concern for COVID exposure as "high." Among the postprocedure cohort, 88% of the patients were likely to undergo repeat endoscopy during the pandemic if recommended. CONCLUSION: Patients are willing to undergo GI endoscopy during the COVID-19 pandemic. Non-white and older patients, and those undergoing screening examinations were more concerned with the GI endoscopy related COVID-19 transmission risk.

Frequency of Adverse Events in the Placebo Arms of COVID-19 Vaccine Trials: A Systematic Review and Meta-analysis.

Importance: Adverse events (AEs) after placebo treatment are common in randomized clinical drug trials. Systematic evidence regarding these nocebo responses in vaccine trials is important for COVID-19 vaccination worldwide especially because concern about AEs is reported to be a reason for vaccination hesitancy. Objective: To compare the frequencies of AEs reported in the placebo groups of COVID-19 vaccine trials with those reported in the vaccine groups. Data Sources: For this systematic review and meta-analysis, the Medline (PubMed) and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched systematically using medical subheading terms and free-text keywords for trials of COVID-19 vaccines published up to July 14, 2021. Study Selection: Randomized clinical trials of COVID-19 vaccines that investigated adults aged 16 years or older were selected if they assessed solicited AEs within 7 days of injection, included an inert placebo arm, and provided AE reports for both the vaccine and placebo groups separately. Full texts were reviewed for eligibility by 2 independent reviewers. Data Extraction and Synthesis: Data extraction and quality assessment were performed independently by 2 reviewers, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline and using the Cochrane risk-of-bias tool. Meta-analyses were based on random-effects models. Main Outcomes and Measures: The primary outcomes were the proportions of placebo recipients reporting overall, systemic, and local (injection-site) AEs as well as logarithmic odds ratios (ORs) to evaluate group differences. Outcomes were tested for significance using z tests with 95% CIs. Results: Twelve articles with AE reports for 45 380 participants (22 578 placebo recipients and 22 802 vaccine recipients) were analyzed. After the first dose, 35.2% (95% CI, 26.7%-43.7%) of placebo recipients experienced systemic AEs, with headache (19.3%; 95% CI, 13.6%-25.1%) and fatigue (16.7%; 95% CI, 9.8%-23.6%) being most common. After the second dose, 31.8% (95% CI, 28.7%-35.0%) of placebo recipients reported systemic AEs. The ratio between placebo and vaccine arms showed that nocebo responses accounted for 76.0% of systemic AEs after the first COVID-19 vaccine dose and for 51.8% after the second dose. Significantly more vaccine recipients reported AEs, but the group difference for systemic AEs was small after the first dose (OR, -0.47; 95% CI, -0.54 to -0.40; P < .001; standardized mean difference, -0.26; 95% CI, -0.30 to -0.22) and large after the second dose (OR, -1.36; 95% CI, -1.86 to -0.86; P < .001; standardized mean difference, -0.75; 95% CI, -1.03 to -0.47). Conclusions and Relevance: In this systematic review and meta-analysis, significantly more AEs were reported in vaccine groups compared with placebo groups, but the rates of reported AEs in the placebo arms were still substantial. Public vaccination programs should consider these high rates of AEs in placebo arms.

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.

Psychological Health Among Gastroenterologists During the COVID-19 Pandemic: A National Survey.

The COVID-19 pandemic poses unprecedented and unique challenges to gastroenterologists eager to maintain clinical practice, patients' health, and their own physical/mental well-being. We aimed to estimate the prevalence and critical determinants of psychological distress in gastroenterologists during the COVID-19 pandemic.

Validation of the Pandemic Emotional Impact Scale.

OBJECTIVE: The COVID-19 pandemic represents the most universal shared stressor for the general United States (U.S) population in many decades. Due to the unprecedented circumstances of COVID-19, no existing questionnaires can comprehensively measure the multi-faceted psychological effects attributable to this health crisis. This study aimed to validate a measure for that purpose. METHODS: A 16-item questionnaire, the Pandemic Emotional Impact Scale (PEIS), was designed and subjected to initial validation in an internet survey completed by a nationally representative sample of 1500 adults living in the U.S. This survey was completed between May 18 and May 30, 2020, during the height of the pandemic's impact on society. RESULTS: The PEIS demonstrated excellent internal consistency (Cronbach's α â€‹= â€‹0.94) and Guttman split-half reliability (0.95). Exploratory factor analysis suggested two sub-scales -- emotional impact and pragmatic worries -- but these were highly correlated with the overall scale score suggesting that the total score can be used in most cases. The PEIS demonstrated good concurrent validity via robust positive correlations with anxiety, depression and stress, and negative correlations with quality of life and happiness. Criterion validity was supported by the finding that individuals who reported employment loss or loss of income due to the pandemic, had experienced COVID-19 infection in their household, or knew somebody personally who died from the pandemic, had elevated scores on the PEIS. CONCLUSIONS: The PEIS questionnaire is a reliable and valid instrument that addresses a significant unmet need for a research instrument that can comprehensively measure pandemic-related effects on the emotional wellbeing of individuals in the U.S population.