Monitoring and responding to signals of suicidal ideation in pragmatic clinical trials: Lessons from the GRACE trial for Chronic Sickle Cell Disease Pain.

Sickle cell disease (SCD) is a hemoglobin disorder and the most common genetic disorder that affects 100,000 Americans and millions worldwide. Adults living with SCD have pain so severe that it often requires opioids to keep it in control. Depression is a major global public health concern associated with an increased risk in chronic medical disorders, including in adults living with sickle cell disease (SCD). A strong relationship exists between suicidal ideation, suicide attempts, and depression. Researchers enrolling adults living with SCD in pragmatic clinical trials are obligated to design their methods to deliberately monitor and respond to symptoms related to depression and suicidal ideation. This will offer increased protection for their participants and help clinical investigators meet their fiduciary duties. This article presents a review of this sociotechnical milieu that highlights, analyzes, and offers recommendations to address ethical considerations in the development of protocols, procedures, and monitoring activities related to suicidality in depressed patients in a pragmatic clinical trial.

COVID-19 vaccination hesitancy among health care workers, communication, and policy-making.

BACKGROUND: Coronavirus disease 2019 (COVID-19) vaccine hesitancy in health care workers (HCWs) contributes to personal and patient risk in contracting COVID-19. Reasons behind hesitancy and how best to improve vaccination rates in HCWs are not clear. METHODS: We adapted a survey using the Health Belief Model framework to evaluate HCW vaccine hesitancy and reasons for choosing for or against COVID-19 vaccination. The survey was sent to 3 large academic medical centers in the Chicagoland area between March and May 2021. RESULTS: We received 1974 completed responses with 85% of HCWs receiving or anticipating receiving COVID-19 vaccination. Multivariable logistic regression found HCWs were less likely to receive COVID-19 vaccination if they were Black (OR 0.34, 95% CI 0.15-0.80), Republican (OR 0.54, 95% CI 0.31-0.91), or allergic to any vaccine component (OR 0.27, 95% CI 0.10-0.70) and more likely to receive if they believed people close to them thought it was important for them to receive the vaccine (OR 5.2, 95% CI 3-8). CONCLUSIONS: A sizable number of HCWs remain vaccine hesitant 1 year into the COVID-19 pandemic. As HCWs are positively influenced by colleagues who believe in COVID-19 vaccination, development of improved communication across HCW departments and roles may improve vaccination rates.