Monitoring and Responding to Signals of Suicidal Ideation in Pragmatic Clinical Trials: Lessons from the GRACE Trial for Chronic Sickle Cell Disease Pain

Overview

Journal Contemp Clin Trials Commun

Date 2023 Oct 16

PMID 37842321

Authors

Eric S Swirsky

Andrew D Boyd

Carol Gu

Larisa A Burke

Ardith Z Doorenbos

Miriam O Ezenwa

Mitchell R Knisely

Jonathan W Leigh

Hongjin Li

Molly W Mandernach

Robert E Molokie

Crystal L Patil

Alana D Steffen

Nirmish Shah

Victoria A deMartelly

Karen L Staman

Judith M Schlaeger

Affiliations

Soon will be listed here.

Abstract

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.

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