Development of the Ketamine Side Effect Tool (KSET)

• Published in: Journal of affective disorders 2020-04, Vol.266, p.615-620
• Main Authors: Short, Brooke, Dong, Vanessa, Gálvez, Verònica, Vulovic, Vedran, Martin, Donel, Bayes, Adam J, Zarate, Carlos A, Murrough, James W, McLoughlin, Declan M, Riva-Posse, Patricio, Schoevers, Robert, Fraguas, Renerio, Glue, Paul, Fam, Johnson, McShane, Rupert, Loo, Colleen K
• Format: Article
• Language: English
• Subjects: Chronic Pain; Depression; Drug-Related Side Effects and Adverse Reactions; Humans; Ketamine; Ketamine - adverse effects; Ketamine Side Effect Tool (KSET); Reproducibility of Results; Safety; Side effects
• ISSN: 0165-0327; 1573-2517
• DOI: 10.1016/j.jad.2020.01.120

•No specific tool exists for the monitoring and reporting of ketamine-related side effects.•The longer-term safety of repeated treatment with ketamine for depression has not been sufficiently assessed.•The Ketamine Side Effect Tool (KSET), is designed for clinical and research use, to monitor for ketamine side effects after single and repeated doses. Currently, no specific, systematic assessment tool for the monitoring and reporting of ketamine-related side effects exists. Our aim was to develop a comprehensive Ketamine Side Effect Tool (KSET) to capture acute and longer-term side effects associated with repeated ketamine treatments. Informed by systematic review data and clinical research, we drafted a list of the most commonly reported side effects. Face and content validation were obtained via feedback from collaborators with expertise in psychiatry and anaesthetics, clinical trial piloting and a modified Delphi Technique involving ten international experts. The final version consisted of four forms that collect information at time points: screening, baseline, immediately after a single treatment, and longer-term follow-up. Instructions were developed to guide users and promote consistent utilisation. Further evaluation of feasibility, construct validity and reliability is required, and is planned across multiple international sites. The structured Ketamine Side Effect Tool (KSET) was developed, with confirmation of content and face validity via a Delphi consensus process. This tool is timely, given the paucity of data regarding ketamine's safety, tolerability and abuse potential over the longer term, and its recent adoption internationally as a clinical treatment for depression. Although based on data from depression studies, the KSET has potential applicability for ketamine (or derivatives) used in other medical disorders, including chronic pain. We recommend its utilisation for both research and clinical scenarios, including data registries.