Brooke Short1, Vanessa Dong2, Verònica Gálvez3, Vedran Vulovic4, Donel Martin2, Adam J Bayes5, Carlos A Zarate6, James W Murrough7, Declan M McLoughlin8, Patricio Riva-Posse9, Robert Schoevers10, Renerio Fraguas11, Paul Glue12, Johnson Fam13, Rupert McShane14, Colleen K Loo15. 1. School of Medicine and Public Health, The University of Newcastle, Newcastle, Australia; Gosford Hospital, Gosford, Australia. 2. School of Psychiatry, University of New South Wales and Black Dog Institute, Sydney, Australia. 3. Corporacio Sanitaria Parc Tauli, Universitat Autonoma de Barcelona, I3PT, Institut d'Investigacio i Innovacio Parc Tauli, Sabadell, Barcelona, Spain. 4. University of New South Wales, Sydney, Australia. 5. School of Psychiatry, University of New South Wales, Sydney, Australia; Black Dog Institute, Sydney, Australia. 6. Division of Intramural Research Program, National Institute of Mental Health, MD, United States. 7. Depression and Anxiety Centre for Discovery and Treatment, Icahn School of Medicine at Mount Sinai, New York, NY, United States. 8. Department of Psychiatry, Trinity College Institute of Neuroscience, Trinity College, Dublin, Ireland. 9. Department of Psychiatry and Behavioral Sciences at Emory University, Atlanta, GA, United States. 10. The University Medical Center Groningen (UMCG), Groningen, the Netherlands. 11. Department and Institute of Psychiatry, University of Sao Paulo (USP), School of Medicine, Division of Psychiatry and Psychology, University Hospital (HU), USP Laboratório de Investigação Médica, Recife, Brazil. 12. Southern DHB and Hazel Buckland Chair in Psychological Medicine, University of Otago, Dunedin, New Zealand. 13. Department of Psychological Medicine, National University Hospital; Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore. 14. Department of Psychiatry, Medical Sciences Division, University of Oxford, Oxford, United Kingdom. 15. School of Psychiatry, University of New South Wales, Sydney, Australia; St George Hospital, Sydney, Australia; Black Dog Institute, Sydney, Australia; Wesley Hospital, Sydney, Australia. Electronic address: colleen.loo@unsw.edu.au.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. LIMITATIONS: Further evaluation of feasibility, construct validity and reliability is required, and is planned across multiple international sites. CONCLUSIONS: 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.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. LIMITATIONS: Further evaluation of feasibility, construct validity and reliability is required, and is planned across multiple international sites. CONCLUSIONS: 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.
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