Development of the Ketamine Side Effect Tool (KSET).
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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
Issue Date
2020-01-25
Type
Journal Article
Research Support, N.I.H., Intramural
Research Support, Non-U.S. Gov't
Systematic Review
Research Support, N.I.H., Intramural
Research Support, Non-U.S. Gov't
Systematic Review
Language
en
Keywords
Depression , Ketamine , Ketamine Side Effect Tool (KSET) , Safety , Side effects
Alternative Title
Abstract
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.
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.
Description
Citation
Short, B., Dong, V., Gálvez, V., Vulovic, V., Martin, D., Bayes, A. J., Zarate, C. A., Murrough, J. W., McLoughlin, D. M., Riva-Posse, P., Schoevers, R., Fraguas, R., Glue, P., Fam, J., McShane, R., & Loo, C. K. (2020). Development of the Ketamine Side Effect Tool (KSET). Journal of affective disorders, 266, 615–620. https://doi.org/10.1016/j.jad.2020.01.120
Publisher
License
Copyright © 2020 Elsevier B.V. All rights reserved.
Journal
Journal of affective disorders
Volume
266
Issue
PubMed ID
DOI
10.1016/j.jad.2020.01.120
10.7326/0003-4819-144-4-200602210-00007
10.1016/j.biopsych.2012.02.039
10.1177/0269881114527361
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10.1007/s00213-003-1656-y
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10.1192/bjp.bp.109.070961
10.1192/bjp.bp.115.165498
10.1111/j.1526-4610.2004.04191.x
10.1017/S1461145714001011
10.1016/S2215-0366(17)30272-9
10.7326/0003-4819-144-4-200602210-00007
10.1016/j.biopsych.2012.02.039
10.1177/0269881114527361
10.1186/s12874-016-0165-8
10.1177/0269881118760660
10.1016/j.jagp.2017.06.007
10.1111/j.1365-2125.2006.02698.x
10.1089/jpm.2012.0617
10.1046/j.0306-5251.2001.01547.x
10.1016/S0893-133X(97)00034-1
10.1056/NEJMp1903305
10.1097/01.fbp.0000095714.39553.56
10.2165/11599770-000000000-00000
10.1017/S0033291714001603
10.1136/bmj.b2535
10.1038/sj.npp.1300342
10.1007/s00213-003-1656-y
10.1111/j.1360-0443.2009.02761.x
10.1136/bmj.329.7456.15
10.1192/bjp.bp.109.070961
10.1192/bjp.bp.115.165498
10.1111/j.1526-4610.2004.04191.x
10.1017/S1461145714001011
10.1016/S2215-0366(17)30272-9
ISSN
1573-2517