School of Medicine and Public Health, The University of Newcastle, Newcastle, Australia; Gosford Hospital, Gosford, Australia.
School of Psychiatry, University of New South Wales and Black Dog Institute, Sydney, Australia.
J Affect Disord. 2020 Apr 1;266:615-620. doi: 10.1016/j.jad.2020.01.120. Epub 2020 Jan 25.
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.
目前，尚无专门用于监测和报告氯胺酮相关副作用的特定、系统的评估工具。我们的目的是开发一种全面的氯胺酮副作用工具（KSET），以捕捉与重复氯胺酮治疗相关的急性和长期副作用。
根据系统评价数据和临床研究，我们起草了一份报告最常见副作用的清单。通过具有精神病学和麻醉学专业知识的合作者的反馈、临床试验试点以及涉及十位国际专家的改良 Delphi 技术获得了表面和内容验证。
最终版本由四份表格组成，在以下时间点收集信息：筛选、基线、单次治疗后即刻和长期随访。制定了说明来指导用户并促进一致使用。
需要进一步评估可行性、结构有效性和可靠性，计划在多个国际地点进行。
通过 Delphi 共识过程，对结构化氯胺酮副作用工具（KSET）进行了开发和确认，内容和表面有效性得到了验证。鉴于氯胺酮在较长时间内的安全性、耐受性和滥用潜力的数据有限，以及其最近在国际上被用作抑郁症的临床治疗方法，该工具具有及时性。虽然基于抑郁症研究的数据，但 KSET 有可能适用于其他医学疾病（包括慢性疼痛）中使用的氯胺酮（或衍生物）。我们建议在研究和临床情况下使用，包括数据登记。
