Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences, Baltimore, MD, United States of America.
Veteran Affairs Boston Healthcare System/Harvard Medical School, Department of Psychiatry, Brockton, MA, United States of America.
J Affect Disord. 2022 Sep 1;312:113-121. doi: 10.1016/j.jad.2022.06.036. Epub 2022 Jun 23.
Given increasing community-based and off-label use of ketamine for psychiatric indications, we examined current informed consent processes from a convenience sample of outpatient ketamine clinics to identify areas of congruence with current evidence and opportunities for growth.
Using a rubric developed from existing practice guidelines, we conducted an exploratory analysis of informed consent documents (IC-Docs) from 23 American clinics offering ketamine as a psychiatric treatment. Domains assessed included clinical content, procedures, and syntax.
Participating clinics (23/288) varied widely in their constitution, training, and services provided. We found that IC-Docs addressed a majority of consent elements, though did so variably on an item-level. Areas for improvement included communication around long-term adverse effects, treatment alternatives, medical/psychiatric evaluation prior to treatment, medical/psychological support during treatment, adjunctive psychological interventions, and subjective/dissociative-type effects. All forms were limited by poor readability.
Our study was limited by convenience sampling along with possible underestimation of verbal consent processes.
As ketamine continues to emerge as a psychiatric intervention, both patients and providers will benefit from a deliberate consent process informed by scientific, ethical, and pragmatic factors toward the goal of shared decision-making regarding treatment.
鉴于社区和非适应证使用氯胺酮治疗精神疾病的情况越来越多,我们从门诊氯胺酮诊所的便利样本中检查了当前的知情同意流程,以确定与当前证据一致的领域和增长机会。
我们使用从现有实践指南中开发的评估表,对提供氯胺酮作为精神科治疗的 23 家美国诊所的知情同意文件(IC-Docs)进行了探索性分析。评估的领域包括临床内容、程序和语法。
参与的诊所(23/288)在构成、培训和提供的服务方面差异很大。我们发现,知情同意文件涵盖了大多数同意要素,但在项目层面上存在差异。需要改进的领域包括长期不良反应、替代治疗方案、治疗前的医学/精神病学评估、治疗期间的医学/心理支持、辅助心理干预以及主观/分离型效应的沟通。所有形式都受到较差的可读性的限制。
我们的研究受到便利抽样的限制,以及口头同意过程可能被低估的限制。
随着氯胺酮继续成为一种精神科干预措施,患者和提供者都将受益于一个精心设计的知情同意过程,该过程将科学、伦理和实际因素纳入其中,以实现关于治疗的共同决策。