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绘制门诊使用氯胺酮治疗精神疾病的同意书实践图。

Mapping consent practices for outpatient psychiatric use of ketamine.

机构信息

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.

出版信息

J Affect Disord. 2022 Sep 1;312:113-121. doi: 10.1016/j.jad.2022.06.036. Epub 2022 Jun 23.

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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.

LIMITATIONS

Our study was limited by convenience sampling along with possible underestimation of verbal consent processes.

CONCLUSIONS

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.

摘要

背景

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。

方法

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。

结果

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。

局限性

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。

结论

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。

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