Mapping consent practices for outpatient psychiatric use of ketamine.
David S Mathai, Scott M Lee, Victoria Mora, Kelley C O'Donnell, Albert Garcia-Romeu, Eric A Storch
Journal of affective disorders September 1, 2022 DOI: 10.1016/j.jad.2022.06.036 via PubMed
Summary
AI-generated from the abstractInformed consent documents from 23 American ketamine clinics for psychiatric treatment cover most required elements but vary greatly in detail. Key gaps include poor communication about long-term side effects, alternative treatments, pre-treatment evaluations, support during treatment, psychological interventions, and dissociative effects. All forms are written at a readability level too high for many patients. The findings suggest that both patients and providers would benefit from more deliberate, evidence-informed consent processes to support shared decision-making as off-label ketamine use expands.
Study at a glance
| Characteristics | Exploratory analysis Peer reviewed |
|---|---|
| Sample size | 23 |
| Population | Outpatient ketamine clinics in the United States offering ketamine as a psychiatric treatment |
| Topics | Depression Ketamine |
| Keywords | Consent Ethics Off-label |
| Citations | 16 |
| Key finding | Informed consent documents from a convenience sample of 23 American ketamine clinics address most consent elements but show significant variability and gaps, particularly regarding long-term adverse effects, treatment alternatives, and readability. |
Abstract
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.