Mapping consent practices for outpatient psychiatric use of ketamine.

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.

Mathai DS ，Lee SM ，Mora V ，O'Donnell KC ，Garcia-Romeu A ，Storch EA ... -  《-》

The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol.

Perrenoud B ，Velonaki VS ，Bodenmann P ，Ramelet AS ... -  《-》

Safe Ketamine Use and Pregnancy: A Nationwide Survey and Retrospective Review of Informed Consent, Counseling, and Testing Practices.

Objective: Ketamine is contraindicated in pregnancy given the lack of knowledge about potential effects on a developing fetus. This study aimed to characterize current clinical practices specific to pregnancy and reproduction related to the use of ketamine for the treatment of psychiatric illness. Methods: Online surveys were sent to outpatient ketamine clinics across the United States inquiring about practices related to pregnancy. Responses were collected between September and November 2023. Additionally, a retrospective medical record review was conducted to ascertain the frequency of pregnancy testing and contraception use with ketamine treatments administered at a large academic health system. Online, publicly available informed consent documents were also reviewed for language related to pregnancy. Results: Fewer than half of survey respondents (n = 126) discuss specific risks related to pregnancy and fetal ketamine exposure during the informed consent process. Twenty percent of clinics require pregnancy tests prior to treatment, and 10.5% require subsequent testing during treatment; however, 22.9% of clinics do not have a standard process for testing. Only 13.7% of clinics specifically recommend or require use of contraception. Retrospective record review revealed that all patients who received intravenous ketamine for psychiatric indications in an academic medical center were pregnancy tested weekly, but only half were using contraception during treatment. Conclusion: Many women with the potential to become pregnant are treated with ketamine for psychiatric illness. Results of the present study reveal that risks of fetal ketamine exposure are often overlooked, indicating a need for increased awareness about reproductive concerns when prescribing ketamine for the treatment of psychiatric disorders.

Pacilio RM ，Lopez JF ，Parikh SV ，Patel PD ，Geller JA ... -  《-》

Mapping the Informed Consent Process for Left Ventricular Assist Devices.

Fedson SE ，MacKenzie KK ，Delgado ED ，Abraham MN ，Estep JD ，Blumenthal-Barby JS ，Bruce CR ... -  《-》

[The origin of informed consent].

Mallardi V 《Acta Otorhinolaryngologica Italica》