TY - JOUR
T1 - Mapping consent practices for outpatient psychiatric use of ketamine
AU - Mathai, David S.
AU - Lee, Scott M.
AU - Mora, Victoria
AU - O'Donnell, Kelley C.
AU - Garcia-Romeu, Albert
AU - Storch, Eric A.
N1 - Funding Information:
DSM and AGR receive support from the Johns Hopkins Center for Psychedelic and Consciousness Research provided by Tim Ferriss, Matt Mullenweg, Blake Mycoskie, Craig Nerenberg, and the Steven and Alexandra Cohen Foundation. AGR also receives support from the Heffter Research Institute and serves as a scientific advisor to ETHA Natural Botanicals and NeonMind Biosciences. SML and VM have no competing financial interests to disclose. KCO practices ketamine-assisted psychotherapy in her private psychiatry practice. EAS receives grant support from NIH, the Ream Foundation, Greater Houston Community Foundation, International OCD Foundation, and Texas Higher Education Coordinating Board. He receives book royalties from Elsevier, Springer, American Psychological Association, Jessica Kingsley, Oxford, and Lawrence Erlbaum. He holds stock in NView, where he serves on the clinical advisory board. He was a consultant for Levo Therapeutics and is currently a consultant for Biohaven Pharmaceuticals.
Funding Information:
DSM and AGR receive support from the Johns Hopkins Center for Psychedelic and Consciousness Research provided by Tim Ferriss, Matt Mullenweg, Blake Mycoskie, Craig Nerenberg, and the Steven and Alexandra Cohen Foundation. AGR also receives support from the Heffter Research Institute and serves as a scientific advisor to ETHA Natural Botanicals and NeonMind Biosciences. SML and VM have no competing financial interests to disclose. KCO practices ketamine-assisted psychotherapy in her private psychiatry practice. EAS receives grant support from NIH , the Ream Foundation , Greater Houston Community Foundation , International OCD Foundation , and Texas Higher Education Coordinating Board . He receives book royalties from Elsevier, Springer, American Psychological Association, Jessica Kingsley, Oxford, and Lawrence Erlbaum. He holds stock in NView, where he serves on the clinical advisory board. He was a consultant for Levo Therapeutics and is currently a consultant for Biohaven Pharmaceuticals.
Publisher Copyright:
© 2022 Elsevier B.V.
PY - 2022/9/1
Y1 - 2022/9/1
N2 - 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.
AB - 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.
KW - Consent
KW - Depression
KW - Ethics
KW - Ketamine
KW - Off-label
KW - Psychedelics
UR - http://www.scopus.com/inward/record.url?scp=85133645284&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85133645284&partnerID=8YFLogxK
U2 - 10.1016/j.jad.2022.06.036
DO - 10.1016/j.jad.2022.06.036
M3 - Article
C2 - 35753499
AN - SCOPUS:85133645284
SN - 0165-0327
VL - 312
SP - 113
EP - 121
JO - Journal of Affective Disorders
JF - Journal of Affective Disorders
ER -