Essentials of Informed Consent to Psychedelic Medicine.

Importance: Interest in administering psychedelic agents as mental health treatment is growing rapidly. As drugmakers invest in developing psychedelic medicines for several psychiatric indications, lawmakers are enacting legal reforms to speed access globally, and health agencies are preparing to approve these treatments. Meanwhile, US states, such as Oregon and Colorado, are making psychedelics available for supervised use outside the conventional health care system. Observations: Despite legal change and potentially imminent regulatory approval in some countries, standards for integrating psychedelics into health care have lagged, including norms for designing and implementing informed consent processes. Informed consent is complicated by the unique features of psychedelics and their means of administration. Because no governments have approved any classic psychedelics for general medical or psychiatric use, only clinical researchers have obtained informed consent from trial participants. Accordingly, there is an unmet need for informed consent processes tailored to the challenges of administering psychedelics in nonresearch settings. Conclusions and Relevance: Analysis of the challenges of designing and implementing psychedelic informed consent practices revealed 7 essential components, including the possibility of short- and long-term perceptual disturbances, potential personality changes and altered metaphysical beliefs, the limited role of reassuring physical touch, the potential for patient abuse or coercion, the role and risks of data collection, relevant practitioner disclosures, and interactive patient education and comprehension assessment. Because publicly available informed consent documents for psychedelic clinical trials often overlook or underemphasize these essential elements, sample language and procedures to fill the gap are proposed.

Religion, Spirituality, and Ethics in Psychiatric Practice.

ABSTRACT: The interface of religion, spirituality, and psychiatric practice has long been of interest to the ethical psychiatrist. Some prominent early psychotherapists had a strained relationship with religion and spirituality. They posited that religion and spirituality were forms of mental illness, which discouraged the discussion of these values during treatment despite the fact that many patients subscribed to a religious or spiritual viewpoint. Contrarily, others supported a harmonious relationship with religion and spirituality and served as trailblazers for the incorporation of religion and spirituality into psychiatric treatment.As the field of psychiatry continues to evolve, additional dimensions of the relationship between religion, spirituality, and psychiatric practice must be explored. Today, many modern psychiatrists appreciate the importance of incorporating religion and spirituality into treatment, but questions such as whether it is ethical to practice psychiatry from a particular religious or spiritual viewpoint or for psychiatrists to advertise that they subscribe to a particular religion or spirituality and to engage in religious or spiritual practices with their patients remain nuanced and complex. In this resource document, the authors put forth and examine the ramifications of a bio-psycho-social-religious/spiritual model for psychological development and functioning, with this fourth dimension shifting the focus from symptom reduction alone to include other aspects of human flourishing such as resilience, meaning-making, and hope.

General Hospital Agitation Management: Leadership Theory and Health Care Team Best Practices Using TeamSTEPPS.

BACKGROUND: Acute agitation management is an emergency clinical intervention, often presenting acute danger to patients and medical staff. Unlike many other emergency clinical interventions, acute agitation management lacks a substantial evidence base regarding leadership and teamwork best practices. The Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) framework is a comprehensive strategy for improving health care outcomes in acute clinical situations. OBJECTIVE: Practical application of TeamSTEPPS frameworks in team-based acute agitation management in the medical setting. METHODS: A literature review was performed from January 1990 to March 2021 for verbal de-escalation in acute agitation management, leadership and teamwork in psychiatry and medicine, and TeamSTEPPS. RESULTS: No literature was found that applied TeamSTEPPS for acute agitation management in the general medical unit context although limited application has been trialed in the inpatient psychiatric context. The verbal de-escalation literature describes applicable content including conflict management approaches, communication strategies, security presence management, modeling therapeutic behavior, and debriefing strategies. Several articles were found regarding a rapid response team model for acute agitation management and describing handoff tools in psychiatric care contexts. Translation of the TeamSTEPPS approach provided many additional approaches for operation of a rapid response team in acute agitation management. CONCLUSIONS: The leadership and teamwork best practices in TeamSTEPPS provide a clear and actionable framework for team-based acute agitation management as an emergency clinical intervention.

MIR spectroscopy versus MALDI-ToF-MS for authenticity control of honeys from different botanical origins based on soft independent modelling by class analogy (SIMCA) - A clash of techniques?

In this study, highly reproducible MIR spectroscopy and highly sensitive MALDI-ToF-MS data were directly compared for the metabolomic profiling of monofloral and multifloral honey samples from three different botanical origins canola, acacia, and honeydew. Subsequently, three different classification models were applied to the data of both techniques, PCA-LDA, PCA- kNN, and soft independent modelling by class analogy (SIMCA) as class modelling technique. All monofloral external test set samples were classified correctly by PCA-LDA and SIMCA with both data sets, while multifloral test set samples could only be identified as outliers by the SIMCA technique, which is a crucial aspect in the authenticity control of honey. The comparison of the two used analytical techniques resulted in better overall classification results for the monofloral external test set samples with the MIR spectroscopic data. Additionally, clearly more multifloral external samples were identified as outliers by MIR spectroscopy (91.3%) as compared to MALDI-ToF-MS (78.3%). The results indicate that the high reproducibility of the used MIR technique leads to a generally better ability of separating monofloral honeys and in particular, identifying multifloral honeys. This demonstrates that benchtop-based techniques may operate on an eye-level with high-end laboratory-based equipment, when paired with an optimal data analysis strategy.

Nitrogen monoxide as dopant for enhanced selectivity of isomeric monoterpenes in drift tube ion mobility spectrometry with 3H ionization.

The ion mobility spectra of the isomeric monoterpenes α-pinene, ß-pinene, myrcene, and limonene in drift tube ion mobility spectrometry (IMS) with 3H radioactive ionization are highly similar and difficult to distinguish. The aim of this work was to enhance the selectivity of IMS by the addition of nitrogen monoxide (NO) as dopant and to investigate the underlying changes in ion formation responsible for the modified ion signals observed in the ion mobility spectra. Even though 3H-based-IMS systems have been used in hyphenation with gas chromatography (GC) for profiling of volatile organic compounds (VOCs), the investigation of ion formation still remains challenging and was exemplified by the investigated monoterpenes. Nonetheless, the formation of monomeric, dimeric, and trimeric ion clusters could be tentatively confirmed by a mass-to-mobility correlation and the highly similar pattern of ion signals in the monomer region was attributed to isomerization mechanisms potentially occurring after proton transfer reactions. The addition of NO as dopant could finally lead to the formation of additional product ions and increased the selectivity of IMS for the investigated monoterpenes as confirmed by principal component analysis (PCA). The discrimination of monoterpenes in the volatile profile is highly relevant in the quality control of hops and was given as the example for application. The results indicate that additional product ions were obtained by the formation of NO+ adduct ions, next to hydride abstraction, charge transfer, or fragmentation reactions. This approach can potentially leverage selectivity issues in VOC profiling of complex matrices, such as food matrices or raw materials in combination with chemometric pattern recognition techniques.

Volatilomic Profiling of Citrus Juices by Dual-Detection HS-GC-MS-IMS and Machine Learning-An Alternative Authentication Approach.

A prototype dual-detection headspace-gas chromatography-mass spectrometry-ion mobility spectrometry (HS-GC-MS-IMS) system was used for the analysis of the volatile profile of 47 Citrus juices including grapefruit, blood orange, and common sweet orange juices without requiring any sample pretreatment. Next to reduced measurement times, substance identification could be improved substantially in case of co-elution by considering the characteristic drift times and m/z ratios obtained by IMS and MS. To discriminate the volatile profiles of the different juice types, extensive data analysis was performed with both datasets, respectively. By principal component analysis (PCA), a distinct separation between grapefruit and orange juices was observed. While in the IMS data grapefruit juices not from fruit juice concentrate could be separated from grapefruit juices reconstituted from fruit juice concentrate, in the MS data, the blood orange juices could be differentiated from the orange juices. This observation leads to the assumption that the IMS and MS data contain different information about the composition of the volatile profile. Subsequently, linear discriminant analysis (LDA), support vector machines (SVM), and the k-nearest-neighbor (kNN) algorithm were applied to the PCA data as supervised classification methods. Best results were obtained by LDA after repeated cross-validation for both datasets, with an overall classification and prediction ability of 96.9 and 91.5% for the IMS data and 94.5 and 87.9% for the MS data, respectively, which confirms the results obtained by PCA. Additional data fusion could not generally improve the model prediction ability compared to the single data, but rather for certain juice classes. Consequently, depending on the juice class, the most suitable dataset should be considered for the prediction of the class membership. This volatilomic approach based on the dual detection by HS-GC-MS-IMS and machine learning tools represent a simple and promising alternative for future authenticity control of Citrus juices.

A paper-based colorimetric sensor array for discrimination of monofloral European honeys based on gold nanoparticles and chemometrics data analysis.

A sensitive and simple nanomaterial based colorimetric sensor array (NBCSA) was developed for discrimination of monofloral honey from various European countries based on three botanical origins as Acacia, Canola and Honeydew. The NBCSA was designed by spotting gold (AuNPs) and silver (AgNPs) nanoparticles synthesized using six different reducing and/or capping agents. The colour intensity of AuNPs represented differential changes when interacting with volatile organic compounds appeared in the headspace of the honey samples. The color difference maps, which are calculated as the difference between color intensity of the sensor before and after exposing to the sample vapors, were used as a fingerprint to discriminate the honey samples based on botanical origin. Classification was achieved utilizing data pre-processing and chemometrics data analysis. Fitting accuracies of 88% and 86% were obtained by partial least squares discriminant analysis and linear discriminant analysis whereas 100% was achieved using support vector machine.

Gas-phase volatilomic approaches for quality control of brewing hops based on simultaneous GC-MS-IMS and machine learning.

For the first time, a prototype HS-GC-MS-IMS dual-detection system is presented for the analysis of volatile organic compounds (VOCs) in fields of quality control of brewing hop. With a soft ionization and drift time-based ion separation in IMS and a hard ionization and m/z-based separation in MS, substance identification in the case of co-elution was improved, substantially. Machine learning tools were used for a non-targeted screening of the complex VOC profiles of 65 different hop samples for similarity search by principal component analysis (PCA) followed by hierarchical cluster analysis (HCA). Partial least square regression (PLSR) was applied to investigate the observed correlation between the volatile profile and the α-acid content of hops and resulted in a standard error of prediction of only 1.04% α-acid. This promising volatilomic approach shows clearly the potential of HS-GC-MS-IMS in combination with machine learning for the enhancement of future quality assurance of hops. Graphical abstract.

Physician-Assisted Death Psychiatric Assessment: A Standardized Protocol to Conform to the California End of Life Option Act.

BACKGROUND: The California End of Life Option Act (EOLOA), which legalized physician-assisted death (PAD), became effective in 2016. The EOLOA does not require a mental health consultation in all cases nor does it state the standards for the mental health assessment. University of California, San Francisco Medical Center (UCSFMC) policy makers decided to require a mental health assessment of all patients seeking PAD under the EOLOA. OBJECTIVES: The Department of Psychiatry was tasked with developing a standard protocol for the mental health assessment of patients seeking PAD. METHODS: Members of the consultation-liaison (C-L) service developed a document to guide members in completing the mental health evaluations for patients requesting PAD. RESULTS: A committee at UCSFMC developed a clinical protocol informed by the law with an additional local expectation of an evaluation by a psychiatrist or clinical psychologist. The C-L psychiatry group at UCSF developed a standard protocol for the psychiatric assessment for use by clinicians performing these assessments. Attention to the cognitive, mood, and decisional capacity status pertinent to choosing PAD is required under the clinical guidance document. Case vignettes of 6 patients evaluated for PAD are presented. CONCLUSIONS: The local adoption of the California EOLOA by UCSFMC requires a mental health assessment of all patients requesting EOL services at UCSF. The clinical guideline for these assessments was locally developed, informed by the literature on EOL in other jurisdictions where it has already been available.

Decisional and Dispositional Capacity Determinations: Neuropsychiatric Illness and an Integrated Clinical Paradigm.

BACKGROUND: Assessment of decisional capacity requires thorough clinical review of a patient's current psychiatric symptoms and cognitive processes. The assessment to determine the patient's capacity for self-management postdischarge is a different clinical concept from decisional capacity. OBJECTIVES: Standardized guidelines for capacity determinations (both for informed consent and for disposition) would be helpful to clinicians, patients, and their caregivers. METHOD: The authors reviewed the recent clinical literature on neuropsychiatric illnesses associated with impaired decisional capacity, as well as for the term "dispositional capacity." RESULTS: Neurocognitive disorders and neurologic disorders are commonly associated with impaired decisional capacity; other psychiatric illnesses are less commonly associated. There were no articles identified that used the term "dispositional capacity" to describe a subtype of decisional capacity determination. No definition or guidelines for determination of dispositional capacity were found. CONCLUSIONS: Routine evaluation for neurocognitive disorders including standardized cognitive assessment should be included in decisional capacity determinations. There is a need for a new subtype of decisional capacity determination, for which we propose the term "dispositional capacity." This concept is introduced and defined. For dispositional capacity determinations, supplementation of the usual decisional capacity evaluation with in vivo demonstration of self-management skills is recommended. Decisional and dispositional capacity determination is conceptualized with a biopsychosociocultural approach and guidelines for standardized assessment are presented.

A Systematic Review of Dropout From Psychotherapy for Posttraumatic Stress Disorder Among Iraq and Afghanistan Combat Veterans.

A significant number of veterans of the conflicts in Iraq and Afghanistan have posttraumatic stress disorder (PTSD), yet underutilization of mental health treatment remains a significant problem. The purpose of this review was to summarize rates of dropout from outpatient, psychosocial PTSD interventions provided to U.S. Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), and Operation New Dawn (OND) veterans with combat-related PTSD. There were 788 articles that were identified which yielded 20 studies involving 1,191 individuals eligible for the review. The dropout rates in individual studies ranged from 5.0% to 78.2%, and the overall pooled dropout rate was 36%, 95% CI [26.20, 43.90]. The dropout rate differed marginally by study type (routine clinical care settings had higher dropout rates than clinical trials) and treatment format (group treatment had higher dropout rates than individual treatment), but not by whether comorbid substance dependence was excluded, by treatment modality (telemedicine vs. in-person treatment), or treatment type (exposure therapy vs. nonexposure therapy). Dropout is a critical aspect of the problem of underutilization of care among OEF/OIF/OND veterans with combat-related PTSD. Innovative strategies to enhance treatment retention are needed.

Voluntary psychiatric hospitalization and patient-driven requests for discharge: a statutory review and analysis of implications for the capacity to consent to voluntary hospitalization.

Along with the advances in civil rights protections for psychiatric patients since the 1970s, so-called voluntary inpatient psychiatric admissions have become common. In most U.S. states, however, these voluntary admissions abridge the rights of patients through legal provisions that limit the conditions under which patients can be discharged upon their request. This phenomenon, including variations in the state laws governing requests for discharge from voluntary psychiatric hospitalization, has received little attention in the psychiatry literature. Using Lexis-Nexis, PubMed, and Web of Science, we conducted a review of state laws regarding patients' legal rights to request discharge from voluntary hospitalization. Our hypothesis was that most states would have provisions limiting access to immediate discharge for patients whose psychiatric admission had been voluntary. Our findings from the review indicate that 49 of the 51 jurisdictions (50 states plus the District of Columbia) have provisions about patients requesting discharge from voluntary psychiatric admission. The majority of states employ a 72-hour period in which patients can be held following a request for discharge from hospitalization. As a general rule, after this evaluation period, either the patient must be discharged, or the facility must initiate involuntary commitment proceedings. Given these provisions, we explore the range of clinical admission procedures and whether voluntary admissions are truly voluntary. We also discuss the implications of our analysis for assessing the decisional capacity of patients seeking voluntary psychiatric admission.