Eligibility for Substance Use Clinical Trials Among Emergency Psychiatry Patients: The Impact of Exclusion Criteria.

Objective: The first objective was to identify common exclusion criteria used in clinical trials. The second objective was to quantify the degree to which these criteria exclude emergency psychiatry patients. Methods: Qualitative Content Analysis was used for the first objective, identifying common exclusion criteria used in recent high-impact substance use clinical trials. A retrospective record review was used for the second objective, which examined the frequency of these exclusion criteria in a 1-month sample of adults receiving psychiatric evaluation in an emergency department. Results: Most trials had exclusions for co-occurring psychiatric problems (76.6%), medical problems (74.0%), prior or current treatment (72.7%), motivation for change (61.1%), pregnancy or lactation (57.1%), or using other specified substances of abuse (54.6%). In the clinical sample, exclusions for co-occurring psychiatric problems would make 94.7% of patients ineligible. Other exclusions had a combined effect of making 76% of patients ineligible. Conclusions: Clinical trials using typical exclusion criteria exclude nearly all emergency psychiatry patients with substance use problems.

Persons Who Engage in Self-Harm While in the Emergency Department: A Case-Control Analysis.

ABSTRACT: Some patients engage in self-harm behaviors while in the emergency department. Risk factors for self-harm have been described for inpatient and outpatient/community settings, but not among emergency department patients. Authors conducted case-control, retrospective reviews of medical records and incident reports for emergency department patients in two academic medical centers. Variables were analyzed using conditional logistic regression. There were 113 individuals who engaged in self-harm while in the emergency department and 226 individuals who did not. Four variables were significant in the final model: a history of nonsuicidal self-harm (odds ratio [OR], 4.28; 95% confidence interval [CI], 1.95-9.41), opioid use in the prior 2 weeks (OR, 2.89; CI, 1.19-7.02), current manic episode (OR, 3.59; CI, 1.33-9.70), and a history of seizures (OR, 4.19; CI, 1.16-15.14). Risk of self-harm while in the emergency department may be mitigated with interventions that support adaptive coping skills, promptly address pain and withdrawal symptoms, and treat mania.

Violence in Psychiatric Settings: Demographic and Clinical Characteristics of Patients Who Were Targets of Aggression.

ABSTRACT: Violence is a serious concern in the psychiatric inpatient and emergency setting. Much of the research on victims of inpatient violence has focused on identifying and supporting staff who are at risk of being victimized when working in psychiatric settings. This article presents an analysis of 72 patients who were targeted during incidents of patient-on-patient physical aggression in hospital-based psychiatric settings (both inpatient and emergency) from 2014 to 2018. Results suggest that patients who are at risk of being targeted by another patient while in the hospital tend to be younger, are more likely to be male, and present with manic symptoms and recent cannabis use. These variables have all been identified as risk factors for perpetration of violence by patients with mental illness. This study adds to a literature demonstrating a consistent overlap between individuals with mental illness who are victimized and those who initiate violence.

Religion as a Risk Factor for Suicide Attempt and Suicide Ideation Among Depressed Patients.

We aimed to examine the relationship between religion and suicide attempt and ideation. Three hundred twenty-one depressed patients were recruited from mood-disorder research studies at the New York State Psychiatric Institute. Participants were interviewed using the Structured Clinical Interview for DSM Disorders, Columbia University Suicide History form, Scale for Suicide Ideation, and Reasons for Living Inventory. Participants were asked about their religious affiliation, importance of religion, and religious service attendance. We found that past suicide attempts were more common among depressed patients with a religious affiliation (odds ratio, 2.25; p = 0.007). Suicide ideation was greater among depressed patients who considered religion more important (coefficient, 1.18; p = 0.026) and those who attended services more frequently (coefficient, 1.99; p = 0.001). We conclude that the relationship between religion and suicide risk factors is complex and can vary among different patient populations. Physicians should seek deeper understanding of the role of religion in an individual patient's life in order to understand the person's suicide risk factors more fully.

Religious Coping Among Adults Caring for Family Members with Serious Mental Illness.

This cross-sectional study investigated the use of religious coping strategies among family members of adults with serious mental illness. A sample of 436 individuals caring for a family member with serious mental illness were recruited into a randomized clinical trial for the National Alliance on Mental Illness Family to Family Education Program. Relationships are reported between religious coping and caregiving, care recipient, and mental health services outcomes. Religious coping was associated with more objective caregiving burden, greater care recipient need, less mental health knowledge, and less receipt of mental health services after adjusting for non-religious types of coping. At the same time, religious coping was associated with a positive caregiving experience and greater religious support. Religious coping plays an important role for many caregivers of persons with serious mental illness. Caregivers who use more religious coping may have an especially high need for mental health education and mental health services.

Psychiatrists' and primary care physicians' beliefs about overtreatment of depression and anxiety.

Critics say that physicians overdiagnose and overtreat depression and anxiety. We surveyed 1504 primary care physicians (PCPs) and 512 psychiatrists, measuring beliefs about overtreatment of depression and anxiety and predictions of whether persons would benefit from taking medication, investing in relationships, and investing in spiritual life. A total of 63% of PCPs and 64% of psychiatrists responded. Most agreed that physicians too often treat normal sadness as a medical illness (67% of PCPs and 62% of psychiatrists) and too often treat normal worry and stress as a medical illness (59% of PCPs, 55% of psychiatrists). Physicians who agreed were less likely to believe that depressed or anxious people would benefit "a lot" from taking an antidepressant (36% vs. 58% of PCPs) or antianxiety medication (25% vs. 42% of PCPs, 42% vs. 57% of psychiatrists). Most PCPs and psychiatrists believe that physicians too often treat normal sadness and worry as a medical illness.

Physician race and treatment preferences for depression, anxiety, and medically unexplained symptoms.

OBJECTIVES: Studies have repeatedly shown racial and ethnic differences in mental health care. Prior research focused on relationships between patient preferences and ethnicity, with little attention given to the possible relationship between physicians' ethnicity and their treatment recommendations. DESIGN: A questionnaire was mailed to a national sample of US primary care physicians and psychiatrists. It included vignettes of patients presenting with depression, anxiety, and medically unexplained symptoms. Physicians were asked how likely they would be to advise medication, see the patient regularly for counseling, refer to a psychiatrist, or refer to a psychologist or licensed mental health counselor. RESULTS: The response rate was 896 of 1427 (63%) for primary care physicians and 312 of 487 (64%) for psychiatrists. Treatment preferences varied across diagnoses. Compared to whites (referent), black primary care physicians were less likely to use antidepressants (depression vignette), but more likely to see the patient for counseling (all vignettes), and to refer to a psychiatrist (depression vignette). Asian primary care physicians were more likely to see the patient for counseling (anxiety and medically unexplained symptoms vignettes) and to refer to a psychiatrist (depression and anxiety vignettes). Asian psychiatrists were more likely to recommend seeing the patient regularly for counseling (depression vignette). CONCLUSIONS: Overall, these findings suggest that physician race and ethnicity contributes to different patterns of treatment for basic mental health concerns.

Ethics in placebo-controlled, acute treatment trials in schizophrenia: Two rival ethical frameworks.

Placebo-controlled, acute treatment trials in schizophrenia enroll acutely symptomatic persons, randomize them to receive placebo or antipsychotic medication for several weeks, and evaluate whether symptoms improve. These trials can have scientific benefits, especially when they test drugs with novel mechanisms of action. However, the use of placebo is ethically problematic inasmuch as standard treatment is withheld and participants are subjected to prolonged psychotic symptoms and associated risks. We propose that both deontological (duty-based) and utilitarian analyses are relevant, that it may be impossible to satisfy the ideals of both frameworks, and that researchers who conduct these trials will unavoidably encounter ethical tension and criticism even when they give careful attention to ethical aspects of study design.

Clinical Trials Studying Suicide Risk Reduction: Who is Excluded From Participation.

OBJECTIVE: The use of exclusion criteria in clinical trials can cause research participants to differ markedly from clinical populations, which negatively impacts generalizability of results. This study identifies and quantifies common and recurring exclusion criteria in clinical trials studying suicide risk reduction, and estimates their impact on eligibility among a clinical sample of adults in an emergency department with high suicide risk. METHOD: Recent trials were identified by searching PubMed (terms suicide, efficacy, effectiveness, limited to clinical trials in prior 5 years). Common exclusion criteria were identified using Qualitative Content Analysis. A retrospective chart review examined a one-month sample of all adults receiving psychiatric evaluation in a large urban academic emergency department. RESULTS: The search yielded 27 unique clinical trials studying suicide risk reduction as a primary or secondary outcome. After research fundamentals (e.g. informed consent, language fluency), the most common exclusion criteria involved psychosis (77.8%), cognitive problems (66.7%), and substance use (63.0%). In the clinical sample of adults with high suicide risk (N = 232), psychosis exclusions would exclude 53.0% of patients and substance use exclusions would exclude 67.2% of patients. Overall, 5.6% of emergency psychiatry patients would be eligible for clinical trials that use common exclusion criteria. CONCLUSIONS: Recent clinical trials studying suicide risk reduction have low generalizability to emergency psychiatry patients with high suicide risk. Trials enrolling persons with psychosis and substance use in particular are needed to improve generalizability to this clinical population.

Exclusion criteria limit who can enroll in trials studying suicide risk reduction.Trials most frequently exclude psychosis, cognitive problems, and substance use.Trials have poor generalizability to emergency psychiatry patients.

Intramuscular ketamine vs. midazolam for rapid risk-reduction in suicidal, depressed emergency patients: Clinical trial design and rationale.

Emergency department (ED) visits for suicidal ideation or behavior have been increasing in all age groups, particularly younger adults. A rapid-acting treatment to reduce suicidal thinking, adapted for ED use, is needed. Previous studies have shown a single dose of ketamine can improve depression and suicidal ideation within hours. However, most studies used 40 min intravenous infusions which can be impractical in a psychiatric ED. The ER-Ketamine study we describe here is a randomized midazolam-controlled clinical trial (RCT; NCT04640636) testing intramuscular (IM) ketamine's feasibility, safety, and effectiveness to rapidly reduce suicidal ideation and depression in a psychiatric ED. A pre-injection phase involves screening, informed consent, eligibility confirmation, and baseline assessment of suicidal ideation, depression, and comorbidities. The randomized double-blind IM injection is administered in the ED under research staff supervision, vital sign monitoring, pharmacokinetic blood sampling, and clinical assessments. The post-injection phase occurs on a psychiatric inpatient unit with follow-up research assessments through four weeks post-discharge. Outcome measures are feasibility, safety, and effects on suicidal ideation and depression at 24 h post-injection, and through follow-up. The target sample is N = 90 adults in a major depressive episode, assessed by ED clinicians as warranting hospitalization for suicide risk. Here we report design, rationale, and preliminary feasibility and safety for this ongoing study. Demographics of the 53 participants (ages 18 to 65 years) randomized to date suggest a diverse sample tending towards younger adults.

Physicians' Beliefs about the nature of addiction: a survey of primary care physicians and psychiatrists.

BACKGROUND AND OBJECTIVES: Society debates whether addiction is a disease, a response to psychological woundedness, or moral failing. METHOD: We surveyed a national sample of 1427 US primary care physicians (PCPs) and 487 psychiatrists, asking "In your judgment, to what extent is alcoholism/drug addiction each of the following? A) a disease B) a response to psychological woundedness C) a result of moral failings." RESULTS: The response rate was 63% for PCPs and 64% for psychiatrists. More psychiatrists than PCPs consider addiction a disease (64% versus 56%). Some PCPs (31%) and psychiatrists (27%) attribute addiction to psychological woundedness. More psychiatrists than PCPs said addiction is "not at all" due to moral failings (55% versus 39%). CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: The disease model for addiction is prominent among physicians, but exists alongside beliefs that addiction is a response to psychological woundedness, or a result of moral failings.

Eligibility of emergency psychiatry patients for clinical trials studying depression.

BACKGROUND: Differences often exist between people with depression who are eligible for clinical trials and those seen in clinical practice. The impact of exclusion criteria on eligibility has been previously reported for inpatients and outpatients, but has not been assessed for emergency psychiatry patients; a group that overlaps with inpatients and outpatients but also has important distinctives. Understanding the frequencies of commonly used exclusion criteria in this population could inform interpretation of existing data (generalizability) and highlight opportunities/needs for future trials. METHODS: We reviewed 67 clinical trials studying depression using Qualitative Content Analysis to identify common and recurring exclusion criteria. We examined the frequency of these exclusion criteria among a clinical sample of emergency psychiatry patients. RESULTS: Most clinical trials had exclusions for basic research requirements, age, symptom severity, psychosis, and substance use. Applying 9 commonly used exclusion criteria to the clinical population resulted in a 3.3 % eligibility rate (95 % CI 1.2 %-7.0 %). Exclusions for psychosis (85.1 % of trials), substance use (83.6 % of trials), and suicide risk (65.7 % of trials) would likely exclude 93 % of emergency psychiatry patients. The prevalence of psychosis, substance use, and suicide risk was much higher among emergency psychiatry patients than among previously studied populations. LIMITATIONS: Some eligibility criteria could not be measured. The Qualitative Content Analysis consolidated similar exclusion criteria, losing potentially important nuances in wordings. CONCLUSIONS: Exclusion criteria commonly used in contemporary clinical trials of depression limit generalizability to emergency psychiatry patients, due in large part to exclusions for psychosis, substance use, and suicide risk.

Physical Assault in the Psychiatry Emergency Room.

Previous studies of physical assaults in hospitals focused primarily on inpatient psychiatric units, leaving unanswered questions about the extent to which findings generalize to psychiatric emergency rooms. Assault incident reports and electronic medical records from one psychiatric emergency room and two inpatient psychiatric units were reviewed. Qualitative methods were used to identify precipitants. Quantitative methods were used to describe characteristics of each event, as well as demographic and symptom profiles associated with incidents. During the five-year study period, there were 60 incidents in the psychiatric emergency room and 124 incidents on the inpatient units. Precipitating factors, incident severity, means of assault, and interventions were similar in both settings. Among patients in the psychiatric emergency room, a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder with manic symptoms (Adjusted Odds Ratio (AOR) 27.86) and presenting with thoughts to harm others (AOR 10.94) were associated with an increased likelihood of having an assault incident report. Similarities between assaults in the psychiatric emergency room and inpatient psychiatric units suggest that the broader literature from inpatient psychiatry can be generalized to the psychiatric emergency room setting, although some differences exist. Reprinted from J Am Acad Psychiatry Law 2020; 48:484-495, with permission from The American Academy of Psychiatry and the Law. Copyright © 2020.

Obstetrician-gynecologists' beliefs about when pregnancy begins.

OBJECTIVE: The purpose of this study was to assess obstetrician-gynecologists' regarding their beliefs about when pregnancy begins and to measure characteristics that are associated with believing that pregnancy begins at implantation rather than at conception. STUDY DESIGN: We mailed a questionnaire to a stratified, random sample of 1800 practicing obstetrician-gynecologists in the United States. The outcome of interest was obstetrician-gynecologists' views of when pregnancy begins. Response options were (1) at conception, (2) at implantation of the embryo, and (3) not sure. Primary predictors were religious affiliation, the importance of religion, and a moral objection to abortion. RESULTS: The response rate was 66% (1154/1760 physicians). One-half of US obstetrician-gynecologists (57%) believe pregnancy begins at conception. Fewer (28%) believe it begins at implantation, and 16% are not sure. In multivariable analysis, the consideration that religion is the most important thing in one's life (odds ratio, 0.5; 95% confidence interval, 0.2-0.9) and an objection to abortion (odds ratio, 0.4; 95% confidence interval, 0.2-0.9) were associated independently and inversely with believing that pregnancy begins at implantation. CONCLUSION: Obstetrician-gynecologists' beliefs about when pregnancy begins appear to be shaped significantly by whether they object to abortion and by the importance of religion in their lives.

Predictors of hospitalised patients' preferences for physician-directed medical decision-making.

BACKGROUND: Although medical ethicists and educators emphasise patient-centred decision-making, previous studies suggest that patients often prefer their doctors to make the clinical decisions. OBJECTIVE: To examine the associations between a preference for physician-directed decision-making and patient health status and sociodemographic characteristics. METHODS: Sociodemographic and clinical information from all consenting general internal medicine patients at the University of Chicago Medical Center were examined. The primary objectives were to (1) assess the extent to which patients prefer an active role in clinical decision-making, and (2) determine whether religious service attendance, the importance of religion, self-rated spirituality, Charlson Comorbidity Index, self-reported health, Vulnerable Elder Score and several demographic characteristics were associated with these preferences. RESULTS: Data were collected from 8308 of 11,620 possible participants. Ninety-seven per cent of respondents wanted doctors to offer them choices and to consider their opinions. However, two out of three (67%) preferred to leave medical decisions to the doctor. In multiple regression analyses, preferring to leave decisions to the doctor was associated with older age (per year, OR=1.019, 95% CI 1.003 to 1.036) and frequently attending religious services (OR=1.5, 95% CI 1.1 to 2.1, compared with never), and it was inversely associated with female sex (OR=0.6, 95% CI 0.5 to 0.8), university education (OR=0.6, 95% CI 0.4 to 0.9, compared with no high school diploma) and poor health (OR=0.6, 95% CI 0.3 to 0.9). CONCLUSIONS: Almost all patients want doctors to offer them choices and to consider their opinions, but most prefer to leave medical decisions to the doctor. Patients who are male, less educated, more religious and healthier are more likely to want to leave decisions to their doctors, but effects are small.

Antipsychotic Maintenance Treatment for Patients With Schizophrenia: The Need for Placebo-Controlled Trials and The Risk of Paradigm Shifts.

Background and Hypothesis: There is limited evidence guiding clinicians and patients on how long to continue antipsychotic medication beyond the first 1-2 years of treatment. Data from long-term (beyond 2 years) placebo-controlled trials would be informative but would be resource-intensive and technically difficult to obtain. Philosophy and history offer perspective on whether schizophrenia researchers should invest in such trials. Study Design: Essay. Results: In Descartes' model of science, knowledge grows by accumulation and evolves from simpler toward more complex areas. From this perspective, the most important questions are when and how to build this evidence base. In Kuhn's model of science, paradigm shifts can occur that reframe which questions and answers are meaningful. From this perspective, the question of whether to invest in long-term placebo-controlled trials is especially important. An historical review of schizophrenia over the past century indicates that major paradigm shifts have occurred regarding schizophrenia treatments, what counts as evidence, and the definition of schizophrenia. Conclusions: While long-term placebo-controlled trials would add value within the current paradigm, if a paradigm shift occurs there is a risk that this value would not be maintained in the new paradigm.

Self-harm During Visits to the Emergency Department: A Qualitative Content Analysis.

BACKGROUND: Some patients engage in self-harm behaviors while in the emergency department, both suicidal and nonsuicidal self-harm. Little is known about what motivates these behaviors. This gap in the empirical literature limits efforts to develop early identification and risk mitigation strategies. OBJECTIVE: To describe methods and motivations when patients self-harm in the emergency department. METHOD: Authors reviewed self-harm incident reports and medical records from two urban academic emergency departments. Event timing and self-harm methods were extracted. Authors performed a qualitative content analysis of self-harm narratives to examine the question, "Which factors motivate patients to engage in deliberate (nonaccidental) self-harm in the emergency department?" RESULTS: The sample included 184 self-harm incidents involving 118 unique patients. A wide variety of self-harm methods were present in the data. Suicidal intent was present in a minority of incidents. Other motives included psychosis, intoxication, aggression, managing distress, communication, and manipulation. CONCLUSIONS: Self-harm behaviors in the emergency department encompassed a variety of methods and motivations. These findings suggest risk mitigation strategies that emphasize suicide screening, reducing environmental hazards, and increasing observation are unlikely to achieve the goal of zero harm. Strategies focusing on engagement may create more fruitful opportunities to improve patient safety.

Obstetrician-gynecologists' views on contraception and natural family planning: a national survey.

OBJECTIVE: The objective of the study was to characterize beliefs about contraception among obstetrician-gynecologists. STUDY DESIGN: National mailed survey of 1800 US obstetrician-gynecologists. Criterion variables were whether physicians have a moral or ethical objection to, and whether they would offer, 6 common contraceptive methods. Covariates included physician demographic and religious characteristics. RESULTS: One thousand one hundred fifty-four of 1760 eligible obstetrician-gynecologists responded (66%). Some obstetrician-gynecologists object to intrauterine devices (4.4% object, 3.6% would not offer), progesterone implants and/or injections (1.7% object, 2.1% would not offer), tubal ligations (1.5% object, 1.5% would not offer), oral contraceptive pills (1.3% object, 1.1% would not offer), condoms (1.3% object, 1.8% would not offer), and the diaphragm or cervical cap with spermicide (1.3% object, 3.3% would not offer). Religious physicians were more likely to object (odds ratio, 7.4) and to refuse to provide a contraceptive (odds ratio, 1.9). CONCLUSION: Controversies about contraception are ongoing but among obstetrician-gynecologists, objections and refusals to provide contraceptives are infrequent.

The rise of empirical research in medical ethics: a MacIntyrean critique and proposal.

Hume's is/ought distinction has long limited the role of empirical research in ethics, saying that data about what something is cannot yield conclusions about the way things ought to be. However, interest in empirical research in ethics has been growing despite this countervailing principle. We attribute some of this increased interest to a conceptual breakdown of the is/ought distinction. MacIntyre, in reviewing the history of the is/ought distinction, argues that is and ought are not strictly separate realms but exist in a close relationship that is clarified by adopting a teleological orientation. We propose that, instead of recovering a teleological orientation, society tends to generate its own goals via democratic methods like those described by Rousseau or adopt agnosticism about teleology such as described by Richard Rorty. In both latter scenarios, the distinction between is and ought is obscured, and the role for empirical research grows, but for controversial reasons. MacIntyre warns that the is/ought distinction should remain, but reminds ethicists to make careful arguments about when and why it is legitimate to move from is to ought.

A historical review of placebo-controlled, relapse prevention trials in schizophrenia: The loss of clinical equipoise.

Recent ethical critiques have proposed that placebo-controlled, relapse prevention trials in schizophrenia are no longer justifiable and are therefore unethical. This review provides an historical perspective on the justifications for these trials and how arguments evolved over several decades. We identified 87 placebo-controlled, relapse prevention trials published over the last seventy years and examined the purpose for each trial. We found that first-generation trials had compelling justifications, yet these arguments changed considerably over time. Second-generation trials offered comparatively weaker-and sometimes no-justifications for their conduct. Without clear and compelling justifications for a given trial, it is not ethical to continue using this study design.