Regulatory and Service System Challenges in Accessing Electroconvulsive Therapy for Catatonia in the Presence of Autism Spectrum Disorder.

In a recent letter to the editor, Dr. Miller and colleagues1 highlighted the disparity of electroconvulsive therapy (ECT) across different states, and the challenges faced by a patient in Colorado for whom ECT was deemed the most appropriate treatment but was not available in this location, forcing the patient to seek care in New Mexico. A subsequent letter by Dr. Ong and colleagues2 presented an additional case, in a different location, where a delay in ECT treatment because of state regulations contributed to substantial patient morbidity. In this letter, we present a patient seen at our facility in California, a state with some of the most stringent regulations regarding ECT treatment in adolescents.3 This case illustrates how ECT was eventually approved by the court system only after the patient's continual deterioration, despite receiving intensive medical treatment on an inpatient pediatric medical unit for a duration of 80 days. Care providers and the patient's family were forced to witness this decline until the patient reached "an emergency situation" and ECT was "deemed a lifesaving treatment," as the California Welfare and Institutions Code (WIC) § 5,326.8(a) forbids the procedure under any other circumstances.

The iatrogenic opioid crisis: An example of 'institutional corruption of pharmaceuticals'?

RATIONALE: Prescribed opioids are major contributors to the international public health opioid crisis. Such widespread iatrogenic harms usually result from collective decision failures of healthcare organizations rather than solely of individual organizations or professionals. Findings from a system-wide safety analysis of the iatrogenic opioid crisis that includes roles of pertinent healthcare organizations may help avoid or mitigate similar future iatrogenic consequences. In this retrospective exploratory study, we report such an analysis. METHODS: The study population encompassed the entire age spectrum and included those in whom opioids prescribed for chronic pain (unrelated to malignancy) were associated with death or morbidity. Root cause analysis, incorporating recent suggestions for improvement, was used to identify possible contributory factors from the literature. Based on their mandated roles and potential influences to prevent or mitigate the iatrogenic crisis, relevant organizations were grouped and stratified from most to least influential. RESULTS: The analysis identified a chain of multiple interrelated causal factors within and between organizations. The most influential organizations were pharmaceutical, political, and drug regulatory; next: experts and their related societies, and publications. Less influential: accreditation, professional licensing and regulatory, academic and healthcare funding bodies. Collectively, their views and decisions influenced prescribing practices of frontline healthcare professionals and advocacy groups. Financial associations between pharmaceutical and most other organizations/groups were common. Ultimately, patients were adversely affected. There was a complex association with psychosocial variables. LIMITATIONS: The analysis suggests associations not causality. CONCLUSION: The iatrogenic crisis has multiple intricately linked roots. The major catalyst: pervasive pharma-linked financial conflicts of interest (CoIs) involving most other healthcare organizations. These extensive financial CoIs were likely triggers for a cascade of erroneous decisions and actions that adversely affected patients. The actions and decisions of pharma ranged from unethical to illegal. The iatrogenic opioid crisis may exemplify 'institutional corruption of pharmaceuticals'.

Gating the holes in the Swiss cheese (part I): Expanding professor Reason's model for patient safety.

INTRODUCTION: Although patient safety has improved steadily, harm remains a substantial global challenge. Additionally, safety needs to be ensured not only in hospitals but also across the continuum of care. Better understanding of the complex cognitive factors influencing health care-related decisions and organizational cultures could lead to more rational approaches, and thereby to further improvement. HYPOTHESIS: A model integrating the concepts underlying Reason's Swiss cheese theory and the cognitive-affective biases plus cascade could advance the understanding of cognitive-affective processes that underlie decisions and organizational cultures across the continuum of care. METHODS: Thematic analysis, qualitative information from several sources being used to support argumentation. DISCUSSION: Complex covert cognitive phenomena underlie decisions influencing health care. In the integrated model, the Swiss cheese slices represent dynamic cognitive-affective (mental) gates: Reason's successive layers of defence. Like firewalls and antivirus programs, cognitive-affective gates normally allow the passage of rational decisions but block or counter unsounds ones. Gates can be breached (ie, holes created) at one or more levels of organizations, teams, and individuals, by (1) any element of cognitive-affective biases plus (conflicts of interest and cognitive biases being the best studied) and (2) other potential error-provoking factors. Conversely, flawed decisions can be blocked and consequences minimized; for example, by addressing cognitive biases plus and error-provoking factors, and being constantly mindful. Informed shared decision making is a neglected but critical layer of defence (cognitive-affective gate). The integrated model can be custom tailored to specific situations, and the underlying principles applied to all methods for improving safety. The model may also provide a framework for developing and evaluating strategies to optimize organizational cultures and decisions. LIMITATIONS: The concept is abstract, the model is virtual, and the best supportive evidence is qualitative and indirect. CONCLUSIONS: The proposed model may help enhance rational decision making across the continuum of care, thereby improving patient safety globally.

Evidence-informed person-centred health care (part II): are 'cognitive biases plus' underlying the EBM paradigm responsible for undermining the quality of evidence?

INTRODUCTION: Recently, some leaders of the evidence-based medicine (EBM) movement drew attention to the "unintended" negative consequences associated with EBM. The term 'cognitive biases plus' was introduced in part I to encompass cognitive biases, conflicts of interests, fallacies and certain behaviours. HYPOTHESIS: 'Cognitive biases plus' in those closely involved in creating and promoting the EBM paradigm are responsible for their (1) inability to anticipate and then recognize flaws in the tenets of EBM; (2) discounting alternative views; and (3) delaying reform. METHODS: A narrative review style was used, with methods as in part I. APPRAISAL OF LITERATURE: Over the past two decades there has been mounting qualitative and quantitative methodological evidence to suggest that the faith placed in (1) the EBM hierarchy with randomized controlled trials and systematic reviews at the summit; (2) the reliability of biostatistical methods to quantitate data; and (3) the primacy of sources of pre-appraised evidence, is seriously misplaced. Consequently, the evidence that informs person-centred care is compromised. DISCUSSION: Arguments focusing on 'cognitive biases plus' are offered to support our hypothesis. To the best of our knowledge, EBM proponents have not provided an explanation. CONCLUSIONS: Reform is urgently needed to minimize continuing risks to patients. If our hypothesis is correct, then in addition to the suggestions made in part I, deficiencies in the paradigm must be corrected. Meaningful solutions are only possible if the biases of scientific inbreeding and groupthink are minimized by collaboration between EBM leaders and those who have been sounding warning bells.

Evidence-informed person-centered healthcare part I: do 'cognitive biases plus' at organizational levels influence quality of evidence?

INTRODUCTION: There is increasing concern about the unreliability of much of health care evidence, especially in its application to individuals. HYPOTHESIS: Cognitive biases, financial and non-financial conflicts of interest, and ethical violations (which, together with fallacies, we collectively refer to as 'cognitive biases plus') at the levels of individuals and organizations involved in health care undermine the evidence that informs person-centred care. METHODS: This study used qualitative review of the pertinent literature from basic, medical and social sciences, ethics, philosophy, law etc. RESULTS: Financial conflicts of interest (primarily industry related) have become systemic in several organizations that influence health care evidence. There is also plausible evidence for non-financial conflicts of interest, especially in academic organizations. Financial and non-financial conflicts of interest frequently result in self-serving bias. Self-serving bias can lead to self-deception and rationalization of actions that entrench self-serving behaviour, both potentially resulting in unethical acts. Individuals and organizations are also susceptible to other cognitive biases. Qualitative evidence suggests that 'cognitive biases plus' can erode the quality of evidence. CONCLUSIONS: 'Cognitive biases plus' are hard wired, primarily at the unconscious level, and the resulting behaviours are not easily corrected. Social behavioural researchers advocate multi-pronged measures in similar situations: (i) abolish incentives that spawn self-serving bias; (ii) enforce severe deterrents for breaches of conduct; (iii) value integrity; (iv) strengthen self-awareness; and (v) design curricula especially at the trainee level to promote awareness of consequences to society. Virtuous professionals and organizations are essential to fulfil the vision for high-quality individualized health care globally.

A successful treatment of buprenorphine withdrawal with the dopamine receptor agonist pramipexole.

BACKGROUND: Buprenorphine, used for treating opioid dependence, may have a withdrawal syndrome requiring treatment. Modulation of the dopamine system, which has been implicated in opioid withdrawal, may be a target for withdrawal for opioids such as buprenorphine. CASE REPORT: A case is reported of a buprenorphine withdrawal syndrome with predominant symptoms of restlessness that were resistant to clonidine and benzodiazepines. It was successfully treated with the dopamine agonist pramipexole. SCIENTIFIC SIGNIFICANCE: Dopamine receptor agonists may have a place in the treatment of restlessness associated with opioid withdrawal and may have value for the broader spectrum of opioid withdrawal symptoms.

Successful treatment of co-occurring catatonia and obsessive-compulsive disorder with concurrent electroconvulsive therapy and benzodiazepine administration.

Catatonia, associated with a variety of medical and psychiatric conditions such as mood disorders and schizophrenia, is frequently treated with either benzodiazepines or with electroconvulsive therapy (ECT) in treatment-resistant cases. Simultaneous treatment with both is usually avoided. Here, we report a case of the use of the benzodiazepine antagonist flumazenil before ECT to facilitate the simultaneous use of lorazepam and ECT for the treatment of co-occurring catatonia and obsessive-compulsive disorder. Both catatonia and obsessive-compulsive disorder symptoms improved in the patient. Physicians should be aware of flumazenil as a clinical tool for use in treatment-resistant cases.

Biases in the evaluation of psychiatric clinical evidence.

The evolution of medical research has vaulted randomized clinical trials to the status of current gold standard of clinical evidence. In parallel, the evolution of the science of decision-making has revealed human beings' universal tendency to make biased judgments and systematic errors in their evaluation of information and choices. As a result of numerous psychological biases, randomized clinical trials are more prone to error, misinterpretation, and faulty judgment than is often acknowledged. Interdisciplinary fields of experimental psychology, economics, and social science are drawn upon to examine psychological biases in the interpretation of clinical evidence. A number of these are postulated to be important, both for the investigators generating clinical evidence and for the clinical observers interpreting clinical trials. This study focuses on the field of psychiatry and on the potentially significant implications of evidence biases for psychiatric practice and clinical understanding.

Biases in medication prescribing: the case of second-generation antipsychotics.

The shift from first-generation antipsychotic medications to second-generation antipsychotic medications initially caused a wave of excitement about the potential for improved and broader efficacy of these medications concurrent with an improved side-effect profile. Recent data from high-quality research analyses have subsequently raised significant questions about these claims. This research evidence has, however, not altered prescribing behavior in a way that would be expected from fully rational evaluation of the evidence. Prescribing decisions represent poorly understood, complex behaviors influenced by a number of external and internal forces, some of which may be elucidated by advances in social and cognitive psychology. In this article, the decision to prescribe first- versus second-generation antipsychotic medications is examined, and specific social psychological biases and individual cognitive biases are hypothesized to be significant influences on clinicians. These biases may perpetuate disparity between research evidence and clinical practice.

Electroconvulsive therapy for depression in a patient with an intracranial arachnoid cyst.

Electroconvulsive therapy (ECT) has been frequently considered relatively contraindicated in patients with space-occupying lesions in the brain. After the 7 cases available in the literature, we describe the safe use of ECT in a depressive patient with arachnoid cyst. We provide a comprehensive review on this clinical association, and we conclude that even if the few data available are reassuring, careful neurological evaluation before the ECT treatment is indicated.