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The Accountability for Reasonableness (A4R) framework addresses the legitimacy of coverage decision processes by defining four conditions for accountable and reasonable processes: Relevance, Publicity, Appeals, Implementation. Cost-per-quality-adjusted life year (QALY) and multicriteria-centered processes may have distinct implications for meeting A4R conditions. The aim of this study was to reflect on how the diverse features of decision-making processes can be aligned with A4R conditions to guide legitimized decision-making. Rare disease and regenerative therapies (RDRTs) pose special decision-making challenges and offer a useful case study.
To support reflection on how different approaches address the A4R conditions, thirty-four features operationalizing each condition were defined and organized into a matrix. Seven experts from six countries explored and discussed these features during a panel (Chatham House Rule) and provided general and RDRT-specific recommendations for each feature. Responses were analyzed to identify converging and diverging recommendations.
Regarding Relevance, panelists highlighted the importance of supporting deliberation, stakeholder participation and grounding coverage decision criteria in the legal framework, goals of sustainable healthcare and population values. Among seventeen criteria, thirteen were recommended by more than half of panelists. Although the cost-effectiveness ratio was deemed sometimes useful, the validity of universal thresholds to inform allocative efficiency was challenged. Regarding Publicity, panelists recommended communicating the values underlying a decision in reference to broader societal objectives, and being transparent about value judgements in selecting evidence. For Appeals, recommendations included clear definition of new evidence and revision rules. For Implementation, one recommendation was to perform external quality reviews of decisions. While RDRTs raise issues that may warrant special consideration, rarity should be considered in interaction with other aspects (e.g. disease severity, age, budget impact).
Improving coverage decision-making towards accountability and reasonableness involves supporting participation and deliberation, enhancing transparency, and more explicit consideration of multiple decision criteria that reflect normative and societal objectives.
This chapter explores that clinical anxiety involves changes in brain systems that are involved in the generation and regulation of normal emotion. It focuses on a core circuit for negative affective reactivity identified in animal and human studies of fear conditioning. The executive working memory system is a set of cortical networks that comprise a system for goal-directed, flexible control over attention and memory. The affective appraisal system is a set of paralimbic cortical and subcortical regions involved in emotion generation and regulation, self-related cognition, long-term memory retrieval, and context based modulation of conditioned fear. The number of functional neuroimaging studies of negative emotion in clinical anxiety disorders has grown at a rapid pace, now reaching a point at which a quantitative meta-analytic review is feasible. Compared to depression, relatively few neuroimaging coupled intervention studies have been reported for each anxiety disorder.
Summary of treatment modalities in psychiatric disorders
Antonio Mantovani, Department of Psychiatry Division of Brain Stimulation and Therapeutic Modulation New York State Psychiatric Institute NY USA,
Arielle D. Stanford, Department of Psychiatry Division of Brain Stimulation and Therapeutic Modulation New York State Psychiatric Institute New York, NY USA,
Peter Bulow, Department of Psychiatry Division of Brain Stimulation and Therapeutic Modulation New York State Psychiatric Institute NY USA,
Sarah H. Lisanby, Department of Psychiatry Columbia University; Department of Biological Psychiatry New York State Psychiatric Institute NY USA
Peter Tyrer, Imperial College of Science, Technology and Medicine, London,Kenneth R. Silk, University of Michigan, Ann Arbor
This chapter illustrates how fast-growing are effective treatments in psychiatry. Twenty years ago the contents of this chapter would hardly be understood by the average clinician; now each new treatment is hammering on the door of clinical practice demanding to be let in. The most researched treatment is transcranial magnetic stimulation (TMS); this has been shown clearly to have antidepressant efficacy and, although not as effective as ECT in severe depression, has fewer adverse effects. All the other treatments are really at the early stage of clinical experience and are not first-line treatments. Magnetic seizure therapy and vagus nerve stimulation may have a role in treatment-resistant depression and deep brain stimulation (DBS) is likely to replace the various forms of leucotomy still practiced in some parts of the world, mainly because DBS can be controlled and directed so much more specifically than the older treatments. Transcranial direct current stimulation (tDCS) may also have antidepressant effects but more studies are needed. We will all be hearing more about these new treatments which have the potential to replace ECT, leucotomy and related treatments entirely.
Advances in the science and technology of neuromodulation over the past two decades have led to several interventions that have rekindled clinical and research interest in nonpharmacological somatic therapies. Although electroconvulsive therapy (ECT) remains the only somatic treatment with widespread acceptance and application based upon 70 years of clinical use, transcranial magnetic stimulation (TMS), magnetic seizure therapy (MST), vagus nerve stimulation (VNS), deep brain stimulation (DBS) and transcranial direct current stimulation (tDCS), all offer novel means of potentially treating neuropsychiatric conditions and may provide a better understanding of the brain pathophysiology of these disorders.
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