Authentic Self and Last Resort: International Perceptions of Psychiatric Neurosurgery.

Psychiatric neurosurgery has resurfaced over the past two decades for the treatment of severe mental health disorders, with improved precision and safety over older interventions alongside the development of novel ones. Little is known, however, about current public opinions, expectations, hopes, and concerns over this evolution in neurotechnology, particularly given the controversial history of psychosurgery. To fill this knowledge gap, we conducted a study with eight focus groups in Vancouver and Montreal (Canada; n = 14), Berlin (Germany; n = 22), and Madrid (Spain; n = 12). Focus group texts were transcribed and analyzed using qualitative content analysis in the language local to each city, guided by the theoretical framework of pragmatic neuroethics. Findings indicate that participants across all cities hold concerns about the last resort nature of psychiatric neurosurgery and the potential impact on the authentic self of patients who undergo these procedures. The views captured serve to advance discussion on the appropriate timing for psychiatric neurosurgery, promote sound health policy for the allocation of this resource, and foster scientific literacy about advances for mental health internationally.

A qualitative study exploring the expectations of people living with type 1 diabetes regarding prospective use of a hybrid closed-loop system.

AIM: To identify the expectations of a diversified sample of informed adults with type 1 diabetes on their prospective use of a hybrid closed-loop system. METHODS: Semi-structured interviews were conducted with 16 adults with type 1 diabetes who shared their expectations on an experimental hybrid closed-loop system after receiving information on its design, functioning and capability. The sample had equal representation of genders and diabetes management methods and was diversified according to age, education and occupation when possible. Qualitative content analysis of the interview transcripts with MaxQDA was used to identify expected benefits, expected inconveniences and concerns, expected improvements to design and functionalities, and interest and trust in the system. RESULTS: Participants expected benefits regarding diabetes management, clinical outcomes, psychosocial aspects of their lives, nutrition and meals, and physical activity. Participants expected inconveniences or shared concerns regarding wearability, costs and technical limitations. According to participants, improvements could be made to the system's physical appearance, practical convenience, functionalities, and software integration. Overall, 12 participants would use the system. While participants' trust could be immediate or grow over time, it could ultimately be conditional on the system's performance. CONCLUSION: Prospective users' general enthusiasm and trust foster the clinical and commercial success of hybrid closed-loop systems. However, poor user satisfaction caused by unrealistic expectations and plausible inconveniences and concerns may limit this success. Providing prospective users with comprehensive information while validating their understanding could mitigate unrealistic expectations. Improvements to design and coverage policies could favour uptake.

A critical review and analysis of ethical issues associated with the artificial pancreas.

The artificial pancreas combines a hormone infusion pump with a continuous glucose monitoring device, supported by a dosing algorithm currently installed on the pump. It allows for dynamic infusions of insulin (and possibly other hormones such as glucagon) tailored to patient needs. For patients with type 1 diabetes the artificial pancreas has been shown to prevent more effectively hypoglycaemic events and hyperglycaemia than insulin pump therapy and has the potential to simplify care. However, the potential ethical issues associated with the upcoming integration of the artificial pancreas into clinical practice have not yet been discussed. Our objective was to identify and articulate ethical issues associated with artificial pancreas use for patients, healthcare professionals, industry and policymakers. We performed a literature review to identify clinical, psychosocial and technical issues raised by the artificial pancreas and subsequently analysed them through a common bioethics framework. We identified five sensitive domains of ethical issues. Patient confidentiality and safety can be jeopardized by the artificial pancreas' vulnerability to security breaches or unauthorized data sharing. Public and private coverage of the artificial pancreas could be cost-effective and warranted. Patient selection criteria need to ensure equitable access and sensitivity to patient-reported outcomes. Patient coaching and support by healthcare professionals or industry representatives could help foster realistic expectations in patients. Finally, the artificial pancreas increases the visibility of diabetes and could generate issues related to personal identity and patient agency. The timely consideration of these issues will optimize the technological development and clinical uptake of the artificial pancreas.

'Around the edges': using behaviour change techniques to characterise a multilevel implementation strategy for a fall prevention programme.

BACKGROUND: Implementation strategies are needed to ensure that evidence-based healthcare interventions are adopted successfully. However, strategies are generally poorly described and those used in everyday practice are seldom reported formally or fully understood. Characterising the active ingredients of existing strategies is necessary to test and refine implementation. We examined whether an implementation strategy, delivered across multiple settings targeting different stakeholders to support a fall prevention programme, could be characterised using the Behaviour Change Technique (BCT) Taxonomy. METHODS: Data sources included project plans, promotional material, interviews with a purposive sample of stakeholders involved in the strategy's design and delivery and observations of staff training and information meetings. Data were analysed using TIDieR to describe the strategy and determine the levels at which it operated (organisational, professional, patient). The BCT Taxonomy identified BCTs which were mapped to intervention functions. Data were coded by three researchers and finalised through consensus. RESULTS: We analysed 22 documents, 6 interviews and 4 observation sessions. Overall, 21 out a possible 93 BCTs were identified across the three levels. At an organisational level, identifiable techniques tended to be broadly defined; the most common BCT was restructuring the social environment. While some activities were intended to encourage implementation, they did not have an immediate behavioural target and could not be coded using BCTs. The largest number and variety of BCTs were used at the professional level to target the multidisciplinary teams delivering the programme and professionals referring to the programme. The main BCTs targeting the multidisciplinary team were instruction on how to perform the (assessment) behaviour and demonstration of (assessment) behaviour; the main BCT targeting referrers was adding objects to the environment. At the patient level, few BCTs were used to target attendance. CONCLUSION: In this study, several behaviour change techniques were evident at the individual professional level; however, fewer techniques were identifiable at an organisational level. The BCT Taxonomy was useful for describing components of a multilevel implementation strategy that specifically target behaviour change. To fully and completely describe an implementation strategy, including components that involve organisational or systems level change, other frameworks may be needed.

Suicide and assisted dying in dementia: what we know and what we need to know. A narrative literature review.

BACKGROUND: Evidence-based data on prevalence and risk factors of suicidal intentions and behavior in dementia are as scarce as the data on assisted dying. The present literature review aimed on summarizing the current knowledge and provides a critical discussion of the results. METHODS: A systematic narrative literature review was performed using Medline, Cochrane Library, EMBASE, PSYNDEX, PSYCINFO, Sowiport, and Social Sciences Citation Index literature. RESULTS: Dementia as a whole does not appear to be a risk factor for suicide completion. Nonetheless some subgroups of patients with dementia apparently have an increased risk for suicidal behavior, such as patients with psychiatric comorbidities (particularly depression) and of younger age. Furthermore, a recent diagnosis of dementia, semantic dementia, and previous suicide attempts most probably elevate the risk for suicidal intentions and behavior. The impact of other potential risk factors, such as patient's cognitive impairment profile, behavioral disturbances, social isolation, or a biomarker based presymptomatic diagnosis has not yet been investigated. Assisted dying in dementia is rare but numbers seem to increase in regions where it is legally permitted. CONCLUSION: Most studies that had investigated the prevalence and risk factors for suicide in dementia had significant methodological limitations. Large prospective studies need to be conducted in order to evaluate risk factors for suicide and assisted suicide in patients with dementia and persons with very early or presymptomatic diagnoses of dementia. In clinical practice, known risk factors for suicide should be assessed in a standardized way so that appropriate action can be taken when necessary.

Real-time electromagnetic seed drop detection for permanent implants brachytherapy: Technology overview and performance assessment.

PURPOSE: To describe the principles and report on the performance of a novel real-time electromagnetic (EM) seed drop detection technology for permanent implants brachytherapy procedures. METHODS: A novel EM hollow needle prototype was recently developed by Philips. It possesses standard 3D tracking capability as well as a seed drop detection mechanism, both performed from a single custom built EM sensor. The detection mechanism is based on the magnetic permeability changes in the sensor as the seeds pass through. Drop position estimates are generated by the tracking information at the dropping instants. Three validation experiments were carried out in this study. First, the robustness of the detection mechanism was tested in free air with four different seed types. Detection waveforms were measured and commented. The accuracy of the seed drop position estimates was then evaluated using both 2D and 3D experiments. The procedures consisted of dropping seeds in phantoms, recording the drop position estimates, and finally registering the resulting spatial distributions on reference ones obtained by accurate modalities. Seeds were dropped on a specially designed plastic support adapted to brachytherapy template dimensions for 2D experiments, and true seed positions (reference distribution) were obtained by optical detection. In 3D experiments, seeds were dropped in edible gelatin and reference distributions were obtained by localizing the implants from CT scans of the phantoms. RESULTS: All four seed types were correctly detected by the needle prototype. In total, 250 seeds were dropped on the plastic support, and 96 were dropped in gelatin phantoms. The detection rate was 100% in both cases. The minimum, maximum, and average drop position errors were, respectively, 0.1(+1.6/ - 0.1), 2.9(+1.4/ - 1.5), and 0.9(+1.4/ - 0.7) mm for 2D, and 0.1(+1.0/ - 0.1), 2.1(+1.1/ - 0.8), and 0.6(+1.2/ - 0.5) mm for 3D experiments. CONCLUSIONS: The hollow needle prototype combines both EM tracking and automatic seed drop detection in a compact and convenient form. The EM detection mechanism is robust, and the seed drop position estimates appear sufficiently accurate for potential integration of the technology to current brachytherapy treatment planning systems. In that context, it would serve as a valuable tool for rapid dosimetry validation in real-time treatment delivery.

Cognitive enhancement in children and adolescents: is it in their best interests?

UNLABELLED: Evidence suggests children and adolescents are consuming stimulants and nonstimulants in the hopes of improving academic performance through cognitive enhancement. As such, clinicians may be faced with requests to prescribe enhancers for their paediatric patients. In this article, we analyse the ethics of cognitive enhancement in paediatrics in the light of the best interests standard, a guiding principle, often used to make decisions for minors in moral, legal, social and medical contexts. CONCLUSION: Cognitive enhancement in children and adolescents does not represent an ethical ideal that societies should strive for. Furthermore, paediatric cognitive enhancement does not meet the criteria for a minimally acceptable practice, given the health-related risks posed by these medications and the coercive environments such a practice creates. In line with a recent policy statement by the American Academy of Neurology, ethical and clinical arguments based on the best interests of paediatric patients encourage clinicians to refrain from engaging in this practice.

Diagnosis and management of Alzheimer's disease: past, present and future ethical issues.

There is great interest in the ethical issues associated with Alzheimer's disease (AD) and related dementias given the prevalence of AD and the evolving neuroscience landscape in matters of diagnoses and therapeutics. Much of the ethics discussion arises in the tension between the principle of not doing harm (principle of non-maleficence) in this vulnerable population and the development of effective treatments (principle of beneficence). Autonomy and capacity issues are also numerous, wide-ranging, and concern (1) day to day affairs such as driving safely and spending money wisely, (2) life-time events such as designating a legal representative in case of incapacity, making a will, (3) consenting to treatment and diagnostic procedures, (4) participating in research. The latter issue is particularly thorny and illustrates well the complexity of tackling concerns related to capacity. The impetus to protect AD patients has partly led to ethics regulation and policies making research on inapt patients more difficult because of stringent requirements for signed informed consent or for showing the value of the research to this specific patient population. New issues are arising that relate to earlier diagnosis using biomarkers and (possibly soon) the use of drugs that modify disease progression. We here summarize and discuss the different ethical issues associated with AD from a historical perspective, with emphasis on diagnostic and treatments issues.

Respect for autonomy in the healthcare context: observations from a qualitative study of young adults with cerebral palsy.

BACKGROUND: Respect for patient autonomy is a cornerstone of contemporary medical ethics and clinical practice. In its different shapes and forms (e.g. being informed, being engaged in discussions and decisions about medical care and being supported in developing healthcare preferences and choices), patient autonomy has been fostered by both paediatric and adult professional societies. The transition from paediatric to adult care creates a complex situation where autonomy for medical decisions shifts to the developing adolescent. More specific challenges to respect for autonomy may be experienced by young adults with cerebral palsy in the transition period where, for example, language and motor impairments may affect communication skills and this may be conflated with cognitive disability. AIM: To characterize perspectives towards autonomy in the healthcare context for young adults with cerebral palsy. METHOD: We carried out semi-structured interviews with 14 young adults (aged 18-25) with cerebral palsy. The audiotaped interviews were transcribed verbatim and analysed using a conventional thematic qualitative content analysis. RESULTS: Participants displayed a range of attitudes towards autonomy, suggesting that the value of autonomy is considered in light of competing values and of context. Testimonials from participants demonstrated that both contextual (e.g. ill-adapted health care, lack of specialized public transport) and relational (e.g. attitudes towards parental involvement in decision making) factors negatively or positively impact autonomy. CONCLUSION: We observed that there were four key elements interwoven in participants' characterization of autonomy: the coupling of decisional and physical autonomy, the influences of family and society on autonomy, the influence of healthcare professionals on autonomy and the need for preparation for autonomy.

The effect of medical nutrition therapy on changes in dietary knowledge and DASH diet adherence in older adults with cardiovascular disease.

OBJECTIVE: To examine the effect of MNT on dietary knowledge of older adults at baseline, 6 months and 12 months and to assess the effect of dietary knowledge on change in DASH diet adherence from baseline to 12 months. DESIGN: Data for the analysis come from a controlled, randomized prospective design conducted from 2003-2005 with the outcome measures taken pre-, mid-, and post-intervention. SETTING: Data were collected from participants in their homes in an urban community in North Carolina. PARTICIPANTS: Participants (N=147) were adults aged 60+ with a diagnosis of hypertension and/or hyperlipidemia. INTERVENTION: Intervention recipients received three sessions of MNT throughout the 1 year study period. The control group received nutrition information at enrollment. MEASUREMENTS: Participants completed a dietary knowledge questionnaire and a 24 dietary recall at baseline, 6 months, and 12 months. Instrumental variables models with participant fixed effects were used to determine the impact of MNT on dietary knowledge and dietary knowledge on DASH diet adherence. RESULTS: Among those who received MNT, dietary knowledge increased from baseline to twelve months (p<.01). Changes in dietary knowledge were not associated with changes in DASH adherence from baseline to 12 months (p=0.44). CONCLUSIONS: The MNT administered was effective at improving dietary knowledge, but not at improving DASH adherence. Three MNT sessions may be insufficient to change behavior. Integrating behavioral change theory and cultural sensitivity to MNT may improve diet adherence among diverse older adults.

Perspectives of Canadian researchers on ethics review of neuroimaging research.

The current and potential uses of neuroimaging in healthcare and beyond have spurred discussion about the ethical issues related to neuroimaging and neuroimaging research. This study examined the perspectives of neuroimagers on ethical issues in their research and on the ethics review process. One hundred neuroimagers from 13 Canadian neuroscience centers completed an online survey and 35 semi-structured interviews were conducted. Neuroimagers felt that most ethical and social issues identified in the literature were dealt with adequately, well, and even very well by research ethics boards (REBs), but some issues such as incidental findings and transfer of knowledge were problematic. Neuroimagers reported a range of practical problems in the ethics review process. We aimed to gather perspectives from REB on the ethics review process, but insufficient participation by REBs prevented us from reporting their perspectives. Given shortcomings identified by neuroimagers as well as longstanding issues in Canadian ethics governance, we believe that substantial challenges exist in Canadian research ethics governance that jeopardize trust, communication, and the overall soundness of research ethics governance. Neuroimagers and REBs should consider their shared responsibilities in developing guidance to handle issues such as incidental findings, risk assessment, and knowledge transfer.

Expectations regarding cognitive enhancement create substantial challenges.

A recent discussion on cognitive enhancers has caused some controversy in the ethics and neuroscience fields by coming out in favour of making neuropharmaceuticals with enhancing properties available for general consumption. We highlight in this brief commentary why concerns regarding efficacy and safety, demands on resources, and public health are substantive enough to warrant serious reconsideration before pharmaceutical performance enhancement can be widely supported.

Media coverage of the persistent vegetative state and end-of-life decision-making.

BACKGROUND: Conflicting perspectives about the diagnosis and prognosis of the persistent vegetative state (PVS) as well as end-of-life (EOL) decision-making were disseminated in the Terri Schiavo case. This study examined print media coverage of these features of the case. METHODS: We retrieved print media coverage of the Schiavo case from the LexisNexis Academic database and used content analysis to examine headlines and text of articles describing Schiavo's neurologic condition, behavioral repertoire, prognosis, and withdrawal of life support. The accuracy of claims about PVS was assessed. RESULTS: Our search yielded 1,141 relevant articles published (1990-2005) in the four most prolific American newspapers for this case. The most frequent headline themes featured legal (31%), EOL (25%), and political (22%) aspects of the case. Of the articles analyzed, 21% reported that Schiavo "might improve" and 7% that she "might recover." Statements explicitly denying the PVS diagnosis were found in 6% of articles. Explanations of PVS and other chronic disorders of consciousness were rare (

Prospects for prediction: ethics analysis of neuroimaging in Alzheimer's disease.

This article focuses on the prospects and ethics of using neuroimaging to predict Alzheimer's disease (AD). It is motivated by consideration of the historical roles of science in medicine and society, and considerations specifically contemporary of capabilities in imaging and aging, and the benefits and hope they bring. A general consensus is that combinations of imaging methods will ultimately be most fruitful in predicting disease. Their roll-out into translational practice will not be free of complexity, however, as culture and values differ in terms of what defines benefit and risk, who will benefit and who is at risk, what methods must be in place to assure the maximum safety, comfort, and protection of subjects and patients, and educational and policy needs. Proactive planning for the ethical and societal implications of predicting diseases of the aging brain is critical and will benefit all stakeholders-researchers, patients and families, health care providers, and policy makers.

The need for a clinical ethics service and its goals in a community healthcare service centre: a survey.

OBJECTIVES: To (1) assess whether according to healthcare providers, the creation of an ethics service responds to a need; (2) assess the importance of an ethics service for healthcare providers; (3) determine what ethics services should be offered and the preferred formats of delivery; and (4) identify key issues to be initially dealt with by the ethics service. DESIGN: A survey of healthcare providers in Québec's Centre Local de Services Communautaires (CLSC), healthcare institutions dedicated to community health and social services. FINDINGS: 96 (95%) respondents agreed that an ethics service was needed, and on average the ethics service project was judged to be very important. Preferred formats for ethics consultation and education were identified, as well as key concerns such as the need of respect for the patient as a person, elder abuse and ethical issues in home care. CONCLUSION: This survey is helping in the implementation of an ethics service and can guide others in similar healthcare institutions.

Practical approach to the use and monitoring of dofetilide therapy.

FDA's requirements for the use of dofetilide are described, and one hospital's strategy for meeting the requirements is discussed. Dofetilide is a specific class III antiarrhythmic agent approved for use in the conversion of atrial fibrillation and atrial flutter and the maintenance of normal sinus rhythm. It is available as an option for highly symptomatic patients who fail to respond to or do not tolerate other antiarrhythmic agents and patients with structural heart disease. Because of the risk of torsade de pointes associated with dofetilide, FDA has mandated in-hospital initiation of dofetilide therapy and has restricted its availability to hospitals and prescribers who have received appropriate education on dofetilide treatment initiation and dosing. Control of the drug's distribution is limited to a single wholesaler and a single mail-order pharmacy. These restrictions, along with the FDA labeling and the inherent risks associated with dofetilide use, have made this drug a complicated agent to use within an institution. When dofetilide was added to the formulary at Harper University Hospital, policies and procedures were developed to ensure appropriate use and monitoring. The use of dofetilide within health systems requires detailed procedures for prescribing, dispensing, and monitoring and thorough education of caregivers about those procedures. Pharmacists have a pivotal role in ensuring the appropriate use of dofetilide.

Recombinant human activated protein C, drotrecogin alfa (activated): a novel therapy for severe sepsis.

Sepsis remains a major cause of death in hospitalized patients. Despite a massive research effort over the past 2 decades to identify innovative therapies for sepsis, current treatment strategies consist primarily of antiinfective agents and a variety of supportive measures. Activated protein C, an endogenous protein that inhibits thrombosis and inflammation while promoting fibrinolysis, plays an important role in the pathogenesis of sepsis. Recombinant human activated protein C, drotrecogin alfa (activated), when compared with placebo in a randomized, double-blind study of 1690 patients with severe sepsis (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis [PROWESS] trial), decreased the relative risk of death at 28 days by 19.4% (95% confidence interval 6.6-30.5%, p=0.005), although there was a trend for more serious bleeding (3.5% vs 2.0%, p=0.06) with its use. Drotrecogin alfa is the first antisepsis drug found to have a mortality benefit. It should be administered only to patients with severe sepsis who meet the PROWESS study inclusion criteria and should be avoided when risk factors for bleeding are present. Ongoing research will help determine the cost-effectiveness of drotrecogin alfa, as well as its role in critically ill populations not studied in the PROWESS trial.

Differentiation of the low-molecular-weight heparins.

The three low-molecular-weight heparins (LMWHs) available in the United States have been extensively evaluated for a wide array of indications. Properties associated with one LMWH cannot be assumed to be the same as those associated with another LMWH, as they are different pharmacologic entities. Therefore, therapeutic interchange of these agents is inappropriate. The pharmacokinetic and pharmacodynamic differences among LMWHs can be explained by comparing methods of preparation, molecular structures, half-lives, antithrombin- and non-antithrombin-mediated actions, effect on thrombus, and dosing interval. The Food and Drug Administration-approved indications and their respective levels of clinical evidence further differentiate these agents. A dichotomy in the results of clinical trials has been observed with the LMWHs. As the LMWHs are distinct compounds that each possess unique pharmacokinetic and pharmacodynamic profiles, treatment decisions should be based on the available safety and efficacy data for each LMWH. Agents should be prescribed only for those indications for which they have been shown to be effective and only at dosages that have been studied.

Clinical and economic effectiveness of an inpatient anticoagulation service.

We conducted a prospective cohort study to evaluate clinical and economic end points achieved by a pharmacist-managed anticoagulation service compared with usual care (50 patients/group). The primary therapeutic end point was the time between starting heparin therapy and surpassing the activated partial thromboplastin time therapeutic threshold. The primary economic end point was the direct variable cost of hospitalization from admission to discharge. No significant differences between groups were noted for the primary therapeutic end point. Total hospital costs were significantly lower for patients receiving pharmacist-managed care than for those receiving usual care ($1594 and $2014, respectively, 1997 dollars, p=0.04). Earlier start of warfarin (p=0.05) and shorter hospital stay (5 and 7 days, p=0.05) were associated with the pharmacist-managed group.