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Background Refractory obsessive-compulsive disorder (OCD) among adults is the first psychiatric indication of deep brain stimulation (DBS) to receive an FDA Humanitarian Device Exemption (HDE). Given the HDE approval and encouraging evidence that has since emerged, exploration of DBS for OCD may expand to adolescents in the future. More than 100,000 adolescents in the U.S. suffer from refractory OCD, and there is already a precedent for the transition of DBS in adults to children in the case of dystonia. However, the risk-benefit analysis of pediatric DBS for OCD may be more complex and raise different ethical questions compared to pediatric DBS for dystonia. Objective This study aimed to gain insight into pressing ethical issues related to using DBS in adolescents with OCD. Methods Semi-structured interviews were conducted with clinicians (n = 25) caring for pediatric patients with refractory OCD. Interview transcripts were coded with MAXQDA 2018 software and analyzed using thematic content analysis to identify emergent themes. Results Five central themes were identified in clinician responses, three of which were exacerbated in the pediatric DBS setting. Clinicians expressed concerns related to conditions of decision-making including adolescents' capacity to assent (80%), the lack of evidence about the outcomes and potential unknown effects of using DBS in adolescents with OCD (68%), and the importance of exhausting other treatment options before considering DBS (20%). Conclusions Strategies to address clinician concerns include implementation of validated decision support tools and further research into the outcomes of pediatric DBS for OCD to establish clear guidelines for patient selection.

Zawadzki and Adamczyk question whether removal of painful memories that anchor one’s narrative identity might leave behind a “free-floating” self plagued by feelings of inauthenticity. We argue that this scenario is unlikely, based on evidence that suggests our neural systems – especially those critical to human functioning1 – are naturally protected against minor, localized disruptions due to their synergistic distribution and redundancy2. For the same reason that artificial deep neural networks are increasingly designed to incorporate computational redundancy (especially those with safety-critical applications, such as self-driving cars), our own neural networks contain a degree of “cognitive reserve”3 to help mitigate against total system failure4,5 by drawing upon supplementary neural networks and forming new and more efficient connections (neuroplasticity) to compensate for disruptions.6 Neural representations of identity, a construct which evolutionary psychologists and behavioral ecologists argue is critical for survival at the individual, group and species levels7, are likely to incorporate such redundancy as a safeguard. The distribution of memory components across different brain regions supports the notion of cognitive reserve in the case of narrative identity. This arrangement complicates the capacity of optogenetic interventions to effectively erase complex autobiographical memories. Even if it were possible, we argue that disruptions to one’s identity and values are not necessarily ethically problematic, and must be viewed within the context of a risk-benefit ratio in which autonomously choosing to modify one’s debilitating or pathology-causing memories may confer benefits that outweigh potential challenges of identity reconstruction and (temporary) feelings of inauthenticity.

When applied in the health sector, AI-based applications raise not only ethical but legal and safety concerns, where algorithms trained on data from majority populations can generate less accurate or reliable results for minorities and other disadvantaged groups.

Bioethicists today are taking a greater role in the design and implementation of emerging technologies by “embedding” within the development teams and providing their direct guidance and recommendations. Ideally, these collaborations allow ethical considerations to be addressed in an active, iterative, and ongoing process through regular exchanges between ethicists and members of the technological development team. In this article, we discuss a challenge to this embedded ethics approach—namely, that bioethical guidance, even if embraced by the development team in theory, is not easily actionable in situ. Many of the ethical problems at issue in emerging technologies are associated with preexisting structural, socioeconomic, and political factors, making compliance with ethical recommendations sometimes less a matter of choice and more a matter of feasibility (at least at the local level in which an embedded bioethicist operates). Moreover, incentive structures within these systemic factors maintain them against reform efforts. We recommend that embedded bioethicists utilize principles from behavioral science (such as behavioral economics) to better understand and account for these incentive structures so as to encourage ethically responsible uptake of technological innovations.

The American Academy of Neurology recently emphasized the importance of communicating with patients’ families to better reflect patient values in clinical care. However, little is known about how decisions about continuing rehabilitative care made by family caregivers and healthcare providers working with minimally conscious patients are informed by conceptualizations of consciousness and moral status. We explored these issues in interviews with 18 family caregivers and 20 healthcare professionals caring for minimally conscious patients. Data were analyzed using thematic content analysis. Results suggest that family members and healthcare professionals share similar views of what consciousness is (“being there”) and what it is indicated by (“a look in the eyes,” and/or an “ability to do”/agency). They also share a belief that the presence (or “level”) of consciousness does not determine whether rehabilitative care should be discontinued. Rather, it should be determined by considerations of suffering and well-being. Providers were more likely to view suffering as rationale for discontinuation of care, while family members viewed suffering as an indicator of and motivator for potential recovery. Findings can help optimize family-provider communications about minimally conscious patients by acknowledging shared assumptions and interpretations of consciousness, as well as key areas where perspectives diverge.Implications for rehabilitationFamily and professional caregivers’ interpretations of consciousness and suffering are implicated in decisions about continuing rehabilitation for minimally conscious patients.Family members and healthcare providers both rely to some extent on non-observable evidence to evaluate consciousness, which may be an adaptive and philanthropic response to clinical uncertainty.Acknowledging shared assumptions and interpretations of consciousness, as well as diverging perspectives, can help to optimize family-provider communications. Family and professional caregivers’ interpretations of consciousness and suffering are implicated in decisions about continuing rehabilitation for minimally conscious patients. Family members and healthcare providers both rely to some extent on non-observable evidence to evaluate consciousness, which may be an adaptive and philanthropic response to clinical uncertainty. Acknowledging shared assumptions and interpretations of consciousness, as well as diverging perspectives, can help to optimize family-provider communications.

The eternal life promised by many religions is mirrored by the drastically longer lifespans proposed by radical life extension (RLE) and transhumanism (H+). RLE and H+ represent extreme contingents...

Psychiatric genomics is a rapidly growing field that holds much promise for improving risk prediction, prevention, diagnosis, treatment selection, and understanding of the pathogenesis of patients' symptoms. The field of psychiatry (i.e., professional organizations, mental health clinicians, educational institutions), however, needs to address numerous challenges to promote the responsible translation of genomic technologies and knowledge into psychiatric practice. The goal of this article is to review how clinicians currently encounter and use genomics in the clinic, to summarize the existing literature on how clinicians feel about the use of genomics in psychiatry, and to analyze foreseeable ethical and legal challenges for the responsible integration of genomics into psychiatric care at the structural and clinic levels. Structural challenges are defined as aspects of the larger system of psychiatric practice that constitute potential barriers to the responsible integration of genomics for the purposes of psychiatric care and prevention. These structural challenges exist at a level where professional groups can intervene to set standards and regulate the practice of psychiatry and genomics. Clinic-level challenges are day-to-day issues clinicians face when managing genomic tests in the clinic. We discuss the need for action to mitigate these challenges and maximize the clinical and social utility of psychiatric genomics, including the following: expanding genomics training among mental health clinicians; establishing practice guidelines that consider potential clinical, psychological, and social implications of psychiatric genomics; promoting an integrated care model for managing genomics in psychiatry; emphasizing patient engagement and informed consent when managing genomic testing in psychiatric care.

Background A central goal among researchers and policy makers seeking to implement clinical interventions is to identify key facilitators and barriers that contribute to implementation success. Despite calls from a number of scholars, empirical insights into the complex structural and cultural predictors of why decision aids (DAs) become routinely embedded in health care settings remains limited and highly variable across implementation contexts. Methods We examined associations between “reach”, a widely used indicator (from the RE-AIM model) of implementation success, and multi-level site characteristics of nine LVAD clinics engaged over 18 months in implementation and dissemination of a decision aid for left ventricular assist device (LVAD) treatment. Based on data collected from nurse coordinators, we explored factors at the level of the organization (e.g. patient volume), patient population (e.g. health literacy; average sickness level), clinician characteristics (e.g. attitudes towards decision aid; readiness for change) and process (how the aid was administered). We generated descriptive statistics for each site and calculated zero-order correlations (Pearson’s r) between all multi-level site variables including cumulative reach at 12 months and 18 months for all sites. We used principal components analysis (PCA) to examine any latent factors governing relationships between and among all site characteristics, including reach. Results We observed strongest inclines in reach of our decision aid across the first year, with uptake fluctuating over the second year. Average reach across sites was 63% (s.d. = 19.56) at 12 months and 66% (s.d. = 19.39) at 18 months. Our PCA revealed that site characteristics positively associated with reach on two distinct dimensions, including a first dimension reflecting greater organizational infrastructure and standardization (characteristic of larger, more established clinics) and a second dimension reflecting positive attitudinal orientations, specifically, openness and capacity to give and receive decision support among coordinators and patients. Conclusions Successful implementation plans should incorporate specific efforts to promote supportive and mutually informative interactions between clinical staff members and to institute systematic and standardized protocols to enhance the availability, convenience and salience of intervention tool in routine practice. Further research is needed to understand whether “core predictors” of success vary across different intervention types.

As researchers involved in examining ethical issues related to neurotechnologies, we see potential utility in tools like the Qualitative Agentive Competency Tool (Q-ACT) designed to help clinicians...

The expansion of research on deep brain stimulation (DBS) and adaptive DBS (aDBS) raises important neuroethics and policy questions related to data sharing. However, there has been little empirical research on the perspectives of experts developing these technologies. We conducted semi-structured, open-ended interviews with aDBS researchers regarding their data sharing practices and their perspectives on ethical and policy issues related to sharing. Researchers expressed support for and a commitment to sharing, with most saying that they were either sharing their data or would share in the future and that doing so was important for advancing the field. However, those who are sharing reported a variety of sharing partners, suggesting heterogeneity in sharing practices and lack of the broad sharing that would reflect principles of open science. Researchers described several concerns and barriers related to sharing, including privacy and confidentiality, the usability of shared data by others, ownership and control of data (including potential commercialization), and limited resources for sharing. They also suggested potential solutions to these challenges, including additional safeguards to address privacy issues, standardization and transparency in analysis to address issues of data usability, professional norms and heightened cooperation to address issues of ownership and control, and streamlining of data transmission to address resource limitations. Researchers also offered a range of views on the sensitivity of neural activity data (NAD) and data related to mental health in the context of sharing. These findings are an important input to deliberations by researchers, policymakers, neuroethicists, and other stakeholders as they navigate ethics and policy questions related to aDBS research.

Dinh et al. (2020) found that the use of cognitive enhancement (CE) is more publicly acceptable when it is: used noncompetitively, becomes more normative among peers, and sanctioned or even encoura...

Interest and investment in closed-loop or adaptive deep brain stimulation (aDBS) systems have quickly expanded due to this neurotechnology's potential to more safely and effectively treat refractory movement and psychiatric disorders compared to conventional DBS. A large neuroethics literature outlines potential ethical concerns about conventional DBS and aDBS systems. Few studies, however, have examined stakeholder perspectives about ethical issues in aDBS research and other next-generation DBS devices. To help fill this gap, we conducted semi-structured interviews with researchers involved in aDBS trials (n = 23) to gain insight into the most pressing ethical questions in aDBS research and any concerns about specific features of aDBS devices, including devices' ability to measure brain activity, automatically adjust stimulation, and store neural data. Using thematic content analysis, we identified 8 central themes in researcher responses. The need to measure and store neural data for aDBS raised concerns among researchers about data privacy and security issues (noted by 91% of researchers), including the avoidance of unintended or unwanted third-party access to data. Researchers reflected on the risks and safety (83%) of aDBS due to the experimental nature of automatically modulating then observing stimulation effects outside a controlled clinical setting and in relation to need for surgical battery changes. Researchers also stressed the importance of ensuring informed consent and adequate patient understanding (74%). Concerns related to automaticity and device programming (65%) were discussed, including current uncertainties about biomarker validity. Additionally, researchers discussed the potential impacts of automatic stimulation on patients' autonomy and control over stimulation (57%). Lastly, researchers discussed concerns related to patient selection (defining criteria for candidacy) (39%), challenges of ensuring post-trial access to care and device maintenance (39%), and potential effects on personality and identity (30%). To help address researcher concerns, we discuss the need to minimize cybersecurity vulnerabilities, advance biomarker validity, promote the balance of device control between patients and clinicians, and enhance ongoing informed consent. The findings from this study will help inform policies that will maximize the benefits and minimize potential harms of aDBS and other next-generation DBS devices.

McGuire et al. (2020) explores the ethical challenges of resource allocation for healthcare needs during the novel coronavirus (COVID-19) pandemic. The authors recommended harmonizing triage guidel...

Background Studies indicate that decision making and informed consent among patients considering left ventricular assist device (LVAD) support for advanced heart failure could be improved. In the VADDA (Ventricular Assist Device Decision Aid) trial, we tested a patient-centered decision aid (DA) to enhance the quality of decision making about LVAD therapy. Methods After an extensive user-centered design process, we conducted a multisite randomized trial of the DA compared with standard education (SE) among inpatients considering LVAD treatment for advanced heart failure The main outcome was LVAD knowledge at 1 week and 1 month after administration of the DA versus the SE, according to a validated scale. Secondary measures included prespecified quality decision making measures recommended by the International Patient Decision Aid Standards collaboration. Results Of 105 eligible patients, 98 consented and were randomly assigned to the DA and SE arms. Patients receiving the VADDA exhibited significantly greater LVAD knowledge than the SE group at 1 week of follow-up (P = .01) but not at 1 month (P = .47). No differences were found between DA and SE patients in rates of acceptance versus decline of LVAD treatment (85% vs 78%; P = .74). Recipients in the DA arm reported greater satisfaction with life after implantation compared with nonrecipients (28 vs 23 out of 30; P = .008), although both arms reported high satisfaction. Patients rated the DA high in acceptability and usability. Conclusions The VADDA enhances LVAD knowledge, particularly in the short term (1 week) during the peak period of decision making. The DA does not encourage decision direction and reflects patient, caregiver, and physician preferences for content and format. Clinical Trial Registration https://clinicaltrials.gov/ct2/show/NCT02248974 . The trial is registered with clinicaltrials.gov (NCT02248974).

This paper discusses motivations for the use of MDMA among young adults in intimate relationships living in resource poor environments, where structural constraints limit potential for economic mobility and impact upon interpersonal relations. Drawing from in-depth interviews with men and women in intimate relationships with one or more partners, we report the range of motivations for MDMA use and their association with indicators of relationship quality, specifically trust and romantic exclusivity. Findings demonstrate that both men and women use MDMA primarily for the purpose of sexual enjoyment. However, men report the use of MDMA for sexual enjoyment more often, while women more frequently report the use of MDMA to compensate for psychological or physical displeasure, particularly in relationships characterised by distrust. We discuss how these motivations to use MDMA are shaped by gender norms and larger contextual and socio-economic factors and conclude with a call for more relational and sexual counselling opportunities for urban young adults to avoid MDMA use for self-medication.

Women are most exposed to sexual health risks within their marital relationships, primarily due to the sexually risky behaviours of their spouses. Studies show that expanding agency is critical for women to mitigate both physical and sexual health risks and is linked to increased psycho-social well-being and economic independence. Drawing on qualitative and quantitative primary data collected from a peri-urban community in Zambia, this paper explores how women exert agency in a community where few educational and economic opportunities and substantial food insecurity exacerbate women's risk for HIV within their marital relationships. It also examines how expressions of agency within marital unions can reduce HIV risk exposure and lead to socio-economic benefits. However, expressions of agency can also create physical, psycho-social and sexual health risks, particularly when spouses do not support independent decision-making and actions that women consider necessary to support the household and maintain intimacy. Findings highlight the importance of community involvement and addressing harmful socio-cultural norms to foster the realisation of women's agency.

Left-ventricular assist device (LVAD) therapy is a growing mechanical circulatory support therapy used to treat patients with advanced heart failure. There is a general assumption among clinicians that patients would prefer to accept a heart to any other treatment were they eligible. However, little research has been done to clarify the nuances of patient treatment preferences for LVAD therapy versus transplantation. The objective of this study was to investigate this treatment preference assumption from patients' perspectives. In a single-site study, 15 LVAD patients, 15 LVAD candidates, 15 LVAD decliners, and 15 LVAD caregivers (n = 60) participated in structured, in-depth interviews to assess decisional processes and treatment preferences for advanced heart failure. The interview guides were consistent with the Ottawa framework on decision-making processes. All participants were identified by the LVAD coordination team and recruited consecutively between February and November 2014. The patient and candidate groups included both LVAD designations: destination therapy (n = 22), bridge-to-transplant (n = 4), as well as four participants who deferred designation pending worsening clinical status. The interviews were analyzed using qualitative description with constant comparisons, aided by ATLAS.ti. Although LVAD eligible patients generally show a preference for heart transplantation as the ideal treatment for heart failure, some patients begin to show ambivalence as they experience LVAD therapy and begin to prefer LVAD as a long-term, destination treatment. Some themes that emerged from the interviews concerning transplantation centered on the consequences of multiple major surgeries (i.e., LVAD placement followed by heart transplantation, n = 18), fears surrounding lifestyle changes of accepting a heart transplant (n = 14) and life satisfaction with an LVAD as a "new normal" (n = 18). Findings suggest that experience with an LVAD can sometimes cause ambivalence about transplant with some patients preferring LVAD as destination even when transplant is an option. We provide clinical and programmatic implications of this, concluding with practical recommendations for how to fully address patients' goals of treatment as their health and situation changes over time.

Background: Illness narratives with meaningful, competent and targeted content have been shown to provide useful guides for patient decision-making and have positive influences on health behaviors. The use of narratives in decision aids can confer a sense of structure, plot and context to illness experiences and help patients make treatment decisions that feel sensible, informed, and transparent. Aim: This paper presents narratives of suffering and healing from patients and their caregivers with advanced heart failure who engaged in decision-making regarding Left Ventricular Device Assist (LVAD) treatment. Methods: Narratives were collected from in-depth interviews with patients who accepted (n = 15) versus declined (n = 15) LVAD implant, LVAD candidates who had received education about LVAD and were in the process of making a decision (n = 15), and caregivers (family or significant others) of LVAD patients (n = 15). Results: Participants shared &ldquo, restitution&rdquo, narratives that most commonly conveyed a shift from pre-implant physical suffering and &ldquo, daily hell,&rdquo, fatigue so intense it &ldquo, hurts,&rdquo, along with emotional suffering from inability to engage with the world, to post-implant improvements in mobility and quality of life, including positivity and family support, adaptation on a &ldquo, journey,&rdquo, &ldquo, getting one&rsquo, s life back&rdquo, and becoming &ldquo, normal&rdquo, again. Conclusion: For LVAD patients, other patients&rsquo, illness narratives can help to give meaning to their own illness and treatment experiences and to more accurately forecast treatment impacts on lifestyle and identity. For clinicians, patient narratives can enhance patient&ndash, practitioner communication and understanding by highlighting perspectives and values that structure patients&rsquo, clinical experiences.

During its first 15 years, neuroethics research focused mostly on theoretical analysis of the ethical implications of emerging neuroscience knowledge and technologies. Kellmeyer and colleagues (201...

In her article, Kreitmair (2019) identifies eight ethical dimensions to address with respect to direct-to-consumer (DTC) neurotechnologies to ensure they contribute to human flourishing. Here we ex...

Background A central tenet of patient-centered health care advocated by the Institute of Medicine and the American Medical Association is to enhance informed decision-making in a way that incorporates patient values, knowledge and beliefs. Achievement of this goal is constrained by a lack of validated measures of patients' knowledge needs. Methods In this study we present a comprehensive and valid methodology for developing a clinically informed and patient­centered measure of knowledge about left ventricular assist device (LVAD) therapy to facilitate discussion and measure candidate understanding of treatment options. Using structured interviews with patients, caregivers, candidates for LVAD treatment (New York Heart Association Class III and IV) and expert clinicians ( n = 71), we identified top patient decisional needs and perspectives on essential knowledge needs for informed decision-making. From this list, we generated 20 knowledge scale question items to refine in cognitive interviews ( n = 5) with patients and patient consultants. Results Good internal consistency and reliability of the knowledge scale (Cronbach's α = 0.81) was seen in 30 LVAD patients and candidates. Knowledge was higher among patients currently with LVADs than candidates, regardless of receiving standard education (with education: 69.9 vs 50.1, adjusted p = 0.02; without education: 69.9 vs 37.6, adjusted p Conclusion The LVAD knowledge scale may be useful in clinical settings to identify gaps in knowledge among patient candidates considering LVAD treatment, and to better tailor education and discussion with patients and their caregivers, and to enhance informed decision-making before treatment decisions are made.

Introduction In addition to a large body of research that shows decision aids (DA) are associated with better patient experiences for many health decisions, a multi-site randomized controlled trial that compared a DA for left ventricular assist device (LVAD) placement with standard LVAD education found that the DA significantly increased patient knowledge and satisfaction with life after implant. However, little evidence exists regarding best practices for implementation of a DA in real-world cardiovascular care. This project evaluated DA implementation at eight U.S. hospitals with a focus on increasing shared decision-making (SDM) and DA use. Methods Participating received a tailored implementation plan and SDM training. To understand the extent to which SDM enhanced behaviors were implemented, LVAD coordinators completed a 10-item Implementation Fidelity Checklist (score 0-10) for each patient. The primary outcome, reach to patients, is calculated by dividing the number of checklists received by the total number of patients receiving pre-LVAD education during evaluation. DA fidelity is calculated using LVAD coordinator self-report of the patient encounter on the Fidelity Checklist. Results Across sites, 607 patients received a DA from September 2018-December 2019. Reach ranged from 29.3%-87.9% of patients across sites with an overall reach of 58.2% and average Fidelity Checklist score of 8.4 (range 6.0-10.0). Over one-third (37.5%) of sites achieved overall reach > 80% indicating a high level of implementation success. Almost half of patients reviewed the DA with a caregiver (48.7%). Clinician users of the decision aid believed additional language translations of the DA and inclusion of institution-specific and personalized risk profiles would promote long-term sustainability of the DA at their institution. Conclusion Findings demonstrate that DAs and SDM can be implemented into diverse cardiovascular care settings with sustained use by clinicians, patients, and caregivers. Future work will evaluate implementation of new DA features requested by clinicians.

Purpose A decision aid (DA) prior to left ventricular assist device (LVAD) placement significantly increased patient knowledge and satisfaction with life after LVAD implant in a multi-site RCT (VADDA). Little evidence exists regarding best practices for implementation of a DA in real-world cardiovascular care. This project aims to evaluate DA implementation at nine U.S. hospitals with a focus on optimizing shared decision-making (SDM). Methods Sites received an implementation plan and participated in a training webinar about ways to use the DA during LVAD evaluation to promote SDM. LVAD coordinators completed a 10-item SDM Implementation Fidelity Checklist (score 0-10) describing optimal DA use and integration of SDM as part of the DA deployment for each patient. DA “reach” is calculated by dividing the number of checklists received by the total number of patients receiving pre-LVAD education during evaluation. DA “fidelity” is calculated using LVAD coordinator self-report of the patient encounter on the Fidelity Checklist. Sites received ongoing monitoring and support from a coordinating center to discuss barriers and facilitators of DA use. Physicians and coordinators (n=30) were surveyed about their attitudes towards use of the LVAD decision aid during the first year of implementation. Results 454 patients received a DA from September 2018-September 2019 with an average Fidelity Checklist score of 8.5 (range 6.2-10.0). Reach ranged from 14.7%-90.2% of patients across sites with an overall reach of 53.2%. At baseline, a majority (60%, SD=1.00) of cardiologist and coordinator stakeholders believed DAs are relevant to clinical practice, and agree they improve patients’ knowledge (63%, SD=0.87), satisfaction (57%, SD=0.95) and decrease anxiety (57%, SD=0.97). The most frequently cited barrier to using DAs was “not enough time to use the tool in its entirety” (50%, SD=1.34) and questioning that “the effectiveness of the aid was not well established” (40%, SD=1.42). Conclusion These findings support the feasibility, high fidelity and usefulness of a LVAD DA into busy real-world cardiovascular care. The majority of clinical providers believe the aid is relevant to clinical practice.

Background. Although effective interventions for shared decision making (SDM) exist, there is a lack of uptake of these tools into clinical practice. “Nudges,” which draw on behavioral economics and target automatic thinking processes, are used by policy makers to influence population-level behavior change. Nudges have not been applied in the context of SDM interventions but have potential to influence clinician motivation, a primary barrier to long-term adoption of SDM tools. Objective. Describe, evaluate, and propose recommendations for the use of a behavioral economics framework (MINDSPACE) on clinician motivation and behavior during implementation of a validated decision aid (DA) for left ventricular assist device at nine hospitals. Methods. Qualitative thematic analysis of process notes from stakeholder meetings during the first 6 months of implementation to identify examples of how the MINDSPACE framework was operationalized. Quantitative implementation progress was evaluated using the RE-AIM framework. Results. MINDSPACE components were translated into concrete approaches that leveraged influential stakeholders, fostered ownership over the DA and positive emotional associations, spread desirable norms across sites, and situated the DA within established default processes. DA reach to eligible patients increased from 9.8% in the first month of implementation to 70.0% in the sixth month. Larger gains in reach were observed following meetings using MINDSPACE approaches. Limitations. The MINDSPACE framework does not capture all possible influences on behavior and responses to nudges may differ across populations. Conclusions. Behavioral economics can be applied to implementation science to foster uptake of SDM tools by increasing clinician motivation. Our recommendations can help other researchers effectively apply these approaches in real-world settings when there are often limited incentives and opportunities to change organizational- or structural-level factors.

Background— Social media have the potential to offer important benefits for patient education, support, and shared decision making. Despite the proliferation of social media use during the past decade, little is known about the scope and quality of available information, or the purposes that social media sites serve for patient decisional and support needs. Methods and Results— We conducted a mixed method study, including content analysis of social media and principal components analysis analysis of data sites discussing left ventricular assist device treatment for heart failure. This study explored aspects of interactivity, user-friendliness, appeal, medium, purpose, audience, and accuracy of information. Higher levels of interactivity (eg, posting comments) seem to enhance the appeal and usability of available information but also introduce greater potential for inaccuracy and inconsistency. The current lack of oversight into the content and quality of available information constitute a challenge for the reliable use of social media as forums for information-seeking and social network–based support. Conclusions— We conclude that social media outlets constitute a promising source of informational and psychosocial support for patients, caregivers, and candidates, and if used in conjunction with patient-provider dialog, can contribute to informed decision making by facilitating reflection and discussion of personal concerns, values, and informational needs.

For a man with end-stage heart failure, a left ventricular assist device prolongs life but brings dire complications.

Scientific literature increasingly calls for studies to translate evidence-based interventions into real-world contexts balancing fidelity to the original design and fit to the new setting. The Risk Avoidance Partnership (RAP) is a health promotion intervention originally designed to train active drug users to become Peer Health Advocates. A theoretically driven approach was used to adapt RAP to fit implementation in outpatient methadone treatment clinics and pilot it with clinic patients. Ethnographic observations and process tracking documented the RAP translation and pilot experience, and clinic and community characteristics relevant to program implementation. Clinic administrators, staff, and patients were interviewed on their values, capacities, interest in RAP, perceived challenges of implementing RAP in drug treatment clinics, and experiences during the pilot. Findings indicated that RAP core components can be met when implemented in these settings and RAP can fit with the goals, interests, and other programs of the clinic. Balancing fidelity and fit requires recognition of the mutual impacts RAP and the clinic have on each other, which generate new interactions among staff and require ongoing specification of RAP to keep abreast of clinic and community changes. Collaboration of multiple stakeholders significantly benefited translation and pilot processes.

Background— How caregivers contribute to positive or negative outcomes for left ventricular assist device (LVAD) patients remains unclear. Our primary study objectives were to (1) identify caregiver support attributes through a retrospective chart review of social workers’ psychosocial assessments for LVAD patients and (2) determine how these attributes associated with patients’ post-LVAD placement mortality and Interagency Registry for Mechanically Assisted Circulatory Support–defined morbidity events. Methods and Results— We retrospectively reviewed and recorded social workers’ clinical assessments of adult patients implanted with durable continuous-flow LVADs as bridge to transplant, destination therapy, or bridge to decision from January 2010 to December 2014. Associations between caregiver characteristics and patient mortality and morbidity events were analyzed using Kaplan–Meier curves and Cox proportional hazards regression. Patient follow-up time was calculated as the time from hospital discharge until the earliest among death with LVAD, transplant, or the last day of the study (December 31, 2015). Patients were censored for death with LVAD at the time of transplant or the last day of the study. A total of 96 LVAD recipients were included in this study. Having a caregiver who understands the severity of the illness and options available to the patient (as determined and documented by the social worker; P =0.01), a caregiver who has identified a backup plan ( P =0.02), and a caregiver who is able to provide logistical support ( P =0.04) significantly mitigated risk of death. The risk of death for an LVAD patient was also significantly lower among those who have at least 1 adult child who lives within 50 miles ( P =0.03) and those who have an extended family who can care for the patient ( P =0.03). The risk of death was 3.1× more likely among patients who live alone compared with those who do not live alone ( P =0.04). No caregiver characteristics were significantly associated with morbidity. Conclusions— This exploratory, hypothesis-generating study suggests that mortality after LVAD placement is impacted by caregiver understanding of patient severity of illness and caregiver presence. This study provides initial evidence to support further work in understanding the associations between caregivers and LVAD patients, as well as interventions that may improve patient outcomes. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT02248974.

We explore ethical issues faced by investigators as they conduct research as part of a peer-delivered HIV/AIDS risk reduction program for injection drug users (IDUs). Staff and participant experiences in peer-delivered interventions among IDUs have come under scrutiny by ethics researchers because of their potential to inadvertently and negatively impact participant rehabilitation due to continued engagement with drug-using networks during the course of outreach. This study explores whether enhanced communication of participant concerns and experiences with clinic and research staff helps to reduce inadvertent malfeasance in peer-delivered drug treatment interventions. Results contribute to the development of patient support infrastructure in peer-delivered risk reduction programs involving IDUs.

Purpose Large-scale array-based and sequencing studies have advanced our understanding of the genetic architecture of psychiatric disorders, but also increased the potential to generate an exponentially larger amount of clinically relevant findings. As genomic testing becomes more widespread in psychiatry research, urgency grows to establish best practices for offering return of results (RoR) to individuals at risk or diagnosed with a psychiatric disorder. Methods We interviewed an international sample (n = 39) of psychiatric genetics researchers to examine conceptualizations of “best practices” for RoR to individual research participants. Results While the vast majority of researchers do not offer RoR, most believed medically actionable findings (85%) and clinically valid but non–medically actionable findings (54%) should be offered. Researchers identified three main areas for improvement: interfacing with individual participants; interdisciplinary training, guidance, and integration; and quality planning and resource allocation for returning results. Conclusion There are significant gaps between researchers’ visions for “best” versus “actual” RoR practices. While researchers call for participant-centered practices, including consent practices that consider any special needs of participants with psychiatric disorders, return of individually meaningful results, and effective follow-up and provisions for treatment, the current reality is that consent and RoR practices lack standardized and evidence-based norms.

While the major scientific discoveries that would extend the length and health of human lives are not yet here, the research that could create them is already underway. As prospects for a world in which extended and improved lives inches closer into reality, the discourse about what to consider as we move forward grows richer, with corporate executives, ideologues, scientists, theologians, ethicists, investigative journalists, and philosophers taking part in imagining and anticipating the rich array of humanity's possible futures. Drawing from in-depth interviews with key stakeholders (n = 22), we offer empirical insights into key values and beliefs animating the “longevity movement,” including what constitutes an ideal human state, the imperative to intervene, and the role of individual liberty and concerns for equality. Emerging from these interviews are common concerns about reducing suffering, preserving diversity in visions of successful aging and how best to promote access to a future that may not remain hypothetical for long.

Education is an important aspect of evaluation and consent for left ventricular assist device (LVAD) candidates. A better understanding of candidate knowledge during the education process can help identify knowledge gaps and improve informed consent processes. This paper presents the results from a validated, LVAD-specific Knowledge Scale administered to candidates before and after education to identify items most and least frequently answered correctly. At baseline and 1-week, both candidates educated with a standard education and an LVAD-specific decision aid were most likely to answer logistical items relating to support and self-care correctly with &ge, 90% of candidates answering these items correctly after education. Candidates were least likely to answer questions about risks, transplant eligibility, and expenses correctly with &lt, 60% of candidates answering them correctly after education. Items with the greatest improvement in correct answers from baseline to 1-week were primarily related to the logistics of living with an LVAD. Candidates educated with the decision aid showed significant improvements on more knowledge items including those related to the forecasting of recovery and complications when compared to candidates educated with a standard education. The 20-item scale provides a standardized way for clinicians to identify knowledge gaps with LVAD candidates, potentially helping to tailor education. Targeted improvements in LVAD education should focus on the understanding of risk and potential complications to ensure that decision-making and informed consent processes emphasize both the patient and clinicians&rsquo, conceptualizations of knowledge needs for informed consent.

This article examines the notion of client-centeredness from the perspective of supported employment specialists and supervisors, identifying barriers and facilitators to implementation in the field. Though by definition client-centered practices give precedence to clients' wishes, in a realistic setting client-centeredness is adapted to account for negotiations among clients, specialists, employers, and mental health service agencies.Qualitative interviews (n = 22) were conducted with employment specialists and supervisors to elicit facilitators and barriers to successful supported employment outcomes. Data were analyzed inductively using ATLAS.ti 5.0 software.Principal factors influencing implementation of client-centeredness include (1) clients' anxieties about their interests and abilities, (2) difficulties interpreting and negotiating clients' preferences in realistic contexts, (3) quality of supervision and guidance in implementing client-centered practices and upholding morale when facing challenges in the field, and (4) managing discrepancies across resource-sharing agencies in what it means to be "client-centered".These factors suggest the need for (1) focused training among employment specialists to better understand and negotiate clients' wishes, (2) more integration and communication between members of the treatment team, (3) hiring supervisors with first-hand supported employment experience, and (4) spreading awareness of the IPS model across resource-sharing agencies.

Vaginal discharge (safed pani in Hindi, meaning "white water") is one of the leading symptoms for which women in India seek care. Treatment-seeking for safed pani is disproportionately high among poor women, representing a physical, emotional and financial burden for low-income families. Safed pani is only rarely indicative of a reproductive tract or sexually transmitted infection. The discrepancy between symptom reports and observed pathology has led some researchers to characterize safed pani as a culturally based expression of more generalized negative life situation. Data are drawn from two prevention intervention studies (2002-2006 and 2007-2012) conducted in economically marginal communities in Mumbai. Results show that husbands as problem generators and spousal abusers and women's greater perceived empowerment and reported tension are significantly associated with safed pani. These results provide the basis for identifying women at greater risk for psychosocial distress and providing supports at the locations at which they seek treatment.

The Individual Placement and Support model of supported employment is one of the most robust interventions available for people with severe mental illness. Supported employment specialists deliver this intervention. There has been little research on what influences specialists' performance in the field. This paper redresses this deficit by documenting characteristics and competencies self-reported by specialists as influential to proficient performance in the field. Twenty-two qualitative interviews were conducted with specialists and their supervisors. Content analysis suggested the importance of eight factors: (1) initiative; (2) outreach; (3) persistence; (4) hardiness; (5) empathy; (6) passion; (7) team orientation (8) professionalism.

Objectives: The aim of this study was to document and analyze common strategies used by supported employment specialists to overcome criminal justice issues among clients with severe mental illness. Methods: Semistructured qualitative interviews were conducted with a group of 22 supported employment specialists and their supervisors. Interviews were open ended and supplemented by ethnographic observation. Data were examined thematically by content analysis. Results: Assisting clients with past and present criminal histories to find employment was confirmed as one of the hardest self-identified challenges for employment specialists. Three specific strategies commonly used by specialists for this subpopulation are documented and analyzed. These include taking an incremental approach with clients vis-a-vis obtaining work and career advancement, using a strengths-based model that emphasizes the client’s strong points, and focusing the job search on “mom and pop” businesses that typically do not conduct background checks or do not have rigid recruitment policies. Enacting these strategies led to some deviation from the individualized placement and support model of supported employment. Participants noted that they felt most challenged when attempting to serve and assist clients with sex offenses. Conclusions: The findings imply that specialists are challenged when dealing with clients with criminal justice issues and use several approaches to overcome these challenges. Current specialist training may be deficient in preparing staff to effectively serve people with criminal justice issues. Further research should assess the efficacy of the approaches outlined in this article to give more guidance to specialists working with clients with criminal justice issues. (Psychiatric Services 60:1637–1641, 2009)

Background A greater understanding of how beliefs and perceptions inform LVAD placement refusals can help ensure that standards for informed decision making are met. We report on the factors that influence refusal and what accounts for changes in decliners' decision-making process when, and if, that occurs. Method and Results We identified candidates (8 bridge to transplant; 6 destination therapy, 7 without designation) who declined LVAD placement (n = 21), 11 of whom were identified prospectively from February 2014 to March 2015, and 10 of whom were identified retrospectively with the use of our program database. Of these 21 decliners, 11 candidates persistently declined LVAD placement, with a median time of 175 days elapsing between time of LVAD offer and March 4, 2015. Ten candidates declined for an average of 224 days before agreeing to LVAD placement. From March 2014 to March 2015, we conducted structured interviews with LVAD decliners. Interviews were audio recorded, transcribed verbatim, and analyzed quantitatively with the use of Atlas.ti. The findings reflect that refusal can evolve over time. Decliners report that their initial refusals were made reflexively, but the 10 decliners who ultimately opted for LVAD placement changed their decisions as symptoms worsened. Decliners have concerns about the impacts of LVAD treatment on mobility, and they distrust LVAD technology. Some decliners believe LVAD placement would affect their ability to receive a transplant. Finally, decliners believe that they are not sick enough for LVAD placement when they are stabilized with medical management. Conclusions Decliners' perspectives are integral for improving informed consent and refusal processes. Our analysis revealed decliners' decision-making processes and factors influencing their decisions. We provide several clinically based practical recommendations based on our findings.

One of the candidate evaluation challenges is determining when and how psychosocial domains influence short- and long-term destination therapy ventricular assist device (DT-VAD) outcomes. There are very few DT-VAD studies and no validated instruments to identify psychosocial risk factors. General practice is to borrow from the transplant literature, which may not be applicable to this unique device application. We question the relevance of using transplant psychosocial evaluation for patients who are candidates for DT-VAD only, particularly because these patients require a certain level of cognitive, psychological, and behavioral functioning to ensure proper long-term self-care with the VAD. We may be missing important psychological characteristics in our pre-evaluations by “borrowing” from the transplant literature, thereby underplaying significant factors that are especially relevant for DT-VAD candidates. Conversely, we may be screening out candidates who may benefit greatly from DT-VAD by using transplant criteria as part of the screening process. We use a case study to illustrate some of the challenges of weighing psychosocial risk factors in the DT-VAD population and to emphasize the need for developing distinct psychosocial assessment criteria for DT-VAD patients.