Positive Endorsement Research Articles

Is Canada Moving towards a More Agile Regulatory Approval and Reimbursement Process with a Shifting Role for Real-World Evidence (RWE) for Oncology Drugs?

Canada is known to have a complex pathway for new drug approval and reimbursement, resulting in delayed access for patients with serious and life-threatening diseases, such as cancer. Several recent publications from key stakeholders, including patients, physicians and policymakers, highlight patient helplessness, physician frustrations and policymakers entangled in a massive network of bureaucracy unable to make headway. Several quantitative and qualitative assessments using time from regulatory approvals to successful reimbursements confirm long review times and high rejection rates for oncology drugs, especially those receiving conditional approvals. A consensus forum of 18 Canadian oncology clinicians recently voiced frustration with the process and inability to deliver guideline-supported efficacious therapies to their patients. This manuscript compares data extracted from publicly available data sources from 2019 to June 2024 to previous publications. Methods: Public databases from Health Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH), which is in the process of changing to Canada's Drug Agency, and the pan-Canadian Pharmaceutical Alliance (pCPA) were reviewed and the data collected were analyzed with descriptive statistics. Results: From the data, three trends emerge, (i) an increasing number of oncology drugs are receiving conditional approvals from Health Canada, (ii) the percentage of conditionally approved oncology drugs receiving positive reimbursement recommendations from CADTH is still low but appears to be improving, but delays in access are now contingent upon pCPA deciding whether to negotiate price and then the duration of any negotiation, and (iii) real-world evidence is no longer part of the decision-making for conditional approvals. A slight increase in the positive endorsement of RWE used to support CADTH recommendations was observed. Conclusions: The lack of timely access to oncology drugs hurts Canadian patients. While a small trend of improvement appears to be emerging, longer-term data collection is required to ensure sustained patient benefits.

Confronting Alzheimer's Disease Risk in Women: A Feasibility Study of Memory Screening as Part of the Annual Gynecological Well-Woman Visit.

Objective: Routine health care visits offer the opportunity to screen older adults for symptoms of Alzheimer's disease (AD). Many women see their gynecologist as their primary health care provider. Given this unique relationship, the Women's Preventive Services Initiative and the American College of Obstetrics and Gynecology advocate for integrated care of women at all ages. It is well-established that women are at increased risk for AD, and memory screening of older women should be paramount in this effort. Research is needed to determine the feasibility and value of memory screening among older women at the well-woman visit. Materials and Methods: Women aged 60 and above completed a 5-item subjective memory screener at their well-woman visit at the Columbia University Integrated Women's Health Program. Women who endorsed any item were considered to have a positive screen and were given the option to pursue clinical evaluation. Rates of positive screens, item endorsement, and referral preferences were examined. Results: Of the 530 women approached, 521 agreed to complete the screener. Of those, 17.5% (n = 91) were classified as positive. The most frequently endorsed item was difficulty with memory or thinking compared with others the same age. Among women with positive screens, 57.5% were interested in pursuing clinical referrals to a memory specialist. Conclusion: Results support the feasibility and potential value of including subjective memory screening as part of a comprehensive well-woman program. Early identification of memory loss will enable investigation into the cause of memory symptoms and longitudinal monitoring of cognitive change.

Self or Non-Self? Self-Essentialism and Well-Being in Tibetan Buddhist Monks

In monastic Tibetan Buddhists, we explored the psychological construct of self-essentialism, looking at links to satisfaction with life and meaning in life. We selected this population due to their deep commitment to teachings that emphasize the notion of “non-self.” We further explored the role of self-construal in the association between self-essentialism and psychological well-being. Finally, we explored how differences between the formal learning stages in Tibetan Buddhism affected our outcome variables. Replicating findings with other samples, there was small positive endorsement of self-essentialism, and a positive association between psychological essentialism and psychological well-being in this Tibetan Buddhist sample. Those on the highest learning stage in Tibetan Buddhism indicated greater self-essentialism, satisfaction with life, and search for life-meaning compared with the other stages. Interdependent self-construal moderated the association of self-essentialism with satisfaction with life. Contextualizing these findings within Tibetan Buddhist doctrine, it appears that Tibetan Buddhist monks utilize self-essentialism to clearly identify their path from the self toward “non-self.”

Whole-cycle management of women with epilepsy of child-bearing age: ontology construction and application.

The effective management of epilepsy in women of child-bearing age necessitates a concerted effort from multidisciplinary teams. Nevertheless, there exists an inadequacy in the seamless exchange of knowledge among healthcare providers within this context. Consequently, it is imperative to enhance the availability of informatics resources and the development of decision support tools to address this issue comprehensively. The development of the Women with Epilepsy of Child-Bearing Age Ontology (WWECA) adhered to established ontology construction principles. The ontology's scope and universal terminology were initially established by the development team and subsequently subjected to external evaluation through a rapid Delphi consensus exercise involving domain experts. Additional entities and attribute annotation data were sourced from authoritative guideline documents and specialized terminology databases within the respective field. Furthermore, the ontology has played a pivotal role in steering the creation of an online question-and-answer system, which is actively employed and assessed by a diverse group of multidisciplinary healthcare providers. WWECA successfully integrated a total of 609 entities encompassing various facets related to the diagnosis and medication for women of child-bearing age afflicted with epilepsy. The ontology exhibited a maximum depth of 8 within its hierarchical structure. Each of these entities featured three fundamental attributes, namely Chinese labels, definitions, and synonyms. The evaluation of WWECA involved 35 experts from 10 different hospitals across China, resulting in a favorable consensus among the experts. Furthermore, the ontology-driven online question and answer system underwent evaluation by a panel of 10 experts, including neurologists, obstetricians, and gynecologists. This evaluation yielded an average rating of 4.2, signifying a positive reception and endorsement of the system's utility and effectiveness. Our ontology and the associated online question and answer system hold the potential to serve as a scalable assistant for healthcare providers engaged in the management of women with epilepsy (WWE). In the future, this developmental framework has the potential for broader application in the context of long-term management of more intricate chronic health conditions.

Examining cognitive accessibility of the VIA Inventory of Strengths for adults with intellectual disability.

We evaluated cognitive accessibility of the VIA Inventory of Strengths Youth short form with adults with intellectual disability for use in strengths-based practice. We conducted cognitive testing with adults with intellectual disability (n = 33; M age = 36.2; range: 20.4-64.2). Data were coded for the extent to which (1) items were interpreted correctly; (2) participants endorsed items as describing themselves. We calculated descriptive statistics to evaluate item interpretation and response scale use. On average, 59% of participants interpreted items correctly, 20% misinterpreted items, 14% had mixed interpretations. Positive item endorsement was most associated with the response 'Very much like me' (77%); mixed endorsement was most associated with 'Somewhat like me' (39%); and negative endorsement of items was most associated with 'Not at all like me' (54%). Revisions are necessary for several items to improve accessibility for adults with intellectual disability and should be made in collaboration with this population.

Development and Validation of the Model Minority Stereotype-Response Scale

The model minority stereotype (MMS) has had a direct and significant impact on Asian Americans and their internal processes, like other stereotypes attributed to a group of people (e.g., stereotype threat; Steele & Aronson, 1995). In this article, we describe the development and validation of a measure named the Model Minority Stereotype-Response Scale (MMS-RS), which is designed to assess the responses Asian Americans experience when faced with the MMS to unveil how the stereotype impacts them. Exploratory and confirmatory factor analyses (CFAs) supported a two-factor structure of the MMS-RS, namely negative responses to and positive endorsement of the MMS. Alongside the reliability estimates, the evidence for construct validity demonstrated that the MMS-RS has good psychometric properties. Interestingly, both negative reaction to and the positive endorsement of the MMS were found to coexist. Overall, the MMS-RS is a useful instrument for scholars who are interested in researching, intervening, and advocating for Asian Americans’ experiences with the MMS.

E-cigarette Device Type, Source, and Use Behaviors of Youth and Young Adults: Findings from the Truth Longitudinal Cohort (2020–2021)

Background: E-cigarette device types vary in the amount of nicotine delivered to users. Given that youth and young adults are using pod-based and disposable e-cigarettes with high nicotine concentrations, it is important to determine how e-cigarette use behaviors associated with nicotine dependence may differ across e-cigarette device type. Methods: Baseline information was collected from September 2020 to March 2021 and follow-up information was collected from July to October 2021 from the Truth Longitudinal Cohort. The final analytic sample included respondents (aged 15–24) who reported current use of e-cigarettes at either baseline or follow-up and provided information on the 4-item E-cigarette Dependence Scale (EDS). Differences in endorsement of items from the EDS by e-cigarette device type (pod-based, disposable, or tank) were assessed using chi-square tests. Results: Participants (N = 308) were evenly split on age (15–20, 21+) and gender. Most 15–20-year-olds used disposable e-cigarettes, while those 21+ years primarily used tank devices. Although EDS score did not differ by e-cigarette device type, positive endorsement of two items from the EDS significantly differed by e-cigarette device type. More tank users endorsed reaching for a device without thinking about it (tank: 92.6%; pod-based: 79.0%; disposables: 79.9%, p = 0.04) and vaping more before going into a situation where vaping is not allowed (tank: 92.9%; pod-based: 71.0%; disposables: 73.0%, p < 0.01). Conclusions: Findings have the potential to inform policy implementation by providing evidence for specific targets for regulatory action that can help to reduce the burdens of e-cigarette use among youth and young adults, as results suggest that tank device users are more likely to endorse use behaviors associated with nicotine dependence.

Evaluating a social risk screening and referral program in an urban safety-net hospital emergency department.

The emergency department (ED) is an opportune venue to screen for unmet social needs and connect patients with social services. This quality improvement study incorporates both qualitative and quantitative data to examine unmet social needs among ED patients and program implementation. From September 2020 to December 2021, an urban safety-net hospital adult ED implemented a social needs screening and referral program. Trained emergency staff screened eligible patients for 5 social needs (housing, food, transportation, utilities, employment), giving resource guides to patients who screened positive (THRIVE+). We collected screening data from the electronic health record, conducted semi-structured interviews with THRIVE+ patients and clinical staff, and directly observed discharge interactions. Emergency staff screened 58.5% of eligible patients for social risk. Of the screened patients, 27.0% reported at least 1 unmet social need. Of those, 74.8% requested assistance. Screened patients reported housing insecurity (16.3%) as the most prevalent unmet social need followed by food insecurity (13.3%) and unemployment (8.7%). Among interviewed patients, 57.1% recalled being screened, but only 24.5% recalled receiving resource guides. Patients who received guides reported little success connecting with resources and supported universal guide dissemination. Staff expressed preference for warm handoff to social services. Of 13 observed discharge interactions, clinical staff only discussed guides with 2 patients, with no positive endorsement of the guides in any observed interactions. An ED social needs screening program can be moderately feasible and accepted. We identified housing as the most prevalent need. Significant gaps exist between screening and referral, with few patients receiving resources. Further training and workflow optimization are underway.

Qualitative Study of Telehealth Delivery of Suicide-Specific Group Treatment "Project Life Force".

Minimal evidence exists for suicide-specific group treatment for high-risk patients offered over telehealth. This qualitative study assessed the acceptability, feasibility, and impact of a telehealth suicide safety planning intervention (SPI) multi-session group. High-risk suicidal Veterans (n = 17) participating in "Project Life Force-telehealth" (PLF-T); a manualized, 10-session SPI video group completed semi-structured qualitative interviews including measures of acceptability, appropriateness, and feasibility. We also interviewed the PLF-T coordinator and PLF-T group facilitators to identify adaptations to deliver PLF-T and learn about barriers and facilitators to implementation. A summary template and matrix analysis approach was used to analyze qualitative data. Veteran group participants were mostly male (88%), age 50 (SD = 15.6), ethnically diverse, and either divorced or separated (54%). Suicide symptoms upon study entry included past month ideation with methods (100%); and past year aborted, interrupted, or actual suicide attempt (59%). Participant interviews revealed an overall positive endorsement of PLF-telehealth with enhanced suicidal disclosure, and improved ability to manage urges and mitigate loneliness. On scales from 1 to 20, PLF-T was rated as highly acceptable (M = 17.50; SD = 2.92), appropriate (M = 17.25; SD = 3.59), and feasible (M = 18; SD = 2.45) by participants. Adaptations to deliver PLF-T included using a communications coordinator to conduct assertive outreach and engagement, adding a telehealth orientation session, restructuring sessions to review suicide severity, and screen-sharing safety plans to maximize learning. PLF-T enhanced convenience and access without compromising safety. Concerns included privacy and technological limitations including connectivity. Project Life Force-telehealth is acceptable and feasible to deliver via telehealth. This opens the possibility of delivery to hard-to-reach high-risk populations. ClinicalTrials.gov Identifier: NCT0365363.

The Impact of Positive and Negative News about Celebrity Endorsers on the Consumer Behavior of Generation Z — Take the Chinese Market as an Example

This study examines whether positive and negative news about celebrity endorsers affects the consumer behavior of Chinese Gen Z consumers. A quantitative research was conducted to measure Changes in Chinese Gen Z consumers’ attitudes, favorability, and purchase intentions before and after the time of positive and negative celebrity endorsement events. The results of the study show that whe a celebrity endorser has negative news, Gen Z consumers’ favorability towards the endorser and the brand as well as their purchase intention will be significantly reduced. On the contrary, when a celebrity endorser has positive news, there is a slight, but not significant increase in Gen Z’s favorability towards endorser and the brand, and their purchase intention.

It’s About Hate: Approval of Donald Trump, Racism, Xenophobia and Support for Political Violence

Is approval of Donald J. Trump associated with support for political violence? If so, what explains the link between Trump approval and political violence? Using an original, nationally representative survey of over 1,500 adults in the United States we produce two findings. First, individuals who express approval for Trump are also significantly more likely to endorse positive descriptors for the January 6, 2021 attack on the U.S. Capitol and are more likely express support for the use of political violence more broadly. Second, the effects of Trump approval on support for the use of political violence are mediated through racist and xenophobic attitudes. Trump supporters in the study disproportionately exhibit racist and xenophobic/anti-foreigner attitudes, and these attitudes are associated with a positive endorsement of both January 6 and the use of political violence.

Interview with Jon Lauck

Interview with Jon Lauck

Food labeling in the European Union: a review of existing approaches

PurposeThis review explores the phenomenon of front-of-pack nutrition labels (FoPNLs) in the European Union (EU). FoPNLs highlight the nutritional quality of food and non-alcoholic beverages and help consumers to make healthier choices. The review explores different types of FoPNLs and evaluates their effectiveness.Design/methodology/approachA policy analysis was conducted, relying on extant academic literature, grey literature and policy documents. The use of current FoPNLs is interpreted in light of national and economic interests.FindingsOur review identifies and describes seven government endorsed FoPNLs that are currently used in the EU. Five are positive endorsement labels (Croatia, Czech Republic, Denmark, Lithuania, Slovenia and Sweden), which only provide a positive indication on more healthy products. The Keyhole is used in three EU countries (Denmark, Lithuania and Sweden), while the others are used in one country each. The Nutri-Score represents a summary label, which provides an overall grade of how healthy a product is. It is used in six countries (Belgium, France, Germany, Netherlands, Spain and Luxembourg). Finally, the Nutrinform battery is a nutrient-specific non-interpretive scheme, indicating the content of nutrients in a portion of a food product. All identified labels are only used on a voluntary basis, encouraging selective use.Originality/valueThis review contributes to a significant discussion about food labeling in the EU. It summarizes existing approaches and evaluates them in terms of their effectiveness. The current schemes in use reflect regional clustering. The most common scheme is the Nutri-Score. This is predominantly found in western EU states. Another major label is the Keyhole, with summary endorsement schemes being prevalent in northern EU states. The least common is Nutrinform, which has some support in southern EU states. The Nutri-score is most effective although economic interests are pushing for the Nutrinform battery in a small number of states. Finally, the review suggests that all existing FoPNLs are voluntary, these labels fail to provide consumers with adequate information about nutrition quality of food products. The EU needs to mobilize support to agree on a single one.

Cross-country variations in the reporting of psychotic symptoms among sub-Saharan African adults: A psychometric evaluation of the Psychosis Screening Questionnaire

BackgroundSelf-reporting of psychotic symptoms varies significantly between cultures and ethnic groups. Yet, limited validated screening instruments are available to capture such differences in the African continent. MethodologyAmong 9,059 individuals participating as controls in a multi-country case–control study of the genetic causes of psychosis, we evaluated the psychometric properties of the Psychosis Screening Questionnaire (PSQ). We applied multi-group confirmatory factor analysis and item response theory to assess item parameters. ResultsThe overall positive endorsement of at least one item assessing psychotic symptoms on the PSQ was 9.7%, with variability among countries (Uganda 13.7%, South Africa 11%, Kenya 10.2%, and Ethiopia 2.8%). A unidimensional model demonstrated good fit for the PSQ (root mean square error of approximation = 0.009; comparative fit index = 0.997; and Tucker-Lewis Index = 0.995). Hypomania had the weakest association with single latent factor (standardized factor loading 0.62). Sequential multi-group confirmatory factor analysis demonstrated that PSQ items were measured in equivalent ways across the four countries. PSQ items gave more information at higher levels of psychosis, with hypomania giving the least discriminating information. LimitationsParticipants were recruited from general medical facilities, so findings may not be generalizable to the general population. ConclusionThe PSQ demonstrated a unidimensional factor structure in these samples. Items were measured equivalently across all study settings, suggesting that differences in prevalence of psychotic symptoms between countries were less likely to represent measurement artifact. The PSQ is more reliable in screening for psychosis in individuals with higher degrees of psychotic experiences—hypomania excluded—and might decrease the false-positive rate from mild nonspecific psychotic experiences.

Empires of Vice: The Rise of Opium Prohibition across Asia by Diana S. Kim (review)

Reviewed by: Empires of Vice: The Rise of Opium Prohibition across Asia by Diana S. Kim Simon Soon Empires of Vice: The Rise of Opium Prohibition across Asia, by Diana S. Kim. Princeton, New Jersey, Princeton University Press, 2020. 336 pp ISBN 978-069-1172-40-8, pb ISBN 978-069-1199-70-2 For the larger part of the 19th century, opium was the chief source of revenue for European colonial enterprises. Since many European colonial port settlements gained competitive edge principally by lowering or abolishing trade tariffs altogether, the funding for public works and town building had to be raised through other means. The narcotic trade offered an easy solution, although the moral quandary would ultimately lead to widespread condemnation from the early 20th century onwards. The story of this shift is the focus of Diana S. Kim's monographic study on the rise of opium prohibition across Southeast Asia. Empire of Vices tracks the story of the changes in governmental and public perception of opium as a unfolding drama across three European colonies: Burma, Malaya and Indochina. To contextualise the significance of opium's reverie inducing signifiance, Kim notes that more than 50 percent of colonial taxes in the British and French colonies of Southeast Asia came from the sale of opium to local inhabitants. In a sense, Kim notes that the legitimacy of the trade was a felicitous alignment of 'the fiscal might and moral right of imperial rule'. During this period, opium was largely seen as a drug that delivers a state of euphoria or other enhanced mood. At times, it was also spoken of positively for its ability to suppress pain as well as induce relaxation, drowsiness, and sedation. Yet, despite the positive health endorsement that opium initially received and its seeming economic indispensability, public perception and colonial administrative policy about the narcotic took a drastic turn at the turn of the century towards [End Page 203] condemnation. By then, the narcotic addictive and debilitating properties became increasingly pronounced and a new moral consensus could no longer justify the trading of opium as a reliable source of public revenue. New strides were made by the very same power to condemn the social danger of the drug. What might account for this change of heart? This is where Kim's Empires of Vices offers a much-needed re-examination of the history of opium prohibition. It is a topic that has acquired general familiarity, although how the story of opium has been told is often conveyed through the pathos of tragedy. Kim eschews these moral theatrics, focusing instead on the how rather than the why. If the why is largely a moral question, the how is a historical one. In turn, story of opium told through this book is not a straightforward didactic story about revenue extraction and social control. The problem Kim sets before herself are two-fold. First, she attempts to make sense of the uneven development of this shared reform across the region by complicating the conventional narrative that changes in colonial policies were simply following metropolitan directives or were mediated by transnational social and religious activists. Second, Kim has set her sights on producing a more satisfying and humanistic account of why the colonial state was willing to abandon its key source of revenue, given that the political economy of colonial enterprises were aimed at maximising profits. In setting out to build up our understanding of opium monopolies in all their complexities, Kim creates a scaffold for the unfolding drama using what she calls a layered comparative approach. At the most direct level, the scaffolding offers a way to iron out discrepancies in sources that a historian is limited to when working across different colonial contexts. Such discrepancies are reasons why comparative research is often thought of as a challenging task. Yet, when comparisons are structured as layers, it functions as a narrative device as well. In this way, Kim's comparative approach also propels a wide range of rich and complex historical sources, ranging from colonial policy papers to literary texts, along a chronological vector. The central topic of the book was the gradual establishment of opium monopolies from 1890s...

Dominant groups support digressive victimhood claims to counter accusations of discrimination

When dominant groups are accused of discrimination against non-dominant groups, they often seek to portray themselves as the victims of discrimination instead. Sometimes, however, members of dominant groups counter accusations of discrimination by invoking victimhood on a new dimension of harm, changing the topic being discussed. Across three studies (N = 3081), we examine two examples of this digressive victimhood – Christian Americans responding to accusations of homophobia by claiming threatened religious liberty, and White Americans responding to accusations of racism by claiming threatened free speech. We show that members of dominant groups endorse digressive victimhood claims more strongly than conventional competitive victimhood claims (i.e., ones that claim “reverse discrimination”). Additionally, accounting for the fact that these claims may also stand to benefit a wider range of people and appeal to more abstract principles, we show that this preference is driven by the perception that digressive victimhood claims are more effective at silencing further criticism from the non-dominant group. Underscoring that these claims may be used strategically, we observed that individuals high in outgroup prejudice were willing to express a positive endorsement of the digressive victimhood claims even when they did not fully support the principle they claimed to be defending (e.g., freedom of religion or speech). We discuss implications for real-world intergroup conflicts and the psychology of dominant groups.

Training Death Investigators to Identify Decedents' Sexual Orientation and Gender Identity: A Feasibility Study.

There is growing impetus within mortality surveillance to identify decedents' sexual orientation and gender identity (SOGI), but key personnel to this effort (eg, death investigators) are not currently trained to collect SOGI information. To address this gap, we developed a training for death investigators on this topic and tested its feasibility with 114 investigators in 3 states. Participants completed pretraining and posttraining questionnaires that measured 4 perceived outcomes: training relevance, success of delivery, adequacy for future use, and likelihood of future use. Overall, strongly positive responses affirmed the training's relevance, success of delivery, and adequacy for future use. Responses about attempting to identify the decedent's SOGI in future cases were not quite as positive, with close to 80% of the participants saying that they were at least "somewhat likely" to collect this information. Despite design limitations, the study results support the feasibility of training death investigators to gather SOGI information. Although not systematically assessed in the study, investigators' positive endorsement of training outcomes seemed higher in training sites where leadership strongly supported SOGI identification, suggesting that the role of leadership may be key to encouraging SOGI identification among death investigators.

Grief-related beliefs in shidu parents with and without prolonged grief disorder: Psychometric properties of a Chinese version of the Typical Beliefs Questionnaire.

The Typical Beliefs Questionnaire (TBQ) assesses common grief-related cognitions, which demonstrated satisfactory psychometric properties in a treatment-seeking sample with prolonged grief disorder (PGD). Chinese shidu parents (bereaved parents over the age of 49 who have lost their only child) are at a high risk of PGD. The current study aimed to examine psychometric properties of the Chinese version of the TBQ (TBQ-C) in a community sample of shidu parents with and without PGD, to compare this to the original validation clinical sample in the United States bereaved of any close relationship and to consider its use as a clinical tool. We examined the rate of positive endorsement, factor structure, internal consistency and validity of the TBQ-C in 310 community-based shidu parents (including 102 who met the criteria for PGD). Results showed that the rate of positive endorsement for each item ranged from 7.2% to 48.6% among non-PGD participants and from 20.6% to 92.2% among PGD participants. Confirmatory factor analysis indicated that the original five-factor structure fit both the non-PGD and PGD shidu parents. The TBQ-C showed acceptable internal consistency and satisfactory convergent and concurrent validity in both groups. It had good discriminant validity and can be helpful in distinguishing shidu parents with and without PGD. The TBQ-C can be used to investigate common grief-related beliefs that may be problematic for both shidu parents with and without PGD.

Neurocognitive Heterogeneity in Social Anxiety Disorder: The Role of Self-Referential Processing and Childhood Maltreatment

Social anxiety disorder (SAD) is characterized by negative self-beliefs and altered brain activation in the default-mode network (DMN). However, the extent to which there is neurocognitive heterogeneity in SAD remains unclear. We had two independent samples of patients perform a self-referential encoding task and complete self-reports of childhood maltreatment, subjective well-being, and emotion regulation. In the replication sample, we also measured DMN activation using functional MRI. We used k-means clustering, which revealed two distinct subgroups of patients with SAD in the discovery sample. Cluster 1 demonstrated higher levels of negative self-referential trait endorsement, lower levels of positive self-referential trait endorsement, and significantly higher levels of childhood emotional maltreatment, lower subjective well-being, and altered emotion-regulation-strategy use. A similar pattern was observed in the replication sample, which further demonstrated higher DMN activation during negative trait judgments in Cluster 1. Participants in the SAD clusters, from both the discovery and replication samples, were significantly distinct from samples of control participants. These findings reveal neurocognitive heterogeneity in SAD and its relationship to emotional maltreatment.

Acceptability of a feasibility randomized clinical trial of a microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices (EMERGE) in young adults: a mixed methods assessment

BackgroundAcceptability is a critical requisite in establishing feasibility when planning a larger effectiveness trial. This study assessed the acceptability of conducting a feasibility randomized clinical trial of a 20-week microenterprise intervention for economically-vulnerable African-American young adults, aged 18 to 24, in Baltimore, Maryland. Engaging MicroenterprisE for Resource Generation and Health Empowerment (EMERGE) aimed to reduce sexual risk behaviors and increase employment and uptake of HIV preventive behaviors.MethodsThirty-eight participants were randomized to experimental (n = 19) or comparison group (n = 19). The experimental group received text messages on job openings plus educational sessions, mentoring, a start-up grant, and business and HIV prevention text messages. The comparison group received text messages on job openings only. Qualitative and quantitative post-intervention, in-person interviews were used in addition to process documentation of study methods.ResultsOur results found that the study design and interventions showed promise for being acceptable to economically-vulnerable African-American young adults. The largely positive endorsement suggested that factors contributing to acceptability included perceived economic potential, sexual health education, convenience, incentives, and encouraging, personalized feedback to participants. Barriers to acceptability for some participants included low cell phone connectivity, perceived payment delays, small cohort size, and disappointment with one’s randomization assignment to comparison group. Use of peer referral, network, or wait-list designs, in addition to online options may enhance acceptability in a future definitive trial. Expanding administrative and mentoring support may improve overall experience.ConclusionMicroenterprise interventions are acceptable ways of providing young adults with important financial and sexual health content to address HIV risks associated with economic vulnerability.Trial registrationClinicalTrials.gov. NCT03766165. Registered 04 December 2018.