"If I could survive without eating, it would be a huge relief": Development and initial validation of the Fear of Food Questionnaire.

BACKGROUND: Fear of food and behavioral avoidance of specific foods, food groups, and food related social situations can substantially reduce health related quality of life in individuals with a wide range of conditions that affect appetite, eating behavior, and digestion, including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), vomit and choking phobias, and food allergies/sensitivities. When this avoidance leads to weight/nutritional and/or psychosocial impairment, the diagnostic criteria for Avoidant/restrictive food intake disorder (ARFID) are met. Fear of food is an important target for interventions designed to improve psychosocial functioning and quality of life in such individuals. The purpose of this research was to develop and validate a novel measure of fear of food. METHODS: Participants (n = 1138) were recruited from ongoing clinical trials for both IBD and IBS, from Amazon's Mechanical Turk, from Reddit support forums for IBS, IBD, and vomit phobia, and from an undergraduate subject pool. Exploratory and confirmatory factor analysis, Pearson's correlations, one-way ANOVA, and intraclass correlation coefficients were used to assess the validity and reliability of the Fear of Food Questionnaire. RESULTS: The final 18 item questionnaire showed excellent internal consistency, test-retest reliability, convergent validity, discriminative (known groups) validity, as well as good factor structure. Fear of food was highly correlated with visceral hypersensitivity, catastrophizing, GI symptom severity and health related quality of life, as well as with self-reported Fear-ARFID symptoms. Individuals meeting study criteria for Fear-ARFID reported the highest scores relative to control and other analogue clinical groups. CONCLUSION: The Fear of Food Questionnaire appears to be reliable and valid across populations and may be a valuable tool in the assessment and treatment of Fear-ARFID.

Self-help Cognitive Behavioral Therapy Improves Health-Related Quality of Life for Inflammatory Bowel Disease Patients: A Randomized Controlled Effectiveness Trial.

Patients with inflammatory bowel disease (IBD) often have poor health-related quality of life (HRQL) and are at risk for anxiety and depression. Cognitive behavioral therapy (CBT) can help patients with IBD cope with their disease. Unfortunately, barriers to care include expense and availability of qualified therapists. Stand-alone, self-help CBT could improve access to care. This study examined the effectiveness of a self-help CBT workbook for patients with IBD. A randomized controlled trial compared the CBT workbook to an active psychoeducational control workbook. A total of 140 participants enrolled. In both groups, scores improved on a range of measures, including catastrophizing, visceral sensitivity, and HRQL, although pre-post effect sizes were generally larger in the CBT group. Only participants in the CBT group experienced significant improvements in anxiety and depression. Improvements were generally maintained or consolidated at 3-month follow-up. Self-help CBT can be an effective and inexpensive way to improve HRQL for patients with IBD.

Measuring the space required for symmetrical prosthetic restorations in the esthetic zone for an orthodontic patient: A dental technique.

This article describes a technique for measuring the length of the edentulous space to be restored and transferring the same size of the dentate space on the contralateral side to plan for symmetrical definitive restorations for the restorative dentist and orthodontist. The technique involves incorporating 2 archwire locks with hooks on a stainless steel wire that can be easily moved and adjusted to assess the curved space being measured.

Inflammatory Bowel Diseases-related Disability: Risk Factors, Outcomes, and Interventions.

The diagnosis of inflammatory bowel disease (IBD) is a life-changing moment for most adults. Biomedical advances over the past 2 decades have resulted in unprecedented growth of therapeutic options for IBD. However, due to the incurable nature of IBD, medical and surgical intervention alone may not be adequate to completely normalize health status and prevent long-term disability. In the biopsychosocial model of health and disease, a person's health and function result from complex physical, psychosocial, and environmental interactions. Adapting the World Health Organization definition, IBD-related disability encompasses limitations in educational and employment opportunities, exclusions in economic and social activities, and impairments in physical and psychosocial function. Although the concept of IBD-related disability is a long-term treatment end point in the updated Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE-II) treatment guideline, it has received limited attention in the literature. This review article explores an etiological framework of the physical and psychosocial aspects that contribute to IBD-related disability. We also explore the impact of IBD-related disability on the direct and indirect costs of IBD. Lastly, we present the available evidence for interventions with the potential to improve function and reduce IBD-related disability.

Managers Can Support Employees in Working-Class Contexts by Promoting Growth Mindsets.

White-collar workplaces are critical "gateway" contexts. They play a crucial role in providing valuable opportunities and upward social mobility. Some groups are less likely, however, to feel they belong in these settings. For example, those with a college degree may feel relatively at ease. However, those without may be uncertain about whether they will be fully included. We examine one possibility for addressing these class-based belonging gaps. A growing education literature demonstrates the power of growth mindsets. We extend this research to the workplace and test its benefits. In two preregistered experiments (N = 1,777), we find that endorsing growth mindsets can support working-class (WK) individuals. When managers have a growth mindset, WK individuals report high sense of belonging. The effect occurred because managers with growth mindsets reduced identity threat. A preregistered survey of employees in the real world (N = 300) triangulated these findings. Sense of belonging was higher among those who believed their manager had a growth mindset. Furthermore, they reported greater job satisfaction and commitment. These findings have important implications for the growing conversation on addressing class divides.

Development of a Multi-Criteria Decision Analysis Rating Tool to Prioritize Real-World Evidence Questions for the Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration.

The Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration developed an MCDA rating tool to assess and prioritize potential post-market real-world evidence (RWE) questions/uncertainties emerging from public drug funding decisions in Canada. In collaboration with a group of multidisciplinary stakeholders from across Canada, the rating tool was developed following a three-step process: (1) selection of criteria to assess the importance and feasibility of an RWE question; (2) development of rating scales, application of weights and calculating aggregate scores; and (3) validation testing. An initial MCDA rating tool was developed, composed of seven criteria, divided into two groups. Group A criteria assess the importance of an RWE question by examining the (1) drug's perceived clinical benefit, (2) magnitude of uncertainty identified, and (3) relevance of the uncertainty to decision-makers. Group B criteria assess the feasibility of conducting an RWE analysis including the (1) feasibility of identifying a comparator, (2) ability to identify cases, (3) availability of comprehensive data, and (4) availability of necessary expertise and methodology. Future directions include partnering with the Canadian Agency for Drugs and Technology in Health's Provincial Advisory Group for further tool refinement and to gain insight into incorporating the tool into drug funding deliberations.

Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners.

Project Orbis was initiated in May 2019 by the Oncology Center of Excellence to facilitate faster patient access to innovative cancer therapies by providing a framework for concurrent submissions and review of oncology products among international partners. Since its inception, Australia's Therapeutic Goods Administration (TGA), Canada's Health Canada (HC), Singapore's Health Sciences Authority (HSA), Switzerland's Swissmedic (SMC), Brazil's National Health Surveillance Agency (ANVISA), United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA), and most recently Israel's Ministry of Health (IMoH) Medical Technologies, Health Information, Innovation and Research (MTIIR) Directorate, have joined Project Orbis. While each country has its own expedited review pathways to bring promising therapies to patients, there are some similarities and differences in pathways and timelines. FDA's fast-track designation and MHRA's marketing authorization under exceptional circumstances (MAEC) allow non-clinical and limited clinical evidence to support approval under these programs. HC's Extraordinary Use New Drug (EUND) pathway allows granting exceptional use authorization with limited clinical evidence. ANVISA, HSA, MTIIR, and TGA do not have standard pathways that allow non-clinical evidence and limited clinical evidence. While there is no definite regulatory pathway for HSA, the current framework for approval does allow flexibility in the type of data (non-clinical or clinical) required to demonstrate the benefit-risk profile of a product. HSA may register a product if the agency is satisfied that the overall benefit outweighs the risk. All Project Orbis Partner (POP) countries have similar programs to the FDA accelerated approval program except ANVISA. Although HSA and MTIIR do not have defined pathways for accelerated approval programs, there are opportunities to request accelerated approval per these agencies. All POP countries have pathways like the FDA priority review except MHRA. Priority review timelines for new drugs range from 120 to 264 calendar days (cd). Standard review timelines for new drugs range from 180 to 365 cd.

Using core values and social influence to increase mask-wearing in non-compliant college students.

Determining the best way to increase public health behaviors like mask-wearing in non-compliant individuals remains an important problem. In this two-part study, we examined the correlates of mask non-compliance in undergraduates at a selective East Coast university, and then developed an intervention designed to appeal to individuals with those traits. We found that being politically conservative and favoring the core values of respect for authority and in-group loyalty were associated with mask non-compliance. We then developed two novel public service announcement (PSA) videos. One featured peer campus leaders (e.g. the president of the College Republicans) to appeal to both social influence and the core values of authority and loyalty. The other featured national and local health care authorities. We found that (a) conservative students rated the two videos as equally authoritative, while liberal students rated the health authority PSA to be significantly more authoritative; (b) conservative participants significantly increased their self-reported mask-wearing rates compared to baseline, narrowing the gap in compliance substantially; and (c) the two PSAs were equally effective for conservative students at increasing mask-wearing. This study shows that public health interventions that target the values and beliefs associated with non-compliance may best influence behavior.

Acceptability and efficacy of the Zemedy app versus a relaxation training and meditation app for IBS: protocol for a randomised controlled trial.

INTRODUCTION: Irritable bowel syndrome (IBS) has high rates of psychiatric comorbidity, and impairs health-related quality of life (HRQL). Cognitive-behavioural therapy (CBT) is an effective treatment for IBS, but access to treatment remains low. Our proposed solution is a CBT-based smartphone app, Zemedy. METHODS AND ANALYSIS: This randomised controlled trial of Zemedy (V.2.0) uses an education and relaxation training active control app meant to simulate treatment as usual. A target N of 300 participants complete baseline questionnaires and consent at screening, and are then allocated to either the immediate treatment (Zemedy) or the active control. Treatment lasts 8 weeks, after which both groups complete the same battery used at baseline, and the control group is crossed over to Zemedy. After another 8 weeks, the crossed-over participants will be surveyed once more. Follow-up questionnaires are administered at 3, 6 and 12 months post-treatment. Primary outcomes include gastrointestinal symptom severity and HRQL. Clinically significant change will be defined as post-treatment scores falling within 2 SD of the healthy mean. Analysis will include intent-to-treat between-groups comparisons, controlling for baseline symptom severity, as well as moderation and mediation analyses. We hypothesise that the Zemedy app will outperform the active control app in reducing IBS symptom severity and improving HRQL. ETHICS AND DISSEMINATION: This study was approved by the Institutional Review Board at the University of Pennsylvania. Results will provide essential information on the efficacy and acceptability of an app-based CBT treatment for IBS. The data gathered may help establish the Zemedy app as an empirically supported intervention for IBS and will assist funding bodies in deciding whether to invest in its further development and dissemination. The results will be disseminated to patients with IBS via the media and the company website, to healthcare professionals via professional training (e.g. webinars and grand rounds talks) and to researchers via conferences and publications. TRIAL REGISTRATION NUMBER: NCT04665271 (https://clinicaltrials.gov/ct2/show/NCT04665271).

Social Interactivity in Live Video Experiences Reduces Loneliness.

Background: Loneliness, especially when chronic, can substantially reduce one's quality of life. However, positive social experiences might help to break cycles of loneliness by promoting more prosocial cognitions and behaviors. Internet-mediated live video communication platforms (eg Zoom and Twitch) may offer an engaging and accessible medium to deliver such social experiences to people at scale. Despite these platforms' widespread use, there is a lack of research into how their socially interactive elements affect users' feelings of loneliness and connection. Objective: We aimed to experimentally evaluate whether socially interactivity in live video experience improves loneliness-related outcomes. Materials and Methods: We recruited participants from an online survey recruitment platform and assigned half to participate in a socially interactive live video experience with 6-12 strangers and the other half to a non-interactive control experience that was designed to be identical in every way but not socially interactive. Participants completed several baseline self-report measures of psychosocial wellbeing, participated in the hour-long video experience (an entertaining astronomy lesson), and then completed some baseline measures again. Four weeks later, we followed up with participants to evaluate their change in trait loneliness since baseline. We Pre-registered our hypotheses and analysis plan and provide our data, analysis code, and study materials online. Results: Two hundred and forty-nine participants completed the initial study and met inclusion criteria, 199 of whom also completed the 4-week follow-up. Consistent with our predictions, we found that directly after the more socially interactive experience, participants' feelings of connectedness increased more (p < 0.001), positive affect increased more (p = 0.002), feelings of loneliness decreased more (p < 0.001), social threat decreased more (p = 0.006), and negative affect decreased more (p = 0.003) than they did after the less interactive experience. However, change in trait loneliness between baseline and 4 weeks later did not differ between conditions (p = 0.953). Conclusions: Including socially interactive components in live video experiences can improve loneliness-related psychosocial outcomes for a short time. Future work should explore leveraging these benefits toward longer-term prosociality. Future work can also identify if the effects we observed generalize across different populations and kinds of online experiences.

Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial.

BACKGROUND: Patients with irritable bowel syndrome (IBS) experience abdominal pain, altered bowel habits, and defecation-related anxiety, which can result in reduced productivity and impaired health-related quality of life (HRQL). Cognitive behavioral therapy (CBT) has been shown to reduce symptoms of IBS and to improve HRQL, but access to qualified therapists is limited. Smartphone-based digital therapeutic interventions have potential to increase access to guided CBT at scale, but require careful study to assess their benefits and risks. OBJECTIVE: The aim of this study was to test the efficacy of a novel app, Zemedy, as a mobile digital therapeutic that delivers a comprehensive CBT program to individuals with IBS. METHODS: This was a crossover randomized controlled trial. Participants were recruited online and randomly allocated to either immediate treatment (n=62) or waitlist control (n=59) groups. The Zemedy app consists of 8 modules focusing on psychoeducation, relaxation training, exercise, the cognitive model of stress management, applying CBT to IBS symptoms, reducing avoidance through exposure therapy, behavioral experiments, and information about diet. Users interact with a chatbot that presents the information and encourages specific plans, homework, and exercises. The treatment was fully automated, with no therapist involvement or communication. At baseline and after 8 weeks, participants were asked to complete the battery of primary (Irritable Bowel Syndrome Quality of Life [IBS-QOL], Gastrointestinal Symptom Rating Scale [GSRS]) and secondary (Fear of Food Questionnaire [FFQ], Visceral Sensitivity Index [VSI], Gastrointestinal Cognition Questionnaire [GI-COG], Depression Anxiety Stress Scale [DASS], and Patient Health Questionnaire-9 [PHQ-9]) outcome measures. Waitlist controls were then offered the opportunity to crossover to treatment. All participants were assessed once more at 3 months posttreatment. RESULTS: Both intention-to-treat and completer analyses at posttreatment revealed significant improvement for the immediate treatment group compared to the waitlist control group on both primary and secondary outcome measures. Gains were generally maintained at 3 months posttreatment. Scores on the GSRS, IBS-QoL, GI-COG, VSI, and FFQ all improved significantly more in the treatment group (F1,79=20.49, P<.001, Cohen d=1.01; F1,79=20.12, P<.001, d=1.25; F1,79=34.71, P<.001, d=1.47; F1,79=18.7, P<.001, d=1.07; and F1,79=12.13, P=.001, d=0.62, respectively). Depression improved significantly as measured by the PHQ-9 (F1,79=10.5, P=.002, d=1.07), and the DASS Depression (F1,79=6.03, P=.02, d=.83) and Stress (F1,79=4.47, P=.04, d=0.65) subscales in the completer analysis but not in the intention-to-treat analysis. The impact of treatment on HRQL was mediated by reductions in catastrophizing and visceral sensitivity. CONCLUSIONS: Despite its relatively benign physical profile, IBS can be an extraordinarily debilitating condition. Zemedy is an effective modality to deliver CBT for individuals with IBS, and could increase accessibility of this evidence-based treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT04170686; https://www.clinicaltrials.gov/ct2/show/NCT04170686.

Project Orbis: Global Collaborative Review Program.

In 2019, the FDA Oncology Center of Excellence launched Project Orbis, a global collaborative review program to facilitate faster patient access to innovative cancer therapies across multiple countries. Project Orbis aims for concurrent submission, review, and regulatory action for high-impact clinically significant marketing applications among the participating partner countries. Current Project Orbis partners (POP) include the regulatory health authorities (RHA) of Australia, Brazil, Canada, Singapore, and Switzerland. Project Orbis leverages the existing scientific and regulatory partnerships between the various RHA under mutual confidentiality agreements. While FDA serves as the primary coordinator for application selection and review, each country remains fully independent on their final regulatory decision. In the first year of Project Orbis (June 2019 to June 2020), a total of 60 oncology marketing applications were received, representing 16 unique projects, and resulting in 38 approvals. New molecular entities, also known as new active substances, comprised 28% of the received marketing applications. The median time gap between FDA and Orbis submission dates was 0.6 months with a range of -0.8 to 9.0 months. Across the program, the median time-to-approval was similar between FDA (4.2 months, range 0.9-6.9, N = 18) and the POP (4.4 months, range 1.7-6.8, N = 20). Participating countries have signified a strong commitment for continuation and growth of the program. Project Orbis expansion considerations include the addition of more countries and management of more complex applications.

Predicting high school truancy among students in the Appalachian south.

Truancy is a considerable problem among adolescents. Considering the historical emphasis on studying truancy in urban regions, a concerted effort is needed to extend this research into rural areas to examine cultural generalizability of findings. The purpose of this study was to assess variables associated with truancy in a rural sample (N = 367) of students attending high school in a southern rural region of the Appalachian Mountains. The primary objective was to assess the relative predictive strength of the following variables: academic performance, religiosity, environmental factors (family structure, parental education, and adolescent perceptions of family functioning), internalizing problems (anxiety, depression, thought problems, attentional problems), externalizing problems (substance use and rule-breaking behaviors), and prosocial overt behaviors (participation in school and leadership activities). Regression analysis indicated that truancy was significantly associated with poor school performance, increased depression, social problems, having a less educated mother, a less structured home environment, higher grade, and decreased participation in school sports. EDITORS' STRATEGIC IMPLICATIONS: These findings are critical for the understanding of truancy in rural areas, and they highlight contextual factors that must be identified and addressed through systematic prevention programs targeting adolescents at risk for truancy.

Fecal incontinence in people with self-reported irritable bowel syndrome: Prevalence and quality of life.

Irritable bowel syndrome (IBS) is a common functional gastrointestinal (GI) disorder characterized by recurrent abdominal pain and altered bowel habits. IBS is a risk factor for fecal incontinence (FI), the unintentional passage of solid or liquid stool. FI can substantially interfere with health related quality of life (HRQL), leading to heightened anxiety and avoidance behavior. Nevertheless, relatively little research has been conducted on the prevalence of FI in IBS patients. This study evaluated the prevalence of FI in people with self-reported IBS and the relationship between FI and HRQL. 703 people who reported a diagnosis of IBS completed questionnaires on IBS symptom severity, FI symptom severity, HRQL, fear of food, anxiety about visceral sensations, and GI specific catastrophizing. Overall, 60% of people with IBS reported experiencing at least one lifetime episode of FI. In a subsample of 360 people who met strict Rome IV criteria and reported no other GI related co-morbidities, 62% reported experiencing at least one lifetime episode. While people who experienced FI more frequently had worse HRQL statistically, the differences in HRQL between people who had experienced FI and those who had not were not clinically significant. Rather than frequency of FI or physical symptom severity, quality of life was mostly determined by psychological variables, such as fear of food, anxiety, and catastrophizing. This study suggests that FI is quite prevalent in IBS patients, but that the best way to improve HRQL for IBS patients with FI may be to focus on reducing anxiety, catastrophizing and avoidance.

Imagery rescripting versus in vivo exposure in the treatment of snake fear.

This study compared imagery rescripting, in vivo exposure therapy and their combination in the treatment of snake fear. Imaginal ability was assessed pre-treatment, and was correlated with baseline avoidance. Snake fearful individuals were randomly assigned to cognitive therapy involving imagery rescripting, in vivo exposure, a combination of the two, or a relaxation control. All active treatment groups improved significantly more than the control group in both fearfulness and behavioral approach. There were no significant differences between the active treatment groups, although the combined treatment tended to be slightly more efficacious.

The role of imagery in the maintenance and treatment of snake fear.

Two studies assessed the role of mental imagery in the maintenance of fear of common phobic stimuli. Study 1 asked participants who were afraid of a wide range of phobic stimuli to report their visual and somatic imagery. Blind ratings of the imagery on horror and vividness were positively correlated with participant's self-reported fear and avoidance. Study 2 tested the efficacy of modifying imagery using cognitive restructuring compared to in vivo exposure and a minimal exposure, relaxation control in snake fearful participants. Both active treatment groups improved significantly more than the control group in self-reported snake fearfulness and behavioral approach. Condition also interacted with initial severity. Highly fearful subjects responded better to the cognitive imagery modification than to the in vivo exposure, and found the cognitive intervention significantly less aversive. These results are seen as supporting a cognitive model of the maintenance of specific phobia.

When timeliness matters: the effect of status on reactions to perceived time delay within distributed collaboration.

This research examines the interactive effects of status and perceived time delay on acceptance of partner knowledge contributions within a distributive collaboration work environment. Results across 2 studies suggest that within distributed collaboration, time delays attributed to low-status partners had a significantly more harmful effect on influence acceptance than time delay attributed to high-status partners. This was so, despite the fact that partners' actual behavior was held constant across experimental conditions. In addition, results indicate that judgments of partner competence significantly mediated the interactive effects of perceived time delay and partner status on acceptance of partner influence.

Construct validity of the Balloon Analog Risk Task (BART): associations with psychopathy and impulsivity.

To continue research assessing the validity of the Balloon Analog Risk Task (BART) as a measure of risk taking, the BART was administered to a nonforensic sample of individuals with varying levels of psychopathic characteristics. Construct validity of the BART was evaluated by measuring risk-taking behavior in relation to self-reported psychopathy, anxiety, psychophysiological data, and demographic variables. Supporting the construct validity of the BART, while controlling for variance accounted for by interrelated variables in the context of hierarchical regression analyses, higher self-reported psychopathy was significantly predictive of increased risk taking on the BART. Findings also revealed interesting gender differences in self-reported psychopathy and a trend for men to engage in riskier behavior. Limitations and research directions are presented.

Condoning stereotyping? How awareness of stereotyping prevalence impacts expression of stereotypes.

The deleterious effects of stereotyping on individual and group outcomes have prompted a search for solutions. One approach has been to increase awareness of the prevalence of stereotyping in the hope of motivating individuals to resist natural inclinations. However, it could be that this strategy creates a norm for stereotyping, which paradoxically undermines desired effects. The present research demonstrates that individuals who received a high prevalence of stereotyping message expressed more stereotypes than those who received a low prevalence of stereotyping message (Studies 1a, 1b, 1c, and 2) or no message (Study 2). Furthermore, working professionals who received a high prevalence of stereotyping message were less willing to work with an individual who violated stereotypical norms than those who received no message, a low prevalence of stereotyping message, or a high prevalence of counter-stereotyping effort message (Study 3). Also, in a competitive task, individuals who received a high prevalence of stereotyping message treated their opponents in more stereotype-consistent ways than those who received a low prevalence of stereotyping message or those who received a high prevalence of counter-stereotyping effort message (Study 4).