Food Insecurity and Psychosocial Burden in a National Community-Based Sample of Households Managing Food Allergy.

BACKGROUND: Experiencing food allergies and food insecurity has been linked to socioeconomic, physical, and mental health-related challenges, but less is known about the intersection of these experiences. This study aims to better understand the impact of food insecurity on food allergy patients and their caregivers, with the intention of informing ongoing efforts to improve screening for food insecurity and mental health concerns and reducing their burden among households managing food allergy. METHOD: As part of a community needs assessment, a cross-sectional survey was administered to a large, national sample (N=5,940) of US households with at least one food-allergic individual, The Hunger Vital Sign was utilized to assess food insecurity, the Patient Health Questionnaire (PHQ-4) and Food Allergy Independent Measure (FAIM) were leveraged to measure psychosocial outcomes. RESULTS: Among respondents, 69.9% screened at-risk of food insecurity on the Hunger Vital Sign, while 5.6% reported very low food security. Both adults and children with food allergy (FA) from households at risk for food insecurity were more likely to report FA-related anxiety, anger, loneliness, fear of eating, and bullying victimization than their counterparts from households not at risk of food insecurity (p < .0001 for all). Among these specific experiences, FA-related anxiety was the most common (25.4%/30.1% of children/adults). Perceived risk of food allergy-related fatality was positively associated with food insecurity status. CONCLUSION: Individuals with food allergies who are concomitantly experiencing food insecurity are at greater risk of a variety of mental health concerns, including those specific to food allergy as well as more general anxiety and depressive symptoms.

Oral Immunotherapy-Related Awareness, Attitudes, and Experiences Among a Nationally Representative Sample of Food Allergy Patients/Caregivers.

BACKGROUND: Advances in oral immunotherapy (OIT) have led to recently expanded treatment options for food allergy (FA) patients. However, to inform future outreach efforts and ensure equitable access to emerging treatments, a greater understanding of current OIT-related awareness, attitudes, and experiences is needed. OBJECTIVE: To characterize current OIT awareness, attitudes, and experiences among a nationally representative sample of U.S. adults with FA and parents/caregivers of pediatric patients. METHODS: A probability-based sample of U.S. adults and parents/caregivers of children with FA was surveyed about OIT-related knowledge, attitudes, and experiences. RESULTS: Surveys were completed by respondents (n = 781) from all 50 states. Overall, 72% did not know what OIT was prior to the survey. Respondents from households earning over $100,000 or with a college degree each had significantly greater odds of reporting any OIT awareness compared with lower-income (odds ratio 2.0; 95% confidence interval 1.2-3.4) and non-college-educated (odds ratio 1.9; 95% confidence interval 1.2-3.0) respondents. Among respondents familiar or unfamiliar with OIT, 54% and 34%, respectively, reported their expected treatment outcome was to obtain protection against accidental exposure. Among respondents familiar or unfamiliar with OIT, 38% and 35%, respectively, reported their expected treatment outcome to be curing the allergy. Furthermore, 55% of OIT unfamiliar respondents said they would not be comfortable initiating a conversation with their health care provider about their suitability for OIT. CONCLUSIONS: This study shows that, among a nationally representative sample of FA patients and pediatric caregivers, awareness of OIT is low, and over 95% of patients lack personal experience with OIT. Furthermore, the data suggest current OIT awareness is disproportionately elevated among wealthier, more highly educated respondents.

Understanding Precautionary Allergen Labeling (PAL) Preferences Among Food Allergy Stakeholders.

BACKGROUND: Food allergy (FA) is an increasing public health concern in the United States, affecting approximately 8% of children and 11% of adults. The United States currently lacks clear requirements for the use of precautionary allergen labeling (PAL) on packaged foods, such as "may contain" or "made on shared equipment." This lack of specific governmental policy results in inconsistent labeling practices and confusion. OBJECTIVE: This study aimed to understand current knowledge and preferences for PAL statements among FA stakeholders. METHODS: A cross-sectional survey was sent to FA stakeholders. Descriptive statistics and associations from logistic regressions were used to assess respondents' knowledge of PAL policy, shopping habits, and preferences around PAL. RESULTS: Of 3008 respondents, 24.2% were able to correctly answer 4 questions surrounding PAL policies. When asked about their shopping habits, the majority of respondents never purchase products with a "May contain traces of allergen" label (85.5%) in comparison with never purchasing products with a "Good manufacturing practices used to segregate ingredients in a facility that also processes allergen" label (35.0%). Their top preferences for a PAL statement were "Not suitable for people with 'blank' allergy" (29.3%) and "May contain" (22.1%). Health care provider discussions around PAL varied and were strongly associated with purchasing behaviors. CONCLUSIONS: These results suggest that FA consumers are not aware of PAL policies and make decisions based on the words in the PAL. They prefer having clearer, more specific, and consistent labeling on products, indicating that explicit PAL policies are needed to allow customers to easily identify safe foods.

Consensus report from the Food Allergy Research & Education (FARE) 2019 Oral Immunotherapy for Food Allergy Summit.

Food allergy is a major health problem affecting 5% to 10% of the population in developed nations, including an estimated 32 million Americans. Despite the large number of patients suffering from food allergies, up until the end of January 2020, no treatment for food allergies had been approved by the US Food and Drug Administration. The only options were avoidance of food allergen triggers and acute management of allergic reactions. A considerable body of data exists supporting oral immunotherapy (OIT) as a promising, novel treatment option, including that for the now Food and Drug Administration-approved peanut OIT product Palforzia (Aimmune Therapeutics, Brisbane, Calif). However, data for long-term quality-of-life improvement with OIT varies, depending on the measures used for analysis. Like many therapies, OIT is not without potential harms, and burdens, and the evaluation of patient-specific risk-benefit ratio of food OIT produces challenges for clinicians and patients alike, with many unanswered questions. Food Allergy Research & Education organized the Oral Immunotherapy for Food Allergy Summit on November 6, 2019, modeled after the PRACTALL sessions between the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma & Immunology to address these critical issues. Health care providers, patient representatives, researchers, regulators, and food allergy advocates came together to discuss OIT and identify areas of common ground as well as gaps in existing research and areas of uncertainty and disagreement. The purpose of this article was to summarize that discussion and facilitate collaboration among clinicians and patients to help them make better-informed decisions about offering and accepting OIT, respectively, as a therapeutic option.

The National Sleep Foundation's Sleep Satisfaction Tool.

OBJECTIVES: The National Sleep Foundation (NSF) sought to test, refine, and add statistical rigor to its previously described provisional Sleep Satisfaction Tool (SST). The tool assesses the general population's sleep satisfaction. DESIGN: In 2017, NSF created a provisional tool through systematic literature review and an expert consensus panel process. This tool was expanded, refined, and tested through an open-ended survey, 2 rounds of cognitive testing, and a national survey of a random sample of Internet users (aged 18-90). Factor analysis and final consensus panel voting produced the robust SST. RESULTS: The exploratory, open-ended surveying for identifying additional factors important to the public led to question formulation around mind relaxation. Cognitive testing yielded significant refinement to question and response option formatting. Factor analysis of questions from field testing indicated loading on one construct identified as "sleep satisfaction." The final 9-item SST demonstrated strong reliability and internal validity with overall SST scores of 56/100 (higher scores indicating greater sleep satisfaction). Individual SST item mean scores ranged from 39 to 66, and overall SST scores varied substantially across demographic groups. CONCLUSIONS: NSF used a series of development and validation tests on its provisional SST, producing a novel and reliable research tool that measures the general population's sleep satisfaction. The SST is a short, reliable, nonclinical assessment that expands the set of tools available to researchers that implements the individual, social, and environmental factors related to sleep satisfaction. Further research will explore refined scoring methods along with factor weighting and use within different populations.

A provisional tool for the measurement of sleep satisfaction.

OBJECTIVES: The goal of this project was to provisionally identify the basic elements of sleep satisfaction within the general population. METHODS: The National Sleep Foundation conducted a systematic literature review and identified 495 published articles evaluating potential indicators of sleep satisfaction. The National Sleep Foundation then convened an expert panel ("Panel"), provided full-text articles and summaries, and used a modified RAND appropriateness method with three total rounds of voting to determine the appropriateness of indicators for sleep satisfaction. RESULTS: The literature review revealed no tools or measures of sleep satisfaction (not dissatisfaction) applied to the general population and directly associated with good health. Nonetheless, a variety of sleep factors were extracted from the extant sleep research literature. Panel members voted on these indicators: sleep environmental factors; and sleep initiation and maintenance parameters. Using these indicators, the Panel constructed provisional questions for measuring sleep satisfaction. CONCLUSIONS: The Panel determined that appropriate sleep satisfaction elements include how an individual feels (a) about their sleep, (b) immediately after their sleep, and (c) during the subsequent day. Additionally, appropriate environmental elements include (a) bedding comfort, (b) bedroom temperature, and (c) noise and light in the bedroom. How one feels with (a) the time it takes to fall asleep, (b) the ease with which one falls back to sleep after awakening during a sleep period, (c) the amount of sleep on weekdays and weekends, as well as how undisturbed one's sleep is also were determined to be appropriate contributors to sleep satisfaction. Finally, the Panel agreed that whether an individual desired to change anything about their sleep, is a relevant question.

The National Sleep Foundation's Sleep Health Index.

OBJECTIVES: A validated survey instrument to assess general sleep health would be a useful research tool, particularly when objective measures of sleep are not feasible. Thus, the National Sleep Foundation spearheaded the development of the Sleep Health Index (SHI). DESIGN: The development of the SHI began with a task force of experts who identified key sleep domains and questions. An initial draft of the survey was created and questions were refined using cognitive testing and pretesting. The resulting 28-question survey was administered via random-sample telephone interviews to nationally representative samples of adults in 2014 (n=1253) and 2015 (n=1250). These data were combined to create the index. A factor analysis linked 14 questions to 3 discrete domains: sleep quality, sleep duration, and disordered sleep. These were assembled as sub-indices, then combined to form the overall SHI, with scores ranging from 0 to 100 (higher score reflects better sleep health). RESULTS: Americans earned an overall SHI score of 76/100, with sub-index scores of 81/100 in disordered sleep, 79/100 in sleep duration, and 68/100 in sleep quality. In regression analyses, the strongest independent predictors of sleep health were self-reported stress (ß=-0.26) and overall health (ß=0.26), which were also the strongest predictors of sleep quality (ß=-0.32 and ß=0.27 respectively). CONCLUSIONS: The current 12-item SHI is a valid, reliable research tool that robustly measures 3 separate but related elements of sleep health-duration, quality, and disorders-and assesses the sleep health status of adults in the United States.

Brief Report: Longitudinal Patterns of Response to Standard of Care Therapy for Systemic Lupus Erythematosus: Implications for Clinical Trial Design.

OBJECTIVE: To evaluate longitudinal patterns of response to standard of care for systemic lupus erythematosus (SLE) in clinical trials and to identify characteristics that differentiate nonresponders from persistent responders. METHODS: Data on 147 patients with moderately to severely active SLE without acute nephritis who were treated with placebo plus standard of care in two 52-week phase II/III trials were obtained from the Collective Data Analysis Initiative of the Lupus Foundation of America. Cross-sectional and longitudinal analyses of British Isles Lupus Assessment Group (BILAG)-based responses (improvement in all baseline A or B scores without new flare) were performed. Baseline characteristics that discriminated persistent responders from nonresponders were identified using logistic regression. RESULTS: Cross-sectional response rates decreased from 46% to 37% between 12 and 52 weeks. The overall rate of complete and sustained response, i.e., response at all visits, was only 14.3% (95% confidence interval 8.6-19.9%). Agreement between response status at 12 weeks and 36-52 weeks was low (κ = 0.15-0.29), and only 31% of initial 12-week responders maintained response at all subsequent visits. Baseline factors predictive of persistent response to standard of care included fewer organs with active disease, high C3 levels, and type of background therapy. CONCLUSION: Use of sustained rather than landmark response may reduce high placebo response rates in SLE trials that continue aggressive standard of care. Further exploration to assess the power of this end point to improve discrimination between active and placebo arms is indicated. Lack of temporal stability in response highlights a potential weakness with shorter studies. Rates of response to standard of care are affected by the severity of the disease and the aggressiveness of background immunosuppressive treatments.