Celiac disease symptom profiles and their relationship to gluten-free diet adherence, mental health, and quality of life.

BACKGROUND: A subgroup of adults with celiac disease experience persistent gastrointestinal and extraintestinal symptoms, which vary between individuals and the cause(s) for which are often unclear. METHODS: The present observational study sought to elucidate patterns of persistent symptoms and the relationship between those patterns and gluten-free diet adherence, psychiatric symptoms, and various aspects of quality of life (QOL) in an online sample of adults with celiac disease. U.S. adults with self-reported, biopsy-confirmed celiac disease (N = 523; Mage = 40.3 years; 88% women; 93.5% White) voluntarily completed questionnaires as part of the iCureCeliac® research network: (a) Celiac Symptoms Index (CSI) for physical symptoms and subjective health; (b) Celiac Dietary Adherence Test for gluten-free diet adherence; (c) PROMIS-29, SF-36, and Celiac Disease Quality of Life Survey for psychiatric symptoms and QOL. Symptom profiles were derived using latent profile analysis and profile differences were examined using auxiliary analyses. RESULTS: Latent profile analysis of CSI items determined a four-profile solution fit best. Profiles were characterized by: (1) little to no symptoms and excellent subjective health (37% of sample); (2) infrequent symptoms and good subjective health (33%); (3) occasional symptoms and fair to poor subjective health (24%); (4) frequent to constant symptoms and fair to poor subjective health (6%). Profiles 2 and 3 reported moderate overall symptomology though Profile 2 reported relatively greater extraintestinal symptoms and Profile 3 reported relatively greater gastrointestinal symptoms, physical pain, and worse subjective health. Profiles differed on anxiety and depression symptoms, limitations due to physical and emotional health, social functioning, and sleep, but not clinical characteristics, gluten-free diet adherence, or QOL. Despite Profile 3's moderate symptom burden and low subjective health as reported on the CSI, Profile 3 reported the lowest psychiatric symptoms and highest quality of life on standardized measures. CONCLUSIONS: Adults with celiac disease reported variable patterns of persistent symptoms, symptom severity, and subjective health. Lack of profile differences in gluten-free diet adherence suggests that adjunctive dietary or medical assessment and intervention may be warranted. Lower persistent symptom burden did not necessarily translate to better mental health and QOL, suggesting that behavioral intervention may be helpful even for those with lower celiac symptom burden.

Developing Patient-Centered Real-World Evidence: Emerging Methods Recommendations From a Consensus Process.

OBJECTIVES: The Joint ISPOR-ISPE Special Task Force on Real-World Evidence included patient/stakeholder engagement as a recommended good procedural practice when designing, conducting, and disseminating real-world evidence (RWE). However, there are no guidelines describing how patient experience data (PED) can be applied when designing real-world data (RWD) studies. This article describes development of consensus recommendations to guide researchers in applying PED to develop patient-centered RWE. METHODS: A multidisciplinary advisory board, identified through recommendations of collaborators, was established to guide development of recommendations. Semistructured interviews were conducted to identify how experienced RWD researchers (n = 15) would apply PED when designing a hypothetical RWD study. Transcripts were analyzed and emerging themes developed into preliminary methods recommendations. An eDelphi survey (n = 26) was conducted to refine/develop consensus on the draft recommendations. RESULTS: We identified 13 recommendations for incorporating PED throughout the design, conduct, and translation of RWE. The recommendations encompass themes related to the development of a patient-centered research question, designing a study, disseminating RWE, and general considerations. For example, consider how patient input can inform population/subgroups, comparators, and study period. Researchers can leverage existing information describing PED and may be able to apply those insights to studies relying on traditional RWD sources and/or patient registries. CONCLUSIONS: Applying these emerging recommendations may improve the patient centricity of RWE through improved relevance of RWE to patient communities of interest and foster greater multidisciplinary participation and transparency in RWD research. As researchers gather experience by applying the methods recommendations, further refinement of these consensus recommendations may lead to "best practices."

Pain as a predictor and consequence of tobacco abstinence effects amongst African American smokers.

African Americans are subject to health disparities in smoking and chronic pain. Given that nicotine has analgesic properties, increases in acute pain may be an expression of the tobacco abstinence syndrome, particularly among African American smokers with chronic pain. This report is a secondary analysis of data from an ongoing study of individual differences in laboratory-derived tobacco abstinence phenotypes in African American smokers. We tested whether overnight smoking abstinence increased acute pain and whether abstinence-induced changes in acute pain were correlated with other expressions of tobacco abstinence and amplified among smokers with chronic pain. African American smokers (N = 214; 10+ cig/day) attended a baseline visit (when chronic pain was reported), and two counterbalanced experimental sessions (ad libitum smoking vs. 16-hr smoking abstinence). At both experimental sessions, measures of self-reported acute pain and other tobacco abstinence symptoms were administered. Smoking abstinence significantly increased acute pain (d = .17, p = .01). Correlations between abstinence-induced changes in acute pain and abstinence-induced changes in negative affect, r = .15, p = .02, smoking urges, r = .13, p = .05, and composite nicotine withdrawal symptoms, r = .13, p = .06, were small and nonsignificant after correction for multiple tests, indicating that phenotypic variation in abstinence-provoked changes in acute pain and other tobacco abstinence expressions were largely independent. Baseline levels of chronic pain predicted greater abstinence-induced pain amplification at experimental sessions (ßs = .29-.31; ps < .001). Acute pain is greater following overnight tobacco abstinence (vs. satiation) among African American smokers, predominantly among those with chronic pain. Addressing pain in tobacco addiction science, treatment, and health equity programming warrants consideration. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Effects of sweet flavorings and nicotine on the appeal and sensory properties of e-cigarettes among young adult vapers: Application of a novel methodology.

INTRODUCTION: Product characteristics that impact e-cigarette appeal by altering the sensory experience of vaping need to be identified to formulate evidence-based regulatory policies. While products that contain sweet flavorings and produce a "throat hit" (i.e., desirable airway irritation putatively caused by nicotine) are anecdotally cited as desirable reasons for vaping among young adults, experimental evidence of their impact on user appeal is lacking. This experiment applied a novel laboratory protocol to assess whether: (1) sweet flavorings and nicotine affect e-cigarette appeal; (2) sweet flavorings increase perceived sweetness; (3) nicotine increases throat hit; and (4) perceived sweetness and throat hit are associated with appeal. METHODS: Young adult vapers (N=20; age 19-34) self-administered 20 standardized doses of aerosolized e-cigarette solutions varied according to a 3 flavor (sweet [e.g., cotton candy] vs. non-sweet [e.g., tobacco-flavored] vs. flavorless)×2 nicotine (6mg/mL nicotine vs. 0mg/mL [placebo]) double-blind, cross-over design. Participants rated appeal (liking, willingness to use again and perceived monetary value), perceived sweetness and throat hit strength after each administration. RESULTS: Sweet-flavored (vs. non-sweet and flavorless) solutions produced greater appeal and perceived sweetness ratings. Nicotine produced greater throat hit ratings than placebo, but did not significantly increase appeal nor interact with flavor effects on appeal. Controlling for flavor and nicotine, perceived sweetness was positively associated with appeal ratings; throat hit was not positively associated with appeal. CONCLUSIONS: Further identification of compounds in e-cigarette solutions that enhance sensory perceptions of sweetness, appeal, and utilization of e-cigarettes are warranted to inform evidence-based regulatory policies.