Acceptability of a Fentanyl Vaccine to Prevent Opioid Overdose and Need for Personalized Decision-Making.

BACKGROUND: The opioid epidemic worsened during the coronavirus disease 2019 (COVID-19) pandemic. Synthetic opioids (primarily fentanyl) comprise the most common drugs involved in overdose (OD) death. A vaccine that blocks fentanyl from reaching the brain to prevent OD is under development, and insight is needed into its acceptability. METHODS: Using a semi-structured interview guide, persons with opioid use disorder (OUD), family, professionals, and the public were interviewed about attitudes and concerns regarding a fentanyl vaccine. Reactions to fictional clinical vignettes of persons at risk of OUD because of pain and/or substance use histories were collected, analyzed, and quantified for favorability. Interviews were transcribed, coded, and analyzed thematically. RESULTS: Among N = 64 participants, (70.3% female, average age 32.4 years), attitudes were favorable toward a fentanyl vaccine, with preference for lifelong durability (76% of n = 55 asked). Perceived benefits centered on the potential for a life-saving intervention, suffering averted, healthcare dollars saved, and the utility of a passive harm reduction strategy. Concerns centered on uncertainty regarding vaccine safety, questions about efficacy, worry about implications for future pain management, stigma, and need for supportive counseling and guidance to personalize decision making. Reactions to vignettes revealed complex attitudes toward fentanyl vaccination when considering recipient age, health history, and future risks for addiction and pain. CONCLUSIONS: Positive responses to a fentanyl vaccine were found along with appreciation for the complexity of a vaccine strategy to prevent OD in the setting of pain and uncertain durability. Further research is needed to elucidate operational, ethical, and communications strategies to advance the model.

Associations Between Patient-Reported Outcome Measures of Physical and Psychological Functioning and Willingness to Share Social Media Data for Research Among Adolescents With a Chronic Rheumatic Disease: Cross-Sectional Survey.

Background: Social media data may augment understanding of the disease and treatment experiences and quality of life of youth with chronic medical conditions. Little is known about the willingness to share social media data for health research among youth with chronic medical conditions and the differences in health status between sharing and nonsharing youth with chronic medical conditions. Objective: We aimed to evaluate the associations between patient-reported measures of disease symptoms and functioning and the willingness to share social media data. Methods: Between February 2018 and August 2019, during routine clinic visits, survey data about social media use and the willingness to share social media data (dependent variable) were collected from adolescents in a national rheumatic disease registry. Survey data were analyzed with patient-reported measures of disease symptoms and functioning and a clinical measure of disease activity, which were collected through a parent study. We used descriptive statistics and multivariate logistic regression to compare patient-reported outcomes between youth with chronic medical conditions who opted to share social media data and those who did not opt to share such data. Results: Among 112 youths, (age: mean 16.1, SD 1.6 y; female: n=72, 64.3%), 83 (74.1%) agreed to share social media data. Female participants were more likely to share (P=.04). In all, 49 (43.8%) and 28 (25%) participants viewed and posted about rheumatic disease, respectively. Compared to nonsharers, sharers reported lower mobility (T-score: mean 49.0, SD 9.4 vs mean 53.9, SD 8.9; P=.02) and more pain interference (T-score: mean 45.7, SD 8.8 vs mean 40.4, SD 8.0; P=.005), fatigue (T-score: mean 49.1, SD 11.0 vs mean 39.7, SD 9.7; P<.001), depression (T-score: mean 48.1, SD 8.9 vs mean 42.2, SD 8.4; P=.003), and anxiety (T-score: mean 45.2, SD 9.3 vs mean 38.5, SD 7.0; P<.001). In regression analyses adjusted for age, sex, study site, and Physician Global Assessment score, each 1-unit increase in symptoms was associated with greater odds of willingness to share social media data, for measures of pain interference (Adjusted Odds Ratio [AOR] 1.07, 95% CI 1.001-1.14), fatigue (AOR 1.08, 95% CI 1.03-1.13), depression (AOR 1.07, 95% CI 1.01-1.13), and anxiety (AOR 1.10, 95% CI 1.03-1.18). Conclusions: High percentages of youth with rheumatic diseases used and were willing to share their social media data for research. Sharers reported worse symptoms and functioning compared to those of nonsharers. Social media may offer a potent information source and engagement pathway for youth with rheumatic diseases, but differences between sharing and nonsharing youth merit consideration when designing studies and evaluating social media-derived findings.

Construct validity of Patient-Reported Outcomes Measurement Information System Paediatric measures in juvenile idiopathic arthritis and systemic lupus erythematosus: cross-sectional evaluation.

OBJECTIVES: Evaluate construct validity of Patient-Reported Outcomes Measurement Information System (PROMIS) Paediatric measures of symptoms and functioning against measures of disease activity among youth with juvenile idiopathic arthritis (JIA) or systemic lupus erythematosus (SLE). DESIGN: Cross-sectional associations among PROMIS measures and clinical metrics of disease activity were estimated. SETTING: Seven clinical sites of the Childhood Arthritis and Rheumatology Alliance (CARRA) in the USA. PARTICIPANTS: Youth aged 8-17 years enrolled in the CARRA Registry. INTERVENTION: PROMIS measures were collected and associations with clinical measures of disease activity estimated, by condition, in bivariate and multivariable analyses with adjustment for sociodemographics, insurance status, medications and disease duration. MAIN OUTCOME MEASURES: PROMIS Paediatric measures of mobility, physical activity, fatigue, pain interference, family relationships, peer relationships, depressive symptoms, psychological stress, anxiety, and meaning and purpose, and clinical metrics of disease. RESULTS: Among 451 youth (average age 13.8 years, 71% female), most (n=393, 87%) had a JIA diagnosis and the remainder (n=58, 13%) had SLE. Among participants with JIA, those with moderate/high compared with low/inactive disease had, on average, worse mobility (multivariable regression coefficient and 95% CIs) (-7.40; -9.30 to -5.50), fatigue (3.22; 1.02 to 5.42), pain interference (4.76; 3.04 to 6.48), peer relationships (-2.58; -4.52 to -1.64), depressive symptoms (3.00; 0.96 to 5.04), anxiety (2.48; 0.40 to 4.56) and psychological stress (2.52; 0.68 to 4.36). For SLE, youth with active versus inactive disease had on average worse mobility (-5.07; -10.15 to 0.01) but PROMIS Paediatric measures did not discriminate participants with active and inactive disease in adjusted analyses. CONCLUSIONS: Seven PROMIS Paediatric measures discriminated between active and inactive disease in youth with JIA. Results advance the usefulness of PROMIS for understanding well-being and improving interventions for youth with JIA, but larger studies are needed to determine utility in SLE cohorts. TRIAL REGISTRATION NUMBER: National Institute of Arthritis and Musculoskeletal and Skin Diseases (U19AR069522).

Effects of a Patient-Centered Intervention to Reduce Alcohol Use Among Youth With Chronic Medical Conditions.

PURPOSE: Alcohol poses unique risks for youth with chronic medical conditions (YCMC) yet many drink. Preventive interventions targeting YCMC are scarce. METHODS: YCMC with type 1 diabetes, juvenile idiopathic arthritis, systemic lupus erythematosus, or inflammatory bowel disease were recruited and randomized to trial the effects of a self-administered condition-tailored psychoeducational intervention on frequency in days of past 3-month alcohol use, alcohol-related risk perceptions, and knowledge. Changes in outcomes over time were measured and compared by treatment arm using multivariate mixed effects models. RESULTS: Among N = 418 participants (average age 16.0 years, 52.2% female, 84.7% white, 90.7% non-Hispanic), 24.2% reported past-year alcohol use at baseline. Alcohol-related knowledge increased overall and was greater for the intervention group (adjusted improvement in knowledge score +7.70, 95% confidence interval [CI] 2.92-12.48). By 6-month follow-up, the percentage of youth reporting any alcohol use is risky/dangerous increased among intervention arm participants from 41.5% to 45.4% at baseline and decreased from 38.9% to 37.4% among controls (adjusted intervention effect odds ratio 1.79, 95% confidence interval 1.02-3.13). Overall, frequency of drinking increased over time from 3.72 to 4.52 days on average, with no differences by treatment group. Among female drinkers, the predicted mean frequency of drinking days declined in the intervention group (4.11-3.33) and increased among controls (2.82-4.55) (adjusted intervention effect rate ratio .50, 95% confidence interval .25-.99). CONCLUSIONS: Exposure to a chronic illness-tailored psychoeducational intervention targeting alcohol use increased knowledge and perceived risk and, among females, reduced alcohol use. Promising results merit future work to optimize the model for both males and females.

Feasibility and Efficacy of Online Strategies to Recruit Parents of Children With Rheumatic Diseases for Research.

OBJECTIVE: We aimed to determine the feasibility and efficacy of online strategies to recruit parents of children with pediatric rheumatic diseases (PRDs) for research and to evaluate the degree to which known features of various rheumatic disease groups were present in the online cohort. METHODS: We studied two cohorts; the first was composed of respondents from a cross-sectional parental survey of children with PRDs contacted through patient support groups and social media platforms, and the second cohort was composed of participants from the Childhood Arthritis and Rheumatology Research Alliance (CARRA) legacy clinical registry. RESULTS: In the social media cohort, 712 complete surveys were analyzed. Most (65.9%) were referred from Facebook. The most common rheumatic disease was juvenile idiopathic arthritis (JIA) (27.1%), followed by juvenile dermatomyositis (22.1%). In the CARRA registry cohort, 7985 records were included. JIA was the largest disease group (70.3%), followed by systemic lupus erythematosus (12.0%). The age at disease onset for most PRDs was similar between those in the social media and CARRA registry cohorts (mean difference = 1.3 years). CONCLUSION: Recruitment through Facebook was the most fruitful. The clinical characteristics of the social media cohort were similar to those of patients recruited through a clinical registry, suggesting the utility of online recruitment for engaging disease-relevant cohorts. Parents of children with rare PRDs were overrepresented in the social media cohort, perhaps reflecting the increased need of those parents to find online information and receive emotional support. Social media recruitment for research studies may help expand the number and diversity of participants in clinical research, especially by including those with rare diseases.

Diabetes and cardiovascular disease risk screening model in community pharmacies in a developing primary healthcare system: a feasibility study.

OBJECTIVES: This study aimed to develop an evidence-based community pharmacist-delivered screening model for diabetes and cardiovascular disease (CVD), and assess its feasibility to identify and refer patients with elevated risk. DESIGN: A feasibility study. SETTING: A purposive sample of 12 community pharmacies in three cities in the United Arab Emirates (UAE). PARTICIPANTS: Adults 40 years of age and above who have not been previously diagnosed with either diabetes or CVD. INTERVENTION: Pharmacist screening of adults visiting pharmacies involved history, demographics, anthropometric measurements, blood pressure and point-of-care testing including glycated haemoglobin (HbA1c) levels and lipid panel. Participants with a 10-year CVD risk ≥7.5%, HbA1c level ≥5.7% or American Diabetes Association (ADA) risk score ≥5 points were advised to visit their physician. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcomes were (1) development of UAE pharmacist-delivered screening model, (2) the proportion of screened participants identified as having high CVD risk (atherosclerotic CVD 10-year risk defined as ≥7.5%) and (3) the proportion of participants identified as having elevated blood glucose (high HbA1c level ≥5.7% (38.8 mmol/mol)) or high self-reported diabetes risk (ADA risk score ≥5 points). Secondary outcome is participants' satisfaction with the screening. RESULTS: The first UAE pharmacist-delivered screening model was developed and implemented. A total of 115 participants were screened, and 92.3% of the entire screening process was completed during a single visit to pharmacy. The mean duration of the complete screening process was 27 min. At-risk individuals (57.4%) were referred to their physicians for further testing, while 94.5% of participants were at least satisfied with their screening experience. CONCLUSIONS: The community pharmacist-delivered screening of diabetes and CVD risk is feasible in the UAE. The model offers a platform to increase screening capacity within primary care and provides an opportunity for early detection and treatment. However, pathways for the integration of the pharmacist-delivered screening service with physicians in primary care are yet to be explored.