The Use of Web-Based Support Groups Versus Usual Quit-Smoking Care for Men and Women Aged 21-59 Years: Protocol for a Randomized Controlled Trial (Preprint)

BACKGROUND Existing smoking cessation treatments are challenged by low engagement and high relapse rates, suggesting the need for more innovative, accessible, and interactive treatment strategies. Twitter is a Web-based platform that allows people to communicate with each other throughout the day using their phone. OBJECTIVE This study aims to leverage the social media platform of Twitter for fostering peer-to-peer support to decrease relapse with quitting smoking. Furthermore, the study will compare the effects of coed versus women-only groups on women’s success with quitting smoking. METHODS The study design is a Web-based, three-arm randomized controlled trial with two treatment arms (a coed or women-only Twitter support group) and a control arm. Participants are recruited online and are randomized to one of the conditions. All participants will receive 8 weeks of combination nicotine replacement therapy (patches plus their choice of gum or lozenges), serial emails with links to Smokefree.gov quit guides, and instructions to record their quit date online (and to quit smoking on that date) on a date falling within a week of initiation of the study. Participants randomized to a treatment arm are placed in a fully automated Twitter support group (coed or women-only), paired with a buddy (matched on age, gender, location, and education), and encouraged to communicate with the group and buddy via daily tweeted discussion topics and daily automated feedback texts (a positive tweet if they tweet and an encouraging tweet if they miss tweeting). Recruited online from across the continental United States, the sample consists of 215 male and 745 female current cigarette smokers wanting to quit, aged between 21 and 59 years. Self-assessed follow-up surveys are completed online at 1, 3, and 6 months after the date they selected to quit smoking, with salivary cotinine validation at 3 and 6 months. The primary outcome is sustained biochemically confirmed abstinence at the 6-month follow-up. RESULTS From November 2016 to September 2018, 960 participants in 36 groups were recruited for the randomized controlled trial, in addition to 20 participants in an initial pilot group. Data analysis will commence soon for the randomized controlled trial based on data from 896 of the 960 participants (93.3%), with 56 participants lost to follow-up and 8 dropouts. CONCLUSIONS This study combines the mobile platform of Twitter with a support group for quitting smoking. Findings will inform the efficacy of virtual peer-to-peer support groups for quitting smoking and potentially elucidate gender differences in quit rates found in prior research. CLINICALTRIAL ClinicalTrials.gov NCT02823028; https://clinicaltrials.gov/ct2/show/NCT0282302

Facebook Recruitment Using Zip Codes to Improve Diversity in Health Research: Longitudinal Observational Study (Preprint)

BACKGROUND Facebook’s advertising platform reaches most US households and has been used for health-related research recruitment. The platform allows for advertising segmentation by age, gender, and location; however, it does not explicitly allow for targeting by race or ethnicity to facilitate a diverse participant pool. OBJECTIVE This study looked at the efficacy of zip code targeting in Facebook advertising to reach blacks/African Americans and Hispanics/Latinos who smoke daily for a quit-smoking web-based social media study. METHODS We ran a general market campaign for 61 weeks using all continental US zip codes as a baseline. Concurrently, we ran 2 campaigns to reach black/African American and Hispanic-/Latino-identified adults, targeting zip codes ranked first by the percentage of households of the racial or ethnic group of interest and then by cigarette expenditure per household. We also ran a Spanish language campaign for 13 weeks, targeting all continental US zip codes but utilizing Facebook’s Spanish language targeting. The advertising images and language were common across campaigns. Costs were compared for advertisement clicks, queries, applications, and participants, and yields were compared for the final three outcomes. We examined outcomes before and after the Cambridge Analytica scandal that broke in March 2018. Finally, we examined 2 promoted Facebook features: lookalike audiences and audience network placement. RESULTS Zip code targeting campaigns were effective for yielding the racial or ethnic groups of interest. The black-/African American–focused versus general market campaign increased black/African American weekly queries (mean 9.48, SD 5.69 vs general market mean 2.83, SD 2.05; P<.001) and applicants (mean 1.11, SD 1.21 vs general market mean 0.54, SD 0.58; P<.001). The Hispanic-/Latino-focused versus general market campaign increased Hispanic/Latino weekly queries (mean 3.10, SD 2.16 vs general market mean 0.71, SD 0.48; P<.001) and applicants (mean 0.36, SD 0.55 vs general market mean 0.10, SD 0.14; P=.001). Cost metrics did not differ between campaigns at generating participants (overall P=.54). Costs increased post- versus prescandal for the black-/African American–focused campaign for queries (mean US $8.51, SD 3.08 vs US$5.87, SD 1.89; P=.001) and applicants (mean US $59.64, SD 35.63 vs US$38.96, SD 28.31; P=.004) and for the Hispanic-/Latino-focused campaign for queries (mean US $9.24, SD 4.74 vs US$7.04, SD 3.39; P=.005) and applicants (mean US $61.19, SD 40.08 vs US$38.19, SD 21.20; P=.001). CONCLUSIONS Zip code targeting in Facebook advertising is an effective way to recruit diverse populations for health-based interventions. Audience network placement should be avoided. The Facebook lookalike audience may not be necessary for recruitment, with drawbacks including an unknown algorithm and unclear use of Facebook user data, and so public concerns around data privacy should be considered. CLINICALTRIAL ClinicalTrial.gov NCT02823028; https://clinicaltrials.gov/ct2/show/NCT0282302

An experimental investigation of the joint effects of advertising and peers on adolescents’ beliefs and intentions about cigarette consumption”

Ninth graders were randomly exposed to one of eight slice-of-life videotapes showing stimulus advertising (cigarette, antismoking, both, neither) and unfamiliar peers who either did or did not smoke cigarettes. The findings indicate that the cigarette advertising primed positive smoker stereotypes, which caused subjects to seek out favorable information about the peers shown smoking. Subjects' beliefs and intentions about cigarette consumption were thereby enhanced by the joint effects of advertising and peers. However, an antismoking advertisement shown in conjunction with cigarette advertising made salient negative smoker stereotypes, evoked unfavorable thoughts about peers shown smoking, and prevented cigarette advertising from promoting smoking

Subjective and Objective Olfactory Abnormalities in Crohn’s disease

The pathogenesis of Crohn’s disease (CD) is still unknown, but the involvement of the olfactory system in CD appears possible. No study to date has systematically assessed the olfactory function in CD patients. We investigated the olfactory function in CD patients in active (n = 31) and inactive disease (n = 27) and in a control group of age- and sex-matched healthy subjects (n = 35). Subjective olfactory testing was applied using the Sniffin’ Sticks test. For olfactory testing, olfactory event–related potentials (OERPs) were obtained with a 4-channel olfactometer using phenyl ethyl alcohol (PEA) and hydrogen sulfide (H2S). Carbon dioxide (CO2) was employed as control stimulus, and chemosomatosensory event–related potentials (CSSERPs) were registered. Results of the Sniffin’ Sticks test revealed significantly different olfactory hedonic judgment with increased olfactory hedonic estimates for pleasant odorants in CD patients in active disease compared with healthy subjects. A statistical trend was found toward lower olfactory thresholds in CD patients. In objective olfactory testing, CD patients showed lower amplitudes of OERPs and CSSERPs. Additionally, OERPs showed significantly shorter N1- and P2 latencies following stimulation of the right nostril with H2S in CD patients in inactive disease compared with controls. Our study demonstrates specific abnormalities of olfactory perception in CD patients

Long-term efficacy and safety of nusinersen in adults with 5q spinal muscular atrophy: a prospective European multinational observational study

Background Evidence for the efficacy of nusinersen in adults with 5q-associated spinal muscular atrophy (SMA) has been demonstrated up to a period of 16 months in relatively large cohorts but whereas patients reach a plateau over time is still to be demonstrated. We investigated the efficacy and safety of nusinersen in adults with SMA over 38 months, the longest time period to date in a large cohort of patients from multiple clinical sites. Methods Our prospective, observational study included adult patients with SMA from Germany, Switzerland, and Austria (July 2017 to May 2022). All participants had genetically-confirmed, 5q-associated SMA and were treated with nusinersen according to the label. The total Hammersmith Functional Motor Scale Expanded (HFMSE) and Revised Upper Limb Module (RULM) scores, and 6-min walk test (6 MWT; metres), were recorded at baseline and 14, 26, and 38 months after treatment initiation, and pre and post values were compared. Adverse events were also recorded. Findings Overall, 389 patients were screened for eligibility and 237 were included. There were significant increases in all outcome measures compared with baseline, including mean HFMSE scores at 14 months (mean difference 1.72 [95% CI 1.19–2.25]), 26 months (1.20 [95% CI 0.48–1.91]), and 38 months (1.52 [95% CI 0.74–2.30]); mean RULM scores at 14 months (mean difference 0.75 [95% CI 0.43–1.07]), 26 months (mean difference 0.65 [95% CI 0.27–1.03]), and 38 months (mean difference 0.72 [95% CI 0.25–1.18]), and 6 MWT at 14 months (mean difference 30.86 m [95% CI 18.34–43.38]), 26 months (mean difference 29.26 m [95% CI 14.87–43.65]), and 38 months (mean difference 32.20 m [95% CI 10.32–54.09]). No new safety signals were identified. Interpretation Our prospective, observational, long-term (38 months) data provides further real-world evidence for the continuous efficacy and safety of nusinersen in a large proportion of adult patients with SMA. Funding Financial support for the registry from Biogen, Novartis and Roche

Improved upper limb function in non-ambulant children with SMA type 2 and 3 during nusinersen treatment: a prospective 3-years SMArtCARE registry study

Background The development and approval of disease modifying treatments have dramatically changed disease progression in patients with spinal muscular atrophy (SMA). Nusinersen was approved in Europe in 2017 for the treatment of SMA patients irrespective of age and disease severity. Most data on therapeutic efficacy are available for the infantile-onset SMA. For patients with SMA type 2 and type 3, there is still a lack of sufficient evidence and long-term experience for nusinersen treatment. Here, we report data from the SMArtCARE registry of non-ambulant children with SMA type 2 and typen 3 under nusinersen treatment with a follow-up period of up to 38 months. Methods SMArtCARE is a disease-specific registry with data on patients with SMA irrespective of age, treatment regime or disease severity. Data are collected during routine patient visits as real-world outcome data. This analysis included all non-ambulant patients with SMA type 2 or 3 below 18 years of age before initiation of treatment. Primary outcomes were changes in motor function evaluated with the Hammersmith Functional Motor Scale Expanded (HFMSE) and the Revised Upper Limb Module (RULM). Results Data from 256 non-ambulant, pediatric patients with SMA were included in the data analysis. Improvements in motor function were more prominent in upper limb: 32.4% of patients experienced clinically meaningful improvements in RULM and 24.6% in HFMSE. 8.6% of patients gained a new motor milestone, whereas no motor milestones were lost. Only 4.3% of patients showed a clinically meaningful worsening in HFMSE and 1.2% in RULM score. Conclusion Our results demonstrate clinically meaningful improvements or stabilization of disease progression in non-ambulant, pediatric patients with SMA under nusinersen treatment. Changes were most evident in upper limb function and were observed continuously over the follow-up period. Our data confirm clinical trial data, while providing longer follow-up, an increased number of treated patients, and a wider range of age and disease severity