Long-Term Effectiveness of a Clinician-Assisted Digital Cognitive Behavioral Therapy Intervention for Smoking Cessation: Secondary Outcomes From a Randomized Controlled Trial.

INTRODUCTION: This study evaluated the secondary effectiveness outcomes for Quit Genius, a digital clinician-assisted cognitive behavioral therapy (CBT) intervention for smoking cessation. METHODS: Adult smokers (N = 556) were randomly assigned to Quit Genius (n = 277), a digital, clinician-assisted CBT intervention or very brief advice (VBA) to stop smoking, an evidence-based, 30-s intervention designed to facilitate quit attempts, coupled with referral to a cessation service (n = 279). Participants were offered combination nicotine replacement therapy (patches and gum) tailored to individual nicotine dependence. Analyses (n = 530), by intention-to-treat, compared Quit Genius and VBA at 4, 26, and 52 weeks post-quit date (QD). The primary outcome was self-reported 7-day point prevalence abstinence (PPA) at 4 weeks post-QD. Consecutive 7-day point-prevalence abstinence, defined as abstinent at two or more consecutive timepoints, was examined at weeks 26 and 52 to indicate long-term effectiveness. Abstinence was verified using a random sample of participants with carbon monoxide breath testing of <5 parts per million (n = 280). RESULTS: Self-reported consecutive 7-day PPA at weeks 26 and 52 for Quit Genius was 27.2% and 22.6%, respectively, compared with VBA which was 16.6% and 13.2% (RR = 1.70, 95% CI, 1.22-2.37; p = .003, 26 weeks; RR = 1.71, 95% CI, 1.17-2.50; P = .005, 52 weeks). Biochemically verified abstinence was significantly different at 26- (p = .03) but not 52 weeks (p = .16). Quit Genius participants were more likely to remain abstinent than those who received VBA (RR = 1.71, 95% CI 1.17-2.50; p = .005). CONCLUSIONS: This study provides secondary evidence for the long-term effectiveness of Quit Genius in comparison with VBA. Future trials of digital interventions without clinician support and comparisons with active treatment are needed. IMPLICATIONS: The long-term effectiveness of clinician-assisted digital smoking cessation interventions has not been well studied. This study established the long-term effectiveness of an extended CBT-based intervention; results may inform implementation of scalable approaches to smoking cessation in the health system.

A new ELISA for autoantibodies to steroid 21-hydroxylase.

BACKGROUND: A new ELISA for autoantibodies to steroid 21-hydroxylase (21-OH Ab) is described. METHODS: In the assay test sample autoantibodies form a bridge between 21-OH coated onto the plate well and liquid phase 21-OH-biotin. Bound 21-OH-biotin is detected by the addition of streptavidin peroxidase and colorogenic peroxidase substrate. RESULTS: Of 100 samples from patients with autoimmune Addison's disease, 86 (86%) were positive for 21-OH Ab ELISA whereas 84 (84%) were positive in an immunoprecipitation assay based on 125I-labeled 21-OH. Six (0.6%) of 928 healthy adult blood donors and 1 (2.0%) of 49 adult patients with type 1 diabetes mellitus (T1DM) were positive by ELISA. No samples from adult patients with Graves' disease (GD; n=50), celiac disease (n=29), systemic lupus erythematosis (n=9) or rheumatoid arthritis (n=20) were positive by ELISA. However, 2/51 (3.9%) children with GD, 3/69 (4.3%) children with Hashimoto's thyroiditis (HT) and 3/119 (2.5%) children with T1DM alone or associated with autoimmune thyroid disorders were ELISA positive. CONCLUSIONS: The new assay should be useful for screening patients known to be at increased risk of developing clinical autoimmune Addison's disease, in particular children with HT, GD and/or T1DM.

Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial.

BACKGROUND: Tobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness. OBJECTIVE: Our objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation. METHODS: A 2-arm, single-blinded, parallel-group randomized controlled trial design was used. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date. RESULTS: A total of 556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed. CONCLUSIONS: The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476.