Importance Digital cognitive behavioral therapy (dCBT) is a scalable and effective intervention for treating insomnia. Most people with insomnia, however, seek help because of the daytime consequences of poor sleep, which adversely affects quality of life. Objectives To investigate the effect of dCBT for insomnia on functional health, psychological well-being, and sleep-related quality of life and to determine whether a reduction in insomnia symptoms was a mediating factor. Design, Setting, and Participants This online, 2-arm, parallel-group randomized trial comparing dCBT for insomnia with sleep hygiene education (SHE) evaluated 1711 participants with self-reported symptoms of insomnia. Participants were recruited between December 1, 2015, and December 1, 2016, and dCBT was delivered using web and/or mobile channels plus treatment as usual; SHE comprised a website and a downloadable booklet plus treatment as usual. Online assessments took place at 0 (baseline), 4 (midtreatment), 8 (posttreatment), and 24 (follow-up) weeks. Programs were completed within 12 weeks after inclusion. Main Outcomes and Measures Primary outcomes were scores on self-reported measures of functional health (Patient-Reported Outcomes Measurement Information System: Global Health Scale; range, 10-50; higher scores indicate better health); psychological well-being (Warwick-Edinburgh Mental Well-being Scale; range, 14-70; higher scores indicate greater well-being); and sleep-related quality of life (Glasgow Sleep Impact Index; range, 1-100; higher scores indicate greater impairment). Secondary outcomes comprised mood, fatigue, sleepiness, cognitive failures, work productivity, and relationship satisfaction. Insomnia was assessed with the Sleep Condition Indicator (range: 0-32; higher scores indicate better sleep). Results Of the 1711 participants included in the intention-to-treat analysis, 1329 (77.7%) were female, mean (SD) age was 48.0 (13.8) years, and 1558 (91.1%) were white. Use of dCBT was associated with a small improvement in functional health compared with SHE (adjusted difference [95% CI] at week 4, 0.90 [0.40-1.40]; week 8, 1.76 [1.24-2.28]; week 24, 1.76 [1.22-2.30]) and psychological well-being (adjusted difference [95% CI] at week 4, 1.04 [0.28-1.80]; week 8, 2.68 [1.89-3.47]; week 24, 2.95 [2.13-3.76]), and with a large improvement in sleep-related quality of life (at week 4, −8.76 [−11.83 to −5.69]; week 8, –17.60 [−20.81 to −14.39]; week 24, −18.72 [−22.04 to −15.41]) (allP < .01). A large improvement in insomnia mediated these outcomes (range mediated, 45.5%-84.0%). Conclusions and Relevance Use of dCBT is effective in improving functional health, psychological well-being, and sleep-related quality of life in people reporting insomnia symptoms. A reduction in insomnia symptoms mediates these improvements. These results confirm that dCBT improves both daytime and nighttime aspects of insomnia, strengthening existing recommendations of CBT as the treatment of choice for insomnia. Trial Registration isrctn.org identifier:ISRCTN60530898

Background The ‘treat to target’ paradigm improves outcomes and reduces costs in chronic disease management but is not yet established in psoriasis. Objective To identify treatment targets in psoriasis using the common measures of disease activity: Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA). Methods Data from a multicentre longitudinal UK cohort of psoriasis patients receiving systemic/biologic therapies (British Association of Dermatologists Biologics and Immunomodulators Register) were used to identify absolute PASI thresholds for 90% (PASI 90) and 75% (PASI 75) improvements in baseline disease activity, using receiver operating characteristic curves. The relationship between PGA (clear/almost clear/mild/moderate/moderate‐severe/severe) and PASI (range 0‐72) was described, and the concordance between absolute and relative definitions of response was determined. The same approach was used to establish treatment response and eligibility definitions based on PGA. Results Data from 13,422 patients were available (58% male, 91% white ethnicity, mean age 44·9 years), including over 23,000 longitudinal PASI and PGA scores. An absolute PASI < 2 was concordant with PASI 90 and an absolute PASI < 4 was concordant with PASI 75 in 90% and 88% of cases, respectively. These findings were robust to subgroups of timing of assessment, baseline disease severity and treatment modality. PASI and PGA were strongly correlated (Spearman's rank correlation coefficient 0·92). The median PASI increased from 0 (IQR 0‐0, range 0‐23) to 19 (IQR 15‐25, range 0‐64) for PGA clear to severe, respectively. PGA clear/almost clear was concordant with PASI < 2 in 90% of cases, and PGA moderate‐severe/severe was concordant with NICE PASI eligibility criteria for biologics in 81% of cases. Conclusions An absolute PASI < 2 and PGA clear/almost clear represent relevant disease endpoints to inform treat to target management strategies in psoriasis.

Background Biologic therapies have revolutionized the treatment of moderate‐to‐severe psoriasis. However, for reasons largely unknown, many patients do not respond or lose response to these drugs. Objectives To evaluate demographic, social and clinical factors that could be used to predict effectiveness and stratify response to biologic therapies in psoriasis. Methods Using a multicentre, observational, prospective pharmacovigilance study (BADBIR), we identified biologic‐naive patients starting biologics with outcome data at 6 (n = 3079) and 12 (n = 3110) months. Associations between 31 putative predictors and outcomes were investigated in univariate and multivariable regression analyses. Potential stratifiers of treatment response were investigated with statistical interactions. Results Eight factors associated with reduced odds of achieving ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90) at 6 months were identified (described as odds ratio and 95% confidence interval): demographic (female sex, 0·78, 0·66–0·93); social (unemployment, 0·67, 0·45–0·99); unemployment due to ill health (0·62, 0·48–0·82); ex‐ and current smoking (0·81, 0·66–0·99 and 0·79, 0·63–0·99, respectively); clinical factors (high weight, 0·99, 0·99–0·99); psoriasis of the palms and/or soles (0·75, 0·61–0·91); and presence of small plaques only compared with small and large plaques (0·78, 0·62–0·96). White ethnicity (1·48, 1·12–1·97) and higher baseline PASI (1·04, 1·03–1·04) were associated with increased odds of achieving PASI 90. The findings were largely consistent at 12 months. There was little evidence for predictors of differential treatment response. Conclusions Psoriasis phenotype and potentially modifiable factors are associated with poor outcomes with biologics, underscoring the need for lifestyle management. Effect sizes suggest that these factors alone cannot inform treatment selection.

We sought to examine the impact of digital cognitive behavioural therapy (dCBT) for insomnia on both self-reported cognitive impairment and objective cognitive performance. The DISCO trial was an online, two-arm, single-blind, randomised clinical trial of dCBT versus wait-list control. Participants were aged 25 years and older, met DSM-5 diagnostic criteria for insomnia disorder and reported difficulties with concentration or memory. Assessments were carried out online at baseline, and 10 and 24 weeks post-randomisation. The primary outcome measure was self-reported cognitive impairment, assessed with the British Columbia Cognitive Complaints Inventory (BC-CCI). Secondary outcomes included tests of cognitive performance, insomnia symptoms, cognitive failures, fatigue, sleepiness, depression and anxiety. 410 participants with insomnia were recruited and assigned to dCBT (N = 205) or wait-list control (N = 205). At 10 weeks post-randomisation the estimated adjusted mean difference for the BC-CCI was -3.03 [95% CI: -3.60,-2.47; p<.0001, d = -0.86], indicating that participants in the dCBT group reported less cognitive impairment than the control group. These effects were maintained at 24 weeks (d = -0.96) and were mediated, in part, via reductions in insomnia severity and increased sleep efficiency. Treatment effects in favour of dCBT, at both 10 and 24 weeks, were found for insomnia severity, sleep efficiency, cognitive failures, fatigue, sleepiness, depression, and anxiety. We found no between-group differences on objective tests of cognitive performance. Our study shows that dCBT robustly decreases self-reported cognitive impairment at post-treatment and these effects are maintained at 6 months.

Objectives: Diet may affect susceptibility of the inner ear to noise and age-related effects that lead to tinnitus and hearing loss. This study used complementary single nutrient and dietary pattern analysis based on statistical grouping of usual dietary intake in a cross-sectional analysis of tinnitus and hearing difficulties in a large population study sample. Design: The research was conducted using the UK Biobank resource. Tinnitus was based on report of ringing or buzzing in one or both ears that lasts more than five minutes at a time and is currently experienced at least some of the time. Identification of a hearing problem was based on self-reported difficulties with hearing. Usual dietary intake and dietary patterns (involving statistical grouping of intake to account for how foods are combined in real-life diets) were estimated based on between two and five administrations of the Oxford Web-Q 24-hour dietary recall questionnaire over the course of a year for 34,576 UK adult participants aged 40 to 69. Results: In a multivariate model, higher intake of vitamin B12 was associated with reduced odds of tinnitus, while higher intakes of calcium, iron, and fat were associated with increased odds (B12, odds ratio [OR] 0.85, 95% confidence interval [CI] 0.75 to 0.97; Calcium, OR 1.20, 95% CI 1.08 to 1.34; Iron, OR 1.20, 95% CI 1.05 to 1.37; Fat, OR 1.33, 95% CI 1.09 to 1.62, respectively, for quintile 5 versus quintile 1). A dietary pattern characterised by high protein intake was associated with reduced odds of tinnitus (OR 0.90, 95% CI 0.82 to 0.99 for quintile 5 versus quintile 1). Higher vitamin D intake was associated with reduced odds of hearing difficulties (OR 0.90, 95% CI 0.81 to 1.00 for quintile 5 versus quintile 1), as were dietary patterns high in fruit and vegetables and meat and low in fat (Prudent diet: OR 0.89, 95% CI 0.83 to 0.96; High protein: OR 0.88, 95% CI 0.82 to 0.95; High fat: OR 1.16, 95% CI 1.08 to 1.24, respectively, for quintile 5 versus quintile 1). Conclusions: There were associations between both single nutrients and dietary patterns with tinnitus and hearing difficulties. Although the size of the associations was small, universal exposure for dietary factors indicates that there may be a substantial impact of diet on levels of tinnitus and hearing difficulties in the population. This study showed that dietary factors might be important for hearing health.

Background: Electronic patient-reported outcomes (ePROs) are commonly used in oncology clinical practice and have shown benefits for patients and health resource use. Objective: The aim of this study was to compare the isolated effect of administering ePROs to patients with cancer versus a control condition. Methods: The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Randomized controlled trials evaluating ePRO interventions that aimed to improve health-related outcomes among patients with cancer were included. The primary outcome was health-related quality of life (HRQOL), and the secondary outcomes were symptoms, hospital admissions, unplanned visits, chemotherapy completion, survival, and satisfaction with care. The effect sizes of ePROs on health-related outcomes were analyzed as standardized mean differences (SMDs) with 95% CIs using a random effects model. Results: The search identified 10,965 papers, of which 19 (0.17%) from 15 studies were included. The meta-analysis showed an improvement in HRQOL at 3 months, measured by the Functional Assessment of Cancer Therapy–General (SMD 0.29, 95% CI 0.19 to 0.39), and at 6 months, assessed using various HRQOL measures (SMD 0.21, 95% CI 0.11 to 0.30). Of the 15 studies, 9 (60%) reported a positive signal on HRQOL, with two-thirds of the studies (n=6, 67%) including tailored patient advice and two-thirds (n=6, 67%) using clinician alert systems. Conclusions: The meta-analysis showed an improvement in HRQOL at 6 months and in Functional Assessment of Cancer Therapy–General scores at 3 months for studies that included tailored advice and clinician alerts, suggesting that these elements may improve ePRO effectiveness. The findings will provide guidance for future use and help health care professionals choose the most suitable ePRO features for their patients. Trial Registration: PROSPERO CRD42020175007; https://tinyurl.com/5cwmy3j6