The Efficacy of "Foundations," a Digital Mental Health App to Improve Mental Well-being During COVID-19: Proof-of-Principle Randomized Controlled Trial.

BACKGROUND: Against a long-term trend of increasing demand, the COVID-19 pandemic has led to a global rise in common mental disorders. Now more than ever, there is an urgent need for scalable, evidence-based interventions to support mental well-being. OBJECTIVE: The aim of this proof-of-principle study was to evaluate the efficacy of a mobile-based app in adults with self-reported symptoms of anxiety and stress in a randomized control trial that took place during the first wave of the COVID-19 pandemic in the United Kingdom. METHODS: Adults with mild to severe anxiety and moderate to high levels of perceived stress were randomized to either the intervention or control arm. Participants in the intervention arm were given access to the Foundations app for the duration of the 4-week study. All participants were required to self-report a range of validated measures of mental well-being (10-item Connor-Davidson Resilience scale [CD-RISC-10], 7-item Generalized Anxiety Disorder scale [GAD-7], Office of National Statistics Four Subjective Well-being Questions [ONS-4], World Health Organization-5 Well-Being Index [WHO-5]) and sleep (Minimal Insomnia Scale [MISS]) at baseline and at weeks 2 and 4. The self-reported measures of perceived stress (10-item Perceived Stress Score [PSS-10]) were obtained weekly. RESULTS: A total of 136 participants completed the study and were included in the final analysis. The intervention group (n=62) showed significant improvements compared to the control group (n=74) on measures of anxiety, with a mean GAD-7 score change from baseline of -1.35 (SD 4.43) and -0.23 (SD 3.24), respectively (t134=1.71, P=.04); resilience, with a mean change in CD-RISC score of 1.79 (SD 4.08) and -0.31 (SD 3.16), respectively (t134=-3.37, P<.001); sleep, with a mean MISS score change of -1.16 (SD 2.67) and -0.26 (SD 2.29), respectively (t134=2.13, P=.01); and mental well-being, with a mean WHO-5 score change of 1.53 (SD 5.30) and -0.23 (SD 4.20), respectively (t134=-2.16, P=.02), within 2 weeks of using Foundations, with further improvements emerging at week 4. Perceived stress was also reduced within the intervention group, although the difference did not reach statistical significance relative to the control group, with a PSS score change from baseline to week 2 of -2.94 (SD 6.84) and -2.05 (SD 5.34), respectively (t134= 0.84, P=.20). CONCLUSIONS: This study provides a proof of principle that the digital mental health app Foundations can improve measures of mental well-being, anxiety, resilience, and sleep within 2 weeks of use, with greater effects after 4 weeks. Foundations therefore offers potential as a scalable, cost-effective, and accessible solution to enhance mental well-being, even during times of crisis such as the COVID-19 pandemic. TRIAL REGISTRATION: OSF Registries osf.io/f6djb; https://osf.io/vm3xq.

What's in a Name? Factors Associated with Documentation and Evaluation of Incidental Pulmonary Nodules.

RATIONALE: Radiologist reports of pulmonary nodules discovered incidentally on computed tomographic (CT) images of the chest may influence subsequent evaluation and management. OBJECTIVES: We sought to determine the impact of the terminology used by radiologists to report incidental pulmonary nodules on subsequent documentation and evaluation of the nodules by the ordering or primary care provider. METHODS: We conducted a retrospective cohort study of patients with incidentally discovered pulmonary nodules detected on CT chest examinations performed during 2010 in a large urban safety net medical system located in northeastern Ohio. MEASUREMENTS AND MAIN RESULTS: Twelve different terms were used to describe 344 incidental pulmonary nodules. Most nodules (181 [53%]) were documented in a subsequent progress note by the provider, and 140 (41%) triggered subsequent clinical activity. In a multivariable analysis, incidental pulmonary nodules described in radiology reports using the terms density (odds ratio [OR], 0.06; 95% confidence interval [CI], 0.01-0.47), granuloma (OR, 0.07; 95% CI, 0.01-0.65), or opacity (OR, 0.09; 95% CI, 0.01-0.68) were less likely to be documented by the provider than those that used the term mass. Patients with nodules described in radiology reports using the term nodule (OR, 0.15; 95% CI, 0.02-0.99), nodular density (OR, 0.09; 95% CI, 0.01-0.63), granuloma (OR, 0.06; 95% CI, 0.01-0.69), or opacity (OR, 0.05; 95% CI, 0.01-0.43) were less likely to receive follow-up than were patients with nodules described using the term mass. The factor most strongly associated with follow-up of pulmonary nodules was documentation by the provider (OR, 5.85; 95% CI, 2.93-11.7). CONCLUSIONS: Within one multifacility urban health system in the United States, the terms used by radiologists to describe incidental pulmonary nodules were associated with documentation of the nodule by the ordering physician and subsequent follow-up. Standard terminology should be used to describe pulmonary nodules to improve patient outcomes.

Architectural heterogeneity in tumors caused by differentiation alters intratumoral drug distribution and affects therapeutic synergy of antiangiogenic organoselenium compound.

Tumor differentiation enhances morphologic and microvascular heterogeneity fostering hypoxia that retards intratumoral drug delivery, distribution, and compromise therapeutic efficacy. In this study, the influence of tumor biologic heterogeneity on the interaction between cytotoxic chemotherapy and selenium was examined using a panel of human tumor xenografts representing cancers of the head and neck and lung along with tissue microarray analysis of human surgical samples. Tumor differentiation status, microvessel density, interstitial fluid pressure, vascular phenotype, and drug delivery were correlated with the degree of enhancement of chemotherapeutic efficacy by selenium. Marked potentiation of antitumor activity was observed in H69 tumors that exhibited a well-vascularized, poorly differentiated phenotype. In comparison, modulation of chemotherapeutic efficacy by antiangiogenic selenium was generally lower or absent in well-differentiated tumors with multiple avascular hypoxic, differentiated regions. Tumor histomorphologic heterogeneity was found prevalent in the clinical samples studied and represents a primary and critical physiological barrier to chemotherapy.