Reacting to crises: The COVID-19 impact on biostatistics/epidemiology
Most crises, though difficult and challenging to address, offer opportunities for change and for development of new perspectives or approaches to deal with traditional strategies. The reaction to and the managing of the COVID-19 pandemic has provided a platform for evaluating how we quantify disease prevalence, incidence, time courses and sequellae as well as how well we plan, design, analyze and interpret health care associated data, including clinical trials and electronic medical records and health claims data. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 10, 2020 Category: Radiology Authors: Robert T. O'Neill Source Type: research

Lowering the impact of food insecurity in African American adults with type 2 diabetes mellitus (LIFT-DM) – Study protocol for a randomized controlled trial
There is strong evidence that disparities in the burden of diabetes exist by both race and poverty. Food insecurity, or an inability to or limitation in accessing nutritionally adequate food, is an important modifiable social determinant of health, particularly in adults with chronic disease. African Americans are more likely to be diagnosed with diabetes and more likely than whites to be food insecure. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 6, 2020 Category: Radiology Authors: Rebekah J. Walker, Rebecca G. Knapp, Clara E. Dismuke-Greer, Renee E. Walker, Mukoso N. Ozieh, Leonard E. Egede Source Type: research

Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 1, 2020 Category: Radiology Source Type: research

Modifications to communities for healthy Living trial design resulting from COVID-19
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 1, 2020 Category: Radiology Authors: Kirsten K. Davison, Sebastien Hanuese Source Type: research

Statistical adaptation to oncology drug development evolution
Cancer treatment started with surgery at least three thousand years ago. Radiation therapy was added in 1896 with chemotherapy started 50  years later. These “cut, burn, and poison” techniques try to kill cancer cells directly and have been the main approaches in treating cancer until recently. In the past few years, immunotherapies have revolutionized cancer treatment. Instead of treating the disease, immunotherapies treat the patient with the disease; more precisely, correct the patient's immune system so that it can fight cancer in a long term, which makes the cure of metastatic cancers a real possibility. (Source...
Source: Contemporary Clinical Trials - October 23, 2020 Category: Radiology Authors: Mingxiu Hu, Miao Yang, Yi Liu Source Type: research

Two basic statistical strategies of conducting causal inference in real-world studies
Randomized controlled clinical trials are the gold standard in drug development, but their costs, duration, and limited generalizability have motivated some to look for real-world studies as alternatives. On the other hand, real-world studies may be less convincing due to the presence of confounding bias. In the literature of causal inference, a variety of statistical methods have been proposed to adjust for confounding bias. However, it is challenging for the users to understand the statistical properties enjoyed by each method and then explicitly specify its underlying model assumptions. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 23, 2020 Category: Radiology Authors: Yixin Fang Source Type: research

Infectious diseases epidemiology, quantitative methodology, and clinical research in the midst of the COVID-19 pandemic: Perspective from a European country
Starting from historic reflections, the current SARS-CoV-2 induced COVID-19 pandemic is examined from various perspectives, in terms of what it implies for the implementation of non-pharmaceutical interventions, the modeling and monitoring of the epidemic, the development of early-warning systems, the study of mortality, prevalence estimation, diagnostic and serological testing, vaccine development, and ultimately clinical trials. Emphasis is placed on how the pandemic had led to unprecedented speed in methodological and clinical development, the pitfalls thereof, but also the opportunities that it engenders for national a...
Source: Contemporary Clinical Trials - October 22, 2020 Category: Radiology Authors: Geert Molenberghs, Marc Buyse, Steven Abrams, Niel Hens, Philippe Beutels, Christel Faes, Geert Verbeke, Pierre Van Damme, Herman Goossens, Thomas Neyens, Sereina Herzog, Heidi Theeten, Koen Pepermans, Ariel Alonso Abad, Ingrid Van Keilegom, Niko Speybroe Source Type: research

Building a healthy temple diabetes self-management education support program in Hispanic faith community settings: A cluster randomized controlled trial
Diabetes self-management is key to preventing diabetes complications disproportionately affecting Hispanics. Church appears a promising setting for delivering a diabetes self-management education support (DSMES) programs. “Faith-placed” (FP) programing refers to health interventions implemented in the church setting; while “faith-based” (FB) signifies integrating spirituality with health interventions. The Building a Health Temple (BHT) DSMES program integrates spirituality with DSMES to improve diabetic outc omes. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 22, 2020 Category: Radiology Authors: Summer Wilmoth, Leah Carrillo, Lauren Correa, Meixia Pan, Deborah Parra-Medina, Erica Sosa, Ramon Reyes, Daniel A. Sass, Meizi He Source Type: research

Intervention to promote physical activation and improve sleep and response feeding in infants for preventing obesity early in life, the baby-act trial: Rationale and design
Infant obesity is increasing in the US, particularly among Hispanics. Rapid weight gain during infancy increases the risk of obesity later in life and could be prevented through multi-modal interventions addressing multiple risk factors through population-level programs. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 21, 2020 Category: Radiology Authors: M. Campos, J. Pomeroy, M.H. Mays, A. Lopez, C. Palacios Source Type: research

Using virtual agents to increase physical activity in young children with the virtual fitness buddy ecosystem: Study protocol for a cluster randomized trial
Designing and implementing a truly self-determined physical activity (PA) intervention has required excessive amounts of labor and expenses that, until recently, have made it prohibitively costly to implement in the field at scale. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 20, 2020 Category: Radiology Authors: Lindsay Hahn, Michael D. Schmidt, Stephen L. Rathbun, Kyle Johnsen, James J. Annesi, Sun Joo Ahn Source Type: research

Bayesian hierarchical model for safety signal detection in multiple clinical trials
Clinical safety signal detection is of great importance in establishing the safety profile of new drugs and biologics during drug development. Bayesian hierarchical meta-analysis has proven to be a very effective method of identifying potential safety signals by considering the hierarchical structure of clinical safety data from multiple randomized clinical trials conducted under an Investigational New Drug (IND) application or Biological License Application (BLA). This type of model can integrate information across studies, for instance by grouping related adverse events using the MedDRA system-organ-class (SOC) and prefe...
Source: Contemporary Clinical Trials - October 19, 2020 Category: Radiology Authors: Yafei Zhang, Shuai Sammy Yuan, Barry A. Eagel, Hal Li, Li-An Lin, William W.B. Wang Source Type: research

Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol
Programs such as the Pediatric Access Line in Washington state have shown decreases in antipsychotic medication use by youth with non-psychotic disorders. Program outcomes have been studied with observational designs. This manuscript describes the protocol for Targeted and Safer Use of Antipsychotics in Youth (SUAY), a randomized controlled trial of psychiatrist review of prescriptions and facilitated access to psychosocial care. The aim of the intervention is to reduce the number of person-days of antipsychotic use among participants. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 19, 2020 Category: Radiology Authors: Robert B. Penfold, Ella E. Thompson, Robert J. Hilt, Kelly J. Kelleher, Nadine Schwartz, Arne Beck, Greg Clarke, James D. Ralston, Andrea L. Hartzler, R. Yates Coley, Mary Akosile, Benedetto Vitiello, Gregory E. Simon Source Type: research

Treatment of comorbid sleep disorders and posttraumatic stress disorder in active duty military: Design and methodology of a randomized clinical trial
Many individuals with posttraumatic stress disorder (PTSD) also suffer from insomnia and nightmares, which may be symptoms of PTSD or constitute partially independent comorbid disorders. Sleep disturbances are resistant to current treatments for PTSD, and those suffering from PTSD, insomnia, and nightmares have worse PTSD treatment outcomes. In addition, insomnia and nightmares are risk factors for depression, substance abuse, anxiety, and suicide. Cognitive-Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) and Cognitive Processing Therapy (CPT) for PTSD are first line treatments of these conditions. (Source: Contem...
Source: Contemporary Clinical Trials - October 19, 2020 Category: Radiology Authors: Daniel J. Taylor, Kristi E. Pruiksma, Jim Mintz, Danica C. Slavish, Sophie Wardle-Pinkston, Hannah Tyler, Katherine A. Dondanville, Stacey Young-McCaughan, Michael K. Scullin, Karin L. Nicholson, Brett T. Litz, Jessica R. Dietch, Douglas E. Williamson, Te Source Type: research

Cognitive behavioral therapy for insomnia to enhance cognitive function and reduce the rate of A β deposition in older adults with symptoms of insomnia: A single-site randomized pilot clinical trial protocol
Lifestyle interventions to increase exercise and improve diet have been the focus of recent clinical trials to potentially prevent Alzheimer's disease (AD) [1,2]. However, despite the strong links between sleep disruptions, cognitive decline, and AD, sleep enhancement has yet to be targeted as a lifestyle intervention to prevent AD. A recent meta-analysis suggests that approximately 15% of AD may be prevented by an efficacious intervention aimed to reduce sleep disturbances and sleep disorders [3]. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 19, 2020 Category: Radiology Authors: Catherine F. Siengsukon, Eryen Nelson, Cierra Williams-Cooke, Rebecca Ludwig, Eber Silveira Beck, Eric D. Vidoni, Jonathan D. Mahnken, Suzanne Stevens, Michelle Drerup, Jared Bruce, Jeffrey M. Burns Source Type: research

Identification of undiagnosed atrial fibrillation patients using a machine learning risk prediction algorithm and diagnostic testing (PULsE-AI): Study protocol for a randomised controlled trial
Atrial fibrillation (AF) is associated with an increased risk of stroke, enhanced stroke severity, and other comorbidities. However, AF is often asymptomatic, and frequently remains undiagnosed until complications occur. Current screening approaches for AF lack either cost-effectiveness or diagnostic sensitivity; thus, there is interest in tools that could be used for population screening. An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 19, 2020 Category: Radiology Authors: Nathan R. Hill, Chris Arden, Lee Beresford-Hulme, A. John Camm, David Clifton, D. Wyn Davies, Usman Farooqui, Jason Gordon, Lara Groves, Michael Hurst, Sarah Lawton, Steven Lister, Christian Mallen, Anne-Celine Martin, Phil McEwan, Kevin G. Pollock, Jenni Source Type: research