Editorial from the new editor-in-chief
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 2, 2020 Category: Radiology Authors: JoAnn E. Manson Source Type: research
Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 31, 2020 Category: Radiology Source Type: research
A multi-modal virtual reality treadmill intervention for enhancing mobility and cognitive function in people with multiple sclerosis: Protocol for a randomized controlled trial
Gait and cognitive impairments are common in individuals with Multiple Sclerosis (MS) and can interfere with everyday function. Those with MS have difficulties executing cognitive tasks and walking simultaneously, a reflection of dual-task interference. Therefore, dual-task training may improve functional ambulation. Additionally, using technology such as virtual reality can provide personalized rehabilitation while mimicking real-world environments. The purpose of this randomized controlled trial is to establish the benefits of a combined cognitive-motor virtual reality training on MS symptoms compared to conventional tre...
Source: Contemporary Clinical Trials - August 24, 2020 Category: Radiology Authors: K.L. Hsieh, A. Mirelman, S. Shema-Shiratzky, I. Galperin, K. Regev, S. Shen, T. Schmitz-H übsch, A. Karni, F. Paul, H. Devos, J.J. Sosnoff, J.M. Hausdorff Source Type: research
DO-HEALTH: Vitamin D3 - Omega3 - Home exercise - Healthy aging and longevity trial - Design of a multinational clinical trial on healthy aging among European seniors
DO-HEALTH is a multi-center clinical trial among 2157 community-dwelling European men and women age 70 and older. The 2x2x2 randomized-control factorial design trial tested the individual and additive benefit, as well as the cost-effectiveness, of 3 interventions: vitamin D 2000 IU/day, omega-3 fatty acids 1000 mg/day (EPA + DHA, ratio 1:2), and a 30-minute 3 times/week home exercise (strength versus flexibility). Each treatment tested has shown considerable prior promise from mechanistic studies, small clinical trials, or large cohort studies, in the prevention of common age-related chronic diseases, but definiti...
Source: Contemporary Clinical Trials - August 24, 2020 Category: Radiology Authors: Heike A. Bischoff-Ferrari, Caroline de Godoi Rezende Costa Molino, Sandrine Rival, Bruno Vellas, Ren é Rizzoli, Reto W. Kressig, John A. Kanis, JoAnn E. Manson, Bess Dawson-Hughes, Endel J. Orav, José A.P. da Silva, Michael Blauth, Dieter Felsenberg, St Source Type: research
The impact of Geriatric Emergency Department Innovations (GEDI) on health services use, health related quality of life, and costs: Protocol for a randomized controlled trial
Older adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits. These ED visits are sentinel health events as discharged patients often return to the ED, experience declines in health-related quality of life (HRQoL) and disability, or are later hospitalized. Those who are admitted incur increased costs and greater risk for poor outcomes including infections, delirium, and falls. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 24, 2020 Category: Radiology Authors: Scott M. Dresden, Alexander X. Lo, Lee A. Lindquist, Masha Kocherginsky, Lori Ann Post, Dustin D. French, Elizabeth Gray, Allen W. Heinemann Source Type: research
Practical considerations of utilizing propensity score methods in clinical development utilizing real-world and historical data
In recent years, with the rapid increase in the volume and accessibility of Real-World-Data (RWD) and Real-World-Evidence (RWE), we have seen the unprecedented opportunities for their use in drug clinical development and life-cycle management. RWD and RWE have demonstrated the significant potential to improve the design, planning, and execution of clinical development. Furthermore, they can feature in the designs as either a substitute or compliment to traditional clinical trials. However, to utilize RWD and RWE appropriately and wisely, it is critical to apply rigorous statistical methodologies that enable the robustness ...
Source: Contemporary Clinical Trials - August 23, 2020 Category: Radiology Authors: Qing Li, Jianchang Lin, Andy Chi, Simon Davies Source Type: research
Independent drug action and its statistical implications for development of combination therapies
Researchers have long sought to find combinations of cancer drugs that might achieve synergy. However, while observed in some preclinical tumor models, synergistic effects are rarely seen in clinical trials. In fact, growing evidence in clinical trial data shows that the treatment effect of most approved combination therapies can be largely explained by the independent drug action model at the patient level. Previous statistical research on drug combinations mainly centered on experimental designs for dose-finding followed by measure of combination efficacy. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 22, 2020 Category: Radiology Authors: Cong Chen, Fang Liu, Yixin Ren, Leah Suttner, Zhiping Sun, Yue Shentu, Emmett V. Schmidt Source Type: research
Comparison of Phase I-II designs with parametric or semi-parametric models using two different risk-benefit trade-off criteria
A semi-parametric stochastic ordering model (SPSO) is introduced to characterize functional relationships between dose level and the probabilities of binary Efficacy and Toxicity events. This model is used to implement a Bayesian adaptive phase I-II clinical trial using one of two different optimality criteria, either dose desirability defined as a function of the marginal Efficacy and Toxicity probabilities, or mean utility based on numerical scores of the four possible (Efficacy, Toxicity) events. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 17, 2020 Category: Radiology Authors: Andrew G. Chapple, Peter F. Thall Source Type: research
Corrigendum to “Virtual immersive gaming to optimize recovery (VIGOR) in low back pain: A phase II randomized controlled trial” [Contemporary Clinical Trials 69 (2018) 83-91]
The authors regret that subsequent to the publication of our article, at the request of the National Institutes of Health, we revised our protocol to include only the virtual dodgeball game (i.e., Dodgeality) for the duration of the intervention. Hence, the Matchality and Fishality games are no longer part of the protocol. The authors would like to apologise for any inconvenience caused. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 17, 2020 Category: Radiology Authors: Christopher R. France, James S. Thomas Tags: Corrigendum Source Type: research
A community-based asthma program: Study design and methods of RVA breathes
Disparities in pediatric asthma morbidity and healthcare utilization exist on the basis of race, ethnicity, environment, and income; interventions are needed to address these inequities. The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors. Community stakeholder feedback was utilized to refine the intervention specifically for the Richmond, Virginia community. The aims of this study are to assess the effect of RVA Breathes on asthma-related healthcare utilization, as well as secondary outcomes of asthm...
Source: Contemporary Clinical Trials - August 17, 2020 Category: Radiology Authors: Robin S. Everhart, Suzanne E. Mazzeo, Rosalie Corona, Rachel L. Holder, Leroy R. Thacker, Michael S. Schechter Source Type: research
Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial
Although as many as 75% of the>2 million annual intensive care unit (ICU) survivors experience symptoms of psychological distress that persist for months to years, few therapies exist that target their symptoms and accommodate their unique needs. In response, we developed LIFT, a mobile app-based mindfulness intervention. LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 13, 2020 Category: Radiology Authors: Christopher E. Cox, Maren K. Olsen, John A. Gallis, Laura S. Porter, Jeffrey M. Greeson, Tina Gremore, Allie Frear, Anna Ungar, Jeffrey McKeehan, Brittany McDowell, Hannah McDaniel, Mark Moss, Catherine L. Hough Source Type: research
The design of a randomized control trial of exoskeletal-assisted walking in the home and community on quality of life in persons with chronic spinal cord injury
There are more than 300,000 estimated cases of spinal cord injury (SCI) in the United States, and approximately 26,000 of these are Veterans. Immobilization from SCI results in adverse secondary medical conditions and reduced quality of life. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care. Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 11, 2020 Category: Radiology Authors: Ann M. Spungen, William A. Bauman, Kousick Biswas, Karen Jones, Amanda J. Snodgrass, Lance Goetz, Peter H. Gorman, Steven Kirshblum, Sunil Sabharwal, Kevin T. White, Pierre K. Asselin, Kel Morin, Christopher M. Cirnigliaro, Grant D. Huang Source Type: research
The AgingPLUS trial: Design of a randomized controlled trial to increase physical activity in middle-aged and older adults
Negative views of aging (NVOA), low self-efficacy beliefs, and poor goal planning skills represent risk factors that undermine adults' motivation to engage in physical activity (PA). Targeting these three risk factors may motivate adults to become physically active. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 9, 2020 Category: Radiology Authors: Manfred Diehl, Abigail Nehrkorn-Bailey, Katherine Thompson, Diana Rodriguez, Kaigang Li, George W. Rebok, David L. Roth, Shang-En Chung, Christina Bland, Skylar Feltner, Garrett Forsyth, Nicholas Hulett, Berkeley Klein, Paloma Mars, Karla Martinez, Sarah Source Type: research
Guilt and expressive writing for reducing alcohol use in college students: Study protocol for a randomized control trial
The current proposed study aims to evaluate expressive writing as a novel intervention for reducing problematic drinking among college students. College students are at increased risk for alcohol misuse compared to other adults, and the development of efficacious intervention approaches is an urgent priority. The vast majority of individually focused brief interventions targeting college drinking have focused on personalized feedback approaches and recent innovations have largely been limited to refinements of this paradigm, which require large-scale assessment and intricate programming for implementation. (Source: Contemp...
Source: Contemporary Clinical Trials - August 8, 2020 Category: Radiology Authors: Clayton Neighbors, Jordanna Lembo Riggs, Chelsie M. Young, Lindsey M. Rodriguez, Joanne Angosta, Pelin Cunningham-Erdogdu, Qian Lu Source Type: research
Covid-19 pandemic research opportunity: Is the Middle East & North Africa (MENA) missing out?
The Covid-19 pandemic has caused fear and panic worldwide, forcing healthcare systems to disregard conventional practices and adopt innovation to contain the infection and death. Globally, there has been a rapid proliferation of research studies and clinical trials assessing risks, infectivity and treatment. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - August 7, 2020 Category: Radiology Authors: Halah Ibrahim, Ashraf M. Kamour, Thana Harhara, Waqar H. Gaba, Satish C. Nair Tags: Review Source Type: research
