Community-based intervention effects on older adults' physical activity and falls: Protocol and rationale for a randomized optimization trial (Ready Steady3.0)
The Ready Steady 3.0 trial is designed to test the main and interactive effects of two behavior change intervention components, within an 8-week physical activity intervention, on older adults' physical activity (PA). Each component is comprised of behavior change strategies that emphasize two different evidence-based ways to motivate older adults to be active: interpersonal and intrapersonal. 308 adults ≥70 years old will be randomized to 1 of 4 conditions in a 2 × 2 full factorial trial in which the two factors represent the receipt (No, Yes) of interpersonal or intrapersonal behavior change strategies. (Source:...
Source: Contemporary Clinical Trials - December 4, 2020 Category: Radiology Authors: Siobhan K. McMahon, Beth Ann Lewis, Weihua Guan, Jean F. Wyman, Alexander J. Rothman Source Type: research
Reporting and design of randomized controlled trials for COVID-19: A systematic review
The novel coronavirus 2019 (COVID-19) pandemic has mobilized global research at an unprecedented scale. While challenges associated with the COVID-19 trial landscape have been discussed previously, no comprehensive reviews have been conducted to assess the reporting, design, and data sharing practices of randomized controlled trials (RCTs). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 3, 2020 Category: Radiology Authors: Alison Dillman, Jay J.H. Park, Michael J. Zoratti, Noor-E Zannat, Zelyn Lee, Louis Dron, Grace Hsu, Gerald Smith, Sahand Khakabimamaghani, Ofir Harari, Kristian Thorlund, Edward J. Mills Source Type: research
Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 1, 2020 Category: Radiology Source Type: research
Targeting self-control as a behavior change mechanism to increase physical activity: Study protocol of a randomized controlled trial
Despite the highly publicized beneficial effects of physical activity, 51.1% of middle-aged US adults do not achieve the recommended minimum of aerobic physical activity needed to maintain health. A sedentary lifestyle can be attributed in part to a lack of self-control and there is some evidence that self-control strategies can be improved with targeted interventions. The overall aim of this study is to test self-control as a behavior change mechanism for physical activity and to investigate whether a smartphone-based self-control intervention can increase physical activity among sedentary middle-aged adults. (Source: Con...
Source: Contemporary Clinical Trials - December 1, 2020 Category: Radiology Authors: Mirjam Stieger, Mathias Allemand, Margie E. Lachman Source Type: research
Standardization of the 6-min walk test in clinical trials of idiopathic pulmonary fibrosis
The 6-min walk test (6MWT) is an important measure of functional capacity in idiopathic pulmonary fibrosis (IPF) and has been an endpoint of several IPF clinical trials. However, current guidance for the 6MWT offers insufficient advice on standardization, particularly oxygen supplementation, for clinical trials. Three physicians experienced with the 6MWT and IPF developed a standardized protocol for the 6MWT based on existing clinical guidelines and published literature. The protocol comprises guidance on test conditions, pre-defined parameters to measure at specified timepoints, and step-by-step instructions on conducting...
Source: Contemporary Clinical Trials - November 24, 2020 Category: Radiology Authors: Lisa Lancaster, Ann Fieuw, Joyce Meulemans, Paul Ford, Steven D. Nathan Source Type: research
Sample size re-estimation in adaptive enrichment design
Clinical trial participants are often heterogeneous, which is a fundamental problem in the rapidly developing field of precision medicine. Participants heterogeneity causes considerable difficulty in the current phase III trial designs. Adaptive enrichment designs provide a flexible and intuitive solution. At the interim analysis, we enrich the subgroup of trial participants who have a higher likelihood to benefit from the new treatment. However, it is critical to control the level of the test size and maintain adequate power after enrichment of certain subgroup of participants. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 24, 2020 Category: Radiology Authors: Ruitao Lin, Zhao Yang, Ying Yuan, Guosheng Yin Source Type: research
Preventing asthma in high risk kids (PARK) with omalizumab: Design, rationale, methods, lessons learned and adaptation
Asthma remains one of the most important challenges to pediatric public health in the US. A large majority of children with persistent and chronic asthma demonstrate aeroallergen sensitization, which remains a pivotal risk factor associated with the development of persistent, progressive asthma throughout life. In individuals with a tendency toward Type 2 inflammation, sensitization and exposure to high concentrations of offending allergens is associated with increased risk for development of, and impairment from, asthma. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 23, 2020 Category: Radiology Authors: Wanda Phipatanakul, David T. Mauger, Theresa W. Guilbert, Leonard B. Bacharier, Sandy Durrani, Daniel J. Jackson, Fernando D. Martinez, Anne M. Fitzpatrick, Amparito Cunningham, Susan Kunsel, Lisa M. Wheatley, Cindy Bauer, Carla M. Davis, Bob Geng, Kirste Source Type: research
A hybrid approach of handling missing data under different missing data mechanisms: VISIBLE 1 and VARSITY trials for ulcerative colitis
Missing data is common in clinical trials. Depending on the volume and nature of missing data, it may reduce statistical power for detecting treatment difference, introduce potential bias and invalidate conclusions. Non-responder imputation (NRI), where patients with missing data to determine endpoint status are considered treatment failures, is widely used to handle missing data for dichotomous efficacy endpoints in inflammatory bowel disease (IBD) trials. However, it does not consider the mechanisms leading to missing data and can potentially underestimate the treatment effect. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 22, 2020 Category: Radiology Authors: Jingjing Chen, Sharon Hunter, Krisztina Kisfalvi, Richard A. Lirio Source Type: research
Innovative trial designs and analyses for vaccine clinical development
In the past decades, the world has experienced several major virus outbreaks, e.g. West African Ebola outbreak, Zika virus in South America and most recently global coronavirus (COVID-19) pandemic. Many vaccines have been developed to prevent a variety of infectious diseases successfully. However, several infections have not been preventable so far, like COVID-19, which induces an immediate urgent need for effective vaccines. These emerging infectious diseases often pose unprecedent challenges for the global heath community as well as the conventional vaccine development paradigm. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 20, 2020 Category: Radiology Authors: Mengya Liu, Qing Li, Jianchang Lin, Yunzhi Lin, Elaine Hoffman Source Type: research
Zero suicide implementation-effectiveness trial study protocol in outpatient behavioral health using the A-I-M suicide prevention model
The treatment of suicidal patients often suffers owing to a lack of integrated care and standardized approaches for identifying and reducing risk. The National Strategy for Suicide Prevention endorsed the Zero Suicide (ZS) model, a multi-component, system-wide approach to identify, engage and treat suicidal patients. The ZS model is a framework for suicide prevention in healthcare systems with the aspirational goal of eliminating suicide in healthcare. While the approach is widely endorsed, it has yet to be evaluated in a systematic manner. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 17, 2020 Category: Radiology Authors: Barbara Stanley, Christa D. Labouliere, Gregory K. Brown, Kelly L. Green, Anga C. Galfalvy, Molly T. Finnerty, Prabu Vasan, Anni Kramer Cummings, Milton Wainberg, Jay W. Carruthers, Lisa B. Dixon Source Type: research
Sample size re-estimation for pivotal clinical trials
It is well known that if the hypothesis test is left unchanged, the Type I error rate may be inflated for sample size re-estimation (SSR) designs. To address this issue, three main approaches have been proposed in the literature: combination test, conditional error and conventional test with sample size increase in the allowable region (AR) only. These three seemingly different approaches are in fact connected. For each combination test, there is a corresponding conditional error function and AR. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 17, 2020 Category: Radiology Authors: Yi Liu, Heng Xu Source Type: research
Using digital technologies in clinical trials: Current and future applications
In 2015, we provided an overview of the use of digital technologies in clinical trials, both as a methodological tool and as a mechanism to deliver interventions. At that time, there was limited guidance and limited use of digital technologies in clinical research. However, since then smartphones have become ubiquitous and digital health technologies have exploded. This paper provides an update to our earlier publication and an overview of how technology has been used in the past five years in clinical trials, providing examples with varying levels of technological integration and across different health conditions. (Sourc...
Source: Contemporary Clinical Trials - November 16, 2020 Category: Radiology Authors: Carmen Rosa, Lisa A. Marsch, Erin L. Winstanley, Meg Brunner, Aimee N.C. Campbell Source Type: research
Development of a mindfulness-based treatment for smoking cessation and the modification of alcohol use: A protocol for a randomized controlled trial and pilot study findings
The combined use of cigarettes and alcohol is associated with an increased risk of morbidity and mortality. Yet, efficacious interventions that address both behaviors concurrently are lacking. Smoking cessation and alcohol modification not only garner health benefits, but there is also value in addressing alcohol use in the context of smoking cessation to reduce the risk for smoking relapse. In this paper we describe the development of mindfulness-based relapse prevention for smoking cessation and alcohol modification (MBRP-SA) and pilot study findings (Phase 1). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 13, 2020 Category: Radiology Authors: Mikaela Hemenway, Katie Witkiewitz, Marina Unrod, Karen O. Brandon, Thomas H. Brandon, David W. Wetter, Steven K. Sutton, Christine Vinci Source Type: research
Evaluation of intervention components to maximize outcomes of behavioral obesity treatment delivered online: A factorial experiment following the multiphase optimization strategy framework
Behavioral lifestyle intervention (BLI) is recommended as a first-line treatment for obesity. While BLI has been adapted for online delivery to improve potential for dissemination while reducing costs and barriers to access, weight losses are typically inferior to gold standard treatment delivered in-person. It is therefore important to refine and optimize online BLI in order to improve the proportion of individuals who achieve a minimum clinically significant weight loss and mean weight loss. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 13, 2020 Category: Radiology Authors: J. Graham Thomas, Carly M. Goldstein, Dale S. Bond, Jason Lillis, Eric B. Hekler, Jessica A. Emerson, Hallie M. Espel-Huynh, Stephanie P. Goldstein, Shira I. Dunsiger, E. Whitney Evans, Meghan L. Butryn, Jeff Huang, Rena R. Wing Source Type: research
Causal inference methods for small non-randomized studies: Methods and an application in COVID-19
The usual development cycles are too slow for the development of vaccines, diagnostics and treatments in pandemics such as the ongoing SARS-CoV-2 pandemic. Given the pressure in such a situation, there is a risk that findings of early clinical trials are overinterpreted despite their limitations in terms of size and design. Motivated by a non-randomized open-label study investigating the efficacy of hydroxychloroquine in patients with COVID-19, we describe in a unified fashion various alternative approaches to the analysis of non-randomized studies. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 11, 2020 Category: Radiology Authors: Sarah Friedrich, Tim Friede Source Type: research
