Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients
We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 15, 2020 Category: Radiology Authors: Federico E. Vaca, James Dziura, Fuad Abujarad, Michael V. Pantalon, Allen Hsiao, Craig A. Field, Gail D'Onofrio Source Type: research
Corrigendum to ‘Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients’
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 15, 2020 Category: Radiology Source Type: research
Rationale and protocol for translating basic habituation research into family-based childhood obesity treatment: Families becoming healthy together study
This publication describes the rationale and protocol, including design, aims, intervention, and measures, of Families Becoming Healthy Together, a randomized clinical trial examining the effect of a limited RED (non-nutrient-dense, energy-dense) food variety prescription delivered within an 18-month family-based behavioral obesity treatment (FBT) on body mass index (BMI) and habituation rate to RED foods. One hundred fifty-six children (ages: 8 –12 y; BMI: ≥ 85th percentile-for-age) and a caregiver (BMI: ≥ 25 kg/m2), both with overweight or obesity, will be randomized to one of two, interventions: FBT or FBT +â€...
Source: Contemporary Clinical Trials - September 15, 2020 Category: Radiology Authors: Steve M. Douglas, Grace M. Hawkins, Kristoffer S. Berlin, Scott E. Crouter, Leonard H. Epstein, John G. Thomas, Hollie A. Raynor Source Type: research
The extension of 2-in-1 adaptive phase 2/3 designs and its application in oncology clinical trials
A 2-in-1 adaptive Phase 2/3 design was proposed by Chen et al. The 2-in-1 design improves the overall clinical trial development efficiency by 1) building in an early and informative decision-making; 2) allowing the flexible endpoint-usage at the decision and the final analysis; 3) potential registration path forward in either Phase 2 or Phase 3. The original paper illustrates a general idea. In this paper, we extend this design to fit more common scenarios. The type I error control in the extended 2-in-1 adaptive Phase 2/3 designs is investigated in both simulation and theoretical ways. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 15, 2020 Category: Radiology Authors: Li Fan, Jing Zhao, Wen Li Source Type: research
Semiparametric Bayesian inference for the transmission dynamics of COVID-19 with a state-space model
The outbreak of Coronavirus Disease 2019 (COVID-19) is an ongoing pandemic affecting over 200 countries and regions. Inference about the transmission dynamics of COVID-19 can provide important insights into the speed of disease spread and the effects of mitigation policies. We develop a novel Bayesian approach to such inference based on a probabilistic compartmental model using data of daily confirmed COVID-19 cases. In particular, we consider a probabilistic extension of the classical susceptible-infectious-recovered model, which takes into account undocumented infections and allows the epidemiological parameters to vary ...
Source: Contemporary Clinical Trials - September 14, 2020 Category: Radiology Authors: Tianjian Zhou, Yuan Ji Source Type: research
Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention
Successful methods for scaling-up evidence-based programs are needed to prevent skin cancer among adults who work outdoors in the sun. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 13, 2020 Category: Radiology Authors: David B. Buller, Mary Klein Buller, Richard Meenan, Gary R. Cutter, Julia Berteletti, Rachel Eye, Barbara J. Walkosz, Sherry Pagoto Source Type: research
Flexible Bayesian subgroup analysis in early and confirmatory trials
Subgroup analysis is one of the most important issues in clinical trials. In confirmatory trials, it is critical to investigate consistency of the treatment effect across subgroups, which could potentially result in incorrect scientific conclusion or regulatory decision. There are many challenges and methodological complications of interpreting subgroup results beyond the regulatory setting. For the early phase or proof of concept trials, particularly in basket trials, it is also important to have reliable estimation of subgroup treatment effect in order to guide the next phase go/no-go decision making when large biases ca...
Source: Contemporary Clinical Trials - September 13, 2020 Category: Radiology Authors: Veronica Bunn, Rachael Liu, Junjing Lin, Jianchang Lin Source Type: research
Mindfulness-based stress reduction for HIV-associated neurocognitive disorder: Rationale and protocol for a randomized controlled trial in older adults
The symptom burden of HIV-associated neurocognitive disorder (HAND) is high among older individuals, and treatment options are limited. Mindfulness-based stress reduction (MBSR) has potential to improve neurocognitive performance, psychosocial wellbeing, and quality of life, but empirical studies in this growing vulnerable population are lacking. In this trial, participants (N  = 180) age 55 and older who are living with HIV infection, are on combination antiretroviral therapy with suppressed viral loads, and yet continue to experience behavioral and cognitive symptoms of HAND, are randomized to MBSR or to a waitlist c...
Source: Contemporary Clinical Trials - September 13, 2020 Category: Radiology Authors: Elizabeth L. Addington, Shireen Javandel, Victor De Gruttola, Robert Paul, Benedetta Milanini, Beau M. Ances, Judith T. Moskowitz, Victor Valcour Source Type: research
Fragility of clinical trials across research fields: A synthesis of methodological reviews
Randomized controlled trials (RCTs) are often used to inform clinical practice and it is desirable that their results be robust. A fragility index (FI), defined as the smallest number of participants in whom an outcome change from non-event to event would turn a statistically significant result to a non-significant result, can be computed to measure robustness. We sought to determine the distribution of fragility indices across various research areas and summarized the factors associated with fragility. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 13, 2020 Category: Radiology Authors: Matthew Holek, Faris Bdair, Mohammed Khan, Michael Walsh, P.J. Devereaux, Stephen D. Walter, Lehana Thabane, Lawrence Mbuagbaw Source Type: research
Early administration of steroids in the ambulance setting: Protocol for a type I hybrid effectiveness-implementation trial with a stepped wedge design
Pediatric asthma exacerbations are a frequent reason for emergency care. Early administration of oral systemic corticosteroids (OCS) in the emergency department (ED) decreases hospitalization rates and ED length-of-stay (LOS). However, it is unknown whether even earlier OCS administration by emergency medical services (EMS) in the prehospital setting further improves outcomes. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 11, 2020 Category: Radiology Authors: Jennifer N. Fishe, Phyllis Hendry, Jennifer Brailsford, Ramzi G. Salloum, Bruce Vogel, Erik Finlay, Sam Palmer, Susmita Datta, Leslie Hendeles, Kathryn Blake Source Type: research
The assertive cardiac care trial: A randomised controlled trial of a coproduced assertive cardiac care intervention to reduce absolute cardiovascular disease risk in people with severe mental illness in the primary care setting
Cardiovascular disease (CVD) accounts for 40% of the excess mortality identified in people with severe mental illness (SMI). Modifiable CVD risk factors are higher and can be exacerbated by the cardiometabolic impact of psychotropic medications. People with SMI frequently attend primary care presenting a valuable opportunity for early identification, prevention and management of cardiovascular health. The ACCT Healthy Hearts Study will test a coproduced, nurse-led intervention delivered with general practitioners to reduce absolute CVD risk (ACVDR) at 12  months compared with an active control group. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 10, 2020 Category: Radiology Authors: Matthew Lewis, Patty Chondros, Cathy Mihalopoulos, Yong Yi Lee, Jane M. Gunn, Carol Harvey, John Furler, David Osborn, David Castle, Sandra Davidson, Mahesh Jayaram, Amanda Kenny, Mark R. Nelson, Vera A. Morgan, Stephen Harrap, Kylie McKenzie, Maria Potir Source Type: research
Selecting appropriate endpoints for assessing treatment effects in comparative clinical studies for COVID-19
To evaluate the efficacy and safety of a new treatment for COVID-19 vs. standard care, certain key endpoints are related to the duration of a specific event, such as hospitalization, ICU stay, or receipt of supplemental oxygen. However, since patients may die in the hospital during study follow-up, using, for example, the duration of hospitalization to assess treatment efficacy can be misleading. If the treatment tends to prolong patients' survival compared with standard care, patients in the new treatment group may spend more time in hospital. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 10, 2020 Category: Radiology Authors: Zachary R. McCaw, Lu Tian, Kevin N. Sheth, Wan-Ting Hsu, W. Taylor Kimberly, Lee-Jen Wei Source Type: research
Sustaining the reach of a scalable weight loss intervention through financial incentives- a pragmatic, feasibility, online randomized trial protocol
High attrition following initial enrollment in evidence-based weight loss programs is a common, challenging, and under-studied issue. A behavioral economics approach consisting of modest monetary incentives may help to engage participants beyond enrollment to close the initial attrition gap. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 10, 2020 Category: Radiology Authors: Tzeyu L. Michaud, Paul A. Estabrooks, Wen You, Todd J. McGuire, Fabio Almeida, Kelly Karls, Kenya Love, Keyonna King, Jennie Hill, Jill Reed, Gwenndolyn Porter, Dejun Su Source Type: research
Sustaining the reach of a scalable weight loss intervention through financial incentives - a pragmatic, online randomized trial protocol
High attrition following initial enrollment in evidence-based weight loss programs is a common, challenging, and under-studied issue. A behavioral economics approach consisting of modest monetary incentives may help to engage participants beyond enrollment to close the initial attrition gap. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 9, 2020 Category: Radiology Authors: Tzeyu L. Michaud, Paul A. Estabrooks, Wen You, Todd J. McGuire, Fabio Almeida, Kelly Karls, Kenya Love, Keyonna King, Jennie Hill, Jill Reed, Gwenndolyn Porter, Dejun Su Source Type: research
Comparing the clinical impact of pancreatic cyst surveillance programs: A trial of the ECOG-ACRIN cancer research group (EA2185)
The optimal surveillance strategy for pancreatic cysts, which occur in up to 20% of the adult population, is ill defined. The risk of malignant degeneration of these cysts is low, however the morbidity and mortality associated with pancreatic cancer are high. Two clinical surveillance guidelines are in regular use. Both the Fukuoka and American Gastroenterological Association (AGA) guidelines rely on radiographic and endoscopic imaging. They differ primarily in their recommended frequencies of interval surveillance imaging. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 9, 2020 Category: Radiology Authors: David S. Weinberg, Constantine Gatsonis, Herbert J. Zeh, Ruth C. Carlos, Peter J. O'Dwyer, on behalf of the EA2185 Team Source Type: research
