Key considerations in the design of real-world studies
Randomized controlled clinical trials (RCTs) are the gold standard for evaluating the safety and efficacy of pharmaceutical drugs, but in many cases their costs, duration, limited generalizability, and ethical or technical feasibility have caused some to look for real-world studies as alternatives. However, real-world studies may be less convincing due to the lack of randomization and blinding. In this article, we discuss some key considerations in the design of real-world studies, which include experimental studies (e.g., hybrid or pragmatic clinical trials and non-randomized single-arm clinical trials with external contr...
Source: Contemporary Clinical Trials - July 24, 2020 Category: Radiology Authors: Yixin Fang, Weili He, Hongwei Wang, Meijing Wu Source Type: research
A sequential multiple assignment randomized trial (SMART) protocol for empirically developing an adaptive preventive intervention for college student drinking reduction
College student alcohol use and associated negative consequences are clear public health problems with consequences including damage to self, others, and institutions. This paper describes the protocol of a research study designed to answer a number of important questions in the development of an adaptive preventive intervention (API) to reduce high-risk drinking among first-year college students. The API is designed to educate students and to motivate heavy-drinking college students to engage in existing resources to support reducing high-risk alcohol use, by leveraging technology-based intervention modalities. (Source: C...
Source: Contemporary Clinical Trials - July 23, 2020 Category: Radiology Authors: Megan E. Patrick, Jeffrey A. Boatman, Nicole Morrell, Anna C. Wagner, Grace R. Lyden, Inbal Nahum-Shani, Cheryl A. King, Erin E. Bonar, Christine M. Lee, Mary E. Larimer, David M. Vock, Daniel Almirall Source Type: research
The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness –implementation trial in integrated primary care (the healthy communities 4 healthy students study)
Parenting interventions like the Family Check-Up have demonstrated effects on child physical and behavioral health outcomes. However, access to these programs is limited, particularly for populations experiencing health disparities. Primary care settings have become recognized as a potential delivery system in which these programs may be implemented at scale. The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 20, 2020 Category: Radiology Authors: Cady Berkel, Justin D. Smith, Meg M. Bruening, Neil Jordan, Emily Fu, Anne M. Mauricio, Kevin J. Grimm, Emily Winslow, Kristen Ray, Annette Bourne, Thomas J. Dishion Source Type: research
Design and rationale for a randomized trial of a theory- and technology- enhanced physical activity intervention for Latinas: The Seamos Activas II study
Latina women report disproportionately high rates of physical inactivity and related chronic health conditions. Physical activity (PA) efforts to date have shown modest success in this at-risk population; thus, more effective interventions are necessary to help Latinas reach national PA guidelines and reduce related health disparities. This paper describes the design, rationale, and baseline findings from the Seamos Activas II intervention. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 15, 2020 Category: Radiology Authors: Tanya J. Benitez, Shira I. Dunsiger, Dori J. Pekmezi, Britta A. Larsen, Andrea S. Mendoza-Vasconez, Sarah E. Linke, Beth C. Bock, Kim M. Gans, Sheri J. Hartman, Bess H. Marcus Source Type: research
THR1VE! Positive psychology intervention to treat diabetes distress in teens with type 1 diabetes: Rationale and trial design
Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control. Building on effective positive psychology interventions to improve adherence in adults, as well as our pilot work to adapt these interventions for adolescents, we developed a positive psychology intervention for adolescents with T1D. The goal of THR1VE! is to reduce diabetes distress in adolescents with T1D and improve their diabetes outcomes. This multi-site randomized controlled trial compares a Diabetes Education + text-message-based Positive Affect intervention, to a Diabet...
Source: Contemporary Clinical Trials - July 15, 2020 Category: Radiology Authors: Sarah S. Jaser, Karishma Datye, Troy Morrow, Manuela Sinisterra, Lauren LeStourgeon, Fayo Abadula, Grace E. Bell, Randi Streisand Source Type: research
The impact of narratives and active video games on long-term moderate-to-vigorous physical activity: A randomized controlled trial protocol
Although physical activity (PA) has been shown in helping prevent and treat obesity, current PA interventions are still not effective in ameliorating the obesity epidemic. Additional forms of PA need to be investigated to improve PA engagement and outcomes. We hypothesize that pairing a narrative (i.e., story) with an active video game (AVG), a less traditional form of PA, will increase participant engagement in PA. This paper presents the rationale, implementation, and pilot results of a study assessing the effect of narrative's impact on PA and a series of other health outcomes. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 15, 2020 Category: Radiology Authors: Dar Alon, Caio Sousa, Romina Cabrera-Perez, Austin Fernandez, Kelly Lee, Aika Misawa, Kyung Jin Sun, Tom Baranowski, Tiago V. Barreira, Kelly Chiu, Amy Fleischman, Shirley Huang, Jungyun Hwang, Melanie C. Green, I. Min Lee, Sarah Lessard, Lynne L. Levitsk Source Type: research
Time limited eating in adolescents with obesity (time LEAd): Study protocol
Time limited eating (TLE) has been shown to be effective for weight loss and improvement of glycemic control in adults with obesity and type 2 diabetes (T2D), but has not been well studied in adolescents. TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 15, 2020 Category: Radiology Authors: Alaina P. Vidmar, Michael I. Goran, Monica Naguib, Cassandra Fink, Choo Phei Wee, Elizabeth Hegedus, Kelleen Lopez, Janelle Gonzalez, Jennifer K. Raymond Source Type: research
Design considerations for phase I/II dose finding clinical trials in Immuno-oncology and cell therapy
Immuno-oncology (IO) and cell therapy, the frontier of cancer treatment, is a rapidly developing area that brings new opportunities to patients. In IO and cell therapy clinical trial development, it is critical to identify the right dose level in early phase of trials thus improving the probability of success in confirmatory trials to test the superiority over other therapies. Given the complex mechanism interacting with immune system for IO drugs especially cell therapy, the traditional oncology dose finding trial designs may not serve the purpose. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 9, 2020 Category: Radiology Authors: Rachael Liu, Jianchang Lin, Pin Li Source Type: research
Testing the effectiveness of physical activity advice delivered via text messaging vs. human phone advisors in a Latino population: The On The Move randomized controlled trial design and methods
Physical inactivity is a key risk factor for a range of chronic diseases and conditions, yet, approximately 50% of U.S. adults fall below recommended levels of regular aerobic physical activity (PA). This is particularly true for ethnic minority populations such as Latino adults for whom few culturally adapted programs have been developed and tested. Text messaging (SMS) represents a convenient and accessible communication channel for delivering targeted PA information and support, but has not been rigorously evaluated against standard telehealth advising programs. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 9, 2020 Category: Radiology Authors: Abby C. King, Ines Campero, Jylana L. Sheats, Cynthia M. Castro Sweet, Patricia Rodriguez Espinosa, Dulce Garcia, Michelle Hauser, Monica Done, Michelle L. Patel, Nina M. Parikh, Cecilia Corral, David K. Ahn Source Type: research
The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching
BackgroundAfrican American patients with uncontrolled diabetes living in medically underserved areas need effective clinic-based interventions to improve self-care behaviors. Text messaging (TM) and health coaching (HC) are among the most promising low-cost population-based approaches, but little is known about their comparative effectiveness in real-world clinical settings.ObjectiveUse a pragmatic randomized controlled trial design to determine the comparative effectiveness of TM and HC with enhanced usual care (EC) in African American adults with uncontrolled diabetes and multiple chronic health conditions. (Source: Cont...
Source: Contemporary Clinical Trials - July 7, 2020 Category: Radiology Authors: James E. Bailey, Satya Surbhi, Justin Gatwood, Susan Butterworth, Mace Coday, Sohul A. Shuvo, Ankur A. Dashputre, Ian M. Brooks, Bonnie Binkley, Carrie Jo Riordan, Helmut Steinberg, Mary Lou Gutierrez, Lauren Haley, Cardella Leak, Elizabeth A. Tolley Source Type: research
Virtual mind-body treatment for adolescents with neurofibromatosis: Study protocol for a single-blind randomized controlled trial
Neurofibromatoses (NF) are a group of genetically distinct disorders of the nervous system unified by the predisposition to nerve sheath tumors. Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs. This paper presents the study design and protocol for the first randomized controlled trial (RCT) of a mind-body intervention for adolescents with NF, Resilient Youth with NF (RY-NF), versus an educational control group, Health Education for NF (HE-NF), both delivered in groups via secure live video. (S...
Source: Contemporary Clinical Trials - July 3, 2020 Category: Radiology Authors: Mira Reichman, Eric Riklin, Eric Macklin, Ana-Maria Vranceanu Source Type: research
Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes
Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups. The shared medical appointment (SMA) model has been effective in multiple healthcare populations, but the feasibility and effectiveness of SMA in AYA patients with T1D is unclear. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 3, 2020 Category: Radiology Authors: Sarah-Jeanne Salvy, Valerie Ruelas, Shideh Majidi, Alex Thomas, Gary Ashwal, Mark Reid, D. Steven Fox, Sally McClain, Jennifer K. Raymond Source Type: research
A new framework to address challenges in quantitative benefit-risk assessment for medical products
In recent years, there has been a proliferation of regulatory and industry-wide initiatives on structured benefit-risk (BR) assessment. Examples of structured BR frameworks include the PrOACT-URL (Problem formulation, Objectives, Alternatives, Consequences, Trade-Offs, Uncertainties, Risk Attitude and Linked Decisions) from European Medicines Agency Work Package 3, multiple U.S. Food and Drug Administration guidance documents on benefit-risk assessment for medical devices, and U.S. Food and Drug Administration implementation plans for benefit-risk assessment in drug regulatory decision-making. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - July 1, 2020 Category: Radiology Authors: Bo Fu, Xuefeng Li, John Scott, Weili He Source Type: research
The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2)
Despite evidence for effective integrated behavior therapy for treating comorbid obesity and depression, treatment response is highly variable and the underlying neurobiological mechanisms remain unknown. This hampers efforts to identify mechanistic targets in order to optimize treatment precision and potency. Funded within the NIH Science of Behavior Change (SOBC) Research Network, the 2-phased ENGAGE research project applies an experimental precision medicine approach to address this gap. The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an...
Source: Contemporary Clinical Trials - June 30, 2020 Category: Radiology Authors: Nan Lv, Olusola A. Ajilore, Corina R. Ronneberg, Elizabeth M. Venditti, Mark B. Snowden, Philip W. Lavori, Lan Xiao, Andrea N. Goldstein-Piekarski, Joseph Wielgosz, Nancy E. Wittels, Amruta Barve, Aashutos S. Patel, Tessa L. Eckley, Patrick Stetz, Ben S. Source Type: research
Design of a Randomized Placebo Controlled Trial of High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation
Delirium is a highly prevalent neuropsychiatric condition with major health consequences in the medically ill [1,2]. Patients undergoing hematopoietic stem cell transplantation (HSCT) are at high risk for delirium because they often present with advanced disease and have completed one or more courses of chemotherapy. Patients receiving allogeneic transplantation may be at even higher risk due to the greater toxicity of their treatment, longer hospitalization, and higher complication rate compared to patients receiving autologous transplantation [3]. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - June 28, 2020 Category: Radiology Authors: Zev M. Nakamura, Allison M. Deal, Donald L. Rosenstein, Laura J. Quillen, Stephanie A. Chien, William A. Wood, Thomas C. Shea, Eliza M. Park Source Type: research
