Using artificial intelligence tools in answering important clinical questions: The KEYNOTE-183 multiple myeloma experience
The phase III, randomized, active-controlled, multicenter, open-label KEYNOTE-183 study (NCT02576977) evaluating pomalidomide and low dose dexamethasone (standard-of-care [SOC]) with or without pembrolizumab in patients with refractory or relapsed and refractory multiple myeloma (rrMM) was placed on full clinical hold by the US FDA on July 03, 2017 due to an imbalance in the number of deaths between arms. Clinically-led subgroup analyses are typically used to shed light on clinical findings. However, this approach is not always successful. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 18, 2020 Category: Radiology Authors: Jason J.Z. Liao, Mohammed Z.H. Farooqui, Patricia Marinello, Jonathan Hartzel, Keaven Anderson, Junshui Ma, Christine K. Gause Source Type: research

An adaptive clinical trial design for cocaine use disorder: Extended-release amphetamine salts for early behavioral intervention non-responders
Cocaine use disorder (CUD) persists as a major public health problem in the United States. Response to evidence-based behavioral treatment has been shown to be predicted by dopaminergic dysfunction. Amphetamine formulations modulate dopaminergic systems and are one of the few agents with positive clinical findings but are associated with unique risks. We aimed to find a model for determining the most appropriate patients for treatment with mixed amphetamine salts-extended-release (MAS-ER) for CUD using an adaptive trial design. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 18, 2020 Category: Radiology Authors: Derek Blevins, Kenneth M. Carpenter, Diana Martinez, John J. Mariani, Frances R. Levin Source Type: research

Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a multicentre randomized controlled trial
Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 17, 2020 Category: Radiology Authors: Sara Z. Kuiper, Carmen D. Dirksen, Merel L. Kimman, Sander M.J. Van Kuijk, Robin R. Van Tol, Jean W.M. Muris, Angus J.M. Watson, Jose M.C. Maessen, Jarno Melenhorst, St éphanie O. Breukink, On behalf of the Napoleon Trial Study Group Source Type: research

Innovation in the design of large-scale hybrid randomized clinical trials
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 17, 2020 Category: Radiology Authors: Pamela M. Rist, Howard D. Sesso, JoAnn E. Manson Source Type: research

Study protocol for a randomized controlled trial of mindfulness-based relapse prevention for opioid use disorders
The opioid misuse epidemic has reached a crisis level in the United States. Though mindfulness-based relapse prevention (MBRP) has been shown as effective in treating substance use disorders, there is limited research on its application to opioid use disorders specifically, and there is a need to understand the underlying mechanisms. This paper outlines a protocol for a randomized controlled trial of MBRP for opioid use disorders. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 17, 2020 Category: Radiology Authors: Heidi Zinzow, Lu Shi, Lior Rennert, Liwei Chen, Snehal Lopes, Lingling Zhang, Karyn Jones, Meenu Jindal, Claire Stam, Michael Mclain Source Type: research

Dec ídetexto: Mobile cessation support for latino smokers. study protocol for a randomized clinical trial
Latinos, the largest minority group in the U.S., experience tobacco-related disparities, including limited access to cessation resources. Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 17, 2020 Category: Radiology Authors: Francisco Cartujano-Barrera, Evelyn Arana-Chicas, Delwyn Catley, Lisa Sanderson Cox, Francisco J. Diaz, Edward F. Ellerbeck, Kristi D. Graves, Chinwe Ogedegbe, Ana Paula Cupertino Source Type: research

Medical assistant health coaching ( “MAC”) for type 2 diabetes in diverse primary care settings: A pragmatic, cluster-randomized controlled trial protocol
In the US, nearly 11% of adults were living with diagnosed diabetes in 2017, and significant type 2 diabetes (T2D) disparities are experienced by socioeconomically disadvantaged, racial/ethnic minority populations, including Hispanics. The standard 15-min primary care visit does not allow for the ongoing self-management support that is needed to meet the complex needs of individuals with diabetes. “Team-based” chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially tra...
Source: Contemporary Clinical Trials - October 10, 2020 Category: Radiology Authors: Addie L. Fortmann, Athena Philis-Tsimikas, Johanna A. Euyoque, Taylor L. Clark, Daniela G. Vital, Haley Sandoval, Julia I. Bravin, Kimberly L. Savin, Jennifer A. Jones, Scott Roesch, Todd Gilmer, Thomas Bodenheimer, James Schultz, Linda C. Gallo Source Type: research

The vitamin D for COVID-19 (VIVID) trial: A pragmatic cluster-randomized design
To determine the effect of vitamin D supplementation on disease progression and post-exposure prophylaxis for COVID-19 infection. We hypothesize that high-dose vitamin D3 supplementation will reduce risk of hospitalization/death among those with recently diagnosed COVID-19 infection and will reduce risk of COVID-19 infection among their close household contacts. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 9, 2020 Category: Radiology Authors: Rui Wang, Victor DeGruttola, Quanhong Lei, Kenneth H. Mayer, Susan Redline, Aditi Hazra, Samia Mora, Walter C. Willett, Davaasambuu Ganmaa, JoAnn E. Manson Source Type: research

The European NAFLD registry: A real-world longitudinal cohort study of nonalcoholic fatty liver disease
Non-Alcoholic Fatty Liver Disease (NAFLD), a progressive liver disease that is closely associated with obesity, type 2 diabetes, hypertension and dyslipidaemia, represents an increasing global public health challenge. There is significant variability in the disease course: the majority exhibit only fat accumulation in the liver but a significant minority develop a necroinflammatory form of the disease (non-alcoholic steatohepatitis, NASH) that may progress to cirrhosis and hepatocellular carcinoma. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 8, 2020 Category: Radiology Authors: Timothy Hardy, Kristy Wonders, Ramy Younes, Guruprasad P. Aithal, Rocio Aller, Michael Allison, Pierre Bedossa, Fay Betsou, Jerome Boursier, M. Julia Brosnan, Alastair Burt, Jeremy Cobbold, Helena Cortez-Pinto, Chris P. Day, Jean-Francois Dufour, Mattias Source Type: research

Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers
We describe a trial of semaglutide treatment for NASH, identify key patient characteristics and compare the relationship of patient characteristics and non-invasive biomarkers/scores.NCT02970942 is a randomised, double-blind, placebo-controlled, multi-national Phase 2 trial of daily subcutaneous semaglutide (0.1  mg, 0.2 mg, 0.4 mg) in patients with biopsy-confirmed NASH, F1–F3 fibrosis, NAFLD Activity Score ≥ 4, and body mass index (BMI) > 25 kg/m2. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 8, 2020 Category: Radiology Authors: Stephen A. Harrison, Salvatore Calanna, Kenneth Cusi, Martin Linder, Takeshi Okanoue, Vlad Ratziu, Arun Sanyal, Anne-Sophie Sejling, Philip N. Newsome Source Type: research

A mHealth intervention to preserve and promote ideal cardiovascular health in college students: Design and protocol of a cluster randomized controlled trial
Cardiovascular disease (CVD) remains the leading cause of death globally. Seven health factors are associated with ideal cardiovascular health: being a non-smoker; not overweight; physically active; having a healthy diet; and normal blood pressure; fasting plasma glucose and cholesterol. Whereas approximately half of U.S. youth have ideal levels in at least 5 of the 7 components of cardiovascular health, this proportion falls to 16% by adulthood. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 6, 2020 Category: Radiology Authors: Angela F. Pfammatter, Katrina E. Champion, Laura E. Finch, Juned Siddique, Donald Hedeker, Bonnie Spring Source Type: research

A randomised, double-blind, placebo-controlled, multi-centre, dose-range, proof-of-concept, 24-week treatment study of lanifibranor in adult subjects with non-alcoholic steatohepatitis: Design of the NATIVE study
BackgroundNon-alcoholic steatohepatitis (NASH), a multifactorial disease, can progress to hepatic fibrosis and cirrhosis. The Peroxysomal Proliferator-Activated Receptors, PPAR α, β/δ and γ, play a central role in the regulation of glucose and lipid metabolism and of the inflammatory and fibrogenic pathways in liver and in other organs that all contribute to NASH pathogenesis. Lanifibranor (IVA337), a panPPAR agonist, by acting on these three different PPAR isotypes, c ombines pharmacological effects that could address the different components of the disease as demonstrated in preclinical models. (So...
Source: Contemporary Clinical Trials - October 6, 2020 Category: Radiology Authors: Francque Sven, Bedossa Pierre, F. Abdelmalek Manal, M. Anstee Quentin, Bugianesi Elisabetta, Ratziu Vlad, Huot-Marchand Philippe, Scherrer Bruno, Junien Jean-Louis, Broqua Pierre, Abitbol Jean-Louis Source Type: research

Facilitating smoking cessation using reduced nicotine cigarettes: Intervention development and RCT study design
Smoking cigarettes with substantially lower nicotine than conventional cigarettes prior to a quit attempt may reduce the reinforcing effects of smoking, which could facilitate smoking cessation through extinction learning. This paper describes the development of a smoking cessation intervention designed to optimize extinction processes using reduced nicotine cigarettes, as well as the design and methods for an ongoing randomized controlled trial (RCT) to evaluate this intervention. Qualitative methods and pilot testing were conducted to develop the novel facilitated extinction (FE) intervention, with a key focus on maximiz...
Source: Contemporary Clinical Trials - October 6, 2020 Category: Radiology Authors: Melissa R. Conn, Thomas H. Brandon, Yenis L. Lorenzo, Leslie E. Sawyer, Vani N. Simmons, Steven K. Sutton, Eric C. Donny, Dorothy Hatsukami, David J. Drobes Source Type: research

Protocol of a randomized trial of acceptance and commitment therapy for fatigue interference in metastatic breast cancer
Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns of metastatic breast cancer patients. To date, there are no evidence-based interventions for reducing fatigue interference in metastatic breast cancer and other advanced cancer populations. In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients. The current Phase II trial seeks to more definitively examine the efficacy of telephone-based ACT for women with metastatic breast cancer who are experiencing fatigue interference. (Source: C...
Source: Contemporary Clinical Trials - October 5, 2020 Category: Radiology Authors: Catherine E. Mosher, Ellen Krueger, Adam T. Hirsh, Kathy D. Miller, Tarah J. Ballinger, Anna Maria Storniolo, Bryan P. Schneider, Erin V. Newton, Victoria L. Champion, Shelley A. Johns Source Type: research

A pharmacist intervention for monitoring and treating hypertension using bidirectional texting: PharmText BP
New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation. We have developed a custom-built bi-directional texting platform for home BP measurements that can then be managed by clinical pharmacists located remotely. The purpose of this study is to evaluate whether the BP texting approach combined with a pharmacist-based intervention improves BP management and to determine if the approach is cost effective. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 5, 2020 Category: Radiology Authors: Linnea A. Polgreen, Barry L. Carter, Philip M. Polgreen, Peter M. Snyder, Daniel K. Sewell, Emine O. Bayman, Shelby L. Francis, Jacob E. Simmering, Christopher Parker, Rachel Finkelstein Source Type: research

Real-world experiences with generating real-world evidence: Case Studies from PCORI's pragmatic clinical Studies program
Over the last decade, randomized studies evaluating outcomes of health care interventions conducted in real-world settings —often termed “pragmatic trials”—have come to be seen as an important means of obtaining relevant, actionable evidence to guide health care decisions. Despite extensive writing on methodological considerations in pragmatic trial design, limited information exists regarding the practical and logistical challenges encountered in carrying out rigorous randomized evaluations in highly representative, real-world contexts. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 5, 2020 Category: Radiology Authors: Mark D. Neuman, Michael D. Kappelman, Elliot Israel, Susan S. Ellenberg, Cindy German, Jess Robb, Allie Rabinowitz, Anne Trontell Source Type: research

The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements
Section 1115 demonstration waivers provide a mechanism for states to implement changes to their Medicaid programs. While such waivers are mandated to include evaluations of their impact, randomization – the gold standard for assessing causality – has not typically been a consideration. In a critical departure, the Commonwealth of Kentucky opted to pursue a two-arm randomized controlled trial (RCT) for their controversial 2018 Medicaid Demonstration waiver, which included work requirements as a condition for the subset of beneficiaries deemed able-bodied to maintain eligibility for benefits. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 5, 2020 Category: Radiology Authors: Kristin A. Linn, Kristen Underhill, Erica L. Dixon, Elizabeth F. Bair, William J. Ferrell, Margrethe E. Montgomery, Kevin G. Volpp, Atheendar S. Venkataramani Source Type: research

TOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocol
Pneumonia is the most frequent complication of COVID-19, due to an aberrant host immune response that is associated with an acute respiratory distress syndrome, and, in most critical patients, with a “cytokine storm”. IL-6 might play a key role in the cytokine storm and might be a potential target to treat severe and critical COVID-19. Tocilizumab is a recombinant humanized monoclonal antibody, directed against IL-6 receptor. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 4, 2020 Category: Radiology Authors: Maria Carmela Piccirillo, Paolo Ascierto, Luigi Atripaldi, Marco Cascella, Massimo Costantini, Giovanni Dolci, Nicola Facciolongo, Fiorentino Fraganza, AnnaMaria Marata, Marco Massari, Vincenzo Montesarchio, Cristina Mussini, Emanuele Alberto Negri, Rober Source Type: research

CITY health II - using entertainment education and social media to reduce HIV among emerging adults: A protocol paper for the beat HIVe project
Despite multiple efforts to reduce HIV rates among African American young adults, a significant racial disparity persists and continues to grow among this population. New approaches are needed to reach this at-risk group and engage them in prevention efforts. The Community Influences Transitions of Youth Health (CITY Health II) study aims to increase HIV preventive behaviors to decrease HIV rates among 18 –25 year old African American emerging adults living in resource-poor southern urban communities. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 4, 2020 Category: Radiology Authors: Susan L. Davies, Tamika L. Smith, Bailey Murphy, M. Scott Crawford, Kathryn A. Kaiser, Olivio J. Clay Source Type: research

Design and methods of NYC care calls: An effectiveness trial of telephone-delivered type 2 diabetes self-management support
Although problems with type 2 diabetes (T2D) self-management and treatment adherence often co-occur with emotional distress, few translatable intervention approaches are available that can target these related problems in primary care practice settings. The New York City (NYC) Care Calls study is a randomized controlled trial that tests the effectiveness of structured support for diabetes self-management and distress management, delivered via telephone by health educators, in improving glycemic control, self-management and emotional well-being among predominantly ethnic minority and socioeconomically disadvantaged adults w...
Source: Contemporary Clinical Trials - October 2, 2020 Category: Radiology Authors: Jeffrey S. Gonzalez, Claire J. Hoogendoorn, Jill Linnell, Sarah Fishman, Victoria Jonas, Hang Pham-Singer, Clyde B. Schechter, Elizabeth A. Walker, Winfred Y. Wu Source Type: research

Accelerated approval of Oxbryta ® (voxelotor): A case study on novel endpoint selection in sickle cell disease
Sickle cell disease (SCD) is an inherited disease characterized by hemolysis, anemia, and vaso-occlusion leading to substantial morbidity and mortality. Development of prior pharmacologic therapies exclusively utilized vaso-occlusive crisis (VOC) as a clinical efficacy endpoint; however, this focus on VOC did not capture the full extent of disease symptomatology and complications and slowed the development of new therapies. Voxelotor, a hemoglobin S polymerization inhibitor, was recently approved in the United States for the treatment of SCD in adults and adolescents 12  years of age and older through an accelerated appr...
Source: Contemporary Clinical Trials - September 29, 2020 Category: Radiology Authors: Joshua Lehrer-Graiwer, Linda Yokoshima, Barbara Tong, Ted W. Love Source Type: research

Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial
The number of older adults who receive life support in an intensive care unit (ICU), now 2 million per year, is increasing while survival remains unchanged. Because the quality of ICU-based palliative care is highly variable, we developed a mobile app intervention that integrates into the electronic health records (EHR) system called PCplanner (Palliative Care planner) with the goal of improving collaborative primary and specialist palliative care delivery in ICU settings. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 28, 2020 Category: Radiology Authors: Christopher E. Cox, Maren K. Olsen, David Casarett, Krista Haines, Mashael Al-Hegelan, Raquel R. Bartz, Jason N. Katz, Colleen Naglee, Deepshikha Ashana, Daniel Gilstrap, Jessie Gu, Alice Parish, Allie Frear, Deepthi Krishnamaneni, Andrew Corcoran, Sharro Source Type: research

Universal childhood obesity prevention in a rural community: Study design, methods and baseline participant characteristics of the NU-HOME randomized controlled trial
Childhood obesity is a major health concern in the United States (US) and those living in rural communities are at higher risk than their urban counterparts. Few prevention trials have engaged whole families of school-age children in community settings, and none to date have promoted family meals, family activity and healthful home environments in rural settings through a rigorous, randomized controlled trial (RCT). The New Ulm at HOME (NU-HOME) study recruited 114 parent/child dyads in a two-arm (intervention versus wait-list control) RCT to test the efficacy of a family meals-focused program aimed to prevent excess weigh...
Source: Contemporary Clinical Trials - September 26, 2020 Category: Radiology Authors: Jayne A. Fulkerson, Melissa L. Horning, Daheia J. Barr-Anderson, Jennifer A. Linde, Abbey C. Sidebottom, Rebecca Lindberg, Sarah Friend, Colleen Flattum, Rebecca L. Freese Source Type: research

Pain relief for osteoarthritis through combined treatment (PROACT): Protocol for a randomized controlled trial of mindfulness meditation combined with transcranial direct current stimulation in non-Hispanic black and white adults with knee osteoarthritis
Knee osteoarthritis (OA) is a leading cause of late life pain and disability, and non-Hispanic black (NHB) adults experience greater OA-related pain and disability than non-Hispanic whites (NHWs). Recent evidence implicates psychosocial stress, cognitive-attentional processes, and altered central pain processing as contributors to greater OA-related pain and disability among NHBs. To address these ethnic/race disparities, this clinical trial will test whether a mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS) will enhance pain modulatory balance a...
Source: Contemporary Clinical Trials - September 24, 2020 Category: Radiology Authors: Roger B. Fillingim, Adam J. Woods, Hyochol Ahn, Samuel S. Wu, David T. Redden, Song Lai, Hrishikesh Deshpande, Georg Deutsch, Kimberly T. Sibille, Roland Staud, Fadel Zeidan, Burel R. Goodin Source Type: research

A dyadic approach for a remote physical activity intervention in adults with Alzheimer's disease and their caregivers: Rationale and design for an 18-month randomized trial
Adults with Alzheimer's disease and related dementia (ADRD) and their caregivers represent a sizeable and underserved segment of the population with low levels of moderate physical activity (MPA). Options for increasing MPA in community dwelling adults with ADRD and their caregivers are limited. A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 22, 2020 Category: Radiology Authors: Lauren T. Ptomey, Amanda N. Szabo-Reed, Eric D. Vidoni, Richard A. Washburn, Anna M. Gorczyca, Todd D. Little, Jaehoon Lee, Brian C. Helsel, Kristine N. Williams, Joseph E. Donnelly Source Type: research

Working with HIV clinics to adopt addiction treatment using implementation facilitation (WHAT-IF?): Rationale and design for a hybrid type 3 effectiveness-implementation study
Tobacco, alcohol and opioid misuse are associated with substantial morbidity and mortality among people with HIV (PWH). Despite existence of evidence-based counseling and medications for addiction, these treatments are infrequently offered in HIV clinics. The Working with HIV clinics to adopt Addiction Treatment using Implementation Facilitation (WHAT-IF?) study was conducted to address this implementation challenge. The study's goals were to conduct a formative evaluation of barriers to and facilitators of implementing addiction treatment for PWH followed by an evaluation of the impact of Implementation Facilitation (IF) ...
Source: Contemporary Clinical Trials - September 21, 2020 Category: Radiology Authors: E. Jennifer Edelman, James Dziura, Denise Esserman, Elizabeth Porter, William C. Becker, Philip A. Chan, Deborah H. Cornman, Gabriel Rebick, Jessica Yager, Kenneth Morford, Srinivas B. Muvvala, David A. Fiellin Source Type: research

Practical Telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial
We describe a study testing a novel telehealth intervention that comprehensively targets clinic-refractory PPDM, and was explicitly developed for practical delivery using existing Veterans Health Administration (VHA) clinical infrastructure. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 20, 2020 Category: Radiology Authors: Elizabeth A. Kobe, David Edelman, Phillip E. Tarkington, Hayden B. Bosworth, Matthew L. Maciejewski, Karen Steinhauser, Amy S. Jeffreys, Cynthia J. Coffman, Valerie A. Smith, Elizabeth M. Strawbridge, Steven T. Szabo, Shivan Desai, Mary P. Garrett, Theres Source Type: research

Real-world exposure to graphic warning labels on cigarette packages in US smokers: The CASA randomized trial protocol
The US lags behind>120 countries in implementing graphic warning labels (GWLs) on cigarette packs. US courts prevented implementation of FDA's 2012 rule requiring GWLs citing the need for more evidence on effectiveness. After more research, in 2020, the FDA proposed a revised rule mandating GWLs. This trial will test how the introduction of GWLs influence cognitions and behavior in US smokers. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 18, 2020 Category: Radiology Authors: P. Pierce John, R. Strong David, D. Stone Matthew, Villase ñor Adriana, V. Dimofte Claudiu, C. Leas Eric, Oratowski Jesica, Brighton Elizabeth, Hurst Samantha, Pulvers Kimberley, Kealey Sheila, Chen Ruifeng, Messer Karen Source Type: research

Data monitoring committees for clinical trials evaluating treatments of COVID-19
The first cases of coronavirus disease 2019 (COVID-19) were reported in December 2019 and the outbreak of SARS-CoV-2 was declared a pandemic in March 2020 by the World Health Organization. This sparked a plethora of investigations into diagnostics and vaccination for SARS-CoV-2, as well as treatments for COVID-19. Since COVID-19 is a severe disease associated with a high mortality, clinical trials in this disease should be monitored by a data monitoring committee (DMC), also known as data safety monitoring board (DSMB). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 18, 2020 Category: Radiology Authors: Tobias M ütze, Tim Friede Source Type: research

COVID-19 hits a trial: Arguments against hastily deviating from the plan
The COVID-19 pandemic has substantially impacted the conduct of clinical trials. While initially preparing for a period of time, where it would likely be impossible to supervise trials in the usual way and precautionary measures had to be implemented to care for medication supply and general safety of study participants it is now important to consider, how the impact of the pandemic on trial outcome can be assessed, which measures are needed to decide, how to proceed with the trial and what is needed to compensate to irregularity introduced by the pandemic situation. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - September 18, 2020 Category: Radiology Authors: Anika Gro ßhennig, Armin Koch Source Type: research

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...
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, 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

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