Guest Editors'-in-Chief Note to COVID-19 Special Issue.
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 16, 2020 Category: Radiology Authors: Zheng Su, Sue-Jane Wang Source Type: research

Engaging fathers in the first 1000  days to improve perinatal outcomes and prevent obesity: Rationale and design of the first heroes randomized trial
We describe the rationale and design of First Heroes, an intervention to improve perinatal and obesity-related outcomes among mother-father-infant triads beginning in pregnancy. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 16, 2020 Category: Radiology Authors: Rachel C. Whooten, Gracia M. Kwete, Haley Farrar-Muir, Rachel N. Cournoyer, Elizabeth A. Barth, Milton Kotelchuck, Elsie M. Taveras Source Type: research

Multiplicity for a group sequential trial with biomarker subpopulations
Biomarker subpopulations have become increasingly important for drug development in targeted therapies. The use of biomarkers has the potential to facilitate more effective outcomes by guiding patient selection appropriately, thus enhancing the benefit-risk profile and improving trial power. Studying a broad population simultaneously with a more targeted one allows the trial to determine the population for which a treatment is effective and allows a goal of making approved regulatory labeling as inclusive as is appropriate. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 15, 2020 Category: Radiology Authors: Ting-Yu Chen, Jing Zhao, Linda Sun, Keaven M. Anderson Source Type: research

Depression, anxiety, pain and chronic opioid management in primary care: Type II effectiveness-implementation hybrid stepped wedge cluster randomized trial
Even though current prescribing trends reveal that high-dose opioid prescribing and opioid prescribing in general has decreased, sustained efforts are needed to help providers adopt and maintain safe prescribing behaviors. The purpose of this four-year type 2 effectiveness-implementation hybrid stepped wedge cluster randomized trial is to: (1) compare the clinical and cost effectiveness of electronic medical record-based clinical decision support [EMR-CDS] versus additional integrated, collaborative behavioral health [EMR-CDS  + BHI-CCM] for opioid management of patients with co-morbid chronic non-cancer pain with depr...
Source: Contemporary Clinical Trials - December 14, 2020 Category: Radiology Authors: Eboni G. Price-Haywood, Jeffrey Burton, Jewel Harden-Barrios, Alessandra Bazzano, John Lefante, Lizheng Shi, Robert N. Jamison Source Type: research

Trauma informed guilt reduction (TrIGR) therapy for guilt, shame, and moral injury resulting from trauma: Rationale, design, and methodology of a two-site randomized controlled trial
Guilt, shame, and moral injury (MI) are common reactions following exposure to traumatic events and are associated with greater severity of several mental health problems, including posttraumatic stress disorder (PTSD), depression, increased risk of suicidal ideation and poorer psychosocial functioning. Trauma-Informed Guilt Reduction (TrIGR) is a transdiagnostic psychotherapy to address guilt, shame, and MI stemming from traumatic events. The primary goals of TrIGR are to help patients accurately appraise their trauma and to re-engage with their values in order to lead a more meaningful life. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 14, 2020 Category: Radiology Authors: Christy Capone, Sonya B. Norman, Moira Haller, Brittany Davis, M. Tracie Shea, Kendall Browne, Ariel J. Lang, Paula P. Schnurr, Shahrokh Golshan, Niloofar Afari, James Pittman, Carolyn B. Allard, Laura Westendorf Source Type: research

A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial
BackgroundAsthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting.Design and AimThe PeRson EmPowered Asthma RElief (PREPARE) Study is a randomized, open-label, pragmatic study which aims to assess whether a patient-guided, reliever-...
Source: Contemporary Clinical Trials - December 11, 2020 Category: Radiology Authors: Elliot Israel, Juan Carlos Cardet, Jennifer K. Carroll, Anne L. Fuhlbrigge, Wilson D. Pace, Nancy E. Maher, Lilin She, Frank W. Rockhold, Maureen Fagan, Victoria E. Forth, Paulina Arias Hernandez, Brian K. Manning, Jacqueline Rodriguez-Louis, Joel B. Shie Source Type: research

Study design and implementation of the PRecision Medicine In MEntal health Care (PRIME Care) Trial
Genomic testing has the potential to improve patient outcomes and reduce patient care costs by personalizing medication selection. Commercial pharmacogenetic (PGx) testing for psychotropic and other medications is widely available and promoted as a means to implement “precision medicine.” Despite evidence that genetic variation affects the metabolism of psychotropic medications, the clinical utility of these test results has not been established. Moreover, implementing such testing in routine clinical care is complex, requiring informatics support and a syst ematic approach to patient and provider education. (S...
Source: Contemporary Clinical Trials - December 10, 2020 Category: Radiology Authors: David W. Oslin, Sara Chapman, Scott L. Duvall, Joel Gelernter, Erin Ingram, Henry R. Kranzler, Lisa Soleymani Lehmann, Julie A. Lynch, Kevin G. Lynch, Jeff M. Pyne, Mei-Chiung Shih, Annjanette Stone, Michael E. Thase, Laura O. Wray Source Type: research

Rationale and design of hyperglycemic profiles in obstructive sleep apnea trial: The HYPNOS trial
The Hyperglycemic Profiles in Obstructive Sleep Apnea (HYPNOS) randomized clinical trial was conducted in adults with type 2 diabetes and moderate-to-severe obstructive sleep apnea (OSA) to determine whether treatment with positive airway pressure (PAP) therapy is associated with improvements in glycemic measures. Participants were randomly assigned to PAP therapy with lifestyle counseling or lifestyle counseling alone. While observational and experimental evidence indicate that intermittent hypoxemia and recurrent arousals in OSA may alter glucose metabolism and worsen glycemic measures, the effect of treating OSA with PA...
Source: Contemporary Clinical Trials - December 10, 2020 Category: Radiology Authors: Mary R. Rooney, R. Nisha Aurora, Dan Wang, Elizabeth Selvin, Naresh M. Punjabi Source Type: research

On selecting the critical boundary functions in group-sequential trials with two time-to-event outcomes
We investigate selection of critical boundary functions for testing the hypotheses of two time-to-event outcomes as both primary endpoints or a primary and a secondary endpoint in group-sequential clinical trials, where (1) the effect sizes of endpoints are unequal, or (2) one endpoint is for short-term evaluation and the other for long-term evaluation. Bonferroni-Holm and fixed-sequence procedures are considered. We assess the effects of the magnitudes of the hazard ratios and the correlation between the endpoints on statistical powers and provide guidance for consideration. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 9, 2020 Category: Radiology Authors: Toshimitsu Hamasaki, H.M. James Hung, Chin-Fu Hsiao, Scott R. Evans Source Type: research

Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy
Based on the adverse consequences and inadequate evidence of effectiveness for long-term opioid therapy (LOT), the CDC developed recommendations to decrease the use of LOT and morphine equivalent dose (MED) for patients receiving LOT. However, the majority of these patients report that opioid medication is significantly beneficial for pain management and are hesitant to reduce/decrease its use. Compounding the problem is poor access to non-pharmacologic therapies for many patients due to insurance reimbursement structures and limited pain-service availability. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 9, 2020 Category: Radiology Authors: Theresa Winhusen, Marian Wilson, Rowena J. Dolor, Jeff Theobald, Daniel Lewis, Saundra L. Regan, Mary Beth Vonder Meulen Source Type: research

Design and rationale for ADAPT+: Optimizing an intervention to promote healthy behaviors in rural, Latino youth with obesity and their parents, using mindfulness strategies
Latino youth living in rural areas represent an ethnic and geographical minority population at increased risk for obesity and obesity-related complications. We previously modified our child obesity intervention to be a multi-family behavioral intervention, Adaptando Dieta y Acci ón Para Todos (ADAPT), to better meet the needs of our target population, rural Latino youth with obesity (8–12 years old) and their parents. Recognizing the role of parent stress on obesity, the main goal of this study is to 1) further refine and optimize the original ADAPT multi-family behavi oral obesity intervention protocol to i...
Source: Contemporary Clinical Trials - December 8, 2020 Category: Radiology Authors: Marilyn Stern, Laura Redwine, Sandra Soca Lozano, Diana Rancourt, Carmen Rodriguez, Heewon L. Gray, Sharen Lock, Rocio Bailey Source Type: research

A culturally and gender responsive stress and chronic disease prevention intervention for low/no-income African American men: The MOCHA moving forward randomized control trial protocol
Low/no-income, African American men are disproportionally burdened by chronic disease resulting from a complex interplay of systemic, sociocultural, and individual factors. These disparities are related to poverty, racism, gender role strain, high levels of stress, low levels of physical activity, and malnutritious diet. Men of Color Health Awareness (MOCHA) is a community-driven movement to address the physical, mental, social, and spiritual needs of men of color. As part of ongoing programming, the MOCHA Standard intervention consists of a 10-week program including: (1) small group discussions of issues particularly rele...
Source: Contemporary Clinical Trials - December 7, 2020 Category: Radiology Authors: Luis A. Valdez, Aline C. Gubrium, Jefferey Markham, Lamont Scott, Albert Hubert, Jerrold Meyer, David Buchanan Source Type: research

Recruitment strategies and design considerations in a trial of resistance training to prevent dose-limiting toxicities in colon cancer patients undergoing chemotherapy
Low muscle is associated with an increased risk of chemotherapy-related dose limiting toxicities (DLT) in cancer patients. Resistance training (RT) improves muscle mass; however, the effects of RT on preventing DLTs and dose reductions in colon cancer patients has not been investigated.FOcus on Reducing dose-limiting toxicities in Colon cancer with resistance Exercise (FORCE) is a multicenter, randomized clinical trial examining the effects of RT on relative dose intensity (RDI; primary outcome) and moderate and severe chemotoxicities (primary outcome) in non-metastatic colon cancer patients receiving adjuvant chemotherapy...
Source: Contemporary Clinical Trials - December 6, 2020 Category: Radiology Authors: Bette J. Caan, Jeffrey A. Meyerhardt, Justin C. Brown, Kristin L. Campbell, Elizabeth M. Cespedes Feliciano, Catherine Lee, Michelle C. Ross, Sara Quinney, Charles Quesenberry, Barbara Sternfeld, Kathryn H. Schmitz Source Type: research

Race and ethnicity reporting for clinical trials in ClinicalTrials.gov and publications
Inclusion and subsequent reporting of minority participants in clinical trials are critical for ensuring external validity and detecting differences among subgroups, however reports suggest that ongoing gaps persist. ClinicalTrials.gov began requiring the reporting of race/ethnicity information (if collected) during results submission for trials in April 2017. For this study, we downloaded and compared trial race/ethnicity information from ClinicalTrials.gov submitted before (N  = 3540) and after (N = 3542) the requirement date. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 5, 2020 Category: Radiology Authors: Kevin M. Fain, Julianne Nelson, Tony Tse, Rebecca J. Williams Tags: Short Communication Source Type: research

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. (S...
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

Reacting to crises: The COVID-19 impact on biostatistics/epidemiology
Most crises, though difficult and challenging to address, offer opportunities for change and for development of new perspectives or approaches to deal with traditional strategies. The reaction to and the managing of the COVID-19 pandemic has provided a platform for evaluating how we quantify disease prevalence, incidence, time courses and sequellae as well as how well we plan, design, analyze and interpret health care associated data, including clinical trials and electronic medical records and health claims data. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 10, 2020 Category: Radiology Authors: Robert T. O'Neill Source Type: research

Lowering the impact of food insecurity in African American adults with type 2 diabetes mellitus (LIFT-DM) – Study protocol for a randomized controlled trial
There is strong evidence that disparities in the burden of diabetes exist by both race and poverty. Food insecurity, or an inability to or limitation in accessing nutritionally adequate food, is an important modifiable social determinant of health, particularly in adults with chronic disease. African Americans are more likely to be diagnosed with diabetes and more likely than whites to be food insecure. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 6, 2020 Category: Radiology Authors: Rebekah J. Walker, Rebecca G. Knapp, Clara E. Dismuke-Greer, Renee E. Walker, Mukoso N. Ozieh, Leonard E. Egede Source Type: research

Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 1, 2020 Category: Radiology Source Type: research

Modifications to communities for healthy Living trial design resulting from COVID-19
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - November 1, 2020 Category: Radiology Authors: Kirsten K. Davison, Sebastien Hanuese Source Type: research

Statistical adaptation to oncology drug development evolution
Cancer treatment started with surgery at least three thousand years ago. Radiation therapy was added in 1896 with chemotherapy started 50  years later. These “cut, burn, and poison” techniques try to kill cancer cells directly and have been the main approaches in treating cancer until recently. In the past few years, immunotherapies have revolutionized cancer treatment. Instead of treating the disease, immunotherapies treat the patient with the disease; more precisely, correct the patient's immune system so that it can fight cancer in a long term, which makes the cure of metastatic cancers a real possibility....
Source: Contemporary Clinical Trials - October 23, 2020 Category: Radiology Authors: Mingxiu Hu, Miao Yang, Yi Liu Source Type: research

Two basic statistical strategies of conducting causal inference in real-world studies
Randomized controlled clinical trials are the gold standard in drug development, but their costs, duration, and limited generalizability have motivated some to look for real-world studies as alternatives. On the other hand, real-world studies may be less convincing due to the presence of confounding bias. In the literature of causal inference, a variety of statistical methods have been proposed to adjust for confounding bias. However, it is challenging for the users to understand the statistical properties enjoyed by each method and then explicitly specify its underlying model assumptions. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 23, 2020 Category: Radiology Authors: Yixin Fang Source Type: research

Infectious diseases epidemiology, quantitative methodology, and clinical research in the midst of the COVID-19 pandemic: Perspective from a European country
Starting from historic reflections, the current SARS-CoV-2 induced COVID-19 pandemic is examined from various perspectives, in terms of what it implies for the implementation of non-pharmaceutical interventions, the modeling and monitoring of the epidemic, the development of early-warning systems, the study of mortality, prevalence estimation, diagnostic and serological testing, vaccine development, and ultimately clinical trials. Emphasis is placed on how the pandemic had led to unprecedented speed in methodological and clinical development, the pitfalls thereof, but also the opportunities that it engenders for national a...
Source: Contemporary Clinical Trials - October 22, 2020 Category: Radiology Authors: Geert Molenberghs, Marc Buyse, Steven Abrams, Niel Hens, Philippe Beutels, Christel Faes, Geert Verbeke, Pierre Van Damme, Herman Goossens, Thomas Neyens, Sereina Herzog, Heidi Theeten, Koen Pepermans, Ariel Alonso Abad, Ingrid Van Keilegom, Niko Speybroe Source Type: research

Building a healthy temple diabetes self-management education support program in Hispanic faith community settings: A cluster randomized controlled trial
Diabetes self-management is key to preventing diabetes complications disproportionately affecting Hispanics. Church appears a promising setting for delivering a diabetes self-management education support (DSMES) programs. “Faith-placed” (FP) programing refers to health interventions implemented in the church setting; while “faith-based” (FB) signifies integrating spirituality with health interventions. The Building a Health Temple (BHT) DSMES program integrates spirituality with DSMES to improve diabetic outc omes. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 22, 2020 Category: Radiology Authors: Summer Wilmoth, Leah Carrillo, Lauren Correa, Meixia Pan, Deborah Parra-Medina, Erica Sosa, Ramon Reyes, Daniel A. Sass, Meizi He Source Type: research

Intervention to promote physical activation and improve sleep and response feeding in infants for preventing obesity early in life, the baby-act trial: Rationale and design
Infant obesity is increasing in the US, particularly among Hispanics. Rapid weight gain during infancy increases the risk of obesity later in life and could be prevented through multi-modal interventions addressing multiple risk factors through population-level programs. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 21, 2020 Category: Radiology Authors: M. Campos, J. Pomeroy, M.H. Mays, A. Lopez, C. Palacios Source Type: research

Using virtual agents to increase physical activity in young children with the virtual fitness buddy ecosystem: Study protocol for a cluster randomized trial
Designing and implementing a truly self-determined physical activity (PA) intervention has required excessive amounts of labor and expenses that, until recently, have made it prohibitively costly to implement in the field at scale. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 20, 2020 Category: Radiology Authors: Lindsay Hahn, Michael D. Schmidt, Stephen L. Rathbun, Kyle Johnsen, James J. Annesi, Sun Joo Ahn Source Type: research

Bayesian hierarchical model for safety signal detection in multiple clinical trials
Clinical safety signal detection is of great importance in establishing the safety profile of new drugs and biologics during drug development. Bayesian hierarchical meta-analysis has proven to be a very effective method of identifying potential safety signals by considering the hierarchical structure of clinical safety data from multiple randomized clinical trials conducted under an Investigational New Drug (IND) application or Biological License Application (BLA). This type of model can integrate information across studies, for instance by grouping related adverse events using the MedDRA system-organ-class (SOC) and prefe...
Source: Contemporary Clinical Trials - October 19, 2020 Category: Radiology Authors: Yafei Zhang, Shuai Sammy Yuan, Barry A. Eagel, Hal Li, Li-An Lin, William W.B. Wang Source Type: research

Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol
Programs such as the Pediatric Access Line in Washington state have shown decreases in antipsychotic medication use by youth with non-psychotic disorders. Program outcomes have been studied with observational designs. This manuscript describes the protocol for Targeted and Safer Use of Antipsychotics in Youth (SUAY), a randomized controlled trial of psychiatrist review of prescriptions and facilitated access to psychosocial care. The aim of the intervention is to reduce the number of person-days of antipsychotic use among participants. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 19, 2020 Category: Radiology Authors: Robert B. Penfold, Ella E. Thompson, Robert J. Hilt, Kelly J. Kelleher, Nadine Schwartz, Arne Beck, Greg Clarke, James D. Ralston, Andrea L. Hartzler, R. Yates Coley, Mary Akosile, Benedetto Vitiello, Gregory E. Simon Source Type: research

Treatment of comorbid sleep disorders and posttraumatic stress disorder in active duty military: Design and methodology of a randomized clinical trial
Many individuals with posttraumatic stress disorder (PTSD) also suffer from insomnia and nightmares, which may be symptoms of PTSD or constitute partially independent comorbid disorders. Sleep disturbances are resistant to current treatments for PTSD, and those suffering from PTSD, insomnia, and nightmares have worse PTSD treatment outcomes. In addition, insomnia and nightmares are risk factors for depression, substance abuse, anxiety, and suicide. Cognitive-Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) and Cognitive Processing Therapy (CPT) for PTSD are first line treatments of these conditions. (Source: Co...
Source: Contemporary Clinical Trials - October 19, 2020 Category: Radiology Authors: Daniel J. Taylor, Kristi E. Pruiksma, Jim Mintz, Danica C. Slavish, Sophie Wardle-Pinkston, Hannah Tyler, Katherine A. Dondanville, Stacey Young-McCaughan, Michael K. Scullin, Karin L. Nicholson, Brett T. Litz, Jessica R. Dietch, Douglas E. Williamson, Te Source Type: research

Cognitive behavioral therapy for insomnia to enhance cognitive function and reduce the rate of A β deposition in older adults with symptoms of insomnia: A single-site randomized pilot clinical trial protocol
Lifestyle interventions to increase exercise and improve diet have been the focus of recent clinical trials to potentially prevent Alzheimer's disease (AD) [1,2]. However, despite the strong links between sleep disruptions, cognitive decline, and AD, sleep enhancement has yet to be targeted as a lifestyle intervention to prevent AD. A recent meta-analysis suggests that approximately 15% of AD may be prevented by an efficacious intervention aimed to reduce sleep disturbances and sleep disorders [3]. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 19, 2020 Category: Radiology Authors: Catherine F. Siengsukon, Eryen Nelson, Cierra Williams-Cooke, Rebecca Ludwig, Eber Silveira Beck, Eric D. Vidoni, Jonathan D. Mahnken, Suzanne Stevens, Michelle Drerup, Jared Bruce, Jeffrey M. Burns Source Type: research

Identification of undiagnosed atrial fibrillation patients using a machine learning risk prediction algorithm and diagnostic testing (PULsE-AI): Study protocol for a randomised controlled trial
Atrial fibrillation (AF) is associated with an increased risk of stroke, enhanced stroke severity, and other comorbidities. However, AF is often asymptomatic, and frequently remains undiagnosed until complications occur. Current screening approaches for AF lack either cost-effectiveness or diagnostic sensitivity; thus, there is interest in tools that could be used for population screening. An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - October 19, 2020 Category: Radiology Authors: Nathan R. Hill, Chris Arden, Lee Beresford-Hulme, A. John Camm, David Clifton, D. Wyn Davies, Usman Farooqui, Jason Gordon, Lara Groves, Michael Hurst, Sarah Lawton, Steven Lister, Christian Mallen, Anne-Celine Martin, Phil McEwan, Kevin G. Pollock, Jenni Source Type: research

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