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
