Trial design of comparing patient-specific versus weight-based protocols to treat vaso-occlusive episodes in sickle cell disease (COMPARE-VOE)
Painful vaso-occlusive episodes (VOE) are the most common reason for emergency department (ED) visits experienced by patients with sickle cell disease (SCD). The National Heart, Lung and Blood Institute (NHLBI) evidence-based recommendations for VOE treatment are based primarily on expert opinion. In this randomized controlled trial (RCT), we will compare changes in pain scores between patients randomized to a patient-specific analgesic protocol versus those randomized to a weight-based analgesic protocol, as recommended by the NHLBI guidelines. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - December 18, 2020 Category: Radiology Authors: Stephanie O. Ibemere, Sarah B. Dubbs, Huiman X. Barnhart, Jacqueline L. Brown, Caroline E. Freiermuth, Patricia Kavanagh, Judith A. Paice, John J. Strouse, R. Gentry Wilkerson, Paula Tanabe, on behalf of the COMPARE-VOE study investigators Source Type: research
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. (Source: C...
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 include min...
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
