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Contemporary Clinical Trials Communications

Twisk J, Bosman L, Hoekstra T, Rijnhart J, Welten M, Heymans M
Background: Regarding the analysis of RCT data there is a debate going on whether an adjustment for the baseline value of the outcome variable should be made. When an adjustment is made, there is a lot of misunderstanding regarding the way this should be done. Therefore, the aims of this educational paper are: 1) to explain different methods used to estimate treatment effects in RCTs, 2) to illustrate the different methods with a real life example and 3) to give an advise on how to analyse RCT data...
June 2018: Contemporary Clinical Trials Communications
Tu Xu, Qin Qin, Xin Wang
The group sequential design has been well understood and widely applied in designs of late phase clinical trial to enable potentially early stopping for efficacy or futility. The information fraction (IF) is one of the key elements to determine the decision boundary at the interim analyses. The family-wise error rate (FWER) control is highly critical for clinical trials with multiple endpoints to be tested. In this article, we illustrate the importance of properly defining the information fraction for each individual endpoint regarding the FWER control through the numerical evaluation and a case study...
June 2018: Contemporary Clinical Trials Communications
Revathi Ananthakrishnan, Stephanie Green, Daniel Li, Michael LaValley
With the emergence of immunotherapy and other novel therapies, the traditional assumption that the efficacy of the study drug increases monotonically with dose levels is not always true. Therefore, dose-finding methods evaluating only toxicity data may not be adequate. In this paper, we have first compared the Modified Toxicity Probability Interval (mTPI) and Toxicity Equivalence Range (TEQR) dose-finding oncology designs for safety with identical stopping rules; we have then extended both designs to include efficacy in addition to safety - we determine the optimal dose for safety and efficacy using these designs by applying isotonic regression to the observed toxicity and efficacy rates, once the early phase trial is completed...
June 2018: Contemporary Clinical Trials Communications
Gregg A Robbins-Welty, Lisa Mueser, Chandler Mitchell, Nicole Pope, Robert Arnold, SeoYoung Park, Doug White, Kenneth J Smith, Charles Reynolds, Margaret Rosenzweig, Marie Bakitas, Yael Schenker
Context: Intervention fidelity is a critical component of behavioral research that has received inadequate attention in palliative care studies. With increasing focus on the need for palliative care models that can be widely disseminated and delivered by non-specialists, rigorous yet pragmatic strategies for training interventionists and maintaining intervention fidelity are needed. Objectives: (1) Describe components of a plan for interventionist training and monitoring and maintaining intervention fidelity as part of a primary palliative care trial (CONNECT) and (2) present data about perceived training effectiveness and delivery of key intervention content...
June 2018: Contemporary Clinical Trials Communications
Sudipta Bhattacharya
Recurrent adverse events, once occur often continue for some duration of time in clinical trials; and the number of events along with their durations is clinically considered as a measure of severity of a disease under study. While there are methods available for analyzing recurrent events or durations or for analyzing both side by side, no effort has been made so far to combine them and present as a single measure. However, this single-valued combined measure may help clinicians assess the wholesome effect of recurrence of incident comprising events and durations...
June 2018: Contemporary Clinical Trials Communications
Christianne L Roumie, Niral J Patel, Daniel Muñoz, Justin Bachmann, Ashton Stahl, Ryan Case, Cardella Leak, Russell Rothman, Sunil Kripalani
Background: The Patient Centered Outcomes Research Institute (PCORI) established Clinical Data Research Networks (CDRNs) to support pragmatic research. The objective was to electronically identify, recruit, and survey coronary heart disease (CHD) patients and describe their characteristics, health status, and willingness to participate in future research. Methods: We developed a computable phenotype and assembled CHD patients 30 years or older and had visits or hospitalizations between 2009 and 2015...
June 2018: Contemporary Clinical Trials Communications
Dalia S Mikhail, Teresa B Jensen, Todd W Wade, Jane F Myers, Jennifer M Frank, Mark Wieland, Don Hensrud, M Molly McMahon, Maria L Collazo-Clavell, Haitham Abu-Lebdeh, Kurt A Kennel, Daniel L Hurley, Karen Grothe, Michael D Jensen
Despite the large number of U.S. adults who overweight or obese, few providers have ready access to comprehensive lifestyle interventions, the cornerstone of medical obesity management. Our goal was to establish a research infrastructure embedded in a comprehensive lifestyle intervention treatment for obesity. The Obesity Treatment Research Program (OTRP) is a multi-specialty project at Mayo Clinic in Rochester, Minnesota designed to provide a high intensity, year-long, comprehensive lifestyle obesity treatment...
June 2018: Contemporary Clinical Trials Communications
Meera Muthukrishnan, Siobhan Sutcliffe, Jean M Hunleth, Jean S Wang, Graham A Colditz, Aimee S James
Background: Colorectal cancer (CRC) is the second most common cancer in the US. Despite evidence that screening reduces CRC incidence and mortality, screening rates are sub-optimal with disparities by race/ethnicity, income, and geography. Rural-urban differences in CRC screening are understudied even though approximately one-fifth of the US population lives in rural areas. This focus on urban populations limits the generalizability and dissemination potential of screening interventions...
June 2018: Contemporary Clinical Trials Communications
Thuva Vanniyasingam, Caitlin Daly, Xuejing Jin, Yuan Zhang, Gary Foster, Charles Cunningham, Lehana Thabane
Objectives: This study reviews simulation studies of discrete choice experiments to determine (i) how survey design features affect statistical efficiency, (ii) and to appraise their reporting quality. Outcomes: Statistical efficiency was measured using relative design (D-) efficiency, D-optimality, or D-error. Methods: For this systematic survey, we searched Journal Storage (JSTOR), Since Direct, PubMed, and OVID which included a search within EMBASE...
June 2018: Contemporary Clinical Trials Communications
Jessica S Merlin, Sarah R Young, Mallory O Johnson, Michael Saag, William Demonte, Robert Kerns, Matthew J Bair, Stefan Kertesz, Janet M Turan, Meredith Kilgore, Olivio J Clay, Dorothy Pekmezi, Susan Davies
Chronic pain is an important comorbidity among individuals with HIV. Behavioral interventions are widely regarded as evidence-based, efficacious non-pharmacologic interventions for chronic pain in the general population. An accepted principle in behavioral science is that theory-based, systematically-developed behavioral interventions tailored to the unique needs of a target population are most likely to be efficacious. Our aim was to use Intervention Mapping to systematically develop a Social Cognitive Theory (SCT)-based intervention for chronic pain tailored to individuals with HIV that will improve pain intensity and pain-related functional impairment...
June 2018: Contemporary Clinical Trials Communications
Thomas Carmody, Tracy L Greer, Robrina Walker, Chad D Rethorst, Madhukar H Trivedi
Objective: Exercise is a promising treatment for substance use disorders, yet an intention-to-treat analysis of a large, multi-site study found no reduction in stimulant use for exercise versus health education. Exercise adherence was sub-optimal; therefore, secondary post-hoc complier average causal effects (CACE) analysis was conducted to determine the potential effectiveness of adequately dosed exercise. Method: The STimulant use Reduction Intervention using Dosed Exercise study was a randomized controlled trial comparing a 12 kcal/kg/week (KKW) exercise dose versus a health education control conducted at nine residential substance use treatment settings across the U...
June 2018: Contemporary Clinical Trials Communications
Marcus R Johnson, Tawni Kenworthy-Heinige, Danielle J Beck, Aliya Asghar, Emily B Broussard, Karen Bratcher, Lynn M Tommessilli, Margaret Antonelli, Beata M Planeta
Background/Aims: The VA Cooperative Studies Program's (CSP) Network of Dedicated Enrollment Sites (NODES) is a consortium of nine VA medical centers (VAMCs) with teams (nodes) dedicated to enhance performance, compliance, and management of CSP multi-site clinical trials. The West Haven CSP Coordinating Center (WH-CSPCC), study coordinating center for CSP #577, Co lo n oscopy Versus F ecal I mmunochemical Test (FIT) in R educing M ortality from Colorectal Cancer (CONFIRM) trial, and NODES piloted a "site mentoring" (hub-and-spoke) model...
March 2018: Contemporary Clinical Trials Communications
Ting-Ting Yeh, Ku-Chou Chang, Ching-Yi Wu, Ya-Yun Lee, Po-Yu Chen, Jen-Wen Hung
Purpose: Cognitive decline after stroke is highly associated with functional disability. Empirical evidence shows that exercise combined cognitive training may induce neuroplastic changes that modulate cognitive function. However, it is unclear whether hybridized exercise-cognitive training can facilitate cortical activity and physiological outcome measures and further influence on the cognitive function after stroke. This study will investigate the effects of two hybridized exercise-cognitive trainings on brain plasticity, physiological biomarkers and behavioral outcomes in stroke survivors with cognitive decline...
March 2018: Contemporary Clinical Trials Communications
David O Garcia, Luis A Valdez, Melanie L Bell, Kyle Humphrey, Melanie Hingle, Marylyn McEwen, Steven P Hooker
Hispanic men have the highest rates of overweight and obesity when compared to men of other racial/ethnic groups, placing them at increased risk for obesity-related disease. Yet, Hispanic men are grossly underrepresented in weight loss research. Tailored intervention strategies to improve obesity treatment programs for this vulnerable racial/ethnic subgroup are needed. This manuscript describes recruitment strategies, methodology, and participant characteristics of the ANIMO study, a 24-week randomized controlled pilot trial testing the effects of a gender- and culturally-sensitive weight loss intervention (GCSWLI) on body weight in Hispanic men compared to a wait-list control condition...
March 2018: Contemporary Clinical Trials Communications
Anna Banck-Petersen, Cecilie K Olsen, Sissal S Djurhuus, Anita Herrstedt, Sarah Thorsen-Streit, Mathias Ried-Larsen, Kell Østerlind, Jens Osterkamp, Peter-Martin Krarup, Kirsten Vistisen, Camilla S Mosgaard, Bente K Pedersen, Pernille Højman, Jesper F Christensen
Background: Low physical activity level is associated with poor prognosis in patients with colorectal cancer (CRC). To increase physical activity, technology-based platforms are emerging and provide intriguing opportunities to prescribe and monitor active lifestyle interventions. The "Interval Walking in Colorectal Cancer"(I-WALK-CRC) study explores the feasibility and efficacy a home-based interval-walking intervention delivered by a smart-phone application in order to improve cardio-metabolic health profile among CRC survivors...
March 2018: Contemporary Clinical Trials Communications
Brian L Egleston, Omar Pedraza, Yu-Ning Wong, Candace L Griffin, Eric A Ross, J Robert Beck
Background: Increasing diversity in clinical trials may be worthwhile. We examined clinical trials that restricted eligibility to a single race or ethnicity. Methods: We reviewed 19,246 trials registered on through January 2013. We mapped trial ZIP-codes to U.S. Census and American Community Survey data. The outcome was whether trials required participants to be from a single racial or ethnic group. Results: In adjusted analyses, the odds of trials restricting eligibility to a single race/ethnicity increased by 4% per year (95% CI 1...
March 2018: Contemporary Clinical Trials Communications
Jessie J Wong, Nev Jones, Christine Timko, Keith Humphreys
Objective: The current paper reviews the English-language research on exclusion criteria in bipolar disorder treatment trials and discusses how study samples compare to the general bipolar patient population. Methods: & Results: Across 8 identified studies of exclusion criteria and their impact, between 55% and 96% of people with bipolar disorder would be excluded from treatment research. The number of exclusion criteria varies across bipolar disorder treatment research, with one study estimate of a median of 7 criteria used across studies...
March 2018: Contemporary Clinical Trials Communications
T van Doeveren, P J van Leeuwen, K K H Aben, M van der Aa, M Barendrecht, E R Boevé, E B Cornel, A G van der Heijden, K Hendricksen, W Hirdes, A Kooistra, B Kroon, A M Leliveld, R P Meijer, H van Melick, B Merks, T M de Reijke, P de Vries, L F A Wymenga, B Wijsman, J L Boormans
Background: Following radical nephro-ureterectomy for urothelial carcinoma of the upper urinary tract (UUT), the reported bladder recurrence rate of urothelial carcinoma is 22-47%. A single intravesical instillation of chemotherapy within 10 days following nephro-ureterectomy has the potential to decrease the risk of a bladder recurrence significantly. Despite recommendation by the European Association of Urology guideline to administer a single instillation postoperatively, the compliance rate is low because the risk of extravasation of chemotherapy...
March 2018: Contemporary Clinical Trials Communications
Amy Corneli, Chris Wheeler, John Bradley, Breck Gamel, Sumathi Nambiar, Gary J Noel, Li Lin, Jamie N Roberts, Daniel K Benjamin
An urgent need exists to develop new antibacterial drugs for children. We conducted research with investigators of pediatric antibacterial drug trials to identify facilitators and barriers in the conduct of these trials. Seventy-three investigators completed an online survey assessing the importance of 15 facilitators (grouped in 5 topical categories) and the severity of 36 barriers (grouped in 6 topical categories) to implementing pediatric antibacterial drug trials. Analysis focused on the identification of key factors that facilitate the successful implementation of pediatric antibacterial drug trials and the key barriers to implementation...
March 2018: Contemporary Clinical Trials Communications
Eric Yang, Christopher O'Donovan, JodiLyn Phillips, Leone Atkinson, Krishnendu Ghosh, Dimitris K Agrafiotis
Background: One of the keys to running a successful clinical trial is the selection of high quality clinical sites, i.e., sites that are able to enroll patients quickly, engage them on an ongoing basis to prevent drop-out, and execute the trial in strict accordance to the clinical protocol. Intuitively, the historical track record of a site is one of the strongest predictors of its future performance; however, issues such as data availability and wide differences in protocol complexity can complicate interpretation...
March 2018: Contemporary Clinical Trials Communications
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