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Contemporary Clinical Trials Communications

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https://www.readbyqxmd.com/read/27900372/application-of-the-marginal-structural-model-to-account-for-suboptimal-adherence-in-a-randomized-controlled-trial
#1
James Rochon, Manjushri Bhapkar, Carl F Pieper, William E Kraus
BACKGROUND: There is considerable interest in adjusting for suboptimal adherence in randomized controlled trials. A per-protocol analysis, for example removes individuals who fail to achieve a minimal level of adherence. One can also reassign non-adherers to the control group, censor them at the point of non-adherence, or cross them over to the control. However, there are biases inherent in each of these methods. Here, we describe an application of causal modeling to address this issue...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27766318/intra-cluster-correlation-estimates-for-hiv-related-outcomes-from-care-and-treatment-clinics-in-dar-es-salaam-tanzania
#2
Dale Barnhart, Ellen Hertzmark, Enju Liu, Ester Mungure, Aisa N Muya, David Sando, Guerino Chalamilla, Nzovu Ulenga, Till Bärnighausen, Wafaie Fawzi, Donna Spiegelman
INTRODUCTION: Researchers planning cluster-randomized controlled trials (cRCTs) require estimates of the intra-cluster correlation coefficient (ICC) from previous studies for sample size calculations. This paper fills a persistent gap in the literature by providing estimates of ICCs for many key HIV-related clinical outcomes. METHODS: Data from HIV-positive patients from 47 HIV care and treatment clinics in Dar es Salaam, Tanzania were used to calculate ICCs by site of enrollment or site of ART initiation for various clinical outcomes using cross-sectional and longitudinal data...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27754492/school-based-mindfulness-intervention-for-stress-reduction-in-adolescents-design-and-methodology-of-an-open-label-parallel-group-randomized-controlled-trial
#3
Jeanette M Johnstone, Chelsea Roake, Ifrah Sheikh, Ashlie Mole, Joel T Nigg, Barry Oken
Adolescents are in a high-risk period developmentally, in terms of susceptibility to stress. A mindfulness intervention represents a potentially useful strategy for developing cognitive and emotion regulation skills associated with successful stress coping. Mindfulness strategies have been used successfully for emotional coping in adults, but are not as well studied in youth. This article details a novel proposal for the design of an 8-week randomized study to evaluate a high school-based mindfulness curriculum delivered as part of a two semester health class...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27570845/mexican-american-perspectives-on-participation-in-clinical-trials-a-qualitative-study
#4
Mariana Arevalo, Natalia I Heredia, Sarah Krasny, Maria L Rangel, Leticia A Gatus, Lorna H McNeill, Maria E Fernandez
Clinical trials are essential to advancing knowledge to reduce disease morbidity and mortality; however, ethnic and racial minorities remain under-represented in those studies. We explored knowledge and perceptions of clinical trials among Mexican-Americans in Texas. We conducted focus groups (N = 128) stratified by gender, language preference, and geographical location. This paper presents four emergent, primary themes: 1) knowledge and understanding of clinical trials, 2) fears and concerns about participating, 3) perceived benefits of participating, and 4) incentives to participate...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27489888/methods-to-reduce-medication-errors-in-a-clinical-trial-of-an-investigational-parenteral-medication
#5
Gillian L Fell, Alison A O'Loughlin, Prathima Nandivada, Alexis K Potemkin, Paul D Mitchell, Judith Mahoney, Kathleen M Gura, Mark Puder
There are few evidence-based guidelines to inform optimal design of complex clinical trials, such as those assessing the safety and efficacy of intravenous drugs administered daily with infusion times over many hours per day and treatment durations that may span years. This study is a retrospective review of inpatient administration deviation reports for an investigational drug that is administered daily with infusion times of 8-24 hours, and variable treatment durations for each patient. We report study design modifications made in 2007-2008 aimed at minimizing deviations from an investigational drug infusion protocol approved by an institutional review board and the United States Food and Drug Administration...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27458608/exploring-willingness-of-elder-chinese-in-houston-to-participate-in-clinical-research
#6
Logan R Thornton, Rossybelle P Amorrortu, Daniel W Smith, Arch G Mainous, Sally W Vernon, Barbara C Tilley
BACKGROUND AND OBJECTIVES: Inadequate minority participation in clinical research can threaten the applicability and strength of scientific findings. Previous research suggests that trial participation rates are lowest among Asian Americans, compared to other groups. This study explored barriers to clinical research participation among elder Chinese living in Houston, Texas. Additionally we administered the Trust in Medical Researchers Scale (TIMRS), used previously in researching trust in medical researchers as related to research participation...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27453960/a-multi-modal-intervention-for-activating-patients-at-risk-for-osteoporosis-apropos-rationale-design-and-uptake-of-online-study-intervention-material
#7
Maria I Danila, Ryan C Outman, Elizabeth J Rahn, Amy S Mudano, Tammi F Thomas, David T Redden, Jeroan J Allison, Fred A Anderson, Julia P Anderson, Peter M Cram, Jeffrey R Curtis, Liana Fraenkel, Susan L Greenspan, Andrea Z LaCroix, Sumit R Majumdar, Michael J Miller, Jeri W Nieves, Monika M Safford, Stuart L Silverman, Ethel S Siris, Daniel H Solomon, Amy H Warriner, Nelson B Watts, Robert A Yood, Kenneth G Saag
OBJECTIVE: To develop an innovative and effective educational intervention to inform patients about the need for osteoporosis treatment and to determine factors associated with its online uptake. METHODS: Postmenopausal women with a prior fracture and not currently using osteoporosis therapy were eligible to be included in the Activating Patients at Risk for OsteoPOroSis (APROPOS). Four nominal groups with a total of 18 racially/ethnically diverse women identified osteoporosis treatment barriers...
December 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27822570/falls-as-adverse-events-in-psychosocial-treatment-of-depression-findings-from-a-clinical-trial-in-nursing-homes
#8
Suzanne Meeks, Brian M Ludwin, Stephen W Looney
Falls pose a significant health risk for nursing home residents and are associated with depression and medical treatments for depression. Data on falls as an adverse event to psychosocial treatments are lacking. We examined risk of falls as an adverse event in a clinical trial of a behavioral treatment for depression. Participants were 82 depressed nursing home residents. Adverse events were recorded at each research contact. We used the rate ratio based on the respective incidence densities in the treatment and control groups to measure association between fall rate and treatment...
August 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27822569/trends-in-research-with-u-s-military-service-member-participants-a-population-specific-clinicaltrials-gov-review
#9
Wendy A Cook, Ardith Z Doorenbos, Elizabeth J Bridges
BACKGROUND: ClinicalTrials.gov reviews have evaluated research trends for specific conditions and age groups but not for specific populations of research participants. No ClinicalTrials.gov reviews have evaluated research with military service member participants. PURPOSE: Study objectives were (a) to use ClinicalTrials.gov to identify trends in biomedical research from 2005 to 2014 in which U.S. military service members actively participated as research participants and (b) to describe a search strategy for adaptation in future ClinicalTrials...
August 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27822568/random-guess-and-wishful-thinking-are-the-best-blinding-scenarios
#10
Heejung Bang
Blinding is a methodologic safeguard of treatment evaluation, yet severely understudied empirically. Mathieu et al.'s theoretical analysis (2014) provided an important message that blinding cannot eliminate potential for bias associated with belief about allocation in randomized controlled trial; just like the intent-to-treat principle does not guarantee unbiased estimation under noncompliance, the blinded randomized trial as a golden standard may produce bias. They showed possible biases but did not assess how large the bias could be in different scenarios...
August 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27822567/lifestyle-modification-intervention-for-overweight-and-obese-hispanic-pregnant-women-development-implementation-lessons-learned-and-future-applications
#11
Roxana Torres, Sandra Soltero, Maria Angelica Trak, Carolyn M Tucker, Keimari Mendez, Maribel Campos, Walter Willett, Marytere Melendez, Mathew W Gillman, Paul W Franks, Kaumudi Joshipura, Jeremy Pomeroy, Cristina Palacios
OBJECTIVES: To describe the development, implementation and lessons learned of lifestyle intervention to promote appropriate gestational weight gain among Hispanic pregnant women. DESIGN: The intervention was informed by an empowerment oriented theoretical framework, and targeted women in the Pregnancy and Early Life Improvement Study. METHODS: The nutrition component consisted of recommendations for total calories, food quantity and improving carbohydrate and fat quality...
August 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27822566/patient-participation-in-cancer-clinical-trials-a-pilot-test-of-lay-navigation
#12
Kathleen B Cartmell, Heather S Bonilha, Terri Matson, Debbie C Bryant, Jane G Zapka, Tricia A Bentz, Marvella E Ford, Chanita Hughes-Halbert, Kit N Simpson, Anthony J Alberg
BACKGROUND: Clinical trials (CT) represent an important treatment option for cancer patients. Unfortunately, patients face challenges to enrolling in CTs, such as logistical barriers, poor CT understanding and complex clinical regimens. Patient navigation is a strategy that may help to improve the delivery of CT education and support services. We examined the feasibility and initial effect of one navigation strategy, use of lay navigators. METHODS: A lay CT navigation intervention was evaluated in a prospective cohort study among 40 lung and esophageal cancer patients...
August 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27822565/teleconsent-a-novel-approach-to-obtain-informed-consent-for-research
#13
Brandon M Welch, Elizabeth Marshall, Suparna Qanungo, Ayesha Aziz, Marilyn Laken, Leslie Lenert, Jihad Obeid
Lack of recruitment of qualified research participants continues to be a significant bottleneck in clinical trials, often resulting in costly time extensions, underpowered results, and in some cases early termination. Some of the reasons for suboptimal recruitment include laborious consent processes and access to participants at remote locations. While new electronic consents technologies (eConsent) help overcome challenges related to readability and consent management, they do not adequately address challenges related to remote access...
August 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27822564/design-of-a-randomized-controlled-clinical-trial-assessing-dietary-sodium-restriction-and-hemodialysis-related-symptom-profiles
#14
Maya N Clark-Cutaia, Marilyn S Sommers, Emily Anderson, Raymond R Townsend
AIM: In hemodialysis patients, the need to have intercurrent sodium and water intake removed by ultrafiltration increases disease burden through the symptoms and signs that occur during hemodialysis (HD). This added burden may be mitigated by reduction of dietary sodium intake. The National Kidney Foundation (NKF) recommends 2400 mg of dietary sodium daily for patients on HD, and the American Heart Association (AHA) suggests 1500 mg, evidence is lacking, however, to support these recommendations in HD...
August 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27617326/recruitment-of-family-child-care-homes-for-an-obesity-prevention-intervention-study
#15
Dianne S Ward, Amber E Vaughn, Regan V Burney, Truls Østbye
OBJECTIVE: Critical to the success of any intervention study is successful recruitment. The aim of this paper was to examine the recruitment process of a randomized controlled trial evaluating an intervention conducted with family child care home providers. Specifically, the recruitment challenges, the efforts employed to address the challenges, and their impact on participant recruitment are discussed. METHODS: The study's original recruitment protocol was employed during waves 1 and 2 (out of 5)...
August 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27141531/project-breakfast-rationale-design-and-recruitment-and-enrollment-methods-of-a-randomized-controlled-trial-to-evaluate-an-intervention-to-improve-school-breakfast-program-participation-in-rural-high-schools
#16
Marilyn S Nanney, Amy Shanafelt, Qi Wang, Robert Leduc, Ellen Dodds, Mary Hearst, Martha Y Kubik, Katherine Grannon, Lisa Harnack
No abstract text is available yet for this article.
August 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/26949747/the-recruitment-experience-of-a-randomized-clinical-trial-to-aid-young-adult-smokers-to-stop-smoking-without-weight-gain-with-interactive-technology
#17
Mace Coday, Phyllis Richey, Fridtjof Thomas, Quynh T Tran, Sarah B Terrell, Fran Tylavsky, Danielle Miro, Margaret Caufield, Karen C Johnson
Multiple recruitment strategies are often needed to recruit an adequate number of participants, especially hard to reach groups. Technology-based recruitment methods hold promise as a more robust form of reaching and enrolling historically hard to reach young adults. The TARGIT study is a randomized two-arm clinical trial in young adults using interactive technology testing an efficacious proactive telephone Quitline versus the Quitline plus a behavioral weight management intervention focusing on smoking cessation and weight change...
April 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/26878069/generalization-of-wei-s-urn-design-to-unequal-allocations-in-sequential-clinical-trials
#18
Wenle Zhao, Viswanathan Ramakrishnan
Wei's urn design was proposed in 1987 for subject randomization in trials comparing m ≥ 2 treatments with equal allocation. In this manuscript, two modified versions of Wei's urn design are presented to accommodate unequal allocations. First one uses a provisional allocation of [Formula: see text] to achieve the target allocation r 1 : r 2, and the second one uses equal allocation for r 1 + r 2 arms to achieve an unequal allocation r 1 : r 2 based on the concept Kaiser presented in his recent paper. The properties of these two designs are evaluated based on treatment imbalance and allocation predictability under different sample sizes and unequal allocation ratios...
April 15, 2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/27536738/exit-interviews-administered-to-patients-participating-in-the-costop-placebo-controlled-randomised-trial-in-uganda
#19
Andrew Nunn, Zacchaeus Anywaine, Janet Seeley, Paula Munderi, Jonathan Levin, Ronnie Kasirye, Anatoli Kamali, Andrew Abaasa, Heiner Grosskurth
INTRODUCTION: COSTOP was a randomised controlled trial designed to assess the risks and benefits to HIV-infected participants stabilised on anti-retroviral treatment of stopping cotrimoxazole (CTX). In order to assess the extent to which patients may have had access to and used CTX other than that supplied as study drug it was decided to conduct an exit interview. METHODS: A structured interview was administered by interviewers who were not associated with the COSTOP trial team in order to make it easier for participants to respond truthfully to sensitive questions about adherence to the study protocol...
2016: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/26878068/real-time-enrollment-dashboard-for-multisite-clinical-trials
#20
William A Mattingly, Robert R Kelley, Timothy L Wiemken, Julia H Chariker, Paula Peyrani, Brian E Guinn, Laura E Binford, Kimberley Buckner, Julio Ramirez
OBJECTIVE: Achieving patient recruitment goals are critical for the successful completion of a clinical trial. We designed and developed a web-based dashboard for assisting in the management of clinical trial screening and enrollment. MATERIALS AND METHODS: We use the dashboard to assist in the management of two observational studies of community-acquired pneumonia. Clinical research associates and managers using the dashboard were surveyed to determine its effectiveness as compared with traditional direct communication...
October 30, 2015: Contemporary Clinical Trials Communications
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