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Clinical Trials: Journal of the Society for Clinical Trials

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https://www.readbyqxmd.com/read/28503947/recommendations-for-data-monitoring-committees-from-the-clinical-trials-transformation-initiative
#1
Karim A Calis, Patrick Archdeacon, Raymond Bain, David DeMets, Miriam Donohue, M Khair Elzarrad, Annemarie Forrest, John McEachern, Michael J Pencina, Jane Perlmutter, Roger J Lewis
Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data monitoring committee composition and conduct. To understand and describe the role and function of data monitoring committees, and establish best practices for data monitoring committee trial oversight, the Clinical Trials Transformation Initiative-a public-private partnership to improve clinical trials-launched a multi-stakeholder project...
May 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28486851/structure-to-utilize-interventionists-implementation-experiences-of-a-family-based-behavioral-weight-management-program-to-enhance-the-dissemination-of-the-standardized-intervention-the-today-study
#2
Jennifer Q Chadwick, Dorothy J Van Buren, Elisa Morales, Alexandra Timpson, Ericka L Abrams, Amy Syme, Jeff Preske, Gerardo Mireles, Barbara Anderson, Nisha Grover, Lori Laffel
Background For a 2- to 6-year period, interventionists for the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) randomized clinical trial delivered a family-based, behavioral weight-loss program (the TODAY Lifestyle Program) to 234 youth with type 2 diabetes. Interventionists held at least a bachelor's degree in psychology, social work, education, or health-related field and had experience working with children and families, especially from diverse ethnic and socioeconomic backgrounds...
May 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28452236/mobile-access-to-virtual-randomization-for-investigator-initiated-trials
#3
Thomas M Deserno, András P Keszei
Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand...
April 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28393632/increasing-response-rates-to-follow-up-questionnaires-in-health-intervention-research-randomized-controlled-trial-of-a-gift-card-prize-incentive
#4
Amy J Morgan, Ronald M Rapee, Jordana K Bayer
Background/aims Achieving a high response rate to follow-up questionnaires in randomized controlled trials of interventions is important for study validity. Few studies have tested the value of incentives in increasing response rates to online questionnaires in clinical trials of health interventions. This study evaluated the effect of a gift card prize-draw incentive on response rates to follow-up questionnaires within a trial of an online health intervention. Method The study was embedded in a host randomized controlled trial of an online parenting program for child anxiety...
April 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28393537/inadequacy-of-ethical-conduct-and-reporting-of-stepped-wedge-cluster-randomized-trials-results-from-a-systematic-review
#5
Monica Taljaard, Karla Hemming, Lena Shah, Bruno Giraudeau, Jeremy M Grimshaw, Charles Weijer
Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting...
April 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28385071/treatment-of-missing-data-in-follow-up-studies-of-randomised-controlled-trials-a-systematic-review-of-the-literature
#6
Thomas R Sullivan, Lisa N Yelland, Katherine J Lee, Philip Ryan, Amy B Salter
BACKGROUND/AIMS: After completion of a randomised controlled trial, an extended follow-up period may be initiated to learn about longer term impacts of the intervention. Since extended follow-up studies often involve additional eligibility restrictions and consent processes for participation, and a longer duration of follow-up entails a greater risk of participant attrition, missing data can be a considerable threat in this setting. As a potential source of bias, it is critical that missing data are appropriately handled in the statistical analysis, yet little is known about the treatment of missing data in extended follow-up studies...
April 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28397569/analysis-of-an-ordinal-endpoint-for-use-in-evaluating-treatments-for-severe-influenza-requiring-hospitalization
#7
Ross L Peterson, David M Vock, John H Powers, Sean Emery, Eduardo Fernandez Cruz, Sally Hunsberger, Mamta K Jain, Sarah Pett, James D Neaton
Background/Aims A single best endpoint for evaluating treatments of severe influenza requiring hospitalization has not been identified. A novel six-category ordinal endpoint of patient status is being used in a randomized controlled trial (FLU-Intravenous Immunoglobulin - FLU-IVIG) of intravenous immunoglobulin. We systematically examine four factors regarding the use of this ordinal endpoint that may affect power from fitting a proportional odds model: (1) deviations from the proportional odds assumption which result in the same overall treatment effect as specified in the FLU-IVIG protocol and which result in a diminished overall treatment effect, (2) deviations from the distribution of the placebo group assumed in the FLU-IVIG design, (3) the effect of patient misclassification among the six categories, and (4) the number of categories of the ordinal endpoint...
March 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28387537/using-phase-ii-data-for-the-analysis-of-phase-iii-studies-an-application-in-rare-diseases
#8
Simon Wandel, Beat Neuenschwander, Christian Röver, Tim Friede
BACKGROUND: Clinical research and drug development in orphan diseases are challenging, since large-scale randomized studies are difficult to conduct. Formally synthesizing the evidence is therefore of great value, yet this is rarely done in the drug-approval process. Phase III designs that make better use of phase II data can facilitate drug development in orphan diseases. METHODS: A Bayesian meta-analytic approach is used to inform the phase III study with phase II data...
March 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28345419/commentary-on-perez-et-al-how-to-create-a-21st-century-adverse-event-reporting-system
#9
Elad Sharon
No abstract text is available yet for this article.
March 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28345368/sponsors-and-investigative-staffs-perceptions-of-the-current-investigational-new-drug-safety-reporting-process-in-oncology-trials
#10
Raymond Perez, Patrick Archdeacon, Nancy Roach, Robert Goodwin, Jonathan Jarow, Nina Stuccio, Annemarie Forrest
BACKGROUND/AIMS: The Food and Drug Administration's final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes...
March 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28359194/data-monitoring-committees-promoting-best-practices-to-address-emerging-challenges
#11
Thomas R Fleming, David L DeMets, Matthew T Roe, Janet Wittes, Karim A Calis, Amit N Vora, Alan Meisel, Raymond P Bain, Marvin A Konstam, Michael J Pencina, David J Gordon, Kenneth W Mahaffey, Charles H Hennekens, James D Neaton, Gail D Pearson, Tomas Lg Andersson, Marc A Pfeffer, Susan S Ellenberg
BACKGROUND AND PURPOSE: Data monitoring committees are responsible for safeguarding the interests of study participants and assuring the integrity and credibility of clinical trials. The independence of data monitoring committees from sponsors and investigators is essential in achieving this mission. Creative approaches are needed to address ongoing and emerging challenges that potentially threaten data monitoring committees' independence and effectiveness. METHODS: An expert panel of representatives from academia, industry and government sponsors, and regulatory agencies discussed these challenges and proposed best practices and operating principles for effective functioning of contemporary data monitoring committees...
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28359193/corrigendum
#12
(no author information available yet)
No abstract text is available yet for this article.
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28359192/impact-of-individual-clinical-outcomes-on-trial-participants-perspectives-on-enrollment-in-emergency-research-without-consent
#13
Louisa W Whitesides, Jill M Baren, Michelle H Biros, Ross J Fleischman, Prasanthi R Govindarajan, Elizabeth B Jones, Arthur M Pancioli, Rebecca D Pentz, Victoria M Scicluna, David W Wright, Neal W Dickert
BACKGROUND: Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. METHODS: Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study...
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28359191/the-in-stability-of-21st-century-orthopedic-patient-contact-information-and-its-implications-on-clinical-research-a-cross-sectional-study
#14
Daniel A London, Jeffrey G Stepan, Charles A Goldfarb, Martin I Boyer, Ryan P Calfee
BACKGROUND: In clinical research, minimizing patients lost to follow-up is essential for data validity. Researchers can employ better methodology to prevent patient loss. We examined how orthopedic surgery patients' contact information changes over time to optimize data collection for long-term outcomes research. METHODS: Patients presenting to orthopedic outpatient clinics completed questionnaires regarding methods of contact: home phone, cell phone, mailing address, and e-mail address...
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28135839/delivering-successful-randomized-controlled-trials-in-surgery-methods-to-optimize-collaboration-and-study-design
#15
Natalie S Blencowe, Jonathan A Cook, Thomas Pinkney, Chris Rogers, Barnaby C Reeves, Jane M Blazeby
Randomized controlled trials in surgery are notoriously difficult to design and conduct due to numerous methodological and cultural challenges. Over the last 5 years, several UK-based surgical trial-related initiatives have been funded to address these issues. These include the development of Surgical Trials Centers and Surgical Specialty Leads (individual surgeons responsible for championing randomized controlled trials in their specialist fields), both funded by the Royal College of Surgeons of England; networks of research-active surgeons in training; and investment in methodological research relating to surgical randomized controlled trials (to address issues such as recruitment, blinding, and the selection and standardization of interventions)...
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28135837/rejoinder
#16
Thomas R Fleming, David L DeMets, Matthew T Roe, Janet Wittes, Karim A Calis, Amit N Vora, Alan Meisel, Raymond P Bain, Marvin A Konstam, Michael J Pencina, David J Gordon, Kenneth W Mahaffey, Charles H Hennekens, James D Neaton, Gail D Pearson, Tomas Lg Andersson, Marc A Pfeffer, Susan S Ellenberg
No abstract text is available yet for this article.
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28124579/using-a-network-based-approach-and-targeted-maximum-likelihood-estimation-to-evaluate-the-effect-of-adding-pre-exposure-prophylaxis-to-an-ongoing-test-and-treat-trial
#17
Laura Balzer, Patrick Staples, Jukka-Pekka Onnela, Victor DeGruttola
BACKGROUND: Several cluster-randomized trials are underway to investigate the implementation and effectiveness of a universal test-and-treat strategy on the HIV epidemic in sub-Saharan Africa. We consider nesting studies of pre-exposure prophylaxis within these trials. Pre-exposure prophylaxis is a general strategy where high-risk HIV- persons take antiretrovirals daily to reduce their risk of infection from exposure to HIV. We address how to target pre-exposure prophylaxis to high-risk groups and how to maximize power to detect the individual and combined effects of universal test-and-treat and pre-exposure prophylaxis strategies...
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28079394/the-positive-emotions-after-acute-coronary-events-behavioral-health-intervention-design-rationale-and-preliminary-feasibility-of-a-factorial-design-study
#18
Jeffery C Huffman, Ariana M Albanese, Kirsti A Campbell, Christopher M Celano, Rachel A Millstein, Carol A Mastromauro, Brian C Healy, Wei-Jean Chung, James L Januzzi, Linda M Collins, Elyse R Park
BACKGROUND: Positive psychological constructs, such as optimism, are associated with greater participation in cardiac health behaviors and improved cardiac outcomes. Positive psychology interventions, which target psychological well-being, may represent a promising approach to improving health behaviors in high-risk cardiac patients. However, no study has assessed whether a positive psychology intervention can promote physical activity following an acute coronary syndrome. OBJECTIVE: In this article we will describe the methods of a novel factorial design study to aid the development of a positive psychology-based intervention for acute coronary syndrome patients and aim to provide preliminary feasibility data on study implementation...
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28068789/pragmatic-trial-of-video-education-in-nursing-homes-the-design-and-rationale-for-a-pragmatic-cluster-randomized-trial-in-the-nursing-home-setting
#19
Vincent Mor, Angelo E Volandes, Roee Gutman, Constantine Gatsonis, Susan L Mitchell
Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems...
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28064525/healthy-children-strong-families-2-a-randomized-controlled-trial-of-a-healthy-lifestyle-intervention-for-american-indian-families-designed-using-community-based-approaches
#20
Emily J Tomayko, Ronald J Prince, Kate A Cronin, Tassy Parker, Kyungmann Kim, Vernon M Grant, Judith N Sheche, Alexandra K Adams
Background/Aims Few obesity prevention trials have focused on young children and their families in the home environment, particularly in underserved communities. Healthy Children, Strong Families 2 is a randomized controlled trial of a healthy lifestyle intervention for American Indian children and their families, a group at very high risk of obesity. The study design resulted from our long-standing engagement with American Indian communities, and few collaborations of this type resulting in the development and implementation of a randomized clinical trial have been described...
April 2017: Clinical Trials: Journal of the Society for Clinical Trials
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