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Clinical Trials: Journal of the Society for Clinical Trials

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https://www.readbyqxmd.com/read/28068834/design-considerations-of-a-randomized-controlled-trial-of-sedation-level-during-hip-fracture-repair-surgery-a-strategy-to-reduce-the-incidence-of-postoperative-delirium-in-elderly-patients
#1
Tianjing Li, L Susan Wieland, Esther Oh, Karin J Neufeld, Nae-Yuh Wang, Kay Dickersin, Frederick E Sieber
Background Delirium is an acute change in mental status characterized by sudden onset, fluctuating course, inattention, disorganized thinking, and abnormal level of consciousness. The objective of the randomized controlled trial "A STrategy to Reduce the Incidence of Postoperative Delirium in Elderly Patients" (STRIDE) is to assess the effectiveness of light versus heavy sedation on delirium and other outcomes in elderly patients undergoing hip fracture repair surgery. Our goal is to describe the design considerations and lessons learned in planning and implementing the STRIDE trial...
January 1, 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
#2
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...
January 1, 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
#3
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...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28064524/an-embedded-randomised-controlled-trial-of-a-teaser-campaign-to-optimise-recruitment-in-primary-care
#4
Hopin Lee, Markus Hübscher, G Lorimer Moseley, Steven J Kamper, Adrian C Traeger, Ian W Skinner, Christopher M Williams, James H McAuley
BACKGROUND: Marketing communication and brand identity is a fundamental principle of advertising and end-user engagement. Health researchers have begun to apply this principle to trial recruitment in primary care. The aim of this study was to evaluate whether a Teaser Campaign using a series of postcards in advance of a conventional mail-out increases the number of primary care clinics that engage with a clinical trial. METHODS: Embedded randomised recruitment trial across primary care clinics (general practitioners and physiotherapists) in the Sydney metropolitan area...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28059578/a-bayesian-meta-analytic-approach-for-safety-signal-detection-in-randomized-clinical-trials
#5
Motoi Odani, Satoru Fukimbara, Tosiya Sato
BACKGROUND/AIM: Meta-analyses are frequently performed on adverse event data and are primarily used for improving statistical power to detect safety signals. However, in the evaluation of drug safety for New Drug Applications, simple pooling of adverse event data from multiple clinical trials is still commonly used. We sought to propose a new Bayesian hierarchical meta-analytic approach based on consideration of a hierarchical structure of reported individual adverse event data from multiple randomized clinical trials...
January 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27889701/publishing-interim-results-of-randomised-clinical-trials-in-peer-reviewed-journals
#6
Nicholas Counsell, Despina Biri, Joanna Fraczek, Allan Hackshaw
BACKGROUND: Interim analyses of randomised controlled trials are sometimes published before the final results are available. In several cases, the treatment effects were noticeably different after patient recruitment and follow-up completed. We therefore conducted a literature review of peer-reviewed journals to compare the reported treatment effects between interim and final publications and to examine the magnitude of the difference. METHODS: We performed an electronic search of MEDLINE from 1990 to 2014 (keywords: 'clinical trial' OR 'clinical study' AND 'random*' AND 'interim' OR 'preliminary'), and we manually identified the corresponding final publication...
November 26, 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27885056/understanding-the-functions-and-operations-of-data-monitoring-committees-survey-and-focus-group-findings
#7
Karim A Calis, Patrick Archdeacon, Raymond P Bain, Annemarie Forrest, Jane Perlmutter, David L DeMets
BACKGROUND: The use of data monitoring committees in the conduct of clinical trials has increased and evolved, but there is a lack of published information on when data monitoring committees are needed and utilized, the acceptable range of data monitoring committee practices, and appropriate qualifications of data monitoring committee members. METHODS: To gain a better understanding of data monitoring committee operations and areas for improvement, the Clinical Trials Transformation Initiative conducted a survey and set of focus groups...
November 24, 2016: 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
#8
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...
November 1, 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27798377/maximizing-value-and-minimizing-barriers-patient-centered-community-consultation-for-research-in-emergency-settings
#9
Christopher B Fordyce, Matthew T Roe, Neal W Dickert
BACKGROUND: Patients with cardiac arrest and other life-threatening emergencies are unable to provide prospective consent for clinical trials. In the United States and other countries, regulations permit an exception from the requirement for informed consent in emergency settings. However, many potential barriers exist, as evidenced by the scarcity of US trials conducted under exception from the requirement for informed consent. One persistent challenge is the requirement that investigators consult communities prior to study approval...
October 25, 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27903947/daniel-j-sargent-1970-2016
#10
Sumithra J Mandrekar
No abstract text is available yet for this article.
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27903946/editorial
#11
EDITORIAL
Colin B Begg
No abstract text is available yet for this article.
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27573636/communicating-with-participants-during-the-conduct-of-multi-center-clinical-trials
#12
Erika F Augustine, E Ray Dorsey, Robert A Hauser, Jordan J Elm, Barbara C Tilley, Karl K Kieburtz
BACKGROUND: Communicating with trial participants is an important aspect of study conduct, relevant for informed consent and respect for participants. Group teleconferences are one means to convey information to trial participants. We used group teleconferences during an ongoing large-scale clinical trial to communicate important trial updates. METHODS: The National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease Longitudinal Study-1 trial studied creatine for treatment of early-stage Parkinson's disease...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27573635/clinical-trial-result-reporting-time-to-move-into-the-21st-century
#13
Sharon F Terry
No abstract text is available yet for this article.
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27562368/health-research-participants-preferences-for-receiving-research-results
#14
Christopher R Long, M Kathryn Stewart, Thomas V Cunningham, T Scott Warmack, Pearl A McElfish
BACKGROUND: Participants in health research studies typically express interest in receiving the results from the studies in which they participate. However, participants' preferences and experiences related to receiving the results are not well understood. In general, the existing studies have had relatively small sample sizes and typically address specific and often sensitive issues within targeted populations. METHODS: This study used an online survey to explore attitudes and experiences of registrants in ResearchMatch, a large database of past, present, and potential health research participants...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27559022/adult-patient-perspectives-on-clinical-trial-result-reporting-a-survey-of-cancer-patients
#15
Kate E Elzinga, Omar F Khan, Andrew R Tang, Conrad V Fernandez, Christine L Elzinga, Daniel Yc Heng, Michael M Vickers, Tony H Truong, Patricia A Tang
BACKGROUND: The provision of study results to research participants is supported by pediatric and adult literature. This study assessed adult cancer patient preferences surrounding aggregate result disclosure to study participants. METHODS: A 46-item questionnaire was given to 250 adult cancer patients who had participated in oncology trials at a single center. Respondents answered questions surrounding their preferences for timing, content, and modality of communication for dissemination of study results...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27439306/non-factorial-analyses-of-two-by-two-factorial-trial-designs
#16
Edward L Korn, Boris Freidlin
BACKGROUND/AIMS: Factorial analyses of 2 × 2 trial designs are known to be problematic unless one can be sure that there is no interaction between the treatments (A and B). Instead, we consider non-factorial analyses of a factorial trial design that addresses clinically relevant questions of interest without any assumptions on the interaction. Primary questions of interest are as follows: (1) is A better than the control treatment C, (2) is B better than C, (3) is the combination of A and B (AB) better than C, and (4) is AB better than A, B, and C...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27430710/a-practical-bayesian-stepped-wedge-design-for-community-based-cluster-randomized-clinical-trials-the-british-columbia-telehealth-trial
#17
Kristen M Cunanan, Bradley P Carlin, Kevin A Peterson
BACKGROUND: Many clinical trial designs are impractical for community-based clinical intervention trials. Stepped wedge trial designs provide practical advantages, but few descriptions exist of their clinical implementational features, statistical design efficiencies, and limitations. OBJECTIVES: Enhance efficiency of stepped wedge trial designs by evaluating the impact of design characteristics on statistical power for the British Columbia Telehealth Trial. METHODS: The British Columbia Telehealth Trial is a community-based, cluster-randomized, controlled clinical trial in rural and urban British Columbia...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27430709/non-inferiority-tests-for-anti-infective-drugs-using-control-group-quantiles
#18
Michael P Fay, Dean A Follmann
BACKGROUND/AIMS: In testing for non-inferiority of anti-infective drugs, the primary endpoint is often the difference in the proportion of failures between the test and control group at a landmark time. The landmark time is chosen to approximately correspond to the qth historic quantile of the control group, and the non-inferiority margin is selected to be reasonable for the target level q. For designing these studies, a troubling issue is that the landmark time must be pre-specified, but there is no guarantee that the proportion of control failures at the landmark time will be close to the target level q...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27371945/a-novel-drug-management-system-in-the-febuxostat-versus-allopurinol-streamlined-trial-a-description-of-a-pharmacy-system-designed-to-supply-medications-directly-to-patients-within-a-prospective-multicenter-randomised-clinical-trial
#19
Amy Rogers, Robert Wv Flynn, Patrick McDonnell, Isla S Mackenzie, Thomas M MacDonald
BACKGROUND: Trials of investigational medicinal products are required to adhere to strict guidelines with regard to the handling and supply of medication. Information technology offers opportunities to approach clinical trial methodology in new ways. This report summarises a novel pharmacy system designed to supply trial medications directly to patients by post in the Febuxostat versus Allopurinol Streamlined Trial. METHOD: A bespoke web-based software package was designed to facilitate the direct supply of trial medications to Febuxostat versus Allopurinol Streamlined Trial participants from a pharmacy based in the Medicines Monitoring Unit, University of Dundee...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/27365012/patient-reported-outcomes-questionnaire-compliance-in-cancer-cooperative-group-trials-alliance-n0992
#20
Pamela J Atherton, Kelli N Burger, Levi D Pederson, Suneetha Kaggal, Jeff A Sloan
BACKGROUND/AIMS: The use of patient-reported outcomes in clinical trials is a focal point for research and policy. Non-compliance with planned questionnaires and missing data can threaten both internal validity and generalizability. This retrospective analysis was conducted to determine the extent of, and characteristics associated with, missing patient-reported outcomes. METHODS: Study characteristics, patient characteristics and adverse events, and reasons for non-compliance were compiled from 14 closed Alliance for Clinical Trials in Oncology, Mayo Clinic Cancer Center, or Mayo Clinic Cancer Research Consortium clinical trials...
December 2016: Clinical Trials: Journal of the Society for Clinical Trials
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