Trials
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Randomized Controlled Trial
Dual antiplatelet therapy in patients with aspirin resistance following coronary artery bypass grafting: study protocol for a randomized controlled trial [NCT01159639].
Coronary artery disease remains the dominant cause of mortality in developed countries. While platelets have been recognized to play a pivotal role in atherothrombosis, the ideal antiplatelet regime after coronary artery surgery remains elusive. The evolution of CABG has presently moved beyond technical improvements to involve modulation of pharmacologic management designed to improve patient outcomes. The aim of this trial will be to test the hypothesis that the addition of clopidogrel to patients with documented postoperative aspirin resistance will reduce the incidence of major cardiovascular events. ⋯ This will be the first trial that will specifically address the issue of dual antiplatelet therapy in patients undergoing coronary artery surgery who have been found to be aspirin resistant. In the event that the addition of clopidogrel proves to be beneficial in this subset of surgical patients, this study could significantly impact their future antiplatelet management. This randomized controlled trial has been registered at the ClinicalTrials.gov website (Identifier NCT01159639).
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Multicenter Study Clinical Trial
The management of dental caries in primary teeth - involving service providers and users in the design of a trial.
There is a lack of evidence for the effective management of dental caries in children's primary teeth. The trial entitled 'Filling Children's Teeth: Indicated Or Not?' (FiCTION) was designed to examine the clinical and cost effectiveness, in primary dental care, of three different approaches to the management of caries in primary teeth. However, before the FiCTION main trial commenced, a pilot trial was designed. Service provider (dentists and other members of the team including dental nurses and practice managers) and participant (child participants and their parents) involvement was incorporated into the pilot trial. The aim of this study is to describe service providers' and users' perspectives on the pilot trial to identify improvements to the conduct and design of the FiCTION main trial. ⋯ The findings provided valuable recommendations to improve the method of recruitment of dental practices and patients, the timing and content of the training, the type of support dentists would value and ways to further engage children and parents in the FiCTION main trial.
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Randomized controlled trials are the principal means of establishing the efficacy of drugs. However pre-marketing trials are limited in size and duration and exclude high-risk populations. They have limited statistical power to detect rare but potentially serious adverse events in real-world patients. ⋯ Meta-analyses of drug safety should include appropriate statistical methods and assess the optimal information size to avoid type 2 errors. They should evaluate outcome reporting biases and missing data to ensure reliable and accurate interpretation of findings. Regulatory and academic partnerships should be fostered to provide an independent and transparent evaluation of drug safety.
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Randomized Controlled Trial Multicenter Study
Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals: study protocol for a randomized controlled trial.
Extended smoking cessation follow-up after hospital discharge significantly increases abstinence. Hospital smoke-free policies create a period of 'forced abstinence' for smokers, thus providing an opportunity to integrate tobacco dependence treatment, and to support post-discharge maintenance of hospital-acquired abstinence. This study is funded by the National Heart, Lung, and Blood Institute (1U01HL1053231). ⋯ This study will provide important evidence for the effectiveness and cost-effectiveness of linking hospital-based tobacco treatment specialists' services with discharge follow-up care.
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Randomized Controlled Trial Multicenter Study
Using "warm handoffs" to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial.
Post-discharge support is a key component of effective treatment for hospitalized smokers, but few hospitals provide it. Many hospitals and care settings fax-refer smokers to quitlines for follow-up; however, less than half of fax-referred smokers are successfully contacted and enrolled in quitline services. "Warm handoff" is a novel approach to care transitions in which health care providers directly link patients with substance abuse problems with specialists, using face-to-face or phone transfer. Warm handoff achieves very high rates of treatment enrollment for these vulnerable groups. ⋯ If successful, this project offers a low-cost solution for more efficiently linking millions of hospitalized smokers with effective outpatient treatment-smokers that might otherwise be lost in the transition to outpatient care.