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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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Multicenter Study
A multisite, multistakeholder validation of the Accreditation Council for Graduate Medical Education competencies.
The Accreditation Council for Graduate Medical Education's (ACGME's) six-competency framework has not been validated across multiple stakeholders and sites. The objective of this study was to perform a multisite validation with five stakeholder groups. ⋯ The ACGME's six-competency framework has reasonable face and construct validity across multiple stakeholders and sites. Stakeholders appear to share a single mental model of competence in this learning environment. Data patterns suggest possible improvements to the competency-milestone framework.
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Multicenter Study
Surgical outcome measurement for a global patient population: validation of the Surgical Apgar Score in 8 countries.
Surgical care is a vital component of health care worldwide, yet there is no clinically meaningful measure of operative outcomes that could be applied globally. The Surgical Apgar Score, a simple metric derived from 3 intraoperative parameters, has been shown in U.S. academic medical centers to predict 30-day patient outcomes after operation, but has not been validated more broadly. ⋯ The Surgical Apgar Score is easily calculated, predictive, and moderately discriminative for major complications among adults undergoing inpatient noncardiac operative procedures. Such a score could provide objective indication of relative postoperative risk for inpatients and provide a potential target for quality improvement efforts, particularly in resource-limited settings.
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Transarterial chemoembolization (TACE) represents a first-line noncurative therapy for hepatocellular carcinoma (HCC). Sorafenib, a multikinase inhibitor, has been shown to be effective and safe monotherapy in patients with advanced HCC and the current study reports the interim results of a prospective Phase II, open label, trial investigating the safety and efficacy of the combination of sorafenib and conventional TACE in patients from the Asia-Pacific region with intermediate HCC. Patients with histologically or clinically diagnosed HCC were treated with conventional TACE followed by sorafenib 4 to 7 days later. ⋯ The mean number of cycles undertaken was 2.1 and 63.3% of patients achieved either partial response or stable disease. Clinically, the disease control rate was 91.2% while the overall response rate was calculated as 52.4%. Our study shows that concurrent sorafenib and TACE therapy is safe and effective with no unexpected side effects.
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Multicenter Study Clinical Trial
Clopidogrel response status assessed with Multiplate point-of-care analysis and the incidence and timing of stent thrombosis over six months following coronary stenting.
Clopidogrel low-responsiveness assessed with multiple electrode platelet aggregometry (MEA) has been shown to be a strong and independent predictor of early stent thrombosis (ST) after coronary stenting. The relation of clopidogrel response status, as assessed with MEA, with incidence and timing of ST during an extended follow-up period has never been reported. Here, we report the six-month follow-up results of a prospective trial assessing clopidogrel responsiveness with MEA in patients undergoing percutaneous coronary intervention (PCI). ⋯ A significant inverse correlation of MEA values and the timing of definite or probable ST (in days) was observed (Spearman coefficient = -0.45; P=0.04) with events occurring earlier in the low-responder group. MEA measurements are highly predictive for the occurrence of ST during the first six months following coronary stenting. In the majority of clopidogrel low responders suffering ST, the ischaemic event occurs early in the course after the procedure.