Trials
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Randomized Controlled Trial Comparative Study
Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial.
The use of a drug-eluting balloon for the treatment of de novo coronary artery lesions remains to be evaluated. A previous trial in patients with stable and unstable angina comparing a bare metal stent mounted on a drug-eluting balloon with a sirolimus-eluting stent failed to meet the prespecified non-inferiority criteria versus the sirolimus-eluting stent. The stent struts of a bare metal stent pre-mounted on a drug-eluting balloon may prevent the appropriate delivery of drugs to the vessel wall and may result in reduced efficacy. In the present study we will therefore evaluate the efficacy of a drug-eluting balloon for treating de novo coronary artery lesions using a strategy designed to uniformly deliver drug to the vessel with a bare metal stent. ⋯ The Comparison of Drug-Eluting Balloon first study will evaluate the clinical efficacy, angiographic outcomes and safety of a drug-eluting balloon first followed by a bare metal stent compared with a drug-eluting stent for the treatment of de novo coronary artery lesions.
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Randomized Controlled Trial
The effectiveness of Grief-Help, a cognitive behavioural treatment for prolonged grief in children: study protocol for a randomised controlled trial.
There is growing recognition of a syndrome of disturbed grief referred to as prolonged grief disorder (PGD). PGD is mostly studied in adults, but clinically significant PGD symptoms have also been observed in children and adolescents. Yet, to date no effective treatment for childhood PGD exists. The aims of this study are: (1) to investigate the effectiveness of Grief-Help, a nine-session cognitive-behavioural treatment for childhood PGD, combined with five sessions of parental counselling, immediately after the treatment and at three, six and twelve months follow-up; (2) to examine tentative mediators of the effects of Grief-Help, (i.e., maladaptive cognitions and behaviours and positive parenting), and (3) to determine whether demographic variables, child personality, as well as symptoms of PGD, anxiety, and depression in parents moderate the treatment effectiveness. ⋯ We aim to contribute to the improvement of mental health care for children and adolescents suffering from loss. By comparing Grief-Help with supportive counselling, and by investigating mediators and moderators of its effectiveness we hope to provide new insights in the effects of interventions for bereaved children, and their mechanisms of change.
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Randomized Controlled Trial
Telephone-based health coaching for chronically ill patients: study protocol for a randomized controlled trial.
The rising prevalence of chronic conditions constitutes a major burden for patients and healthcare systems and is predicted to increase in the upcoming decades. Improving the self-management skills of patients is a strategy to steer against this burden. This could lead to better outcomes and lower healthcare costs. Health coaching is one method for enhancing the self-management of patients and can be delivered by phone. The effects of telephone-based health coaching are promising, but still inconclusive. Economic evaluations and studies examining the transferability of effects to different healthcare systems are still rare. Aim of this study is to evaluate telephone-based health coaching for chronically ill patients in Germany. ⋯ This study will provide evidence regarding economic and clinical effects of telephone-delivered health coaching. Additionally, this study will show whether health coaching is an adequate option for the German healthcare system to address the growing burden of chronic diseases.
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Randomized Controlled Trial
Value of information: interim analysis of a randomized, controlled trial of goal-directed hemodynamic treatment for aged patients.
A randomized, controlled trial, intended to include 460 patients, is currently studying peroperative goal-directed hemodynamic treatment (GDHT) of aged hip-fracture patients. Interim efficacy analysis performed on the first 100 patients was statistically uncertain; thus, the trial is continuing in accordance with the trial protocol. This raised the present investigation's main question: Is it reasonable to continue to fund the trial to decrease uncertainty? To answer this question, a previously developed probabilistic cost-effectiveness model was used. That model depicts (1) a choice between routine fluid treatment and GDHT, given uncertainty of current evidence and (2) the monetary value of further data collection to decrease uncertainty. This monetary value, that is, the expected value of perfect information (EVPI), could be used to compare future research costs. Thus, the primary aim of the present investigation was to analyze EVPI of an ongoing trial with interim efficacy observed. ⋯ If future trial costs are below EVPI, further data collection is potentially cost-effective. When applying a cost-effectiveness model, statements such as 'further research is needed' are replaced with 'further research is cost-effective and 'further funding of a trial is justified'.
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Spin in the reporting of randomized controlled trials, where authors report research in a way that potentially misrepresents results and mislead readers, has been demonstrated in the broader medical literature. We investigated spin in wound care trials with (a) no statistically significant result for the primary outcome and (b) no clearly specified primary outcome. ⋯ Spin is a frequent phenomenon in reports of RCTs of wound treatments. Studies without statistically significant results for the primary outcome used spin in 71% of cases. Furthermore, 33% (43/132) of reports of wound RCTs did not specify a primary outcome and there was evidence of spin and selective outcome reporting in the abstracts of these. Readers should be wary of only reading the abstracts of reports of RCTs of wound treatments since they are frequently misleading regarding treatment effects.