BMJ open
-
Randomized Controlled Trial Multicenter Study
Process evaluation of the impact and acceptability of a polypill for prevention of cardiovascular disease.
The Use of a Multidrug Pill In Reducing cardiovascular Events (UMPIRE) trial has shown improved adherence with the use of a polypill strategy when compared with usual medications for cardiovascular disease (CVD) prevention. To advance from efficacy to impact, we need a better understanding of why and how such a strategy might be deployed in complex health systems. ⋯ Adherence to treatment lists with multiple medications is complex and influenced by several factors. Simplifying medication by using a once-daily polypill is one approach to CVD prevention that may enhance adherence. Prescribers should also consider the wide variety of adjustments that individuals need to make to cope with daily medication.
-
Randomized Controlled Trial Multicenter Study
Securing All intraVenous devices Effectively in hospitalised patients--the SAVE trial: study protocol for a multicentre randomised controlled trial.
Over 70% of all hospital admissions have a peripheral intravenous device (PIV) inserted; however, the failure rate of PIVs is unacceptably high, with up to 69% of these devices failing before treatment is complete. Failure can be due to dislodgement, phlebitis, occlusion/infiltration and/or infection. This results in interrupted medical therapy; painful phlebitis and reinsertions; increased hospital length of stay, morbidity and mortality from infections; and wasted medical/nursing time. Appropriate PIV dressing and securement may prevent many cases of PIV failure, but little comparative data exist regarding the efficacy of various PIV dressing and securement methods. This trial will investigate the clinical and cost-effectiveness of 4 methods of PIV dressing and securement in preventing PIV failure. ⋯ Ethical approval has been received from Queensland Health (HREC/11/QRCH/152) and Griffith University (NRS/46/11/HREC). Results will be published according to the CONSORT statement and presented at relevant conferences.
-
Randomized Controlled Trial Multicenter Study
Protocol for a randomised controlled trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb: UK Wound management of Open Lower Limb Fractures (UK WOLFF).
Patients who sustain open lower limb fractures have reported infection risks as high as 27%. The type of dressing applied after initial debridement could potentially affect this risk. In this trial, standard dressings will be compared with a new emerging treatment, negative pressure wound therapy, for patients with open lower limb fractures. ⋯ Ethical approval was given by NRES Committee West Midlands-Coventry & Warwickshire on 6/2/2012 (ref: 12/WM/0001). The results of the trial will be disseminated via peer-reviewed publications and presentations at relevant conferences.
-
To evaluate the multinational medical-student-delivered tobacco prevention programme for secondary schools for its effectiveness to reduce the smoking prevalence among adolescents aged 11-15 years in Germany at half year follow-up. ⋯ We report a significant secondary preventive (smoking cessation) effect at 6-month follow-up. Long-term evaluation is planned.
-
Alternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances. ⋯ Our study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication and appropriate timing of deferred consent discussions.