BMJ open
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Randomized Controlled Trial Comparative Study
Arthroscopic-assisted balloon tibioplasty versus open reduction internal fixation (ORIF) for treatment of Schatzker II-IV tibial plateau fractures: study protocol of a randomised controlled trial.
Arthroscopic-assisted balloon tibioplasty is an emerging technology that has shown advantages in recovering depression of the articular surface. However, studies evaluating clinical outcomes between arthroscopic-assisted balloon tibioplasty and traditional open reduction internal fixation (ORIF) are sparse. This is the first randomised study to compare arthroscopic-assisted balloon tibioplasty with ORIF, and will provide guidance for treating patients with Schatzker types II, III and IV with depression of the medial tibial plateau only. ⋯ This study has been reviewed and approved by the Institutional Review Board of the Second Affiliated Hospital of Wenzhou Medical University (batch: 2017-12). The results will be presented in peer-reviewed journals after completion of the study.
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Randomized Controlled Trial
Promoting hygienic weaning food handling practices through a community-based programme: intervention implementation and baseline characteristics for a cluster randomised controlled trial in rural Gambia.
Contamination of weaning food leads to diarrhoea in children under 5 years. Public health interventions to improve practices in low-income and middle-income countries are rare and often not evaluated using a randomised method. We describe an intervention implementation and provide baseline data for such a trial. ⋯ This research has potential as a new low-cost and broadly available public health programme to reduce infection through weaning food. The theory-based intervention was widely consulted in the Gambia and with experts and was well accepted by the communities. Baseline analysis provides socioeconomic data and confirmation of Unicefs Multiple Indicator Cluster Survey (MICS) data on the prevalence of diarrhoea and respiratory symptoms in the dry season in the poorest region of Gambia.
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Hazardous alcohol consumption is common among people experiencing depression, often acting to exacerbate depressive symptoms. While many people with these co-occurring disorders do not seek face-to-face treatment, they do seek help online. There are effective internet interventions that target hazardous alcohol consumption or depression separately but none that combine these online interventions without the involvement of a therapist. In order to realise the potential of internet interventions, we need to develop an evidence base supporting the efficacy of internet interventions for co-occurring depression and hazardous alcohol use without any therapist involvement. This study aims to evaluate the effects on drinking, and on depressive symptoms, of combining an internet intervention targeting hazardous alcohol consumption with one for depression. ⋯ This research comprises the crucial first steps in developing lower-cost and efficacious internet interventions for people suffering from depression who also drink in a hazardous fashion-promoting the widespread availability of care for those in need. This study has been approved by the standing ethics review committee of the Centre for Addiction and Mental Health, and findings will be disseminated in the form of at least one peer-reviewed article and presentations at conferences.
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Randomized Controlled Trial Comparative Study
Randomised controlled feasibility trial of real versus sham repetitive transcranial magnetic stimulation treatment in adults with severe and enduring anorexia nervosa: the TIARA study.
Treatment options for severe, enduring anorexia nervosa (SE-AN) are limited. Non-invasive neuromodulation is a promising emerging intervention. Our study is a feasibility randomised controlled trial of repetitive transcranial magnetic stimulation (rTMS) in individuals with SE-AN, which aims to inform the design of a future large-scale trial. ⋯ The treatment protocol is feasible and acceptable to participants. Outcomes provide preliminary evidence for the therapeutic potential of rTMS in SE-AN. Largest effects were observed on variables assessing mood. This study supports the need for a larger confirmatory trial to evaluate the effectiveness of multi-session rTMS in SE-AN. Future studies should include a longer follow-up period and an assessment of cost-effectiveness.
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Randomized Controlled Trial
Impact of a modified version of baby-led weaning on iron intake and status: a randomised controlled trial.
To determine the iron intake and status of infants following a version of baby-led weaning (BLW) modified to prevent iron deficiency (Baby-Led Introduction to SolidS; BLISS) compared with those of infants following traditional spoon-feeding. ⋯ A baby-led approach to complementary feeding does not appear to increase the risk of iron deficiency in infants when their parents are given advice to offer 'high-iron' foods with each meal.