Trials
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An extension of the Consolidated Standards of Reporting Trials (CONSORT) statement provides a checklist of items to improve the reporting quality of abstracts of randomized controlled trials (RCTs). However, authors of abstracts in some fields have poorly adhered to this guideline. We did an extensive literature survey to examine the quality of reporting trial abstracts in major critical care journals before and after announcement of the CONSORT guideline for abstracts. ⋯ Reporting of some items in abstracts for critical care trials improved over time, but the adherence to the CONSORT guideline for abstracts was still suboptimal.
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Randomized Controlled Trial Multicenter Study
The effects of ventilation tubes versus no ventilation tubes for recurrent acute otitis media or chronic otitis media with effusion in 9 to 36 month old Greenlandic children, the SIUTIT trial: study protocol for a randomized controlled trial.
The prevalence of otitis media in Greenlandic children is one of the highest in the world. International studies have shown that otitis-prone children may benefit from tubulation of the tympanic membrane. However, it is unknown whether these results can be applied to Greenlandic children and trials on the effects of ventilation tubes in high-risk populations have, to our knowledge, never been conducted. ⋯ This trial will provide evidence-based knowledge of the effects of ventilation tubes in children with middle ear infections from the high-risk Greenlandic population. Furthermore, this trial will improve the understanding of conducting randomized clinical trials in remote areas, where management of logistical aspects is particularly challenging.
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Randomized Controlled Trial Multicenter Study
The (cost-)effectiveness of a patient-tailored intervention programme to enhance adherence to antihypertensive medication in community pharmacies: study protocol of a randomised controlled trial.
Medication non-adherence is a complex health care problem. Due to non-adherence, substantial numbers of cardiovascular patients benefit from their medication to only a limited extent. In order to improve adherence, a variety of pharmacist-led interventions have been developed. However, even the most effective interventions achieved only a modest positive effect. To be effective, interventions should be targeted at underlying barriers to adherence, developed in a systematic manner and tailored to specific features of a target group and setting. The current paper describes the design of the Cardiovascular medication non-Adherence Tailored Intervention (CATI) study aimed to evaluate the (cost-)effectiveness of a patient-tailored intervention programme in patients using antihypertensive medication. ⋯ This study will provide insight into the (cost-)effectiveness of a patient-tailored, pharmacist-led intervention programme in non-adherent patients using antihypertensive medication. This intervention programme allows community pharmacists to support their patients in overcoming barriers to adherence and improving medication adherence in a structured and patient-tailored manner. An effective intervention will not only enhance medication adherence, but may also improve health outcomes and decrease health care utilisation and costs.
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).
While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. ⋯ This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial.
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Randomized Controlled Trial
Moderated online social therapy for carers of young people recovering from first-episode psychosis: study protocol for a randomised controlled trial.
First-episode psychosis most often has its onset during late adolescence. In caring for the young person, families endure high levels of stress and depression. Meanwhile, the social networks of families often erode. Our group has previously shown that family cognitive behaviour therapy (CBT) leads to significantly improved perceived stress compared with specialist first-episode treatment as usual; however, there are well-known barriers to the dissemination of effective family interventions. To address this, we have developed a novel online intervention entitled 'Altitudes' that fully integrates purpose-built online social networking, expert and peer moderation, and evidence-based psychoeducation within a single application. The primary aim of this trial is to evaluate the effectiveness of Altitudes in reducing stress in carers over a 6-month period. ⋯ This is the first randomised controlled trial designed to evaluate an online intervention for carers of young people recovering from FEP. It has the potential to produce evidence in support of a highly novel, accessible, and cost-effective intervention to reduce stress in carers who are providing support to young people at a critical phase in their recovery from psychosis.