Trials
-
Randomized Controlled Trial
The GoodNight study--online CBT for insomnia for the indicated prevention of depression: study protocol for a randomised controlled trial.
Cognitive Behaviour Therapy for Insomnia (CBT-I) delivered through the Internet is effective as a treatment in reducing insomnia in individuals seeking help for insomnia. CBT-I also lowers levels of depression in this group. However, it is not known if targeting insomnia using CBT-I will lower depressive symptoms, and thus reduce the risk of major depressive episode onset, in those specifically at risk for depression. Therefore, this study aims to examine whether Internet delivery of fully automated self-help CBT-I designed to reduce insomnia will prevent depression. ⋯ This trial is the first randomised controlled trial of an Internet-based insomnia intervention as an indicated preventative programme for depression. If effective, online provision of a depression prevention programme will facilitate dissemination.
-
A complete description of the intervention in a published trial report is necessary for readers to be able to use the intervention, yet the completeness of intervention descriptions in trials is very poor. Low awareness of the issue by authors, reviewers, and editors is part of the cause and providing specific instructions about intervention reporting to authors and encouraging full sharing of intervention materials is important. We assessed the extent to which: 1) journals' Instructions to Authors provide instructions about how interventions that have been evaluated in a randomised controlled trial (RCT) should be reported in the paper; and 2) journals offer the option of authors providing online supplementary materials. ⋯ Most journals' Instructions to Authors do not provide any specific instructions regarding reporting of interventions or encourage authors to provide online supplementary materials to enhance intervention reporting. Journals can help to improve the problem of incomplete intervention reporting by providing specific instructions to authors and peer reviewers about intervention reporting and requiring full intervention descriptions to be provided.
-
After the genocide in Rwanda, the country's healthcare system collapsed. Remarkable gains have since been made by the state to provide greater clinical service capacity and expand health policies that are grounded on locally relevant evidence. ⋯ Through local examples, we discuss how a clinical trial infrastructure can be constructed by (1) building educational capacity; (2) encouraging the testing of relevant interventions using appropriate and cost-effective designs; and, (3) promoting ethical and regulatory standards. The future is bright for clinical research in Rwanda and with a renewed appetite for locally generated evidence it is necessary that we discuss the challenges and opportunities in drawing up a clinical trials agenda.
-
From previous reviews, there still have been controversies over the effect of metformin (MET) on reproductive function in PCOS patients. The reasons for the inconsistent findings especially lie in the transparency and accuracy of randomized controlled trials (RCTs) reports. However, we could find no data about the quality of RCTs reporting in MET for PCOS. Thus, a retrospective survey related to the quality of reporting in MET for PCOS was conducted. ⋯ Although the overall reporting quality of RCTs in MET for PCOS has improved over time, reporting of key methodological items remains poor. Reporting of RCTs on MET for PCOS should keep up with the standards of the CONSORT statement.
-
Systematic procedures addressing the limitations of eligibility determination are needed to improve the quality of participant recruitment and enrollment in randomized clinical trials. This paper describes an eligibility determination process developed by and in use at a chiropractic research center engaged in community recruitment for clinical trials studying spinal pain conditions. ⋯ The case review process uses the expertise of study coordinators, research clinicians, project managers, and investigators to render eligibility decisions consistent with study aims for the duration of the trial. This formal eligibility determination process includes steps designed to mitigate the potential for participant misclassification from clinician advocacy or misunderstanding of eligibility criteria, and helps ensure that participants can safely take part in study procedures.