Trials
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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.
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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.
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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.
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Low back pain (LBP) is one of the most disabling and costly disorders affecting modern society, and approximately 90% of patients are labelled as having non-specific LBP (NSLBP). Several interventions for patients with NSLBP have been assessed in clinical trials, but heterogeneous reporting of outcomes in these trials has hindered comparison of results and performance of meta-analyses. Moreover, there is a risk of selective outcome reporting bias. To address these issues, the development of a core outcome set (COS) that should be measured in all clinical trials for a specific health condition has been recommended. A standardized set of outcomes for LBP was proposed in 1998, however, with evolution in COS development methodology, new instruments, interventions, and understanding of measurement properties, it is appropriate to update that proposal. This protocol describes the methods used in the initial step in developing a COS for NSLBP, namely, establishing a core domain set that should be measured in all clinical trials. ⋯ We present the initial step in developing a COS for NSLBP. The next step will be to determine which measurement instruments adequately cover the domains.