Study Finds Inadequate Reporting of Adverse Effects in RCTs
A recent study published in the Journal of Clinical Epidemiology, with DOI: 10.1016/j.jclinepi.2021.04.020, has analysed 1,200 Randomised Controlled Trials (RCTs) to assess the reporting of adverse effects. The study, titled 'Time to improve the reporting of harms in randomized controlled trials', found that despite guidelines, reporting of adverse effects remains inadequate.
The study, conducted by authors whose specific details can be found in the journal, analysed RCTs published over 17 years. It found that while there has been some improvement, reporting of adverse effects is still insufficient. Less than half of the RCTs provided enough information to assess reported adverse effects. Moreover, some trials selectively reported harms, potentially painting an incomplete picture of a drug's cast.
The study highlights that many trials focus more on the benefits than the adverse effects of the drugs being trialled. Major guidelines on reporting RCTs, published in 2004, aimed to improve the reporting of adverse effects. However, the study suggests that these guidelines have not been fully implemented. The NHS, policy makers, and patients rely on reliable information about both benefits and adverse effects of treatments. The lack of comprehensive reporting can create a false impression of safety and misinform decisions.
The study underscores the need for improved reporting of adverse effects in RCTs. It calls for better implementation of existing guidelines and more focus on the potential harms of treatments, alongside their benefits. This will ensure that the NHS, policy makers, and patients have access to comprehensive and reliable information.
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