Current medical research and opinion
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Randomized Controlled Trial
Paediatric adverse event rating scale: a measure of safety or efficacy? Novel analysis from the MADDY study.
The Pediatric Adverse Event Rating Scale (PAERS) measured adverse events of children aged 6-12 years with ADHD and emotional dysregulation in the Micronutrients for ADHD in Youth (MADDY) study, an eight week multi-site randomized clinical trial of a broad-spectrum multinutrient treatment. Treatment sensitivity of the PAERS was assessed by calculating the treatment difference in change of the item scores from baseline to end of the RCT. ⋯ The multinutrient supplement did not result in more adverse events than placebo, suggesting it is a safe intervention. In addition to assessing actual adverse events, the PAERS may be a useful adjunct outcome measure for ADHD behaviors.
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Multicenter Study
Mapping author taxonomies and author criteria: good practices for thinking through complex authorship situations.
Authorship criteria can be difficult to apply in complex situations, such as multicenter clinical trials, multidisciplinary research, or manuscripts reporting the results of several studies. Authors may need additional guidance to appropriately credit their colleagues even when using existing accepted author criteria and/or contributor taxonomies to guide their decisions. Definitions and explanations of authorship by various editorial groups such as International Committee of Medical Journal Editors, the Committee on Publication Ethics, the World Association of Medical Editors, and the Council of Science Editors emphasize intellectual input and accountability. ⋯ The literature was searched for existing guidelines for authors that suggest how to apply accepted authorship criteria to activities listed in contributor taxonomies. No publication was identified that mapped specific authorship criteria to particular contributor taxonomies. Suggestions were developed to assist in differentiating activities that meet author criteria from other contributions outlined in two existing contributor taxonomies.
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Cardiac resynchronization therapy (CRT) can improve cardiac function in patients with heart failure (HF); however, in some patients, HF worsens despite CRT. This study characterized the long-term clinical burden of patients with and without HF worsening (HFW) within 6 months post CRT implantation. ⋯ Patients with early HFW post-CRT experienced a significantly higher clinical burden than those without HFW. Vigilance for signs of worsening HF in the first 6 months post-CRT is warranted.
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With the development of linnovative regulations on drug clinical trials in mainland China, the quantity and quality of drug clinical trials have gradually improved over the past decade. Based on the information of the clinical trials from the online drug clinical trial registration platform of National Medical Products Administration, we reviewed the data of drug clinical trials in mainland China from 2009 to 2020. A total of 8,593 clinical trials have been conducted during this period. ⋯ However, there were only 116 and 130 clinical trials of drugs for children and rare diseases respectively. The geographical distribution of the sites was uneven. This mapping review provides an overall look of clinical trials in China, which may be useful for domestic and international sponsors.
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The R.Evolution project aimed to reach a consensus on the main challenges of conducting clinical research in Italy and possible strategies and approaches to address them and optimize clinical research management. ⋯ According to the R.Evolution project, possible strategies to improve clinical research management in Italy include a deeper understanding of the value of clinical research, the creation of long-term plans for hiring, training, organizing and motivating clinical trial staff, the simplification and harmonization of administrative procedures, as well as protocol design, and the development of stronger networks of centers and stakeholders.