Current medical research and opinion
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When using administrative data, validation is essential since these data are not collected for research purposes and misclassification can occur. Thus, this study aimed to develop algorithms identifying pregnancy and to evaluate the validity of administrative claims data in Japan. ⋯ The combination algorithm to identify pregnancy demonstrated a high PPV and moderate SE. The algorithm validated in this study is expected to accelerate future studies that aim to identify pregnancies and evaluate pregnancy outcome.
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To develop a claims-based algorithm identifying systemic lupus erythematosus (SLE) flares using a linked claims-electronic medical record (EMR) dataset. ⋯ The final algorithm shows promise in providing an alternative and more streamlined way for identifying likely flares in administrative claims data that will advance the study of SLE within the context of flares.
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To examine whether QT interval shortening is an overlooked adverse event as compared to QT prolongation through a review of preclinical, clinical and post-marketing adverse event data available to the regulator for centrally and nationally authorized medicinal products. ⋯ From a regulatory perspective one cannot refute the possibility of a clinically relevant risk from QT shortening through the current testing requirements. Lack of further investigations into any potential morphological changes to the AP, or APD90 shortening beyond a specified threshold in our opinion does not fully exclude the possibility of proarrhythmic effects of active substances.
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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.