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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Randomized Controlled Trial
Impact of lurasidone on health-related quality of life in adults with bipolar depression: a post-hoc analysis.
The objective of this post-hoc analysis was to assess the impact of lurasidone monotherapy on health-related quality of life (HRQoL) in adults with bipolar depression. ⋯ Treatment with lurasidone provided a significant improvement across HRQoL items including overall life satisfaction, social and family relationships, medication satisfaction, and ability to function in daily life. Improvements were sustained during the 6-month OLE.
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In a previous study on the reasons for discontinuation of novel oral anticoagulation therapy (NOAC) in patients with atrial fibrillation, we showed that minor bleeding was the second most important reason for NOAC discontinuation. This finding suggest that the impact of minor bleeds on the patient's perspective on NOACs cannot be ignored, especially those minor bleeds for which the patient searched medical care. We therefore performed a study in which we explored the impact of minor bleed (clinically relevant non-major bleeds) on patient confidence in therapy, adherence to treatment and quality of life in AF patients using NOAC's. ⋯ In our study the level of trust, annoyance and concern were not significantly impacted by the CRNMB, nor the adherence to treatment and impact on daily life and physical activities. However, on an individual basis, there were patients that reported a high impact. We hope that future data on impact of this type of minor bleeds will help us identify and guide suboptimaly adherent NOAC patients in shared decision manner.
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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.