- Prevalence of anxiety in patients with an implantable cardioverter defibrillator: measurement equivalence of the HADS-A and the STAI-S. [Journal Article]
- QLQual Life Res 2019 Jun 22
- CONCLUSIONS: STAI-S and HADS-A reflect a common anxiety attribute, but using the recommended cutoff scores on the respective measures show very different prevalence rates and would classify patients as anxious with the STAI-S who would not be identified as such with the HADS-A. Clinicians and researchers should be aware of the inequivalence when using these measures for screening and determining the prevalence of probable clinical anxiety levels.
- Validation of the electronic PASI application: establishing measurement equivalence. [Journal Article]
- JAJ Am Acad Dermatol 2019 Jun 19
- Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial. [Journal Article]
- TTrials 2019 Jun 21; 20(1):376
- CONCLUSIONS: Our study will provide evidence to inform national and international policies, standard care guidelines and training program curricula on treatment of second-trimester incomplete abortion for improved access.
- Nanomedicines - Tiny particles and big challenges. [Journal Article]
- ADAdv Drug Deliv Rev 2019 Jun 18
- After decades of research, nanotechnology has been used in a broad array of biomedical products including medical devices, drug products, drug substances, and pharmaceutical-grade excipients. But lik…
After decades of research, nanotechnology has been used in a broad array of biomedical products including medical devices, drug products, drug substances, and pharmaceutical-grade excipients. But like many great achievements in science, there is a fine balance between the risks and opportunities of this new technology. Some materials and surface structures in the nanosize range can exert unexpected toxicities and merit a more detailed safety assessment. Regulatory agencies such as the United States Food and Drug Administration or the European Medicines Agency have started dealing with the potential risks posed by nanomaterials. Considering that a thorough characterization is one of the key aspects of controlling such risks this review presents the regulatory background of nanosafety assessment and provides some practical advice on how to characterize nanomaterials and drug formulations. Further, the challenges of how to maintain and monitor pharmaceutical quality through a highly complex production processes will be discussed.
- Disparities in Dietary Patterns by Urbanization Among US Adults, 2013-2016 (P04-104-19). [Journal Article]
- CDCurr Dev Nutr 2019; 3(Suppl 1)
- CONCLUSIONS: Disparities in dietary patterns exist by urbanization. Additional research may show how these differences impact health and identify opportunities to improve health in rural communities.
- Effect of Red Raspberry (Rubus idaeus L.) Consumption With or Without Fructo-Oligosaccharide on Metabolic Indices: A Single-Blinded Randomized, Crossover Clinical Trial (OR29-03-19). [Journal Article]
- CDCurr Dev Nutr 2019; 3(Suppl 1)
- CONCLUSIONS: 4-week RRB intervention improves glycemic and lipid profiles in people with IR. Adding FOS to RRB supplement enhanced the glycemic benefits, but attenuated the lipid-lowering effect of RRB.
- Assessing Statistical Similarity and Differences in Dietary Intakes of Women of Reproductive Age in Bangladesh (P10-058-19). [Journal Article]
- CDCurr Dev Nutr 2019; 3(Suppl 1)
- CONCLUSIONS: Dietary intakes of PW and LW are similar to NPNL women in rural Bangladesh. There is a need to enhance women's diets, especially during pregnancy and lactation when demand for macronutrients and micronutrients is elevated.
- The 'totality-of-the-evidence' approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product. [Review]
- TATherap Adv Gastroenterol 2019; 12:1756284819852535
- The 'totality-of-the-evidence' biosimilarity concept requires that sufficient structural, functional, nonclinical, and clinical data are acquired in a stepwise manner, to demonstrate that no clinical…
The 'totality-of-the-evidence' biosimilarity concept requires that sufficient structural, functional, nonclinical, and clinical data are acquired in a stepwise manner, to demonstrate that no clinically meaningful differences in quality, safety, or efficacy are observed compared with the reference product. We describe the totality of the evidence for PF-06438179/GP1111 (PF-SZ-IFX; IXIFI™ [infliximab-qbtx]/Zessly®) that supported its approval as an infliximab (IFX) biosimilar for all eligible indications of reference IFX (ref-IFX; Remicade®) in Europe and in the US. Analytical similarity involving in vitro assays capable of distinguishing structural or functional differences between PF-SZ-IFX and ref-IFX formed a foundation for the biosimilarity exercise. Differences identified in N-glycosylation and charge heterogeneity were found not to impact the results in in vitro biological assays reflective of the pharmacology underlying the mechanisms of action (tumor necrosis factor binding, reverse signaling, antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity) of IFX across disease indications. Similarity was assessed in a comparative clinical pharmacokinetic study and in a clinical efficacy and safety study in patients with rheumatoid arthritis, where therapeutic equivalence between PF-SZ-IFX and ref-IFX provided confirmatory evidence of biosimilarity, and, when coupled with the analytical similarity already established, supported extrapolation to all eligible disease indications of ref-IFX.
- Are Juveniles Who Have Committed Sexual Offenses the Same Everywhere? Psychometric Properties of the Juvenile Sex Offender Assessment Protocol-II in a Portuguese Youth Sample. [Journal Article]
- SASex Abuse 2019 Jun 21; :1079063219858070
- Over the last decade, we have witnessed consistent advances in risk assessment procedures, namely the validation of those used with juveniles who have committed sexual offenses. The adaptation of the…
Over the last decade, we have witnessed consistent advances in risk assessment procedures, namely the validation of those used with juveniles who have committed sexual offenses. The adaptation of these instruments into other languages requires research examining the conceptual and metric equivalence of the instruments, not just translation equivalence. Informed by data from 141 boys, aged 13 to 18, the psychometric properties of the Portuguese version of the Juvenile Sex Offender Assessment Protocol-II (J-SOAP-II), regarding reliability and construct validation, are presented and discussed. Factor structure, internal consistency, and interrater reliability were examined, and a reliable factorial structure that was consistent with the original validation of the J-SOAP was found. Scales 2 and 3 had good internal consistency, and Scale 1 had acceptable internal consistency. Results regarding concurrent validity revealed mostly statistically significant correlations. The implications of this research for juvenile sex offender risk assessments are discussed.
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- Cost Comparison of Benign Prostatic Hyperplasia Treatment Options. [Review]
- CUCurr Urol Rep 2019 Jun 19; 20(8):45
- To provide an economic context within which to consider treatment options for benign prostatic hyperplasia (BPH). To this end, this review provides a comparison of the costs of combination medical th…
To provide an economic context within which to consider treatment options for benign prostatic hyperplasia (BPH). To this end, this review provides a comparison of the costs of combination medical therapy, operative treatment, and office-based therapies for BPH from a payer perspective.