Current medical research and opinion
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Review
A systematic literature review of the economic and healthcare resource burden of cytomegalovirus.
Cytomegalovirus (CMV) can infect individuals at any age, including infants, who may contract it from infected mothers (congenital CMV [cCMV]). Whereas CMV infection is typically asymptomatic or causes mild illness in healthy individuals, infection can result in severe outcomes in immunocompromised individuals and in infants with cCMV. This systematic review aims to characterize the economic impact of CMV and cCMV infections. ⋯ CMV and cCMV infections impose a considerable economic impact on different countries, populations, and outcomes. There are substantial evidence gaps where further research is warranted.
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Review
Patient-reported outcomes validated in Phase 3 clinical trials: a targeted literature review.
Regulatory guidance advises validation of patient-reported outcome (PRO) instruments prior to use in pivotal clinical studies, which may then be used to generate critical patient-centered evidence and support labelling claims. This targeted literature review aimed to determine if PRO instruments psychometrically validated in a phase 3 trial setting could support label claims from the same phase 3 study (i.e. PRO data were generated as an endpoint). ⋯ These results suggest that quantitative validation of novel PRO instruments, and existing PROs for new indications, can occur within the context of phase 3 trials, and these PROs can also support label claims.
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Medical Information in the pharmaceutical industry involves the creation and dissemination of evidence-based scientific medical content in response to questions about medicines and therapy areas for patients and healthcare professionals. Health information equity can be broadly defined as the distribution of health information in a way that is accessible and understandable to all users, allowing them to benefit and reach their full potential for health. Ideally, this information would be made available to all those in need across the globe. ⋯ The World Health Organization defines health inequity as differences in health status or in the distribution of health resources between different population groups. Health inequities are influenced by the social conditions in which people are born, grow, live, work and age. This article explains select key factors influencing health information inequity and addresses opportunities where Medical Information departments can make a difference to improve global public health.
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Treatment guidelines recommend integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) regimens for treatment naïve people living with HIV (PLWH) in the United States (US). This retrospective database study compared weight changes following initiation of INSTI-, non-nucleoside reverse transcriptase inhibitor (NNRTI)-, or protease inhibitor (PI)-based ART in treatment-naïve PLWH. ⋯ Study findings highlight the need to monitor an increase in weight and potential metabolic complications among PLWH starting ART with INSTI.
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Medicare Part D Star Ratings are instrumental in shaping healthcare quality improvement efforts. However, the calculation metrics for medication performance measures for this program have been associated with racial/ethnic disparities. In this study, we aimed to explore whether an alternative program, named Star Plus by us that included all medication performance measures developed by Pharmacy Quality Alliance and applicable to our study population, would reduce such disparities among Medicare beneficiaries with diabetes, hypertension, and/or hyperlipidemia. ⋯ Our study demonstrated that racial/ethnic disparities may be eliminated by including additional medication performance measures to Star Ratings.