Current medical research and opinion
-
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.
-
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.
-
Multicenter Study
Clinical and inflammation marker features of cancer patients with COVID-19: data of Istanbul, Turkey multicenter cancer patients (2020-2022).
We aimed to identify a rapid, accurate, and accessible biomarker in the early stages of COVID-19 that can determine the prognosis of the disease in cancer patients. ⋯ This is the first study to investigate the distribution and characteristics of cancer patients, with a focus on the years of their COVID-19 diagnosis. Based on the data from our study, bilateral lung involvement is an independent factor for severe disease, and the CRP/L inflammation index appears to be the most reliable prognostic marker.
-
Randomized Controlled Trial
Uric acid-lowering therapy with benzbromarone in hypertension with asymptomatic hyperuricemia: a randomized study focusing left ventricular diastolic function.
Both hypertension and hyperuricemia are closely associated with the morbidity and mortality of heart failure with preserved ejection fraction (HFpEF). However, there is limited evidence on the effect of uric acid-lowering therapy on left ventricular (LV) diastolic function in this population. In this randomized study, we prescribed benzbromarone, a uric acid-lowering drug, to those with hypertension and asymptomatic hyperuricemia to investigate its clinical benefits by evaluating LV diastolic function, incidence of HFpEF and hospitalization for heart failure and cardiovascular death. ⋯ Our study demonstrated the efficiency of benzbromarone in hypertensive patients with concomitant asymptomatic hyperuricemia, including the benefits on ameliorating LV diastolic dysfunction as well as improving composite endpoints.
-
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.