Search

Abstract Background Understanding patients’ perspectives regarding drug tolerability, in addition to effectiveness, provides a complete picture of the patient experience and supports more informed therapeutic decision-making. The item library of the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed to measure patient-reported frequency, severity, and interference of adverse events (AEs) associated with cancer therapies. This qualitative interview study assessed the suitability of items selected from the PRO-CTCAE library for assessing tolerability of selexipag, a medication targeting the prostacyclin pathway for patients with pulmonary arterial hypertension (PAH). Methods Two rounds of 10 qualitative, web-assisted telephone interviews following a semi-structured guide were conducted in individuals with recent experience taking oral selexipag for PAH. Each interview included concept elicitation to gather participants’ perspectives on symptomatic AEs (type, frequency, severity, and interference) and cognitive debriefing of PRO-CTCAE items addressing the most frequently reported AEs of oral selexipag. Results Interviews were conducted with 20 participants with PAH (mean [range] age 50 [24–68] years; 75% female; 85% in World Health Organization Functional Class II–III), comprising different races/ethnicities, levels of education, and employment status. Fifteen participants were currently treated with selexipag; five had taken selexipag for ≥ 6 months before discontinuing. The most frequently reported AEs included headache, jaw pain, and nausea (n = 15, 12, and 10 participants, respectively). Diarrhea and headache were identified as the most bothersome AEs by 5 and 4 participants, respectively. Some AEs were transitory (e.g., jaw pain); others were long-lasting (e.g., muscle pain). Based on findings from Round 1 interviews, a flushing item was added and the PRO-CTCAE general pain item was modified to be specific to jaw pain for testing in Round 2. Interview findings identified the following AEs as relevant to assess in a PAH clinical trial: nausea, vomiting, diarrhea, flushing, jaw pain, headache, aching muscles, and aching joints. Conclusions The PRO-CTCAE items selected in this study and the additional symptomatic AEs identified as patient-relevant have the potential to be included in assessments capturing the patient perspective on tolerability in future studies of selexipag and possibly other PAH therapies.

Summary: Larger vehicles, such as sports utility vehicles, consume more energy than cars. Their increasing popularity runs contrary to the goal of fuel economy regulations to reduce fossil fuel consumption and greenhouse gas emissions and can be explained by consumer preference and lower regulation stringency, which is due to footprint, truck classification, and the omission of heterogenous lifetime vehicle distance traveled among vehicle classes. This study shows that, for both the US and China, large vehicles travel more, last longer, and are owned by higher income consumers. This means large vehicles and their high-income owners use more fuel and emit more pollutants than represented by current policy and thus raises both policy effectiveness and energy equity concerns. We propose and estimate Sales Adjustment Factors that weigh fuel economy standards based on vehicle lifetime usage and demonstrate the resultant significant improvements in the effectiveness and equity of fuel economy regulations.

Objectives To describe the outcomes of pregnancies in antiphospholipid antibody (aPL)-positive patients since the inception of the AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking Registry.Methods We identified persistently aPL-positive patients recorded as ‘pregnant’ during prospective follow-up, and defined ‘aPL-related outcome’ as a composite of: (1) Preterm live delivery (PTLD) at or before 37th week due to pre-eclampsia (PEC), eclampsia, small-for-gestational age (SGA) and/or placental insufficiency (PI); or (2) Otherwise unexplained fetal death after the 10th week of gestation. The primary objective was to describe the characteristics of patients with and without aPL-related composite outcomes based on their first observed pregnancies following registry recruitment.Results Of the 55 first pregnancies observed after registry recruitment among nulliparous and multiparous participants, 15 (27%) resulted in early pregnancy loss

The books of Ezekiel and Daniel, specifically Ezek 4.9 and Daniel 1, 3, and 6, are now being used to market healthy eating and diet plans to Christians, especially evangelical Christians, in ways that are the opposite of how the texts appear in their historical and literary contexts. Such usage is a potentially problematic example of prophetic reception history and its contemporary significance because the language in these plans is the same language found in secular diet plans with biblical prooftexts added to them. The addition may actually make the plans even more problematic by linking weight and fitness to religion and spirituality.

Julius Wellhausen (1844–1918) is in many ways the ancestor of modern Hebrew Bible scholarship. His Prolegomena to the History of Israel condensed decades of source critical work on the Torah into a documentary hypothesis that is still taught today in almost all Hebrew Bible courses in some form. What is not taught as frequently is the anti-Judaism that underpins his hypothesis. This is in part due to unapologetic apologetics regarding Wellhausen’s bias, combined with the insistence that a nineteenth-century scholar cannot be judged by twenty-first century standards. These calls for compassion are made exclusively by white male scholars, leaving Jewish scholars the solitary task of pointing out Wellhausen’s clear anti-Judaism. In a discipline that is already overwhelmingly white, male and Christian, the minimizing of Wellhausen’s racism suggests two things. First, those who may criticize contextual biblical studies done by women and scholars of color have no problem pleading for a contextual understanding of Wellhausen while downplaying the growing anti-Judaism and nationalism that was a part of nineteenth-century Germany. Second, recent calls for inclusion in the Society of Biblical Literature may be well intentioned but ultimately useless if the guild cannot simply call one of its most brilliant founders the biased man that he was.