Catholics & Cultures as an Act of Improvisation: A Response

This essay responds to seven articles published in the same issue of the Journal of Global Catholicism on the use of Catholics & Cultures, a multimedia website, as a pedagogical resource for college classrooms. The site is deliberately presented in a fashion that undermines notions of center and periphery and presents Catholicism from a lay, lived-religion perspective as the multicultural faith that it is, minimizing reference to religious typologies. Particular attention is given to how to navigate tensions around theorizing, categorizing and sorting information for cross-cultural comparison. Given scholars’ current state of knowledge, writing about and teaching about global Catholicism requires willingness to grapple with material that is inevitably new to us, and that we can only improvisationally categorize and theorize about

Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: a multicenter, randomized, double-blind, placebo-controlled study.

BackgroundIn a previous randomized, double-blind, proof-of-concept study in rapidly escalating migraine, a 3 mg dose of subcutaneous sumatriptan (DFN-11) was associated with fewer and shorter triptan sensations than a 6 mg dose. The primary objective of the study was to assess the efficacy and safety of acute treatment with DFN-11 compared with placebo in episodic migraine.MethodsThis was a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of DFN-11 in the acute treatment of adults with episodic migraine (study RESTOR). The primary endpoint was the proportion of subjects taking DFN-11 who were pain free at 2 h postdose in the double-blind period compared with placebo. Secondary endpoints included earlier postdose timepoints, assessments of pain relief and subjects' freedom from their most bothersome symptom (MBS) (among nausea, photophobia, and phonophobia). Safety and tolerability were assessed.ResultsA total of 392 subjects was screened, 268 (68.4%) were randomized, and 234 (87.3% of those randomized) completed the double-blind treatment period. The proportion of subjects who were pain free at 2 h postdose was significantly greater in the DFN-11 group than in the placebo group (51.0% vs 30.8%, P  =  0.0023). Compared with placebo, significantly higher proportions of subjects treated with DFN-11 were also pain free at 30, 60, and 90 min postdose (P  ≤  0.0195). DFN-11 was significantly superior to placebo for pain relief at 60 min, 90 min, and 2 h postdose (P ≤ 0.0179). At 2 h postdose, DFN-11 was also significantly superior to placebo for freedom from photophobia (P  =  0.0056) and phonophobia (P  =  0.0167). Overall, 33.3% (37/111) who received DFN-11 and 13.4% (16/119) who received placebo experienced at least 1 treatment-emergent adverse event (TEAE), the most common of which were injection site swelling (7.2% vs 0.8%) and pain (7.2% vs 5.9%). Chest discomfort was about half as common in the DFN-11 treatment group as it was in the placebo group (0.9% vs 1.7%).ConclusionsThis study met its primary endpoint, pain freedom at 2 h postdose, with DFN-11 significantly better than placebo, and the incidence of TEAEs and triptan sensations with DFN-11 was low. The 3 mg dose of sumatriptan in DFN-11 appears to be an effective alternative to a 6 mg SC dose of sumatriptan, with good safety and tolerability. ( clinicaltrials.gov : NCT02569853; registered 07 October 2015)

Wearables and Warranties

The last few years have seen an explosion of wearable digital health products. Where a doctor’s visit used to be required for a basic check-up, now a patient’s health status is increasingly at his or her fingertips. We have the ability to track fitness levels, monitor lung and heart capacity, check skin temperature, and observe blood pressure with a simple wearable device

Gridsemble: Selective Ensembling for False Discovery Rates

In this paper, we introduce Gridsemble, a data-driven selective ensembling algorithm for estimating local false discovery rates (fdr) in large-scale multiple hypothesis testing. Existing methods for estimating fdr often yield different conclusions, yet the unobservable nature of fdr values prevents the use of traditional model selection. There is limited guidance on choosing a method for a given dataset, making this an arbitrary decision in practice. Gridsemble circumvents this challenge by ensembling a subset of methods with weights based on their estimated performances, which are computed on synthetic datasets generated to mimic the observed data while including ground truth. We demonstrate through simulation studies and an experimental application that this method outperforms three popular R software packages with their default parameter values\unicode{x2014}common choices given the current landscape. While our applications are in the context of high throughput transcriptomics, we emphasize that Gridsemble is applicable to any use of large-scale multiple hypothesis testing, an approach that is utilized in many fields. We believe that Gridsemble will be a useful tool for computing reliable estimates of fdr and for improving replicability in the presence of multiple hypotheses by eliminating the need for an arbitrary choice of method. Gridsemble is implemented in an open-source R software package available on GitHub at jennalandy/gridsemblefdr.Comment: 12 pages, 3 figures (+ references and supplement). For open-source R software package, see https://github.com/jennalandy/gridsemblefdr. For all code used in the simulation studies and experimental application, see https://github.com/jennalandy/gridsemble_PAPE