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\"Go behind the scenes of seven of today's most popular narrative radio shows and podcasts, including This American Life and RadioLab, in graphic narrative. Every week, millions of devoted fans tune in to or download This American Life, The Moth, Radiolab, Planet Money, Snap Judgment, Serial, Invisibilia and other narrative radio shows. Using personal stories to breathe life into complex ideas and issues, these beloved programs help us to understand ourselves and our world a little bit better. Each has a distinct style, but every one delivers stories that are brilliantly told and produced. Out on the Wire offers an unexpected window into this new kind of storytelling--one that literally illustrates the making of a purely auditory medium. With the help of This American Life's Ira Glass, Jessica Abel, a cartoonist and devotee of narrative radio, uncovers just how radio producers construct narrative, spilling some juicy insider details. Jad Abumrad of RadioLab talks about chasing moments of awe with scientists, while Planet Money's Robert Smith lets us in on his slightly goofy strategy for putting interviewees at ease. And Abel reveals how mad--really mad--Ira Glass becomes when he receives edits from his colleagues. Informative and engaging, Out on the Wire demonstrates that narrative radio and podcasts are creating some of the most exciting and innovative storytelling available today\"-- Provided by publisher.

Chronic idiopathic constipation (CIC) is a prevalent functional gastrointestinal disorder diagnosed based on patient-reported symptoms and the absence of structural gastrointestinal abnormalities. Individuals with CIC typically institute dietary changes and use stool softeners or over-the-counter (OTC) laxatives, possibly at the direction of a healthcare provider, before prescription medications for CIC are initiated. Although highly prevalent, there is limited information regarding CIC patient experiences with OTC medications. This post-hoc analysis used patient-reported data from a questionnaire administered during patient screening for a prospective linaclotide Phase 3b clinical trial in patients with CIC (N = 1482 screened). The questionnaire asked patients to report their experiences with OTC CIC medications over the preceding 6 months. Among patients with screening responses (N = 1423), most were female (85%) and white (66%), with a mean age of 48.9 years. A high proportion of patients had used one or more OTC medications (70% had ≥1 OTC; 19% had ≥3 OTCs), with the majority being bisacodyl (33%) and polyethylene glycol (30%). The most commonly cited reason for stopping an OTC medication was insufficient symptom relief (17-40%). The majority of patients taking OTC medications reported no or little satisfaction with the medication's effect on their constipation (62%) and CIC-specific abdominal symptoms (78%). Many patients had little to no confidence in bowel movement (BM) frequency after taking OTC medications and their confidence in their ability to predict BM timing was also low (49-81% not at all confident). Treatment effects on individual CIC symptoms, predictability of bowel habits, and satisfaction with treatment are all important factors for healthcare providers and patients to consider when establishing an effective treatment regimen for CIC. NCT01642914.

Linaclotide improves abdominal pain and constipation in patients with constipation-predominant irritable bowel syndrome (IBS-C). Patients report additional bothersome abdominal symptoms of bloating and discomfort. The intention of this study was to evaluate linaclotide's efficacy in relieving IBS-C-related abdominal symptoms (bloating, discomfort, and pain) using a novel multi-item Abdominal Score (AS). Patients with IBS-C with abdominal pain ≥3 (0-10 scale) were randomized to linaclotide 290 μg or placebo daily for 12 weeks. The AS, derived from the Diary for IBS Symptoms-Constipation, is the average of abdominal bloating, discomfort, and pain at their worst (0 = none, 10 = worst possible). The primary end point was overall change from baseline (CFB) in AS. Secondary end points included CFB in 12-week AS evaluated using cumulative distribution function and 6-week/12-week AS responder (AS improvement ≥2 points for ≥6-week/12-week). Overall, 614 patients (mean age 46.7 years; 81% female) were randomized. All prespecified end points showed significant benefit of linaclotide vs placebo. The mean overall CFB AS reduction for linaclotide was -1.9 vs -1.2 for placebo (P < 0.0001); the 6-week/12-week AS responder rate was 40.5% for linaclotide vs 23.4% for placebo (odds ratio = 2.2 [95% confidence interval, 1.55-3.12; P < 0.0001]). Diarrhea was the most common treatment-emergent adverse event (linaclotide = 4.6%, placebo = 1.6%). Linaclotide significantly reduced multiple abdominal symptoms important to patients with IBS-C (bloating, discomfort, and pain) compared with placebo, as measured by a novel multi-item AS. The AS, derived from the Diary for IBS Symptoms-Constipation, should be considered for use in future IBS-C clinical studies to measure clinically meaningful improvements beyond traditional end points.

Background Patient-reported outcomes (PROs) are required to assess the efficacy of treatments for functional constipation (FC), which is one of the most common functional gastrointestinal disorders in children. A novel PRO, the Pediatric Functional Constipation Symptom Diary (PFCSD), was developed to assess 7 core symptoms of FC (stool frequency, stool consistency, incomplete evacuation, straining, abdominal pain, abdominal bloating, and fecal incontinence) in pediatric FC patients. Here, we describe the psychometric analyses of the PFCSD using data from a phase 3 clinical trial of linaclotide (LIN-MD-64; NCT04026113) in children with FC. Methodology This psychometric evaluation assessed the measurement properties (reliability, validity, responsiveness) and meaningful within-patient change thresholds for symptom scores derived from the PFCSD. Since spontaneous bowel movement (SBM) frequency and stool consistency (measured using the pediatric Bristol Stool Form Scale in the PFCSD) were key endpoints for the phase 3 clinical trial of linaclotide, scores from these 2 items were the primary focus of these psychometric analyses. Daily and weekly responses on the PFCSD were assessed across a 14-week period from 328 pediatric patients aged 6 to 17 years who met the modified Rome III criteria for child/adolescent FC. Results Test-retest reliability, construct validity, and responsiveness of SBM frequency and stool consistency scores on the PFCSD were supported by this psychometric evaluation. Using intraclass correlation coefficients (ICCs), PFCSD scores on items measuring SBM frequency (ICC = 0.91) and stool consistency (ICC = 0.56) were consistent across repeated administrations. Convergent and discriminant correlations underscored the validity of SBM frequency and stool consistency scores on the PFCSD. The meaningful change threshold for weekly SBM frequency was identified as a change from baseline of ≥ 2 SBMs. For stool consistency, the meaningful change threshold ranged between + 0.8 to + 1.7 on the pediatric Bristol Stool Form Scale. Conclusions The PFCSD is a novel, fit-for-purpose PRO measure evaluating key symptoms experienced by patients with FC aged 6 to 17 years. These analyses support the reliability, validity, and responsiveness of SBM frequency rate and stool consistency scores on the PFCSD in this target population and provide further guidance for interpreting meaningful changes in these scores at the individual level.

This study aimed to evaluate gold nanoparticles (GNPs) and photobiomodulation (PBM), associated with antibothropic serum (AS), to treat a muscle lesion induced by Bothrops jararaca venom. Methods: 108 Swiss male mice were used, divided into nine groups ( n  = 12) with different combinations of treatments. Animals were inoculated with 250 µg of B. jararaca venom at the right gastrocnemius muscle. The treatment started 12 h after the venom injection and occurred daily for 7 days. AS was administered as recommended by the Ministry of Health. Low-power aluminum gallium indium phosphide (AlGaInP) with continuous emission (wavelength 660 nm; average power 30 mW ± 20%; beam size of 0.06310 cm 2 ; and dose of 2 J for ± 1 min per point). Irradiation was applied to five distinct areas surrounding the wound, at a perpendicular angle to the skin. The groups treated with GNPs received treatment through the application of 1 mL of 20 nm GNPs (30 mg/L). Muscle, heart, and kidneys were removed for histological and biochemical analysis. Results: GNPs can improve the results achieved by PBM and the standard treatment, presenting significant benefits in histological parameters, such as the increase of new blood vessels, fibroblasts, collagen, and a reduction of inflammatory infiltrate. Conclusion: GNPs can be considered an option to accelerate the recovery of Bothrops lesions. Graphical Abstract

Sensor-based digital health technologies (DHTs) enable continuous collection of physiological data, sensor-based functional outcomes, and performance outcomes in clinical and real-world settings. However, cross-therapeutic reviews examining sensor-based DHTs as outcome measurement tools rather than interventions in recent pharmaceutical and device trials are lacking, limiting understanding of practical implementation and utility in COA development for use in clinical trials. To address this gap, a scoping review was conducted that encompassed clinical studies that used sensor-based DHTs and were published in MEDLINE, MEDLINE In-Process, and PsycINFO databases from January 2021-December 2023. In total, 48 studies were included, and most ( n = 38; 79%) collected sensor-based physiological data, with continuous glucose monitoring (CGM) being the most frequent. Additionally, 12 studies (25%) described sensor-based outcomes, such as physical activity and sleep; 2 studies collected both sensor-based physiological data and clinical outcomes. Our findings highlight the use of sensor-based DHTs in clinical research to measure patient outcomes and describe challenges in implementing these technologies in clinical trials.

Purpose Irritable bowel syndrome with diarrhea (IBS-D) significantly impacts health-related quality of life (HRQOL). This post hoc analysis of two phase III trials evaluated the effects of eluxadoline treatment on disease-specific HRQOL among patients with IBS-D. Methods Adult patients meeting Rome III criteria for IBS-D were randomized to oral eluxadoline (75 mg or 100 mg) or placebo twice daily in two phase III clinical trials for 52 weeks (IBS-3001) and 26 weeks (IBS-3002). The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire assessed disease-specific HRQOL throughout the study. Changes from baseline to Week 26 in IBS-QOL total and subscale scores were analyzed using an analysis of covariance model. Percentages of IBS-QOL responders with ≥ 14- and 20-point changes were evaluated for IBS-QOL total and subscale scores. A longitudinal mixed-effects model was fitted to evaluate mean IBS-QOL total scores. A cumulative distribution function for change from baseline to Week 26 in IBS-QOL total score was plotted. Results Mean changes from baseline to Week 26 for the IBS-QOL total and all subscale scores were significantly higher for patients treated with eluxadoline (both doses) compared to placebo. A significantly greater proportion of eluxadoline-treated patients were responders compared to placebo. Mean and mixed-effects model estimated mean IBS-QOL total scores were consistently higher for eluxadoline versus placebo over 52 weeks. Conclusions Compared to placebo, twice-daily eluxadoline treatment significantly improved HRQOL among patients with IBS-D in two phase III trials.