Equivalent user experience and improved community augmented meta-analyses knowledge for a new version of a Plain Language Summary guideline.

Plain Language Summaries (PLS) offer a promising solution to make meta-analytic psychological research more accessible for non-experts and laypeople. However, existing writing guidelines for this type of publication are seldom grounded in empirical studies. To address this and to test two versions of a new PLS guideline, we investigated the impact of PLSs of psychological meta-analyses on laypeoples' PLS-related knowledge and their user experience (accessibility, understanding, empowerment). In a preregistered online-study, N = 2,041 German-speaking participants read two PLSs. We varied the inclusion of a disclaimer on PLS authorship, a statement on the causality of effects, additional information on community augmented meta-analyses (CAMA) and the PLS guideline version. Results partially confirmed our preregistered hypotheses: Participants answered knowledge items on CAMA more correctly when a PLS contained additional information on CAMA, and there were no user experience differences between the old and the new guideline versions. Unexpectedly, a priori hypotheses regarding improved knowledge via the use of a disclaimer and a causality statement were not confirmed. Reasons for this, as well as general aspects related to science communication via PLSs aimed at educating laypeople, are discussed.

Indicators of trustworthiness in lay-friendly research summaries: Scientificness surpasses easiness.

Lay readers' trust in scientific texts can be shaped by perceived text easiness and scientificness. The two effects seem vital in a time of rapid science information sharing, yet have so far only been examined separately. A preregistered online study was conducted to assess them jointly, to probe for author and text trustworthiness overlap, and to investigate interindividual influences on the effects. N = 1467 lay readers read four short research summaries, with easiness and scientificness (high vs low) being experimentally varied. A more scientific writing style led to higher perceived author and text trustworthiness. Higher personal justification belief, lower justification by multiple-sources belief, and lower need for cognitive closure attenuated the influence of scientificness on trustworthiness. However, text easiness showed no influence on trustworthiness and no interaction with text scientificness. Implications for future studies and suggestions for enhancing the perceived trustworthiness of research summaries are discussed.

Effects of vegan diets on cardiometabolic health: A systematic review and meta-analysis of randomized controlled trials.

In parallel with an increased focus on climate changes and carbon footprint, the interest in plant-based diets and its potential health effects have increased over the past decade. The objective of this systematic review and meta-analysis was to examine the effect of vegan diets (≥12 weeks) on cardiometabolic risk factors in people with overweight or type 2 diabetes. We identified 11 trials (796 participants). In comparison with control diets, vegan diets reduced body weight (-4.1 kg, 95% confidence interval (CI) -5.9 to -2.4, p < 0.001), body mass index (BMI) (-1.38 kg/m2 , 95% CI -1.96 to -0.80, p < 0.001), glycated hemoglobin (HbA1c ) (-0.18% points, 95% CI -0.29 to -0.07, p = 0.002), total cholesterol (-0.30 mmol/L, 95% CI -0.52 to -0.08, p = 0.007), and low-density lipoprotein cholesterol (-0.24 mmol/L, 95% CI -0.40 to -0.07, p = 0.005). We identified no effect on blood pressure, high-density lipoprotein cholesterol, and triglycerides. We found that adhering to vegan diets for at least 12 weeks may be effective in individuals with overweight or type 2 diabetes to induce a meaningful decrease in body weight and improve glycemia. Some of this effect may be contributed to differences in the macronutrient composition and energy intake in the vegan versus control diets. Therefore, more research is needed regarding vegan diets and cardiometabolic health.

To Have the Best Interest at Heart: Analyzing the Match Between Laypersons' Interests and Publication Activity in Psychology.

There is a growing public interest in science and, by extension, in psychology, and human behavior. Yet, detailed investigations on whether academic psychological research activity matches lay interests are still scarce. In addition, while lay-friendly communication of research findings becomes continually more important, it is unclear which subfields of psychological research are particularly interesting to laypeople. To address these research gaps, we carried out an explorative study of psychological literature included in two large reference databases, one with a German (PSYNDEX) and one with an international (PsycInfo) scope. The years of 2018-2020 were scanned for articles belonging to one of 20 topic areas assessed as most interesting by lay participants in a previous study. We determined and compared the share of empirical research and research syntheses for each topic area and database and computed rank correlations between lay interest and academic publication volume. Results suggest a positive relationship between lay interest and academic publication activity specifically for research syntheses. Additionally, topic areas associated with clinical psychology offered a large share of research syntheses, while other topic areas such as "Psychodynamics" or "Industrial & Organizational Psychology" encompassed a smaller share of syntheses. Finally, we outline perspectives for long-term monitoring of psychology-related lay interests. Thus, the present study connects academic activity with the public interest in psychology by identifying and quantifying research syntheses for topics garnering the most lay interest.

How to Put It Plainly? Findings From Two Randomized Controlled Studies on Writing Plain Language Summaries for Psychological Meta-Analyses.

Plain language summaries (PLS) aim to communicate research findings to laypersons in an easily understandable manner. Despite the societal relevance of making psychological research findings available to the public, our empirical knowledge on how to write PLS of psychology studies is still scarce. In this article, we present two experimental studies investigating six characteristics of PLS for psychological meta-analyses. We specifically focused on approaches for (1) handling technical terms, (2) communicating the quality of evidence by explaining the methodological approach of meta-analyses, (3) explaining how synthesized studies operationalized their research questions, (4) handling statistical terms, (5) structuring PLS, and (6) explaining complex meta-analytic designs. To develop empirically validated guidelines on writing PLS, two randomized controlled studies including large samples stratified for education status, age, and gender (N Study1=2,288 and N Study2=2,211) were conducted. Eight PLS of meta-analyses from different areas of psychology were investigated as study materials. Main outcome variables were user experience (i.e., perceived accessibility, perceived understanding, and perceived empowerment) and knowledge acquisition, as well as understanding and knowledge of the quality of evidence. Overall, our hypotheses were partially confirmed, with our results underlining, among other things, the importance of explaining or replacing content-related technical terms (i.e., theoretical concepts) and indicating the detrimental effects of providing too many details on statistical concepts on user experience. Drawing on these and further findings, we derive five empirically well-founded rules on the lay-friendly communication of meta-analytic research findings in psychology. Implications for PLS authors and future research on PLS are discussed.

Patterns of univariate and multivariate plasticity to elevated carbon dioxide in six European populations of Arabidopsis thaliana.

The impact of elevated carbon dioxide on plants is a growing concern in evolutionary ecology and global change biology. Characterizing patterns of phenotypic integration and multivariate plasticity to elevated carbon dioxide can provide insights into ecological and evolutionary dynamics in future human-altered environments. Here, we examined univariate and multivariate responses to carbon enrichment in six functional traits among six European accessions of Arabidopsis thaliana. We detected phenotypic plasticity in both univariate and multivariate phenotypes, but did not find significant variation in plasticity (genotype by environment interactions) within or among accessions. Eigenvector, eigenvalue variance, and common principal components analyses showed that elevated carbon dioxide altered patterns of trait covariance, reduced the strength of phenotypic integration, and decreased population-level differentiation in the multivariate phenotype. Our data suggest that future carbon dioxide conditions may influence evolutionary dynamics in natural populations of A. thaliana.

Induced mutations alter patterns of quantitative variation, phenotypic integration, and plasticity to elevated CO2 in Arabidopsis thaliana.

A key step toward predicting responses to climate change is characterizing genetic variation in populations. While short-term responses will likely be shaped by currently available genetic variation, longer-term evolutionary responses will depend on the supply of novel variation by, ultimately, mutation. Studying mutational contributions to phenotypic variation can provide insights into the extent of potential variation on which selection may operate in future human-altered environments. Here we used the chemical mutagen ethyl methanesulfonate (EMS) to explore mutational contributions to phenotypic variation, integration, and plasticity to elevated carbon dioxide (eCO2) in three accessions of Arabidopsis thaliana. We found that (1) mutagenesis increased broad-sense heritabilities and variation in plasticity to eCO2 (genotype by environment interactions); (2) mutational effects varied among the three genetic backgrounds; (3) induced mutations had non-random (biased) effects on patterns of phenotypic integration. To our knowledge, this is the first study to address the effects of chemically induced mutations on phenotypic plasticity to eCO2 in a model plant. We discuss our results in light of emerging insights from theoretical and empirical quantitative genetics, suggest potential avenues of research, and identify approaches that may help advance our understanding of climate-driven evolution in plants.

Seladelpar (MBX-8025), a selective PPAR-δ agonist, in patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid: a double-blind, randomised, placebo-controlled, phase 2, proof-of-concept study.

BACKGROUND: Many patients with primary biliary cholangitis have an inadequate response to first-line therapy with ursodeoxycholic acid. Seladelpar is a potent, selective agonist for the peroxisome proliferator-activated receptor-delta (PPAR-δ), which is implicated in bile acid homoeostasis. This first-in-class study evaluated the anti-cholestatic effects and safety of seladelpar in patients with an inadequate response to ursodeoxycholic acid. METHODS: The study was a 12-week, double-blind, placebo-controlled, phase 2 trial of patients with alkaline phosphatase of at least 1·67 times the upper limit of normal (ULN) despite treatment with ursodeoxycholic acid. Patients, recruited at 29 sites in North America and Europe, were randomly assigned to placebo, seladelpar 50 mg/day, or seladelpar 200 mg/day while ursodeoxycholic acid was continued. Randomisation was done centrally (1:1:1) by a computerised system using an interactive voice-web response system with a block size of three. Randomisation was stratified by region (North America and Europe). The primary outcome was the percentage change from baseline in alkaline phosphatase over 12 weeks, analysed in the modified intention-to-treat (ITT) population (any randomised patient who received at least one dose of medication and had at least one post-baseline alkaline phosphatase evaluation). This study is registered with ClinicalTrials.gov (NCT02609048) and the EU Clinical Trials Registry (EudraCT2015-002698-39). FINDINGS: Between Nov 4, 2015, and May 26, 2016, 70 patients were screened at 29 sites in North America and Europe. During recruitment, three patients treated with seladelpar developed fully reversible, asymptomatic grade 3 alanine aminotransferase increases (one on 50 mg, two on 200 mg), ranging from just over five to 20 times the ULN; as a result, the study was terminated after 41 patients were randomly assigned. The modified ITT population consisted of 12 patients in the placebo group, 13 in the seladelpar 50 mg group, and 10 in the seladelpar 200 mg group. Mean changes from baseline in alkaline phosphatase were -2% (SD 16) in the placebo group, -53% (14) in the seladelpar 50 mg group, and -63% (8) in the seladelpar 200 mg group. Changes in both seladelpar groups versus placebo were significant (p<0·0001 for both groups vs placebo), with no significant difference between the two seladelpar groups (p=0·1729). All five patients who received seladelpar for 12 weeks had normal alkaline phosphatase values at the end of treatment, based on a central laboratory ULN for alkaline phosphatase of 116 U/L. The most frequently reported adverse events were pruritus (16%; one patient on placebo, four on seladelpar 50 mg, and one on seladelpar 200 mg), nausea (13%; one patient on placebo, three on seladelpar 50 mg, and one on seladelpar 200 mg), diarrhoea (10%; two patients on placebo, one on seladelpar 50 mg, and one on seladelpar 200 mg), dyspepsia (8%; two patients on seladelpar 50 mg and one on seladelpar 200 mg), muscle spasms (8%; three patients on seladelpar 200 mg), myalgia (8%; one patient on placebo and two on seladelpar 200 mg), and dizziness (8%; one patient on placebo and two on seladelpar 50 mg). INTERPRETATION: Seladelpar normalised alkaline phosphatase levels in patients who completed 12 weeks of treatment. However, treatment was associated with grade 3 increases in aminotransferases and the study was stopped early. The effects of seladelpar should be explored at lower doses. FUNDING: CymaBay Therapeutics.

Hawaiian Drosophila genomes: size variation and evolutionary expansions.

This paper reports genome sizes of one Hawaiian Scaptomyza and 16 endemic Hawaiian Drosophila species that include five members of the antopocerus species group, one member of the modified mouthpart group, and ten members of the picture wing clade. Genome size expansions have occurred independently multiple times among Hawaiian Drosophila lineages, and have resulted in an over 2.3-fold range of genome sizes among species, with the largest observed in Drosophila cyrtoloma (1C = 0.41 pg). We find evidence that these repeated genome size expansions were likely driven by the addition of significant amounts of heterochromatin and satellite DNA. For example, our data reveal that the addition of seven heterochromatic chromosome arms to the ancestral haploid karyotype, and a remarkable proportion of ~70 % satellite DNA, account for the greatly expanded size of the D. cyrtoloma genome. Moreover, the genomes of 13/17 Hawaiian picture wing species are composed of substantial proportions (22-70 %) of detectable satellites (all but one of which are AT-rich). Our results suggest that in this tightly knit group of recently evolved species, genomes have expanded, in large part, via evolutionary amplifications of satellite DNA sequences in centric and pericentric domains (especially of the X and dot chromosomes), which have resulted in longer acrocentric chromosomes or metacentrics with an added heterochromatic chromosome arm. We discuss possible evolutionary mechanisms that may have shaped these patterns, including rapid fixation of novel expanded genomes during founder-effect speciation.

Lack of Clostridium difficile infection in patients treated with rifaximin for hepatic encephalopathy: a retrospective analysis.

GOALS: The purpose of this study was to assess the incidence of Clostridium difficile infection in patients who received rifaximin for the treatment of hepatic encephalopathy (HE). METHODS: Medical charts of patients who received rifaximin for the treatment of HE were reviewed. The number of patients who developed diarrhea during treatment with rifaximin and results of latex agglutination assays to detect C. difficile in stool samples were analyzed. RESULTS: A total of 211 patients received rifaximin for HE. Of these, 152 were treated in a university practice and 59 were treated in community practices. The mean dose of rifaximin was 1055 mg/d (range, 600 to 1600 mg/d) for a mean duration of 250 days (range, 180 to 385 d). Eighteen patients developed diarrhea during rifaximin treatment. None of these patients tested positive for C. difficile. CONCLUSIONS: This study demonstrates that treatment of HE with the safe, nonsystemic, gut-selective antibiotic rifaximin was not associated with the development of C. difficile infection.

Durability of rifaximin response in hepatic encephalopathy.

GOALS: To evaluate the durability of the response to rifaximin for treatment of hepatic encephalopathy (HE). BACKGROUND: The nonsystemic antibiotic rifaximin has been approved for maintenance of HE remission, and several studies have indicated the efficacy of rifaximin for acute HE; however, the duration of therapeutic response for >6 months remains unknown. STUDY: Medical records of patients with cirrhosis who received rifaximin maintenance therapy for HE between January 2004 and May 2009 were reviewed. Model for end-stage liver disease (MELD) scores were obtained every 3 months during therapy. RESULTS: Of 203 patients with HE (Conn score ≥2), 149 received rifaximin monotherapy (400 to 1600 mg/d) and 54 received rifaximin (600 to 1200 mg/d) and lactulose (90 mL/d) dual therapy. Maintenance of HE remission for 1 year occurred in 81% and 67% of patients who received rifaximin monotherapy and rifaximin and lactulose dual therapy, respectively. Patient populations with a baseline mean MELD score ≤20 had few overt HE events, suggesting increased response to rifaximin in these patients. CONCLUSIONS: Rifaximin is effective for the management of HE in patients with cirrhosis, particularly in populations with MELD scores ≤20. Additional studies are needed to investigate the potential association between MELD scores and the efficacy of HE treatments.

Farglitazar lacks antifibrotic activity in patients with chronic hepatitis C infection.

BACKGROUND & AIMS: Farglitazar (GI262570), an insulin-sensitizing agent, selectively binds and activates peroxisome proliferator-activated receptor gamma (PPARgamma) and inhibits stellate cell activation. We evaluated its antifibrotic effect in patients with chronic hepatitis C that did not respond to standard-of-care therapy. METHODS: Patients with fibrosis of Ishak stages 2-4 (n = 265), based on analysis of liver biopsy samples, were randomly assigned to groups given once-daily doses of 0.5 mg farglitazar, 1.0 mg farglitazar, or placebo for 52 weeks; repeat liver biopsy samples were then obtained. The primary end points were changes in levels of alpha-smooth muscle actin (SMA) expression and collagen, based on morphometry and ranked histologic assessments. RESULTS: Two hundred nine patients had paired biopsy specimens adequate for analysis (81.5% with pretreatment Ishak scores of stage 2 or 3). There was no overall difference in SMA (P = .58) or collagen (P = .99) levels at week 52. SMA levels increased by a median of 49% in samples from patients given placebo, 58% in patients given 0.5 mg farglitizar and 52% in patients given 1.0 mg farglitizar, respectively. Collagen increased by 27% in placebo samples and 31% in samples from patients given either dose of farglitizar. There were no significant differences between treatment groups in the ranked assessment of paired biopsy specimens or in the proportion of patients with a change in fibrosis score > or = Ishak stage. CONCLUSIONS: In patients with chronic hepatitis C and moderate fibrosis, 52 weeks of treatment with farglitazar does not affect stellate cell activation or fibrosis (measured by morphometry or comparison of paired biopsy specimens).

Adult onset urea cycle disorder in a patient with presumed hepatic encephalopathy.

Deficiency of any of the 5 enzymes in the urea cycle results in the accumulation of ammonia, leading to encephalopathy; which if untreated, can be lethal and produce devastating neurologic sequelae in long-term survivors. We hereby present an interesting case that presented with hyperammonemia and encephalopathy; later found to have an urea cycle defect.