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Background: Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials.Methods and Findings: We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of seven papers stated that "all adverse events were recorded." For one trial, we identified an additional 1,318 adverse events that were not listed or mentioned in the CSR itself but could be identified through manually counting individual adverse events reported in an appendix. We discovered that the majority of patients had multiple episodes of the same adverse event that were only counted once, though this was not described in the CSRs. We also discovered that participants treated with orlistat experienced twice as many days with adverse events as participants treated with placebo (22.7 d versus 14.9 d, p-value < 0.0001, Student's t test). Furthermore, compared with the placebo group, adverse events in the orlistat group were more severe. None of this was stated in the CSR or in the published paper. Our analysis was restricted to one drug tested in the mid-1990s; our results might therefore not be applicable for newer drugs.Conclusions: In the orlistat trials, we identified important disparities in the reporting of adverse events between protocols, clinical study reports, and published papers. Reports of these trials seemed to have systematically understated adverse events. Based on these findings, systematic reviews of drugs might be improved by including protocols and CSRs in addition to published articles. [ABSTRACT FROM AUTHOR]

The safety of highly aggregated tourist crowds is a challenging and important issue. This paper not only provided a comprehensive analysis of the accidents of highly aggregated tourist crowds but also determined the occurrence mechanism and coping paths. Based on the analysis of multiple cases, we found that the variable status of highly aggregated tourist crowds was the result of the interaction of three main elements: multisource pressure, state mutations and management responses. A series of factors interact and result in accidents, and the lack of a management response or a low-quality management response is the root cause of such accidents. A high-quality management response is a basic safety precaution for highly aggregated tourist crowds. Therefore, forming a virtuous circle of multisource pressure, state mutations and management responses is an effective path for coping with accidents. [ABSTRACT FROM AUTHOR]

When many events contributed to an outcome, people consistently judge some more causal than others, based in part on the prior probabilities of those events. For instance, when a tree bursts into flames, people judge the lightning strike more of a cause than the presence of oxygen in the air—in part because oxygen is so common, and lightning strikes are so rare. These effects, which play a major role in several prominent theories of token causation, have largely been studied through qualitative manipulations of the prior probabilities. Yet, there is good reason to think that people’s causal judgments are on a continuum—and relatively little is known about how these judgments vary quantitatively as the prior probabilities change. In this paper, we measure people’s causal judgment across parametric manipulations of the prior probabilities of antecedent events. Our experiments replicate previous qualitative findings, and also reveal several novel patterns that are not well-described by existing theories. [ABSTRACT FROM AUTHOR]

Background: The reasons for the persistence of risky sexual behaviours among adolescents and young adults in sub-Saharan Africa despite the increasing knowledge about the associated risks continue to attract scholarly debates. Drawing from a cross-sectional study conducted among male and female Nigerian university students, we examined the relationship between family structure, family support and transactional sex. Methods: A pre-validated questionnaire was administered to 800 male and female students selected using stratified sampling; however, we performed the analysis on 630 participants who had ever engaged in sex. Transactional sex was operationalised as self-reporting of giving or receiving money, gifts or favour in exchange for sex. We fitted a list-wise logistic regression model to examine the relationship between family structure, family support and transactional sex while controlling for essential covariates. Results: Of the 630 participants included in the analysis, 17.9% had given and 23.8% had received money, gift or favour in exchange for sex. Our bivariate analysis shows that individuals from polygamous families had higher odds of reporting that they have ever given (AOR: 1.89; CI: 1.05–3.39) or received (AOR: 1.85; CI: 1.85–3.19) money, gift or favour in exchange for sex; however, the relationship was not statistically significant after controlling for relevant covariates. After controlling for essential covariates, the odds of giving or receiving money, gift or favour in exchange for sex was 56% lower in individuals who received adequate family support compared to those who received no or insufficient family support. Conclusion: In conclusion, this paper lends support to the assertion that family structure and family support are protective factors against transactional sex among adolescents and young adults. Future surveys need to include a larger sample in order to explore the effect of single-parent and polygamous family on transactional sex in Nigeria where family formation is changing rapidly. [ABSTRACT FROM AUTHOR]

The accuracy and diversity of recommendation algorithms have always been the research hotspot of recommender systems. A good recommender system should not only have high accuracy and diversity, but also have adequate robustness against spammer attacks. However, the issue of recommendation robustness has received relatively little attention in the literature. In this paper, we systematically study the influences of different spammer behaviors on the recommendation results in various recommendation algorithms. We further propose an improved algorithm by incorporating the inner-similarity of user’s purchased items in the classic KNN approach. The new algorithm effectively enhances the robustness against spammer attacks and thus outperforms traditional algorithms in recommendation accuracy and diversity when spammers exist in the online commercial systems. [ABSTRACT FROM AUTHOR]

Study objectives: In order to increase the value of randomized response techniques (RRTs) as tools for studying sensitive issues, the present study investigated whether the prevalence estimate for a sensitive item assessed with the unrelated questionnaire method (UQM) is influenced by changing the probability of receiving the sensitive question p. Material and methods: A short paper-and-pencil questionnaire was distributed to 1.243 university students assessing the 12-month prevalence of physical and cognitive doping using two versions of the UQM with different probabilities for receiving the sensitive question (p ≈ 1/3 and p ≈ 2/3). Likelihood ratio tests were used to assess whether the prevalence estimates for physical and cognitive doping differed significantly between p ≈ 1/3 and p ≈ 2/3. The order of questions (physical doping and cognitive doping) as well as the probability of receiving the sensitive question (p ≈ 1/3 or p ≈ 2/3) were counterbalanced across participants. Statistical power analyses were performed to determine sample size. Results: The prevalence estimate for physical doping with p ≈ 1/3 was 22.5% (95% CI: 10.8–34.1), and 12.8% (95% CI: 7.6–18.0) with p ≈ 2/3. For cognitive doping with p ≈ 1/3, the estimated prevalence was 22.5% (95% CI: 11.0–34.1), whereas it was 18.0% (95% CI: 12.5–23.5) with p ≈ 2/3. Likelihood-ratio tests revealed that prevalence estimates for both physical and cognitive doping, respectively, did not differ significantly under p ≈ 1/3 and p ≈ 2/3 (physical doping: χ2 = 2.25, df = 1, p = 0.13; cognitive doping: χ2 = 0.49, df = 1, p = 0.48). Bayes factors computed with the Savage-Dickey method favored the null (“the prevalence estimates are identical under p ≈ 1/3 and p ≈ 2/3”) over the alternative (“the prevalence estimates differ under p ≈ 1/3 and p ≈ 2/3”) hypothesis for both physical doping (BF = 2.3) and cognitive doping (BF = 5.3). Conclusion: The present results suggest that prevalence estimates for physical and cognitive doping assessed by the UQM are largely unaffected by the probability for receiving the sensitive question p. [ABSTRACT FROM AUTHOR]

This paper studies the Retailer Stackelberg game in a supply chain consisting of two manufacturers and one retailer where they compete simultaneously under three factors including price, service and simple price discount contract. It is assumed that the second manufacturer provides service directly to his customers, and the retailer provides service for the first product’s customers, while the retailer buys the first product under price discount from the first manufacturer. The analysis of the optimal equilibrium solutions and the results of the numerical examples show that if a manufacturer chooses the appropriate range of discount rate, he will gain more profit than when there is no discount given to the retailer. This situation can be considered as an effective tool for the coordination of the first manufacturer and the retailer to offer discount by manufacturer and to provide the service by the retailer. We obtain equilibrium solution of Retailer Stackelberg game and analyze the numerical examples under two cases: a) the manufacturers sell their products to the retailer without price discount contract. b) The first manufacturer sells his products to the retailer with the simple price discount contract. The preliminary results show that the service and the price discount contract can improve the performance of supply chain. [ABSTRACT FROM AUTHOR]

In recent years, major global institutions have amplified their efforts to address intimate partner violence (IPV) against women—a global health and human rights violation affecting 15–71% of reproductive aged women over their lifetimes. Still, some scholars remain concerned about the validity of instruments used for IPV assessment in population-based studies. In this paper, we conducted two validation analyses using novel data from 450 women-men dyads across nine villages in Northern Tanzania. , we examined the level of inter-partner agreement in reporting of men’s physical, sexual, emotional and economic IPV against women in the last three and twelve months prior to the survey, ever in the relationship, and during pregnancy. , we conducted a convergent validity analysis to compare the relative efficacy of men’s self-reports of perpetration and women’s of victimization as a valid indicator of IPV against Tanzanian women using logistic regression models with village-level clustered errors. We found that, for every violence type across the recall periods of the last three months, the last twelve months and ever in the relationship, at least one in three couples disagreed about IPV occurrences in the relationship. Couples’ agreement about physical, sexual and economic IPV during pregnancy was high with 86–93% of couples reporting concordantly. Also, men’s self-reported perpetration had statistically significant associations with at least as many validated risk factors as had women’s self-reported victimization. This finding suggests that men’s self-reports are at least as valid as women’s as an indicator of IPV against women in Northern Tanzania. We recommend more validation studies are conducted in low-income countries, and that data on relationship factors affecting IPV reports and reporting are made available along with data on IPV occurrences. Keywords: Intimate partner violence; measurement; validity; survey research; Tanzania. [ABSTRACT FROM AUTHOR]

For the past 50 years, acknowledgments have been studied as important paratextual traces of research practices, collaboration, and infrastructure in science. Since 2008, funding acknowledgments have been indexed by Web of Science, supporting large-scale analyses of research funding. Applying advanced linguistic methods as well as Correspondence Analysis to more than one million acknowledgments from research articles and reviews published in 2015, this paper aims to go beyond funding disclosure and study the main types of contributions found in acknowledgments on a large scale and through disciplinary comparisons. Our analysis shows that technical support is more frequently acknowledged by scholars in Chemistry, Physics and Engineering. Earth and Space, Professional Fields, and Social Sciences are more likely to acknowledge contributions from colleagues, editors, and reviewers, while Biology acknowledgments put more emphasis on logistics and fieldwork-related tasks. Conflicts of interest disclosures (or lack of thereof) are more frequently found in acknowledgments from Clinical Medicine, Health and, to a lesser extent, Psychology. These results demonstrate that acknowledgment practices truly do vary across disciplines and that this can lead to important further research beyond the sole interest in funding. [ABSTRACT FROM AUTHOR]

The West African Ebola epidemic of 2013–2016 was by far the largest outbreak of the disease on record. Sierra Leone suffered nearly half of the 28,646 reported cases. This paper presents a set of culturally contextualized Ebola messages that are based on the findings of qualitative interviews and focus group discussions conducted in 'hotspot' areas of rural Bombali District and urban Freetown in Sierra Leone, between January and March 2015. An iterative approach was taken in the message development process, whereby (i) data from formative research was subjected to thematic analysis to identify areas of community concern about Ebola and the national response; (ii) draft messages to address these concerns were produced; (iii) the messages were field tested; (iv) the messages were refined; and (v) a final set of messages on 14 topics was disseminated to relevant national and international stakeholders. Each message included details of its rationale, audience, dissemination channels, messengers, and associated operational issues that need to be taken into account. While developing the 14 messages, a set of recommendations emerged that could be adopted in future public health emergencies. These included the importance of embedding systematic, iterative qualitative research fully into the message development process; communication of the subsequent messages through a two-way dialogue with communities, using trusted messengers, and not only through a one-way, top-down communication process; provision of good, parallel operational services; and engagement with senior policy makers and managers as well as people in key operational positions to ensure national ownership of the messages, and to maximize the chance of their being utilised. The methodological approach that we used to develop our messages along with our suggested recommendations constitute a set of tools that could be incorporated into international and national public health emergency preparedness and response plans. [ABSTRACT FROM AUTHOR]

The aim of this paper is to propose a new method to identify main paths in a technological domain using patent citations. Previous approaches for using main path analysis have greatly improved our understanding of actual technological trajectories but nonetheless have some limitations. They have high potential to miss some dominant patents from the identified main paths; nonetheless, the high network complexity of their main paths makes qualitative tracing of trajectories problematic. The proposed method searches backward and forward paths from the high-persistence patents which are identified based on a standard genetic knowledge persistence algorithm. We tested the new method by applying it to the desalination and the solar photovoltaic domains and compared the results to output from the same domains using a prior method. The empirical results show that the proposed method can dramatically reduce network complexity without missing any dominantly important patents. The main paths identified by our approach for two test cases are almost 10x less complex than the main paths identified by the existing approach. The proposed approach identifies all dominantly important patents on the main paths, but the main paths identified by the existing approach miss about 20% of dominantly important patents. [ABSTRACT FROM AUTHOR]

This paper investigates how social influence can alter physiological, psychological, and functional responses to a placebo product and how such responses influence the ultimate endorsement of the product. Participants consumed a product, “AquaCharge Energy Water,” falsely-labeled as containing 200 mg of caffeine but which was actually plain spring water, in one of three conditions: a no social influence condition, a disconfirming social influence condition, and a confirming social influence condition. Results demonstrated that the effect of the product labeling on physiological alertness (systolic blood pressure), psychological alertness (self-reported alertness), functional alertness (cognitive interference), and product endorsement was moderated by social influence: participants experienced more subjective, physiological and functional alertness and stronger product endorsement when they consumed the product in the confirming social influence condition than when they consumed the product in the disconfirming social influence condition. These results suggest that social influence can alter subjective, physiological, and functional responses to a faux product, in this case transforming the effects of plain water. [ABSTRACT FROM AUTHOR]

Background: Interventions to prevent rape perpetration must be designed to address its drivers. This paper seeks to extend understanding of drivers of single and multiple perpetrator rape (referred to here as SPR and MPR respectively) and the relationships between socio-economic status, childhood trauma, peer pressure, other masculine behaviours and rape. Method: 1370 young men aged 15 to 26 were interviewed as part of the randomised controlled trial evaluation of Stepping Stones in the rural Eastern Cape. We used multinomial to compare the characteristics of men who reported rape perpetration at baseline. We used structural equation modelling (SEM) to examine pathways to rape perpetration. Results: 76.1% of young men had never raped, 10.0% had perpetrated SPR and 13.9% MPR. The factors associated with both MPR and SPR (compared to never having raped) were indicators of socio-economic status (SES), childhood trauma, sexual coercion by a woman, drug and alcohol use, peer pressure susceptibility, having had transactional sex, multiple sexual partners and being physically violent towards a partner. The SEM showed the relationship between SES and rape perpetration to be mediated by gender inequitable masculinity. It was complex as there was a direct path indicating that SES correlated with the masculinity variable directly such that men of higher SES had more gender inequitable masculinities, and indirect path mediated by peer pressure resistance indicated that the former pertained so long as men lacked peer pressure resistance. Having a higher SES conveyed greater resistance for some men. There was also a path mediated through childhood trauma, such that men of lower SES were more likely to have a higher childhood trauma exposure and this correlated with a higher likelihood of having the gender inequitable masculinity (with or without the mediating effect of peer pressure resistance). Discussion: Both higher and lower socio-economic status were associated with raping. Prevention of rape perpetration must focus on changing men’s gender ideals, entitlements and inequitable practices. Reducing poverty and adverse childhood experiences should also be of benefit. [ABSTRACT FROM AUTHOR]

Current models of bilateral trade neglect the effects of income distribution. This paper addresses the issue by accounting for non-homothetic consumer preferences and hence investigating the role of income distribution in the context of the gravity model of trade. A theoretically justified gravity model is estimated for disaggregated trade data (Dollar volume is used as dependent variable) using a sample of 104 exporters and 108 importers for 1980–2003 to achieve two main goals. We define and calculate new measures of income distribution similarity and empirically confirm that greater similarity of income distribution between countries implies more trade. Using distribution-based measures as a proxy for demand similarities in gravity models, we find consistent and robust support for the hypothesis that countries with more similar income-distributions trade more with each other. The hypothesis is also confirmed at disaggregated level for differentiated product categories. [ABSTRACT FROM AUTHOR]

The problem of link prediction has recently received increasing attention from scholars in network science. In social network analysis, one of its aims is to recover missing links, namely connections among actors which are likely to exist but have not been reported because data are incomplete or subject to various types of uncertainty. In the field of criminal investigations, problems of incomplete information are encountered almost by definition, given the obvious anti-detection strategies set up by criminals and the limited investigative resources. In this paper, we work on a specific dataset obtained from a real investigation, and we propose a strategy to identify missing links in a criminal network on the basis of the topological analysis of the links classified as marginal, i.e. removed during the investigation procedure. The main assumption is that missing links should have opposite features with respect to marginal ones. Measures of node similarity turn out to provide the best characterization in this sense. The inspection of the judicial source documents confirms that the predicted links, in most instances, do relate actors with large likelihood of co-participation in illicit activities. [ABSTRACT FROM AUTHOR]

The aim of this paper is to estimate the cumulative effect of childhood household dysfunction (CHD) on alcohol related illness and death later in life and to test the interaction between CHD and socioeconomic background. The study utilised Swedish national registers including data of a Swedish national cohort born 1973–82 (n = 872 912), which was followed from age 18 to 29–40 years. Cox regression analyses were used to calculate hazard ratios (HR) for alcohol related illness or death in young adulthood. The CHD measure consisted of seven indicators: parental alcohol/drug misuse, mental health problems, criminality, death, divorce, social assistance, and child welfare interventions. Childhood socioeconomic position (SEP) was indicated by parental occupational status. Outcomes were alcohol related inpatient hospital care, specialised outpatient care or deaths. Using the highest socioeconomic group without CHD experience as a reference, those in the same socioeconomic group with one indicator of CHD had HRs of 2.1 [95% CI: 1.7–2.5], two CHD indicators 5.6 [4.4–7.1], three or more indicators 9.4 [7.1–12.4] for retrieving inpatient care. Socioeconomic disadvantage further increased the risks–those with low socioeconomic background and three CHD indicators or more had a HR of 12.5 [10.9–14.3]. Testing for interaction suggests that the combined HRs deviates from additivity [Synergy index: 1.6, 95% CI: 1.4–1.9]. The results for outpatient care were similar, but not as pronounced. In conclusion, this Swedish national cohort study shows that childhood household dysfunction is strongly and cumulatively associated to alcohol related illness later in life and that it interacts with socioeconomic disadvantage. [ABSTRACT FROM AUTHOR]