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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]

Physical inactivity has been identified as a leading risk factor for premature mortality globally, and adolescents, in particular, have low physical activity levels. Schools have been identified as a setting to tackle physical inactivity. Economic evidence of school-based physical activity programmes is limited, and the costs of these programmes are not always collected in full. This paper describes a micro-costing and cost-consequence analysis of the ‘Girls Active’ secondary school-based programme as part of a cluster randomised controlled trial (RCT). Micro-costing and cost-consequence analyses were conducted using bespoke cost diaries and questionnaires to collect programme delivery information. Outcomes for the cost-consequence analysis included health-related quality of life measured by the Child Health Utility-9D (CHU-9D), primary care General Practitioner (GP) and school-based (school nurse and school counsellor) service use as part of a cluster RCT of the ‘Girls Active’ programme. Overall, 1,752 secondary pupils were recruited and a complete case sample of 997 participants (Intervention n = 570, Control n = 427) was used for the cost-consequence analysis. The micro-costing analysis demonstrated that, depending upon how the programme was delivered, ‘Girls Active’ costs ranged from £1,054 (£2 per pupil, per school year) to £3,489 (£7 per pupil, per school year). The least costly option was to absorb ‘Girls Active’ strictly within curriculum hours. The analysis demonstrated no effect for the programme for the three main outcomes of interest (health-related quality of life, physical activity and service use).Micro-costing analyses demonstrated the costs of delivering the ‘Girls Active’ programme, addressing a gap in the United Kingdom (UK) literature regarding economic evidence from school-based physical activity programmes. This paper provides recommendations for those gathering cost and service use data in school settings to supplement validated and objective measures, furthering economic research in this field. Trial registration: -ISRCTN, . [ABSTRACT FROM AUTHOR]

Quality circles or peer review groups, and similar structured small groups of 6–12 health care professionals meet regularly across Europe to reflect on and improve their standard practice. There is debate over their effectiveness in primary health care, especially over their potential to change practitioners’ behaviour. Despite their popularity, we could not identify broad surveys of the literature on quality circles in a primary care context. Our scoping review was intended to identify possible definitions of quality circles, their origins, and reported effectiveness in primary health care, and to identify gaps in our knowledge. We searched appropriate databases and included any relevant paper on quality circles published until December 2017. We then compared information we found in the articles to that we found in books and on websites. Our search returned 7824 citations, from which we identified 82 background papers and 58 papers about quality circles. We found that they originated in manufacturing industry and that many countries adopted them for primary health care to continuously improve medical education, professional development, and quality of care. Quality circles are not standardized and their techniques are complex. We identified 19 papers that described individual studies, one paper that summarized 3 studies, and 1 systematic review that suggested that quality circles can effectively change behaviour, though effect sizes varied, depending on topic and context. Studies also suggested participation may affirm self-esteem and increase professional confidence. Because reports of the effect of quality circles on behaviour are variable, we recommend theory-driven research approaches to analyse and improve the effectiveness of this complex intervention. [ABSTRACT FROM AUTHOR]

Aim: We aimed to identify and evaluate the quality and evidence of the motor learning literature about intervention studies regarding the contextual interference (CI) effect (blocked vs. random practice order) in children with brain lesions and typically developing (TD) children. Method: Eight databases (Cinahl, Cochrane, Embase, PubMed, Pedro, PsycINFO, Scopus and Web of Knowledge) were searched systematically with predefined search terms. Controlled studies examining the CI effect in children (with brain lesions or TD) were included. Evidence level, conduct quality, and risk of bias were evaluated by two authors independently. A best evidence synthesis was performed. Results: Twenty-five papers evaluating TD children were included. One of these studies also assessed children with cerebral palsy. Evidence levels were I, II, or III. Conduct quality was low and the risk of bias high, due to methodological issues in the study designs or poor description thereof. Best evidence synthesis showed mainly no or conflicting evidence. Single tasks showed limited to moderate evidence supporting the CI effect in TD children. Conclusion: There is a severe limitation of good-quality evidence about the CI effect in children who practice different tasks in one session, especially in children with brain lesions. [ABSTRACT FROM AUTHOR]

Background: The establishment of trust between researchers and participants is critical to advance HIV and HCV prevention particularly among people who inject drugs (PWID) and other marginalized populations, yet empirical research on how to establish and maintain trust in the course of community health research is lacking. This paper documents ideas about trust between research participants and researchers amongst a sub-sample of PWID who were enrolled in a large, multi-year community health study of social networks and HIV/HCV risk that was recently conducted in rural Puerto Rico. Methods: Qualitative research was nested within a multi-year Social Network and HIV/HCV Risk study involving N = 360 PWID > 18 years of age living in four small, rural Puerto Rican communities. Semi-structured interviews were conducted between March 2017 and April 2017 with a subset of 40 active PWID who had been enrolled in the parent study. Interview questions invited participants to draw upon their recent experience as research participants to better understand how PWID perceive and understand participant-researcher trust within the context of HIV/HCV-related epidemiological research. Results: Fear of police, stigma and concerns regarding confidentiality and anonymity were identified as structural factors that could compromise participation in HIV/HCV-related research for PWID. While monetary compensation was an important motivation, participants also valued the opportunity to learn about their HIV/HCV status. During their participation in the study, gaining knowledge of safe injection practices was perceived as a valuable benefit. Participant narratives suggested that PWID may adopt an incremental and ongoing approach in their assessment of the trustworthiness of researchers, continuously assessing the extent to which they trust the research staff throughout the course of the research. Trust was initially generated through peer Respondent Driven Sampling recruitment. Research staff who maintained a presence in the community for the entire duration of the prospective study reinforced trust between participants and the research team. Conclusion: Although PWID face numerous structural barriers to research-related trust in HIV/HCV research, we found that using a peer-based recruitment method like RDS, and employing a research staff who are knowledgeable about the targeted population, culturally sensitive to their needs, and who maintain a long-term presence in the community may help mitigate many of these barriers. The reputation of the research is built incrementally as participants join the study. This contributes to a “street reputation” that grows as current or former participants vouch for the study. Establishing trust was identified as only the first step towards building a collaborative relationship with participants, and our findings suggest that steps to address criminalization and stigmatization also are necessary to support research trust. [ABSTRACT FROM AUTHOR]

Background: Four decades of conflict has indelibly impacted the lives of Afghans, exposing many to different forms of trauma. The aim of this paper investigate a hypothesis that (mostly war related) trauma is a key driver of partner violence in Afghanistan. Methods: 1,463 women aged 18–48 were recruited into a randomised controlled trial (RCT) to evaluate a women empowerment intervention in 8 villages of Kabul and Nangarhar provinces. The women were interviewed at baseline. The analysis uses multivariable logistic regression and structural equation modelling (SEM) to describe relationships between measures. Results: 57.4% of women reported exposure to one of four types of trauma: 23.3% an armed attack, 39.4% had felt close to death, 10.6% witnessed a friend or family member being killed and 21.4% witnessed the death of a stranger or someone unknown. Trauma exposure was associated with being older, Pashtan, madrassa educated, and food insecure. Women who were trauma exposed were more likely to have ever experienced IPV, have hit their children in the last 4 weeks, and be hit by a sibling or relative of their husband or their mother-in-law in the last year. They held less patriarchal personal gender attitudes and perceived the community to be more patriarchal. The SEM showed that all pathways between trauma exposure and IPV were ultimately mediated by either (mostly mental) ill-health or quarrelling, but not both of these. There were multiple paths through which trauma exposure impacted women’s past year experience of physical IPV. One was mediated by childhood trauma exposure and a latent variable for ill health. Other paths were mediated by women’s education and personal gender attitudes and ill-health, or else by quarrelling. Trauma exposure was related to lower educational levels. Another path was mediated by less patriarchal personal gender attitudes and ill health. Community gender attitudes was a mediating variable on a path which was also mediated by ill health and another mediated by quarrelling. It was also a mediator on a path which included personal gender attitudes and ill-health. Food insecurity mediated another path with ill health. It was also connected to childhood trauma, community gender attitudes and educational level. Conclusion: Trauma exposure due to conflict will persist until the conflict ends but the impact on women can be ameliorated. This analysis suggests interventions to reduce women’s exposure to IPV should focus on reducing poverty, changing social norms on gender, providing relationship skills to help reduce quarrelling and supporting women’s mental health. [ABSTRACT FROM AUTHOR]

Background: Bangladesh reports one of the highest rates of intimate partner violence (IPV) in the world. Despite wide recognition of IPV as an important public health and human rights issue, evidence for IPV prevention is still inadequate. Lack of guidance on effective IPV prevention in Bangladesh resulted in targeting only women in most of the programmes. Methods: This paper assesses impact of SAFE, a 20-month intervention (March 2012 to October 2013) in slums of Dhaka on IPV and tests effectiveness of female only groups vs. no groups; and female + male groups vs. female only groups on IPV in the community using a three-arm cluster randomized controlled trial. SAFE’s core activities included interactive group sessions, community mobilisation, and services. The last two activities were common across arms. Findings: Regression analyses (female survey: baseline n = 2,666; endline n = 2,670) showed no effect of SAFE on IPV against women aged 15–29. However, sub-group analyses demonstrated 21% risk reduction of physical IPV against adolescent girls aged 15–19 in the female + male group intervention arm. A consistent reduction in sexual violence was observed in both female and female + male arms for both groups of women, but the results were not statistically significant. Interpretation: The findings emphasise the importance of combining male and female interventions for reducing physical IPV against adolescent girls. Implications for future research have been discussed. [ABSTRACT FROM AUTHOR]

A cost-effective and interactive way of promoting healthy nutrition behaviors among adolescents is using information and communication technologies (ICTs). We systematically reviewed studies to identify technologies and their main characteristics used for nutritional interventions for adolescents, as well as to evaluate their quality and effectiveness. Our full protocol is available on the PROSPERO website (#CRD42016035882). A search was conducted across five databases for articles describing nutritional interventions that used ICTs designed mainly for healthy adolescents. Randomized controlled trials, quasi-experimental and observational studies, and full and original papers, all of them published from 2005 to 2015, were included. Study quality was assessed by the Effective Public Health Practice Project Quality Assessment Tool. Our search yielded 559 titles and abstracts. Eleven studies met the inclusion criteria. Participants were recruited mostly from schools. Study follow-up ranged from two weeks to two years. Four interventions were based on the Social Cognitive Theory. Interventional strategies included computer games, programs, text messages, and interactive CD-ROMs. Nine studies used computer-mediated ICTs. Five studies focused on multiple behaviors simultaneously. Participants were exposed to interventions only once, daily, weekly, or according to a pre-determined number of lessons. Five studies had significant outcomes. Our quality assessment revealed three studies to be weak due to non-representativeness of their samples and usage of non-validated questionnaires. Besides the heterogeneity and poor quality of the analyzed studies, it can be suggested that long-term interventions for adolescents that make use of frequent exposure to technological resources, and that have a theoretical component aimed at a single health behavior change, tend to be more successful. [ABSTRACT FROM AUTHOR]

Background: A majority of academic medical centers (AMCs) have now adopted conflict of interest policies (COI) to address relationships with pharmaceutical and device industries that can increase the risk of bias in patient care, education and research. However, AMCs may have little information on the impact of their policies. This paper provides a new method, which is a free, publicly-available survey, to fill this information gap and improve COI programs at AMCs. Methods & findings: The survey, piloted in three AMCs and designed in collaboration with national conflicts of interest policy experts, covers a range of universal compliance-related concerns, which allows institutions to tailor questions to align with their own policies and culture. The survey was low-burden, and provided important data for these AMCs to evaluate their policies. A descriptive analysis of the pooled pilot site data (n = 1578) was performed, which found that a majority of respondents did not have financial ties with industry and a majority was satisfied with specific COI policies at their institutions. The analysis also showed that the survey is sensitive to differences that AMCs will find meaningful. For instance, individuals with industry ties were significantly more likely than individuals without ties to think that COI policies unnecessarily hindered interactions with industry (p = .004), were ineffective at reducing harm to patients (p < .001), and were ineffective in reducing bias in medical education (p>.001). Conclusion: The survey is now free and publicly available for use by any institution. AMCs can use the results to update and refine policies, and to provide ongoing education regarding existing policies. [ABSTRACT FROM AUTHOR]

The Health Literacy Questionnaire (HLQ), developed in Australia in 2012 using a ‘validity-driven’ approach, has been rapidly adopted and is being applied in many countries and languages. It is a multidimensional measure comprising nine distinct domains that may be used for surveys, needs assessment, evaluation and outcomes assessment as well as for informing service improvement and the development of interventions. The aim of this paper is to describe the German translation of the HLQ and to present the results of the validation of the culturally adapted version. The HLQ comprises 44 items, which were translated and culturally adapted to the German context. This study uses data collected from a sample of 1,058 persons with chronic conditions. Statistical analyses include descriptive and confirmatory factor analyses. In one-factor congeneric models, all scales demonstrated good fit after few model adjustments. In a single, highly restrictive nine-factor model (no cross-loadings, no correlated errors) replication of the original English-language version was achieved with fit indices and psychometric properties similar to the original HLQ. Reliability for all scales was excellent, with a Cronbach’s Alpha of at least 0.77. High to very high correlations between some HLQ factors were observed, suggesting that higher order factors may be present. Our rigorous development and validation protocol, as well as strict adaptation processes, have generated a remarkable reproduction of the HLQ in German. The results of this validation provide evidence that the HLQ is robust and can be recommended for use in German-speaking populations. Trial Registration: German Clinical Trial Registration (DRKS): . Registered 23 March 2011. [ABSTRACT FROM AUTHOR]

The extraction of information from social media is an essential yet complicated step for data analysis in multiple domains. In this paper, we present Vigi4Med Scraper, a generic open source framework for extracting structured data from web forums. Our framework is highly configurable; using a configuration file, the user can freely choose the data to extract from any web forum. The extracted data are anonymized and represented in a semantic structure using Resource Description Framework (RDF) graphs. This representation enables efficient manipulation by data analysis algorithms and allows the collected data to be directly linked to any existing semantic resource. To avoid server overload, an integrated proxy with caching functionality imposes a minimal delay between sequential requests. Vigi4Med Scraper represents the first step of Vigi4Med, a project to detect adverse drug reactions (ADRs) from social networks founded by the French drug safety agency Agence Nationale de Sécurité du Médicament (ANSM). Vigi4Med Scraper has successfully extracted greater than 200 gigabytes of data from the web forums of over 20 different websites. [ABSTRACT FROM AUTHOR]