The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies

Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the websites of PLoS Medicine, Annals of Internal Medicine and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.

Drug eluting and bare metal stents in people with and without diabetes: collaborative network meta-analysis

Objective To compare the effectiveness and safety of three types of stents (sirolimus eluting, paclitaxel eluting, and bare metal) in people with and without diabetes mellitus. Design Collaborative network meta-analysis. Data sources Electronic databases (Medline, Embase, the Cochrane Central Register of Controlled Trials), relevant websites, reference lists, conference abstracts, reviews, book chapters, and proceedings of advisory panels for the US Food and Drug Administration. Manufacturers and trialists provided additional data. Review methods Network meta-analysis with a mixed treatment comparison method to combine direct within trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Overall mortality was the primary safety end point, target lesion revascularisation the effectiveness end point. Results 35 trials in 3852 people with diabetes and 10 947 people without diabetes contributed to the analyses. Inconsistency of the network was substantial for overall mortality in people with diabetes and seemed to be related to the duration of dual antiplatelet therapy (P value for interaction 0.02). Restricting the analysis to trials with a duration of dual antiplatelet therapy of six months or more, inconsistency was reduced considerably and hazard ratios for overall mortality were near one for all comparisons in people with diabetes: sirolimus eluting stents compared with bare metal stents 0.88 (95% credibility interval 0.55 to 1.30), paclitaxel eluting stents compared with bare metal stents 0.91 (0.60 to 1.38), and sirolimus eluting stents compared with paclitaxel eluting stents 0.95 (0.63 to 1.43). In people without diabetes, hazard ratios were unaffected by the restriction. Both drug eluting stents were associated with a decrease in revascularisation rates compared with bare metal stents in people both with and without diabetes. Conclusion In trials that specified a duration of dual antiplatelet therapy of six months or more after stent implantation, drug eluting stents seemed safe and effective in people both with and without diabetes.

[The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies]

Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September, 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed explanation and elaboration document is published separately and is freely available on the websites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE statement will contribute to improving the quality of reporting of observational studies.

[The Strengthening the Reporting of Observational Studies in Epidemiology [STROBE] statement: guidelines for reporting observational studies]

Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September, 2004, with methodologists, researchers, and journal editors to draft a che-cklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed explanation and elaboration document is published separately and is freely available on the websites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE statement will contribute to improving the quality of reporting of observational studies.

Through the back door : Melungeon literacies and 21st century technologies

The Melungeons, a minority recognized in Southern Appalachia where they settled in the early 1800s, have mixed heritage—European, Mediterranean, Native American, and Sub-Saharan African. Their dark skin and distinctive features have marked them and been the cause of racial persecution both by custom and by law in Appalachia for two centuries. Their marginalization has led to an insider mentality, which I call a “literacy” of Melungeon-ness that affects every facet of their lives. Just a century ago, while specialized practices such as farming, preserving food, hunting, gathering, and distilling insured survival in the unforgiving mountain environment, few Melungeons could read or write. Required to pay property taxes and render military service, they were denied education, suffrage, and other legal rights. In the late 1890s visionary Melungeon leader Batey Collins invited Presbyterian homemissionaries to settle in one Tennessee Melungeon community where they established a church and built a school of unparalleled excellence. Educator-ministers Mary Rankin and Chester Leonard creatively reified the theories of Dewey, Montessori, and Rauschenbusch, but, despite their efforts, school literacy did not neutralize difference. Now, taking reading and writing for granted, Melungeons are exploring their identity by creating websites and participating in listserv discussions. These online expressions, which provide texts for rhetorical, semiotic, and socio-linguistic analysis, illustrate not solidarity but fragmentation on issues of origins and legitimacy. Armed with literacies of difference stemming from both nature and nurture, Melungeons are using literacy practices to embrace the difference they cannot escape.

The website as a domain-specific genre

The paper takes an initial look at how the medial conditions of the screen and the Internet define new constraints for language and style of company websites. The paper first discusses how the impact of bad grammar is enhanced by the salience and universal visibility on the screen. The main part of the paper argues that the language of company websites often represents fossilized rhetorical structures as a paper text hangover from the medial conditions of reading written texts and views this residue as an evolutionary stage of the evolution towards a medially appropriate style.

Internet Service Providers Liability in Spain

The article focuses on the current situation of Spanish case law on ISP liability. It starts by presenting the more salient peculiarities of the Spanish transposition of the safe harbours laid down in the E-Commerce Directive. These peculiarities relate to the knowledge requirement of the hosting safe harbour, and to the safe harbour for information location tools. The article then provides an overview of the cases decided so far with regard to each of the safe harbours. Very few cases have dealt with the mere conduit and the caching safe harbours, though the latter was discussed in an interesting case involving Google’s cache. Most cases relate to hosting and linking safe harbours. With regard to hosting, the article focuses particularly on the two judgments handed down by the Supreme Court that hold an open interpretation of actual knowledge, an issue where courts had so far been split. Cases involving the linking safe harbour have mainly dealt with websites offering P2P download links. Accordingly, the article explores the legal actions brought against these sites, which for the moment have been unsuccessful. The new legislative initiative to fight against digital piracy – the Sustainable Economy Bill – is also analyzed. After the conclusion, the article provides an Annex listing the cases that have dealt with ISP liability in Spain since the safe harbours scheme was transposed into Spanish law.

Igbo Nationalism and Biafra

When I was living in Igboland in 1993 and from 1994 to 1996, there was not much talk about Biafra, the secessionist republic that had been defeated by the Nigerian army in 1970. Not one Igbo politician suggested that his or her people in the southeast of Nigeria should secede again and proclaim a second Biafra. Since 1984, Nigeria had been ruled by the military, and political hopes focused on a return to democracy. Democracy did come in 1999, but it proved a big disappointment. It did not end the marginalisation of the Igbo but led to an increase in the number of ethnic and religious clashes, with Igbo 'migrants' in northern Nigeria as the main victims. It was Nigeria's fourth transition to democracy, and the Igbo lost out again. When I returned to Igboland for brief visits between 2000 and 2007, the option of a new Biafra was widely discussed. Many of my former colleagues at the University of Nsukka seemed to be in favour of the secession project. I talked to supporters of the main separatist organisation, Movement for the Actualisation of a Sovereign State of Biafra (MASSOB), and I discussed the project with members of Ohanaeze, a loose association of Igbo politicians, most of whom had distanced themselves from radical secessionism. In order to learn more about the resurgence of Igbo nationalism, I collected Igbo periodicals. A few of them, such as the New Republic, resembled newspapers; others, like News Round, Eastern Sunset or Weekly Hammer (with eight pages in A4 size), looked more like political pamphlets. Street vendors used back issues as wrapping paper, so they were easy to get. Most of them had been edited not in Igboland, but in Lagos, Nigeria's commercial centre and former capital which is home to a huge Igbo diaspora. Though written in English, these publications are addressed exclusively to an Igbo readership, discussing global and domestic affairs from a nationalist point of view. Articles printed here, no matter their topic, are nationalist in the sense that they assess things from the standpoint of Igbo interests. The same is true of many articles on Igbo websites and of some books and brochures written for an Igbo audience. Another source of information on Igbo nationalism are statements by Igbo governors, ministers, members of parliament and other professional politicians who are quoted in newspapers, such as Vanguard or Guardian, and in weekly magazines such as Newswatch, Tell or The News – all with a Nigeria-wide circulation and a multi-ethnic readership. Nigeria's papers and magazines are among the best in Africa. They try to be balanced in their coverage of ethnic conflicts, and they give reliable information. The same cannot be said of periodicals produced by Igbo nationalists. They provide space for Igbo all over the world to voice their opinions, and they tolerate much controversy, but they are not accurate when reporting facts.

Proportionality of Website Blocking: Internet Connectivity Providers as Copyright Enforcers

Internet connectivity providers have been ordered to block access to websites facilitating copyright infringement in various EU countries.In this paper, the proportionality of these enforcement measures is analysed. After addressing preliminary questions, the recent ECJ ruling UPC Telekabel Wien (C-314/12) and then case law from all Member States are examined from the perspective of proportionality. Finally, five criteria are submitted for proportionality analysis, and a proportionality evaluation is provided. The major observation is that the underlying goal of copyright enforcement has implications on how the scale tilts. In particular, ineffective enforcement mechanisms can be more easily accepted if the goal of symbolic, educational or politically motivated enforcement is considered legitimate. On the other hand, if the goal is to decrease the impact of infringement, higher efficiency and economically quantifiable results may be required

Circumcision and HIV infection among men who have sex with men in Britain: the insertive sexual role

The objective was to examine the association between circumcision status and self-reported HIV infection among men who have sex with men (MSM) in Britain who predominantly or exclusively engaged in insertive anal intercourse. In 2007-2008, a convenience sample of MSM living in Britain was recruited through websites, in sexual health clinics, bars, clubs, and other venues. Men completed an online survey which included questions on circumcision status, HIV testing, HIV status, sexual risk behavior, and sexual role for anal sex. The analysis was restricted to 1,521 white British MSM who reported unprotected anal intercourse in the previous 3 months and who said they only or mostly took the insertive role during anal sex. Of these men, 254 (16.7 %) were circumcised. Among men who had had a previous HIV test (n = 1,097), self-reported HIV seropositivity was 8.6 % for circumcised men (17/197) and 8.9 % for uncircumcised men (80/900) (unadjusted odds ratio [OR], 0.97; 95 % confidence interval [95 % CI], 0.56, 1.67). In a multivariable logistic model adjusted for known risk factors for HIV infection, there was no evidence of an association between HIV seropositivity and circumcision status (adjusted OR, 0.79; 95 % CI, 0.43, 1.44), even among the 400 MSM who engaged exclusively in insertive anal sex (adjusted OR, 0.84; 95 % CI, 0.25, 2.81). Our study provides further evidence that circumcision is unlikely to be an effective strategy for HIV prevention among MSM in Britain.

Euthanasia and assisted suicide in selected European countries and US states: systematic literature review

BACKGROUND Legal in some European countries and US states, physician-assisted suicide and voluntary active euthanasia remain under debate in these and other countries. OBJECTIVES The aim of the study was to examine numbers, characteristics, and trends over time for assisted dying in regions where these practices are legal: Belgium, Luxembourg, the Netherlands, Switzerland, Oregon, Washington, and Montana. DESIGN This was a systematic review of journal articles and official reports. Medline and Embase databases were searched for relevant studies, from inception to end of 2012. We searched the websites of the health authorities of all eligible countries and states for reports on physician-assisted suicide or euthanasia and included publications that reported on cases of physician-assisted suicide or euthanasia. We extracted information on the total number of assisted deaths, its proportion in relation to all deaths, and socio-demographic and clinical characteristics of individuals assisted to die. RESULTS A total of 1043 publications were identified; 25 articles and reports were retained, including series of reported cases, physician surveys, and reviews of death certificates. The percentage of physician-assisted deaths among all deaths ranged from 0.1%-0.2% in the US states and Luxembourg to 1.8%-2.9% in the Netherlands. Percentages of cases reported to the authorities increased in most countries over time. The typical person who died with assistance was a well-educated male cancer patient, aged 60-85 years. CONCLUSIONS Despite some common characteristics between countries, we found wide variation in the extent and specific characteristics of those who died an assisted death.

Measuring Information Quality on the Internet - a User Perspective

Research into information quality on the internet, in particular on websites, has become increasingly important in recent years. In this paper a research project is described in which a measurement instrument was developed that enables the information quality of websites to be determined and analyzed from the customer perspective. The measurement instrument was developed in several stages and on the basis of a methodical-theoretical approach. In a first step, previous research results and measurement instruments were systematically analyzed. In a second step, these results were adjusted and supplemented on the basis of a qualitative study. A quantitative test of the measurement instrument is planned.

The German business and information technologies project

The Business and Information Technologies (BIT) project strives to reveal new insights into how modern IT impacts organizational structures and business practices using empirical methods. Due to its international scope, it allows for inter-country comparison of empirical results. Germany — represented by the European School of Management and Technologies (ESMT) and the Institute of Information Systems at Humboldt-Universität zu Berlin — joined the BIT project in 2006. This report presents the result of the first survey conducted in Germany during November–December 2006. The key results are as follows: • The most widely adopted technologies and systems in Germany are websites, wireless hardware and software, groupware/productivity tools, and enterprise resource planning (ERP) systems. The biggest potential for growth exists for collaboration and portal tools, content management systems, business process modelling, and business intelligence applications. A number of technological solutions have not yet been adopted by many organizations but also bear some potential, in particular identity management solutions, Radio Frequency Identification (RFID), biometrics, and third-party authentication and verification. • IT security remains on the top of the agenda for most enterprises: budget spending was increasing in the last 3 years. • The workplace and work requirements are changing. IT is used to monitor employees' performance in Germany, but less heavily compared to the United States (Karmarkar and Mangal, 2007).1 The demand for IT skills is increasing at all corporate levels. Executives are asking for more and better structured information and this, in turn, triggers the appearance of new decision-making tools and online technologies on the market. • The internal organization of companies in Germany is underway: organizations are becoming flatter, even though the trend is not as pronounced as in the United States (Karmarkar and Mangal, 2007), and the geographical scope of their operations is increasing. Modern IT plays an important role in enabling this development, e.g. telecommuting, teleconferencing, and other web-based collaboration formats are becoming increasingly popular in the corporate context. • The degree to which outsourcing is being pursued is quite limited with little change expected. IT services, payroll, and market research are the most widely outsourced business functions. This corresponds to the results from other countries. • Up to now, the adoption of e-business technologies has had a rather limited effect on marketing functions. Companies tend to extract synergies from traditional printed media and on-line advertising. • The adoption of e-business has not had a major impact on marketing capabilities and strategy yet. Traditional methods of customer segmentation are still dominating. The corporate identity of most organizations does not change significantly when going online. • Online sales channel are mainly viewed as a complement to the traditional distribution means. • Technology adoption has caused production and organizational costs to decrease. However, the costs of technology acquisition and maintenance as well as consultancy and internal communication costs have increased.

Internet-based individually versus group guided self-help treatment for social anxiety disorder: protocol of a randomized controlled trial

BACKGROUND: Social anxiety disorder (SAD) is one of the most common mental disorders and causes subjective suffering and economic burden worldwide. Although effective treatments are available, a lot of cases go untreated. Internet-based self-help is a low-threshold and flexible treatment alternative for SAD. Various studies have already shown that internet-based self-help can be effective to reduce social phobic symptoms significantly. Most of the interventions tested include therapist support, whereas the role of peer support within internet-based self-help has not yet been fully understood. There is evidence suggesting that patients' mutual exchange via integrated discussion forums can increase the efficacy of internet-based treatments. This study aims at investigating the added value of therapist-guided group support on the treatment outcome of internet-based self-help for SAD. METHODS/DESIGN: The study is conducted as a randomized controlled trial. A total of 150 adults with a diagnosis of SAD are randomly assigned to either a waiting-list control group or one of the active conditions. The participants in the two active conditions use the same internet-based self-help program, either with individual support by a psychologist or therapist-guided group support. In the group guided condition, participants can communicate with each other via an integrated, protected discussion forum. Subjects are recruited via topic related websites and links; diagnostic status will be assessed with a telephone interview. The primary outcome variables are symptoms of SAD and diagnostic status after the intervention. Secondary endpoints are general symptomology, depression, quality of life, as well as the primary outcome variables 6 months later. Furthermore, process variables such as group processes, the change in symptoms and working alliance will be studied. DISCUSSION: The results of this study should indicate whether group-guided support could enhance the efficacy of an internet-based self-help treatment for SAD. This novel treatment format, if shown effective, could represent a cost-effective option and could further be modified to treat other conditions, as well.

The Inverted Phantom Giant

In his famous children’s book, “Jim Button and Luke the Engine Driver”, Michael Ende describes a curious character: A phantom giant. Clothed in rags and with a long beard, the phantom giant appears enormous from far away, but shrinks to normal size as one gets closer. Most people avoid the poor creature, but the ones that dare approach it encounter a gentle, lonely being called Mr. Tur Tur. Chemical ecology is just the opposite of Mr. Tur Tur: A phantom dwarf. Or, in other words, an inverted phantom giant. From a distance, chemical ecology appears like a slightly odd, marginal section of biology and chemistry. But, as the interested scholar approaches, it starts growing and very quickly reaches gigantic dimensions, because all life is explained by chemistry, and all biological chemistry is guided by ecological principles. Herein lies the difficulty with chemical ecology: As it is not perceived well by biologists and chemists, few approach it to understand its significance, and the ones that do find themselves in front of a giant that defies their attempts to define and contain it. This is where the Journal of Chemical Ecology comes in: It invites us to take a closer look at an underestimated discipline and supports us to explore it and deal with its multidimensionality through the promotion of knowledge and methods. These services are unique and make the journal stand out of the crowd of scientific journals. Writing children’s books has become difficult in the era of information technology. And, so has the job of the Journal of Chemical Ecology. Young scientists gather information through accessible, dynamic websites and social platforms. They want articles that are available through a single mouse click, anywhere, anytime. They prefer advanced interactive hypertext protocols over clumsy pdf files. They care about transparency, non-profit and open access just as much as about traditional journal properties. In my view, reaching “the kids” is the major challenge of the Journal over the next years. Promoting an inverted phantom giant in the 21st century requires a combination of high-quality information and boosted visibility. In Michael Ende’s book, Jim and Luke follow exactly this strategy with Mr. Tur Tur: They become friends and offer him a job as a living lighthouse to protect their small island. They combine a quality relationship with high visibility, et voilà, the story ends well! I am looking forward to seeing if the Journal of Chemical Ecology will follow a similar path to reach the next generation of biologists and chemists. If yes, there is a good chance that in 40 years from now, somebody will write a laudation and refer to another famous book by Michael Ende: “The Neverending Story”.