Editorial research and the publication process in biomedicine and health: Report from the Esteve Foundation Discussion Group, December 2012.

Despite the fact that there are more than twenty thousand biomedical journals in the world, research into the work of editors and publication process in biomedical and health care journals is rare. In December 2012, the Esteve Foundation, a non-profit scientific institution that fosters progress in pharmacotherapy by means of scientific communication and discussion organized a discussion group of 7 editors and/or experts in peer review biomedical publishing. They presented findings of past editorial research, discussed the lack of competitive funding schemes and specialized journals for dissemination of editorial research, and reported on the great diversity of misconduct and conflict of interest policies, as well as adherence to reporting guidelines. Furthermore, they reported on the reluctance of editors to investigate allegations of misconduct or increase the level of data sharing in health research. In the end, they concluded that if editors are to remain gatekeepers of scientific knowledge they should reaffirm their focus on the integrity of the scientific record and completeness of the data they publish. Additionally, more research should be undertaken to understand why many journals are not adhering to editorial standards, and what obstacles editors face when engaging in editorial research

Thrombose veineuse profonde : une thrombolyse est-elle efficace ? : revue cochrane pour le praticien

Scénario: Une patiente de 45 ans vous consulte car sa jambe droite est bleue, cyanosée, avec une tension dans le mollet depuis cinq jours, qui s'est étendue progressivement jusqu'au haut de la cuisse. La circonférence du mollet droit est 4 cm plus grande que celle du mollet gauche. La patiente est en surpoids (IMC à 35 kg/m2) et suit depuis quelques années un traitement oestro-progestatif. Elle n'a pas d'anamnèse familiale ou d'antécédent de maladie thromboembolique. Un ultrason montre une thrombose veineuse profonde (TVP) avec un thrombus s'étendant de la veine poplitée à la veine iliaque externe. Question: La patiente pourrait-elle bénéficier d'une thrombolyse? Contexte: Les complications de la TVP comprennent l'embolie pulmonaire et le syndrome post-thrombotique. Un syndrome post-thrombotique léger à modéré peut survenir chez 30-50% des patients malgré un traitement anticoagulant, qui prévient principalement l'embolie pulmonaire et la récidive de TVP. Cette mise à jour de revue systématique compare l'efficacité du traitement anticoagulant à celui combinant les anticoagulants et la thrombolyse (par streptokinase, urokinase ou activateur tissulaire du plasminogène)

Thrombolyse bei tiefer Venenthrombose? [Thrombolytic therapy in deep venous thrombosis?]

Sie sehen eine 45-jährige Patientin mit einem bläulich-zyanotischen rechten Bein. Vor fünf Tagen habe ein Spannungsschmerz in der Wade begonnen und sich zunehmend in den Oberschenkel hochgezogen. Die rechte Wade misst im Umfang 4 cm mehr als die linke. Die Anamnese ergibt keine familiäre oder persönliche Vorgeschichte einer thromboembolischen Erkrankung. Die Patientin ist übergewichtig ( BMI 35 kg/m2) und nimmt seit einigen Jahren eine Östrogen-Progesteron-Kombination. Der Ultraschall zeigt eine Thrombose der tiefen Beinvenen, die bis in die äussere Beckenvene reicht

Comparison of randomized controlled trials discontinued or revised for poor recruitment and completed trials with the same research question: a matched qualitative study.

More than a quarter of randomized controlled trials (RCTs) are prematurely discontinued, mostly due to poor recruitment of patients. In this study, we systematically compared RCTs discontinued or revised for poor recruitment and completed RCTs with the same underlying research question to better understand the causes of poor recruitment, particularly related to methodological aspects and context-specific study settings. We compared RCTs that were discontinued or revised for poor recruitment to RCTs that were completed as planned, matching in terms of population and intervention. Based on an existing sample of RCTs discontinued or revised due to poor recruitment, we identified matching RCTs through a literature search for systematic reviews that cited the discontinued or revised RCT and matching completed RCTs without poor recruitment. Based on extracted data, we explored differences in the design, conduct, and study settings between RCTs with and without poor recruitment, separately for each research question using semi-structured discussions. We identified 15 separate research questions with a total of 29 RCTs discontinued or revised for poor recruitment and 48 RCTs completed as planned. Prominent research areas in the sample were cancer and acute care. The mean number of RCTs with poor recruitment per research question was 1.9 ranging from 1 to 4 suggesting clusters of research questions or settings prone to recruitment problems. The reporting quality of the recruitment process in RCT publications was generally low. We found that RCTs with poor recruitment often had narrower eligibility criteria, were investigator- rather than industry-sponsored, were associated with a higher burden for patients and recruiters, sometimes used outdated control interventions, and were often launched later in time than RCTs without poor recruitment compromising uncertainty about tested interventions through emerging evidence. Whether a multi- or single-center setting was advantageous for patient recruitment seemed to depend on the research context. Our study confirmed previously identified causes for poor recruitment, i.e., narrow eligibility criteria, investigator sponsorship, and a reduced motivation of patients and recruiters. Newly identified aspects were that researchers need to be aware of all other RCTs on a research question so that compromising effects on the recruitment can be minimized and that a larger number of centers is not always advantageous

Impact of STROBE Statement Publication on Quality of Observational Study Reporting: Interrupted Time Series versus Before-After Analysis

Background:In uncontrolled before-after studies, CONSORT was shown to improve the reporting of randomised trials. Before-after studies ignore underlying secular trends and may overestimate the impact of interventions. Our aim was to assess the impact of the 2007 STROBE statement publication on the quality of observational study reporting, using both uncontrolled before-after analyses and interrupted time series.Methods:For this quasi-experimental study, original articles reporting cohort, case-control, and cross-sectional studies published between 2004 and 2010 in the four dermatological journals having the highest 5-year impact factors (≥4) were selected. We compared the proportions of STROBE items (STROBE score) adequately reported in each article during three periods, two pre STROBE period (2004-2005 and 2006-2007) and one post STROBE period (2008-2010). Segmented regression analysis of interrupted time series was also performed.Results:Of the 456 included articles, 187 (41%) reported cohort studies, 166 (36.4%) cross-sectional studies, and 103 (22.6%) case-control studies. The median STROBE score was 57% (range, 18%-98%). Before-after analysis evidenced significant STROBE score increases between the two pre-STROBE periods and between the earliest pre-STROBE period and the post-STROBE period (median score2004-0548% versus median score2008-1058%, p<0.001) but not between the immediate pre-STROBE period and the post-STROBE period (median score2006-0758% versus median score2008-1058%, p = 0.42). In the pre STROBE period, the six-monthly mean STROBE score increased significantly, by 1.19% per six-month period (absolute increase 95%CI, 0.26% to 2.11%, p = 0.016). By segmented analysis, no significant changes in STROBE score trends occurred (-0.40%; 95%CI, -2.20 to 1.41; p = 0.64) in the post STROBE statement publication.Interpretation:The quality of reports increased over time but was not affected by STROBE. Our findings raise concerns about the relevance of uncontrolled before-after analysis for estimating the impact of guidelines

Socioeconomic status as a risk factor for dementia death:individual participant meta-analysis of 86 508 men and women from the UK

Background Life-course socioeconomic factors may have a role in dementia aetiology but there is a current paucity of studies. Meta-analyses of individual participant data would considerably strengthen this evidence base. Aims To examine the association between socioeconomic status in early life and adulthood with later dementia death. Method Individual participant meta-analysis of 11 prospective cohort studies (1994-2004, n = 86 508). Results Leaving full-time education at an earlier age was associated with an increased risk of dementia death in women (fully adjusted hazard ratio (HR) for age ⩽14 v. age ⩾16: HR = 1.76, 95% CI 1.23-2.53) but not men. Occupational social class was not statistically significantly associated with dementia death in men or women. Conclusions Lower educational attainment in women was associated with an increased risk of dementia-related death independently of common risk behaviours and comorbidities

Hepatitis C, diagnosis and management: a survey of practicing physicians in Hawaii.

We surveyed 652 Hawaii physicians who diagnosed hepatitis C (HCV) since 1997. Less than 20% of licensed physicians have diagnosed HCV and initial estimates suggest there are 12,000 to 18,000 undiagnosed HCV cases in Hawaii. Treatment is concentrated among twelve physicians and aggressive case finding may overwhelm present resources. More primary care physicians need to participate in the detection and management of HCV

Evolution of a Course: Instructional Design Elements and Impacts

During the 2017 spring semester, international educators from the United States and Sweden collaborated on an Information Systems, Analysis, Design and Modeling course at the University of Business and Technology (UBT) in Kosovo for graduate students. In the spring of 2018, the collaboration and course were repeated with both graduate and undergraduate students. In the initial course, student work was focused on the conceptual design of a UBT Knowledge Center through the lenses of soft systems methodology and co- design activities. The Spring 2018 course built upon and expanded this work with additional stakeholder input from a mixed group of students from the Computer Science undergraduate and Information Systems graduate students, forming a richer and more meaningful exploration of the topic. Moving beyond the conceptual visioning activities from the 2017 course, the 2018 students were also required to analyze, design and model platforms for an institutional repository of UBT knowledge and reflect on its impact to multiple stakeholder groups at the institutional, regional and global levels. Differences between the pedagogical course design, learning outcomes, and student reflections will be explored in this paper to highlight the impact of flipped classroom teaching, cross-disciplinary/cross-degree group work and introducing soft systems thinking to students without a prior background in this methodology

Das Strengthening the Reporting of Observational Studies in Epidemiology (STROBE-) Statement: Leitlinien für das Berichten von Beobachtungsstudien

Zusammenfassung: Ein Großteil der biomedizinischen Forschung ist beobachtend, und die Qualität der veröffentlichten Berichte über diese Forschung ist oft unzureichend. Dies behindert die Beurteilung der Stärken und Schwächen einer Studie und ihrer Übertragbarkeit. Die Strengthening the Reporting of Observational Studies in Epidemiology (STROBE-) Initiative hat Empfehlungen entwickelt, was in einem akkuraten und vollständigen Bericht einer Beobachtungsstudie enthalten sein sollte. Die Empfehlungen wurden von uns so definiert, dass sie 3Hauptstudientypen abdecken: Kohorten-, Fallkontroll- und Querschnittsstudien. Im September 2004 veranstalteten wir einen zweitägigen Workshop mit Methodikern, Forschern und Herausgebern wissenschaftlicher Zeitschriften, um eine Checkliste zu entwerfen. Anschließend wurde der Entwurf bei mehreren Treffen der Koordinierungsgruppe und nach E-Mail-Diskussionen mit der erweiterten STROBE-Gruppe revidiert und dabei empirische Evidenz und methodologische Aspekte berücksichtigt. Das Ergebnis des Workshops und des anschließenden iterativen Prozesses aus Beratung und Revision war eine Checkliste von 22Punkten (STROBE-Statement), die sich auf die Bereiche Titel, Abstract, Einleitung, Methoden, Ergebnisse und Diskussion eines Artikels beziehen. 18 der Punkte sind relevant für alle 3Studiendesigns, während 4 der Punkte spezifisch für Kohorten-, Fallkontroll- und Querschnittsstudien sind. Ein ausführlicher Begleitartikel (Explanation and Elaboration) wurde separat veröffentlicht und ist auf den Webseiten von PLoS Medicine, Annals of Internal Medicine und Epidemiology frei zugänglich. Wir hoffen, dass das STROBE-Statement dazu beitragen kann, dass Beobachtungsstudien besser berichtet werde