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

Quels sont les bénéfices d'une immunisation passive postexpositionnelle contre la rougeole ? : Revue Cochrane pour le praticien

Question clinique : Une patiente de 43 ans connue pour un lupus érythémateux disséminé et une néphropathie lupique stable et traitée par hydroxychloroquine et mycophénolate mofétil vous rapporte avoir eu contact il y a quatre jours avec un enfant atteint de la rougeole. Elle ne présente aucun symptôme et son dernier bilan vaccinal montre un taux d'anticorps contre la rougeole non protecteur. La patiente devrait-elle recevoir une immunisation active ou passive contre la rougeole? Contexte En Suisse : la couverture vaccinale contre la rougeole n'est pas assez importante pour empêcher sa diffusion. L'immunisation passive avec des immunoglobulines est destinée aux personnes non immunes exposées à la rougeole, recommandée en Suisse aux personnes à haut risque. Cette revue visait à évaluer l'efficacité et l'innocuité de l'injection intramusculaire ou de la perfusion intraveineuse d'immunoglobulines pour prévenir la rougeole chez les personnes susceptibles avant l'apparition des symptômes

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

How do authors of systematic reviews deal with research malpractice and misconduct in original studies? A cross-sectional analysis of systematic reviews and survey of their authors.

OBJECTIVES: To study whether systematic reviewers apply procedures to counter-balance some common forms of research malpractice such as not publishing completed research, duplicate publications, or selective reporting of outcomes, and to see whether they identify and report misconduct. DESIGN: Cross-sectional analysis of systematic reviews and survey of their authors. PARTICIPANTS: 118 systematic reviews published in four journals (Ann Int Med, BMJ, JAMA, Lancet), and the Cochrane Library, in 2013. MAIN OUTCOMES AND MEASURES: Number (%) of reviews that applied procedures to reduce the impact of: (1) publication bias (through searching of unpublished trials), (2) selective outcome reporting (by contacting the authors of the original studies), (3) duplicate publications, (4) sponsors' and (5) authors' conflicts of interest, on the conclusions of the review, and (6) looked for ethical approval of the studies. Number (%) of reviewers who suspected misconduct are reported. The procedures applied were compared across journals. RESULTS: 80 (68%) reviewers confirmed their data. 59 (50%) reviews applied three or more procedures; 11 (9%) applied none. Unpublished trials were searched in 79 (66%) reviews. Authors of original studies were contacted in 73 (62%). Duplicate publications were searched in 81 (69%). 27 reviews (23%) reported sponsors of the included studies; 6 (5%) analysed their impact on the conclusions of the review. Five reviews (4%) looked at conflicts of interest of study authors; none of them analysed their impact. Three reviews (2.5%) looked at ethical approval of the studies. Seven reviews (6%) suspected misconduct; only 2 (2%) reported it explicitly. Procedures applied differed across the journals. CONCLUSIONS: Only half of the systematic reviews applied three or more of the six procedures examined. Sponsors, conflicts of interest of authors and ethical approval remain overlooked. Research misconduct is sometimes identified, but rarely reported. Guidance on when, and how, to report suspected misconduct is needed

Pre-hospital tracheal intubation in patients with traumatic brain injury: systematic review of current evidence

Background We reviewed the current evidence on the benefit and harm of pre-hospital tracheal intubation and mechanical ventilation after traumatic brain injury (TBI). Methods We conducted a systematic literature search up to December 2007 without language restriction to identify interventional and observational studies comparing pre-hospital intubation with other airway management (e.g. bag-valve-mask or oxygen administration) in patients with TBI. Information on study design, population, interventions, and outcomes was abstracted by two investigators and cross-checked by two others. Seventeen studies were included with data for 15 335 patients collected from 1985 to 2004. There were 12 retrospective analyses of trauma registries or hospital databases, three cohort studies, one case-control study, and one controlled trial. Using Brain Trauma Foundation classification of evidence, there were 14 class 3 studies, three class 2 studies, and no class 1 study. Six studies were of adults, five of children, and three of both; age groups were unclear in three studies. Maximum follow-up was up to 6 months or hospital discharge. Results In 13 studies, the unadjusted odds ratios (ORs) for an effect of pre-hospital intubation on in-hospital mortality ranged from 0.17 (favouring control interventions) to 2.43 (favouring pre-hospital intubation); adjusted ORs ranged from 0.24 to 1.42. Estimates for functional outcomes after TBI were equivocal. Three studies indicated higher risk of pneumonia associated with pre-hospital (when compared with in-hospital) intubation. Conclusions Overall, the available evidence did not support any benefit from pre-hospital intubation and mechanical ventilation after TBI. Additional arguments need to be taken into account, including medical and procedural aspect

Technology for large-scale translation of clinical practice guidelines : a pilot study of the performance of a hybrid human and computer-assisted approach

Background: The construction of EBMPracticeNet, a national electronic point-of-care information platform in Belgium, was initiated in 2011 to optimize quality of care by promoting evidence-based decision-making. The project involved, among other tasks, the translation of 940 EBM Guidelines of Duodecim Medical Publications from English into Dutch and French. Considering the scale of the translation process, it was decided to make use of computer-aided translation performed by certificated translators with limited expertise in medical translation. Our consortium used a hybrid approach, involving a human translator supported by a translation memory (using SDL Trados Studio), terminology recognition (using SDL Multiterm termbases) from medical termbases and support from online machine translation. This has resulted in a validated translation memory which is now in use for the translation of new and updated guidelines. Objective: The objective of this study was to evaluate the performance of the hybrid human and computer-assisted approach in comparison with translation unsupported by translation memory and terminology recognition. A comparison was also made with the translation efficiency of an expert medical translator. Methods: We conducted a pilot trial in which two sets of 30 new and 30 updated guidelines were randomized to one of three groups. Comparable guidelines were translated (a) by certificated junior translators without medical specialization using the hybrid method (b) by an experienced medical translator without this support and (c) by the same junior translators without the support of the validated translation memory. A medical proofreader who was blinded for the translation procedure, evaluated the translated guidelines for acceptability and adequacy. Translation speed was measured by recording translation and post-editing time. The Human Translation Edit Rate was calculated as a metric to evaluate the quality of the translation. A further evaluation was made of translation acceptability and adequacy. Results: The average number of words per guideline was 1,195 and the mean total translation time was 100.2 min/1,000 words. No meaningful differences were found in the translation speed for new guidelines. The translation of updated guidelines was 59 min/1,000 words faster (95% CI 2-115; P=.044) in the computer-aided group. Revisions due to terminology accounted for one third of the overall revisions by the medical proofreader. Conclusions: Use of the hybrid human and computer-aided translation by a non-expert translator makes the translation of updates of clinical practice guidelines faster and cheaper because of the benefits of translation memory. For the translation of new guidelines there was no apparent benefit in comparison with the efficiency of translation unsupported by translation memory (whether by an expert or non-expert translator

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