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Biomedical subjects

Elizabeth Wager

Publications and source records attributed to Elizabeth Wager.

13 recordsLinked to original sources

European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications.

BACKGROUND: Many papers in biomedical journals are drafted not by the named authors, but by professional medical writers working under the direction of those authors, usually funded by pharmaceutical companies. Although this practice can improve both the quality and speed of publications, it has attracted controversy as a result of concerns about the inappropriate influence of pharmaceutical companies. OBJECTIVES: To define ethical standards for professional medical writers who prepare papers for publication in medical journals. CONSENSUS METHODS: Guidelines were drafted after a 4-round Delphi consultation among a group of experienced medical writers. The guidelines were then further refined by seeking comments on the draft from a range of interested parties. FINDINGS AND CONCLUSIONS: The guidelines stress the importance of respecting widely recognised authorship criteria, and in particular of ensuring that those listed as named authors have full control of the content of papers. The role of medical writers must be transparent, which normally means a mention in the acknowledgements section, together with a statement about funding. Writers and authors must have access to relevant data while writing papers. Medical writers have professional responsibilities to ensure that the papers they write are scientifically valid and are written in accordance with generally accepted ethical standards.

Authorship↗

Depressing research.

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Clinical Trials as Topic↗

The need for trial identifiers.

The medical literature is distorted by publication bias, duplicate publication and under-reporting of clinical trials. This can create problems in systematic numbering systems. The inclusion of trial identifiers reviews and meta-analysis which are increasingly used as the basis for evidence-based guidelines and therefore for treatment decisions. Various schemes for identifying trials and their associated publications are reviewed. These include trial registers and trial in all publications could greatly enhance the value of the medical literature and increase the robustness of systematic reviews and meta-analyses.

Clinical Trials as Topic↗

Get peered!

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Play and Playthings↗

Good publication practice for pharmaceutical companies.

Guidelines on Good Publication Practice (GPP) for pharmaceutical companies are presented. The aim of the guidelines is to ensure that clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner. The guidelines cover companies' responsibility to an endeavour to publish results of all studies, companies' relations with investigators, measures to prevent redundant or premature publication, methods to improve trial identification and the role of professional medical writers. Our aim in publishing the GPP guidelines, which are the first to be developed by and for those working on publications in the pharmaceutical industry, is to stimulate discussion between journals, investigators and trial sponsors and to provide guidance to those who seek it. We also hope that pharmaceutical companies and others involved in developing publications arising from sponsored clinical trials will endorse the guidelines.

Drug Industry↗

Effects of editorial peer review: a systematic review.

CONTEXT: Editorial peer review is widely used to select submissions to journals for publication and is presumed to improve their usefulness. Sufficient research on peer review has been published to consider a synthesis of its effects. METHODS: To examine the evidence of the effects of editorial peer-review processes in biomedical journals, we conducted electronic and full-text searches of private and public databases to June 2000 and corresponded with the World Association of Medical Editors, European Association of Science Editors, Council of Science Editors, and researchers in the field to locate comparative studies assessing the effects of any stage of the peer-review process that made some attempt to control for confounding. Nineteen of 135 identified studies fulfilled our criteria. Because of the diversity of study questions, methods, and outcomes, we did not pool results. RESULTS: Nine studies considered the effects of concealing reviewer/author identity. Four studies suggested that concealing reviewer or author identity affected review quality (mostly positively); however, methodological limitations make their findings ambiguous, and other studies' results were either negative or inconclusive. One study suggested that a statistical checklist can improve report quality, but another failed to find an effect of publishing another checklist. One study found no evidence that training referees improves performance and another showed increased interrater reliability; both used open designs, making interpretation difficult. Two studies of how journals communicate with reviewers did not demonstrate any effect on review quality. One study failed to show reviewer bias, but the findings may not be generalizable. One nonrandomized study compared the quality of articles published in peer-reviewed vs other journals. Two studies showed that editorial processes make articles more readable and improve the quality of reporting, but the findings may have limited generalizability to other journals. CONCLUSIONS: Editorial peer review, although widely used, is largely untested and its effects are uncertain.

Peer Review, Research↗

Measuring the quality of editorial peer review.

CONTEXT: The quality of a process can only be tested against its agreed objectives. Editorial peer-review is widely used, yet there appears to be little agreement about how to measure its effects or processes. METHODS: To identify outcome measures used to assess editorial peer review as performed by biomedical journals, we analyzed studies identified from 2 systematic reviews that measured the effects of editorial peer review on the quality of the output (ie, published articles) or of the process itself (eg, reviewers' comments). RESULTS: Ten studies used a variety of instruments to assess the quality of articles that had undergone peer review. Only 1, nonrandomized study compared the quality of articles published in peer-reviewed and non-peer-reviewed journals. The others measured the effects of variations in the peer-review process or used a before-and-after design to measure the effects of standard peer review on accepted articles. Eighteen studies measured the quality of reviewers' reports under different conditions such as blinding or after training. One study compared the time and cost of different review processes. CONCLUSIONS: Until we have properly defined the objectives of peer-review, it will remain almost impossible to assess or improve its effectiveness. The research needed to understand the broader effects of peer review poses many methodologic problems and would require the cooperation of many parts of the scientific community.

Evaluation Studies as Topic↗

Effects of technical editing in biomedical journals: a systematic review.

CONTEXT: Technical editing supposedly improves the accuracy and clarity of journal articles. We examined evidence of its effects on research reports in biomedical journals. METHODS: Subset of a systematic review using Cochrane methods, searching MEDLINE, EMBASE, and other databases from earliest entries to February 2000 by using inclusive search terms; hand searching relevant journals. We selected comparative studies of the effects of editorial processes on original research articles between acceptance and publication in biomedical journals. Two reviewers assessed each study and performed independent data extraction. RESULTS: The 11 studies on technical editing indicate that it improves the readability of articles slightly (as measured by Gunning Fog and Flesch reading ease scores), may improve other aspects of their quality, can increase the accuracy of references and quotations, and raises the quality of abstracts. Supplying authors with abstract preparation instructions had no discernible effect. CONCLUSIONS: Considering the time and resources devoted to technical editing, remarkably little is know about its effects or the effects of imposing different house styles. Studies performed at 3 journals employing relatively large numbers of professional technical editors suggest that their editorial processes are associated with increases in readability and quality of articles, but these findings may not be generalizable to other journals.

Peer Review, Research↗