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[The ultimate fate of articles rejected for publication in the Nederlands Tijdschrift voor Geneeskunde].

OBJECTIVE: Determining the fate of articles rejected for publication by the Dutch Medical Journal (Nederlands Tijdschrift voor Geneeskunde, NTvG). DESIGN: Retrospective. SETTING: Editorial office of the NTvG. METHOD: Using a Medline search and questionnaire for authors, the fate of 108 manuscripts, (definitively) rejected for publication in the second half of 1992, was determined. Articles were divided according to the various headings, which they received upon submission. RESULTS: Of all the 108 rejected manuscripts, 14 were found in Medline, of which 5 had already been published, when submitted to the NTvG (4 of these were unannounced duplicate publications). The inquiry had a response rate of 84%; 93 manuscripts could be included in the study. The over-all publication percentage of rejected articles was 60% ((46/93 (49%) published, 10/93 (II%) accepted for publication)); 5 articles were published twice in different journals. The mean time lapse between rejection and publication of the articles published after rejection was II months. Of all articles published or accepted for publication (n = 62; duplicate publications included) 25 appeared in an English journal, 37 in a Dutch journal. CONCLUSION: Of articles rejected by the NTvG 60% is eventually published in another journal.

Duplicate Publications as Topic↗

Publication bias in editorial decision making.

CONTEXT: Studies with positive results are more likely to be published than studies with negative results (publication bias). One reason this occurs is that authors are less likely to submit manuscripts reporting negative results to journals. There is no evidence that publication bias occurs once manuscripts have been submitted to a medical journal. We assessed whether submitted manuscripts that report results of controlled trials are more likely to be published if they report positive results. METHODS: Prospective cohort study of manuscripts submitted to JAMA from February 1996 through August 1999. We classified results as positive if there was a statistically significant difference (P<.05) reported for the primary outcome. Study characteristics and indicators for quality were also appraised. We included manuscripts that reported prospective studies in which participants were assigned to an intervention or comparison group and statistical tests compared differences between groups. RESULTS: Among 745 manuscripts, 133 (17.9%) were published: 78 (20.4%) of 383 with positive results, 51 (15.0%) of 341 with negative results, and 4 (19.0%) of 21 with unclear results. The crude relative risk for publication of studies with positive results compared with negative results was 1.36 (95% confidence interval [CI], 0.99-1.88). After being adjusted simultaneously for study characteristics and quality indicators, the odds ratio for publishing studies with positive results was 1.30 (95% CI, 0.87-1.96). CONCLUSIONS: Among submitted manuscripts, we did not find a statistically significant difference in publication rates between those with positive vs negative results.

Biomedical Research↗

Association between time interval to publication and statistical significance.

CONTEXT: Studies have shown that reports from clinical trials with statistically significant results tend to be submitted and published more rapidly than reports from studies with null or insignificant findings. METHODS: We wanted to determine whether manuscripts reporting positive results from controlled clinical trials are published more quickly than those reporting negative results. We tracked manuscripts from submission to JAMA until the publication decision. We classified results as positive if a statistically significant difference was reported for the primary outcome. Manuscripts were further classified according to indicators of methodologic quality and other study characteristics. We included manuscripts if they were submitted from February 1996 through August 1999, reported results of a prospective study in which participants were assigned to a treatment or comparison group, used statistical tests to compare differences between groups, and were accepted for publication. RESULTS: One hundred thirty-three manuscripts met our inclusion criteria, 78 (59%) reported positive results, 51 (38%) reported negative results. We were unable to classify the direction of results for 4 articles (3%). The time interval between submission and publication was not associated with positive results: median time between submission and publication was 7.8 months for reports with positive vs 7.6 months for reports with negative results (P =.44). Time to publication also was not associated with any marker of study quality or study characteristic. CONCLUSIONS: Among 133 published controlled trials, time to publication was not associated with statistical significance, methodologic quality, or other study characteristics.

Controlled Clinical Trials as Topic↗

Preparing manuscripts for submission to medical journals: the paper trail.

CONTEXT: Preparing a manuscript for publication in a medical journal is hard work. OBJECTIVE: To make it easier to prepare a readable manuscript. APPROACH: Start early--A substantial portion of the manuscript can be written before the project is completed. Even though you will revise it later, starting early will help document the methods and guide the analysis. Focus on high-visibility components--Pay attention to what readers are most likely to look at: the title, abstract, tables, and figures. Strive to develop a set of tables and figures that convey not only the major results but also the basic methods. Develop a systematic approach to the body of the paper--A standard framework can make it easier to write the introduction, methods, results, and discussion. An obvious organization with frequent subheadings and consistent labels makes the paper easier to read. Finish strong--Improve the paper by sharing it with others and by learning how to elicit and receive their feedback. Take the time to incorporate useful feedback by revising frequently.

Data Display↗

AAPS/RAPS/CAPRA collaborative program: exploring the challenges of drug regulation in a global environment: clinical concerns.

Globalization of the pharmaceutical industry has led to a need to harmonize the regulatory requirements governing the marketing of medicinal products. To minimize the barriers impeding global drug product registration, the International Conference on the Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH) was established in 1990. The ICH has developed a series of guidelines that reflect agreements reached by participating nations on aspects of the chemistry and clinical technical sections that will fulfill the regulatory requirements of these various jurisdications. Nevertheless, there continue to be points of divergent perspectives and barriers that can impede the use of foreign clinical data. Given the importance of these issues, the Regulatory Science (RS) section of the American Association of Pharmaceutical Scientists (AAPS), in conjunction with the Regulatory Affairs Professional Society (RAPS) and the Canadian Association of Professional Regulatory Affairs (CAPRA) cosponsored a public forum on this topic. This manuscript provides a summary of the speaker presentations and audience discussions regarding the design of clinical trials and the extrapolation of results from these trials to support international drug registration.

Clinical Trials as Topic↗

Development and evaluation of a quality score for abstracts.

BACKGROUND: The evaluation of abstracts for scientific meetings has been shown to suffer from poor inter observer reliability. A measure was developed to assess the formal quality of abstract submissions in a standardized way. METHODS: Item selection was based on scoring systems for full reports, taking into account published guidelines for structured abstracts. Interrater agreement was examined using a random sample of submissions to the American Gastroenterological Association, stratified for research type (n = 100, 1992-1995). For construct validity, the association of formal quality with acceptance for presentation was examined. A questionnaire to expert reviewers evaluated sensibility items, such as ease of use and comprehensiveness. RESULTS: The index comprised 19 items. The summary quality scores showed good interrater agreement (intra class coefficient 0.60 - 0.81). Good abstract quality was associated with abstract acceptance for presentation at the meeting. The instrument was found to be acceptable by expert reviewers. CONCLUSION: A quality index was developed for the evaluation of scientific meeting abstracts which was shown to be reliable, valid and useful.

Congresses as Topic↗

The art of scientific writing: how to get your research published!

The purpose of this article is to provide potential authors with a contemporary guide to scientific writing. It is in essence a handbook that covers the planning for a scientific publication from inception of the project or study to manuscript preparation and, ultimately, acceptance by a journal. Major topics such as manuscript formatting, data analysis, use of charts, graphs and images, reference formats, and manuscript submission are presented.

Bibliographies as Topic↗