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Original Article| Volume 64, ISSUE 11, P1216-1222, November 2011

Incomplete reporting of recruitment information in breast cancer trials published between 2003 and 2008

  • Author Footnotes
    1 Contributorship: S.T. had the initial idea for the study. K.L. did the literature retrieval. Both authors reviewed abstracts, read potentially relevant articles, and extracted data. S.T. wrote the initial draft of the article, and both authors contributed to subsequent drafts. S.T. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
    Shaun Treweek
    Correspondence
    Corresponding author. Tel.: +44 777 901 6955; fax: +1382 420010.
    Footnotes
    1 Contributorship: S.T. had the initial idea for the study. K.L. did the literature retrieval. Both authors reviewed abstracts, read potentially relevant articles, and extracted data. S.T. wrote the initial draft of the article, and both authors contributed to subsequent drafts. S.T. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
    Affiliations
    Quality, Safety & Informatics Research Group, University of Dundee, Kirsty Semple Way, Dundee DD2 4BF, UK
    Search for articles by this author
  • Author Footnotes
    1 Contributorship: S.T. had the initial idea for the study. K.L. did the literature retrieval. Both authors reviewed abstracts, read potentially relevant articles, and extracted data. S.T. wrote the initial draft of the article, and both authors contributed to subsequent drafts. S.T. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
    Kirsty Loudon
    Footnotes
    1 Contributorship: S.T. had the initial idea for the study. K.L. did the literature retrieval. Both authors reviewed abstracts, read potentially relevant articles, and extracted data. S.T. wrote the initial draft of the article, and both authors contributed to subsequent drafts. S.T. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
    Affiliations
    Quality, Safety & Informatics Research Group, University of Dundee, Kirsty Semple Way, Dundee DD2 4BF, UK
    Search for articles by this author
  • Author Footnotes
    1 Contributorship: S.T. had the initial idea for the study. K.L. did the literature retrieval. Both authors reviewed abstracts, read potentially relevant articles, and extracted data. S.T. wrote the initial draft of the article, and both authors contributed to subsequent drafts. S.T. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

      Abstract

      Objectives

      To review the reporting of key items of recruitment information in trial reports and estimate the number needed to screen to recruit one additional participant.

      Study Design and Setting

      Review of breast cancer trials published in the years 2003–2005, 2007, and 2008.

      Results

      The search identified 1,570 potentially eligible studies. After a random selection of 20% from each year and checking against inclusion criteria, a total of 207 studies were included in the review. Some items of information were well reported, such as the number included in the analysis. Sample size calculations were often not presented, but reporting is slowly improving. Who recruits participants and how many individuals were screened are often not reported. The median number needed to screen to recruit one additional participant was two (range, 1–593).

      Conclusions

      Without reporting the when, where, by whom, and how many of recruitment, trialists deny readers part of the contextual description they need to judge whether a trial’s results are applicable to their own situation. Trialists and journal editors need to be more diligent in following the reporting recommendations of the Consolidated Standards of Reporting Trials statement.

      Keywords

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