Methodological reporting of randomized clinical trials in major gastroenterology and hepatology journals in 2006

Authors

  • Yu Bai,

    1. Evidence-Based Medicine Group, Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China
    2. Center of Clinical Epidemiology, Changhai Hospital, Second Military Medical University, Shanghai, China
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    • Dr. Bai Yu and Dr. Gao Jun contributed equally to this work.

  • Jun Gao,

    1. Evidence-Based Medicine Group, Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China
    2. Center of Clinical Epidemiology, Changhai Hospital, Second Military Medical University, Shanghai, China
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    • Dr. Bai Yu and Dr. Gao Jun contributed equally to this work.

  • Duo-Wu Zou,

    1. Evidence-Based Medicine Group, Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China
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  • Zhao-Shen Li

    Corresponding author
    1. Evidence-Based Medicine Group, Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China
    2. Center of Clinical Epidemiology, Changhai Hospital, Second Military Medical University, Shanghai, China
    • Department of Gastroenterology, Changhai Hospital, Second Military Medical University, 168 Changhai Road, Shanghai, China
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    • fax: (86)-21-55621735.


  • Potential conflict of interest: Nothing to report.

Abstract

To determine the current quality of reporting of randomized clinical trials (RCTs) in the field of gastroenterology and hepatology, we evaluated the methodological reporting of RCTs in six major gastroenterology and hepatology journals. The methodological quality, including generation of the allocation sequence, allocation concealment, double-blinding, and sample size calculation; number of patients; disease area; and funding source was also retrieved from each trial, and the relevant trials were identified by searching MEDLINE in 2006 using a highly sensitive search strategy. The status of reporting the methodological quality of RCTs was descriptively reported. One hundred five trials were included in the final analysis; of these, 81% (85/105) reported adequate generation of the allocation sequence, 61% (64/105) reported adequate allocation concealment, 51% (54/105) were double-blind, and 75% (79/105) reported adequate sample size calculation. The reported methodological quality greatly improved when compared with historical cohorts. Conclusion: This study shows that there was substantial improvement in the reported methodological quality in the major gastroenterology and hepatology journals, but this quality can be further improved. (HEPATOLOGY 2009.)

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