References for CONSORT Plus Guideline

This page briefly describes the rationale behind some of our recommendations for trial reporting. Further details are available in the cited references. If you know of references that should be here but aren't, please contact us.

 ... This page is under construction.

General

• Bailar JC, Mosteller F. Guidelines for statistical reporting in articles for medical journals. Ann Intern Med. 1988;108:266-273

• Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials: a survey of three medical journals. N Engl J Med. 1987;317: 426-432

• The Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. JAMA. 1994;272:1926-1931. Correction: JAMA. 1995;273:776.

• Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature: a position paper. Ann Intern Med. 1994;121: 894-895

Administration

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Study Design

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Subjects and Recruitment

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Treatment Assignment

• Randomization Sequence: 

  • Proper randomization is required to generate comparable treatment groups, but the reporting of randomization methods is often inadequate
    

    • Schulz KF, Chalmers I, Grimes DA, Altman DG. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. JAMA. 1994;272:125-128

• Allocation Concealment: 

  • Lack of allocation concealment is associated with exaggerated estimates of effect.
    

    • Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273: 408-412.

Interventions

• Control: 

  • The use of a placebo control should be justified because it is considered unethical to use a placebo control if a knwon effective treatment exists
    

    • Declaration of Helsinki, 2000

    • Rothman KJ; Michels KB. The continuing unethical use of placebo controls. New England Journal of Medicine, 1994 Aug 11, 331(6):394-8.

Outcomes and Measurements

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Outcomes Assessment

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Followup

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Results

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Publications

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