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Related Experiment Videos

Randomisation in clinical trials.

L O Ogundipe1, A P Boardman, A Masterson

  • 1Department of Psychiatry, School of Postgraduate Medicine, Keele University, Staffordshire.

The British Journal of Psychiatry : the Journal of Mental Science
|May 2, 2000
PubMed
Summary
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Reporting of randomisation methods in psychiatric journals was inadequate. Many randomised controlled trials (RCTs) lacked sufficient detail, casting doubt on their methodological rigor.

Area of Science:

  • Psychiatry
  • Clinical Trials
  • Research Methodology

Background:

  • Previous studies highlighted poor reporting of randomisation in non-psychiatric medical journals.
  • Inadequate reporting of randomisation processes can compromise the integrity of clinical trial results.

Purpose of the Study:

  • To assess the reporting quality of randomisation procedures in parallel-design randomised controlled trials (RCTs).
  • Focus on publications in the British Journal of Psychiatry (BJP) and the American Journal of Psychiatry (AJP).

Main Methods:

  • A systematic survey of all BJP and AJP issues from January 1990 to December 1998.
  • Examination of reported RCTs for the adequacy of randomisation process reporting.

Main Results:

Related Experiment Videos

  • 183 RCTs were identified (73 in BJP, 110 in AJP).
  • Only 8.2% in AJP and 6 in BJP described randomisation sequence generation.
  • Treatment allocation mechanisms were described in 1.8% of AJP and 15.1% of BJP papers.
  • Just one paper in AJP and five in BJP detailed both sequence generation and allocation.

Conclusions:

  • Adequate reporting of randomisation methods was infrequent in both journals.
  • The methodological validity of numerous reported RCTs is questionable due to insufficient reporting.