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Quality criteria for randomized controlled studies: obstetrical journal guidelines.

Kathryn Anderson1, Roberto Romero2, Anthony O Odibo3

  • 1Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA (Mrs Anderson).

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PubMed
Summary

Most obstetrics and gynecology journals require specific criteria for randomized controlled trials (RCTs), including registration, ethical approval, and data sharing. However, submission software often fails to enforce these crucial quality standards.

Keywords:
CONSORT guidelinesauthor guidelinesdata sharingethical approvalinformed consentob-gyn journalsquality criteriarandomized controlled trialregistration

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Area of Science:

  • Obstetrics and Gynecology
  • Medical Ethics
  • Clinical Research

Background:

  • Scientific misconduct leads to frequent retractions in obstetrics and gynecology publications.
  • Preventing the publication of flawed randomized controlled trials (RCTs) is preferable to later retractions.

Purpose of the Study:

  • To evaluate author guidelines and submission systems of obstetrics and gynecology and top medical journals.
  • To assess policies on RCT registration, ethics approval, protocols, CONSORT guidelines, and data sharing.
  • To identify common quality criteria for RCTs in these journals.

Main Methods:

  • Analysis of author guidelines from selected obstetrics and gynecology and top general medical journals.
  • Mock submission of RCTs to assess electronic submission system requirements.
  • Evaluation of criteria including prospective registration, ethics committee approval, research protocols, CONSORT adherence, and data sharing.

Main Results:

  • Most journals require 7 specific criteria in author guidelines for RCT submissions.
  • Key required criteria include prospective registration, ethical approval, CONSORT adherence, and data sharing statements.
  • Submission software generally lacks enforcement of these quality criteria, with minimal differences between journal types.

Conclusions:

  • Leading medical and obstetrics and gynecology journals request specific RCT quality criteria.
  • Journals aim to standardize and mandate these criteria through author guidelines and improved submission software.