Does a 'Level I Evidence' rating imply high quality of reporting in orthopaedic randomised controlled trials?
2006

Quality of Reporting in Orthopaedic Trials

Sample size: 3543 publication Evidence: moderate

Author Information

Author(s): Poolman Rudolf W, Struijs Peter AA, Krips Rover, Sierevelt Inger N, Lutz Kristina H, Bhandari Mohit

Primary Institution: McMaster University

Hypothesis

Level I evidence studies in a high impact general orthopaedic journal would not necessarily have high quality reporting and the reporting quality of RCTs would not differ among trials labelled as Level I or Level II evidence.

Conclusion

Readers should not assume that studies labelled as Level I have high reporting quality or that Level I studies have better reporting quality than Level II studies.

Supporting Evidence

  • Only 3.4% of publications in JBJS-A were RCTs that fit the inclusion criteria.
  • The Cochrane reporting quality scores did not differ significantly between Level I and Level II studies.
  • Only 13% of RCTs were reported according to the CONSORT statement.

Takeaway

This study looked at how well orthopaedic trials report their methods and found that just because a study is labeled as high quality doesn't mean it actually is.

Methodology

The study assessed the reporting quality of RCTs published in JBJS-A from 2003 to 2004 using the Cochrane reporting quality assessment tool.

Potential Biases

The study's findings may not be generalizable to other surgical fields and journals.

Limitations

The study was underpowered to explore the influence of various factors on reporting quality due to the small number of Level II studies.

Participant Demographics

The included RCTs had a total of 3543 patients, with sample sizes ranging from 17 to 514 patients.

Statistical Information

Confidence Interval

95%CI:0.60 to 0.90

Statistical Significance

p > 0.05

Digital Object Identifier (DOI)

10.1186/1471-2288-6-44

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