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Most comparative effectiveness research (CER) studies fail to report clinical significance. This oversight can lead to inappropriate healthcare recommendations based on statistical significance alone.

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Area of Science:

  • Health Services Research
  • Clinical Epidemiology

Background:

  • Comparative Effectiveness Research (CER) evaluates treatments in real-world settings.
  • Statistical significance does not always equate to clinical significance, potentially leading to flawed clinical decisions and increased healthcare costs.

Purpose of the Study:

  • To assess the frequency of reporting clinical significance in current CER.
  • To identify how clinical significance is defined and utilized in CER publications.

Main Methods:

  • Systematic review of CER studies published in 2022 across five major surgical and medical journals.
  • Two independent investigators assessed the "Methods" section for explicit definitions of clinically significant differences.

Main Results:

  • Only 8.5% of 307 reviewed studies specified a clinically significant difference.
  • Of studies recommending clinical changes, most (71.4%) lacked a defined clinical significance.
  • Clinical significance, when defined, predominantly used validated standards.

Conclusions:

  • Contemporary CER frequently omits reporting of clinical significance.
  • Recommendations for clinical decision-making are often based solely on statistical significance, highlighting a gap in reporting practices.