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Core Outcome Set-STAndards for Development: The COS-STAD recommendations.

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Summary

This study established 11 minimum standards for developing core outcome sets (COS). These Core Outcome Set-STAndards for Development (COS-STAD) improve COS quality and assess development methods.

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Area of Science:

  • Health Research Methodology
  • Clinical Trial Design
  • Evidence Synthesis

Background:

  • Core Outcome Sets (COS) are crucial for relevant research outcome measurement.
  • Hundreds of COS projects exist, but formal quality assessment has been lacking.
  • The Core Outcome Set-STAndards for Development (COS-STAD) project addresses this gap.

Purpose of the Study:

  • To identify minimum standards for the design of Core Outcome Set (COS) studies.
  • To improve the quality of COS development.
  • To support the assessment of COS development methodologies.

Main Methods:

  • An international expert group, including patient representatives, developed recommendations.
  • An open survey and a 2-round Delphi survey involving ~250 participants refined the standards.
  • Consensus was defined as at least 70% of participants from each stakeholder group scoring 7-9.

Main Results:

  • The COS-STAD project resulted in 11 minimum design standards for COS development.
  • These standards cover key domains: scope, stakeholders, and consensus process.
  • The recommendations aim to enhance the rigor and consistency of COS development.

Conclusions:

  • The COS-STAD project established 11 minimum standards for COS development.
  • These standards guide COS developers in planning projects.
  • Users can employ these standards to evaluate the reasonableness of COS development methods.