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Sample size determination for EQ-5D-5L value set studies.

Mihir Gandhi1,2,3, Ying Xu4, Nan Luo5

  • 1Department of Biostatistics, Singapore Clinical Research Institute, #02-01, Nanos, 31 Biopolis Way, Singapore, Singapore. mihir.gandhi@scri.edu.sg.

Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation
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Summary
This summary is machine-generated.

This study introduces four methods for determining sample sizes for EuroQol 5-Dimension 5-Level (EQ-5D-5L) health state valuation studies. These approaches ensure robust data collection for cost-utility analyses in healthcare.

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Area of Science:

  • Health Economics
  • Psychometrics
  • Biostatistics

Background:

  • The EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a key instrument for health status assessment in cost-utility analyses.
  • Standardized protocols for EQ-5D-5L valuation studies have been recently developed.

Purpose of the Study:

  • To propose and describe four distinct approaches for estimating the required sample size for EQ-5D-5L valuation studies.
  • To provide guidance for researchers conducting health state valuation studies using the EQ-5D-5L instrument.

Main Methods:

  • Regression modeling for estimating mean health state utility values with desired precision.
  • An empirical approach using mean absolute error from a reference study.
  • Methods for assessing the significance and precision of regression coefficients for health state descriptors.

Main Results:

  • Parameters for sample size determination, including the design effect, were estimated using Singaporean study data.
  • Each proposed sample size estimation approach was illustrated with practical examples.
  • Pragmatic recommendations for sample size determination were provided.

Conclusions:

  • Four novel sample size estimation approaches are presented, tailored for EQ-5D-5L valuation studies.
  • These methods facilitate the determination of appropriate sample sizes, enhancing the reliability of value set studies.