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A diffusing capacity of the lung for carbon monoxide (DLCO) biologic quality control (BioQC) coefficient of variation (CV) of 6% is achievable. This ensures DLCO measurements are within an expected range, similar to ATS/ERS standards.

Keywords:
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Area of Science:

  • Pulmonary Function Testing
  • Respiratory Physiology
  • Quality Control in Clinical Trials

Background:

  • Current ATS/ERS DLCO standards lack guidance on establishing expected values for biologic quality control (BioQC) variables.
  • This study addresses the need for defined expected values in DLCO BioQC.

Purpose of the Study:

  • To determine expected values for DLCO BioQC using coefficient of variation (CV).
  • To compare the precision of a mean ± 2 SD control rule against the mean ± 12% of the mean rule.

Main Methods:

  • Collected DLCO BioQC data from a multi-center inhaled medication study over 42 months.
  • Calculated annual DLCO CV based on 10 DLCO values and computed the root mean square CV (RMSCV).
  • Determined 90th percentile values for annual control rule limits/mean DLCO.

Main Results:

  • Annual RMSCV values were 5.3%, 4.5%, and 4.6% over three years.
  • No significant change in CV was observed for subjects with complete 3-year data (P = .07).
  • The 90th percentile of 2 SD/mean DLCO decreased from 15% to 11% over the study period.

Conclusions:

  • A DLCO BioQC CV of ≤ 6% is achievable across diverse settings and equipment.
  • This CV ensures DLCO measurements fall within an expected range.
  • The mean ± 2 SD control rule demonstrated similar precision to the mean ± 12% of the mean rule.