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DLCO Biologic Quality-Control Findings From a Multi-Center Global Study
Ellen A Becker1, Ellen M Moran2, Jason B Blonshine3
1Rush University Medical Center, Chicago, Illinois. Ellen_Becker@rush.edu.
Respiratory Care
|May 16, 2023
Summary
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.
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.
