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Validity of bronchiolitis outcome measures.

Ricardo M Fernandes1, Amy C Plint2, Caroline B Terwee3

  • 1Department of Pediatrics, Santa Maria Hospital, Lisbon Academic Medical Centre, Lisbon, Portugal; Clinical Pharmacology Unit, Instituto de Medicina Molecular, University of Lisbon, Lisbon, Portugal; rmfernandes@campus.ul.pt.

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The Respiratory Distress Assessment Instrument (RDAI) and Respiratory Assessment Change Score (RACS) show moderate responsiveness in bronchiolitis trials. However, the RDAI has limited construct validity and test-retest reliability, indicating potential measurement error.

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Area of Science:

  • Pediatric Respiratory Medicine
  • Clinical Trial Methodology
  • Measurement Properties of Clinical Instruments

Background:

  • The Respiratory Distress Assessment Instrument (RDAI) and Respiratory Assessment Change Score (RACS) are commonly used in bronchiolitis clinical trials.
  • Limited evidence exists regarding the measurement properties of RDAI and RACS.

Purpose of the Study:

  • To investigate the validity, reliability, and responsiveness of the RDAI and RACS in infants with bronchiolitis.
  • To assess the construct validity, test-retest agreement, interrater reliability, and responsiveness of these instruments.

Main Methods:

  • Analysis of data from 1765 infants with bronchiolitis across two pediatric emergency department studies.
  • Assessed construct validity through correlations with physiologic measures and hospitalization predictors.
  • Evaluated responsiveness using change anchors and area under the curve; assessed reliability using limits of agreement and intraclass correlation coefficients.

Main Results:

  • RDAI showed weak correlation with respiratory rate (r=0.38) but was associated with hospitalization (OR=1.36) and differed across admission statuses.
  • Test-retest agreement for RDAI had limits of agreement of -3.80 to 3.64 (20% of range); interrater reliability was good (ICC=0.93).
  • Both RDAI and RACS demonstrated moderate responsiveness (AUC: RDAI, 0.64-0.70; RACS, 0.72).

Conclusions:

  • The RDAI exhibits poor to moderate construct validity and significant test-retest measurement error, despite good discriminative properties.
  • RDAI and RACS are responsive to changes in respiratory distress in bronchiolitis but may not capture all severity determinants.