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Use of Both Qualitative and Quantitative Methods to Estimate Meaningful Change Thresholds for Key Endpoints in

Rob Arbuckle1, Hannah Staunton1, Kate Sully1

  • 1Adelphi Values, Macclesfield, Cheshire, UK.

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
|March 6, 2019
PubMed

Insights

Children and parents can estimate meaningful changes in asthma control, including symptom-free days (SFDs) and rescue medication-free days (RFDs). This research provides valuable data for pediatric asthma clinical trials.

Area of Science:

  • Pediatric Pulmonology
  • Clinical Trial Endpoints
  • Asthma Management

Background:

  • Symptom-free days (SFDs) and rescue medication-free days (RFDs) are key clinical trial endpoints for asthma.
  • Meaningful change estimates for SFDs and RFDs are lacking in pediatric populations.
  • The Childhood Asthma Control Test (C-ACT) is a crucial tool for assessing asthma control in children.

Purpose of the Study:

  • To establish meaningful within-patient change estimates for SFDs and RFDs in pediatric asthma.
  • To generate updated estimates for meaningful change in the C-ACT for children aged 5-11.
  • To provide evidence supporting the interpretation of clinical trial results in pediatric asthma.

Main Methods:

  • Qualitative interviews with children (8-11 years) and parents/caregivers (4-11 years) of children with asthma.
  • Participants completed daily asthma diaries for 4-9 days prior to interviews.
  • Exploration of patient and caregiver perceptions of meaningful change in asthma symptoms and control.

Main Results:

  • Parent/caregiver estimates of meaningful change in SFDs aligned with children's reports (1.8 vs. 1.4 SFDs).
  • Both children and parents could articulate meaningful changes at the item level for the C-ACT.
  • Qualitative data suggest meaningful C-ACT change estimates of 1-3 categories, potentially translating to 7-15 points on the total score.

Conclusions:

  • Children with asthma and their caregivers can quantitatively and qualitatively assess meaningful changes in SFDs and RFDs.
  • Findings support the use of SFDs, RFDs, and C-ACT as meaningful endpoints in pediatric asthma research.
  • This study provides essential data for interpreting the clinical significance of treatment effects in pediatric asthma trials.
Abstract

Keywords:
C-ACTChildhood Asthma Control TestMIDasthmaimportant changemeaningful changepediatricrescue medication-free dayssymptom-free days

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