Validation of a pediatric asthma caregiver diary.
BACKGROUND
Young children are generally not able to consistently and reliably perform tests of airway function, and normative values are not available. Reliable and valid measures of parental reporting of asthma symptoms and functioning are needed to determine the efficacy of asthma interventions.


OBJECTIVE
A pediatric asthma caregiver diary was developed and validated for use in interventional asthma studies.


METHODS
A 3-week prospective study of 125 caregiver parents and their children, aged 2 to 5 years, with persistent asthma was conducted. At baseline, children were classified as either stable (no change to anti-inflammatory therapy) or unstable (anti-inflammatory therapy added or increased).


RESULTS
A symptom scale and day without asthma symptoms (DWAS) were defined from pediatric asthma caregiver diary questions. The scale and DWAS statistically differentiated between the stable and unstable groups at week 1 and detected change between the 2 groups (P <.01). On average, caregivers reported low symptom scores. However, the frequency of DWAS was only 43% of days in the stable group and 22% in the unstable group.


CONCLUSIONS
The pediatric asthma caregiver diary scale and DWAS have acceptable measurement characteristics for use in clinical trials of children with asthma symptoms. The DWAS indicates an opportunity for improvement in asthma control in this population.
Santanello
N C
NC
Merck Research Laboratories, West Point; the Allergy & Asthma Medical Group and Research Center, San Diego, CA, USA.
Demuro-Mercon
C
C
Davies
G
G
Ostrom
N
N
Noonan
M
M
Rooklin
A
A
Knorr
B
B
D000287:Administration, Topical; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology*; D017028:Caregivers; D002675:Child, Preschool; D003371:Cough; D004205:Cromolyn Sodium / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids; D006801:Humans; D008297:Male; D008499:Medical Records; D010865:Pilot Projects; D011446:Prospective Studies; D013256:Steroids; D011795:Surveys and Questionnaires
D018927:Anti-Asthmatic Agents; D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D013256:Steroids; D004205:Cromolyn Sodium