Arch Dis Child 1999;80:414-420 ( May )

Validation of an asthma symptom diary for interventional studies

Nancy C Santanello,^a Glenn Davies,^a Stanley P Galant,^c Andrew Pedinoff,^d Richard Sveum,^e James Seltzer,^f Beth C Seidenberg,^b Barbara A Knorr^b

^a Department of Epidemiology, Merck Research Laboratories, PO Box 4, BL-3, West Point, PA 19486, USA, ^b Department of Clinical Research, Merck Research Laboratories, ^c Clinical Trials of Orange County, Orange, CA 92668, USA, ^d Princeton Allergy and Asthma Associates, Princeton, NJ 08540, USA, ^e Allergy Department, Park Nicollet Clinic, Minneapolis, MN 55416, USA, ^f Allergy and Asthma Prevention and Treatment Center, San Diego, CA 92067, USA

Correspondence to: Dr Santanello.

Accepted 22 December 1998

OBJECTIVEThe Pediatric Asthma Diary was developed and validated to assess efficacy of interventions in children with asthma.
DESIGN, PATIENTS, AND SETTINGDiary validation was performed in a three week, prospective study of 106 children aged 6-14 years with asthma. Children were classified at baseline as either stable (requiring no additional asthma treatment) or new onset/worse (requiring either addition of or increase in anti-inflammatory treatment).
RESULTSA daytime symptom scale and "day without asthma" were defined from diary questions. Both measures demonstrated significant validity and responsiveness to anti-inflammatory treatment. The stable group experienced a higher percentage of days without asthma during week 1 compared with the new onset/worse group (39.6% v 11.6%, respectively). The new onset/worse patients experienced significant improvement in days without asthma (24.5%) compared with stable patients (6.4%).
CONCLUSIONSThe Pediatric Asthma Diary daytime symptom scale and day without asthma are acceptable measures for use in asthma intervention studies of children aged 6-14 years.


Keywords: asthma; outcomes research; reliability and validity; questionnaire; Pediatric Asthma Diary

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© 1999 by Archives of Disease in Childhood
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