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. Author manuscript; available in PMC: 2018 Sep 1.
Published in final edited form as: Contemp Clin Trials. 2017 Jun 12;60:14–23. doi: 10.1016/j.cct.2017.06.008

Table 5.

Primary and secondary clinical outcomes.

Primary clinical outcomes Primary indices
Maximum asthma symptom days in past two weeks Maximum number of
  1. Days with wheezing, tightness in the chest, or cough and/or

  2. Nights with disturbed sleep as a result of asthma and/or

  3. Days on which the child had to slow down or discontinue play activities because of asthma

Secondary Clinical and Economic Outcomes Primary indices
School Absences Number of school days missed because of asthma/2 weeks
Health Care Utilization Total asthma-related unscheduled visits (UVs) defined as sum of unscheduled clinic visits and emergency department visits, and asthma-related overnight hospitalizations/school yeara
Composite Asthma Severity Indexa Day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function, and exacerbations (defined as systemic steroids for asthma)a
Pulmonary Function (PFT) FEV1; FEV1/FVCa
[Secondary indices: (a) FEF25–75
(b) Bronchodlilater responsiveness (% change in FEV1 post albuterol)]
Degree of Exposure Reduction Health Outcomes (Primary and Secondary)
Health-related quality of life (HRQL) ranges 0–100 and will also be converted to quality-adjusted life years
a

Standardized core asthma outcomes from Asthma Outcomes Workshop