Objectives: The goals of this study were
to: (1) determine if management according to a standardized clinical management
pathway/algorithm (compared with usual treatment) improves clinical outcomes by
6 weeks; and (2) assess the reliability and validity of a standardized clinical
management pathway for chronic cough in children.
total of 272 children (mean ± SD age: 4.5 ± 3.7 years) were enrolled in a
pragmatic, multicenter, randomized controlled trial in 5 Australian centers.
Children were randomly allocated to 1 of 2 arms: (1) early review and use of cough
algorithm (“early-arm”); or (2) usual care until review and use of cough
algorithm (“delayed-arm”). The primary outcomes were proportion of children
whose cough resolved and cough-specific quality of life scores at week 6.
Secondary measures included cough duration postrandomization and the
algorithm’s reliability, validity, and feasibility.
resolution (at week 6) was significantly more likely in the early-arm group
compared with the delayed-arm group (absolute risk reduction: 24.7% [95%
confidence interval: 13–35]). The difference between cough-specific quality of
life scores at week 6 compared with baseline was significantly better in the
early-arm group (mean difference between groups: 0.6 [95% confidence interval:
0.29–1.0]). Duration of cough postrandomization was significantly shorter in
the early-arm group than in the delayed-arm group (P = .001). The cough
algorithm was reliable (κ = 1 in key steps). Feasibility was demonstrated by
the algorithm’s validity (93%–100%) and efficacy (99.6%). Eighty-five percent
of children had etiologies easily diagnosed in primary care.
of children with chronic cough, in accordance with a standardized algorithm,
improves clinical outcomes irrespective of when it is implemented. Further
testing of this standardized clinical algorithm in different settings is