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Developing a core outcome set for children with protracted bacterial bronchitis.

Francis J Gilchrist1,2, Imran Ali1, Malcolm Brodlie3,4

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ERJ Open Research
|February 15, 2020
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Summary

A new core outcome set (COS) for protracted bacterial bronchitis (PBB) has been developed. This standardized set of outcomes will improve clinical trials for chronic wet cough in children.

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Area of Science:

  • Pediatric Pulmonology
  • Clinical Trial Methodology
  • Infectious Diseases

Background:

  • Protracted bacterial bronchitis (PBB) is a chronic endobrochial infection causing persistent wet cough in children.
  • Optimal PBB treatment requires randomized controlled trials, but a standardized core outcome set (COS) is lacking.
  • A COS ensures consistent measurement and reporting in clinical trials for comparable results.

Purpose of the Study:

  • To develop a core outcome set (COS) for clinical trials investigating protracted bacterial bronchitis (PBB).
  • To standardize outcome measures for future PBB research and treatment evaluations.

Main Methods:

  • Outcomes were identified through systematic review, parent interviews, and clinician surveys.
  • A two-round Delphi survey engaged healthcare professionals to reach consensus on core outcomes.
  • The final COS was determined at a consensus meeting with parent representatives and clinicians.

Main Results:

  • Initially, 20 potential outcomes were identified; 10 achieved consensus via Delphi survey.
  • The final COS comprises six key outcomes: cough resolution, relapse/antibiotic use, quality of life, antibiotic resistance, bronchiectasis development, and microbiological clearance.
  • Outcomes were refined and agreed upon during a consensus meeting.

Conclusions:

  • A standardized core outcome set (COS) for protracted bacterial bronchitis (PBB) has been successfully developed.
  • This COS will minimize outcome heterogeneity and bias in future PBB clinical trials.
  • The standardized outcomes will facilitate better comparison and interpretation of research findings across studies.