Wheeze as an adverse event in pediatric vaccine and drug randomized controlled trials: A systematic review.

ABSTRACT:

Introduction

Wheeze is an important sign indicating a potentially severe adverse event in vaccine and drug trials, particularly in children. However, there are currently no consensus definitions of wheeze or associated respiratory compromise in randomized controlled trials (RCTs).

Objective

To identify definitions and severity grading scales of wheeze as an adverse event in vaccine and drug RCTs enrolling children <5 years and to determine their diagnostic performance based on sensitivity, specificity and inter-observer agreement.

Methods

We performed a systematic review of electronic databases and reference lists with restrictions for trial settings, English language and publication date ≥1970. Wheeze definitions and severity grading were abstracted and ranked by a d

SUBMITTER: Marangu D 

PROVIDER: S-EPMC4743983 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature