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post in: Video Date:15 Nov 2017, 11:21 views:2808
Respiratory Research: Why Is It So Difficult?
Martha Curley, from the Children's Hospital of Philadelphia, began with a provocative discussion of the difficulties often encountered in clinical trials within the respiratory care field. 1, the key question addressed was, why are pediatric data so limited?
The potential answers included: An insufficient number of mechanically ventilated children, especially those with substantial lung injury, to support large-scale randomized controlled trials (RCTs).
Heterogeneity of the population to be studied in terms of age, size, and medical and surgical diagnoses. Variable expression of respiratory disease, especially across the age range seen in pediatrics. Loss of equipoise secondary to the extrapolation of data from previous neonatal and/or adult clinical trials (eg, low VT ventilation for adult acute lung injury ALI).
So what have we done over the years without definitive pediatric data?
Often, clinicians have simply learned to function without definitive evidence for their management approach. Pediatric clinicians have become comfortable (for right or for wrong) children extrapolating data from the neonatal and adult worlds.
But Curley stressed the clear need to do better in the future. A key recommendation was to build a strong program of research rather than performing isolated studies. This approach allows for the formation of a solid foundation so that future studies can grow from prior successes.
Investigator-initiated RCTs are optimally conducted as the capstone project within a program of research. 2, it must be stressed that building a program of research takes time, persistence, and stable and adequate funding. An excellent example of this approach is the pediatric prone positioning study.
In 1999, Curley and others systematically reviewed prone positioning of patients with acute respiratory distress syndrome (ards). 3, in 2000, Curley et al conducted a single-center pilot study of early and repeated prone positioning in pediatric patients with ALI. 4, and in 2005, Curley et al reported a multicenter study of prone positioning in children with ALI.