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In Reply Dr Hauer raises cogent issues about the surgical treatment of gastroesophageal reflux (GERD) in children with neurological impairment (NI). The issues she presents resonate with us; we concur that future prospective studies with highly detailed attributes of the digestive and neurological functioning and respiratory risk of children with NI are needed to guide families making decisions about surgical treatment of GERD.
Pragmatic clinical trials (or well-constructed observational studies) characterized by sufficient statistical power; clinically appropriate, well-defined patient variables; and comprehensive, meaningful patient outcomes have the greatest potential to identify ideal surgical candidates. These would also potentially reduce the extreme variation in surgical practice observed in our study.1 Unless prospective studies have careful patient selection, including a rigorous, standardized evaluation and preoperative management of the GERD symptoms, some infants may be enrolled for a procedure that cannot be expected to provide benefit. An additional important consideration for future studies is the inclusion of both practical and robust measures of functional impairment because the degree of functional impairment is related to overall survival, including respiratory compromise from aspiration pneumonia.2 Several prospective studies have used standardized, validated functional motor classification instruments.3 Alternatively, for infants in whom these instruments have not been validated, other clinical criteria have been used (eg, hand use, arm use) to analyze children with NI.4
Barnhart DC, Berry JG, Srivastava R. Does Nissen Fundoplication Decrease Reflux-Related Problems Including Respiratory Illness in Children With Neurological Impairment?—Reply. JAMA Pediatr. 2014;168(2):188-189. doi:10.1001/jamapediatrics.2013.4700