Study design (if review, criteria of inclusion for studies)
Simulation approach with decision trees analysis.
Participants
Newborns
Interventions
Immunoreactive trypsinogen (IRT) screening followed by a second IRT test against an IRT/DNA analysis.
Outcome measures
The numbers of newborns given a diagnosis of cystic fibrosis and costs of screening strategy at each branch and cost per newborn.
Main results
Simulations revealed a substantial number of potential missed diagnoses for the IRT/IRT system versus IRT/DNA. Although the IRT/IRT strategy with commonly used cutoff values offers an average overall cost savings of $2.30 per newborn, a breakdown of costs by societal segments demonstrated higher out-of-pocket costs for families. Two potential system failures causing delayed diagnoses were identified relating to the screening protocols and the follow-up system.
Authors' conclusions
The IRT/IRT screening algorithm reduces the costs to laboratories and insurance companies but has more system failures. IRT/DNA offers other advantages, including fewer delayed diagnoses and lower out-of-pocket costs to families.