Evaluating Harms in the Assessment of Net Benefit: A Framework for Newborn Screening Condition Review
Authors
Goldenberg, Aaron J.Comeau, Anne Marie
Grosse, Scott D.
Tanksley, Susan
Prosser, Lisa A.
Ojodu, Jelili
Botkin, Jeffrey R.
Kemper, Alex R.
Green, Nancy S.
UMass Chan Affiliations
Department of Pediatrics, Division of GeneticsNew England Newborn Screening Program
Document Type
Journal ArticlePublication Date
2016-03-01Keywords
BurdensFalse positive
Harms
Net benefit
Newborn screening
Maternal and Child Health
Medical Genetics
Pediatrics
Metadata
Show full item recordAbstract
BACKGROUND: The Department of Health and Human Services (HHS) Advisory Committee on Heritable Disorders in Newborns and Children ("Advisory Committee") makes recommendations to the HHS Secretary regarding addition of new conditions to the national Recommended Uniform Screening Panel for newborns. The Advisory Committee's decision-making process includes assessing the net benefit of screening for nominated conditions, informed by systematic evidence reviews generated by an independent Condition Review Workgroup. The evidence base regarding harms associated with screening for specific conditions is often more limited than that for benefits. PROCEDURES: The process for defining potential harms from newborn screening reviewed the frameworks from other public health evidence-based review processes, adapted to newborn screening by experts in systematic review, newborn screening programs and bioethics, with input from and approval by the Advisory Committee. MAIN FINDINGS: To support the Advisory Committee's review of nominated conditions, the Workgroup has developed a standardized approach to evaluation of harms and relevant gaps in the evidence. Types of harms include the physical burden to infants; psychosocial and logistic burdens to families from screening or diagnostic evaluation; increased risk of medical treatment for infants diagnosed earlier than children with clinical presentation; delayed diagnosis from false negative results; psychosocial harm from false positive results; uncertainty of clinical diagnosis, age of onset or clinical spectrum; and disparities in access to diagnosis or therapy. CONCLUSIONS: Estimating the numbers of children at risk, the magnitude, timing and likelihood of harms will be integrated into Workgroup reports to the Advisory Committee.Source
Matern Child Health J. 2016 Mar;20(3):693-700. doi: 10.1007/s10995-015-1869-9. Link to article on publisher's siteDOI
10.1007/s10995-015-1869-9Permanent Link to this Item
http://hdl.handle.net/20.500.14038/43764PubMed ID
26833040Related Resources
Link to Article in PubMedae974a485f413a2113503eed53cd6c53
10.1007/s10995-015-1869-9