Details:

Alternative Title:
Matern Child Health J
Personal Author:
Goldenberg, Aaron J. ; Comeau, Anne Marie ; Grosse, Scott D. ; Tanksley, Susan ; Prosser, Lisa A. ; ... More +
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. Less -
Description:
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.


Subjects:
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Advisory Committees Article Burdens Decision Making Evidence-Based Medicine False Positive Female Harms Humans Infant Infant, Newborn Mass Screening National Health Programs Neonatal Screening Net Benefit Newborn Screening Program Evaluation
Source:
Matern Child Health J. 20(3):693-700.
Pubmed ID:
26833040
Pubmed Central ID:
PMC4819963
Document Type:
Journal Article
Funding:
CC999999/Intramural CDC HHS/United States
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:61e588a4f11a41d0f9193009606d3205dae37e3aa013124d4d5166464552054b
Download URL:
https://stacks.cdc.gov/view/cdc/38815/cdc_38815_DS1.pdf
File Type:

Supporting Files

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