PLENARY 3. Is Universal Newborn CMV Screening Good Public Health Policy
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1 PLENARY 3 Is Universa Newborn CMV Screening Good Pubic Heath Poicy Prof Wiiam Rawinson 2016 CMV Pubic Heath and Poicy Conference Austin Texas
2 There is no better idea of rationaity than that of a readiness to accept criticism; that is criticism which discusses the merits of competing theories from the point of view of the reguative idea of truth Kar Popper 1992 ARC Linkage grant with Abbott Austraia - competed, unremunerated Advisory Board of Genetic Signatures, and joint Innovation Austraia grant GSK vaccine Funding NHMRC, APA
3 Based on the knowedge avaiabe today, woud you choose no screening, targeted screening or universa screening. 1. Why have you chosen this? 2. How woud you achieve this? 3. What resources woud be needed medicay? 4. What resources woud be needed for parents? 5. Woud your choice sti be necessary if a protective vaccine became avaiabe?
4 Based on the knowedge avaiabe today, woud you choose no screening, targeted screening or universa screening. 1. Why have you chosen this? Targeted testing of infants with confirmed hearing oss on UNHS Universa screening of a infants Non excusive
5 Based on the knowedge avaiabe today, woud you choose no screening, targeted screening or universa screening. 2. How woud you achieve this? Targeted testing through existing UNHS cinics using existing aboratory services with nationa additiona funding for testing coordinators, state based Specific funding for universa neonata screening, with state based coordinators for testing Use of heath economic data and use of added benefit data Distinguish advocacy from science-based recommendations
6 Annua incidence of conditions screened in USA core pane compared with congenita CMV Number of affected chidren [Cannon, 2014]
7 Screening neonates hearing oss 4,248, % Live births 4,222,512 Chidren born without congenita CMV infection 0.6% 25,488 Chidren born with congenita CMV infection 12.8% 87.2% 22,226 Chidren who are asymptomatic at birth 5.3% 815 Symptomatic chidren diagnosed cinicay with congenita CMV 1,504 No hearing oss 25% 61.4% 3,262 Chidren who are symptomatic at birth 75% 2,447 Symptomatic chidren not diagnosed cinicay with congenita CMV 27.4% 3.2% 3.2% 670 Hearing oss at birth 78 Deayed hearing oss <9 months 4.8% 78 Deayed hearing oss 9 24 months 1,245 Hearing oss at birth 117 Deayed hearing oss months 5.6% 1% 1% 222 Deayed hearing oss <9 months Quaity of evidence Good evidence Fair evidence Poor evidence No benefit 1,067 Deayed hearing oss months 178 Deayed hearing oss 9 24 months Cannon, 2014
8 Screening neonates cognitive deficit 4,248, % Live births 4,222,512 Chidren born without congenita CMV infection 0.6% 25,488 Chidren born with congenita CMV infection 12.8% 87.2% 22,226 Chidren who are asymptomatic at birth 3,262 Chidren who are symptomatic at birth 95.3% 4.7% 41% 1,337 Chidren with cognitive deficit 21,181 Chidren with no cognitive deficit 1,045 Chidren with cognitive deficit 57.1% 42.9% Quaity of evidence 763 Chidren with cognitive deficit who are diagnosed cinicay with congenita CMV 574 Chidren with cognitive deficit who are not diagnosed cinicay with congenita CMV Fair evidence No benefit Cannon, 2014
9 Based on the knowedge avaiabe today, woud you choose no screening, targeted screening or universa screening. 3. What resources woud be needed medicay? Targeted testing additiona state coordinator Universa testing agreed agorithm - DBS existing infrastructure - Saiva/urine additiona coection infrastructure - High throughput testing for <$1 per test - Pooing of sampes - Automated seection of positive sampes
10 Based on the knowedge avaiabe today, woud you choose no screening, targeted screening or universa screening. 4. What resources woud be needed for parents? Counseing avaiabiity Pre test and post test Onine access Post resut counseing
11 Additiona stress of CMV screening Ø Most women view information on congenita CMV positivey [Ader 2004] Ø Ony 14-20% of women in US have heard of CMV, ranks ast as known cause of birth defects [Jeon 2006, Ross 2008, Shand 2016] Ø Parent s generay approve of CMV neonata screening [Engman 2011] Ø Parents of chidren with fase pos CMV screen more worried about their chid s heath [Engman 2011] Ø Parents have a high toerance for fase positive screening resuts [Prosser 2008] Ø US parents accept costs, worry, anxiety [Din 2011] Additiona stress studies (of metaboic screening) Ø Additiona issues with infectious pathogens Ø Fase positives ead to stress [Fyro 1987, 1988] Ø Fase positives do not reduce eary heath care utiisation [Lipstein 2009] Ø Babies risk being medicaised [Wicken 2010]
12 Based on the knowedge avaiabe today, woud you choose no screening, targeted screening or universa screening. 5. Woud your choice sti be necessary if a protective vaccine became avaiabe? Targeted screening Yes Universa screening Initiay - Vaccines are <100% protective - Identica cinica conditions due to other pathogens, conditions Continued need for prevention and education
13 I fee confident about giving advice and answering questions about CMV and pregnancy N=726 7% of midwives, 18% of GPs, 41% of trainees and 47% of speciaists stated that they fet confident about giving advice (P<0.0001) [Shand 2016]
14 I reay wish that I wasn t writing to you and I wish that I wasn t aware about a virus caed CMV. However this isn t the case, I ike many other peope had never heard of CMV unti a few weeks ago. I went to Liverpoo Hospita for a foow up on an echogenic bowe abnormaity..
15 SCREENING Procedure to identify, in an organised way, a specified disease or condition among asymptomatic individuas [Peters 1996] Appication of a test to peope who are as yet asymptomatic for the purpose of cassifying them with respect to their ikeihood of having a particuar disease [Hennekens 1987] Presumptive identification of unrecognised disease or defects by means of tests, other procedures that can be appied rapidy, to identify pre disease, eary disease, risk markers [WHO]
16 Potentia testing agorithms Test at risk popuations Test a neonates Ø Hearing oss on UNHS Ø Primary infections Ø Symptomatic women
17 Potentia testing agorithms Test at risk popuations Issues Ø Hearing oss on UNHS Ø 7.2% ccmv (9/125) Ø Test <21 dys difficut Ø Sampe urine + saiva
18 Testing abnorma UNHS Number tested Age (days)
19 Hearing oss aetioogy
20 Potentia testing agorithms Test at risk popuations Issues Ø Primary infections Ø Identification seroogicay
21 SCREENING ALGORITHM [Munro 2005]
22 Potentia testing agorithms Ø Symptomatic women Issues Ø Low symptomatic rate Ø Non specific symptoms Ø Improves timing when combined with seroogy
23
24 Potentia testing agorithms Test a neonates
25 SCREENING Procedure to identify, in an organised way, a specified disease or condition among asymptomatic individuas [Peters 1996] Appication of a test to peope who are as yet asymptomatic for the purpose of cassifying them with respect to their ikeihood of having a particuar disease [Hennekens 1987] Presumptive identification of unrecognised disease or defects by means of tests, other procedures that can be appied rapidy, to identify pre disease, eary disease, risk markers [WHO]
26 Potentia benefits of screening neonates Cost savings Ø Reduce testing, hospitaisation, therapy Prognostic information Ø Genetic cause very unikey Ø Reduced stress Therapy directed at CMV Ø Antiviras
27 Estimates of congenita CMVreated vision impairment in the United States 29,736 Chidren born with congenita CMV infection 12.7% a 4.248,000 Live births 0.7% a 87.3% a 99.3% a 4,218,264 Chidren born without congenita CMV infection 25,960 Chidren who are asymptomatic at birth 3,776 Chidren who are symptomatic at birth 93.7% b,c 6.3% b,c 98.3% c,d,e,f VL 25,519 Chidren with no vision impairment 1.7% c,d,e,f L 441 Chidren with vision impairment VL 3,538 Chidren with no vision impairment a Doard et a., Rev Med Viro, 2007 b Boppana et a., Pediatr, 1999 c Ahfors et a., Scand J Infect Dis, 1999 d Britt, Infect Dis Fetus Newborn Infant, 2011 e Coats et a., J AAPOS, 2000 f Saiga et a., Am J Dis Chid, 1082 L 238 Chidren with vision impairment unknown how many woud be diagnosed cinicay with congenita CMV Potentia benefit from newborn CMV screening L: Limited evidence of benefit VL: Very imited evidence of benefit
28 Neonata screening - parameters Numbers Ø Birth prevaence 0.6% Ø Likey cinica diagnoses without screening 25% (3.8-25%) Iness Ø Hearing oss deayed Ø Unti 9 mths % Ø Unti 3 yrs % Ø Neurodeveopmenta deay Ø Vision impairment %
29 RISK OF SCREENING Issues Ø Type of screen proposed Ø Resources avaiabe Additiona stress studies (of metaboic screening) Ø Additiona discussions arise Ø Fase positives ead to stress [Fyro 1987, 1988] Ø Fase positives do not reduce eary heath care utiisation [Lipstein 2009]
30 What is the probem? Congenita CMV is the most common infectious cause of congenita maformation in deveoped countries In Austraia each year (of ~296,000 ivebirths) 594 babies with cerebra pasy 346 babies with congenita CMV disease 330 (of 781) babies with Down syndrome [Laws 2010 AIHW]
31 Potentia testing agorithms Test at risk popuations Test a neonates Ø Hearing oss on UNHS Ø Primary infections Ø Symptomatic women
32
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