NHS Fetal Anomaly Screening Programme (NHS FASP) Mrs. Pat Ward National Programme Director

Transcription

1 NHS Fetal Anomaly Screening Programme (NHS FASP) Mrs. Pat Ward National Programme Director

2

3 Programme Centre Based at the University of Exeter core staff supported by independent consultants Director Mrs Pat Ward Fetal Maternal and Child Health Group (FMCH) Dr Anne Mackie Programmes Director Fetal Anomaly Screening Programme Steering Group (FASPSG) Chair : Professor Peter Soothill Meets 3 times a year UK National Screening Committee DH Other project work. Report from Mrs. Pat Ward 32 projects DQASS monitoring office University of Plymouth Prof. Dave Wright and Dr. Barry Nix Technical team Steering group. NHS FASP Programme Structure 2010 QA of NT management Group Chair: Fiona Maddocks Kinghorn Group Chair: Tom Brown Education and Training ultrasound group Chair: Prof Audrey Patterson Public and Professional Information Group Chair: Prof. Jenny Hewison QC group Chair: Dr Angela Mallard

4 Remit of the National Programme for England Down s syndrome screening Fetal Anomaly Ultrasound screening ( week to 20 week 6 day ultrasound scan) Includes:- Advising on policy setting. Implementation throughout England of a uniform and equitable service. Standard setting. Monitoring against standards ensuring a safe and effective test. Setting up of QA services. Developing and distribution of patient and professional information.

5

6

7 Present policy. (Down s syndrome screening) In 2003 the first issue of the Model of Best Practice was published. At this point it became a national screening programme. The second review of policy took place in 2006/2007 with the recommendation of combined screening as a way forward up to 2010 which should reach a 75%dr for a 3%spr. With Quadruple as the second trimester test and a developmental standard of 90% dr for a 2%spr. The NHS commits to provide screening programmes as recommended by the UK National Screening Committee. NHS Constitution Jan 09

8 2010 review of screening policy 2010 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan 1.Initial review 2. Small group 3.Larger meeting 4.Consultation doc 5.Ratify comments 6.FMCH and UKNSC 7.Gateway process

9 Areas to be reviewed New strategies or evidence which may improve the sensitivity and specificity, including nasal bones and ductus venosus. Reviewing the present cut offs Reviewing the present overall standard of sensitivity and specificity. Assessing whether T13 and T18 screening can be incorporated into the earlier combined screening rather than the later US scan at 18 weeks. The possibility of screening before 10 weeks of pregnancy Generally do we continue with combined screening.

10 Review of evidence (1) Main systematic review extensive. Evidence level one HTA, ( Health Technology Assessments) - NICE reviews, - Professional recommendations or guidance - Other country recommendations

11 Review of evidence (2) Evidence level 2. - Large published studies and trials - Other systematic reviews Evidence level 3 - Individual case studies - Single studies or a number of studies from one source

12 Combined test: week 12 Detection Rate (%) in in in in 100 Change from 1 in 250 to 1 in 150 reduces DR from 88% to 85% Change from 1 in 250 to 1 in 150 reduces FPR from 3.9% to 2.5% False Positive Rate (%)

13 1 in 150 (term) Maternal Age FPR (%) DR (%) 20 and under Overall* 2.6% 85%

14 Mean spr (%) for England from October 2006 to March 2010 In 6 monthly cycles % Oct 06 Mar 2010

15

16 Total screening tests Source 1 st cycle 2 nd cycle 3 rd cycle 4 th cycle 5 th cycle 6th Cycle DQASS Oct 06 Apr 07 Oct 07 Apr 08 Oct 08 Apr.09 NHSFASP /Mar 07 /Sept 07 /Mar 08 /Oct 08 /Mar09 /Oct.09 Number of screens 275,366* 180, , , , ,182 * This contained numbers from the pilot stage

17 Reduction in invasive procedures Type of invasive procedure Number undertaken 2003/2004 Number undertaken 2004/2005 Number undertaken 2005/2006 Number undertaken 2006/2007 Number undertaken 2007/2008 Number undertaken 2008/2009 Number undertaken 2009/2010 Amniocentesis 28,700 24,349 22,625 14,733 12, CVS 8,268 7,980 7,819 4, 781 4, TOTAL 36,968 32,329 30,444 19,514 17,613 15,665 13,595 23,373 less invasive procedures per year since less fetal losses ( 1 in 100 miscarriage loss rate) per year Information from ACC Reduction in costs of 9million per year from 2004

18 DQASS Workshop on Standardisation, Monitoring and Updating Medians: Why, When and How? A Two Day Workshop Thursday 17 and Friday 18 January 2008 Presented by: Amy Baker Barry Nix Dave Worthington Dave Wright Workshops Lab reports ~70 per year Cycle reports

19 ALL Aug Jul Monitoring change over time Monitoring change over time Median MoM Free beta-hcg Apr May Jun Month

20 Effects of bias - biochemistry Median MoM PAPP-A hcg β FPR (%) DR (%) % 85% % 87% % 83% % 83% % 86% % 85% % 84% % 88% % 81% A 30% increase in SPR

21 >120kg kg 70-80kg 80-90kg kg kg By maternal weight By maternal 1.5 weight n= n= 1359 n= Weight group MoM PAPP-A n= 974 n= 409 n= 186 n= 94 n= 47 n= 30 <50kg 50-60kg 60-70kg

22 By Sonographer! PAPP-A MoM n= 29 n= 80 n= n= 27 n= 35 n= 47 n= 68 n= 79 n= 153 n= 186 n= 34 n= 66 n= 70 n= n= 37 n= 38 n= 75 n= 77 n= 104 n= n= 33 Operator

23 Effects of CRL biases on biochemistry MoM values CRL Error Error in GA Median MoM (mm) (days) PAPP-A hcg beta DR FPR % 1.4% % 1.6% % 1.9% % 2.0% % 2.4% % 2.7% % 3.1% % 3.7% % 4.1% % 4.8% % 5.5% Note that Down s syndrome presents as biochemical immaturity so effects of errors on PAPP-A and hcg β combine.

24 Effects of bias - biochemistry CRL Error Error in GA Median MoM (mm) (days) PAPP-A hcg beta DR FPR % 1.4% % 1.6% % 1.9% % 2.0% % 2.4% % 2.7% % 3.1% % 3.7% % 4.1% % 4.8% % 5.5%

25 Training and supervision structure

26 The vital role of DQASS in QA DQASS analysis 25 paired measurements (NT and CRL) during training phase and provide feedback to the individual Sonographer and the SSS. Two audit cycles per year, data using unique Sonographer codes sent via the screening laboratory, reports provided by DQASS each cycle to labs, USS departments and NHS FASP Coding system No action required, continue screening Continue screening. Discuss areas with SSS where adjustments could be made to improve practice even further Action required. Devise a supportive action plan with SSS.

27 Example of red flag distribution for NT Expected relationship with CRL Expected degree of scatter about the curve Nuchal Translucency (mm) Operator: (n =289) NT values greater than 4mm shows as 4mm 1 NT values greater than 4mm shows as 4mm 18% Bias 82% Bias = -0.44mm Values show more spread than would be expected: Crown-rump length(mm)

28

29 Thank you