quality-assured immunochemical testing proposal for a
TRANSCRIPT
Ústav zdravotnických informací a statistiky České republikyInstitute of Health Information and Statistics of the Czech Republic
Czech National Coordination Centre for Prevention of Serious DiseasesCZ.03.2.63/0.0/0.0/15_039/0006904
www.nkc.uzis.cz
Quality-assured immunochemical testing – proposal for a pilot project
in the Czech Republic
Ondřej Májek, Štěpán Suchánek
CRC screening in the Czech Republic
Regulation of the Ministry of Health, 70/2012:preventive check-ups
examination of faecal occult blood by a special test
Standard for providing and reporting of colorectal cancer screening procedures (Bulletin of MH, 1/2009)
initial screening method is a faecal occult blood test
Regulation of the Ministry of Health, 350/2015:catalogue of medical procedures including valuation
Determination of occult blood in stool with a special test within colorectal cancer screening
using immunochemical test with cut-off 75-100 ng per ml in an asymptomatic individual
Legislative setting
KT: 5,2
JH: 8,7
ZR: 8,8
KV: 5,9
ZN: 6,8
BR: 8,2
PB: 7,5
CB: 6,8
CK: 4,0
TR: 8,6PT: 9,2
OL: 6,4
JI: 6,8
TA: 6,1
TC: 9,2
SY: 6,9
PS: 6,8
SU: 5,9
BN: 11,6
PE: 6,8PI: 6,5
HB: 6,0
FM: 7,5
UO: 8,2
BV: 7,2
LT: 7,1
CL: 9,5
TU: 9,8
VS: 6,2
LN: 8,5
PJ: 6,3OP: 6,5
ZL: 5,1
ST: 8,6
HO: 6,4
MB: 6,6
CR: 6,7
RK: 8,0
UH: 6,7
NJ: 6,3
BK: 6,2
DO: 13,3
CV: 5,2
KH: 9,3
JC: 6,8
RA: 8,6
PA: 5,9
PR: 6,5
HK: 8,0NB: 6,0
KO: 7,6
JE: 4,9
SM: 6,9
BE: 8,6
BO: 6,9
LI: 6,1
CH: 7,7
VY: 8,5
DC: 7,0
NA: 7,8
PV: 6,9
KM: 6,6
SO: 4,6
KD: 6,5
ME: 7,8
PZ: 7,6
PH: 8,9
AX: 9,2
RO: 11,4
TP: 5,5MO: 6,4 JN: 9,7
UL: 7,0
KA: 4,6
BM: 7,6
OT: 5,9
PM: 7,2
FOBT positivity in Czech districts
Year 2016, N = 662,347 examinationsSource of data: Healthcare payers
Men and women over 50
FOBT positivity [%]
> 9,5
8,0-9,5
6,5-8,0
5,0-6,5
< 5,0< 5,05,0 – 6,56,5 – 8,08,0 – 9,5> 9,5
Total positivity (2016): 7.2 % (range between districts: 4,0-13,3 %)
there is a substantial variability in FOBT positivity
and types of tests used in practice
results of a survey performed in 2014:
types of FOBT test in use by individual GPs
66% cassette immunochemical test (8 different types)
23.5% POCT FIT analyser (3 different types)
3% gFOBT
7.5% laboratory examination
Situation in the Czech Republic
Král, N. (2015). Variability tests for occult blood used by general practitioners inscreening for colorectal cancer in the Czech Republic. Gastroenterologie a hepatologie, 69(3).
Time trends in types of FOBTs
49% 54% 52% 52% 50% 55% 51% 53% 58% 56% 55% 57% 55% 54% 54% 56% 53% 54% 55%
26% 22% 22% 21% 19%19% 20% 18%
18% 16% 17% 17% 17% 16% 18% 17% 18% 18% 16%
20% 21% 22% 24% 26% 22% 24% 26% 22% 25% 25% 23% 26% 28% 27% 26% 27% 26% 27%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
FIT - quantitative FIT - qualitative FIT - unknown type gFOBT
June 2015–2016, 29,414 FOBT+ colonoscopy examinations, CRC screening registry
Pro
po
rtio
n o
f in
div
idu
al F
OB
T ty
pe
Month
National Action Plan for the Development of Medical Screening Programmes, including the strategic area ‘Ensure innovations of screening programmes according to the current scientific evidence’
ESF project ‘Czech National Coordination Centre for Prevention of Serious Diseases’
Institute of Health Information and Statistics established the Czech National Coordination Centre for Prevention of Serious Diseases (PreSeD), which provide governance, expertise and administrative support for piloting of early detection and prevention activities
Project and institutional background
1. To create methodology for realization of the project for quantitative evaluation of faecal occult blood at the national level
2. To verify practical setting and logistics of the process of quantitative evaluation of faecal occult blood
3. To assess feasibility, outcomes and cost-effectiveness of the proposed process for the project for quantitative evaluation of faecal occult blood, in relation to the benefits for the target population
Pilot project: Aims
Representatives of
General practice
Gastroenterology
Biochemistry
Epidemiology
Healthcare payers
Ministry of health
Secretariat provided by
Institute of Health Information and Statistics – Czech National Coordination Centre for Prevention of Serious Diseases
Pilot project: Working group
Pilot project: Indicative timetable2017 Q3 2017 Q4 2018 Q1 2018 Q2 2018 Q3 2018 Q4 2019 Q1 2019 Q2 2019 Q3 2019 Q4
Organisation and methodology- establish working group- establish project team- prepare guidelines for pilot project, including methodology for evaluation of centralised quantitative FIT- statistical analysis plan and eCRF
Pilot project- screening examination in recruited individuals- collection of data
Project evaluation- analytical project report- complex health technology assessment report- recommendation for revision of the national CRC screening programme
project will recruit patients coming for their usual colorectal cancer screening examination (age over 50)
patients will be recruited by their GP, who will include defined type of quantitative FOBT in their screening testing
the project will include centralized evaluation for faecal occult blood, and will allow to test for feasibility and acceptability of the centralized testing
the project should include approximately 1000-1500 patients
if tested positive, the participants will continue with usual care defined within the screening programme
results will be recorded in an electronic data capture system
Pilot project: Implementation
Appropriate size of the study (patients, providers)(scientific objectives?)
Role of gastroenterologists – actively involved or only included as experts within the working group?
Comparison with usual practice – cross-over study or comparison with general population? (monitoring and reimbursement mechanisms in question)
Inclusion of different quantitative FIT technologies (centralised vs. POCT)?
Centralised distribution of FIT tests?
Open questions:to be solved by the working group