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

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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