Development of the national colorectal cancer screening program

Prof. Cristian Gheorghe, Conf. Mircea Manuc

The Gastroenterology Clinic of the Fundeni Clinical Institute of Bucharest applied for the POCCU programs related to the development and implementation of a national screening program in colorectal cancer (ROCCAS I and II projects).

1. ROCCAS I program – SMIS code 128106 – “Development and implementation at national level of the organizational framework necessary to initiate screening in colorectal cancer” – (Project value: RON 22,949,605.43)

Assoc. Prof. Dr. Mircea Mănuc was appointed project manager. The project is developed and implemented in partnership with the National Institute of Public Health. In this project a unique national standard was developed for the implementation of colorectal cancer screening in Romania as well as the methodology for the development and development of pilot screening projects in 4 designated regions (South-East, South-Muntenia, South-West, Bucharest-Ilfov ).

In this large-scale project we started from the capitalization of the expertise and experience of the Scientific Council coordinated by Prof. Cristian Gheorghe. The Council included the following experts (Prof. Mircea Beuran, Prof. Marcel Tanțău, Prof. Mariana Jinga, Prof. Dan Gheonea, Prof. Eugen Dumitru, Prof. Vasile Drug, Prof. Dana Dobru, Prof. Adrian Goldis, Conf. Mihai Ciocîrlan ) and also benefited from the expertise offered by other international experts coordinated by Prof. Carlo Senore, among whom we mention Prof. Cesare Hassan, Prof. Michal Kaminski, Prof. Evelien Dekker.

The result was a package of protocols, procedures, standardized forms and a strategy for testing, diagnosis, treatment, monitoring, taking into account the need to ensure a continuum in the management of these patients.

The major difficulty of the methodology was the harmonization of the 3 different components:

1. EU recommendations on screening strategy
– Screening organized at national level in the target population of 50-75 years
– Existence of a national screening registry with the ability to link to the cancer registry
– Use of the quantitative FIT test as the first screening test
– Use of colonoscopy in positive FITs
– Quality assurance at all levels

2. Regulations on ESF funds as technical implementation
– Special financing methodology
– Special methodology for data reporting (POCCU – FORM)
– Providing services to groups from the vulnerable population (60%)
– Limit the implementation in time until the end of 2023

3. The Romanian realities
– Hard to reach population
– lack of a national cancer registry
– Specific screening flow
– Use of a cancer risk questionnaire
– Active involvement of the family doctor
– Use of NGOs for information, education, invitation, active recruitment, transport to the endoscopy laboratory of the vulnerable population

The following objectives have been achieved so far in this project:

1. National colorectal cancer screening registry
The computer application has password access for health care providers and was developed in order to centralize the essential data on patients tested in screening, but also for subsequent monitoring of those screened. This register will be used and validated by the pilot regional projects.
The elaborate registry design, implemented in collaboration with the National Institute of Public Health, includes not only the examined population and test results, but also standardized endoscopic and histopathological bulletins that are completed online by the procedure provider. The database is hoarded by the National Institute of Public Health, together with the other screening registries being implemented.
It has the possibility to evaluate the traceability of clinical, endoscopic and histopathological activities and to monitor the quality parameters of each intervention both individually and for the whole process.

* Standardized endoscopic bulletin

The register allows the registration (and implicitly the evaluation) of the following parameters (components of the computer flow addressed to the endoscopist can be viewed in the appendix):
– Quality of training (Boston scale)
– Comorbidities and chronic medication
– Sedation (ASA score, type, dose, duration)
– The colonoscopic procedure itself (total time, withdrawal time, type of lesions, diagnostic / therapeutic procedures performed)
– Standardization of polypoid / tumor lesions) – NICE and Paris classification
– description of tight lesions
– description of other diagnosed lesions
– Incidents, accidents, complications (type, cause, therapy addressed) – events can be reported up to 14 days post-procedural

* Standardized histopathological bulletin

The register allows the cascade evaluation of each biopsy piece or endoscopic resections (components of the computer flow addressed to the pathologist can be viewed in the appendix):
– Description, morphological characters and classification of adenomas
– staging of dysplasia
– Description of malignant adenomas and evaluation of their resections using Haggit and Kikuchi classifications
– Description of tight lesions
– evaluation of the resection margins of the resected polyps
– Recommendation for further monitoring (depending on the final endoscopic and histopathological diagnosis

2. Organizing training courses at national level

These are dedicated to the doctors involved in the implementation of the screening (family doctors, gastroenterologists, pathologists).
A training curriculum has been established for family doctors, for gastroenterologists (screening colonoscopy, standardized endoscopic bulletin), anatomo-pathologists (histopathological director and standardized bulletin)
439 family doctors and 22 gastroenterologists were trained during 7 courses (online, hybrid, live) for family doctors, respectively 2 live endoscopy courses (which also included a hands-on training component). at least 150 more specialists will be trained this year (family doctors, gastroenterologists, pathologists)

3. Elaboration of documents and forms subsequent to the screening

All screening implementation documents, OIR reporting documents, informative materials for the screened population, etc. were developed.
– Screening invitation
– Informed consent for screening / colonoscopy,
– GDPR agreement
– Subsequent forms for POCU projects (target group classification form, target group eligibility statement, reporting activities to OIR)
– Colorectal cancer risk questionnaire
– interpretation of a negative / positive FIT result
– Standardized endoscopic bulletin with adjacent forms
– Standardized histopathological bulletin with adjacent forms

Presumed benefits:
Through this system it will be possible to obtain valuable reports on the annual evolution and by age categories of prevalence in the tested populations. The information thus obtained will constitute certain data for the development of subsequent public measures / strategies / policies in order to reduce the effects of colorectal cancer in Romania.

2. The project – ROCCAS II -Sud-Muntenia SMIS- 136828 “Providing health services from the programs of prevention, early detection, diagnosis and early treatment of colorectal precancerous lesions. (financing RON 23,859,231.79)

Prof. Cristian Gheorghe was appointed project manager. The project is developed and implemented in partnership with the foundations “RENAISSANCE for education, health and culture and the Roma Center for Health Policies – SASTIPEN”.

Among the objectives of the project we mention 50,000 FIT tests to be taught, 2104 colonoscopies to be performed, 60% of the screened persons included in the vulnerable categories,

In December 2021, the actual screening activities for the South-Muntenia region began. After 3 months of actual implementation, the data of the screening register records:
– No family doctors currently involved: 44
– Highest number of persons / doctor examined: 460
– Nr. of the first visits (March 24, 2022) – 7727
– No FIT tests offered – 7598
– Vulnerable people – 70.1%
– FIT test return rate – 83%
– Percentage of positivity – 5.42%
– Percentage of inconclusive tests – 1.09%
– Acceptance rate for colonoscopy: 75%
– Nr. of colonoscopies – 129
– Percentage of polypoid lesions – 60%
– Number of cancers – 6 cases

In accordance with the recommendations of the international experts, after 10,000 FIT tests returned and the subsequent colonoscopic evaluation of the positive ones, an ad-interim analysis of the evaluation of the process indicators is made. Current data overlap with the optimal figures recommended by the European Quality Assurance Guide in Colorectal Cancer Screening.

This fact allows the initial evaluation of the results of the ROCCAS I and II South-Muntenia projects to be a positive one, the stage analyzes and the final analysis of all 4 regional pilots will allow the finalization of a screening methodology adapted to Romanian realities. they benefited in the first stage from these programs, the extension in the regions already piloted and finally a roll-out at national level. This is obviously a long process, with national experiences in other EU countries spanning a possible 10 years.

Moreover, a sustained effort is needed from all those involved in the pilot projects to complete them by the end of next year.

In addition, the development of the screening register in general and the standardized endoscopic bulletin in particular will ensure the quality of colonoscopy, in accordance with ESGE recommendations, and moreover, will allow the extension of quality in colonoscopy activities outside the screening program.

Updated data related to the ROCCAS I and Roccas II projects will also be presented at the 41st Congress of Gastroenterology, Hepatology and Digestive Endoscopy Bucharest 2022.