Design of the Polish Colonoscopy Screening Program: a randomized health services study
submitted: 03. Dezember 2014
accepted after revision: 20. Juni 2015
30. Oktober 2015 (eFirst)
Background and study aims: Colonoscopy screening for colorectal cancer has been implemented without evidence from randomized controlled trials quantifying its benefit and invariably as an opportunistic program, both of which are contrary to the European Union guideline recommendations. The aim of this paper is to describe the rationale and design of the first population-based colonoscopy screening program (PCSP), which was launched in Poland in 2012 as a randomized health services (RHS) study.
Methods: The PCSP is a natural extension of opportunistic colonoscopy screening implemented in 2000. It uses colonoscopy capacity, a quality assurance program, and a network of 92 centers built up during the opportunistic screening phase to develop a countrywide PCSP. Within the PCSP, single screening colonoscopy is offered to a target population aged 55 – 64 years. The PCSP uses an RHS design, which means that eligible individuals drawn from population registries are randomly assigned to immediate or postponed invitation to screening. Individuals from birth cohorts that will reach the upper age limit for screening before full implementation of the PCSP are randomly assigned, in a 1:1:1 ratio, to “immediate” screening, “postponed” screening, or a “never invited” control group. The RHS design is a natural platform that will evaluate the effectiveness of screening, and compare different age ranges for screening, invitation procedures, and quality improvement interventions. Up to 2015, 24 centers have been developed, with 34.2 % geographic coverage and 851 535 individuals enrolled.
Conclusions: The PCSP sets an example for implementation of population-based colonoscopy screening with experimental design to ensure proper evaluation of its effectiveness.
RHS registration number: 007_2015_1_RHS.
- 1 Ferlay J, Parkin DM, Steliarova-Foucher E. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer 2010; 46: 765-781
- 2 Wojciechowska U, Didkowska J, Zatoński W. Nowotwory złośliwe w Polsce w 2008 roku. Cancer in Poland in 2008. Gdańsk: Centrum Onkologii-Instytut; 2010
- 3 Force USPST. Screening for colorectal cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2008; 149: 627-637
- 4 Segnan N, Patnick J, von Karsa L. European guidelines for quality assurance in colorectal cancer screening and diagnosis. Luxembourg: Publications Office of the European Union; 2010
- 5 Kaminski MF, Bretthauer M, Zauber AG et al. The NordICC Study: rationale and design of a randomized trial on colonoscopy screening for colorectal cancer. Endoscopy 2012; 44: 695-702
- 6 Quintero E, Castells A, Bujanda L et al. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med 2012; 366: 697-706
- 7 Kalager M, Zelen M, Langmark F et al. Effect of screening mammography on breast-cancer mortality in Norway. N Engl J Med 2010; 363: 1203-1210
- 8 Malila N, Anttila A, Hakama M. Colorectal cancer screening in Finland: details of the national screening programme implemented in Autumn 2004. J Med Screen 2005; 12: 28-32
- 9 Bretthauer M, Hoff G. Comparative effectiveness research in cancer screening programmes. BMJ 2012; 344: e2864
- 10 Malila N, Oivanen T, Malminiemi O et al. Test, episode, and programme sensitivities of screening for colorectal cancer as a public health policy in Finland: experimental design. BMJ 2008; 337: a2261
- 11 Regula J, Rupinski M, Kraszewska E et al. Colonoscopy in colorectal-cancer screening for detection of advanced neoplasia. N Engl J Med 2006; 355: 1863-1872
- 12 Kaminski MF, Kraszewska E, Polkowski M et al. Continous quality improvement of screening colonoscopy: data from a large colorectal cancer screening program. Gastrointest Endosc 2009; 69: AB215
- 13 Kaminski MF, Regula J, Kraszewska E et al. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med 2010; 362: 1795-1803
- 14 Bretthauer M, Kalager M. Colonoscopy as a triage screening test. N Engl J Med 2012; 366: 759-760
- 15 Kaminski MF, Regula J, Bartnik W et al. Polish Society of Gastroenterology guidelines for colonoscopy surveillance following polypectomy – adapted European guidelines. Gastroenterologia Klin 2011; 2: 55-62
- 16 Schoen RE, Pinsky PF, Weissfeld JL et al. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. N Engl J Med 2012; 366: 2345-2357
- 17 Brenner H, Chang-Claude J, Seiler CM et al. Long-term risk of colorectal cancer after negative colonoscopy. J Clin Oncol 2011; 29: 3761-3767
- 18 Hakama M, Malila N, Dillner J. Randomised health services studies. Int J Cancer 2012; 131: 2898-2902
- 19 Hoff G, Bretthauer M, Huppertz-Hauss G et al. The Norwegian Gastronet project: continuous quality improvement of colonoscopy in 14 Norwegian centres. Scand J Gastroenterol 2006; 41: 481-487
- 20 Kaminski MF, Anderson J, Valori R et al. Leadership in training to improve adenoma detection rate in screening colonoscopy: a nationwide randomized trial. Gut 2015; DOI: 10.1136/gutjnl-2014-307503.
- 21 Pox C, Schmiegel W, Classen M. Current status of screening colonoscopy in Europe and in the United States. Endoscopy 2007; 39: 168-173
- 22 Didkowska J, Wojciechowska U, Zatonski W. Prediction of cancer incidence and mortality in Poland up to the year 2025. Warsaw, Poland: The National Cancer Registry; 2009 Available from: http://onkologia.org.pl/publikacje/
- 23 Edwards BK, Ward E, Kohler BA et al. Annual report to the nation on the status of cancer, 1975–2006, featuring colorectal cancer trends and impact of interventions (risk factors, screening, and treatment) to reduce future rates. Cancer 2010; 116: 544-573
- 24 Cuzick J, Cafferty FH, Edwards R et al. Surrogate endpoints for cancer screening trials: general principles and an illustration using the UK Flexible Sigmoidoscopy Screening Trial. J Med Screen 2007; 14: 178-185