Result card

  • LEG1: Is the voluntary participation of patients guaranteed properly?
Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening
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Is the voluntary participation of patients guaranteed properly?

Authors: Ingrid Wilbacher

Internal reviewers: Gottfried Endel

Acknowledgments: Hans Seyfried for voluntarily reviewing

Literature research

Usually it seems to be standard to assume that people want to participate in screening programmes, although the participation rate does not proof this assumption. In the literature search for the legal domain a critical discussion about the legal mandate for implementing a prevention register for hereditary coloncancer was found. A legally mandated cancer prevention and treatment tool for hereditary cancers, however, would mean that patients who have chosen not to participate in the programme would be called for check-ups, as well.{2} Although it addresses only the hereditary crc, the aspects are also interesting for general crc screening and invitation systems, especially in terms of refused screening participation. A repeated call to participate could be interpreted as an unwanted pressure.

Recent European studies report an average of 45% screening participation for FOBT (iFOBT, gFOBT): 19% in Croatia {3}; 30% in France {5}; 42,1% {6}, 52% {4} and between 61% and 64,7% {7} in the Netherlands; 60,6% in the UK {8}; 64,3% in Spain (Basque) {9}; 34,2% in Spain (Canaries) {10}, 49,7% in Italy {11}.

Legislation

Several legislations secure the right of access to (best) health care {12,13,14}, but less about refusal or forced participation. Usually the law takes the view that a patient wants' to have health services available.

Bodily harm is legally forbidden, except for physicians and related occupations in case of treatment and with the implicit understanding and consent of the patient. {15} Therefore it is more or less the non-refusal or the explicit consensus of the patient joining a (nationwide) screening program.

According to article 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms {16}, Article 8, Everyone has the right to respect for his private and family life, his home and his correspondence. and There shall be no interference by a public authority with the exercise of this right except such […] for the protection of health or morals, […].

Court decisions

No international EUGH case law was found for diagnostic matters and voluntary participation. (search done in http://curia.europa.eu/juris/recherche.jsf?language=de – limitation to health sector, last 5 years – no results (3.5.2013)

The patient's right for non-treatment is discussed controversially (Several legal rules against euthanasia {17}, legislation about genetic testing {18}) and more or less just in the view of death.

Conclusion

-          Several legislations secure the right of access to (best) health care {12,1314}, but less about refusal or forced participation. Usually the law takes the view that a patient wants' to have health services available.

-          The invitation to participate in a screening program can be interpreted as "freedom in participation", if it is free of pressure or consequences, and if an objective and understandable information is provided. According to article 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms {16}, Article 8, Everyone has the right to respect for his private and family life, his home and his correspondence. and There shall be no interference by a public authority with the exercise of this right except such […] for the protection of health or morals, […].

-          Usually it seems to be standard to assume that people want to participate in screening programmes, but this should be discussed critically if it comes to a legally mandated cancer prevention and treatment tool for (hereditary) cancers. Bodily harm is legally forbidden, except for physicians and related occupations in case of treatment and with the implicit understanding and consent of the patient. {15} Therefore it is more or less the non-refusal or the explicit consensus of the patient joining a (nationwide) screening program.

-          Different screening participation rates could be a sign for different information levels about the screening test and possible consequences

-          No international EUGH case law was found for diagnostic matters. (search done in http://curia.europa.eu/juris/recherche.jsf?language=de – limitation to health sector, last 5 years – no results (3.5.2013)

-          The patient's right for non-treatment is discussed controversially (Several legal rules against euthanasia {17}, legislation about genetic testing {18}) and more or less just in the view of death.

As long as there is no legal mandate for cancer prevention and treatment (register) and no other forced screening participation which limits or exceeds the objective information the voluntary participation should be guaranteed.

Important
Completely
Wilbacher I Result Card LEG1 In: Wilbacher I Legal aspects In: Jefferson T, Cerbo M, Vicari N [eds.]. Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali; 2014. [cited 7 February 2023]. Available from: http://corehta.info/ViewCover.aspx?id=206

References

[2] A. Tupsela {2006) European Journal of Cancer Care 15, 257-266. When legal worlds collide: from research to treatment in hereditary cancer prevention

[3] Katicic M, Antoljak N, Kujundzic M, Stamenic V, Skoko Poljak D, Kramaric D, Stimac D, Strnad Pesikan M, Samija M, Ebling Z. Results of National Colorectal Cancer Screening Program in Croatia {2007-2011). World J Gastroenterol. 2012 Aug 28;18{32):4300-7. doi: 10.3748/wjg.v18.i32.4300.

[4] Denters MJ, Deutekom M, Bossuyt PM, Fockens P, Dekker E. A feces collection paper does not enhance participation in a fecal immunochemical test-based colorectal cancer screening program: randomized clinical trial. Eur J Cancer Prev. 2012 Nov 18.

[5] Le Breton J, Journy N, Attali C, Le Corvoisier P, Brixi Z, Bastuji-Garin S, Chevreul K. Improving participation in colorectal cancer screening: targets for action. Prev Med. 2012 Nov;55{5):488-92. doi: 10.1016/j.ypmed.2012.08.004. Epub 2012 Aug 21.

[6] Van Roosbroeck S, Hoeck S, Van Hal G. Population-based screening for colorectal cancer using an immunochemical faecal occult blood test: a comparison of two invitation strategies. Cancer Epidemiol. 2012 Oct;36{5):e317-24. doi: 10.1016/j.canep.2012.04.003. Epub 2012 May 5.

[7] van Roon AH, Goede SL, van Ballegooijen M, van Vuuren AJ, Looman CW, Biermann K, Reijerink JC, Mannetje H', van der Togt AC, Habbema JD, van Leerdam ME, Kuipers EJ. Random comparison of repeated faecal immunochemical testing at different intervals for population-based colorectal cancer screening. Gut. 2013 Mar;62{3):409-15. doi: 10.1136/gutjnl-2011-301583. Epub 2012 Mar 2.

[8] Libby G, Brewster DH, McClements PL, Carey FA, Black RJ, Birrell J, Fraser CG, Steele RJ. The impact of population-based faecal occult blood test screening on colorectal cancer mortality: a matched cohort study. Br J Cancer. 2012 Jul 10;107{2):255-9. doi: 10.1038/bjc.2012.277. Epub 2012 Jun 26.

[9] Portillo I, Idigoras I, Ojembarrena E, Arana E, Luis Hurtado J, Basurko R, Tapia M, Luz Pena M. [Lesions detected in a colorectal cancer screening program in the Basque Country: first round {2009-2011)]. Gastroenterol Hepatol. 2013 May;36{5):301-8. doi: 10.1016/j.gastrohep.2013.02.004. Epub 2013 Apr 22.

[10] Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas A, Andreu M, Carballo F, Morillas JD, Hernandez C, Jover R, Montalvo I, Arenas J, Laredo E, Hernandez V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andres M, Teruel G, Peris A, Roncales. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366{8):697-706. doi: 10.1056/NEJMoa1108895.

[11] Parente F, Boemo C, Ardizzoia A, Costa M, Carzaniga P, Ilardo A, Moretti R, Cremaschini M, Parente EM, Pirola ME. Outcomes and cost evaluation of the first two rounds of a colorectal cancer screening program based on immunochemical fecal occult blood test in northern Italy. Endoscopy. 2013 Jan;45{1):27-34. doi: 10.1055/s-0032-1325800. Epub 2012 Dec 19.

[12] International Covenant on Economic, Social and Cultural Rights {1966); Article 12; http://www.ohchr.org/EN/ProfessionalInterest/Pages/CESCR.aspx {2.5.2013)

[13] European Code of Social Security {Revised); Article 8 + Article 10; http://conventions.coe.int/treaty/en/Treaties/Html/139.htm {2.5.2013)

[14] A Declaration on the Promotion of Patients' Rights in Europe, WHO 1994; http://www.who.int/genomics/public/eu_declaration1994.pdf {2.5.2013)

[15] criminal law on national level;i.e. A: §§ 83–88 StGB {http://www.ris.bka.gv.at/Dokument.wxe?Abfrage=Bundesnormen&Dokumentnummer=NOR40124586) {2.5.2013); D: § 223-§ 231, § 340 StGB {http://dejure.org/gesetze/StGB/223.html) {2.5.2013); Pl: Dz.U. 1997 nr 88 poz. 553 - Kodeks karny {http://isap.sejm.gov.pl/DetailsServlet?id=WDU19970880553) {2.5.2013);

[16] http://conventions.coe.int/Treaty/EN/Treaties/Html/005.htm {14.5.2013)

[17] German Court, Bundesgerichtshof 2 StR 454/09) 25th June 2010; http://hudoc.echr.coe.int/sites/eng/pages/search.aspx?i=001-113680#{"itemid":["001-113680"]} {2.5.20139

Wet toetsing levensbeëindiging op verzoek en hulp bij zelfdoding http://www.st-ab.nl/wetten/0829_Wet_toetsing_levensbeeindiging_op_verzoek_en_hulp_bij_zelfdoding.htm {2.5.2013)

PROPOSITION DE LOI relative à l'euthanasie volontaire; http://www.senat.fr/leg/ppl10-031.html {2.5.2013)

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[18] Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes; Articles 1 - 22 and Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes; Articles 1 - 24; http://conventions.coe.int/treaty/en/treaties/html/203.htm {2.5.2013)

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