Screening: the information individuals need to support their decision: per protocol analysis is better than intention-to-treat analysis at quantifying potential benefits and harms of screening

BMC Medical Ethics

Paolo Giorgi Rossi¹ 

[1] Servizio Interaziendale di Epidemiologia, AUSL Reggio Emilia, Via Amendola 2, Reggio Emilia I42122, Italy

关键词: Health literacy;    Consumer health information;    Systematic reviews;    Per protocol analysis;    Intention to treat analysis;    Informed choice;    Participation;    Informed consent;    Mass screening;   

Others  :  799556
DOI  :  10.1186/1472-6939-15-28

 received in 2014-03-08, accepted in 2014-03-25,  发布年份 2014

【 摘 要 】

Background

Providing individuals with the information necessary to make informed decisions is now considered an ethical standard for health systems and general practitioners.

Discussion

Results from intention-to-treat analysis have thus far been used to illustrate screening benefits and harms, but intention-to-treat analysis in most screening trials compares no intervention to invitation to screening. Therefore, the intervention arm includes everyone who was invited, regardless of actual participation. These results may be misleading for individual decision-making. We propose to use a per protocol analysis that includes all subjects who presented to screening and compares them to those in control arm, adjusting for self-selection bias. Such an analysis can give more accurate and useful information for individual decision-making.

Summary

Correct information for individual decision to participate in screening or not should consider the efficacy, benefits, and harms observed for subjects who actually participated at least once in screening compared to the control arm, adjusting for self-selection bias. Thus, per protocol analysis, even a very conservative one, should be used, not a full intention-to-treat analysis.

【 授权许可】

   
2014 Giorgi Rossi; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Austoker J: Gaining informed consent for screening. Is difficult—but many misconceptions need to be undone. BMJ 1999, 319:722-723.
• [2]Giordano L, Webster P, Segnan N, Austoker J, et al.: Guidance On Breast Screening Communication. In European Guidelines For Quality Assurance In Breast Cancer Screening And Diagnosis. 4th edition. Edited by Perry N, Broeders M, de Wolf C. Luxembourg: European Communities; 2006:379-394.
• [3]Austoker J, Giordano L, Hewitson P, Villain P: Communication. In European guidelines for quality assurance in colorectal cancer screening and diagnosis. 1st edition. Edited by Segnan N, Patnick J, von Karsa L. Luxembourg: European Communities; 2010:301-339.
• [4]EUROSCREEN Working Group: Summary of evidence of breast cancer service screening outcomes in Europe and first estimates of benefit and harm balance sheet. J Med Screen 2012, 19(Suppl. 1):5-13.
• [5]Independent UK Panel on Breast Cancer Screening: The benefits and harms of breast cancer screening: an independent review. Lancet 2012, 17;380(9855):1778-1786.
• [6]Hardin centre for Health Litteracy: Fact boxes. (last access 30/08/2013). http://www.harding-center.com/index.php/en/what-you-should-know/facts-boxes webcite
• [7]Giordano L, Cogo C, Patnik J, Paci E, Euroscreen Working Group: Communicating the balance sheet in breast cancer screening. J Med Screen 2012, 19(Suppl. 1):67-71.
• [8]Timmermans DR, Ockhuysen-Vermey CF, Henneman L: Presenting health risk information in different formats: the effect on participants’ cognitive and emotional evaluation and decisions. Patient Educ Couns 2008, 73:443-447.
• [9]Jepson R, Clegg A, Forbes C, Lewis R, Sowden A, Kleijnen J: The determinants of screening uptake and interventions for increasing uptake: a systematic review. Health Technol Assess 2000, 4:i-vii. 1-133
• [10]Ferroni E, Camilloni L, Jimenez B, Furnari G, Borgia P, Guasticchi G, Giorgi Rossi P: Working group methods to increase participation: how to increase uptake in oncologic screening: a systematic review of studies comparing population-based screening programs and spontaneous access. Prev Med 2012, 55:587-596.
• [11]Andriole GL, Crawford ED, Grubb RL 3rd, Buys SS, Chia D, Church TR, Fouad MN, Gelmann EP, Kvale PA, Reding DJ, Weissfeld JL, Yokochi LA, O’Brien B, Clapp JD, Rathmell JM, Riley TL, Hayes RB, Kramer BS, Izmirlian G, Miller AB, Pinsky PF, Prorok PC, Gohagan JK, Berg CD, PLCO Project Team: Mortality results from a randomized prostate-cancer screening trial. N Engl J Med 2009, 360(13):1310-1319.
• [12]Schröder FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, Kwiatkowski M, Lujan M, Lilja H, Zappa M, Denis LJ, Recker F, Berenguer A, Määttänen L, Bangma CH, Aus G, Villers A, Rebillard X, van der Kwast T, Blijenberg BG, Moss SM, de Koning HJ, Auvinen A, ERSPC Investigators: Screening and prostate-cancer mortality in a randomized European study. N Engl J Med 2009, 360:1320-1328.
• [13]Gøtzsche PC, Jørgensen KJ: Screening for breast cancer with mammography. Cochrane Database Syst Rev 2013, 6:CD001877. doi: 10.1002/14651858.CD001877.pub5. Review. PubMed PMID: 23737396
• [14]Hewitson P, Glasziou P, Irwig L, Towler B, Watson E: Screening for colorectal cancer using the faecal occult blood test, Hemoccult. Cochrane Database Syst Rev 2007, (1):CD001216. Review. PubMed PMID: 17253456
• [15]Duffy SW, Hsiu-Hsi Chen T, Smith RA, Ming-Fang Yen A, Tabar L: Real and artificial controversies in breast cancer screening. Breast Cancer Manage 2013, 2:519-528.
• [16]Montori VM, Guyatt GH: Intention-to-treat principle. CMAJ 2001, 165:1339-1341.