- Email: [email protected]
Including values in evidence-based policy making for breast screening: An empirically grounded tool to assist expert decision makers
Accepted Manuscript Title: Including values in evidence-based policy making for breast screening: an empirically grounded tool to assist expert decision makers Author: Lisa Parker PII: DOI: Reference:
S0168-8510(17)30063-5 http://dx.doi.org/doi:10.1016/j.healthpol.2017.03.002 HEAP 3707
To appear in:
Health Policy
Received date: Revised date: Accepted date:
1-12-2016 12-2-2017 1-3-2017
Please cite this article as: Parker Lisa.Including values in evidence-based policy making for breast screening: an empirically grounded tool to assist expert decision makers.Health Policy http://dx.doi.org/10.1016/j.healthpol.2017.03.002 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Title Page Including values in evidence-based policy making for breast screening: an empirically grounded tool to assist expert decision makers
Lisa Parker Researcher Centre for Values, Ethics and the Law in Medicine (VELiM), Sydney School of Public Health, University of Sydney, NSW 2006, Australia. [email protected]
Highlights
Values are an important part of evidence-based policy decision making. Breast screening policy committee members hold a range of values. Widely differing values may be difficult to incorporate into policy decisions. A tool to assist breast screening policy makers by structuring values-based discussions is provided.
Abstract Values are an important part of evidence-based decision making for health policy: they guide the type of evidence that is collected, how it is interpreted, and how important the conclusions are considered to be. Experts in breast screening (including clinicians, researchers, consumer advocates and senior administrators) hold differing values in relation to what is important in breast screening policy and practice, and committees may find it difficult to incorporate the complexity and variety of values into policy decisions. The decision making tool provided here is intended to assist with this process. The tool is modified from more general frameworks that are intended to assist with ethical decision making in public health, and informed by data drawn from previous empirical studies on values amongst Australian breast screening experts. It provides a structured format for breast screening committees to consider and discuss the values of themselves and others, suggests relevant topics for further inquiry and highlights areas of need for future research into the values of the public. It enables committees to publicly explain and justify their decisions with reference to values, improving transparency and accountability. It is intended to act alongside practices that seek to accommodate the values of individual women in the informed decision making process for personal decision making about participation in breast screening. Keywords: Mass screening; Breast neoplasms; Mammography; Evidence-based medicine; Medical ethics; Health policy; Policy making; Social values
Introduction After several decades of organised breast screening, leading experts in the field continue to disagree about aspects of its policy and practice.[1-5] There is particularly strong debate about whether or not the benefits of breast screening outweigh the harms amongst certain population groups, and the level of information detail to provide for women. Reasons for disagreement are often attributed to disputes about the epidemiological evidence[6-11] or to conflicts of interest,[6, 12-14] and there have been calls to deliver better epidemiological education for experts,[11, 15] provide clearer communication of trial results,[14, 16, 17] and focus on independent analysis of quantitative data.[6, 12, 17, 18] Despite implementing at least some of these ideas, disputes continue: that is, even when capable, well-meaning experts agree about numbers they may still disagree about one or more aspect of breast screening.[2, 7, 12, 19] Thus it appears that epidemiological misunderstandings, epistemic differences and conflicts of interests may not entirely explain expert disagreement. In light of this, and recognising the self-evident concept that health policy decisions depend not only on analysis of epidemiological evidence but also on what is valued in relation to that evidence,[20-22] it seems likely that different values (views about what is right and wrong[23]) may be at least partly responsible for disagreements in relation to breast cancer screening.
There has been growing acceptance of the need to explicitly consider values in the process of evidence-based healthcare decision making. For example, the GRADE framework for producing evidence-based guidelines incorporates assessments of values regarding benefits and harms, in particular, the extent to which intervention outcomes are generally regarded as being desirable or undesirable. GRADE authors recommend that decision-making committees should use the perspective of patients when thinking about benefits and
harms,[24] and should be transparent about their estimates or assumptions regarding these typical patient values.[25, 26] The GRADE framework is widely endorsed, although the (limited) empirical evidence about its usability and effectiveness suggests there may be room for improvement.[27-30] This may be especially relevant to the field of public health, where value judgements about benefits and harms may be more complex, and where other relevant principles (such as supporting autonomy) might be prioritised by some.[31]
There is less endorsement of the idea that values held by informed experts are relevant and important to the policy decision-making process. Some writers have proposed that values of committee members have no role in decision making, arguing for a so-called “objective” interpretation of “raw evidence”,[32]p956 implying that this is possible, that it would yield a value-free view of breast screening, and would resolve disagreement. Others, including myself, contend that it is unrealistic and unhelpful to suggest that an expert’s personal values can be removed from decision making.[19, 21, 33] Evidence is vital in answering questions about breast screening policy and practice but evidence is not value-free. Values are inherent in the type of questions that are asked, the methods that are used to address those questions, the ways that results are interpreted and communicated, and the importance that is placed upon the conclusions.[34] Thus the collection and analysis of evidence is fundamentally driven by what is considered to be important, meaning that values, rather than “massed files of scientific evidence”[32]p310 lie at the heart of decision making.
Accepting that values are an integral part of evidence-informed policy making is an important first step; the next challenge is to think about how they might best be incorporated. Much of the literature that refers to values in the context of breast screening tends to concentrate on
selected dominant interpretations of what is important, often discussing the pros and cons of two apparently competing ethical principles (rules that guide moral action,[35]p124), such as ‘maximising benefit’ or ‘supporting autonomy’, conceptualised in a particular way.[36-38] [39] [40] (Conceptualisation of values refers to the way that a particular ethical principle is interpreted: for example, conceptualisation of what it means to respect a woman’s autonomy in this context might include one or more of: unfettered access to breast screening on demand; strong encouragement to attend breast screening in order to maximise a woman’s knowledge about her breast anatomy and pathology; detailed information about screening benefits and harms.[41])
Such head-on comparisons leave little space for decision makers and others to reach an understanding of how and why others think the way they do, or recognise points of agreement. In addition, my previous empirical work mapping the broad range of values in use amongst those who influence breast screening policy and practice [41] suggests that these “either/or” kinds of values-based policy discussion are too narrowly focused for a complex topic such as breast screening, as they fail to recognise the plurality of ways to conceptualise and prioritise ethical principles and thus ignore a multitude of potentially relevant ethical considerations. (Combining a particular conceptualisation and prioritisation of values delivers a view about what is considered to be most important in breast screening: for example one individual might focus on delivering benefit, conceptualised as high breast screening participation rates, while another might be particularly concerned about avoiding harm, conceptualised as reducing participation amongst those less likely to benefit from mammographic screening.) The impact of these simplified forms of values-based discussions is likely to be success for those with the loudest or most influential voice rather than
endorsement of what is most ethically correct, or to a stalemate position with experts unwilling to be persuaded of alternative points of view.
The rationale for this study was to facilitate values-based discussions amongst breast screening policy makers in a way that (1) would encourage decision makers to consider the broad range of relevant values and the wide variety of ways that values are conceptualised and prioritised, and (2) would enable committees to explain their decisions to the public using the language of values in order to facilitate transparency and accountability. Ultimately this will deliver breast screening policies and practices that are more ethically sound and appropriate for the given context and population group. The specific objective was to develop a concrete tool to assist decision makers discuss and incorporate values into evidence-based decision making for breast screening policies and practices. The tool provided here is intended as a preliminary draft, to provide some guidance and to stimulate further conversation in this arena. While the tool development was informed by empirical work, it has not yet been formally tested and there is scope for ongoing research in this area.
Methods The tool draws on existing frameworks that provide general guidance for ethical decision making in public health by listing the kinds of ethical principles that are likely to be relevant.[30, 42-44] The ethical framework model was modified by expanding out relevant abstract ethical principles into concrete values, and including a wide range of conceptualisations of each value. This was informed by the results of prior empirical qualitative research involving long interviews with 33 influential Australian breast screening experts including consumers, clinicians, researchers and adminstrative personnel, which
demonstrated the braod range of ways that values were conceptualised and prioritised amongst this group.[41] (Further detail on the methods for this empirical work are available in Appendix 1.) Commentary and questions about each value were drawn from extensive reading on the topic of ethics in breast cancer screening, undertaken as part of a larger project on cancer screening ethics in Australia.(cancerscreeningethics.org)
Results The study resulted in a tool to assist policy makers incorporate values into evidence-based breast screening decision making. (See Tables 1 and 2.) The tool is an empirically informed framework of relevant values that enables and prompts a deep and rich discussion about what is considered important in breast screening. It provides specific and detailed assistance to breast screening policy committees by providing a clear format for values-based discussions and enabling the committee to explain their decisions with reference to values.
The tool exists in the form of an incomplete table that guides committees through a structured conversation. Firstly, decision makers are invited to identify the ethical principles that are relevant to their particular breast screening context, and how these principles are conceptualised. Table 2 provides a list (drawn from the public health ethics and cancer screening ethics literature[41-44, 49, 53-57]) that can be used as a starting point. It is likely that committees will produce a range of conceptualisations for each principle; they are encouraged to draw from the popular and academic literature, as well as their own ideas,[41, 49, 50, 58] and may find the assistance of a professional ethicist useful.[59] Secondly, decision makers are directed to debate the different conceptualisations of principles, and, informed by evidence, to identify strengths and weaknesses of each. Finally, the tool
provides questions to encourage reflection and research about the extent to which each concept is important in the breast screening context. Table 2 provides selected examples of topics for debate, and questions for further research, more examples are provided in Appendix 2.
The tool does not proscribe any particular values or actions or provide a neat solution for all breast screening controversies. It does, however, act as a guide for how to discuss and identify important concepts in breast screening, and how to cohesively incorporate values alongside evidence in the decision-making process. As a result of using the tool, panel members will be able to explain and justify their decisions by referring to values.[60] Table 3 provides worked examples of how this could look.
Discussion This tool provides assistance for the incorporation of values into decision making for breast screening policies and practices in order to deliver decisions that appropriately reflect contemporary ethical values. [60-63] It is not intended to be the only possible method,[60] but it may be useful for those who seek structured guidance in this field. It is potentially suitable for use by decision-making committees at times of policy set-up, evaluation, and review, as well as during times of controversy and decisional conflict. Group deliberation on moral aspects of a given topic will arguably increase the likelihood that decision makers will identify a broader range of relevant viewpoints, and recognise possible biases in their own preliminary conclusions. The tool also aims to provide greater transparency in decision making, allowing for a fuller evaluation of decision-making processes and outcomes.[21] In addition, the process of discussing values regularly should provide more opportunity for
those involved in decision making to address any values-based conflict that emerges in the future.
Study limitations This study relied on data from previous research that was collected in the context of the Australian breast screening program, which may not be directly transferable to other regions. However the Australian breast screening program has similar purposes and practices to programs in the UK and many European countries: BreastScreen Australia offers free mammographic breast screening at two yearly intervals to all women from aged 40 years, with the target population aged 50-74 years.[64, 65] It is likely, therefore, that the results will be at least partly applicable to other regions. In addition, it is possible that the data used to flesh out the table may not have accommodated the entirety of relevant values, but there is ample space and opportunity for local policy committees to include additional values-based information and ideas.
Implications for practice In order to use this tool most effectively, decision makers are encouraged to: endorse the role of values in shaping healthcare policies and practices; expect, and be committed to discuss, a plurality of views;[6, 7, 19, 66, 67] and be prepared to publicly explain and justify the values that were most influential in guiding decisions. Experts who are reluctant or inexperienced in ethics discussion and self-reflection might find it useful to receive extra training and support in this area prior to the decision making process.[61, 62]
The tool requires that decision making bodies obtain and consider the values of the public when considering breast screening policy. (This does not preclude or negate the importance of seeking an individual woman’s values for the process of facilitating and supporting her informed decision about participation in breast screening.) The collective values of women and others are relevant to decisions about breast screening policies and practices, but the tool described here does not insist that public values necessarily drive policy in a direct manner: this may not be possible for cost reasons, and it may not be desirable - for example, the public may be ill-informed about the topic, or the values of the majority may fail to accommodate important minority interests.[53, 68] Nevertheless, the tool accommodates the values of the public in order to provide decision-making legitimacy, and because the public perspective provides additional, relevant information.[68-70]
There are several ways of seeking out public values. Consumer representation on decisionmaking committees is one widely used method, and individual consumers can often provide valuable insight derived from personal experience with breast cancer or breast screening. A limitation of this method is that individual representatives may not necessarily present a view that matches the ideas of the broader public.[68] For example, it may be that many people who participate as formal consumer representatives are also consumer advocates for a particular policy; for example, most consumer representatives in breast screening may be motivated by personal enthusiasm towards breast screening and therefore tend to present just one set of views about the program, which may not be shared by women more broadly.[41]
Another option is to garner the views of the public through direct polling or through more sophisticated discrete choice experiments.[71, 72] While these may be useful, they might not
be well suited to this context: breast screening is a complex topic and not always accurately presented in the media or other information sources commonly used by the public, which are subject to possible vested interests of corporations.[73, 74] Thus, people’s existing views about breast screening may not necessarily derive from a balanced picture of the available evidence[73-75] or accurately reflect their values.[49] Polling or discrete choice experiments may not allow sufficient opportunity for citizens to fully realise and ponder the complexities of the topic.
An alternative approach to gaining the views of the public is via deliberative democratic methods, something that has been gaining increasing attention in recent years. This involves working with a small, diverse group of people from the community, providing them with relevant information and education, creating opportunities for discussion between experts, researchers and citizens, and then seeking the (informed) opinions of citizens. Several types of deliberative techniques have been developed; citizens’ juries are one of the more popular methods[76] and have been convened to consider controversial topics in screening including breast screening.[77, 78] While such an approach can be expensive, and its usefulness is somewhat dependent on the skill of the convenors, it can provide a public consensus and reasoning with relatively greater legitimacy compared to other methods, as the people involved have had more opportunity to discuss and understand relevant technical and ethical details.[14, 76, 77]
Further research Evaluation is an important pre-requisite to wider implementation of the tool. This discussion paper is a preliminary step in that process. The next phase might be to use qualitative
methods to obtain feedback about the tool from members of decision-making committees, with particular attention to acceptability and functionality. This could be followed by empirical testing of outcomes from incorporating the tool into decision making processes, assessing parameters such as its effect on committee members’ understandings of the ways in which relevant ethical values are conceptualised by others; and its impact on communications to the public about values and their role in policy decisions.
Conclusions Breast screening is a major public health intervention practiced throughout much of the developed world but disputes over contested areas of breast screening continue to feature regularly in the academic literature, frequently involving respected experts with strongly opposing views. Conflicts spill over into the public domain, involving politicians and the media, leaving many consumers angry and confused. Given that some of the disagreement appears to result from differences in values, values-based discussions are likely to be an important part of the solution. Experts involved in evidence-based decision making for breast screening might find it useful to use a structured tool to guide these kinds of discussions, and to facilitate the justification of their decisions using the language of values. Reflection and discussion about values will assist decision makers to address values-based conflict and to develop ethically sound breast screening for the future.
Funding: This work was supported by the National Health and Medical Research Council of Australia [grant numbers 1038517 & 1023197].
Conflicts of interest: none
Acknowledgements: I thank Stacy Carter and Lucie Rychetnik for their support and guidance with the research that this paper builds upon, and am particularly grateful to SC for assistance with earlier drafts of this manuscript. I also thank Lisa Bero for assistance with information about GRADE and Angus Dawson for conceptual assistance regarding values in public health decision making.
References 1. Marmot MG. Sorting through the arguments on breast screening. JAMA 2013;309(24):2553-4. 2. Quanstrum K, Hawyard R. Lessons from the mammography wars. N Engl J Med 2010;363:1076-1077. 3. Duffy SW. Breast cancer screening causes more harm than good: No. J Prim Health Care 2014;6(1):81-2. 4. Heath I. Breast cancer screening causes more harm than good: Yes. J Prim Health Care 2014;6(1):79-80. 5. Roder DM, Olver IN. Do the benefits of screening mammography outweigh the harms of overdiagnosis and unnecessary treatment?--yes. Med J Aust 2012;196(1):16. 6. Plutynski A. Ethical issues in cancer screening and prevention. J Med Philos 2012;37(3):310-23. 7. Harris R, Sawaya GF, Moyer VA, Calonge N. Reconsidering the criteria for evaluating proposed screening programs: reflections from 4 current and former members of the U.S. Preventive services task force. Epidemiol Rev 2011;33:20-35. 8. Flitcroft K, Gillespie J, Carter S, Salkeld G, Trevena L. Incorporating evidence and politics in health policy: can institutionalising evidence review make a difference? Evid Policy 2013;10(3):439-455. 9. Panagiotou OA, Ioannidis JP. Primary study authors of significant studies are more likely to believe that a strong association exists in a heterogeneous meta-analysis compared with methodologists. J Clin Epidemiol 2012;65(7):740-7. 10. Young SN. Bias in the research literature and conflict of interest: an issue for publishers, editors, reviewers and authors, and it is not just about the money. J Psychiatry Neurosci 2009;34(6):412-7. 11. Esserman LJ, Thompson IM, Reid B, Nelson P, Ransohoff DF, Welch HG, et al. Addressing overdiagnosis and overtreatment in cancer: a prescription for change. Lancet Oncol 2014;15(6):e234-42. 12. Autier P, Esserman L, Flowers C, Houssami N. Breast cancer screening: the questions answered. Nat Rev Clin Oncol 2012;9(10):599-605.
13. Bewley S. The NHS breast screening programme needs independent review. BMJ 2011;343:d6894. 14. Harris RP, Wilt TJ, Qaseem A. A value framework for cancer screening: advice for high-value care from the American College of Physicians. Ann Intern Med 2015;162(10):712-7. 15. Gigerenzer G, Edwards A. Simple tools for understanding risk: from innumeracy to insight. BMJ 2003;327(7417):741-4. 16. Fletcher SW. Breast Cancer Screening: A 35-year perspective. Epidemiologic Reviews 2011;33(1):165-175. 17. McPherson K. Screening for breast cancer: balancing the debate. BMJ 2010;340:233235. 18. Richards M. An independent review is under way. BMJ 2011;343:d6843. 19. Greenhalgh T, Russell J. Evidence-based policymaking: a critique. Perspect Biol Med 2009;52(2):304-18. 20. Eddy DM. Clinical decision making: from theory to practice. Anatomy of a decision. JAMA 1990;263(3):441-3. 21. Nicholls SG, Newson AJ, Ashcroft RE. The need for ethics as well as evidence in evidence-based medicine. J Clin Epidemiol 2016. 22. DeJean D, Giacomini M, Simeonov D, Smith A. Finding qualitative research evidence for health technology assessment. Qualitative Health Research 2016:1049732316644429. 23. Rachels J, Rachels S. The elements of moral philosophy. 6th ed. Boston: McGraw Hill; 2010. 24. Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol 2011;64(4):395-400. 25. Andrews J, Guyatt G, Oxman AD, Alderson P, Dahm P, Falck-Ytter Y, et al. GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations. J Clin Epidemiol 2013;66(7):719-25. 26. Andrews JC, Schunemann HJ, Oxman AD, Pottie K, Meerpohl JJ, Coello PA, et al. GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength. J Clin Epidemiol 2013;66(7):726-35. 27. Kavanagh BP. The GRADE system for rating clinical guidelines. PLoS Med 2009;6(9):e1000094. 28. Alexander PE, Gionfriddo MR, Li SA, Bero L, Stoltzfus RJ, Neumann I, et al. A number of factors explain why WHO guideline developers make strong recommendations inconsistent with GRADE guidance. J Clin Epidemiol 2016;70:111-22. 29. Hartling L, Fernandes RM, Seida J, Vandermeer B, Dryden DM. From the trenches: a cross-sectional study applying the GRADE tool in systematic reviews of healthcare interventions. PLoS One 2012;7(4):e34697. 30. Schopper D, Dawson A, Upshur R, Ahmad A, Jesani A, Ravinetto R, et al. Innovations in research ethics governance in humanitarian settings. BMC Med Ethics 2015;16:10. 31. Rehfuess EA, Akl EA. Current experience with applying the GRADE approach to public health interventions: an empirical study. BMC Public Health 2013;13:9. 32. Mayor S. Row over breast cancer screening shows that scientists bring "some subjectivity" into their work. BMJ 2001;323(7319):956.
33. Willis K. Row over breast cancer screening shows that scientists bring "some subjectivity" into their work. Rapid response: Agreeement is "objective"; disagreement is "subjective". BMJ 2001;323(956). 34. Kelly MP, Heath I, Howick J, Greenhalgh T. The importance of values in evidencebased medicine. BMC Med Ethics 2015;16(1):69. 35. Kerridge I, Lowe M, Stewart C. Ethics and law for the health professions. 4th ed. Annandale: The Federation Press; 2013. 36. Irwig L, McCaffery K, Salkeld G, Bossuyt P. Screening and choice - Informed choice for screening: implications for evaluation. BMJ 2006;332(7550):1148-1150. 37. Hersch J, Jansen J, Irwig L, Barratt A, Thornton H, Howard K, et al. How do we achieve informed choice for women considering breast screening? Prev Med 2011;53(3):1446. 38. Austoker J. Gaining informed consent for screening. Is difficult--but many misconceptions need to be undone. BMJ 1999;319(7212):722-3. 39. Keating NL, Pace LE. New Guidelines for Breast Cancer Screening in US Women. JAMA 2015;314(15):1569-71. 40. Raffle AE. Information about screening - is it to achieve high uptake or to ensure informed choice? Health Expect 2001;4(2):92-8. 41. Parker L, Rychetnik L, Carter S. Values in breast cancer screening: an empirical study with Australian experts. BMJ Open 2015;5(5):e006333. 42. Kass NE. An ethics framework for public health. Am J Public Health 2001;91(11):1776-82. 43. Childress JF, Faden RR, Gaare RD, Gostin LO, Kahn J, Bonnie RJ, et al. Public health ethics: Mapping the terrain. Journal of Law Medicine and Ethics 2002;30(2):170-178. 44. Upshur REG. Principles for the justification of public health intervention. Canadian Journal of Public Health 2002;93(2):101-103. 45. Baum M. Harms from breast cancer screening outweigh benefits if death caused by treatment is included. BMJ 2013;346:f385. 46. Welch HG. Overdiagnosed: making people sick in the pursuit of health. Boston: Beacon Press; 2011. 47. Jorgensen KJ, Gotzsche PC. Overdiagnosis in publicly organised mammography screening programmes: systematic review of incidence trends. BMJ 2009;339:b2587. 48. Dixon JM. Breast screening has increased the number of mastectomies. Breast Cancer Res 2009;11 Suppl 3:S19. 49. Parker LM, Carter S. Social and ethical considerations in breast cancer screening. In: Houssami N, Miglioretti DL, editors. Breast cancer screening: an examination of scientific evidence. London: Academic Press Inc; 2016. 50. Parker LM, Rychetnik L, Carter S. Framing overdiagnosis in breast screening: a qualitative study with Australian experts. BMC Cancer 2015;15:606. 51. Moutel G, Duchange N, Darquy S, de Montgolfier S, Papin-Lefebvre F, Jullian O, et al. Women's participation in breast cancer screening in France--an ethical approach. BMC Med Ethics 2014;15:64. 52. Torgerson DJ, Donaldson C. An economic view of high compliance as a screening objective. BMJ 1994;308(6921):117-9. 53. Juth N, Munthe C. The ethics of screening in health care and medicine: serving society or serving the patient? Dordrecht: Springer; 2012.
54. Dawson A, Jennings B. The place of solidarity in public health ethics. Public Health Reviews 2012;34(1):65-79. 55. University of Toronto Joint Centre for Bioethics Pandemic Ethics Working Group. Stand on guard for thee: ethical considerations in preparedness planning for pandemic influenza. Toronto: University of Toronto Joint Centre for Bioethics; 2005. 56. Verweij M. The prevention paradox and tensions between private and public interests. In: Verweij M, editor. Preventive medicine between obligation and aspiration. Dordrecht: Kluwer Academic Publishers; 2000. p. 51-67. 57. Viens AM. Public health, ethical behavior and reciprocity. Am J Bioeth 2008;8(5):13. 58. Parker LM, Rychetnik L, Carter S. The role of communication in breast cancer screening: a qualitative study with Australian experts. BMC Cancer 2015;15(741). 59. Behrmann J. Bioethics in health policy development: a primer for decision-makers. BioéthiqueOnline 2012;1/8. 60. Grill K, Dawson A. Ethical Frameworks in Public Health Decision-Making: Defending a Value-Based and Pluralist Approach. Health Care Anal 2015. 61. Cribb A, Haran D. The benefits and ethics of screening for breast cancer. Public Health 1991;105(1):63-7. 62. Daniels N. Reflective equilibrium. In: Zalta E, editor. The Stanford encyclopedia of philosophy. 2013 Winter [cited 2016 January 16] ed. 63. Willison DJ, Ondrusek N, Dawson A, Emerson C, Ferris LE, Saginur R, et al. What makes public health studies ethical? Dissolving the boundary between research and practice. BMC Med Ethics 2014;15:61. 64. Giordano L, von Karsa L, Tomatis M, Majek O, de Wolf C, Lancucki L, et al. Mammographic screening programmes in Europe: organization, coverage and participation. J Med Screen 2012;19 Suppl 1:72-82. 65. BreastScreen Australia. In. Australia:: Department of Health, Australian Government. 66. Eddy DM. Clinical decision making: from theory to practice. Practice policies --what are they? JAMA 1990;263(6):877-8, 880. 67. Ransohoff DF, Harris RP. Lessons from the mammography screening controversy: can we improve the debate? Ann Intern Med 1997;127(11):1029-34. 68. Irvin R, Stansbury J. Citizen participation in decision making: is it worth the effort? Public Administration Review 2004;64(1):55-65. 69. Abelson J, Forest P, Eyles J, Smith P, Martin E, Gauvin F. Obtaining public input for health systems decision making: past experiences and future prospects. Canadian Public Administration 2002;45(1):70-97. 70. Bruni RA, Laupacis A, Martin DK, University of Toronto Priority Setting in Health Care Research G. Public engagement in setting priorities in health care. CMAJ 2008;179(1):15-8. 71. Ryan M. Discrete choice experiments in health care. BMJ 2004;328(7436):360-1. 72. Sculpher M, Bryan S, Fry P, de Winter P, Payne H, Emberton M. Patients' preferences for the management of non-metastatic prostate cancer: discrete choice experiment. BMJ 2004;328(7436):382. 73. Jones SC, Rossiter JR. Breast cancer detection messages in Australian print media advertising - are they promoting correct information? In: 31st European marketing academy conference. Braga, Portugal. ; 2002.
74. Kaufert PA. Women and the debate over mammography: an economic, political and moral history. In: Sargent CF, Brettell CB, editors. Gender and Health: an international perspective. New Jersey: Simon & Schuster; 1996. p. 167-186. 75. King S. Pink ribbons, inc. Breast cancer and the politics of philanthropy. Minneapolis: University of Minnesota Press; 2006. 76. Degeling C, Carter SM, Rychetnik L. Which public and why deliberate?--A scoping review of public deliberation in public health and health policy research. Soc Sci Med 2015;131:114-21. 77. Rychetnik L, Carter SM, Abelson J, Thornton H, Barratt A, Entwistle VA, et al. Enhancing citizen engagement in cancer screening through deliberative democracy. J Natl Cancer Inst 2013;105(6):380-6. 78. Paul C, Nicholls R, Priest P, McGee R. Making policy decisions about population screening for breast cancer: the role of citizens' deliberation. Health Policy 2008;85(3):31420. 79. Cribb A. Why ethics? What kind of ethics for public health? In: Peckam S, Hann A, editors. Public health ethics and practice. Bristol: The Policy Press; 2010. p. 17-32.
Table 1. Decision-making tool explanation and instructions for use. The decision-making tool consists of a tabled list of ethical principles that are relevant to breast screening policy and practice. Column One lists a range of conceptualisations for each principle. Subsidiary information in Columns Two and Three provide commentaries and questions for further research. Instructions for use:
Look at the list of principles (maximising health benefits; minimising harms; delivering more benefits than harms; maintaining cost-efficiency; supporting autonomy; distributing benefits and harms justly; communicating honestly; making policy with a transparent process; upholding reciprocal obligations to the public; facilitating connections between community members). Add any other principles that are relevant to your particular breast screening context.
Read the list of conceptualisations for each principle (Column One). Discuss which one or more is used by each member of the group uses, and which are used by others, including consumers and citizens. Add any other relevant conceptualisations that are not provided.
Using the notes in Column Two as a guide, consider the strengths and weaknesses of each conceptualisation (e.g. what a given conceptualisation might miss; whether or not there are inconsistencies or inaccuracies in a given conceptualisation.) Discuss which conceptualisations the group wishes to endorse most strongly and why. If a widely held conceptualisation is held to be inadequate or problematic in some way, consider engaging in wider public debate and discussion about this.
Using the questions in Column Three as a guide, write a list of topics that require further research and/or discussion in order to determine the relevance and importance of each concept for the current breast screening context. Obtaining answers to these questions should assist the group in making ethically justified decisions about breast screening policy and practice.
Table 2. Framework tool to guide decision making in breast screening policy and practice. (Selected examples are provided in this table; more examples are provided in Appendix 2.) RELEVANT PRINCIPLES and range of conceptualisations for each relevant principle
Notes on strengths or weaknesses of a given conceptualisation
MAXIMISING HEALTH BENEFITS Reducing population mortality rate It may be unreasonable to expect to obtain from breast cancer and/or all causes. evidence of all-cause mortality reduction associated with breast cancer screening because of the large numbers of research participants that would be required. A disease-specific (i.e. breast cancer) mortality rate is more amenable to empirical study than an all-cause mortality rate although may not provide a complete picture: i.e. may miss mortality implications of overdiagnosis.[45] Reducing population breast cancer Any apparent reduction in treatmentmorbidity by enabling less aggressive related morbidity as a result of breast breast cancer treatment for individuals. screening may be offset by the increased morbidity associated with overdiagnosis.[46-48] Providing relief from breast cancer This apparent benefit may be artificial: related anxiety. reduced anxiety after a negative screen may partly derive from previously inflated anxiety due to screening promotion.[49]
Improving the overall health of the entire population.
While the availability of breast screening might offer benefits to a population, it also: delivers harms; is an expensive program with high opportunity costs; and arguably fails to address the main health needs of those with the poorest health outcomes.[41, 50]
Questions (& evidence) to consider when debating the relative importance of each concept
How much, and what kind of health benefit accrues from breast screening, and how certain is the evidence about this? To what extent is anxiety about breast cancer inflated by a breast screening program and related promotional activities? To what extent do efforts to maximise the health benefits of breast screening impinge on other relevant values, e.g. by delivering
RELEVANT PRINCIPLES and range of conceptualisations for each relevant principle
Notes on strengths or weaknesses of a given conceptualisation
Questions (& evidence) to consider when debating the relative importance of each concept harms, consuming financial resources, maintaining or increasing health inequalities?
MINIMISING HARMS Monitoring and/or ensuring a low occurrence rate in one or more of the Examples for the remaining principles are provided in following outcomes: overdiagnosis; Appendix 2 overtreatment; false positive test; false negative test; radiation damage; personal financial burden. Avoiding an excessive increase in societal and/or individual anxiety about breast cancer suffering and death. Avoiding an excessive burden of decision making for women in regard to the consideration of breast screening participation. Paying close attention to quality control in breast screening services DELIVERING MORE BENEFITS THAN HARMS Ensuring that breast screening reflects experts’ considered decisions on how to design the program so that resulting population health benefits outweigh population harms. Ensuring that women make an informed choice about breast screening participation, incorporating their personal views on benefits and harms. Ensuring, and regularly reassessing whether or not breast screening is, overall, in the public interest. MAINTAINING COST-EFFICIENCY Ensuring that the financial cost of avoiding one breast cancer death is comparable to the cost of other similarly effective healthcare interventions.
RELEVANT PRINCIPLES and range of conceptualisations for each relevant principle
Notes on strengths or weaknesses of a given conceptualisation
Maintaining a minimum breast screening participation rate of around 70% in order to deliver benefits in a cost-effective manner.[51,52] Minimising administrative inefficiencies associated with the breast screening program. RESPECTING, SUPPORTING OR ENHANCING AUTONOMY Ensuring that women are not coerced into participating in breast screening. Providing relevant information and opportunities for women to make an informed choice about participating in breast screening (including informing about harms). Increasing available options for effective treatment (by providing the opportunity to access less aggressive, earlier treatment) Providing ready access to breast screening for all women, including those younger and older than the target age range. DISTRIBUTING BENEFITS AND HARMS IN A JUST MANNER Ensuring that all women in the target screening population have an equal opportunity to be informed about, and participate in, breast screening.. Having an even distribution of breast screening participation rates across the population. Facilitating an even distribution of breast cancer mortality, or overall health, across the population. COMMUNICATING HONESTLY Providing relevant information about the harms of breast screening to consumers and the general public. Using independent experts to provide information to women to assist them in making an informed choice about breast screening participation.
Questions (& evidence) to consider when debating the relative importance of each concept
RELEVANT PRINCIPLES and range of conceptualisations for each relevant principle
Notes on strengths or weaknesses of a given conceptualisation
Questions (& evidence) to consider when debating the relative importance of each concept MAKING POLICY DECISIONS WITH A FAIR, HONEST, AND TRANSPARENT PROCESS Using independent experts to review the evidence and/or make policy decisions. Ensuring that policy decision-makers disclose any conflicts of interest. Ensuring that all relevant stakeholders, including clinical experts, have an opportunity to participate in decisions about breast screening policy. Publicly disclosing the values used to guide breast screening policy and practice; possibly involving the public to decide on these values. UPHOLDING RECIPROCAL OBLIGATIONS (OF GOVERNMENT & PUBLIC HEALTH PROVIDERS TO THE PUBLIC) Maintaining efforts to measure and reduce population burdens, harms and costs associated with breast screening. Considering other, less burdensome and/or less expensive ways to reduce population breast cancer mortality and morbidity. Supporting those who are most burdened by breast screening (e.g. those likely to have been overdiagnosed). RESPECTING AND FACILITATING CONNECTIONS BETWEEN COMMUNITY MEMBERS Including considerations of community interests when making decisions about breast screening policy and practice. Ensuring similar healthcare access and support exists for women diagnosed with breast cancer and women attending screening. Encouraging women to see participation in breast screening as a moral obligation to others.
Add any other principles that are relevant to your particular breast screening context.
Table 3. Illustrations of how the decision-making tool might facilitate particular decisions and assist with public communication about the decision-making process.
Committee A considered that minimising overdiagnosis was a particularly important conceptualisation of the principle of minimising harm in relation to breast screening, and deserving of priority action. As such, it decided to make breast screening for average-risk women available only to those within the target age range, reducing overdiagnosis harms while maintaining screening related benefits.
Committee B considered that supporting autonomy, conceptualised as providing access to subsidised breast screening on demand, was more of a priority than reducing population harms of overdiagnosis. It decided to maintain, or even expand existing access to publically funded breast screening for women outside the target age range.
Committee C considered that delivering benefits, conceptualised as reducing the population breast cancer mortality rate, was of primary importance. It decided to endorse promotional campaigns for breast screening, and the provision of incentives for screening providers aimed at increasing the breast screening participation rate within the target population.
In contrast, Committee D considered that a significant conceptualisation of supporting autonomy was facilitating the process of women making a breast screening choice that fully reflected their personal views. It was concerned that breast screening providers were potentially conflicted by institutional goals around high participation rates and might present breast screening information to women incompletely or in such a way as to guide a woman towards participation, regardless of whether or not this matched her personal goals for her life. As such, this committee decided that information about breast screening should be as complete as possible, and delivered to all women by trained counsellors, in an independent organisation.
S0168-8510(17)30063-5 http://dx.doi.org/doi:10.1016/j.healthpol.2017.03.002 HEAP 3707
To appear in:
Health Policy
Received date: Revised date: Accepted date:
1-12-2016 12-2-2017 1-3-2017
Please cite this article as: Parker Lisa.Including values in evidence-based policy making for breast screening: an empirically grounded tool to assist expert decision makers.Health Policy http://dx.doi.org/10.1016/j.healthpol.2017.03.002 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Title Page Including values in evidence-based policy making for breast screening: an empirically grounded tool to assist expert decision makers
Lisa Parker Researcher Centre for Values, Ethics and the Law in Medicine (VELiM), Sydney School of Public Health, University of Sydney, NSW 2006, Australia. [email protected]
Highlights
Values are an important part of evidence-based policy decision making. Breast screening policy committee members hold a range of values. Widely differing values may be difficult to incorporate into policy decisions. A tool to assist breast screening policy makers by structuring values-based discussions is provided.
Abstract Values are an important part of evidence-based decision making for health policy: they guide the type of evidence that is collected, how it is interpreted, and how important the conclusions are considered to be. Experts in breast screening (including clinicians, researchers, consumer advocates and senior administrators) hold differing values in relation to what is important in breast screening policy and practice, and committees may find it difficult to incorporate the complexity and variety of values into policy decisions. The decision making tool provided here is intended to assist with this process. The tool is modified from more general frameworks that are intended to assist with ethical decision making in public health, and informed by data drawn from previous empirical studies on values amongst Australian breast screening experts. It provides a structured format for breast screening committees to consider and discuss the values of themselves and others, suggests relevant topics for further inquiry and highlights areas of need for future research into the values of the public. It enables committees to publicly explain and justify their decisions with reference to values, improving transparency and accountability. It is intended to act alongside practices that seek to accommodate the values of individual women in the informed decision making process for personal decision making about participation in breast screening. Keywords: Mass screening; Breast neoplasms; Mammography; Evidence-based medicine; Medical ethics; Health policy; Policy making; Social values
Introduction After several decades of organised breast screening, leading experts in the field continue to disagree about aspects of its policy and practice.[1-5] There is particularly strong debate about whether or not the benefits of breast screening outweigh the harms amongst certain population groups, and the level of information detail to provide for women. Reasons for disagreement are often attributed to disputes about the epidemiological evidence[6-11] or to conflicts of interest,[6, 12-14] and there have been calls to deliver better epidemiological education for experts,[11, 15] provide clearer communication of trial results,[14, 16, 17] and focus on independent analysis of quantitative data.[6, 12, 17, 18] Despite implementing at least some of these ideas, disputes continue: that is, even when capable, well-meaning experts agree about numbers they may still disagree about one or more aspect of breast screening.[2, 7, 12, 19] Thus it appears that epidemiological misunderstandings, epistemic differences and conflicts of interests may not entirely explain expert disagreement. In light of this, and recognising the self-evident concept that health policy decisions depend not only on analysis of epidemiological evidence but also on what is valued in relation to that evidence,[20-22] it seems likely that different values (views about what is right and wrong[23]) may be at least partly responsible for disagreements in relation to breast cancer screening.
There has been growing acceptance of the need to explicitly consider values in the process of evidence-based healthcare decision making. For example, the GRADE framework for producing evidence-based guidelines incorporates assessments of values regarding benefits and harms, in particular, the extent to which intervention outcomes are generally regarded as being desirable or undesirable. GRADE authors recommend that decision-making committees should use the perspective of patients when thinking about benefits and
harms,[24] and should be transparent about their estimates or assumptions regarding these typical patient values.[25, 26] The GRADE framework is widely endorsed, although the (limited) empirical evidence about its usability and effectiveness suggests there may be room for improvement.[27-30] This may be especially relevant to the field of public health, where value judgements about benefits and harms may be more complex, and where other relevant principles (such as supporting autonomy) might be prioritised by some.[31]
There is less endorsement of the idea that values held by informed experts are relevant and important to the policy decision-making process. Some writers have proposed that values of committee members have no role in decision making, arguing for a so-called “objective” interpretation of “raw evidence”,[32]p956 implying that this is possible, that it would yield a value-free view of breast screening, and would resolve disagreement. Others, including myself, contend that it is unrealistic and unhelpful to suggest that an expert’s personal values can be removed from decision making.[19, 21, 33] Evidence is vital in answering questions about breast screening policy and practice but evidence is not value-free. Values are inherent in the type of questions that are asked, the methods that are used to address those questions, the ways that results are interpreted and communicated, and the importance that is placed upon the conclusions.[34] Thus the collection and analysis of evidence is fundamentally driven by what is considered to be important, meaning that values, rather than “massed files of scientific evidence”[32]p310 lie at the heart of decision making.
Accepting that values are an integral part of evidence-informed policy making is an important first step; the next challenge is to think about how they might best be incorporated. Much of the literature that refers to values in the context of breast screening tends to concentrate on
selected dominant interpretations of what is important, often discussing the pros and cons of two apparently competing ethical principles (rules that guide moral action,[35]p124), such as ‘maximising benefit’ or ‘supporting autonomy’, conceptualised in a particular way.[36-38] [39] [40] (Conceptualisation of values refers to the way that a particular ethical principle is interpreted: for example, conceptualisation of what it means to respect a woman’s autonomy in this context might include one or more of: unfettered access to breast screening on demand; strong encouragement to attend breast screening in order to maximise a woman’s knowledge about her breast anatomy and pathology; detailed information about screening benefits and harms.[41])
Such head-on comparisons leave little space for decision makers and others to reach an understanding of how and why others think the way they do, or recognise points of agreement. In addition, my previous empirical work mapping the broad range of values in use amongst those who influence breast screening policy and practice [41] suggests that these “either/or” kinds of values-based policy discussion are too narrowly focused for a complex topic such as breast screening, as they fail to recognise the plurality of ways to conceptualise and prioritise ethical principles and thus ignore a multitude of potentially relevant ethical considerations. (Combining a particular conceptualisation and prioritisation of values delivers a view about what is considered to be most important in breast screening: for example one individual might focus on delivering benefit, conceptualised as high breast screening participation rates, while another might be particularly concerned about avoiding harm, conceptualised as reducing participation amongst those less likely to benefit from mammographic screening.) The impact of these simplified forms of values-based discussions is likely to be success for those with the loudest or most influential voice rather than
endorsement of what is most ethically correct, or to a stalemate position with experts unwilling to be persuaded of alternative points of view.
The rationale for this study was to facilitate values-based discussions amongst breast screening policy makers in a way that (1) would encourage decision makers to consider the broad range of relevant values and the wide variety of ways that values are conceptualised and prioritised, and (2) would enable committees to explain their decisions to the public using the language of values in order to facilitate transparency and accountability. Ultimately this will deliver breast screening policies and practices that are more ethically sound and appropriate for the given context and population group. The specific objective was to develop a concrete tool to assist decision makers discuss and incorporate values into evidence-based decision making for breast screening policies and practices. The tool provided here is intended as a preliminary draft, to provide some guidance and to stimulate further conversation in this arena. While the tool development was informed by empirical work, it has not yet been formally tested and there is scope for ongoing research in this area.
Methods The tool draws on existing frameworks that provide general guidance for ethical decision making in public health by listing the kinds of ethical principles that are likely to be relevant.[30, 42-44] The ethical framework model was modified by expanding out relevant abstract ethical principles into concrete values, and including a wide range of conceptualisations of each value. This was informed by the results of prior empirical qualitative research involving long interviews with 33 influential Australian breast screening experts including consumers, clinicians, researchers and adminstrative personnel, which
demonstrated the braod range of ways that values were conceptualised and prioritised amongst this group.[41] (Further detail on the methods for this empirical work are available in Appendix 1.) Commentary and questions about each value were drawn from extensive reading on the topic of ethics in breast cancer screening, undertaken as part of a larger project on cancer screening ethics in Australia.(cancerscreeningethics.org)
Results The study resulted in a tool to assist policy makers incorporate values into evidence-based breast screening decision making. (See Tables 1 and 2.) The tool is an empirically informed framework of relevant values that enables and prompts a deep and rich discussion about what is considered important in breast screening. It provides specific and detailed assistance to breast screening policy committees by providing a clear format for values-based discussions and enabling the committee to explain their decisions with reference to values.
The tool exists in the form of an incomplete table that guides committees through a structured conversation. Firstly, decision makers are invited to identify the ethical principles that are relevant to their particular breast screening context, and how these principles are conceptualised. Table 2 provides a list (drawn from the public health ethics and cancer screening ethics literature[41-44, 49, 53-57]) that can be used as a starting point. It is likely that committees will produce a range of conceptualisations for each principle; they are encouraged to draw from the popular and academic literature, as well as their own ideas,[41, 49, 50, 58] and may find the assistance of a professional ethicist useful.[59] Secondly, decision makers are directed to debate the different conceptualisations of principles, and, informed by evidence, to identify strengths and weaknesses of each. Finally, the tool
provides questions to encourage reflection and research about the extent to which each concept is important in the breast screening context. Table 2 provides selected examples of topics for debate, and questions for further research, more examples are provided in Appendix 2.
The tool does not proscribe any particular values or actions or provide a neat solution for all breast screening controversies. It does, however, act as a guide for how to discuss and identify important concepts in breast screening, and how to cohesively incorporate values alongside evidence in the decision-making process. As a result of using the tool, panel members will be able to explain and justify their decisions by referring to values.[60] Table 3 provides worked examples of how this could look.
Discussion This tool provides assistance for the incorporation of values into decision making for breast screening policies and practices in order to deliver decisions that appropriately reflect contemporary ethical values. [60-63] It is not intended to be the only possible method,[60] but it may be useful for those who seek structured guidance in this field. It is potentially suitable for use by decision-making committees at times of policy set-up, evaluation, and review, as well as during times of controversy and decisional conflict. Group deliberation on moral aspects of a given topic will arguably increase the likelihood that decision makers will identify a broader range of relevant viewpoints, and recognise possible biases in their own preliminary conclusions. The tool also aims to provide greater transparency in decision making, allowing for a fuller evaluation of decision-making processes and outcomes.[21] In addition, the process of discussing values regularly should provide more opportunity for
those involved in decision making to address any values-based conflict that emerges in the future.
Study limitations This study relied on data from previous research that was collected in the context of the Australian breast screening program, which may not be directly transferable to other regions. However the Australian breast screening program has similar purposes and practices to programs in the UK and many European countries: BreastScreen Australia offers free mammographic breast screening at two yearly intervals to all women from aged 40 years, with the target population aged 50-74 years.[64, 65] It is likely, therefore, that the results will be at least partly applicable to other regions. In addition, it is possible that the data used to flesh out the table may not have accommodated the entirety of relevant values, but there is ample space and opportunity for local policy committees to include additional values-based information and ideas.
Implications for practice In order to use this tool most effectively, decision makers are encouraged to: endorse the role of values in shaping healthcare policies and practices; expect, and be committed to discuss, a plurality of views;[6, 7, 19, 66, 67] and be prepared to publicly explain and justify the values that were most influential in guiding decisions. Experts who are reluctant or inexperienced in ethics discussion and self-reflection might find it useful to receive extra training and support in this area prior to the decision making process.[61, 62]
The tool requires that decision making bodies obtain and consider the values of the public when considering breast screening policy. (This does not preclude or negate the importance of seeking an individual woman’s values for the process of facilitating and supporting her informed decision about participation in breast screening.) The collective values of women and others are relevant to decisions about breast screening policies and practices, but the tool described here does not insist that public values necessarily drive policy in a direct manner: this may not be possible for cost reasons, and it may not be desirable - for example, the public may be ill-informed about the topic, or the values of the majority may fail to accommodate important minority interests.[53, 68] Nevertheless, the tool accommodates the values of the public in order to provide decision-making legitimacy, and because the public perspective provides additional, relevant information.[68-70]
There are several ways of seeking out public values. Consumer representation on decisionmaking committees is one widely used method, and individual consumers can often provide valuable insight derived from personal experience with breast cancer or breast screening. A limitation of this method is that individual representatives may not necessarily present a view that matches the ideas of the broader public.[68] For example, it may be that many people who participate as formal consumer representatives are also consumer advocates for a particular policy; for example, most consumer representatives in breast screening may be motivated by personal enthusiasm towards breast screening and therefore tend to present just one set of views about the program, which may not be shared by women more broadly.[41]
Another option is to garner the views of the public through direct polling or through more sophisticated discrete choice experiments.[71, 72] While these may be useful, they might not
be well suited to this context: breast screening is a complex topic and not always accurately presented in the media or other information sources commonly used by the public, which are subject to possible vested interests of corporations.[73, 74] Thus, people’s existing views about breast screening may not necessarily derive from a balanced picture of the available evidence[73-75] or accurately reflect their values.[49] Polling or discrete choice experiments may not allow sufficient opportunity for citizens to fully realise and ponder the complexities of the topic.
An alternative approach to gaining the views of the public is via deliberative democratic methods, something that has been gaining increasing attention in recent years. This involves working with a small, diverse group of people from the community, providing them with relevant information and education, creating opportunities for discussion between experts, researchers and citizens, and then seeking the (informed) opinions of citizens. Several types of deliberative techniques have been developed; citizens’ juries are one of the more popular methods[76] and have been convened to consider controversial topics in screening including breast screening.[77, 78] While such an approach can be expensive, and its usefulness is somewhat dependent on the skill of the convenors, it can provide a public consensus and reasoning with relatively greater legitimacy compared to other methods, as the people involved have had more opportunity to discuss and understand relevant technical and ethical details.[14, 76, 77]
Further research Evaluation is an important pre-requisite to wider implementation of the tool. This discussion paper is a preliminary step in that process. The next phase might be to use qualitative
methods to obtain feedback about the tool from members of decision-making committees, with particular attention to acceptability and functionality. This could be followed by empirical testing of outcomes from incorporating the tool into decision making processes, assessing parameters such as its effect on committee members’ understandings of the ways in which relevant ethical values are conceptualised by others; and its impact on communications to the public about values and their role in policy decisions.
Conclusions Breast screening is a major public health intervention practiced throughout much of the developed world but disputes over contested areas of breast screening continue to feature regularly in the academic literature, frequently involving respected experts with strongly opposing views. Conflicts spill over into the public domain, involving politicians and the media, leaving many consumers angry and confused. Given that some of the disagreement appears to result from differences in values, values-based discussions are likely to be an important part of the solution. Experts involved in evidence-based decision making for breast screening might find it useful to use a structured tool to guide these kinds of discussions, and to facilitate the justification of their decisions using the language of values. Reflection and discussion about values will assist decision makers to address values-based conflict and to develop ethically sound breast screening for the future.
Funding: This work was supported by the National Health and Medical Research Council of Australia [grant numbers 1038517 & 1023197].
Conflicts of interest: none
Acknowledgements: I thank Stacy Carter and Lucie Rychetnik for their support and guidance with the research that this paper builds upon, and am particularly grateful to SC for assistance with earlier drafts of this manuscript. I also thank Lisa Bero for assistance with information about GRADE and Angus Dawson for conceptual assistance regarding values in public health decision making.
References 1. Marmot MG. Sorting through the arguments on breast screening. JAMA 2013;309(24):2553-4. 2. Quanstrum K, Hawyard R. Lessons from the mammography wars. N Engl J Med 2010;363:1076-1077. 3. Duffy SW. Breast cancer screening causes more harm than good: No. J Prim Health Care 2014;6(1):81-2. 4. Heath I. Breast cancer screening causes more harm than good: Yes. J Prim Health Care 2014;6(1):79-80. 5. Roder DM, Olver IN. Do the benefits of screening mammography outweigh the harms of overdiagnosis and unnecessary treatment?--yes. Med J Aust 2012;196(1):16. 6. Plutynski A. Ethical issues in cancer screening and prevention. J Med Philos 2012;37(3):310-23. 7. Harris R, Sawaya GF, Moyer VA, Calonge N. Reconsidering the criteria for evaluating proposed screening programs: reflections from 4 current and former members of the U.S. Preventive services task force. Epidemiol Rev 2011;33:20-35. 8. Flitcroft K, Gillespie J, Carter S, Salkeld G, Trevena L. Incorporating evidence and politics in health policy: can institutionalising evidence review make a difference? Evid Policy 2013;10(3):439-455. 9. Panagiotou OA, Ioannidis JP. Primary study authors of significant studies are more likely to believe that a strong association exists in a heterogeneous meta-analysis compared with methodologists. J Clin Epidemiol 2012;65(7):740-7. 10. Young SN. Bias in the research literature and conflict of interest: an issue for publishers, editors, reviewers and authors, and it is not just about the money. J Psychiatry Neurosci 2009;34(6):412-7. 11. Esserman LJ, Thompson IM, Reid B, Nelson P, Ransohoff DF, Welch HG, et al. Addressing overdiagnosis and overtreatment in cancer: a prescription for change. Lancet Oncol 2014;15(6):e234-42. 12. Autier P, Esserman L, Flowers C, Houssami N. Breast cancer screening: the questions answered. Nat Rev Clin Oncol 2012;9(10):599-605.
13. Bewley S. The NHS breast screening programme needs independent review. BMJ 2011;343:d6894. 14. Harris RP, Wilt TJ, Qaseem A. A value framework for cancer screening: advice for high-value care from the American College of Physicians. Ann Intern Med 2015;162(10):712-7. 15. Gigerenzer G, Edwards A. Simple tools for understanding risk: from innumeracy to insight. BMJ 2003;327(7417):741-4. 16. Fletcher SW. Breast Cancer Screening: A 35-year perspective. Epidemiologic Reviews 2011;33(1):165-175. 17. McPherson K. Screening for breast cancer: balancing the debate. BMJ 2010;340:233235. 18. Richards M. An independent review is under way. BMJ 2011;343:d6843. 19. Greenhalgh T, Russell J. Evidence-based policymaking: a critique. Perspect Biol Med 2009;52(2):304-18. 20. Eddy DM. Clinical decision making: from theory to practice. Anatomy of a decision. JAMA 1990;263(3):441-3. 21. Nicholls SG, Newson AJ, Ashcroft RE. The need for ethics as well as evidence in evidence-based medicine. J Clin Epidemiol 2016. 22. DeJean D, Giacomini M, Simeonov D, Smith A. Finding qualitative research evidence for health technology assessment. Qualitative Health Research 2016:1049732316644429. 23. Rachels J, Rachels S. The elements of moral philosophy. 6th ed. Boston: McGraw Hill; 2010. 24. Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol 2011;64(4):395-400. 25. Andrews J, Guyatt G, Oxman AD, Alderson P, Dahm P, Falck-Ytter Y, et al. GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations. J Clin Epidemiol 2013;66(7):719-25. 26. Andrews JC, Schunemann HJ, Oxman AD, Pottie K, Meerpohl JJ, Coello PA, et al. GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength. J Clin Epidemiol 2013;66(7):726-35. 27. Kavanagh BP. The GRADE system for rating clinical guidelines. PLoS Med 2009;6(9):e1000094. 28. Alexander PE, Gionfriddo MR, Li SA, Bero L, Stoltzfus RJ, Neumann I, et al. A number of factors explain why WHO guideline developers make strong recommendations inconsistent with GRADE guidance. J Clin Epidemiol 2016;70:111-22. 29. Hartling L, Fernandes RM, Seida J, Vandermeer B, Dryden DM. From the trenches: a cross-sectional study applying the GRADE tool in systematic reviews of healthcare interventions. PLoS One 2012;7(4):e34697. 30. Schopper D, Dawson A, Upshur R, Ahmad A, Jesani A, Ravinetto R, et al. Innovations in research ethics governance in humanitarian settings. BMC Med Ethics 2015;16:10. 31. Rehfuess EA, Akl EA. Current experience with applying the GRADE approach to public health interventions: an empirical study. BMC Public Health 2013;13:9. 32. Mayor S. Row over breast cancer screening shows that scientists bring "some subjectivity" into their work. BMJ 2001;323(7319):956.
33. Willis K. Row over breast cancer screening shows that scientists bring "some subjectivity" into their work. Rapid response: Agreeement is "objective"; disagreement is "subjective". BMJ 2001;323(956). 34. Kelly MP, Heath I, Howick J, Greenhalgh T. The importance of values in evidencebased medicine. BMC Med Ethics 2015;16(1):69. 35. Kerridge I, Lowe M, Stewart C. Ethics and law for the health professions. 4th ed. Annandale: The Federation Press; 2013. 36. Irwig L, McCaffery K, Salkeld G, Bossuyt P. Screening and choice - Informed choice for screening: implications for evaluation. BMJ 2006;332(7550):1148-1150. 37. Hersch J, Jansen J, Irwig L, Barratt A, Thornton H, Howard K, et al. How do we achieve informed choice for women considering breast screening? Prev Med 2011;53(3):1446. 38. Austoker J. Gaining informed consent for screening. Is difficult--but many misconceptions need to be undone. BMJ 1999;319(7212):722-3. 39. Keating NL, Pace LE. New Guidelines for Breast Cancer Screening in US Women. JAMA 2015;314(15):1569-71. 40. Raffle AE. Information about screening - is it to achieve high uptake or to ensure informed choice? Health Expect 2001;4(2):92-8. 41. Parker L, Rychetnik L, Carter S. Values in breast cancer screening: an empirical study with Australian experts. BMJ Open 2015;5(5):e006333. 42. Kass NE. An ethics framework for public health. Am J Public Health 2001;91(11):1776-82. 43. Childress JF, Faden RR, Gaare RD, Gostin LO, Kahn J, Bonnie RJ, et al. Public health ethics: Mapping the terrain. Journal of Law Medicine and Ethics 2002;30(2):170-178. 44. Upshur REG. Principles for the justification of public health intervention. Canadian Journal of Public Health 2002;93(2):101-103. 45. Baum M. Harms from breast cancer screening outweigh benefits if death caused by treatment is included. BMJ 2013;346:f385. 46. Welch HG. Overdiagnosed: making people sick in the pursuit of health. Boston: Beacon Press; 2011. 47. Jorgensen KJ, Gotzsche PC. Overdiagnosis in publicly organised mammography screening programmes: systematic review of incidence trends. BMJ 2009;339:b2587. 48. Dixon JM. Breast screening has increased the number of mastectomies. Breast Cancer Res 2009;11 Suppl 3:S19. 49. Parker LM, Carter S. Social and ethical considerations in breast cancer screening. In: Houssami N, Miglioretti DL, editors. Breast cancer screening: an examination of scientific evidence. London: Academic Press Inc; 2016. 50. Parker LM, Rychetnik L, Carter S. Framing overdiagnosis in breast screening: a qualitative study with Australian experts. BMC Cancer 2015;15:606. 51. Moutel G, Duchange N, Darquy S, de Montgolfier S, Papin-Lefebvre F, Jullian O, et al. Women's participation in breast cancer screening in France--an ethical approach. BMC Med Ethics 2014;15:64. 52. Torgerson DJ, Donaldson C. An economic view of high compliance as a screening objective. BMJ 1994;308(6921):117-9. 53. Juth N, Munthe C. The ethics of screening in health care and medicine: serving society or serving the patient? Dordrecht: Springer; 2012.
54. Dawson A, Jennings B. The place of solidarity in public health ethics. Public Health Reviews 2012;34(1):65-79. 55. University of Toronto Joint Centre for Bioethics Pandemic Ethics Working Group. Stand on guard for thee: ethical considerations in preparedness planning for pandemic influenza. Toronto: University of Toronto Joint Centre for Bioethics; 2005. 56. Verweij M. The prevention paradox and tensions between private and public interests. In: Verweij M, editor. Preventive medicine between obligation and aspiration. Dordrecht: Kluwer Academic Publishers; 2000. p. 51-67. 57. Viens AM. Public health, ethical behavior and reciprocity. Am J Bioeth 2008;8(5):13. 58. Parker LM, Rychetnik L, Carter S. The role of communication in breast cancer screening: a qualitative study with Australian experts. BMC Cancer 2015;15(741). 59. Behrmann J. Bioethics in health policy development: a primer for decision-makers. BioéthiqueOnline 2012;1/8. 60. Grill K, Dawson A. Ethical Frameworks in Public Health Decision-Making: Defending a Value-Based and Pluralist Approach. Health Care Anal 2015. 61. Cribb A, Haran D. The benefits and ethics of screening for breast cancer. Public Health 1991;105(1):63-7. 62. Daniels N. Reflective equilibrium. In: Zalta E, editor. The Stanford encyclopedia of philosophy. 2013 Winter [cited 2016 January 16] ed. 63. Willison DJ, Ondrusek N, Dawson A, Emerson C, Ferris LE, Saginur R, et al. What makes public health studies ethical? Dissolving the boundary between research and practice. BMC Med Ethics 2014;15:61. 64. Giordano L, von Karsa L, Tomatis M, Majek O, de Wolf C, Lancucki L, et al. Mammographic screening programmes in Europe: organization, coverage and participation. J Med Screen 2012;19 Suppl 1:72-82. 65. BreastScreen Australia. In. Australia:: Department of Health, Australian Government. 66. Eddy DM. Clinical decision making: from theory to practice. Practice policies --what are they? JAMA 1990;263(6):877-8, 880. 67. Ransohoff DF, Harris RP. Lessons from the mammography screening controversy: can we improve the debate? Ann Intern Med 1997;127(11):1029-34. 68. Irvin R, Stansbury J. Citizen participation in decision making: is it worth the effort? Public Administration Review 2004;64(1):55-65. 69. Abelson J, Forest P, Eyles J, Smith P, Martin E, Gauvin F. Obtaining public input for health systems decision making: past experiences and future prospects. Canadian Public Administration 2002;45(1):70-97. 70. Bruni RA, Laupacis A, Martin DK, University of Toronto Priority Setting in Health Care Research G. Public engagement in setting priorities in health care. CMAJ 2008;179(1):15-8. 71. Ryan M. Discrete choice experiments in health care. BMJ 2004;328(7436):360-1. 72. Sculpher M, Bryan S, Fry P, de Winter P, Payne H, Emberton M. Patients' preferences for the management of non-metastatic prostate cancer: discrete choice experiment. BMJ 2004;328(7436):382. 73. Jones SC, Rossiter JR. Breast cancer detection messages in Australian print media advertising - are they promoting correct information? In: 31st European marketing academy conference. Braga, Portugal. ; 2002.
74. Kaufert PA. Women and the debate over mammography: an economic, political and moral history. In: Sargent CF, Brettell CB, editors. Gender and Health: an international perspective. New Jersey: Simon & Schuster; 1996. p. 167-186. 75. King S. Pink ribbons, inc. Breast cancer and the politics of philanthropy. Minneapolis: University of Minnesota Press; 2006. 76. Degeling C, Carter SM, Rychetnik L. Which public and why deliberate?--A scoping review of public deliberation in public health and health policy research. Soc Sci Med 2015;131:114-21. 77. Rychetnik L, Carter SM, Abelson J, Thornton H, Barratt A, Entwistle VA, et al. Enhancing citizen engagement in cancer screening through deliberative democracy. J Natl Cancer Inst 2013;105(6):380-6. 78. Paul C, Nicholls R, Priest P, McGee R. Making policy decisions about population screening for breast cancer: the role of citizens' deliberation. Health Policy 2008;85(3):31420. 79. Cribb A. Why ethics? What kind of ethics for public health? In: Peckam S, Hann A, editors. Public health ethics and practice. Bristol: The Policy Press; 2010. p. 17-32.
Table 1. Decision-making tool explanation and instructions for use. The decision-making tool consists of a tabled list of ethical principles that are relevant to breast screening policy and practice. Column One lists a range of conceptualisations for each principle. Subsidiary information in Columns Two and Three provide commentaries and questions for further research. Instructions for use:
Look at the list of principles (maximising health benefits; minimising harms; delivering more benefits than harms; maintaining cost-efficiency; supporting autonomy; distributing benefits and harms justly; communicating honestly; making policy with a transparent process; upholding reciprocal obligations to the public; facilitating connections between community members). Add any other principles that are relevant to your particular breast screening context.
Read the list of conceptualisations for each principle (Column One). Discuss which one or more is used by each member of the group uses, and which are used by others, including consumers and citizens. Add any other relevant conceptualisations that are not provided.
Using the notes in Column Two as a guide, consider the strengths and weaknesses of each conceptualisation (e.g. what a given conceptualisation might miss; whether or not there are inconsistencies or inaccuracies in a given conceptualisation.) Discuss which conceptualisations the group wishes to endorse most strongly and why. If a widely held conceptualisation is held to be inadequate or problematic in some way, consider engaging in wider public debate and discussion about this.
Using the questions in Column Three as a guide, write a list of topics that require further research and/or discussion in order to determine the relevance and importance of each concept for the current breast screening context. Obtaining answers to these questions should assist the group in making ethically justified decisions about breast screening policy and practice.
Table 2. Framework tool to guide decision making in breast screening policy and practice. (Selected examples are provided in this table; more examples are provided in Appendix 2.) RELEVANT PRINCIPLES and range of conceptualisations for each relevant principle
Notes on strengths or weaknesses of a given conceptualisation
MAXIMISING HEALTH BENEFITS Reducing population mortality rate It may be unreasonable to expect to obtain from breast cancer and/or all causes. evidence of all-cause mortality reduction associated with breast cancer screening because of the large numbers of research participants that would be required. A disease-specific (i.e. breast cancer) mortality rate is more amenable to empirical study than an all-cause mortality rate although may not provide a complete picture: i.e. may miss mortality implications of overdiagnosis.[45] Reducing population breast cancer Any apparent reduction in treatmentmorbidity by enabling less aggressive related morbidity as a result of breast breast cancer treatment for individuals. screening may be offset by the increased morbidity associated with overdiagnosis.[46-48] Providing relief from breast cancer This apparent benefit may be artificial: related anxiety. reduced anxiety after a negative screen may partly derive from previously inflated anxiety due to screening promotion.[49]
Improving the overall health of the entire population.
While the availability of breast screening might offer benefits to a population, it also: delivers harms; is an expensive program with high opportunity costs; and arguably fails to address the main health needs of those with the poorest health outcomes.[41, 50]
Questions (& evidence) to consider when debating the relative importance of each concept
How much, and what kind of health benefit accrues from breast screening, and how certain is the evidence about this? To what extent is anxiety about breast cancer inflated by a breast screening program and related promotional activities? To what extent do efforts to maximise the health benefits of breast screening impinge on other relevant values, e.g. by delivering
RELEVANT PRINCIPLES and range of conceptualisations for each relevant principle
Notes on strengths or weaknesses of a given conceptualisation
Questions (& evidence) to consider when debating the relative importance of each concept harms, consuming financial resources, maintaining or increasing health inequalities?
MINIMISING HARMS Monitoring and/or ensuring a low occurrence rate in one or more of the Examples for the remaining principles are provided in following outcomes: overdiagnosis; Appendix 2 overtreatment; false positive test; false negative test; radiation damage; personal financial burden. Avoiding an excessive increase in societal and/or individual anxiety about breast cancer suffering and death. Avoiding an excessive burden of decision making for women in regard to the consideration of breast screening participation. Paying close attention to quality control in breast screening services DELIVERING MORE BENEFITS THAN HARMS Ensuring that breast screening reflects experts’ considered decisions on how to design the program so that resulting population health benefits outweigh population harms. Ensuring that women make an informed choice about breast screening participation, incorporating their personal views on benefits and harms. Ensuring, and regularly reassessing whether or not breast screening is, overall, in the public interest. MAINTAINING COST-EFFICIENCY Ensuring that the financial cost of avoiding one breast cancer death is comparable to the cost of other similarly effective healthcare interventions.
RELEVANT PRINCIPLES and range of conceptualisations for each relevant principle
Notes on strengths or weaknesses of a given conceptualisation
Maintaining a minimum breast screening participation rate of around 70% in order to deliver benefits in a cost-effective manner.[51,52] Minimising administrative inefficiencies associated with the breast screening program. RESPECTING, SUPPORTING OR ENHANCING AUTONOMY Ensuring that women are not coerced into participating in breast screening. Providing relevant information and opportunities for women to make an informed choice about participating in breast screening (including informing about harms). Increasing available options for effective treatment (by providing the opportunity to access less aggressive, earlier treatment) Providing ready access to breast screening for all women, including those younger and older than the target age range. DISTRIBUTING BENEFITS AND HARMS IN A JUST MANNER Ensuring that all women in the target screening population have an equal opportunity to be informed about, and participate in, breast screening.. Having an even distribution of breast screening participation rates across the population. Facilitating an even distribution of breast cancer mortality, or overall health, across the population. COMMUNICATING HONESTLY Providing relevant information about the harms of breast screening to consumers and the general public. Using independent experts to provide information to women to assist them in making an informed choice about breast screening participation.
Questions (& evidence) to consider when debating the relative importance of each concept
RELEVANT PRINCIPLES and range of conceptualisations for each relevant principle
Notes on strengths or weaknesses of a given conceptualisation
Questions (& evidence) to consider when debating the relative importance of each concept MAKING POLICY DECISIONS WITH A FAIR, HONEST, AND TRANSPARENT PROCESS Using independent experts to review the evidence and/or make policy decisions. Ensuring that policy decision-makers disclose any conflicts of interest. Ensuring that all relevant stakeholders, including clinical experts, have an opportunity to participate in decisions about breast screening policy. Publicly disclosing the values used to guide breast screening policy and practice; possibly involving the public to decide on these values. UPHOLDING RECIPROCAL OBLIGATIONS (OF GOVERNMENT & PUBLIC HEALTH PROVIDERS TO THE PUBLIC) Maintaining efforts to measure and reduce population burdens, harms and costs associated with breast screening. Considering other, less burdensome and/or less expensive ways to reduce population breast cancer mortality and morbidity. Supporting those who are most burdened by breast screening (e.g. those likely to have been overdiagnosed). RESPECTING AND FACILITATING CONNECTIONS BETWEEN COMMUNITY MEMBERS Including considerations of community interests when making decisions about breast screening policy and practice. Ensuring similar healthcare access and support exists for women diagnosed with breast cancer and women attending screening. Encouraging women to see participation in breast screening as a moral obligation to others.
Add any other principles that are relevant to your particular breast screening context.
Table 3. Illustrations of how the decision-making tool might facilitate particular decisions and assist with public communication about the decision-making process.
Committee A considered that minimising overdiagnosis was a particularly important conceptualisation of the principle of minimising harm in relation to breast screening, and deserving of priority action. As such, it decided to make breast screening for average-risk women available only to those within the target age range, reducing overdiagnosis harms while maintaining screening related benefits.
Committee B considered that supporting autonomy, conceptualised as providing access to subsidised breast screening on demand, was more of a priority than reducing population harms of overdiagnosis. It decided to maintain, or even expand existing access to publically funded breast screening for women outside the target age range.
Committee C considered that delivering benefits, conceptualised as reducing the population breast cancer mortality rate, was of primary importance. It decided to endorse promotional campaigns for breast screening, and the provision of incentives for screening providers aimed at increasing the breast screening participation rate within the target population.
In contrast, Committee D considered that a significant conceptualisation of supporting autonomy was facilitating the process of women making a breast screening choice that fully reflected their personal views. It was concerned that breast screening providers were potentially conflicted by institutional goals around high participation rates and might present breast screening information to women incompletely or in such a way as to guide a woman towards participation, regardless of whether or not this matched her personal goals for her life. As such, this committee decided that information about breast screening should be as complete as possible, and delivered to all women by trained counsellors, in an independent organisation.