A systematic review of risk communication in clinical trials: How does it influence decisions to participate and what are the best methods to improve understanding in a trial context?

Maeve Coyle, Katie Gillies, Maeve Coyle, Katie Gillies

Abstract

Background: Effective risk communication is challenging. Ensuring potential trial participants' understand 'risk' information presented to them is a key aspect of the informed consent process within clinical trials, yet minimal research has looked specifically at how to communicate probabilities to support decisions about trial participation. This study reports a systematic review of the literature focusing on presentation of probabilistic information or understanding of risk by potential trial participants.

Methods: A search strategy for risk communication in clinical trials was designed and informed by systematic reviews of risk communication in treatment and screening contexts and supplemented with trial participation terms. Extracted data included study characteristics and the main interventions/findings of each study. Explanatory studies that investigated the methods for presenting probabilistic information within participant information leaflets for a clinical trial were included, as were interventions that focused on optimising understanding of probabilistic information within the context of a clinical trial.

Results: The search strategy identified a total of 4931 studies. Nineteen papers were selected for full text screening, and seven studies included. All reported results from risk communication studies that aimed to support potential trial participants' decision making set within hypothetical trials. Five of these were randomised comparisons of risk communication interventions, and two were prospectively designed, non-randomised studies. Study interventions focused on probability presentation, risk framing and risk interpretation with a wide variety of interventions being evaluated and considerable heterogeneity in terms of outcomes assessed. Studies show conflicting findings when it comes to how best to present information, although numerical, particularly frequency formats and some visual aids appear to have promise.

Conclusions: The evidence base surrounding risk communication in clinical trials indicates that there is as yet no clear optimal method for improving participant understanding, or clear consensus on how it affects their willingness to participate. Further research into risk communication within trials is needed to help illuminate the mechanisms underlying risk perception and understanding and provide appropriate ways to present and communicate risk in a trial context so as to further promote informed choices about participation. A key focus for future research should be to investigate the potential for learning in the evidence on risk communication from treatment and screening decisions when applied to decisions about trial participation.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. The PRIMSA diagram details our…
Fig 1. The PRIMSA diagram details our search and selection process applied during the literature review.

References

    1. Hansson S. (2014). Why and for what are clinical trials the gold standard? Scandinavian Journal of Public Health, 42(13_suppl), pp.41–48. 10.1177/1403494813516712
    1. Nishimura A., Carey J., Erwin P., Tilburt J., Murad M. and McCormick J. (2013). Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Medical Ethics, 14(1). 10.1186/1472-6939-14-28
    1. —Last accessed 10/07/19
    1. —Last accessed 10/07/19
    1. Lipkus I. (2007). Numeric, verbal, and visual formats of conveying health risks: suggested best practices and future recommendations. Medical Decision Making, 27(5), pp.696–713. 10.1177/0272989X07307271
    1. Edwards A. and Elwyn G. (2001). Understanding risk and lessons for clinical risk communication about treatment preferences. Quality and Safety in Health Care, 10(Supplement 1), pp.i9–i13. 10.1136/qhc.0100009
    1. Anderson E. and Iltis A. (2008). Assessing and improving research participants’ understanding of risk: potential lessons from the literature on physician-patient risk communication. Journal of Empirical Research on Human Research Ethics, 3(3), pp.27–37. 10.1525/jer.2008.3.3.27
    1. Infanti J., Sixsmith J., Barry M., Núñez-Córdoba J., Oroviogoicoechea-Ortega C. and Guillén-Grima F. (2013). A literature review on effective risk communication for the prevention and control of communicable diseases in Europe. Stockholm: ECDC.
    1. Ahmed H., Naik G., Willoughby H. and Edwards A. (2012). Communicating risk. BMJ, 344(jun18 1), pp.e3996–e3996.
    1. Naik G., Ahmed H. and Edwards A. (2012). Communicating risk to patients and the public. British Journal of General Practice, 62(597), pp.213–216 10.3399/bjgp12X636236
    1. Dowding D. (2018). Review: personalised risk communication may improve uptake of screening tests more than general risk communication.
    1. Spiegelhalter D., Pearson M. and Short I. (2011). Visualizing uncertainty about the future. Science, 333(6048), pp.1393–1400. 10.1126/science.1191181
    1. McCann S., Campbell M. and Entwistle V. (2010). Reasons for participating in randomised controlled trials: conditional altruism and considerations for self. Trials, 11(1).
    1. Linden H., Reisch L., Hart A., Harrington M., Nakano C., Jackson J. et al. (2007). Attitudes toward participation in breast cancer randomized clinical trials in the african american community. Cancer Nursing, 30(4), pp.261–269. 10.1097/01.NCC.0000281732.02738.31
    1. Tooher R., Middleton P. and Crowther C. (2008). A thematic analysis of factors influencing recruitment to maternal and perinatal trials. BMC Pregnancy and Childbirth, 8(1). 10.1186/1471-2393-8-36
    1. Kenyon S., Dixon-Woods M., Jackson C., Windridge K. and Pitchforth E. (2006). Participating in a trial in a critical situation: a qualitative study in pregnancy. Quality and Safety in Health Care, 15(2), pp.98–101. 10.1136/qshc.2005.015636
    1. Gillies K., Huang W., Skea Z., Brehaut J. and Cotton S. (2014). Patient information leaflets (PILs) for UK randomised controlled trials: a feasibility study exploring whether they contain information to support decision making about trial participation. Trials, 15(1), p.62 10.1186/1745-6215-15-62
    1. Gillies K., Skea Z. and Campbell M. (2014). Decision aids for randomised controlled trials: a qualitative exploration of stakeholders’ views. BMJ Open, 4(8), pp.e005734–e005734. 10.1136/bmjopen-2014-005734
    1. Juraskova I., Butow P., Lopez A., Seccombe M., Coates A., Boyle F., et al. (2008). Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS). Health Expectations, 11(3), pp.252–262. 10.1111/j.1369-7625.2008.00498.x
    1. Fagerlin A., Zikmund-Fisher B. and Ubel P. (2011). Helping patients decide: ten steps to better risk communication. JNCI Journal of the National Cancer Institute, 103(19), pp.1436–1443. 10.1093/jnci/djr318
    1. Rowlands C, Rooshenas L, Fairhurst K, Rees J, Gamble C, Blazeby J. Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital. BMJ Open. 2018; 8(2): e018581 10.1136/bmjopen-2017-018581
    1. Berry DC & Hochhauser M. Verbal labels can triple perceived risk in clinical trials. Drug Info Journ. 2006. 40:249–258.
    1. Cheung YB, Wee HL, Thumboo J, Goh C, Pietrobon R, Toh HC, et al. Risk communication in clinical trials: A cognitive experiment and survey. BMC Medical Informatics and Decision Making 2010, 10:55 10.1186/1472-6947-10-55
    1. Kim syh, Wilson R, De Vries R, Kim HM, Holloway RG, Kieburtz K. ‘It is not guaranteed that you will benefit: True but misleading? Clin Trials. 2015. 12 (4): 424–431. 10.1177/1740774515585120
    1. Schwartz A and Hasnain M. Risk perception and risk attitude in informed consent. Risk Decision and Policy. 2002. 7:121–130.
    1. Tait AR, Zikmund-Fisher B, Fagerlin A, Vopel-Lewis T. Effect of various risk/benefit trade-offs on parents’ understanding of a paediatric research study. Paediatrics. 2010. 125(6). e1475 10.1542/peds.2009-1796
    1. Treschan TA, Scheck T, Kober A, Fleischmann E, Birkenberg B, Petschnigg B, et al. The influence of protocol pain and risk on patients’ willingness to consent for clinical studies: a randomised trial. Anesth Analg. 2003. 96:498–506. 10.1097/00000539-200302000-00037
    1. Sutherland HJ, Lockwood GA, Till JE. Are we getting informed consent from patients with cancer? Journal Royal Soc Med. 1990. 83 439
    1. Trevena L., Barratt A., Butow P. and Caldwell P. (2006). A systematic review on communicating with patients about evidence. Journal of Evaluation in Clinical Practice, 12(1), pp.13–23. 10.1111/j.1365-2753.2005.00596.x
    1. Garcia-Retamero R., Galesic M. and Gigerenzer G. (2010). Do icon arrays help reduce denominator neglect?. Medical Decision Making, 30(6), pp.672–684. 10.1177/0272989X10369000
    1. Price M., Cameron R. and Butow P. (2007). Communicating risk information: the influence of graphical display format on quantitative information perception—accuracy, comprehension and preferences. Patient Education and Counseling, 69(1–3), pp.121–128. 10.1016/j.pec.2007.08.006
    1. Gigerenzer G. (2003). Reckoning with risk Learning to live with uncertainty. London: Penguin Books.
    1. Refractor (2001). Uncertainty. The Lancet, 358(9298), p.2090.
    1. Canvin K. and Jacoby A. (2006). Duty, desire or indifference? A qualitative study of patient decisions about recruitment to an epilepsy treatment trial. Trials, 7(1). 10.1186/1745-6215-7-32
    1. Tversky A. and Kahneman D. (1981). The framing of decisions and the psychology of choice. Science, 211(4481), pp.453–458. 10.1126/science.7455683
    1. Abhyankar P., Summers B., Velikova G. and Bekker H. (2014). Framing options as choice or opportunity: Does the frame influence decisions?. Medical Decision Making, 34(5), pp.567–582. 10.1177/0272989X14529624
    1. Stead M. (2005). "Hello, hello—it’s English I speak!": a qualitative exploration of patients’ understanding of the science of clinical trials. Journal of Medical Ethics, 31(11), pp.664–669. 10.1136/jme.2004.011064
    1. Siminoff L. (2003). Toward improving the informed consent process in research with humans. IRB: Ethics and Human Research, Suppl 25(5),: S1–S3
    1. Kent G. (1996). Shared understandings for informed consent: The relevance of psychological research on the provision of information. Social Science & Medicine, 43(10), pp.1517–1523. 10.1016/0277-9536(96)00173-6
    1. Zipkin DA, Umscheid CA, Keating N, Allen E, Aung K, Bevth R, et al. (2014) Evidence-Based Risk Communication: A Systematic Review: Annals of Internal Medicine: Vol 161, No 4 10.7326/M14-0295
    1. Elwyn G, O’Connor A, Stacey D, et al. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ 2006;333:417 10.1136/
    1. Trevena L., Zikmund-Fisher BJ., Edwards A., Gaissmaier W., Galessic M., Han PKJ., et al. (2013). Presenting quantitative information about decision outcomes: a risk communication primer for patient decision aid developers. BMC Medical Informatics and Decision Making, 13 (S7) 10.1186/1472-6947-13-S2-S7
    1. Oxman AD, Glenton C, Flottorp S, et al. Development of a checklist for people communicating evidence-based information about the effects of healthcare interventions: a mixed methods study BMJ Open 2020;10:e036348 10.1136/bmjopen-2019-036348

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir