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The Effect of Positively Framing Side-Effect Risk in Two Different Formats on Side-Effect Expectations, Informed Consent and Credibility: A Randomised Trial of 16- to 75-Year-Olds in England

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Abstract

Introduction

Reframing side-effect information in patient information leaflets (PILs) in terms of those who remain side-effect–free may reduce negative expectations and side-effects, although there are concerns this may impact informed consent. This study compared two versions of positively framed PILs with current practice to see which reduces side-effect expectations whilst maintaining informed consent and credibility.

Methods

We commissioned Ipsos MORI to conduct an online survey of 16- to 75-year-olds in England. 1067 people completed the study and were randomised to receive a PIL for a hypothetical new antibiotic that either communicated side-effects following current practice (n = 356), used positive framing with natural frequencies (n = 356), or positive framing with percentages (n = 355). After reading the leaflet, participants completed measures of their side-effect expectations, absolute risk perceptions, and satisfaction and credibility of the leaflet.

Results

Both positively framed PILs resulted in significantly lower side-effect expectations compared with the current PIL for all side-effects (ps < 0.001), apart from seizure. Pairwise comparisons showed no difference in side-effect expectations between the two positively framed PILs (ps > 0.626). The positively framed PIL using natural frequencies produced more accurate risk perceptions than the same leaflet using percentages; but performed equally to the current PIL. There was no difference between the leaflets in terms of satisfaction with or credibility of the PILs.

Conclusion

Positively framed PILs using natural frequencies significantly reduced side-effect expectations and provided the most accurate risk perceptions without impacting satisfaction or credibility. Replication is needed with patients prescribed new medication and those with lower educational status.

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Acknowledgements

We would like to thank the study participants for their time in completing this survey, and Penny and team from Ipsos MORI for carrying out the data collection. Ipsos MORI was responsible for the fieldwork and data collection only and not responsible for the questionnaire design, analysis, reporting or interpretation of the survey results.

Funding

This research was funded by the BA/Leverhulme Small research grants scheme awarded to Dr Rebecca Webster (SRG19\190568), derived from the Academy’s partnership with the Department for Business, Energy and Industrial Strategy. Dr G. James Rubin is affiliated to the National Institute for Health Research Health Protection Research Unit (NIHR HPRU) in Emergency Preparedness and Response at King’s College London in partnership with Public Health England (PHE), in collaboration with the University of East Anglia and Newcastle University. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, the Department of Health and Social Care or Public Health England.

Author information

Authors and Affiliations

  1. Department of Psychology, University of Sheffield, Cathedral Court, 1 Vicar Lane, Sheffield, UK

    Rebecca K. Webster

  2. Department of Psychological Medicine, King’s College London, Institute of Psychiatry, Psychology and Neuroscience, Weston Education Centre, Denmark Hill, London, UK

    G. James Rubin

  3. National Institute for Health Research Health Protection Research Unit (NIHR HPRU) in Emergency Preparedness and Response, King’s College London, London, UK

    G. James Rubin

Authors
  1. Rebecca K. Webster
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Contributions

RW developed the research question, design, methodology and carried out the data analysis and write up. IPSOS Mori conducted the field work and data collection. GJR provided input into the design, methodology and data analysis and reviewed the draft manuscript.

Corresponding author

Correspondence to Rebecca K. Webster.

Ethics declarations

Conflicts of interest

None to declare.

Ethical approval

This study was approved by the Research Ethics Committee at King’s College London (reference MRA-19/20-14325). All procedures performed in studies involving human participants were in accordance with the ethical standards of King’s College London and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. However, we did not publish the protocol on a publicly accessible database as it is not industry standard for market research surveys to be registered in advance.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Availability of data and material

The datasets generated during the current study are available in the Open Science Framework repository, https://osf.io/mjk9b/

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 59 kb)

Supplementary file2 (DOCX 58 kb)

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Webster, R.K., Rubin, G.J. The Effect of Positively Framing Side-Effect Risk in Two Different Formats on Side-Effect Expectations, Informed Consent and Credibility: A Randomised Trial of 16- to 75-Year-Olds in England. Drug Saf 43, 1011–1022 (2020). https://doi.org/10.1007/s40264-020-00959-8

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