Webster, R.K. orcid.org/0000-0002-5136-1098, Weinman, J. and Rubin, G.J. (2018) Positively framed risk information in patient information leaflets reduces side effect reporting : a double-blind randomized controlled trial. Annals of Behavioral Medicine, 52 (11). pp. 920-929. ISSN 0883-6612
Abstract
Background
Many medication side effects are the result of a psychologically mediated “nocebo effect,” triggered by negative expectations.
Purpose
This study investigated if changing how side effect information is framed in patient information leaflets (PILs) reduces symptom reporting.
Methods
A total of 203 healthy volunteers aged 18 or over were recruited from December 1, 2015 to December 5, 2016 into a double-blind randomized controlled trial carried out at the Clinical Research Facility at King’s College Hospital. King’s Clinical Trial Unit randomized participants (stratified by gender) to receive a PIL for “a well-known tablet available without prescription” that used standard side effect risk information (e.g., “Common, 1 in 10 people will be affected”) or positively framed wording (e.g., “Uncommon, 90% of people will not be affected”). After reading their PIL, participants took the tablet (a placebo) and completed symptom reports 1 hr later. The main outcomes included the number of participants who attributed symptoms to the tablet, and the number and severity of attributed symptoms.
Results
A total of 101 participants were assigned the standard PIL and 102 the positive framed PIL. Significantly more standard PIL participants attributed symptoms to the tablet (n = 55, 54.5%) compared to positively framed PIL participants (n = 40, 39.2%), odds ratio (OR) = 0.66, 95% CI: 0.46–0.93. Positive framing did not significantly reduce the total number (p = .148) or severity (p = .149) of symptoms attributed to the tablet.
Conclusion
Positive framing reduced the likelihood of participants attributing nocebo-induced side effects to the tablet. Work is needed to assess the effectiveness in a patient population.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2018 Society of Behavioral Medicine. |
Keywords: | Positive framing; Side effects; Risk communication; Nocebo; Placebo |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Science (Sheffield) > Department of Psychology (Sheffield) |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 03 Apr 2020 13:24 |
Last Modified: | 03 Apr 2020 13:24 |
Status: | Published |
Publisher: | Oxford University Press (OUP) |
Refereed: | Yes |
Identification Number: | 10.1093/abm/kax064 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:159130 |