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.

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.

journal_name

Drug Saf

journal_title

Drug safety

authors

Webster RK,Rubin GJ

doi

10.1007/s40264-020-00959-8

subject

Has Abstract

pub_date

2020-10-01 00:00:00

pages

1011-1022

issue

10

eissn

0114-5916

issn

1179-1942

pii

10.1007/s40264-020-00959-8

journal_volume

43

pub_type

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