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Positively Framed Risk Information in Patient Information Leaflets Reduces Side Effect Reporting: A Double-Blind Randomized Controlled Trial

Research output: Contribution to journalArticle

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Positively Framed Risk Information in Patient Information Leaflets Reduces Side Effect Reporting : A Double-Blind Randomized Controlled Trial. / Webster, Rebecca K.; Weinman, John Alfred; Rubin, Gideon James.

In: Annals of Behavioral Medicine, Vol. 52, No. 11, 11.2018, p. 920–929.

Research output: Contribution to journalArticle

Harvard

Webster, RK, Weinman, JA & Rubin, GJ 2018, 'Positively Framed Risk Information in Patient Information Leaflets Reduces Side Effect Reporting: A Double-Blind Randomized Controlled Trial', Annals of Behavioral Medicine, vol. 52, no. 11, pp. 920–929. https://doi.org/10.1093/abm/kax064

APA

Webster, R. K., Weinman, J. A., & 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), 920–929. https://doi.org/10.1093/abm/kax064

Vancouver

Webster RK, Weinman JA, Rubin GJ. Positively Framed Risk Information in Patient Information Leaflets Reduces Side Effect Reporting: A Double-Blind Randomized Controlled Trial. Annals of Behavioral Medicine. 2018 Nov;52(11):920–929. https://doi.org/10.1093/abm/kax064

Author

Webster, Rebecca K. ; Weinman, John Alfred ; Rubin, Gideon James. / Positively Framed Risk Information in Patient Information Leaflets Reduces Side Effect Reporting : A Double-Blind Randomized Controlled Trial. In: Annals of Behavioral Medicine. 2018 ; Vol. 52, No. 11. pp. 920–929.

Bibtex Download

@article{3437fed85b7b4fd8a10f0bfd409e617f,
title = "Positively Framed Risk Information in Patient Information Leaflets Reduces Side Effect Reporting: A Double-Blind Randomized Controlled Trial",
abstract = "BackgroundMany medication side effects are the result of a psychologically mediated “nocebo effect,” triggered by negative expectations.PurposeThis study investigated if changing how side effect information is framed in patient information leaflets (PILs) reduces symptom reporting.MethodsA 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{\textquoteright}s College Hospital. King{\textquoteright}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.ResultsA 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.ConclusionPositive 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.",
author = "Webster, {Rebecca K.} and Weinman, {John Alfred} and Rubin, {Gideon James}",
year = "2018",
month = nov,
doi = "10.1093/abm/kax064",
language = "English",
volume = "52",
pages = "920–929",
journal = "Annals of Behavioral Medicine",
issn = "0883-6612",
publisher = "Springer",
number = "11",

}

RIS (suitable for import to EndNote) Download

TY - JOUR

T1 - Positively Framed Risk Information in Patient Information Leaflets Reduces Side Effect Reporting

T2 - A Double-Blind Randomized Controlled Trial

AU - Webster, Rebecca K.

AU - Weinman, John Alfred

AU - Rubin, Gideon James

PY - 2018/11

Y1 - 2018/11

N2 - BackgroundMany medication side effects are the result of a psychologically mediated “nocebo effect,” triggered by negative expectations.PurposeThis study investigated if changing how side effect information is framed in patient information leaflets (PILs) reduces symptom reporting.MethodsA 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.ResultsA 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.ConclusionPositive 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.

AB - BackgroundMany medication side effects are the result of a psychologically mediated “nocebo effect,” triggered by negative expectations.PurposeThis study investigated if changing how side effect information is framed in patient information leaflets (PILs) reduces symptom reporting.MethodsA 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.ResultsA 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.ConclusionPositive 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.

U2 - 10.1093/abm/kax064

DO - 10.1093/abm/kax064

M3 - Article

VL - 52

SP - 920

EP - 929

JO - Annals of Behavioral Medicine

JF - Annals of Behavioral Medicine

SN - 0883-6612

IS - 11

ER -

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