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Informing adults with back pain about placebo effects: randomized, controlled evaluation of a new website with potential to improve informed consent in clinical research

Informing adults with back pain about placebo effects: randomized, controlled evaluation of a new website with potential to improve informed consent in clinical research
Informing adults with back pain about placebo effects: randomized, controlled evaluation of a new website with potential to improve informed consent in clinical research
Background: Placebo effects and their underpinning mechanisms are increasingly well understood. However, this is poorly communicated to participants in placebo-controlled trials. For valid informed consent, participants should be informed about the potential benefits and risks of participating in placebo-controlled trials. Existing information leaflets often fail to describe the potential benefits and adverse effects associated with placebo allocation. This study tested the effects of a new website designed to inform patients about placebo effects (The Power of Placebos, PoP). PoP was designed using qualitative methods in combination with theory- and evidence-based approaches to ensure it was engaging, informative, and addressed patients’ concerns.

Objective: This study aimed to test the effects of PoP, compared with a control website, on people’s knowledge about placebo and the ability to make an informed choice about taking part in a placebo-controlled trial.

Methods: A total of 350 adults with back pain recruited from 26 general practices in Southern England participated in this Web-based study. Participants were randomly assigned to PoP (which presented scientifically accurate information about placebo effects in an engaging way) or a control website (based on existing information leaflets from UK trials). Participants self-completed Web-based pre- and postintervention questionnaire measures of knowledge about placebo effects and preintervention questionnaire measures of attitudes toward and intentions to participate in a placebo-controlled trial. The 2 primary outcomes were (1) knowledge and (2) informed choice to take part in a placebo-controlled trial (computed from knowledge, attitudes, and intentions).

Results: After viewing PoP, participants had significantly greater knowledge about placebos (mean 8.28 [SD 1.76]; n=158) than participants who viewed the control (mean 5.60 [SD 2.24]; n=174; F1,329=173.821; P<.001; η2=.346). Participants who viewed PoP were 3.16 times more likely than those who viewed the control to make an informed choice about placebos (χ21=36.5; P<.001).

Conclusions: In a sample of adults with back pain, PoP increased knowledge and rates of informed choice about placebos compared with a control website. PoP could be used to improve knowledge about placebo effects in back pain. After essential further development and testing in clinical trial settings, it could support informed consent in placebo-controlled trials.
1438-8871
Bishop, Felicity
1f5429c5-325f-4ac4-aae3-6ba85d079928
Greville-Harris, Madeleine L.
15fdf3ab-d129-4191-bfd4-9c14c910bfef
Bostock, Jennifer
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Din, Amy, Elizabeth
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Graham, Cynthia
ac400331-f231-4449-a69b-ec9a477224c8
Lewith, George
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Liossi, Christina
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O'Riordan, Tim
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White, Peter J.
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Yardley, Lucy
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Bishop, Felicity
1f5429c5-325f-4ac4-aae3-6ba85d079928
Greville-Harris, Madeleine L.
15fdf3ab-d129-4191-bfd4-9c14c910bfef
Bostock, Jennifer
209fe50a-0710-4023-aa51-5582b8b0eca5
Din, Amy, Elizabeth
90f6f38e-8b75-413b-ac0e-b2eb50beeea7
Graham, Cynthia
ac400331-f231-4449-a69b-ec9a477224c8
Lewith, George
0fc483fa-f17b-47c5-94d9-5c15e65a7625
Liossi, Christina
fd401ad6-581a-4a31-a60b-f8671ffd3558
O'Riordan, Tim
d6ba191a-e432-41f8-b3da-176d28355579
White, Peter J.
f33829fd-24c9-4b44-a148-24eca9d52253
Yardley, Lucy
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Bishop, Felicity, Greville-Harris, Madeleine L., Bostock, Jennifer, Din, Amy, Elizabeth, Graham, Cynthia, Lewith, George, Liossi, Christina, O'Riordan, Tim, White, Peter J. and Yardley, Lucy (2019) Informing adults with back pain about placebo effects: randomized, controlled evaluation of a new website with potential to improve informed consent in clinical research. Journal of Medical Internet Research, 21 (1), [e9955]. (doi:10.2196/jmir.9955).

Record type: Article

Abstract

Background: Placebo effects and their underpinning mechanisms are increasingly well understood. However, this is poorly communicated to participants in placebo-controlled trials. For valid informed consent, participants should be informed about the potential benefits and risks of participating in placebo-controlled trials. Existing information leaflets often fail to describe the potential benefits and adverse effects associated with placebo allocation. This study tested the effects of a new website designed to inform patients about placebo effects (The Power of Placebos, PoP). PoP was designed using qualitative methods in combination with theory- and evidence-based approaches to ensure it was engaging, informative, and addressed patients’ concerns.

Objective: This study aimed to test the effects of PoP, compared with a control website, on people’s knowledge about placebo and the ability to make an informed choice about taking part in a placebo-controlled trial.

Methods: A total of 350 adults with back pain recruited from 26 general practices in Southern England participated in this Web-based study. Participants were randomly assigned to PoP (which presented scientifically accurate information about placebo effects in an engaging way) or a control website (based on existing information leaflets from UK trials). Participants self-completed Web-based pre- and postintervention questionnaire measures of knowledge about placebo effects and preintervention questionnaire measures of attitudes toward and intentions to participate in a placebo-controlled trial. The 2 primary outcomes were (1) knowledge and (2) informed choice to take part in a placebo-controlled trial (computed from knowledge, attitudes, and intentions).

Results: After viewing PoP, participants had significantly greater knowledge about placebos (mean 8.28 [SD 1.76]; n=158) than participants who viewed the control (mean 5.60 [SD 2.24]; n=174; F1,329=173.821; P<.001; η2=.346). Participants who viewed PoP were 3.16 times more likely than those who viewed the control to make an informed choice about placebos (χ21=36.5; P<.001).

Conclusions: In a sample of adults with back pain, PoP increased knowledge and rates of informed choice about placebos compared with a control website. PoP could be used to improve knowledge about placebo effects in back pain. After essential further development and testing in clinical trial settings, it could support informed consent in placebo-controlled trials.

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More information

Accepted/In Press date: 4 October 2018
e-pub ahead of print date: 17 January 2019
Published date: January 2019

Identifiers

Local EPrints ID: 427346
URI: http://eprints.soton.ac.uk/id/eprint/427346
ISSN: 1438-8871
PURE UUID: 37a4dd89-276e-4b7e-90cf-117da2ff9f87
ORCID for Felicity Bishop: ORCID iD orcid.org/0000-0002-8737-6662
ORCID for Madeleine L. Greville-Harris: ORCID iD orcid.org/0000-0001-8191-9614
ORCID for Cynthia Graham: ORCID iD orcid.org/0000-0002-7884-599X
ORCID for Christina Liossi: ORCID iD orcid.org/0000-0003-0627-6377
ORCID for Tim O'Riordan: ORCID iD orcid.org/0000-0003-4905-7430
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X

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Date deposited: 14 Jan 2019 17:30
Last modified: 22 Oct 2020 04:01

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