Informing adults with back pain about placebo effects: Randomized controlled evaluation of a new website with potential to improve informed consent in clinical research
Authors: Bishop, F.L., Greville-Harris, M., Bostock, J., Din, A., Graham, C.A., Lewith, G., Liossi, C., O'Riordan, T., White, P. and Yardley, L.
Journal: Journal of Medical Internet Research
Volume: 21
Issue: 1
eISSN: 1438-8871
DOI: 10.2196/jmir.9955
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.
https://eprints.bournemouth.ac.uk/32885/
Source: Scopus
Informing Adults With Back Pain About Placebo Effects: Randomized Controlled Evaluation of a New Website With Potential to Improve Informed Consent in Clinical Research.
Authors: Bishop, F.L., Greville-Harris, M., Bostock, J., Din, A., Graham, C.A., Lewith, G., Liossi, C., O'Riordan, T., White, P. and Yardley, L.
Journal: J Med Internet Res
Volume: 21
Issue: 1
Pages: e9955
eISSN: 1438-8871
DOI: 10.2196/jmir.9955
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.
https://eprints.bournemouth.ac.uk/32885/
Source: PubMed
Informing Adults With Back Pain About Placebo Effects: Randomized Controlled Evaluation of a New Website With Potential to Improve Informed Consent in Clinical Research
Authors: Bishop, F.L., Greville-Harris, M., Bostock, J., Din, A., Graham, C.A., Lewith, G., Liossi, C., O'Riordan, T., White, P. and Yardley, L.
Journal: JOURNAL OF MEDICAL INTERNET RESEARCH
Volume: 21
Issue: 1
ISSN: 1438-8871
DOI: 10.2196/jmir.9955
https://eprints.bournemouth.ac.uk/32885/
Source: Web of Science (Lite)
Informing Adults With Back Pain About Placebo Effects: Randomized Controlled Evaluation of a New Website With Potential to Improve Informed Consent in Clinical Research.
Authors: Bishop, F.L., Greville-Harris, M., Bostock, J., Din, A., Graham, C.A., Lewith, G., Liossi, C., O'Riordan, T., White, P. and Yardley, L.
Journal: Journal of medical Internet research
Volume: 21
Issue: 1
Pages: e9955
eISSN: 1438-8871
ISSN: 1439-4456
DOI: 10.2196/jmir.9955
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.https://eprints.bournemouth.ac.uk/32885/
Source: Europe PubMed Central
Informing Adults With Back Pain About Placebo Effects: Randomized Controlled Evaluation of a New Website With Potential to Improve Informed Consent in Clinical Research.
Authors: Bishop, F.L., Greville-Harris, M., Bostock, J., Din, A., Graham, C.A., Lewith, G., Liossi, C., O'Riordan, T., White, P. and Yardley, L.
Journal: Journal of Medical Internet Research
Volume: 21
Issue: 1
ISSN: 1439-4456
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.
https://eprints.bournemouth.ac.uk/32885/
Source: BURO EPrints