Informing Adults With Back Pain About Placebo Effects: Randomized Controlled Evaluation of a New Website With Potential to Improve Informed Consent in Clinical Research

Felicity L Bishop, Maddy Greville-Harris, Jennifer Bostock, Amy Din, Cynthia A Graham, George Lewith, Christina Liossi, Tim O'Riordan, Peter White, Lucy Yardley

Research output: Contribution to journalArticle (Academic Journal)peer-review

2 Citations (Scopus)
172 Downloads (Pure)

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
Original languageEnglish
Article numbere9955
Number of pages15
JournalJMIR
Volume21
Issue number1
Early online date17 Jan 2019
DOIs
Publication statusPublished - 17 Jan 2019

Structured keywords

  • Physical and Mental Health
  • Digital Health

Keywords

  • placebos
  • placebo effects
  • informed consent
  • research ethics
  • health knowledge, attitudes, practice
  • internet

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