Informing Patients About Placebo Effects: Using Evidence, Theory, and Qualitative Methods to Develop a New Website.
BACKGROUND
According to established ethical principles and guidelines, patients in clinical trials should be fully informed about the interventions they might receive. However, information about placebo-controlled clinical trials typically focuses on the new intervention being tested and provides limited and at times misleading information about placebos.


OBJECTIVE
We aimed to create an informative, scientifically accurate, and engaging website that could be used to improve understanding of placebo effects among patients who might be considering taking part in a placebo-controlled clinical trial.


METHODS
Our approach drew on evidence-, theory-, and person-based intervention development. We used existing evidence and theory about placebo effects to develop content that was scientifically accurate. We used existing evidence and theory of health behavior to ensure our content would be communicated persuasively, to an audience who might currently be ignorant or misinformed about placebo effects. A qualitative 'think aloud' study was conducted in which 10 participants viewed prototypes of the website and spoke their thoughts out loud in the presence of a researcher.


RESULTS
The website provides information about 10 key topics and uses text, evidence summaries, quizzes, audio clips of patients' stories, and a short film to convey key messages. Comments from participants in the think aloud study highlighted occasional misunderstandings and off-putting/confusing features. These were addressed by modifying elements of content, style, and navigation to improve participants' experiences of using the website.


CONCLUSIONS
We have developed an evidence-based website that incorporates theory-based techniques to inform members of the public about placebos and placebo effects. Qualitative research ensured our website was engaging and convincing for our target audience who might not perceive a need to learn about placebo effects. Before using the website in clinical trials, it is necessary to test its effects on key outcomes including patients' knowledge and capacity for making informed choices about placebos.
Psychology Department, Faculty of Social and Human Sciences, University of Southampton, Southampton, United Kingdom.
Maddy
http://orcid.org/0000-0001-8191-9614
M
Greville-Harris
Jennifer
http://orcid.org/0000-0001-9261-9350
J
Bostock
Amy
http://orcid.org/0000-0002-1594-5280
A
Din
Cynthia A
http://orcid.org/0000-0002-7884-599X
CA
Graham
George
http://orcid.org/0000-0002-2364-3960
G
Lewith
Christina
http://orcid.org/0000-0003-0627-6377
C
Liossi
Tim
http://orcid.org/0000-0003-4905-7430
T
O'Riordan
Peter
http://orcid.org/0000-0003-3988-2250
P
White
Lucy
http://orcid.org/0000-0002-3853-883X
L
Yardley
Felicity L
http://orcid.org/0000-0002-8737-6662
FL
Bishop
consumer health information; health attitudes; informed consent; placebo effect; qualitative research