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      Informing Patients About Placebo Effects: Using Evidence, Theory, and Qualitative Methods to Develop a New Website

      research-article
      , MSc,PhD 1 , , MA 2 , , BSc (Hons),MSc,MBAcC 3 , , BA,MAppSci,PhD 1 , , MA,DM,FRCP,MRCGP 4 , , BA,MSc,MPhil,DPsych,AFBPsS,CPsychol 1 , , MA,MSc 5 , , BSc,PhD 3 , , BSc,MSc,PhD,CPsychol 1 , , MA,MSc,PhD,AFBPsS,CPsychol 1 ,
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      placebo effect, informed consent, qualitative research, health attitudes, consumer health information

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          Abstract

          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.

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          Most cited references50

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          The magical number 4 in short-term memory: a reconsideration of mental storage capacity.

          M N Cowan (2001)
          Miller (1956) summarized evidence that people can remember about seven chunks in short-term memory (STM) tasks. However, that number was meant more as a rough estimate and a rhetorical device than as a real capacity limit. Others have since suggested that there is a more precise capacity limit, but that it is only three to five chunks. The present target article brings together a wide variety of data on capacity limits suggesting that the smaller capacity limit is real. Capacity limits will be useful in analyses of information processing only if the boundary conditions for observing them can be carefully described. Four basic conditions in which chunks can be identified and capacity limits can accordingly be observed are: (1) when information overload limits chunks to individual stimulus items, (2) when other steps are taken specifically to block the recording of stimulus items into larger chunks, (3) in performance discontinuities caused by the capacity limit, and (4) in various indirect effects of the capacity limit. Under these conditions, rehearsal and long-term memory cannot be used to combine stimulus items into chunks of an unknown size; nor can storage mechanisms that are not capacity-limited, such as sensory memory, allow the capacity-limited storage mechanism to be refilled during recall. A single, central capacity limit averaging about four chunks is implicated along with other, noncapacity-limited sources. The pure STM capacity limit expressed in chunks is distinguished from compound STM limits obtained when the number of separately held chunks is unclear. Reasons why pure capacity estimates fall within a narrow range are discussed and a capacity limit for the focus of attention is proposed.
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            • Article: not found

            Test-enhanced learning: taking memory tests improves long-term retention.

            Taking a memory test not only assesses what one knows, but also enhances later retention, a phenomenon known as the testing effect. We studied this effect with educationally relevant materials and investigated whether testing facilitates learning only because tests offer an opportunity to restudy material. In two experiments, students studied prose passages and took one or three immediate free-recall tests, without feedback, or restudied the material the same number of times as the students who received tests. Students then took a final retention test 5 min, 2 days, or 1 week later. When the final test was given after 5 min, repeated studying improved recall relative to repeated testing. However, on the delayed tests, prior testing produced substantially greater retention than studying, even though repeated studying increased students' confidence in their ability to remember the material. Testing is a powerful means of improving learning, not just assessing it.
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              • Article: not found

              A comprehensive review of the placebo effect: recent advances and current thought.

              Our understanding and conceptualization of the placebo effect has shifted in emphasis from a focus on the inert content of a physical placebo agent to the overall simulation of a therapeutic intervention. Research has identified many types of placebo responses driven by different mechanisms depending on the particular context wherein the placebo is given. Some placebo responses, such as analgesia, are initiated and maintained by expectations of symptom change and changes in motivation/emotions. Placebo factors have neurobiological underpinnings and actual effects on the brain and body. They are not just response biases. Other placebo responses result from less conscious processes, such as classical conditioning in the case of immune, hormonal, and respiratory functions. The demonstration of the involvement of placebo mechanisms in clinical trials and routine clinical practice has highlighted interesting considerations for clinical trial design and opened up opportunities for ethical enhancement of these mechanisms in clinical practice.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                Apr-Jun 2016
                10 June 2016
                : 5
                : 2
                : e106
                Affiliations
                [1] 1Psychology Department Faculty of Social and Human Sciences University of Southampton SouthamptonUnited Kingdom
                [2] 2Institute of Psychiatry, Psychology & Neuroscience King's College London LondonUnited Kingdom
                [3] 3Centre for Innovation & Leadership in Health Sciences Faculty of Health Sciences University of Southampton SouthamptonUnited Kingdom
                [4] 4Primary Care and Population Sciences Faculty of Medicine University of Southampton SouthamptonUnited Kingdom
                [5] 5ZeMedia SouthamptonUnited Kingdom
                Author notes
                Corresponding Author: Felicity L. Bishop f.l.bishop@ 123456southampton.ac.uk
                Author information
                https://orcid.org/http://orcid.org/0000-0001-8191-9614
                https://orcid.org/http://orcid.org/0000-0001-9261-9350
                https://orcid.org/http://orcid.org/0000-0002-1594-5280
                https://orcid.org/http://orcid.org/0000-0002-7884-599X
                https://orcid.org/http://orcid.org/0000-0002-2364-3960
                https://orcid.org/http://orcid.org/0000-0003-0627-6377
                https://orcid.org/http://orcid.org/0000-0003-4905-7430
                https://orcid.org/http://orcid.org/0000-0003-3988-2250
                https://orcid.org/http://orcid.org/0000-0002-3853-883X
                https://orcid.org/http://orcid.org/0000-0002-8737-6662
                Article
                v5i2e106
                10.2196/resprot.5627
                4920960
                27288271
                ceb62540-7f64-434e-bf38-408f73104ca2
                ©Maddy Greville-Harris, Jennifer Bostock, Amy Din, Cynthia A. Graham, George Lewith, Christina Liossi, Tim O’Riordan, Peter White, Lucy Yardley, Felicity L. Bishop. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 10.06.2016.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 9 February 2016
                : 10 March 2016
                : 23 March 2016
                : 30 March 2016
                Categories
                Original Paper
                Original Paper

                placebo effect,informed consent,qualitative research,health attitudes,consumer health information

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