Evidence map›Paper›PMID 30664462›Full record

Trial reportJournal of medical Internet research2019

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

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of medical Internet research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Felicity L BishopDepartment of Psychology, University of Southampton, Southampton, United Kingdom.ORCID 0000-0002-8737-6662
Maddy Greville-HarrisDepartment of Psychology, University of Southampton, Southampton, United Kingdom.ORCID 0000-0001-8191-9614
Jennifer BostockInstitute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.ORCID 0000-0001-9261-9350
Amy DinCentre for Innovation & Leadership in Health Sciences, School of Health Sciences, University of Southampton, Southampton, United Kingdom.ORCID 0000-0002-1594-5280
Cynthia A GrahamDepartment of Psychology, University of Southampton, Southampton, United Kingdom.ORCID 0000-0002-7884-599X
George LewithPrimary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.ORCID 0000-0002-2364-3960
Christina LiossiDepartment of Psychology, University of Southampton, Southampton, United Kingdom.ORCID 0000-0003-0627-6377
Tim O'RiordanZemedia, Southampton, United Kingdom.ORCID 0000-0003-4905-7430
Peter WhiteCentre for Innovation & Leadership in Health Sciences, School of Health Sciences, University of Southampton, Southampton, United Kingdom.ORCID 0000-0003-3988-2250
Lucy YardleyDepartment of Psychology, University of Southampton, Southampton, United Kingdom.ORCID 0000-0002-3853-883X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPlacebo 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.

objectiveThis 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.

methodsA 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).

resultsAfter 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; F

conclusionsIn 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.

Indexed as

Health Knowledge, Attitudes, PracticePlacebo EffectBack PainFemaleHumansInformed ConsentInternetMaleSurveys and Questionnaireshealth knowledge, attitudes, practiceinformed consentinternetplacebo effectsplacebosresearch ethics

Identifiers

PMID30664462
PMCPMC6354200

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.