Evidence map›Paper›PMID 28663259›Full record

ArticleJournal of medical ethics2017

What trial participants need to be told about placebo effects to give informed consent: a survey to establish existing knowledge among patients with back pain.

John Hughes, Maddy Greville-Harris, Cynthia A Graham, George Lewith, Peter White, Felicity L Bishop

Abstract read
In one paragraph

Article in Journal of medical ethics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

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

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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

6 authors.

John HughesRoyal London Hospital for Integrated Medicine, London, UK.
Maddy Greville-HarrisDepartment of Psychology, University of Southampton, Southampton, UK.
Cynthia A GrahamDepartment of Psychology, University of Southampton, Southampton, UK.
George LewithSchool of Medicine, Southampton University, Southampton, UK.
Peter WhiteDepartment of Health Sciences, University of Southampton, Southampton, UK.
Felicity L BishopDepartment of Psychology, University of Southampton, Southampton, UK.ORCID 0000-0002-8737-6662

Funding

Arthritis Research UK 20113
6 · The paper itself

Abstract

introductionPatients require an accurate knowledge about placebos and their possible effects to ensure consent for placebo-controlled clinical trials is adequately informed. However, few previous studies have explored patients' baseline (ie, pretrial recruitment) levels of understanding and knowledge about placebos. The present online survey aimed to assess knowledge about placebos among patients with a history of back pain.

designA 15-item questionnaire was constructed to measure knowledge about placebos. Additional questions assessed sociodemographic characteristics, duration and severity of back pain, and previous experience of receiving placebos.

settingParticipants recruited from community settings completed the study online.

results210 participants completed the questionnaire. 86.7% had back pain in the past 6 months, 44.3% currently had back pain. 4.3% had received a placebo intervention as part of a clinical trial and 68.1% had previously read or heard information about placebos. Overall knowledge of placebos was high, with participants on average answering 12.07 of 15 questions about placebos correctly (SD=2.35). However, few participants correctly answered questions about the nocebo effect (31.9% correct) and the impact of the colour of a placebo pill (55.2% correct).

conclusionsThe findings identified key gaps in knowledge about placebos. The lack of understanding of the nocebo effect in particular has implications for the informed consent of trial participants. Research ethics committees and investigators should prioritise amending informed consent procedures to incorporate the fact that participants in the placebo arm might experience adverse side effects.

Indexed as

Access to InformationCommunicationHealth Knowledge, Attitudes, PracticePlacebosAdolescentAdultAgedBack PainBiomedical ResearchEthics, ResearchFemaleHumansInformed ConsentMaleMiddle AgedNocebo EffectPlacebosClinical trialsInformed consentPatient perspective

Identifiers

PMID28663259
PMCPMC5827710

What OpenQuestion holds

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Registered trials

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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.