Evidence map›Paper›PMID 29785686›Full record

Trial reportInternational journal of behavioral medicine2018

Decreasing the Burden of Side Effects Through Positive Message Framing: an Experimental Proof-of-Concept Study.

Marcel Wilhelm, Winfried Rief, Bettina K Doering

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of behavioral medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
2.0field-weighted citation impact, top 14% of its field
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

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. The Nocebo Effect: A Review of Contemporary Experimental Research.International journal of behavioral medicine · 2022
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  5. Changing Mindsets About Side Effects of the COVID-19 Vaccination: A Randomized Controlled Trial.Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · 2023
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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

3 authors at 2 institutions in 1 country.

Marcel WilhelmDepartment of Clinical Psychology and Psychotherapy, University of Marburg, Gutenbergstraße 18, 35032, Marburg, Germany. marcel.wilhelm@uni-marburg.de.ORCID http://orcid.org/0000-0001-8055-9346
Winfried RiefDepartment of Clinical Psychology and Psychotherapy, University of Marburg, Gutenbergstraße 18, 35032, Marburg, Germany.
Bettina K DoeringDepartment of Clinical and Biological Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.
Philipps University of Marburg · DECatholic University of Eichstätt-Ingolstadt · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeInforming patients about treatment side effects increases the occurrence and intensity of side effects. Since the obligatory informed consent procedure in drug treatments requires transparency and nocebo research suggests that the informed consent of a drug leads to an increased occurrence of the mentioned side effects, the aim of this proof of concept study was to determine the effect of two different framings of informed consent on the occurrence, intensity, and perceived threat of side effects.

methodsHealthy male participants (n = 80) were randomized to one of two framing groups. The positive framing group was informed that the common side effect dizziness was a sign that the drug had started to work, while the neutral framing group was told that dizziness is an unpleasant but well-known side effect. Side effects were measured after the administration of metoprolol, an antihypertensive agent. Post hoc moderator analyses investigated the effect of pre-existing negative beliefs about the general harm of medication on the framing manipulation.

resultsMetoprolol-specific drug-attributed side effects were rated significantly less threatening in the positive framing group. The between-group effect size (Cohen's d) was small (d = 0.38, p = 0.049). Exploratory post hoc moderator analyses suggest that participants who believed that medication is a source of harmful effects benefited from positive framing, compared to neutral framing of drug-attributed side effects.

conclusionsPositive framing was partially effective in decreasing specific side effect measures, particularly among participants with a tendency to believe that medicine is harmful. Informed consent procedures should therefore be personalized, focusing on patients with negative treatment beliefs.

Indexed as

Informed ConsentAdolescentAdultAntihypertensive AgentsDrug-Related Side Effects and Adverse ReactionsFemaleHumansMaleNocebo EffectPerceptionProof of Concept StudyYoung AdultAntihypertensive AgentsExperimentInformed consentMessage framingNoceboSide effects

Identifiers

PMID29785686
OpenAlexW2804389151

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.