Evidence map›Paper›PMID 39486820›Full record

ArticleBMJ open2024

Do summaries of evidence enable informed decision-making about COVID-19 and influenza vaccination equitably across more and less disadvantaged groups? Study protocol for a multi-centre cluster randomised controlled trial of 'fact boxes' in health and social care in Germany.

Christin Ellermann, Nicolai Savaskan, Felix G Rebitschek

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06076421 (Do Evidence-based Fact Boxes Improve Informed Decision-making About COVID-19 and Influenza Vaccination in More and Less Disadvantaged Groups Equally? - Study Protocol for a Multi-center Cluster RCT in Health and Social Care in Germany), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT06076421 naunknown statusnot on this map

Do Evidence-based Fact Boxes Improve Informed Decision-making About COVID-19 and Influenza Vaccination in More and Less Disadvantaged Groups Equally? - Study Protocol for a Multi-center Cluster RCT in Health and Social Care in Germany

TypeinterventionalSponsorHarding Center for Risk LiteracyRan2023 to 2024Enrolled800ConditionsCOVID-19, InfluenzaArmsFact box
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

3 authors.

Christin EllermannHarding Center for Risk Literacy, Faculty of Health Sciences Brandenburg, University of Potsdam, Potsdam, Brandenburg, Germany christin.ellermann@uni-potsdam.de.ORCID http://orcid.org/0000-0003-4674-8260
Nicolai SavaskanPublic Health Service Neukölln, Department of Public Health Service Neukölln, Berlin, Germany.ORCID http://orcid.org/0000-0003-1348-094X
Felix G RebitschekHarding Center for Risk Literacy, Faculty of Health Sciences Brandenburg, University of Potsdam, Potsdam, Brandenburg, Germany.ORCID http://orcid.org/0000-0001-7653-8278

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEvidence summaries on the benefits and harms of treatment options support informed decisions under controlled conditions. However, few studies have investigated how such formats support decision-making across different social groups. There is a risk that only disadvantaged people will be able to make informed health decisions-possibly increasing the health equity gap. It is also unclear whether they support decision-making in the field at all. The aim of our study is to assess whether evidence summaries based on the fact box format can help people from different social groups make informed decisions about COVID-19 and influenza vaccinations, and thus reduce inequity in health communication. METHODS AND ANALYSIS: In a multi-centre, cluster-randomised, controlled trial, health educators from usual care and outreach work in Germany will be randomised in a 1:1 ratio to provide either usual health communication plus an evidence summary ('fact box') or usual health communication. Health educators provide a flyer about COVID-19 or influenza vaccination which contains a link to an online study either with (intervention) or without (control) fact box on the reverse side. Flyer and online study will be available in Arabic, German, Turkish and Russian language. The primary outcome is informed vaccination intention, based on vaccination knowledge, attitudes, intentions and behaviour. Secondary outcomes include risk perception, decisional conflict and shared decision-making. We will use linear mixed models to analyse the influence of both individual (eg, education status) and cluster level factors and account for the expected cluster variability in realising usual health communication or the intervention. The statistical analysis plan includes the selection of appropriate measures of effect size and power calculation, assuming a sample size of 800 patients. ETHICS AND DISSEMINATION: The trial has been approved by the Ethics Committee of the University of Potsdam, Germany (application numbers: 34/2021 and 57/2022).Results will be disseminated through peer-reviewed journals, conferences and to relevant stakeholders. PROTOCOL VERSION: Version 6 (4 October 2024); Preprint available on Research Square: https://doi.org/10.21203/rs.3.rs-3401234/v3 TRIAL REGISTRATION NUMBER: NCT06076421.

Indexed as

COVID-19Decision MakingInfluenza, HumanInfluenza VaccinesCOVID-19 VaccinesGermanyHealth CommunicationHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicSARS-CoV-2VaccinationVulnerable PopulationsCOVID-19 VaccinesInfluenza VaccinesDecision MakingHealth EquityHealth LiteracyHealth Services AccessibilityPatient ParticipationRandomized Controlled Trial

Identifiers

PMID39486820
PMCPMC11529688

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Registered trials

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.