Effect of Communicating Structured Benefit and Harm Information in European Patient Leaflets on Individuals' Expectations About Medicines
NCT ID: NCT07061197
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
2100 participants
INTERVENTIONAL
2025-08-31
2025-08-31
Brief Summary
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Detailed Description
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This study aims to evaluate the effect of including information about drug benefits, either qualitatively or both qualitatively and quantitatively, on individuals' expectations of a new cancer drug, using the European patient leaflet.
In this online randomized controlled trial, a nationally representative sample of adults from the United Kingdom will be randomly assigned to 1 of 3 versions of a patient leaflet: (1) the standard patient information leaflet (control), (2) a leaflet with the EMA's proposed key information section containing qualitative statements, or (3) a leaflet with a key information section providing both qualitative and quantitative data on the drug's benefits and harms. The patient leaflet used in the study was for a cancer drug (tivozanib).
The primary outcome is participants' expectations regarding the drug's benefits and harms. Secondary outcomes include participants' understanding of the information, participants perceived magnitude of the drug's benefits and harms, and their satisfaction with the leaflet content.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Control (standard patient leaflet)
Control (standard patient leaflet)
The standard patient information leaflet for a recently approved cancer drug, tivozanib (Fotivda), obtained electronically from the EMA website. The standard patient information does not contain structured benefit information.
Patient leaflet with the EMA's proposed key information section including qualitative statements
Patient leaflet with the EMA's proposed key information section including qualitative statements.
The standard patient leaflet supplemented with a key information section. This section included qualitative descriptions of the goal of treatment, the main benefits, contraindications, and the most serious side effects. The content was designed to reflect the EMA's proposed format for improving the patient information leaflet.
Patient leaflet with a key information section providing qualitative and quantitative information
Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms.
The standard patient leaflet, supplemented with a key information section including quantitative data on the drug's main benefits and side effects, presented in a summary table format. This section provided structured information about the indication and goal of treatment, how the drug was studied (the comparator treatment and number of patients enrolled in the clinical trial that supported the drug's approval), and data on the drug's benefits and side effects.
Interventions
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Patient leaflet with the EMA's proposed key information section including qualitative statements.
The standard patient leaflet supplemented with a key information section. This section included qualitative descriptions of the goal of treatment, the main benefits, contraindications, and the most serious side effects. The content was designed to reflect the EMA's proposed format for improving the patient information leaflet.
Control (standard patient leaflet)
The standard patient information leaflet for a recently approved cancer drug, tivozanib (Fotivda), obtained electronically from the EMA website. The standard patient information does not contain structured benefit information.
Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms.
The standard patient leaflet, supplemented with a key information section including quantitative data on the drug's main benefits and side effects, presented in a summary table format. This section provided structured information about the indication and goal of treatment, how the drug was studied (the comparator treatment and number of patients enrolled in the clinical trial that supported the drug's approval), and data on the drug's benefits and side effects.
Eligibility Criteria
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Inclusion Criteria
* Adults fluent in English,
* Adults residing in the United Kingdom (i.e., nationally representative sample of UK adults).
Exclusion critera:
18 Years
ALL
Yes
Sponsors
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King's College London
OTHER
London School of Economics and Political Science
OTHER
Responsible Party
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Central Contacts
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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494342
Identifier Type: -
Identifier Source: org_study_id
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