Effect of Communicating Structured Benefit and Harm Information in European Patient Leaflets on Individuals' Expectations About Medicines
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient leaflet with the EMA's proposed key information section including qualitative statements., Control (standard patient leaflet), Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms..
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Communicating Structured Benefit and Harm Information in European Patient Leaflets on Individuals' Expectations About New Medicines: a Randomized Controlled Trial
Overview
This online randomized controlled trial will evaluate whether adding a key information section to patient information leaflets leads to more accurate expectations and improves participants' understanding. We will test the impact of including quantitative information on drug benefits in addition to qualitative statements, versus including qualitative statements only. Participants will be randomly assigned to one of three groups: (1) a standard patient leaflet that contains no information on drug benefits, (2) a leaflet featuring a key information section that includes qualitative statements about drug benefits, or (3) a leaflet featuring a key information section that includes quantitative information about drug benefits in addition to qualitative statements.
Detailed description
Currently, European legislation requires that patient information leaflets accompanying all prescription medicines list the adverse effects of the medicine and provide guidance on its safe and appropriate use. In 2025, the European Medicines Agency (EMA) launched a public consultation on a proposal to include a new 'key information section' in the patient leaflets across Europe. A key information section is intended to help users quickly access non-promotional information about both the drug benefits and risks of a drug.
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.
Interventions
- Other 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. - Other 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. - Other 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.
Primary outcome measures
- Expectations [Time frame: Assessed during 15-minute survey.]
Secondary outcome measures (3)
- Understanding [Time frame: Assessed during 15-minute survey.]
- Perceived magnitude of benefits and harms [Time frame: Assessed during 15-minute survey]
- Satisfaction with information in the patient leaflet [Time frame: Assessed during 15-minute survey.]
Eligibility criteria
Inclusion criteria
- Adults 18 years of age and older,
- Adults fluent in English,
- Adults residing in the United Kingdom (i.e., nationally representative sample of UK adults).
Exclusion critera:
\- Participants who do not meet all 3 inclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07061197 · 494342