Effect of Communicating Structured Benefit and Harm Information in European Patient Leaflets on Individuals' Expectations About New Medicines: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,101
- 试验地点
- 1
- 主要终点
- Expectations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Expectations
时间窗: Assessed during 15-minute survey.
Multiple choice questions assessing expectations about the benefits of tivozanib, a cancer drug approved by the European Medicines Agency. For example, "does Fotivda cure advanced kidney cancer?" Measured on a 4 point-Likert scale: definitely yes; probably yes; probably no; definitely no.. See attached protocol.
次要结局
- Understanding(Assessed during 15-minute survey.)
- Perceived magnitude of benefits and harms(Assessed during 15-minute survey)
- Satisfaction with information in the patient leaflet(Assessed during 15-minute survey.)