Visualizing Uncertainty Among Laypersons and Experts (VISUALizE )
Research type
Research Study
Full title
A web-based, non-interventional, cross-sectional study of graphical formats for presenting efficacy and safety data for medicinal products and the uncertainty surrounding this data, the impact of the graphical format on perception of risk and benefit and the comparison of two methods for the elicitation of preferences for treatment outcomes among patients (diagnosed with breast cancer, atrial fibrillation, and diabetes), healthcare professionals and the medical assessors who assess medicinal products.
IRAS ID
137933
Contact name
Artak Khachatryan
Contact email
Sponsor organisation
La-ser
Research summary
The aim of the study is to measure the understanding of benefit and risk (side effects) data of medicines using several graphical presentation formats among patients and health care professionals. The investigators hope to use the results of this study to improve the communication of the benefits and risks of medicinal drugs in order to aid patients and healthcare professionals in their decisions of treatment choice.
The evaluation of the balance between benefits and risks of drugs is fundamental to all stakeholders (patients, healthcare providers, regulators and pharmaceutical companies)involved in the development, registration and use of drugs. There are many ways in which benefits and risks are presented and communicated i.e., textual or visual, however there is an absence of consensus on which representation is most suitable to aid decisions of treatment choice.
The study is developed within the context of the Innovative Medicines Initiative, under the research programme “Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium” (PROTECT). The research group is formed by staff from the European Medicines Agency, the University of Groningen, the University of Utrecht, the Danish Medicines Agency, Sanofi-Aventis, Laser and Amgen.
The study will be conducted in three disease areas: breast cancer, atrial fibrillation and diabetes. The study population will consist of patients, healthcare professionals and medical assessors in the United Kingdom, France and the Netherlands. Data will be collected from the study popolation via a web-based questionnaire. Participants in the study will be asked to provide responses to a series of questions that will reveal their level of comprehension of benefit and risk data for medicines presented in various graphical formats. They will also be asked to indicate which of the graphical formats they prefer.REC name
London - City & East Research Ethics Committee
REC reference
14/LO/1359
Date of REC Opinion
26 Aug 2014
REC opinion
Further Information Favourable Opinion