scholarly journals Changes in Side Effect Risk Communication in Patient Information Leaflets over the Past Decade: Results of a Survey

Drug Safety ◽  
2015 ◽  
Vol 38 (8) ◽  
pp. 721-727 ◽  
Author(s):  
Katherine Harris ◽  
Rebecca Dickinson ◽  
David K. Raynor ◽  
Jan MacDonald ◽  
Peter Knapp
Author(s):  
Antoinette Mary Fage-Butler

There is wide recognition that the communication of risk in Patient Information Leaflets (PILs) – the instructions that accompany medications in Europe – problematises the reception of these texts. There is at the same time growing understanding of the mediating role of trust in risk communication. This paper aims to analyse how risk is discursively constructed in PILs, and to identify and analyse discourses that are associated with trust-generation. The corpus (nine PILs chosen from the British online PIL bank, www.medicines.org.uk) is analysed using Foucauldian (1972) discourse analysis: specifically, this involves identifying the functions of the statements that constitute the discourses. A discourse analysis of the corpus of PILs reveals that the discourse of risk revolves around statements of the potential harm that may be caused by taking the medication, whilst trust is constructed through three discourses: the discourses that relate to competence and care, in accordance with the trust theories of Poortinga/Pidgeon (2003) and Earle (2010), and a third discourse, corporate accountability, which functions to construct an ethical (trustworthy) identity for the company. This paper contributes to PIL literature in the following ways: it introduces a methodology that has not been used before in relation to these texts, namely, Foucauldian discourse analysis; it helps to identify the presence of trust-generating discourses in PILs; and analysing the discourses of risk and trust at statement-level facilitates a better understanding of how these discourses function in texts that are generally not well-received by the patients for whom they are intended.


2021 ◽  
Author(s):  
Martina Svobodova ◽  
Rachel Hale ◽  
Kerry Hood ◽  
Katie Gillies ◽  
Jennifer Bostock ◽  
...  

Patients need to be informed about potential risks of taking part in clinical trials. A problem is that there are no standards telling researchers or ethics committees how these risks need to be communicated. Our background research suggests that the way harms are communicated can actually increase the risks of the harms occurring. Over half of our sample of 250,000 patients who took placebo pills (like sugar pills) in clinical trials reported some negative side effect (like pain or nausea but also more serious things). The aim of this study is to understand what information about trial harms and benefits stakeholders consider to be important for ‘principled participant information leaflets’ or ‘PrinciPILs’ to contain. The stakeholders will include patients, ethics committee members, industry representatives, medico-legal experts, psychologists, and trial managers.


2014 ◽  
Vol 11 (3) ◽  
Author(s):  
Inger Askehave ◽  
Karen Korning Zethsen

Since becoming mandatory in the EU in 1992, the patient information leaflet (PIL) has been the subject of an on-going discussion regarding its ability to provide easily understandable information. This study examines whether the lay-friendliness of Danish PILs has improved from 2000 to 2012 according to the Danish consumers. A reproduction of a questionnaire study from 2000 was carried out. The responses of the 2012 survey were compared to those of the 2000 survey and the analysis showed that Danes are less inclined to read the PIL in 2012 compared to 2000 and that the general interest in PILs has decreased. The number of respondents who deem the PIL easy to read has gone down. According to Danish consumers, the lay-friendliness of PILs has not improved from 2000 to 2012 and a very likely explanation could be that the PIL as a genre has become far too regulated and complex to live up to its original intentions. On the basis of the empirical results the article furthermore offers suggestions for practice changes.


Radiography ◽  
1999 ◽  
Vol 5 (1) ◽  
pp. 11-14 ◽  
Author(s):  
Linda Tutty ◽  
Geraldine O'Connor

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