Preliminary investigation of patient information leaflets as package inserts

<p>Being concerned with (what has hitherto been) a marginal and under-researched area of Translation Studies, viz. intralingual translation, this paper focuses on the particular type of monolingual rewriting which consists in the transformation of specialized LSP texts into a new text type aimed at lay readership. As a specific example of this type of transformation, the paper investigates the rewriting of pharmaceutical product specifications into medicinal package inserts (so-called patient information leaflets). In Translation Studies terms, in other words, the pharmaceutical texts are treated as source texts and the patient information leaflets as target texts. The paper examines certain core intralingual translation <em>strategies </em>employed to make the specialized information accessible to the non-expert audience. The focus is primarily on strategies employed to convert medical terminology into more lay-friendly wordings. The exact linguistic nature of these strategies is examined, and the ways in which they contribute to target-text lay-friendliness are charted.</p>

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Side Effects of Side Effect Information in Drug Information Leaflets

Journal of Technical Writing and Communication ◽

10.2190/lek9-vujp-l3b9-v2ld ◽

1994 ◽

Vol 24 (4) ◽

pp. 389-404 ◽

Cited By ~ 6

Author(s):

H. Pander Maat ◽

R. Klaassen

Keyword(s):

Side Effects ◽

Patient Information ◽

Drug Information ◽

The Other ◽

Package Inserts ◽

Patient Information Leaflets ◽

Information Leaflets ◽

Dependent Variables ◽

Preliminary Study ◽

Therapy Compliance

This study examines the way side effects information is presented in patient information leaflets about drugs. In a field experiment, we tested the effects of two attempts to improve a side effects paragraph in a leaflet about a nonsteroid anti-inflammatory drug. First, a short introductory passage on the nature of side effects was added. Second and more importantly, we changed the frequency descriptors (FDs) for the side effects. A preliminary study had shown that the frequencies associated with common Dutch FDs are much higher than the writers of patient information leaflets and package inserts mean to convey. In our experiment we replaced the original FDs by lower-assessed FDs. For instance, soms (sometimes) was replaced by zelden (seldomly). Replacing FDs led to lower recall for the side effects mentioned in the leaflet. It also decreased the number of side effects experienced. Contrary to our expectations, lower FDs did not significantly increase the confidence in the safety and effectiveness of the drug, nor did they increase therapy compliance; incompliance was extremely rare in our sample of patients. Adding an introductory passage on the nature of side effects lowered FD interpretations. It did not significantly affect any of the other dependent variables.

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A comparative analysis of the lay-friendliness of Danish EU patient information leaflets from 2000 to 2012

Communication & Medicine ◽

10.1558/cam.v11i3.20700 ◽

2014 ◽

Vol 11 (3) ◽

Cited By ~ 2

Author(s):

Inger Askehave ◽

Karen Korning Zethsen

Keyword(s):

Comparative Analysis ◽

Patient Information ◽

Patient Information Leaflet ◽

General Interest ◽

Information Leaflet ◽

Empirical Results ◽

Patient Information Leaflets ◽

Information Leaflets ◽

The Subject ◽

The Eu

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.

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