Abstract
Despite a slight increase in the readability of patient information leaflets (PILs) – also known as the “patient package inserts” in the USA, “written drug information” in the UK, “package leaflet” in the EU and “consumer medicine information” in Australia – due to regulatory pressure and calls from PIL users for plain language, most PILs still employ lexicogrammatical constructions that render them illegible, difficult to read and comprehend, and therefore of little to no use to the patient. Consequently, many users of PILs may miss important information about their medicines that they should be aware of, which may lead to additional costs to treat the effects of underdosing or overdosing, and in some cases may even cause death.
In this study, the researcher has set out to determine the effectiveness of South African PILs as instructive texts for South African readers against the background of the linguistic and educational challenges that most South Africans face. He also investigated how plain language guidelines and document design elements can be used to improve the accessibility (i.e., the legibility, readability, comprehensibility and usability) of PILs. These four concepts are suggested as the outcomes of effective and successful plain language use in PILs. A further research aim was to investigate how PILs, revised according to these four outcomes, can be made available in languages other than English and Afrikaans, the languages in which PILs are currently mostly available.
The researcher adopted a discourse-historical approach to critical discourse studies to respond to the research questions and meet the research aims. The methodology comprised three clearly delineated stages.
The first stage comprised the sociodiagnostic critique. The researcher provided an overview of the setting in which PILs are used, including South Africa’s socio-economic context, the health care industry and applicable legislation. He also interviewed a first group of respondents as part of an exploratory study into the behaviour of PIL users.
The second stage consisted of the text-immanent critique. The researcher first evaluated 15 South African PILS to identify typical linguistic constructions and document design features that may hinder access of information contained in these PILs. Thereafter, he performed a similar albeit more in-depth evaluation of the Panado PIL. These two steps comprised the text-directed approach of the text-immanent critique. A target group-directed approach was then followed employing an adapted plus-minus method. This involved a second group of respondents who
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were instructed to identify words or terms, sentences and paragraphs in the Panado PIL that they found difficult to process and understand.
The prognostic critique comprised the third and final stage of the methodology. To produce the Panado PIL in plain language, the researcher 1) used the data that was collected from respondents during the first two critiques, 2) applied plain language guidelines and document design principles, and 3) adhered to applicable legislation. An expert-directed approach was then followed: the revised PIL was presented to an expert in the pharmaceutical industry, who was requested to confirm the correctness and completeness of the revised Panado PIL. Any recommendations by the expert were considered, which resulted in a second revised version of the Panado PIL. Thereafter, excerpts from the revised Panado PIL were presented to a fourth group of respondents, who had to indicate by way of a split-run session whether they preferred the original or the revised Panado PIL.
The findings of the study reveal that respondents found the original Panado PIL difficult to read, comprehend and use on word level (morphology, semantics and pragmatics), sentence level (syntax) and macro-textual level (document design elements). On the other hand, the final revised Panado PIL was overwhelmingly preferred over the original version. The findings suggest that PIL users prefer PILs that are written in plain language and that employ the principles of good document design.
The researcher proposed plain language guidelines for English that can be consulted when existing PILs are revised or new PILs composed. He further developed a model that can be consulted to direct the process of composing or revising PILs. The ILTPL model is centred around the four outcomes of plain language for PILs. These four outcomes inform the proposed guidelines and the required linguistic and extralinguistic knowledge that the plain language practitioner must possess. The model also incorporates compliance within a particular regulatory framework, as well as legal and pharmaceutical expert approval. An advantage of the model is its flexibility to be adapted to the include the plain language principles of other languages, as well as different text types. Lastly, the researcher proposed solutions to making PILs available in languages other than English and Afrikaans in formats that go beyond the traditional printed PIL, including web-based alternatives.