How to Test Mandatory Text Templates: The European Patient Information Leaflet

The structure of patient information leaflets (PILs) supplied with medicines in the European Union is largely determined by a regulatory template, requiring a fixed sequence of pre-formulated headings and sub-headings. The template has been criticized on various occasions, but it has never been tested with users. This paper proposes an alternative template, informed by templates used in the USA and Australia, and by previous user testing.The main research question is whether the revision better enables users to find relevant information. Besides, the paper proposes a methodology for testing templates. Testing document templates is complex, as they are “empty”. For both the current and the alternative template, we produced a document with bogus text and real headings (reflecting the empty template) and a real-life document with readable text (reflecting the “filled” template). The documents were tested both in Dutch and in English, with 64 British and 64 Dutch users. The test used a set of scenario questions that covers the full range of template (sub)topics; users needed to indicate the text locations where they expected each question to be answered. The revised template improved findability of information; this effect was strongest for the “filled” template with readable text. When participants were shown both filled templates, there was a clear preference for the revised template. A closer analysis of the findability data revealed question-specific effects of topic grouping, topic ordering, subtopic granularity and wording of headings. Most of these favoured the revised template, but our revision led to adverse effects as well, for instance in the new heading Check with your doctor. Language-specific effects showed that the wording of the headings is a delicate task. Generally, we conclude that document template designs can be analyzed in terms of the four parameters grouping, ordering, granularity and wording. Furthermore, they need to be tested on their effects on information findability, with template translations requiring separate testing. The methodology used in this study seems an appropriate one for such tests. More specifically, we find that the new patient information leaflet template proposed here provides better information findability

Determining subjectivity in text: The case of backward causal connectives in Dutch

This article addresses the question of how to systematically determine the degree of subjectivity expressed in a text, more specifically, the degree of subjectivity expressed in causal coherence relations. The main hypothesis is that the distribution of Dutch backward causal connectives (want, omdat, aangezien, and doordat) can be explained by the degree of subjectivity of the participant primarily involved in the causal relation (the causally primary participant or CP). The notion of subjectivity is defined on the basis of 2 different conceptions of subjectivity: speaker subjectivity and perspective. On the basis of this notion, a set of 8 text features is established, namely the CP's role in the causality, his or her nature, the mode in which his or her words or thoughts are represented, referential choice (presence and type of referential expression), and predicate features (tense, voice, polarity). This set of features is subsequently applied to an analysis of backward causal connectives in Dutch. The results of a series of corpus analyses are reported. The results show that the distribution of these connectives can successfully be explained in terms of the concept of subjectivity as developed in this article, and they underline the importance of investigating the expression of the self in text. Copyright © 2006, Lawrence Erlbaum Associates, Inc

Aanvullend materiaal Pander Maat & Gravekamp 2022

1 Experimentele teksten 2 Mediatieanalyses bij de zorgteks

De invloed van de formulering van informatie over bijwerkingen op interpretaties door patiënten en op gemelde bijwerkingen

Doel.\ud Nagaan of (niet-inhoudelijke) veranderingen in de informatie over bijwerkingen in een patiëntenbijsluiter gevolgen hebben voor het interpreteren en onthouden van deze informatie door patiënten en voor het aantal gerapporteerde bijwerkingen.\ud \ud Opzet.\ud Gerandomiseerd gecontroleerd onderzoek.\ud \ud Plaats.\ud Utrecht.\ud \ud Methode.\ud In een veldexperiment werden, behalve de originele versie van de bijsluiter van diclofenac, gerandomiseerd ook twee alternatieve versies getest bij respectievelijk 33, 30 en 34 patiënten. In versie 2 werden lagere frequentieaanduidingen bij de bijwerkingen gebruikt (bijvoorbeeld: ‘soms’ werd vervangen door ‘zelden’), en in versie 3 werd een korte inleiding toegevoegd met algemene informatie over bijwerkingen.\ud \ud Resultaten.\ud De schattingen door patiënten van bijwerkingsfrequenties liepen enorm uiteen. Ook lage en verlaagde frequentieaanduidingen werden nog met te hoge frequenties geassocieerd. De versie met lagere frequentieaanduidingen verlaagde niet alleen de frequentieschattingen, maar zorgde er ook voor dat minder bijwerkingen uit de tekst onthouden werden en dat minder bijwerkingen uit de tekst werden gerapporteerd als feitelijke klacht. De inleiding had als enig effect dat frequenties van de bijwerkingen lager geschat werden.\ud \ud Conclusie.\ud Informatie over bijwerkingen met een hoger opgegeven frequentie wordt aandachtiger gelezen. Een discussie is wenselijk over de voor- en nadelen van getalsmatige frequentieaanduidingen of eventueel aanduidingen van frequentie-intervallen