title: Controlled language and information on vaccines: application to package inserts.
abstract: Any ambiguity in texts used in the communication about vaccines can not only interfere with comprehension, but also generate safety and liability issues. Within a survey on the quality of written protocols for at-risk interventional procedures and sanitary crises, we analyzed documents relating to vaccination, and among them, the "package-leaflet" of an anti-H1N1 influenza vaccine, widely disseminated to the public in 2009-2010. Among the most common mistakes, we observed that 1) language was not always adjusted to the non-specialist's level of knowledge; 2) chronology, logic, consistency, and homogeneity were often missing; 3) crucial pieces of information were disseminated all over the text, 4) use of the passive voice did not distinguish between instructions and information; 5) use of synonyms could be misleading and impair translation. We propose the use of "Controlled language" (CL) to improve the situation. By constraining lexicon, grammar and syntax, CL is a way to write documents that are clear, accurate and devoid of ambiguity. However, the set of rules necessary to write in CL is difficult to memorize. We thus developed authoring software (Rédacticiel Prolipsia) to make the creation of a CL by linguists and its use by health professionals easy and adapted to any domain. It may considerably improve the writing of vaccine package inserts/leaflets. It could be used to write information documents about vaccines and their safety, and operating procedures for professionals to prepare, store, and administer vaccines, decide upon proper indication of vaccines, and follow patients after vaccine injection.
authors: Julie
authors: J
authors: Renahy
authors: WHO Collaborating Center on Prevention and Treatment of Human Echinococcosis; Parasitology Dept., CHRU Jean Minjoz, 25030, Besancon, France. dvuitton@univ-fcomte.fr.
authors: Dominique A
authors: DA
authors: Vuitton
authors: Barbara
authors: B
authors: Rath
authors: Izabella
authors: I
authors: Thomas
authors: Valerie
authors: V
authors: de Grivel
authors: Sylviane
authors: S
authors: Cardey
mesh_terms: D001291:Attitude of Health Personnel; D032882:Comprehension; D004348:Drug Labeling; D058015:Health Communication / Q000379:methods*; D057220:Health Literacy; D006801:Humans; D010174:Pamphlets; D010353:Patient Education as Topic; D061214:Patient Safety; D065840:Protective Factors; D018570:Risk Assessment; D012307:Risk Factors; D014611:Vaccination / Q000009:adverse effects; D014612:Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D018875:Vocabulary, Controlled; D014956:Writing
chemical_list: D014612:Vaccines