Lisibilité de l’information écrite destinée aux sujets se prêtant à une recherche biomédicale (original) (raw)

Objective We compared informed consent forms of subjects participating in biomedical research with those of references texts in order to determine the factors that influence readability. Methods We assessed the readability of 73 informed consent forms of research protocols conducted in the clinical investigation centres in the Rhône-Alpes area, and then compared them with 33 reference texts corresponding to 5 French school grades (first year infant, primary school, GCS level, high school, and classics aggregation), using the Flesch test and Cordial" analyser. Results Median Flesch scores were 66 for the first year infant level, 62 for the primary school level, 58 for the GCS level, 42 for the high school level, and 43 for the aggregation level. It was 22 for the informed consent forms. Median Cordial ® scores were 86 for the first year infant level, 77 for the second, 74 for the third, 49 for the fourth, 43 for the fifth. It was 1 for the informed consent forms. No methodological factor correlated with Flesch and Cordial" results. Conclusion The quantitative readability scores for informed consent forms for subjects participating in biomedical research are low, lower than those proposed to aggregation candidates, whatever the type of protocol. Some thought must be given to the impact of the reduced readability on patients' understanding, and steps should be taken to improve the readability of the forms. A. Paris, J.-L. Cracowski, N. Ravanel, C. Cornu, F. Gueyffier, B. Deygas et al. Presse Med 2005; 34: 13-18 © 2005, Masson, Paris 15 janvier 2005 • tome 34 • n°1 Figure 1 Comparaison des indices de Flesch et Cordial ® des formulaires d'information et de consentement par rapport aux différentes catégories de textes de référence. La barre centrale du rectangle indique la médiane, les limites hautes et basses du rectangle les 25°e t 75°percentiles, et les extrémités des barres les 10°et 90°percentiles. C.P. N=7 ; C.M.2 N=7 ; Brevet N=5 ; Baccalauréat N=11, agrégation N=7, protocoles N=73 © D R © D R