Readability of the Written Study Information in Pediatric Research in France

BACKGROUND: The aim was to evaluate the readability of research information leaflets (RIL) for minors asked to participate in biomedical research studies and to assess the factors influencing this readability. METHODS AND FINDINGS: All the pediatric protocols from three French pediatric clinical research units were included (N = 104). Three criteria were used to evaluate readability: length of the text, Flesch's readability score and presence of illustrations. We compared the readability of RIL to texts specifically written for children (school textbooks, school exams or extracts from literary works). We assessed the effect of protocol characteristics on readability. The RIL had a median length of 608 words [350 words, 25(th) percentile; 1005 words, 75(th) percentile], corresponding to two pages. The readability of the RIL, with a median Flesch score of 40 [30; 47], was much poorer than that of pediatric reference texts, with a Flesch score of 67 [60; 73]. A small proportion of RIL (13/91; 14%) were illustrated. The RIL were longer (p<0.001), more readable (p<0.001) and more likely to be illustrated (p<0.009) for industrial than for institutional sponsors. CONCLUSION: Researchers should routinely compute the reading ease of study information sheets and make greater efforts to improve the readability of written documents for potential participants

The Readability of Information and Consent Forms in Clinical Research in France

BACKGROUND: Quantitative tools have been developed to evaluate the readability of written documents and have been used in several studies to evaluate information and consent forms. These studies all showed that such documents had a low level of readability. Our objective is to evaluate the readability of Information and Consent Forms (ICFs) used in clinical research. METHODS AND FINDINGS: Clinical research protocols were collected from four public clinical research centers in France. Readability was evaluated based on three criteria: the presence of an illustration, the length of the text and its Flesch score. Potential effects of protocol characteristics on the length and readability of the ICFs were determined. Medical and statutory parts of the ICF form were analyzed separately. The readability of these documents was compared with that of everyday contracts, press articles, literary extracts and political speeches. We included 209 protocols and the corresponding 275 ICFs. The median length was 1304 words. Their Flesch readability scores were low (median: 24), and only about half that of selected press articles. ICF s for industrially sponsored and randomized protocols were the longest and had the highest readability scores. More than half (52%) of the text in ICFs concerned medical information, and this information was statistically (p<0.05) more readable (Flesch: 28) than statutory information (Flesch: 21). CONCLUSION: Regardless of the field of research, the ICFs for protocols included had poor readability scores. However, a prospective analysis of this test in French should be carried out before it is put into general use

Flesch index for each category of reference texts, compared to those of information and consent forms.

<p>Central bars correspond to the medians, the ends of the boxes to the 25^th and 75^th percentiles and ends of the bars to the maximum and minimum values. ICF: Information and Consent Form. N.S: Not Significant. ICFs (N = 275) have significantly (p<0.05) lower readability scores than literary extracts (N = 9), political speeches (N = 5) and articles from the press (N = 51), but similar scores to everyday contracts (N = 6).</p

The informatic processing of information and consent documents.

<p>It includes three steps: the first is applicable to all European languages. The second step is specific to the language considered. The last step is the calculation of the Flesch index with the variables obtained from the previous steps.</p

ICF length (in number of words), Flesch scores and statistically significant differences between types and contexts of studies.

<p>One standard page contains around 250 words. ICF: Information and Consent Form. NS: Not statistically significant.</p

Readability data for 91 research information leaflets used in biomedical research studies, classified by age of the intended reader.

<p>Text length and Flesch score also differed significantly between the 4 groups (p<0.001).</p

Comparison of the Flesch scores of RIL and comparison texts.

<p>Comparison of the Flesch scores of RIL and comparison texts.</p

Flow chart of the study.

<p>RIL: Research Information Leaflet.</p