Readability and understandability of instruments for collecting patient-generated data (PGD).

person Camila Kelly Chiodi Cancer Survivorship Group, INSERM Unit 981, Gustave Roussy, Villejuif, France info_outline Camila Kelly Chiodi, Johanna Arvis, Elise Martin, Aude Barbier, Antonio Di Meglio, Guillemette Jacob, Gwenn Menvielle, Sibille Everhard, Francis Guillemin, Ines Maria Vaz Duarte Luis, Maria Alice B Franzoi

Authors person Camila Kelly Chiodi Cancer Survivorship Group, INSERM Unit 981, Gustave Roussy, Villejuif, France info_outline Camila Kelly Chiodi, Johanna Arvis, Elise Martin, Aude Barbier, Antonio Di Meglio, Guillemette Jacob, Gwenn Menvielle, Sibille Everhard, Francis Guillemin, Ines Maria Vaz Duarte Luis, Maria Alice B Franzoi Organizations Cancer Survivorship Group, INSERM Unit 981, Gustave Roussy, Villejuif, France, Seintinelles, Paris, France, Institut Pierre Louis d'Epidémiologie et Santé Publique, Paris, France, Unicancer, Paris, France, Université de Lorraine, Vandoeuvre-Les-Nancy, France, INSERM Unit 981, Gustave Roussy, Villejuif, France Abstract Disclosures Research Funding No funding received None. Background: PGD are crucial to inform and optimize cancer care. These may include patient-reported outcomes measures (PROMs), patient-reported experience measures (PREMS), or patient preferences information (PPI). The increasing use of PGD has led to the need for the adaptation of instruments to different languages and cultures. Recent data has brought attention to the additional need to consider patients’ ability to understand written information included in PROMs. Low health literacy is associated with higher risk for quality-of-life deterioration and generates disparities, including underrepresentation in cancer research. Aiming at improving equity and representation, we evaluated readability and understandability of nine French-language PROMs that are currently used in a contemporary cohort of breast cancer survivors. Methods: Readability of PROMs was assessed using the Flesh Reading Ease Score (FRES), the Gunning’s Fog Index (FOG), and the FRY graphics (yielding a mean score representing the n. of school years required to understand the respective text). Readability was considered ideal if mean score ≤6 th grade level and acceptable if between 6-8 th grade. Understandability was evaluated using the Patient Education Materials Assessment Tool (PEMAT, range 0-100%, higher scores corresponding to easier understandability) and defined as ideal if PEMAT ≥ 80%. Plain-language best practice was met if both readability and understandability were ideal. The Evaluative Linguistic Framework for Questionnaires (ELF-Q) provided additional qualitative elements to assess understandability. Two native French speakers, including a patient representative, independently evaluated each PROM. An additional independent assessment was requested if discordance. Results: None of the 9 PROMs evaluated had ideal readability scores, and only 1 had an acceptable score. Understandability ranged from 55-91%, and only 3 PROMs had ideal scores. None of the instruments met the definition of plain-language best practice. ELF-Q identified points for improvement in several dimensions of the PROMs (Table). Conclusions: The use of comprehensive linguistic and cultural frameworks during the development and translation of self-reported PGD instruments may improve experience and engagement of patients with lower literacy and foster equity and representation in cancer cohort studies. PROM Readability Mean Score PEMAT (%) ELF-Q assessment* LOT 8.5 67 O, H, MD,WRR, TV, LD, F SF12 12.5 85 O, H, WRR, TV, LD, F QLQ C30 13.0 66 O, MD, WRR, TV, LD QLQ BR23 10.5 62 O, MD, WRR, TV, LD HADS 7.5 91 O, MD, WRR, TV, LD FA12 10.5 59 O, WRR, TV, LD GPAQ16 17.0 88 O, WRR, TV, LD, F BDI-SF 8.5 55 O, H, MD, WRR, TV, LD IOC-VC 10.0 59 O, H, WRR, TV, LD, F *Dimensions amenable for improvement: O: organization, H: headings, MD: metadiscourse, WRR: Writer-reader relationship, TV: technicality of vocabulary, LD: lexical density, F: format.