Evaluation of the BIOSECURE Questionnaire in Patients Followed for Inflammatory Rheumatological and Gastrointestinal Diseases Through the Analysis of This Questionnaire
Authors: Beissat Myriam , Geoffroy Marion , Bolko Loïs , Hittinger Ambre , Bonnet Morgane , Cadiot Guillaume , Salmon Jean Hugues 
Published: January 2025

Therapeutic education (TE) plays a central role in the management of chronic inflammatory rheumatic diseases and inflammatory bowel disease. The BIOSECURE questionnaire was developed and validated in 2012 to assess self-management and patient safety, initially in rheumatology. Objectives: The aim of our study was to assess the knowledge of patients followed in both rheumatology and gastroenterology regarding their treatment through the BIOSECURE questionnaire. The secondary objective was to identify factors associated with a low level of knowledge according to the BIOSECURE questionnaire. Methods: This was a descriptive observational study, conducted in a single center at the Reims University Hospital between January 2023 and April 2024. The population was divided into quartiles. Participation in therapeutic education (TE) included receiving brochures about their disease or treatment and/or participation in group or individual TE sessions. We compared the patients with the lowest scores to those with the highest scores. Results: The study population consisted of 312 patients, including 32.05% with rheumatoid arthritis (RA) and 29.81% with Crohn’s disease. In our population, 82.03% had participated in therapeutic education, which included a TE session and/or the distribution of brochures about their disease and/or treatment. The median [IQR] BIOSECURE score was 71.04/100 [IQR 61.77–81.9]. When comparing patients with a low BIOSECURE score (<61.77) to those with a high score (>81.9), univariate factors associated with a low score were older age (p = 0.02), less participation in therapeutic education (p = 0.01), shorter duration of targeted therapy (p = 0.01), and lower level of education (p < 0.05). Conversely, patients who had received therapeutic education had a higher BIOSECURE score (p = 0.01). There was no difference in BIOSECURE scores based on place of residence, location of patient follow-up, route of administration, or type of inflammatory disease. In a multivariate analysis with a model including age, TE participation, and duration of targeted therapy, the results remained significant (p < 0.05). Discussion: We were able to compare the results of our study with two other French studies previously conducted on the same population of 677 patients undergoing biotherapy for chronic inflammatory rheumatism. The median BIOSECURE score in those studies was 73/100. In the study by Rat AC, published in 2017, the population was divided based on their BIOSECURE questionnaire results into three groups; they compared high and low response levels. Similarly to our study, a lower educational level and unemployment were associated with a lower rate of correct responses. The same was true for the absence of therapeutic education (TE) or distribution of brochures. Conclusions: The analysis of the BIOSECURE questionnaire in our population provides a practical message: factors associated with a low BIOSECURE score include older age, lower educational level, recent initiation of targeted therapy, and lack of participation in therapeutic education. This population could be a priority target for TE in order to ensure treatment safety for these patients.