BioSecure Questionnaire Research Articles

Efficacy of a nurse-led patient education intervention in promoting safety skills of patients with inflammatory arthritis treated with biologics: a multicentre randomised clinical trial

ObjectiveTo evaluate the effect of a nurse-led patient education on safety skills of patients with inflammatory arthritis treated with biologic disease-modifying antirheumatic drugs (bDMARDs).MethodsThis is a multicentre, open-labelled, randomised controlled...

Measuring the impact of an educational intervention in rheumatoid arthritis: An open-label, randomized trial.

Objectives This study aims to determine whether patients with active rheumatoid arthritis (RA), either starting on or changing biological or targeted synthetic disease-modifying antirheumatic drugs (DMARDs), demonstrate better self-management safety skills three months after receiving a multidisciplinary educational intervention compared to patients receiving usual care.Patients and methods Between October 2015 and October 2018 , this open-label, randomized-controlled trial included a total of 107 RA patients (27 males, 80 females; mean age: 60.2±10.4 years; range, 54 to 71 years) who were on treatment or in whom treatment was changed with a biological or targeted synthetic DMARD. The patients were randomized into two groups: Group 1 (n=57) received additional intervention with educational DVD and one teleconference session and Group 2 (n=55) received usual care and were offered the intervention at three months. All patients underwent a final visit at six months. At each visit, the patients completed the BioSecure questionnaire measuring the self-care safety skills, a behavioral intention questionnaire, and the Beliefs about Medicines Questionnaire (BMQ).Results No significant difference was observed in the Biosecure score at three months between the two groups (p=0.08). After pooling the first three-month data in Group 1 and the last three-month data in Group 2, the mean score of the BioSecure questionnaire increased to 7.10±0.92 in the group receiving educational intervention (p<0.0001). This increase was maintained at six months in Group 2 (p=0.88). The rate of appropriate behavioral intention increased over time (76% at baseline and 85% at six months for both groups). There was no significant change in the BMQ (p=0.44 to 0.84).Conclusion The development of an educational DVD followed by a teleconference seem to improve self-care safety skills of the patients in practical situations.

Adherence to and patient's knowledge of self-management of subcutaneous biologic therapy in chronic inflammatory rheumatic diseases: results of a multicentre cross-sectional study.

Non-adherence to biologic therapy is an issue in chronic inflammatory rheumatic diseases (CIRDs) and might be related to poor patient knowledge of the risk of these therapies. Our aim here was to evaluate the level of patient adherence to and knowledge of self-care safety skills for biologic therapy. This was a multicentre, cross-sectional study in which out-patients visited an office- or hospital-based rheumatologist. All the patients received subcutaneous biologic therapy for CIRDs. We collected data on: 1. the level of CIRD patient adherence to current subcutaneous biologic therapy using both the self-administered Compliance Questionnaire Rheumatology 5 items (CQR5) and a simple adherence question; 2. patients' knowledge of self-management of biologic therapy by the self-administered BIOSECURE questionnaire; 3. sources of information related to biologic therapy. In all, 285 patients (rheumatoid arthritis, n=103; spondyloarthritis, n=153; psoriatic arthritis, n=25) were enrolled by 19 rheumatologists. The mean (SD) biologic therapy duration was 5.9 (4.9) years. Adherence to the current biologic therapy was high (79.3% and 57.5% according to the CQR5 questionnaire and the adherence question, respectively). Level of knowledge of self-care safety skills (median BIOSECURE score 71) was in the acceptable range. Level of adherence and level of knowledge of self-care safety skills for biologic therapy were not associated. Patients declared that the main sources of information were their rheumatologist (92.6%) and the rheumatology team (30.5%). According to the patients' estimation, adherence to biologic therapy and the level of knowledge of self-care safety skills related to biologic therapy are acceptable, and these domains are not related (e.g. level of adherence and level of knowledge of risks).

Education models and acquisition of biotherapies safety skills in chronic inflammatory rheumatism

Introduction: The biotherapies prescribed to chronic inflammatory rheumatism patients carry risks, about which these patients must be informed. Objective: To evaluate which educational model is the best for maintaining optimal safety in terms of biotherapy self-management. Method: This observational retrospective monocentric study involved patients who had received therapeutic education while on biotherapy from 2009 to 2013, categorized in terms of the educational model received (information: M1, individual education: M2, in terms of the educational model received (information: M1, individual education: M2, individual and group education: M3) and given the Biosecure questionnaire (assessing their theoretical and practical understanding of biotherapy) to complete. Results: Overall, 222 patients were included (67% women, mean age: 53.9 years), 106 of whom had received M1, 88 M2, and 28 M3. The highest Biosecure scores were generated by young, female, employed, college-level educated patients, with the most recent diagnoses, and on intravenous biotherapies. The mean Biosecure score was 76.6 (±13.8) (min-max: 11.52–100). On multivariate analysis, the Biosecure total score was highest in the M3 group, compared to M1 (p = 0.02) and M2 (p = 0.04). Conclusion: The combination of individual and group education resulted in higher Biosecure scores than individual education or simply providing information.

Factors associated with knowledge and safety skills of arthritis patients receiving biologics: A survey of 677 patients

ObjectiveWe aimed to determine patient and rheumatologist factors associated with the safety skills of patients receiving bDMARDs for inflammatory arthritis. MethodsData were obtained from a descriptive observational cross-sectional nationwide survey performed in 2011 in France. Community- and hospital-based rheumatologists were selected at random. The BioSecure questionnaire was used to collect information on patient safety skills. ResultsOf the 677 patients included (mean age 53±13years old; 452 (67%) women, 411 (61%) had RA; 421 (64%) received subcutaneous bDMARDs). Patients had received information about their treatments from their physician 610 (90%), a nurse 207 (31%), by a written booklet 398 (59%), and/or during therapeutic patient education (TPE) sessions 99 (15%). The median BioSecure total score was 72/100 (IQR 60-82). In total, 99 (16.4%) patients had a low skill level; 321 (53.2%) a moderate skill level and 183 (30.3%) a high skill level. On multivariate regression analysis, as compared with high safety skills, low skills were associated with living alone (OR 2.8 [95% CI 1.3⿿6.0]), low educational level (OR 4.3 [2.1⿿8.9]), living in a large city (OR 3.1 [1.2⿿8.2]), being unemployed (OR 3.3 [1.6⿿6.7]) and not receiving written information, participating in TPE sessions or consulting a nurse (OR 3.8 [1.6⿿8.8]). One rheumatologist-related factor was a high number of patients receiving bDMARDs in the practice. ConclusionWe reveal factors associated with low safety skills of patients receiving bDMARDs for inflammatory arthritis, which should be addressed to improve safety skills in this population.

Cross-sectional study of self-care safety skills in 677 patients on biodrugs for inflammatory joint disease

RationaleBiodrugs carry specific risks that patients must be aware of and capable of managing. Until now, few studies have addressed the self-care safety skills of patients taking biodrugs. The primary objective of this study was to describe the self-care safety skills of patients taking biodrugs for chronic inflammatory joint disease. MethodsWe conducted a nationwide cross-sectional survey. To obtain the most representative sample possible of patients taking biodrugs, we selected rheumatologists at random from the directory of the French Society for Rheumatology (SFR). Each rheumatologist was to include 5 consecutive patients receiving biodrugs. The BioSecure questionnaire was used to collect information on patient self-care safety skills. ResultsOf the 677 included patients, with a mean age of 53 years, 33% were males, 62% had rheumatoid arthritis, and 47% had previously received a therapeutic patient education (TPE) session. The median BioSecure score (percentage of correctly answered items) was 73% (interquartile range, 60–82). The dimensions with the lowest scores were the symptoms requiring a physician visit (median, 75), vaccinations (median, 75), contraception (median, 50), and subcutaneous biodrugs (median, 68). The replies to theoretical items (assessing knowledge) and those to problem-case items (assessing adaptive skills) were discordant. ConclusionThis study provides concrete data of use for improving the information and TPE of patients taking biodrugs. Skills regarding the symptoms that require a physician visit, vaccinations, contraception, and subcutaneous treatments need to be improved. Interesting information can be obtained by simultaneously testing knowledge and coping.

Safety of biologics: Elaboration and validation of a questionnaire assessing patients’ self-care safety skills: The BioSecure questionnaire. An initiative of the French Rheumatology Society Therapeutic Education section

BackgroundBiologics are known to entail specific risks (e.g. infections). Patients should possess self-care safety skills to develop appropriate behaviors in situations of risks (e.g. fever). To date, there is no adequate tool to assess these skills. ObjectivesTo elaborate a questionnaire to measure knowledge and skills regarding safety issues, for patients treated by biologics. MethodsThree-step process. (1) A steering group of 10 rheumatologists, one pharmacist and two allied health professionals elaborated an exhaustive list of safety skills. Through a 3-round Delphi process involving the steering group, 14 patients on biologics and 14 other allied health professionals, the list of skills was reduced. (2) A corresponding series of questions and of clinical situations with multiple-choice answers were designed. (3) Preliminary validation was performed against the physician's opinion on skills, and reliability was assessed. ResultsThe list includes 24 skills e.g. how to deal with fever, planned surgery, dental care, travel, minor traumas, and immunizations. A 55-question questionnaire was constructed. Preliminary validation (62 patients) showed the questionnaire was filled in 10minutes (median) and correlated to the physician's opinion of skills (R=0.47, P<0.0001) but not to disease status or disease duration. The median score was 75% (range 20%–96%). The questionnaire was reliable: intraclass correlation coefficient, 0.83 (95% CI: 0.63–0.93). ConclusionA simple (multiple-choice questionnaire) and valid tool investigating a core set of safety skills has been developed. This tool could be useful to detect further educational needs regarding biologics safety, and to assess the efficacy of oriented educational interventions.

OP0286 Effects of an Educational Program on the Safety Knowledge and Skills of Patients with Rheumatoid Arthritis Treated by Biologics

BackgroundBiologics are very efficient drugs used in rheumatoid arthritis (RA) but they are also known for entailing specific risks. Therefore, it is necessary to translate the patients’ skills of safety...