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.

OBJECTIVE: To 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). METHODS: This is a multicentre, open-labelled, randomised controlled trial comparing an intervention group (face-to-face education by a nurse at baseline and 3 months later) with a control group (usual care) at the introduction of a first subcutaneous bDMARD. The primary outcome was score on the BioSecure questionnaire at 6 months (0-100 scale), a validated questionnaire assessing competencies in dealing with fever, infections, vaccination and daily situations. The secondary outcomes were disease activity, coping, psychological well-being, beliefs about medication, self-efficacy and severe infection rate. RESULTS: 129 patients with rheumatoid arthritis and spondyloarthritis were enrolled in nine rheumatology departments; 122 completed the study; 127 were analysed; and 64 received the intervention (mean duration: 65 min at baseline and 44 min at 3 months). The primary outcome was met: the BioSecure score was 81.2±13.1 and 75.6±13.0 in the education and usual care groups (difference: +6.2, 95% CI 1.3 to 11.1, p=0.015), demonstrating higher safety skills in the education group. Exploratory analyses showed better skills regarding infections, greater willingness for vaccinations and greater adherence-related behaviours in the education group. Coping was significantly more improved by education; other secondary outcomes were improved in both groups, with no difference. CONCLUSIONS: Educating patients was effective in promoting patient behaviours for preventing adverse events with bDMARDs. An education session delivered to patients starting a first bDMARD can be useful to help them self-manage safety issues. TRIAL REGISTRATION NUMBER: NCT02855320.

Multidisciplinary team intervention to reduce the nocebo effect when switching from the originator infliximab to a biosimilar.

OBJECTIVES: To evaluate an intervention to reduce the nocebo effect (NE) when switching from the originator infliximab (OI) to the infliximab biosimilar SB2 in chronic inflammatory rheumatic disease (CIRD). METHODS: An intervention was built with healthcare professionals (HPs) and a patient representative, based on a systematic review of interventions reducing the NE in musculoskeletal diseases and semi-directed questioning of five patients. Our strategy consisted of training HPs, switch information given by the nurses, a consistent vocabulary. All CIRD patients switched from OI to SB2 were included for the intervention. The primary outcome was the SB2 retention rate (RR) at 34 weeks. Secondary outcomes were the SB2 RR at 12 months, discontinuation rates due to a possible NE and comparison with a historical cohort of CIRD patients receiving the OI and 6 published European cohorts. RESULTS: 45 patients were included from March 2018 (rheumatoid arthritis, n=17, spondylarthritis, n=28). After 34 weeks, the SB2 RR was 91.2%, similar to the historical cohort RR (p=0.41) but higher than the 3 European cohort RRs (p<0.05). At 12 months, the SB2 RR was 84.5% vs 88.4% for the historical cohort (p=0.52). SB2 discontinuation due to a possible NE was 6.6% after 12 months. CONCLUSIONS: A tailored communication with a prominent role of nurses reduced the NE in non-medical switches from the OI to SB2 as compared to published results. The RR was similar to the historical cohort RR. The methodology used to construct this intervention may help improve the outcomes of switches with upcoming biosimilars.

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

RATIONALE: Biodrugs 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. METHODS: We 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. RESULTS: Of 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. CONCLUSION: This 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.

BACKGROUND: Biologics 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. OBJECTIVES: To elaborate a questionnaire to measure knowledge and skills regarding safety issues, for patients treated by biologics. METHODS: Three-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. RESULTS: The 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 10 minutes (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). CONCLUSION: A 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.

[Osteoarthritis and self-esteem]. / Arthrose et estime de soi.

Osteoarthritis is a pathology which forces patients who suffer from it to deal with their illness and to endure it by living differently. The nurse therefore plays a major role in supporting these patients in order to help them regain their self-esteem.