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

OBJECTIVE: We aimed to determine patient and rheumatologist factors associated with the safety skills of patients receiving bDMARDs for inflammatory arthritis. METHODS: Data 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. RESULTS: Of 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 1.3â¿¿6.0]), low educational level (OR 4.3 [2.1â¿¿8.9]), living in a large city (OR 3.1 [1.2â¿¿8.2]), being unemployed (OR 3.3 [1.6â¿¿6.7]) and not receiving written information, participating in TPE sessions or consulting a nurse (OR 3.8 [1.6â¿¿8.8]). One rheumatologist-related factor was a high number of patients receiving bDMARDs in the practice. CONCLUSION: We 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.

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.

Radiographic methods for evaluating osteoporotic vertebral fractures.

UNLABELLED: Reproducible methods for the radiological assessment of osteoporotic vertebral fractures, defined based on accurate criteria, are needed in everyday practice and in therapeutic trials and epidemiological studies. OBJECTIVES: To describe and to evaluate methods for osteoporotic vertebral fracture assessment based on standard radiographs or dual-energy X-ray absorptiometry (DXA) and to determine the role for each method in clinical practice, therapeutic trials, and epidemiological studies. METHODS: A review written by a rheumatologist based on his clinical experience and on a literature review was submitted to four experts. Studies in English or French published between 1975 and February 2008 were retrieved from Medline using the keywords vertebral fracture, osteoporosis, vertebral deformity, and vertebral fracture assessment. RESULTS: One hundred forty-nine articles were selected and read in their full-text version. There was no consensus regarding the definition of osteoporotic vertebral fractures. The following methods were evaluated: visual assessment, Genant's semi-quantitative assessment, Jiang's algorithm-based qualitative method, morphometric radiography, and DXA of the spine. In everyday practice, Genant's semi-quantitative assessment on standard radiographs may provide useful information on the severity and prognosis of osteoporosis. DXA done for bone mineral density measurement may detect vertebral fractures in asymptomatic patients. Assessment of standard radiographs remains the reference standard for diagnosing vertebral fractures in patients with suggestive symptoms (e.g., pain in the thoracic or lumbar spine, height loss, or thoracic kyphosis). For therapeutic trials and epidemiological studies, Genant's semi-quantitative assessment used by a trained and experienced observer is the preferred method, based on its good reproducibility and ability to differentiate fractures from other deformities. However, thousands of radiographs may be needed, making routine interpretation by an expert impractical. A visual semi-quantitative method may be used to separate normal radiographs from radiographs showing possible or obvious fractures, which can then be read by an expert. Alternatively, radiomorphometric indices can be determined on digitized radiographs in combination with a semi-quantitative assessment, with discordant cases being reviewed by an expert. We do not recommend Jiang's method at present, as it is still undergoing validation.