Fear-avoidance beliefs about back pain in patients with acute LBP.

OBJECTIVE: We aimed to assess fear-avoidance beliefs in patients with acute low back pain (LBP) and to identify features of patients and general practitioners (GPs) associated with patients' fear-avoidance beliefs. METHODS: A cross-sectional study conducted in primary care practice in France. A total of 709 GPs completed a self-administered questionnaire assessing fear-avoidance beliefs [the Fear-Avoidance Beliefs Questionnaire (FABQ)] and 2,727 patients with acute LBP completed a self-administered questionnaire assessing pain, perceived handicap and disability (on the Quebec Back Pain Disability Scale) and fear-avoidance beliefs (on the FABQ). RESULTS: Patients' FABQ mean scores were 16.8+/-5.0 for physical activities (FABQ Physical) and 19.5+/-10.9 for occupational activities (FABQ Work). From multivariate analysis, the following factors were associated with patients' FABQ Phys and Work scores: having a GP with a high rating on the FABQ Phys (P=0.0001 and 0.02 for FABQ Phys and Work, respectively), no sport practice (vs. occasional: P=0.0003 and 0.03; vs. usual/competition: P=0.0001 and 0.004), disability score (Quebec) (P=0.0001 for both FABQ scores), and pain intensity (P=0.0012 and 0.0013). CONCLUSIONS: High levels of fear-avoidance beliefs occur early in LBP patients, and key messages on this topic should probably be delivered at a very early stage of the disease.

Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting.

OBJECTIVE: Mass-media campaigns have been known to modify the outcome of low back pain (LBP). We assessed the impact on outcome of standardized written information on LBP given to patients with acute LBP. DESIGN: A 3-month pragmatic, multicenter controlled trial with geographic stratification. SETTING: Primary care practice in France. PARTICIPANTS: 2752 patients with acute LBP. INTERVENTION: An advice book on LBP (the "back book"). MAIN OUTCOME MEASURES: The main outcome measure was persistence of LBP three months after baseline evaluation. RESULTS: 2337 (85%) patients were assessed at follow-up and 12.4% of participants reported persistent LBP. The absolute risk reduction of reporting persistent back pain in the intervention group was 3.6% lower than in the control group (10.5% vs. 14.1%; 95% confidence interval [-6.3% ; -1.0%]; p value adjusted for cluster effect = 0.01). Patients in the intervention group were more satisfied than those in the control group with the information they received about physical activities, when to consult their physician, and how to prevent a new episode of LBP. However, the number of patients who had taken sick leave was similar, as was the mean sick-leave duration, in both arms, and, among patients with persistent pain at follow-up, the intervention and control groups did not differ in disability or fear-avoidance beliefs. CONCLUSIONS: The level of improvement of an information booklet is modest, but the cost and complexity of the intervention is minimal. Therefore, the implications and generalizability of this intervention are substantial. TRIAL REGISTRATION: ClinicalTrials.gov NCT00343057.

General practitioners' fear-avoidance beliefs influence their management of patients with low back pain.

The objectives of this cross-sectional study conducted in primary care practice in France were to describe general practitioners' (GPs) fear-avoidance beliefs about low back pain (LBP), investigate the impact of these beliefs on their following guidelines for bed rest, physical activities, and sick leave, and uncover factors associated with GPs' fear-avoidance beliefs. A total of 864 GPs completed a 5-part self-administered questionnaire. Parts 1, 2, and 3 concerned demographic, professional data, and personal history of back pain, respectively. Part 4 dealt with GPs' education about LBP and practice for LBP. Part 5 assessed GPs' fear-avoidance beliefs on the Fear-Avoidance Beliefs Questionnaire (FABQ). GPs' mean age was 48.2+/-7.0 years, 80% were male, 88% had been practicing for more than 10 years, and 52% reported a previous personal episode of acute LBP. Forty-six percent had participated in an educational session on LBP during the last 3 years. Mean scores for the FABQ Phys and Work were 9.6+/-4.8 and 17.5+/-6.7, respectively. Sixteen percent of participants had high rating on the FABQ Phys (FABQ Phys score>14). FABQ Phys score was associated with recommendation of bed rest or rest during sick leave (p<0.0001) for acute LBP and less advice to maintain maximum bearable physical activities (p<0.001) for chronic LBP. FABQ Work score was associated with prescribing sick leave during painful periods (p<0.005) for acute LBP and less advice to maintain maximum bearable physical activities (p<0.001) for chronic LBP. GPs' fear-avoidance beliefs about LBP negatively influence their following guidelines concerning physical and occupational activities for patients with LBP.

Validation of the short-form REFLUX-QUAL (RQS), a gastro-esophageal reflux disease (GERD) specific quality of life questionnaire.

INTRODUCTION: Being an easy-to-use (eight items) quality of life questionnaire specific to GERD, the Reflux-Qual Short form (RQS) was developed for use in everyday practice. The purpose of this study was to assess the psychometric properties of the RQS. METHODS AND MATERIALS: The reliability of the RQS was measured by the Cronbach's alpha coefficient and its clinical validity by comparing the RQS score for increasing clinical severity groups. The RQS discriminative power was compared with that of the SF12. Sensitivity to change over time was measured by calculating effect-sizes. RESULTS: The reliability and validity of the questionnaire were assessed on a sample of 1195 patients. Its psychometric properties were very satisfactory: Cronbach alpha = 0.84; RQS score significantly reduced for the worst-affected patients; the discriminative power was up to 5 times higher when compared with the SF-12. Sensitivity to change over time, evaluated with 362 patients, showed highly significant differences between groups with different levels of clinical progression (P = 0.0001). CONCLUSION: The RQS is a quality of life measurement instrument specific to GERD which is short, reliable, valid, and sensitive to within and between-subject differences.

Efficacy and safety of leflunomide and predisposing factors for treatment response in patients with active rheumatoid arthritis: RELIEF 6-month data.

OBJECTIVE: The RELIEF investigation was a 48-week, multicenter, international study comprising 2 phases. Results from the first phase, a 24-week open-label cohort study that evaluated the safety and efficacy of leflunomide, as well as predisposing factors to treatment response, are reported here. METHODS: Patients received leflunomide 100 mg once daily for 3 days, followed by 20 mg once daily thereafter. All adverse events were documented. Efficacy variables were the European League Against Rheumatism (EULAR) response criteria using the Disease Activity Score (DAS 28) responder rate and the response rate according to American College of Rheumatology (ACR) criteria. At Week 24, baseline data were analyzed to determine predictive factors for treatment response. RESULTS: A total of 969 patients were entered in the trial. No adverse events that have not previously been seen with leflunomide were reported. Among 968 evaluable patients, 673 (69.6%) completed 24 weeks of treatment and were responders according to DAS 28 response rate, and 587 (60.6%) completed 24 weeks of treatment and were responders according to ACR 20%. Thus, there was a high correlation between the EULAR and ACR criteria in determining treatment response. In addition, 240 (24.8%) patients had a low DAS 28 (< or = 3.2) and 123 (12.7%) patients fulfilled the disease remission criteria (DAS 28 < 2.6) at the end of the study. CONCLUSION: This study demonstrates that leflunomide is well tolerated, with a safety profile similar to that seen previously in Phase III studies, and confirms the efficacy of leflunomide across a range of patient categories.