The purpose of this study was to compare the efficacy and tolerance of a single dose of the acetaminophen 400 mg-codeine 25 mg combination (ACC) aspirin 1000 mg (A) and a placebo (P) for the treatment of acute migraine attack. The study design was randomized, multicentre, double-blind and double dummy with cross-over on three periods. Of the 198 patients who had three attacks 29.8%, 52.3% and 49.7% had recorded the complete or almost complete disappearance of the pain at 2 h after P, A and ACC respectively. When compared with the placebo, the difference was significant for the A and ACC. When complete disappearance of pain at 2 h was used as a criterion, no significant difference was observed. These results enabled the sensitivity of the evaluation criteria suggested for clinical trials of migraine attack to be discussed.
Giving RA patients access to the interactive Sanoia e-health platform led to a small improvement in patient-perceived patient-physician interactions. A disjunction between patient satisfaction and access to the platform was noted. E-Health platforms are promising in RA.
ObjectivesTo explore beliefs and apprehensions about disease and its treatment in patients with rheumatoid arthritis and spondyloarthritis.Methods25 patients with rheumatoid arthritis and 25 with spondyloarthritis participated in semi-structured interviews about their disease and its treatment. The interviews were performed by trained interviewers in participants' homes. The interviews were recorded and the main themes identified by content analysis.ResultsPatients differentiated between the underlying cause of the disease, which was most frequently identified as a hereditary or individual predisposition. In patients with rheumatoid arthritis, the most frequently cited triggering factor for disease onset was a psychological factor or life-event, whereas patients with spondyloarthritis tended to focus more on an intrinsic vulnerability to disease. Stress and overexertion were considered important triggering factors for exacerbations, and relaxation techniques were frequently cited strategies to manage exacerbations. The unpredictability of the disease course was a common source of anxiety. Beliefs about the disease and apprehensions about the future tended to evolve over the course of the disease, as did treatment expectations.ConclusionsPatients with rheumatoid arthritis and spondyloarthritis hold a core set of beliefs and apprehensions that reflect their level of information about their disease and are not necessarily appropriate. The physician can initiate discussion of these beliefs in order to dispel misconceptions, align treatment expectations, provide reassurance to the patient and readjust disease management. Such a dialogue would help improve standards of care in these chronic and incapacitating diseases.
Introduction There is little sound information on how urologists manage erectile dysfunction (ED) arising after radical prostatectomy (RP) in a real-world situation. Aim To perform a national survey of how French urologists manage ED after RP in routine practice. Main Outcome Measures Choice of first-line treatment, type of treatment (rehabilitation of erectile function vs. treatment on demand for intercourse), and timing and duration of treatment. Methods All French urologists were invited to take part in a survey; 59.7% accepted provisionally (760/1,272). They received the survey questionnaire and 10 patient data forms to be completed during the visits of the first 10 patients with fewer than 12 months follow-up post-RP. These were returned to an independent third party for analysis. Results The final response rate was 535/1,272 (42%). Before performing RP, 80% of the urologists assessed sexual activity and 76% erectile function; 9% did neither. Thirty-eight percent reported that they systematically proposed ED treatment to their patients post-RP (“routine prescribers”). The remainder was treated on occasion, either at the patients' request (49%) or at their own discretion (13%). Routine prescribers tended to be younger and had performed more RPs in the preceding year. Most urologists (88%) always used the same first-line treatment: regular intracavernosal injections (ICIs) for rehabilitation, 39%; ICI on demand for intercourse, 30%; phosphodiesterase type 5 (PDE5) inhibitors on demand, 16%, or regular PDE5 inhibitors for rehabilitation, 8%; alternating ICI and PDE5 inhibitors, 7%; vacuum device, <1%. ED treatment was initiated within 3 months of RP by 72% of the urologists (92% of routine prescribers). The percentage of urologists recommending ED treatment for 6 months was 20%, 38% for 1 year, and 33% for 2 years. Conclusion ED was commonplace after RP. French urologists reported a proactive attitude to ED treatment, many favoring pharmacologic rehabilitation therapy. ICI was their first-line treatment of choice.
Objective.To compare the clinical efficacy of certolizumab pegol (CZP) with that of other anticytokine agents indicated for the treatment of rheumatoid arthritis (RA) with identical therapeutic indication (anti-tumor necrosis factor-α, anti-interleukin 1 or 6), with the objective of determining the noninferiority of CZP.Methods.A systematic review was performed to identify randomized controlled trials that assessed the efficacy of anticytokine agents in combination with conventional disease-modifying antirheumatic drugs (DMARD) after 6 months of treatment, using the American College of Rheumatology (ACR) response criteria, in patients with RA who have shown inadequate response to DMARD including methotrexate. Indirect treatment comparisons were carried out by a multiple-treatment Bayesian random-effects metaanalysis. Data were analyzed using the Markov chain Monte Carlo simulation. Noninferiority of CZP was assessed in comparison with a predefined equivalence margin of 5%.Results.Nineteen placebo-controlled studies were identified: 14 evaluated the efficacy of 5 anti-TNF-α agents (infliximab, etanercept, adalimumab, golimumab, CZP) and 5 evaluated efficacy of 2 anti-interleukin agents (anakinra, tocilizumab). Every treatment showed significant efficacy versus placebo in individual studies. The multiple-treatment metaanalysis showed a highest OR for CZP on ACR20 response. Metaanalysis indicates that the efficacy of CZP according to ACR20 response is superior to that of infliximab, adalimumab, and anakinra, and equivalent or superior to that of etanercept, golimumab, and tocilizumab. According to ACR50 response, the efficacy of CZP is equivalent or superior to that of all other anticytokines.Conclusion.Results of this original multiple-treatment Bayesian metaanalysis indicate that certolizumab pegol is at least as efficacious as the preexisting antirheumatic anticytokine biotherapies.
Introduction Little stress has been placed on patients' satisfaction with regard to management of erectile dysfunction (ED) after radical prostatectomy (RP) and on how physicians' and patients' views may differ in this respect. Aim To assess the extent to which urologists' perceptions of their patients' expectations and the actual needs expressed by these patients coincide with regard to ED and its management. Methods Those French urologists who provisionally accepted to participate in the survey (760/1,272; 59.7%) received a physician survey instrument, 10 patient data forms to be completed during the first 10 consultations of patients who had undergone RP less than 12 months previously, and 10 copies of a questionnaire for patients to complete. Main Outcome Measures Patient-reported sexual activity, satisfaction with sexual activity (Male Sexual Health Questionnaire), and treatment expectations; urologists' subjective assessment of the importance given by their patients to ED; the timing they propose for starting ED treatment. Results Overall, 535/1,272 urologists (42%) returned the physician survey instrument (45.6 ± 8.7 years, 28–67) and 2,644 patients completed the patient questionnaire (64.0 ± 6.1 years, 44–79). The percentage of patients having intercourse pre RP was highly age-dependent (89% at 55–59 years; 56% at ≥70 years); 70–75% of patients claimed to be satisfied with their pre-RP sexual activity. Post RP, 27–53% of patients (depending upon length of follow-up), who were sexually active pre RP, had intercourse. Only 18% (<5 months' follow-up) or 28% (>5 months' follow-up) were satisfied. Over half (53%)—and especially the younger patients—expected early ED treatment (1 or 3 months post RP). Agreement between patients' expectations and urologists beliefs on timing of ED treatment was poor. At the 1- or 2-month visits, 73% of patients were already finding ED frustrating. Conclusions Erectile dysfunction is an important issue for patients who have undergone RP. Urologists tend to underestimate patients' distress and desire for early treatment.
ObjectivesTo develop and validate an outcome measure for assessing fears in patients with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA).MethodsFears were identified in a qualitative study, and reformulated as assertions with which participants could rate their agreement (on a 0–10 numeric rating scale). A cross-sectional validation study was performed including patients diagnosed with RA or axSpA. Redundant items (correlation >0.65) were excluded. Internal consistency (Cronbach’s α) and factorial structure (principal component analysis) were assessed. Patients were classified into fear levels (cluster analysis). Associations between patient variables and fear levels were evaluated using multiple logistic regression.Results672 patients were included in the validation study (432 RA, 240 axSpA); most had moderate disease activity and were prescribed biologics. The final questionnaire included 10 questions with high internal consistency (α: 0.89) and a single dimension. Mean scores (±SD) were 51.2 (±25.4) in RA and 60.5 (±22.9) in axSpA. Groups of patients with high (17.2%), moderate (41.1%) and low (41.7%) fear scores were identified. High fear scores were associated with high Arthritis Helplessness Index scores (OR 6.85, 95% CI (3.95 to 11.87)); high Hospital Anxiety and Depression Scale anxiety (OR 5.80, 95% CI (1.19 to 4.22)) and depression (OR 2.37, 95% CI (1.29 to 4.37)) scores; low education level (OR 3.48, 95% CI (1.37 to 8.83)); and high perceived disease activity (OR 2.36, 95% CI (1.10 to 5.04)).ConclusionsOverall, 17.2% of patients had high fear scores, although disease was often well controlled. High fear scores were associated with psychological distress. This questionnaire could be useful both in routine practice and clinical trials.
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