Performances of the Assessment of SpondyloArthritis International Society axial spondyloarthritis criteria for diagnostic and classification purposes in patients visiting a rheumatologist because of chronic back pain: results from a multicenter, cross-sectional study.

OBJECTIVE: To evaluate the performances (sensitivity, specificity, and positive and negative predictive values) at diagnosis and study visit of the Assessment of SpondyloArthritis international Society (ASAS) criteria in axial spondyloarthritis in patients with chronic back pain (CBP). A secondary objective was to identify the most contributory item to diagnosis/classify spondyloarthritis. METHODS: We conducted a multicenter, cross-sectional study. Patients were ages <45 years with a history of CBP and seeing a rheumatologist in France. Data included items from the different sets of criteria, checking if present at diagnosis ("diagnosis")/after diagnosis, but at study visit ("classification"), and the rheumatologist's diagnosis at study visit. Statistical analysis included descriptive characteristics and performances for diagnosis and classification. The diagnosis of the rheumatologist was considered the "gold standard." RESULTS: A total of 1,210 patients were eligible for our analysis. Sensitivity and specificity for ASAS axial criteria were 0.76 and 0.94, respectively, and 0.87 and 0.92 for diagnostic and classification purposes, respectively. The positive likelihood ratio of the ASAS axial criteria was 13.6 and 10.30 for diagnostic and classification purposes, respectively. The most contributory items to diagnosis and classification were radiographic sacroiliitis, followed by magnetic resonance imaging sacroiliitis for diagnosis and history of uveitis for classification. CONCLUSION: We confirm the validity of the ASAS criteria for both diagnostic and classification purposes in a clinical setting of patients with CBP.

[Rationale for the use of long-acting injectable risperidone: a survey of French psychiatrists]. / Motifs et délais pour l'initiation de la forme injectable à libération prolongée de la rispéridone: enquête auprès de 399 psychiatres français.

INTRODUCTION: Poor adherence is a major concern for the effectiveness of antipsychotic treatment in patients with schizophrenia. In particular, compliance problems constitute a poor prognostic factor for this disorder due to increasing risk of relapse and hospitalization. As maintaining antipsychotic therapy is a key element to prevent relapse, the use of depot preparations is therefore considered as a useful therapeutic option since it prevents covert non-adherence. When compared with neuroleptics, novel antipsychotic agents are also better tolerated by patients. In this study, the rationale for the use of long-acting injectable risperidone combining the benefits of novel antipsychotic agent and depot preparation is investigated in patients with psychosis. A secondary objective of the study is to assess the level of therapeutic adherence and to confirm the role of its key determinants. METHODS: An observational survey assessed the time and reasons to switch to long-acting risperidone in 1887 hospitalized and community-dwelling patients with psychosis (61.6% schizophrenia) defined by the CIM-10, and treated by 399 psychiatrists with oral risperidone for a recent acute episode. In a cross-sectional study performed under real-life conditions, treatment adherence was assessed by patients themselves using the Medication Adherence Questionnaire (MAQ) and therapeutic alliance was assessed by the 4-Point Alliance Scale (4-PAS). Psychiatrists assessed treatment acceptance using the Compliance Rating Scale (CRS), disease severity using the CGI, and insight using the G12 item from the Positive and Negative Syndrome Scale (PANSS). RESULTS: In the population studied, disorder severity (CGI) was defined as "moderate to marked" in 67.7% and "severe or among the most severe" for 21.1%. Insight (PANSS G12) was defined as normal for 36.6% of patients, moderate for 34.8% and low for 28.6%. The mean time to medication switch was 8 weeks after the start of care of the acute episode. The two main reasons to start the long-acting injectable risperidone were related to non-compliance with oral antipsychotic treatment (92.4%) and intention to improve efficacy (86.4%). Maintenance of a good therapeutic alliance (70.3%) and treatment tolerability (54.6%) were also often cited. For psychiatrists, 41.6% of patients demonstrated reticence or active reluctance to treatment. Therapeutic compliance (MAQ) for oral medication before the long-acting injectable risperidone was started was estimated as "mild" for 53.1% (n=852) of patients. Poor adherence strongly correlated with low insight (P<0.001) and with a disorder estimated as "severe" (P<0.001). Therapeutic alliance was higher for patients with a better level of treatment acceptance assessed by psychiatrists (P<0.001) and with a higher compliance with MAQ estimated by patients (P<0.001). Therapeutic alliance was lower for patients with a disorder defined as "severe" (P<0.001) and with poor insight (P<0.001). CONCLUSION: In this French survey, the two main reasons for psychiatrists to start long-acting injectable risperidone were related to non-compliance with oral antipsychotic treatment and with the desire to improve therapeutic efficacy. In accordance with results of previous studies, insight and therapeutic alliance were found to be associated with poor compliance. The main goal in the treatment of psychotic disorders is to obtain a functional remission and to reduce the incidence of relapse. Considering its improved efficiency and reduced dependence on patient compliance, the use of long-acting injectable risperidone is recommended as a useful therapeutic strategy.

Prevalence and factors associated with uveitis in spondylarthritis patients in France: results from an observational survey.

OBJECTIVE: To accurately estimate the prevalence of and the factors associated with uveitis in spondylarthritis (SpA) patients in France. METHODS: In an observational survey of SpA patients (diagnosis confirmed by the European Spondylarthropathy Study Group and/or Amor's criteria) consulting their rheumatologist for routine followup, we collected information regarding present/past history of uveitis, as well as detailed characteristics of the disease. Factors independently associated with uveitis were determined. RESULTS: From September 2008 to January 2009, 202 rheumatologists participated in the survey and recruited 902 patients (61% men) with a mean ± SD age of 45.3 ± 13.4 years and a mean ± SD disease duration of 10.4 ± 9.6 years. The SpA diagnoses were ankylosing spondylitis (71%), psoriatic arthritis (18%), or other SpA (11%). The HLA-B27 positivity rate was 76%. Uveitis prevalence was 32.2% (95% confidence interval [95% CI] 29.1-35.3%) since psoriasis and inflammatory bowel disease were 22.3% (95% CI 19.5-25.0%) and 8.6% (95% CI 6.7-10.5%), respectively. Recurrence of uveitis occurred in 52.3% and complications occurred in 11.7% of patients. Factors independently associated with uveitis were HLA-B27 positivity (adjusted odds ratio [OR(adj) ] 2.97 [95% CI 1.83-4.81], P < 0.0001) and disease duration (OR(adj) 1.28 [95% CI 1.16-1.41], P < 0.0001 for ≥10 years). CONCLUSION: Results indicate that uveitis is the most common extraarticular feature of SpA, occurring preferentially in HLA-B27-positive patients over the entire course of the disease.

[Impact of nocturia on sleep efficiency in patients with benign prostatic hypertrophy]. / Etude observationnelle nationale (Association française d'urologie) de l'impact de la nycturie sur le sommeil des patients porteurs d'une hyperplasie bénigne de la prostate.

OBJECTIVE: To assess sleep efficiency in patients presenting with nocturia and symptomatic benign prostatic hypertrophy (BPH). MATERIAL AND METHODS: This prospective observational survey was carried out in France by 113 urologists. A total of 1376 patients (mean+/-SD age: 68.8+/-9.0 years) consulting for BPH with greater than two nocturia episodes per 24 hours were assessed with a mean I-PSS score of 15.5+/-6.4 (symptoms greater than 19 [severe] in 26.9% of cases). Patients used a sleep diary to record the previous night's total; sleep efficiency is expressed as percentage ratio, representing the total amount of actual sleep between initial sleep onset and final awakening. Sleep disorders were assessed using HD-43 questionnaire based on International classification of sleep disorders. RESULTS: 29.2% of the patients suffered from chronic insomnia, considered as primary insomnia (in 29.5% of cases) or related to either BPH (63.0%); snoring/sleep apnoea in 12.5% of cases. The mean sleep efficiency index was 87.2+/-13.7% and appeared to be significantly lower in BPH-related insomnia. Significantly lower sleep efficiency index values were observed as the severity (I-PSS score) of the BPH symptoms increased (89.5+/-12.1% for mildly symptomatic BPH vs. 84.0+/-15.6% for severely symptomatic BPH, P<0.001). Sleep efficiency index lowered with nocturia frequency (89.8+/-11.3% for two nocturia episodes vs. 80.4+/-17.3% for five nocturia episodes or more, P<0.001) and chronic insomnia frequency increased with nocturia frequency (21.4% for two nocturia episodes vs. 45.2% for five nocturia episodes or more, P<0.001). CONCLUSIONS: Insomnia is frequent in patients presenting with BPH-related lower urinary tract symptoms (LUTS) and is mainly secondary to these LUTS. There is a significant correlation between the frequency of nocturia and the severity of insomnia.

History of 7,093 patients with lower urinary tract symptoms related to benign prostatic hyperplasia treated with alfuzosin in general practice up to 3 years.

OBJECTIVES: As we have previously published 4 articles reporting the treatment of 7,093 clinical benign prostatic hyperplasia (BPH) patients treated with alfuzosin in a 3-month open-labelled study which was subsequently extended to 12, 24, and 36 months, the objective of this article is to provide additional data on dropouts, acute urinary retention (AUR), progression to surgery, and safety under the natural conditions of general practice, paying special attention to the predictive factors. METHODS: 7,093 patients were initially enrolled by 1,812 centers for up to 3 months. Subsequently 1,508, 1,325, and 812 general practitioners agreed to extend the study up to 12, 24, and 36 months, respectively, which corresponds to 4 patient populations. RESULTS: The baseline symptom profile of patients who completed the study was identical to that of patients who dropped out (because the center resigned or during treatment). In the 4 patient populations, the percentage of patients per month who dropped out, experienced adverse effects, AUR and surgery were 0. 6-1.6, 0.1-0.5, 0.01-0.03, and 0.1-0.3%, respectively. The classes of symptom severity were not predictive for dropouts: 3.5, 12.6, 20, and 14.3% of the severe patients dropped out during treatment versus 4.2, 13.7, 22.9, and 14.0% of the moderate patients who dropped out up to 3, 12, 24, and 36 months, respectively. Safety was satisfactory regarding the number of adverse events and blood pressure measurement. No retrograde ejaculation was reported. CONCLUSION: Under the natural conditions of general practice the reasons for dropping out were not correlated with symptom severity.

One-year follow-up of 2829 patients with moderate to severe lower urinary tract symptoms treated with alfuzosin in general practice according to IPSS and a health-related quality-of-life questionnaire. BPM Group in General Practice.

OBJECTIVES: To determine the effectiveness of alfuzosin on symptom reduction, patients' perceived health-related quality of life (HRQL) improvement, adverse outcomes, treatment failure, and progression to acute urinary retention and prostate surgery in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH) in a 1-year prospective, open-labeled study. METHODS: A total of 2829 patients (mean age 65.9 years) were included in the study and received either alfuzosin 2.5 mg three times daily or alfuzosin slow release 5 mg twice daily. The evaluation was based on the International Prostate Symptom Score (IPSS), the eighth IPSS question, and a nine-item BPH HRQL questionnaire (BPHQL9) exploring well-being, the patient's perceived sexual life, and BPH-specific interferences with activities. RESULTS: A total of 2442 patients (86. 3%) completed the study; the main reasons for noncompletion were adverse events (n = 141, 5.0%), lack of efficacy (n = 136, 4.8%), and death (n = 48, 1.7%); 121 patients (4.3%) underwent prostate surgery, and 33 patients (1.2%) experienced acute urinary retention. No correlation was found between noncompletion and prostate volume or baseline severity. The distribution of patients (in percentages) according to the IPSS, IPSS question 8, and BPHQL9 classes of severity (mild/moderate/severe) at baseline was 1.9/49.0/49.1, 0. 7/65.5/33.8, and 7.7/50.4/41.9, respectively, and at 1 year was 47. 4/50.3/2.4, 34.1/64.9/1.0, and 39.0/50.9/10.1, respectively. The IPSS (19.5 +/- 0.1) was reduced by 49.6% (9.9 +/- 0.1) at 6 months and by 53.8% (11.1 +/- 0.1) at 12 months. Symptom reduction strongly correlated with the initial symptom severity (P <0.0001). The BPHQL9 score (34.6 +/- 0.3) gradually improved up to 12 months (52 +/- 0.4; +93.3%), and this improvement involved all three dimensions. Vertigo (n = 53, 1.9%), hypotension (n = 47, 1.6%), and dizziness (n = 16, 0. 6%) were the most frequent adverse events. CONCLUSIONS: This study confirms the effectiveness of alfuzosin and the need to include HRQL measurement in the decision-making process when assessing patients with lower urinary tract symptoms.

[Prospective follow-up of 3,228 patients suffering from clinical benign prostatic hyperplasia (BPH) treated for 3 years wi alfuzosin in general practice. BPH Group in General Practice]. / Suivi prospectif de 3.228 patients souffrant d'une hypertrophie bénigne de la prostate (HBP) clinique traités pendant 3 ans par l'alfuzosine en médecine générale. Groupe HBP en Médecine Générale.

OBJECTIVE: To determine (a) the amplitude and duration of reduction of the symptom score and improvement of the HRQL score (including sexual function), (b) the adverse effects and (c) the incidence of acute urinary retention and prostatic surgery during the 3 years of alfuzosin treatment. MATERIAL AND METHODS: 3,228 patients suffering from BPH were included by 812 centers in a 3-year open prospective study and were treated with alfuzosin (immediate release) at the recommended dosage. A symptom score (modified Boyarsky) and a specific HRQL score, comprising 20 items including 3 questions on sexuality (Urolifetm BPH Qol20) were self-administered on inclusion and after 3, 6, 12, 18, 24, 30 and 36 months. RESULTS: 2,579 patients (79.9%) completed the 3 years of the study. The symptom score was significantly decreased by 54% at 3 months and this reduction was maintained until 36 months (-48.4%); the HRQL score was significantly improved by 45.4% at 12 months and this improvement was maintained until 36 months (+43.4%). Alfuzosin was well tolerated: the qualitative and quantitative distribution of adverse effects was identical to that previously observed in placebo-controlled trials (vertigo-dizziness: 2.1%). Adverse effects were responsible for 4.2% of drop-outs from the trial. 120 patients (3.7%) were operated for BPH and 9 patients (0.3%) developed acute urinary retention. CONCLUSION: This prospective study confirms the long-term safety of use of alfuzosin under routine general practice conditions and emphasizes the need to measure HRQL in the context of the patient's opinion.

[alpha-beta L-aspartate magnesium in treatment of chronic benzodiazepine abuse: controlled and double-blind study versus placebo]. / alpha-beta L-aspartate de magnésium dans l'arrêt de la consommation chronique des benzodiazépines: étude contrôlée en double aveugle versus placebo.

OBJECTIVE: To evaluate the efficacy of alpha-beta L-Aspartate Magnesium (Asp Mg) in discontinuation of long-term benzodiazepine use and to search for a predictive model of success for BZD cessation. METHOD: Using a double-blind procedure, 144 patients selected as chronic users of one of 3 BZD lorazepam, alprazolam or bromazepam (duration of use > 6 months; regular dose > or = 3 mg lorazepam equivalent) and with clinical remission (score on Hamilton-Anxiety < 14; Raskin-Depression < 6) had entered a controlled study (versus placebo) and were randomized in two parallel groups. The trial was conducted on 3 consecutive phases (co-administration of Asp Mg or placebo with BZD during 1 month; gradual taper of BZD during 1 month; follow-up during a third month after complete BZD discontinuation, with urinary BZD control on d75 and d90). RESULTS: The intent-to-treat analysis showed at the endpoint an overall rate of 80% of "BZD discontinuation" and of 35.4% of "BZD cessation without withdrawal" in the total population (no significant intergroup differences were observed on these rates). However, there were some tendencies to positive differences between Asp Mg versus placebo on the following: 1) prolonged delay of BZD use if reintake (30 days vs 20 days, p [log-rank] = 0.5); 2) reduction of withdrawal intensity: 11% of important difficulties during BZD cessation versus 23% with placebo (p = 0.2) and on Benzodiazepine Withdrawal Symptoms Questionnaire (BWSQ) (final score 4.0 vs 4.8, p = 0.10); 3) lower modification of anxiety during BZD tapering and discontinuation (rate of increase on HAM-A between d30-d90 of 6% vs 23% in placebo group, p = 0.10). Moreover, 3 predictive factors of "success" (BZD cessation without withdrawal phenomenon) were identified by uni- and multivariate analysis with logistic regression: chronicity of anxiety disorder (p = 0.04) and amplitude of BWSQ change during tapering phase (p < 0.0001) as negative factors; and initial score of Speilberger Anxiety Inventory "Anxiety-Trait" (p = 0.002) as positive factor. A predictive model is constructed according to these 3 parameters. Further clinical trials are needed to explore the benefits of alpha-beta L-Aspartate Magnesium in different criteria of prescription (dosage, duration of treatment, repetitive cures...).

Clinical uroselectivity: a 3-year follow-up in general practice. BPH Group in General Practice.

The objectives of this open-labeled study were to assess the clinical uroselectivity of alfuzosin in a long-term follow-up study in general practice. A total of 3,228 patients with clinical benign prostatic hyperplasia (BPH) from 812 centers were included in a prospective 3-year open-labeled study and treated with alfuzosin (immediate-release formulation) at the recommended dosage. Symptom score (Boyarsky, modified) and a 20-item BPH-specific health related quality of life (HRQL) score (Urolife BPH QoL 20), which included three questions on sexuality, were self-administered at baseline, 3, 6, 12, 18, 24, 30 and 36 months. Symptom score was significantly reduced by 54% at 3 months and this reduction was maintained up to 36 months; the HRQL score was significantly improved by 45.4% at 12 months and this improvement was also maintained up to 36 months. Alfuzosin was well tolerated: the quantitative and qualitative distribution of adverse events (AEs) was similar to that previously observed in placebo-controlled studies. 4.2% of the patients dropped out due to AEs. This study confirms the long-term safety profile of alfuzosin in general practice and highlights the need to measure HRQL in the context of clinical uroselectivity.

Three-year prospective study of 3228 clinical BPH patients treated with alfuzosin in General Practice.

Objectives: To investigate (a) the magnitude and durability of symptom score reduction and HRQL score improvement (including sexual drive); (b) adverse outcomes; and (c) progression to acute urinary retention and prostate surgery up to three years of treatment with alfuzosin. Methods: Three thousand two hundred and twenty-eight BPH-patients out of 812 centers were included in a prospective three-year open-labelled study and treated with alfuzosin (immediate release formulation) at the recommended dosage. A symptom score (Boyarsky modified) and a 20-item BPH specific HRQL score including three questions of sexuality (Urolife(TM) BPH QoL 20) were self-administered at baseline, 3, 6, 12, 18, 24, 30, and 36 months. Results: Two thousand five hundred and seventy-nine patients (79.9%) completed the study at the end of three years. Symptom score was significantly reduced by 54% at 3 months and this reduction was maintained up to 36 months (-48.4%); HRQL score was significantly improved by 45.4% at 12 months and this improvement was maintained up to 36 months (+43.4%). Alfuzosin was well tolerated: the quantitative and qualitative distribution of adverse events was similar to that previously observed in placebo-controlled studies (vertigo/dizziness: 2.1%). Adverse events accounted for 4.2% of the drop-outs. 120 patients (3.7%) were operated on for BPH and nine patients (0.3%) experienced acute urinary retention. Conclusion: This medical outcomes study confirms the long-term safety profile of alfuzosin in the naturalistic conditions of general practice and highlights the need to measure HRQL in the context of patient's preferences.

Construction and validation of a short-form benign prostatic hypertrophy health-related quality-of-life questionnaire. BPH Group in General Practice.

OBJECTIVE: To construct and validate a short-form benign prostatic hypertrophy (BPH) health-related quality-of-life (HRQL) questionnaire which is more practical in use and as informative as the 20-item visual analogue scale questionnaire (QOL20) previously validated in French. PATIENTS AND METHODS: From the factorial structure of the QOL20, a nine-item questionnaire (QOL9) was constructed using stepwise linear regression and factorial analysis. The feasibility and reliability of the QOL9 were analysed in a cross-sectional case-control study and a longitudinal cohort study, including symptomatic patients with BPH treated for 6 months with an alpha 1-blocker (alfuzosin). RESULTS: The reduction of the QOL20 to QOL9 showed a minimal loss of information (90-95% of the variance of QOL20 was explained by QOL9) and lead to a three-dimensional structure: well being, patients' perceived sexual-life status, and BPH interference with activities. The QOL9 was practical in use (completion rate 87-100%; duration of completion at inclusion 11.6, SD 2.0 min), consistent (Cronbach's alpha > 0.7), reliable (intraclass correlation coefficient > 0.80) and responsive (effect-size index 0.9, SD 0.01 in the longitudinal study). CONCLUSIONS: The QOL9 is a good BPH HRQL questionnaire, including an assessment of patients' perceived sexual-life status; it easy to administer, accurate, reproducible and responsive to change with treatment. We suggest that the QOL9 be substituted for the QOL20 and administered in addition to the International Prostate Symptom Score to obtain a better assessment of the patients' perception of their disease.

[Drug interactions in chronic prescription]. / Interacciones farmacológicas en la prescripción crónica.

OBJECTIVE: Application of computerized program for detection of potential drug interactions (PDI) in chronic prescriptions in four primary care centers. To evaluate the clinical significance of PDI identified according to clinical criterions. DESIGN: An observational crossover study. SETTING: Clutat Vella health district (City of Barcelona). MEASUREMENTS AND RESULTS: Using information of Consejo General de Colegios Oficiales de Farmaceuticos databases and the chronic prescriptions database of the primary care centers, computerized drug-interaction system have been developed for detection of PDI in patients. A panel of primary care physicians and clinical pharmacists developed criteria that were used to evaluate the clinical significance of PDI. 9840 Cards of Authorized Prescription (CAP) were analyzed, 36108 medicaments and 42877 drugs. A total of 2140 patients were involved for a total of 3406 PDI, 21.75% of patients with CAP. Clinical signification for the panel was found in 40.07% of these 3406 PIF; 3.78% were suggest to avoid the association drugs. CONCLUSIONS: The incidence of PDI with clinical signification are lower than other studies of the literature; it suggest a appropriate knowledge of drug prescription. The application of computerized program make much more easy the detection of adverse drug interactions in chronic prescription.

[Development and validation of a quality of life scale associated with health status, specific for benign hypertrophy of the prostate and including a sexuality evaluation scale]. / Construction et validation d'une échelle de qualité de vie liée à l'état de santé, spécifique de l'hypertrophie bénigne de la prostate et comportant une échelle d'évaluation de la sexualité.

In order to develop a quality of life scale related to the state of health, specific for benign prostatic hypertrophy, a group of French specialists constructed a self-administered questionnaire, designed to complete the usual evaluations of the efficacy and safety of new medical treatments for this disease. This questionnaire was well accepted, reliable, clinically valid and sensitive to clinical changes occurring in a given patient. It includes questions concerning sexuality. An abbreviated form of the questionnaire was then developed in order to obtain a tool suitable for use in daily practice, in combination with the International Prostate Symptom Score (IPPS).