The Economic Burden of Severe Osteoporotic Fractures in the French Healthcare Database: The FRACTOS Study.

Osteoporosis carries a high medical, economic, and societal burden principally because of the risk of severe fractures. The objective of this cost-of-illness study was to describe health resource utilization and associated costs in all patients aged ≥50 years hospitalized for a severe osteoporotic fracture over a 6-year period (2009 to 2014) in France. Data were extracted from the French national healthcare database (SNDS) on all health care resource utilization between the index date (date of hospitalization for first fracture during the enrollment period) and study end (December 31, 2016) or until the patient died. Costing was restricted to direct costs and determined from the payer perspective. Variables related to costs were identified through multivariate logistic regression analysis. A total of 356,895 patients were included (median follow-up 39.1 months). In the year after the index fracture, 36,622 patients (10.5%) were rehospitalized for a fracture-related reason. Only 18,474 (5.3%) underwent bone densitometry and 58,220 (16.7%) received a specific treatment. The total annual per capita osteoporosis-related cost in the year after the index severe osteoporotic fracture was €18,040 (from €8598 for multiple ribs to €21,085 for hip fracture) of which €17,905 was incurred by fracture-related costs. The cost incurred by management of osteoporosis was €135. Over years 2 to 5, the mean annual per capita costs of fracture treatment (€806, mostly attributable to the treatment of refractures) continued to dominate those of osteoporosis management (€99). Total annual cost of care was €1260 million (year 2014). Variables associated with higher cost were older age, male sex, site of fracture, a history of prior osteoporotic fracture, and the number of refracture events. The 5-year cost of severe osteoporotic fractures to the French health care system is high and mostly attributable to the treatment of refractures. Improved fracture prevention measures in patients with osteoporosis is crucial to reduce the economic burden of the disease. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Refracture and mortality following hospitalization for severe osteoporotic fractures: The Fractos Study.

Severe osteoporotic fractures (hip, proximal humerus, pelvic, vertebral and multiple rib fractures) carry an increased risk of mortality. This retrospective cohort study in the French national healthcare database aimed to estimate refracture and mortality rates after severe osteoporotic fractures at different sites, and to identify mortality-related variables. A total of 356,895 patients hospitalized for severe osteoporotic fracture between 2009 and 2014 inclusive were analyzed. The cohort was followed for 2 to 8 years up to the study end or until the patient died. Data were extracted on subsequent hospitalizations, refracture events, treatments, comorbidities of interest and survival. Time to refracture and survival were described using Kaplan-Meier analysis by site of fracture and overall. Mortality risk factors were identified using a Cox model. Hip fractures accounted for 60.4% of the sample (N = 215,672). In the 12 months following fracture, 58,220 patients (16.7%) received a specific osteoporosis treatment, of whom 21,228 were previously treatment-naïve. The 12-month refracture rate was 6.3% (95% confidence interval [CI], 6.2%-6.3%), ranging from 4.0% (95% CI, 3.7%-4.3%) for multiple rib fractures to 7.8% (95% CI, 7.5%-8.1%) for pelvic fractures. Twelve-month all-cause mortality was 12.8% (95% CI, 12.7%-12.9%), ranging from 5.0% (95% CI, 4.7%-5.2%) for vertebral fractures to 16.6% (95% CI, 16.4%-16.7%) for hip fractures. Osteoporosis-related mortality risk factors included fracture site, previous osteoporotic fracture (hazard ratio 1.21; 95% CI, 1.18-1.23), hip refracture (1.74; 95% CI, 1.71-1.77), and no prior osteoporosis treatment (1.24; 95% CI, 1.22-1.26). Comorbid cancer (3.15; 95% CI, 3.09-3.21) and liver disease (2.54; 95% CI, 2.40-2.68) were also strongly associated with mortality. In conclusion, severe osteoporotic fractures, including certain non-hip nonvertebral fractures, carry a high burden in terms of mortality and refracture risk. However, most patients received no anti-osteoporotic treatment. The findings emphasize the importance of better management of patients with severe fractures, and of developing effective strategies to reduce fracture risk in patients with osteoporosis. © 2021 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

Immunotherapy with grass pollen tablets reduces medication dispensing for allergic rhinitis and asthma: A retrospective database study in France.

BACKGROUND: Moderate-to-severe allergic rhinitis (AR) may increase the risk of developing or worsening asthma, whereas treatment of AR with subcutaneously or sublingual allergen immunotherapy (SLIT) may slow this progression. METHODS: In a retrospective real-world analysis, prescription fulfilment data were gathered from French retail pharmacies between 1 March 2012 and 31 December 2016. Using linear regression analyses, patients having received at least two prescriptions of grass pollen SLIT tablets over at least 2 successive years were compared with control patients having received symptomatic medications only. RESULTS: A total of 1099 SLIT patients and 27 475 control patients were included in the main analysis. With regard to symptomatic AR medication dispensing, we observed a 50% decrease in the pre-index/follow-up ratio in the SLIT group, a 30% increase in the control group without age matching (P < 0.0001 vs SLIT) and a 20% increase in the control group with age matching (P < 0.0001 vs SLIT). During the follow-up, 11 (1.8%) and 782 (5.3%) patients initiated asthma treatment in the SLIT and control groups, respectively. The relative risk of medication dispensing for new asthma was lower in the SLIT group (by 62.5% [29.1%-80.1%] without age matching (P = 0.0025) and by 63.7% [31.5%-80.7%] with age matching; P = 0.0018). SLIT was also associated with slower progression of asthma medication dispensing during the follow-up period, relative to the control group (regression coefficient: -0.58 [-0.74 to 0.42] without age matching (P < 0.0001) and -0.61 [-0.76 to -0.46] with age matching; P < 0.0001). CONCLUSION: Prescription of grass pollen SLIT tablets reduced the dispensing of AR and asthma medications in real life.

Real-life cost of vitamin K antagonist treatment in patients with non-valvular atrial fibrillation in France in 2013.

AIMS: Data highlighting the cost drivers for non-valvular atrial fibrillation (NVAF) patients in terms of vitamin K antagonist (VKA) treatment and monitoring are lacking in France. This study aimed to evaluate the real-life daily cost of VKA treatment in 2013, in French patients suffering from NVAF. METHODS: This longitudinal observational study was performed using the EGB (Echantillon Généraliste des Bénéficiaires) database, a random sample of the French national insurance (NHI) database, which covers 80% of the population. All adult patients whose first NVAF anticoagulant treatment in 2013 was a VKA were analyzed. Costs were calculated for the duration of follow-up and then divided by the number of days of therapy. The analysis was performed both from the French NHI perspective (amount reimbursed by the NHI) and from a collective perspective. RESULTS: In this study, 3,254 NVAF patients treated with VKA in 2013 were included, and this sample comprised 52.6% males. The mean daily cost of VKA treatment was €1.13 (±1.18) according to the collective perspective (89.4% of this cost was associated to INR measurement) and €1.05 (±1.16) according to the NHI perspective. LIMITATIONS: As diagnoses associated with procedures are not available in the EGB database, proxies were used, and an algorithm was created to define the AF population. CONCLUSIONS: This analysis is the first to consider an exhaustive spectrum of the costs of VKA treatment in France using EGB data. VKA medication requires exhaustive follow-up, and, thus, associated costs are important. The results of the present study confirmed this close follow-up for VKA patients, making the cost of treatment by VKA nearly 10-times more expensive than the cost of medication itself.

Cross-cultural validation of Lupus Impact Tracker in five European clinical practice settings.

Objectives: The aim was to evaluate the cross-cultural validity of the Lupus Impact Tracker (LIT) in five European countries and to assess its acceptability and feasibility from the patient and physician perspectives. Methods: A prospective, observational, cross-sectional and multicentre validation study was conducted in clinical settings. Before the visit, patients completed LIT, Short Form 36 (SF-36) and care satisfaction questionnaires. During the visit, physicians assessed disease activity [Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI], organ damage [SLICC/ACR damage index (SDI)] and flare occurrence. Cross-cultural validity was assessed using the Differential Item Functioning method. Results: Five hundred and sixty-nine SLE patients were included by 25 specialists; 91.7% were outpatients and 89.9% female, with mean age 43.5 (13.0) years. Disease profile was as follows: 18.3% experienced flares; mean SELENA-SLEDAI score 3.4 (4.5); mean SDI score 0.8 (1.4); and SF-36 mean physical and mental component summary scores: physical component summary 42.8 (10.8) and mental component summary 43.0 (12.3). Mean LIT score was 34.2 (22.3) (median: 32.5), indicating that lupus moderately impacted patients' daily life. A cultural Differential Item Functioning of negligible magnitude was detected across countries (pseudo- R 2 difference of 0.01-0.04). Differences were observed between LIT scores and Physician Global Assessment, SELENA-SLEDAI, SDI scores = 0 (P < 0.035) and absence of flares (P = 0.004). The LIT showed a strong association with SF-36 physical and social role functioning, vitality, bodily pain and mental health (P < 0.001). The LIT was well accepted by patients and physicians. It was reliable, with Cronbach α coefficients ranging from 0.89 to 0.92 among countries. Conclusion: The LIT is validated in the five participating European countries. The results show its reliability and cultural invariability across countries. They suggest that LIT can be used in routine clinical practice to evaluate and follow patient-reported outcomes in order to improve patient-physician interaction.

Quality of Life in Patients Suffering from Active Exudative Age-Related Macular Degeneration: The EQUADE Study.

PURPOSE: Age-related macular degeneration (AMD) is the main cause of visual loss in the elderly population. With the use of anti-vascular endothelial growth factor, the visual outcomes of exudative AMD patients have been improved. This study was aimed at assessing the quality of life (QoL) of exudative AMD patients treated with ranibizumab and at determining its drivers in a real-life setting. METHODS: We performed a national, cross-sectional, observational survey based on questionnaires sent to members of French associations relative to AMD between December 2012 and March 2013. Patients suffering from exudative AMD with at least one intravitreal injection of ranibizumab within the last 6 months were included. Demographics, AMD characteristics, visual acuity (VA) and past and ongoing treatments were collected. The 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) was self-administered. A multivariate model was used to identify QoL drivers. RESULTS: 416 questionnaires fulfilled the complete criteria for both QoL and cost analyses. The mean age of exudative AMD patients was 78.0 years and bilateral involvement was reported in 60.4%. The overall mean QoL score was 53.4. Mental health, driving and role difficulties were the most widely affected domains. After bivariate analyses, long-term illness status, worse VA and higher number of unpaid aids were associated with worse QoL, with odds ratios of 2.4, 5.2 and 11.6, respectively. The mean cost per year and per patient was 1,741 EUR. The main components of costs were aids and services and the purchase of visual equipment. CONCLUSIONS: The main predictors of QoL in exudative AMD patients treated with ranibizumab are VA outcomes, home healthcare and social services provided to the patients.

Clinical profile and direct medical cost of care of adults presenting with systemic lupus erythematosus in Italy.

OBJECTIVES: To determine the clinical profile and estimate the annual direct medical cost of care of adult patients with active, autoantibody positive systemic lupus erythematosus (SLE) in Italy. METHODS: A two-year, retrospective, multicentre, observational study was conducted from January to May 2011. Patients' characteristics, SLE disease activity and severity, rate of flares, healthcare consumption (e.g. medications, etc.) were evaluated. Medical costs were assessed from the Italian National Health Insurance perspective. RESULTS: Four centres enrolled 96 eligible patients, including 85.4% women. Patients were equally stratified per disease severity (severe SLE: 51%). The mean (SD) age was 42.9 (13.8) years. At baseline, SLE duration was 12.6 (7.2) years. The mean (SD) SELENA-SLEDAI score was higher in severe than in non-severe patients 9.2 (6.4) vs. 3.3 (3.1) (p<0.001). The mean (SD) SLICC/ACR index score was similar in the two subgroups: 0.4 (0.8) vs. 0.3 (0.8). Over the study period, severe patients experienced on average 0.73 (0.56) flares/year and non-severe patients 0.57 (0.63). The annual medical cost was 1.6 times higher in severe than in non-severe patients (€2,101 vs. €1,320; p=0.031). The cost of medications was also 2.5 times higher in severe patients (€1101 vs. €445, p=0.007). Low C3/C4 complement levels and each severe flare incremented the annual cost of €550 (p=0.011) and €465 (p=0.02), respectively. CONCLUSIONS: The medical cost of SLE in Italy is related to disease severity and flares. Medications identified as the main cost drivers, and low C3/C4 complement levels and severe flares as the main cost predictors, increased significantly the cost of SLE management.

The daily cost of ICU patients: A micro-costing study in 23 French Intensive Care Units.

OBJECTIVES: To estimate the daily cost of intensive care unit (ICU) stays via micro-costing. METHODS: A multicentre, prospective, observational, cost analysis study was carried out among 21 out of 23 French ICUs randomly selected from French National Hospitals. Each ICU randomly enrolled 5 admitted adult patients with a simplified acute physiology II score ≥ 15 and with at least one major intensive care medical procedure. All health-care human resources used by each patient over a 24-hour period were recorded, as well as all medications, laboratory analyses, investigations, tests, consumables and administrative expenses. All resource costs were estimated from the hospital's perspective (reference year 2009) based on unitary cost data. RESULTS: One hundred and four patients were included (mean age: 62.3 ± 14.9 years, mean SAPS II: 51.5 ± 16.1, mean SOFA on the study day: 6.9 ± 4.3). Over 24 hours, 29 to 186 interventions per patient were performed by different caregivers, leading to a mean total time spent for patient care of 13:32 ± 05:00 h. The total daily cost per patient was € 1425 ± € 520 (95% CI = € 1323 to € 1526). ICU human resources represented 43% of total daily cost. Patient-dependent expenses (€ 842 ± € 521) represented 59% of the total daily cost. The total daily cost was correlated with the daily SOFA score (r = 0.271, P = 0.006) and the bedside-time given by caregivers (r = 0.716, P < 0.0001). CONCLUSION: The average cost of one day of ICU care in French National Hospitals is strongly correlated with the duration of bedside-care carried out by human resources.

EQOFIX: a combined economic and quality-of-life study of hemophilia B treatments in France.

BACKGROUND: EQOFIX is a medicoeconomic study that analyzed the health-related quality of life (HRQoL) and costs of care of the moderate and severe forms of hemophilia B, treated on demand or by prophylaxis with either plasma-derived Factor IX (pdFIX) or recombinant FIX (rFIX). STUDY DESIGN AND METHODS: The primary objectives were evaluations of the impact of hemophilia B on HRQoL and of the costs associated with its management. The secondary objectives were evaluations of the clinical efficacy and costs of care of pdFIX and rFIX. In this observational study we included and followed for 1 year severe and moderate hemophilia B patients without inhibitor. HRQoL was evaluated through generic and disease-specific questionnaires. Information on the health resources consumed was collected every 3 months. RESULTS: The EQOFIX cohort was composed of 155 patients, including 51 children and 104 adults, with 114 having severe disease and 41 having moderate disease. The regimens were prophylactic for 61 and on demand for 94. Altogether, 78 were treated with rFIX and 77 with pdFIX. There was no difference in the QoL between the pdFIX and rFIX treatments. The extra cost of prophylaxis was €22,605 per bleeding event prevented. The consumption of FIX was 1.4-fold higher for the patients treated with rFIX than for the patients treated with pdFIX. CONCLUSION: Our findings in a cohort composed of 25% of the French population of moderate and severe hemophilia B patients show, with similar clinical and HRQoL results, that treatment with rFIX is more expensive than treatment with pdFIX.

Annual direct medical cost of active systemic lupus erythematosus in five European countries.

OBJECTIVES: To evaluate the annual direct medical cost of managing adult systemic lupus erythematosus (SLE) patients with active autoantibody positive disease in Europe. METHODS: A 2-year, retrospective, multicentre, observational study was conducted in five countries (France, Germany, Italy, Spain and the UK). Data included patients' characteristics, disease activity and severity, flare assessments and health resource use (eg, laboratory tests, medications, specialist visits and hospitalisations). Costs were assessed from the public payers' perspective. Cost predictors were estimated by multivariate regression models. RESULTS: Thirty-one centres enrolled 427 consecutive eligible patients stratified equally by disease severity. At baseline, mean (SD) age was 44.5 (13.8) years, 90.5% were women and mean (SD) SLE duration was 10.7 (8.0) years. The SELENA-SLEDAI (11.2 vs 5.3) and SLICC/ACR index (1.0 vs 0.7) scores were higher in severe patients. Over the study period, patients experienced on average 1.02 (0.71) flares/year. The mean annual direct medical cost was higher in severe compared to non-severe patients (€4748 vs €2650, p<0.001). Medication costs were €2518 in severe versus €1251 in non-severe patients (p<0.001). Medications represented 53% and 47% of the total cost for severe and non-severe patients, respectively, primarily due to immunosuppressants and biologics. Flares, especially severe flares, were identified as the major cost predictor, with each flare increasing the annual total cost by about €1002 (p<0.001). CONCLUSIONS: The annual direct medical cost of SLE patients in Europe is related to disease severity and flares. Medical treatments were the main cost drivers. Severe flares and major organ involvement were identified as important cost predictors.

Spectacle independence and subjective satisfaction of ReSTOR multifocal intraocular lens after cataract or presbyopia surgery in two European countries.

PURPOSE: To determine the percentage of patients implanted bilaterally with ReSTOR((R)) requiring spectacles at 18 months, the patient satisfaction, and factors that predict spectacles independence. METHODS: The medical and surgical data were collected from patient records. The 'Freedom from Spectacles Value Scale' (FGVS) was used to rank their experiences via telephone interview. A Bayesian network was used to predict postoperative spectacles use. RESULTS: 304 patients (65.6 years) were included. Postoperative visual acuity was >/=0.8 in 93.3% of patients for near vision and in 88.6% of patients for distance vision. After surgery, 87.2% of the patients were spectacles free. 88.2% of the patients rated their vision as being better following the surgery and 93.1% thought that surgery resulted in a positive change. FGVS mean scores (5 the most favorable rating) were: 'Practical Advantages' 3.8, 'Psychological Advantages' 3.8, 'Evaluation of the Result' 4.5, 'Feelings' 4.4, and 'Global Judgement' 4.4. Patients who stated that spectacles wear was particularly bothersome and those who thought that their appearance was more favorable without spectacles were 3 times more likely not to wear spectacles postoperatively. CONCLUSION: ReSTOR((R)) provides patients with good distance and near vision, a high rate of spectacles independence, and a high degree of patient satisfaction.

Daily costs of prostaglandin analogues as monotherapy or in fixed combinations with timolol, in Denmark, Finland, Germany and Sweden.

BACKGROUND: To compare the daily costs of 3 prostaglandin analogues (bimatoprost, latanoprost, travoprost), alone, and associated with timolol in 4 European countries (Denmark, Finland, Germany, and Sweden). METHODS: Six glaucoma products were sampled by buying 5 bottles from 1 suburban pharmacy in each of the 4 countries. Drops were weighed by a single operator at 1 site according to standardized procedures. Residual drops were then counted. Unit bottle costs were estimated from tariff lists. Eye-drop weights were entered into a nested analysis of variance comprising drug, instillation day, country, the interaction, and a sample factor nested within the country factor. Effectiveness was represented by treatment failure rates estimated from a meta-analysis and a general practitioner survey. RESULTS: Every drug bottle contained sufficient drops to treat 1 patient for 28/31 days. Drop-size heterogeneity between countries was observed for bimatoprost and bimatoprost/timolol. Mean travoprost and travoprost/timolol drop-sizes were the smallest, and drop-counts per bottle were the lowest for latanoprost, or latanoprost/timolol. In all 4 countries annual costs were least for travoprost and travoprost/timolol. CONCLUSIONS: On taking into account drug costs and effectiveness, travoprost and travoprost/timolol were cheaper and more effective than latanoprost and latanoprost/timolol and were cheaper than bimatoprost and bimatoprost/timolol.

Effectiveness of a lumbar belt in subacute low back pain: an open, multicentric, and randomized clinical study.

STUDY DESIGN: Multicentric, randomized, and controlled study of clinical evaluation of medical device in subacute low back pain. OBJECTIVE: To evaluate the effects of an elastic lumbar belt on functional capacity, pain intensity in low back pain treatment, and the benefice on medical cost. SUMMARY OF BACKGROUND DATA: There is limited evidence of efficiency of lumbar supports for treatment of low back pain. There is also a lack of the methodology in the studies reported on the efficiency of this device. METHODS: This study is randomized, multicentric, and controlled with 2 groups: a patient group treated with a lumbar belt (BWG) and a control group (CG). The main criteria of clinical evaluation were the physical restoration assessed with the EIFEL scale, the pain assessed by a visual analogic scale, the main economical criteria was the overall cost of associated medical treatments. RESULTS: One hundred ninety-seven patients have participated. The results show a higher decrease in EIFEL score in BWG than CG between days 0 and 90 (7.6 +/- 4.4 vs. de 6.1 +/- 4.7;P = 0.023). Respectively significant reduction in visual analogic scale was also noticed (41.5 +/- 21.4 vs. 32.0 +/- 20; P = 0.002). Pharmacologic consumption decreased at D90 (the proportion of patients who did not take any medication in BWG is 60.8% vs. 40% in CG;P = 0.029). CONCLUSION: Lumbar belt wearing is consequent in subacute low back pain to improve significantly the functional status, the pain level, and the pharmacologic consumption. This study may be useful to underline the interest of lumbar support as a complementary and nonpharmacologic treatment beside the classic medication use in low back pain treatment.

Health-related quality of life and utility in patients with age-related macular degeneration.

OBJECTIVE: To assess the impact of best-eye and worst-eye visual acuity (BEVA and WEVA, respectively) on health-related quality of life and utility in patients with wet age-related macular degeneration. DESIGN: This cross-sectional, prospective, observational, multicenter study was performed in France, Germany, and Italy. Patients were stratified into 4 severity groups (BEVA, 20/40; WEVA, 20/200). Patients completed the National Eye Institute 25-Item Visual Function Questionnaire, the Macular Disease Quality of Life Scale, and the Health Utility Index 3. Analysis of variance was used to adjust for age, sex, and country. RESULTS: Patients (N = 360) were mainly female (59.6%), with a mean age of 77 years and mean time since age-related macular degeneration diagnosis of 2.3 years. Health Utility Index 3 scores decreased with VA severity from 0.62 to 0.39. The National Eye Institute 25-Item Visual Function Questionnaire global score decreased with VA severity from 67.0 to 40.7 and was related to the BEVA (P < .001) and WEVA (P = .03). Corresponding changes were observed on the general vision, distance vision, driving, and mental health dimensions. The average weighted impact score on the Macular Disease Quality of Life varied from -4.6 to -2.6, decreasing with VA severity. Both eyes contributed to the average weighted impact score. CONCLUSION: The BEVA and WEVAs influenced vision-related quality of life independently, as measured by the National Eye Institute 25-Item Visual Function Questionnaire and Macular Disease Quality of Life Scale.

Anxiety and depression prevalence rates in age-related macular degeneration.

PURPOSE: To estimate the prevalence rates of depression and anxiety in patients with wet age-related macular degeneration (AMD) and the relationship with visual acuity and to develop a simple algorithm for depression screening. METHODS: This cross-sectional, prospective, observational, multicenter study was performed in France, Germany, and Italy. Retina specialists at 10 centers per country each enrolled 12 consecutive patients with wet ARMD. Patients were stratified into four severity groups by using best eye (BE) and worst eye (WE) visual acuity (VA) thresholds (BE:VA 20/40 and WE:VA 20/200). Patients rated themselves on the Hospital Anxiety and Depression Scale (HADS). Analysis of variance was performed to estimate the effect of VA severity levels on HADS scores adjusted on age, gender, and country. RESULTS: Patients (females 60%) were recruited, with a mean age of 77 years and 2.3 years' disease duration. Mean BE:VA at inclusion was 0.49 logMar (logarithm of the minimum angled of resolution) and WE:VA 1.0 logMar. The prevalence of severe depression increased from 0% (BE:VA > or = 20/40+WE:VA > or = 20/200) to 7.6% (BE:VA < 20/40+WE:VA < 20/200), whereas anxiety was unrelated to VA loss. Moreover, total depression scores were strongly associated with VA severity (P = 0.006), but not total anxiety scores (P = 0.840). Responses to two HADS items ("I still enjoy things I used to enjoy"; "I can enjoy a good book or radio or television program") identified 95% of severely to moderately depressed patients. CONCLUSIONS: Self-rated depression in patients with AMD was associated with VA severity level. It should, therefore, be relatively easy for ophthalmologists to implement the screening procedure and refer identified patients to psychiatrists for proper assessment and treatment.

Impact of irritable bowel syndrome (IBS) on health-related quality of life (HRQOL).

AIMS: To assess the impact of irritable bowel syndrome (IBS) on patient-reported health-related quality of life (HRQOL). METHODS: Two HRQOL instruments were administered by telephone interviews to a sample of 253 IBS French patients recruited from the general population. IBS was diagnosed according to the Manning, Rome I and Rome II criteria. Patients with organic diseases were excluded from the study. A generic instrument, the Short Form 36 (SF-36), and an IBS disease-specific instrument, the IBSQOL, were used. RESULTS: Patients with IBS had statistically significant (P<0.05) lower scores for all SF-36 QOL domains compared with the general French population. Women (N=192) reported significantly (P<0.05) poorer HRQOL on both the SF-36 and the IBSQOL scores than men (N=61) for all domains except energy on the SF36 and the sleep on the IBSQOL. HRQOL deteriorated with time since onset of IBS symptoms for some domains such as diet. For both instruments, a positive correlation was observed between low scores and intensity of pain and discomfort. IBS patients with a predominance of diarrhea (N=72) exhibited significantly greater impairment of HRQOL in the emotional domain than IBS persons with constipation predominance (N=65) (P

[Cost-effectiveness analysis of capecitabine in combination with docetaxel in comparison to docetaxel monotherapy in advanced or metastatic breast cancer in France]. / Analyse coût/efficacité de l'association capécitabine-docétaxel versus docétaxel en monothérapie dans le cancer du sein métastatique ou localement avancé en France.

Objective to estimate the cost-effectiveness ratio of adopting capecitabine/docetaxel combination therapy in place of docetaxel alone, in France, in patients with metastatic breast cancer (MBC), resistant to, or relapsing after anthracycline-containing therapy, The SO14999 trial is a multicenter trial, randomized, including 511 patients equitably divided between the two groups. In addition to efficacy data, medical resource consumption related to adverse events were also collected in this trial ("piggy-back" analysis). French cost were associated to each data in order to estimate the medical cost of the two strategies from a healthpayer perspective. Afterwards, incremental cost-effectiveness analysis was performed based on the overall survival outcome and progression free survival. The addition of capecitabine to docetaxel resulted in an increase in median survival of 90 days (442 versus 352 days; p = 0.0126) and increase in the duration of progression free survival of 58 days (186 versus 128 days; p = 0.0001) compared with docetaxel alone. The total medical cost by patient was evaluated at 11,786 on average IC95% = [10,982-12,591] in the arm in association versus 11,570 IC95% = [10,719-12,421] in the arm in monotherapy; that is to say a non-significant overcost of 216 under capecitabine (p = 0.642). Moreover, the additional cost per year of life saved was estimated at 952 and the one without progression of the disease was established at 1,198 . A combined treatment associating capecitabine and docetaxel proves to be a cost-effectiveness strategy compared with the use of docetaxel alone, in the treatment of locally advanced or metastatic breast cancer in France.

Prevalence of irritable bowel syndrome (IBS) and variability of diagnostic criteria.

OBJECTIVES: The main objectives of this study were to assess whether the use of different definitions of irritable bowel syndrome (IBS) could influence measurements of its prevalence and characterize the patient population fulfilling these different diagnostic criteria. METHOD: A telephone survey was carried out by contacting 8,221 subjects aged >or=18 Years representative of the French population. A "screening" questionnaire based on three algorithms of IBS classification (Manning, with or without a notion of a minimal duration of symptoms, Rome I and Rome II) was used by specialised inquirers. RESULTS: Twenty three percent of the subjects interviewed stated that they had suffered from abdominal pain during the previous 12 Months. The prevalence of IBS considerably varied, depending on the diagnostic criteria used: 12% based on Manning criteria without reference to the duration of symptoms; 2.5% if the notion of duration of symptoms was added to the Manning criteria, and 2.1% and 1.1% based on the Rome I and Rome II criteria, respectively (the latter including the same notion of duration). In total, 212 subjects (2.6%) met at least one of the criteria including a minimal duration of symptoms, with a predominance for women (sex-ratio close to 2). CONCLUSION: The prevalence of IBS is strongly dependent on the classification algorithm employed. The requirement of a minimum duration of symptoms eliminates IBS in a large number of subjects complaining of abdominal disorders. Once these methodological variations were taken into account, the prevalence of IBS in France was found to be comparable to that published in international literature.