Cost-effectiveness of osteoporosis treatments in postmenopausal women using FRAX™ thresholds for decision.

PURPOSE: FRAX™ is a fracture prediction algorithm to determine a patient's absolute fracture risk. There is a growing consensus that osteoporosis treatment should be based on individual 10-year fracture probability, as calculated in the FRAX™ algorithm, rather than on T-scores alone. OBJECTIVE: Our objective was to evaluate the cost-effectiveness of five years of branded alendronate therapy in postmenopausal French women with a known FRAX™ score. METHOD: A Markov cohort state transition model using FRAX™ values and whenever possible population-specific data and probabilities. We estimated the incremental cost-effectiveness ratio (ICER) of alendronate versus no treatment in postmenopausal women with FRAX™ ranging from 10 to 3%. OUTCOMES: Number of women to treat (NNT) for preventing hip fracture, costs, quality-adjusted life-years, incremental cost-effectiveness ratios. RESULTS: The incremental cost-effectiveness ratios (ICER) compared to no treatment at age 70 ranged from €104,183 to €413,473 per QALY when FRAX™ decreased from 10 to 3%. The NNTs for preventing one hip fracture ranged from 97 to 388 according to age (50-80 years) and FRAX™. Sensitivity analyses showed that the main determinants of cost-effectiveness were adherence to therapy and cost of treatment. CONCLUSION: Using French costs of branded drug and current estimates of treatment efficacy, alendronate therapy for 70-year-old women with 10-year probability of hip fracture of 10% just meets the accepted cost-effectiveness threshold. Improving treatment adherence and/or decreasing treatment cost lowers the ICER. The model however underestimates the potential benefit by excluding other fractures.

Cost-effectiveness of mass screening for colorectal cancer: choice of fecal occult blood test and screening strategy.

BACKGROUND: Colorectal cancer is a major cause of mortality. This gives high public health priority to mass screening using a noninvasive, fecal occult blood test of asymptomatic individuals. A positive test selects those who should undergo colonoscopy to ensure early detection of colorectal cancer. Guaiac fecal occult blood test has low sensitivity. Automated immunochemical tests that measure the fecal human hemoglobin concentration are more sensitive and can be simplified as a 1- to 3-sample format with optimum cutoff points. OBJECTIVE: The aim was to improve the sensitivity of the test by choosing an accurate format (1- to 3-sample and optimum hemoglobin concentration) while maintaining acceptable specificity and avoiding alteration of the screening program in terms of quality of life and economic outputs. METHODS: We used a Markov model to estimate the cost-effectiveness of a screening program for a population of 100,000 asymptomatic individuals by use of immunological fecal tests with different cutoffs, leading to different sensitivity/specificity ratios, and to compare its incremental cost-effectiveness ratio compared with the guaiac fecal test program. RESULTS: The results suggest that a 3-sample immunological test with 50 ng/mL as a positive cutoff is cost-effective. It provides more asymptomatic cancer detection without significantly increasing normal colonoscopies. CONCLUSION: This format should be prospectively evaluated in mass screening.

Increased residual disability among poststroke survivors and the repercussions for the lives of informal caregivers.

PURPOSE: To analyze the associations between increased residual disability among poststroke survivors and the repercussions for their informal caregivers' lives, taking into account the latter's gender and education level. METHODS: 215 stroke survivors (64.5 years; 55.8% men) were recruited by one neurologist from each of the 22 French regions. Katz Index of Independence in Activities of Daily Living (Katz ADL) was mean 9.3, and 54% still had impairments in "more than two of the six neurological domains" of the American Heart Association Stroke Outcome Classification (AHA.SOC): motor, sensory, vision, affect, cognition, and language. The 215 caregivers (57.8 years; 72.1% women) completed a face-to-face questionnaire concerning their social (8 items), material (4 items), and emotional (8 items) repercussions. RESULTS: Katz ADL and AHA.SOC were significantly related to social repercussions for caregivers. Lack of autonomy among stroke survivors (low Katz ADL) was associated with the material difficulties of most concern to caregivers: "I needed to move house" (odds ratio [OR] 1.16; 95% CI, 1.07-1.27) and "I cannot go out anymore" (OR 1.29; 95% CI, 1.16-1.44). Being a male caregiver was strongly associated with a feeling of injustice (OR 2.53; 95% CI, 1.07-6.00). A low educational level was linked to an increased feeling of fear (OR 2.61; 95% CI, 1.05-6.51) and a greater feeling of isolation (OR 6.49; 95% CI, 1.20-35.02). CONCLUSION: Increased dependency post stroke leads to impoverishment in the caregiver's social relationships. Evaluating the emotional repercussions, particularly for men, is an important aspect of enabling survivors to continue to live at home. Innovative accompaniment and counseling services should be considered.

Does the availability of positron emission tomography modify diagnostic strategies for solitary pulmonary nodules? An observational study in France.

BACKGROUND: Previous studies showed that at the individual level, positron emission tomography (PET) has some benefits for patients and physicians in terms of cancer management and staging. We aimed to describe the benefits of (PET) in the management of solitary pulmonary nodules (SPNs) in a population level, in terms of the number of diagnostic and invasive tests performed, time to diagnosis and factors determining PET utilization. METHODS: In an observational study, we examined reports of computed tomography (CT) performed and mentioning "spherical lesion", "nodule" or synonymous terms. We found 11,515 reports in a before-PET period, 2002-2003, and 20,075 in an after-PET period, 2004-2005. Patients were followed through their physician, who was responsible for diagnostic management. RESULTS: We had complete data for 112 patients (73.7%) with new cases of SPN in the before-PET period and 250 (81.4%) in the after-PET period. Patients did not differ in mean age (64.9 vs. 64.8 years). The before-PET patients underwent a mean of 4 tests as compared with 3 tests for the after-PET patients (p = 0.08). Patients in the before-PET period had to wait 41.4 days, on average, before receiving a diagnosis as compared with 24.0 days, on average, for patients in the after-PET period who did not undergo PET (p < 0.001). In the after-PET period, 11% of patients underwent PET during the diagnostic process. A spiculated nodule was more likely to determine prescription for PET (p < 0.001). Multivariate analysis revealed that patients in both periods underwent fewer tests when PET was prescribed by general practitioners (p < 0.001) and if the nodule was not spiculated (p < 0.001). The proportion of unnecessary invasive approaches prescribed (47% vs. 49%) did not differ between the groups. CONCLUSION: In our study, 1 year after the availability of PET, the technology was not the first choice for diagnostic management of SPN. Even though we observed a tendency for reduced number of tests and mean time to diagnosis with PET, these phenomena did not fully relate to PET availability in health communities. In addition, the availability of PET in the management of SPN diagnosis did not reduce the overall rate of unnecessary invasive approaches.

Management of SPN in France. Pathways for definitive diagnosis of solitary pulmonary nodule: a multicentre study in 18 French districts.

BACKGROUND: The process of diagnosis and management of solitary pulmonary nodules (SPNs) between 1 and 3 cm is not standardized. This multicentre study investigated how diagnosis of newly discovered SPNs is managed in routine practice. METHODS: We examined 11,515 radiology reports of patients undergoing chest computed tomography (CT) at all 76 radiology centres in 18 French administrative districts covering 8,220,000 people. Information on diagnostic procedures and treatment administered from discovery to definitive diagnosis of SPN was collected prospectively. RESULTS: We identified 152 cases of newly diagnosed SPNs. Follow-up was complete for 112 patients. The median number of diagnostic tests was 4 and the mean time to diagnosis was 41.4 days. Marked variability was observed in the sequence of diagnostic tests, and 8 diagnostic pathways were identified. Patients' characteristics and radiological features of SPNs influenced the number of tests performed. Referral by specialist, history of smoking and spiculated SPN predicted the performance of at least one invasive procedure (P < 0.01). Definitive diagnosis was a malignant disease in 30 patients (26%). CONCLUSION: The diagnosis of SPN is a complex process that physicians approach in markedly different ways. Implementing practice guidelines for managing the diagnosis of SPN requires clarification.

Economic impact of migraine and other episodic headaches in France: data from the GRIM2000 study.

BACKGROUND: Migraine is a prevalent and incapacitating condition that affects individuals in the prime of their productive life, thus generating an economic burden for both society and healthcare systems. The direct annual healthcare costs of migraine in France were assessed over 10 years ago, and the current study updates these figures. OBJECTIVE: The objective of this study was to determine the economic cost (primarily direct costs) of migraine and other episodic headache in France based on a general population survey of headache, the GRIM2000 (Groupe de Researche Interdisciplinaire sur la Migraine). DESIGN: From a representative general population sample of 10,585 individuals aged > or = 15 years in France in 1999, 1486 individuals experiencing headaches were identified and interviewed regarding healthcare resource consumption in the previous 6 months. By applying unit costs to the resource data, costings (in 1999 values) were determined for physician consultations, hospitalisation, medication use and diagnostic/laboratory tests, and evaluated from a healthcare system perspective. Information on absenteeism and lost productivity was derived from the Migraine Disability Assessment Score (MIDAS) questionnaire. RESULTS: The prevalence of migraine (including migrainous disorder) was determined to be 17%. Total annual direct healthcare costs were estimated to be Euros 128 per individual with migraine in 1999, corresponding to Euros 1044 million when extrapolated to all individuals experiencing migraine and aged > or = 15 years. Around two-thirds of this cost accrued to the social security system (Euros 698 million; Euros 85 per individual). The total annual direct cost of other forms of episodic headache was much lower at Euros 28 per individual (social security cost Euros 18); with a prevalence of 9.2%, the annual national direct cost for other forms of episodic headache totalled Euros 124 million. The principal cost element was physician consultations. However, it was found that many individuals had never consulted a physician for their headaches, and self-medication contributed substantially to the medication costs (the second greatest cost factor for migraine). The cost per individual rose steeply with increasing severity of headache. CONCLUSIONS: The direct healthcare costs of migraine do not seem to have risen significantly over the past decade. A small minority of individuals with more severe headaches consume most of the healthcare resources devoted to migraine, while most individuals generate relatively low direct costs. The total annual direct costs in France for migraine are almost 10-fold higher than those of other episodic headache.