Impact of pigmentary disorders on quality of life in Japan: Interest of the BeautyQoL instrument.

Skin pigmentary disorders and uneven skin tone represent common cosmetic concerns in Japan where fairer skin is culturally desirable. As the demographics of Asian countries continue to evolve, there is a need to understand the impact of cosmetic skin concerns on quality of life (QoL). 199 Japanese women self-claiming facial skin pigmentation disorders were asked to complete the BeautyQoL questionnaire, and the results were compared with those of a control group of 200 women. Of the five dimensions of the BeautyQoL questionnaire, the dimension "mood" appeared to be significantly lower in the group presenting facial dark spots, as compared with the control group (p < 0.05). In the group presenting facial dark spots, the five dimensions and the global score showed that subjects concerned had lower scores than subjects less concerned, even if statistical significance was not reached. This study confirms that common pigmentary disorders such as facial black spots may negatively impact QoL. Further comparative studies with a controlled randomized design would be necessary to confirm these findings.

Cost-effectiveness of escitalopram vs. citalopram in major depressive disorder.

Clinical trials have shown better efficacy of escitalopram over citalopram, and review-based economic models the cost-effectiveness of escitalopram vs. citalopram (brand and generic). No head-to-head clinical trial has, however, evaluated the cost-effectiveness of both drugs so far. The aim of this study was to assess the relative cost-effectiveness of escitalopram compared with citalopram in patients with major depressive disorder. An economic evaluation was conducted alongside a double-blind randomized clinical trial conducted by general practitioners and psychiatrists comparing fixed doses of escitalopram (20 mg/day) or citalopram (40 mg/day) over 8 weeks in ambulatory care patients with major depressive disorder (baseline Montgomery-Asberg Depression Rating Scale score > or =30). Resources use was recorded using a standardized form recording use of healthcare services and days of sick leave for the 2-month prestudy period and for the 8-week study period. Statistically significant improvements were observed in patients treated with escitalopram. Mean per-patient costs for the escitalopram group, compared with the citalopram group, were 41% lower (96 euro vs. 163 euro; P<0.05) from a healthcare perspective. Differences were mostly related to lower hospitalization costs for escitalopram compared with citalopram recipients, assuming a parity price between escitalopram and citalopram. Bootstrapped distributions of the cost-effectiveness ratios also showed better effectiveness and lower costs for escitalopram compared with citalopram. Escitalopram is significantly more effective than citalopram, and is associated with lower healthcare costs. This prospective economic analysis demonstrated that escitalopram is a cost-effective first-line treatment option for major depressive disorder.

[Socio-economic impact of migraine and headaches in France]. / Impact socio-economique de la migraine et des céphalées en France.

The International Headache Society has defined a clear diagnostic guideline classifying headaches into three categories. It is now well known that headaches have a significant effect on the quality of life and the professional, school or family activities of individuals, and that the economic impact is far from negligible. An extensive survey drawn from a sample of 10 585 individuals in the French adult population was carried out in the last three months of 1999. The results showed a prevalence of 17.3% for migraine and nearly 30% for headaches. The average expenditure for a headache patient is about 220 Euro, divided as follows: 10% for GP consultations, 11% for laboratory evaluations, 17% for specialist consultations, 18% for drugs and 44% for hospital costs. But this breakdown depends largely on the headache category. Although the most acute headaches lead to the most severe deterioration of quality of life, professional or school activities are not affected in the same way.

Validation of the underlying assumptions of the quality-adjusted life-years outcome: results from the ECHOUTCOME European project.

BACKGROUND: Quality-adjusted life-years (QALYs) have been used since the 1980s as a standard health outcome measure for conducting cost-utility analyses, which are often inadequately labeled as 'cost-effectiveness analyses'. This synthetic outcome, which combines the quantity of life lived with its quality expressed as a preference score, is currently recommended as reference case by some health technology assessment (HTA) agencies. While critics of the QALY approach have expressed concerns about equity and ethical issues, surprisingly, very few have tested the basic methodological assumptions supporting the QALY equation so as to establish its scientific validity. OBJECTIVES: The main objective of the ECHOUTCOME European project was to test the validity of the underlying assumptions of the QALY outcome and its relevance in health decision making. METHODS: An experiment has been conducted with 1,361 subjects from Belgium, France, Italy, and the UK. The subjects were asked to express their preferences regarding various hypothetical health states derived from combining different health states with time durations in order to compare observed utility values of the couples (health state, time) and calculated utility values using the QALY formula. RESULTS: Observed and calculated utility values of the couples (health state, time) were significantly different, confirming that preferences expressed by the respondents were not consistent with the QALY theoretical assumptions. CONCLUSIONS: This European study contributes to establishing that the QALY multiplicative model is an invalid measure. This explains why costs/QALY estimates may vary greatly, leading to inconsistent recommendations relevant to providing access to innovative medicines and health technologies. HTA agencies should consider other more robust methodological approaches to guide reimbursement decisions.

Quality of life assessment in cosmetics: specificity and interest of the international BeautyQol instrument.

The wide use of cosmetics and their perceived benefits upon well-being imply objective descriptions of their effects upon the different dimensions contributing to the quality of life (QoL). Such a goal pleas for using relevant and validated scientific instruments with robust measurement methods. This paper discusses the interest of the new validated questionnaire BeautyQoL specifically designed to assess the effect of cosmetic products on physical appearance and QoL. After conducting a review of skin appearance and QoL, three phases of the international codevelopment have been carried out in the following sequence: semi-directed interviews (Phase 1), acceptability study (Phase 2), and validation study (Phase 3). Data collection and validation process have been carried out in 16 languages. This review confirms that QoL instruments developed in dermatology are not suitable to assess cosmetic products, mainly because of their lack of sensitivity. General acceptability of BeautyQol was very good. Forty-two questions have been structured in five dimensions that explained 76.7% of the total variance: Social Life, Self-confidence, Mood, Vitality, and Attractiveness. Cronbach's alpha coefficients are between 0.932 and 0.978, confirming the good internal consistency of the results. The BeautyQol questionnaire is the first international instrument specific to cosmetic products and physical appearance that has been validated in 16 languages and could be used in a number of clinical trials and descriptive studies to demonstrate the added value of these products on the QoL.

Prevalence and description of chronic daily headache in the general population in France.

The objective of this study was to describe the epidemiology, clinical presentation and consequences of chronic daily headache (CDH) in France. A representative nation-wide sample of the general population was identified using a stratified sampling method. Ten thousand five hundred and eight-five subjects were screened in face-to-face interviews, and data collected using a standard questionnaire. An overall point prevalence of CDH in the general population of 2.98% was observed. Two-thirds of these subjects presented migraine-like features. Severity, functional impact and healthcare consumption were higher than in subjects reporting episodic migraine in the same sample. Of the subjects, 28.2% reported the most severe migraine disability assessment scores (Grades 3 and 4), compared to 12% of episodic migraineurs. A qualité de vie et migraine score of 68.4 was observed, indicating severely attenuated quality of life. Only 6.6% of subjects were taking prophylactic treatment, whilst 88% were using non-specific acute headache treatments. The frequency of physician consultations and laboratory examinations was significantly higher than in individuals with episodic headache. CDH is thus a relatively prevalent condition in the general French population, associated with an important burden of suffering and with considerable expenditure in the health service. Management of this condition is generally inappropriate.

Analysis of the cost effectiveness of recombinant versus urinary follicle-stimulating hormone in in vitro fertilization/intracytoplasmic sperm injection programs in the United States.

OBJECTIVE: To compare the cost effectiveness of recombinant human FSH (Gonal-F; Serono, Inc., Randolph, MA) and urinary FSH (Fertinex; Serono, Inc.) for ovarian stimulation during IVF with or without intracytoplasmic sperm injection for the treatment of infertility. DESIGN: Clinical decision analysis techniques (the Markov model) were used to model the direct medical costs per patient during assisted reproductive technology. MAIN OUTCOME MEASURE(S): Clinical and economic outcomes of two different ovarian stimulation protocols (recombinant human FSH or urinary FSH) during three treatment cycles were considered. RESULT(S): More ongoing pregnancies were achieved, with fewer stimulation cycles, after recombinant human FSH (Gonal-F) than after urinary FSH (Fertinex) (40,665 versus 37,890). In addition, recombinant human FSH was also found to be more cost effective per ongoing pregnancy. From a societal perspective, the mean cost per pregnancy was $40,688 for recombinant human FSH versus $47,096 for urinary FSH. From the insurers' perspective, the mean cost/pregnancy for recombinant human FSH was $28,481 versus $32,967 for urinary FSH. CONCLUSION(S): Recombinant human FSH (Gonal-F) is not only more efficient clinically than urinary FSH (Fertinex), but also more cost effective. This analysis illustrates the point that the economic effectiveness of a drug depends less on its acquisition costs and rather more on the clinical outcomes associated with its use.

Limitations of the methods used for calculating quality-adjusted life-year values.

OBJECTIVE: To test the validity of the techniques used to calculate quality-adjusted life-year (QALY) values based on utility functions, using a real population dataset. DESIGN: Using the standard gamble technique, we gathered the preferences of a population sample of 189 individuals on a combination of probabilities concerning four simple health states (no physical disability, limp, walk with crutches and need a wheelchair), and three life-year spans (5, 10 and 15 years). Each of the four assumptions of the multiplicative model was tested based on the results of the experiment. RESULTS: The utility of the health state "limp" was high at 0.89 and that of "walk with crutches" only slightly lower at 0.85. However, of the 189 individuals, only 57 are not in contradiction with the assumption of mutual utility independence since they strictly preferred (15 years, "need a wheelchair") over (10 years, "need a wheelchair") and (15 years, "need a wheelchair") over (5 years, "need a wheelchair"). For these 57 individuals, the results of this study do not fit the assumptions underpinning the multiplicative model. CONCLUSION: This work suggests that the techniques used as a basis from which to calculate QALY values are flawed. In particular, the underlying assumptions of the multiattribute utility model do not correspond to behaviour patterns observed in a real population. It therefore appears that use of the QALY technique should be questioned in healthcare decision-making settings.

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.

Difference of perceptions and evaluation of cognitive dysfunction in major depressive disorder patients across psychiatrists internationally.

BACKGROUND: Many studies have suggested that major depressive disorder (MDD) is often associated with cognitive dysfunction. Despite this, guidance addressing assessment of cognitive dysfunction in MDD is lacking. The aim of this study was to examine psychiatrists' perceptions and evaluation of cognitive dysfunction in routine practice in MDD patients across different countries. METHOD: A total of 61 psychiatrists in the US, Germany, France, Spain, Hong Kong, and Australia participated in an online survey about perceptions of cognitive dysfunction in MDD patients, evaluation of cognition and instruments used in cognitive evaluation. RESULTS: Most psychiatrists reportedly relied on patient history interviews for cognitive evaluation (83% in France and approximately 60% in the USA, Germany, Australia and Hong Kong). The remainder used a cognitive instrument or a combination of cognitive instrument and patient history interview for assessment. Of those using instruments for cognitive assessment, only nine named instruments that were appropriate for cognitive evaluation. The remainder reported other clinical measures not intended for cognitive evaluation. CONCLUSIONS: Overall, psychiatrists in routine clinical practice value the assessment of cognitive in MDD. However, there is a lack of standardization in these assessments and misconceptions regarding proper assessment.

Comparing antidepressant treatment patterns in older and younger adults: a claims database analysis.

OBJECTIVES: To compare depressed older (≥65) and younger (25-64) adults with regard to antidepressant treatment patterns and to assess factors associated with 180-day nonpersistence. DESIGN: Retrospective matched cohort study. SETTING: U.S. managed care population. PARTICIPANTS: Older and matched younger adults diagnosed with depression and treated with antidepressants. MEASUREMENTS: Sociodemographic characteristics, comorbidities, polypharmacy, and characteristics of antidepressant treatment at 180 days were compared between older and younger adults. Analyses were conducted before and after the implementation of Medicare Part D on January 1, 2006, to consider the effect of this policy. RESULTS: Few participants received psychotherapy, especially older ones; rates were constant before and after 2006. Before 2006, older adults more frequently received antidepressants at lower (odds ratio (OR)=5.38, 95% confidence interval (CI)=3.57-8.13) or intermediate dose (OR=2.42, 95% CI=1.93-3.02) and had poorer adherence to treatment (P<.001) than younger adults. After 2006, older adults received similar proportions of intermediate or high antidepressant doses as younger adults, but a lower dosage was still more likely to be prescribed (OR=1.87, 95% CI=1.09-3.20) and had higher treatment adherence (P<.001). Medication profile did not significantly affect the risk of nonpersistence, but increased with lower antidepressant dose (P<.001). Whereas nonpersistence was higher in older adults before 2006 (hazard ratio (HR)=1.25, 95% CI=1.22-1.46), the trend reversed after 2006 (HR=0.76, 95% CI=0.66-0.88). CONCLUSION: More than half of participants with depression discontinued antidepressant treatment, and psychotherapy was rarely used. Implementation of Medicare Part D was associated with substantial changes in treatment of older adults with depression. The presence of comorbidities or polypharmacy was not associated with nonpersistence in depressed older adults.

Antidepressant monotherapy: A claims database analysis of treatment changes and treatment duration.

BACKGROUND: The basic principles of pharmacotherapy for depression are consistent among most US and western European guidelines. All recommend ≥6 months of antidepressant therapy and propose several alternatives in cases of inappropriate response. OBJECTIVES: The aims of this analysis were to describe antidepressant treatment changes and treatment duration in patients undergoing treatment for a new episode of depression and to identify risk factors for treatment changes and treatment discontinuation. METHODS: For this claims database analysis, adults and children treated with antidepressants for a new episode of depression in the time period from 2004 to 2006 were identified using the IMS LifeLink Health Plan Database. Treatment changes (defined as switches to an antidepressant or antipsychotic; combination with an antidepressant; or augmentation with lithium, an anticonvulsant, or an atypical antipsychotic) were described. Antidepressant treatment duration was assessed and described per treatment change. Risk factors for treatment change or discontinuation were identified using multivariate logistic regression (treatment change) or Cox regression (treatment duration). RESULTS: Of 134,287 patients identified using the database (mean [SD] age, 39.1 [14.9] years; 68.1% women), 31,123 (23.2%) had a treatment change, most commonly an antidepressant switch (12,735 [9.5%]) or combination (12,214 [9.1%]). Antipsychotics were introduced in <5% of patients. The median overall treatment duration (111 days) was shorter than that recommended in the guidelines (≥ 6 months). Index antidepressant class was significantly associated with treatment change (higher for tricyclic antidepressants [TCAs] [odds ratio (OR) = 1.59 (95% CI, 1.48-1.70)]; lower for selective serotonin reuptake inhibitors [OR = 0.87 (95% CI, 0.84-0.91)]) and duration (increased risk for early discontinuation for TCAs [hazard ratio (HR) = 1.36 (95% CI, 1.30-1.44)]; lower risk for late discontinuation for serotonin-norepinephrine reuptake inhibitors [HR = 0.81 (95% CI, 0.79-0.84)]). Indicators of depression severity or complexity (prescription by a mental health specialist, previous use of psychotropics, previous psychiatric hospitalization, and presence of psychosomatic comorbidities) were associated with a higher risk for treatment change and inconsistently associated with treatment duration. Two health plans were associated with increased risk for discontinuation (Medicaid, HR = 1.35 [95% CI, 1.28-1.42]; Medicare, HR = 1.38 [95% CI, 1.12-1.71]). Combination and augmentation strategies were associated with a lower risk for treatment discontinuation (combination, HR = 0.83 [95% CI, 0.81-0.86]; augmentation, HR = 0.75 [95% CI, 0.73-0.77]). Overall treatment duration was <30 days in 31,177 patients (26.2%) and >6 months in 54,502 (37.5%). CONCLUSIONS: In this claims database analysis, changes in antidepressant treatment involved 23.2% of patients. The median overall treatment duration was shorter than recommended by guidelines due to a quarter of patients having early treatment discontinuation.

Impact of headache on quality of life in a general population survey in France (GRIM2000 Study).

OBJECTIVES: The objectives of this study were to determine the impact of headache on health-related quality of life in a nationwide sample of the French general population using a disease-specific measure, the Qualité de Vie et Migraine (QVM), to compare quality of life in subjects reporting different headache to types, and to evaluate the relationship between quality of life and severity, frequency, associated disability, and treatment responsiveness of headaches. METHODS: The QVM questionnaire was included within a large epidemiological survey of 1486 headache sufferers. Diagnosis was assigned retrospectively using an algorithm based on the International Headache Society classification. Headache severity was assessed with the MIGSEV scale and disability with the MIDAS scale. RESULTS: The mean global QVM score in the sample was 80.2. Quality of life was poorer in subjects with chronic daily headache (QVM score: 66.2) than in those with migraine (QVM score: 76.7), while those with other forms of episodic headache had the best quality of life (QVM score: 91.7). Quality-of-life scores were correlated with frequency, severity, disability, and treatment resistance of headaches (P <.001). CONCLUSION: The QVM scale is a sensitive tool to measure health-related quality of life in headache sufferers in the general population.