Psychometric properties of a questionnaire (HEMO-FISS-QoL) to evaluate the burden associated with haemorrhoidal disease and anal fissures.

AIM: Current questionnaires designed to evaluate the burden of haemorrhoidal disease ignore symptoms such as bleeding, pain and itching. A specific questionnaire is needed to evaluate the global impact of anal disorders on patients' daily lives. METHOD: We developed a questionnaire (HEMO-FISS-QoL) to assess the symptom burden of anal disorders and administered it to 256 patients (mean age 46.2 years; men 60.4%) with haemorrhoidal disease (67.2%), anal fissure (29.3%) or both (3.5%). Psychometric properties were evaluated by testing the acceptability, construct validity and reliability of the questionnaire. Principal components and multi-trait analyses were used to identify dimensions and to assess construct validity. Backward Cronbach alpha curves and a graded response model were used to reduce the number of items and modalities. External validity was evaluated against SF-12 and the Psychological Global Well-Being Index (PGWBI) using Spearman's correlation coefficient. RESULTS: Principal component analysis defined four dimensions: physical disorders, psychology, defaecation and sexuality. The number of questions was reduced from 38 to 23. The HEMO-FISS-QoL scores correlated well with those of the SF-12 and PGWBI (P < 0.001). Cronbach's coefficients (all > 0.7) reflected good internal reliability of the different dimensions. The total score increased with the severity of the anal disorders and with their consequences (days off work and personal spending related to the disease). CONCLUSION: The HEMO-FISS-QoL questionnaire reliably evaluates the global impact of haemorrhoids and anal fissures on patients' daily lives. This simple tool may prove useful for treatment evaluation in clinical trials and daily practice.

[Efficacy of moxifloxacin in treating bacterial conjunctivitis: a meta-analysis]. / Efficacité de la moxifloxacine dans le traitement de la conjonctivite bactérienne aiguë : une méta-analyse.

PURPOSE: To estimate the effectiveness of moxifloxacin instillation in the treatment of bacterial conjunctivitis. PATIENTS AND METHODS: Five randomized clinical trials on moxifloxacin were identified, three versus placebo, one versus ofloxacin, and another versus levofloxacin. The effectiveness parameters included clinical efficacy and drop-out rates for all reasons including lack of efficacy. The fixed and random effects were estimated on intent-to-treat populations. Models for risk ratios and risk differences as well as tests for study homogeneity were computed. RESULTS: Patients treated with moxifloxacin dropped out less frequently (OR=2.22 [1.62-3.03]; p<0.001), had less treatment failure (OR=3.61 [2.30-5.65]; p<0.001), and experienced clinical cure more often (OR=1.59 [1.21-2.04]; p=0.001) than placebo-treated patients. In comparison to ofloxacin, patients treated with moxifloxacin had fewer drop-outs for reasons other than treatment failure (OR=1.92 [1.28-2.89]; p=0.02) and fewer drop-outs for treatment failure (OR=2.53 [1.41-4.56]; p=0.002). CONCLUSION: This meta-analysis demonstrated the clinical efficacy of moxifloxacin compared to placebo. Fewer patients dropped out from moxifloxacin treatment compared to ofloxacin.

Transforming scales of measurement of visual acuity at the group level.

AIM: To provide formulae that may be used to transform sample-based estimates of group-level mean and standard deviation of visual acuity (VA) across different scales of measurement. METHODS: We focused on 3 transformations: (1) ETDRS letters - LogMAR (2) Decimal - LogMAR and (3) Snellen - LogMAR. We assumed that logMAR follows a normal distribution in the underlying population and used the empirical asymptotic normal approximation of the joint distribution of average and standard deviation in order to derive formulae for transformation of group-level estimates. We considered that the true population parameters are not known and are to be estimated using data from a sample of patients (which is essentially always the case). We compared estimates obtained with the proposed sample-based approach with those based on a "naïve" approach in which individual-level formulae are used directly for transformation of means and standard deviations at the group-level. RESULTS: Applying formulae that are appropriate for transformations of scales of measurement for data at the individual- (or patient-) level, to transform VA at the group level, can lead to biased estimates of means and standard deviations. In particular, it could lead to underestimation of the average logMAR VA in studies that use decimal VA. Such bias will be greater in magnitude when disease strongly affects VA. CONCLUSIONS: This paper provides formulae that can be easily implemented in standard spreadsheet software programs, and which allow appropriate transformations of group-level estimates of mean and standard deviation of VA across different scales of measurement. These transformations are helpful for performing meta-analyses or for comparisons of results across studies when VA is expressed in different units.

Lifetime costs and effectiveness of ReSTOR compared with a monofocal IOL and Array-SA40 in the Netherlands.

PURPOSE: To estimate the lifetime cost consequences for society and the National Health Service (NHS) of bilateral monofocal (SI40NB) or multifocal (ReSTOR or Array-SA40) intraocular lense (IOL) implantation after cataract surgery. SETTING: Public hospital in the Netherlands. METHODS: A Markov model simulated three cohorts of patients followed 69 until 100 years of age, or death. Spectacle independence rates for each IOL were adjusted to the results of a randomized clinical trial that compared monofocal and multifocal Array-SA40 IOL implants, together with a prospective cohort of patients implanted with ReSTOR. Adjustment was performed using the propensity score method in a multivariate analysis. Resource consumption was estimated from a dedicated Dutch survey. Dutch unit costs were applied to spectacles, cataract surgery, IOLs, visits to ophthalmologists, optometrists, transport, and spectacle cleaning materials. Cost discounted at 4% and undiscounted economic results were calculated. RESULTS: Spectacle independence rates were 86.0% for ReSTOR, 8.7% for monofocal IOLs, and 8.5% for Array-SA40. Patients lived without needing spectacles for 12.9 years after ReSTOR, for 1.4 years after monofocal IOLs, and 1.3 years after Array-SA40. ReSTOR patients bought 6.4 fewer pairs of spectacles than monofocal patients. Lifetime discounted cost consequences for the society were ReSTOR euro3969, monofocal IOLs euro4123, and Array-SA40 euro5326. Corresponding costs for the NHS were euro2415, euro2555, and euro2556, respectively. CONCLUSIONS: ReSTOR IOLs provided higher levels of spectacle independence than monofocal SI40NB or multifocal Array-SA40 IOLs resulting in savings, compared to a monofocal, over the period modelled of euro315 for society and euro140 for the NHS.

Modelling lifetime cost consequences of toric compared with standard IOLs in cataract surgery of astigmatic patients in four European countries.

OBJECTIVE: To compare the lifetime costs of freeing astigmatic patients from spectacles after bilateral cataract surgery implanting toric intraocular lenses (IOLs: i.e., Acrysof Toric) versus monofocal IOLs, in France, Italy, Germany and Spain. METHODS: A Markov model followed patient cohorts from cataract surgery until death. Prevalence rates of patients not needing spectacles and the types of spectacles prescribed for those requiring them were obtained from clinical trials and national surveys. The economic perspective was societal. Mortality rates were incorporated into the model. Discount rates were applied. A sensitivity analysis was performed on non-discounted costs. RESULTS: Fewer patients with toric IOLs needed spectacles for distance vision than patients with monofocal IOLs. With monofocal IOLs more than 66% of patients needed complex spectacles compared to less than 25% implanted with toric IOLs. In France and Italy, toric IOLs reduced overall costs relative to otherwise high spectacle costs after cataract surgery. Savings were 897.0 euros (France), 822.5 euros (Germany), 895.8 euros (Italy) and 391.6 euros (Spain), without discounting. On applying a 3% discount rate the costs became 691.7 euros, 646.4 euros, 693.9 euros and 308.2 euros, respectively. CONCLUSIONS: Bilateral toric IOL implants in astigmatic patients decreased spectacle dependence for distance vision and the need for complex spectacles. The economic consequences for patients depended on the national spectacle costs usually incurred after cataract surgery.

Modelling lifetime cost consequences of ReSTOR for presbyopia in four European countries.

AIMS: To compare the lifetime cost consequences, in France, Italy, Germany and Spain, of liberating presbyopic patients from spectacles by implanting the multifocal intraocular lens ReSTOR. METHODS: A Markov model was created to compare a patient cohort implanted with ReSTOR at age 45 years, with a cohort using spectacles, until death or age 100 years. Prevalence rates of patients not requiring spectacles after surgery were obtained from clinical trials. Resource utilisation included implant surgery, spectacles, visits to ophthalmologists and optic centres, transport and time lost by patients. Economic perspectives were those of society and sickness funds. Mortality rates were introduced into the model. Cataract surgery was allowed just for the spectacles-only cohort. RESULTS: Rate of spectacle independence was fixed at 80% for ReSTOR. When time spent to care for refraction was not taken into account, lifelong ReSTOR cost was higher than spectacles in all countries (293 euro; 1013 euro), according to the societal perspective. When time was included, cost saving was observed in Italy (136 euro) and the incremental cost to be free of spectacles comprised between \[euro]11 and \[euro]816. According to the NHS perspective, ReSTOR is a cost saving strategy (-274 euro; -605 euro). CONCLUSIONS: At a 3% discount rate, savings achieved by liberating patients from spectacles counterbalanced partially the initially higher cost of ReSTOR according to the society perspective. ReSTOR could be considered as cost-effective in the four countries provided that the willingness to pay of patients to be free of spectacles would be lower than 23.65 euro/year.

Intermediate visual acuity without spectacles following bilateral ReSTOR implantation.

PURPOSE: This survey determined uncorrected visual acuity (VA) at near, intermediate, and far distances in cataract patients implanted with ReSTOR, and assessed patient satisfaction. METHODS: Consecutive cataract patients implanted bilaterally with ReSTOR were followed up at least 4 months. The Early Treatment Diabetic Retinopathy Study scale was used to measure VA for near (40 cm), intermediate (50, 60, and 70 cm), and distance vision, with VAs expressed in logMAR and adjusted for distance using Bennett's (1993) formula. Satisfaction was self-rated on a visual analogue scale ranging from 0 (poor) to 10 (high). RESULTS: Twenty-four consecutive patients (mean age 67.6 years) were operated upon by a single surgeon and followed up for a mean of 336.5 days after second eye surgery. Average postoperative VAs for uncorrected distance were 0.06 logMAR and intermediate VAs were 0.21 logMAR at both 50 cm and 60 cm and 0.22 logMAR at 70 cm. These levels of uncorrected intermediate VA would allow patients to read Word computer text in Times New Roman font 8 zoomed to 100%, at 70 cm from the monitor screen. The authors found that23/24 patients (96%) no longer wore spectacles. The remaining patient required correction for astigmatism as this refraction error is not yet correctable by ReSTOR. Average selfrated satisfaction was 8.54. CONCLUSIONS: In an everyday surgical practice, none of the studied bilateral ReSTOR cataract patients without astigmatism required spectacles when followed up 6 months or later. Intermediate VA was compatible with reading and led to high patient satisfaction.

Costs and persistence of carbonic anhydrase inhibitor versus alpha-2 agonists, associated with beta-blockers, in glaucoma and ocular hypertension: an analysis of the UK-GPRD database.

OBJECTIVE: To compare the effectiveness and associated costs of carbonic anhydrase inhibitors + beta-blocker versus alpha-2 adrenergic agonists + beta-blocker in glaucoma therapy, as documented by The United Kingdom General Practitioner Research Database (UK-GPRD). RESEARCH DESIGN: Patient chart analysis. METHODS: Patient records were screened for diagnoses of ocular hypertension or glaucoma, and for surgery, laser therapy or medication specific to glaucoma. Selected patients were those prescribed either carbonic anhydrase inhibitors + beta-blocker or alpha-2 adrenergic agonists + beta-blocker. Treatment failure was defined as a glaucoma prescription change, i.e. addition, cessation or replacement of medication, surgery or laser therapy. Times to treatment failure were compared with an adjusted Cox model. MAIN OUTCOME MEASURES: Treatment persistence and cost. RESULTS: Included patients were those treated with either carbonic anhydrase inhibitors + beta-blocker (n = 5581) or alpha-2 adrenergic agonists + beta-blocker (n = 1164). The average age at diagnosis was 68.1 years and 48.2% were male. Treatment failure at one year was significantly (p < 0.001) less frequent after carbonic anhydrase inhibitors + beta-blocker (57% of patients) than after alpha-2 adrenergic agonists + beta-blocker (64.3%). The hazard ratio for failure was lower (0.82: p < 0.0001) with carbonic anhydrase inhibitors + beta-blocker following adjustment for age, gender, comorbidities and duration of follow-up. Adjusted annual costs of glaucoma management were pound 348.04 for carbonic anhydrase inhibitors + beta-blocker and pound 356.80 for alpha-2 adrenergic agonists + beta-blocker. CONCLUSIONS: According to UK-GPRD information, glaucoma therapy with carbonic anhydrase inhibitors + beta-blocker is more persistent than with alpha-2 adrenergic agonists + beta-blocker at a similar cost.

Treatment carryover impacts on effectiveness of intraocular pressure lowering agents, estimated by a discrete event simulation model.

PURPOSE: To compare the effectiveness of two treatment sequences, latanoprost-latanoprost timolol fixed combination (L-LT) versus travoprost-travoprost timolol fixed combination (T-TT), in the treatment of open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: A discrete event simulation (DES) model was constructed. Patients with either OAG or OHT were treated first-line with a prostaglandin, either latanoprost or travoprost. In case of treatment failure, patients were switched to the specific prostaglandin-timolol sequence LT or TT. Failure was defined as intraocular pressure higher than or equal to 18 mmHg at two visits. Time to failure was estimated from two randomized clinical trials. Log-rank tests were computed. Linear functions after log-log transformation were used to model time to failure. The time horizon of the model was 60 months. Outcomes included treatment failure and disease progression. Sensitivity analyses were performed. RESULTS: Latanoprost treatment resulted in more treatment failures than travoprost (p<0.01), and LT more than TT (p<0.01). At 60 months, the probability of starting a third treatment line was 39.2% with L-LT versus 29.9% with T-TT. On average, L-LT patients developed 0.55 new visual field defects versus 0.48 for T-TT patients. The probability of no disease progression at 60 months was 61.4% with L-LT and 65.5% with T-TT. CONCLUSIONS: Based on randomized clinical trial results and using a DES model, the T-TT sequence was more effective at avoiding starting a third line treatment than the L-LT sequence. T-TT treated patients developed less glaucoma progression.

Costs and effectiveness of travoprost versus a dorzolamide + timolol fixed combination in first-line treatment of glaucoma: analysis conducted on the United Kingdom General Practitioner Research Database.

OBJECTIVE: To compare the effectiveness and associated costs of travoprost versus a fixed combination of dorzolamide + timolol as first-line therapy for glaucoma according to data collected by the United Kingdom General Practitioner Research Database (UK-GPRD). METHODS: Patients with a diagnosis of ocular hypertension, glaucoma, or who had been treated topically by surgery or laser therapy were selected. Patients starting first-line treatment with travoprost or a fixed dorzolamide + timolol combination were included. Times to treatment failure were compared with an adjusted Cox model. MAIN OUTCOME MEASURES: Cost and treatment failure defined as a prescription change (adding or removing a topical treatment, or initiating laser therapy or surgery). RESULTS: 56 612 patients were extracted from the database and 39 808 patients received at least one topical prescription for IOP-lowering (intraocular pressure) therapy. Of these, 639 were treated with travoprost and 387 with dorzolamide + timolol, as first-line therapies. No significant difference was found between patient characteristics. Patients were aged 70.0 years and 48.5% were male. At 1 year, treatment failure was experienced by 30.4% of patients receiving travoprost and 49.4% receiving dorzolamide + timolol (p < 0.001). The hazard ratio for failure was 0.79 (p < 0.03) less with travoprost, after adjusting on age, gender, comorbidities and duration of follow-up. Adjusted annual costs of glaucoma management were significantly (p < 0.001) lower with travoprost ( pound198.31) than with dorzolamide + timolol ( pound312.21). CONCLUSION: This retrospective costs and consequences analysis study showed that travoprost is more efficient than dorzolamide + timolol as first-line therapy for glaucoma patients. Patients continued longer with first-line treatment when prescribed travoprost at a lower cost.

Self-reported visual impairment and mortality: a French nationwide perspective.

PURPOSE: To estimate the association between self-reported visual impairment and mortality. METHODS: Two national surveys in community and institutionalized populations were combined. First, 2,075 institutions for children with impairments, adults with impairments aged persons, and psychiatric patients were selected randomly. The sample comprised 15,403 subjects of whom 14,603 (94.9%) were interviewed. Second, a random, stratified sample of 21,760 persons living in the community was selected, and 16,945 (77.9%) were interviewed. Types of impairment were identified by face-to-face interviews. Two years later, 14,497 subjects in institutions and 15,648 in the community were revisited. Data on death were obtained from either the National Register or households. Death rates were related to age, gender, and impairment. A logistic regression was performed including impairments, activities of daily living, age, gender, type of residence, and geographical area. RESULTS: Strong, independent associations were found between particular impairments, institutional residence, activities of daily living, age, gender, and risk of death. Associations between mortality and type of impairment could be ranked as follows: motor (OR = 1.235), brain (OR = 1.552), low vision (OR = 1.681), speech (OR = 2.090), visceral (OR = 2.233) and blindness (OR = 2.262). CONCLUSIONS: Self-reported visual impairment is an independent factor associated with mortality.

A meta-analysis of topical prostaglandin analogues intra-ocular pressure lowering in glaucoma therapy.

OBJECTIVE: To compare the efficacy of latanoprost, bimatoprost and travoprost for lowering IOP in patients with glaucoma. RESEARCH DESIGN AND METHODS: In order to carry out this meta-analysis, randomized trials (2001-2004) were identified on Medline and EMBASE using the following key words: glaucoma, ocular hypertension (OHT), randomization, trial, latanoprost, bimatoprost and travoprost. The studies had to compare at least two prostaglandin analogues as mono-therapy. Cross-over experimental designs were excluded. The main outcome measure was IOP at final visit. Statistical analyses included random effects, pooled estimates of treatment effects, tests for publication bias, and random-effects models to obtain adjusted treatment effects on final IOP after lowering for baseline IOP, and duration of follow-up. Random effects Poisson regression models were used to estimate the adjusted effects of treatments on response rates (IOP < 18 mmHg). RESULTS: Nine studies were used in the analysis. Patient mean age varied from 56.7 to 68.8 years and baseline IOP ranged from 22.3 to 26.5 mmHg. Three hundred and seventy-eight patients were treated with bimatoprost, 385 with travoprost and 555 with latanoprost. Patients treated with travoprost and bimatoprost had lower IOP levels at the end of follow-up (-0.98 mmHg [95% CI: -2.08; 0.13; p = 0.08] and -1.04 mmHg [95% CI: -2.11;0.04; p = 0.06], respectively) than those treated with latanoprost. The combined effect of newer prostaglandin analogues (bimatoprost/travoprost) was an adjusted decrease of 1.00 mmHg [95% CI: -1.91;-0.10], p = 0.03], or a 17% higher adjusted response rate (Incidence Rate Ratio 1.17, 95% CI, 1.00-1.35, p = 0.04), compared to latanoprost. CONCLUSION: Travoprost and bimatoprost may have greater efficacy in lowering IOP for patients with OHT or glaucoma.

Effects of dyskinesias in Parkinson's disease on quality of life and health-related costs: a prospective European study.

The treatment of Parkinson's disease (PD) with l-DOPA leads to involuntary movements (dyskinesias). This 6-month observational study in three European countries in PD patients with various degrees of motor complications examined the effects of dyskinesias on the quality of life (QoL) of patients and health care costs. Retrospective and prospective health economic data were collected, and QoL of patients was measured using the Short Form-36 (SF-36) and the PD Quality of Life (PDQL) Scale. Regression analysis was used to estimate the adjusted effects of dyskinesias on QoL and costs, whilst accounting for the potentially confounding effects of disease progression, motor fluctuations and country. Increasing dyskinesia scores on either the Unified PD Rating Scale or the Goetz Dyskinesia Rating Scale were associated with significant reductions in QoL scores on the SF-36 and PDQL Scale. Increasing dyskinesia severity was also associated with increased depression scores on the Montgomery-Asberg Depression Rating Scale along with significant increases in health care costs. The effects of dyskinesia on QoL, depression and costs decreased but remained significant after adjustment for the confounding effects of disease progression and motor fluctuations. In conclusion, dyskinesias may adversely affect QoL and increase health care costs in patients with PD. Future studies should evaluate the potentially beneficial effects in terms of QoL and health care costs of strategies to delay the onset of, or the treatment of, dyskinesias.

Blindness, low vision, and other handicaps as risk factors attached to institutional residence.

AIMS: To estimate the risk of living in an institution and being visually impaired. METHODS: Two national surveys were pooled: (1) 2075 institutions (for children or adults with handicaps, old people, and psychiatric centres) were selected randomly, in 18 predefined strata, from the French health ministry files. From these institutions, 15 403 subjects were selected randomly and handicap was documented by interview in 14 603 (94.9%) of them; (2) level of handicap was documented in a randomised, stratified sample of 356 208 citizens living in the community; from this sample, 21 760 subjects were further selected at random and 16 945 people were interviewed. Data on handicaps (visual, auditory, speech, brain, visceral, motor, and other) and activities of daily living (ADL) were extracted. The odds ratio (OR) of living in an institution was estimated, using stepwise logistic regressions with age, geographical area, handicaps, and ADL as co-variables. RESULTS: Subjects in institutions, compared to those living at home, were, respectively, more often female (64.3% v 52.4%) and older (68.7 v 38.0 years); they more often had handicaps (ORs: speech, 6.59; brain, 10.17; motor, 8.86; visceral, 3.49; auditory, 2.66; other, 1.53); and were less often able to perform their ADL (46.2% v 97.1%) without assistance. Below 80 years, blind people were more often in institutions (ORs 0.239 to 0.306); whereas in older people the association was reversed (OR: 3.277). Low vision was always significantly associated with institutional residence (ORs from 0.262 to 0.752). CONCLUSION: Visual handicap was associated with institutional residence. The link persisted after adjustment for known confounding factors.

[Circadian rhythm variations of intraocular pressure and therapeutic decisions: interpretation of clinical trial results based on a statistical model]. / Variations nycthémérales de la pression intraoculaire et décisions thérapeutiques: Interprétation des résultats d'essais cliniques à partir d'un modèle statistique.

Therapeutic decisions (treatment initiation, continuation, change, combination, etc.) based on intraocular pressure (IOP) monitoring require knowledge of both circadian IOP fluctuations and the pharmacological circadian rhythm of the active ingredients. A simple model was applied to data from two clinical trials to estimate the consequences of circadian IOP fluctuations on (1) ocular hypertension diagnosis, (2) therapeutic adjustments, and (3) the daily cumulative effect of marginally low therapeutic differences. A grid for clinical interpretation of the average IOP differences is presented. The probability of an IOP that exceeds the target value for the diagnosis or therapy varied to a large extent throughout the day. IOP was higher in the morning than in the evening. The IOP variance (measured by standard deviation) was an important factor in decision-making, regardless of the IOP value itself. Regular IOP monitoring over the entire day allowed minimization of the time spent above a target value. IOP differences that seemed low when expressed in average values in therapeutic trials could have clinically significant consequences in the practitioner's decisions. The data presented suggest that ocular hypertension diagnosis and therapeutic decisions should be made early in the morning, at least for most patients. In any case, the time of the measurement should be considered in the therapeutic approach.

Estimating the long-term visual field consequences of average daily intraocular pressure and variance : a clinical trial comparing timolol, latanoprost and travoprost.

OBJECTIVE: To estimate the long-term consequences of average daily intraocular pressure (IOP) and variance in patients treated with travoprost, latanoprost or timolol. DESIGN AND SETTING: IOP measures were derived from a 12-month randomised, double-masked, double-dummy, phase III clinical trial conducted in patients with primary open angle glaucoma (POAG) or ocular hypertension. IOP was measured at weeks 2, 12, 24 and 48, at 8am, 10am and 4pm. The visual field defect (VFD) risk functions estimated by Stewart were applied, the statistical unit being the eye. A second-order analysis of variance was performed including eye, time, treatment and investigator. Analyses according to baseline IOP were performed to identify patients at risk. INTERVENTIONS: IOP-lowering drugs: travoprost 0.004% once daily, latanoprost 0.005% once daily and timolol 0.5% twice daily. OUTCOME MEASURE: Daily IOP average and variance, and daily minimum and maximum IOP and VFD. RESULTS: Travoprost-treated patients (n = 200) had a daily IOP average significantly lower than timolol-treated patients (n = 200; p < 0.0001) and latanoprost-treated patients (n = 196; p < 0.001). Similar results were found for daily minimal and maximal IOP values. No difference was found for IOP variance between the prostaglandin analogues (p < 0.25), while timolol-treated patients had a higher value than travoprost-treated patients (p < 0.004). Consequently, patients treated with timolol would have a 1.54 greater chance of developing a new VFD over 5 years than those using latanoprost. Patients treated with latanoprost would have a 1.11 greater chance of developing a new VFD than travoprost-treated patients. CONCLUSIONS: Better control of daily IOP average and variance should avoid new VFDs. Prostaglandins controlled the variance better than timolol, and travoprost was found to be the drug having the most effect on IOP average. Longitudinal prospective data collection should be performed to confirm these findings.

Socioeconomic aspects of laser in situ keratomileusis, eyeglasses, and contact lenses in mild to moderate myopia.

PURPOSE: To compare the societal costs and consequences of 3 strategies to correct mild to moderate myopia: laser in situ keratomileusis (LASIK), eyeglasses, and contact lenses (CLs). SETTING: Instituto Oftalmológico de Alicante, Alicante, Spain. METHODS: A Markov model was set up to compare the present value of LASIK, eyeglasses, and CLs. A structured questionnaire was administered to 40 consecutive patients with mild to moderate myopia to collect resource information including direct medical and nonmedical costs as well as indirect costs (transportation, time spent, hotel, eyeglasses, CLs, LASIK, cleaning products, visits to ophthalmologist/optometrist/optical center, and adverse events linked to LASIK and CLs). The time period ranged from 10 to 30 years with a 5% discount rate. The Spanish population was used as the basis for the economic data. Full sensitivity analyses were conducted. RESULTS: Based on the time period, LASIK saved from 18 to 278 km in distance to care centers compared with eyeglasses and from 405 to 1436 km compared with CLs. The time to care for visual acuity was similar between LASIK and CLs, but up to 1180 additional hours were spent by CL users. Laser in situ keratomileusis saved from 4.69 to 12.07 eyeglasses and from 28 to 84 eyeglass cleaning packs. With LASIK, there were 18 to 50 visits to the optical center compared with 41 to 117 visits with CLs. Laser in situ keratomileusis saved 4.7 to 12.2 visits to correct visual acuity compared with eyeglasses and CLs. It prevented 95 to 295 per 10 000 cases of CL-related keratitis. Contact lenses were always more costly than LASIK, which was always more costly than eyeglasses. The 2 sensitivity parameters were time period and discount rate. CONCLUSIONS: Laser in situ keratomileusis was less costly than CLs and more expensive than eyeglasses, although the potential nonmonetary benefit of LASIK over eyeglasses was not taken into account.

The epidemiology, economics and quality of life burden of age-related macular degeneration in France, Germany, Italy and the United Kingdom.

Age-related macular degeneration (AMD) is a major public health issue, but little is known about the economics of the disease. This contribution describes the epidemiology and the economics of AMD in four European countries: France, Germany, Italy and the United Kingdom (UK). We reviewed published information on AMD, including guidelines, official statistics, and local literature and interviewed AMD experts. All available health-related quality of life studies (HRQoL) on AMD were also reviewed. Data collection focused on epidemiology, medical management and resource use (both medical and non-medical items). Prevalence of AMD among persons older than 65 years is 8% and increases with age. There are two forms of the disease: atrophic (80-85% of AMD cases) and exudative, which is characterised by choroidal neovascularisation (CNV; 15-20% of AMD cases). No treatment for the atrophic form is available. Laser photocoagulation is the mainstay of treatment for CNV, although less than 30% of persons with CNV can benefit from it. Photodynamic therapy (PDT), a new treatment for CNV, reduces the risk of vision loss in forms with predominantly visible lesions. Several other new procedures are also under development. Rehabilitation and low-vision aids are useful palliative interventions when there is a residual visual acuity. The yearly budget impact of AMD was found to be between 51.3 and 101.1 million euros in the four countries studied. Information on social services and resource use was scant and little is reported on the impact of AMD on HRQoL. Economic studies of AMD should be conducted in order to assist public health decision making.

Cost effectiveness of emedastine versus levocabastine in the treatment of allergic conjunctivitis in 7 European countries.

OBJECTIVE: To assess the cost effectiveness of emedastine, a new antihistamine, versus levocabastine in the treatment of acute allergic conjunctivitis (AAC) in Belgium, France, Germany, The Netherlands, Norway, Portugal and Sweden. DESIGN AND SETTING: Randomised double-blind multicountry clinical trial followed by economic modelling from the treatment provider perspective. PATIENTS: A total of 221 patients (109 emedastine, 112 levocabastine) with AAC were included. METHODS: The clinical trial compared the efficacy and safety of emedastine 0.05% and levocabastine 0.05%, both twice daily, for 42 days, using ocular redness, itching, days without symptoms and clinical failure as outcome measures. The cost of first-line treatment failure, including visits, drugs and laboratory examinations, was established in each country from a panel of ophthalmologists and general practitioners. Full sensitivity analyses were conducted. RESULTS: From day 7 to 42, patients treated with emedastine had less itching (p < 0.001) and less redness (p < 0.001). The failure rate was 10% less (p < 0.02) with emedastine and patients treated with emedastine had an incremental 8.5 days (p < 0.01) without symptoms. Emedastine and levocabastine were equally well tolerated. In all European countries, the cost of failure was lower with emedastine. Emedastine was found to be economically dominant relative to levocabastine, i.e. more effective and less expensive, in Belgium, Germany, Portugal and Sweden; in France, The Netherlands and Norway the incremental cost was low (less than 1 euro per additional symptom-free day). CONCLUSION: Through a model based on a randomised clinical trial and cost estimates of treatment failure derived from practitioner interviews, emedastine is a cost-effective treatment of AAC.

Diagnosis related group costs in a regulated environment. A note about their economic interpretation.

The availability of the Diagnosis Related Group (DRG) system for determining hospital costs in some European countries has encouraged its use in pharmacoeconomic evaluations. The DRG system was developed in the US to provide data for prospective payments for hospitals. However, the financing of hospitals in some European countries is still based on the so-called 'global budget' approach. Therefore, results of pharmacoeconomic studies involving hospitals financed by the 'global-budget' approach in which DRG costs have been used require careful consideration. The main points to consider are: (i) that most of the cost components constituting the DRGs are in fact charges fixed by the government. This cost-charge ratio varies significantly across different DRGs, altering economic consequences when cost-shifting between DRGs; (ii) that there is rarely a perfect concordance between attributable cost (as proposed by the DRGs) and the definition of variable cost (as defined in economic evaluations); (iii) from the Sickness Fund's point of view, the way DRGs could be interpreted is rather unclear: financing or bench-marking?; and (iv) the perspective of DRG cost is a mixed patient-hospital perspective which is neither the societal nor the health insurance perspective generally used in pharmacoeconomic evaluations. In conclusion, the use of DRG costs is a major improvement for pharmacoeconomic evaluation. However, many hypotheses still need to be made in these studies, depending on the economic perspective of the study. Therefore, the results of pharmacoeconomic studies should be considered and discussed in line with the national financing system of the hospitals involved.