Quality of life and utility decrement associated with Clostridium difficile infection in a French hospital setting.

BACKGROUND: Clostridium difficile infection (CDI) is associated with a substantial Quality of life impact on patients that has not been so far measured with a generic validated instrument. METHODS: A prospective study was performed in 7 French acute-care settings in patients presenting with a bacteriologically-confirmed CDI. The EQ-5D-3 L was filled in by patients at 7 ± 2 days after CDI diagnosis to describe their state of health at that date as well as their state of health immediately before the CDI episode (baseline). Individual utility decrement was obtained by subtracting the corresponding utilities. The Quality Adjusted Life Year (QALY) loss was calculated by multiplying the days spent from baseline to the date of the interview, by the decrement of utility. A multivariate analysis of variance of the utility decrement according to CDI and patients characteristics was performed. RESULTS: Eighty patients were enrolled (mean age: 69.4 years, 55% females). The utility scores dropped from a mean 0.542 (SD: 0.391) at baseline to 0.050 (SD: 0.404) during the CDI episode with a mean adjusted utility decrement of 0.492 (SD: 0.398) point. This decrement increased significantly with CDI severity (Zar score ≥ 3) (p = 0.001), in patients with a positive baseline utility (p = 0.032), in women as compared to men (p = 0.041) and in patients aged more than 65 years (p = 0.041). No association with the Charlson index was found. The associated QALY loss not integrating the excess mortality was 0.028 (SD: 0.053). CONCLUSIONS: The impact on quality of life of CDI episodes is major and translates in a substantial QALY loss despite their short duration.

[Self-monitoring of blood glucose in France: data from a national survey]. / Pratique de l'auto-surveillance glycémique en France : données d'une enquête nationale.

Objectives: To describe Self-Monitoring of Blood Glucose (SMBG) practices in France in patients with type 1 (T1DM) or type 2 (T2DM) diabetes, by estimating the proportion of patients performing SMBG at the recommended testing frequency and the proportion of patients complying with the current quality control guidelines on SMBG. Materials and methods: National cross-sectional study conducted in 238 pharmacies. A questionnaire was completed with adult diabetic patients buying SMBG devices or reagent strips for themselves, using a blood glucose meter for at least 6 months, treated with insulin or sulfonylurea/glinides ± other oral hypoglycaemic agents (HA). Results: Data from 449 patients were analysed: 85 T1DM and 121 T2DM patients treated by multiple basal-bolus injections ± HA (Group A and Group B), 123 T2DM patients treated by basal insulin ± HA (Group C), 102 patients treated by other insulin regimens ± HA (Group D) and 120 T2DM patients treated by sulfonylurea / glinides without insulin ± other HA (Group E). The recommended test frequency was observed by 29.8%, 36.4%, 61.8% and 69.2% of patients in Group A, Group B, Group C, and Group E, respectively. The quality of self-monitoring was insufficient in terms of device cleaning, storage conditions/expiry date of reagent strips, or use of control solutions. Patients displayed a limited capacity to take decisions in relation to their SMBG results (Group A: 56.5%, Group B: 70.2%, Group C: 49.2%, Group E: 36.0%) and limited knowledge about their glucose targets (Group A: 81%, Group B: 80.5%, Group C: 68.6%, Group E: 73.7%). Conclusion: SMBG use and compliance with quality guidelines must be improved, but healthcare professionals and patients must also focus their efforts on education to interpret SMBG results.

Quality of life in SSc-ILD patients: Understanding the impact of the ILD and the needs of the SSc-ILD patients and their need for caregivers in France.

Objectives: The objectives of this study were to describe the impact of systemic sclerosis associated interstitial lung disease, on quality of life, to estimate the correlation between quality of life and severity of lung disease and to assess the impact of interstitial lung disease on caregivers. Methods: Seven investigators included systemic sclerosis associated interstitial lung disease patients from December 2019 to April 2020. Sociodemographics and clinical data were collected. Patients reported outcomes and questionnaires were used with 1 generic patients reported outcome (EQ-5D-5L), 1 specific PRO (Brief Interstitial Lung Disease) and 2 self-reported questionnaires on impact of SSc complications and impact on caregivers. The correlation between forced vital capacity and EQ-5D-5L score was estimated with a multivariate linear regression model adjusted on several covariates. Results: In all, 89 patients were included. 26.4% were males, mean age was 58.2 ± 14.5 years. Mean EQ-5D-5L score = 0.79 ± 0.22 (median = 0.85). Mean EQ-5D-5L visual analog scale score = 60.8 ± 20.4 (median = 61.5). Mean King's Brief Interstitial Lung Disease score = 58.4 ± 12.7 (median = 58.0). After adjustment on covariates, a significant correlation between forced vital capacity and EQ-5D-5L score was found with an increase of 0.003 of the EQ-5D-5L score for a 1% increase of FVC (p = 0.0096). No significant correlation between forced vital capacity and the EQ-VAS and King's Brief Interstitial Lung Disease score were found. The impact of SSc on other organs was significantly correlated with EQ- 5D-5L score, respectively, for the impact scores on the lung system (p = 0.0003), heart system (p = 0.0182), Raynaud's syndrome (p = 0.0015), digestive system (p = 0.0032), joints/muscles (p = 0.0003), skin (p < 0.0001), kidney (p = 0.0052) and gastro-oesophageal reflux (p = 0.0063). Significant correlations between King's Brief Interstitial Lung Disease score and lung system (p < 0.0001), heart system (p < 0.0001), digital ulcers (p = 0.058), digestive system (p < 0.0001), kidney (p = 0.0004), skin (p = 0.0499) and gastro-oesophageal reflux (p = 0.0033) scores were found 68.5% of patients reported their need for a caregiver to help them in their daily life activities. Conclusion: Our study highlighted the strong burden of systemic sclerosis associated interstitial lung disease` for patients, especially with an impact on quality of life, on other organs manifestations and need for caregivers in their daily life.

Treatment Costs of Basal Insulin Regimens for Type 2 Diabetes Mellitus in France.

OBJECTIVE: Our objectives were to describe the basal insulin treatment regimens most widely used in a real-world setting in France and to estimate the associated treatment costs in people with type 2 diabetes mellitus (T2DM). METHODS: A cross-sectional observational study was conducted (November 2017-February 2018) among adult patients with T2DM requiring basal insulin therapy for their own use in a representative sample of pharmacies. Costs were compared between patients treated with three recently marketed insulins (glargine 300 U/ml [Gla-300], biosimilar glargine 100 U/ml [Gla-100] and a fixed-ratio combination of insulin degludec and liraglutide) and those treated with three established basal or intermediate insulins: branded glargine 100 U/ml, insulin detemir and neutral protamine Hagedorn insulin [NPH]). RESULTS: Overall, 1933 patients were analysed. Gla-300 accounted for 59.9% of novel basal insulin prescriptions, and branded Gla-100 accounted for 67.9% of established insulin prescriptions. Recent insulins were more frequently associated with glucagon-like peptide-1 (GLP-1) analogues. Results confirmed a lower rate of severe hypoglycaemia with Gla-300 than with Gla-100. On average, weekly total costs of treatment with all basal insulins were not significantly different, except with detemir, where they were higher. CONCLUSION: New basal insulins are expected to be integrated into clinical practice. This analysis shows that their use does not impact upon the management cost of insulin therapy in people with T2DM.

Intraocular pressure control with latanoprost/timolol and travoprost/timolol fixed combinations : a retrospective, multicentre, cross-sectional study.

OBJECTIVE: The aim of this study was to confirm randomized clinical trial results showing that a fixed timolol/travoprost combination (TT; DuoTrav) controls intraocular pressure (IOP) better than a fixed timolol/latanoprost combination (TL; Xalacom) in everyday ophthalmic practice, when measured in the morning and >24 hours after instillation. METHODS: Patients with ocular hypertension or primary open angle glaucoma stabilized on TT or TL were included in this retrospective cross-sectional study. Data on demographics, medical history and previous treatments were extracted from the patients' medical records. Last treatment instillation times and IOP values were recorded at clinic visits. Treatments were compared by analyses of variance, logistic regressions and propensity scores adjusted for confounding factors. RESULTS: Out of 316 patients included, 124 instilled TT, 192 instilled TL and 266 (84.2%) overall had instilled their eye drops within 24 hours. The patients' mean age was 64.5 years and 51.6% were female. Treatment groups were comparable except for longer disease and treatment durations in TL recipients. Worse eye mean IOPs were 25.8 mmHg at diagnosis and 21.9 mmHg on starting their designated fixed combination treatment. The best IOP control was provided by TT instillations (mean IOP 17.1 and 19.0 mmHg in the TT and TL groups, respectively; p < 0.001). This difference was reinforced by results in the subgroup of patients who instilled treatment >24 hours prior to IOP measurement (mean IOP 17.0 and 20.3 mmHg in the TT and TL groups, respectively; p < 0.004). Also, 82.6% of TT patients satisfied their ophthalmologists' IOP targets versus 51.1% of TL patients (p < 0.001). All significant differences persisted after adjustment for confounding factors. CONCLUSION: This study, conducted in routine ophthalmic practice, confirmed published clinical trial results showing that TT provides better IOP control than TL when measured in the morning, and that travoprost has longer-lasting residual effects than latanoprost when IOP is measured >24 hours after instillation. However, readers should interpret these findings in the context of a cross-sectional observational study conducted in a naturalistic setting.

Prevalence of fibrodysplasia ossificans progressiva (FOP) in France: an estimate based on a record linkage of two national databases.

BACKGROUND: Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling, and life-shortening genetic disorder that causes the formation of heterotopic bone within soft connective tissue. Previous studies found that the FOP prevalence was about one in every two million lives. The aim of this study is to estimate the FOP prevalence in France by probabilistic record-linkage of 2 national databases: 1) the PMSI (Programme de médicalisation des systèmes d'information), an administrative database that records all hospitalization activities in France and 2) CEMARA, a registry database developed by the French Centres of Reference for Rare Diseases. RESULTS: Using a capture-recapture methodology to adjust the crude number of patients identified in both data sources, 89 FOP patients were identified, which results in a prevalence of 1.36 per million inhabitants (CI95% = [1.10; 1.68]). FOP patients' mean age was 25 years, only 14.9% were above 40 years, and 53% of them were males. The first symptoms - beside toe malformations- occurred after birth for 97.3% of them. Mean age at identified symptoms was 7 years and above 18 years for only 6.9% of patients. Mean age at diagnosis was 10 years, and above 18 years for 14.9% of the patients. FOP patients were distributed across France. CONCLUSIONS: Despite the challenge of ascertaining patients with rare diseases, we report a much higher prevalence of FOP in France than in previous studies elsewhere. We suggest that efforts to identify patients and confirm the diagnosis of FOP should be reinforced and extended at both national and European level.

Prevalence and risk factors for ocular surface disease among patients treated over the long term for glaucoma or ocular hypertension.

Purpose. To determine the prevalence of ocular surface diseases and identify risk factors in a population of patients receiving antiglaucomatous eyedrops over the long term. Methods. An observational cross-sectional study was designed to investigate ocular surface signs and symptoms using simple clinical tools. An ocular surface disease intensity score was calculated based on 10 questions regarding ocular surface symptoms and signs with a 4-grade scale. Patients were classified into 3 groups (A, B, and C) according to this total score. A multinomial logistic regression was performed in order to identify risk factors for surface disease. Results. In an overall population of 516 patients, 49% belonged to group A, 30% to group B, and 21% to group C. The multivariate analysis showed that the following factors were correlated with the severity of ocular surface disease: patient age, number of daily eyedrops, past topical treatment changes for ocular intolerance (found in the history of 40% of the patients), intraocular pressure (found to be significantly higher in patients with more severe ocular surface disease), and glaucoma severity. Conclusions. Patients treated for primary open-angle glaucoma or ocular hypertension often have ocular surface diseases, more often and more severely in older patients receiving more drugs and presenting with more severe glaucoma. These high prevalence values might therefore have consequences on the burden of the disease in terms of adherence to treatment and quality of life.

Measurement of treatment compliance using a medical device for glaucoma patients associated with intraocular pressure control: a survey.

OBJECTIVE: To identify and characterize treatment compliance profiles of glaucoma patients and evaluate the association with intraocular pressure (IOP). METHODS: A computerized device (Travalert((R))) that recorded daily instillation times and eye-drop counts was given for 3 months. Patients were declared compliant when at least 2 drops were instilled per day. Compliance rates were calculated for weekdays and weekends, separately, over 8 consecutive weeks. A principal components analysis (PCA) was followed by an ascendant hierarchical classification (AHC) to identify compliance groups. RESULTS: 140 patients were recruited (mean age 65.5 years; 51.8% female) of whom 83.6% had primary open-angle glaucoma with mean IOP 23.9 mmHg before Travalert((R)) use. 60.7% were treated with DuoTrav((R)) (travoprost timolol fixed combination) and 39.3% with travoprost. The PCA identified two axes (compliance and treatment weeks). The AHC identified 3 compliance groups: 'high' (56.6%, approx. 80% compliance), 'medium' (21.2%, approx. 50% compliance), and 'low' (22.1%, approx. 20% compliance). Demographics and glaucoma parameters did not predict low compliance. Final mean IOP was 16.1 mmHg, but higher in the low compliance group (17.7 mmHg, P = 0.02). CONCLUSIONS: Compliance measurement by a medical device showed compliance rates <80% by 50% (approx.) of patients, significantly impacting IOP control. No demographic or glaucoma variable was associated with low compliance.

Incidence of Nd:YAG laser capsulotomies after cataract surgery: comparison of 3 square-edged lenses of different composition.

OBJECTIVE: To compare the incidence of Nd:YAG laser treatment following 3 square-edged intraocular lenses (IOLs) of different composition implanted during cataract surgery. DESIGN: Patient chart analysis. PARTICIPANTS: Patients aged 50-85 years and given a hydrophobic acrylic IOL (either SA60AT or AR40E) or hydrophilic acrylic IOL (XL-Stabi) were included. Analysis was conducted of 767 eyes treated with SA60AT (n = 250), AR40E (n = 254), or XL-Stabi (n = 263). METHODS: This retrospective study involved patients who had undergone cataract surgery between 2001 and 2002. Ophthalmology centres were accepted into the study if they used at least 2 of the IOLs being investigated. The medical files of patients fulfilling the inclusion criteria were listed, and eligible cases were selected randomly. Patients' characteristics were obtained from their medical files. Data on postsurgical complications and Nd:YAG laser treatment over 3 years were also extracted. Follow-up data were obtained from the medical files and the patients' ophthalmologists. Time to Nd:YAG laser treatment was analysed using Kaplan-Meier survival curves adjusted with a Cox model. RESULTS: After 3 years' follow-up the proportions of patients who had not received Nd:YAG laser treatment were 87.0% with SA60AT, 76.6% with AR40E, and 54.6% with XL-Stabi (p < 0.001). Cox's model adjusted for centre effects and the presence of diabetes estimated risk ratios of 2.8 for AR40E (p < 0.0005) and 5.1 for XL-Stabi (p < 0.0001), compared with the reference lens SA60AT. CONCLUSIONS: Of the 3 square-edged lenses studied, the SA60AT was associated with a lower incidence of Nd:YAG laser treatment than either AR40E or XL-Stabi.

Cost of cataract surgery after implantation of three intraocular lenses.

BACKGROUND: Posterior capsule opacification is one of the most frequent adverse events following cataract surgery. This manuscript reports the lifetime cost of complications linked to posterior capsule opacification using three types of intraocular lens with square edges. METHODS: Costs were estimated from a retrospective study of patients who underwent cataract surgery and data from the literature. The lenses studied were hydrophobic acrylic (SA60AT and AR40E) and hydrophilic acrylic (XL-Stabi) lenses with square edges. The frequency of Nd-Yag laser capsulotomies after 4 years' survival was estimated by two methods: the first involved linear adjustment of the rate at 5 and 6 years follow-up and then application of a constant rate after 6 years; the second involved linear adjustment after 5 years follow-up. The economic perspective was that of the French Sickness Fund. RESULTS: After 3 years' follow-up the percentage of patients who had not undergone laser Nd-Yag capsulotomy was 86.9% with SA60AT, 76.6% with AR40E and 54.6% with XL-Stabi lenses (p < 0.001). The total cost of capsulotomy and management of complications per patient lifetime was estimated to be euro90.5 for SA60AT, euro189.5 for AR40E and euro288.0 for XL-Stabi lenses by the first extrapolation method. With the second method of extrapolation the costs were euro94.8, euro200.0 and euro300.2, respectively. INTERPRETATION: Lower costs for cataract surgery and management of related complications were observed with the two hydrophobic acrylic lenses; the lowest costs were observed with SA60AT lenses as they were associated with fewer Nd-Yag laser capsulotomies.

A European survey of patient satisfaction with spectacles after cataract surgery and the associated costs in four European countries (france, Germany, Spain, and Italy).

UNLABELLED: With multifocal intraocular lenses, the majority of the patients do not wear glasses after cataract surgery which is a potential source of savings. PURPOSE: To collect data in four European countries on the associated costs for society of wearing spectacles after cataract surgery and the patient willingness to pay to be free of spectacles. METHODS: Cross-sectional survey of centers that recruited patients who wore refractive spectacles after cataract surgery. Costs were expressed in 2006 Euros Results: 408 patients were recruited by 22 centers. Patients with a mean age of 68.5 years underwent cataract surgery about 3 years prior to recruitment. In all countries, prescribed lenses were mainly mono-focal and the mean cost of spectacles was EUR366.3. Half the patient population with private health insurance was reimbursed for spectacles at a level of 50%, except Spanish patients who were reimbursed at only 5.3%. However, a large part of the cost was directly paid by the patients. Out of a total mean cost of EUR354.9, patients paid EUR285.2 and health insurances only EUR69.7. More than half the patients were willing to pay at least 0.5EUR/day to be free of spectacles. CONCLUSION: Large differences were found among the 4 countries. Almost half of all subjects had private health insurance. The total cost of refraction includes a variety of resources not limited to spectacles. A large part of the cost was borne by patients and there is a high patient willingness to pay to be free of spectacles in this population.