Current characteristics of a population of psoriatic arthritis and gender disparities.

Background and Aim: Psoriatic arthritis (PsA) is a polymorphic disease associated with numerous comorbidities. The objective of this study was to describe the main clinicobiological and imaging characteristics of a population of PsA and to extract any disparities between men and women. Methods: A total of 132 patients in the rheumatology department of Amiens University Hospital with a confirmed diagnosis of PsA according to the CASPAR criteria were included over a period of 4 months. All data were collected retrospectively in this observational and single-center study. Results: The sex ratio was 1 and the average age at inclusion was 54.9 years. Peripheral PsA was the predominant clinical form. Axial PsA represented 12.1% of cases. Enthesitis was noted in 52.3% of cases while dactylitis was identified in 29.5% of cases. Moreover, 12.1% had a joint symptomatology preceding the appearance of cutaneous signs. HLA-B*27 positivity was found in 33.3% of cases. Chronic hyperuricemia accounted for 10% of our population. Sacroiliitis was observed in 41% of cases. The disparities between men and women are multiple and consistent with the literature: Polyarticular form, enthesitis, obesity, more intensive prescription of s-DMARDs, and b-DMARDs are more associated with the female population. Oligoarticular form, psoriatic nail dystrophy, radiological axial involvement, and chronic hyperuricemia are more encountered in the male population. Conclusions: Our study found a very heterogeneous disease, with marked differences between men and women. Peripheral PsA remains predominant but the search for associated axial involvement, which is probably underestimated, seems essential. Relevance for Patients: This work studied the main characteristics of patients with PsA followed in real life, in a regional university reference center. We have highlighted a very heterogeneous disease as well as some gender disparities, not well described in the literature, which should be taken into account in order to optimize therapeutic management.

Effectiveness of fracture liaison services in osteoporosis.

BACKGROUND: In response to the gradual decline in the number of prescriptions for anti-osteoporosis medication (AOM) following fragility fractures, fracture liaison services (FLSs) have been set up around the world with the aim of filling this treatment gap. Several studies have already reported the benefits of such organizations, particularly in reducing fracture risk, mortality rates and healthcare costs, and literature on FLSs has increased at a steady pace over time. METHODS: A narrative review was conducted on the latest available findings on the effectiveness of FLSs. Various approaches to implementing an effective FLS program are discussed. RESULTS: FLS programs have enhanced the management of osteoporosis-related fractures. However, several studies have highlighted that not all FLSs are necessarily effective in reducing subsequent fracture risk and mortality. Long-term AOM persistence and monitoring are another critical issue in FLS programs. A few studies have reported that FLSs are associated with an improvement in AOM persistence, regardless of the type of AOM. Practitioners in the FLS setting need to be aware of the impact of recency of fracture and fracture recurrence rates, and the need for timely interventions. The administration of zoledronic acid in an in-patient setting may improve AOM treatment rates in patients, who often encounter obstacles to outpatient follow-up. Introducing 'vertebral fracture identification services' in FLS programs is also an option. However, doing so leads to an increase in workload and this would need to be considered by any FLS that is considering introducing such a service. Evidence suggests that digital technologies can support (i) multidisciplinary teams in providing the best possible patient care based on current evidence, and (ii) patient self-management. However, as the methodological quality of many of the studies evaluating these technologies was poor, their validity of their results is limited. CONCLUSION: Further research should focus on the optimal implementation of post-fracture care using automated systems, and standardized reporting of patient's characteristics and outcome measures using key performance indicators.

Costs of patient management over 18 months following a hip, clinical vertebral, distal forearm, or proximal humerus fragility fracture in France-results from the ICUROS study.

This observational study prospectively assessed direct and indirect costs related to patient management over 18 months following hip, clinical vertebral, humeral, or distal forearm fracture events in France. It appears that their levels were much higher than the previous estimates, raising the burden of osteoporosis-related fractures on public health expenditures. INTRODUCTION: This prospective observational study assessed the costs related to patient management over the 18-month period following the event of a hip, clinical vertebral, humeral, or distal forearm fracture in France. METHODS: Individuals aged ≥ 50 years old with the diagnosis of a fragility fracture in six French University Hospitals were enrolled in the International Costs and Utilities Related to Osteoporotic Fractures Study (ICUROS). All resources used over the defined period and related to fracture and the underlying osteoporosis management were collected by questionnaires at baseline, 4 months, 12 months, and 18 months. Information was collected by direct or phone contact completed by patients' records and interviews of partner, family, and general practitioners. Costs were estimated from a societal perspective, including direct and indirect costs. We implemented recursive partitioning analysis (RPA), a statistical learning algorithm to identify predictors of costs. RESULTS: Four hundred thirty-one patients (mean age 72.5 years; 84.6% women) were evaluated. Among them, 17.6% had a prior fracture in the last 5 years. Approximately half of the whole group lived alone in the community, and 56.8% were from a low- or middle-income category. Over the 18-month period of evaluation, total costs (including initial fracture-related and follow-up ones) were 23 926 €, 14 561 €, and 6 905 € for the hip, clinical vertebral, and distal forearm fracture, respectively. Over a year, costs related to a humeral fracture were 10 319 €. The RPA identified mobility impairment prior to fracture as a predictor of increase in costs related to fracture. CONCLUSIONS: Our study for the first time prospectively assessed total costs related to the four main osteoporotic fractures in France. It appears that their levels were much higher than previous estimates, raising the burden of osteoporosis-related fractures on public health expenditures.

The clinical and economic burden after an osteoporosis fracture in France: a nationwide population-based study.

Osteoporosis-related fragility fractures increase the risk of subsequent fractures and are associated with substantial morbidity and mortality. Emphasis should be placed on the prevention of recurrent fractures, which will decrease both the clinical burden on patients and the economic burden on the health system. INTRODUCTION: Fragility fractures are associated with increased morbidity and mortality. Quantifying the clinical and economic burden of subsequent fractures following an initial osteoporosis-related fracture is a key to informing public health policies. METHODS: A retrospective cohort study, using the national French health insurance claims database. Males and females ≥ 50 years, with a hospital discharge diagnosis of osteoporosis with fracture or a relevant fragility fracture (hip, vertebrae, femur, pelvis, wrist/hand, forearm, humerus/clavicle) between 2011 and 2014, were included and followed until death or end of 2016, whichever came first. Index fracture was the first qualifying hospitalization; subsequent fractures were defined as those occurring either at a different site from the index fracture or at the same site ≥ 90 days apart. Costs abstracted included hospitalization, external consultation, outpatient visits, and treatment. RESULTS: A total of 544,426 participants (132,148 [24.3%] males and 412,278 [75.7%] females), of whom 16,110 (12.2%) males and 73,538 (17.8%) females had at least one subsequent fracture during follow-up, were included. Incidence of subsequent fracture was highest in the first year following index fracture. During follow-up, 161,179 patients died; mortality was highest among those with a hip fracture at index (29,971 (51.6%) males and 65,254 (39.6%) females). Total mean costs per patient in the year following index fracture were highest for males and females with a hip fracture (€18,585 and €15,754, respectively). CONCLUSION: Subsequent fractures among osteoporotic participants with an initial fracture result in increased clinical mortality and high healthcare resource use. Emphasis should be placed on the prevention of recurrent fractures.

French law: what about a reasoned reimbursement of serum vitamin D assays?

The number of serum 25-hydroxyvitamin D (25OHD) assays has increased tenfold in France in less than 10 years, sometimes for invalidated reasons. In 2013, the French National Authority for Health (Haute autorité de santé, or HAS) limited the indications for serum 25OHD measurements to rickets/osteomalacia, older adults with recurrent falls, monitoring of kidney transplant in adults, and surgical treatment of obesity in adults. Our aim here was to note that other indications for serum 25OHD measurements are supported by previous literature and by a number of national and international recommendations, in particular the following: any situation of bone fragility, any chronic renal failure <45 mL/min/1.73m2, any situation of malabsorption, clinical signs consistent with vitamin D deficiency or vitamin D overload, and calcium phosphorus evaluation. We suggest that the measurement of serum 25OHD concentration should remain reimbursed as part of these extended indications.

The KHOALA cohort of knee and hip osteoarthritis in France.

OBJECTIVES: This study aimed to describe the prevalence of symptomatic knee and hip osteoarthritis (OA) and its course over time, as well as identify prognostic factors of OA course and determinants of costs and access to care in France in a patient cohort. METHODS: Subjects aged 40 to 75 years, with uni- or bilateral symptomatic hip and/or knee OA (ACR criteria), Kellgren and Lawrence (KL) stage 2 or greater, were recruited from a French national prevalence survey for the multicenter KHOALA cohort study. Data collected at baseline included sociodemographic and clinical data; WOMAC, IKS and Harris scores for pain and function; MAQ score for physical activity; functional comorbidity index; GHQ28 score for psychological status; and SF-36 (generic) and OAKHQOL (specific) scores for quality of life. Blood and urine samples were collected. RESULTS: Eight hundred and seventy-eight subjects were included, 222 with OA of the hip (mean age 61.2±8.8 years), 607 knee (mean age 62.0±8.5 years) and 49 both hip and knee (mean age 64.9±7.9 years). Mean body mass index was 26.9±4.5 for hip OA and 30.3±6.3 for knee OA. Hip and knee OA patients had 1.99 and 2.06 comorbidities, on average, respectively. Disease severity on X-rays for KL stages 2, 3 and 4 for hip OA was 69.8, 26.1 and 4.1%, respectively, and for knee OA, 44.5, 30.3, and 25.2%. As compared with population norms, age- and sex-standardized SF-36 scores were greatly decreased for both knee and hip OA in all dimensions, particularly physical and emotional dimensions. PERSPECTIVES: Patients will be followed up annually, alternately by mail and clinical visit. This cohort of representative patients with knee and hip OA will be an opportunity for future collaborative research.

Responsiveness of EQ-5D and SF-6D in patients with early arthritis: results from the ESPOIR cohort.

OBJECTIVES: The revolution of early aggressive treatments for early arthritis (EA) has fuelled the search for better approaches to establishing their cost-utility ratio. The authors aimed to compare the responsiveness of the EQ-5D and the SF-6D in a large prospective cohort of patients with EA. METHODS: EQ-5D and SF-6D utility measures were assessed in 813 patients with EA over 2 years. Responsiveness was analysed by the standardised response mean (SRM) and effect size between baseline and 6, 12 and 24 months for the entire sample and subgroups by disease evolution (increase or decrease in Disease Activity Score for 28 joints). Bootstrap methods were used to estimate 95% CI. RESULTS: The EQ-5D provided larger absolute mean change estimates with greater variance than the SF-6D, whatever the direction of change. At 12 months, the SF-6D was more sensitive to change with improved condition than the EQ-5D: SRM 0.83 (0.82 to 0.84) versus 0.57 (0.56 to 0.58). In contrast, the EQ-5D was more sensitive to change with deteriorated condition than the SF-6D: SRM -0.20 (-0.23 to -0.18) versus -0.11 (-0.14 to -0.08). Results were similar for 6 and 24 months. CONCLUSIONS: The SF-6D was more responsive than the EQ-5D with improved EA condition. Confidence in the relative cost-effectiveness of two treatments would be better with the SF-6D because of its smaller variance. The SF-6D provided more conservative cost-effectiveness ratios than the EQ-5D and may be more appropriate for trials of biological treatments for patients with EA.

The influence of the definition of patient global assessment in assessment of disease activity according to the Disease Activity Score (DAS28) in rheumatoid arthritis.

OBJECTIVE: Patient global assessment (PGA) is one of the 4 items included in the Disease Activity Score (DAS28) for evaluation of activity of rheumatoid arthritis (RA). We studied the influence of the use of 3 different techniques of PGA on the assessment of disease activity. METHODS: We evaluated 3 different DAS28 according to the technique of PGA in 108 patients with active RA before and after 12 weeks of etanercept therapy. RESULTS: The reliability (intraclass coefficient of correlation) between screening and baseline was very high and similar for the 3 DAS28. The percentage of patients in the different states of disease (from remission to higher disease activity) and the sensitivity to change across the 3 DAS28 scales were very similar. CONCLUSION: The different techniques of collection of PGA to be included in the DAS calculation yield similar results. However, an accepted, unequivocal technique should be encouraged in order to reduce heterogeneity in scoring DAS among patients with RA.

Influence of vertebral fracture assessment by dual-energy X-ray absorptiometry on decision-making in osteoporosis: a structured vignette survey.

OBJECTIVE: Vertebral fracture assessment (VFA) is a radiographic method using DXA to diagnose vertebral fractures, validated for reproducibility, sensitivity and specificity as compared with spine radiographs. This study was designed to assess the impact of VFA results on decision-marking in osteoporosis, using a clinical vignette-based approach. METHODS: Twenty-nine rheumatologists provided data on post-menopausal women consulting for BMD measurement: clinical risk factors for osteoporosis, clinical characteristics of patients, BMD, T-score and VFA images. Standardized clinical vignettes were generated from these patients, and each rheumatologist assessed five vignettes assigned at random, in two distinct steps: first step without and second step with VFA data. At each step, they had to answer questions about the prescription of radiographs and treatments, using a yes/no format. RESULTS: A total of 117 vignettes were available [117 patients: mean age 65.1 (10.1) years, lumbar spine T-score: -1.64 (0.92)], 36.7% with a personal history of fracture. Rheumatologists intended to prescribe radiographs in 62.4 and 46.2% cases (P = 0.0206) before and after VFA results, respectively; a change occurred in 36.8% of patients, i.e. a de novo prescription of radiographs in 12 patients, and a deleted prescription in 31 patients. VFA data induced a therapeutic change for 30.8% of patients. CONCLUSION: This study shows that VFA results influence patient management, both for radiographs and treatment prescriptions.

Comparison of the EQ-5D and the SF-6D utility measures in 813 patients with early arthritis: results from the ESPOIR cohort.

OBJECTIVE: The revolution of early aggressive therapy in early arthritis (EA) has fueled the search for better approaches to establish cost-effectiveness. Our objective was to compare the EuroQol EQ-5D health outcome measure and the SF-6D and to investigate their relationship to clinical variables in a large prospective cohort of patients with EA. METHODS: The EQ-5D and SF-6D utility measures were longitudinally assessed in 813 patients with EA. Agreement and aspects of validity (construct validity, discrimination) were assessed. RESULTS: At baseline, mean values for EQ-5D were 0.52 ± 0.31 (range -0.59 to 1.0) and for SF-6D were 0.58 ± 0.11 (range 0.30 to 0.92), with a bimodal distribution for the EQ-5D. Agreement was low for patients with severe disability or active disease: the utility was systematically lower with EQ-5D. The intraclass correlation coefficient was 0.42 at baseline and increased to 0.53 at 6 months and 0.57 at 1 and 2 years. Correlations between the 2 utility scores and the Health Assessment Questionnaire were good, and remained similar and stable over 2 years (r = -0.70). Correlations with the Disease Activity Score for 28 joints and the physical component of the MOS 36-item Short-form Health Survey (SF-36) were moderate to good and stable. In contrast, correlation with the mental component of the SF-36 was better with the SF-6D, and the correlation with pain, weak at baseline, improved at 6 months and remained stable thereafter. The SF-6D was better able to discriminate patients with high disease activity. CONCLUSION: There was systematic disagreement between EQ-5D and SF-6D in EA, especially in patients with worse clinical outcomes. Using the 2 instruments could be appropriate to conduct sensitivity analyses of cost-utility ratios because the instruments measure utility with closely similar measured properties, but at different levels.

Epidemiology of osteoporosis-related fractures in France: a literature review.

OBJECTIVES: To evaluate the health implications and economic burden on society of osteoporotic fractures as a major source of morbidity and mortality in the ageing population. METHODS: We have summarised the findings of a literature review of French studies published between 1960 and 2009, characterised the epidemiology of osteoporosis and osteoporotic fractures, and predicted future trends. RESULTS: Published data for France supported the observation that osteoporosis is under-diagnosed in many countries. The incidence of fracture increased exponentially with age, alongside a concurrent decrease in bone mineral density, a risk factor for fracture. Combined with a projected rise in the French elderly population, this poses a significant burden for the future. The incidence of fracture was high in the osteopenic population; consequently, fragility fractures may be underestimated if reports focus on osteoporotic women only. As in many other countries, French data revealed that women have a higher incidence of osteoporotic fractures than men, although mortality from hip fracture was higher in men. DISCUSSION: Due to ageing of the population, an increase in the number of people suffering from fractures is predicted over the next few decades unless preventative action is taken, highlighting the need for improved diagnosis and screening in postmenopausal women.

Cost-effectiveness model of using zoledronic acid once a year versus current treatment strategies in postmenopausal osteoporosis.

OBJECTIVES: To compare effectiveness, associated cost of outcomes and cost-effectiveness of a single annual infusion of zoledronic acid versus current treatment strategies plans for postmenopausal osteoporosis in France. METHODS: Twelve simulation-based models were built to investigate three types of fractures: vertebral (VF), non-vertebral excluding hip (NVF) and hip (HF), comparing two groups: zoledronic acid and current postmenopausal antiosteoporotic treatment strategies. Two effectiveness comparability assumptions have been tested: specific agent efficacy values, and same standard efficacy values for all active agents. Direct medical costs included drug costs, medical visits, monitoring and fracture management. Adherence levels were integrated into the model under the assumption that non-adherent patients had treatment effects similar to the levels of placebo effectiveness. RESULTS: Using the most conservative assumption (same standard efficacy values for all active agents), zoledronic acid strategy results in less vertebral, non-vertebral and hip fractures than other current antiosteoporotic treatment options over 3 years: 12.04% vs. 14.18%, 10.61% vs. 11.28% and 2.82% vs. 4.64% respectively, (p<0.001). In addition, zoledronic acid is more cost-effective than the current treatment strategies in all types of fractures (p<0.001): 1497 euros vs. 1685 euros per VF avoided, 1337 euros vs. 1404 euros per NVF avoided and 1216 euros vs. 1323 euros per HF avoided. CONCLUSION: Zoledronic acid is a cost-effective treatment strategy regardless of fracture type or effectiveness comparability assumptions.

Incidence and cost of osteoporotic fractures in France during 2001. A methodological approach by the national hospital database.

The objective of this study was to describe the hospital incidence rate and the in-patient costs of three peripheral "osteoporotic" fractures (proximal humerus and hip, distal radius and/or ulna) in women and men aged over 45 in France during 2001. Each stay for fracture was selected from the dataset of the French national hospital database in 2001. The incidence rate (CI 95%) was standardized by age and gender according to the last census of the French population (1999). The effect of age and existence of geographical difference in incidence rates has been studied. For each fracture, we described the number of stays, rate of surgical procedure and in-patient costs according to the 2004 French list of cost per diagnosis-related group (2004 Euros); 118,839 fractures were registered during 2001 (61% hip, 28% distal radius and 11% proximal humerus; sex ratio 0.26). The incidence rate for all fracture was 7,567 (7,519-7,615) and 2,312 (2,283-2,341) for 10(6) inhabitants in women and men aged over 45 years, respectively. The incidence increased significantly whatever type of fracture and gender. There were more fracture incidents in the east of France compared to the west and in the south compared to the north, whatever type of fracture in women and only for hip fracture in men. Surgical procedures were performed in 91% of proximal hip fractures, 83% of distal radius fractures and 53% of proximal humerus fractures. The median in-patient costs were 3,786 Euros for the humerus, from 2,363 to 2,574 Euros for the radius and from 8,048 to 8,727 Euros for the hip. The evaluation of the burden of peripheral fractures is possible using national hospital data in France. The incidence of fractures increased with age and is more common in women. Hip fracture with its higher occurrence, rate of procedure and in-patient costs could be used as a marker of osteoporosis for evaluating strategies of management.