Quality of life in patients with uveitis: data from the ULISSE study (Uveitis: cLInical and medico-economic evaluation of a Standardised Strategy for the Etiological diagnosis).

AIMS: To assess vision-related (VR-QOL) and health-related quality of life (HR-QOL) in a large series of patients with de novo uveitis at baseline and 6-month follow-up. METHODS: Non-inferiority, prospective, multicentre, cluster randomised controlled trial registered under the Unique Identifier: NCT01162070. VR-QOL and HR-QOL were assessed by the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) and the Medical Outcomes Study 36-item Short Form Survey (SF-36). RESULTS: At inclusion, 466 patients completed the VFQ-25. The mean composite score was 80.0 (±16.7). In multivariate analysis, higher age, female sex and insidious onset were significantly associated with lower QOL. At 6 months, 138 patients completed the VFQ-25, with a significantly higher mean composite score of 82.6 (±16.7). SF-36 mental component was 42.9 (±11.3) and physical component was 47.2 (±8.5) at inclusion (n=425). HR-QOL improvement at 6 months was not clinically significant. CONCLUSION: QOL seems relatively well preserved in this cohort; only VR-QOL improved significantly at 6 months, especially in patients with low initial visual acuity.

Paramedical students' perceptions of research: a survey.

BACKGROUND: There is a general perception that research is underdeveloped in rehabilitation professions. However, a PubMed search found that the growth in publications in the rehabilitation field was twice that of the general medical field. Despite this growth, another study focusing on Europe found that the proportion of articles reporting on clinical research in the rehabilitation field remained low (less than 40% of articles). This could be due to lack of teaching about research in rehabilitation schools or the late introduction of such courses. AIMS: Describe the students' perceptions of research: their desire to conduct research, the usefulness of research and research competence. METHODS: Questionnaire survey targeting all French paramedical students (speech therapy, occupational therapy, psychomotricity, audiometry, physiotherapy, orthoptics) in their final year of study in 2018-2019. RESULTS: Overall, 791 students completed the full survey representing a response rate of 36.3% of the students contacted. Only 34.3% of rehabilitation students were willing to conduct research despite finding it useful (98.6%). The main barrier was the preference for their core operational work (cited 444 times, representing 17.6% of citations). There was a significant relation between perceived competence and the attractiveness of research: 84% of the students not interested in research felt they were not competent to conduct research but this figure dropped to 57.6% amongst the students interested in research (OR 4.0; 95% CI 2.9-5.6). Using a multivariate analysis, we confirmed that the main incentive was feeling competent, as well as past contact with research and supervisors who promoted research work. CONCLUSION: Students have little contact with research during their internships, low perceived competence and, consequently, little desire to conduct research.

Evaluating the cost-consequence of a standardized strategy for the etiological diagnosis of uveitis (ULISSE study).

MAIN OBJECTIVE: To prospectively assess the cost-consequence of a standardized diagnostic strategy as to compared to an open one for the etiological diagnosis of uveitis. DESIGN: This was a prospective, non-inferiority, multicentre, randomized controlled trial. METHODS: We included all consecutive patients with uveitis who had visited at least one of the Departments of Ophthalmology. In the standardized group, patients had a minimal work-up regardless of the type of uveitis (including evaluation of the CBC, ESR, C-reactive protein, tuberculin skin test, syphilis serology and chest X-ray). Depending on ophthalmological findings, further investigations could be performed. In the open strategy, ophthalmologists were free to order any kind of investigation. The main outcome was the mean cost per patient of each strategy. RESULTS: 903 uveitis patients were included from January, 2010 to May, 2013. The mean cost per patient of the standardized strategy was 182.97 euros [CI 95% (173.14; 192.80)], and the mean cost per patient of the open strategy was 251.75 euros [CI 95% (229.24; 274.25)]. Therefore, the mean cost per patient of the standardized strategy was significantly lower than the mean cost per patient of the open strategy (p<0.001). There were significantly fewer visits (p<0.001), fewer radiological procedures (p<0.004) and fewer laboratory investigations (p<0.001) in the standardized group. CONCLUSION: A standardized strategy is a cost-saving approach for the etiological diagnosis of uveitis.

Effects of modification of trauma bleeding management: A before and after study.

OBJECTIVE: We hypothesised that the association of tranexamic acid (TXA) administration and thromboelastometry-guided haemostatic therapy (TGHT) with implementation of Damage Control Resuscitation (DCR) reduced blood products (BP) use and massive transfusion (MT). METHODS: Retrospective comparison of 2 cohorts of trauma patients admitted in a university hospital, before (Period 1) and after implementation of DCR, TXA (first 3-hours) and TGHT (Period 2). Patients were included if they received at least 1 BP (RBC, FFP or platelet) or coagulation factor concentrates (fibrinogen or prothrombin complex) during the first 24-hours following the admission. RESULTS: 380 patients were included. Patients in Period 2 (n = 182) received less frequently a MT (8% vs. 33%, P < 0.01), significantly less BP (RBC: 2 units [1-5] vs. 6 [3-11]; FFP: 0 units [0-2] vs. 4 [2-8]) but more fibrinogen concentrates (3.0 g [1.5-4.5] vs. 0.0 g [0.0-3.0], P < 0.01). Multivariate logistic regression analysis identified Period 1 as being associated with an increased risk of receiving MT (OR: 26.1, 95% CI: 9.7-70.2) and decreased survival at 28 days (OR: 2.0, 95% CI: 1.0-3.9). After propensity matching, the same results were observed but there was no difference for survival and a significant decrease for the cost of BP (2370 ± 2126 vs. 3284 ± 3812 €, P: 0.036). CONCLUSION: Following the implementation of a bundle of care including DCR, TGHT and administration of TXA, we observed a decrease to the use of blood products, need for MT and an improvement of survival.

Assessment of the clinical relevance of pharmacists' interventions performed during medication review in a rheumatology ward.

BACKGROUND: Pharmacists contribute to reduce the number of medication errors during medication review. Nevertheless, few French studies report the potential clinical impact of pharmacists' interventions performed after detecting drug-related problems. The objective was to evaluate the clinical relevance of pharmacists' interventions in a rheumatology ward from medical and pharmaceutical perspectives. METHOD: The analysis was conducted on pharmacists' interventions performed between January 1 and December 31, 2015 in a French teaching hospital. Similar pharmacists' interventions were grouped in one item and they were analysed according to 11 drug categories. The clinical significance of pharmacists' interventions was considered independently by a pharmacist and a rheumatologist using a validated French scale that categorises drug-related problems from minor to catastrophic. The agreement between the two professionals was analysed using the weighted kappa coefficient. RESULTS: Of 1313 prescriptions reviewed, 461 pharmacists' interventions (171 items) were formulated for drug-related problems with an acceptance rate of 67.2%. Of the 418 interventions selected for clinical significance analysis, 235 interventions (56.2%) for the physician and 400 interventions (95.7%) for the pharmacist were at least significant. The two professionals evaluated equally the clinical relevance of 90 items (50.6%). The categories with the most similarities were the analgesics/anti-inflammatory drugs (78.1%), the antidiabetics (75.0%) and the anticoagulants (71.4%). The agreement was estimated by a weighted kappa coefficient of 0.29. CONCLUSION: This work highlights the positive clinical relevance of pharmacists' interventions in rheumatology and the importance of medico-pharmaceutical collaboration to prevent medication errors.

Assessment of Dural Ectasia Using Computed Tomodensitometry as a Criterion in Marfan Syndrome.

OBJECTIVE: The aim of this study was to reevaluate dural ectasia criteria in Marfan syndrome patients fulfilling the revised Ghent criteria. METHODS: Lumbar computed tomography scans of 19 Marfan patients and 30 matched control subjects were retrospectively assessed. Dural sac ratio (DSR), nerve root sleeve diameter, pedicle width, and a scalloping or meningocele presence were each assessed by 2 readers blinded from the diagnosis. Mann-Whitney-Wilcoxon tests compared the patient and control groups. Receiver operating characteristic curve analysis and multivariate models determined the optimal cutoff value. RESULTS: A DSR value greater than 0.69 at L5 (DSR-L5) such as L4 scalloping of more than 2.65 mm (scall-L4) and 6 or more vertebrae showing a scalloping of more than 3 mm (6-scall) were found very specific but with limited sensitivity. Multivariate model combining DSR-L5 + scall-L4 showed good positive predictive value, whereas model combining DSR-L5 + 6-scall showed good negative predictive value. CONCLUSIONS: Assessment of DSR and vertebral scalloping allows valuable depiction of dural ectasia in Marfan syndrome patients.

Contribution of diagnostic tests for the etiological assessment of uveitis, data from the ULISSE study (Uveitis: Clinical and medicoeconomic evaluation of a standardized strategy of the etiological diagnosis).

PURPOSE: ULISSE is the only study that prospectively assessed the efficiency of a standardized strategy, compared to an open strategy for the etiologic diagnosis of uveitis. Our aim was to evaluate the diagnostic yield of the tests prescribed in the ULISSE study to clarify their relevance. METHODS: ULISSE is a non-inferiority, prospective, multicenter and cluster randomized study. The standardized strategy is a two-steps strategy: in the first step, common standard tests were performed, and in the second step, tests were guided by the clinical and anatomic type of uveitis. We reported the relevance of the diagnostic tests used in the standardized strategy, as well as the profitability of the tests that were prescribed to more than twenty patients in each group. Based on diagnostic criteria, either an ophthalmologist, or an internist, established the profitability of a test by considering whether the test lead to a diagnosis or not. RESULTS: Among the 676 patients included (standardized 303; open 373), a diagnosis was made for 152 (50.4%) in the standardized group and 203 (54.4%) in the open group. The most common entities were HLA-B27 associated uveitis (22%), spondyloarthritis (11%), sarcoidosis (18%), tuberculosis (10.7%) and herpes virus infections (8.5%). Among the first step's systematic tests, tuberculin skin test was the most contributive investigation (17.1%), followed by chest X-ray (8.4%), C reactive protein and ESR (6.6% and 5.1%), complete blood count (2.2%) and VDRL (2.0%). The second step's most often contributive tests were: HLA B27 (56.3%), chest-CT (30.3%) and angiotensin converting enzyme (ACE) (16.5%). HLA B27 and ACE were significantly more contributive in the standardized group than in the open group. Immunological tests were never contributive. Among the free investigations, or among the investigations guided by clinical or paraclinical findings, the most often contributive tests were: Quantiferon® (24%), electrophoresis of serum protein (7.8%) and sacroiliac imagery (46.4%). Intracellular serologies (1.7%), serum calcium (2.1%) and hepatic tests (3.3%) were exceptionally contributive. Among the third intention tests, labial salivary gland biopsies were contributive in 17.9% of cases, but the profitability of other invasive investigations (anterior chamber tap, vitrectomy, bronchoscopy and lumbar puncture) or specialized imagery (18F-FDG PET, Brain MRI) could not be determined since these test were rarely performed. CONCLUSION: Only a few diagnostic tests are useful for the etiological assessment of uveitis. They are often cheap, simple, more often guided by the clinical findings, and lead to an etiological diagnosis in most patients. On the other hand, some tests are never or exceptionally contributive, such as immunological tests or intracellular serologies. Further studies are required to evaluate the profitability of third intention imagery and invasive investigations.

Fate of protocols submitted to a French national funding scheme: a cohort study.

BACKGROUND: The fate of clinical research projects funded by a grant has been investigated, but there is no information on the projects which did not receive funding. The fate of these projects is not known: do they apply for and/or receive funding from other sources or are they carried out without specific funding? PURPOSE: The aim of the study was to describe all clinical research projects submitted to a French national funding scheme (PHRC 2000) and to assess project initiation, completion and publication status taking into account whether or not they received funding. METHODS: This study is a retrospective cohort. The initial project characteristics were retrieved from the submission files and follow-up information was collected from the primary investigator. The percentages of projects started, completed and published were studied. RESULTS: A total of 481 projects were studied. Follow-up information was obtained for 366. Overall, 185 projects were initiated (51%); 139 of them were funded by the PHRC 2000 or other sources. The most commonly cited reason for not initiating a project was a lack of funding. Subsequently, 121 of the projects initiated were completed (65%). Accrual difficulties were the main reason cited to explain why studies were stopped prematurely or were still ongoing. Finally, 88 of the completed projects were published (73%). Amongst the completed projects, the only factor explaining publication was the statistical significance of the results. CONCLUSIONS: Obtainment of funding was a determining factor for project initiation. However, once initiated, the funding did not influence completion or publication.

Medical device assessment: scientific evidence examined by the French national agency for health - a descriptive study.

BACKGROUND: Scientific evidence supports decision-making on the use of implantable medical devices (IMDs) in clinical practice, but IMDs are thought to be far less investigated than drugs. In the USA, studies have shown that approval process of high-risk medical devices was often based on insufficiently robust studies, suggesting that evidence prior to marketing may not be adequate. This study aimed to ascertain level of evidence available for IMDs access to reimbursement in France. METHODS: The objective was to examine the scientific evidence used for IMDs assessment by the French National Authority for Health. We collected all public documents summarising supportive clinical data and opinions concerning IMDs issued in 2008. An opinion qualifies the expected benefit (EB) of the IMD assessed as sufficient or insufficient, and if sufficient, the level of improvement of the expected benefit (IEB) on a scale from major (level I) to no improvement (level V). For each opinion, the study with the highest level of evidence of efficacy data, and its design were collected, or, where no studies were available, any other data sources used to establish the opinion. RESULTS: One hundred and two opinions were analysed, with 72 reporting at least one study used for assessment (70.6%). When considering the study with the highest level of evidence: 34 were clinical non-comparative studies (47.2%); 29 were clinical comparative studies of which 25 randomised controlled trials (40.3%); 5 were meta-analyses of randomised controlled trials (6.9%); and 4 were systematic literature reviews (5.6%). The opinions were significantly different according to the study design (p < 0.001). The most frequent design for insufficient EB, IEB level V and IEB level IV was a non-comparative study (10/19, 52.6%; 15/24, 62.5%; and 8/15, 53.3%; respectively). For the 30 opinions with no supporting clinical study, 16 (53.3%) were based on an expert-based process, 9 (30.0%) were based on the conclusions of a previous opinion (all concluding IEB level V), and 5 (16.7%) reported no data (concluding insufficient EB for 4 and IEB level V for 1). CONCLUSIONS: This study confirmed that level of evidence of clinical evaluation of IMDs is low and needs to be improved.

[Direct medical cost of erythropoiesis-stimulating agents in anaemia treatment of chronic renal failure patient: a literature review]. / Coût médical direct des agents stimulant l'érythropoïèse dans le traitement de l'anémie chez le patient insuffisant rénal chronique: revue de la littérature.

INTRODUCTION: Management of anaemia in chronic renal insufficiency (CRI) represents an important medico-economic challenge because of the great number of patients and the cost of the erythropoiesis-stimulating agent (ESA). The aim of this study was to identify determinants of the costs associated with these treatments in order to choose, with equal efficacy, the most efficient ASE. METHOD: A bibliographic research was realised by Medline database interrogation. RESULTS: Among the direct medical costs, five studies showed that acquisition of epoetine alfa (EA) compared to darbepoetin alfa (DA) was less expensive. Concerning the costs associated with the route of administration, the subcutaneous injection (SC) of epoetine allowed a gain in costs because of the decrease of doses compared to the intravenous (IV) route. The switch from EA in SC to DA in IV, for hemodialysis patients, was associated with a reduction of the number of injections and with a treatment's cost lower by DA than by EA. Costs related to the regimen of administration, notably those related to nursing, medical and pharmaceutical time, were negligible towards those associated to the acquisition of the ASE. Finally, the costs of the therapeutic follow-up and treatment of the adverse effects of the ASE were similar between the EA and the DA. CONCLUSION: The costs associated with the prices of acquisition of the ASE, negotiated by the structure of care, represent the most important part of the direct medical costs.

Impact of funding on biomedical research: a retrospective cohort study.

BACKGROUND: Public funding is aimed at facilitating the initiation, completion and publication of research study protocols. However, no evaluation is made to investigate the impact of grant success on the conduct of biomedical research. It is therefore of great interest to compare the fate of funded protocols versus not funded: Are they initiated? Are they completed? Did the results confirm the hypothesis? Were they published? The objective was to investigate the fate of protocols submitted for funding, whether they were funded or not. METHODS: Retrospective cohort study of protocols submitted for funding to the Greater Lyon regional scientific committee in 1997. Initial characteristics of protocols (design, study size, investigator status) were abstracted from archives, and follow-up characteristics (initiation, completion and publication) from a mailed questionnaire to the principal investigators. RESULTS: Among the 142 submitted protocols, follow-up information was available for 114 (80%). As a whole, 38% of studies were funded by the Greater Lyon research committee. The rate of initiation varied from 62% for studies with no acknowledged funding to 100% for studies with both committee and other simultaneous funding. When initiated, the rate of completion was 62% for studies with at least one funding and 40% for studies without acknowledged funding. When completed, publication was reached for 77% of studies with either committee or external funding, for 58% of studies without acknowledged funding and for 37% of studies with both committee and external funding. CONCLUSION: Some protocols submitted for funding were initiated and completed without any funding declared. To our understanding this mean that not all protocols submitted really needed funding and also that health care facilities are unaware that they implicitly financially support and pay for biomedical research.