[Cancers of the external genital organs of male in Hérault: Results from the Hérault tumor register (RTH) over a period of 30 years (1987-2016)]. / Le cancer des organes génitaux externes de l'homme dans le département de l'Hérault: résultats de 30 ans d'enregistrement du registre des tumeurs de l'Hérault (1987­2016).

AIM: The objective of this study is to present the history of cancers of the external genital organs of male in Hérault using data from the Hérault tumor register (RTH) over a period of 30 years. PATIENTS AND METHODS: Using the RTH database, we studied the development of testicular germ cell tumors (TGCT) and penile cancer (PC) over 30 years, from 1987 to 2016. We analyzed the incidence and mortality data for these tumors. We compared these results to French, European and global data. RESULTS: In 30 years of registration we have recorded 725 cases of TGCT and 175 cases of PC. The age standardized incidence rate (ASR) of TGCT has doubled between 1987 and 2016 (4.2 per 100,000 in 1987 and 9.3 per 100,000 in 2016). It was multiplied by 2.63 in the population of patients aged 30 to 44. There is a decrease of the mortality rate with a ASR of 0.8 deaths per 100,000 in 1987, and 0.4/100 000 in 2016. The PC incidence ASR was stable between 1987 and 2016 (0.4-0.9/100,000). Mortality is stable with a ASR between 0.1 and 0.3 deaths per 100,000 between 1987 and 2016. CONCLUSION: The incidence of TGCT has increased sharply in the Hérault over the past 30 years, while a decrease in mortality has been observed. The proportion of seminomas is increasing; it has gone from 53 % to 60 % in 30 years in the Hérault. The incidence and mortality of PC shows a stability in the Hérault over the past 30 years.

[Renal cell carcinoma in the department of Hérault: Results over a 30 year period]. / Le cancer du rein dans le département de L'Hérault : résultats de 30 ans d'enregistrement.

OBJECTIVE: The objective of the study was to determine the specificities of renal cell carcinoma (RCC) in the department of Herault using the Herault Tumor Registry over 30 years. METHODS: Data of this study were obtained from the Herault cancer database. We analysed the evolution of RCC from 1987 to 2016, including the incidence, mortality, cancer pathology and staging at the moment of diagnosis. We compared our results with national and international data. RESULTS: We identified 3769 newly diagnosed RCC: 2628 in men (69,7%) and 1141 in women (30,3%). In 2016, RCC was the 8th most frequent cancer, both genders combined, the 7th most frequent cancer in men and the 11th in women. New cases of RCC increased by 4.2 in men and 3.3 in women over the study period. The number of localised forms increased by 9% over 20 years. In 2016, the probability of having a RCC before the age of 75 was of 2.11% for a man and of 0.62% for a woman. CONCLUSION: Over 30 years, the incidence rate of RCC increased in the department of Herault; however, mortality decreased over the same period. This analytical data should be improved by the development of the Registry of Herault Specialised in Onco-Urology (RHESOU). LEVEL OF EVIDENCE: 3.

[RHESOU (Registry in HErault Specialized in Onco-Urology) : the first French Registry specialized in Onco-Urology. One-year experience]. / RHESOU (Registre de l'Hérault spécialisé en onco-urologie) : le premier registre français spécialisé en onco-urologie. Un outil méthodologique de recueil de données en onco-urologie. Bilan de faisabilité sur un an d'expérience.

PURPOSE: In 2016, the Herault tumor registry collected 1961cancers in urology (21.4 % from all Herault cancers this year). RHESOU was created to complete RTH' data with specific parameters in onco-urology. The aim of this study is to describe RHESOU and to give some examples with our first results. MATERIAL AND METHODS: In November 2018, RHESOU (Registry HErault Specialised in Onco-Urology) was founded with the same registry recommendations. It collects specific oncologic parameters and also complete RTH's data. For each urological cancer, a specific survey with different choices was performed to collect a maximum of data which could be present in patients' file. These surveys were used for urological cancers cases that live in Herault in 2017. RESULTS: In 2017, we collected 970 prostate cancers, 581 bladder cancers, 212 kidney cancers, 51 upper excretory tract cancers, 28 testicle cancers and 9 penil cancers. Our urological data collection gives many possibilities to create many requests for detailed analysis in urological cancers. In this article, we reported data from kidney, bladder and prostate cancers. CONCLUSIONS: RHESOU is a new tool opened to the different urologic corporations (urologists, pathologists, oncologists, radiotherapists, radiologists) that permits an overview in urological cancers in Herault. Finally, one important aim is that this tool will be adapted when new treatments or new important parameters appear in the years ahead. LEVEL OF EVIDENCE: 3.

Evolution of silent myocardial ischaemia prevalence and cardiovascular disease risk factor management in Type 2 diabetes over a 10-year period: an observational study.

AIMS: To assess the evolution of silent myocardial ischaemia prevalence and of cardiovascular disease risk factor management over 10 years in people with Type 2 diabetes. METHODS: This repeated cross-sectional study prospectively included 770 people with Type 2 diabetes who presented at our centre in the period 1999-2009. All had at least one additional cardiovascular disease risk factor, no history of coronary disease and were screened for silent myocardial ischaemia using myocardial perfusion imaging. The prevalence of silent myocardial ischaemia, clinical and biological variables and treatments were collected and compared among participants screened in three periods: 1999 to 2002; 2003 to 2005; and 2006 to 2009. We also identified predictive factors for silent myocardial ischaemia. RESULTS: Participants had a mean ± sd age of 62.3 ± 9.3 years, 57.4% were men and the mean time from diagnosis of diabetes was 13.4 ± 9.3 years. Overall, silent myocardial ischaemia screening was positive in 13.9% of participants. This prevalence decreased sharply over the 10-year study period (22.6% in 1999-2002, 13.7% in 2003-2005 and 5.9% in 2006-2009; P<0.0001). In parallel, diastolic and systolic blood pressure, HbA1c and LDL cholesterol significantly decreased and glitazone and statin use increased (all P<0.001). Male gender, peripheral artery disease, diastolic blood pressure >80 mmHg and LDL cholesterol >2.6 mmol/l were independently associated with silent myocardial ischaemia. Further adjustment showed the screening period had a significant effect, which erased the effects of diastolic blood pressure and LDL cholesterol. CONCLUSIONS: The prevalence of silent myocardial ischaemia decreased sharply over time, and control of the main cardiovascular disease risk factors improved. Although the causality link cannot be established, the present study supports current recommendations advocating glycaemic control and intensive management of cardiovascular factors instead of systematic screening.

Allergic Rhinitis Control Test questionnaire-driven stepwise strategy to improve allergic rhinitis control: a prospective study.

BACKGROUND: Allergic Rhinitis Control Test (ARCT) has been validated for assessing allergic rhinitis (AR) control and identifying severe AR. The aim of the study was to assess the ARCT questionnaire as a tool for stepwise pharmacotherapy. METHODS: A standard pharmacotherapy regimen from Step 1 (oral second-generation H1 antihistamine as needed) to Step 5 (oral corticosteroid) was carried out prospectively in a Chinese AR population. The AR patients were initiated with Allergic Rhinitis and its Impact on Asthma (ARIA) appropriate step treatment and assessed with ARCT every 15 days. If ARCT score was equal or above 20 (controlled AR) and maintained for 15 days, the patient would finish the study; if ARCT score was strictly <20 (uncontrolled AR), the patient would receive higher step treatment according to a predefined open design up to Step 5. The different AR control subgroups were compared. RESULTS: A total of 255 patients were enrolled in the study; 5 patients dropped out and 2 (0.8%) were controlled at day 0, 85 (34.0%) at day 15, 177 (70.8%) at day 30, 222 (88.8%) at day 45, 241 (96.4%) at day 60 and 242 (96.8%) at day 75. Only 8 (3.2%) patients remained uncontrolled at the endpoint of the study. Patients with ARIA moderate/severe or persistent symptoms, moderate/severe impaired quality of life, asthma history, rhinorrhea and cough symptoms always needed up to Step 4 (nasal corticosteroid plus antihistamine) and prolonged treatments to achieve disease control. CONCLUSIONS: The majority of AR can be controlled with standard stepwise treatment. ARCT offers an objective criterion for the stepwise pharmacotherapy of AR.

Comparison of the long-term outcome for patients with rheumatoid arthritis with persistent moderate disease activity or disease remission during the first year after diagnosis: data from the ESPOIR cohort.

OBJECTIVE: To investigate if patients with early RA with persistent moderate disease activity during the first year after diagnosis have a worse 3-5 year outcome than those who achieve sustained clinical remission within the first year, in a daily life setting. METHODS: The ESPOIR cohort included patients with early arthritis of <6 months' duration. Treatment was the standard of care. We had 5-year follow-up data for 573 patients. This study compared patients who had persistent moderate disease activity (Disease Activity Score in 28 joints (DAS28)>3.2 and ≤5.1) at both the 6- and 12-month visits, with those who were in sustained DAS28 remission. The primary outcome was radiographic progression at the 36-month visit. Secondary endpoints were clinical remission (DAS28 score, Simplified Disease Activity Index, ACR/EULAR criteria), Health Assessment Questionnaire-Disability Index (HAQ-DI) and number of missed workdays at months 36 and 60. A Fisher exact test was used to compare categorical variables, and the Kruskal-Wallis test for quantitative variables. Logistic regression analysis was used to determine predictors of outcome. RESULTS: Patients were aged 48.1±12.5 years and their duration of symptoms was 103.2±52.1 days. Mean baseline DAS28 was 5.1±1.3. Persistent moderate disease activity (107 patients) rather than sustained remission (155 patients) during the first year was associated with increased radiographic disease progression at 3 years (OR=1.99 (95% CI 1.01 to 3.79)), increased HAQ-DI at 3 and 5 years (5.23 (2.81 to 9.73) and 4.10 (2.16 to 7.80), respectively), a 7-11 times smaller chance of achieving clinical remission and a five times greater number of missed workdays. CONCLUSIONS: Patients with early RA with persistent moderate disease activity during the first year had a worse outcome than patients who achieved sustained clinical remission. Persistent moderate disease activity affects long-term structure, remission rate and functional and work disability. Such patients may benefit from intensive treatment.

Vitamin D is associated with degree of disability in patients with fully ambulatory relapsing-remitting multiple sclerosis.

BACKGROUND AND PURPOSE: Vitamin D deficiency is a recognized risk factor for multiple sclerosis (MS) and is associated with increased disease activity. It has also been proposed that the lower the vitamin D levels are, the higher is the handicap. METHODS: To refine the links between vitamin D insufficiency and disability in MS patients, a retrospective cohort analysis was performed including 181 patients prospectively followed without previous vitamin D supplementation, and age, gender, age at MS onset, MS type, MS activity, Expanded Disability Status Scale (EDSS) were analysed in correlation with plasma vitamin D levels. RESULTS: Vitamin D levels were significantly higher in relapsing-remitting MS than in progressive forms of MS in multivariate analyses adjusted for age, ethnicity, gender, disease duration and season (P = 0.0487). Overall, there was a negative correlation between vitamin D level and EDSS score (P = 0.0001, r = -0.33). In relapsing-remitting MS, vitamin D levels were only correlated with disability scores for EDSS < 4 (P = 0.0012). Patients with >20 ng/ml of vitamin D were 2.78 times more likely to have an EDSS < 4 (P = 0.0011, 95% confidence interval 1.49-5.00). CONCLUSION: Data support previous work suggesting that vitamin D deficiency is associated with higher risk of disability in MS. Vitamin D levels also correlated with the degree of disability in fully ambulatory patients with relapsing-remitting MS. These additional results support the pertinence of randomized controlled trials analysing the interest of an early vitamin D supplementation in MS patients to influence evolution of disability.

Breast conserving surgery in multicentric breast cancer, preliminary data of our experience.

INTRODUCTION: It is widely supported that multicentric disease of the breast (MCDB) is a contraindication of breast conservative surgery (BCS). MATERIALS AND METHODS: This is a multicentric study (two breast cancer units from Greece, one from France) involving patients with at least two primary tumors in separate quadrants of the breast and no diffuse suspicious microcalcifications on mammography. Sixty-one patients were included in the study, but 49 were followed up to the end. Patients were randomly assigned in total mastectomy (TM) and BCS groups. End point of the study was disease-free survival rates three and five years after initial operation. RESULTS: Three years after BCS, local recurrence (LR) was observed in two patients (7%) and one after five years (total recurrence rate: 11%). A TM was performed in these patients, and in two there was no LR or distant metastasis (DM) five years after. The third patient was disease free two-years later. Three years after TM, eight patients (36.4%) had DM and 14 (63.6%) did not (p = 0.004). Five years after TM, eight patients (36.4%) had DM and 14 patients (63.6%) di not (p = 0.03). CONCLUSION: The results showed that conservative surgery was an alternative surgical option in multicentric breast cancer with good results regarding disease-free survival and recurrence.

Predictors of radiographic progression in the ESPOIR cohort: the season of first symptoms may influence the short-term outcome in early arthritis.

OBJECTIVES: To determine predictors of short-term radiographic progression in an inception cohort of patients with early arthritis. METHODS: Patients presenting with synovitis of at least two joints for 6 weeks to 6 months were included in the Etude et Suivi des POlyarthrites Indifferenciées Récentes (ESPOIR) cohort. Univariate analysis was used to determine the relationship between baseline variables and radiographic outcome (assessed by the modified total Sharp score (mTSS)) after 6 and 12 months. Stepwise multiple logistic regression was used to select independent predictive factors. The sensitivity and specificity of rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA) at baseline in discriminating between erosive and non-erosive disease were determined by receiver operating characteristic (ROC) curves. RESULTS: From data available for 736 patients, radiographic progression at 6 months was independently predicted by baseline ACPA, human leucocyte antigen (HLA)-DRB1*01 and/or 04 genes, erythrocyte sedimentation rate and mTSS. Interestingly, the season of onset of the first symptoms was associated with the severity of early arthritis (OR 1.66, 95% CI 1.07 to 2.59, in winter and spring vs summer and autumn). Univariate analysis revealed similar results for season at 12 months (OR 1.68, 95% CI 1.20 to 2.37). The peak of the ROC curves for radiographic outcome occurred with ACPA and RF values similar to the cut-offs provided by manufacturers. CONCLUSION: The authors found the onset of arthritis symptoms during winter or spring associated with greater radiographic progression at 6 months for patients with early arthritis. These data could reinforce the role of environmental factors in the development and outcome of rheumatoid arthritis.

Methotrexate pharmacokinetics in childhood acute lymphoblastic leukaemia: a prognostic value?

WHAT IS KNOWN AND OBJECTIVE: In industrialized countries, acute lymphoblastic leukaemia (ALL) is the most frequent cancer in children aged less than 15 years. High-dose methotrexate is a common component of many chemotherapeutic protocols for childhood with ALL. Our objective was to retrospectively evaluate the pharmacokinetics and plasma levels of high-dose methotrexate as it relates to event-free survival (EFS) in children with ALL. METHODS: Relapsed patients and subjects in EFS were compared for MTX serum concentrations 24, 36, 48 and 72 h after the start of 24 h infusion. Clearance (Cl), area under the curve (AUC) and volume of distribution (V(d) ) of the drug were estimated by the NONMEM computer program and also compared between both groups. RESULTS AND DISCUSSION: Among 69 children included, 54 (78·3%) were still in EFS, whereas 15 (21·7%) relapsed. The difference between relapsed and EFS patients for the pharmacokinetic parameters studied was not significant. On the contrary, the cohort studied was representative and known prognostic factors for relapse in ALL were significantly associated with relapse. WHAT IS NEW AND CONCLUSION: Serum concentrations and pharmacokinetic parameters of MTX are not associated with outcome in ALL. Prognoses based on single-drug pharmacokinetic estimates within a complex multiple-agent protocol appear to be unreliable. However, therapeutic drug monitoring of high-dose methotrexate remains a useful tool for early detection of impaired elimination and for avoiding systemic toxicity.

Evaluating self-reported pressure ulcer prevention measures in persons with spinal cord injury using the revised Skin Management Needs Assessment Checklist: reliability study.

STUDY DESIGN: Cross-cultural adaptation and reliability study. OBJECTIVE: To translate, evaluate the reliability and cross-culturally adapt the Skin Management Needs Assessment Checklist (SMnac), a questionnaire evaluating the knowledge on pressure ulcer (PU) prevention measures in persons with spinal cord injury (SCI). SUBJECTS: 138 persons with SCI, mean age 45.9 years, mean time since injury 94 months. MATERIAL AND METHOD: The study was carried out in two stages. First, the questionnaire went through a forward-backward translation process and was cross-culturally adapted, according to a validated methodology for self-reported measures. Then, the test-retest reliability was evaluated on a population of persons with SCI. RESULTS: The standardized back-translation and cross-cultural adaptation led to the revised Smack grid, with the addition of seven items representing an update of PU prevention measures. The reliability was excellent (intraclass correlation coefficient: 0.899). CONCLUSION: The revised SMnac is an adaptation of the SMnac, including therapeutic education frameworks and the latest PU prevention practices. It appears to be a reliable tool for assessing the knowledge and benefits of PU prevention in persons with SCI. Further studies are needed to explore its validity and responsiveness to change.

Time-dependent ROC analysis for a three-class prognostic with application to kidney transplantation.

The medical decision-making community has an extensive literature on the use of receiver operating characteristic (ROC) graphs for diagnostic testing. Heagertybiet al. have recently developed this ROC curve theory within the context of survival data (Biometrics 2000; 56:337-344). The time-dependent ROC method allows evaluating the accuracy of a marker to predict a time-dependent failure, whereas the classic methodology focuses on diagnosis. One limitation to this approach, however, is to analyse a single failure. In many medical situations, a marker can be useful to predict different competitive failures. For example in kidney transplantation, the terminal evolution can be a return to dialysis or the death of the patient. With this application in mind, our paper proposes an extension of the time-dependent ROC method for analysing the accuracy of a marker to predict two competitive events.

Using an analytical hierarchy process (AHP) for weighting items of a measurement scale: a pilot study.

BACKGROUND: Many clinical scales contain items that are scored separately prior to being compiled into a single score. However, if the items have different degrees of importance, they should be weighted differently before being compiled. The principal aims of this study were to show how the "analytic hierarchy process" (AHP), which has never been used for this purpose, can be applied to weighting the six items of the "London handicap scale", and to compare the AHP to the "conjoint analysis" (CA), which was previously implemented by Harwood et al. (1994) [1]. DESIGN: In order to assess the relative importance of the six items, we submitted AHP and CA to a group of 10 physiatrists. We compared the methods in terms of item ranking according to importance, assessment of fictitious patients based on weights determined by each method, and perceived difficulty by the physiatrist. RESULTS: For both techniques, "Physical independence" (PHY) was the best-weighted item, but other ranks varied depending on the technique. AHP was better than CA in terms of accuracy (global assessment of the clinical status) and perceived difficulty. CONCLUSION: AHP may be used to reveal the importance that experts assign to the items of a multidimensional scale, and to calculate the appropriate weights for specific items. For this purpose, AHP seems to be more accurate than CA.

Plasma proteasome level is a reliable early marker of malignant transformation of liver cirrhosis.

BACKGROUND: Proteasomes are the main non-lysosomal proteolytic structures which regulate crucial cellular processes. Circulating proteasome levels can be measured using an ELISA test and can be considered as a tumour marker in several types of malignancy. Given that there is no sensitive marker of hepatocellular carcinoma (HCC) in patients with cirrhosis, we measured plasma proteasome levels in 83 patients with cirrhosis (33 without HCC, 50 with HCC) and 40 controls. METHODS AND RESULTS: Patients with HCC were sub-classified into three groups according to tumour mass. alpha-Fetoprotein (AFP) was also measured. Plasma proteasome levels were significantly higher in patients with HCC compared to controls (4841 (SEM 613) ng/ml vs 2534 (SEM 187) ng/ml; p<0.001) and compared to patients with cirrhosis without HCC (2077 (SEM 112) ng/ml; p<0.001). This difference remained significant when the subgroup of patients with low tumour mass (proteasome level 3970 (SEM 310) ng/ml, p<0.001) was compared to controls and patients with cirrhosis without HCC. Plasma proteasome levels were independent of the cause of cirrhosis and were weakly correlated with AFP levels. With a cut-off of 2900 ng/ml, diagnostic specificity for HCC was 97% with a sensitivity of 72%, better than results obtained with AFP. Diagnostic relevance of plasma proteasome measurement was also effective in low tumour mass patients (sensitivity 76.2% vs 57.1% for AFP). CONCLUSION: The plasma proteasome level is a reliable marker of malignant transformation in patients with cirrhosis, even when there is a low tumour mass.

[Validation of the 13-30ARAMAV assessment, a new quality of life and autonomy questionnaire adapted to visually impaired patients]. / Validation du bilan 13­30ARAMAV, un nouveau questionnaire de qualité de vie et d'autonomie adapté aux patients déficients visuels.

PURPOSE: To evaluate the ARAMAV 13-30 questionnaire, a new autonomy and quality of life questionnaire developed for visually impaired patients. METHODS: We carried out a single-center prospective study at the ARAMAV institute in collaboration with the University Hospital of Nîmes. The patients included were admitted for low vision rehabilitation. Each patient received an occupational therapy assessment, the Short Forms 36 (SF36) quality of life questionnaire and the ARAMAV 13-30 questionnaire at the start and at the end of rehabilitation. We verified the reproducibility, the sensitivity to change, and internal and external consistency of the questionnaire. RESULTS: We included 231 patients over a period of 4 years. All the patients were blind or visually impaired. We observed excellent intra- and interuser reproducibility of the questionnaire, with a Lin coefficient>0.9 (0.99 and 0.91, respectively). By comparing the variations of the different scores between before and after low vision rehabilitation, we observed excellent sensitivity to change for both the autonomy and quality of life portions of the questionnaire. Finally, we observed excellent internal and external consistency. CONCLUSION: We therefore propose the ARAMAV 13-30 questionnaire as a new tool in evaluating autonomy and quality of life specifically in visually impaired patients, which may also be used to assess the effect of low vision rehabilitation.

Protein biochip array technology to monitor rituximab in rheumatoid arthritis.

In rheumatoid arthritis (RA) there are currently no good indicators to predict a clinical response to rituximab. The purpose of this study was to monitor and determine the role of peripheral blood cytokine profiling in differentiating between a good versus poor response to rituximab in RA. Blood samples were collected at baseline and at 3 months from 46 RA patients who were treated with rituximab. Responders are defined by the presence of three of four American College of Rheumatology criteria: >or=20% decrease in C-reactive protein, visual analogical score of disease activity, erythrocyte sedimentation rate and improvement of the disease activity score (28) (four values) by >or=1.2 obtained at 3 months. Twelve cytokines were measured from serum collected on days 0 and 90 by proteomic array, including interleukin-6 (IL-6), tumour necrosis factor-alpha, IL-1a, IL-1b, IL-2, IL-8, interferon-gamma, IL-4, IL-10, monocyte chemoattractant protein-1, epidermal growth factor and vascular growth factor. We showed that C-reactive protein and IL-6 levels decrease significantly at 3 months in the responder group compared with baseline. At day 90 we identified a cytokine profile which differentiates responders and non-responders. High serum levels of two proinflammatory cytokines, monocyte chemoattractant protein-1 and epidermal growth factor, were significantly higher in the responder group at day 90 compared with non-responders. However, we were not able to identify a baseline cytokine profile predictive of a good response at 3 months. These findings suggest that cytokine profiling by proteomic analysis may be a promising tool for monitoring rituximab and may help in the future to identify responder RA patients.

Reporting of patient-reported outcomes in recent trials in rheumatoid arthritis: a systematic literature review.

OBJECTIVES: Patient-reported outcomes (PROs) have been increasingly recognised as important in rheumatoid arthritis (RA). The objective of this study was to assess the frequency of use of different PROs in recently published RA articles and to compare the tools used through a systemic literature review. METHODS: (1) DATA SOURCE: In PUBMED MEDLINE database, articles reporting any type of clinical study for adult patients with RA, published between February 2005 and February 2007, and reporting any type of PRO. Articles were excluded if they did not concern adult RA or if they did not report any PROs. (2) DATA EXTRACTION: demographic characteristics of patients, study design, treatment assessed and all PROs. (3) DATA ANALYSIS: descriptive. RESULTS: Of 109 reports, 50 (45%) were randomised controlled trials and 59 were other types of studies. A total of 63 questionnaires or tools for PROs were used, corresponding to 14 domains of health. Frequently reported domains (and most frequent tools) were: function, 83% (most frequent tool, health assessment questionnaire, HAQ); patient global assessment, 61% (most frequent tool, visual analogue scale, VAS); pain, 56% (VAS); and morning stiffness 27%. Domains such as fatigue, coping or sleep disturbance were infrequently reported. CONCLUSIONS: PROs are reported with great heterogeneity in recently published trials in RA. Some domains that appear important from the patient's perspective are infrequently reported. Further work is needed in this field.

Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative.

BACKGROUND: Current response criteria in rheumatoid arthritis (RA) usually assess only three patient-reported outcomes (PROs): pain, functional disability and patient global assessment. Other important PROs such as fatigue are not included. OBJECTIVE: To elaborate a patient-derived composite response index for use in clinical trials in RA, the RA Impact of Disease (RAID) score. METHODS: Ten patients identified 17 domains or areas of health relevant for inclusion in the score, then 96 patients (10 per country in 10 European countries) ranked these domains in order of decreasing importance. The seven most important domains were selected. Instruments were chosen for each domain after extensive literature research of psychometric properties and expert opinion. The relative weight of each of the domains was obtained from 505 patients who were asked to "distribute 100 points" among the seven domains. The average ranks of importance of these domains were then computed. RESULTS: The RAID score includes seven domains with the following relative weights: pain (21%), functional disability (16%), fatigue (15%), emotional well-being (12%), sleep (12%), coping (12%) and physical well-being (12%). Weights were similar across countries and across patient and disease characteristics. Proposed instruments include the Health Assessment Questionnaire and numerical ratings scales. CONCLUSION: The preliminary RAID score is a patient-derived weighted score to assess the impact of RA. An ongoing study will allow the final choice of questionnaires and assessment of validity. This score can be used in clinical trials as a new composite index that captures information relevant to patients.

Time trends in prevalence and severity of childhood asthma and allergies from 1995 to 2002 in France.

OBJECTIVE: To assess time trends in symptoms of asthma, allergic rhinitis and atopic eczema among adolescents in Languedoc Roussillon, France. METHODS: Two cross-sectional surveys were conducted 7 years apart using the same protocol. School-based samples of 3383 participants in the 1995 survey and 1642 participants in the 2002 survey respectively were recruited. RESULTS: There was a tendency towards stagnation in current symptoms of asthma, rhinoconjunctivitis and eczema. Indices related to lifetime diagnosis of asthma, hay fever and eczema increased. For all the conditions, indices of severity also showed a decrease in the 7-year study period. CONCLUSIONS: Our study shows that symptoms of asthma, allergic rhinitis and eczema were stable, supporting the effectiveness of national asthma prevention and management guidelines for such diseases. The increase in indices related to lifetime diagnosis could be the result of increased public and professional awareness of the diseases and changes in diagnostic labelling in recent years.

The CONSORT statement checklist in allergen-specific immunotherapy: a GA2LEN paper.

The methodology of randomized clinical trials is essential for the critical assessment and registration of therapeutic interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement was developed to alleviate the problems arising from the inadequate reporting of randomized controlled trials. The present article reflects on the items that we believe should be included in the CONSORT checklist in the context of conducting and reporting trials in allergen-specific immunotherapy. Only randomized, blinded (in particular blinding of patients, health care providers, and outcome assessors), placebo-controlled Phase III studies in this article. Our analysis focuses on the definition of patients' inclusion and exclusion criteria, allergen standardization, primary, secondary and exploratory outcomes, reporting of adverse events and analysis.