World Trade Organization: notification of sanitary and phytosanitary measures.

This paper provides an overview of the importance of transparency at the World Trade Organization, a basic principle that translates into notification obligations. In particular, the paper details the related obligations under the Agreement on the Application of Sanitary and Phytosanitary Measures, and how it applies to trade in animals and animal products.

Les auteurs offrent une vue d'ensemble du rôle joué par la transparence au sein de l'Organisation mondiale du commerce, principe de base qui se traduit par une obligation de notification. En particulier, ils précisent les obligations prévues en vertu de l'Accord sur l'application des mesures sanitaires et phytosanitaires et la manière dont ce principe s'applique aux échanges internationaux d'animaux et de produits d'origine animale.

Los autores explican la importancia que dentro de la Organización Mundial del Comercio reviste la transparencia, un principio básico que se traduce en obligaciones de notificación. En particular, describen en detalle las obligaciones que en este sentido impone el Acuerdo sobre la Aplicación de Medidas Sanitarias y Fitosanitarias y cómo se aplica dicho principio al comercio de animales y productos de origen animal.

Patient eligibility for thrombectomy after acute stroke: Northern French Alps database analysis.

BACKGROUND: Since 2015, the emergence of mechanical thrombectomy as standard care in acute stroke has involved organizational changes not only for stroke centers, but also for entire emergency regional networks. The aim of our study was to assess the proportion of ischemic stroke patients, admitted to stroke units in the Northern French Alps within the first 6h of onset, eligible for thrombectomy. METHODS: This study retrospectively analyzed the clinical and radiological data of all acute stroke patients hospitalized at three stroke units of the Northern French Alps Emergency Network (RENAU) in 2014. Eligible patients had proximal arterial occlusions of the anterior and posterior cerebral circulation, as confirmed by brain imaging, which could be treated by thrombectomy within 6h of symptom onset. RESULTS: Of the 435 cases of acute ischemic stroke, 152 patients were treated by intravenous thrombolysis (IV rtPA). Of these patients, 83 (55%) had intracranial occlusions and were eligible for combined thrombectomy. Of the 283 patients not treatable by IV rtPA, 32 patients (11%) were eligible for primary thrombectomy. CONCLUSION: Thrombectomy could be performed in 26% of our acute ischemic stroke patients (n=115/435), and a large increase in endovascular procedures is expected over the next few years that will require close collaboration among all partners in the emergency networks. Using our RENAU stroke database, it will be possible to compare various factors contributing to effective activity.

Biotherapies in stroke.

Stroke is the second leading cause of death worldwide and the most common cause of severe disability. Neuroprotection and repair mechanisms supporting endogenous brain plasticity are often insufficient to allow complete recovery. While numerous neuroprotective drugs trials have failed to demonstrate benefits for patients, they have provided interesting translational research lessons related to neurorestorative therapy mechanisms in stroke. Stroke damage is not limited to neurons but involve all brain cell type including the extracellular matrix in a "glio-neurovascular niche". Targeting a range of host brain cells, biotherapies such as growth factors and therapeutic cells, currently hold great promise as a regenerative medical strategy for stroke. These techniques can promote both neuroprotection and delayed neural repair through neuro-synaptogenesis, angiogenesis, oligodendrogliogenesis, axonal sprouting and immunomodulatory effects. Their complex mechanisms of action are interdependent and vary according to the particular growth factor or grafted cell type. For example, while "peripheral" stem or stromal cells can provide paracrine trophic support, neural stem/progenitor cells (NSC) or mature neurons can act as more direct neural replacements. With a wide therapeutic time window after stroke, biotherapies could be used to treat many patients. However, guidelines for selecting the optimal time window, and the best delivery routes and doses are still debated and the answers may depend on the chosen product and its expected mechanism including early neuroprotection, delayed neural repair, trophic systemic transient effects or graft survival and integration. Currently, the great variety of growth factors, cell sources and cell therapy products form a therapeutic arsenal that is available for stroke treatment. Their effective clinical use will require prior careful considerations regarding safety (e.g. tumorgenicity, immunogenicity), potential efficacy, cell characterization, delivery route and in vivo biodistribution. Bone marrow-derived cell populations such as mesenchymal stromal/stem cells (MSC) or mononuclear cells (MNC), umbilical cord stem cells and NSC are most investigated notably in clinical trials. Finally, we discuss perspectives concerning potential novel biotherapies such as combinatorial approaches (growth factor combined with cell therapy, in vitro optimization of cell products, or co-transplantation) and the development of biomaterials, which could be used as injectable hydrogel scaffold matrices that could protect a cell graft or selectively deliver drugs and growth factors into the post-stroke cavity at chronic stages. Considering the remaining questions about the best procedure and the safety cautions, we can hope that future translational research about biotherapies will bring more efficient treatments that will decrease post-stroke disability for many patients.

Cost of stroke in France.

BACKGROUND AND PURPOSE: A cost of illness study was undertaken on behalf of the French Ministry of Health to estimate the annual cost of stroke in France with the goal of better understanding the current economic burden so that improved strategies for care may be developed. METHODS: Using primary data from exhaustive national databases and both top-down and bottom-up approaches, the stroke-related costs for healthcare, nursing care and lost productivity were estimated. RESULTS: The total healthcare cost of stroke patients in France in 2007 was €5.3 billion, 92% of which was borne by statutory health insurance. The average cost of incident cases was €16 686 per patient in the first year, while the annual cost of prevalent cases was a little less than half that amount (€8099). Nursing care costs were estimated at €2.4 billion. Lost productivity reached €255.9 million and that income loss for stroke patients was partially compensated by €63.3 million in social benefit payments. CONCLUSIONS: With healthcare costs representing 3% of total health expenditure in France, stroke constitutes an ongoing burden for the health system and overall economy. Nursing care added nearly half again the amount spent on healthcare, while productivity losses were more limited because nearly 80% of acute incident strokes were in patients over age 65. The high cost of illness underscores the need for improved prevention and interventions to limit the disabling effects of stroke.

New Zealand experience with implementation of the ESO-ESMO consensus guidelines for advanced breast cancer-report of achievements and lessons learned.

BACKGROUND: People with advanced breast cancer (ABC) in New Zealand (NZ) have a poorer five-year survival than their peers in other developed countries. Comparisons of ABC care in NZ with other countries suggest that NZ is sometimes out of line with international standards and that inequities exist within the NZ healthcare system. Our aim was to develop nationwide consensus guidelines for diagnosis and treatment of ABC that are uniquely suited for the NZ context and can be applied across the nation. We describe the process of creating, voting on, and disseminating the guidelines, and provide insight into how we can better optimize these processes for the NZ context in the future. METHODS: The ABC5 ESO-ESMO consensus guidelines were used and adapted to the NZ clinical context. A panel of breast cancer clinicians voted on these guidelines using the same model of membership representation as ABC5. OUTCOME: Overall consensus was equally high between ABC5 and ABC-NZ. Four NZ specific guidelines were introduced. The European-style panel discussion needs some adaptations for the NZ situation and a wider and more thorough consultation process, before voting begins, is preferred. The NZ Breast Special Interest Group has endorsed and agreed to take ownership of these and future guidelines and to facilitate the next iteration of the ABC-NZ guidelines meeting. CONCLUSIONS: The process was successful in creating the guidelines but can be improved in future meetings to streamline the process of creating and updating guidelines in the manner most suited to the NZ context and audience.

Age-dependent antibody response to Plasmodium falciparum merozoite surface protein 2 (MSP-2).

Merozoite surface protein 2 (MSP-2), a very immunogenic malaria antigen, is a highly polymorphic 45-53 kDa merozoite surface protein, which is regarded as a promising vaccine candidate. The highly polymorphic nature of MSP-2 suggests that the molecule can be involved in protective immunity against malaria. The antibody responses to MSP-2 antigen are mostly directed against polymorphic and dimorphic regions of the protein. The current study aimed at testing the reactivity of human sera from a malaria-endemic area of Gambia against MSP-2 regions 2, 3 and 4 compared to crude schizont extract in a period of 20 years. The age-dependent immunity was analysed in a manner of cross-sectional study (the data of the first visit) and also a longitudinal study design (analysing the data at four different time points from 1960 to 1980) testing the sera of 178 individuals randomly selected from the Keneba Serum Collection by using MSP-2 recombinant protein. The total IgG responses were measured by ELISA. Kolmogorov-Smirnov was used to check the normal distribution of OD, Hb and parasitaemia, and then Spearman correlation was applied to analyse the data. Most sera recognized, predominantly, the variable regions of the MSP-2, particularly the domain 3. The IgG response against all the antigens increased with age. The IgG responses against domain 3 of MSP-2 were associated with an increase in haemoglobin levels but a decrease in parasitaemia, suggesting that this immune response may be one of the most useful means for further studies on protective immunity against malaria.

Surface alterations of erythrocytes in Plasmodium falciparum malaria. Antigenic variation, antigenic diversity, and the role of the spleen.

The surface of erythrocytes infected with late developmental stages of Plasmodium falciparum is profoundly altered and new antigenic determinants can be detected by surface immunofluorescence using immune squirrel monkey serum. The expression of these parasite-specific antigenic determinants on the surface of the host erythrocyte can be modulated by the presence or absence of the spleen and by immune pressure. An antigenic switch occurred when a cloned population of the Ugandan Palo Alto strain of P. falciparum was transferred from a splenectomized into an intact monkey and this switch was reversible. In another strain (Indochina-1), we showed that the parasites isolated during secondary and recrudescent peaks expressed erythrocyte-associated surface antigens different from the parasites isolated during the primary infection; six variant antigenic types distinct from the original population were isolated in this way. The passive transfer of immune serum can induce antigenic variation and this can occur in a cloned parasite. The various mechanisms of antigenic variation in P. falciparum are discussed in the context of strain-specific diversity and the role of antigenic diversity in acquired immunity.

Small, clonally variant antigens expressed on the surface of the Plasmodium falciparum-infected erythrocyte are encoded by the rif gene family and are the target of human immune responses.

Disease severity in Plasmodium falciparum infections is a direct consequence of the parasite's efficient evasion of the defense mechanisms of the human host. To date, one parasite-derived molecule, the antigenically variant adhesin P. falciparum erythrocyte membrane protein 1 (PfEMP1), is known to be transported to the infected erythrocyte (pRBC) surface, where it mediates binding to different host receptors. Here we report that multiple additional proteins are expressed by the parasite at the pRBC surface, including a large cluster of clonally variant antigens of 30-45 kD. We have found these antigens to be identical to the rifins, predicted polypeptides encoded by the rif multigene family. These parasite products, formerly called rosettins after their identification in rosetting parasites, are prominently expressed by fresh isolates of P. falciparum. Rifins are immunogenic in natural infections and strain-specifically recognized by human immune sera in immunoprecipitation of surface-labeled pRBC extracts. Furthermore, human immune sera agglutinate pRBCs digested with trypsin at conditions such that radioiodinated PfEMP1 polypeptides are not detected but rifins are detected, suggesting the presence of epitopes in rifins targeted by agglutinating antibodies. When analyzed by two-dimensional electrophoresis, the rifins resolved into several isoforms in the pI range of 5.5-6.5, indicating molecular microheterogeneity, an additional potential novel source of antigenic diversity in P. falciparum. Prominent polypeptides of 20, 22, 76-80, 140, and 170 kD were also detected on the surfaces of pRBCs bearing in vitro-propagated or field-isolated parasites. In this report, we describe the rifins, the second family of clonally variant antigens known to be displayed by P. falciparum on the surface of the infected erythrocyte.

Primary follicular and marginal-zone lymphoma of the breast: clinical features, prognostic factors and outcome: a study by the International Extranodal Lymphoma Study Group.

BACKGROUND: Primary breast lymphoma (PBL) of low-grade histology is a rare disease. This multicentric retrospective study was carried out to determine clinical features, prognosis and relapse. PATIENTS AND METHODS: Patients with histologically proven, previously untreated follicular or marginal-zone PBL (MZL PBL) diagnosed from 1980 to 2003 were included in the study. Major end points were progression-free survival (PFS), overall survival (OS) and potential prognostic factors. RESULTS: We collected data on 60 cases of PBL [36 follicular and 24 marginal-zone lymphoma (MZL)]. Stage was I(E) or II(E) in 57 patients and IVE in three patients due to bilateral breast involvement. Surgery, chemotherapy and radiotherapy (RT), alone or in combination, were used as first-line treatments in 67%, 42% and 52% of patients, respectively. Overall response rate was 98%, with a 93% complete response rate. Five-year PFS were 56% for MZL and 49% for follicular PBL (P = 0.62). Relapses were mostly in distant sites (18 of 23 cases); no patients relapsed within RT fields. CONCLUSIONS: Our data showed an indolent behaviour of MZL PBL, comparable to other primary extranodal MZL. Conversely, patients with follicular PBL had inferior PFS and OS when compared with limited-stage nodal follicular non-Hodgkin's lymphomas, suggesting an adverse prognostic role of primary breast localisation in this histological subgroup.

A global phenomenological model of ischemic stroke with stress on spreading depressions.

In this paper, we establish a new global phenomenological model of ischemic stroke. It takes into account local ischemia, energy reduction, propagation of spreading depressions (SD), damages to the cells and cellular death by apoptosis or necrosis. The spatial diffusion of the ions in the extracellular space which triggers the propagation of SD is a central point here. First we expose the various biological hypotheses that we have made in this model, and then we explain how to determine the parameters and solve the system of equations that we obtain. Next we present some results of this model: we simulate a KCl injection and then a local ischemia. Finally we discuss results and propose some improvements for this model.

A numerical study of the blocking of migraine by Rolando sulcus.

Migraine with aura is a complex phenomena, which remains still not completely understood. A striking fact is that its clinical manifestations may change from one patient to another. Migraine with aura may only consist in visual hallucinations, but may as well go on to temporary aphasy. However, for all the patients it always stops before it goes from area 3 to area 4, thus just before crossing Rolando sulcus. In this paper, we give arguments showing that the detailed geometry of Rolando sulcus in human cortex may by itself explain that migraine attack never crosses Rolando sulcus.

Social dysfunctioning after mild to moderate first-ever stroke at vocational age.

BACKGROUND: With improvements in stroke treatments, the number of patients with dramatic recovery is increasing. However, many of them are still complaining of difficulties in returning to work and every day activities. The aim was to assess work and social dysfunctioning in patients with minor to moderate stroke and explore its contributing factors. METHODS: Consecutive patients were prospectively included at a median 7 months after a first-ever stroke. Scores on the Work and Social Adjustment Scale (WSAS), a generic self-reported scale for assessing social functioning, were correlated with scores on the National Institutes of Health Stroke Scale (NIHSS), activities of daily living, Hospital Anxiety and Depression scale (HAD) and MMSE, Iowa Scale of Personality Changes and return to work at 1 year. RESULTS: Among the 84 included patients (mean age 43.5 years), 57 (68%; 95% CI 57 to 78%) complained of significant perturbation of functioning attributed to stroke. WSAS was highly significantly related to modified Rankin scale, daily living activities, Iowa Scale of Personality Changes and return to work at 1 year. Using ordinal logistic regression, the contributors to WSAS were initial neurological severity (NIHSS at admission), HAD and MMSE. CONCLUSIONS: The study showed that up to 68% of our patients complained of significant work and social dysfunction due to stroke, despite a good clinical outcome. This self-estimation was correlated to external validation criteria, stressing the high burden of stroke from the patient's viewpoint. Moreover, when compared across diseases, social dysfunctioning after mild stroke was as important as in other major disabling diseases.

Cognitive determinants of social functioning after a first ever mild to moderate stroke at vocational age.

BACKGROUND AND AIMS: Social functioning is impaired in approximately two-thirds of stroke patients of vocational age, even several months after a first ever mild to moderate stroke. The known predictors of social functioning are initial stroke severity, anxiety and depression, and the Mini-Mental State Evaluation, suggesting that cognitive deficits contribute to post-stroke social dysfunctioning. The aim of this study was to evaluate whether cognitive domains correlated with social functioning and to determine the cognitive predictors of social dysfunctioning. METHODS: 74 patients were prospectively included 6 months after a first ever stroke. National Institutes of Health Stroke Scale (NIHSS), modified Rankin scale, depression and anxiety were recorded. Social functioning was recorded using the Work and Social Adjustment Scale (WSAS). An extensive neuropsychological test battery explored general cognitive functioning, episodic memory, instrumental functions, executive functions and working memory. Univariate comparisons assessed the relationships between the neuropsychological tests and scores on the WSAS. Predicting factors for WSAS were determined using ordinal logistic regression. RESULTS: 52 patients (70%; 95% confidence interval 58% to 80%) complained of significant perturbations in work and social functioning. In univariate comparisons, general cognitive functioning, memory, instrumental functions, executive functions and working memory significantly correlated with social functioning. Working memory was the most affected domain. With multivariate modelling, the NIHSS at admission, Hospital Anxiety Depression scale and Owen's Spatial Working Memory test were independent predictors of WSAS. CONCLUSIONS: All cognitive domains were associated with social functioning, working memory being the main cognitive determinant. Our results suggest that cognitive impairment impacts on social dysfunctioning, which is known to be a component of quality of life.

Primary diffuse large B-cell lymphoma of the breast: prognostic factors and outcomes of a study by the International Extranodal Lymphoma Study Group.

BACKGROUND: Primary diffuse large B-cell lymphoma (DLBCL) of breast is rare. We aimed to define clinical features, prognostic factors, patterns of failure, and treatment outcomes. PATIENTS AND METHODS: A retrospective international study of 204 eligible patients presenting to the International Extranodal Lymphoma Study Group-affiliated institutions from 1980 to 2003. RESULTS: Median age was 64 years, with 95% of patients presenting with unilateral disease. Median overall survival (OS) was 8.0 years, and median progression-free survival 5.5 years. In multifactor analysis, favourable International Prognostic Index score, anthracycline-containing chemotherapy, and radiotherapy (RT) were significantly associated with longer OS (each P < or = 0.03). There was no benefit from mastectomy, as opposed to biopsy or lumpectomy only. At a median follow-up time of 5.5 years, 37% of patients had progressed--16% in the same or contralateral breast, 5% in the central nervous system, and 14% in other extranodal sites. CONCLUSIONS: The combination of limited surgery, anthracycline-containing chemotherapy, and involved-field RT produced the best outcome in the pre-rituximab era. A prospective trial on the basis of these results should be pursued to confirm these observations and to determine whether the impact of rituximab on the patterns of relapse and outcome parallels that of DLBCL presenting at other sites.

Bronchial fistulae in ARDS patients: management with an extracorporeal lung assist device.

Patients with bronchial tree lesions feature, in particular, a high risk for developing bronchial fistulae after surgical repair when the clinical situation is complicated by acute lung injury (ALI)/acute respiratory distress syndrome (ARDS) and mechanical ventilation is needed. The current authors hypothesised that extracorporeal carbon dioxide removal would significantly decrease inspiratory airway pressures, thus promoting the protection of surgical bronchial reconstruction. Four patients were studied after surgical reconstruction of bronchial fistulae in whom ALI/ARDS developed and mechanical ventilation with positive end-expiratory pressure was required. Gas exchange, tidal volumes, airway pressures, respiratory frequency, vasopressor and sedation requirements were analysed before and after initiation of a pumpless extracorporeal lung assist device (pECLA; NovaLung, Talheim, Germany). Initiation of pECLA treatment enabled a reduction of inspiratory plateau airway pressures from 32.4 to 28.6 cmH(2)O (3.2 to 2.8 kPa), effectively treated hypercapnia (from 73.6 to 53.4 mmHg (9.8 to 7.1 kPa)) and abolished respiratory acidosis (from pH 7.24 to 7.41). All patients survived and were discharged to rehabilitation clinics. In patients after surgical bronchial reconstruction that was complicated by acute lung injury/acute respiratory distress syndrome, use of pumpless extracorporeal carbon dioxide removal was safe and efficient. Initiation of a pumpless extracorporeal lung assist device enabled a less invasive ventilator management, which may have contributed to healing of surgical bronchial repair.

Evidence-based therapy of severe acute respiratory distress syndrome: an algorithm-guided approach.

Despite considerable research and constantly emerging treatment modalities, the mortality associated with acute respiratory distress syndrome (ARDS) has remained virtually unchanged over the last decade. Clinical studies have been unable to show a reduction in mortality for most therapeutic interventions except for low tidal volume ventilation. Failure to prove a mortality benefit might be a result of the varying severity of ARDS in the patients studied. Nevertheless, positive responses to single supportive measures (inhaled nitric oxide, prone positioning and extracorporeal membrane oxygenation) have been demonstrated in multiple trials. Criteria for administration, weaning and discontinuation of these supportive interventions have never been described in detail. In this context, implementation of an evidence-based algorithm might facilitate clinical management of severe ARDS. This review summarizes the current evidence base and proposes a new treatment algorithm that aims to prioritize the administration of advanced strategies in a multimodal approach for ARDS.

Reduction of Prolonged Excessive Pressure in Seated Persons With Paraplegia Using Wireless Lingual Tactile Feedback: A Randomized Controlled Trial.

Pressure ulcers (PU) are known to be a high-cost disease with a risk of severe morbidity. This paper evaluates a new clinical strategy based on an innovative medical device [Tongue Display Unit (TDU)] that implements perceptive supplementation in order to reduce prolonged excessive pressure, recognized as one of the main causes of PU. A randomized, controlled, and parallel-group trial was carried out with 12 subjects with spinal cord injuries (SCI). Subjects were assigned to the control (without TDU, [Formula: see text]) or intervention (with TDU, [Formula: see text]) group. Each subject took part in two sessions, during which the subject, seated on a pressure map sensor, watched a movie for one hour. The TDU was activated during the second session of the intervention group. Intention-to-treat analysis showed that the improvement in adequate weight shifting between the two sessions was higher in the intervention group (0.84 [0.24; 0.89]) than in the control group (0.01 [-0.01; 0.09]; [Formula: see text]) and that the ratio of prolonged excessive pressure between the two sessions was lower in the intervention group (0.74 [0.37; 1.92]) than in the control group (1.72 [1.32; 2.56]; [Formula: see text]). The pressure map sensor was evaluated as being convenient for use in daily life; however, this was not the case for the TDU. This paper shows that persons with SCI could benefit from a system based on perceptive supplementation that alerts and guides the user on how to adapt their posture in order to reduce prolonged excessive pressure, one of the main causes of PU.

[French language training course: malaria workshop organized by Institut Pasteur de Madagascar]. / Formation francophone Sud/Sud: l'atelier paludisme de l'Institut Pasteur de Madagascar.

The Malaria Workshop organized by Institut Pasteur de Madagascar is an original course that applies innovative concepts to training of health professionals involved in malaria control in endemic countries. Course objectives are to enhance the skills needed to fight malaria (transversal competencies, critical approach, and position statement), to reinforce project cycle management proficiency, and to demonstrate how the Internet can be used as a source of documentation to compensate for geographical isolation. The Malaria Workshop is a six-consecutive-week full-day course that has been presented once a year since 2003. Seventy-six researchers, physicians or health ministry officials have already benefited from this training. Teaching methods emphasize andragogy that facilitates a learner/mentor relationship promoting exchange rather than transmission of knowledge and problem-based learning that engages learners to take an active part in gathering information. These methods in combination with the diverse backgrounds and experience of course participants foster a positive dynamic environment for learning that is monitored by weekly progress evaluation. Follow-up surveys have confirmed the positive effect of this training on the professional performance of former participants who become more involved in program development and fund-raising efforts. A professional network is growing and learners are starting to their experience. In this report workshop organizers describe the course's origins and concepts and present the conclusions drawn based on the first five yearly sessions.

[Epidemiology of athrotherombotic lower limb arterial disease]. / Epidémiologie de l'artériopathie des membres inférieurs d'origine athérothrombotique.

Chronic occlusive arterial disease of the lower limbs is a common presentation of atherothrombotic disease. This systematic review of the literature analyses the natural history of this condition and the prevalence of asymptomatic lesions of other arterial localisations requiring specific treatment. The Medline database was researched and completed by a bibliography of the principal articles selected, Internet sites and their publication reviews and also the Cochrane database. The incidence of systemic complications has been assessed in many good quality epidemiological study. It increases with the severity of lower limb arterial disease, but in asymptomatic patients defined by a pathological systolic pressure index (< 0.90) the cardiovascular mortality is already 2% per year, the incidence of myocardial infarction 3% per year and that of cerebrovascular accidents 1 to 2% per year. The prevalence of asymptomatic lesions in other arterial sites is less well documented, the evaluations varying according to the population studied and criteria of significant lesions: 21 to 69% for coronary artery disease, 12 to 59% for carotid artery stenosis, 14 to 40% for renal artery stenosis and 6 to 14% for abdominal aortic aneurysms. Despite the uncertainty of these estimations, the prevalence of asymptomatic atherothrombotic lesions is high in all arterial networks and justifies the setting up of studies to assess the clinical benefits of their systematic diagnostic investigations.

[Readability of informed consent forms for subjects participating in biomedical research: updating is required]. / Lisibilité de l'information écrite destinée aux sujets se prêtant à une recherche biomédicale: une nécessaire remise en question.

OBJECTIVE: We compared informed consent forms of subjects participating in biomedical research with those of references texts in order to determine the factors that influence readability. METHODS: We assessed the readability of 73 informed consent forms of research protocols conducted in the clinical investigation centres in the Rhone-Alpes area, and then compared them with 33 reference texts corresponding to 5 French school grades (first year infant, primary school, GCS level, high school, and classics aggregation), using the Flesch test and Cordial" analyser. RESULTS: Median Flesch scores were 66 for the first year infant level, 62 for the primary school level, 58 for the GCS level, 42 for the high school level, and 43 for the aggregation level. It was 22 for the informed consent forms. Median Cordial scores were 86 for the first year infant level, 77 for the second, 74 for the third, 49 for the fourth, 43 for the fifth. It was 1 for the informed consent forms. No methodological factor correlated with Flesch and Cordial" results. CONCLUSION: The quantitative readability scores for informed consent forms for subjects participating in biomedical research are low, lower than those proposed to aggregation candidates, whatever the type of protocol. Some thought must be given to the impact of the reduced readability on patients' understanding, and steps should be taken to improve the readability of the forms.