GEnZ explorer: a tool for visualizing agroclimate to inform research and regulatory risk assessment.

Confined field trials (CFT) of genetically engineered (GE) crops are used to generate data to inform environmental risk assessments (ERA). ERAs are required by regulatory authorities before novel GE crops can be released for cultivation. The transportability of CFT data to inform risk assessment in countries other than those where the CFT was conducted has been discussed previously in an analysis showing that the primary difference between CFT locations potentially impacting trial outcomes is the physical environment, particularly the agroclimate. This means that data from trials carried out in similar agroclimates could be considered relevant and sufficient to satisfy regulatory requirements for CFT data, irrespective of the country where the CFTs are conducted. This paper describes the development of an open-source tool to assist in determining the transportability of CFT data. This tool provides agroclimate together with overall crop production information to assist regulators and applicants in making informed choices on whether data from previous CFTs can inform an environmental risk assessment in a new country, as well as help developers determine optimal locations for planning future CFTs. The GEnZ Explorer is a freely available, thoroughly documented, and open-source tool that allows users to identify the agroclimate zones that are relevant for the production of 21 major crops and crop categories or to determine the agroclimatic zone at a specific location. This tool will help provide additional scientific justification for CFT data transportability, along with spatial visualization, to help ensure regulatory transparency.

The EU's GM crop conundrum: Did the EU policy strategy to convert EFSA GMO guidance into legislation deliver on its promises?: Did the EU policy strategy to convert EFSA GMO guidance into legislation deliver on its promises?

Efforts by the EU to improve its regulatory framework for importing GM food and feed have done nothing to make the process easier and more predictable for applicants.

Sensibilidad al gluten/trigo no celíaca: Una patología en busca de claros criterios diagnósticos / No disponible

No disponible

A retrospective and prospective 12-month observational study of the socioeconomic burden of moderate to severe irritable bowel syndrome with constipation in Spain / Estudio observacional, retrospectivo y prospectivo a 12 meses del coste socioeconómico del síndrome del intestino irritable moderado a grave con estreñimiento en España

Introduction: The socioeconomic burden of irritable bowel syndrome with constipation (IBS-C) has never been formally assessed in Spain. Patients and methods: This 12-month (6-month retrospective and prospective periods) observational, multicentre study assessed the burden of moderate-to-severe IBS-C in Spain. Patients were included if they had been diagnosed with IBS-C (Rome III criteria) within the last 5 years and had moderate-to-severe IBS-C (IBS Symptom Severity Scale score [IBS-SSS] ≥175) at inclusion. The primary objective was to assess the direct cost to the Spanish healthcare system (HS). Results: A total of 112 patients were included, 64 (57%) of which had severe IBS-C at inclusion. At baseline, 89 (80%) patients reported abdominal pain and distention. Patient quality of life (QoL), measured by the IBS-C QoL and EQ-5D instruments, was found to be impaired with a mean score of 59 and 57 (0-100, worst-best), respectively. Over the 6-month prospective period the mean IBS-C severity, measured using the IBS-SSS showed some improvement (315-234 [0-500, best-worst]). During the year, 89 (80%) patients used prescription drugs for IBS-C, with laxatives being the most frequently prescribed (n=70; 63%). The direct cost to the HS was €1067, and to the patient was €568 per year. The total direct cost for moderate-to-severe IBS-C was €1635. Discussion: The majority of patients reported continuous IBS-C symptoms despite that 80% were taking medication to treat their IBS-C. Overall healthcare resource use and direct costs were asymmetric, with a small group of patients consuming the majority of resources

Introducción: El coste socioeconómico del síndrome del intestino irritable con estreñimiento (SII-E) no ha sido evaluado formalmente en España. Pacientes y métodos: Este estudio observacional, multicéntrico a 12 meses (periodos retrospectivo y prospectivo de 6 meses) evaluó el coste del SII-E moderado-grave en España. Se incluyeron pacientes diagnosticados con SII-E (criterios Roma III) en los últimos 5 años y SII-E moderado-grave (puntuación IBS-Symptom Severity Scale [IBS-SSS]≥175) en la inclusión. El objetivo principal fue evaluar el coste directo para el sistema sanitario (SS) español. Resultados: Se incluyeron un total de 112 pacientes, 64 (57%) de los cuales presentaban SII-E grave en la inclusión. En el momento basal, 89 (80%) pacientes presentaron dolor y distensión abdominal. La calidad de vida del paciente, medida mediante los instrumentos IBS-C QoL y EQ-5D, estaba deteriorada, con una puntuación de 59 y 57 (0-100, peor-mejor), respectivamente. En el periodo prospectivo la gravedad media del SII-E, medida mediante IBS-SSS, mostró alguna mejoría (315 a 234 [0-500, mejor-peor]). Durante el periodo a studio, 89 (80%) pacientes usaron fármacos prescritos para el SII-E, principalmente laxantes (n=70; 63%). El coste directo anual fue de 1.067€ y 568€ para el SS y el paciente, respectivamente. El coste total directo del SII-E moderado-grave fue de 1.635€. Discusión: La mayoría de pacientes presentaron síntomas continuos del SII-E pese a que el 80% tomaban medicación específica. El uso de recursos sanitarios y los costes directos globales fueron asimétricos, con un pequeño grupo de pacientes consumiendo la mayoría de los recursos

A retrospective and prospective 12-month observational study of the socioeconomic burden of moderate to severe irritable bowel syndrome with constipation in Spain.

INTRODUCTION: The socioeconomic burden of irritable bowel syndrome with constipation (IBS-C) has never been formally assessed in Spain. PATIENTS AND METHODS: This 12-month (6-month retrospective and prospective periods) observational, multicentre study assessed the burden of moderate-to-severe IBS-C in Spain. Patients were included if they had been diagnosed with IBS-C (Rome III criteria) within the last 5 years and had moderate-to-severe IBS-C (IBS Symptom Severity Scale score [IBS-SSS] ≥175) at inclusion. The primary objective was to assess the direct cost to the Spanish healthcare system (HS). RESULTS: A total of 112 patients were included, 64 (57%) of which had severe IBS-C at inclusion. At baseline, 89 (80%) patients reported abdominal pain and distention. Patient quality of life (QoL), measured by the IBS-C QoL and EQ-5D instruments, was found to be impaired with a mean score of 59 and 57 (0-100, worst-best), respectively. Over the 6-month prospective period the mean IBS-C severity, measured using the IBS-SSS showed some improvement (315-234 [0-500, best-worst]). During the year, 89 (80%) patients used prescription drugs for IBS-C, with laxatives being the most frequently prescribed (n=70; 63%). The direct cost to the HS was €1067, and to the patient was €568 per year. The total direct cost for moderate-to-severe IBS-C was €1635. DISCUSSION: The majority of patients reported continuous IBS-C symptoms despite that 80% were taking medication to treat their IBS-C. Overall healthcare resource use and direct costs were asymmetric, with a small group of patients consuming the majority of resources.

Transportability of confined field trial data for environmental risk assessment of genetically engineered plants: a conceptual framework.

It is commonly held that confined field trials (CFTs) used to evaluate the potential adverse environmental impacts of a genetically engineered (GE) plant should be conducted in each country where cultivation is intended, even when relevant and potentially sufficient data are already available from studies conducted elsewhere. The acceptance of data generated in CFTs "out of country" can only be realized in practice if the agro-climatic zone where a CFT is conducted is demonstrably representative of the agro-climatic zones in those geographies to which the data will be transported. In an attempt to elaborate this idea, a multi-disciplinary Working Group of scientists collaborated to develop a conceptual framework and associated process that can be used by the regulated and regulatory communities to support transportability of CFT data for environmental risk assessment (ERA). As proposed here, application of the conceptual framework provides a scientifically defensible process for evaluating if existing CFT data from remote sites are relevant and/or sufficient for local ERAs. Additionally, it promotes a strategic approach to identifying CFT site locations so that field data will be transportable from one regulatory jurisdiction to another. Application of the framework and process should be particularly beneficial to public sector product developers and small enterprises that develop innovative GE events but cannot afford to replicate redundant CFTs, and to regulatory authorities seeking to improve the deployment of limited institutional resources.

Protection goals in environmental risk assessment: a practical approach.

Policy protection goals are set up in most countries to minimise harm to the environment, humans and animals caused by human activities. Decisions on whether to approve new agricultural products, like pesticides or genetically modified (GM) crops, take into account these policy protection goals. To support decision-making, applications for approval of commercial uses of GM crops usually comprise an environmental risk assessment (ERA). These risk assessments are analytical tools, based on science, that follow a conceptual model that includes a problem formulation step where policy protection goals are considered. However, in most countries, risk assessors face major problems in that policy protection goals set in the legislation are stated in very broad terms and are too ambiguous to be directly applicable in ERAs. This means that risk assessors often have to interpret policy protection goals without clear guidance on what effects would be considered harmful. In this paper we propose a practical approach that may help risk assessors to translate policy protection goals into unambiguous (i.e., operational) protection goals and to establish relevant assessment endpoints and risk hypotheses that can be used in ERAs. Examples are provided to show how this approach can be applied to two areas of environmental concern relevant to the ERAs of GM crops.

Bringing policy relevance and scientific discipline to environmental risk assessment for genetically modified crops.

Although public opinion is important in deciding what is valued by society, governments have determined that scientific expertise is required to evaluate potential environmental effects of genetically modified (GM) crops. We suggest how to evaluate rigorously the environmental effects of GM crops in the context of a scientific investigation. Following a disciplined scientific approach to environmental risk assessment (ERA) for GM crops should help resolve controversy in identifying and addressing risk.

Constructive thinking, rational intelligence and irritable bowel syndrome.

AIM: To evaluate rational and experiential intelligence in irritable bowel syndrome (IBS) sufferers. METHODS: We recruited 100 subjects with IBS as per Rome II criteria (50 consulters and 50 non-consulters) and 100 healthy controls, matched by age, sex and educational level. Cases and controls completed a clinical questionnaire (including symptom characteristics and medical consultation) and the following tests: rational-intelligence (Wechsler Adult Intelligence Scale, 3rd edition); experiential-intelligence (Constructive Thinking Inventory); personality (NEO personality inventory); psychopathology (MMPI-2), anxiety (state-trait anxiety inventory) and life events (social readjustment rating scale). Analysis of variance was used to compare the test results of IBS-sufferers and controls, and a logistic regression model was then constructed and adjusted for age, sex and educational level to evaluate any possible association with IBS. RESULTS: No differences were found between IBS cases and controls in terms of IQ (102.0 +/- 10.8 vs 102.8 +/- 12.6), but IBS sufferers scored significantly lower in global constructive thinking (43.7 +/- 9.4 vs 49.6 +/- 9.7). In the logistic regression model, global constructive thinking score was independently linked to suffering from IBS [OR 0.92 (0.87-0.97)], without significant OR for total IQ. CONCLUSION: IBS subjects do not show lower rational intelligence than controls, but lower experiential intelligence is nevertheless associated with IBS.

Influence of psychological distress on characteristics of symptoms in patients with GERD: the role of IBS comorbidity.

UNLABELLED: A link between gastroesophageal reflux disease (GERD) and psychological distress has been suggested; psychological factors may modulate the characteristics of symptoms. Besides, irritable bowel syndrome (IBS) frequently coexists with GERD so it may be hypothesized that psychological distress in GERD might be an epiphenomenon of IBS comorbidity. AIMS: Evaluate the association of psychological distress with GERD, the influence of psychological factors on symptoms, whether psychological distress is explained by a subset of GER patients, and if coexistence with IBS would be a surrogate marker. METHODS: We performed a prospective case-control study. Cases were patients diagnosed with GERD reporting heartburn at least 2 days per week as the main complaint. Controls were matched healthy subjects without or occasional symptoms. All individuals completed a set of validated questionnaires to evaluate GERD and IBS symptoms and psychological distress (SCL-90R). RESULTS: Ninety-two patients and 92 controls were included. Fifty-seven patients and six controls fulfilled Rome II criteria for IBS. Body mass index (BMI), somatization, and IBS were independently related to GERD. Patients with and without IBS were not different in any measure of psychological distress. Characteristics of symptoms did not correlate to psychological measures. Cluster analysis isolated a cluster of nondistressed from distressed subjects. A higher proportion of GERD patients than controls were classified as distressed (29.7% versus 7.7%). No variable (including IBS) distinguished nondistressed from distressed GERD patients, except for sex. CONCLUSIONS: Nearly one-third of GERD patients attending a gastroenterologist office are psychological distressed; they cannot be identified by features of symptoms or IBS comorbidity so a specific anamnesis under the scope of a biopsychosocial model is warranted.

Determinants of quality of life in irritable bowel syndrome.

OBJECTIVES: Health-related quality of life (HRQOL) is a main outcome in irritable bowel syndrome (IBS), but most studies have been conducted on moderate-severe patients. We sought to ascertain the relative contribution of severity, anxiety, and personality to impairment of HRQOL in a sample representative of the entire IBS spectrum. MATERIALS AND METHODS: IBS consulters, IBS nonconsulters, and controls were invited to complete questionnaires designed to measure severity of IBS (Functional Bowel Disease Severity Index), anxiety (State-trait Anxiety Inventory), personality (Minnesota Multiphasic Personality Inventory-2), and HRQOL [Short Form 36 (SF-36)]. The SF-36 scores of the study groups were compared, and a multiple regression model was constructed. RESULTS: Sixty-six IBS consulters, 70 nonconsulters, and 117 controls were studied. All 3 groups differed in terms of SF-36 physical (46.5+/-9.4 vs. 50.5+/-8.0 vs. 54.5+/-6.0) and mental composite scores (38.2+/-12.5 vs. 43.2+/-12.0 vs. 46.7+/-10.6). Although physical scores were linked to hypochondriasis (beta=-0.39; P<0.001), severity of pain (beta=-0.28; P<0.001), and age, mental scores were associated with state anxiety (beta=-0.36; P<0.001) and trait anxiety (beta=-0.40; P<0.001). CONCLUSIONS: HRQOL is impaired in all subgroups of IBS sufferers, with the degree of impairment depending mostly on symptom severity and psychologic factors (hypochondriasis and anxiety).

A tiered system for assessing the risk of genetically modified plants to non-target organisms.

Representatives of the developers of modern agricultural biotechnology are proposing a tiered approach for conducting non-target organism risk assessment for genetically modified (GM) plants in Europe. The approach was developed by the Technical Advisory Group of the EuropaBio Plant Biotechnology Unit (http://www.europabio.org/TAG.htm) and complements other international activities to harmonize risk assessment. In the European Union (EU), the principles and methods to be followed in an environmental risk assessment for the placing on the market of GM plants are laid out in Annex II of Directive 2001/18/EC on the deliberate release into the environment of GMOs, Commission Decision 2002/623/EC and Regulation (EC) No. 1829/2003. Additional information is provided in the European Food Safety Authority guidance document of 2004. However, risk assessment for effects to non-target organisms could benefit from further clarification and remains the subject of much discussion in Europe. The industry-wide approach developed by EuropaBio is based on the fundamental steps of risk evaluation, namely hazard and exposure assessment. It follows a structured scheme including assessment planning, product characterization and assessment of hazard/exposure (Tier 0), single high dose and dose response testing (Tier 1), refined hazard characterization and exposure assessment (Tier 2) and further refined risk assessment experiments (Tier 3). An additional tier (Tier 4) was included to reflect the fact that post-market activities such as monitoring are required under Directive 2001/18/EC. The approach is compatible with conditions of commercial release in the EU and around the world.