Advancing tools for human early lifecourse exposome research and translation (ATHLETE): Project overview.

Early life stages are vulnerable to environmental hazards and present important windows of opportunity for lifelong disease prevention. This makes early life a relevant starting point for exposome studies. The Advancing Tools for Human Early Lifecourse Exposome Research and Translation (ATHLETE) project aims to develop a toolbox of exposome tools and a Europe-wide exposome cohort that will be used to systematically quantify the effects of a wide range of community- and individual-level environmental risk factors on mental, cardiometabolic, and respiratory health outcomes and associated biological pathways, longitudinally from early pregnancy through to adolescence. Exposome tool and data development include as follows: (1) a findable, accessible, interoperable, reusable (FAIR) data infrastructure for early life exposome cohort data, including 16 prospective birth cohorts in 11 European countries; (2) targeted and nontargeted approaches to measure a wide range of environmental exposures (urban, chemical, physical, behavioral, social); (3) advanced statistical and toxicological strategies to analyze complex multidimensional exposome data; (4) estimation of associations between the exposome and early organ development, health trajectories, and biological (metagenomic, metabolomic, epigenetic, aging, and stress) pathways; (5) intervention strategies to improve early life urban and chemical exposomes, co-produced with local communities; and (6) child health impacts and associated costs related to the exposome. Data, tools, and results will be assembled in an openly accessible toolbox, which will provide great opportunities for researchers, policymakers, and other stakeholders, beyond the duration of the project. ATHLETE's results will help to better understand and prevent health damage from environmental exposures and their mixtures from the earliest parts of the life course onward.

Validation of the Spanish version of the Side Effect and Life Satisfaction Inventory in patients with epilepsy.

OBJECTIVE: The goal of the study described here was to obtain psychometric validation of the Spanish version of the 38-item Side Effects and Life Satisfaction (SEALS) Inventory. METHODS: A cross-cultural adaptation of the inventory was performed. A total of 595 patients with epilepsy were included in a multicenter cross-sectional study. The SEALS Inventory was completed, together with the Hospital Anxiety and Depression Scale and SF-12 Health Survey. RESULTS: The mean SEALS score was 60.7. SEALS presented high internal consistency, with a Cronbach alpha coefficient of 0.93, and good test-retest reliability, with an intraclass correlation coefficient of 0.92. The pattern of correlations with the Hospital Anxiety and Depression Scale and SF-12 Health Survey indicated good convergent and divergent validity. SEALS scores discriminated patients according to epilepsy-related factors, emotional disturbances, and the generic quality of life. CONCLUSION: The Spanish version of the SEALS Inventory is a valid psychometric instrument. It may be used in routine clinical practice and in clinical trials in patients with epilepsy to capture the cognitive and behavioral aspects of quality of life.

Acceptability of lansoprazole orally disintegrating tablets in patients with gastro-oesophageal reflux disease : ACEPTO study.

OBJECTIVE: To assess the acceptability of lansoprazole orally disintegrating tablets (LODT) in patients with gastro-oesophageal reflux disease (GORD). METHODS: A multicentre, observational, cross-sectional study of patients diagnosed with GORD aged > or =18 years under the care of 272 gastroenterologists. Acceptability was determined by global patient assessment whereby the drug's organoleptic characteristics and properties were evaluated by a self-administered 11-item ad hoc questionnaire with a 5-point Likert-type scale. RESULTS: A total of 734 patients (mean age 49.6 years [SD = 15.2]) with GORD who had been prescribed LODT > or =14 days prior to inclusion in the study were evaluable for the main endpoint. Of these, 51.1% were men. Most patients (80.7%) had been treated with doses of LODT 30mg/day for an average of 52.7 days (SD = 59.3). Overall, 93.6% of patients rated LODT treatment as 'very acceptable' or ''acceptable'. The degree of acceptability was associated with the perception that the formulation helps treatment compliance (p < 0.001). The drug's properties were rated as follows: size 'neither large nor small' (70.0%); flavour 'very pleasant' or 'pleasant' (75.2%); intensity of flavour 'neither strong nor mild', 'mild' or 'very mild' (86.1%); no 'sandy sensation' (53.4%); speed of dissolving 'fast' or 'very fast' (80.2%); use of tablets 'very easy' or 'easy' (92.4%) and use of tablets 'very convenient' or 'convenient' (91.0%). Three adverse reactions, none of them serious, were reported in three patients (0.4%). CONCLUSIONS: LODT were well accepted by patients with GORD. Patients reported that this formulation improved compliance with therapy. Tolerability was excellent.

Factors related with treatment adherence to interferon beta and glatiramer acetate therapy in multiple sclerosis.

BACKGROUND: Awareness of the factors influencing discontinuation of immunomodulatory drugs (IMD) treatment in multiple sclerosis (MS) can help to find approaches to patient management with the aim of establishing more specific indications and also attaining more optimal patient selection in future clinical trials. OBJECTIVE: To identify the causes that influence adhesion to IMD therapy within the clinical practice in a large cohort of patients with MS. PATIENTS AND METHODS: We have studied all MS patients who have initiated IMD in our hospital. All patients took part in training sessions where treatment expectations and side effects were explained and they received training in the administration technique. Reasons for stopping therapy were recorded during follow-up. RESULTS: We studied 632 MS patients (mean follow-up was 47.1 (28.7) months). At the time of analysis, 107/632 patients (17%) were no longer receiving IMD. Almost half of the patients who stopped IMD (52/107) did so within the first two years on therapy. Fifty-six patients stopped IMD because of lack of efficacy. Only 27 patients (4.3%) discontinued treatment for reasons other than inefficacy or side effects. The proportion of patients with secondary progressive MS that stopped IMD therapy was 30%, while only 13.5% of the patients with relapsing remitting MS stopped therapy (P < 0.0001). Expanded Disability Status Scale (EDSS) score at entry was the main factor that predicted interruption of therapy. CONCLUSIONS: The proportion of patients interrupting IMD in our centre is low, possibly due to individualized care. Higher EDSS, mainly in the first two years of treatment, is the main factor related with interruption. Close follow-up of these patients would be useful in avoiding early discontinuation of therapy.