[An analysis of patient information sheets for obtaining informed consent in clinical trials]. / Análisis de las hojas de información al paciente para la obtención de su consentimiento informado en ensayos clínicos.

BACKGROUND: The written information provided to the potential participants in a clinical trial must have certain qualitative and quantitative characteristics to reach the ethical requirements governing the theory of the informed consent. MATERIAL AND METHODS: In a sample of 101 clinical trial protocols approved in two Spanish university general hospitals, the following items were evaluated: a) the amount and quality of the written information given to the patient, in accordance with the established in the Spanish legislation; b) the formal readability of this written forms, by means of the Flesch method, and c) the level of complexity of the vocabulary, by means of the number of non-comprehensible words for two volunteers unaware of the health professions, with high studies. RESULTS: The balance of benefits and risks, the identification and the way of contact with the main investigator, the description of the alternative treatments and the specification of the compensations in case of lesions were the items with highest noncompliance. The mean global readability by means of the index of Flesch was of -12.7 (text with a high level of complexity). The mean percentage of words non-comprehensible for the volunteers that analyzed the texts was 0.3%. CONCLUSIONS: The written form of information provided to the patient in the clinical trials developed in Spain has serious deficiencies, either in their formal readability (complexity of the linguistic structure) or in the amount and quality of the information that provides. These deficiencies could have a wrong influence in the appropriate obtention of the informed consent from the patients.

[Iga and IgG antireticuline in celiac disease. Their application as diagnostic markers of the disease]. / Estudio de la reactividad IgA e IgG antirreticulina en la enfermedad celíaca. Su aplicación como marcador diagnóstico de la enfermedad.

We report the results of indirect immunofluorescent (IFI) detection of IgA and IgG antireticulin antibodies (IgA-ARA and IgG-ARA, respectively) in 283 serum samples from pediatric patients with coeliac disease (with and without gluten containing diets), patients with non-coeliac gastrointestinal disease, patients without gastrointestinal disease (control group) and patients with an increased risk for coeliac disease (diabetes mellitus, dermatitis herpetiformis or first grade relatives of coeliac patients). Our results indicate that IgA-ARA is a reproducible marker, with high positive (99-100%) and negative (100%) prediction values, when it is applied to children who have been on gluten containing diets for a long time (more than six months). The IgA-ARA measurement is not applicable in cases of selective IgA deficiency. Although IgG-ARA has a high predictive positive value, its low predictive negative value makes it a poor diagnostic tool. In the risk groups, our results suggest that these antibodies are useful in patient selection for intestinal biopsy.

[The role of IgA and IgA antigliadin antibodies in the diagnosis and management of celiac disease]. / Importancia de los anticuerpos antigliadina de tipo IgA e IgG en el diagnóstico y seguimiento de la E. celíaca.

The authors reports the results of ELISA IgG and IgA antigliadin antibodies measurements in a study of 271 serum samples proceeding from celiac patients (with and without gluten containing diet) and control subjects. IgA antigliadin antibody measurement had the most specificity and positive predictive value, IgG antigliadin antibody measurement had the most sensitivity and negative predictive value. Our results point out that antigliadin antibodies are helpful in the diagnosis and management of celiac disease. Un the same manner, antigliadin antibodies are helpful to evaluate the adherence of patients to gluten-free diet.

[Anti-endomysium antibodies: new serological markers for the diagnosis and follow-up of patients with gluten-sensitive enteropathy. Preliminary study]. / Anticuerpos antiendomisio: un nuevo marcador serológico para el diagnóstico y seguimiento de pacientes afectos de enteropatía sensible al gluten. Estudio preliminar.

The authors value the parameters of diagnostic efficacy in a preliminary study of anti-endomysium antibodies (EmA), in the diagnostic and follow-up of patients with gluten sensitive enteropathy. The study was made with 84 subjects distributed into four groups. Group I consisted of 21 patients with gluten sensitive enteropathy (GSE) who were eating gluten at the time of diagnosis. Group II consisted of 20 patients with gluten sensitive enteropathy with different periods of time of gluten free diet. Group III consisted of 16 subjects with non-evolutive neuropathies and without intestinal disease. This group was considered as controls. Group IV consisted of 27 patients with toddler diarrhoea. The sensitivity, specificity, positive predictive value, negative predictive value and efficiency were 100%.

[The FTA-abs test in the diagnosis of congenital syphilis]. / La prueba del FTA-abs, en el diagnóstico de la sífilis congénita.

Present survey has analysed the results obtained from 13 children whose FTA-abs (IgG) test proved to be positive. For assessing their anti-Treponemal and reaginic antibodies, the RPR, passive hemagglutination (MHA-TP) and FTA-abs trials were carried out, the existence of specific IgG and IgM being noticed from the latter. Out of the 13 samples subject to our analyses, 7 showed some specific IgM antibodies, with the existence of a congenital syphilis being clinically assessed from three of them, whereas the remaining 6 samples only showed some IgG antibodies. The need for an early diagnosis during the first and third quarters of pregnancy is indicated, through a reaginic (RPR o VDRL) trial or a treponemic (MHA-TP) one, as well as the assessing of anti-Treponema pallidum antibodies in the umbilical cord blood, where a positive luetic serology appears to be the case during the period of pregnancy.

Anticuerpos anti-citomegalovirus en pacientes de la consulta de enfermedades de transmision sexual (E.T.S.). / Antibodies anti-cytomegalovirus in patients attending veneral diseases clinics

En el presente trabajo se estudian 273 muestras de suero, de las cuales 178 correspondian a pacientes procedentes de la consulta de enfermedades de transmision sexual (E.T.S.) 52 a pacientes procedentes de las consultas pediatricas y 43 a donantes de sangre. Para la determinacion de la tasa de anticuerpos anti-citomegalovirus se ha utilizado la tecnica inmunoenzimatica ELISA. El titulo medio de anticuerpos anti-citomegalovirus en E.T.S. fue de 2275,14, en ninos de 474,73 y en donantes de 511,16, con una diferencia significativa estadisticamente (p < 0,001). En cuanto al porcentaje de seronegativos, se encuentra una diferencia significativa (p < 0,001) entre la poblacion infantil y la poblacion adulta