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Biomedical subjects

M Bonati

Publications and source records attributed to M Bonati.

At least 37 records · Page 2Linked to original sources
PubMed2000

Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children.

OBJECTIVE: To determine the extent of use of unlicensed and off label drugs in children in hospital in five European countries. DESIGN: Prospective study of drugs administered to children in general paediatric medical wards over four weeks. SETTING: Children's wards in five hospitals (one each in the United Kingdom, Sweden, Germany, Italy, and the Netherlands). SUBJECTS: Children aged 4 days to 16 years admitted to general paediatric medical wards. MAIN OUTCOME MEASURE: Proportion of drugs that were used in an unlicensed or off label manner. RESULTS: 2262 drug prescriptions were administered to 624 children in the five hospitals. Almost half of all drug prescriptions (1036; 46%) were either unlicensed or off label. Of these 1036, 872 were off label and 164 were unlicensed. Over half of the patients (421; 67%) received an unlicensed or off label drug prescription. CONCLUSIONS: Use of off label or unlicensed drugs to treat children is widespread. This problem is likely to affect children throughout Europe and requires European action.

Adolescent↗
PubMed2000

Mothers as active partners in the prevention of childhood diseases: maternal factors related to immunization status of preschool children in Italy.

BACKGROUND: We examined how maternal socio-demographic factors, together with mother's education, knowledge, and perception of immunizations, can affect the uptake of optional vaccinations of preschool children in Italy. METHODS: Interviews of Italian mothers were performed using a structured questionnaire administered by trained interviewers with no specific medical competence. RESULTS: A convenience sample of 1,035 mothers were interviewed. Fifty-nine percent of the respondents reported to have had their child immunized with the MMR vaccine and 54% reported to have had their child immunized against pertussis. In logistic regression analysis, three variables were significantly associated with both the immunization outcomes: mother's positive attitude toward immunization (OR = 1.69; IC 1.13-2.52 for pertussis; OR = 1.86, IC 1. 17-2.96 for MMR); mothers' residency in the North of the country (OR = 1.74; IC 1.32-2.30 for pertussis; OR = 1.63, IC 1.18-2.24 for MMR); and mother's receipt of satisfactory information on immunization (OR = 1.67; IC 1.15-2.21 for pertussis; OR = 2.25, IC 1. 47-3.43 for MMR). An immunization performed in recent years (after 1994), probably following the widespread use of acellular vaccine, was the most significant predictor for pertussis immunization (OR = 3.21; IC 2.43-4.24). CONCLUSIONS: The findings suggest that mothers' attitudes, educational level, and socio-demographic characteristics, as well as socio-economic factors and local health policies, can influence children's immunization uptake. Health promotion, based on a partnership between parents and health professionals, should become a priority in Italian vaccination policies.

Analysis of Variance↗
PubMed2000

Parents on the web: risks for quality management of cough in children.

BACKGROUND: Health information on the Internet, with respect to common, self-limited childhood illnesses, has been found to be unreliable. Therefore, parents navigating on the Internet risk finding advice that is incomplete or, more importantly, not evidence-based. The importance that a resource such as the Internet as a source of quality health information for consumers should, however, be taken into consideration. For this reason, studies need to be performed regarding the quality of material provided. Various strategies have been proposed that would allow parents to distinguish trustworthy web documents from unreliable ones. One of these strategies is the use of a checklist for the appraisal of web pages based on their technical aspects. OBJECTIVE: The purpose of this study was to assess the quality of information present on the Internet regarding the home management of cough in children and to examine the applicability of a checklist strategy that would allow consumers to select more trustworthy web pages. METHODS: The Internet was searched for web pages regarding the home treatment of cough in children with the use of different search engines. Medline and the Cochrane database were searched for available evidence concerning the management of cough in children. Three checklists were created to assess different aspects of the web documents. The first checklist was designed to allow for a technical appraisal of the web pages and was based on components such as the name of the author and references used. The second was constructed to examine the completeness of the health information contained in the documents, such as causes and mechanism of cough, and pharmacological and nonpharmacological treatment. The third checklist assessed the quality of the information by measuring it against a gold standard document. This document was created by combining the policy statement issued by the American Academy of Pediatrics regarding the pharmacological treatment of cough in children with the guide of the World Health Organization on drugs for children. For each checklist, the web page contents were analyzed and quantitative measurements were assigned. RESULTS: Of the 19 web pages identified, 9 explained the purpose and/or mechanism of cough and 14 the causes. The most frequently mentioned pharmacological treatments were single-ingredient suppressant preparations, followed by single-ingredient expectorants. Dextromethorphan was the most commonly referred to suppressant and guaifenesin the most common expectorant. No documents discouraged the use of suppressants, although 4 of the 10 web documents that addressed expectorants discouraged their use. Sixteen web pages addressed nonpharmacological treatment, 14 of which suggested exposure to a humid environment and/or extra fluid. In most cases, the criteria in the technical appraisal checklist were not present in the web documents; moreover, 2 web pages did not provide any of the items. Regarding content completeness, 3 web pages satisfied all the requirements considered in the checklist and 2 documents did not meet any of the criteria. Of the 3 web pages that scored highest in technical aspect, 2 also supplied complete information. No relationship was found, however, between the technical aspect and the content completeness. Concerning the quality of the health information supplied, 10 pages received a negative score because they contained more incorrect than correct information, and 1 web page received a high score. This document was 1 of the 2 that also scored high in technical aspect and content completeness. No relationship was found, however, among quality of information, technical aspect, and content completeness. CONCLUSIONS: As the results of this study show, a parent navigating the Internet for information on the home management of cough in children will no doubt find incorrect advice among the search results. (ABSTRACT TRUNCATED)

Antitussive Agents↗
PubMed2000

Risk classification systems for drug use during pregnancy: are they a reliable source of information?

BACKGROUND: In several countries, risk classification systems have been set up to summarise the sparse data on drug safety during pregnancy. However, these have resulted in ambiguous statements that are often difficult to interpret and use with accuracy when counselling patients on drug use in pregnancy. OBJECTIVES: The objective of this study was to compare and analyse the consistency between and the criteria for risk classification for medications used during pregnancy included in 3 widely used international risk classification systems. All 3 systems use categories based on risk factors to summarise the degree to which available clinical information has ruled out the risk to unborn offspring, balanced against the drug's potential benefit to the patient. METHODS: Drugs included in the risk classification systems from the US Food and Drug Administration (FDA), the Australian Drug Evaluation Committee (ADEC) and the Swedish Catalogue of Approved Drugs (FASS), were reviewed and compared on basis of the risk factor category to which they had been assigned. Agreement between the systems was calculated as the number of drugs common to all 3 and assigned to the same risk factor category. In addition, evidence on teratogenicity and adverse effects during pregnancy was retrieved using a MEDLINE search (from 1966 up to 1998) for common drugs classified as teratogenic. RESULTS: Differences in the allocation of drugs to different risk factor categories were found. Risk factor category allocation for 645 drugs classified by the FDA, 446 classified by ADEC and 527 classified by FASS was compared. Only 61 (26%) of the 236 drugs common to all 3 systems were placed in the same risk factor category. Analysis of studies on the safety of common drugs during pregnancy of drugs classified as X by the FDA indicated that the variability in category allocation was not only attributable to the different definitions for the categories, but also depended on how the available scientific literature was handled. CONCLUSIONS: Differences in category allocation for the same drug can be a source of great confusion among users of the classification systems as well as for those who require information regarding risk for drug use during pregnancy, and may limit the usefulness and reliability of risk classification systems.

Animals↗
PubMed1999

High vitamin A intake in early pregnancy and major malformations: a multicenter prospective controlled study.

The European Network of the Teratology Information Services (ENTIS) collected and evaluated data on 423 pregnancies exposed during the first 9 weeks of gestation to a "high" dose of vitamin A (10,000 IU per day or more). Data were collected prospectively; 394 women (93.1%) were followed by telephone interview up to the first few weeks after the expected date of delivery, using standardized procedures. The presence of major structural malformations, excluding chromosomal and genetic diseases, was evaluated in 311 infants exposed to a median daily dose of vitamin A of 50,000 IU per day (range, 10,000-300,000 IU per day; interquartile range, 25,000-60,000 IU per day). Three infants with a major malformation were reported: pulmonary stenosis, stenotic anus with fistula, and bilateral inguinal hernia. No congenital malformations were reported among 120 infants exposed to more than 50,000 IU per day of vitamin A. When the birth prevalence rate of major malformations in the study group was compared with two internal control groups of infants exposed to: 1) "high" vitamin A exposure later in pregnancy, and 2) nonteratogenic agent exposures, the rate ratio was, respectively, 0.28 (CI 95% interval, 0.06, 1.23) and 0.50 (CI 95% interval, 0.14, 1.76). The studied sample did not provide evidence for an increased risk of major malformations, associated with "high" vitamin A intake during the organogenetic period, higher than 2.76 above the control reference risk of 1.91% (power 80%, alpha 0.10).

Abnormalities, Drug-Induced↗
PubMed1999

Pregnancy outcome after gestational exposure to terfenadine: A multicenter, prospective controlled study.

BACKGROUND: Terfenadine is a selective, nonsedative, H(1)-blocker antihistamine used for a variety of allergic conditions. The widespread popularity of terfenadine and its use by many women in their reproductive age raises concerns regarding its safety during pregnancy. Presently, no prospective controlled study has addressed its safety during gestation. OBJECTIVE: We sought to determine whether terfenadine use during pregnancy is associated with an increased risk of major malformations, decreased birth weight, perinatal complications, or developmental delays. METHODS: A multicenter, prospective controlled study was performed. Pregnant women exposed to terfenadine during gestation were matched with control subjects exposed to drugs not known to adversely affect pregnancy outcome. The primary end point was the incidence of major malformations. Secondary outcomes of interest were pregnancy outcome, rates of preterm delivery, birth weight, and developmental milestones. RESULTS: One hundred eighteen women were exposed to terfenadine during pregnancy. Among those exposed during the first trimester (n = 65), rates of major malformations in the terfenadine group did not differ from rates in their matched control subjects (0% vs 2%; relative risk, 0.57; 95% confidence interval, 0.06-5.39; P =.53). The birth weight in the terfenadine-exposed newborns was significantly lower compared with that in their matched control subjects (3335 +/- 582 vs 3499 +/- 617 g; P =.04). However, the rates of birth weight below 2500 g and birth weight below the 10th percentile for gestational age were not different between the groups. Univariate and multiple regression analysis revealed that none of the terfenadine therapy-related factors (daily dose, duration of therapy, and trimester of exposure) had a significant predictive effect on birth weight. Gestational age at delivery, rates of preterm deliveries, and developmental milestones were comparable between the groups. CONCLUSIONS: On the basis of the limited sample size of this study, it appears that terfenadine is not associated with a 6-fold or greater increased incidence of major malformations. Terfenadine use during gestation was not associated with increased rates of prematurity or developmental delays. Further studies will be needed to confirm the finding of lower birth weight in newborns exposed to terfenadine.

Adult↗
PubMed1998

Perfluorocarbon broncho-alveolar lavage and liquid ventilation versus saline broncho-alveolar lavage in adult guinea pig experimental model of meconium inhalation.

OBJECTIVE: This study compares perfluorocarbon broncho-alveolar lavage (PFC-BAL) with isotonic saline broncho-alveolar lavage (saline-BAL) in an experimental model of meconium aspiration in adult guinea pigs. DESIGN: Prospective controlled experimental study. PATIENTS AND METHODS: Ten male guinea pigs were given 1 ml of human meconium, diluted to 10% in isotonic saline, via tracheostomy and then artificially ventilated. After stabilization, five animals (control group) underwent BAL with 10 ml/ kg isotonic saline solution. After bronchial suctioning, a further BAL with 2 ml/kg saline was performed. The other five animals (study group) underwent BAL with 100 ml/kg of PFC (RIMAR 101). Bronchosuction was effected at 5 min and then a BAL with PFC 2 ml/kg was performed. Both groups received conventional mechanical ventilation during the lavage procedures. Within 20 min all the saline-BAL treated animals died, whereas the PFC-BAL treated animals survived and were then treated with total liquid ventilation (TLV) by gravity. MEASUREMENTS AND RESULTS: After meconium inhalation in both groups, a large alveolar-arterial oxygen difference, hypercarbia, severe acidosis and tachycardia were noticed. In PFC treated animals, an improvement in blood gases was noted and acid-base balance remained stable compared to saline-BAL treated animals. No haemodynamic change was observed during or after PFC-BAL, while during saline-BAL there was evidence of bradycardia, hypotension and respiratory failure, which led to the death of the animals. The histological lung sections in the PFC-BAL group showed evidence of normal alveolar expansion with a minimal presence of meconium debris in the small bronchioles. In saline-BAL treated animals, the lung structure appeared severely compromised with the presence of meconium in bronchioles and alveoli, intra-alveolar oedema and haemorrhagic areas. CONCLUSIONS: This study confirms the detrimental effects of meconium aspiration and the impairment of lung function following saline-BAL. By contrast, PFC-BAL and TLV by gravity seemed to prevent absorption of meconium, facilitate its removal, improve gas exchange and reduce lung barotrauma.

Acute Disease↗
PubMed1998

The safety of omeprazole during pregnancy: a multicenter prospective controlled study.

OBJECTIVES: Our purpose was to determine whether omeprazole use during pregnancy is associated with an increased risk of malformations, spontaneous abortions, decreased birth weight, or perinatal complications. STUDY DESIGN: In a multicenter, prospective controlled study, pregnant women exposed to omeprazole during gestation were matched with controls exposed to nonteratogens and with disease-paired controls who used histamine blockers for similar indications. The primary end point was the incidence of major malformations. RESULTS: One hundred thirteen pregnant women were exposed to omeprazole during pregnancy. Rates of major malformations in the omeprazole group (4%) did not differ from controls exposed to nonteratogens (2%) (P = .68, relative risk = 1.94, 95% confidence interval 0.36 to 10.36) and disease-paired controls (2.8%). Birth weight, gestational age at delivery, preterm deliveries, and neonatal complications were comparable among the three groups. CONCLUSIONS: No association was found between exposure to omeprazole during the period of organogenesis and increased risk for major malformations. Exposure throughout pregnancy is not associated with increased risk of spontaneous abortions, decreased birth weight, or perinatal complications.

Abnormalities, Drug-Induced↗
PubMed1998

Informing women about drugs they take during pregnancy: promoting consumers' drug information as integral part of care.

Although it is recommended that drugs be avoided as much as possible during pregnancy, attitudes towards setting, time and method of the performed studies, and characteristics of the investigated population have been shown to vary. A collaborative and permanent network of different observational points is essential in monitoring and assessing the rational use of drugs, especially during pregnancy. In a context where knowledge is often scant and contradictory, the importance and the need for information on drug use during pregnancy remain unquestioned. If health (drug) information is the interface between those who produce and have knowledge and those who are beneficiaries of such knowledge, information for pregnant women (as well as for all lay people) is mandatory. Initiatives, people and instruments whose job it is to produce and diffuse informations have to be assessed and qualitatively harmonized to adequately answer to questions and needs. Women need information (concerning both pregnancy and drugs) on which to base choices on their own health care (and pregnancy). Clearly, this interaction depends on the kind of information and on the spirit with which it is provided. Thus it is essential that information (especially during pregnancy) be based on transparency and accountability, and it be directed by the principles of equity, effectiveness and affordability.

Drug Information Services↗
PubMed1998

Pregnancy outcome following gestational exposure to fluoroquinolones: a multicenter prospective controlled study.

Concerns regarding the teratogenicity of fluoroquinolones have resulted in their restricted use during gestation. This is despite an increasing need for their use due to emerging bacterial resistance. The objectives of the present investigation were to evaluate pregnancy and fetal outcomes following maternal exposure to fluoroquinolones and to examine whether in utero exposure to quinolones is associated with clinically significant musculoskeletal dysfunctions. We prospectively enrolled and followed up 200 women exposed to fluoroquinolones (norfloxacin, ciprofloxacin, ofloxacin) during gestation. Pregnancy outcome was compared with that for 200 controls matched for age and for smoking and alcohol consumption habits. Controls were exposed to nonteratogenic, nonembryotoxic antimicrobial agents matched by indication, duration of therapy (+/- 3 days), and trimester of exposure. Rates of major congenital malformations did not differ between the group exposed to quinolones in the first trimester (2.2%) and the control group (2.6%) (relative risk, 0.85; 95% confidence interval, 0.21 to 3.49). Women treated with quinolones had a tendency for an increased rate of therapeutic abortions compared with the rate among women exposed to nonteratogens (relative risk, 4.50; 95% confidence interval, 0.98 to 20.57), resulting in lower live-birth rates (86 versus 94%; P = 0.02). The rates of spontaneous abortions, fetal distress, and prematurity and the birth weight did not differ between the groups. Gross motor developmental milestone achievements did not differ between the children of the mothers in the two groups. We concluded that the use of fluoroquinolones during embryogenesis is not associated with an increased risk of major malformations. There were no clinically significant musculoskeletal dysfunctions in children exposed to fluoroquinolones in utero. The higher rate of therapeutic abortions observed in quinolone-exposed women compared to that for their controls may be secondary to the misperception of a major risk related to quinolone use during pregnancy.

Abnormalities, Drug-Induced↗
PubMed1997

Reliability of health information for the public on the World Wide Web: systematic survey of advice on managing fever in children at home.

OBJECTIVE: To assess the reliability of healthcare information on the world wide web and therefore how it may help lay people cope with common health problems. METHODS: Systematic search by means of two search engines, Yahoo and Excite, of parent oriented web pages relating to home management of feverish children. Reliability of information on the web sites was checked by comparison with published guidelines. MAIN OUTCOME MEASURES: Minimum temperature of child that should be considered as fever, optimal sites for measuring temperature, pharmacological and physical treatment of fever, conditions that may warrant a doctor's visit. RESULTS: 41 web pages were retrieved and considered. 28 web pages gave a temperature above which a child is feverish; 26 pages indicated the optimal site for taking temperature, most recommending rectal measurement; 31 of the 34 pages that mentioned drug treatment recommended paracetamol as an antipyretic; 38 pages recommended non-drug measures, most commonly tepid sponging, dressing lightly, and increasing fluid intake; and 36 pages gave some indication of when a doctor should be called. Only four web pages adhered closely to the main recommendations in the guidelines. The largest deviations were in sponging procedures and how to take a child's temperature, whereas there was a general agreement in the use of paracetamol. CONCLUSIONS: Only a few web sites provided complete and accurate information for this common and widely discussed condition. This suggests an urgent need to check public oriented healthcare information on the internet for accuracy, completeness, and consistency.

Analgesics, Non-Narcotic↗
PubMed1997

Cisapride use during human pregnancy: a prospective, controlled multicenter study.

The objective of this prospective multicenter study was to determine whether cisapride is associated with increased risk of malformations, spontaneous abortions, or decreased birthweight when used during pregnancy. Cases were paired for age, smoking, and alcohol consumption with controls exposed to nonteratogens, as well as with disease-paired controls. One hundred and twenty-nine pregnant women were exposed to cisapride during pregnancy, including 88 during the period of fetal organogenesis. There were no differences in maternal history, birthweight, gestational age at delivery, and rates of livebirths, spontaneous or therapeutic abortions, fetal distress, and major or minor malformations among groups. It is concluded that exposure to cisapride during pregnancy is not associated with a major increased risk of malformations or spontaneous abortions or with decreased birthweight.

Abnormalities, Drug-Induced↗