1,721,063 research outputs found

    Aspetti critici negli studi clinici: problemi di metodo e applicazione

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    A clinical study is useful to clarify some planned questions and it follows a well defined scheme (the study design). This PhD thesis has been divided in five main sections following a scheme guiding the reader in the analysis of critical aspects it's possible to find, first in data management, then in the study design and during the development and the final phases of a clinical study. Section A, Problems in database management, proposes a chapter about Record Linkage and a second chapter about Missing Values. Record Linkage consists in a series of statistical and data processing techniques for data integration and for the union of more datasets on the basis of patients' identifying variables. The problem of missing values is frequently present in a study: when a database contains missing values it's possible to turn to specific systems useful to calculate a suitable value for the unit without information, through statistical programs. In section B, Study design, first clinical trials are analysed, then surveys are described and divided in cohort studies and case-control studies. In a cohort study (also called follow-up or prospective study) one or more groups of subjects are defined in accordance with the exposure to risk factors for one or more diseases, or not. Subjects are prospectively followed to study the disease(s) incidence and to observe if the disease(s) is(are) correlated with the etiological factors. A case-control study (or retrospective study) provides a research strategy to investigate possible factors preventing or causing a particular disease. The method implies a comparison between patients with the disease (cases) and a control group (healthy subjects). The comparison ends to find out factors which can be different in the two groups, explaining the presence of the disease in patients. Section C concerns Variables treatment and Outcome variable classifications. In the first part, types of variables, their measurement scales, their reduction in indicators and their transformations are analysed. In the second part the classifications of the outcome variable is described. These classifications may regard a specific disease (ICD IX and X), the patient's symptoms (ICD) or a disease effect, i.e. an impairment, a disability or a handicap (ICIDH and ICF). Sections D and E deal with choice of the multivariate analysis method. Section D aims to give a synthesis of the main analysis methods, dividing them in accordance with the variables symmetry. If there is a distinction between outcome variable and covariates, a multiple regression (stepwise or logistic) analysis method is suggested; discriminant analysis is useful if there are more outcome variables. If variables are all on the same level, factors analysis, principal components analysis, correspondences analysis and cluster analysis are proposed in conformity with the specific analysis aims. In section E logistic regression analysis is developed, pointing out the main aspects and considering the conditional logistic regression analysis for a Matched Case-Control Study design. Every chapter is organized in two parts: in the first one a synthesis of theory and practical methods are given to explain how literature deals with the specific problem in a clinical study; in the second one a specific application is presented to show how the author solved the methodology problems in a particular clinical-genetic study carried out at the Children's Hospital of Oulu University - Finland. In this Institute a substantial work on a preterm infants database creation has been performed. The database collected all the clinical and genetic information about preterm infants born in one of the three main hospitals in Northern-central Finland, Oulu, Tampere and Seinäjoki. Through this final database containing all patients from the three hospitals, a clinical-genetic case-control study (match 1-1) on the association between Respiratory Distress Syndrome (RDS) and single nucleotide polymorphisms (SNPs) has been carried out using a conditional logistic regression analysis. The project was directed by Prof. M. Hallman

    ICIDH – ICF: due classificazioni a confronto, MR Giornale Italiano di Medicina Riabilitativa

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    L'International Classification of Impairments, Disabilities and Handicaps (ICIDH) del 1980 viene messa a confronto con l'International Classification of Functioning, Disability and Health (ICF) del 2001, con traduzione in italiano nel 200

    Durata di degenza per parto in Trentino: caratteristiche materne e volumi di attività del punto nascita in relazione alla probabilità di dimissione precoce di neonati sani e a termine

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    (Length of stay for childbirth in the province of Trento: maternal characteristics and volumes of activity in the maternity unit associated with the early discharge of infants) - Early discharge (ED) of healthy term infants has become a common practice due to current socialeconomic needs. The objectives of the study are: to evaluate trends in ED of healthy term neonates (≥ 37 gestational weeks) by delivery method (caesarean and vaginal) in maternity units in the province of Trento; to identify the socio-demographic and clinical characteristics of mothers whose infants were discharged early. This retrospective study reviewed records of live births from 2006 to 2016, for a total of 45,314 healthy term infants. The trend for ED grew significantly in the period 2006-16, for both caesarean and vaginal deliveries. The multiple logistic regression analysis shows how the determinants of ED are maternal age, birth order (firstborn, second-born son, etc.), citizenship of mother, maternal smoking, maternal employment status and number of births per day. The post partum length of stay should be adjusted based on the characteristics and needs of the mother-infant dyad, identifying the criteria for safe discharge. In province of Trento, various programmes are becoming more uniform today with the intention to provide an integrated assistance

    [Current data to monitor health in early childhood: potential and perspectives]

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    Current data to monitor health in early childhood: potential and perspective

    A case study of young patients affected by Turner syndrome: Competency and psychopathology

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    Aim: This study's purpose was to evaluate psychological and affective-relational characteristics in a group of pre adolescents and adolescents affected by Turner syndrome, with the aim to focus on the importance of a multidisciplinary intervention. Materials and methods: A group of 47 girls affected by Turner syndrome and a group of 47 healthy girls were enrolled. The age of the subjects was between 10 and 19 years. In order to evaluate emotional and social aspects in Turner girls compared to healthy girls, a semistructured interview was conducted to collect personal data, family, psycho-social, extra-school habits and therapeutic intervention. Furthermore, in order to evaluate psychopathological dimensions, T. Achenbach's Youth Self Report was administered to patients and controls. Results: This study highlighted some critical aspects regarding Turner girls, like dissatisfaction with their appearance, the importance of the relationship with parents which influences both the acceptance of the illness and several other psycho-social aspects, difficulties with their peer groups, and the presence of psychopathological symptoms (internalizing problems rather than externalizing ones). Conclusions: Patients undergoing a psychiatric/psychological consultation received benefits, particularly regarding social integration, self-fulfilment, and satisfaction with one's own appearance. A multidisciplinary intervention is strongly suggested with patients affected by Turner syndrome, particularly in adolescent age

    Retrospective cohort study on weight gain among pregnant women of the Italian province of Trento during the 2020 lockdown due to COVID-19

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    Objective. The lockdown due to COVID-19 has been associated with a reduction of physical activity and a change in eating behaviors, with consequent weight gain, in general and specific populations. The objective of this study was to assess whether women whose pregnancies encompassed the lockdown due to COVID-19 in 2020 had an excess gestational weight gain as compared with those who were pregnant in the same periods of previous years. Materials and Methods. This was a retrospective cohort study based on anonymous data from the Birth Attendance Certificate (CedAP) information flow which is mandatorily collected in all Italian Regions. In the Autonomous Province of Trento, North-Eastern Italy, more information than those required as a minimum data set are collected, including maternal weight at the first gestational obstetric visit, initial body mass index (BMI), and maternal weight at delivery. We calculated mean gestational weight gain for women whose pregnancy encompassed the 2-month lockdown in 2020 and for those who were pregnant in corresponding periods of the years 2016-2019. Linear and logistic regression models were built to assess the association between lockdown and weight gain or excess weight gain, respectively, adjusting for the potential confounding effect of gestational month at the beginning of lockdown or corresponding period and pre-pregnancy body mass index. Results. In 2020, mean gestational weight gain was not significantly different from the previous years, nor was the likelihood of gaining excess weight. Conclusions. Unlike other populations that increased weight during the COVID-19 lockdown, the Italian population of pregnant women described in this study has a gestational weight gain comparable with that of the previous years. Public health and environmental interventions, as well as dedicated programs taking care of women from conception to post-partum may have a role in the health of future mothers and should be promoted

    A case study of young patients affected by Turner syndrome: competency and psychopathology

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    Aim This study’s purpose was to evaluate psychological and affective- relational characteristics in a group of pre adolescents and adolescents affected by Turner syndrome, with the aim to focus on the importance of a multidisciplinary intervention. Materials and methods A group of 47 girls affected by Turner syndrome and a group of 47 healthy girls were enrolled. The age of the subjects was between 10 and 19 years. In order to evaluate emotional and social aspects in Turner girls compared to healthy girls, a semistructured interview was conducted to collect personal data, family, psycho-social, extra-school habits and therapeutic intervention. Furthermore, in order to evaluate psychopathological dimensions, T. Achenbach’s Youth Self Report was administered to patients and controls. Results This study highlighted some critical aspects regarding Turner girls, like dissatisfaction with their appearance, the importance of the relationship with parents which influences both the acceptance of the illness and several other psycho-social aspects, difficulties with their peer groups, and the presence of psychopathological symptoms (internalizing problems rather than externalizing ones). Conclusions Patients undergoing a psychiatric/psychological consultation received benefits, particularly regarding social integration, self-fulfilment, and satisfaction with one’s own appearance. A multidisciplinary intervention is strongly suggested with patients affected by Turner syndrome, particularly in adolescent age

    Comparison of 2Win and plusoptiX A12R refractometers with Retinomax handheld autorefractor keratometer

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    PURPOSE To test the accuracy and validity of the 2Win and the plusoptiX A12R refractometers in detecting amblyopia risk factors.METHODS Children were screened using both devices, using two sets of referral criteria each, and underwent complete ophthalmic examination, including cycloplegic refraction. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. Median values for the pairs of refractometers were compared using the Wilcoxon signed-rank sum test for sphere, cylinder, and power vectors J0 and J45 for axis (both eyes).RESULTS A total of 284 eyes of 142 children (mean age, 37.9 +/- 19.8 months) were included. Comparison of mean cycloplegic and manifest refractometer measurements provided statistically significant differences in both eyes. For sphere, the means were lower and for cylinder, higher for both devices, and both correlated well with the gold standard for astigmatic power vectors J0 and J45. Using referral criteria 1, the sensitivity, specificity, PPV and NPV, and inconclusive results were 67.4%, 83.7%, 87.9%, 59.4%, and 4.9%, respectively, for the 2Win, with sensitivity of 13% in the hyperopia group; 73.1%, 95.9%, 96.6%, 69.1%, and 10.6%, respectively, for the plusoptiX A12R, with a sensitivity of 33.3% in the hyperopia group. Using criteria 2, the values were 98.8%, 38.8%, 73.9%, and 95.0% (2Win) and 94.9%, 65.3%, 81.3%, and 88.9% (plusoptiX A12R).CONCLUSIONS In manifest conditions, the accuracy of the 2Win and plusoptiX A12R refractometers is low in hyperopia and astigmatism, but the devices are well correlated with each other, and both have high specificity; sensitivity is low in hyperopia, resulting in the underestimation of hyperopic refractive error. The optional Plusoptix sensitive referral criteria seems to be appropriate for the A12R. The 2Win provided fewer inconclusive results and was preferred for use with younger and developmentally delayed children

    Early childhood eye diseases and perinatal risk factors: potential of record linkage between current information flows

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    BACKGROUND: The aim of this study was to analyze the occurrence of specific maternal, obstetric or neonatal factors, by performing a comparison between children with refractive error, strabismus and/or amblyopia (cases) and unaffected children (controls) in the province of Trento (North-East Italy).METHODS: In 2012-2014, 14,346 children attending the second year of nursery school were assessed through the pre -school orthoptic screening scheme (covering 91% of the preschool population). Record linkage was performed between the orthoptic screening database and birth records (birth confirmation certificate database) for the corresponding birth cohorts (2008-2010), to examine specific maternal factors (age, smoking, nationality/race), obstetric factors (type of delivery) and neonatal factors (gestational age, weight at birth, Apgar Score, congenital birth defects, hospitalization at birth). The correlations were investigated using univariate and multivariate analysis in accordance with the logistic regression method.RESULTS: During orthoptic screening, 6.4% of children were found to have at least one refractive error, with astigma-tism being the most common condition (5.1%). 1.9% of children were found to have strabismus and 1.8% amblyopia. Multivariate logistic regression analysis showed that the risk of developing a refractive error is associated with: maternal age >= 45 years, foreign nationality, vacuum-assisted delivery and neonatal weight <1500 grams. An excessive risk of strabismus was observed in children whose mother had smoked during pregnancy (adjusted OR=1.64).CONCLUSIONS: Preschool orthoptic screening is a well-consolidated practice in the province of Trento, with adhesion values consistently over 90%. Studies of this type show the potential of record linkage between current information flows

    Obstetric outcomes for women coming to the Trento family planning centre for a voluntary termination of pregnancy. Data for 2003-2017

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    AIM: What was the purpose of the study? The purpose of the study was to assess the obstetric outcomes in users of the Trento family planning centre who obtained voluntary termination certification between 01/01/2003 and 31/12/2017, by comparing the social and demographic characteristics of women who chose to have a termination with those of women who decide to continue their pregnancy. METHODS: A brief description of the materials/patients or subjects and method used The data concerning the users of Trento family planning centre who obtained termination certification are entered in a dedicated database. For each case, we collected a series of variables, most of which are the same as those recorded with the D12 template, the tool the Italian Institute of Statistics uses to monitor terminations. For each case relating to a woman residing in the province of Trento we assessed the obstetric outcomes in the 9 months following the issuance of the termination certificate, using the appropriate Trento health authority archives: births register, miscarriage register and the Accident & Emergency Dept. records. A multiple logistic regression model was used to evaluate the differences in the social and demographic characteristics of women who opted for a termination and those who decided to continue their pregnancy. RESULTS: What were the main findings Of the 3563 female residents to whom Trento family planning centre issued a termination certificate in the period 2003-2017, it was observed that, with the exception of 46 cases that could not be confirmed, 82.6% actually had a termination, 6.0% had a miscarriage after having planned a termination, 0.6% decided to continue their pregnancy and subsequently had a miscarriage and 9.6% decided to continue the pregnancy and actually gave birth. The trend over time for cases of termination is not statistically significant and the social and demographic factors associated with the likelihood of continuing the pregnancy are: age between 30 and 34 years rather than minors, being married/cohabiting rather than single, being of a non-EU nationality, being nulliparous or primiparous rather than pluriparous, not having had a termination in the past. CONCLUSION: What are the main conclusions or implications of the study Issuance of a termination certificate does not automatically entail the performance of a termination procedure. By Italian law, women must be allowed adequate time to decide. The woman’s social and demographic characteristics weigh heavily on the final decision. Family planning centres can provide great support to women’s health when they interact correctly with the other health services. Interaction with local epidemiological services can afford a more accurate assessment of its work
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