Adaptation and validation of an Italian version of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI).

OBJECTIVE: The Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) is a measure of health-related quality of life (HRQoL) in advanced hormone-resistant prostate cancer. In this study, we aimed at performing a cross-cultural adaptation and validation of the Italian version of the PROSQOLI. PATIENTS AND METHODS: The original version of the PROSQOLI underwent several turnarounds of translations. A total of 472 patients treated with radical prostatectomy, radiotherapy or medical therapy were enrolled for the validation of the questionnaire. The PROSQOLI was administered together with the SF-12. Reliability indexes were calculated by using Cronbach alpha. To evaluate the validity of the construct, relationships between PROSQOLI and SF12 were assessed. The ANOVA test was used to evaluate the differences between groups of patients who had received different treatments. RESULTS: The reliability coefficient was 0.91. Item-to-total correlation indices were in most cases >0.70. The correlation between the scores of the PROSQOLI and those of the SF-12 questionnaire was high (r=0.8139, p<0.0001). The ANOVA test showed significant differences between groups (p<0.01) based on age, recurrence risk and treatment. CONCLUSIONS: The adaptation process showed that the PROSQOLI Italian version has high reliability and presents both convergent and discriminant validity. This version of the tool can be used to assess HRQoL in Italian men who underwent radical treatment for advanced prostate cancer.

[Effects of folic acid supplementation on pregnancy outcomes: a review of randomized clinical trials]. / Revisione narrativa dei risultati degli studi clinici controllati sull'efficacia della supplementazione con folati nel migliorare l'esito della gravidanza.

Despite the causal association between defects of the metabolism of the folate (hyperhomocysteinemia) and risk of neural tube defects are both well documented, the association between folate deficiency and other pregnancy pathologies is still not entirely clear. The present article aims to gather the data published about the relationship between serum folate and pregnancy pathologies, distinguishing between the evidences emerged from the observational studies and the results of the clinical trials. We carried out a brief examination of the relationships between folate metabolism and homocysteine. Observational studies have suggested that a good level of folate in pregnancy is associated with higher birthweight, increased placental weight and fewer preterm birth. These results were not entirely consistent with findings from clinical trials. We have identified 12 randomized clinical studies with folate supplementation versus placebo. In the clinical studies where folic acid (FA) could improve pregnancy outcomes, its effect was not statistically significant, except for three studies where FA showed a significant decrease of low birthweight. With regard to preterm birth, pre-eclampsia and abruptio placentae, although in some observational studies AF was found to be associated with a reduction of these adverse outcomes, in currently available controlled clinical trials, FA supplementation had no statistically significant effects.

Induced abortion and risk of small-for-gestational-age birth.

OBJECTIVE: To investigate the possibility of an association between previous induced abortion and subsequent birth of a small-for-gestational-age (SGA) infant. DESIGN: Case-control study. SETTING: General and university hospitals. METHODS: Cases were 555 women who delivered SGA babies. Controls were 1966 women who gave birth at term (>37 weeks of gestation) to healthy infants of normal weight on randomly selected days at the hospital where cases had been identified. All women in the case and control categories were interviewed on the obstetric wards by one of a team of six interviewers. During the interviews, information was obtained regarding general socio-demographic factors, personal characteristics and habits, gynaecological and obstetric history, general anamnesis, family history of obstetric and gynaecological diseases, and the age of the father of the child. Further information on current pregnancy and delivery was also collected. We used conditional multiple logistic regression (with age as the matching variable), with maximum likelihood fitting, to obtain odds ratios and their corresponding 95% CIs. Included in the regression equations were terms for education, plus terms significantly associated in this data set with the risk of SGA birth (smoking in pregnancy, history of SGA, gestational hypertension and parity). POPULATION: Women admitted to a general and a university hospital. RESULTS: No significant increase in the risk of SGA birth was observed in women with a previous induced abortion [odds ratio (OR) 1.0; 95% CI 0.6-1.7]. The OR for SGA birth was 1.2 (95% CI 0.7-2.1) for preterm and 1.0 (95% CI 0.7-1.4) for term SGA births. CONCLUSION: This study found no association between risk of SGA birth and induced abortion.

Neonatal resuscitation of extremely low birthweight infants: a survey of practice in Italy.

Delivery room management of extremely low birthweight infants (ELBWIs) has been little studied. A questionnaire was sent to the heads of the 86 Italian neonatal intensive care units provided with on site delivery. The practice of and approach to the resuscitation of ELBWIs were very different among the centres surveyed, reflecting a paucity of evidence and consequent uncertainty among clinicians.

[Periconceptional supplementation with folic acid for the primary prevention of congenital malformations]. / La supplementazione con acido folico nel periodo periconcezionale: un intervento di prevenzione primaria delle malformazioni congenite.

Most international trials support the recommendation that all women planning or at risk of pregnancy take a daily multivitamin supplement containing folic acid, beginning one month before conception and continuing through the first trimester for primary prevention of neural tube defects and other congenital malformations. Recently an intervention project started also in Italy, in order to support and maintain the periconceptional supplementation and to evaluate the efficacy of a national preventive campaign on parents' behaviour.

Developmental assessment of preterm and term children at 18 months: reproducibility and validity of a postal questionnaire to parents.

AIM: To examine the degree of agreement between the paediatrician's assessment and parental reporting of infants' development using a postal questionnaire. METHODS: The developmental status of 241 infants in the charge of 9 community paediatricians or discharged from one Neonatal Intensive Care Unit (NICU) was assessed by their parents 18 mo after delivery, using a postal questionnaire regarding child's height, weight. respiratory, hearing and vision problems, and items taken mainly from the Griffiths' Developmental Scales. At this age, infants were seen by the community or NICU paediatricians, for a complete physical and neurodevelopmental examination. RESULTS: The mean agreement on items regarding developmental areas between parents and paediatricians was 93.0%. In general, parents and professionals agreed on items describing gross motor behaviour (k from 0.39 to 0.83) and disagreed on individual questions describing language/relational behaviour (k from 0 to 0.38). A 97.9% level of agreement was found for hearing status (k = 0), and 96.2% for assessment of vision (k = 0.29), whereas the level of agreement ranged from 43.2% to 86.2% (k from 0 to 0.15) for the three questions describing respiratory problems. The mean weight and height assessments by paediatricians and parents of infants at 18 mo of age were similar. CONCLUSIONS: Further improvement of the questionnaire is needed, but our findings suggest that this methodology can be considered for use in comparing large cohorts of infants included in randomized clinical trials.

[Epidemiology of identical twin pregnancy]. / Epidemiologia della gravidanza gemellare.

On the basis of MEDLINE and manual search, we looked at the main papers in English literature published from 1976, regarding risk factors for spontaneous (i.e. not related to fertility drug use) multiple births. The constant frequency of monozygotic (MZ) pregnancies over time and in different geographic areas suggests that determinants of MZ twins are largely unchanged over time and that genetic mechanism may act a role. On the contrary, temporal and geographic trends observed in dizygotic (DZ) pregnancies suggest that environmental factors play a role in determining this condition. At present maternal age and hereditary components are the better defined determinants for spontaneous multiple births.

Nifedipine administered in pregnancy: effect on the development of children at 18 months.

The safety of use of the calcium channel blocker nifedipine in pregnancy as it affects child development has not been well evaluated. We report the results, with regard to the safety for children of use of nifedipine in pregnancy, on children followed up at 18 months of age born from women recruited in a study comparing routine treatment with nifedipine compared with no treatment.

Determinants of response to intracervical prostaglandin E2 for cervical ripening. Gruppo di Studio sull'Induzione del Travaglio di Parto.

OBJECTIVE: To analyze the determinants of response to intracervical prostaglandin E2 (PGE2) in cervical ripening. STUDY DESIGN: A total of 250 women with normal pregnancy, parae three or less, with intact membranes between 40 and 42 weeks of gestation and Bishop's score < or = 4 were treated with 0.5 mg PGE2 intracervical repeated after 12 hours if cervical Bishop's score was still < or = 4. RESULTS: After the first administration of PGE2, labor was induced in 106 (42.4%) women. Nulliparae had a significant longer interval from the first PGE2 dose to delivery and more failures of treatment and caesarean sections than parae. There was a tendency towards a shorter interval between the first administration and delivery and a decrease in the frequency of treatment failures with increasing Bishop's score, but the finding was not statistically significant. No fetal or neonatal death occurred. There were eight neonates at one min and three neonates at five min with an Apgar score less than seven. There were 22 neonates admitted to Neonatal Intensive Care Unit. There were 20 cases of jaundice. CONCLUSIONS: The study confirms that the main determinant of treatment failure with PGE2 gel in cervical ripening is nulliparity.

[Timing of radiotherapy in the treatment of breast carcinoma. Review of the literature]. / Timing della radioterapia nel trattamento del carcinoma mammario. Revisione della letteratura.

Combined modality treatments are indicated for most patients with breast cancer. The definition of a proper treatment schedule and of the timing of each modality is a relevant issue that affects the feasibility and the clinical outcome of the treatment. A review of the literature was done on the timing of radiation therapy (RT) in the post-operative treatment of breast cancer. Retrospective studies and randomized clinical trials addressing the issue were considered and grouped according to the combined modality treatments performed. With regard to breast conserving surgery and adjuvant RT, it was verified that a delay up to 8 weeks between breast surgery and start of RT is not associated with an increased risk of local failure if compared with RT started within 4 weeks. Concerning breast conserving surgery followed by adjuvant RT and chemotherapy, the choice of the best schedule is still a complex unresolved issue. More results on sequential schedule of adjuvant RT and chemotherapy from recently published randomized studies are available. The reconstruction of the breast after conservative surgery is rarely necessary and is usually performed immediately after surgical treatment. With regard to mastectomy followed by adjuvant RT and breast reconstruction, it appears from some retrospective studies that autologous tissue transfer offers better results over implants. Concerning the transverse rectus abdominis muscle (TRAM) procedure, either immediate reconstruction before RT or delayed reconstruction after RT was feasible without significative differences in complication rates. Further randomized clinical studies are required to address the unresolved issues linked to the timing of RT. At present the treatment plan should be based on the patient's individual circumstances with regard to risk of metastasis and local failure.

The epidemiology of multiple births.

On the basis of MEDLINE and manual searches, we examined the main papers in the English literature regarding risk factors for spontaneous (i.e. not related to fertility drug use) multiple births. The constant frequency of monozygotic (MZ) pregnancies over time and in different geographical areas suggests that the determination of MZ twins is largely unchanged over time, and that a genetic mechanism may have a role. In contrast, temporal and geographical trends observed in dizygotic (DZ) pregnancies suggest that environmental factors play a role in determining this condition. At present, maternal age and hereditary components are the best-defined determinants for spontaneous multiple births.

[Follow-up of children in obstetrical clinical trials: research experience in Italy]. / Il follow-up dei bambini nei trial clinici ostetrici: esperienze di ricerca in Italia.

The effectiveness of treatments for the mother exposed to adverse events in pregnancy is not always interpreted in the light of possible effects on the child. The follow-up of infants is an important component of obstetric and perinatal audit not only in randomised clinical trials but as part of routine health care. The results of the 18 month's follow-up of children born from women recruited in the Italian Study of Aspirin in Pregnancy and in the Italian Trial on Nifedipine in Pregnancy are discussed. No significant differences emerged between treatment and no-treatment groups with respect to indicators of development and health status. Malformations, diseases, and other health problems showed no specific patterns and were much the same in the groups. Our findings suggest that the use of low-dose aspirin and calcium channel blocker nifedipine in pregnancy is safe with respect to the risks of malformation and of major impairment in development at 18 months of age.

Placental ratio in pregnancies at different risk for intrauterine growth.

OBJECTIVE: We have analyzed the placental/birthweight ratio in women at increased risk of intrauterine growth retardation and pregnancy-induced hypertension and in women with pregnancy 'complicated' by these conditions. STUDY DESIGN: A total of 89 women with small gestational age (SGA) infants, 355 with appropriate gestational age infants (200 in the uncomplicated pregnancy group) and 28 with large for gestational age (LGA) infants were considered. RESULTS AND CONCLUSION: The mean placental weight showed a significant increase from the SGA to the LGA in the two groups. The placental ratio tended to increase from the LGA group to the SGA one both in infants of women with uncomplicated pregnancy and with pregnancy complicated by intrauterine growth retardation or pregnancy-induced hypertension; these findings were statistically significant.

Paternal and maternal smoking habits before conception and during the first trimester: relation to spontaneous abortion.

PURPOSE: This study examined the association between maternal smoking before and during the first trimester of pregnancy and spontaneous abortion. METHODS: We have been conducting a hospital-based case-control study on risk factors for spontaneous abortion in the greater Milan area. We collected information from 782 cases of spontaneous abortions and 1543 controls (women who delivered at term healthy infants). RESULTS: With respect to never smokers, the odds ratio (OR) were 0.7 (95%, confidence interval (CI), 0.5-1.0) for women who quit smoking and 1.3 (95% CI, 1.0-1.6) for those who continued during pregnancy. Women who smoked more than 10 cigarettes/day in the first trimester were at increased risk of miscarriage, with an OR of 1.4 (95% CI, 1.0-2.1). No relationship was evident between the number of cigarettes smoked before conception and the risk of abortion. Likewise, no association emerged between paternal smoking and miscarriage. Moreover, no significant interaction or modification effect was obtained when strata of age and other major characteristics were investigated. CONCLUSIONS: The risk of abortion associated with cigarette smoking during the first trimester of pregnancy was measurable and noticeable in this population, and accounted for 9% (95% CI, 6-13%) of all cases. The increased risk of spontaneous abortion in women smoking during pregnancy is a further reason to encourage pregnant women to quit.

[Birth weight of infants born between the 23rd and 42nd gestational week in Italy]. / Distribuzione del peso nei nati tra la 23a e la 42a settimana di gestazione in Italia.

The Italian distribution of birth weight has been computed using information routinely collected by the Italian Central Institute of Statistics on about 1,150,000 births in the period 1984-1985. Individual records include data on birth weight for single/multiple births for 28th-42nd gestational weeks and for delivery modalities for 23rd-27th gestational weeks, according to sex. This analysis shows, from a large national data-set, distribution of weight at birth from a Southern European population, providing to obstetrics and perinatologists curves of fetal growth more directly representative of the population under their care.

[Follow-up of children included in the Italian Study on the Use of Low-Dose Aspirin During Pregnancy: development at 18 months of life and birth weight]. / Follow-up dei bambini inclusi nello Studio Italiano sull'utilizzo di basse dosi di Aspirina in gravidanza: sviluppo a 18 mesi di vita e peso alla nascita.

To assess the relationship between birthweight and the child's development at 18 months of age, we sent a postal questionnaire to the parents of 861 singleton children, born in the framework of the Italian Study of Aspirin in Pregnancy, 18 months after delivery. A total of 623 (72.4%) were returned. There were 94 children weighing < 2500-1500 g at birth and 19 < 1500 g. Children with weight and height less than the 10th percentile at 18 months were significantly more frequent in the low birthweight group (p < 0.01). Motor problems were about six times more common in children with birthweight less than 2500 g than in those with birthweight > or = 2500 g (p < 0.001). A larger proportion of children with birthweight < 2500 g than > or = 2500 g had respiratory problems (15% vs 11%, p = ns). Finally admission to hospital was more common in children with birthweight less than 2500 g (p < 0.01). This study confirms the differences in growth and development for children in low and normal birthweight groups.

[Study of the reliability of a parenteral questionnaire used in a pediatric follow-up of 18-month-old children]. / Studio di validazione di un questionario ai genitori di bambini con età intorno ai 18 mesi utilizzato nei follow-up pediatrici.

We are conducting a validation study of questionnaire to the parents according to the Griffiths Mental Developmental Scale, used in pediatric follow-up of obstetric studies among the Italian population. The questionnaire concerns the child's gross and fine motor and language development, swallowing, respiratory, hearing and vision problems, and hospital admissions within the first 18 months of life. The purpose of this study is to examine the degree of agreement between parental and professional assessment of normal and high-risk infants development at 18 months of life.

Hepatitis C virus and non-Hodgkin's lymphomas.

Hepatitis C virus (HCV) seems to be the aetiologic agent of mixed cryoglobulinaemia, and as this 'benign' lymphoproliferative disorder can frequently develop into more aggressive haematological disorders, this study was undertaken to determine the prevalence of HCV infection in non-Hodgkin's lymphomas. 199 unselected subjects treated by three haematological centres in Northeast Italy were investigated for the presence of HCV infection. As controls, the prevalence of HCV infection was determined in a group of patients affected by other haematological malignancies (153 subjects) and in the general population of the same geographical area in the cohort study called the Dyonisos project (6917 subjects). The presence of anti-HCV antibodies was determined by a commercial kit and, in positive cases, by PCR amplification of the 5' untranslated region of the virus. The HCV genotype was also obtained by PCR amplification of the Core region with type-specific primers. The presence of serum cryoglobulins was determined in each case of NHL. HCV infection was significantly (P < 0.00000001) higher in patients with non-Hodgkin's lymphomas (28.0%) when compared with that of the general population (2.9%), and with the group of patients affected by other malignancies (3.1%). The prevalence is particularly high in low-grade (38.4%), as compared with intermediate (11.4%), or high-grade (15.2%) lymphomas. The presence of the virus is significantly (P < 0.000001) associated with the presence of detectable levels of cryoglobulins. On the basis of these findings. HCV seems to play an important role in the development of low-grade non-Hodgkin's lymphomas.