Routine use of external cephalic version in three hospitals.

BACKGROUND: External cephalic version has been advocated as a safe alternative to vaginal breech delivery or cesarean birth. The purpose of this study was to determine the efficacy of routine use of external cephalic version at 36 weeks or more of gestation in three different levels of hospitals. METHODS: External cephalic version was performed on 923 women with a single breech fetus at three hospitals in Italy. The procedure was attempted with a tocolytic agent for uterine relaxation and with no maternal analgesia. The version technique adopted was the "forward roll." RESULTS: Version was successfully performed on 579 fetuses (62.7%); each hospital had a similar success rate, and 56.9 percent of the women delivered vaginally. The procedure was more successful in multiparas and in women with an incomplete type of breech, polyhydramnios, and posterior localization of the placenta. Vaginal bleeding was experienced by 14 women; eight cesarean sections were performed for suspected abruptio placentae, confirmed in four cases. Two cephalic-turned fetuses experienced an episode of persistent bradycardia and were turned again to breech; in five cases a nonstress test recorded after the version showed repeated variable decelerations and in one case a cesarean section was performed. Neonatal outcomes were good in 922 infants. A fracture of the femur attributable to the version was observed in one newborn. CONCLUSIONS: External cephalic version is effective in reducing the number of cesarean deliveries in term breech infants in different obstetric settings, with no major neonatal adverse outcomes.

Clinical outcome and its predictors in 1560 patients with critical leg ischaemia. Chronic Critical Leg Ischaemia Group.

OBJECTIVE: to assess the predictivity of clinical variables in patients with chronic critical leg ischaemia (CLI). Design observational prospective cohort study. METHODS: the i.c.a.i. (ischemia critica degli arti inferiori) trial database was used to assess the impact of patients' history, cardiovascular risk, manifestations of the disease and specific invasive and pharmacological interventions on mortality, amputation rate and persistence of CLI. RESULTS: of 1560 patients, 298 died within one year; at six months 187 were amputees and 746 still suffered from CLI. Prior major vascular events doubled the risk of dying within one year. Previous revascularisation was associated with a lower mortality, but also with a higher probability of amputation. Among cardiovascular risk factors, only diabetes affected prognosis, in terms of increased mortality and lower probability of recovery from CLI. Patients with tissue loss had a higher amputation rate and less probability of recovery. Ankle pressure was predictive of mortality and amputation only when unmeasurable. Patients requiring revascularisation had better chances of recovering from CLI, but not of longer-term survival or limb salvage compared to those in whom surgery was deemed unnecessary. Antiplatelet drugs caused resolution of CLI and decreased the amputation rate by about 1/3, while the advantage of the test treatment (alprostadil-alpha-cyclodextrine) was confined to CLI resolution only. CONCLUSIONS: this study documents the high mortality and heterogeneity of patients with CLI. It provides stratification criteria for reliably estimating the achievable benefit in routine practice and for clinical trials.

Laminin receptor in lymph node negative breast carcinoma.

BACKGROUND: Expression of 67 kD laminin binding protein, 67LR, is reported to be associated with invasive and metastatic phenotypes in several types of human malignancies. In mammary carcinomas, however, the biologic role of 67LR has been less clear. The authors explored the potential biologic significance of expression of 67LR in 148 patients with axillary lymph node negative breast carcinoma. METHODS: Formalin fixed, paraffin embedded histologic sections were immunohistochemically evaluated for 67LR using monoclonal antibody MLuC5. The staining results were correlated with morphologic data as well as with estrogen receptor content and p53 product accumulation. RESULTS: There were statistically significant correlations between positivity for 67LR and lower histologic grade (P = 0.003), lower nuclear grade (P = 0.002), positivity for estrogen receptor (P = 0.003), and lack of p53 abnormality (P < 0.001). Expression of 67LR had no independent effect on the disease free or overall survival of lymph node negative patients with breast carcinoma. Nevertheless, in the subgroup of 67LR positive patients, positivity for estrogen receptor was associated with significantly longer overall survival (P = 0.008). CONCLUSIONS: The data from this study suggest that tissue expression of 67LR, as detected by antibody MLuC5, is associated with better differentiated, less aggressive forms of axillary lymph node negative breast carcinoma.

Epidemiology of psychiatric care of patients with severe mental disorders in Italy. Rationale and design of a prospective study, and characteristics of the cohort. Italian Collaborative Study Group.

The rationale and design of a large, multicentre, prospective follow-up study on the outcome of severe mental disorders is presented. The study is currently under way in Italy, where psychiatric care has been uniquely characterised since 1978 by the statutory prohibition of admitting patients to psychiatric hospitals. The main purpose of the study is to describe the 5-year outcome of patients with a diagnosis of schizophrenia, paranoid disorder, affective psychosis, reactive psychosis or personality disorder with respect to five areas (clinical condition, personal autonomy, work, and family and social relationships); a secondary objective is to describe the heterogeneity of practices and resources of psychiatric services. The study is being carried out by 76 outpatient psychiatric services throughout the country, covering approximately one-tenth of the Italian population.

[Risk/benefit profile of hormone replacement therapy in postmenopause. From research to practice]. / Il profilo beneficio/rischio della terapia ormonale sostitutiva nella post-menopausa. Dalla ricerca alla pratica.

The menopause has been transformed from a marginal subject to a central event of medical interest. The gap between evidence derived from epidemiological research and clinical practice seems to be wider in post-menopausal area than in other fields. Most of the evidence were obtained from observational epidemiological studies and only in part from randomized clinical trials. Current results suggest that hormonal replacement therapy may represent a useful treatment and probably a preventive tool. Nevertheless, given the side effects and the risks involved, greater attention should be given to the individual choices of the women.

Mental health care in the primary health care setting: a collaborative study in six countries of Central America.

The results of a naturalistic epidemiological study conducted in 6 Central American countries in collaboration with the WHO/PAHO Regional Office are reported, aimed at describing the patients with mental distress presenting to the primary health care setting, the interventions enacted and the evolution of the patients over the 6 months following recruitment. A total of 812 patients were recruited by the personnel of 11 primary health care centres. A high degree of heterogeneity was observed with respect to the patients' characteristics and the patterns of care provided. The factors potentially contributing to the heterogeneity, identified through multivariate analyses, are discussed in detail against the specific background differences between countries and between areas within each country. Interestingly albeit expectedly, besides the differences in health care provision and availability, social needs appear to influence both interventions and outcomes.

Consequences of mental distress recognition in general practice in Italy: a follow-up study. Italian Cooperative Group on Mental Distress in General Practice.

Many reports have been recently published on the accuracy of mental distress detection by general practitioners. Recognition of 'caseness', irrespective of its accuracy, nevertheless determines the implementation of therapeutic interventions. This paper reports the results of a naturalistic study describing the consequences for the patients of being identified as 'cases' in the general practice (in terms of referral strategies at recruitment and outcome 3 months and 1 year later), in the context of care provision generated by the 1978 Italian psychiatric reform. Sixty-eight GPs recruited 878 'cases' according to implicit criteria. Overall 20% of the patients were referred the psychiatric setting; only half of these for psychiatric care. After 3 months and 1 year from recruitment respectively 12% and 23% of the subjects were no longer 'cases'. The factors contributing to predict the outcome at three months were age, symptom duration, comorbidity, presence of social context risk factors and prior psychiatric history (or presence of 'major' symptoms); after one year the predictors of caseness were caseness status at 3 months, and clinical severity, symptom duration and presence of somatization at recruitment. GPs remain the main care providers in the short- and long-term. The results of the study indicate the need for a reappraisal of the emphasis to be put on caseness recognition and on the development of standardized instruments for the identification of mental distress. Non-clinical variables concurring in the definition of caseness in general practice, and the factors influencing physicians' decision-making in the implementation of alternative intervention strategies should be further clarified by ad hoc studies.

Is there still an avoidable fraction of post-operative thromboembolic complications with heparin prophylaxis? The results of a case-control surveillance. Collaborative Group on Heparin Prophylaxis in Surgery (S.E.P.E.C.).

A case-control multicenter study was set up in 68 general and specialistic wards in Italian regional hospitals in order to assess whether underuse of heparin prophylaxis may account for at least a fraction of the thromboembolic events still occurring in surgical patients. 100 cases with clinically relevant thromboembolic or hemorrhagic events occurring during hospitalization for major surgery and 200 controls were identified. Controls were selected among patients not presenting any of the events under study during the same period of observation and were matched with cases for age, sex, and type of surgery. The results of the study suggest that heparin use in routine conditions of care closely reflects the "consensus" knowledge, patients at higher risk (specifically orthopedic surgical patients, those with varicose veins or with preoperative bed rest longer than 3 days) being treated more frequently with heparin. Absence of heparin prophylaxis does not appear to represent a specific risk factor for the occurrence of index events (OR 0.73, 95% CI = 0.42-1.26). Despite the higher rates of heparin exposure, the presence of varicose veins is associated with a statistically significant increase in the risk of postoperative complications (OR 2.23, 95% CI = 1.07-4.65). This study indicates that among known pre- and peri-operative risk factors only varicose veins may be unprotected by the current prophylaxis practice.

Outcome of discharged psychiatric patients after short inpatient treatment: an Italian collaborative study.

This paper presents the results of an Italian multicentre study on the 6-month outcome of psychiatric patients discharged after short-term in-patient treatment from 21 general hospital psychiatric units. Two outcome measures were used: relapses (defined as readmissions for psychiatric treatment or suicide) and community tenure. The data showed, on average, a fairly high relapse rate (43% in 6 months) combined with a good community tenure. The findings are discussed in the light of the heterogeneity in patterns of care provision observed in Italian psychiatric services after the changes introduced by the 1978 Mental Health Act, reported in a previous paper.

Patterns of aftercare for psychiatric patients discharged after short inpatient treatment. An Italian collaborative study.

This is the first of a series of papers presenting the results of an Italian collaborative study on psychiatric inpatient service utilisation. Patterns of care of a large sample of patients discharged after short inpatient treatment are discussed in the light of the changes introduced by the 1978 Mental Health Act in the Italian psychiatric care delivery system. Three closely related issues are considered: a) use of psychiatric hospitalisation, b) relationships between inpatient and community treatment before and after an admission episode, c) continuity of care. The main findings are: 1) great variability between services suggests that local factors play an important role in determining the contents of care in Italian post-reform psychiatry. 2) The relationship between inpatient and community services is complex, partial integration being the most common picture. 3) Psychiatric hospitalisation is the entry point into the care system for a sizeable group of patients. 4) Continuity of care is achieved for half the patients, mostly with diagnoses of severe mental disorders. 5) Subjects with a recent history of revolving door behaviour or a past history of mental hospital admission show the highest likelihood of remaining in community care following discharge.

Randomized clinical trial of transabdominal versus transcervical chorionic villus sampling methods.

The relative advantages and disadvantages of transabdominal (TA) and transcervical (TC) chorionic villus sampling (CVS) in terms of fetal risks and efficacy were evaluated in a clinical trial conducted on 1194 women randomized at 7-12 weeks' gestation. The results of the study indicate that, if any, the relative risk of fetal loss following either procedure is less than double that of the alternative technique when performed by a skilled operator. Overall, the fetal loss rate (spontaneous abortions following randomization, terminations of pregnancy, and perinatal deaths) is 16.5 and 15.5 per cent, respectively, among women allocated to TA- and TC-CVS. The two procedures are equally effective, although TA-CVS is associated with a significantly lower rate of repeat device insertions; on the other hand, a higher weight of chorionic tissue is obtained, on average, with TC-CVS. Bleeding is more common following TC-CVS, while peritoneal reaction developed only after TA-CVS. No diagnostic problems specifically related to one sampling technique were identified.

Transabdominal versus transcervical chorionic villus sampling: a randomized trial.

Chorionic villus sampling (CVS) is still considered to be an applied research method and its safety is under evaluation in randomized trials. Moreover, no knowledge is available about the comparative efficiency and risks of transcervical and transabdominal chorionic villus sampling. A preliminary analysis of the first 639 consecutive cases of an ongoing trial in which cases are randomized between transcervical and transabdominal aspiration techniques shows: (a) an overall sampling success rate of greater than 99% obtained by both techniques; however, the number of repeat insertions of the sampling device was higher for the transcervical route; (b) a significant shift towards lighter tissue samples for the transabdominal route; however, very light specimens, less than 10 mg, were equally distributed in both groups; and (c) approximately 10% of cases underwent a different procedure from the allocated one because of an anatomical or clinical contraindication, with a higher rate of deviation for the transcervical technique.

A survey of diagnostic amniocenteses in Oxford from 1974-1981.

A survey was conducted of the results of mid-trimester diagnostic amniocenteses in the Oxford Region from 1974 to 1981. The survey used data relating to all 4357 singleton pregnancies in which an amniocentesis was performed during this period. Follow-up information on outcome was obtained in respect of 4284 (98 per cent) pregnancies. A cell culture to determine karyotype and an alpha-fetoprotein determination was carried out in all cases. From 1974 to 1981 amniocenteses became increasingly common, rising from 2 to 32 per 1000 births. The most common indication for amniocentesis was a high risk of a chromosome abnormality--56 per cent of all amniocenteses. Within this group advanced maternal age was responsible for 89 per cent of the cases. The next most common indication was a high risk of a neural tube defect (37 per cent of all amniocenteses) --in 1974 a raised maternal serum alpha-fetoprotein level accounted for only 4 per cent of these; by 1981 this had risen to 67 per cent. There were seven false-positive and 132 true-positive diagnoses of neural tube defect; since 1981, with the introduction of amniotic fluid acetylocholinesterase determination as a secondary diagnostic test for neural tube defects, there have been no further false-positive diagnoses. In 1981 76 per cent of women aged 35 years or more did not have an amniocentesis. It is not known to what extent this was due to not offering women in this age group amniocentesis or to women not accepting such an offer.