Biomedical subjects
P Mosconi
Publications and source records attributed to P Mosconi.
Levonorgestrel-releasing intrauterine device versus hysteroscopic endometrial resection in the treatment of dysfunctional uterine bleeding.
OBJECTIVE: To compare the effect of a levonorgestrel-releasing intrauterine device with that of endometrial resection on menstrual bleeding, patient satisfaction, and quality of life in menorrhagic women during 12 months of follow-up. METHODS: Seventy premenopausal women with dysfunctional uterine bleeding were enrolled in a prospective, open, parallel-group, controlled trial. They were randomized to either insertion of an intrauterine system releasing 20 micrograms/day of levonorgestrel (n = 35) or endometrial resection (n = 35). The women were evaluated at baseline, and thereafter, uterine bleeding was assessed monthly with a pictorial blood loss assessment chart. Clinical gynecologic examination was performed bimonthly, and the hematologic variables were measured at 6 and 12 months. On the latter occasion, the women were requested to rate the degree of satisfaction with the effect of their treatment and to complete the Short Form 36 General Health Survey questionnaire. RESULTS: Recurrent menorrhagia was observed at 12 months in four women in the intrauterine device group (including two with partial expulsion of the device) and in three women in the resection group. Compared with baseline values, at 1 year, the pictorial blood loss assessment chart score was reduced by 79% in the former group and by 89% in the latter. Amenorrhea or hypomenorrhea at 12 months was reported by 65% of the women with an intrauterine device compared with 71% who underwent endometrial resection. The degree of satisfaction with treatment was high in both groups, with 29 of 34 (85%) women being satisfied or very satisfied in the intrauterine device group versus 33 of 35 (94%) in the resection group. Health-related quality of life perception was not significantly different in the two treatment groups. CONCLUSION: Somewhat less satisfactory results were obtained with a levonorgestrel-releasing intrauterine system compared with endometrial resection for dysfunctional uterine bleeding at 1 year of follow-up.
Health status assessment and managed care competition: are we on target?
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Truth telling: a cultural or individual choice?
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[Hemorrhages of the upper gastrointestinal tract and nonsteroidal anti-inflammatory drugs: the results of a case-controlled surveillance].
A postmarketing surveillance case-control study was set up and applied in an Italian Hospital network to quantify the risk of upper gastrointestinal bleeding (UGB) and exposure to non steroidal anti-inflammatory drugs (NSAIDs). During the period of study 441 cases of UGB and 1323 controls were recruited. The odds ratios (OR) associated with NSAIDs use were estimated for intake occurring over two different periods of time prior to hospital admission (i.e. during the preceding week and month). A strong association emerged for aspirin intake, both in the week (ORMLR = 11.2; 95% CI 7.8-16.9) and in the month (ORMLR = 6.9; 95% CI 4.6-10.2) preceding hospital admission. [MLR = Multiple logistic regression; CI = Confidence interval]. A significant increase in the risk of UGB and use of diclofenac, phenylpropionic acid derivatives, and indomethacin was also found in the two exposure periods considered, while for piroxicam a significant association was only apparent in the analysis of 1-month exposure. As expected, paracetamol and pyrazolone derivatives were not associated with UGB. This pilot experience has shown the feasibility of setting up a multicenter post-marketing surveillance programme and of establishing a network for drug monitoring within the Italian National Health Service, capable of providing a thorough evaluation of the benefit/risk profile of drugs.
Breast cancer surgery in 30 Italian general hospitals.
The utilization of limited surgery in patients with breast cancer operated between September 1986 and July 1988 was assessed using information collected within a cohort subsequently enrolled in a randomized clinical trial testing the efficacy of post-surgical follow up. Overall 30% had limited surgery, 61% had other more radical procedures and 9% are still undergoing an unnecessary Halsted mastectomy. Several factors were related to the lower likelihood of getting a conservative procedure: geographic distribution, age, level of education, quadrant and nodal state. The paper discusses the implications of these findings in view of the otherwise growing consensus that more radical surgery should be abandoned.
Epidemiology and risk factors of pneumonia in critically ill patients. Intensive Care Unit Group for Infection Control.
Risk factors for pneumonia were analysed in a large population of critically ill patients, collected in two prospective multicentre "pneumonia studies" in Italy. Twenty-three intensive care units were involved and the study time was 150 unit months. Only patients without previous pulmonary infection, with intensive care unit stay greater than or equal to 48 hours and no rapidly irreversible illness at admission were included. The incidence of pneumonia in the 1475 selected patients was 15% (220 cases). 239 patients died in ICU; the mortality rate was significantly higher in patients developing pneumonia (p less than 0.0001); pneumonia was found to be an independent highly significant risk factor for death in critically ill patients (OR = 3.88; p less than 0.0001). Multivariate analysis of seven risk factors for pneumonia showed a significantly higher risk in patients with neuromuscular disease (OR = 3.8, p less than 0.002), impairment of airway reflexes at admission (OR = 2.93, p less than 0.0001), and greater than or equal to 24h respiratory assistance (OR = 3.05, p less than 0.0001). Impairment of airway reflexes at admission to the emergency room or intensive care unit identifies the population who will experience 3/4 of the overall lower respiratory tract infections. Rapid recognition of at-risk patients seems clinically important and may improve awareness programs and preventive approaches.
Disclosure of breast cancer diagnosis: patient and physician reports. GIVIO (Interdisciplinary Group for Cancer Care Evaluation, Italy)
Although there is considerable controversy about what information regarding the diagnosis of cancer is most helpful to patients in meeting their psychological and medical needs, little research exists on what patients who are treated in non-specialized institutions are told about their diagnosis and treatment. We assessed the information that breast cancer patients received about their diagnosis from the perspective of both the patient and the physician, in order to determine whether they agree in their perceptions of communication, and whether the nature of patient-physician communication is associated with patient satisfaction. Questionnaires were completed by 1171 Italian breast cancer patients (representing a 81.5% response rate) and their physicians at the time of surgery for breast cancer. Only a minority of patients (47%) reported having been told that they had cancer. Satisfaction with information was highest among women who had been told the diagnosis. Patient and physician reports of what information was conveyed about the diagnosis differed for over half of patients, with highest satisfaction levels reported when both patient and physician stated that the diagnosis had been conveyed. While comparison of patient and physician reports should not be used to validate either source of information, the degree of patient-physician disagreement found in this research may alert physicians to potential difficulties that can arise in communicating with cancer patients.
The role of attitudes, beliefs, and personal characteristics of Italian physicians in the surgical treatment of early breast cancer.
The influence of Italian physicians' attitudes, beliefs, and personal characteristics on medical decision making is examined in the case of surgical treatment of early breast cancer. Responses to a mail survey of 657 physicians from different specialties were analyzed comparing doctors recommending a radical procedure (9%) to those preferring a conservative procedure for younger patients only (25%), and those considering conservative surgery the treatment of choice regardless of patients' age (66%). The findings suggest that the likelihood of physicians' preferring a conservative procedure is influenced by their specialty and the extent to which they feel that a patient should have a role in the treatment decision more than by differences in the beliefs of treatment outcomes. Only preferences of the small group indicating radical surgery as the sole admissible treatment can be accounted for by ignorance or distrust of results of recent trials. These findings suggest that other than scientific factors guide many doctors in their decision making; they may help to explain why the diffusion of research results into clinical practice is often disappointingly slow.
Psychological outcomes in women with early breast cancer.
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Quality of care of colorectal cancer patients in general hospitals: diffusion and impact of management guidelines.
Over the last ten years the Italian National Research Council (C.N.R.) has launched an educational program aimed at favoring the delivery of the most up to date care for cancer patients in community hospitals. Among various tumors for which this effort was undertaken, management guidelines for colorectal cancer were developed in 1978 by a multidisciplinary team of national experts and reported in booklets distributed nationwide under the aegis of the Colorectal Cancer Task Force. In 1988, the C.N.R. funded an evaluation to learn whether: a) the guidelines were widely diffused in the target physician populations; b) their content was accepted by those who received them and, c) practice patterns were consistent with the recommendations in the guidelines. Overall results indicate only a limited effect. Despite clear evidence of a positive self-selection in the physicians' survey, guidelines were familiar to only 47% of responders. Although acceptance of at least some specific recommendations was good among doctors aware of the guidelines (greater than or equal to 60% responders), this finding loses relevance since a not negligible proportion of those not aware of them had the same convictions. Finally, analysis of practice patterns showed serious deficiencies (mostly in terms of thoroughness of operative staging) even in centers where more widespread knowledge of the guidelines should have led to better quality of care. The paper also discusses the comparability of our findings to results of a similar evaluation carried out in the U.S.A. Our results underscore the importance of analyzing the process of diffusion in any assessment of interventions based on knowledge dissemination.
Trends in patterns of care for breast cancer in Italy (1979-1987).
We reviewed care delivered to about 2,500 breast cancer patients in general hospitals over the period 1979-1987 using data from three surveys. The most important and consistent failure was in diagnostic timeliness: about one out of four patients was diagnosed six or more months after the first symptom leading to an almost doubled probability of being diagnosed with more advanced disease. Acceptance of treatment recommendations seemed less satisfactory for surgery than for adjuvant treatments. Conservative surgery still appeared to have limited acceptance for patients with small primary tumor (21 and 23% in 1983 and 1987, respectively) although, starting 1983, there was a shift from the Halsted to the Patey type of radical mastectomy. Follow-up was routine in most node-negative patients and adjuvant chemotherapy was already well established treatment for most pre-menopausal node-positive women (64, 79 and 76% in 1979, 1983 and 1987, respectively). Some form of adjuvant treatment in post-menopausal node-positive women was already present in 1983 but became more widespread in 1987 (82%): this being mostly accounted for by the increase in the use of tamoxifen (delivered alone or in combination with chemotherapy to 53% of women). Overall, our results suggest that areas of care more dependent on organization or doctors' and patients' education (i.e. diagnostic timeliness and accessibility) are those where deficiencies seen to be least amenable to change in the absence of concerted intervention. Among more narrowly defined clinical issues, there appeared to be some dissonance between the rapid acceptance of adjuvant treatments and the still slow pace of acceptance of less aggressive procedures by surgeons.
Prevention of pneumonia in an intensive care unit: a randomized multicenter clinical trial. Intensive Care Unit Group of Infection Control.
In a randomized multicenter clinical trial on antibiotic prophylaxis, 1,319 patients in 23 ICUs were enrolled over a 4-month period. The end-point of the study was the prevention of early onset pneumonia (EOP), defined as acquired pneumonia diagnosed within 4 days of ICU admission; this accounted for greater than 50% of overall pneumonia. Patients eligible for the study were divided into three groups which received either cefoxitin (2 g iv for three doses/8 h), penicillin G (2 million U iv for four doses/6 h), or no antibiotic (control group). In the overall population, the incidence of EOP was 6.1% in the prophylaxis recipients vs. 7.2% in the control group (a 15.3% reduction). No statistically different rates of pneumonia or death were found among the groups. Patients with impaired reflexes on admission or prolonged ventilatory support were noted to have a lower incidence of EOP and an improved outcome when treated with cefoxitin.
Long-term respiratory support and risk of pneumonia in critically ill patients. Intensive Care Unit Group of Infection Control.
In 724 critically ill patients who had received prolonged (greater than 24 h) ventilatory assistance since admission to the ward, we analyzed the relationship between artificial ventilatory support and pulmonary infection. Two different approaches were used. The first, plotting the incidence of pneumonia versus the duration of ventilatory support, confirms previous data: the incidence rises from 5% in patients receiving one day of respiratory assistance to 68.8% in patients receiving more than 30 days. In the second approach, the same data were computed as an actuarial life table with the day of pneumonia onset as terminal event. This different approach, focusing on the onset of infection rather than on incidence, allows a new insight into the problem of nosocomial infection: pneumonia in patients with respiratory support is an early occurrence with a high and constant rate of acquisition and, therefore, a high risk of infection in the first eight to ten days. Later pneumonia acquisitions were rare, and the risk after ten days of ventilatory support is low.
Early onset pneumonia: a multicenter study in intensive care units.
A prospective multicenter study concerning the incidence, onset time, risk factors and mortality of pneumonia was carried out by the Intensive Care Units Collaborative Group for Infection Control in Lombardy, Northern Italy. Out of 1304 patients admitted over 3 months in 16 intensive care units (ICUs), 441 met the criteria for the protocol (no previous pulmonary infection or irreversible terminal illness, ICU stay greater than 48 h). The incidence of acquired pneumonia was 21.3% (94/441), with 54.2% of cases diagnosed within 4 days of admission (early onset pneumonia). Impairment of airway reflexes on admission and more than 24 h respiratory assistance were shown as significant risk factors (RR) for early onset pneumonia (respectively RR = 12.4, with 95% confidence interval (CI) = 5.3-28.9 and RR = 3.3, with 95% CI = 1.8-5.9). A suggested pathogenetic mechanism is aspiration of oropharyngeal contents at the onset of acute illness, due to depression of protective reflexes with delayed clearance of bacterial contamination. No protection was offered by routinely applied prophylactic antibiotic therapy.
Pharmacokinetics of aztreonam in critical patients.
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Is pneumonia developing in patients in intensive care always a typical "nosocomial" infection?
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Local tolerance evaluation of intramuscular drug preparations.
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