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Biomedical subjects

A Nicolucci

Publications and source records attributed to A Nicolucci.

At least 55 records · Page 3Linked to original sources
PubMed1993

Survival after PBSC transplantation and comparison of engraftment speed with autologous and allogeneic marrow transplantation: results of a multicenter study.

We have analyzed the results of a multicenter study on peripheral blood stem cell transplantation (PBSCT) performed on 55 patients suffering from various neoplastic diseases. After myeloablative therapy, they received a median of 6.8 x 10(8)/kg MNC and 11.4 x 10(4)/kg CFU-GM harvested by a median of 9 apheresis after mobilization with chemotherapy alone. As of date, 34 of the 55 patients are alive and 28 of them are in continuous complete remission after a follow-up of 30 months. The probability of survival was related to the disease status at transplant, CR/PR vs. PD (p = 0.0001) and the bone marrow involvement, BM-vs. BM+ (P = 0.009). Furthermore, a comparative study on speed of engraftment and clinical management was conducted on the 55 PBSCT patients as well as on 41 autoBMT and 52 alloBMT patients. Days to reach WBC > 1.0 x 10(9)/L, PMN > 0.5 x 10(9)/L and PLT > 50 x 10(9)/L was 12/14/33 for PBSCT, 17/20/23 for ABMT and 15/16.5/18 for BMT, respectively. Days with fever > 38 degrees C, systemic antibiotic therapy and length of hospitalization was 3/12/36 for PBSCT, 5/18.5/42 for ABMT and 9/25/46 for BMT respectively.

Bone Marrow Transplantation↗
PubMed1993

[The adjuvant treatment of operable breast carcinoma. The current status and outlook].

Breast cancer represents one of the most frequent neoplasm: every year, in Italy, 25,000 new cases are diagnosed with more than 9,000 deaths. In Italy--and also in other countries--has been shown a broad variability in the use of diagnostic or therapeutic procedures caused by different hospitals' characteristics, patients' conditions and physicians' opinions. Among the different therapeutic options, post-surgical therapy, that extends the disease-free interval and survival, fills an important position in the cure of breast cancer in relation to the overview published on Lancet the 4th and the 11th January 1992. According to this overview, patients who had surgery for breast cancer benefitted by an adjuvant therapy--hormonal or cytotoxic--with a reduction of mortality between 15 and 20%. That means, in Italy, a reduction of one thousand deaths per year for this neoplasm. Particularly the effectiveness of hormonal treatment in postmenopausal patients (not only in the oestrogen receptor (ER) positive but in the ER poor too), of ovarian ablation and chemotherapy in premenopausal patients was confirmed. In node negative patients the present overview recommends the adjuvant treatment for the risk reduction in recurrence and mortality. Nevertheless important research implications persist about treatment and a better definition of high risk patients; therefore more patient should be included in the randomized clinical trial.

Adult↗
PubMed1992

Staging of cervical cancer: reliability of transrectal US.

One hundred twenty-four patients with invasive carcinoma of the cervix were examined with transrectal ultrasound (TRUS) before treatment. Since surgery preceded any other kind of therapy, sonographic findings could be compared with the surgical pathologic stage. The accuracy of staging with TRUS was 83%, compared with an accuracy of 78% for clinical staging performed according to the criteria of the International Federation of Gynecology and Obstetrics (FIGO). For extent of parametrial involvement, the sensitivity of TRUS evaluation was 78%, with a specificity of 89% and a diagnostic accuracy of 87%. The same reliability parameters for clinical evaluation were 52%, 92%, and 84%, respectively. From these data and from analysis of the cases--in which a discrepancy between clinical and TRUS staging was observed--it can be concluded that TRUS could be usefully applied to routine pretreatment evaluation of patients with cervical carcinoma.

Adult↗
PubMed1991

The impact of patient management guidelines on the care of breast, colorectal, and ovarian cancer patients in Italy.

The impact of a national education program based on the dissemination of written guidelines for the treatment of breast, colorectal, and ovarian cancer was investigated in Italy. Through a survey of 770 physicians exploring their knowledge and attitudes and a review of medical records of 1,483 patients assessing current clinical practice, this study examined whether 1) the guidelines reached the target population of physicians, 2) they were effective in shaping doctors' opinions, and 3) care patterns conformed with the guidelines. Overall, the net effect of the intervention appeared to be limited in terms of actual diffusion, attributable influence, and impact. As for diffusion, only 60%, 47%, and 44% of doctors were aware of breast, colorectal, and ovarian cancer guidelines, respectively. Although doctors who were aware of the guidelines had more appropriate opinions than those who were not, overall agreement with recommendations was often unsatisfactory. With reference to guidelines recommendations, quality of care was far from optimal, especially in relation to diagnosis and staging. Marked variations in compliance with recommendations emerged with values ranging from 37% to 89%, from 48% to 82%, and from 10% to 97% for breast, colorectal, and ovarian cancer, respectively, and this held true even in hospitals where the larger awareness of the guidelines might have been expected to result in better quality care. It was concluded that any thorough assessment of the impact of educational interventions should include a careful analysis of the strategy and process of dissemination. The availability of clinically relevant messages must also be realistically considered before deciding whether the "guidelines approach" is the strategy most likely to succeed.

Adult↗
PubMed1991

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.

Adult↗
PubMed1990

The impact of cancer treatment guidelines on actual practice in Italian general hospitals: the case of ovarian cancer.

Over the past ten years the Italian National Research Council (C.N.R.) has carried out an educational program based on the preparation and dissemination of guidelines to facilitate delivery in community hospitals of the most up-to-date care to patients with ovarian cancer. In 1988 an assessment was begun to determine (a) whether the guidelines reached the target physician population; (b) whether they were accepted by those they reached, and (c) whether treatment patterns thereafter conformed to the guidelines. Overall results of this evaluation provide no evidence of clinically relevant effects of the program. The guidelines were not widely disseminated: only 44% of responders were aware of them. Moreover, analysis of practice patterns showed serious deficiencies in diagnostic procedure and surgical staging (information on grading and residual tumour was available only in 30% and 45% of cases, respectively, and only 10% of the patients had random biopsies as part of their surgical staging). The only observation supporting some effect of this educational intervention in terms of knowledge modification was of certain therapeutic preferences among those aware of the guidelines. This finding, however, is highly susceptible to confounding by other factors (e.g. physicians' greater expertise, spillover effect of the program) not entirely avoidable in an observational study. We conclude that any assessment of procedures based on dissemination of information must include a careful analysis of the method of dissemination. The availability of clinically applicable information must also be realistically appraised before the guidelines approach can be accepted as the most effective.

Adult↗
PubMed1990

[Impact of the National Task Force on the quality of assistance to neoplasm patients: results and implications of a study on implementation of educational intervention].

Over the last ten years the Italian National Research Council (CNR) has launched an educational program aimed at facilitating the delivery of the most up to date care to cancer patients in community hospitals. Management guidelines were developed for breast, colo-rectal and ovarian cancer by multidisciplinary teams of national experts reported in booklets distributed nationwide under the aegis of disease oriented Task Forces. Some of them in addition endorsed other educational activities and sponsored multicenter trials. In 1988, the CNR funded a study to assess the impact of the whole effort. In particular the evaluation program was designed to see whether: a) the guidelines had a large diffusion in the target physicians' population; b) their content was accepted by those exposed to them and, c) practice patterns were consistent with the guidelines' recommendations. The above mentioned end-points were investigated through physicians' surveys and patterns of care studies carried out in a nationwide sample of 45 community hospitals and, on the whole, involving 1874 doctors (response rate was 41%) and 1483 patients with one of the three cancers. Results indicate a very limited impact of the program. Awareness of the guidelines was unsatisfactorily low (65%, 47% and 48% for breast, colo-rectal and ovarian cancer, respectively) and seemed to be more related to individual physicians' interest than to the functioning of the program. Analysis of practice patterns showed serious deficiencies even in centers where a more widespread awareness of the guidelines might have been expected to result in a better quality of care. We conclude that any assessment of interventions based on diffusion of information must include careful analysis of the process of diffusion itself and that the availability of clinically relevant messages must also be realistically considered before deciding whether the "guidelines approach" is the strategy most likely to succeed.

Adult↗
PubMed1989

Quality, evolution, and clinical implications of randomized, controlled trials on the treatment of lung cancer. A lost opportunity for meta-analysis.

A review of 150 published randomized trials on the treatment of lung cancer showed serious methodological drawbacks. Handling of withdrawals (only 7 trials had no dropouts), a priori estimates of sample size (only 9 trials specified the required number of patients), blinding of randomization (only 22 trials had a satisfactory procedure), and information on eligible nonrandomized patients (only 13 studies reported it precisely) were areas of major concern. Although trial quality improved over time both in design/execution (study size estimation and analysis by prognostic factors became more frequent) and reporting (information on patients' characteristics and side effects were more thoroughly reported), their evolution was inconsistent. For non-small-cell lung cancer-despite the persistent lack of proof of efficacy of any active treatment-an untreated control arm was prematurely abandoned and a wide variety of tested regimens prevailed even in better-quality studies. Slightly more promising is the picture for small-cell lung cancer, where research indicates somewhat more reliable-though limited-progress. While clinical research in lung cancer has contributed little to defining the best standard care, we conclude that its heterogeneity makes it unlikely that quantitative meta-analysis of existing trials will be constructive.

Combined Modality Therapy↗
PubMed1989

Is the published literature a reliable guide for deciding between alternative treatments for patients with early cervical cancer?

The quality of the methodology and reporting of studies on the treatment of early cervical cancer published in English and French language over the period 1975-1985 were examined using an explicit, pre-defined protocol aimed at assessing their internal validity and generalizability. One hundred and fifty-two articles reporting results on over 40,000 patients treated with surgery, radiotherapy, or the combination of the two, were examined. The astonishing lack of formal comparative studies together with the poor quality of those actually carried out were the two major findings of our study. More than half of the reviewed papers (54%) were single series studies. Among the remaining 46% only a few formally compared the two treatments (i.e. surgery vs. radiotherapy), the remainder dealing with comparisons of specific surgical or radiotherapeutic techniques. With reference to study quality, the existence of a pre-specified research protocol could not be ascertained in most studies. A description of patients' characteristics and information on the source population were deficient in most papers reviewed; information on the two aspects was in fact satisfactorily reported in only 7% and 47% of the papers, respectively. Finally, the lack of standardization of follow-up methods (i.e. type and modalities) and of information on treatment compliance were two other severe methodological deficiencies. In view of this poor quality and of the intrinsic difficulty of drawing firm scientific conclusions from non-experimental investigations, the reliability of this literature remains highly dubious. Another possible caveat is that what is published is a biased sample of the overall evidence because of the well known tendency of authors to write about and editors to publish positive results more frequently than negative ones.

Clinical Trials as Topic↗
PubMed1989

[Use of a nonionic contrast medium (Omnipaque 350) in hysterosalpingography. A comparison with ionic contrast media].

The comparative adequacy was investigated of a nonionic contrast medium (iohexol) versus the ionic contrast medium usually employed in hysterosalpingography. The contrast radiologic features and the radiodiagnostic possibilities of both cm are definitely good. The nonionic contrast medium diffuses quickly and causes the uterine cavity to expand less than ionic contrast media do, thus allowing a better depiction of mucosal and/or parietal pathology. Moreover, nonionic cm allows tubal patency and peritoneal diffusion to be clearly demonstrated, particularly in uncertain cases. As compared to ionic cm, Iohexol did not cause any side effects, except for a mild discomfort. Our results lead us to suggest the use of nonionic contrast medium as the routine contrast medium in hysterosalpingography.

Adult↗
PubMed1985

[Insulin secretion after a protein and lipid meal in healthy subjects].

Previous studies suggested that insulin requirement in type I diabetics could be split in a "basal" insulin requirement, mainly related to body weight and in a "post-prandial" insulin requirement, mainly related to carbohydrates intake. In the present study we wanted to investigate the occurrence and the magnitude of insulin response to protein only or fat only meals in normal subjects, trying to obtain some evidences for an insulin requirement possibly related to these substrates in diabetic subjects. Fat only meals did not evoke any insulin response while a small but significant increase in plasma insulin was observed after a protein only meal (from 16.6 +/- 2.85 to 25.83 +/- 2.52 microU at 90', p less than 0.05). Blood glucose remained unchanged after fat or protein meals. It is concluded that a small sovrabasal insulin dose would be probably required by diabetic patients after a protein meal: this is however so small that a carbohydrates related insulin dose given before a normal mixed meal would be able to normalize aminoacids as well as glucose metabolism.

Adult↗
PubMed1984

[Administration of semisynthetic human insulin by a spray injector].

The use of Jet injection in insulin administration pointed out the question whether this route could affect insulin absorption and plasma insulin profiles. To compare plasma insulin profiles following an administration of an identical insulin dose by jet injection or by conventional subcutaneous route (syringe with needle) 8 healthy subjects (age 24-28 yrs., non obese) were given at 09.00 h of two different days 200 mU/kg/BW of human semisynthetic regular insulin (Novo Actarapid) alternatively subcutaneously by a syringe with needle or transcutaneously by jet injection (DG 77 - Sicim - Gorizia). Before insulin administration and then 15, 30, 60, 90, 120 and 180 minutes after, blood samples were drawn for plasma insulin and C-peptide determination. Higher plasma insulin levels after administration by jet were found at 15' and 30' minutes (62,58 +/- 6,31 v.s. 36,94 +/- 3,31 microunits/ml at 15' and 76,51 +/- 9,60 v.s. 51,65 +/- 9,95 at 30', p less than 0,01 and p less than 0,005, paired Student t test). No difference could be observed for the other times. C-peptide was found to fall to undetectable values, confirming the nearly total suppression of endogenous insulin production. It is concluded that total regular insulin absorption does not differ after transcutaneous jet injection or administration by syringe with needle, but in the first case it is faster. This last finding should be considered in planning insulin treatment schedules.

Adult↗
PubMedDate not supplied

Risk factors for lower limb complications in diabetic patients. The Italian Study Group for the Implementation of the St. Vincent Declaration.

Diabetic lower extremity complications may be influenced by a number of factors, including those related to the interaction between patients and the health-care system. Our objective is to identify risk factors for the development of lower limb complications, by looking for classical clinical variables and those related to quality of care. A case-control study was carried out between December 1993 and June 1994 by interviewing 348 patients with lower-limb diabetic complications and 1050 controls enrolled from 35 diabetes outpatient clinics and 49 general practitioner's offices in Italy. Among sociodemographic characteristics associated with increased risk of lower limb complications were male gender [odds ratio (OR) = 2.5, confidence interval (CI) 1.6-3.9], age between 50 and 70 years as opposed to younger than 50 (OR = 3.6, CI 2.1-6.3) and being single as opposed to married (OR = 1.4, CI 1.1-1.8). Among clinical variables, treatment with insulin for IDDM and NIDDM patients was an important predictor of lower extremity complications compared to NIDDM patients not being treated with insulin. Cardio-cerebrovascular disease and presence of diabetic neuropathy were associated with a higher risk of being a case (OR = 1.4, CI 1.2-1.8 and OR = 3.0, CI 2.1-4.2, respectively). Patients who needed help to reach the health facility before the onset of the complications and those who did not attend health facilities regularly were more liable to develop complications (OR = 1.5, CI 1.1-2.2 and OR = 2.0, CI 1.3-3.0, respectively). Patients who had never received educational intervention had a threefold risk of being a case as compared to those who received health information regularly. The study identifies factors most likely to be related to adverse outcome and permits to discriminate between avoidable and unavoidable factors.

Adult↗
PubMedDate not supplied

Effect of coexistent diseases on survival of patients undergoing dialysis.

A cohort retrospective study was used to analyze the effect of comorbidity on survival of end-stage renal disease (ESRD) patients undergoing dialysis. The authors analyzed the survival of 255 patients (144 men, 111 women; median age 54 years; range 8-81 years) followed at the District Hemodialysis Unit in Foggia, Italy, over a 15 year period (median follow-up 30 months; range 1-190 months). Two subscales assessing the overall severity of the identified coexistent diseases and overall physical impairment, and a composite four level index of coexistent diseases (ICED) were assembled using information recorded at the time of admission. The Cox proportional hazard model was applied to evaluate the association of various patient characteristics with the probability of death. Mortality risk was associated with patient age (RR = 3.4 for patients aged 42-61; RR = 4.8 for patients older than age 61 compared with patients younger than age 42), initial condition leading to renal failure (RR = 3.1 for diabetes compared with primary renal disease) and ICED (RR = 3.0 for patients with uncontrolled coexistent disease or severe impairment compared with patients with no coexistent disease and no or mild impairment). Gender and type of dialysis were not associated with mortality risk. It was concluded that, as is the case with other chronic conditions, co-morbidity is a powerful independent prognostic factor in determining the mortality of ESRD patients.

Adolescent↗
PubMedDate not supplied

Why do we need outcomes research in end stage renal disease?

Despite effective therapeutic strategies to slow or arrest the progression of chronic renal diseases, the number of patients entering renal replacement programs is increasing, with a dramatic burden in terms of morbidity, mortality and resource consumption. While in the past the attention was mainly devoted to the improvement of dialysis care, it has recently been argued that the timing and quality of care before dialysis is started may significantly affect the prognosis. Problems of transfer of research results, together with differences in physicians' attitudes and beliefs as well as in structural and organisational aspects make pre-end-stage renal disease (ESRD) care extremely heterogeneous. This lack of uniformity in medical practice has stimulated extensive inquiry into the relation between the use of clinical services and their end results--the outcomes. Outcomes research investigates medical effectiveness, meaning how well prevailing treatments work in different clinical practice settings. It is thus an important tool to help patients, providers and purchasers to make sound decisions, based on a deeper knowledge of how different choices affect the patient's life. By using a broad array of outcome measures, this research serves to evaluate the effectiveness of complex health care strategies from the different points of view of patients, providers and purchasers, reconciling their needs. Starting from these premises, initiatives aimed to evaluate the avoidability of ESRD morbidity and mortality are urgently needed. To this purpose, the care delivered to ESRD patients and its impact on clinical variables, quality of life and resource consumption need to be longitudinally monitored. Outcomes research thus represents a unique opportunity to increase our knowledge on pre-ESRD care and to identify those strategies more likely to reduce the unwanted outcomes related to the initiation of dialytic treatment.

Costs and Cost Analysis↗