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Biomedical subjects

A Liberati

Publications and source records attributed to A Liberati.

At least 73 records · Page 4Linked to original sources
PubMed1994

[Comorbidity and the physician's decision: the case of undertreatment in care of breast tumors].

When a physician has to come to a decision while caring for a given patient, he is supposed to take into account several kind of information related to the disease, illness or patients' personal characteristics. Although it is wellknown that the framework in which such decision has to be taken is complex, most of the scientific knowledge is based on pieces of evidence that derive from studies where complexity is avoided by applying restriction rules. The goal of this approach is to enhance the internal validity while preserving the generalizability of the findings. But in some cases this approach raises more doubts than certainty. It is the case of the process to assemble practice guidelines to reduce the gap between the best care and what is observed into practice using the available knowledge (i.e., available literature or experts' recommendations). As a variety of relevant clinical and patients' personal characteristics are not available at all or little is known on their impact on patients global health status, variables that actually do drive the practice are not included in guidelines that are intended to change it. This paper introduces the conceptual model of such debate and assesses the impact of co-morbidity--a variable seldom taken into account in effectiveness, quality and appropriateness studies- on the kind of medical care given to a sample of 1019 patients with early stage breast cancer. Empirical results and future implications are eventually discussed.

Adult↗
PubMed1993

Is proper methodology associated with the use of a clinically relevant outcome measure? The case of randomized clinical trials on medical treatment of open-angle glaucoma.

OBJECTIVE: The aim of this study was to assess critically the published literature concerning medical treatment of primary open-angle glaucoma (POAG), and to see whether trial methodologic quality was related to a clinically relevant outcome measure. METHODS: We identified and reviewed the methodologic quality of 102 published randomized clinical trials (RCTs) on treatment of POAG using an explicit protocol and explored the association between selected aspects of design and conduct and the studies' clinical relevance. RESULTS: Our analysis revealed serious methodologic problems with the trials reviewed. Areas of major concern were: use of unsatisfactory or unspecified methods of randomization (89% of the trials reported no information), exclusion of some patients from the analysis (53% of the studies), failure to provide evidence of having estimated the number of patients needed to detect a prespecified treatment difference (96% failed to provide such an estimate), and incomplete description of patient characteristics (in 39% of the RCTs information on this item was insufficient). Within this generally unsatisfactory picture we found, however, that those studies adopting a double-masked design and those not excluding patients after randomization followed patients for longer periods of time and assessed treatment effectiveness using a clinically relevant outcome (that is, visual field changes) compared to other studies. CONCLUSIONS: For clinicians to make use of the results of clinical trials, future studies must be adequately designed and conducted. In particular, proper method of randomization, masking of the observers, and inclusion of all randomized patients in the analysis must be used. Of perhaps even greater importance is the need for trials to measure clinically relevant outcomes.

Clinical Protocols↗
PubMed1993

Randomized clinical trials on medical treatment of glaucoma. Are they appropriate to guide clinical practice?

A systematic quantitative and qualitative overview of published randomized clinical trials was undertaken to assess the yield of medical treatment on the outcome of patients with primary open angle glaucoma. Reports of 102 randomized clinical trials were published between 1975 and 1991, totalling about 5000 patients. Only 16% (16/102) of the trials were, however, properly designed (ie, comparing an active treatment with a placebo-treated or untreated control group) to answer the question of whether any medical treatment can effectively cure patients with primary open angle glaucoma. Pooled analysis showed a moderate yet statistically significant reduction in mean intraocular pressure (-4.9 mm Hg; 95% confidence interval [CI], -7.3 to -2.5 mm Hg); however, data on long-term visual field changes were available in only three randomized clinical trials, and their statistical combination failed to show a significant protective effect of active treatment (odds ratio, 0.75; 95% CI, 0.42 to 1.35). All of the remaining 86 randomized clinical trials looked at the effectiveness of one drug vs another in lowering intraocular pressure and were thus of no use in the overview. Practicing ophthalmologists should be aware that the effectiveness of pressure-lowering agents in the treatment of primary open angle glaucoma is still to be determined and that the vast majority of published trials are not appropriate to guide clinical practice. It is urgent to plan trials with end-point and follow-up duration that is fully relevant for the health of patients.

Clinical Protocols↗
PubMed1993

Interferon treatment in patients with chronic hepatitis B: a meta-analysis of the published literature.

The randomised clinical trials testing the effectiveness of interferon treatment on Chronic Hepatitis B patients were reviewed by means of meta-analysis. Twenty-two trials, published between 1987 and 1990, have identified where 1290 adult patients had been studied. Overall, interferon increased the rates of serum HBV-DNA clearance and amino-transferases normalization about 3 times at one year. However, when an analysis of internal consistency, clinical relevance and methodology of these studies was made, the trials were not sufficient to confirm the clinical effectiveness of the treatment since they had been planned for short-term assessment based on biochemical and viral end points alone. The link of these end points to other outcomes of more obvious clinical relevance (i.e. evolution to cirrhosis or deterioration of cirrhosis, death) is, in fact, questionable and thus the value of a meta-analysis based on currently available trials is uncertain as a source for practical guidelines. We conclude that the effectiveness of interferon in patients with chronic hepatitis B has yet to be confirmed by long-term prospective studies which assess the outcome by clinically meaningful end points such as cirrhosis, liver failure, or death.

Adolescent↗
PubMed1993

The influence of patient characteristics on the appropriateness of surgical treatment for breast cancer patients. Progetto Oncologia Femminile.

BACKGROUND: Within the framework of a multi-annual educational intervention sponsored by the Ministry of Health and regional health authorities, patterns of the care delivered to breast cancer patients in Italian general hospitals were monitored in order to identify areas of practice whose quality was in need of improvement. DESIGN: Information on the diagnostic and therapeutic procedures in 63 general hospitals in eight Italian regions performed in 1724 consecutive breast cancer patients were retrospectively gathered from medical records. Quality of care was assessed by a diagnostic and therapeutic score based on the observed degree of compliance with previously established courses of action. RESULTS: The median value of the overall diagnostic and staging score was 60%. About one-third of surgical operations (38%) were inappropriate: one-fourth (24%) of patients with stage I-II disease had unnecessarily radical surgery (i.e., Halsted mastectomy), and limited surgery in patients with small tumors (i.e., < or = 2 cm) was under utilized. Chronological age influenced physicians' behaviour: elderly patients were more likely to have a less intensive diagnostic work-up and less appropriate surgical treatment (with more frequent performance of an unnecessary radical operation and a less frequent utilization of limited surgery), independently of their overall health status. The presence of one or more co-existent diseases was associated with a failure to undergo axillary clearance and with a lower utilization of conservative surgery independently of age. CONCLUSION: In accord with others, this study confirms the existence of a clinically important effect of patient age on diagnostic and therapeutic behaviour and the use of unnecessarily radical surgery procedures. The paper discusses the implications of these findings for the next stage of the educational project, in which practice guidelines will be developed and implemented to improve the quality of care for breast cancer patients.

Adenocarcinoma↗
PubMed1993

Inappropriate Halsted mastectomy and patient volume in Italian hospitals.

To study whether Halsted mastectomy was used only when properly indicated, a prospective survey was undertaken on the process of care of 985 breast cancer patients seen consecutively at 62 general hospitals in Northern and Central Italy. Overall, 79% of Halsted mastectomies were performed inappropriately. The procedure was less likely to be performed on more educated patients and, other factors considered, on those seen at hospitals with larger volume. We conclude that the measurement of utilization of a surgical procedure for which only a few appropriate indications exist may help identify important relationships between hospital characteristics and quality of surgical care.

Adult↗
PubMed1993

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.

Breast Neoplasms↗
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

The social and vocational outcome of spinal cord injury patients.

Functional status, perception of adjustment, occupational outcome and social functioning were investigated in a group of spinal cord injury (SCI) patients (mean age 34, range 10-74 years) seen at a specialised spinal unit over the period January 1984-December 1988. Functional status was assessed using a standardised scale measuring patients' performance of specific tasks, and other measures of outcome were investigated by a structured interview. Almost two thirds (68%) of the patients were independent according to the standardised scale (33% quadriplegic and 84% paraplegic). Patients' autonomy appeared to be threatened by architectural barriers in and about the house: approximately one third (34%) of those classified as 'independent' on the standardised rehabilitation scale used needed some help in their everyday life. A negative occupational outcome emerged: compared to the pre-morbid situation, 43 patients (44%) were worse off; 48 (49%) did not experience substantial changes--though it must be noted that 68% of these (33/48) were virtually unemployed (ie student, home maker, retired, unemployed) before the injury; and for 6 (7%) some improvement took place. With a multivariate analysis age was the only statistically significant predictor of poor occupational outcome, with older patients being worse off irrespective of the extent of disease and functional autonomy. The paper discusses these results and stresses the need for integrating results based on the use of standardised rehabilitation scales with the analysis of potential barriers influencing a patient's ability to exploit his/her autonomy.

Activities of Daily Living↗
PubMed1991

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.

Aged↗