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Biomedical subjects

A Liberati

Publications and source records attributed to A Liberati.

At least 55 records · Page 3Linked to original sources
PubMed1997

Treatment of hepatocellular carcinoma: a systematic review of randomized controlled trials.

BACKGROUND: Hepatocellular carcinoma (HCC) is a leading cause of cancer-related death. Many treatments have been proposed but considerable uncertainty still remains about their effectiveness. In this review we evaluated the quality, clinical coherence, consistency and results of Randomized Controlled Trials (RCT) of non-surgical treatments for HCC. METHODS: Thirty-seven RCTs examining the effect of different treatments were retrieved using MEDLINE (November 1978 to December 1995) and a review of reference lists. Selected aspects of the quality of design, conduct and reporting were examined. The odds ratio for the probability of surviving up to one year was calculated according to the Mantel Haenszel Peto method and displayed using l'Abbe plots. RESULTS: The 37 RCTs overall included 2803 patients (median 56, range 20-289). Patients prognosis varied widely across studies which also failed to report on important information about their characteristics. Only 10 RCTs had an untreated control group; the remaining 27 compared different regimens of intravenous or intraarterial chemotherapy with or without embolization of hepatic artery, hormono- and immunotherapy regimens. Some evidence of a moderate benefit emerged only from RCTs using tamoxifen and transcatheter arterial embolization vs. no treatment in unresectable patients: pooled odds ratio for 1-year survival were, respectively, 2.0 (95% confidence intervals (CI) 1.1-3.6) and 2.0 (95% CI 1.1-3.6). At 2 years, however, pooled odds ratio were no longer statistically significant for tamoxifen 1.2 (95% CI 0.6-2.6) but was significant for embolization 2.3 (95% CI 1.2-4.6). No evidence of efficacy was detected for embolization as adjuvant therapy in resected or transplanted patients nor for chemotherapy added to intraarterial embolization. CONCLUSIONS: This systematic review of RCTs on HCC, mostly in non resectable patients, indicate that the non-surgical current treatments are ineffective or minimally and uncertainly effective. The three treatment modalities minimally and uncertainly effective (i.e., embolization, tamoxifen and IFN) can deserve further assessment by larger and methodologically more sound randomized trials.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1997

[Appropriateness of indicating aortocoronary bypass and coronary angioplasty: results of an observational prospective study in the Lombardy region. Gruppo Interdisciplinare Valutazione Appropriatezza Rivascolarizzazione Coronarica].

OBJECTIVE: Most studies on the appropriateness of cardiac revascularization procedures have been aimed at detecting "overuse" (ie when patients get a procedure without a clear indication), while little attention has been paid yet to "underuse" (when patients who could benefit from a procedure do not get it). This study was planned to assess the extent of over- and underuse of revascularization procedures in northern Italy. METHODS: A multidisciplinary panel of experts convened by the Italian Association of Hospital Cardiologists (ANMCO) rated the appropriateness of 898 "theoretical indications" for coronary artery by-pass grafting (CABG) and percutaneous transluminal angioplasty (PTCA) using the RAND Corporation methodology. Standardized information has been collected on a consecutive sample of patients in the Lombardy region and identified during performance of a coronary angiogram at one of the services belonging to the GISE (Gruppo Italiano Studi Emodinamica) network. Out of the 2718 consecutive patients undergoing a coronary angiogram during the recruitment period (February-May 1995), a total of 1821 (70%) were eligible for the appropriateness study. RESULTS: Indication for CABG were appropriate in 565 (80%) patients, uncertain in 111 (16%) and inappropriate in 25 (4%). Corresponding values for PTCA were: 40% (n = 262), 46% (n = 300) and 14% (n = 90). Among the 394 to whom a medical therapy was recommended after angiography, the indication was considered appropriated in only 14% (n = 57) and uncertain for 30% (n = 117). For the remaining 220, the indication was considered inappropriate, suggesting that according to the panel criteria, 56% of the patients should have received a revascularization procedure (either a CABG or PTCA) instead. CONCLUSIONS: These results suggest that underuse of revascularization procedures represents a substantial health care problem in Lombardy region, at least with reference to the period covered by this study. The study in itself does not make it possible to understand whether these results reflect a structural shortage of services (limited accessibility and/or unprioritized waiting lists) or a more general quality-of-care problem. The study protocol now foresees a follow-up for 9 months after the index angiogram to assess the eventual utilization pattern of CABG/PTCA.

Angioplasty, Balloon, Coronary↗
PubMed1996

Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews.

BACKGROUND: Lately, the number of systematic reviews published has increased substantially. Many systematic reviews exclude trials published in languages other than English. However, there is little empirical evidence to support this action. We looked for differences in the completeness of reporting between trials published in other languages and those published in English, to see whether the exclusion of trials published in other languages is justified. METHODS: We compared completeness of reporting, design characteristics, and analytical approaches of 133 randomised controlled trials (RCTs) published in English between 1989 and 1994 and 96 published in French, German, Italian, or Spanish during the same time. RCTs were identified by hand searching of journals (seven in English and six in the other languages). FINDINGS: We found no significant differences between trials published in English and other-language trials for any single item in the completeness of reporting scale (randomisation, double-blinding, withdrawals), or for the overall score (percentage of maximum possible score 51.0% for trials in English, 46.2% for trials in other languages; 95% CI for difference -1.1 to 10.5). Other-language trials were more likely than English-language trials to have adult participants, to use two or more interventions, and to compare two or more active treatments without an untreated control group. Trials in other languages were less likely to report a clearly prespecified primary outcome or any rationale for sample size estimation. INTERPRETATION: These results provide evidence for inclusion of all trial reports, irrespective of the language in which they are published, in systematic reviews. Their inclusion is likely to increase precision and may reduce systematic errors. We hope that our findings will prove useful to those developing guidelines and policies for the conduct of reporting of systematic reviews.

Adult↗
PubMed1996

A meta-analysis of trials on aldose reductase inhibitors in diabetic peripheral neuropathy. The Italian Study Group. The St. Vincent Declaration.

Peripheral neuropathy is one of the most common and disabling long-term sequelae of diabetes mellitus. Aldose reductase inhibitors (ARIs) have been proposed and are increasingly used in many countries for the prevention and treatment of diabetic neuropathy. The aim of this study was to review existing evidence on the effectiveness of ARIs in the treatment of peripheral diabetic neuropathy, with particular reference to the type and clinical relevance of the end point used and to the consistency of results across studies. Thirteen randomized clinical trials (RTCs) comparing ARIs with placebo, published between 1981 and 1993 were included in the meta-analysis. Nerve conduction velocity (NCV) was the only end point reported in all trials. Treatment effect was thus evaluated in terms of NCV mean difference in four different nerves: median motor, median sensory, peroneal motor, and sural sensory. A statistically significant reduction in decline of median motor NCV was present in the treated group as compared to the control group (mean 0.91 ms-1; 95% CI 0.41-1.42 ms-1). For peroneal motor, median sensory, and sural sensory nerves results did not show any clear benefit for patients treated with ARIs. When the analysis was limited to trials with at least 1-year treatment duration, a significant effect was present for peroneal motor NCV (mean 1.24 ms-1; 95% CI 0.32-2.15 ms-1) and a benefit of borderline statistical significance was also present for median motor NCV (mean 0.69 ms-1; 95% CI-0.07-1.45 ms-1). A heterogeneous picture emerged when looking at the results of different studies and serious inconsistencies were also present in the direction of treatment effects among nerves in the same studies. Although the results of 1-year treatment on motor NCV seem encouraging, the uncertainty about the reliability of the end-point employed and the short treatment duration do not allow any clear conclusion about the efficacy of ARIs in the treatment of peripheral diabetic neuropathy.

Aldehyde Reductase↗
PubMed1996

Physicians' view of practice guidelines. A survey of Italian physicians.

After more than 10 years of development, two different views of practice guidelines are emerging: either as an educational tool for the medical profession, or as a forum where health care issues can be debated by physicians and non-medical groups. Physicians use practice guidelines in the former model to set their own standards of good quality care, while the latter approach needs contributions from other components in order to decide what should be provided by our health care systems. In a survey of Italian physicians' opinions and attitudes toward practice guidelines, responders supported the "narrowest" model. More than 80% stated that improvement of quality of care and reduction of variation in clinical and practice styles should be the aim of practice guidelines, without representatives from outside the medical profession being involved (61%, 79% and 86% disagreed with a possible involvement, respectively, of patients, health care administrators and representatives of the public at large). Overall, 38% of physicians had a positive attitude toward guidelines viewed as a quality assurance tool for the medical profession. Overall, physicians seem to ignore that the need to rationalize health care calls for input from other professions and members of society. Indeed, most of the issues facing medicine today are mainly a matter of how much value our societies attach to the benefit expected from the available health services. The answers as to what should be done in health care probably cannot be left to the medical profession alone.

Adult↗
PubMed1996

Beware of surrogate outcome measures.

Surrogate outcome measures may speed up clinical research if they can be measured earlier in a study than the primary outcome of interest. We review the justification for their use and conclude that reliance on them may be harmful. Results obtained with surrogates should therefore be regarded as preliminary. Large, definitive trials with clinically relevant outcomes should always be performed before new interventions are accepted.

Data Interpretation, Statistical↗
PubMed1995

Benefits and costs of screening and treatment for early breast cancer. Development of a basic benefit package.

OBJECTIVE: To develop a basic benefit package for detection and treatment of early breast cancer by evaluating the effectiveness and costs for screening mammography, primary surgery, adjuvant therapy, and follow-up care. DATA SOURCES: Published articles were retrieved through MEDLINE; additional articles were obtained through searches of their bibliographies. Cancer statistics were taken from Surveillance, Epidemiology, and End Results (SEER) Program data, population statistics were taken from US Census data, and charges from 1993 Southern California Medicare fees were used to represent costs. STUDY SELECTION: Studies were selected on the basis of their design. Preference, in decreasing order, was given to meta-analyses of randomized trials, individual randomized clinical trials, prospective cohort studies, retrospective cohort studies, and case series. DATA EXTRACTION: Studies were examined for the effect of the intervention on overall survival, disease-free survival, and health-related quality of life. We evaluated effects on survival in terms of number of lives saved at 10 years and average years of life saved. Costs were related to the benefits observed and modeled onto a hypothetical health care organization of 500,000 lives. RESULTS: Based on this analysis, we recommend a basic benefit plan for the detection and treatment of early breast cancer that would include the following: (1) screening mammography only for women aged 50 to 69 years; (2) choice of mastectomy or breast-conserving surgery with radiation therapy for all women with early breast cancer; (3) adjuvant therapy for all women at risk of recurrence; and (4) only clinical follow-up without routine testing for metastatic disease. CONCLUSIONS: By choosing which services they provide to specific groups of patients, providers can substantially reduce their expenses and still provide quality health benefits.

Adult↗
PubMed1995

"Meta-analysis: statistical alchemy for the 21st century": discussion. A plea for a more balanced view of meta-analysis and systematic overviews of the effect of health care interventions.

The paper discusses some of the most common criticisms to meta-analysis presented by Professor Feinstein in this Conference. As many of the points raised in his contributions are not new, a critique to them is presented in the context of the type of contribution given by systematic reviews (meta-analysis) to the analysis of the effects of health care interventions. After discussing some terminological issues, the paper challenges Feinsteins' arguments indicating that meta-analysis is inherently faulted on four grounds: (a) reproducibility, (b) precision, (c) suitable extrapolation, (d) fair comparison. Each point is discussed providing examples drawn from the published literature with a view to indicate that--despite their current limitations--systematic reviews are a necessary step to synthesize information, orient clinical research and help produce practice guidelines.

Bias↗
PubMed1995

The GIVIO trial on the impact of follow-up care on survival and quality of life in breast cancer patients. Interdisciplinary Group for Cancer Care Evaluation.

BACKGROUND: The aim of the study was to prospectively assess the impact on survival and health-related quality of life of two different follow-up policies in patients with early breast cancer. PATIENTS AND METHODS: A consecutive sample of 1320 women with stage I, II and III unilateral primary breast cancer, aged up to 70 years, were randomly assigned to an intensive surveillance which included physician visits, and performance of bone scans, liver sonograms, chest X-rays and laboratory tests at predefined intervals (655 patients) or to a control regimen (665 patients) in which patients were seen by their doctors at the same frequency but only clinically motivated tests were performed. Both groups received a yearly mammogram aimed at detecting contralateral breast cancer. The primary end-points were overall survival and health-related quality of life. RESULTS: Compliance to the two follow-up policies was over 80%. After a median follow-up of 71 months, no difference was apparent in overall survival with 132 (20%) and 122 (18%) deaths in the intensive and control group, respectively. No significant differences were apparent in time to detection of recurrence between the two groups. Measurements of health-related quality of life (i.e., overall health and quality of life perception, emotional well-being, body image, social functioning, symptoms and satisfaction with care) at 6, 12, 24 and 60 months of follow-up did not differ according to regimen. CONCLUSIONS: Results of this trial support the view that a policy of frequent laboratory and X-ray tests and procedures after primary treatment for breast cancer does not improve survival nor influence health-related quality of life. Routine use of these tests should be discouraged.

Aged↗
PubMed1995

A European project assessing the appropriateness of hospital utilization: background, objectives and preliminary results. The Project Steering Group and the Coordinating Center.

This paper presents the background, objectives and preliminary results of a coordinated European Project involving researchers in seven countries aimed at harmonizing methods to assess inappropriate use of hospital care and qualifying its determinants. After briefly reviewing the philosophy of the European Union "Concerted Action" program in the context of current attempts at reforming the way health care is financed and delivered in several member states, the paper presents results obtained so far. Besides a method workshop where the approaches and methodologies used were compared, during the first year the following tasks have been undertaken: (a) identification and appraisal of a few dozen empirical studies conducted in various countries; (b) qualitative comparison of the instruments used to assess appropriateness; (c) initial development of a common list of reasons for inappropriate hospital use of potential relevance in European health care systems. While the project has already undoubtedly indicated the great potential of European collaboration in health services research, the large number of unpublished studies traced indicates--among other things--the need to create channels through which results of this type of research can be disseminated.

Algorithms↗
PubMed1995

Appropriateness of hospital use: an overview of Italian studies.

This paper reports on the general features and findings of 11 studies conducted in Italy on appropriateness of hospital admission and days of stay using the Appropriateness Evaluation Protocol (AEP). Studies have been grouped for presentation in two categories. The first comprises six heterogeneous studies illustrating different ways of targeting the use of the AEP: two used it to assess appropriateness of admission in an emergency room setting, two measured appropriateness of days of stay in patients with AIDS and nosocomial infections and finally two others evaluated hospital days in a group of elderly patients and "before and after" the institution of a domiciliary nursing service, respectively. The second group comprises five more homogeneous utilization review studies aimed at assessing inappropriateness of admissions and days of stay in medical/surgical departments of large hospitals in northern Italy. Besides detecting a substantial amount of inappropriateness in admission (range = 25-38%) and days of stay (range = 28-49%) this latter group of studies suggests that delays in execution and reporting of laboratory investigations, unavailability of operating rooms and delays due to difficulties in transferring patients to long-term care facilities are the most common causes of inappropriate days of stay. Despite the differences in their objectives, design and methods of sampling, these studies indicate that an explicit, diagnosis-independent and standardized instrument such as the AEP can help to uncover a substantial amount of the potentially avoidable use of hospital resources in the Italian context.

Health Services Research↗
PubMed1994

Variation in use of breast surgery and characteristics of hospitals' surgical staff.

OBJECTIVE: To assess whether and how the characteristics of hospitals' surgical staff can predict utilization of breast conserving surgery. We anticipated that the use of the procedure was more frequent in hospitals with a greater proportion of younger and female surgeons on their staff. SETTING: Sixty-two hospitals with different level of organization for the care of cancer patient from eight Italian regions were included. DESIGN: We collected information on the personal characteristics (age and sex) of all surgeons on the staff of the participating centers. A concurrent pattern of care study was undertaken, in order to assess the utilization of breast conserving procedures. RESULTS: The use of conservative surgery was 16%, 20%, 31%, in centers with 0%, < 20% and 20-50% female surgeons respectively (p = 0.003), while no associations emerged between the mean age of the surgical staff and the use of conservative surgery. This relationship also held true after adjusting for other patients' characteristics, such as stage of disease, age and presence of comorbidity. However, overall the use of patient-related and staff-related characteristics to predict the number of breast conserving surgeries performed in each area was able to explain only 16% of the observed variability in the use of breast conserving surgery. CONCLUSIONS: Even though in this study a large proportion of the observed variation in the use of breast conserving surgery was still left unexplained, this finding suggests that assessing the relationship between doctors' characteristics and the use of scientific evidence is an important topic for health service research and can be of some help in exploring variations in clinical practice styles.

Adult↗