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R Grilli

Publications and source records attributed to R Grilli.

At least 73 records · Page 4Linked to original sources

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↗

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↗

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.

Adult↗

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.

Breast Neoplasms↗

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↗

Critical review of the quality and development of randomized clinical trials (RCTs) and their influence on the treatment of advanced epithelial ovarian cancer.

Trials on chemotherapy of advanced ovarian cancer published between 1975-88 were systematically reviewed for quality (according to the method of Chalmers) and consistency of tested hypotheses with a view to a meta-analysis of all published studies in the field. Median overall, internal and external validity scores were 47%, 43% and 53%, respectively. No association was found between scores and key features of trials, such as percentage studies with significant results in response or survival or percentage studies with high or low follow-up retention (withdrawal rates less than or greater than or equal to 15%). Only 21% of trials reported a fully blind randomization procedure and only in 13% were drop-outs accounted for by the intent-to-treat method. Only 4 trials entered more than 150 patients per arm, a sample size consistent with detection of an absolute difference of 11% in mortality. The majority of trials (58%) investigated the role of combination regimens versus a single-agent control arm. The remaining trials tested different polychemotherapies. However, within these two general issues, treatment options were quite heterogeneous: seven subgroups were identified by whether cisplatin was present in either the treatment or the control arm. We conclude that the internal coherence and development of randomized clinical trials in advanced ovarian cancer and their methodologic soundness are quite poor. In this situation meta-analysis cannot go beyond a systematic attempt to answer a very general "treatment effectiveness" question.

Antineoplastic Agents↗

[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↗

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↗

A randomized clinical trial comparing radiation therapy v radiation therapy plus cis-dichlorodiammine platinum (II) in the treatment of locally advanced non-small cell lung cancer.

Cis-Dichlorodiammine platinum (II) (cis-DDP) was demonstrated to be a potentiator of radiation therapy (RT) in experimental tumor models and in cultured cells. To assess the effectiveness of a combined modality treatment including RT and a weekly low-dose administration of cis-DDP, from January 1986 to June 1987, 95 patients with unresectable locally advanced non-small cell carcinoma of the lung (stage IIIa, b) were randomized for study. Fifty patients received RT alone at doses of 50 Gy; 45 patients received the same RT plus cis-DDP 15 mg/m2 IV weekly. An overall response rate of 50% and 64% was observed in the RT and RT + cis-DDP group, respectively. No statistically significant differences were detected with regard to median survival time (11 months for RT v 16 months for RT + cis-DDP) and progression-free interval (7 months in the RT arm v 9 months in the RT + cis-DDP arm), but the patterns of the first failure appeared to be affected by treatment. In fact, a lower number of intrathoracic relapses was observed in the RT + cis-DDP arm (12 in the RT + cis-DDP v 23 in the RT arm). Toxicity was mild and the feasibility of this schedule must be remarked. A better local control of disease can be obtained using cis-DDP as a radiation potentiator, but the true influence of this combined modality treatment on the length of survival, and the optimal cis-DDP timing and dosage are still to be evaluated in further clinical trials.

Carcinoma, Non-Small-Cell Lung↗

Small peptides as potent releasers of growth hormone.

Newly synthesized peptides are described which release growth hormone in the infant rat and their biological activity is compared with known GHRPs. Some of these peptides are the most potent GHRPs reported to date.

Amino Acid Sequence↗

[Evaluation of the impact of guidelines for rationalizing the prescription of preop tests for patients ASA 1 and 2 undergoing elective surgery].

OBJECTIVES: To evaluate the impact of implementation of guidelines aimed at reducing the use of laboratory and diagnostic preoperative tests in patients with low anesthesiologic risk, admitted to six public hospital of Ente Ospedaliero Cantonale in Cantone Ticino (Switzerland). DESIGN: Observational study. METHODS: Time series analysis of patterns of use of preoperative tests, on 14,585 patients admitted to public hospitals form March 1996 to June 1998. PRINCIPAL OUTCOME MEASURE: Proportion of patients undergoing a laboratory or other diagnostic tests during three six months periods before guidelines implementation (baseline), during the six months of the implementation phase and during the following four months of adoption of the guidelines in the participating centres. RESULTS: During the four months following the implementation, we observed a reduction of 15% (95% CI: 1%-27%) in the use of azotemia, and a reduction of 34% (95% CI: 18%-50%) for coagulation tests. Corresponding figures for glycemia and chest x-ray indicated a reduction of 44% (95% CI: 32%-54%) and of 22% (95% CI: 8%-34%), respectively. As for other tests (creatinine, ECG), no statistically significant reduction was observed. Most of the observed effect was explained by a reduction in use in patients at a low risk (ASA 1 and 2). In addition, guidelines appeared to have a greater impact in the four small (i.e. < 200 beds) hospitals, as compared with the two centres of greater size. CONCLUSIONS: Consistently with the empirical evidence available in this area, this study suggests that guidelines can change clinical practice, when they are implemented through a strategy taking into account adaptation of the recommendations to local circumstances and involvement of health professionals.

Adult↗

[How have opinions of medical oncologists changed regarding compared guidelines? Findings from two surveys conducted in 1993-1997].

OBJECTIVES: To assess changes in physicians' attitudes toward practice guidelines and towards the role of empirical evidence in the development of recommendations for clinical practice. DESIGN: Comparison of findings from two surveys carried out in Italy in 1993 and 1997 on the same random sample of 300 physicians from two specialty societies dealing with cancer care. RESULTS: As for goals, the only change was the increasing (from 26% in 1993 to 40% in 1997; p = 0.010) number of physicians indicating cost containment. More clinicians (43% in 1993 vs 58% in 1997; p < 0.01) stated that guidelines should be based primarily on empirical evidence, rather than on clinical experience, and that the Ministry of Health should have a role in issuing guidelines (from 21% in 1993 to 46% in 1997; p < 0.001). Physicians supporting the participation of representatives from outside the medical profession in developing guidelines increased from 6% in 1993 to 26% in 1997 (p < 0.001) for consumers, from 24% to 38% (p = 0.015) for patients, and from 16% to 33% (p = 0.003) for health care administrators. CONCLUSIONS: Overall, these changes indicate that an increasing number of clinicians acknowledge the role of empirical evidence and the need for a confrontation with other professional and societal components as to what should be done in clinical practice.

Adult↗

[From the Mailing List SIN: Epidemic of infections caused by 'aquatic' bacteria in patients undergoing hemodialysis via central venous catheters].

UNLABELLED: Bacteremia due to central venous catheter (CVC) infection is the most frequent complication of CVC use as vascular access for hemodialysis (HD). We report a case of an epidemic of CVC infections caused by 3 strains of unusual bacteria: Ralstonia pickettii (Rp), Leifsonia xyli/Leifsonia aquatica (Lxa), Tsuckamurella strandjordae (Ts). From 20/8/01 to 30/9/01, 23 of 35 patients dialyzed via CVCs experienced intra-HD pyrogenic reactions. Their hemocultures were positive for: Rp (14 pts), Lxa (3 pts), Rp+Lxa (5 pts) and Rp+Ts (1 pt). The hemocultures of 12/35 asymptomatic pts were positive for: Rp 2 pts, Lxa 2 pts, Rp+Lxa 2 pts, Ts 1 pt, Rp+Ts 1 pt. The epidemiological and microbiological analyses of environmental samples failed to identify the source of the epidemic. Actions taken were: a) replacement of the batches of disposable materials; b) removal of CVCs in cases where possible to prepare a different access; c) treatment of the infections with intra-CVC antibiotic lock therapy. No relapses were recorded until April 2002, when 8 pts had again pyrogenic reactions due to Rp. After quick substitution of the CVC and repetitions of the action a), no relapses of pyrogenic reactions were observed. CONCLUSIONS: 1) given the characteristics of Rp, Lxa and Ts, saprophytes of moist environments, the most plausible source of the epidemic was a low-charge contaminated solution that was not identified due to low sensitivity of environmental sample culturing methods; 2) antibiotic lock therapy is a viable option for the conservative treatment of CVC infections.

Bacterial Infections↗

[Cochrane EPOC group: closing the gap between quality assurance and organization of care research and front line professionals].

Keeping physicians informed on an ongoing basis is a new challenge for continuing medical education and quality assurance. In Italy over the last 5 years interest in evidence based literature is growing. This is demonstrated by the launch of an Italian edition of Clinical Evidence and by the growing number of guidelines and systematic reviews produced by Italian authors and institutions. However, there is some uncertainty concerning the familiarity of Italian policy makers and public health physicians with the evidence-based resources, including also how to access them. This article attempts to close this gap, by describing the activities of the Cochrane Collaboration and, within it, of the Cochrane Effective Practice and Organisation of Care Group (EPOC), both aim to prepare and maintaining SR of health care interventions. Specifically, the EPOC group develops systematic reviews of professional, financial, organisational and regulatory interventions that are designed to improve professional practice and the delivery of effective health services. EPOC has 31 reviews and 24 protocols published in Issue 4, 2004 of the Cochrane Library and has developed standard methods to assist people, such as quality criteria for study design specific to health services research. The EPOC specialized register contains details of over 2200 studies that fall within the group's scope. Systematic reviews provide a valuable and efficient source of information for policy makers and health care professionals aimed at implementing effective and efficient strategies to encourage medical behavioural change and deliver of high quality services.

Biomedical Research↗