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Biomedical subjects

A Liberati

Publications and source records attributed to A Liberati.

At least 91 records · Page 5Linked 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↗

Cooperation in mental health: an Italian project in Nicaragua.

The experience acquired over the last four years in developing a program of cooperation in mental health in Nicaragua is reported. The concept of 'transfer' underlying the intervention and the general framework of Nicaragua's mental health system is discussed together with the results of the cooperative work. This included organizing training for mental health workers in six teaching and supervision modules, drawing up a mental health manual for primary health care workers, and survey of patterns of care in the 15 existing psychiatric services. Besides the key aspects of general reform of the psychiatric system after the revolution, the paper focuses on differences between organization and patterns of care in urban and rural areas.

Adult↗

[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↗

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↗

Health care research: what is it about?

Interest in research on health care has become quite substantial, in part as a result of the recent emergence of public-policy concern for quality assurance and cost-containment. Yet, the essence of this novel line of research has remained, regrettably, a matter of confusion. In particular, the distinction between health care research on one side and health research on the other is being missed in some eminent writings. We emphasize that, properly, the former is to be viewed as having health care, rather than health, as its object, and as being largely descriptive fact-finding about the nature and occurrence of various processes of health care. In these terms it serves policy and administrative decisions in the context of whatever knowledge is available from health research--as to the health consequences of such processes of care. Health research (applied), in turn, addresses the nature and occurrence of phenomena of health (their frequency)--in relation to type of health care, inter alia. Using the example of the North Karelia project, we illustrate the negative consequences of including under health care research inquiries into the premises of health care--notably studies on the effects of care on health outcome.

Goals↗

Determinants of physicians' preferences for alternative treatments in women with early breast cancer.

To learn about factors, that influence a physician's decision making, a mail survey was conducted asking physicians about their preferences for radical mastectomy vs. local excision plus irradiation, and for adjuvant chemotherapy vs. no adjuvant treatment for two hypothetical women with operable, clinical stage I breast cancer - one 35 years old and the other 60 years old. Two hundred and sixty-one physicians from varied specialties in Connecticut and Massachusetts returned the questionnaire. Approximately half of the respondents would accept either mastectomy or limited surgery plus radiation therapy for either patient. Adjuvant chemotherapy was recommended by 97% of respondents for the younger patient and by 66% for the older patient. Several factors appeared to be related to therapeutic preferences. An individual physician's attitude towards patient involvement in decision making was the most important predictor of surgical preference for both the patients, whereas the role of specialty (i.e., surgeons vs. other providers) was more important for the surgical management of the older patient. For the decision involving adjuvant chemotherapy, specialty, hospital size, and presence of radiotherapy equipment on site were important predictors. Factors other than survival (such as disease-free interval and cosmetic results) were viewed as important standards of effectiveness by some physicians.

Adult↗

Organization of services and pattern of psychiatric care in Nicaragua: result of a survey in 1986.

Organization of services and patterns of psychiatric care were studied in Nicaragua in 1986, 7 years after the substantial changes in health policy launched after the revolution. The overall re-organization of the system is indicated by the progressive abandoning of the mental hospital as the center of psychiatric care and the creation of 15 community-based mental health centers now functioning throughout the country. Quality of care judged through analysis of a consecutive sample of 342 patients seen by services over a month confirmed the positive orientation of the system which seemed able to deliver good care following the new perspective of "de-institutionalization". Some problems emerged to a large extent common to psychiatric care in industrialized countries looking at psychotropic drug use and at the relationship between primary health care and the psychiatric system especially when care delivered in urban and rural areas was compared.

Adolescent↗

Quality of care assessment for breast cancer: how to measure benefits of prevention and therapy in oncology.

Over the last few years evaluation of quality of diagnostic and therapeutic care has become one of the most controversial and fastest growing fields of research in many areas of medicine. In this situation, oncology represents a model case as the conditions in which new therapeutic strategies are tested and implemented largely differ from routine practice, both in terms of availability of sophisticated technology and comparability of patient populations. The promising role of health care research for the understanding of factors through which research advances can be generalized to routine clinical practice has only recently being appreciated. From this point of view, the paper discusses the rationale and key findings of a multi-annual++ evaluation program on breast cancer care, underway in Italy since 1980. Special attention is given to how results (such as data on diagnostic delay or non-adherence to recommended treatment guidelines) can be used for the implementation of educational programs, controlled studies and ad hoc demonstration projects.

Breast Neoplasms↗

Adjuvant chemotherapy for breast cancer. A pooled estimate based on published randomized control trials.

The use of adjuvant chemotherapy for treating patients with operable breast cancer remains a worldwide controversy. Using the data from published randomized control trials with a minimum two-year follow-up, pooled estimates of relapse-free survival rates and overall survival rates were calculated. Relapse-free survival rates were improved by 12.5% (95% confidence interval [CI] +/- 4.5%) at three years and by 8% (CI +/- 6%) at five years, with studies using multiple agents showing a greater effect. A significant advantage was also present in overall survival rates at three years, but only for studies involving multiple agents (4% +/- 3.5%). Results from combining data for other types of trials were inconclusive. The use of this method is presented to illustrate its value as an explicit and systematic one for combining data from several randomized control trials in assessing a therapeutic controversy.

Antineoplastic Agents↗

A quality assessment of randomized control trials of primary treatment of breast cancer.

The methodology of randomized control trials (RCTs) of the primary treatment of early breast cancer has been reviewed using a quantitative method. Sixty-three RCTs comparing various treatment modalities tested on over 34,000 patients and reported in 119 papers were evaluated according to a standardized scoring system. A percentage score was developed to assess the internal validity of a study (referring to the quality of its design and execution) and its external validity (referring to presentation of information required to determine its generalizability). An overall score was also calculated as the combination of the two. The mean overall score for the 63 RCTs was 50% (95% confidence interval [CI] = 46% to 54%) with small and nonstatistically significant differences between types of trial. The most common methodologic deficiencies encountered in these studies were related to the randomization process (only 27 of the 63 RCTs adopted a truly blinded procedure), the handling of withdrawals (only 26 RCTs included all patients in the analyses), the description of the follow-up schedule (only 12 RCTs reported adequately), the report of side effects (adequate information given in 33 RCTs), and the description of the patient population (satisfactory in 29 RCTs). Telephone calls to the principal investigators improved the quality scores by seven points on a scale of 100, indicating that some of the deficiencies lay in reporting rather than performance. There was evidence that quality has improved over time and that the increasing tendency of involving a biostatistician in the research team was positively associated with the improvement of the internal validity but not with the external.

Breast Neoplasms↗

Patients' assessment of quality of care: a survey of a group of breast cancer patients in Italy.

Patients' assessment of quality of care was investigated in 825 women with breast cancer treated in a group of specialized and non-specialized institutions in Italy. A 10-page mail questionnaire explored patients' adjustment to the disease, satisfaction with care, and quality of the information on diagnosis and treatment. Most of the 428 (52%) responders reported good or acceptable adjustment to the disease (as reflected by acceptable performance in some daily living activities), and favorable judgment about care providers, but many women complained of hospital organizational deficiencies. A contradictory picture emerged regarding the quality of information. Completeness and thoroughness appeared seriously deficient when examined objectively using a series of explicit predefined criteria, but patients' assessments showed in most cases moderate or high satisfaction. The paper presents these results and discusses pros and cons in the use of patients' opinions for evaluation of quality of care.

Adaptation, Psychological↗

Process and outcome of care for patients with ovarian cancer.

The process and outcome of care for a group of patients with ovarian cancer treated over two years in two groups of Italian general hospitals were investigated. The quality of diagnostic and therapeutic measures did not substantially differ in specialised and non-specialised centres when selected indicators of quality of care were examined. Similarly, no differences in survival emerged for the two groups of hospitals. Overall results of the Italian series compared well with statistics of survival published by international centres for cancer, suggesting that when the yield of available treatments is limited both the process and outcome of care should be evaluated to obtain a reliable picture of quality of care. In the light of these results there are useful implications for planning future clinical trials and ways of caring.

Adult↗