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Showing papers by "Alessandro Liberati published in 1989"


Journal ArticleDOI
20 Oct 1989-JAMA
TL;DR: It is concluded that clinical research in lung cancer's heterogeneity makes it unlikely that quantitative meta-analysis of existing trials will be constructive, and trial quality improved over time both in design/execution and reporting.
Abstract: 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 indesign/execution(study size estimation and analysis by prognostic factors became more frequent) andreporting(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. (JAMA. 1989;262:2101-2107)

74 citations


Journal ArticleDOI
TL;DR: 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.
Abstract: 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 19752985 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 thetwo 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.

25 citations


Journal ArticleDOI
01 Apr 1989-Tumori
TL;DR: The quality of diagnostic and therapeutic care was examined in a series of 380 consecutive newly diagnosed cases of primary lung cancer seen in 20 Italian general hospitals between January and June 1987, showing a lack of progress in the treatment of lung cancer over the last decades seems to have resulted in widely varying practice patterns.
Abstract: The quality of diagnostic and therapeutic care was examined in a series of 380 consecutive newly diagnosed cases of primary lung cancer seen in 20 Italian general hospitals between January and June 1987. At diagnosis most patients (78%) had one or more symptoms related to the tumor, and in an additional 9 % symptoms were related to the presence of distant metastases. The median diagnostic time lag between first symptoms and final diagnosis was 50 days with a significantly longer delay in patients first seen by their general practitioner compared with those who sought first care in hospital outpatient departments. The diagnostic process was satisfactorily carried out in fewer than two-thirds of the patients leading to complete ascertainment of disease stage and histology in 58% cases with significantly better performance in more specialized institutions. Analysis of the first-line treatment profile indicated a rather aggressive therapeutic attitude In the case of patients with non-small cell lung cancer – 28% of them had chemotherapy despite the lack of any proof of efficacy in controlled clinical trials – and a failure to identify among the patients with small cell disease those amenable to more aggressive treatment. The lack of progress in the treatment of lung cancer over the last decades seems to have resulted in widely varying practice patterns where a mixture of aggressive and laissez-faire attitudes does not take into account that in the absence of effective therapies a more conservative attitude would at least have some advantage in terms of quality of remaining life for many patients.

10 citations


Journal ArticleDOI
TL;DR: The example of the North Karelia project is used to 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.
Abstract: 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.

7 citations