Showing papers by "Alessandro Liberati published in 1994"

Impact of Follow-up Testing on Survival and Health-Related Quality of Life in Breast Cancer Patients: A Multicenter Randomized Controlled Trial

Abstract: Objective. —To assess prospectively the impact on survival and health-related quality of life of two follow-up protocols in patients with early breast cancer. Design. —Randomized controlled clinical trial. Setting. —Multicenter study involving 26 general hospitals in Italy. Patients. —A consecutive sample of 1320 women younger than 70 years with stage I, II, and III unilateral primary breast cancer. Intervention. —Patients were randomly assigned to an intensive surveillance, which included physician visits and performance of bone scan, liver echography, chest roentgenography, and laboratory tests at predefined intervals (n=655), or to a control regimen (n=665), in which patients were seen by their physicians at the same frequency but only clinically indicated tests were performed. Both groups received a yearly mammogram aimed at detecting contralateral breast cancer. Main Outcome Measures. —Primary end points were overall survival and health-related quality of life. Results. —Compliance to the two follow-up protocols was more than 80%. At a median follow-up of 71 months, no difference was apparent in overall survival with 132 deaths (20%) in the intensive group and 122 deaths (18%) in the control group. No significant differences were apparent in time to detection of recurrence between the two groups. Measurements of health-related quality of life (ie, 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 show differences by type of care received. Conclusions. —Results of this trial support the view that a protocol of frequent laboratory tests and roentgenography after primary treatment for breast cancer does not improve survival or influence health-related quality of life. Routine use of these tests should be discouraged. (JAMA. 1994;271:1587-1592)

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

Abstract: • 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, totaling 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 [Cl], −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.

Variation in Use of Breast Surgery and Characteristics of Hospitals' Surgical Staff

Abstract: 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.

Conclusions. 1: The relationship between clinical trials and clinical practice: The risks of underestimating its complexity

Abstract: Two main points are addressed in the following remarks. The first is that the survival of randomized clinical trials (RCTs) as the gold standard by which to assess the effectiveness of medical technology is being seriously challenged. It is incumbent upon methodologists and clinical researchers to understand why this is happening and commit themselves to improving the process through which new possibilities for improved treatments are selected, prioritized and implemented. The second point is that trialists should abandon the idea that the availability of relevant information is a sufficient condition for a timely and widespread acceptance of RCTs results. Contrary to what health services research has repeatedly indicated, trialists still, by and large, seem to believe in a simplistic model that assumes a one-way linear and rapid relationship between scientific knowledge and clinical practice. In the concluding section the paper pinpoints some issues to be further discussed from the point of view of monitoring and conducting trials.

Selective decontamination of the digestive tract.

Abstract: EDITOR, - M J M Bonten and colleagues agree with us that meta-analysis helps to clarify the methodological quality and clinical consistency of published research.1 They also acknowledge the merits of our recent review of trials of selective decontamination of the digestive tract in making clear important differences in study design, population, and methods that may explain why results of different studies differ.2 They criticise us, however, for using the “number to be treated” as a measure of the effect of …