Heterogeneity in the evaluation of observational studies by Italian ethics committees.

OBJECTIVE AND METHOD: In Italy, observational research is rarely brought to the attention of ethics committees (ECs). This study assessed to what extent the observational studies conducted within the Careggi Hospital (2000 beds) and retrieved from MEDLINE after their publication could be traced back from the registries of our EC. Another aim was to compare the different opinions expressed by 28 ECs throughout Italy about the same multi-centre clinical protocol (an oncologic observational study). RESULTS: Our analysis shows that, in this sample of observational studies, the rate of submission to the EC is 0%. In the second part of our study, the evaluations of the same protocol by the different ECs were extremely different and ranged from unconditioned approval to rejection. CONCLUSION: Our proposal is that clinicians should always notify their observational studies to ECs. On the other hand, ECs should simply accept the observational protocols (without introducing any modifications except cases of macroscopic errors). The heterogeneity in the evaluation of a single protocol by different ECs raises the need to develop some forms of intervention to solve this source of inconsistency.

Factors influencing the length of hospitalisation in intensive care units: a prospective observational study.

INTRODUCTION: The length of stay (LOS) in patients admitted to intensive care units (ICUs) is influenced by the clinical history of the patient, so the main factors affecting clinical outcome are logical candidates to be predictors of LOS. Since there is still limited information about which factors can influence LOS in these patients, we undertook this observational study in Italian hospitals. MATERIALS AND METHODS: From 1 August to 31 October 2001 we enrolled a maximum of 10 consecutive patients admitted to ICUs in 16 Italian hospitals. The following information was recorded from each patient: date of admission; APACHE II score on admission; active sepsis and/or septic shock on admission; sepsis and/or septic shock developed during the stay in ICU; Glasgow coma scale on the third day; date and clinical outcome upon discharge from the hospital (alive or dead). RESULTS: In the study 131 patients were enrolled; 31 (23.7%) had active sepsis upon admission to ICU and 10 (7.6%) had septic shock; 12 (9.2%) developed sepsis during hospitalization and 12 (9.2%) developed septic shock. At the end of the study, 101 patients were alive and 30 had died. The overall mean LOS was 12 days. The mean LOS was 18.3 days for the subgroup with sepsis and 8.3 days in the subgroup without sepsis. Sepsis was the only factor that significantly influenced the LOS (P = 0.016). CONCLUSIONS: Our study was aimed to analyse the factors that influence the LOS in ICU patients and found that among the variables that affected LOS, sepsis had the greatest impact. Other studies had evaluated the impact of some variables on LOS and identified sepsis and infection as a determinant prolonging LOS.

Clinical-economic appropriateness of drug treatments: designing a method that combines evidence-based information and cost assessments to construct league tables accounting for the potential number of patients.

This paper presents a method to assess drug treatment appropriateness, based on an original combination of economic analysis, pharmacoepidemiological techniques and evidence-based information. This method generates an index of clinical-economic appropriateness for the treatment under examination, by comparing the theoretically expected health gain (EHG) to the yearly national expenditure (EXPEND) on that drug and the amount of health that is thought to be gained in the 'real' patients (RHG). This paper reviews all the analyses conducted so far using this method, and discusses their main results. The primary aim of this article is to suggest a ranking approach for allocating the drug budgets of national health systems.

Pharmacotherapy of multiple myeloma: an economic perspective.

Since new treatments have recently been proposed for patients with multiple myeloma, the aim of this article is to review the main innovations in this therapeutic area and to examine the cost-effectiveness ratio. Innovative approaches include autologous transplantation and thalidomide, which are both utilised as induction or salvage treatments. According to a randomised trial conducted in 1996, the survival after autologous transplantation seems to be better than that following standard therapy; however, this result has not been confirmed by a recent study. Thalidomide has been found to be effective for relapsed or refractory myeloma and, more recently, also as induction therapy. Preliminary cost-effectiveness assessments about autologous transplantation and thalidomide have given promising results; yet one regulatory problem with thalidomide is that, both in Europe and in the US, the drug has not yet been approved for this indication.

Clinical trial response and dropout rates with olanzapine versus risperidone.

BACKGROUND: In schizophrenia, comparing treatment dropouts between olanzapine and risperidone can be useful to better understand their relative effectiveness. OBJECTIVE: To analyze the differences in the rates of dropout from clinical trials and response between these 2 antipsychotics. METHODS: Literature search was based on MEDLINE (1966-May 2002). Analysis 1 included 4 randomized studies (838 patients), analysis 2 included 2 randomized studies (n = 716), and analysis 3 assessed 5 clinical studies for olanzapine (n = 928) and 3 for risperidone (n = 290). Odds ratios were estimated by the fixed-effect model. RESULTS: The risk of treatment discontinuation (analysis 1) was significantly greater for risperidone than for olanzapine (42% vs. 33%, respectively). The response rates were identical for the 2 drugs (analysis 2). A slightly better pattern of maintenance of response was found for olanzapine (analysis 3). CONCLUSIONS: The pattern of dropout and maintenance of remission seems to be better controlled for olanzapine than for risperidone.