Pulsed-field ablation for paroxysmal atrial fibrillation: An indirect comparison of effectiveness among three proprietary devices conducted in the absence of randomized trials.

Introduction: In patients with paroxysmal atrial fibrillation, pulsed-field ablation has been developed as an alternative to thermal ablation. Three devices are currently available: Farawave by Boston, PulseSelect by Medtronic, and Varipulse by Johnson. In the present report, we studied the outcomes at 12 months of these three devices using indirect comparisons.

A retrospective observational analysis to evaluate the off-label use of bevacizumab alone or with irinotecan in recurrent glioblastoma.

Background: Recurrent glioblastoma is nearly always fatal, with median survival rates of approximately 12-14 months. Previous phase II clinical trials showed promising results with bevacizumab, alone or in combination with irinotecan, in patients with recurrent glioblastoma.

Objective: To assess whether the survival of patients with recurrent glioblastoma receiving bevacizumab alone or with irinotecan in everyday practice is comparable to that reported in clinical trials.

Triptans in the Italian population: a drug utilization study and a literature review.

Previous studies performed in selected populations show a poor utilization of triptans for migraine. The objectives of our study were to establish patterns of triptans utilization in a large sample, covering 1/10 of Italian population (5.57 millions), and to perform a review of published studies on this topic.

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).

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.

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.

Survival of patients with recurrent malignant glioma treated with temozolomide: a retrospective observational study.

Objective: To assess whether the survival of patients with recurrent malignant glioma receiving temozolomide in everyday practice is comparable to that reported in previous studies.

Study Design: We conducted a retrospective observational study that included patients with recurrent malignant glioma who where treated with temozolomide.

Patients And Methods: The study was based on prospective clinical databases managed by the Italian Local Health Units; the databases are required by Italian Law 648/96 for patients treated with temozolomide before drug approval by the reimbursement agency of the Italian Ministry of Health.

Antithrombin III in patients admitted to intensive care units: a multicenter observational study.

Introduction: The administration of antithrombin III (ATIII) is useful in patients with congenital deficiency, but evidence for the other therapeutic indications of this drug is still uncertain. In Italy, the use of ATIII is very common in intensive care units (ICUs). For this reason we undertook an observational study to determine the pattern of use of ATIII in ICUs and to assess the outcome of patients given this treatment.