0000000000014602
AUTHOR
Diana Giannarelli
Calibration of the PREdiction of DELIRium in ICu Patients (PRE-DELIRIC) Score in a Cohort of Critically Ill Patients: A Retrospective Cohort Study
BACKGROUND: To predict delirium in intensive care unit (ICU) patients, the Prediction of Delirium in ICU Patients (PRE-DELIRIC) score may be used. This model may help nurses to predict delirium in high-risk ICU patients. OBJECTIVES: The aims of this study were to externally validate the PRE-DELIRIC model and to identify predictive factors and outcomes for ICU delirium. METHOD: All patients underwent delirium risk assessment by the PRE-DELIRIC model at admission. We used the Intensive Care Delirium Screening Check List to identify patients with delirium. The receiver operating characteristic curve measured discrimination capacity among patients with or without ICU delirium. Calibration abili…
Chronic non-cancer pain in primary care: an Italian cross-sectional study
Chronic non-cancer pain is a complex health condition that affects more than a quarter of the Italian population who mainly refers to general practitioners and primary care for their treatment. There are little information on the epidemiological and clinical characteristics and types of treatments for these patients who suffer from chronic pain. The aim of the study was to provide epidemiological and clinical information about patients with chronic non-cancer pain who refers to GPs for their treatment. An observational, multicentre, cross-sectional study was carried out using retrospectively reviewed clinical records from 29 GPs. Some pharmacoeconomic aspects were also investigated. A total…
Two consecutive clinical trials on cisplatin (CDDP), hepatic arterial infusion (HAI), and I.V. 5-fluorouracil (5-FU) chemotherapy for unresectable colorectal liver metastases: An alternative to FUdR-based regimens?
Several phase III clinical trials demonstrated that hepatic arterial chemotherapy for unresectable colorectal liver metastases is able to provide significantly higher response rates than those obtained by systemic route: in more than 500 patients collected from 6 randomized trials, the median values of objective response rates were 55% after fluoxuridine (FUdR) continuous hepatic arterial infusion (HAI) vs. 18.5% after FUdR or 5-fluorouracil (5-FU) intravenous (i.v.) chemotherapy. Furthermore, the majority of those studies reported that median survival increased in the patient subgroups treated with intrahepatic chemotherapy, even if not always statistically significant [1-6]. Certainly, FU…
A multicenter phase III prospective randomized trial of high-dose epirubicin in combination with cyclophosphamide (EC) versus docetaxel followed by EC in node-positive breast cancer. GOIM (Gruppo Oncologico Italia Meridionale) 9902 study
Background: The Gruppo Oncologico Italia Meridionale 9902 trial compared four cycles of high-dose epirubicin plus cyclophosphamide (EC) with four cycles of docetaxel (Taxotere, D) followed by four cycles of EC as adjuvant treatment of node-positive breast cancer. Patients and methods: Patients were randomly assigned to EC (E 120 mg/m 2 , C 600 mg/m 2 , arm A) for four cycles or four cycles of D (100 mg/m 2 ) followed by four cycles of EC (arm B), both regimens every 21 days. Hormone receptor-positive patients were given hormonal therapy for 5 years. Primary end point was 5-year disease-free survival (DFS). Secondary objectives were overall survival (OS) and safety. Results: There were 750 p…
Inequity in palliative care service full utilisation among patients with advanced cancer: a retrospective Cohort study.
Background: Advanced cancer patients often die in hospital after receiving needless, aggressive treatment. Although palliative care improves symptom management, barriers to accessing palliative care services affect its utilisation, and such disparities challenge the equitable provision of palliative care. This study aimed to identify which factors are associated with inequitable palliative care service utilisation among advanced cancer patients by applying the Andersen Behavioural Model of Health Services Use.Material and methods: This was a retrospective cohort study using administrative healthcare data. A total of 13,656 patients residing in the Lazio region of Italy, who died of an advan…
Prevalence and risk factors of delirium in the intensive care unit: An observational study
Background: Several risk factors, such as age, alcohol abuse, dementia, and severe illness, can contribute to the development of delirium. However, limited information is available in the literature regarding the risk of delirium among surgical, trauma, neurological, and medical intensive care patients. Aims and objectives: To describe the prevalence of risk factors associated with delirium in intensive care units. Design: This study used an observational design. Methods: We enrolled 165 patients hospitalized in two intensive care units in Italy. Patients were first evaluated using the Prediction of Delirium model and were subsequently evaluated using the Intensive Care Delirium Screening C…
Quality of life and disability of chronic non-cancer pain in adults patients attending pain clinics: A prospective, multicenter, observational study
What do we already know about this subject? • Chronic pain can have negative effects on quality of life. It is associated with a reduced ability to work, quality of life and disability, conditions that should be treated in specialized pain management clinics. In Italy very little information on clinical outcomes after chronic pain treatments is provided. What does our study add to the already existing information • This study is the first to provide clinical data about the impact of chronic pain in terms of quality of life and disability on patients who attended pain management clinics in Italy. • Chronic pain has a negative impact on quality of life and disability and causes presenteeism. …
Supplementary_Material_-_online_only – Supplemental material for Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG
Supplemental material, Supplementary_Material_-_online_only for Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG by Melissa Bersanelli, Diana Giannarelli, Ugo De Giorgi, Sandro Pignata, Massimo Di Maio, Elena Verzoni, Alberto Clemente, Valentina Guadalupi, Diego Signorelli, Marcello Tiseo, Raffaele Giusti, Marco Filetti, Marilena Di Napoli, Lorenzo Calvetti, Alessandro Cappetta, Paola Ermacora, Diego Zara, Fausto Barbieri, Cinzia Baldessari, Vieri Scotti, Francesca Mazzoni, Antonello Veccia, Pamela Francesca Guglielmini, Marco Maruzzo, Ernesto Rossi, Francesco Grossi, Chiara Casad…
Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors. Prospective analysis from a multicentre observational trial by FICOG
Background:This prospective, multicentre, observational INVIDIa-2 study is investigating the clinical efficacy of influenza vaccination in advanced-cancer patients receiving immune-checkpoint inhibitors (ICIs), enrolled in 82 Italian centres, from October 2019 to January 2020. The primary endpoint was the incidence of influenza-like illness (ILI) until 30 April 2020. All the ILI episodes, laboratory tests, complications, hospitalizations and pneumonitis were recorded. Therefore, the study prospectively recorded all the COVID-19 ILI events.Patients and methods:Patients were included in this non-prespecified COVID-19 analysis, if alive on 31 January 2020, when the Italian government declared …
Efficacy of nivolumab in pre-treated non-small-cell lung cancer patients harbouring KRAS mutations
Background: The present study investigated the efficacy and safety of nivolumab in pre-treated patients with advanced NSCLC harbouring KRAS mutations. Methods: Clinical data and KRAS mutational status were analysed in patients treated with nivolumab within the Italian Expanded Access Program. Objective response rate, progression-free survival and overall survival were evaluated. Patients were monitored for adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events. Results: Among 530 patients evaluated for KRAS mutations, 206 (39%) were positive while 324 (61%) were KRAS wild-type mutations. KRAS status did not influence nivolumab efficacy in terms of …
Bolus vs. continuous hepatic arterial infusion of cisplatin plus intravenous 5-fluorouracil chemotherapy for unresectable colorectal metastases.
A multicenter, randomized Phase 2 study that compared patients, affected by colorectal liver metastases, who received intrahepatic arterial infusion with two different schedules of cisplatin, bolusvs. continuous infusion, and systemic 5-fluorouracil. PURPOSE: The aim of this study was to validate results of a previous Phase 2 trial on bolus cisplatin intrahepatic arterial infusion, which reported a 47 percent response rate and a 32 percent 4-year survival rate for Gennari's Stage 2 patients, with a high rate of neurologic, gastrointestinal, and hematologic toxicity. METHODS: One hundred nine patients were randomized in a Phase 2 study to receive cisplatin intrahepatic arterial infusion (24 …
Chronic Non-cancer Pain Management in a Tertiary Pain Clinic Network: a Retrospective Study
Introduction: Chronic pain is a distressing condition that should be treated in specialized pain clinics. Pain clinics offer a holistic, evidence-based approach, including pharmacological, complementary, and invasive treatments. This study aimed to provide preliminary information regarding chronic pain treatments and identify reasons for accessing an important hub-spoke pain clinic network. Methods: A retrospective multicenter cross-sectional study was carried out. A total of 1606 patients’ records were included. Patients were selected from the 26 pain clinics of a single region in Italy. Univariate and multivariate logistic regression models were used. Results: Multivariate models showed t…
INfluenza Vaccine Indication during therapy with Immune checkpoint inhibitors: A multicenter prospective observational study (INVIDIa-2)
BackgroundUntil now, no robust data supported the efficacy, safety and recommendation for influenza vaccination in patients with cancer receiving immune checkpoint inhibitors (ICIs).MethodsThe prospective multicenter observational INfluenza Vaccine Indication During therapy with Immune checkpoint inhibitors (INVIDIa-2) study investigated the clinical effectiveness of influenza vaccination in patients with advanced cancer receiving ICIs, enrolled in 82 Italian centers from October 2019 to January 2020. The primary endpoint was the time-adjusted incidence of influenza-like illness (ILI) until April 30, 2020. Secondary endpoints regarded ILI severity and vaccine safety.ResultsThe study enrolle…