Biostatistics and Clinical Trials Unit

Meldola, Italy

Biostatistics and Clinical Trials Unit

Meldola, Italy

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Maltoni M.,Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST IRCCS | Scarpi E.,Biostatistics and Clinical Trials Unit | Dall'Agata M.,Biostatistics and Clinical Trials Unit | Zagonel V.,Veneto Institute of Oncology IOV IRCCS | And 50 more authors.
European Journal of Cancer | Year: 2016

Background Early palliative care (EPC) in oncology has been shown to have a positive impact on clinical outcome, quality-of-care outcomes, and costs. However, the optimal way for activating EPC has yet to be defined. Methods This prospective, multicentre, randomised study was conducted on 207 outpatients with metastatic or locally advanced inoperable pancreatic cancer. Patients were randomised to receive ‘standard cancer care plus on-demand EPC’ (n = 100) or ‘standard cancer care plus systematic EPC’ (n = 107). Primary outcome was change in quality of life (QoL) evaluated through the Functional Assessment of Cancer Therapy – Hepatobiliary questionnaire between baseline (T0) and after 12 weeks (T1), in particular the integration of physical, functional, and Hepatic Cancer Subscale (HCS) combined in the Trial Outcome Index (TOI). Patient mood, survival, relatives' satisfaction with care, and indicators of aggressiveness of care were also evaluated. Findings The mean changes in TOI score and HCS score between T0 and T1 were −4.47 and −0.63, with a difference between groups of 3.83 (95% confidence interval [CI] 0.10–7.57) (p = 0.041), and −2.23 and 0.28 (difference between groups of 2.51, 95% CI 0.40–4.61, p = 0.013), in favour of interventional group. QoL scores at T1 of TOI scale and HCS were 84.4 versus 78.1 (p = 0.022) and 52.0 versus 48.2 (p = 0.008), respectively, for interventional and standard arm. Until February 2016, 143 (76.9%) of the 186 evaluable patients had died. There was no difference in overall survival between treatment arms. Interpretations Systematic EPC in advanced pancreatic cancer patients significantly improved QoL with respect to on-demand EPC. © 2016 Elsevier Ltd


Scarpi E.,Biostatistics and Clinical Trials Unit | Calistri D.,Biosciences Laboratory | Klepstad P.,Norwegian University of Science and Technology | Klepstad P.,European Palliative Care Research Center | And 7 more authors.
Oncologist | Year: 2014

Objective. The study objective was to evaluate whether there are clinical or genetic differences between patients with cancer-induced bone pain (CIBP) and patients with non-CIBP, and, in the CIBP group, in those with good versus poor opioid response.Materials and Methods. A total of 2,294 adult patients with cancer who were receiving opioids for moderate or severe pain were included in the European Pharmacogenetic Opioid Study. Pain intensity and pain relief were measured using the Brief Pain Inventory. Linkage disequilibrium of 112 single nucleotide polymorphisms was evaluated in 25 candidate genes, and 43 haplotypes were assessed. Correlations among demographical factors, disease-related factors, genetic factors, CIBP, and pain relief were analyzed by logistic regression models corrected for multiple testing. Patients with bone metastases and bone/soft tissue pain were defined as having prevalent bone pain (CIBP population). This population was compared with patients who had other types of cancer pain (non-CIBP).Results. A total of 577 patients (26.2%) had CIBP, and 1,624 patients (73.8%) had non-CIBP. Patients with CIBP had more breakthrough cancer pain episodes (64.2% vs. 56.4%, p = .001), had significantly higher pain interference in“walkingability in the past 24 hours” (p < .0001), used more adjuvant drugs (84.1% vs. 78.3%, p = .003), and had a higher, albeit nonsignificant, median overall survival (3.8 vs. 2.9 months, p = .716) than patients with non-CIBP. None of the examined haplotypes exceeded p values corrected for multiple testing for the investigated outcomes.Conclusion. Patients with CIBP who were taking opioids had a clinical profile slightly different from that of the non-CIBP group. However, no specific genetic pattern emerged for CIBP versus non-CIBP or for responsive versus nonresponsive patients with CIBP. The Oncologist 2014;19:1276–1283 © AlphaMed Press 2014.


Pezzi R.,Biostatistics and Clinical Trials Unit | Fontana V.,Biostatistics and Clinical Trials Unit | Pistillo M.P.,Tumor Genetics and Epigenetics Unit
Cancer Investigation | Year: 2013

Soluble mesothelin-related peptide (SMRP) is regarded as an FDA approved biomarker for the diagnosis and monitoring of pleural malignant mesothelioma (MPM). We detected the SMRP levels in pleural effusions (PE) by means of an ELISA and analyzed their diagnostic relevance to differentiate MPM from benign pathology and from non-MPM pleural metastasis. Comparison with cytology in MPM-PE was also performed. We found that SMRP detection in MPM-PE can help the diagnosis of MPM and provide additional diagnostic value to cytology. We concluded that SMRP test may be incorporated into clinical practice of PE from patients suspicious for MPM. Copyright © 2013 Informa Healthcare USA, Inc.


Stella A.,Italian National Cancer Institute | Piccardo M.T.,Italian National Cancer Institute | Pala M.,Italian National Cancer Institute | Balducci D.,Italian National Cancer Institute | And 3 more authors.
Journal of the Air and Waste Management Association | Year: 2012

From 1995 to 2004, in Genoa, Italy, daily concentrations of twelve polycyclic aromatic hydrocarbons (PAHs) were measured in particulate phase (PM10), around a coke oven plant in operation from the 1950s and closed in 2002. The study permitted to identify the coke oven as the main PAH source in Genoa, causing constant exceeding of benzo(a)pyrene (BaP) air quality target (1.0 ng/m3) in the urban area till 1,900 meters distance downwind the plant. For this reason the plant was closed. Distance and daily hours downwind the coke plant were the main sources of variability of toxic BaP equivalent (BaPeq) concentrations and equations that best fitted these variables were experimentally obtained. During full plant activity, annual average BaPeq concentrations, measured in the three sampling sites aligned downwind to the summer prevalent winds, were: 85 ng/m3 at 40 m (site 2, industrial area), 13.2 ng/m3 at 300 m (site 3, residential area) and 5.6 ng/m3 at 575 m (site 4, residential area).Soon after the coke oven's closure (February 2002) BaPeq concentrations (annual average) measured in residential area, decreased drastically: 0.2 ng/m3 at site 3, 0.4 ng/m3 at site 4. Comparing 1998 and 2003 data, BaPeq concentrations decreased 97.6% in site 3 and 92.8% in site 4.Samples collected at site 3, during the longest downwind conditions, provided a reliable PAH profile of fugitive coke oven emissions. This profile was significantly different from the PAH profile, contemporary found at site 5, near the traffic flow.This study demonstrates that risk assessment based only on distance of residences from a coke plant can be heavily inaccurate and confirmed that seasonal variability of BaPeq concentrations and high variability of fugitive emissions of PAHs during coke oven activities require at least one year of frequent and constant monitoring (10-15 samples each month).Around a coking plant, polycyclic aromatic hydrocarbons (PAHs), concentrations depend mainly on downwind hours and distance. Equations that best fit these variables were experimentally calculated. Fugitive emissions of an old coke oven did not comply with the threshold BAP air concentration proposed by the World Health Organization (WHO), up to 1,900 m distance. The study identified the PAH profile of fugitive emissions of a coke oven, statistically different from the profile of traffic emissions. During its activity, in the Genoa residential area, 575 m away from the plant, 92.8% of found PAHs was due to coke oven emission only.Supplemental materials are available for this article. Go to the publisher's online edition of the Journal of the Air & Waste Management Association for information about samples analyses, statistical analyses and regression models figure. © 2012 Copyright 2012 A&WMA.


Maltoni M.,Instituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori Irst | Scarpi E.,Biostatistics and Clinical Trials Unit | Pittureri C.,Palliative Care Unit | Martini F.,Palliative Care Unit | And 7 more authors.
Oncologist | Year: 2012

Purpose. Predicting prognosis in advanced cancer aids physicians in clinical decision making and can help patients and their families to prepare for the time ahead. Materials and Methods. This multicenter, observational, prospective, nonrandomized population-based study evaluated life span prediction of four prognostic scores used in palliative care: the original Palliative Prognostic Score (PaP Score), a variant of PaP Score including delirium (DPaP Score), the Palliative Performance Scale, and the Palliative Prognostic Index. Results. A total of 549 patients were enrolled onto the study. Median survival of the entire group was 22 days (95% confidence intervals [95% CI] = 19 -24). All four prognostic models discriminated well between groups of patients with different survival probabilities. Log-rank tests were all highly significant (p <.0001). The PaP and D-PaP scores were the most accurate, with a C index of 0.72 (95% CI = 0.70-0.73) and 0.73 (95% CI = 0.71-0.74), respectively. Conclusion. It can be confirmed that all four prognostic scores used in palliative care studies accurately identify classes of patients with different survival probabilities. The PaP Score has been extensively validated and shows high accuracy and reproducibility in different settings. © AlphaMed Press.


Rubartelli P.,ASL3 Ospedale Villa Scassi | Crimi G.,ASL3 Ospedale Villa Scassi | Bartolini D.,ASL3 Ospedale Villa Scassi | Bellotti S.,ASL3 Ospedale Villa Scassi | And 2 more authors.
Journal of Interventional Cardiology | Year: 2014

Objectives This study sought to describe the change of first choice access site from transfemoral (TF) to transradial (TR) in primary percutaneous coronary intervention (pPCI) in a single center.Background TR-pPCI, when performed by experienced operators, can reduce bleeding events and improve clinical outcome. However, little is known about the learning curve of TR-pPCI and the results obtained by less experienced operators. © 2014, Wiley Periodicals, Inc.Methods Time to reperfusion, contrast and radiation doses, and 30-day clinical events were evaluated. The relationship between operator experience and procedural results was assessed.Results During 6.5 years, 1,045 patients with STEMI underwent pPCI. The rate of TR-pPCI increased gradually from about 40% to 90% and remained stable thereafter. The crossover from TR to TFpPCI occurred in 4.6% of patients and was not related to the operator experience. Patients selected for TR-pPCI had a lower risk profile and lower incidence of 30-day mortality and bleeding events. Time to reperfusion, contrast volume, fluoroscopy time, and angiographic success was not significantly different between the 2 vascular approaches, nor was it associated to the operator experience. At roughly 200 PCIs as operator experience, a slight adjusted reduction in the time form first coronary angiogram to balloon was detected with both vascular approaches.Conclusions A progressive transition from TF to TR-pPCI could be implemented over a 4-year period without increasing overall treatment delay. The impact of operator experience on procedural results appeared to be modest and it did not differ in the study access groups.


Ibrahim T.,Instituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori Irst | Sacanna E.,Instituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori Irst | Gaudio M.,Morgagni Pierantoni Hospital | Mercatali L.,Instituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori Irst | And 7 more authors.
Clinical Breast Cancer | Year: 2011

Background: The RANK/RANKL/OPG system is active in primary cancers such as breast, prostate, and also in their bone metastases. CXCR4 chemokine receptor is highly expressed in human breast cancer cells and is believed to facilitate the homing of tumor cells to organs such as bone that express high levels of its ligand SDF1. Our study aimed to investigate whether the analysis of these markers with an inexpensive and simple test can help to predict bone metastases in breast cancer patients. Patients and Methods: Marker expression was evaluated by immunohistochemical staining in paraffin-embedded tissue sections of primary breast cancers from 40 individuals: 20 patients with bone metastases (BM), 10 with visceral metastases (VM; considered together as the relapsed group), and 10 with no evidence of disease (NED). Results: RANKL was not detected in tumor cells. OPG- and RANK-positive tumors are found with similar frequency in NED (20%) and in relapsed patients (23% and 17%, respectively). However, in the latter subgroup, only RANK positivity was always associated with bone relapse. The frequency of CXCR4-positive tumors was three-fold higher in relapsed (30%) than in NED (10%) patients and positivity was always linked to bone metastases. Considering NED and VM patients together versus BM patients, we observed that CXCR4 expression, alone (P =.008) or in combination with RANK (P <.001), identified patients destined to relapse to bone. Conclusion: Our results provide the first clinical evidence to support a pivotal role of combined CXCR4 and RANK expression in predicting bone relapse. © 2011 Elsevier Inc. All rights reserved.


Sossai D.,Prevention and Protection Unit | Di Guardo M.,Prevention and Protection Unit | Foscoli R.,Prevention and Protection Unit | Pezzi R.,Biostatistics and Clinical Trials Unit | And 5 more authors.
Journal of Preventive Medicine and Hygiene | Year: 2016

Healthcare workers who use or may be exposed to needles are at risk of needlestick injuries. A which can lead to serious infections by bloodborne pathogens. These injuries can be avoided by eliminating the unnecessary use of needles and using safety devices. The present study was aimed at evaluating the impact of a safety-engineered device, with passive fully automatic needlestick protection, on the rate of needlestick injuries among healthcare workers. The setting of the study was a network of five public healthcare institutions situated in a Northern Italian Region. Data on the type of device, the number of employees and the number of catheter devices used per year were collected through regular meetings with healthcare workers over a period of five years. The most notable result of this study was the huge risk reduction associated with safety devices. Indeed, the risk of needlestick injuries due to conventional devices was found to be 25-fold higher than that observed for safety devices. However, it is noteworthy that a considerable part of this excess can be explained by the different background number of devices used. Moreover, descriptive analysis suggested that individuals with a poor/moderate training level had a lower risk than those with good/high training, though the difference was not statistically significant. In conclusion, there is convincing evidence of a causal connection between the introduction of safety devices and the reduction in needlestick injuries. This consideration should prompt the introduction of safety devices into daily clinical practice.


PubMed | Mutagenesis Unit, Prevention and Protection Unit, Occupational Needlestick Injuries Study Group and Biostatistics and Clinical Trials Unit
Type: Journal Article | Journal: Journal of preventive medicine and hygiene | Year: 2016

Healthcare workers who use or may be exposed to needles are at risk of needlestick injuries, which can lead to serious infections by bloodborne pathogens. These injuries can be avoided by eliminating the unnecessary use of needles and using safety devices. The present study was aimed at evaluating the impact of a safety-engineered device, with passive fully automatic needlestick protection, on the rate of needlestick injuries among healthcare workers. The setting of the study was a network of five public healthcare institutions situated in a Northern Italian Region. Data on the type of device, the number of employees and the number of catheter devices used per year were collected through regular meetings with healthcare workers over a period of five years. The most notable result of this study was the huge risk reduction associated with safety devices. Indeed, the risk of needlestick injuries due to conventional devices was found to be 25-fold higher than that observed for safety devices. However, it is noteworthy that a considerable part of this excess can be explained by the different background number of devices used. Moreover, descriptive analysis suggested that individuals with a poor/moderate training level had a lower risk than those with good/high training, though the difference was not statistically significant. In conclusion, there is convincing evidence of a causal connection between the introduction of safety devices and the reduction in needlestick injuries. This consideration should prompt the introduction of safety devices into daily clinical practice.

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