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Modena, Italy

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Modena, Italy
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Colosimo C.,University of Rome La Sapienza | Morgante L.,Messina University | Antonini A.,Parkinson Institute | Barone P.,University of Naples Federico II | And 26 more authors.
Journal of Neurology | Year: 2010

The PRIAMO study is a cross-sectional longitudinal observational study aimed at describing epidemiology and evolution of non-motor symptoms (NMS) in patients with different forms of parkinsonism recruited in 55 Italian centres and evaluated over 24 months. In this paper, we are reporting prevalence and clinical characteristics of NMS in patients with atypical and secondary parkinsonism. Out of 1307 consecutive patients with a diagnosis of parkinsonism, 83 patients had vascular parkinsonism (VP), 34 had multiple system atrophy (MSA), 30 had progressive supranuclear palsy (PSP), 14 had dementia with Lewy bodies (DLB) and 11 had corticobasal degeneration (CBD). MSA and DLB had the highest number of NMS domains and symptoms, respectively. Gastrointestinal symptoms, pain, urinary problems and postural instability due to orthostatic hypotension were most frequent in MSA. Sleep disturbances were also common with a prevalence of approximately 70% in all diagnostic groups but CBD (36%). Psychiatric symptoms and attention and memory impairment were frequently observed in all diagnoses but were most prevalent among DLB patients, whereas the prevalence of skin and respiratory disorders was rather low in all forms, ranging between 10 and 30%. Atypical parkinsonism patients also reported a low QoL, with no significant differences among the different forms, whereas PD and VP patients had a better QoL. © 2009 Springer-Verlag.


Abbruzzese G.,University of Genoa | Barone P.,University of Salerno | Fabbrini G.,University of Rome La Sapienza | Lessi P.,Boehringer Ingelheim | And 4 more authors.
Neurological Sciences | Year: 2015

To assess over a period of 9 months in a sample of Italian Parkinson’s disease (PD) patients reasons leading the neurologist to modify dopaminergic treatment and patients’ causes of dissatisfaction with ongoing therapy. To evaluate the influence of disease severity on therapy persistence. A disease severity balanced sample of PD patients with stable anti-parkinsonian drugs (APD) treatment was enrolled and evaluated every 3 months. Patients requiring APD treatment modifications were discontinued from the study. The probability to modify APD treatment is greater for higher motor (UPDRS scores) and non-motor symptoms (NMSS score) severity. Both from neurologist’s and patient’s perspective, motor symptoms were the main determinants underlying APD treatment modifications. Non-motor symptoms were cause of dissatisfaction with ongoing APD treatment for 52 % of the patients, while only 36 % of the neurologists considered these as valid reasons for therapy change. REASON is the first study in PD patients that prospectively examined reasons driving APD treatment changes. Results show that the disease severity significantly increases the probability of APD treatment change. Patients attribute greater relevance than neurologists to non-motor symptoms as reason requiring treatment changes. This confirms that patient and neurologist perceptions only partially overlap. © 2015, Springer-Verlag Italia.


PubMed | Azienda Ospedaliera di Treviglio Caravaggio, MediData srl, Azienda Ospedaliera di Perugia, Azienda Ospedaliera Santa Maria di Terni and 4 more.
Type: Journal Article | Journal: Lung cancer (Amsterdam, Netherlands) | Year: 2015

Clinical practice guidelines represent a key tool to improve quality and reduce variability of cancer care. In 2004, Italian Association of Medical Oncology (AIOM) launched the RIGHT (research for the identification of the most effective and highly accepted clinical guidelines for cancer treatment) program. The third step, RIGHT-3, evaluated the concordance between AIOM lung cancer guidelines and Italian clinical practice.RIGHT-3 was a retrospective observational study, conducted in 53 Italian centers treating lung cancer. Sampling from AIOM database of 230 centers was stratified by presence of thoracic surgery and geographic distribution. To describe the adherence to AIOM guidelines (2009 edition), 11 indicators regarding diagnostic and treatment procedures were identified. Patients with non-small-cell lung cancer (NSCLC) diagnosis who had first visit in 2010 were divided into 3 groups, based on TNM stage: I-II-IIIA (5 indicators), IIIB (3 indicators) and IV (3 indicators).708 patients were enrolled; 680 were eligible: 225 patients in stage I-II-IIIA; 156 patients in stage IIIB; 299 patients in stage IV. Cyto-histological diagnosis was available in 96%, 97%, 96% of stage I-II-IIIA, IIIB, IV respectively. Positron-emission tomography was performed in 64% of stage I-II-IIIA and 46% of stage IIIB. 88% of stage I-II patients eligible for surgery underwent lobectomy; after surgery, 61% of stage II and 57% of stage IIIA patients received adjuvant chemotherapy. Among stage IIIB patients who received combined chemo- radiotherapy, sequential approach was more common than concomitant treatment (86% vs. 14%). Among stage IV patients, 87% received platinum-based first-line treatment, and 70% received second-line.The RIGHT-3 study showed that, in 2010, adherence to Italian NSCLC guidelines was high for many indicators (including those related to treatment of stage IV patients), but lower for some diagnostic procedures. Guidelines adherence monitoring can be useful to reduce variability in cancer care.


PubMed | U.O. di Medicina Interna, Struttura Complessa Reumatologia, Pfizer, Ambulatorio Immuno Reumatologico and 8 more.
Type: | Journal: Clinical and experimental rheumatology | Year: 2016

Rheumatoid arthritis (RA) patients with moderate disease activity show progression of joint damage and have impaired quality of life, physical function, work and daily activities. Little is known about management of patients with moderate RA. The aim of the study was to assess the 1-year response to anti-TNF in biologic-nave RA patients with moderate (3.2 3.2 and 5.1), and were nave to anti-TNF treatment.Among 157 RA patients, 93 (59%) underwent etanercept, 43 (22%) adalimumab, 26 (17%) certolizumab, 10 golimumab and 2 infliximab; 80% of patients were still in treatment after 12-month observation. One-year clinical remission was achieved by 27 RA patients (21%), reduction of DAS28 score greater than 1.2 was observed in 75 (58%) patients. Moderate and good response according to EULAR criteria was observed in 59 (46%) and 45 (35%) patients, respectively.Results confirm the efficacy of anti-TNF alpha also in moderate RA patients, who may achieve a substantial decrease of disease activity, and improve their quality of life. The low rate of patients achieving remission may suggest that therapeutic strategies should be more timely and aggressive.


Amboni M.,IDC Hermitage Capodimonte Naples | Amboni M.,University of Salerno | Stocchi F.,Institute of Research and Medical Care | Abbruzzese G.,University of Genoa | And 11 more authors.
Parkinsonism and Related Disorders | Year: 2015

Freezing of Gait (FOG) is a common and disabling symptom in patients with Parkinson disease (PD). The relationship between FOG and dopaminergic medication is complex. The aim of the present study was to estimate the prevalence of self-reported FOG, its associated clinical features, and its relationship with wearing-off in a wide PD population.This is an observational multicenter study of 634 consecutive non-demented PD patients. Patients were identified either as freezers or non-freezers based on item-3 of the Freezing of Gait-Questionnaire. FOG was then classified as on, off and onoff freezing based on its relationship with wearing-off. Patients were assessed with Unified Parkinson's Disease Rating Scale, Hoehn and Yahr scale, 8-item Parkinson's disease Questionnaire, Mini-Mental State Examination.Data from 593 patients were analyzed, 325 (54.3%) were freezers of whom 200 (61.6%) experienced FOG only during off state (off-freezers), 6 (1.8%) only during on state and 119 (36.6%) either in on and off states or independently of dopaminergic response-related symptoms (onoff-freezers). Overall, freezers vs non-freezers had longer disease duration, more advanced disease and greater disability. Moreover, freezers more frequently reported wearing-off and experienced worse quality of life. Onoff-freezers vs off-freezers were older, more severely disabled, less likely to experience wearing-off, treated with lower levodopa equivalent daily dose and with poorer cognitive performance.Self-reported FOG is mainly recognizable in advanced PD and is associated with more disability and worse quality of life. Onoff-FOG may represent the result of under-treatment or rather interpretable as a distinct clinical entity. © 2015 Elsevier Ltd.


PubMed | University of Genoa, Medidata srl, University of Chieti Pescara, NeuroLogica and 7 more.
Type: Journal Article | Journal: Parkinsonism & related disorders | Year: 2015

Freezing of Gait (FOG) is a common and disabling symptom in patients with Parkinson disease (PD). The relationship between FOG and dopaminergic medication is complex. The aim of the present study was to estimate the prevalence of self-reported FOG, its associated clinical features, and its relationship with wearing-off in a wide PD population. This is an observational multicenter study of 634 consecutive non-demented PD patients. Patients were identified either as freezers or non-freezers based on item-3 of the Freezing of Gait-Questionnaire. FOG was then classified as on, off and onoff freezing based on its relationship with wearing-off. Patients were assessed with Unified Parkinsons Disease Rating Scale, Hoehn and Yahr scale, 8-item Parkinsons disease Questionnaire, Mini-Mental State Examination. Data from 593 patients were analyzed, 325 (54.3%) were freezers of whom 200 (61.6%) experienced FOG only during off state (off-freezers), 6 (1.8%) only during on state and 119 (36.6%) either in on and off states or independently of dopaminergic response-related symptoms (onoff-freezers). Overall, freezers vs non-freezers had longer disease duration, more advanced disease and greater disability. Moreover, freezers more frequently reported wearing-off and experienced worse quality of life. Onoff-freezers vs off-freezers were older, more severely disabled, less likely to experience wearing-off, treated with lower levodopa equivalent daily dose and with poorer cognitive performance. Self-reported FOG is mainly recognizable in advanced PD and is associated with more disability and worse quality of life. Onoff-FOG may represent the result of under-treatment or rather interpretable as a distinct clinical entity.


PubMed | University of Genoa, MediData srl, San Camillo Forlanini Hospital, Novartis and 4 more.
Type: | Journal: TheScientificWorldJournal | Year: 2015

The early detection of wearing-off in Parkinson disease (DEEP) observational study demonstrated that women with Parkinsons disease (PD) carry an increased risk (80.1%) for wearing-off (WO). This post hoc analysis of DEEP study evaluates gender differences on WO and associated phenomena.Patients on dopaminergic treatment for 1 year were included in this multicenter observational cross-sectional study. In a single visit, WO was diagnosed based on neurologist assessment as well as the use of the 19-item wearing-off questionnaire (WOQ-19); WO was defined for scores 2. Post hoc analyses were conducted to investigate gender difference for demographic and clinical features with respect to WO.Of 617 patients enrolled, 236 were women and 381 were men. Prevalence of WO was higher among women, according to both neurologists judgment (61.9% versus 53.8%, P = 0.045) and the WOQ-19 analysis (72.5% versus 64.0%, P = 0.034). In patients with WO (WOQ-19), women experienced 1 motor symptom in 72.5% versus 64.0% in men and 1 nonmotor symptom in 44.5% versus 36.7%, in men.Our results suggest WO as more common among women, for both motor and nonmotor symptoms. Prospective studies are warranted to investigate this potential gender-effect.


Stendardo A.,University of Pavia | Preite F.,Legal Study Miari Preite | Preite F.,MediData S.r.l | Gesuita R.,Marche Polytechnic University | And 2 more authors.
Epidemiology Biostatistics and Public Health | Year: 2013

The Observational Studies working group of the Italian Association of Medical Statistics and Clinical Epidemiology (SISMEC) has undertaken to study the impact of recent healthcare sector regulations on the legal and organisational aspects of managing all EMR databases with emphasis on Legislative Decree No. 196/2003 (the Italian Personal Data Protection Law). This paper examines six issues relating to theirs legal implications. The first section, "Confidentiality", provides definitions and the regulatory context for the terms confidentiality and personal data. In the second, "Nature of data held in electronic medical record archives", we discuss the problem of sensitive data and procedures to make the identification code anonymous. In "Data ownership" we highlight the difference between the data controller and the database controller. The fourth section, "Conditions for processing", discusses problems associated with using research data from one study in other investigations. In the fifth, "Patient consent", we address the problems related to patient consent. Finally in "Penalties" we outline the main civil and criminal liability issues applied in case of non-compliance with the provisions of the Personal Data Protection Code. Where possible, we provide suggestions on how to comply with the legal requirements of managing medical record archives in order to make it easier for researchers to remain in compliance with the relevant provisions.


Colombo D.,Novartis | Chimenti S.,University of Rome Tor Vergata | Grossi P.,Ospedale di Circolo e Fondazione Macchi | Marchesoni A.,Instituto Ortopedico Pini | And 6 more authors.
BioMed Research International | Year: 2014

We have prospectively evaluated psoriatic arthritis (PsA) patients for (1) seropositivity for former viral infections and seroconversion and (2) efficacy of cyclosporine A (CsA) alone or in combination with other immunosuppressants in a time period of 12 months. Screening included HBV antibodies and antigens, HCV antibodies and RNA, HSV 1-2, HZV, EBV, and CMV IgG, and IgM, HHV-6 DNA, and HIV 1-2 antibodies. PsA was evaluated by the Psoriasis Area Severity Index (PASI), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Visual Analogue Scale (VAS). At baseline, 126 (56%) out of 225 evaluable patients had 2 or more seropositivities indicative of former infections, and 31 patients (13.8%) presented seropositivity for HCV, HBV, HSV-1 and -2, HHV-6, EBV, or parvovirus infection; one of them, positive for HBAg, was treated with lamivudine, while the remaining 30 received no specific treatment. None of the 31 patients developed virus reactivation. A reduction (P<0.001) of PASI, BASDAI, and VAS scores was observed at 6 and 12 months. The treatment of PsA with CsA as monotherapy or in combination was safe and effective. In vitro experiments and clinical findings, including those from our study, suggest that CsA as monotherapy or in combination with biologics might be the treatment of choice in PsA HCV-positive patients. © 2014 Delia Colombo et al.


PubMed | Orthopaedic Institute Pini, MediData srl, University of Naples Federico II, S Orsola Malpighi Polyclinic and 3 more.
Type: | Journal: Clinical, cosmetic and investigational dermatology | Year: 2016

Sex medicine studies have shown that there are sex differences with regard to disease characteristics in immune-mediated inflammatory diseases, including psoriasis, in immune response and susceptibility to viral infections. We performed a post hoc analysis of the Observational Study of infectious events in psoriasis complicated by active psoriatic arthritis (SYNERGY) study in patients with psoriatic arthritis (PsA) treated with immunosuppressive regimens including cyclosporine, in order to evaluate potential between-sex differences in severity of disease and prevalence of viral infections.SYNERGY was an observational study conducted in 24 Italian dermatology clinics, which included 238 consecutively enrolled patients with PsA, under treatment with immunosuppressant regimens including cyclosporin A. In this post hoc analysis, patients demographical data and clinical characteristics of psoriasis, severity and activity of PsA, prevalence of seropositivity for at least one viral infection, and treatments administered for PsA and infections were compared between sexes.A total of 225 patients were evaluated in this post hoc analysis, and 121 (54%) were males. Demographic characteristics and concomitant diseases were comparable between sexes. Statistically significant sex differences were observed at baseline in Psoriasis Area and Severity Index score (higher in males), mean number of painful joints, Bath Ankylosing Spondylitis Disease Activity Index, and the global activity of disease assessed by patients (all higher in females). The percentage of patients with at least one seropositivity detected at baseline, indicative of concomitant or former viral infection, was significantly higher among women than among men. No between-sex differences were detected in other measures, at other time points, and in treatments. Patients developed no hepatitis B virus or hepatitis C virus reactivation during cyclosporine treatment.Our post hoc sex analysis suggests that women with PsA have a greater articular involvement and a higher activity of disease compared to males. Immunosuppressive treatment with cyclosporine seems not to increase susceptibility to new infections or infectious reactivations, with no sex differences.

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