Castelfranco Emilia, Italy
Castelfranco Emilia, Italy

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PubMed | Agenzia Sanitaria e Sociale Regionale, Instituto Ortopedico Rizzoli, Science Reumatologia, Servizio di Reumatologia and 3 more.
Type: | Journal: Clinical and experimental rheumatology | Year: 2017

To perform a population-based study in rheumatoid arthritis (RA) patients, in order to evaluate the efficacy and safety of pharmacologic treatments.1087 patients with RA were enrolled; inclusion criteria were: newly diagnosed RA, already diagnosed RA with high disease activity (HDA) (DAS284.2) starting biologic DMARDs (bDMARDs), already diagnosed RA with HDA continuing with conventional DMARDs (cDMARDs). The following data were collected: demographics, clinical and laboratory features, imaging and prescribed drugs. All parameters except immunology and imaging (performed yearly) were repeated at each follow-up evaluations (after 3, 6 and 12 months, and thereafter every 12 months). In order to evaluate clinical response, the EULAR response criteria were used as the gold standard.414 (38.1%) newly diagnosed patients with RA, 477 (43.9%) RA patients who started bDMARDs and 196 (18.0%) RA patients who continued with cDMARDs were enrolled from April 2012 to March 2015 at 12 Rheumatology Centres in the Emilia Romagna Region. Statistical analyses showed a relative risk ratio (RRR) for moderate response of 1.65 in RA patients who started bDMARDs (p=0.16) and 2.49 for newly diagnosed RA (p=0.01). Sex, age and Health Assessment Questionnaire were not statistically significant. A RRR of 2.00 has been confirmed for RA patients who started bDMARDs (p<0.0005) for a good response as well as 2.20 for newly diagnosed RA (p<0.0005). An increase in adverse events among bDMARDs was found, but when looking at infections or neoplasia, no differences were highlighted between RA which started bDMARDs and RA who continued with cDMARDs.Our results are in line with already published papers from British and Swedish Registries: a greater likelihood to have a good response is demonstrated for not longstanding RA starting cDMARDs or RA with HDA when a bDMARD is started. Also a good safety profile is demonstrated.


May C.R.,University of Southampton | Finch T.,Newcastle University | Ballini L.,Agenzia Sanitaria e Sociale Regionale | MacFarlane A.,National University of Ireland | And 4 more authors.
BMC Health Services Research | Year: 2011

Background: Normalization Process Theory (NPT) can be used to explain implementation processes in health care relating to new technologies and complex interventions. This paper describes the processes by which we developed a simplified version of NPT for use by clinicians, managers, and policy makers, and which could be embedded in a web-enabled toolkit and on-line users manual. Methods. Between 2006 and 2010 we undertook four tasks. (i) We presented NPT to potential and actual users in multiple workshops, seminars, and presentations. (ii) Using what we discovered from these meetings, we decided to create a simplified set of statements and explanations expressing core constructs of the theory (iii) We circulated these statements to a criterion sample of 60 researchers, clinicians and others, using SurveyMonkey to collect qualitative textual data about their criticisms of the statements. (iv) We then reconstructed the statements and explanations to meet users' criticisms, embedded them in a web-enabled toolkit, and beta tested this 'in the wild'. Results: On-line data collection was effective: over a four week period 50/60 participants responded using SurveyMonkey (40/60) or direct phone and email contact (10/60). An additional nine responses were received from people who had been sent the SurveyMonkey form by other respondents. Beta testing of the web enabled toolkit produced 13 responses, from 327 visits to http://www. normalizationprocess.org. Qualitative analysis of both sets of responses showed a high level of support for the statements but also showed that some statements poorly expressed their underlying constructs or overlapped with others. These were rewritten to take account of users' criticisms and then embedded in a web-enabled toolkit. As a result we were able translate the core constructs into a simplified set of statements that could be utilized by non-experts. Conclusion: Normalization Process Theory has been developed through transparent procedures at each stage of its life. The theory has been shown to be sufficiently robust to merit formal testing. This project has provided a user friendly version of NPT that can be embedded in a web-enabled toolkit and used as a heuristic device to think through implementation and integration problems. © 2011 May et al; licensee BioMed Central Ltd.


Vignali L.,University of Parma | Saia F.,University of Bologna | Belotti L.M.B.,Agenzia Sanitaria e Sociale Regionale | Solinas E.,University of Parma | And 6 more authors.
Catheterization and Cardiovascular Interventions | Year: 2015

Objectives The aim of this study was to compare long-term clinical outcomes in patients treated with new-generation drug-eluting stent (DES) or early-generation DES in a real-world registry. Background New-generation DESs have proved to be more effective and safer than early-generation DES in randomized trials. However, the effects of new-generation DES versus early-generation DES in everyday clinical practice deserve further verification. Methods A propensity-score and inverse-probability weighted analysis of 5,332 patients undergoing DES implantation (2,557 new-generation and 2,775 early-generation) between January 1, 2007 and June 30, 2011 was performed, with a median follow-up of 3 years. We assessed the incidence of major adverse cardiovascular events (MACE: all-cause death, nonfatal myocardial infarction [MI], and target vessel revascularization [TVR]), and angiographic stent thrombosis (ST) during follow-up. Results At 3-years, new-generation DES in comparison with early-generation DES were associated with a reduced risk of MI (5% versus 7.4%, hazard ratio [HR] = 0.65, 95% confidence interval [CI] = 0.51-0.82, P = 0.0004) and angiographic ST (0.5% vs. 1.1%, HR = 0.35, 95% CI 0.17-0.72, P = 0.004), whereas, the risk of TVR (10.9% vs. 13.5%; HR 0.99, 95% CI 0.84-1.16, P = 0.99) and overall MACE was not significantly different (19.2% vs. 22.4%, HR = 0.94, 95% CI = 0.83-1.07, P = 0.35). Conclusions Our data from a large all-comers multicenter registry confirm that, in comparison with early-generation DES, the use of new-generation DES is associated with similar efficacy and increased long-term safety, because of a reduced risk of ST and MI. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.


Allegranzi B.,First Global Patient Safety Challenge | Gayet-Ageron A.,University of Geneva | Damani N.,Craigavon Area Hospital | Bengaly L.,HOpital Gabriel Toure | And 8 more authors.
The Lancet Infectious Diseases | Year: 2013

Background: Health-care-associated infections are a major threat to patient safety worldwide. Transmission is mainly via the hands of health-care workers, but compliance with recommendations is usually low and effective improvement strategies are needed. We assessed the effect of WHO's strategy for improvement of hand hygiene in five countries. Methods: We did a quasi-experimental study between December, 2006, and December, 2008, at six pilot sites (55 departments in 43 hospitals) in Costa Rica, Italy, Mali, Pakistan, and Saudi Arabia. A step-wise approach in four 3-6 month phases was used to implement WHO's strategy and we assessed the hand-hygiene compliance of health-care workers and their knowledge, by questionnaire, of microbial transmission and hand-hygiene principles. We expressed compliance as the proportion of predefined opportunities met by hand-hygiene actions (ie, handwashing or hand rubbing). We assessed long-term sustainability of core strategy activities in April, 2010. Findings: We noted 21884 hand-hygiene opportunities during 1423 sessions before the intervention and 23746 opportunities during 1784 sessions after. Overall compliance increased from 51·0% before the intervention (95% CI 45·1-56·9) to 67·2% after (61·8-72·2). Compliance was independently associated with gross national income per head, with a greater effect of the intervention in low-income and middle-income countries (odds ratio [OR] 4·67, 95% CI 3·16-6·89; p<0·0001) than in high-income countries (2·19, 2·03-2·37; p<0·0001). Implementation had a major effect on compliance of health-care workers across all sites after adjustment for main confounders (OR 2·15, 1·99-2·32). Health-care-workers' knowledge improved at all sites with an increase in the average score from 18·7 (95% CI 17·8-19·7) to 24·7 (23·7-25·6) after educational sessions. 2 years after the intervention, all sites reported ongoing hand-hygiene activities with sustained or further improvement, including national scale-up. Interpretation: Implementation of WHO's hand-hygiene strategy is feasible and sustainable across a range of settings in different countries and leads to significant compliance and knowledge improvement in health-care workers, supporting recommendation for use worldwide. Funding: WHO, University of Geneva Hospitals, the Swiss National Science Foundation, Swiss Society of Public Health Administration and Hospital Pharmacists. © 2013 World Health Organization. Published by Elsevier Ltd/Inc/BV. All rights reserved.


Botturi D.,Agenzia Sanitaria e Sociale Regionale | Rodella S.,Agenzia Sanitaria e Sociale Regionale
Recenti Progressi in Medicina | Year: 2014

The concept of "patient-reported outcomes" have been proposed by the Food and Drug Administration in the year 2000, in order to describe one of the different and potential sources of information on the drug's safety and effectiveness. It represents an "umbrella" term, which covers a multiplicity of meanings and primarily identifies a conceptual approach and a methodology specifically oriented to the patients' point of view on outcomes, instead of the traditional clinical and professional perspective. The patient-reported outcomes measures are frequently selfcompleted questionnaires. The measures can be classified in general and specific. The first one, general, relates to the assessment of the quality of life or the health status, in the general population or in subgroups with particular health problems (eg. SF-36 Health Survey, EQ-5D). The second one, specific, mainly relates to the assessment of particular types of symptoms (eg. pain, anxiety, fear, depression) and functions (eg. daily living activities), in population's subgroups with definite health problems, undergoing or not to a healthcare procedure (eg. Adult Asthma Quality of Life Questionnaire, Kidney Disease Quality of Life Instrument, Oxford Hip Score, Oxford Knee Score). For the selection of an instrument a series of criteria needs to be taken into account, among which the psychometric properties, the expert judgement, the interpretability, the acceptability, and the feasibility of the entire process. Copyright - Il Pensiero Scientifico Editore.


Fabbri A.,Presidio | Servadei F.,Unit Operativa di Neurochirurgia | Marchesini G.,University of Bologna | Negro A.,Agenzia Sanitaria e Sociale Regionale | Vandelli A.,Presidio
Injury | Year: 2010

Objective: To explore the temporal trend of incidence, causes of injury and main characteristics of adolescent and adult subjects with mild head injury (MHI). Design: This study had a retrospective design. Setting: The study was conducted in a longitudinal database of an Italian Emergency Department (ED). Participants: The study comprised 19 124 consecutive subjects who visited and were managed within 24 h from the event, according to a predefined protocol for MHI from 1997 to 2008. Main outcome measures: Incidence, demography, cause of injury and characteristics of any post-traumatic intracranial lesion within 7 days from MHI. Results: The number of subjects with MHI decreased from 2019 per year (1997-1999) to 1232 per year (2006-2008; P for linear trend <0.001), without differences in the total number of subjects visited in the ED. The decrease was observed in all age-decades, in particular, in subjects in the age ranges of 20-29 and 30-39 years. Over time, the age of subjects with MHI lost a bimodal distribution, and the mean age increased from 43 (25-69) years (median (interquartile range)) in 1997-1999 to 56 (33-78) years in 2006-2008 (P < 0.001). The prevalence of falls increased from 36.5% to 55.0%, whereas crashes fell from 53.2% to 31.9%. The incidence of subdural haematoma (SDH) and epidural haematoma (EDH) did not change over time, whereas traumatic subarachnoid haemorrhage (t-SAH) and intra-cerebral haematoma/brain contusion (ICH) increased (from 0.7% to 1.9% and from 2.5% to 3.2%; P for trend: <0.001 for both. Conclusions: The incidence and the clinical characteristics of MHI subjects are rapidly changing in our setting. These data need to be considered in defining the effectiveness of preventive measures and deciding resource allocation. © 2009 Elsevier Ltd. All rights reserved.


Botturi D.,Agenzia Sanitaria e Sociale Regionale | Rodella S.,Agenzia Sanitaria e Sociale Regionale
Recenti Progressi in Medicina | Year: 2014

This paper describes the applications of the patient-reported outcome measures, focusing on the National Health Service (NHS) in the United Kingdom. Over the years the use of some related measures has widened, moving from research to clinical practice, and, only recently, to the healthcare quality assessment. The program launched by the United Kingdom Department of Health in April 2009 falls into the latter one, and requires the collection of patient-reported outcome measures for selected surgical procedures (hip or knee replacement, inguinal hernia, varicose veins) within all the health facilities financed by the National Health Service. Several of questionnaires are administered before and after the procedure, thus allowing to assess the health outcomes reported by the patient. From 2009 to 2013, the total number of questionnaires analyzed was high and steadily growing; in the period April 2009-March 2010 184.818 pre-procedure and 134.768 post-procedure questionnaires were completed by the patients and returned, with a 17% and 11% increase, respectively, compared to the previous period (April 2009-March 2010). The analysis of the United Kingdom's experience offers some reflections for the Italian Health Service with regard to some issues, such as the feasibility and the resources, the most appropriate methodology, and the professional culture. Copyright - Il Pensiero Scientifico Editore.


Bartoli S.,Agenzia Sanitaria e Sociale Regionale | Ferro S.,Servizio Presidi Ospedalieri | De Palma R.,Agenzia Sanitaria e Sociale Regionale
Italian Journal of Medicine | Year: 2012

Introduction: Chronic conditions represent an urgent health-care challenge for three main reasons: 1) their frequency is increasing all over the world, mainly as a result of longer life expectancy; 2) they require complex, long-term response that goes beyond the acute-care hospital setting; and 3) they place a heavy burden on health-care systems. Materials and methods: The authors conducted a critical review of the literature to obtain an overview of the theoretical frameworks and strategies that have been developed to tackle chronic diseases, with special emphasis on intermediate care. Results: Several frameworks and models of care delivery for people with long-term conditions were frequently discussed in the literature. Thus far, however, no consensus has been reached on the definition of "intermediate care". The authors report the experience of the Stroke Care program in the Emilia Romagna Region of Italy as an example of integrated care delivery. Discussion: The management of chronic diseases is considered a priority. Although there is no consensus definition of the term "intermediate care", the authors attempted to highlight its main characteristics. Their analysis of the Stroke Care program provides an illustration of how theory and practice are combined. © 2011 Elsevier Srl.


PubMed | University of Turin, University dellAquila, Agenzia sanitaria e sociale regionale, Applicate and University of Piemonte Orientale
Type: Journal Article | Journal: Epidemiologia e prevenzione | Year: 2016

to compare the methodological characteristics of the studies investigating the middle- and long-term health effects of the LAquila earthquake with the features of studies conducted after other earthquakes occurred in highincome Countries.a systematic comparison between the studies which evaluated the health effects of the LAquila earthquake (Central Italy, 6th April 2009) and those conducted after other earthquakes occurred in comparable settings.Medline, Scopus, and 6 sources of grey literature were systematically searched. Inclusion criteria comprised measurement of health outcomes at least one month after the earthquake, investigation of earthquakes occurred in high-income Countries, and presence of at least one temporal or geographical control group.out of 2,976 titles, 13 studies regarding the LAquila earthquake and 51 studies concerning other earthquakes were included. The LAquila and the Kobe/Hanshin- Awaji (Japan, 17th January 1995) earthquakes were the most investigated. Studies on the LAquila earthquake had a median sample size of 1,240 subjects, a median duration of 24 months, and used most frequently a cross sectional design (7/13). Studies on other earthquakes had a median sample size of 320 subjects, a median duration of 15 months, and used most frequently a time series design (19/51).the LAquila studies often focussed on mental health, while the earthquake effects on mortality, cardiovascular outcomes, and health systems were less frequently evaluated. A more intensive use of routine data could benefit future epidemiological surveillance in the aftermath of earthquakes.


PubMed | Thomas Jefferson University, Agenzia Sanitaria e Sociale Regionale and University of Bologna
Type: | Journal: Tumori | Year: 2016

Despite the preference of many patients to die at home, high proportions of patients with advanced cancer undergo major procedures, receive intensive care, and die in the hospital. The goal of this study is to examine variation in hospital utilization and site of death for patients dying with poor-prognosis cancer in the Regione Emilia-Romagna (RER), Italy.We conducted a retrospective, population-level study using administrative data. Patients were included if they died in 2012 and had at least one hospital admission for metastatic or poor-prognosis cancer within 180 days of death. Variations in the use of the hospital, intensive care, and procedures performed were evaluated.11,470 patients died with metastatic or poor-prognosis cancer in 2012. Seventy-eight percent of patients were hospitalized in the last month of life while 50.7% of patients died in the hospital. Results varied by local health authority from 38.3% to 69.3%. Of patients who had an ICU stay, 55.1% in the community hospitals and 59.8% in the teaching hospitals were admitted to the ICU on the day of death or the day before death. 7.5% of patients underwent a major procedure in the last 30 days of life.The overall high rate, and substantial variation, in hospital care at the end of life offers the RER the opportunity to evaluate if increasing availability of palliative care, along with provider and patient education, could reduce utilization of high-cost hospital care and increase patient and family satisfaction.

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