Laboratory for Mother and Child Health CESAV A. e A. Valenti Centre for Health Economics Laboratory of Clinical Epidemiology. Annual Report 2012

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1 Mario Negri Institute for Pharmacological Research IRCCS Laboratory for Mother and Child Health CESAV A. e A. Valenti Centre for Health Economics Laboratory of Clinical Epidemiology Annual Report 2012 Via G. La Masa Milan, Italy - Tel Telefax publichealth@marionegri.it

2 Since January 2013 the Laboratory of Medical Research and Consumer Involvement headed by Dr Paola Mosconi has been part of the Department of Public Health.

3 DEPARTMENT OF PUBLIC HEALTH REPORT 2012 CONTENT THE DEPARTMENT OF PUBLIC HEALTH pag 6 1 THE LABORATORY FOR MOTHER AND CHILD HEALTH pag Introduction pag The Staff pag Publications pag Publications in peer-reviewed journals pag Impact factor and H-Index pag Transfer of information pag Features pag Abstracs pag Research Activities pag Efficacy of Nebulised Beclometasone versus placebo in preventing viral wheezing in pre-school children. (ENBe) pag Pharmacoepidemiology in the Lombardy Region pag 18 a) Paediatric prescription profile of antibiotic drugs pag. 18 b) Generic drug prescribing pag. 19 c) Evaluation of diagnostic and therapeutic pathways of asthmatic children pag Prevalence of post-partum depression in mothers and fathers pag Fp7 Projects pag 21 a) TINN - Treat Infections in NeoNates pag 21 b) TINN2 - Treat Infections in NeoNates pag 21 c) COHEMI pag The Lombardy Region s ADHD Register pag Co-operation with countries with limited resources pag Other interventions/products pag 25 a) The activities of the Italian NGO Group for the CRC pag 26 b) Foster care families in Mantova pag 26 c) Summer School pag. 27 d) Drug utilization through administrative databases pag. 28 e) Lo sai Mamma ( Hey mom, did you know? ) pag 29 f) The Survey pag 30 - The prescriptions in paediatric outpatients pag 30 - Migrant and Health pag 30 - Evaluation of the assistance provided in the transition to adult ADHD services for patients in the national register pag 31

4 DEPARTMENT OF PUBLIC HEALTH REPORT 2011 g) The NewsLetters - ADHD pag 32 - ENBe pag 32 - COHEMI pag 33 h) Ricerca & Pratica pag And then pag Commissions and Committees pag 35 a) Technical commission for the elaboration of the regional therapeutic formulary pag 35 b) Ethics committee of Crema s Ospedale Maggiore pag Conferences, workshops, presentations, pag Other interventions/citations in the media and mass media pag Report pag Contributions, contracts, pag National collaborations pag International collaborations pag Editorial board membership pag Peer review activities pag 42 2 CESAV A. E A. VALENTI CENTRE FOR HEALTH ECONOMICS pag Introduction pag The Staff pag Publications pag Publications in peer-reviewed journals pag Impact Factor pag Transfer of information pag Research Activities pag Educational activities pag Economic evaluation of health care programs pag Comparative health policy analysis pag Quaderni di FarmacoEconomia pag And then pag Conferences, workshops, presentations, pag Contributions, contracts, pag National collaborations pag International collaborations pag Editorial board membership pag Peer review activities pag 53 4

5 REPORT 2012 DEPARTMENT OF PUBLIC HEALTH 3 LABORATORY OF CLINICAL EPIDEMIOLOGY pag Introduction pag The Staff pag Publications pag Publications in peer-reviewed journals pag Impact Factor pag Research activities pag Quality of care in the intensive care units pag Appropriateness of the intensive care units pag The reconstruction of clinical reasoning in medical practice and education pag An electronic health record to promote research in intensive care medicine pag Home artificial nutrition in Italy pag And then pag Commissions and Committees pag 63 a) Scientific council of the Interdisciplinary Research Centre for Human Sciences, Health and Disease. Department of Human Sciences, Bergamo University pag 63 b) Lombardy Region s technical group on cancer research pag 63 c) National Health Plan Research Commission, Emilia Romagna Region pag Conferences, workshops, presentations, pag Report pag Contributions, contracts, pag National collaborations pag International collaborations pag Editorial board membership pag Peer review activities pag 67 5

6 DEPARTMENT OF PUBLIC HEALTH REPORT THE DEPARTMENT OF PUBLIC HEALTH The main objectives of public health and of the department are to understand the underlying health factors of individuals and populations and to define efficient interventions to address health needs. Particular attention is therefore paid to prevention, in order to reduce the risk of disease, and to the dissemination of evidencebased, independent information. All this has to take into consideration the complexity of the National Health System (NHS), which must guarantee patients access to, and quality of, care, based on principles of equity and appropriateness, and must do so especially for patients that belong to the most vulnerable groups or populations. This is the contextual framework in which the Department of Public Health works. The Public Health Department is made up of: the Laboratory for Mother and Child Health, which is aimed at improving the overall welfare of mothers and children from birth and throughout development; the Centre for Health Economics (CESAV), which analyses the costs and benefits of interventions within the health system; the Laboratory of Clinical Epidemiology which operates mainly in intensive care and rare diseases. 6

7 REPORT 2012 DEPARTMENT OF PUBLIC HEALTH In addition to formal research activities, the department actively participates in, and organizes, initiatives promoting information, training, and debate aimed at both professionals in the health and social sectors and at the general public. With these objectives in mind, the department also publishes 2 journals: Ricerca&Pratica and Quaderni di Farmaco Economia. (the first related to transforming research results into clinical practice and the second dealing with economical aspects related to medicines) R&P was born in January 1985 as a feature of the Mario Negri Institute for Pharmacological Research; today the journal is enhanced by the collaboration of the most advanced Italian clinical research teams and of a group of independent national journals that belong to the International Society of Drug Bulletins. QdF, a quarterly journal published by CESAV on pharmacoeconomic information, designed as a tool to favour a critical approach to the economical aspects of the pharmaceutical sector among the NHS professionals, with particular reference to economic evaluations and to drug policies at the national and international levels. A total of 104 papers were published on peer reviewed scientific journals by the department s staff during The overall impact factor of these papers was The overall impact factor of the papers published during 2012 was

8 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2012 Laboratory FOR MOTHER AND CHILD HEALTH Via G. La Masa MILAN, Italy Tel fax mother_child@marionegri.it 8

9 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH INTRODUCTION Research, as a multidimensional approach to producing knowledge, characterises the laboratory s activity. Research provides the basis for planning and carrying out the laboratory s activity in a critical way and involves the participation of health professionals, social workers, mothers, children, and parents. Special attention is given to activities involving countries in the north and south of the world. The main objective of the Laboratory for Mother and Child Health is to ensure a better mother and child well-being by undertaking interdisciplinary and collaborative work in the field. Four broad areas, or spheres, of research have been selected: monitoring and epidemiological evaluation of utilisation and effects of drugs and vaccines; research methodology in general hospital and paediatric community practice; public health determinants of children s well-being; transfer of health information to the community. Each initiative is aimed at developing greater equity and appropriateness of care. 9

10 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT THE STAFF Laboratory Head Maurizio BONATI, MD Scientists Marina BIANCHI, MD PhD (part-time 75%) Rita CAMPI, STAT. D (part-time 75%) Chiara PANDOLFINI, PhD (part-time 75%) Research Fellow Massimo CARTABIA, STAT. D Valeria M CONFALONIERI, MD Consultant (part-time 75% - since September 1st) Filomena FORTINGUERRA, PHARM D Pharmacological Sciencies Research Doctorate Than Hang NGUYEN, MD Pharmacological Sciencies Research Doctorate Claudia PANSIERI, PHARM D (since 2/05/12) Michele ZANETTI, IT Anna DIDONI, PSYCHOL D (From 7/01/09 to 31/01/12) Francesca ML SEVERINO, PHILOS D (From 2/03/09 to 30/04/2012) Assistants Daniela MIGLIO Editorial Secretary of Ricerca&Pratica (part-time 75%) Nicoletta RASCHITELLI, SC MOT D Secretary of the Laboratory for Mother and Child Health and of the Department Visiting Scientists Aurora BONACCORSI, BIOL D Laura REALE, MD (since 2/07/12) Rossano REZZONICO, MD Gisele Silvestre BELBER, SC INF D (From 9/01/12 to 31/10/12) 10

11 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH Marta BORGHI, BIOL D (From 9/01/12 to 31/10/12) Anna IOMMARINI, PHARM D (From 1/10/11 to 20/01/12) Simona RIGGIERO, PHARM D (From 2/07/12 to 12/11/2012) Pharmacoepidemiology Unit Head of Unit Antonio CLAVENNA, MD PhD Research Fellow Daniele PIOVANI, PHARM D Marco SEQUI, STAT D (part-time 50%) Assistant Maria Grazia CALATI Secretary (part-time 75%) 11

12 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT PUBLICATIONS PUBLICATIONS IN PEER-REVIEWED JOURNALS Arcieri R, Germinario EAP, Bonati M, Masi G, Zuddas A, Vella S, Chiarotti F, Panei P and Italian regional reference centers. Cardiovascular Measures in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder Who Are New Users of Methylphenidate and Atomoxetine. Journal of Child and Adolescent Psycopharmacology 2012;22: IF: 2,884 Bianchi M, Clavenna A, Sequi M, Bortolotti A, Fortino I, Merlino L, Bonati M. Spirometry testing in a population of italian children: age and gender differences. Respiratory Medicine 2012;106(10): IF: 2,475 Bonati M, Clavenna A. Seasonal influenza immunization in early infancy? BMC Public Health 2012;12:873. IF: 1,997 Cartabia M, Campi R, Clavenna A, Bortolotti A, Fortino I, Merlino L, Bonati M. Geographical of antibacterials in the preschool age. Intern J Health Geographics 2012;11(1):52. IF: 2,617 Clavenna A, Cartabia M, Sequi M, Costantino A, Bortolotti A, Fortino I, Merlino L, Bonati M. Burden of psychiatric disorders in the pediatric population. Eur Neuropsychopharm 2012 ( j.euroneuro ); May 4[e-pub]. IF: 4,046 Gallo M, Clavenna A, Bonati M, Siani P, Irpino A, Rossi F, Capuano A and ADR Regional Study Group. Active surveillance of adverse drug reactions in children in five Italian paediatric wards. Open Journal of Pediatrics 2012;2: Fortinguerra F, Clavenna A, Bonati M. Ocular medicines in children. BMC Pediatrics 2012;12:8 [e-pub]. IF: 1,885 Kaguelidou F, Pandolfini C, Manzoni P, Choonara I, Bonati M, Jacqz-Aigrain E. European survey on the use of prophylactic fluconazole in Neonatal Intensive Care Units. Eur J Ped 2012;171: IF: 1,879 Pandolfini C, Sequi M, Jacqz-Aigrain E, Choonara I, Turner M, Manzoni P, Bonati M. Wide intra- and inter-country variability in drug use and dosage in very-low-birth-weight newborns with severe infections. Eur J Clin Pharmacol 2012; (doi: /s ) 5 Oct [e-pub]. IF: 2,516 Piovani D, Clavenna A, Cartabia M, Bonati M. The regional profile of antibiotic prescriptions in Italian outpatient children. Eur J Clin Pharmacol 2012;68: IF: 2,845 12

13 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH Review Sequi M, Campi R, Clavenna A, Bonati M. Methods in Pharmacoepidemiology: a review of statistical analyses applied in pediatric drug utilization studies. Eur J Clin Pharmacol 2012 (doi: /s y: e-pub) Jul 26. IF: 2,845 Letter Bonati M, Confalonieri V. Global rights for global diseases. The shortage of benznidazole case. Eur J Public Health 2012; forum/topic/eurpub_el%3b316 [e-pub]. IF: 2,728 Comment Bianchi M, Clavenna A, Bonati M. Age and number of prescriptions are relevant when estimating asthma prevalence. PLoS ONE 2012; B8FB75F956D6EECFB41F1?root=50785: e-pub. IF: 4, IMPACT FACTOR (IF) AND H-INDEX During the period the Laboratory published 51 papers on peerreviewed scientific journals, with a overall Impact Factor (IF) of In 2012, the overall IF of the 13 published papers was The H-index of the Laboratory's scientific studies is 30, with a total of 3,676 cited studies, including self-citations. Without auto-citations, the H-index is 23, with a total of 3,317 cited studies TRANSFER OF INFORMATION Bonati M. Vaccinare i neonati contro l influenza stagionale? Medico e Bambino 2012;31: Bonati M. Un anno di saudade! R&P 2012;167: Bonati M. Sandro Liberati: ragione e passione giocose. R&P 2012;163:3-4. Bonati M, Confalonieri V. The need of more equality for global health. The shortage of benznidazole case. R&P 2012;164: Campi R. Guida pratica al monitoraggio della CRC. R&P 2012;163: Clavenna A. La profilassi con vitamina K nel neonato. Medico e Bambino 2012;31:

14 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2012 Confalonieri V. QI vs QE: quoziente intellettivo vs quoziente emotivo. R&P 2012;165: Confalonieri V. Non smettere di interrogarsi sulle notizie in medicina. R&P 2012;167:225. Confalonieri V. Farmaco per ridurre la trasmissione sessuale dell HIV. R&P 2012;167: Guarnaccia S, Bianchi M, D Agata E, Boldini G, Pluda A, Boldi A, Clavenna A, Cartabia M, Bonati M. Valutazione dell efficacia di un percorso terapeuticoeducazionale nel migliorare il controllo dell asma in bambini e adolescenti. Medico & Bambino 2012; pagine elettroniche 15(9) Piovani D. I database amministrativi per la sorveglianza della sicurezza del farmaco. R&P 2012;167:223. Piovani D. Segnalazioni in rete. R&P 2012;166: Piovani D, Clavenna A, Sequi M, Cartabia M, Bortolotti A, Merlino L, Fortino I, Bonati M. Voce di spesa per antibiotici ai bambini in Lombardia: si puo' risparmiare. R&P 2012;164: Rezzonico R, Caccamo M L, Sanchez N, Parades S, Cartabia M, Froesch P, Cavalli F. Efficacia della ventilazione non invasiva neonatale a basso costo in Nicaragua. R&P 2012;167: Lay press Corriere della Sera Bonati M, Garattini S Sindaco, il garante per l'infanzia? (20 novembre 2012; pag. 7) FEATURES The laboratory has been running the Farmacipì feature in the Quaderni acp journal since 2006 and the Farmacia Clinica Pediatrica feature in the Giornale italiano di Farmacia Clinica since Clavenna A, Fortinguerra F, Piovani D. Bambini, malattie (più o meno) trascurate e accesso ai farmaci: cattive nuove e buone nuove. Quaderni acp 2012;19:39. Clavenna A, Fortinguerra F, Piovani D. Psicofarmaci e bambini: il monitoraggio è essenziale. Quaderni acp 2012;19:84. 14

15 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH Clavenna A, Fortinguerra F, Piovani D. Antibiotici: a chi troppi e a chi niente? Qualche autocitazione (forse di troppo) per riflettere sulla prescrizione di antibiotici in età pediatrica. Quaderni acp 2012;19:133. Clavenna A, Fortinguerra F, Piovani D. Cefalosporine per la faringotonsillite: una raccomandazione che lascia perplessi. Quaderni acp 2012;19:180. Clavenna A, Fortinguerra F, Piovani D. Farmaci e bambini: persiste il divario tra carico di malattia e sperimentazione clinica. Quaderni acp 2012;19: Fortinguerra F. Licenze d'uso ed etichette dei farmaci utilizzati in un reparto di oncologia pediatrica. Farmacia Clinica Pediatrica. GIFC 2012;26:45. Fortinguerra F. Le iniziative pediatriche nel mondo. A che punto siamo? Farmacia Clinica Pediatrica. GIFC 2012;26: The Laboratory collaborates with the Health supplement of the Corriere della Sera newspaper ( for information regarding drug use in pregnancy, breastfeeding and infancy. In particular, the Laboratory acts as moderator for a Forum concerning the drug use in pregnancy (Farmaci in gravidanza, and publishes posts in a blog dedicated to moms and dads ("Dubbi di mamma e papà", 15

16 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT ABSTRACTS Bianchi M, Clavenna A, Sequi M, Bortolotti A, Fortino I, Merlino L, Bonati M. Spirometry testing in a population of Italian asthmatic children. Pharmacoepidemiol Drug Saf 2012;21 SUPPL. 3: Clavenna A, Cartabia M, Costantino A, Bortolotti A, Fortino I, Merlino L, Bonati M. Burden of mental disorders in childhood estimate using administrative health data. Pharmacoepidemiol Drug Saf 2012;21 SUPPL. 3:150. Bonati M, Confalonieri V. Coordinating resources to assess and improve the health of migrants from Latin America (COHEMI). In: Abstract from 4 th Conference on Migrant and Ethic Minority Health in Europe. Università Bocconi, Milano June Giusti A, Farina ML, Clavenna A, Gruppo di Lavoro FARFALLA. Uso dei farmaci, farmacovigilanza e gestione dell allattamento. In: ISTISAN Congressi. XXI Seminario Nazionale La valutazione dell uso e della sicurezza dei farmaci: esperienze in Italia. ISS, Roma 10 dicembre /C6:41. Fortinguerra F, Bonati M. Antipsychotic agents, anxiolytics, hypnotic and sedatives during breastfeeding. In: Abstracts from the 16th International Society for Research in Human Milk and Lactation Conference for Breastfeeding Medicine. Breastfeeding Medicine 2012;7: Piovani D, Bortolotti A, Fortino I, Merlino L, Davoli M, Kirchmayer U, Aquilino A, Bux F, D Ettore A, Lepore V, Clavenna A, Bonati M. Prescrizioni antibiotiche nei bambini: comparazione multiregionale a livello di distretto. In: ISTISAN Congressi. XXI Seminario Nazionale La valutazione dell uso e della sicurezza dei farmaci: esperienze in Italia. ISS, Roma 10 dicembre /C6:72. Piovani D, Clavenna A, Bonati M. Antibiotic prescriptions in outpatient children: A multiregional comparison. Pharmacoepidemiol Drug Saf 2012;21 SUPPL. 3:130. Piovani D, Clavenna A, Fortinguerra F, Bonati M a nome del Gruppo di Lavoro PeFAB. Una lista essenziale dei farmaci per i bambini. Uno strumento prodotto da/per i pediatri di libera scelta. In: ISTISAN Congressi. XXI Seminario Nazionale La valutazione dell uso e della sicurezza dei farmaci: esperienze in Italia. ISS, Roma 10 dicembre 2012;12/C6:71. The laboratory s activity was made possible also with the help of the Institute s technicians and administrative service, and, especially, with the assistance of the G.A. Pfeiffer Library s personnel (Vanna Pistotti, Giusy Petruzzelli, Elena Alaimo), the photographers (Felice De Ceglie and Alessandro Soave), and Sergio Vicario of the press office. 16

17 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH 1.4 RESEARCH ACTIVITIES EFFICACY OF NEBULISED BECLOMETASONE VERSUS PLACEBO IN PREVENTING VIRAL WHEEZING IN PRE- SCHOOL CHILDREN. (ENBE) The Laboratory for Mother and Child Health coordinates the Efficacy Of Nebulised Beclometasone Versus Placebo In Preventing Viral Wheezing In Pre-School Children (ENBe) randomised controlled trial. The study is funded by the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) with a grant for independent research on drugs and it is performed in collaboration with the Associazione Culturale Pediatri and the "Angelo and Angela Valenti" Centre for Health Economics (CESAV). The ENBe study involved 40 family paediatricians in 9 Italian local health units (LHU) representative of geographical distribution and setting. The aim of the study was to evaluate the safety and effectiveness of beclometasone in preventing wheezing in viral upper respiratory tract infection (URTI). The study started in October 2010 and ended in October In all, 1371 children 1-5 years of age with upper respiratory tract infection and at least one viral wheezing episode in the 12 months preceding the visit were visited. A total of 525 children were enrolled: 319 males and 206 females, with a mean age of 2 years. The main reason for exclusion was the presence of wheezing at the entry visit (71% of the excluded children). Parents did not give consent for 20% of the eligible children. 264 children were randomized to beclometasone (400 mcg) and 261 to placebo. Both drug and placebo were administered twice daily through a nebuliser. The therapy lasted 10 days. 521 children were visited at the end of the treatment period and 507 completed the 6 month observational follow up period. The percentage of children with wheezing (diagnosed by the paediatrician) during the URTI episode was the primary outcome measure. 17

18 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT PHARMACOEPIDEMIOLOGY IN THE LOMBARDY REGION The Laboratory for Mother and Child Health is involved in the analysis of the drug prescription profile in children and adolescents in the EPIFARM (Epidemiologia del farmaco) project funded by the Lombardy Region. During 2011 the activities regarded, in particular, an evaluation of the: a) paediatric prescription profile of antibiotic drugs b) generic drug prescribing c) evaluation of diagnostic and therapeutic pathways of asthmatic children. a) Paediatric prescription profile of antibiotic drugs The evaluation of the antibiotic prescription profile focused on the analysis of territorial differences. Wide differences have been observed in antibiotic prescription prevalence rates. These differences are greater when comparing the municipalities and smaller when comparing Local Health Units (LHUs). Clusters of municipalities characterised by different prevalence rates have been found. In particular, the eastern part of the region is characterised by a higher prevalence rate, while in the northern part the prevalence is lower. There was no significant correlation between prevalence and hospitalisation rates, both at the district and the municipality levels. These data show that the differences municipalities with high prescription rates observed among geographical areas municipalities with low prescription rates do not seem to be related to differences in epidemiology of diseases; on the contrary, these differences may be due to a different prescribing attitude of the paediatricians. 18

19 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH b) Generic drug prescribing The evaluation of generic drug prescriptions was focused on antibiotics. Overall, 79% of antibiotic prescriptions involved off-patent drugs, but only 29% were generic drugs. Generic medicines covered about 15% of the total expenditure for antibiotics. The percentage of generic prescriptions varied among the different active substances from 6% (clarithromycin) to 72% (amoxicillin). Differences have been observed between Local Health Units, ranging from 12 to 48%. The average percentage of generic prescriptions per paediatrician was 38.5 (median 37.7). The percentage of generic drugs used was slightly lower for paediatricians classified as high prescribers with respect to their colleagues classified as low prescribers (median: 32.0 versus 40.6; p=0.02). The exclusive prescription of generic drugs for the four most prescribed antibiotics (amoxicillin, amoxicillin clavulanate, clarithromycin, and cefaclor) would have allowed the parents to save about Euros. c) Evaluation of diagnostic and therapeutic pathways in asthmatic children The Laboratory evaluated the diagnostic-therapeutic pathways of asthmatic children and adolescents (6-17 year olds) of the Lombardy Region prior to, and after, hospitalization for asthma (indicator of asthma attacks not manageable at home). 183 subjects undergoing an incident hospitalization for asthma (without hospitalization during the previous 24 months) were identified. 19

20 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT % of children and adolescents hospitalized did not receive anti-asthma therapy during the 12 months prior to hospitalization, and 23% did not receive any therapy also during the 12 months after hospitalization. 83% of children and adolescents with anti-asthma therapy before hospitalization received short acting ß2 agonists, 74% of whom in association with a controller therapy (mainly inhaled corticosteroids and long acting ß2 agonists) PREVALENCE OF POST-PARTUM DEPRESSION IN MOTHERS AND FATHERS The Laboratory for Mother and Child Health participates in the study Valutazione dell incidenza della depressione post-partum nelle madri e nei padri. (Evaluation of postpartum depression in mothers and fathers). The project is funded by the Local Health Unit Milan 1, and involves family paediatricians and mental health services. The aim of the study was to estimate the prevalence of post-partum depression in mothers and fathers, through a screening with the Edinburgh Postnatal Depression Scale performed in the paediatric primary care setting. The screening was proposed by paediatricians to parents of children born between 1 February and 31 July Parents with depressive symptoms were advised to contact a mental health service. In all, 4,128 EPDS were collected, 2705 completed by mothers and 1423 by fathers (for a total of 2727 newborns). The data analyses are ongoing. 20

21 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH FP7 PROJECTS a) TINN - TREAT INFECTIONS IN NEONATES The TINN project, Treat Infections in Neonates, is part of the European Union s Seventh Framework Project and is aimed at gathering the experience in the neonatal research field of numerous centres across Europe in order to produce detailed evidence on the safety and efficacy of ciprofloxacin and fluconazole use in neonatal sepsis. The final goal of the project is to obtain a Paediatric Use Marketing Authorization (PUMA) for the two drugs. A survey on the use of ciprofloxacin and fluconazole by neonatal intensive care units (NICU) in Europe was conducted in the first phase of the project (2009/2010) and 200 NICUs participated, representing 32 countries, mainly Italy, the UK, and France. The survey found great variability in therapeutic schemes and indications for use of the two drugs, both between and within countries. Significant doubts on the part of clinicians concerning safety and efficacy issues were also revealed, highlighting a need for additional evaluation and information on the optimal use of the drugs. The survey, however, also found a notable interest on the part of NICUs across Europe in participating in studies on the two drugs in order to obtain the necessary, lacking information. b) TINN2 The TINN2 (Treat Infections in Neonates 2) project began in January 2011 and is a complementary part of the first TINN project. It is also part of the European Union s 7th Framework Programme (GA ). TINN2 s aim is to study azithromycin, an antibiotic effective against Ureaplasma causing broncopulmonary dysplasia (BPD) in neonates. 21

22 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2012 BPD is one of the European Medicines Agency s selected therapeutic areas that need specific pharmacological assessments specific to neonates. The final goal of the TINN2 project is the PUMA (Pediatric Use Marketing Authorization). As for the first TINN, the initial stage of the project included a European survey intended to define the use of this antibiotic in the neonatal intensive care units (NICU), and to collect the opinion of senior neonatologists about its use in the treatment of Ureaplasma infections. Over 800 TIN, located in 28 different countries, have been selected and contacted and about 200 TIN have completed the entire questionnaire. The results show that there is still much uncertainty about the actual involvement of Ureaplasma in the development of BPD, azithromycin is a drug of first choice for the treatment of BPD, but there are still doubts about its safety and efficacy in neonates. c) COHEMI Coordinating resources to assess and improve health status of migrants from Latin America COHEMI Project- HEALTH Coordinating resources to assess and improve health status of migrants from Latin America- COHEMI Project- HEALTH European health systems are committed to meeting the challenge of understanding the needs of migrant populations and adapting their services to meet these needs. The difficulties inextricably linked to this challenge are caused by the complexity of migration patterns and the differences between migrant population across EU countries. Currently, the limited available data show that attempts to incorporate migrants health needs, in particular those of migrants from non-eu countries, into EU health systems have remained scattered and uncoordinated. In January 2011 a project called COHEMI-Coordination resources to Assess and Improve health status of migrants from Latin America, began. It is a threeyear project, funded under the 7th Framework Programme for Research and 22

23 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH Technological Development (Programme Cooperation- Health, GA ) that sees the Mario Negri Institute as coordinator of a major consortium of 10 partners located in Europe (Italy, Spain, The Netherlands and UK) and Latin America (Bolivia, Ecuador and Peru). COHEMI s general objective is to coordinate referral centres dealing with endemic Latin American (LA) diseases in order to: provide an analysis of health systems and legislation on migrants and assess the determinants of health; evaluate the care strategy of 3 diseases typical of LA countries (Chagas, Cisticercosis/Epilepsy, Strongyloidiasis); produce, as a product of the first two steps, new procedures and suggestions shared at the migration policies level, that take into account the specific cultural needs of migrants. Many bibliographic reviews have been carried out in the different specific sections of the project (health care organization and legislation, Chagas disease, Cisticercosis/Epilepsy, Strongyloidiasis, tuberculosis, hypertension and cardiovascular diseases, anthropological and socio-cultural aspects) and the study design for evaluating specific diseases has been defined. The work done has been shared among all the partners and presented at public scientific meetings in Italy and abroad. 23

24 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT THE LOMBARDY REGION S ADHD REGISTER The project called Sharing diagnostic-therapeutic approaches for ADHD in Lombardy was launched in January 2012 with funding from the Lombardy Region. The project involves 18 referral centres and the coordinator is the UONPIA (Child and Adolescent Neuropsychiatric Unit) of the A.O. Spedali Civili of Brescia. The project includes training initiatives for health care workers who provide assistance to ADHD patients and their families, initiatives to increase information on ADHD, and a regional register of ADHD cases. The register was designed as a disease registry and therefore collects information not only on patients diagnosed with ADHD under pharmacological treatment (as foreseen by the national register), but also on all potential ADHD patients who visit the referral centres. The register will then permit the: monitoring of diagnostic paths; outlining of the prevalence of the disorder; monitoring of non-drug treatment programs as well; continuation of pharmacovigilance by extending the monitoring on the use of the drugs, including drugs other than atomoxetine and methylphenidate; quantifying the workload for the referral centres The Register has been accessible to the 18 referral centers since June 30th, patients have been included, 520 of whom with a confirmed diagnosis, 219 without ADHD, and 262 still under evaluation. In most cases those who referred the patients to the centers have been the school (33%) and the parents (28%). Of the 520 patients with ascertained ADHD diagnosis, 54% received a prescription that involved non pharmacological therapy, 6% only pharmacological, 20% both, and the remaining patients is awaiting therapy. The most frequent comorbidities were learning disabilities (32%) and oppositional/defiant disorder (10%). 24

25 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH CO-OPERATION WITH COUNTRIES WITH LIMITED RESOURCES As an expression, test, and original method of expression of the choice to make the laboratory s research transferable and accessible to all populations, the laboratory promoted and provided assistance to projects in, and for, the South of the world, in collaboration with Non-Governmental Organizations (NGOs) and also with the World Health Organization. The technical and organisational support for carrying out socio-sanitary projects in countries with limited resources continues OTHER INTERVENTIONS/PRODUCTIONS In addition to the formal research activities, the laboratory promotes initiatives in the public health field, in particular those involving mother and child health care. The initiatives involve the participation in, and the organisation of, educational, training, and informationdissemination activities. The critical and active transfer of scientific knowledge is a continuous, daily stimulus to the laboratory s activity. 25

26 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2012 a) THE ACTIVITIES OF THE ITALIAN NGO GROUP FOR THE CRC The laboratory is part of the Working Group for the "Convention on the Rights of the Child" (CRC) in Italy. The Laboratory has actively contributed to the writing and distribution of the 5th update Report on the implementation of the UN Convention on the Rights of the Child (CRC) in Italy and its Optional Protocols, presented on 5 June During over ten years of collaborative work, participation in the CRC group was expanded to new associations, extending the monitoring of children s rights to cover new issues. CRC reports have a wide distribution throughout the country and represent a point of reference for updated content and references to specific standards and practices - not only for the organizations but also for institutions and professionals. The report is available at: b) FOSTER CARE FAMILIES IN MANTOVA Familynet Mantova is a project that aims to strengthen networks of available foster care families and to raise awareness among families in the community in order to support children living in difficult situations and foster families. The project will also activate a collaboration network between social services, associations, and cooperatives. In order to identify problems and needs and forms of support available to foster families, a study was undertaken that involved six districts of the province of Mantova. The information was gathered through interviews with the operators of social services and family care. The reported cases concern 53 children, 42 foster families, and 40 families of origin, constituted by both parents or by a single parent (40 mothers, 33 fathers). The types of fosters are: consensual (21%), judiciary (77%), and non-formalized (2%). 45% of fosters were set up before being formalized by a court order. The most frequent reasons that have contributed to foster care were severe neglect and abandonment, abuse, and death of a parent. Foster care was considered, by the operators, to be a succesful intervention with respect to the re-establishment of the parental role in 30% of cases, the welfare of the child in 89% of cases, and the ability of caregivers to best fulfill their role in 70% of cases. 26

27 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH Due to the heterogeneity of situations and needs documented it was not possible, however, to identify a specific type of support that could be considered useful in all cases. The project also highlighted the absence of systematic and detailed information on the conditions of the child as well as a lack of integration and working methods between the various parties involved in foster care (social services / child protection, associations, other services). c) SUMMER SCHOOL The laboratory has participated in the organization and promotion of the Summer School held in Avigliana (TO) from 31 May to 2 June The Summer School was designed not as training in the classical sense, but as a laboratory for research and innovation, aimed at health, social, and justice professionals. The school made available a method for creating local search paths that give visibility to the most fragile and vulnerable populations that risk having their right to health denied. Four workshops animated by four working groups formed by the promoters were organized on the following topics: 1) Programming the territory: measure the health and well-being; 2) Child-migrant-health; 3) Home care of people with serious health conditions; 4) Deprivation, segregation, health, and personal autonomy. The task of the laboratory was to facilitate the exchange of skills available for the construction of one or more ideas to be translated into a research protocol and presented to all participants of the summer school during the final afternoon. Materials are available at: Promoters: Lec Consorzio Negri Sud (S.Maria Imbaro; Chieti) Centro Studi del Gruppo Abele (Torino), Dipartimento di Salute Pubblica dell Istituto Mario Negri (Milano), Laboratorio Wiss della scuola Sant Anna/Dirpolis (Pisa), Acli Lombardia (Milano), Associazione Nazionale Cooperative Sociali Legacoop Comitato Regionale Emilia Romagna (Bologna) e Piemonte (Torino), ASGI (Torino), Libera (Roma), Fondazione Santi Medici (Bitonto; Bari). 27

28 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2012 d) DRUG UTILIZATION THROUGH ADMINISTRATIVE DATABASES A workshop entitled Drug utilization through administrative databases was held at the Mario Negri Institute on November 27. Numerous Italian groups that have, for years, been carrying out research and information activities promoting a rational use of drugs participated in the event. Despite the considerable contribution to scientific knowledge by the participants, also through publications on high-impact, international journals, this was the first time that a collegial debate and consideration on the tools and approaches used in the different national contexts was held. The first session concerned an analysis of the potentials and limits of the data sources which involved administrative databases and/or electronic health records, and the possibility of integrating different sources, connecting data on drug prescriptions with those concerning admissions, community level services, and health and social data. The second session concerned the various methods used by the research groups, with different focus points: a description of the population prescription profile, disease epidemiology, and an assessment of drug safety and treatment outcome. It is possible to view the workshop presentations: ftp://ftp.marionegri.it/workshop_durg_27novembre/ 28

29 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH e) LO SAI MAMMA (HEY MOM, DID YOU KNOW?) The laboratory, along with the Associazione Culturale Pediatri (Paediatricians Cultural Association) and the Federfarma Lombarda participates in the initiative Lo sai mamma? ( Mom, did you know? ). The initiative is aimed at providing mothers with information on their children s health through the creation of informational pamphlets distributed in pharmacies throughout the Lombardy Region. Faetures: 2005: Acido Folico; Viaggiare in Auto - la cinestosi; 2006: Febbre tosse mal d orecchio; Vacanza al mare - sole; Vomito diarrea; Punture d insetto; La pediculosi; Malattie Infettive - 1 PARTE; 2007: Malattie Infettive - 2 PARTE; Vitamine e Neonati; Stipsi; Ossiuri; Influenza; 2008: Celiachia; Impetigine (March); Acari e Allergie; HPV papilloma virus; Scabbia; Dermatite; 2010: Nati per leggere; Bambini e TV; Mononucleosi; Bambini e Internet; Epilessia e Maternità; Coliche nel Neonato; Depressione post parto 2011: SIDS morte in culla; Incidenti domestici; Nati per la musica; Igiene dentale; Sicurezza in bici, Sicurezza in moto 2012 Piedibus 38 Per una buona notte 39 Asma 40 La febbre nel bambino 41 Psoriasi

30 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2012 f) SURVEY - PRESCRIPTIONS IN PAEDIATRIC OUTPATIENTS A plethora of drugs are prescribed to paediatric outpatients, and only a limited amount of active substances is shared by the majority of paediatricians. The laboratory led a survey including 67 paediatricians working in the area of Monza and Brianza, which have been involved in cultural and educational initiatives concerning appropriateness of care for several years. The aim of the study was to identify the most common drugs among those prescribed in daily clinical practice, including those prescribed following a specialist s indication. A total of 35,381 packages were prescribed during two consecutive months: 86% were class A drugs, 7% were SOP/OTC, and 7% were class C. About 4% of prescriptions were filled following indication by a specialist. The drugs shared by at least half of the paediatricians were 8.4%, while those shared by over 75% of the paediatricians were 4.6% of the total. Five active substances were shared among all paediatricians: amoxicillin, salbutamol, betamethasone, cetirizine, and amoxicillin clavulanate. The study represents the first phase of a project whose aim is to identify a common therapeutic list. - MIGRANTS AND HEALTH As part of the activities performed by the Laboratory for the COHEMI project, a series of interviews to policy makers working in the field of migration was carried out in Italy on priority issues for the implementation and development of policies on the health of migrants. 30

31 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH - EVALUATION OF THE ASSISTANCE PROVIDED IN THE TRANSITION TO ADULT ADHD SERVICES FOR PATIENTS IN THE NATIONAL REGISTER The literature review highlights the fact that 40% of adolescents with ADHD may need to maintain therapy into adulthood, especially those who have one or more psychiatric comorbidities. Up to now, the prevalence of patients who have continued to access the territorial child neuropsychiatric services once they turned 18 years old, as well as the transition passages to adult psychiatric services, have not been formally assessed. For these reasons the project foresees the involvement of both the ADHD referral centres and the Lombardy Region s territorial child neuropsychiatric services. The main objective is to evaluate the current provision of assistance and the transition passage to adult ADHD services in order to: - perform a quantitative and qualitative analysis of ADHD subjects who have reached the adult age and of those who are almost adults (16-17 years); - analyse the procedures currently employed in the transition from child and adolescent neuropsychiatric services to adult psychiatry services and the difficulties in this passage; - set out shared procedures that can guarantee continued assistance while taking into consideration the needs of ADHD patients and their families. 31

32 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2012 g) THE NEWSLETTERS - ADHD The publication of ADHDNEWS continues. It is a laboratory initiative aimed mainly at providing a monthly bibliographic update of the recent scientific literature to those interested. By December 2012, 62 issues of the newsletter had been published and sent to the 420 people registered (137 psychiatrists and neuropsychiatrists, 75 psychologists, 72 medical doctors, 35 paediatricians, 25 members of school staff, and 76 others ) and 3549 scientific studies had been reported. The newsletter is available on the Mario Negri s website in the section L Istituto Mario Negri per il Medico : - ENBE As part of the study Efficacy Of Nebulised Beclometasone Versus Placebo In Preventing Viral Wheezing In Pre-School Children (ENBe) the Laboratory set up a newsletter aimed at providing investigators and interested health operators with a periodic bibliographic update of the recent scientific literature via . ENB e A total of 9 issues have been sent to 104 health professionals (mainly family paediatricians). The newsletter has identified a total of 127 scientific articles. enbe@marionegri.it 32

33 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH - COHEMI Publication of the of the COHEMI project s newsletter began in The newsletter, which is one of the project s official products, represents an information and updating tool for two types of users: health staff and members of the general public interested in migrant health, and COHEMI partners working on the project alongside the Mario Negri Institute. The version addressed to the general public includes a bibliographic update from the recent scientific literature on migrant health and diseases covered by the COHEMI project: Chagas disease, Strongyloidiasis, Cisticercosis, Tuberculosis, and Cardiovascular diseases. Those who wish to receive the newsletter may insert their address on the related section of the project webpage In addition to a bibliographical update, the version designed for the project s partners includes news and updates on the work performed and information on scheduled meetings and events. Two newsletters were published in 2011 and three in The COHEMI newsletter (2012 issues) is available on the Mario Negri s website in the section: L Istituto Mario Negri per il Medico : 33

34 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2012 h) RICERCA & PRATICA (R&P) Ricerca & Pratica was born in January, 1985, as a manifestation of the Mario Negri Institute for Pharmacological Research. Today, the journal is part of the International Society of Drug Bulletins (ISDB), which represents independent journals. For more than twenty years, the journal has represented an arena for all those professionals who collect data and carry out studies in general practice with the aim to increase their knowledge and to improve their practice. R&P is also appreciated for its ability to go beyond the merely clinical aspect of medicine, without, however, forgetting that it is to this aspect that the readers dedicate most of their time and effort. Through its activity, R&P can therefore represent an exclusive, independent observation point. It is also an area that promotes contemplation, evaluation, and information by applying of tools such as data trustworthiness and importance, the balance between benefits and risks and between benefits and costs, independence from conflicts of interest, and the realistic objective to contribute to a progressive, equally distributed improvement in the population s health. Editor: Maurizio Bonati Editorial board: Roberto Alfieri, Vittorio Bertelè, Guido Bertolini, Antonio Clavenna, Daniele Coen, Vittorio Demicheli, Paolo Longoni, Alessandro Nobili, Chiara Pandolfini, Giacomo Toffol Scientific Committee: Giancarlo Biasini, Albano Del Favero, Silvio Garattini, Valerio Reggi, Gianni Tognoni, Massimo Valsecchi, Giampaolo Velo Managing editor: Manuela Baroncini Secretary: Daniela Miglio ricercaepratica@marionegri.it 34

35 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH 1.5 AND THEN COMMISSIONS AND COMMITTEES a) TECHNICAL COMMISSION FOR THE ELABORATION OF THE REGIONAL THERAPEUTIC FORMULARY The Valle d Aosta Autonomous Region set up an agreement with the Mario Negri Pharmacological Research Institute, assigning the Laboratory, as temporary representative of the Mario Negri Institute, the periodic task of providing technical advice on the fulfillment of the following activities: updating and revision of the regional therapeutic formulary (PTR) predisposing opinions on trial protocols on pharmaceutical drug products and other therapeutic remedies creating documentation on topics on which the collaboration is based b) ETHICS COMMITTEE OF CREMA S OSPEDALE MAGGIORE The laboratory is part of the ethics committee of Crema s Ospedale Maggiore, which is an independent, interdisciplinary organisation. The ethics committee is responsible for guaranteeing the protection of the rights, safety, and well-being of people participating in any clinical trial on drugs, medical devices, or any diagnostic or innovative therapeutic procedures carried out at Crema s hospital, and to provide public guarantee of such protection CONFERENCES, WORKSHOPS, PRESENTATIONS, January PERCORSI DI CURA DEI DISTURBI NEUROPSICHIATRICI IN ETA EVOLUTIVA. Seminary Il Policlinico incontra il Mario Negri. Fondazione IRCCS Ca Granda; Milan. March ADHD IN ITALIA: PROSSIMO ANNO. IV ADHD. Workshop: Dalle evidenze alla pratica clinica. Università degli Studi di Cagliari, Dipartimento di Scienze Biomediche; Azienda Ospedaliero- Universitaria di Cagliari, Clinica di NeuroPsichiatria Infantile. Cagliari. LO SCREENING DELLA DEPRESSIONE POST PARTUM NEL SETTING DELLA PEDIATRIA DI FAMIGLIA. UNO STUDIO OSSERVAZIONALE CON I PLS DELLA ASL MILANO 1. Course: I disturbi psicopatologici nel periodo perinatale. Evidenze internazionali e nuove progettualità. Azienda Ospedaliera Guido Salvini Garbagnate Milanese e Regione Lombardia; Rho, (MI). 35

36 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2012 LA PRESCRIZIONE DEI FARMACI OFF-LABEL. Course: Agitazione psicomotoria: proposta di un percorso diagnostico terapeutico. Ospedale Niguarda Ca Granda; Milan. FARMACI, SALUTE, BAMBINI... Meeting Scuola Telethon. Istituto di Ricerche Farmacologiche Mario Negri; Milan. April EPIDEMIOLOGIA GEOGRAFICA DELLE PRESCRIZIONI DI ANTIBIOTICI. 13 Italian Conference: Utenti ESRI. Esri Italia Intelligenza del Territorio; Rome. May DIFFERENT TYPES OF PEDIATRIC RESEARCH. Course: Ethics of Pediatric Research. Università degli studi di Padova; Padova. THE TINN2 SAFETY AND ETHICS MONITORING BOARD PRESENTATION OF THE MEMBERS AND ON-GOING ACTIVITIES. Seminary: TINN2 First 18 months General Meeting. TINN2; Paris, Francie. LA PRESCRIZIONE DEI FARMACI IN ETA PEDIATRICA. FARMACI IN GRAVIDANZA E ALLATTAMENTO. Course. Associazione Culturali Pediatri (ACP); Brindisi. FARMACI ESSENZIALI: REPERIMENTO, CONSERVAZIONE, DISTRIBUZIONE. Course. Medici in Africa; Genoa. L INFORMAZIONE SULL USO DEI FARMACI IN ALLATTAMENTO. Formazione sull uso dei farmaci, farmacovigilanza e gestione dell allattamento (FARFALLA). Istituto Superiore di Sanità; Rome. June LA NASCITA E L INFANZIA, INDICATORI DI DIRITTO. Course Summer School (Salute e/è diritto. Popolazioni invisibili, competenze, networking. Certosa Gruppo Abele e LEC; Torino. VULNERABILITA /DISASTRO. Seminario Architettura per lo sviluppo. Architetti Senza Frontiere Italia e Fondazione Ordine Architetti P.P.C. Provincia di Milano; Milan. COORDINATING RESOURCES TO ASSESS AND IMPROVE THE HEALTH STATUS OF MIGRANTS FROM LATIN AMERICA (COHEMI). 4 th Conference on Migrant and Ethnic Minority Health in Europe: Facts Beiong Figures. Communi-Care for Migrants and Ethnic Minorities. Università Bocconi; Milan. REAZIONI AVVERSE IN GRAVIDANZA. Master Corso di Perfezionamento in Farmacovigilanza. Servizio di Epidemiologia e Farmacologia Preventiva; Milan. IL SELF HELP INFETTIVOLOGICO: PERCHE. Course Self help infettivologico. ASL Milano Regione Lombardia; Milan. FARMACI E BAMBINI. Course Scuola di specializzazione in Farmacia Ospedaliera. Università degli Studi di Milano; Milan. July L USO DEI FARMACI PER I BAMBINI. Course Summer Students. Istituto di Ricerche Farmacologiche Mario Negri; Milan. September TERAPIA PSICOFARMACOLOGICA NELL ETÀ EVOLUTIVA: USO RAZIONALE DEI FARMACI ADHD. Seminary Qualità delle cure in età pediatrica. Un Progetto da sostenere e difendere. Università degli Studi di Pavia, Scuola di Specializzazione in Neuropsichiatria Infantile, Pavia. FARMACI ESSENZIALI IN PEDIATRIA:UTILIZZO RAZIONALE NELLE PATOLOGIE INFETTIVE, RESPIRATORIE E GASTROENTERICHE. 2 National Congress SiMPeF Qualità delle cure in età pediatrica. Un Progetto da sostenere e difendere. Sindacato Medici Pediatri di Famiglia (SiMPeF); Baveno (VB). LA PRESCRIZIONE DI ANTIBIOTICI IN ETA PEDIATRICA. Course. Associazione per la Formazione permanente dei Pediatri altoatesini (AFPA); Bolzano. TERAPIA PSICOFARMACOLOGICA NELL ETÀ EVOLUTIVA: USO RAZIONALE DEI FARMACI ADHD, GTS, AUTISMO. Seminary Qualità delle cure in età pediatrica. Un Progetto da sostenere e difendere. Università degli Studi di Pavia, Scuola di Specializzazione in Neuropsichiatria Infantile, Pavia. 36

37 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH October MATERNAL HEALTH CONCERNS. 16th ISRHML Conference Breastfeeding and the Use of Human Milk. Science & Practice. International Society for Research in Human Milk and Lactation; Trieste. REGISTRO REGIONALE LOMBARDIA PER L ADHD. Congress ADHD dalla clinica, alla scuola, alla famiglia. Una sfida da vincere insieme. AIFA Onlus; Naples. LINEE GUIDA: COME SCEGLIERLE. Seminary Il medico e l industria della salute: rischi e benefici. ASL Cagliari; Associazione Culturali Pediatri (ACP); Associazione Nazionale cardiologi Extraospedalieri (ANCE). Cagliari. EFFICIENZA ED EFFICACIA DELLA PSICOFARMACOLOGIA NELL'ETÀ EVOLUTIVA. Seminary Qualità delle cure in età pediatrica. Un Progetto da sostenere e difendere. Università degli Studi di Pavia, Scuola di Specializzazione in Neuropsichiatria Infantile, Pavia. RESEARCH AND ACTIVITIES IN MOTHER AND CHILD HEALTH. European Master in Sustainable Regional Health System: Erasmus Mundus. IRFMN; Milan. FARMACOTERAPIA: FARMACI UTILI, INUTILI E FARMACI FUTILI. Meeting III Focus di Pediatria. Ospedale Sacro Cuore di Gesù Fatebenefratelli - U.O.C. di Pediatria Neonatologia - UTIN; Benevento. November IL MONITORAGGIO DEI PAZIENTI CON ADHD: ESPERIENZE REGIONALI ITALIANE. Corso di formazione Sindrome da Deficit Attentivo ed Iperattività. Scuola Umbra di Amministrazione Pubblica; Perugia. LE PRIORITÀ PER UNA PERSONA CON MALATTIA CRONICA. XVIII Italian Congress of the Fibrosi Cistica e VIII National Congresso f the Società Italiana per lo Studio della Fibrosi Cistica Ridefiniamo le priorità delle persone con FC. Società Italiana di Fibrosi Cistica; Tirrenia (PI). PROBLEMATICHE ETICHE DELL USO DEI FARMACI OFF-LABEL. 3 Convegno del progetto MEAP La farmacovigilanza tra Scienza ed Etica. Regione Lombardia e Ospedale Luigi Sacco; Milano. I FARMACI ANTI VEGF NEL NEONATO PREMATURO. IL PUNTO DI VISTA DEL FARMACOLOGO. 92 Congresso Nazionale SOI dove si incontrano i protagonisti dell oftalmologia. Società Oftalmologica Italiana; Roma. I FARMACI EQUIVALENTI. IL PROFILO PRESCRITTIVO DEI FARMACI IN PEDIATRIA. Corso di Aggiornamento Pediatri La prescrizione dei farmaci in pediatria. ASL di Taranto; Martina Franca (TA). December MOLTEPLICITA. Congress La sanità tra ragione e pasione. LIB talks; Bologna. FARMACI E BAMBINI. Course. Università degli Studi di Milano-Bicocca, Facoltà di Medicina e Chirurgia, Scuola di Specializzazione in Pediatria; Monza (MB) OTHER INTERVENTIONS/CITATIONS IN THE MEDIA AND MASS MEDIA January l'unità Farmaci, liberalizzando prezzi giù del 24% Cinotti E. (2 gennaio 2012; pag ) viveresani Stop allo sciroppo che calma i bambini Raviolo R. (20 gennaio 2012; pag ) left Troppe pillole ai bambini Bembina A. (13 gennaio 2012; pag. 64) MAMMEONLINE NET. Allattamento al seno, farmaci e cure mediche Carabetta M. (WEB) ( 37

38 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2012 e-coop (WEB) Anche per i generici è una corsa a ostacoli ( Quaderni ACP Uso razionale dei farmaci per i bambini e i loro genitori: un obiettivo dinamico e strategico Reali L. Quaderni acp 2012;19(1):48 NoiMamme (WEB) Farmaci e allattamento (ant /73/0/anche-per-i-generici-e-una-corsa-a-ostacoli.dhtml) February Insieme Streptococco che rebus! Bonetti A. (febbraio 2012; pag ) Panorama.it (WEB) Controllare il colesterolo a tutti i bambini? Mattalia D. In Italia sarebbe inutile ( 14 febbraio 2012) pubblibaby (WEB) SOS raffreddore Bisceglia A. ( febbraio 2012) Genitori Magazine (WEB) Piano Vaccini 2012, rimangono le differenze Domenici D. tra le Regioni italiane ( March Donna & Mamma Febbre che fare? Capelli F. (marzo 2012; pag. 32) Dica 33 (WEB) Farmaci in gravidanza, sicurezza Zazzetta S. per mamma e bambino ( 14 marzo 2012) Corriere della Sera (WEB) Psicofarmaci, se la cura è fai-da-te Valtolina G. (Blog - Solferino 28 anni /03/24/psicofarmaci-se-la-cura-e-fai-da-te/; 24 marzo2012) April Nostro Figlio (WEB) Farmaci, due su tre non hanno dati Bisceglia A; Pozzoli S. sull'uso durante allattamento e gravidanza ( 26 aprile 2012) Avvenire Farmaci online acquisti pericolosi Losito F. (1 aprile 2012; pag. 11) May Visto Contro i dolori più comuni non Frati R. impasticcarti... a caso (17 maggio 2012; pag ) June Panorama.it Il pediatra spiega i sintomi che precedono ANSA il colpo di calore ( 26 giugno 2012.) July Io e il mio bambino Mamma. Quando sole e farmaci Cozza G. (WEB) non vanno d'accordo ( luglio 2012) Milano Ogginotizie (WEB) Milano - Cresce il consumo di antidepressivi tra giovani a bambini ( 16 luglio 2012) Io e il mio bambino Farmaci: abuso no, buon uso si. Capelli F. (3 luglio 2012; pag. 18) 38

39 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH August Superquark Farmaci per bambini Pasquini A. (Rai 1) ( agosto 2012) September SEFAP (WEB) Profilo regionale di prescrizione degli antibiotici nei bambini ( 13 settembre 2012) WellMe.it (WEB) Farmaci in pediatria: ne basterebbero solo Giona F. 20 per curare i bambini ( Adnkronos Salute (WEB) SALUTE: 1,129 bambino iperattivicurati in Centri riferimento Lombardia. Meno casi che all'estero e minore ricorso ai farmaci. ( 20 settembre 2012) GoSalute (WEB) Qualcosa si muove per i bambini e gli adolescenti con disturbo da deficit attentivo e iperattività in Regione Lombardia ( 20 settembre 2012) clicmedicina (WEB) ( 24 settembre 2012) Supermoney News (WEB) Come ridurre le spese per i farmaci pediatrici Colao R. ( 24 settembre 2012) Dica 33 (WEB) Asma pediatrico: scarso il ricorso alla spirometria ( Quitidianosanità.it (WEB) Pediatria. In arrivo il "Prontuario dei farmaci essenziali" ( 18 settembre 2012) October Io e il mio Bambino Raffreddore D'Orsi L. (1 ottobre 2012; pag ) Panorama della Sanità Troppi Farmaci ai Bambini (1 ottobre 2012; pag. 46) Corriere della Sera.it Adhd ed esposizione al mercurio in gravidanza. Cuppini L. (WEB) Studio Usa ipotizza che ci sia un legame ( 10 ottobre 2012) Class MSNBC - Latti per l'infanzia TG della convenienza (25 ottobre 2012) RegioneLombardia Bimbi iperattivi: dal bilancio del Registro regionale (WEB) su 610 nuovi casi, solo 30% necessita di farmaci (28 ottobre 2012) November Lettera Donna Adhd, attente agli psicofarmaci Canzi G. ( December Io e il mio Bambino REPORT Farmaci ai bambini: meno è meglio (1 dicembre 2012; pag. 28) The Laboratory contributed to the report "Child Health in the European Union" editors Adriano Cattaneo, Laura Cogoy, Anna Macaluso, Giorgio Tamburlini, published by the European Commission.. [Report] 39

40 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT CONTRIBUTIONS, CONTRACTS, Brescia s A.O. Spedali Civili European Commission DG SANCO ICEI, Istituto Cooperazione Economica Internazionale. IRCCS Burlo Garofolo, Trieste IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano Italian Drug Agency, (AIFA) Lombardy Region Assessorato alla Sanità Milan Province Valle d'aosta Region Assessorato alla Sanità NATIONAL COLLABORATIONS Centro per la Salute del Bambino, (CSB) Cultural Paediatric Association, (ACP) Federfarma Lombardia Hospital of Brescia Spedali Civili Hospital of Bergamo Ospedali Riuniti, Poison Control Centre, Unit Clinical Toxicology Institute Don Calabra (CTD), Negrar Italian Drug Agency, (AIFA) Italian Global Health Watch (OISG) Italian National Institute of Health (ISS) Italian Society of Preparers Pharmacists (SIFAP) Il Pensiero Scientifico Editore Lombardy Region, Ministry of Health Operating unity of Neuropsychiatry of the childhood and of the adolescence, Foundation Policlinico di Milano, (UONPIA) Società Italiana di Farmacisti Preparatori (SIFAP) University of Florence, Departments Area Biomedical, Medical Surgical Critical Area University of Milan-Bicocca, Faculty Medicine, Paediatric Clinic 40

41 REPORT 2012 LABORATORY FOR MOTHER AND CHILD HEALTH INTERNATIONAL COLLABORATIONS Centre for Tropical Diseases (CECOMET), Ecuador Clínica Infantil Colsubsidio, Bogotà, Colombia Coletivo de Estudios Aplicado y Desarrollo Social Juan XXIII, Bolivia European Medicines Agency (EMA) European Society for Developmental, Perinatal and Paediatric Pharmacology (ESDPPP) European Union (EU) Fundació Privada Clinic per la Ricerca Biomedica, Spain Fundacion Salud Ambiente y Desarrollo, Ecuador Hospital Robert Debré, Paris, France International Society of Drug Bulletins (ISDB) Taller de Educacion y Comunicacion Guarani Asociacion, Bolivia World Health Organization (WHO) Universidad Peruana Cayetano Heredia, Perù University of Amsterdam, Universiteit Van Amsterdam, Netherlands University College London Hospital NHS Fuondation Trust, United Kingdom University of Nottingham, Derbyshire Children s Hospital, Derby, United Kingdom Universidad Peruana Cayetano Heredia, Perù EDITORIAL BOARD MEMBERSHIP International: European Journal Clinical Pharmacology; Revista Paulista de Pediatria; Journal of Clinical Pharmacology & Pharmacoepidemiology; Saludarte. National: Dialogo sui Farmaci; Disturbi d Attenzione e Iperattività; Quaderni di Farmacoeconomia; Ricerca & Pratica. 41

42 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT PEER REVIEW ACTIVITIES International: Acta Paediatrica; Annals of African Medicine; Archives of Disease in Childhood; Basic & Clinical Pharmacology & Toxicology; BMC Clinical Pharmacology; BMJ Open; Breastfeeding Medicine; British Journal of Clinical Pharmacology; European Child and Adolescent Psychiatry; European Journal of Clinical Pharmacology; Expert Opinion On Drug Safety; Health and Quality of Life Outcome; Infection; International Journal of Tropical Disease & Health; Italian Journal of Pediatrics; Journal of Child Health Care; Springer Plus; Pharmacoepidemiology and Drug Safety; Pediatric Pulmonology; Pediatrics; PLoS ONE; The Journal of Pediatrics; The Pediatric Infectious Disease Journal. National: Dialogo sui Farmaci; Medico e Bambino; Quaderni ACP. 42

43 CESAV Angelo e Angela VALENTI CENTRE FOR HEALTH ECONOMICS CLINICAL RESEARCH CENTER OF RARE DISEASES ALDO E CELE DACCÒ Via Camozzi 3, Ranica (BG) Tel , Fax lgarattini@marionegri.it 43

44 CESAV REPORT INTRODUCTION The "Angelo e Angela Valenti" Centre for Health Economics (CESAV) was established in 1992 at the "M. Negri Institute" and based at Villa Camozzi- Ranica (Bergamo)-Italy. CESAV is primarily a research centre, but also does educational work. The centre is involved in health economics and health policy research. The main areas of research are: Economic Evaluation of Health Care Programs (i.e. assessment of costs and benefits of alternative health care treatments and services) and Comparative Health Policy Analysis (i.e. study of domestic and foreign health care systems, in particular aimed at identifying possible innovations for European countries). 44

45 REPORT 2011 CESAV 2.2 THE STAFF Laboratory Head Livio GARATTINI, ECON D Research Fellow Alessandro CURTO, ECON D Roberta LO MUTO, BIOTECH D Katelijne VAN DE VOOREN, PHARM D. Visiting Scientists Gianluigi CASADEI, MD Paola DE COMPADRI, ECON D Silvy DURANTI, DOTT. ECON. Simone GHISLANDI, ECON D 45

46 CESAV REPORT PUBLICATIONS PUBLICATIONS IN PEER-REVIEWED JOURNALS Curto A, van de Vooren K, Bonati M, Garattini L. The model to calculate the economic burden of HPV-related diseases in Italy lacks transparency and contains flaws. Plos ONE action;jsessionid=7d534db49b1bbc5db180349f5676e9ca?root=60089 [e-pub]. IF: 4,092 Garattini L, Van de Vooren K. Extending HPV vaccination to boys: an economic perspective. BMJ 13 Jan /01/13/re-should-hpv-vaccine-be-given-men. [e-pub] IF: 14,093 Garattini L, Van de Vooren K. HPV vaccination for boys? Talking economic sense for the Journal of Sexual Medicine. Journal of Sexual Medicine 2012;9(8):1-2. IF: 3,552 Garattini L, Van de Vooren K. Could co-payments on drugs help to make EU health care systems less open to political influence? Eur J Health Econ 2012 Sep 9 [e-pub ahead of print] Garattini L, Van de Vooren K, Curto A. Pricing Human Papillomavirus Vaccines, Lessons from Italy. PharmacoEconomics 2012;30: IF: 2,663 Garattini L, Van de Vooren K, Curto A. Human papillomavirus vaccination is not exclusively a matter of price. The author's reply. PharmacoEconomics 2012;30(5): IF: 2,663 Garattini L, Van de Vooren K, Curto A. Will the reform of community pharmacies in Italy be of benefit to patients or the Italian National Health Service? Drugs and Therapy Perspectives 2012;28(11): Garattini L, de Vooren K, Curto A. Regional HTA in Italy: promising or confusing? Health Policy 2012;108(2-3): IF: 1,506 Raho G, Koleva D, Garattini L, Naldi L. The Burden of Moderate to Severe Psoriasis: An Overview. PharmacoEconomics 2012;30: IF: 2, IMPACT FACTOR (IF) A total of 27 papers were published on peer-reviewed scientific journals by the laboratory s staff during the period. The overall impact factor of these papers was The overall impact factor of the 8 papers published during 2012 was

47 REPORT 2011 CESAV TRANSFER OF INFORMATION Casadei G, Garattini L. Liberalizzazioni in farmacia: Cosa cambia e cosa cambiare? Dialogo sui Farmaci 2012;1: Casadei G. Recessione economica e HTA: una sinergia da sviluppare. QdF 2012;18:5-7. Casadei G, Garattini L. Liberalizzazioni e farmacie: eppur si muove. R&P 2012;165: Casadei G. Farmaci oncologici e tempi di accesso al mercato in Italia. R&P 2012;28 (6): Curto A, Garattini L. Estensione della vaccinazione HPV ai maschi: una chiave di lettura economica. QdF 2012;17:5-8. Curto A, Garattini L. Liberalizzazioni dei farmaci. Consumatori, Diritti e Mercato 2012;2: Curto A, Garattini L. Liberalizzazioni in farmacia: un analisi della riforma in prospettiva europea. QdF 2012;18: Curto A, Lo Muto R, Casadei G. Health Technology Assessment a livello regionale: fra mito e realtà. QdF 2012;17: Curto A, Van de Vooren K, Garattini L. Compartecipazione alla spesa farmaceutica in una prospettiva europea. QdF 2012;19: Garattini L. Decretone Balduzzi : basteranno i buoni propositi. QdF 2012;19:5-7. Lo Muto R, Caiazzo M, Fabiano V, Giacomet V, Rampon O, Garattini L. Il costo delle infezioni HIV in età pediatrica. Quaderni di Farmaco Economia 2012;18:8-16. Lo Muto R, Curto A. Revisione delle valutazioni economiche sul Cetuximab applicato al CCR. QdF 2012;17:8-21. Lo Muto R, Curto A, De Compadri P, Garattini L. Assistenza domiciliare: revisione critica delle valutazioni economiche in Europa. QdF 2012;19:

48 CESAV REPORT RESEARCH ACTIVITIES EDUCATIONAL ACTIVITIES Educational activities are developed only if related to research studies, in order to offer original contributions which naturally reinforce the research aims ECONOMIC EVALUATION OF HEALTH CARE PROGRAMS The main objective of this line of research is to assess the economic impact of diseases and diagnostic and therapeutic alternatives available. In general, analyses can be classified into two groups: observational studies on the costs of a disease or economic evaluation studies (usually cost-effectiveness analyses). In the first case the method employed consists of studying cohorts of patients with the same disease for a significant period of time, in order to check health care resource consumption and to then calculate the unit costs of individual exams/visits. The goal, especially in hospitals, is to estimate unit costs through the centers accounting data, when available. 48

49 REPORT 2011 CESAV In the second case, the cost analysis is performed in addition to an assessment of the effectiveness of the alternatives taken into account (clinical information on treatments analyzed is therefore collected) in order to calculate the cost-effectiveness ratio COMPARATIVE HEALTH POLICY ANALYSIS The main objective of this line of research is to study the organization of health care systems in order to construe suggestions from their systematic comparison. The choices made by national legislators, as a consequence of each country s common problems, can vary greatly from one country to another. Government intervention is usually present in every country, although it may vary greatly because the health service does not have regulatory market mechanisms related to the law of supply and demand. The comparative analysis of these choices at the international level is therefore useful in verifying the level of rationality achieved by each national health policy. CESAV s work provides for a more thorough understanding of the institutional framework, the main services provided, and the financial management of the evaluated system in order to produce the most comprehensive description possible, leading to a set of positive and negative indications concerning the system s efficacy. 49

50 CESAV REPORT QUADERNI DI FARMACOECONOMIA QdF is a quarterly journal of pharmacoeconomics published by CESAV. It is designed as a tool to favour a critical approach to the economic aspects of the pharmaceutical sector among NHS professionals, with particular reference to economic evaluations and drug policies at the national and international levels. It was first published in 2006 with the aim to keep the "voice" of independent research alive and to improve the critical skills of Italy s health workers. The editors of QdF believe in the importance of offering the chance to receive updates and critical inputs on pharmacoeconomy to health system operators without a strong background on the subject. The ultimate goal is a context in which those working in this field won t have the illusion of finding a "magic solution" and won t accept for gold everything that is published. There is a critical risk, however, of disappointment in the long run and a loss of credibility in the pharmacoeconomy field. This magazine represents an opportunity to read the more debated economic and drug policy issues with a critical mind and adequate tools. Editor: Livio Garattini WEB coordination: Gianluigi Casadei Editorial coordination: Alberto Salmona Editorial board: Antonella Barale, Corrado Barbui, Ettore Beghi, Maurizio Bonati, Gianluigi Casadei, Enrica Daina, Roberto Dall Aglio, Giovanni Fattore, Ida Fortino, Loredano Giorni, Roberto Grilli, Luigi Mezzalira, Fulvio Moirano, Alessandro Nobili, Luigi Patregnani, Rosa Prato, Riccardo Roni, Giovanna Scroccaro, Francesca Tosolini, Gianvincenzo Zuccotti. WEB Secretery: Marzia Manasse 50

51 REPORT 2011 CESAV 2.5 AND THEN CONFERENCES, WORKSHOPS, PRESENTATIONS, April CO-PAYMENTS ON DRUGS IN WESTERN EUROPEAN COUNTRIES. ETHICS AS A RISING ISSUE FOR TARGETED THERAPIES: THE METASTATIC COLORECTAL EXAMPLE. Congress First Bosnian-Herzegovinian and second adriatic congress on pharmacoeconomics and outcomes research. Sarajevo. May LA SPECIFICITÀ DELLE FARMACIE. LA SITUAZIONE NEI VARI PAESI EUROPEI. FOCUS SU REGNO UNITO E OLANDA. HTA: STATO DELL ARTE A LIVELLO REGIONALE. REVISIONE CRITICA DELLE VALUTAZIONI ECONOMICHE PIÙ RECENTI. Congress Economia del farmaco- Fra soluzioni tecniche e decisioni politiche. CESAV; Ranica (BG). June LE POLITICHE SANITARIE E SOCIALI NEL CONTESTO ECONOMICO: ANALISI COSTO/EFFICACIA DELLE CURE DOMICILIARI. Congress Home care, le cure domiciliari nella medicina della complessità. Centro studi cure domiciliari, Università degli studi di Milano, Homecare Europe, Pio Albergo Trivulzio; Milan. I FARMACI BIOSIMILARI: LA FARMACOECONOMIA. Congress L oggi e il domani, costi e prospettive dei farmaci in onco-ematologia per un futuro sostenibile. EVERywhERE; Udine. BIOSIMILARI INTRODUZIONE. SVILUPPO E PRODUZIONE DEI BIOSIMILARI: ASPETTI BIOTECNOLOGI. INQUADRAMENTO GENERALE SULLA NORMATIVA RIFERITA AI BIOSIMILARI: LA SITUAZIONE A LIVELLO EUROPEO E ITALIANO. Congress Ematologia e biosimilari. Regione Lombardia; Milan. September SEMEJANZAS Y DIFERENCIAS EN LAS REFORMAS SANITARIAS ITALIANA Y ESPAÑOLA: DESCENTRALIZACIÓN, CARTERA DE SERVICIOS, E INCORPORACIÓN DE LA INNOVACIÓN, CONCLUSIONES. Congress Las Reformas Sanitarias en España e Italia: Descentralización, Cartera de Servicios, e incorporación de la Innovación. Pharma Mar (gruppo Zeltia); Madrid. October I FARMACI BIOSIMILARI: LE POLITICHE REGIONALI DEL FARMACO. Congress I farmaci biosimilari, un impiego intelligente di risorse. ASL di Bergamo; Bergamo. December IMPATTO ECONOMICO DELLA MALATTIA DIABETICA NELLA PROGRAMMAZIONE SANITARIA. IL SIGNIFICATO DEGLI INDICATORI DI EFFICIENZA TERAPEUTICA E METODOLOGIE DI CONFRONTO. PROFILI COSTO-EFFICACIA DELLE CURE PER IL DIABETE. Convegno Il protocollo di gestione del paziente diabetico. Accura; Lecco. 51

52 CESAV REPORT CONTRIBUTIONS, CONTRACTS, Abbott Astra Zeneca AIFA Boehringer-Ingelheim Daiichi Sankyo Eisai Grunenthal-Prodotti Formenti Hospira Novartis Sanofi Aventis Sanofi Pasteur MSD Nycomed Vivisol NATIONAL COLLABORATIONS Collaborations with private institutions (companies of associations in the sector). Public national institutions (Public Health Ministry, Regional Councillorship, Local Health Units, Hospitals) INTERNATIONAL COLLABORATIONS CES (Collège des Economistes de la Santé) of Paris Corvinus University of Budapest Global Fund of Geneva WidO of Bonn Servicio Canario de la Salud, S/C de Tenerife University of Birmingham University of Hannover University of York University Pompeu Fabra of Barcelona University Erasmus of Rotterdam 52

53 REPORT 2011 CESAV EDITORIAL BOARD MEMBERSHIP International: Acta Bio Medica; Applied Health Economics and Health Policy; Biomedical Statistics and Clinical Epidemiology; BMC-Health Services Research; Health Policy; Journal of Medical Economics; The European Journal of Health Economics. National: FarmacoEconomia News; Farmeconomia e Percorsi Terapeutici; L'Internista; PharmacoEconomics Italian Research Articles; Quaderni di FarmacoEconomia PEER REVIEW ACTIVITIES Applied Health Economics and Health Policy; BMC-Health Services Research; Health Policy; PharmacoEconomics; The European Journal of Health Economics; Epilepsia; British Medical Journal. 53

54 Laboratory of CLINICAL EPIDEMIOLOGY CLINIC RESEARCH OF DISEASES ALDO E CELE DACCÒ Via Camozzi 3, Ranica (BG) Tel , Fax giviti@marionegri.it 54

55 REPORT 2011 LABORATORY OF CLINICAL EPIDEMIOLOGY INTRODUCTION The general aim of the Laboratory of Clinical Epidemiology is to contribute to the improvement of health care in different medical fields. There are two main guiding principles: to help physicians in using the available knowledge and resources at their best, and to contribute to the growth of applied knowledge for clinical practice. The laboratory operates in the field of Intensive Care Medicine and Rare Diseases. Within the Laboratory, the Unit of Clinical Knowledge Engineering aims to bring the value of clinical reasoning out, through the implementation of probabilistic models for its formalization, thus favoring the evaluation and the continuous improvement of complex clinical activities. The main area of activity of the Unit of Computer Methods and Programs for Clinical Research is the development of an electronic case report form for the ICU that would be able to conjugate the needs of clinical practice with those of clinical research, with the aim of closing the gap between the two. 55

56 LABORATORY OF CLINICAL EPIDEMIOLOGY REPORT THE STAFF Laboratory Head Guido BERTOLINI, MD Scientists Mauro BIANCHI, IT ENG Consultant Obou BRISSY, IT D Specialist in Biomedical Research Daniele CRESPI, IT Matteo MONDINI, IT D Consultant Giovanni NATTINO, MAT D Specialist in Biomedical Research Carlotta ROSSI, STAT D (part-time 75%) Claudio PREVITALI, IT D Specialist in Biomedical Research Michele GIARDINO, IT Technical Giampiero TRUSSARDI, IT Simone GHETTI, IT ENG (dal 6/07/10 al 1/03/12) Assistent Luana NAVA Secretary Visiting Scientist Simone PIVA, MD (dal 7/01/09 al 1/01/12) Clinical Knowledge Engineering Unit Unit Head Davide LUCIANI, MD 56

57 REPORT 2011 LABORATORY OF CLINICAL EPIDEMIOLOGY PUBLICATIONS PUBLICATIONS IN PEER-REVIEWED JOURNALS Bonaldi G, Bertolini G, Marrocu A, Cianfoni A. Posterior Vertebral Arch Cement Augmentation (Spinoplasty) to Prevent Fracture of Spinous Processes after Interspinous Spacer Implant. AJNR Am J Neuroradiol 2012;33: IF: 2,928 Gatti E, Luciani D, Stella F. A continuous time Bayesian network model for cardiogenic heart failure. Flexible Services Manufacturing Journal 2012;24: IF: 0,25 Luciani D, Bazzoni G. From networks of protein interactions to networks of functional dependencies. BMC Syst Biol 2012;6:44. IF: 3,148 Luciani D, Stefanini FM. Automated interviews on clinical case reports to elicit directed acyclic graphs. Artif Intell Med 2012;55:1-11. IF: 1,345 Pereira JM, Moreno RP, Matos R, Rhodes A, Martin-Loeches I, Cecconi M, Lisboa T, Rello J, Bertolini G; ESICM H1N1 Registry Steering Committee; ESICM H1N1 Registry Contributors. Severity assessment tools in ICU patients with 2009 influenza A (H1N1) pneumonia. Clin Microbiol Infect 2012;18: IF: 4,540 Poole D, Bertolini G, Garattini S. Withdrawal of Xigris from the market: old and new lessons. J Epidemiol Community Health 2012;66: IF: 3,192 Poole D, Rossi Carlotta, Latronico N, Rossi G, Finazzi S, Bertolini G, GIVITI. Comparison between SAPS II and SAPS 3 in predicting hospital mortality in a cohort of 103 Italian ICUs. Is new always better? Intensive Care Med 2012;38: IF: 5,399 Squizzato A, Luciani D, Rubboli A, Gennaro LD, Landolfi R, De Luca C, Porro F, Moia M, Testa S, Imberti D, Bertolini G. Erratum to: Differential diagnosis of pulmonary embolism in outpatients with non-specific cardiopulmonary symptoms. Intern Emerg Med 2012 Nov 18. [Epub ahead of print]. IF: 2, IMPACT FACTOR (IF) A total of 26 papers were published on peer-reviewed scientific journals by the laboratory s staff during the period. The overall impact factor of these papers was The overall impact factor of the 8 papers published during 2012 was

58 LABORATORY OF CLINICAL EPIDEMIOLOGY REPORT RESEARCH ACTIVITIES QUALITY OF CARE IN THE INTENSIVE CARE UNITS The main purpose of these research projects is the assessment and improvement of the quality of care in Italian Intensive Care Units (ICUs). It is a multi-annual project promoted on behalf of GiViTI, a collaborative network composed by more than half of the Italian ICUs and coordinated by the laboratory. The main focus is the Project Margherita. Its aim is the continuous evaluation of the quality of care and it is based on a free software developed by the laboratory and distributed to all the ICUs adhering to the GiViTI group. The software has been realized on a modular structure, which enables to easily integrate the basic data collection (the core of Margherita) with the data collection of specific research projects (the petals of Margherita). Since January 2011, Margherita became an international project. Thanks to funding from the European Union have in fact been able to develop new software and to distribute the project to six countries: Slovenia, Hungary, Poland, Cyprus, Israel, Afghanistan, Sudan and Switzerland. 58

59 REPORT 2011 LABORATORY OF CLINICAL EPIDEMIOLOGY APPROPRIATENESS OF THE INTENSIVE CARE UNITS Intensive care units are a high technology environment requiring a large number of highly skilled personnel. The costs of these units are therefore significant and special attention is placed on using resources appropriately. The StART study (Studio sull Appropriatezza dei Ricoveri in Terapia intensiva Study on the appropriateness of intensive care admissions) was set up in this context in the Lombardy Region. Specifically, the evaluation of appropriateness of use of intensive care is based on the hierarchical classification of healthcare assistance levels, which is, in turn, based on the intensity and complexity of the services rendered: 1) level of intensive care, 2) level of sub-intensive care, and 3) level or ordinary care. The corresponding levels of assistance that can be provided by the ICUs were, at the same time, identified, based on the availability of both technical and personnel resources. Ideally, an ICU bed equipped to provide a certain level of assistance should be used only for the corresponding level of complexity of the problem and of the healthcare need. When this occurs, it can be considered an appropriate healthcare assistance level. Again, ideally, there should be clear boundaries between levels: a higher healthcare assistance level should not be used to treat a problem of a smaller size, just as a low or medium assistance level should not be employed to treat a problem of greater need. When this occurs, it is considered an inappropriate use of resources. 59

60 LABORATORY OF CLINICAL EPIDEMIOLOGY REPORT 2011 An inappropriate service can therefore be one that could be provided at a lower assistance level (the inappropriateness, in this case, can be referred to as a waste of high-level resources), or one that should be provided at a higher assistance level (inappropriateness in terms of suitability of the ICU). The StART study s aim is to assess these phenomenons and identify their causes in order to improve the appropriateness of ICU admissions THE RECONSTRUCTION OF CLINICAL REASONING IN MEDICAL PRACTICE AND EDUCATION This area represents the main concern of the Unit of Clinical Knowledge Engineering, whose objective is the valorization of clinical reasoning in solving complex clinical problems. The diagnosis of pulmonary embolism still represents a relevant clinical challenge, due to the complexity of the patient's clinical presentation and the variability of diagnostic resources among Centres. In this regards, we are conducting an Italian multicenter study, involving mainly Emergency Units, with the aim of prospectively validating the diagnostic software BayPAD (Bayes Pulmonary embolism Assisted Diagnosis). 60

61 REPORT 2011 LABORATORY OF CLINICAL EPIDEMIOLOGY Such a tool, relying on a probabilistic model covering 72 clinical variables and doing without the need to input all the contemplated observations, would overcome the main reasons which prevented ordinary clinical guidelines to be largely accepted. Moreover, the results of the retrospective validation of the system have been obtained. The Unit started a project for the realization of a software assisting the physician in tracing back the basis of his clinical decisions before the description provided by clinical reports, among those that are typical of particular medical specialty. The software has the double target to create specific applications based on probabilistic models representing complex clinical decision problems, and to involve physicians in their construction. The last target is achievable given the strong analogy between the causal structure of the exploited models (bayesian networks) and the pathophysiological structure of medical knowledge. By this, it will be given the chance to adopt this system within medical training projects, with a special attention to e-learning programs. 61

62 LABORATORY OF CLINICAL EPIDEMIOLOGY REPORT AN ELECTRONIC HEALTH RECORD TO PROMOTE RESEARCH IN INTENSIVE CARE MEDICINE The main aim of this project is to develop an electronic health record (EHR) the allows the assessment of indicators of the process of care in the ICU. A multidisciplinary team of intensivists, ICU nurses, epidemiologists, statisticians, and IT specialists, had the responsibility of planning the HER, that is now already shared by 15 Italian ICUs HOME ARTIFICIAL NUTRITION IN ITALY The SINPE (Italian Society of Artificial Nutrition and Metabolism) with the support of the Laboratory of Clinical Epidemiology promotes the project "DOMUS, the new register of home artificial nutrition". DOMUS project created with the aim to describe three types of patients who are subjected to artificial nutrition at home: - cancer patients - patients with benign severe chronic intestinal - patients undergoing enteral nutrition at home and to reveal the activity, efficacy and safety of programs of NAD (Artificial Nutrition at Home), on base of SINPE indicators. 62