Laboratory for Mother and Child Health CESAV A. e A. Valenti Centre for Health Economics Laboratory of Clinical Epidemiology. Annual Report 2011

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1 Mario Negri Institute for Pharmacological Research Laboratory for Mother and Child Health CESAV A. e A. Valenti Centre for Health Economics Laboratory of Clinical Epidemiology Annual Report 2011 Via G. La Masa Milan, Italy - Tel Telefax publichealth@marionegri.it

2 DEPARTMENT OF PUBLIC HEALTH REPORT 2011 CONTENT THE DEPARTMENT OF PUBLIC HEALTH pag 5 1 THE LABORATORY FOR MOTHER AND CHILD HEALTH pag Introduction pag The Staff pag Publications pag Publications in peer-reviewed journals pag Impact factor pag Transfer of information pag Features pag Books pag Book chapters pag Book reviews pag Research Activities pag Efficacy of Nebulised Beclometasone versus placebo in preventing viral wheezing in pre-school children. (ENBe) pag Studio SONDO pag Pharmacoepidemiology in the Lombardy Region pag Migration and psychological difficulties in growth and adulthood pag Complex communication needs and participation (CAA: Augmentative Alternative Communication) pag Fp7 Projects pag 20 a) TINN - Treat Infections in NeoNates pag 20 b) TINN2 - Treat Infections in NeoNates pag 20 b) COHEMI pag Neonatology pag Io e l Asma Project ( Asthma and I ) pag The Lombardy Region s data from the National ADHD Register pag The Lombardy Region s ADHD Register pag Co-operation with countries with limited resources pag Other interventions/productions pag 26 a) The activities of the Italian NGO Group for the CRC pag 27 b) Rational use of drugs for children and their parents: a dynamic and strategic goal pag 27 c) Lo sai Mamma ( Hey mom, did you know? ) pag 31 d) The Newsletter - The ADHD Newsletter pag 32 - The ENBe Newsletter pag 32 - The COHEMI Newsletter pag 33

3 REPORT 2011 DEPARTMENT OF PUBLIC HEALTH e) The rights of people with complex disabilities in accessing health services pag 34 f) Ricerca & Pratica pag And then pag Commissions and Committees pag 37 a) Technical commission for the elaboration of the regional therapeutic formulary pag 37 b) Ethics committee of Crema s Ospedale Maggiore pag Conferences, workshops, presentations, pag Other interventions/citations in the media and mass media pag Reports pag Contributions, contracts, pag National collaborations pag International collaborations pag Editorial board membership pag Peer review activities pag 44 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 55 3

4 DEPARTMENT OF PUBLIC HEALTH REPORT LABORATORY OF CLINICAL EPIDEMIOLOGY pag Introduction pag The Staff pag Publications pag Publications in peer-reviewed journals pag Impact factor pag Transfer of information pag Research activities pag Quality of care in the intensive care units pag Appropriateness of the intensive care units pag Studies on multiple organ failure pathological processes pag The reconstruction of clinical reasoning in medical practice and education pag An electronic health record to promote research in intensive care medicine pag And then pag Commissions and Committees pag 64 a) National Health Plan Research Commission of the Trent Autonomous Province pag. 64 b) Scientific council of the Interdisciplinary Research Centre for Human Sciences, Health and Disease. Department of Human Sciences, Bergamo University pag 64 c) Lombardy Region s technical group on cancer research pag 64 d) National Health Plan Research Commission, Emilia Romagna Region pag Reports pag Conferences, workshops, presentations, pag Contributions, contracts, pag National collaborations pag International collaborations pag Editorial board membership pag Peer review activities pag 67 4

5 REPORT 2011 DEPARTMENT OF PUBLIC HEALTH 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 analyzes the costs and benefits of interventions within the health system; the Laboratory of Clinical Epidemiology which operates mainly in intensive care and rare diseases. 5

6 DEPARTMENT OF PUBLIC HEALTH REPORT 2011 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 119 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 2011 was

7 [Digitare il testo] Laboratory FOR MOTHER AND CHILD HEALTH Mario Negri Institute for Pharmacological Research Via G. La Masa MILAN, Italy Tel fax mother_child@marionegri.it - 7

8 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 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. 8

9 REPORT 2011 LABORATORY FOR MOTHER AND CHILD HEALTH 1.2 THE STAFF Laboratory Head Maurizio BONATI, MD Scientists Marina BIANCHI, MD, PhD (part-time 75%) Rita CAMPI, STAT. D (part-time 75%) Antonio CLAVENNA, MD, PhD Chiara PANDOLFINI, PhD (part-time 75%) Valeria M CONFALONIERI, MD Consultant (part-time 75% - since September 1st) Research Fellow Massimo CARTABIA, STAT. D Anna DIDONI, PSYCHOL D (part-time 50%) Filomena FORTINGUERRA, PHARM D Pharmacological Sciencies Research Doctorate Daniele PIOVANI, PHARM D Marco SEQUI, STAT D (part-time 50%) Francesca ML SEVERINO, PHILOS D (part-time 50% - maternity leave from September) Michele ZANETTI, IT Assistants Maria Grazia CALATI Secretary, of the Centre for Drug and Health Information (part-time 75%) 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 Elisa BARBUI, MD Aurora BONACCORSI, BIOL D Alice CORINALDI, PHIL D (from 2 May to 22 May) Valeria MANNINO, MD (from 17 June to 23 December) Anna IOMMARINI, PHARM D (Since October, 15) Rossano REZZONICO, MD 9

10 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT PUBLICATIONS PUBLICATIONS IN PEER-REVIEWED JOURNALS Bonati M, Severino F, Bagnati R, Carrà A, Fanelli R. Millet-porridge with Artemisa annua as first aid for African children with malaria? Journal Alternative and Complementary Medicine 2011;17: IF: 1,69 Caccia S, Clavenna A, Bonati M. Antipsychotic drug toxicology in children. Expert Opin Drug Metab Toxicol 2011;7: IF: 3,08 Clavenna A, Andretta M, Pilati P, Mezzalira L, Dusi M, Gangemi M, Gattoni MB, Lombardo G, Zoccante L, Bonati M. Antidepressant and antipsychotic use in an Italian pediatric population. BMC Pediatrics 2011;11:40. IF: 1,904 Clavenna A, Bonati M. Differences in antibiotic prescribing in paediatric outpatients. Arch Dis Child 2011;96: IF: 2,616 Didoni A, Sequi M, Panei P, Bonati M, on behalf of the Lombardy ADHD Registry Group. One-Year Prospective Follow-up of Pharmacological Treatment in Children with Attention- Deficit/Hyperactivity Disorder. Eur J Clin Pharmacol 2011;67: IF: 3,032 Franchi C, Sequi M, Bonati M, Nobili A, Pasina L, Bortolotti A, Fortino I, Merlino L, Clavenna A. Differences in outpatient antibiotic prescription in Italy s Lombardy region. Infection 2011;39: IF: 2,244 Marchetti F, Maestro A, Rovere F, Zanon D, Arrighini A, Bertolani P, Biban P, Da Dalt L, Di Pietro P, Renna S, Guala A, Mannelli F, Pazzaglia A, Messi G, Perri F, Reale A, Urbino AF, Valletta E, Vitale A, Zangardi T, Tondelli MT, Clavenna A, Bonati M, Ronfani L. Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial. BMC Pediatrics 2011;11: IF: 1,904 Neubert A, Hsia Y, de Jong-van den Berg LTW, Janhsen K, Glaeske G, Furu C, Kieler H, Nørgaard M, Clavenna A, Wong ICK Comparison of anti-diabetic drug prescribing in children and adolescents in seven European countries. Br J Clin Pharmacol 2011;72: IF: 3,63 Racca F, Berta G, Sequi M, Bignamini E, Capello E, Cutrera R, Ottonello G, Ranieri M, Salvo I, Wolfler A, Bonati M. Long-term Home Ventilation of Children in Italy: a National Survey. Pediatr Pulm 2011;46: IF: 2,239 Racca F, Bonati M, Del Sorbo L, Berta G, Sequi M, Capello EC, Wolfler A, Salvo I, Bignamini E, Ottonello G, Cutrera R, Biban P, Benini F, Ranieri VM on behalf of the LTV Pediatric Italian Network Invasive and non-invasive long term mechanical ventilation in italian children. Minerv Anest 2011;77: IF: 2,581 Bianchi M, Clavenna A, Sequi M, Bortolotti A, Fortino I, Merlino L, Bonati M. Anti-asthma medication prescribing to children in the Lombardy Region of Italy: chronic versus new users. BMC Pulmonary Medicine 2011;11: IF: 1,33 10

11 REPORT 2011 LABORATORY FOR MOTHER AND CHILD HEALTH Editorial Bonati M, Pandolfini C. Off-label drug use in children should be rational. Arch Dis Child 2011;96: IF: 2,616 Letter Bianchi M, Campi R, Bonati M. Smoke-free legislation and hospitalizations for childhood asthma. N Engl J Med 2011;364: IF: 53,484 Bianchi M, Clavenna A, Sequi M, Bonati M. Asthma diagnosis VS. analysis of anti-asthmatic prescriptions to identify asthma in children. Eur J Clin Pharmacol 2011;67: IF: 3,032 Bianchi M, Clavenna A, Sequi M, Bonati M. Infant antibiotic use and asthma risk: the chicken or the egg causality dilemma. Pediatrics 2011; content/127/6/1125/reply#pediatrics_el_ IF: 5,391 Bonati M, Rezzonico R. Although a model is low-cost its tranfer from developed to developing countries is not necessarily a priority. ADC Fetal & Neonatal 2011; IF: 3, IMPACT FACTOR (IF) AND H-INDEX During the period the Laboratory published 60 papers on peerreviewed scientific journals, with a overall Impact Factor (IF) of 385,873. In 2011, the overall IF of the 16 published papers was 93,903 and 26,25 for the 11 research articles. The H-index of the Laboratory's scientific studies is 25 with a total of 3262 cited studies, including auto-citations. Without auto-citations, the H-index is 23, with a total of 2784 cited studies TRANSFER OF INFORMATION Bianchi M. Il dolore nel bambino. R&P 2011;158: Bianchi M. Fattori di rischio indoor per allergie e asma: la prevenzione nelle scuole. R&P 2011;158: Bonati M. Quale strategia per la salute dei cittadini? R&P 2011;157:1-3. Bonati M. Ma è solo un problema di mancanza di medici? R&P 2011;159: Bonati M. Trasparenza: un diritto e un dovere anche per la solidarietà. R&P 2011;160: 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. 11

12 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2011 Bonati M, Zuddas A, Masi G, Costantino A, Panei P. Domande inevase sull ADHD. Il Sole24 ore Sanità 2011;n.23:25. Campi R, Bonati M. Sviluppare la salute (per tutti) oltre il Pil. La Rivista delle Politiche Sociali 2011;1: Campi R, Bonati M. PIL: alla ricerca di un alternativa. SaluteInternazionale.info Clavenna A, Bonati M. Sono troppi 19 mesi per far partire un trial. Sole 24 Ore Sanità 2011;n.5:14. Clavenna A, Bonati M. Se 19 mesi vi sembrano pochi, provate voi... R&P 2011;159: Colombo C, Clavenna A, Bonati M, Mosconi P. La ricerca risponde ai bisogni dei pazienti? R&P 2011;160: Fortinguerra F, Clavenna A, Bonati M. L uso dei farmaci oftalmologici nella popolazione pediatrica in Italia. M&B 2011;30: Fortinguerra F, Didoni A, Bonati M. L'uso del metilfenidato in Italia: bisogni ancora inevasi per i pazienti con ADHD. GIFC 2011;25: Garattini S, Bonati M, Pandolfini C. Online il registro degli studi clinici dell'irfmn. R&P 2011;159: Severino F, Bonati M. La salute dei migranti e di chi li ospita. R&P 2011;160:167. In the media Corriere della Sera Bonati M, Garattini S Milano promuova il garante per l'infanzia (19 novembre 2011; pag. 1 e 3) Corriere della Sera.it Clavenna A, Piovani D, Fortinguerra F Farmaci in gravidanza: l'esperto risponde. Un team di specialisti a disposizione per i quesiti dei lettori di Corriere.it ( 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. In Europa molti bambini ricevono ancora farmaci off label. Quaderni ACP 2011;18:91. 12

13 REPORT 2011 LABORATORY FOR MOTHER AND CHILD HEALTH Clavenna A, Fortinguerra F. Le raccomandazioni dell AIFA su farmaci e bambini per una maggiore appropriatezza di impiego. Quaderni ACP 2011;18:33. Clavenna A, Fortinguerra F. Nuovo formulario dell OMS dei farmaci essenziali per bambini. Quaderni acp 2011;18:129. Clavenna A, Fortinguerra F, Piovani D. Tre revisioni sistematiche su efficacia e sicurezza dei farmaci. Quaderni acp 2011;18:176 Clavenna A, Fortinguerra F, Piovani D. L agenzia europea dei medicinali ha approvato le prime due autorizzazioni al commercio per uso pediatrico. Quaderni acp 2011;18: 228. Clavenna A, Fortinguerra F, Piovani D. La vitamina A in età prescolare nei Paesi a risorse limitate: intervento salvavita. Quaderni acp 2011;18: Fortinguerra F. 1. OMS: nuovo formulario per farmaci ad uso pediatrico. 2. Un RCT per valutare l efficacia del paracetamolo e del ketoprofene sale di lisina nel dolore nei bambini con faringotonsillite. GIFC 2011;25: BOOKS Clavenna A. Drug Use In Outpatient Children: Epidemiological Evaluations. Lambert Academic Publishing; Saarbrücken, Germany; BOOK CHAPTERS Tirrò S, Di Giorgio D, Valvo L, Reggi V, Bonati M. Il progetto AIFA-WHO sulle farmacie on line. In: Farmaci Contraffatti. AIFA, Borgomanero (NO) 2011; BOOK REVIEWS Campi R. Epidemiologia di cittadinanza. R&P 2011;159: Didoni A. Le difficoltà della maternità. R&P 2011;158: Severino F. Il fenomeno migratorio entra nella fase strutturale. R&P 2011;158:

14 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 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 involves 40 family paediatricians in 9 Italian local health units (LHU) representative of geographical distribution and setting. The aim of the study is to evaluate the safety and effectiveness of beclometasone in preventing wheezing in viral upper respiratory tract infection (URTI). A total of 576 children 1-5 years old, with at least one episode of viral wheezing in the previous 12 months, will be enrolled. Children with steroid hypersensitivity, chronic respiratory disease (e.g. cystic fibrosis, bronchopulmonary dysplasia), presence of wheezing at the entry visit or using inhaled and/or oral corticosteroidz in the preceding month will be excluded. Patients will be randomly allocated to receive beclometasone suspension 400 mcg b.i.d or placebo b.i.d. Active drug and placebo will be administered through a nebuliser, in the morning and in the evening. The duration of the treatment will be 10 days, and a 6-month follow up period will be performed to monitor the recurrence of respiratory tract infections and viral wheezing. The percentage of children with wheezing (diagnosed by the paediatrician) during the URTI episode will be the primary outcome measure. The bureaucratic procedures for obtaining the authorization by each LHU ethics committee lasted a total of 19 months and only by October 2010 was it possible to start patient enrolment. 14

15 REPORT 2011 LABORATORY FOR MOTHER AND CHILD HEALTH On 15 January 2012, 66 weeks after the beginning of the study, 1337 eligible children were visited, 474 of which (35.4%) were enrolled: 294 were males and 180 females, with an average age of 2.5 years. In all 387 children completed the 6 month follow-up period STUDIO SONDO The Laboratory collaborates with Trieste s Istituto per l Infanzia IRCCS Burlo Garofolo (the main coordinator) in coordinating the study Controlled randomized multi center trial of comparative evaluation of ondansetron vs domperidone for the symptomatic treatment of children s gastroenteritis acute vomit (ONdansetron vs DOmperidone Study, SONDO). The study is funded by the Italian Drug Agency s grant for independent research 2008 (FARM8E53XM project) and its aim is to evaluate the efficacy of an orally administered symptomatic drug (ondansetron or domperidone) in cases of acute gastroenteritis in order to prevent the need for rehydration administered intravenously or via nasogastric tube. The trial began in June 2011, includes 15 Paediatric Emergency Rooms, and plans to enrol 540 children aged 1-6 years. By January 16, 2012, 312 children had been visited in 12 of the 15 participating ERs, and 65 of them (21%) had been enrolled 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 the evaluation of the: 1) antibiotic prescription profile 2) incidence and prevalence of asthma and adherence to the treatment guidelines 3) burden of mental disorders in the paediatric population. 15

16 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT ) Antibiotic prescription profile The antibiotic prescription pattern in the outpatient paediatric population was evaluated in 8 Italian regions. A total of 4,828,569 children under 15 years old were included (58% of the Italian population) living in 8 regions. - The estimated average prevalence rate was 50.5%. Between-region prevalence rates ranged from 42.6% to 62.1%. In southern regions antibiotics were more frequently prescribed: the prevalence was 61.1% versus 44.1 and 46.5% in the central and northern regions, respectively. At the LHU level the prevalence ranged from 35.6% to 68.5%. - An inverse correlation was found between the prevalence rate and the HDI, while a direct correlation was found with paediatricians per 1,000 resident children. - Overall, penicillins (first choice antibiotics) covered 53.1% of antibiotic prescriptions, with differences between regions, ranging from 39.2% to 62.5%. Southern regions were characterized by a lower consumption of penicillins and a greater prescription of second choice antibiotics (cephalosporins and macrolides). 2) Incidence and prevalence of asthma and adherence to the treatment guidelines The Laboratory began the evaluation of diagnostic-therapeutic pathways of asthmatic children and adolescents (6-17 year olds) of the Lombardy region. - Using a previously validated strategy, asthmatic children/adolescents were been selected based on anti-asthmatic drug prescriptions received (in age-appropriate formulations). An asthma incidence of 0.8% and a prevalence of 3.5% were estimated. Among the 15 regions Local Health Units (LHUs), asthma prevalence ranged from 2.5% (in Pavia) to 5.1% (in Mantova). 16

17 REPORT 2011 LABORATORY FOR MOTHER AND CHILD HEALTH In all, 2.7% of children/adolescents had been treated with anti-asthmatic drugs for at least three years. - The prescription of long acting adrenergic ß 2 agonists as first therapy to new cases of asthma (as the only therapy in 2% of the new cases and with inhaled steroids in 7% of the new cases) was one of the instances reflecting a lack of adherence with the treatment guidelines. - Only 30% of subjects underwent annual spirometry testing, as recommended by the guidelines, ranging from 21% in Sondrio to 40% in Lodi. - After adjusting for age, LHU of residence and asthma severity, boys had a two-fold greater likelihood to receive a prescription for spirometry testing than girls. 3) Burden of mental disorders in the paediatric population Children and adolescents with a putative mental disorder were identified using the Lombardy Region s administrative health database (children with at least one psychotropic drug prescription and/or hospitalization for a psychiatric disorder, and/or child neuropsychiatric visit) - In all, 63,550 youths (39 per 1,000) were identified as users of health care resources for a putative mental disorder. The prevalence was higher in boys than in girls (47.0 versus 31.3 ) and the highest value was recorded in 8 year old children (60.2 ). - A total of 59,987 youths (37.1 ) attended a child and adolescent neuropsychiatry service at least once, 3605 (2.2 ) were admitted to the hospital (mainly for delays in development, psychosis and mental retardation), and 2761 (1.7 ) received at least one psychotropic drug prescription (in particular antidepressants) - 57% of youths receiving psychotropic drug prescriptions did not attend a child psychiatry service. This percentage was higher in youths treated with antidepressants: 69% of them were not cared for by a specialist. - In all, 14,741 youths (prevalence: 9 ) had a disorder that required a high intensity of care (e.g. recurrent visits or drug prescriptions). 17

18 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT MIGRATION AND PSYCHOLOGICAL DIFFICULTIES IN GROWTH AND ADULTHOOD The Project involves Milan s seven Childhood and Adolescence Neuropsychiatry Units (UONPIAs), 2 Psychiatric Services, the Family, Childhood and School-Age Service of Milan s local Health Unit, Milan s Social and Educational Services, the Cesare Beccaria Penal Institute for Minors, 7 third-sector Organizations, the Provincial School Office, and the Mario Negri Institute. The project aims to improve the response to the specific problems of the school-aged migrant population, with particular attention to adolescents and minors who arrived in Italy unaccompanied by family members. Since 2010, data concerning 1632 patients aged between 0 and 32 years (mode: 7 years) have been collected and analyzed, most of which concerns males. 66% were born in Italy. In 37,7% of the cases the school sent the children to the services, most commonly for academic difficulties, behavioural problems, and language or communication problems. In 62% of cases, migrant patients, who are not Italian citizens, have regular residence permits. Patients generally have a good knowledge of Italian. The mother tongue is Italian in only 11.6% of patients. The patients parents were generally born abroad, migrated without the family of origin (52,2%) in order to search for a job, and both hold a residence permit in 41% of cases COMPLEX COMMUNICATION NEEDS AND PARTICIPATION (CAA: AUGMENTATIVE ALTERNATIVE COMMUNICATION) Children who do not speak or who can only say a few words, children who have difficulty in understanding another s words... There are about 8000 people between 0 and 18 years old in the Lombardy Region who suffer from communication disorders, some for a few months, others for years, some forever. In Italy there are almost 50,000. Some also have mobility problems, others a genetic syndrome or autistic disorder. For all, growing up without the 18

19 REPORT 2011 LABORATORY FOR MOTHER AND CHILD HEALTH ability to communicate is very tough, and it is essential to find ways of making it possible to communicate without use of the voice, through measures of support (augmentative communication). Symbol-based systems, as well as images, can be used, in which all the figures are written above the word or the verb they represent. The child is therefore able to recognize the images and the interlocutor to read the words. Digital tools programmed to lend a voice when necessary can be used, as well as information technology and computer technology adapted to personal needs and systems that allow people who cannot use the alphabet or cannot use a pen, to read and write. Anyone who needs to communicate with a child must use a language (written, spoken, visual) appropriate to the child s ability and this should be implemented and guaranteed forever. For this reason, it is not enough to train specific operators, but it is necessary to also involve parents and teachers. To date, only a few patients can access the required support interventions for communication, and this generally occurs very late due to the shortage of adequately trained personnel within departments of Child and Adolescent Psychiatry. To meet these unaddressed needs, Milan s Local Health Unit (ASL) has launched a specific project, financed by the Lombardy Region for the years , involving 15 of the region s Child and Adolescent Psychiatry Units. In this context, a conference was organized on October 21st by the IRCCS Ca Granda Ospedale Maggiore Policlinico of Milan s Foundation s Centro Sovrazonale di Comunicazione Aumentativa (Supranational Centre for Augmentative Communication), in collaboration with Milan s Local Health Unit (ASL), Treviglio s UONPIA (Infant and Adolescent Neuropsychiatry Operational Unit), and the Laboratory for Mother and Child Health of the Mario Negri Institute for Pharmacological Research. The conference addressed the complex communication needs in children, described what represents an augmentative communication intervention, and how it can be applied to certain situations in order to become a possible resource for all children. The project was presented in detail and a series of experiences already in place that led to the structuring of the project were described. 19

20 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 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 (GA ) 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, from December 2009 to June A total of 200 NICUs participated, representing 32 countries. The countries represented by the greatest number of NICUs (disregarding country size), were Italy, the United Kingdom, and France. The survey results highlight a heterogeneous picture of the 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, in neonates. This is one of the European Medicines Agency s selected therapeutic areas that need specific pharmacological assessments specific to neonates. 20

21 REPORT 2011 LABORATORY FOR MOTHER AND CHILD HEALTH 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 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. This first year of work has been dedicated to the establishment of a solid network between the COHEMI partners in order to permit active collaboration and efficient information exchange. Many bibliographic reviews have been 21

22 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2011 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). The work done has been shared among all the partners (by and thanks to the organization of internal meetings and phone calls) and presented at public meetings, including the 7 European Congress of Tropical Medicine and International Health (Barcelona, October 2011). - COHEMI S CITATIONS IN THE MEDIA AND MASS MEDIA La Stampa Il Sole 24 Ore Sanità Corriere Medico Progetto su salute migranti (4 aprile 2011; pag. 22) Dalla Calabria a Milano reti di solidarietà per gli immigrati (14 aprile 2011; pag. 4) L Arena Le migrazioni portano malattie "dimenticate" Madinelli C (29 aprile 2011; pag. 19) Il WEB ImmigrazioneOggi L Istituto Mario Negri di Milano coordina un progetto per confrontare le normative sanitarie sulla salute degli immigrati di 10 Paesi (24 marzo 2011; Sanità News Al via un progetto Europeo per la salute die migranti SN e per i paesi che li ospitano (21marzo 2011; Virgilio (WEB) Immigrati/ Al via progetto Ue per confrontare normative sanitarie (23 Marzo 2011; virgilio.notizie.it) Quotidiano.net La salute dei migranti e di chi li ospita ( Diario 7 La salute dei migranti e di chi li ospita Mishima Il Giorno.it GoSalute ClicMedicina Verona Sera L Adige di Verona ( La salute dei migranti e di chi li ospita ( La salute dei migranti e di chi li ospita ( La salute dei migranti e di chi li ospita ( Le migrazioni riportano in Italia malattie debellate ( Le_migrazioni_riportano_in_Italia_malattie_debellate_06754.htm) Malattie tropicali. Cosa sta succedendo in Italia, Veneto e Verona? (27 aprile 2011; 22

23 REPORT 2011 LABORATORY FOR MOTHER AND CHILD HEALTH NEONATOLOGY There are three projects underway, two of which are related to developing countries: a literature review on the use of drugs in neonatal intensive care units in low to middle income countries; an assessment of mortality and duration of stay of neonates admitted to the largest neonatal intensive care unit in Nicaragua, after modification of the strategy used to employ mechanical ventilation; a literature review on the use of moderate cerebral hypothermia for prevention of brain injury, with particular attention to neonatal hypoxic-ischaemic encephalopathy IO E L ASMA PROJECT The analysis of the data collected during the "Io e l asma" project, performed by the Bronchopneumology Unit of the Hospital of Brescia, was concluded this year. The aim of the project was to create a multidisciplinary network of different figures (physicians, nurses, parents, teachers, educators) sharing common educational and therapeutic approaches for the management of asthma. During the September 2007-September 2010 period a total of 515 children (64% male) made at least three visits to the Bronchopneumology Unit. Asthma control was measured following GINA guidelines. 40% of the children had adequate control of asthma at the baseline visit, a figure that increased to 76% at the time of the third visit (after weeks). The degree of asthma control improved in 47% of children, and, in particular, in 6% of children it shifted from the level of uncontrolled to the level partially controlled ; 18% from uncontrolled to controlled ; 23% from partially controlled to controlled. An adequate control was maintained in 34% of the cases. The rate of hospitalization and of school absences due to asthma in children followed at the clinic were reduced (from 7.6 to 2.7%, and from 13.4 to 6.1%, respectively). 30% of children did not need any controller medication, while 62% of children receiving drug therapy were treated with an inhaled steroid (fluticasone) at low doses. 23

24 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2011 After attending the unit all children used a spacer device that was appropriate for age, and in 2/3 of the cases the symptoms were recorded on a daily diary. Although this study does not allow an evaluation of the main component (therapeutic or educational) responsible for the benefit, it suggests that a multidisciplinary approach is effective in improving and maintaining an adequate control of asthma symptoms in more than 80% of children THE LOMBARDY REGION S DATA FROM THE NATIONAL ADHD REGISTER The Laboratory for Mother and Child health, as part of the scientific committee, participated in writing the protocol that defines the National ADHD Register s structure and activities and in monitoring it. In November 2011, the Lombardy Region was, with 358 patients, the first among the regions in number of patients (residents) and treated patients, monitored by the national register. There are 206 patients (58%) being treated with methylphenidate or atomoxetine in 15 Referral Centers in the Lombardy Region: 135 patients began treatment with atomoxetine (66%), 71 with methylphenidate. In all, 89% of patients are male, aged between 6 and 18 years (median 11 years, mode 9). The most common diagnosis was complex ADHD (82%), followed by the disorder characterized prevalently by attention deficit (15%), or hyperactivity (3%). In 112 cases (39% of the total) no comorbidities were found, while in 173 cases anxiety, depression or learning disabilities were also found (in 37 of these cases more than one of the different comorbidities was present). The most common comorbidities were learning disorders (52%). 24

25 REPORT 2011 LABORATORY FOR MOTHER AND CHILD HEALTH THE LOMBARDY REGION S ADHD REGISTER Thanks also to the network created after the above mentioned project, it was possible for the referral centers to actively set up a three-year project Sharing diagnostic-therapeutic approaches for ADHD in Lombardy. The project, whose coordinator is the UONPIA A.O. Spedali Civili of Brescia, began in January 2010, involves 18 Referral Centers, and is funded by the Lombardy Region. The new register was designed to be more practical than the national one in order to increase the centers compliance in providing information and to therefore improve data quality. The register is a disease register so it is extended not only to patients with a diagnosis of ADHD undergoing drug treatment with methylphenidate or atomoxetine, but to all those who belong to the referral center and who have suspected ADHD. The register will then permit the: monitoring of diagnostic paths; outlining of the prevalence of the disorder; monitoring of also non-drug treatment programs; maintenance of pharmacovigilance by extending the monitoring on the use of the drugs, including drugs other than atomoxetine and methylphenidate; quantifying the workload The Register has been accessible to the 18 referral centers since June 30th, patients have been included, 60 of whom with a confirmed diagnosis, 21 without ADHD, and 89 still under evaluation. In most cases those who referred the patients to the referral centers have been parents (31 %) or the school (23%). Of the 60 patients with ADHD diagnosis at the end of the first visit, 52% received a non pharmacological therapy prescription, 12% only pharmacological, and 25% both of them. The most frequent comorbidity were learning disabilities (30%) and oppositional/defiant disorder (13%). 25

26 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 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. 26

27 REPORT 2011 LABORATORY FOR MOTHER AND CHILD HEALTH 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. In October 2010, the Italian NGO Group for the CRC sent the Report to the UN Committee. In June 2011 a delegation of the Italian NGO Group for the CRC attended the pre-session in Geneva with the UN Committee on the Rights of the Child. In September 2011 a delegation participated as observer to the Session between the UN Committee and the Italian Government. In October 2011, the UN Committee published the concluding observations for Italy. In November 2011, the second edition of the Practical Guide to the monitoring of the Convention on the Rights of the Child, with which the CRC Group intends to formalize its commitment and work plan for the next five years ( ) and provide a tool to facilitate the participation of those who want to contribute to the monitoring of CRC, was published. The text was revised on the basis of work performed in the past and the new recommendations of the UN Committee. b) RATIONAL USE OF DRUGS FOR CHILDREN AND THEIR PARENTS: A DYNAMIC AND STRATEGIC GOAL 9 SEPTEMBER 2011 CONGRESS 50 YEARS BY THE PATIENT S SIDE: 25 YEARS ALSO ON THE SIDE OF MOTHERS AND CHILDREN! The main aim of the Institute s activities is to contribute to the protection of health and human life. To achieve this goal it is first of all necessary to deepen the understanding of the internal operating mechanism of living organisms, to find the reasons why different diseases arise, to know the processes that develop inside organisms following the introduction of foreign substances: it is in this direction that Institute s research develops, from the molecular level up to mankind. 27

28 LABORATORY FOR MOTHER AND CHILD HEALTH REPORT 2011 In addition to research activities, the Institute provides courses for the professional training of laboratory technicians and graduate researchers. In addition, the Institute contributes to the diffusion of scientific culture in the biomedical filed through a variety of initiatives, both general ones as well as intitiatives aimed at providing specific support to the health care practice, particularly for a more rational drug use. Among the priority areas to which the Institute is committed there is mother and child health. The main goal of the activities carried out by the Laboratory for Mother and Child Health is to contribute to the improvement of the wellness of the mother and the child through an interdisciplinary and collective work in public health. On occasion of the first 50 years of the Institute s activity, a meeting based on the fundamental issue of the right to health, which accompanied a large community of young researchers at the laboratory for an extended period of time, was set up. The idea was to collectcritical contributions of some of those who began their professional training at the institute in a broad, complex area such as clinical pharmacology. The invitation was extended to all those people who followed the laboratory s work attentively and who demonstrated willingness to participate. A CD has been produced with the day s presentations and the journal citations related to the event. - CITATIONS RELATING TO THE CONGRESS La Stampa Brescia Oggi I bimbi bresciani? «Imbottiti di farmaci» Spatola G (11 Settembre 2011; pag. 14) Avvenire Troppi antibiotici ai bambini del belpaese (10 settembre 2011; pag. 9) Il Giorno I bambini italiani prendono troppi antibiotici (12 settembre 2011; pag. 38) Il Resto del Carlino I bambini italiani prendono troppi antibiotici (12 settembre 2011; pag. 38) Corriere della Sera Antibiotici ai bambini: a Brescia se ne danno troppi (13 settembre 2011; pag. 11) Giornale di Brescia Terapie Troppi antibiotici per bambini che sono sani (13 settembre 2011; pag. 48) Il Mattino SOS antibiotici: i bambini italiani ne usano il triplo degli inglesi (14 settembre 2011; pag. 9) L'informazione di Troppi farmaci in età pediatrica San Marino (19 settembre 2011; pag. 13) 28

29 REPORT 2011 LABORATORY FOR MOTHER AND CHILD HEALTH Il Corriere di Firenze Troppi farmaci ai più piccoli (24 settembre 2011; pag. 26) Il Giornale di Brescia Troppi farmaci inutili dati ai bambini (20 dicembre 2011; pag. 57) Della Moretta A Il WEB Il pensiero.it Dalla parte dei bambini e dei genitori (luglio 2011; Brescia Oggi I bimbi bresciani? «Imbottiti di farmaci» Spatola G ( i_bimbi_ bresciani_imbottiti_di_farmaci/) Universonline Farmaci in età pediatrica ( NostroFiglio.it Troppi antibiotici ai bambini italiani Renis MC ( ASCA.IT Salute: per 52% bambini italiani almeno un antibiotico durante l'anno ( PER_52_PERCENTO BAMBINI_ITALIANI_ ALMENO_UN_ANTIBIOTICO_DURANTE_L_ANNO ATT--salute.html) CorriereDellaSera.it Troppi bimbi italiani usano antibiotici ( PER_52_PERCENTO BAMBINI_ITALIANI_ ALMENO_UN_ANTIBIOTICO_DURANTE_L_ANNO ATT--salute.html) Bambini.guidone.it I bambini italiani abusano degli antibiotici Scavuzzo G Fibonacci GoSalute PharmaStar.it Fai.informazione.it Il Serpente di galeno ( I bambini italiani abusano degli antibiotici ( Convegno del 'Mario Negri' su farmaci e bambini ( In Italia troppi farmaci inutili somministrati ai bambini ( Bambini: Convegno sull'uso razione dei farmaci all'irfmn di Milano ( Bambini: Convegno sull'uso razione dei farmaci all'irfm di Milano ( Guida Genitori WEB I bambini e gli antibiotici ( I%20bambini%20e%20gli%20antibiotici) Il Pensiero Scientifico Verso un uso razionale dei farmaci per i bambini: a che punto siamo? ( R&P Bimbi a Rimini QuotidianoSanità.it Bliz Quotidiano Info Consumatori intopic.it Verso un uso razionale dei farmaci per i bambini: a che punto siamo? ( Salute: i bimbi che in Italia usano antibiotici sono più del triplo di quelli inglesi ( Farmaci. Troppi farmaci inutili somministrati ai bambini ( Troppi antibiotici ai nostri bambini. Allarme dell IRFMN ( Farmaci. I bambini ne assumono troppi. Istituto Mario Negri ( Farmaci. I bambini ne assumono troppi. Istituto Mario Negri ( 29