Annual Report 2014 - Istituto di Ricerche Farmacologiche Mario Negri

Transcript

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
 Laboratory of Medical Research and Consumer Involvement
Annual Report
2014
Via G. La Masa 19 – 20156 Milano, Italy - Tel. 02 39014.511 - Telefax 02 3550924
http://www.marionegri.it/en_US/home/research_en/dipartimenti_en/public_health;
e-mail: [email protected]
REPORT 2014
DEPARTMENT OF PUBLIC HEALTH
CONTENT
THE DEPARTMENT OF PUBLIC HEALTH
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1 – LABORATORY FOR MOTHER AND CHILD HEALT
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1.1 –
Introduction
1.2 –
The Staff
1.3 –
Pubblications
1.3.1
Publications in peer-reviewed journals
1.3.2
Impact Factor and H-Index
1.3.3
Transfer of information
1.3.4
Features
1.4 –
Research Activities
1.4.1
Pharmacoepidemiology in the Lombardy Region
a) Comparison of recurrent prescriptions in children receiving generic or
brand name antibiotics
b) Health care resources consumption in immigrant and native Italian paediatric population
c) Psychotropic drug prescription in Italian children: a multiregional study
1.4.2
FP7 Projects
a) TINN - Treat Infections in NeoNates
b) TINN2 - Treat Infections in NeoNates
1.4.3
The Lombardy Region’s ADHD Register
1.4.4
Co-operation with countries with limited resources
1.4.5
Other interventions/products
a) The activities of the Italian NGO Group for the CRC
b) “Lo sai Mamma” (“Hey mom, did you know?”)
c) The Newsletter ADHD
d) Organization of events
- I pedal for research (Io pedalo per la ricerca)
- Congresses, seminars, meetings
e) Ricerca & Pratica
1.5 –
And then …
1.5.1
Commissions and Committees
a) Technical commission for the elaboration of the regional therapeutic formulary
1.5.2
Conferences, workshops, presentations, …
Other interventions/citations in the media and mass media
1.5.3
1.5.4
Contributions, contracts, …
1.5.5
National collaborations
1.5.6
International collaborations
1.5.7
Editorial board membership
1.5.8
Peer review activities
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2 – CESAV – “A. E A. VALENTI” CENTRE FOR HEALTH ECONOMICS
2.1 –
2.2 –
2.3 –
Introduction
The Staff
Publications
2.3.1
2.3.2
Impact Factor
2.3.3
2.4 –
Research Activities
2.4.1
Educational activities
2.4.2
Economic evaluation of health care programs
2.4.3
Comparative health policy analysis
2.4.4
a) Congresses, seminars, meetings
b) Quaderni di FarmacoEconomia
2.5 –
And then …
2.5.1
2.5.2
2.5.3
Contributions, contracts
2.5.4
2.5.5
2.5.6
2.5.7
3 – LABORATORY OF CLINICAL EPIDEMIOLOGY
3.1 –
3.2 –
3.3 –
Introduction
The Staff
Publications
3.3.1
3.3.2
Impact Factor
3.3.3
3.3.4
Report
3.4 –
Research Activities
3.4.1
Quality of care in the intensive care units
3.4.2
Appropriateness of the intensive care units
3.4.3
The reconstruction of clinical reasoning in medical practice and education
3.4.4
An electronic health record to promote research in intensive care medicine
3.4.5
Home artificial nutrition in Italy
3.4.6
a) Congresses, seminars, meetings …
Workshop
Congress
3.5 –
And then …
3.5.1
H2020 Work Programme 2014-2015 Call “Personalising Health and Care”
3.5.2
3.5.3
Contributions, contracts
3.5.4
3.5.5
3.5.6
3.5.7
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REPORT 2014
4 – LABORATORY OF MEDICAL RESEARCH AND CONSUMER INVOLVEMENT
4.1 –
4.2 –
4.3 –
Introduction
The Staff
Publications
4.3.1
4.3.2
Impact Factor
4.3.3
4.3.4
Abstract
4.4 –
Research activities
4.4.1
ECRAN Project
4.4.2
IN-DEEP Project
4.4.3
Citizen Jury
4.4.4
PartecipaSalute: a strategic allineance between patient groups, citizens and
scientific medical communities
4.4.5
Gynecological cancers and Mattioli Foundation
4.4.6
Study on the evaluation of the effectiveness follow-up in oncology setting
4.4.7
Orojects on the quality of life evaluation
4.4.8
a) Organization of events
4.5 –
And then …
4.5.1
a) Slow Medicine Steering Committee
b) Scientific and Technical Committee of ATCO
c) Onlus Attilia Pofferi Steering Committee
d) Fondazione Nerina e Mario Mattioli onlus Steering Committee
e) AIOM Committee, psychosocial guidelines
f) Other Boards
4.5.2
4.5.3
4.5.4
Contributions, contracts, …
4.5.5
4.5.6
4.5.7
4.5.8
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REPORT 2014
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.
Special emphasis is therefore placed on prevention, so that the risks of contracting illness are
lowered, and on the dissemination of independent, evidence-based information. The department’s
effort cannot disregard the National Health System, however, which must guarantee access to, and
quality of, care that is based on principles of equity and appropriateness and must guarantee it
especially to the more vulnerable patient groups. It is in this context that the Public Health
Department carries out its activities.
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.
 the Laboratory of Medical Research and Consumer Involvement, aimed primarily at
increasing patients' and citizens' involvement in health-related decisions.
In addition to its formal research activity, the department participates in, and organises, initiatives
involving information dissemination, training, and debate aimed at healthcare professionals and
social care workers, but also at the general population. These activities are also supported by the
publication of the department’s two journals: Ricerca&Pratica and Quaderni di Farmaco Economia,
and by the development of the @Partecipasalute website (www.partecipasalute.it).

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.

(www.partecipasalute.it) has an innovative twist in the Italian
research arena; the project site, compared to Italian health websites, uses ad hoc tools to
propose and promote the transfer of information in an active manner.
A total of 169 papers were published on peer reviewed scientific journals by the department’s staff during
2010-2014. The overall impact factor of these papers was 643.349. The overall impact factor of the papers
published during 2014 was 114.174.
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[Digitare il testo]
Laboratory
FOR MOTHER AND
CHILD HEALTH
Via G. La Masa 19– 20156 MILAN, Italy
Tel. 02 39014.511 - fax 02 3550924
http://www.marionegri.it/en_US/home/research_en/dipartimenti_en/public_health/mother_and_child_health;
@MumChild_IRFMN; twitter.com/MumChild_IRFMN
LABORATORY FOR MOTHER AND CHILD HEALTH
REPORT 2014
1.1 - 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.
.
1.2 – THE STAFF
Laboratory Head
Maurizio BONATI, MD
Scientists
Marina BIANCHI, MD PhD
(part-time 75%)
Rita CAMPI, STAT. D
(part-time 75%)
Chiara PANDOLFINI, B.A. PhD
(part-time 75%)
Research Fellow
Federica ARIENTI, STUD. MD
University Student
Massimo CARTABIA, STAT. D
Valeria Maria CONFALONIERI, MD
Consulent (until 31st March 2014)
Filomena FORTINGUERRA, PHARM D
Consulent (until 29 August 2014)
Than Hang NGUYEN, MD
PhD Student (until 11 November 2014)
Claudia PANSIERI, PHARM D
Michele ZANETTI, IT
Technical in Biomedical Research
Assistents
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
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REPORT 2014
Visiting Scientists
Beatrice BARTOLI, MD
Aurora BONACCORSI, BIOL D.
Adriano CARNEVALI, MD
(from 10 June to 23 December 2014)
Alice FAGGIANELLI, OSTETR. D
(from 13 May to 23 December 2014)
Laura REALE, MD
Rossano REZZONICO, MD
(until 23 December 2014)
Elena SELETTI, BIOL D
(until 4 April 2014)
Pharmacoepidemiology Unit
Head of Unit
Antonio CLAVENNA, MD PhD
Research Fellow
Daniele PIOVANI, PHARM D
PhD Student
Daria PUTIGNANO, PHARM D
Pharmacological Sciencies Research Doctorate
Marco SEQUI, STAT. D
(untill 27 May 2014)
Assistent
Maria Grazia CALATI
Segretary (part-time 75%)
1.3 - PUBLICATIONS
1.3.1 – PUBLICATIONS IN PEER-REVIEWED JOURNALS

Bisoffi Z, Buonfrate D, Sequi M, Meja R, Cimino RO,Krolewiecki AJ, Albonico M, Gobbo M,
Bonafini S, Angheben A, Requena-Mendez A, Muñoz J, Nutman TB. Diagnostic accuracy of five
serologic tests for strongyloides stercoralis infection. PLoS Negl Trop Dis 2014;8(1):e2640. IF: 4,569

Carrà A, Bagnati R, Fanelli R, Bonati M. Fast and reliable artemisinin determination from different
Artemisia annua leaves based alimentary products by high performance liquid chromatography-tandem
mass spectrometry. Food Chem 2014;142:114-120.
IF: 3,259

Clavenna A, Sequi M, Cartabia M, Fortinguerra F, Borghi M, Bonati M and ENBe Study Group.
Effectiveness of nebulized beclomethasone in preventing viral wheezing: an RCT. Pediatrics
2014;133(3):e505-e512.
IF: 5,297

Costantino MA, Bonati M. A scoping review of interventions to supplement spoken communication for
children with limited speech or language skills. PLoS One 2014;9:e90744; 2014.
IF: 3,534

Nguyen Thanh H, Pandolfini C, Chiodini P, Bonati M. Tubercolosis care for pregnant women: a
systematic review. BMC Infect Dis 2014;14:617.
IF: 2,561

Pansieri C, Bonati M, Choonara I, Jacqz-Aigrain E. Neonatal drug trials: impact of EU and US
paediatric regulations. Arch Dis Child Fetal Neonatal 2014;99:F438.
IF: 3,861

Pansieri C, Pandolfini C, Elie V, Turner MA, Kotecha S, Jacqz-Aigrain E, Bonati M. Ureaplasma,
bronchopulmonary dysplasia, and azithromycin in European neonatal intensive care units: a survey. Sci
Rep 2014;4:4076.
IF: 5,078
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REPORT 2014
Piovani D, Clavenna A, Bonati M, on behalf of PeFAB group. Review of Italian primary care
paediatricians identifies 38 commonly prescribed drugs for children. Acta Paediatr 2014;103:e532e537.
IF: 1,842
Review


Clavenna A, Bonati M. Safety of medicines used for ADHD in children: a review of published
prospective clinical trials. Arch Dis Child 2014;99:866-872.
IF: 2,905
Ruggiero S, Clavenna A, Reale L, Capuano A, Rossi F, Bonati M. Guanfacine for attention deficit and
hyperactivity disorder in pediatrics: a systematic review and meta-analysis. Eur Neuropsychopharmacol
2014;24:1578-1590.
IF: 5,395
Letter


Clavenna A, Bonati M. In the real-life setting nebulized beclomethasone is scantly effective in
preventing episodic viral wheezing. Pediatrics 2014;e-letter:
http://pediatrics.aappublications.org/content/133/3/e505/reply#content-block.
IF: 5,297
Reale L, Clavenna A, Panei P, Bonati M. More and better should be done to guarantee evidence-based
management of ADHD in children across Europe. Eur J Pediatr 173(4): 549; 2014.
IF: 1,983
1.3.2 – IMPACT FACTOR (IF) E H-INDEX
During the 2010-2014 period the Laboratory published 73 papers on peer-reviewed scientific journals, with a overall
Impact Factor (IF) of 239.936. In 2014, the overall IF of the 12 published papers was 45.581.
The H-index of the Laboratory's scientific studies is 32, with a total of 4,283 cited studies, including self-citations.
Without self-citations, the H-index is not different, with a total of 3,580 cited studies.
1.3.3 – TRANSFER OF INFORMATION

Bianchi M. Trend della mortalità per le malattie croniche del fegato. R&P 2014;180: 268.

Bonaccorsi A. Corruzione e farmaci stimolanti nella sindrome ADHD. R&P 179:225-228; 2014.

Bonaccorsi A. L’industria farmaceutica Merck sotto accusa. R&P 2014;178:168-170.

Bonaccorsi A. La storia di una vita dalla parte dei pazienti. R&P 2014;177:128-129.

Bonaccorsi A. Lettera aperta: introduzione alla ricerca clinica nelle scuole europee. R&P 2014;177:129-130.

Bonaccorsi A. Promuovere la prescrizione di medicine appropriate. R&P 2014;175:33-34.

Bonaccorsi A. Perché non tutti i bambini ricevono le terapie necessarie. R&P 179:222-224; 2014.

Bonaccorsi A. Tamiflu e Relenza: sono efficaci? quanto? R&P 2014;177:132-134.

Bonati M. Ci vuole coraggio. R&P 2014;175:3.

Bonati M. I naufraghi della nave dei folli. R&P 2014;179:195-197.

Bonati M. Non si muore quando si deve, ma quando si può. R&P 2014;180:243-244.

Bonati M, Rossi AG. Gli interventi degli esperti in programmazione sanitaria. Prospettive in Pediatria
2014;44:128-130.

Bonati M. Spendere con saggezza è fare meglio con meno. Negri News 2014;167.

Bonati M. Spendere con saggezza è fare meglio con meno. I presupposti indispensabili tra bisogni di salute e
risorse economiche. R&P 2014;177:99-100.

Campi R. L’Italia non è un “paese per bambini”. R&P 2014;178:174-175.
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REPORT 2014

Clavenna A. Allattamento al seno e capacità cognitive, di linguaggio e motorie, all’età di 18 mesi - L’esperto in
Salute Pubblica. Quaderni ACP 2014;21:253.

Clavenna A. Lo strano derby tra bevacizumab e ranibizumab. Ma il biglietto chi lo paga? R&P 2014;180:252255.

Clavenna A. Melanoma cutaneo nei bambini e adolescenti: l’esperienza del progetto tumori rari in età pediatrica.
R&P 2014;180:269.

Clavenna A. Wikipedia fa davvero male alla salute? R&P 2014;177:134-135.

Clavenna A, Bonati M. La Chiesi ci scrive. Quaderni ACP 2014;21:46-48.

Clavenna A, Guardabasso V, Santoro E. Le “cure” di Wikipedia non affidabili? Ancora meno lo è chi lo afferma.
Sole 24 Ore Sanità 28 (24/06/2014):10-11.

Clavenna A, Seletti E, Cartabia M, Didoni A, Fortinguerra F, Sciascia T, Brivio L, Malnis D, Bonati M, a nome
del Gruppo di studio sulla depressione post partum. Screening della depressione post partum da parte del
pediatra di famiglia: uno studio pilota. R&P 2014;177:101-108.

Clavenna A, Sequi M, Confalonieri V, Bortolotti A, Fortino I, Merlino L, Bonati M. Prescrizione di farmaci
nella popolazione pediatrica immigrata della Regione Lombardia. R&P 2014;176:52-60.

Confalonieri V. I bisogni di salute dei migranti: L’esperienza toscana. R&P 2014;175:30-31.

Confalonieri V. Costruire percorsi urbani di felicità. R&P 2014;176:82.

Confalonieri V. Minori in terra straniera: avere il tempo di costruire un futuro. R&P 2014;175:31-32.

Confalonieri V. Welfare Generativo e opportunità collettive. R&P 2014;177:126.

Costantino A, Bonati M. Le gravi disabilità della comunicazione: i bisogni dei pazienti (e delle loro famiglie).
R&P 2014;176:61.

Costantino A, Bonati M. Progetto Migranti: Migrazione e disagio psichico, dall’età evolutiva all’età adulta. R&P
2014;177:109-118.

Fortinguerra F. Big Pharma: i 10 farmaci più venduti al mondo. R&P 2014;177:131-132.

Pansieri C. Devo pagare per i vostri comportamenti a rischio? R&P 180:268; 2014.

Piovani D. Profilassi della polmonite da pneumocystis in bambini immunocompromessi. R&P 2014;177:123.

Piovani D, Clavenna A, Bonati M, e il Gruppo PeFAB Una lista di farmaci condivisa per la pediatria territoriale
di famiglia: uno studio osservazionale. Medico e Bambino 2014;5:315-321.

Progetto COHEMI. Condivisione di percorsi per migliorare la salute dei migranti in Europa. R&P 2014;175:4142.

Progetto COHEMI. Malattia di Chagas. R&P 2014;176:75.

Progetto COHEMI. Taenia solium taeniasis/Cisticercosi. R&P 2014;177:119.

Reale L. Controllo psicologico, qualità del contesto familiare e soddisfazione per la vita in un gruppo di
adolescenti italiani. R&P 2014;175:29.

Reale L. Educare alla salute mentale bambini e ragazzi. R&P 2014;178:166-167.

Reale L. Livelli ematici di serotonina: un biomarker per l’autismo? Risultati di una revisione sistematica. R&P
2014;180:269.

Reale L, Zanetti M, Cartabia M, Fortinguerra F, Bonati M, a nome del Gruppo Regionale Lombardo ADHD.
Due anni di attività del Registro ADHD della Regione Lombardia: analisi dei percorsi di cura diagnostici e
terapeutici. R&P 2014;179:198-211.

Velo G P, Font M, Zanfi D, Magrini N, Bonati M. Pilloleamare: fare rete funziona? R&P 2014;178:180-181.
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REPORT 2014
1.3.4 – FEATURES
The laboratory has been running the “Farmacipì” feature in the Quaderni acp journal since 2006.


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Clavenna A, Fortinguerra F, Piovani D. Le priorità della ricerca in pediatria non sono dettate dai bisogni
terapeutici. Quaderni ACP 2014 21:81
Clavenna A, Fortinguerra F, Piovani D. L'Agenzia Italiana del Farmaco (AIFA) promuove l'uso sicuro dei
farmaci in gravidanza e in pediatria. Quaderni ACP 2014 21:179
Piovani D, Clavenna A Psicofarmaci e bambini: la distanza tra ricerca e pratica clinica. Qualche riflessione dopo
alcune letture (critiche) estive. Quaderni ACP 2014 21:279
The Laboratory collaborates with the Health supplement of the Corriere della Sera newspaper
(http://www.corriere.it/salute/) for information regarding drug use in pregnancy, breastfeeding and infancy.
In particular, the Laboratory acts as moderator for a Forum concerning drug use in pregnancy (Farmaci in gravidanza,
http://forum.corriere.it/farmaci-e-gravidanza/) and publishes posts in a blog dedicated to moms and dads ("Dubbi di
mamma e papà", http://bambini.corriere.it/).
INTERVENTIONS/CITATIONS IN THE MEDIA AND MASS MEDIA
March
Corriere della Sera
Pillola sospesa. Quando un bambino?
(pag. 51)
June
Corriere della Sera
I diuretici possono nuocere al feto?
(15 giugno 2014; pag. 59)
September
Corriere della Sera
Antiepilettici nell'«attesa», vanno sospesi?
(28 settembre 2014; pag. 48)
November
Corriere della Sera
Vaccino antinfluenzale durante l'«attesa»?
(2 novembre 2014; pag. 51)
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.
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REPORT 2014
1.4 – RESEARCH ACTIVITIES
1.4.1 – 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 2014 the activities regarded, in particular, the following topics:
a. Comparison of recurrent prescriptions in children receiving generic or brand name antibiotics;
b. Health care resources consumption in immigrant and native Italian paediatric population;
c. Psychotropic drug prescription in Italian children: a multiregional study.
a.
Comparison of recurrent prescriptions in children receiving generic or brand name antibiotics
−
The aim of the study was to evaluate effectiveness and safety of paediatric generic antibiotic formations
compared to the brand name ones. The rate of antibiotic recurrent prescription (therapeutic failure issue) and
hospital admission (complication or severe adverse reaction issues) were compared in children and adolescents
who had been prescribed a generic of a brand name formulation of the same antibiotic.
Children receiving an antibiotic prescription (index prescription)
between February and April 2010 who did not receive any
prescription in the previous 28 days were identified through the
administrative database of reimbursed prescriptions of the
Lombardy region. A recurrent prescription was defined as a
prescription occurring within 28 days from the initial one which
was defined index prescription. It was evaluated if the child
required a new antibiotic course (recurrent prescription) or hospital
admission in the 28 days period following the index prescription.
The rates of recurrent prescription and hospital admission were
calculated for amoxicillin, amoxicillin clavulanate, clarithromycin,
and cefaclor, and stratified by age class. For these four active
substances a paediatric generic formulation was available from at
least 2 years.
The percentage of children and adolescents that received at least one recurrent prescription was 17.7%. The
rate of recurrent prescription was slightly lower in children receiving at least a generic formulation at the index
prescription (OR 0.96; 95% IC 0.93-0.98) compared to those receiving a brand name one. The percentage of
hospital admission was 1.01% (95% IC 0.98-1.08) in children receiving a brand name formulation, and 1.03%
(95% IC 0.96-1.06) without significant differences (p=0.43).
Children treated with a generic antibiotic did not show different outcome measures compared to those treated
with a brand name one. The results provide more evidence about the effectiveness and safety of generic
antibiotics.
−
−
−
b.
Health care resources consumption in immigrant and native Italian paediatric population
‒
The study compared the health care resources consumption (drug prescriptions, diagnostic exams, specialist
visits) in 12,287 children and adolescents less than 18 years old born in low-middle income country outside the
EU-27 and 24,574 Italian children, matched for age and physician.
In all, 4,673 immigrants (38%) e 11,723 natives (48%) received at least a drug prescription. The mean number
of prescriptions was respectively 3.2 (SD 5.4) in immigrants and 3.3 (SD 4.3) in natives (t=0.42; p=0.67).
Italian children and adolescents received more frequently anti-asthmatic and systemic steroid prescriptions. On
the contrary, the percentage of anthelmintic and antianemic drugs was two-fold higher in immigrant than in
Italian children.
‒
‒
15
−
REPORT 2014
−
The rate of hospital admission was comparable in the two groups (3.7 and 3.5%), however immigrant children
received less frequently diagnostic exam prescriptions (40 vs 53%) and specialist visits (49 vs 58%).
Differences in the prevalence of prescription among different geographical areas of origin have been observed,
with the lowest value observed in immigrants from East Asia (immigrants/Italians ratio 0.5).
c.
Psychotropic drug prescription in Italian children: a multiregional study
−
The 2006-2011 prescription trend of psychotropic drugs in the paediatric population was evaluated in seven
Italian region: Friuli-Venezia-Giulia, Veneto, Lombardy, Emilia Romagna, Abruzzo, Lazio e Puglia.
The source of data were the regional administrative prescription databases.
Prevalence and incidence rates by age and sex were calculated for any psychotropic drug, antidepressants,
antipsychotics, and ADHD medications.
In 2011 the prevalence was 1.76‰ ( 95% IC 1.72-1.80), ranging between 1.56 and 2.17‰ among regions. The
incidence of new psychotropic drug users was 1.03‰ (1.00-1.06). Antidepressants were the most prevalent
class (1.02‰), followed by antipsychotics (0.70‰) and ADHD medications (0.19‰). Prevalence rate
increased with age until 4.2‰ in the 12-17 years old age class. Males were more exposed than females (ratio =
1.23). Antipsychotics were mostly prescribed in males, and antidepressants in females.
In the 2006-2011 period the prevalence rate was stable (p=0.97).
The prevalence rate of psychotropic drugs in Italy in 2006-2011 did not change and was lower than what has
been observed at the international level.
−
−
−
1.4.2 –FP7 PROJECTS
a) TINN
The TINN project, Treat Infections in Neonates, is part of
the European Union’s Seventh Framework Project (GA223614 and is aimed at gathering the experience of
numerous centres across Europe in the neonatal research
field in order to produce detailed evidence on the safety and
efficacy of ciprofloxacin and fluconazole use in neonatal
sepsis. The project began in 2008 and has, as one of its
goals, the obtainment of a Paediatric Use Marketing
Authorization (PUMA).
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). In all, 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 TINN study was recently granted a two-year extension in order to conclude the ongoing clinical trials and will end
in 2015.
(http://www.tinn-project.org/)
16
REPORT 2014
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-260908). TINN2’s aim is
to study azithromycin, an antibiotic effective against Ureaplasma, for the
prevention of broncopulmonary dysplasia (BPD) in neonates. One of the goals
of the project is to obtain the PUMA (Pediatric Use Marketing Authorization)
for the drug. Several studies show a relationship between Ureaplasma
colonization and BPD development in neonates.
Azithromycin is an antibiotic effective against this mycoplasma and studies conducted up to the present show
interesting results.
BPD is one of the European Medicines Agency’s selected therapeutic areas that need pharmacological assessments
specific to neonates.
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 NICUs, located in 28 different countries, were selected and contacted
and about 200 NICU completed the entire questionnaire. The results, published in the Scientific Reports journal, show
that there is still much uncertainty about the actual involvement of Ureaplasma in the development of BPD, that
azithromycin is not a drug of first choice for the treatment of BPD, and that there are still doubts about its safety and
efficacy in neonates.
The survey also allows the identification of the NICUs where the trial will be conducted.
The project is ongoing and is expected to end in 2015. However, to allow the clinical trials to be carried out, a request
for a project extension will be made to the EMA.
(http://tinn2-project.org/)
1.4.3 – THE LOMBARDY REGION’S ADHD REGISTER
The Lombardy Region’s ADHD Register was launched in June 2011 within the project called
“Sharing diagnostic-therapeutic approaches for ADHD in Lombardy” with the funding of 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 the ADHD cases.
The register was designed as a disease register and therefore collected information not only
on the patients diagnosed with ADHD under pharmacological treatment (as foreseen by the
national register), but also on all patients who visited the referral Centres for a suspected
ADHD.
The register then permits the:
 monitoring of diagnostic paths;
 defining of the prevalence of the disorder;
 monitoring of non pharmacological treatment programs as well;
 continuation of pharmacovigilance activity by extending the monitoring on the use
of the drugs other than atomoxetine and methylphenidate;
 quantifying the workload for the referral Centres.
At the end of 2014, 2.061 patients have been included in the register, 1.210 of whom had a
confirmed ADHD diagnosis, 631 were not diagnosed for ADHD, and 220 were still under
diagnostic evaluation. In the most cases patients were referred to the Centers by the school
(34%) or the parents (22%).
In all, 80% of the 1.210 patients with a confirmed ADHD diagnosis received a non pharmacological prescription, 3%
only a pharmacological one, 13% both the prescriptions, and the remaining patients are still awaiting for any therapy.
The most frequent comorbidities were learning disabilities (35%), sleep disorders (14%) and oppositional/defiant
disorder (13%).
17
REPORT 2014
IlGiornale.it
Deficit attenzione ed iperattività, sovrastimata l'incidenza
Redazione Salute
(http://salute.ilgiornale.it/news/20676/studio-adhd-incidenza-negri-istituto/1.html)
Mi-Lorenteggio.com
Studio Regione Lombardia e Istituto Mario Negri - Ma dove sono tutti questi bambini
iperattivi?
AboutPharma
Sovrastimati i casi di ADHD, in Lombardia sono 15 volte inferiori alla media mondiale
(http://www.mi-lorenteggio.com/news/32825)
(http://www.aboutpharma.com/news/medicina-e-salute/bimbi-iperattivi-in-lombardia-quindici-volte-meno-rispettoalla-media-mondiale/)
agiellenews
Milano: Bambini iperattivi, Istituto Mario Negri, lo studio coinvolge l'intera regione
(http://www.agiellenews.it/articolo/agielle-milano-bambini-iperattivi-2-istituto-mario-negri-lo-studio-coinvolge-lintera-regione/13852)
ANSA
Troppe diagnosi iperattività bimbi, sono 15 volte di meno
(http://www.ansa.it/saluteebenessere/notizie/rubriche/salute_bambini/medicina/2014/11/03/troppe-diagnosiiperattivita-bimbisono-15-volte-di-meno-_25ccfab4-5269-475e-b1e7-c056ad17177b.html)
Sindacato
DONNA Diario del Web Ma dove sono allora tutti questi bambini iperattivi?
(http://donna.diariodelweb.it/donna/articolo/?nid=20141103_323599)
Health Desk
Adhd: non è l'epidemia che si crede
(http://www.healthdesk.it/ricerca/adhd_non_lepidemia_che_si_crede/1415067600)
Salute of Mind
Ma dove sono allora tutti questi bambini iperattivi? Incidenza di ADHD quindici volte
inferiore alle attese
Emerge il Futuro
Iperattività infantile, casi sovrastimati di oltre 15 volte
(http://www.stateofmind.it/2014/11/adhd-incidenza-reale-lombardia/)
(http://news.emergeilfuturo.it/salute-e-benessere/1065-iperattivita-infantile-casi-sovrastimati-di-oltre-quindicivolte.html)
Mainfatti
ADHD: troppe diagnosi di bambini iperattivi, almeno del 15%
(http://www.mainfatti.it/ADHD/ADHD-troppe-diagnosi-di-bambini-iperattivi-almeno-del-15_070535033.htm)
Virgilio Notizie
IRCCS: Ma dove sono allora tutti questi bambini iperattivi?
(http://notizie.virgilio.it/notizie/cronaca/2014/11_novembre/03/Troppe_diagnosi_iperattivit_agrave_bimbi_sono_15_volte_di_stimati,43833621.html)
Si Viaggia
benessereguidone.it
West - Welfare
Società Territorio
Intopic
Dica33
Bambini iperattivi? Bambini dislessici? Sono molto di meno di quanto pensiamo
(http://www.siviaggia.it/search/focus/30783584/bambini-iperattivi-bambini-dislessici-sono-molti-di-meno-diquanto/)
(http://benessere.guidone.it/2014/11/04/bambini-iperattivi-bambini-dislessici-sono-molti-di-meno-di-quantopensiamo/)
Iperattività nei bambini, sovradiagnosi in Lombardia
M Rosini (http://www.west-info.eu/it/iperattivita-nei-bambini-sovradiagnosi-in-lombardia/?ref=feed)
(http://www.intopic.it/notizia/7352641/)
Adhd: studio lombardo ridimensiona il problema e ridefinisce terapie
(http://www.doctor33.it/forum/default.aspx?g=posts&t=5353)
italia salute
L'ADHD è sovrastimato
Di Lei
(http://www.italiasalute.it/6061/h/L%27ADHD-%C3%A8-sovrastimato.html)
(http://ricerca.dilei.it/focus/30777721/l-adhd-%C3%A8-sovrastimato/)
Pediatria: studio Mario Negri, dati bimbi iperattivi sovrastimati 15 volte
tiscali.notizie
Corriere Nazionale
Medici Italiani
Yahoo Notizie
Panorama.it
Padova News
Sassari Notizie
Olbia Notizie
Libero.it
Oggi Treviso.it
Facebook
Focus.it
(http://lifestyle.tiscali.it/salute/feeds/14/11/03/t_16_ADN20141103123728.html?news)
(http://www.corrierenazionale.it/salute/news-2014-11-03-12-37-00-pediatria__studio_mario_negri_dati_
bimbi_iperattivi_sovrastimati_15_volte-57422/)
(http://www.sindacatomedicitaliani.it/smi/?content=AKS20141103123335)
(https://it.notizie.yahoo.com/pediatria-studio-mario-negri-dati-bimbi-iperattivi-sovrastimati-113700430.html)
(http://www.panorama.it/scienza/salute/pediatria-studio-mario-negri-dati-bimbi-iperattivi-sovrastimati-15-volte/)
(http://www.padovanews.it/speciali/salute/318395-pediatria-studio-mario-negri-dati-bimbi-iperattivi-sovrastimati15-volte.html)
(http://www.sassarinotizie.com/24ore-articolo-289363-pediatria_studio_mario_negri_dati_
bimbi_iperattivi_sovrastimati_15_volte.aspx)
(http://www.olbianotizie.it/24ore-articolo-193695-pediatria_339_bimbi_lombardi_iperattivi_
nel_2012_farmaci_solo_per_14.aspx)
(http://247.libero.it/rfocus/21612887/1/pediatria-studio-mario-negri-dati-bimbi-iperattivi-sovrastimati-15-volte/)
(http://www.oggitreviso.it/pediatria-studio-mario-negri-dati-bimbi-iperattivi-sovrastimati-15-volte-99800)
(https://it-it.facebook.com/lasaluteinpillole/posts/10152693690318941)
(http://www.focus.it/scienza/salute/pediatria-studio-mario-negri-dati-bimbi-iperattivi-sovrastimati-15-volte)
18
REPORT 2014
Valtellina News
Deficit dell'attenzione, in Lombardia 4200 giovani ne soffrono
(http://www.valtellinanews.it/articoli/Deficit-dell-attenzione-in-Lombardia-4200-giovani-ne-soffrono-20141103/)
MeteoWeb.eu
Ricerca: dove sono tutti i bambini iperattivi?
(http://www.meteoweb.eu/2014/11/ricerca-dove-tutti-questi-bambini-iperattivi/343386/)
Resegoneonline.it
Bambini iperattivi, in Lombardia 15 volte meno che nel resto mondo
(http://www.resegoneonline.it/articoli/Bambini-iperattivi-in-Lombardia-15-volte-meno-che-nel-resto-mondo20141103/)
Corriere della Sera
Casi iperattività bimbi 15 volte in meno
(http://www.corriere.it/notizie-ultima-ora/Scienza_e_salute/Casi-iperattivita-bimbi-volte-meno/03-11-2014/1A_015079023.shtml)
Corriere della Sera
Troppe diagnosi di iperattività in Lombardia sovrastimati 15 volte
(http://www.corriere.it/salute/pediatria/14_novembre_03/troppe-diagnosi-iperattivita-lombardia-sovrastimati-15volte-05bae3bc-6351-11e4-bb4b-8f3ba36eaccf.shtml)
ISS
Comunicato Stampa. IRCCS Mario Negri "Ma dove sono tutti questi bambini iperattivi?"
(http://www.iss.it/adhd/?lang=1&id=568&tipo=7)
Mnduria Oggi
Bambini iperattivi: chi li ha visti?
(www.manduriaoggi.it/notizia.asp?idnews=27160 )
Nicola Piccinini
BES, DSA, ADHD, sentenze di tribunale ed intervento psicologico
(http://nicolapiccinini.it/bes-dsa-adhd-e-sentenze-di-tribinale-su-mancanza-di-percorsi-personalizzati/2014/11/)
Tempi
Adhd, studio italiano conferma: le stime sono esagerate. "Colpa dell'allarmismo e di
diagnosi troppo generiche"
(http://www.tempi.it/adhd-studio-italiano-conferma-le-stime-sonop-esagerate-allarmismo-diagnosi-generiche#VJQcfVsU)
Mamma che pancioni
Iperattività, i bambini colpiti sono 15 volte meno del previsto
(http://mammachepancioni.altervista.org/blog/category/home/page/22/)
Mamme Domani
Troppe diagnosi di Adhd (deficit dell'attenzione ed iperattività): sovrastimata l'incidenza
L Perugia
(http://www.mammedomani.it/bambini/articoli/5776-troppe-diagnosi-di-adhd-deficit-dellattenzione-ed-iperattivitasovrastimata-lincidenza.html; 3 novembre 2014)
il Pediatra
Adhd: in Lombardia prevalenza molto più bassa
(http://www.ilpediatranews.it/2014/11/20/adhd-in-lombardia-prevalenza-molto-piu-bassa/ )
Linkiesta
Bambini iperattivi: non è vero che sono così tanti
(http://www.linkiesta.it/sindrome-deficit-attenzione)
Orizzonte.Scuola.it
ADHD: uno studio conferma una prevalenza 15 volte inferiore a quella mondiale
P Del Pidio
(http://www.orizzontescuola.it/news/adhd-studio-conferma-prevalenza-15-volte-inferiore-quella-mondiale)
Scienze in rete
IRCCS: Ma dove sono allora tutti questi bambini iperattivi?
(http://www.scienzainrete.it/contenuto/news/irccs-ma-dove-sono-tutti-questi-bambini-iperattivi/novembre-2014)
ADN Kronos
Ambulatoriprivati.it
Informazione.it
Iperattivi ma non troppo: per gli esperti i dati sui bimbi con Adhd sono sovrastimati
(http://www.adnkronos.com/salute/medicina/2014/11/03/iperattivi-non-troppo-per-gli-esperti-dati-sui-bimbi-conadhd-sono-sovrastimati_Ucl2fyQGRjbdoKyBaJvaYL.html)
(http://www.ambulatoriprivati.it/notizie-sanita-medicina-salute-da-google-news/iperattivi-ma-non-troppo-per-gliesperti-i-dati-sui-bimbi-con-adhd-the-horsemoon-post.html)
Adhd: non è l'epidemia che si crede
(http://www.informazione.it/a/1BB7C4B9-35E9-46C8-BF84-0A09EE468479/Adhd-non-e-l-epidemia-che-si-crede)
La Provincia Quotidiano
di Cremona
Bimbi, troppe diagnosi di iperattività. Sono 15 volte meno di quelli stimati
(2 dicembre 2014; pag. 19)
1.4.4 – CO-OPERATION WITH COUNTRIES WITH LIMITED RESOURCES
As an expression, test, and original method of manifesting 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 the World Health Organization. The technical and
organisational support for carrying out socio-sanitary
projects in countries with limited resources continues.
19
REPORT 2014
1.4.5 – OTHER INTERVENTIONS/PRODUCTS
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 organization of, educational, training, and informationdissemination activities.
The critical and active transfer of scientific knowledge is a continuous, daily stimulus to the laboratory’s activity.
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. On June 17, 2014 was released on the 7th up Reports on the
monitoring of the Convention on the Rights of the Child in Italy, in the presence of the
Minister for Labour and Social Policy Giuliano Poletti and the Guarantor for the ' childhood
and adolescence, Vincenzo Spadafora.
The 87 associations Group CRC are turning to the representatives of the new government
and parliamentarians, as well as to local authorities hope that each institution may, within
its field of action, grasp the importance and urgency of the critical issues raised and take
action to resolve them , taking charge of the recommendations contained in the Report.
With the publication of the 7th Report of the Group updated CRC continue the monitoring
of the implementation, in our country, the UN Convention on the Rights of the Child
(CRC) and its Optional Protocols, undertaken starting from processing 1st Supplementary
Report in 2001.
In over ten years of the CRC Group has published seven reports annual update and two
Supplementary Reports that were sent to the UN Committee to help with the Government
Report to the analysis of the implementation of the Convention in Italy.
The annual publication testifies to the perseverance and the commitment of the associations in ensuring a constant and
regular update on the implementation of the rights of children and adolescents in our country, even when the different
institutional levels are not always able to maintain the rights of ' childhood on the political agenda..
The report can be downloaded from the website: http://www.gruppocrc.net
November
Save the Children
Facebook
A 25 anni dall’approvazione della Convenzione Onu sui diritti dell’infanzia e
dell’adolescenza - La situazione in Italia
(http://www.savethechildren.it/informati/comunicati/a_25_anni_dall_approvazione_della_convenzione_onu_sui_dir
itti_dell_infanzia_e_dell_adolescenza_si_afferma_una_cultura_dell_infanzia_ma_non_una_strategia?year=2014)
(https://www.facebook.com/notes/istituto-mario-negri/a-25-anni-dallapprovazione-della-convenzione-onu-suidiritti-dellinfanzia-e-dell/879412765411539)
20
REPORT 2014
b) HEY MOM, DID YOU KNOW? (“LO SAI MAMMA”)
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.
The pamphlets have been published on Ricerca & Pratica (www.ricercaepratica.it)
Features:
2005:
2006:
2007:
2008:
2009:
2010:
2011:
2012:
2013:
Acido Folico; Viaggiare in Auto - La cinetosi
Febbre tosse mal d’orecchio; Vacanza al mare - sole; Vomito diarrea; Punture
d’insetto; La pediculosi; Malattie Infettive - 1 PARTE
Malattie Infettive - 2 PARTE; Vitamine e Neonati; Stipsi; Ossiuri; Influenza
Celiachia; Impetigine; Acari e Allergie; HPV – Papilloma virus; Scabbia; Dermatite
Acne;Verruche; Congiuntivite; Micosi; Le Influenze; Allattamento e Farmaci
Nati per leggere; Bambini e TV; Mononucleosi; Bambini e Internet; Epilessia e
Maternità; Coliche nel Neonato; Depressione post parto
SIDS – Morte in culla; Incidenti domestici; Nati per la musica; Igiene dentale;
Sicurezza in bici, Sicurezza in moto
Piedibus; Per una buona notte; Asma; La febbre nel bambino; Psoriasi
Alimentazione e gravidanza; Sport e bambini; Controlli in gravidanza; Medicine e
bambini; Lavarsi le mani
2014
Laringospasmo
Dolore nel bambino
Svezzamento
ADHD (deficit di attenzione)
Autismo
scheda 48
scheda 49
scheda 50
scheda 51
scheda 52
http://www.marionegri.it/mn/it/servizi/mamma.html
Providing information aimed at improving the general wellbeing of mothers and
children is one of the activities of the Mario Negri Institute’s Laboratory for Mother
and Child Health.
Over the years, several information cards have been created to answer the most
common or urgent questions asked by parents concerning their children’s health.
These cards are based on evidence of appropriateness and are aimed at managing or
preventing common childhood health-related problems. The material, produced in
collaboration with the Italian Associazione Culturale Pediatri, is based on the
abundant experiences of experts (and parents).
This “guide” is meant to be an essential, accurate, and effective information tool to
educate parents on the importance of implementing positive educational models for
health, which respect the rights of their children. The guide contains clear and useful
information aimed at reducing anxiety and limiting potential errors.
We hope that the “guide” may become an easy to read tool for parents and for all
those who care for children and young adolescents as they grow.
21
REPORT 2014
c) ADHD NEWSLETTER
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 2014, 86 issues of the newsletter had been published and sent to the
530 people registered (154 child psychiatrists, 98 psychologists, 84 medical doctors,
36 paediatricians, 35 members of school staff, and 123 “others”) and 5953 scientific
studies had been reported.
The newsletter is available on the Mario Negri’s website:
http://www.marionegri.it/it_IT/home/medico/ricerca_clinica/registri_patologia/registro_adhd/Newsletter_ADHD
and in: ADHD.marionegri.it
d) ORGANIZATION OF EVENTS
- I PEDAL FOR RESEARCH (IO PEDALO PER LA RICERCA)
The Laboratory participated in organizing the second edition of the
bike event "IO PEDALO PER LA RICERCA" (I pedal for
research), which was held on Sunday, 11th May 2014; the initiative
with the support the city of Milan. About 200 cyclists, between
institute staff and friends, biked through downtown Milan in order
to highlight the importance of the development of, and support for,
scientific research for the health and wellness of all.
A gazebo was set up along the
route, near the Parco Montanelli
in
Via
Palestro,
where
informational material on the
institute’s
activities
was
distributed.
The beautiful day, passersby
heading to Orticola (the plant
fair), and the larger city-wide
initiative, contributed to the
visibility of the IO PEDALO
PER LA RICERCA bike event,
and therefore of the institute.
22
REPORT 2014
- CONGRESSES, SEMINARS, MEETINGS
During 2014 the laboratory organized one scientific congress and six seminars as thematic study meetings.
CONGRESS:
Outcome evaluation in clinical practice in complex situations
for treating and taking care of patients
Outcome evaluation for interventions for the individual, for
services, and for the community represents an inevitable theme for
contemporary clinical practice, especially in complex situations
such as those present in the daily practice of the child and
adolescent neuropsychiatric services (NPIA).
The contemporary presence of multiple clinical and psychosocial
components does not only lead to a “sum of the problems”, but
their non-linear interaction causes them to have exponential
positive and negative effects. The multidimensional aspect thus
becomes an essential element in the initial patient (and family)
evaluation in order to identify and decide on the most adequate
priorities and set up the interventions.
The multidimensional quality is also inevitable in the outcome
evaluation because of the presence of multiple subjects, healthcare
staff, and institutions, with different roles and responsibilities, each
of which contribute to defining the objectives and to the
achievement of the expected results. It is increasingly necessary to
make what is explicit implicit: to oneself, one’s colleagues, and to
patients/families. The afternoon work groups also have the roles
of: launching and maintaining a more thorough analysis and a true
comparison between services, of facilitating the introduction and
diffusion of sustainable strategies for improvement, of elaborating
proposals of the clinical-professional, managerial, and research
and experimental areas, and of laying the foundation of an
expanded network.
The aim of the meeting was to stimulate thoughts and a thorough discussion on the topic, and to guide participants
towards the building of a practice community that knows how to develop new solutions for treating and for taking care
of patients in order to achieve better outcomes. The meeting is part of the child neuropsychiatry’s “Migration and
psychiatric emergencies in adolescence” project, led by the UONPIA Fondazione Policlinico, carried out by ASL
Milano, and funded by the Lombardy Region with DGR 3798 del 08/05/2014.
Secolo d'Italia
In Italia 3,6 milioni di minori con problemi neuropsichici
Redazione (18 settembre 2014; pag. 5)
PrimaDaNoi.it
La Voce
(18 settembre 2014; pag.6)
Milano. In Italia 3,6 MLN bimbi ha disturbi neuripsichici
clic Medicina
Aumentano i bambini con Disturbi Neuropsichiatrici
(http://www.clicmedicina.it/pagine-n-59/aumentano-bambini-con-disturbi-neuropsichiatrici-09840.htm)
DD Archimede Rozzano Convegno "La Valutazione di esito nella pratica clinica in situazioni di complessità"
(http://www.archimederozzano.it/convegno-la-valutazione-di-esito-nella-pratica-clinica-in-situazioni-dicomplessita- per-curare-e-prendersi-cura/)
Fondazione Zancan
Il Pensiero Scientifico
Gruppo CRC
Persone con Disabilità
Facebook
Artelier
Aris
SOS Sanità
La Valutazione di esito nella pratica clinica in situazioni di complessità
(https://www.fondazionezancan.it/news/view/645)
(http://www.pensiero.it/news/news.asp?IDNews=1387)
(http://gruppocrc.net/La-Valutazione-di-esito-nella)
(http://www.personecondisabilita.it/page.asp?menu1=4&notizia=4889)
(https://it-it.facebook.com/events/718244318240989/?ref=22)
(http://www.artelier.org/la-valutazione-di-esito-nella-pratica-clinica-a-settembre-un-convegno-di-approfondimentoallistituto-di-ricerche-farmacologiche-mario-negri/)
(http://www.arisassociazione.it/settembre_2014.html)
(http://www.sossanita.it/valutesitozancanegri_719.html)
23
SEMINARS:
REPORT 2014
Thematic study meetings
-
Zoom Approach: una strategia per valutare gli out come (6 febbraio)
Dott.ssa Cinzia Canali e Dott. Tiziano Vecchiato;
Autismo. Un’umanità possibile (5 marzo)
Prof. Francesco Barale;
OMS: i governi non si facciano intimidire dalle case farmaceutiche (31 marzo)
Dott.ssa Nicoletta Dentico;
I disturbi dell’apprendimento: in una società disattenta (16 aprile)
Prof. Cristiano Termine;
Abilitazione precoce nella SMA1 e valutazione degli interventi (7 maggio)
Chiara Mastella e Grazie Zappa;
Per il superamento (abolizione) degli Ospedali Psichiatrici Giudiziari (30 maggio)
Prof. Angelo Righetti.
24
REPORT 2014
e) 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
SSecretary: Daniela Miglio
http://www.ricercaepratica.it
1.5 – AND THEN …
1.5.1 – 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.
25
REPORT 2014
1.5.2 – CONFERENCES, WORKSHOPS, PRESENTATIONS, …
January
TAVOLA ROTONDA DI PROSPETTIVE IN PEDIATRIA. Giornate di pediatria “Giovani”. Società Italiana di
Ricerca Pediatrica; Napoli.
February
BURDEN OF PSYCHIATRIC DISORDERS IN THE PAEDIATRIC POPULATION. 9° Workshop
internazionale “Child Health in Camangüey”. Camagüey Children’s Hospital Department of Provincial Health
Camaguey and University of Nottingham, Camagüey Cuba.
WRITING AN ABSTRACT. Workshop “Writing Scientific Papers”. University of Havana, Havana Cuba.
March
IL PERCORSO DELL’ASSISTITO IN ETÀ EVOLUTIVA CON PROBLEMI NEUROPSICHIATRICI.
Esperienze: LA RETE REGIONALE ADHD. Corso. Società Italiana di Igiene Medicina Preventiva e Sanità Pubblica,
Sezione Lombardia; Milano.
IMPACT OF OFF-LABEL DRUG USE IN PEDIATRICS ON DRUG SAFETY AND EFFECTIVENESS
PROFILE. Annual meeting “ISPE 2014”. International Society for Pharmacoepidemiology; Rotterdam, The
Netherland.
April
LA SALUTE INFANTILE NEI PAESI IN VIA DI SVILUPPO. PVS. Corso elettivo “Promozione della salute
infantile nei paesi in Via di Sviluppo”. Università degli Studi di Milano-Bicocca, Facoltà di Medicina e Chirurgia,
Scuola di Medicina; Monza (MB).
PER UNA INFORMAZIONE PARTECIPATA: “LO SAI MAMMA”. Riunione annuale 2014. Associazione
Alessandro Liberati Network Italiano Cochrane; IRCCS Istituto di Ricerche Farmacologiche Mario Negri; Milano.
June
REAZIONI AVVERSE IN GRAVIDANZA. Master di perfezionamento in farmacologia. Servizio di
Epidemiologia e farmacologia Preventiva (SEFAP), Università degli Studi di Milano, Dipartimento di Scienze
Farmacologiche; Milano.
AGGIORNAMENTO TERAPEUTICO IN TEMA DI WHEEZING E ASMA. Scuola di Specializzazione in
Pediatria. Università degli Studi di Milano-Bicocca, Facoltà di Medicina e Chirurgia, Scuola di Medicina; Monza
(MB).
July
L’USO DEI FARMACI PER I BAMBINI. Corso “Summer Students”. IRCCS Istituto di Ricerche Farmacologiche
Mario Negri; Milano.
L’UTILIZZO OFF LABEL DEI FARMACI IN NEUROPSICHIATRIA INFANTILE: NORMATIVE,
CRITERI DI IMPIEGO E CRITICITÀ. Corso “L’uso di farmaci off Label in Neuropsichiatria Infantile:
normative, criticità, proposte operative”. Fondazione IRCCS Ca’Granda Ospedale Maggiore Policlinico; Milano.
September
UN MODELLO PER IL MONITORAGGIO E LA VALUTAZIONE DEI PERCORSI IN NPIA.
CONTINUITA’ DELLE CURE VERSO L’ETA’ ADULTA IN REGIONE LOMBARDIA. CONDIVISIONE
E MONITORAGGIO DEI PERCORSI DIAGNOSTICI E TERAPEUTICI IN NEUROPSICHIATRIA: IL
PROGETTO ADHD LOMBARDIA. XXVI Congresso Nazionale SINPIA. Società Italiana di Neuropsichiatria
dell’Infanzia e dell’Adolescenza; Roma.
L’USO DI CGAS E CGI NEGLI UTENTI DEL REGISTRO LOMBARDO ADHD. LA SFIDA DELLA
COMPLESSITA’. Convegno “La valutazione di esito nella pratica clinica in situazioni di complessità per curare e
prendersi cura”. Fondazione IRCCS Ca’Granda Ospedale Maggiore Policlinico, Fondazione Emanuela Zancan
Onlus, la Nuova Famiglia Eugenio Medea; Milano.
October
APPROPRIATEZZA PRESCRITTIVA IN GRAVIDANZA. FARMACINETICA E ALLATTAMENTO.
Convegno “L’uso dei farmaci in gravidanza e allattamento”. Società Italiana di Tossicologia (SITOX); Pavia.
MAMME «LO SAI MAMMA». FARMACI, GRAVIDANZA E ALLATTAMENTO. Corso “Settimana
(in)formazione a cura dei ricercatori dell’IRCCS Istituto di Ricerche Farmacologiche Mario Negri”. Comune di
Noto, IRCCS Istituto di Ricerche Farmacologiche Mario Negri; Noto (SR).
November
LA SALUTE INFANTILE NEI PAESI CON SCARSE RISORSE. Congresso “Salute, malattie e cure nel
mondo globalizzato”. MNIAA Mario Negri Institute Alumni Association, Società Svizzera Milano; Milano.
LA SALUTE DEI BAMBINI. ASPETTI EPIDEMIOLOGICI. Convegno, seconda edizione “Outdoor
Education, l’educazione Sicura all’aperto”. Comune di Bologna; Bologna.
FARMACI, NEONATI E BAMBINI… DALL’OFF-LABEL ALL’“ON” EVIDENCE. III Congresso Nazionale
“Farmaci e Neonato: Luci, Ombre e Prospettive”. Gruppo di Studio di Farmacoterapia Neonatale (SIN); Roma.
26
REPORT 2014
VITAMINE, INTEGRATORI E OLIGOELEMENTI: QUANDO, A CHI, COME E PERCHÈ. 1° Incontro di
Pediatri di Famiglia del Ducato “Famolo Strano! 2014”. Federazione Italiana Medici Pediatrici Sezione di Parma;
Fornovo di Taro (PR).
December
FARMACI E BAMBINI. Scuola di Specializzazione in Pediatria. Università degli Studi di Milano-Bicocca,
Facoltà di Medicina e Chirurgia; Monza (MB).
FARMACI: LA MARCA FA LA DIFFERENZA? Corso di formazione “farmaci equivalenti e farmaci di marca a
confronto”. ASS 1 Triestina; Trieste.
GROW OLD IN THE PUBLIC MENTAL HEALTH SYSTEM OF LOMBARDY REGION: FINDINGS
FROM TWO COHORT STUDIES. European Conference “Youth Mental Health: from continuity of
psychopatology to continuity of care”. IRCCS Fatebenefratelli di Brescia; Venezia.
1.5.3 – OTHER INTERVENTIONS/CITATIONS IN THE MEDIA AND MASS MEDIA
January
Donna Moderna
Avvenire
February
Io e il Mio Bambino
Io e il Mio Bambino
E' il momento dell'areosol
L D'Orsi (pag. 88-89)
Neuropsichiatria: è boom di richieste tra minori immigrati
F Rizzi (pag. 27)
Gengivite gravidica: Che fare?
L D’Orsi (pag. 76-79)
SOS malanni di stagione
(10 febbraio; pag. 43)
Consultant360
March
Il Salvagente
Inhaled steroids don't prevent recurrent viral wheeze: study
(http://www.consultant360.com/story/inhaled-steroids-dont-prevent-recurrent-viral-wheeze-study)
Alluminio e latte artificiale. Il muro di gomma dei produttori
(pag. 23-25)
April
Radio RAI 3
Intervista: Pillole di troppo
M Motta
(http://www.radio3.rai.it/dl/radio3/programmi/puntata/ContentItem-391a4f1d-0a29-4f54-814d-520a3530e9f2.html)
Io e il mio Bambino
May
AIFA
Mamma mi curi tu?
MC Valsecchi (pag. 18-22)
Farmaci essenziali per i bambini
M Bonati (http://www.agenziafarmaco.gov.it/it/content/farmaci-essenziali-i-bambini)
June
Corriere della Sera
Perché tanti malati nel nostro paese. I rischi di encefalite
L Ripamonti (1 giugno 2014; pag. 19)
Il Venerdì di Repubblica Paracetamolo: panacea o veleno? Questioni di dosi
A Saragosa (27 giugno 2014; pag. 63)
July
Il salvagente
Farmaci. La lista nera dei 353 da evitare
M Strinati (pag. 31-40)
qui - mamme
I farmaci pediatrici sicuri? Quelli conosciuti
F Bertamini (http://www.quimamme.it/con-la-tribu/2014/07/14/i-farmaci-pediatrici-sicuri-quelli-conosciuti/)
August
Il Venerdì di Repubblica Attenti al bambino se la pillola va giù
A Saragosa (1 agosto 2014; pag. 74-75)
GiraMolfetta
Per le malattie più comuni dei bambini sono sufficienti 20 medicinali
(http://www.giramolfetta.it/content_/news_zoom.asp?id_news=3729&lan=ita)
September
il Pediatra
Wheezing nelle infezioni virali e nebulizzazione di beclometasone
Giornale di Brescia
Terapia. Sono venti i farmaci essenziali per i bimbi.
27
Farmacista33
REPORT 2014
Pletora di farmaci prescritti dai pediatri, ma ne basterebbero 20
R Torlaschi
(http://www.farmacista33.it/pletora-di-farmaci-prescritti-dai-pediatri-ma-ne-basterebbero-/pianeta-farmaco/news-28751.html)
Medico e Bambino.com Sono 20 i farmaci essenziali per bambini,il resto 'fotocopie'
(http://www.medicoebambino.com/?id=NEWS1407_10.html)
(http://www.ansa.it/saluteebenessere/notizie/rubriche/medicina/2014/08/29/sono-20-i-farmaci-essenziali-perbambiniil-resto-fotocopie_716e6883-9f88-4ffb-8524-62f13fd8299d.html)
ANSA
Leonardo.it
Per le malattie più comuni dei bambini sono sufficienti 20 medicinali
(http://www.paginemamma.it/it/581/news/farmacologia-medica/detail_214529_per-le-malattie-piu-comuni-deibambini-sono-sufficienti-20-medicinali.aspx?c1=30
Pharmawizard
Farmaci per bambini: come e quali medicine dare ai più piccoli
(http://www.pharmawizard.it/blog/)
WIRED
Troppi farmaci pediatrici, per gli esperti ne basta la metà
C Da Rold (http://www.wired.it/lifestyle/salute/2014/09/08/troppi-farmaci-pediatrici/)
SCOOP:IT
Di Lei
(http://www.scoop.it/t/tutto-farmaci-online-farmacie-di-turno-foglietto-illustrativo)
(http://ricerca.dilei.it/focus/30225072/troppi-farmaci-pediatrici-per-gli-esperti-ne-basta-la-et%C3%83%C6%
92%C3% 86%E2%80%99%C3%83%E2%80%9A%C3%82%C2%A0/)
October
Milano Today
PartecipaMI.it
WikiEventiMilano
Vivi Milano
L'Unione sarda
Tavola Rotonda: salute, malattie e cure nel mondo globalizzato il 3 novembre a Milano
(22 ottobre 2014; http://www.milanotoday.it/eventi/tavola-rotonda-salute-malattie-3-novembre-milano.html)
(http://www.partecipami.it/calendar/event/1/3246)
http://www.wikieventi.it/milano/index.php?id_evento=95896&evento=Tavola_Rotonda_Salute_Malattie_e_Cure_ne
l_Mondo_Globalizzato)
(29 ottobre 2014; pag. 63)
Farmaci ai bambini, se ne parla al caffè
(24 ottobre 2014; pag. 22)
Radiolina
Intervista: Troppi Farmaci ai Bambini
P Pilia, A URGU
(24 ottobre 2014; programma l'Unione in Diretta")
La Sicilia
"Tra mito e realtà" corso di formazione sull'uso dei farmaci
(5 ottobre 2014; pag. 36)
NostroFiglio.it
Raffreddore neonati e bambini, consigli e cure
(http://www.nostrofiglio.it/neonato/cura-e-salute/il-neonato-ha-il-raffreddore-e-il-naso-chiuso)
BimbiSani&Belli
Farmaci: per curare i bambini bastano 20 molecole
(http://www.bimbisaniebelli.it/mamma-e-famiglia/bambino/1-3-anni/salute/farmaci-curare-i-bambini-bastano-20Molecole)
November
Io e il mio Bambino
Avvenire
Pediatria: dopo i tagli che futuro ci aspetta
C Sandrucci (1 novembre 2014; pag. 17-21)
Istituto Negri. Salute, malattie e cure nel mondo globalizzato
(2 novembre 2014; pag. 29)
Doctor33
L’indagine, donne più propense all’abuso di psicofarmaci
R Torlaschi
(http://www.doctor33.it/lindagine-donne-piu-propense-allabuso-di-psicofarmaci/pianeta-farmaco/news53172.html?xrtd=YPYCCTXSRTVTVVAXLRCRALR)
1.5.4 – CONTRIBUTIONS, CONTRACTS, …
−
−
−
−
−
−
−
−
AIFA, Agenzia Italiana del Farmaco
A.O. Spedali Civili di Brescia
IRCCS Burlo Garofolo, Trieste
IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano
Provincia di Milano
Regione Lombardia – Assessorato alla Sanità
Regione Valle d'Aosta – Assessorato alla Sanità
Unione Europea
28
REPORT 2014
1.5.5 – NATIONAL COLLABORATIONS
−
−
−
−
−
−
−
−
−
−
−
−
−
Associazione Culturale Pediatri (ACP)
A.O. Spedali Civili di Brescia
Centro Antiveleni –Tossicologia Clinica – Ospedale Papa Giovanni XXIII, Bergamo
Centro per la Salute del Bambino (CSB)
Fondazione Emanuela Zancan Onlus
Il Pensiero Scientifico Editore
Istituto Superiore di Sanità (ISS)
Istituto Don Calabria CTD Negrar
Osservatorio Italiano Salute Globale (OISG)
Unità Operativa di Neuropsichiatria dell'Infanzia e dell'Adolescenza, Fondazione IRCCS Ca’ Granda –
Ospedale Maggiore Policlinico di Milano
Università degli Studi di Firenze – Dipartimento Area Critica Medico Chirurgica Clinica Malattie Infettive,
S.O.D. Malattie Infettive e Tropicali
Università degli Studi di Milano, Bicocca – Facoltà di Medicina – Clinica Pediatrica
Università degli Studi di Pavia – Scuola di Specializzazione in Neuropsichiatria Infantile
1.5.6 – INTERNATIONAL COLLABORATIONS
−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
European Medicines Agency (EMA)
Centro de Epidemiología Comunitaria y Medicina Tropical (CECOMET), Ecuador
Clinica Infantil Colsubsidio, Colombia
Coletivo de Estudios Aplicado y Desarrollo Social Juan XXIII, Bolivia
European Society for Developmental Perinatal & Paediatric Pharmacology (ESDPPP)
Fundació Privada Clinic per la Ricerca Biomedica, Spain
Fundacion Salud Ambiente y Desarrollo, Ecuador
International Society of Drug Bulletins (ISDB)
Hopital Robert Debré, France
World Health Organization (WHO)
Taller de Educacion y Comunicacion Guarani Asociacion, Bolivia
European Union (EU)
University of Amsterdam – Universiteit Van Amsterdam, the Netherlands
University College London Hospital NHS Fondation Trust, UK
University of Nottingham - Derbyshire Children's Hospital, UK
Universidad Peruana Cayetano Heredia, Perù
Universidad de Medicina de Camanguey, Cuba
1.5.7 – EDITORIAL BOARD MEMBERSHIP
International:
European Journal Clinical Pharmacology; Saludarte.
National:
Quaderni di Farmacoeconomia; Recenti Progressi in Medicina; Ricerca & Pratica.
1.5.8 – PEER REVIEW ACTIVITIES
International:
Allergologia et Immunopathologia; Archives of Disease in Childhood; BMJ Open; British Journal of Clinical
Pharmacology; Canadian Medical Association Journal; Clinical Infectious Diseases; Epidemiology and Psychiatric
Sciences; Expert Opinion on Pharmacotherapy; Expert Review of Clinical Pharmacology; European Journal of
Pediatrics; European Journal of Clinical Pharmacology; European Neuropsychopharmacology; Italian Journal of
Pediatrics; Pharmacotherapy; Pediatrics; Pediatric Drugs; PLoS ONE; The New England Journal of Medicine; Thorax.
National:
Medico e Bambino.
29
CESAV
RAPPORTO 2011
30
CESAV
“Angelo e Angela VALENTI”
CENTRE FOR HEALTH
ECONOMICS
CLINICAL RESEARCH CENTER OF RARE DISEASES ALDO E CELE DACCÒ
VIA CAMOZZI 3, 24020 RANICA (BG) TEL. 03545351, FAX 0354535371
http://www.marionegri.it/en_US/home/research_en/dipartimenti_en/public_health/angelo_angela_valenti_centre;
CESAV
REPORT 2014
2.1 - 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 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);
Comparative Health Policy Analysis (i.e. study of domestic and foreign health care systems, in particular
aimed at identifying possible innovations for European countries).
2.2 – THE STAFF
Laboratory Head
Livio GARATTINI, ECON D
Research Fellow
Alessandro CURTO, ECON D
Specialist in Biomedical Research
Silvy DURANTI, ECON D
Katelijne VAN DE VOOREN, PHARM D
Visiting Scientists
Gianluigi CASADEI, MD
Paola DE COMPADRI, ECON D
Simone GHISLANDI, ECON POL D
32
REPORT 2014
CESAV
2.3 - PUBLICATIONS

Curto A, Garattini L. Comment on: Current Status and Trends in Performance-Based Risk-Sharing
Arrangements Between Healthcare Payers and Medical Product Manufacturers. Appl Health Econ Health Policy
2014;12(5):565.

Curto A, Duranti S, Van de Vooren K, Garattini L. Vaccination planning and vaccine prices in a decentralizing
country – Italy. Expert Rev Pharmacoecon Outcomes Res 2014;14:195-202.
IF: 1,87

Curto A, Ghislandi S, van de Vooren K, Duranti S, Garattini L. Regional tenders on biosimilars in Italy: an
empirical analysis of awarded prices. Health Policy 2014;116(2-3):182-7.
IF: 1,725

Garattini L, van de Vooren K. Are high prices a barrier to human papillomavirus vaccination in the United
States? Not in Italy. JAMA Pediatrics 2014;168(6):584.
IF: 4,25

Garattini L, Van de Vooren K, Freemantle Nick. Tendering and Value-Based Pricing: lessons from Italy on HPV
vaccines? Journal of the Royal Society of Medicine 2014;107(1):4-5.
IF: 2,019

van de Vooren K, Duranti S, Curto A, Garattini L. A Critical Systematic Review of Budget Impact Analyses on
Drugs in the EU Countries. Appl Health Econ Health Policy 2014;12(1):33-40.

van de Vooren K, Duranti S, Curto A, Garattini L. Cost effectiveness of the new pneumococcal vaccines: A
systematic review of European studies. PharmacoEconomics 2014;32(1):29-45.
IF: 3,338
2.3.2 – IMPACT FACTOR (IF)
A total of 38 papers were published on peer-reviewed scientific journals by the laboratory’s staff during the 2010-2014
period. The overall impact factor of these papers was 98.081. The overall impact factor of the 7 papers published during
2014 was 13.202.

Casadei G. Accesso dei farmaci: la riforma ha centrato l’obiettivo? R&P 2014;30:245-251.

Curto A, Garattini L. La riforma delle cure primarie nel Servizio Sanitario Nazionale: fra teoria e pratica (Parte
prima). Quaderni di Farmacoeconomia 2014;24:20-31.

Curto A, Rancati E, Duranti S, Garattini L. Value Based Pricing: la nuova frontiera nella fissazione dei prezzi
dei farmaci?. Quaderni di Farmacoeconomia 2014;23:32-39.

Duranti S, Curto A, Garattini L. Costo efficacia dei nuovi vaccini antipneumococcici: una revisione degli studi
europei. Quaderni di Farmacoeconomia 2014;23:9-31.

Duranti S, Curto A, Garattini L. Revisione delle valutazioni economiche europee su boceprevir e telaprevir per
l’epatite C. Quaderni di Farmacoeconomia 2014;25:9-25.

Duranti S, van de Vooren K, Garattini L. Trastuzumab nel carcinoma mammario metastatico in ambito UE: un
esercizio di HTA. Quaderni di Farmacoeconomia 2014;24:10-19.
33
CESAV
REPORT 2014
2.4.1 – EDUCATIONAL ACTIVITIES
Educational activities are developed only if related to
research studies, in order to offer original contributions
which naturally reinforce the research aims..
2.4.2 – 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 costeffectiveness 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.
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.
34
REPORT 2014
CESAV
2.4.3 – 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.
In addition to the formal research activities, CESAV promotes initiatives in the public health field, in particular those
concerning health economics.
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 CESAV’s activity.
35
CESAV
REPORT 2014
a) CONGRESS, SEMINARS, MEETINGS …
During 2014 the CESAV organized:
CONGRESS:
Drug Economics
Between technical solutions and political decisions
The annual meeting, organized by the Centro di Economia Sanitaria
A. e A. Valenti and this year held on 21-22 May in Ranica, Bergamo,
addresses the hottest topics in pharmacoeconomics.
The meeting was made up of 6 sections:
1) Monitoring registries
2) Outcome contracts
3) Continuity in community-level assistance
4) Regional purchasing process for biosimilars
5) Pharmacoeconomics
6) Therapies for Hepatitis C
To watch the slideshow of the event follow the link:
http://www.quadernidifarmacoeconomia.com/video/video2014.html
Meeting:
BIOSIMILARI Project
FARMAGOOD is a collaborative project in which the l’IRCCSIstituto di Ricerche Farmacologiche Mario Negri makes its
scientific skills in the drug and pharmacoeconomic areas available
to the Lombardy Region’s Health System in order to identify and
analyse the problematic issues on the use of biosimilars (phase I)
and to promote the appropriate use of these drugs through the
carrying out of informational initiatives and systematic reviews and
metanalyses.
The objective of the meeting was to present the project and to
launch a debate on the regulatory implications and on the economic
aspects related to the availability of biosimilars that are already
present on the market and of those that are expected to be available
within the next three years.
36
REPORT 2014
CESAV
b) 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 coordinator: Alberto Salmona
Editorial board: Antonella Barale, Corrado Barbui, Ettore Beghi, Maurizio Bonati, Gianluigi Casadei, Erica
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,
Gianvincenzo Zuccotti.
WEB secretary: Marzia Manasse
http://www.quadernidifarmacoeconomia.com/
37
CESAV
REPORT 2014
April
VALUTAZIONE ECONOMICA HPV. Corso “HPV: un problema di sanità pubblica”. ASL AL, Regione
Piemonte; Torino.
RISK-SHARING AGREEMENTS IN ITALY. Congresso “Third Croatian and third adriatic congress on
pharmacoeconomics and outcomes research”. Section for Pharmacoeconomics and Outcomes Research, Croatian
Society of Clinical Pharmacology and Therapeutics, Croatian Medical Association; Ohrid, Macedonia.
May
REGISTRI DI MONITORAGGIO.
CONTRATTI D’ESITO.
CONTINUITÀ ASSISTENZIALE TERRITORIALE.
PROCESSI DI ACQUISTO REGIONALI DEI BIOSIMILARI.
FARMACOECONOMIA: LE TERAPIE PER L’EPATITE C. Congresso Nazionale di farmacoeconomia
“Economia del farmaco- Fra soluzioni tecniche e decisioni politiche”. CESAV; Ranica (BG).
June
DAI GENERICI AI BIOSIMILARI. Incontro “Il mercato del farmaco e i bisogni indotti”. Altroconsumo; Trento.
October
BIOSIMILARI: UNA CHIAVE DI LETTURA ECONOMICA.
UN’ANALISI EMPIRICA DELLE GARE D’ACQUISTO REGIONALI DI BIOSIMILARI IN ITALIA.
Evento formativo “Dai farmaci equivalenti ai biosimilari di anticorpi monoclonali”. ASL Brindisi; Brindisi.
MARKET-ACCESS AGREEMENTS. Congress “Risk-sharing agreements in Poland”. Sequence HC Partners
HTA Consulting KPRW; Varsavia, Polonia.
November
THE CRITICAL SUCCESS FACTORS FOR PERSONALIZED MEDICINE DATA DEVELOPMENT AND
DEMONSTRATING VALUE. ISPOR 17th Annual European Congress “Personalized medicine workshop”.
International Society for Pharmacoeconomics and Outcomes Research (ISPOR); Amsterdam, The Netherlands.
BIOSIMILARI: UNA CHIAVE DI LETTURA ECONOMICA.
UN’ANALISI EMPIRICA DELLE GARE D’ACQUISTO REGIONALI DI BIOSIMILARI IN ITALIA.
SVILUPPO E PRODUZIONE DEI BIOSIMILARI: ASPETTI BIOTECNOLOGICI E IMPLICAZIONI
REGOLATORIE. Incontro “Progetto biosimilari”. CESAV, Dipartimento di Salute Pubblica IRCCS Istituto di
Ricerche Farmacologiche Mario Negri; Milano.
December
HEALTH SYSTEM AND VALUE PRICING IN ITALY. Conference “PLC France-Italy HLG joint meeting”.
Italy HLG e PLCF; Milano.
May
Libero.it
'Check-up dei diritti' Altroconsumo a Trento per il Festival dell'Economia
(15 maggio 2014; http://247.libero.it/rfocus/20464475/1/partenza-in-grande-stile-per-il-secondo-ferraraaltroconsumo-festival/)
Festival Economia
Il mercato del farmaco e i bisogni indotti
(http://2014.festivaleconomia.eu/-/il-mercato-del-farmaco-e-i-bisogni-indotti/)
Vita Trentina
Altroconsumo e l'uso critico dei farmaci
(27 maggio 2014; http://www.vitatrentina.it/Cronaca/Altroconsumo-e-l-uso-critico-dei-farmaci)
La voce del Trentino
Altroconsumo e il mercato dei farmaci: se ne parla a Trento
(28 maggio 2014; http://www.lavocedeltrentino.it/index.php/cronaca/news-dal-trentino-2/13601-altroconsumo-e-ilmercato-dei-farmaci-se-ne-parla-a-trento)
Trento today
"Check-up dei diritti" Altroconsumo a Trento per il Festival dell'Economia
(http://www.trentotoday.it/eventi/cultura/il-mercato-del-farmaco-e-i-bisogni-indotti-2-giugno-2014-altroconsumo2162075.html)
38
REPORT 2014
June
AIRC.it
CESAV
L’esperto che fa i conti in tasca alla salute
C Ferrario
(1 giugno 2014; http://www.airc.it/finanziamenti/informazione/fondamentale/giugno-2014/economistasanitario/)
L’Adige
I Farmaci
(2 giugno 2014; pag. 6)
Altroconsumo
Crushsite.it
Trento Cultura
Corriere del Trentino
Il mercato del farmaco e i bisogni indotti
(2 giugno 2014; http://www.altroconsumo.it/organizzazione/seguici/cerca-l-evento/2014/checkup-diritti-evento-tn)
(2 giugno 2014; http://www.crushsite.it/it/incontri/2014/il-mercato-del-farmaco-e-i-bisogni-indotti.html)
(2 giugno 2014; http://www.trentocultura.it/?lang=it&s=3&mod=cultura&task=events&cId=856593)
Farmaci da banco. Serve più informazione
A Rossi Tonon
(3 giugno 2014; pag. 7)
ANSA
Farmaci: Altroconsumo, informiamo per creare uso consapevole
(3 giugno 2014; http://www.ansa.it/sito/notizie/postit/Altroconsumo_Check_up_Diritti_/2014/06/03/farmacialtroconsumo-informiamo-per-creare-uso-consapevole_dbb4d2b0-ad44-408f-8edb-05fbdfdfa73b.html)
TEVAlab.it
Farmaci da banco. Serve più informazione
(http://www.teva-lab.it/portale/news.php?id_news=4041&id_newscategory=17&father=4)
December
ScienceDaily
Princing for new drugs lacks transparence, experts say
SAGE Publications
(9 dicembre 2014; http://www.sciencedaily.com/releases/2014/12/141209082309.htm)
−
−
−
−
−
−
−
−
Abbott
AIFA
Grunenthal-Prodotti Formenti
Merck Serono
Sanofi Aventis
Sanofi Pasteur MSD
Schering Plough
Vivisol
−
−
Enti pubblici nazionali (Ministero della Salute, Assessorati Regionali, Aziende Sanitarie Locali, Aziende
Ospedaliere).
Collaborazioni con enti privati (aziende del settore e associazioni di categoria).
−
−
−
−
−
−
−
−
−
−
Associazione Francese degli economisti sanitari, Parigi
Corvinus University, Budapest, Hungary
Global Fund , Geneve
WidO Institut, Bonn, Germany
Servicio Canario de la Salud, S/C de Tenerife
University of Birmingham, UK
University of Hannover, Germany
University of York, UK
Universitat Pompeu Fabra, Barcellona
Erasmus University, Rotterdam, the Netherlands
39
CESAV
REPORT 2014
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.
International:
Applied Health Economics and Health Policy; BMC-Health Services Research; Health Policy; PharmacoEconomics;
The European Journal of Health Economics; Epilepsia; British Medical Journal.
40
REPORT 2014
CESAV
CESAV
REPORT 2014
Laboratory of
CLINICAL
EPIDEMIOLOGY
CLINIC RESEARCH OF DISEASES ALDO E CELE DACCÒ
VIA CAMOZZI 3, 24020 RANICA (BG) TEL. 0354535313, FAX 0354535354
http://www.marionegri.it/en_US/home/research_en/dipartimenti_en/public_health/clinical_epidemiology;
REPORT 2014
LABORATORY OF CLINICAL EPIDEMIOLOGY
3.1 - INTRODUCTION
The general aim of the Laboratory of Clinical Epidemiology is to contribute to the improvement of health care in
different medical fields.
The guiding principles are mainly two:
– to help physicians in using the available knowledge and resources at their best;
– to contribute to the growth of applied knowledge for clinical practice.
The Laboratory operates in the field of Intensive Care Medicine. In the main area of activity the laboratory developed
an electronic health record for the ICU which serves the dual purpose of:
– simplifying and improving clinical documentation
– provide accurate data to search for the improvement of quality of care.
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 favouring the evaluation and the
continuous improvement of complex clinical activities.
3.2 - THE STAFF
Laboratory Head
Guido BERTOLINI, MD
Scientists
Obou BRISSY, IT D
Greta CARRARA, IT ENG
Consulent
Daniele CRESPI, IT
Joanne FLEMING, DOTT. MODERN LINGUAGES
Consulente
Michele GIARDINO, IT
Tecnico
Matteo MONDINI, IT D
Consulent
Giovanni NATTINO, MAT. D
Giulia PACI, DOTT SCI NUR MIDW
Claudio PREVITALI, INF D
Carlotta ROSSI, STAT D
(part-time 75%)
Giampiero TRUSSARDI, IT
Consulent
Assistent
Luana NAVA
Secretary
Clinical Knowledge Engineering Unit
Unit Head
Davide LUCIANI, MD
43
REPORT 2014
3.3 - PUBLICATIONS






Mt-Isa S, Hallgreen C, Wang N, Callreus T, Genov G, Hirsch I, Hobbiger S F, Hockley K S, Luciani D,
Phillips L D, Quartey G, Sarac S B, Stoeckert I, Tzoulaki I, Micaleff A, Ashby D, IMI-PROTECT benefit-risk
participants. Balancing benefit and risk of medicines: a systematic review and classification of available
methodologies. Pharmacoepidemiol Drug Saf 2014;23:667-678.
IF: 3.172
Hallgreen C E, Van den Ham H A, Mt-Isa S, Ashworth S, Hermann R, Hobbiger S, Luciani D, Micaleff A,
Thomson A, Wang N, van Staa T P, Downey G, Hirsch I, Hockley K, Juhaeri J, Metcalf M, Mwangi J, Nixon
R, Peters R, Stoeckert I, Waddingham E, Tzoulaki I, Ashby D, Wise L. Benefit-risk assessment in a postmarket setting: a case study integrating real-life experience into benefit-risk methodology. Pharmacoepidemiol
Drug Saf 2014;23:974-983.
IF: 3.172
Daniele Poole, Giovanni Nattino, Guido Bertolini. Overoptimism in the interpretation of statistics.The ethical
role of statistical reviewers in medical journals. Intensive Care Medicine 2014; 40: 1927-1929.
IF: 5.544
Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G, GiViTI. Efficacy of Coupled
Plasma Filtration Adsorption (CPFA) in patients with septic shock. A multicenter randomized controlled
clinical trial. BMJ open 2014 Jan;4(1):e003536.
IF: 2.063
Nattino G, Finazzi S, Bertolini G. Comments on: Graphical assessment of internal and external calibration of
logistic regression models by using loess smoothers' by Peter C. Austin and Ewout W. Steyerberg. Stat Med
2014;33:2696-8.
IF: 2.037
Nattino G, Finazzi S, Bertolini G. A new calibration test and a reappraisal of the calibration belt for the
assessment of prediction models based on dichotomous outcomes Stat Med 2014;33:2390-07.
IF: 2.037
period. The overall impact factor of these papers was 204,819. The overall impact factor of the 6 papers published
during 2014 was 18.025.



Bertelè V, Bertolini G, Garattini S. Trasparenza della ricerca: a che punto siamo? R&P 2014;176:84-85.
Bertolini G. Da una medicina basata sulle evidenze a una medicina basata sulle conoscenze. Recenti progressi
in medicina 2014;105(1):7-8.
Bertolini G. Terapie intensive polivalenti. R&P 2014;175:36-37.
3.3.4 – REPORT

GiViTI. Progetto MargheritaPROSAFE – PROmoting patient
SAFEty research and quality improvement in critical care
medicine. RAPPORTO 2013. Bergamo: Edizioni Sestante, 2014.
44
REPORT 2014
3.4.1 – 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 and other contracts of the laboratory have in
fact been able to develop new software and to distribute the project to eigth
countries: Slovenia, Hungary, Poland, Cyprus, Israel, Afghanistan, Sudan and
Switzerland.
http://www.giviti.marionegri.it/
3.4.2 – APPROPRIATENESS OF THE INTENSIVE CARE UNITS
ICU is a high technology environment, that requires a high number of
high-level personnel. Hence, the cost of these units is extremely
important and a special attention not to waste resources is mandatory.
In this field, the Laboratory launched a study to assess the level of
appropriateness of the use of ICU beds, in three Italian regions:
Lombardia Toscana e Veneto.
Such an evaluation is based on the understanding that the level of care
provided by an ICU should correspond to the level of care it can
theoretically provide, given the available resources. In this
framework, patients are classified as requiring high-, low-, or
ordinary-care, and beds are independently classified are high- or lowlevel.
The appropriateness evaluation protocol adopted verify the concordance between these two separate classifications.
45
REPORT 2014
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.
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.
3.4.3 – 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 regard, 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).
Such a tool, relying on a probabilistic model covering 72 clinical variables
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 aimed at designing 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.
It will be possible to incorporate this software within medical training
projects, with a special attention to e-learning programs.
46
REPORT 2014
3.4.4 – 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) that 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, which is now already shared
by 30 Italian ICUs.
This made it possible to launch the first analysis of the process that has as its goal the
improvement of the practice of weaning from the ventilator.
3.4.5 – 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".
The DOMUS project was 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.
In addition to the formal research activities, the Laboratory promotes initiatives in the public health field, in particular
regarding the improvement of health care.
The critical and active transfer of scientific knowledge is a continuous, daily stimulus to the laboratory’s activity.
In the context of the projects followed by the Laboratory meetings were organized with the aim to evaluate the work
done and to stimulate reflections and exchange of views.
47
REPORT 2014
a) CONGRESS, SEMINARS, MEETINGS …
WORKSHOP:
1. Il follow-up telefonico nel trauma cranico
17-18 Febbraio – Bertinoro (FC)
2. The CREACTIVE telephone follow-up
5-6 Marzo – Bertinoro (FC)
3. 1st CREACTIVE Scientific Advasory Board meeting
31 March – Ranica (BG)
Case Report Form (CRF)
CRF: differences with Common Data Elements (CDE)
CRF: Anatomical severity (worst CT) Pediatric CRF
Follow-up
Organization of and training for follow-up
Validated scales for the follow-up
Specific follow-up for children
4. Pediatric CREACTIVE
2 April – Ranica (BG)
1. Review of pediatric CREACTIVE Case Report Form, item by item
2. Review of the follow-up protocol for pediatric patients
- Telephone follow up using the Pediatric GOS Extended scale to evaluate disability and the PedsQL to evaluate
quality of life
- Sleep disorders draft protocol for Israel with a clear idea of how to apply the protocol in Italy and the PICUs of the
other participating countries
- Functional MRI draft protocol for Israel to be extended, where possible, to the other participating ICUs
- Ambulatory examination draft protocol for Israel and discussion of proposed cognitive testing
3. Any other aspects of pediatric patient follow up
48
REPORT 2014
5. 1st CREACTIVE Ethics Advisory Board meeting
6 May – Milan
How the Ethics Advisory Board was formed and its role in CREACTIVE
Overall presentation of the project
Problem areas to discuss
- Informed consent to data handling in both adults and children
- Collection of human biological samples in adults
- Biomarker analysis
- Genetic testing
- International shipment of samples
- Imaging data collection
- Data handling
- Banking of images
- Ethical aspects of patient follow up in both adults and children
- Involvement of minors in CREACTIVE
6. Investigator meeting compact 2
20 May – Ranica (BG)
COMbining Plasmafiltration and Adsorption Clinical Trial - 2
8. Il follow up telefonico in CREACTIVE
1st October – Milan
7. Meeting annuale Margherita Tre
15-16 September – Ranica (BG)
49
9.
REPORT 2014
10. BIOBANCA e IMMAGINI:
i sottostudi CREACTIVE
17 December – Ranica (BG)
CREACTIVE
Country Coordinator Meeting
21-22 October – Budapest
CREACTIVE: where are we now?
Monitoring system: methods and tools
Translations
Ethical issues
CRF
Website
Adult follow up
CREACTkids: paediatric follow-up
Imaging
Biomarkers
Accounting and timesheets
CONGRESS:
23rd GiViTI Meeting
5-6-7 November, Pesaro
Le tappe del GiViTI sulla strada di una medicina basata anche
sulle relazioni.
La resistenza ai carbapenemi nelle terapie intensive italiane.
L’utilizzo degli antibiotici con un occhio ai germi multiresistenti: due modelli a confronto.
Le lineeguida come strumento di miglioramento della pratica
clinica? Due punti di vista a confronto. (Parte 1)
Le lineeguida come strumento di miglioramento della pratica
clinica? Due punti di vista a confronto. (Parte 2)
Proporzionalità delle scelte, proporzionalità delle norme.
L'angolo dell'informatica: dati strutturali e altre novità.
L’importanza del follow-up per il ricercatore.
Siamo tutti esperti di alzate... Le basi per processi decisionali in
team efficaci e positivi.
COMPACT-2: si parte!
La coagulopatia nel trauma.
I fluidi.
50
REPORT 2014
H2020 WORK PROGRAMME 2014 – 2015
CALL "PERSONALISING HEALTH AND CARE"
Referee of projects submitted for “Understanding health, ageing and
disease: determinants, risk factors and pathways” and “New therapies
for chronic non-communicable diseases” topics
February
IL CONTESTO E L’EDUCAZIONE CONTINUA TRA ESPERIENZA, RICERCA E RELAZIONE CON
IL MALATO.
Convegno: “FORMARE E FORMARSI. Alla ricerca di una visione condivisa”, 13 Febbraio – Crema.
CREACTIVE (COLLABORATIVE RESEARCH ON ACUTE TRAUMATIC BRAIN INJURY IN
INTENSIVE CARE MEDICINE IN EUROPE). ESERCITAZIONI INIZIALI. LA SCHEDA DI
RACCOLTA DATI. LA GOSE QOLIBRI-OS IN DETTAGLIO.
Workshop: “Il follow-up telefonico nel trauma cranico”, 17-18 Febbraio – Bertinoro (FC).
March
GLI STUDI PER LA VALUTAZIONE DELLA QUALITÀ DELL'ASSISTENZA.
Corso: “Formazione Monitor”, 4 Marzo – Milano.
THE PROSAFE DATABASE.
Workshop: “The CREACTIVE telephone follow-up”, 5-6 Marzo – Bertinoro (FC).
CASE REPORT FORM: DIFFERENCES WITH CDES PROPOSED BY THE TRAUMATIC BRAIN
INJURY COMMON DATA ELEMENT WORKING GROUP (VERSION 2.0). ORGANIZATION OF
PATIENT FOLLOW-UP AND FOLLOW-UP PROVIDER TRAINING.
Workshop: “1° CREACTIVE Scientific Advasory Board meeting”, 31 Marzo – Ranica (BG).
April
CREACTIVE PEDIATICO.
Workshop: “CREACTIVE pediatrico”, 2 Aprile – Ranica (BG).
LA QUALITÀ DEL DATO NEI PROGETTI GIVITI. TEST D'IPOTESI. STATISTICA DESCRITTIVA.
INTERVALLI DI CONFIDENZA.
Corso: “Formazione Monitor”, 7 Aprile – Milano.
May
1°CREACTIVE ETHICS ADVISORY BOARD MEETING.
Workshop: “1°CREACTIVE Ethics Advisory Board meeting”, 6 Maggio – Milano.
PERCHÉ È STATO SOSPESO LO STUDIO? ASPETTI METODOLOGICI DEL PROTOCOLLO.
MONITORAGGIO DELLO STUDIO.
Workshop: “Investigator meeting compact 2”, 20 Maggio – Ranica (BG).
LA COMPARATIVE EFFECTIVENESS RESEARCH (CER) NEL TRAUMA CRANICO.
Convegno: “6° NEUROMEETING”, 22 Maggio – Napoli.
June
UTILIZZO DELLA CARTELLA CLINICA ELETTRONICA MARGHERITA TRE.
Corso: “Utilizzo del software Margherita Tre”, 13 Giugno – Treviso.
CREACTIVE PRESENTATION.
Workshop, “3rd International Traumatic Brain Injury Research (InTBIR) Meeting”, 28-29 Giugno – San Fancisco.
51
REPORT 2014
July
ASSESSING QUALITY OF CARE TO SEEK IMPROVEMENT. COMPARATIVE EFFECTIVENESS
RESEARCH IN TRAUMATIC BRAIN INJURY.
Workshop, “The 56th Annual Conference of The Israeli Society of Critical Care Medicine”, 10 Luglio – Herzliya
(Tel Aviv).
September
REVISIONE NUOVI MODULI:BILANCIO IDRICO, TECNICHE DEPURATIVE, PARAMETRI VITALI,
DOCUMENTO DI SINTESI DECORSO CLINICO. MODIFICHE PRESIDI – BISOGNI ASSISTENZIALI.
DISCUSSIONE SU REALE UTILIZZO NEI CENTRI. PROTOCOLLI E PROGETTI CONDIVISI. QUALI
SVILUPPI E PROSPETTIVE: ANALISI DI DATI: QUALI ARGOMENTI? PROPOSTE E DEFINIZIONE
DI OBIETTIVI: MARGHERITA TRE - PROSAFE, SCORE DI GRAVITÀ. INTEGRAZIONI CON
SISTEMI INFORMATICI AZIENDALI E REGIONALI. INTEGRAZIONE POMPE INFUSIONALI.
Workshop, “Meeting annuale Margherita Tre”, 15-16 Settembre – Ranica (BG).
October
CREACTIVE (COLLABORATIVE RESEARCH ON ACUTE TRAUMATIC BRAIN INJURY IN
INTENSIVE CARE MEDICINE IN EUROPE): FACCIAMO IL PUNTO! CREACTKIDS: IL FOLLOW-UP
PEDIATRICO. LA SCHEDA DI RACCOLTA DATI IN PROSAFE.
Workshop, “Il follow up telefonico in CREACTIVE”, 1 Ottobre – Milano.
IL MALATO END STAGE: OUTCOMES IN TERAPIA INTENSIVA.
Workshop, “Grandi insufficienze d’organo End Stage: Cure intensive, Cure ordinarie o Cure palliative?”, 4 Ottobre
– Sassari.
LAVORARE NELLA RICERCA SCIENTIFICA.
Corso: “Settimana di (in)formazione a cura dei ricercatori dell’Istituto di Ricerche Farmacologiche Mario Negri”, 9
Ottobre – Noto, Siracusa.
CREACTIVE: WHERE ARE WE NOW? (SITUATION CENTRE BY CENTRE AND DISCUSSION WITH
EACH COUNTRY COORDINATOR). MONITORING SYSTEM: METHODS AND TOOLS (GIVITI WEB
AND THE CENTRAL MONITORING SYSTEM; USING THE ANALYZER). TRANSLATIONS
(LANGUAGE BY LANGUAGE UPDATE AND PRIORITIES: PROBLEMS AND ANY OTHER ISSUES).
ETHICAL ISSUES: ETHICS ADVISORY BOARD MEETING, INFORMED CONSENT AMENDMENTS,
ETHICS COMMITTEE APPROVALS IN DIFFERENT COUNTRIES. CRF: PATIENT DETAILS,
TRAUMA DYNAMICS, TREATMENTS, PAEDIATRIC GCS, FACILITY DATA, ANY OTHER
BUSINESS. WEBSITE (PRESENTATION AND CONTENTS). BIOMARKERS (SITUATION IN ITALY).
ACCOUNTING AND TIMESHEETS (DISCUSSION ON A CENTRE BY CENTRE BASIS OF PROBLEMS
AND ANY OTHER ISSUES).
Workshop, “CREACTIVE Country Coordinator Meeting”, 21-22 Ottobre – Budapest.
November
LE TAPPE DEL GIVITI SULLA STRADA DI UNA MEDICINA BASATA ANCHE SULLE RELAZIONI.
LA RESISTENZA AI CARBAPENEMI NELLE TERAPIE INTENSIVE ITALIANE. LE LINEE GUIDA
COME STRUMENTO DI MIGLIORAMENTO DELLA PRATICA CLINICA? (DUE PUNTI DI VISTA A
CONFRONTO). L'ANGOLO DELL'INFORMATICA: DATI STRUTTURALI E ALTRE NOVITÀ.
ESERCITAZIONI SUI DATI PROSAFE TRAMITE L’ANALIZZATORE. L’IMPORTANZA DEL
FOLLOW-UP PER IL PERSONALE, PER IL RICERCATORE, PER IL PAZIENTE. COMPACT-2: SI
PARTE!
Congresso, “23° GiViTI Meeting”, 5-6-7 Novembre, Pesaro
PRESENTATION OF PROSAFE/CREACTIVE. THE USEFULNESS OF DATA FROM PROSAFE FOR
THE CLINICIAN, THE HEAD OF THE DEPARTMENT AND THE RESEARCHER - SHOWN
GENERALLY AND IN SPECIFIC CASES.
Convegno “PROSAFE/CREACTIVE Slovenian national meeting”, 12 Novembre – Ljubljana.
DECIDERE IN CONDIZIONI DI INCERTEZZA: QUALCHE SPUNTO DI METODO.
Convegno: “Le Infezioni in Terapia Intensiva”, 14 Novembre – Napoli.
CPFA – COSA ABBIAMO IMPARATO DAGLI STUDI COMPACT?
Convegno: “Questioni aperte in Terapia Inensiva: dai Biomarcatori ai Trattamenti Depurativi per la Sepsi”, 29
Novembre – Bergamo.
December
CREACTIVE: SITUAZIONE ATTUALE.
Workshop: “BIOBANCA e IMMAGINI: i sottostudi CREACTIVE”, 17 Dicembre – Ranica (BG).
52
REPORT 2014
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−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
−
Bellco SpA
Commissione Europea DG Research & Innovation
Brahms
CNT
Regione Toscana
Regione Veneto
Astellas
Novartis
A.O. Como
A.O. Lecco
A.O. Reggio Emilia
ASL AL
Dedalus
ASL TO2
ASL TO4
ASL 1 Sassari
ASL 2 Olbia
ASL 3 Genovese
AUSL Romagna
Azienda Sanitaria di Firenze
Fondazione Poliambulanza di Brescia
Ospedale Evangelico Internazionale di Genova
IRCCS Policlinico S.Matteo di Pavia
USL1 Massa Carrara
USL 7 di Siena
Azienda USL9 Grosseto
−
−
−
−
SINPE (Società Italiana di Nutrizione Artificiale e Metabolismo)
Università di Milano Bicocca, Dipartimento di Informatica Sistemistica e Comunicazione.
Università degli Studi di Verona.
CNT, Centro Nazionale Trapianti.
−
−
−
−
−
−
Department of Anaesthesiology and Intensive Therapy, Semmelweis University, Budapest, Hungary
Department of Anesthesiology and Intensive Care, University of Warsaw, Poland
Department of Intensive Care, Novo mesto General Hospital, Novo mesto, Slovenia, Slovenia
Department of Pneumology and Intensive Care, Nicosia General Hospital, Cyprus
Pediatric Intensive Care Unit Soroka University Medical Center, Beer-Sheva, Israel
Department of Intensive Care Medicine, Heraklion University Hospital, Crete, Greece
53
REPORT 2014
National:
Ricerca & Pratica;
Dedalo. Gestire i sistemi complessi in sanità.
International:
Annals of Internal Medicine; American Journal of Respiratory and Critical Care Medicine; BMJ Open; Critical
Care Medicine; Intensive Care Medicine; PLOS ONE, Critical Care; Lancet Neurology.
National:
Ricerca & Pratica.
54
[Digitare il testo]
A
Laboratory of
MEDICAL
RESEARCH
AND
CONSUMER INVOLVEMENT
Via G. La Masa 19 - 20156 MILAN, Italy
Tel. 02 39014.503 - fax 02 33200231
http://www.marionegri.it/en_US/home/research_en/dipartimenti_en/public_health/medical_research_and_consumer_involvement;
REPORT 2014
LABORATORY OF MEDICAL RESEARCH AND CONSUMER INVOLVEMENT
4.1 - INTRODUCTION
The Laboratory promotes various research activities to foster the involvement of citizens, patients and their
representatives in healthcare decisions.
Different methods of involvement have been applied, such as consensus conferences, citizen juries, ad hoc
surveys and focus groups, covering topics as drug therapies, diagnostic tests and screening.
In order to promote a large and widespread involvement, the Laboratory offers training courses for citizens’ and
patients’ associations to deal effectively with the medical and scientific stakeholders, organizing initiatives of
collaboration and discussion with scientific societies. Eight editions have been organized until now.
Among the Laboratory’s research lines there are research projects to assess the information provided to lay
people and patients on diseases and treatments; research on how disseminate health information and results of
scientific research; development of Internet portals on health issues and information (www.partecipasalute.it,
www.fondazionemattioli.it, http://indeep.istituto-besta.it/).
The Laboratory is also active in projects involving groups of patients for the definition and publication of
information brochures. Finally, part of the activities of the Laboratory projects concerns the evaluation of quality
of life and health, both through studies of selected groups of patients, and through the development of
questionnaires
4.2 - THE STAFF
Laboratory Head
Paola MOSCONI, BIOL D
Research Fellow
Cinzia COLOMBO, PHILOS D
Anna ROBERTO, NEUROBIOL D
Specialista in Ricerca Biomedica
Assistent
Gianna COSTA
Secretary
57
REPORT 2014
4.3 - PUBLICATIONS






Colombo C, Mosconi P. Transparency of funding of patient groups is mandatory but is not enough. BMJ
2014;349:g6301.
IF: 17,215
Colombo C, Mosconi P, Confalonieri P, Baroni I, Traversa S, Hill SJ, Synnot AJ, Oprandi N, Filippini G. Web
search behavior and information needs of people with multiple sclerosis: focus group study and analysis of
online postings. Interact J Med Res 2014;3:e12.
Corli O, Roberto A. Pharmacological and clinical differences among transmucosal fentanyl formulations for
the treatment of breakthrough cancer pain: a review article. Minerva Anestesiol 2014;80:1123-1134. IF: 2,272
Greco M T, Roberto A, Corli O, Deandrea S, Bandieri E, Cavuto S, Apolone G. Quality of cancer pain
management: an update of a systematic review of undertreatment of patients with cancer. J Clin Oncol
2014;32(36):4149-54.
IF: 17,879
Mosconi P, Castellani C, Villani W, Satolli R. Cystic fibrosis: to screen or not to screen? Involving a Citizens’
jury in decisions on screening carrier. Health Expect 2014 doi:10.1111/hex.12261.
Synnot AJ, Hill SJ, Garner KA, Summers MP, Filippini G, Osborne RH, Shapland SDP, Colombo C, Mosconi
P. Online health information-seeking: how people with multiple sclerosis find, assess and integrate treatment
information to manage their health. Health Expect 2014 doi:10.1111/hex.12253.
period. The overall impact factor of these papers was 100.513. The overall impact factor of the 6 papers published
during 2014 was 37.366.
4.3.3 – TRASFERIMENTO DI INFORMAZIONI














Amato L, Davoli M, Parmeli E, Ciccone G, D’Amico R, De Fiore L, Filippini G, Magrini N, Moja L, Mosconi
P. La randomizzazione come atto di altruismo. R&P 2014;175:19-22.
Colombo C. Accesso pubblico ai dati: l’EMA stabilisce la nuova politica. http://www.partecipasalute.it/
cms_2/node/5045; 20/10/2014.
Floriani I, Torri V, Mosconi P. Un atto di tutela per i pazienti. R&P 2014;175:22-23.
Mosconi P. Definire le priorità della ricerca coinvolgendo cittadini e pazienti. Evidence
2014;6(11):e000094.http://www.evidence.it/articoli/pdf/e1000094.pdf
Mosconi P. Giurie dalla parte della gente. AZ Salute Settembre 2014;8:13.
Mosconi P. Amori difficili: ricerca e comunicazione possono andare d’accordo? Newsletter Gidif 214;24(2):5.
Mosconi P. Informazione e strumenti innovativi per il coinvolgimento dei cittadini in sanità. Intervista.rilasciata
a Morfologie, Numero 14-2014:6-7.
Mosconi P. Gli studi clinici. Cosa sono e come saperne di più. Seconda parte: Informazione e strumenti
innovativi per il coinvolgimento dei cittadini in sanità. Morfologie, Numero 14-2014:4-5.
Mosconi P. Gli studi clinici. Cosa sono e come saperne di più. Prima parte. Morfologie, Numero 13-2014:6-7.
Mosconi P. La Giornata Internazionale dei Trial deve coinvolgere anche i cittadini-pazienti. Aboutpharma
Giugno 2014 n.119:77-79.
Mosconi P. Screening mammografico: una storia senza fine. AALert luglio 2014:3-5.
Mosconi P. L’Unione europea e la ricerca clinica. AALert maggio 2014:5-6.
Mosconi P. La ricerca clinica riguarda anche te: vuoi saperne di più? Sclerodermia, Giugno 2014:14-16.
http://www.ails.it/portale/la-ricerca-clinica-riguarda-anche-te-vuoi-saperne-di-piu/.
Mosconi P. Gerardi C. Non ho nulla da perdere a provarlo: le cure miracolose. http://www.partecipasalute.it/
cms_2/node/2909; 18/2/2014.
58
REPORT 2014


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
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Mosconi P, Roberto A. Verso la rivoluzione con il British Medical Journal. http://www.partecipasalute.it/
cms_2/node/2910; 18/2/2014.
Mosconi P. Quando l’interesse è cieco: sanzionate Roche e Novartis. http://www.partecipasalute.it/
cms_2/node/3046; 5/3/2014.
Mosconi P. Empowerment e alfabetizzazione. http://www.partecipasalute.it/cms_2/node/2732 24/1/2014.
Roberto A. La Biobanca – Le Biobanche: una risosrsa?. http://www.fondazionemattioli.it/news/49-le-biobancheuna-risorsa; 05/05/2014.
Roberto A. Screening per il tumore ovarico: gli ultimi aggiornamenti. http://www.fondazionemattioli.it/
news/43-screening-per-il-tumore-ovarico-gli-ultimi-aggiornamenti; 24/1/2014.
4.3.4 – ABSTRACTS


Mosconi P. Trial without tribulation. In: International Innovation. Meeting of minds. Research Media Ltd.,
Bristol (UK) 2014 Issue 152:86-88.
Mosconi P, Castellani C. Citizens’ jury and decision making on cystic fibrosis carrier screening: to screen or not
to screen?. Atti del Convegno XII Convention d’Autunno dei ricercatori in fibrosi cistica, Garda (Vr) 27/-29
novembre 2014 pag. 32 n. 28.
4.4.1 – ECRAN PROJECT
The ECRAN Project –
European Communication Research Awareness Needs,
has been developed and ended in 2014, as part of the 7th EU
Framework Programme.
The project was designed with the aim to promote information on independent
clinical research for European citizens, developing different information and
education
materials. According with the interest of the European Community to support independent and multinational clinical
trials, the project has developed tools to communicate key messages on clinical trials for European citizens and patients,
including the younger generation. In particular, the project focused on these key messages:
-
public understanding of the basic principles of clinical research and the need to
organize clinical trials, promoting both the participation of patients in clinical
studies, and the participation of patients’ representatives in their design;
-
the need for independent clinical trials, promoted on the basis of real public health
problems and according to the real needs of patients;
-
promotion of transparent information on clinical trials and best use of the results
obtained;
-
promotion of cooperation and collaboration between European countries,
considering the amount of the European population and its characteristics.
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REPORT 2014
These messages have been addressed and developed with communication tools, including: an online database with
resources available in several European languages, a website and tools WEB2.0, an animated film about clinical trials,
dubbed in 23 European official languages. All these tools are freely available on the project’s website and can be useful
for health professionals, researchers, policy makers, scientific societies, associations of citizens and patients and
journalists to clarify any aspect of clinical research, as well as to support the need to rely on independent research.
The project – through the development of materials in several European
languages – has thus exceeded the language barriers translating in different
languages all the tools developed and providing EU citizens with the good
quality materials already available. The film "Clinical research is also about
you: do you want to know more?" (http://www.ecranproject.eu/en/node/10 )
is available in 23 languages while the website is developed in 6 languages,
with some tools in 23 languages.
The project involved nine different partners, including representatives of
groups of citizens and patients. All the materials and information in the ECRAN project are available at
www.ecranproject.eu
4.4.2 –IN-DEEP PROJECT
INTEGRATING THE EXPERIENCES AND PREFERENCES OF PATIENTS WITH MULTIPLE SCLEROSIS WITH THE RESULTS
OF SCIENTIFIC RESEARCH TO DEVELOP HEALTH INFORMATION USEFUL FOR INFORMED AND SHARED DECISIONS
The IN-DEEP project is an Australian-Italian collaboration between the Centre for Health
Communication and Participation, Department of Public Health, La Trobe University,
Melbourne, the Cochrane Multiple Sclerosis Group, IRCCS Carlo Besta Neurological
Institute and IRCCS-Institute for Pharmacological Research Mario Negri, and was funded by
the Italian Multiple Sclerosis Foundation. The project advisory board includes neurologists,
people with multiple sclerosis, experts in health literacy and communication and
representatives of the Italian and Australian MS societies.
The project's objective is to know how, where and when people with multiple
sclerosis seek information online and how they use it to make decisions, and then
develop a model of good-quality information on the basis of their information needs
(http://indeep.istituto-besta.it). Interferon was the first topic covered. The model of
information on interferon was then evaluated by users through a questionnaire.
During the current year, we proceeded with the development of the module on the symptom fatigue, a topic of particular
interest for people with multiple sclerosis, and with the pubblication of the projects’ results.
4.4.3 – CITIZENS' JURY: CYSTIC FIBROSIS SCREENING
The Mario Negri Institute, the Agency of Scientific Publishing Zadig and the Cystic
Fibrosis Center Hospital Borgo Trento Verona have promoted the project "Citizens' Jury
and decision making on cystic fibrosis carrier screening: to screen or not to screen? "
supported by the Foundation for Cystic Fibrosis (FFC) Research's Fund.
The basic idea of the project is that decisions on medical interventions - that have collective
nature and impact on the community, as well as on the individual - should be shared with
citizens, put in a position to decide, thanks to a transparent and complete information.
Aim of this project, which follows the pilot project supported by the FFC and held in
Verona (http://www.partecipasalute.it/cms_2/node/1840), is to organize two juries of
citizens in other cities, and launch a public consultation via internet through a questionnaire
aimed at citizens, patients, health care professionals, health care decision-makers and scientific societies.
http://www.partecipasalute.it/cms_2/giurie-cittadini/prostata/fibrosi2014
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REPORT 2014
4.4.4 – PARTECIPASALUTE: A STRATEGIC ALLIANCE BETWEEN PATIENT GROUPS,
CITIZENS AND SCIENTIFIC MEDICAL COMMUNITIES
This project, held in collaboration with the Italian Cochrane Centre and Zadig scientific publishing agency, began in
September 2003. During these years, initiatives aimed at training patient and citizen associations to increase their
participation and discussion on health-care topics and in decision making have been tested. Activities targeted to
scientific and professional societies have also been organized in order to foster constructive relationships with patients
and citizens and their associations, considering their questions and expectations regarding the production of clinical
research and the dissemination of scientific information. The project and the working group born around the project
remain an important reference point for activities involving citizens and patients in the health-care debate. One of the
strength of the project is the development and continuous updating of the website www.partecipasalute.it , with new
articles and insights every week and a newsletter sent every month to a mailing list of more than 2,500 people.
4.4.5 – GYNECOLOGICAL TUMORS AND FOUNDATION NERINA AND MARIO MATTIOLI
ONLUS
Since 1995, the Foundation Nerina and Mario
Mattioli Onlus, in collaboration with the Department
of Oncology-IRCCS Istituto Mario Negri, has
helped to develop and catalyze an interdisciplinary
collaboration among different research institutes and
hospitals and facilitate the transfer of knowledge
from the research laboratory to the clinical setting,
hoping to obtain benefits for all patients with
gynecological cancer, especially ovarian cancer.
The ovarian cancer is the sixth most common type of
cancer in European women, as well as the first cause
of cancer death among gynecological cancers.
The Laboratory is part of the Steering Committee
since 2014 and since then it has been developing the
website www.fondazionemattioli.it, publishing
specific articles and general information about
laboratory and clinical research, strengthening
relationships with other groups of researchers.
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REPORT 2014
4.4.6 – STUDY
ON THE EVALUATION OF THE EFFECTIVENESS OF FOLLOW-UP IN
ONCOLOGY
Two multicenter, randomized trials and the trial Futura Totem - respectively on breast
and endometrial cancer - are comparing different types of follow-up. Ongoing trials will
try to redeem the question about the value of follow-up: in some cases, for example in
breast and colorectal cancer, follow-up is still performed in clinical practice, even if
randomized clinical trials, meta-analysis, consensus conferences, and authoritative
statements of associations and scientific societies suggest that there is no evidence of
substantial benefit in making intensive diagnostic tests after the primary therapy. In
endometrial cancer data on the benefits of follow-up are even less.
4.4.7 – PROJECT ON THE QUALITY OF LIFE EVALUATION
As in the previous year, the Laboratory provided
support and coordination to groups that use the quality
of life questionnaires translated and validated by the
Laboratory - such as SF-36, SF-12, PGWBI. The
questionnaires are available on the site:
http://crc.marionegri.it/qol
MEETING
"The Health Service should or not organize a screening in the population with the aim of
identifying healthy people who may have children suffering from cystic fibrosis?
In Pistoia (May 2014) and Palermo (September 2014), two juries composed of citizens belonging to patient and
volunteer associations based in the these provinces were organized. The question for deliberation was: "The Health
Service should or not organize a screening in the population with the aim of identifying healthy people who may have
children suffering from cystic fibrosis?".
Jurors first discussed with a group of experts, then a pros and cons debate followed. The jurors actively participate in
the debate asking all the questions needed to better understand the information provided before the event. In the
afternoon, behind closed doors, the jurors made their deliberation, after a discussion led by a facilitator. The project will
continue with a public consultation on the web that will involve health professionals and citizens, and with a final
conference of presentation of all the results. More information about
http://www.partecipasalute.it/cms_2/giurie-cittadini/fibrosi2014.
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REPORT 2014
a) SLOW MEDICINE STEERING COMMITTEE
A network of ideas in motion that relies on the presence of network points that are
particularly active: scientific societies, associations, colleges and professional
associations, professional groups, groups of citizens who share and support ideas
that are related to, or collaborate in various ways, with the activities and projects of
Slow Medicine. The Laboratory is present in the Slow Medicine Steering
Committee.
b) SCIENTIFIC AND TECHNICAL COMMITTEE OF ATCO
The Scientific and Technical Committee of ATCO, a non-profit organization, is composed of
eight members, men and women, who play a prominent role on the national and international
levels, making their skills available to the Association.
c)
ONLUS ATTILIA POFFERI STEERING COMMITTEE
The scientific committee of a private non-profit organization whose purpose is to support
scientific research in the field of oncology, either directly, with studies carried out in the
community (the Province of Pistoia), or collaborating with other organizations and institutions
that pursue the same purposes. The Laboratory is present in the Steering Committee.
d) FONDAZIONE NERINA E MARIO MATTIOLI ONLUS STEERING COMMITTEE
Since 1995, the Nerina and Mario Mattioli Foundation Onlus has helped develop and promote
interdisciplinary cooperation and facilitate the rapid transfer of knowledge between the
laboratory and clinic in the hope of improving the lives of patients with tumors of the female
genital tract. The Laboratory is present in the Steering Committee.
e)
AIOM COMMITTEE, PSYCHOSOCIAL GUIDELINES
The diagnosis of cancer and its consequences can have a major impact on the lives of
patients and their families, well beyond the range of physical symptoms on which the
attention of patients generally focuses. Despite the importance of these issues and the
evidence available, the psychosocial needs are often not acknowledged and therefore
not treated in a timely manner.
It is therefore more than ever necessary to provide professional guidance based on
evidence of effectiveness to guide them towards an understanding of the emotional
impact of the disease on their patients and the implementation of strategies to reduce
it. The AIOM, in collaboration with the Italian Society of Psycho-Oncology (SIPO)
has decided to create its first Italian guidelines for the improvement of psychosocial
status of patients with cancer (www.aiom.it).
63
f)
REPORT 2014
OTHER BOARDS
The Laboratory is also present in the committees of several research projects, as:
–
“Randomized clinical trial to evaluate the efficacy of high dose of folic acid
to prevent the occurrence of congenital malformations “Trial folico AIFA”,
Ulss 4 “Alto Vicentino”
–
“Migliorare la sintesi dei risultati della ricerca sui trattamenti nella sclerosi
multipla per il loro utilizzo nella pratica clinica e per influenzare l'agenda
della ricerca futura”, Centro Cochrane Italiano
–
“La prevenzione e la gestione dell’emorragia del post-partum”, Istituto
Superiore di Sanità (National Health Institute)
–
Supporting Informed Healthcare Choices in Low Income Countries
(SIHCLIC), funded by the Norwegian Research Council.
February
ECRAN PROJECT: TOOLS, MATERIALS AND DISSEMINATION. Meeting “First HIV ECAB”. EATG
European AIDS Treatment Group; Brussels.
GENERAL OVERVIEW OF THE ACTIVITIES DONE, DISSEMINATION. Workshop “ECRAN Project
Meeting”. IRCCS Istituto di Ricerche Farmacologiche Mario Negri; Milano.
EMPOWERMENT DEI CITTADINI NELLA RICERCA. Convegno “La ricerca oncologica per il paziente,
con il paziente”. Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC); Firenze.
May
PRESENTATION OF THE ECRAN PROJECT. ECRAN Project Meeting “International Clinical Trials’ Day”.
ECRIN, ECRAN, ICTD e CRP; Luxembourg.
INTRODUZIONE ALLA GIORNATA. Convegno “Gli amori difficili. Ricerca e comunicazione possono andare
d’accordo?”. Associazione Alessandro Liberati, Network Italiano Cochrane; Milano.
June
MODERATORE. Corso “Comprehensive geriatric assessment nella patologia oncologica”. Azienda Ospedaliera
S. Maria Nuova Reggio Emilia; Reggio Emilia.
July
ASSOCIAZIONI E PAZIENTI. Corso “Health Technology assessment in sanità”. Società Italiana di Igiene
(SITI); Milano.
September
BEYOND THE MEDICAL ASPECT: THE POINT OF VIEW OF THE PATIENT. Convegno “Follow up in
gynaecological malignancies”. European Society of Gynaecological Oncology (ESGO); Torino.
QUALE RUOLO PER LE ASSOCIAZIONI DEI PAZIENTI. Convegno “Le Associazioni dei pazienti tra
dimensione europea, mondo mediatico, contenimento della spesa sanitaria e quotidianità”. Associazione Nazionale
Italiana Patologie Ipofisarie (ANIPI); Verona.
October
LA RELAZIONE MEDICO-PAZIENTE.FAMIGLIA NELL’ELABORAZIONE DEI VISSUTI DI
MALATTIA. Seminario “Obiettivi di salute:stato di avanzamento del progetto CCM 2012” Azienda Usl di Reggio
Emilia; Reggio Emilia.
IL MODELLO DELLE “GIURIE DEI PAZIENTI”: ESPERIENZA RIPRODUCIBILE? Convegno “Il
medico di fronte ai dilemmi della salute. PSA nella diagnosi precoce del cancro della prostata: utile, inutile,
dannoso?”. Azienda UIss 12 Veneziana; Venezia.
IL PUNTO DI VISTA DI PAZIENTI E CITTADINI. 40° Congresso Nazionale ANMDO “Ripensare la Sanità:
ruoli strategici e responsabilità”. Associazione Nazionale dei Medici delle Direzioni Ospedaliere (ANMDO);
Napoli.
LA VALENZA DELL’OPEN ACCESS E DELL’OPEN SCIENCE PER L’AMBITO DELLA SALUTE
PUBBLICA. Seminario “Open science in open society: prospettive sul valore sociale dell’accesso aperto”
Università del Piemonte Orientale UPO; Novara.
64
REPORT 2014
PROSPETTIVE DI COLLABORAZIONE. Incontro “Le azioni effettuate, programmate e da programmare nei
confronti dei cittadini”. Slow Medicine, IRCCS Istituto di Ricerche Farmacologiche Mario Negri; Milano.
QUALITÀ DELL’INFORMAZIONE NELLE GRANDI PATOLOGIE CRONICHE: QUALE
CONTRIBUTO PROGETTUALE PER LA FONDAZIONE SMITH KLINE? Convegno “I think tank FSK:
fatti, riflessioni, progetti”. Fondazione Smith Kline; Bologna.
November
TRIALS CLINICI E TRASPARENZA. 13° Congresso Nazionale AME “Ruolo attivo dei pazienti nella ricerca
e sviluppo dei farmaci: utopia o realtà?”. Associazione Medici Endocrinologi (AME); Roma.
DEFINIRE LE PRIORITÀ DELLA RICERCA COINVOLGENDO CITTADINI E PAZIENTI. Convention
Nazionale Sperimentazioni Cliniche “Nuove sfide per i Comitati Etici”. Fondazione GIMBE; Bologna.
CITTADINI INFORMATI, ALLARMATI O DISARMATI? 99° Congresso Riunione superspecialistica
G.L.O.B.E. Public Reporting in Sanità “Il ruolo delle Società Scientifiche nella comunicazione con i pazienti e con
i media”. Società Italiana di Ortopedia e Traumatologia (SIOT); Roma.
PRESENTAZIONE POSTER CITIZENS’ JURY AND DECISION MAKING ON CYSTIC FIBROSIS
CARRIER SCREENING: TO SCREEN OR NOT TO SCREEN? Convegno “XII Convention d’Autunno dei
ricercatori in fibrosi cistica”. Fondazione Ricerca Fibrosi Cistica Onlus; Verona.
December
RESPONSABILITÀ CONDIVISA. Workshop Nazionale “Consumismo Sanitario Responsabilità condivisa”.
Ordine Provinciale dei Medici Chirurghi e degli Odontoiatri di Arezzo; Arezzo.
February
Il Sole 24 Ore
Ultime notizie su Paola Mosconi
Argomenti del Sole – News 24
(http://argomenti.ilsole24ore.com/paola-mosconi.html)
September
AZ Salute
Giurie dalla parte della gente
P Mosconi
(http://magazine.azsalute.it/wp-content/uploads/2014/10/2014-08-AZS-Settembre-2014.pdf; pag. 12)
November
Parent Project onlus
AME 2014 Simposio Paola Mosconi 2
(http://www.parentproject.it/formare-100mila-pazienti-in-europa-per-aiutare-ricerca/ame-2014-simposio-paolamosconi-2/)
December
Time Out Intensive
La Fragilità E La Vulnerabilità In Sanità. Una Ricerca sul Campo
(http://www.timeoutintensiva.it/g_news.php?id=606&f=E1)
−
−
−
−
−
Associazione Italiana Sclerosi Multipla AISM/Fondazione Italiana Sclerosi Multipla FISM, Genova
European Commission, Brussels
Fondazione per la ricerca sulla Fibrosi Cistica FFC Onlus, Verona
IRCCS Istituto Neurologico Carlo Besta, Milano
Fondazione Nerina e Mario Mattioli Onlus, Milano
65
REPORT 2014
−
−
−
−
−
−
−
−
−
−
−
Age.Na.S. Agenzia Nazionale per i Servizi Sanitari Regionali, Roma
Alleanza contro il Tumore Ovarico ACTO, Milano
Associazione Alessandro Liberati – Network Italiano Cochrane
Associazione Italiana Sclerosi Multipla AISM, Genova
Azienda Ospedaliera, Arcispedale S. Maria Nuova, Reggio Emilia
Centro Cochrane Italiano, Modena
Fondazione Attilia Pofferi Onlus, Pistoia
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano
Fondazione Nerina e Mario Mattioli Onlus, Milano
Fondazione per la ricerca sulla Fibrosi Cistica Onlus FFC, Verona
Zadig agenzia di editoria scientifica, Milano
−
−
−
−
−
−
−
−
Centre for Health Communication and Participation, Australian Institute for Primary Care and
Ageing, La Trobe University, Melbourne, Australia
Cochrane Consumer Network, Regno Unito
European AIDS Treatment Group, Belgio
German Network of the Coordinating Centres for Clinical Trials U Koeln , Germania
Institute National de la Santè et de la Recherche Médicale, Francia
Oxford University Hospitals, Regno Unito
Rigshospitalet, Copenhagen University Hospital Copenhagen, Trial Unit, Danimarca
University Medical Center Freiburg (Universitäsklinikum Freiburg), Germania
International:
Health and Quality of Life Outcomes
National:
www.partecipasalute.it
www.fondazionemattioli.it
International:
Health Expectations, The Breast, Health and Quality of Life Outcomes, Cochrane Collaboration, Journal of
Biological Markers.
National:
Ricerca & Pratica.
66
REPORT 2014
Department Staff
Department Head
Maurizio BONATI, MD
 Laboratory for Mother and Child Health
Head of Laboratory
Maurizio BONATI, MD
Unit Head
Antonio CLAVENNA, MD PhD
Pharmacoepidemiology Unit
 "Angelo & Angela Valenti" Centre for Health Economics (CESAV)
Head of Laboratory
Livio GARATTINI, Econ.D.
sostienici con il tuo
 Laboratory of Clinical Epidemiology
Head of Laboratory
Guido BERTOLINI, MD
Clinical Knowledge Engineering Unit
Unit Head
Davide LUCIANI, MD
 Laboratory of Medical Research and Consumer Involvement
Head of Laboratory
Paola MOSCONI, Biol.D.
03254210150
The 2014 Report is available online at:
http://www.marionegri.it/media/sezione_ricerca/sezione_dipartimenti/salute_pubblica/DEPARTMENT_OF_PUBLIC_HEALTH.pdf

Annual Report 2014 - Istituto di Ricerche Farmacologiche Mario Negri

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