i registri come strumenti per la ricerca indipendente · i registri come strumenti per la ricerca...

I registri come strumenti per la

ricerca indipendente

Luigi Naldi

USC Dermatologia, Azienda Ospedaliera

papa Giovanni XXIII, Bergamo

Conflitto di interessi

Il dott. Naldi ha svolto, negli ultimi tre anni, consulenza

scientifica retribuita per le seguenti aziende: Abbvie,

Amgen, Baxter, Boehringer Ingelheim, Celgene,

Janssen-Cilag, Lilly, Menarini, Newron, Novartis,

Pfitzer, Sanofi-Pasteur, Teofarma

• Di cosa parliamo quando parliamo di

registri?

• Un modo ottimale per valorizzare e

mettere in comune l’esperienza clinica

• Un antidoto all’auto-referenzialità

• registri come nucleo di germinazione di

differenti approcci di ricerca

What is a registry?

A systematic collection of information on all the

cases of a particular disease or other health

relevant condition. The term applies to the

process of collecting data and to the final result of

such a process (ie, the file or database containing

the information, properly, the ‘‘register’’)


registri?






1. Unambiguous case definition

2. Thorough procedures to identify cases

3. Systematic methods for case registration that

minimize missing data

4. Standardized procedures for collecting and storing

data and ensuring data confidentiality

Registry requirements

EM majus

Stevens-Johnson syndrome

Overlap SJS/TEN

Atypical target Spot

Il professor Keating nel film L’attimo fuggente

Treatment registries

• Observational (non-experimental) studies

that actively enroll subjects

• Registration is ideally prospective

– Drug exposure at entry

– Only treatment newly started (inception

cohort)

Healthy worker effect Depletion of susceptible

Cum

ula

tive

surv

ival

months

Conventional

Biologicals

Research Design -

Patient Follow-up

– Patient follow-up:

• Update drug exposure & risk factor information

• Collect information on outcome and any new relevant

diagnosis of interest

• Consistent, similar follow-up for all people to avoid

bias

• Specify criteria to define subjects that are pending

and those lost to follow-up

.000

05

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01

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01

5.0

00

2

0 200 400 600Analysis time (days)

DMARD Anti-TNF

Hazard plot

Incident serious infections - on drug

Influence of ‘non-adjustable’ factors

Pre-

treatment

Screening

‘Healthy users’ continue

Selection

Bias

4.0

3.0

2.0

Incid

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1.0

0.8

0.6

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1 2 3

Follow-up period of risk estimate

UK national register

US claims data

German national register

Swedish national register

RCT meta-analysis

Time period of risk assessment (years)

Slide Courtesy of Will Dixon


registri?






REGIONE Abitanti (1.1.2007) Centri Psocare

Abruzzo 1.309.797,00 6

Basilicata 591.338,00 1

Calabria 1.998.052,00 8

Campania 5.790.187,00 13

Emilia Romagna 4.223.264,00 11

Friuli Venezia Giulia 1.212.602,00 5

Lazio 5.493.308,00 12

Liguria 1.607.878,00 7

Lombardia 9.545.441,00 19

Marche 1.536.098,00 6

Molise 320.074,00 1

Piemonte 4.352.828,00 10

Puglia 4.069.869,00 8

Sardegna 1.659.443,00 5

Sicilia 5.016.861,00 12

Toscana 3.638.211,00 13

Trentino Alto Adige 994.703,00 5

Umbria 872.967,00 2

Valle D'Aosta 124.812,00 1

Veneto 4.773.554,00 9

Totale 59.131.287,00 154

Numero pazienti inseriti per data

9 73 173380

709

1460

2220

2637

3209

3788

42504426

5017

5512

6011

6629

7000

7474

8072

8456

8831

92929562

976210020

10333

10736

14202

13814

14130

13580

13320

13055

1224012643

11340

11840

11085

0

1000

2000

3000

4000

5000

6000

7000

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10000

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28-set-05

28-ott

27-nov

27-dic

30-gen-06

24-feb

31-mar

28-apr

26-mag

30-giu

28-lug

25-ago

29-set

27-ott

24-nov

29-dic

26-gen-07

23-feb

30-mar

27-apr

25-mag

29-giu

27-lug

31-ago

28-set

26-ott

30-nov

28-dic

25-gen

29-feb

28-mar

25-apr

30-mag

27-giu

25-lug

29-ago

26-set

3-ott

• Meta-analysis of effect

measures

• Effect measures are

calculated using the

same methods and after

adjusting for the same

confounders.

UN

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August 22, 2008 Time: 03:48pm t1-v1.4

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Evaluation of Patient Education

Luigi Naldi and Fabrizia Sassi

Health Education and Behavioural Changes

Patient education is the process of enabling individuals to make informed deci-

sions about their personal health-related behaviour. It aims to improve health by

encouraging compliance with medical treatment regimens and promoting healthy

lifestyles [1]. Patients have a right to receive appropriate education, so they can

utilize their knowledge to participate in decision-making process [2]. Professionals

in health care have a commitment to provide unbiased and evidence-based informa-

tion to help educate patients. Virtually every patient encounter should include some

element of patient education. The physician who uses a variety of strategies (e.g.,

verbal messages, printed materials, computerized information) and involves staff in

patient education efforts is most likely to be a successful patient educator [3].

Building a partnership with patients over time and understanding the perceptions,

values, and beliefs that influence their health behaviours are the underlying princi-

ples of clinical practice that provide the foundation for helping patients to change.

It is in the context of “continuity of care” that theories of health behaviour are most

beneficial [4].

Behavioural Models

Behavioural change for patients is a complex process and requires more than the

simple acquisition of knowledge. In fact, the choices that patients make may be

influenced by many factors beyond knowledge, including personal, familial, spir-

itual, and social issues. Several educational models based on behavioural theories

have been developed to explain individuals’ health-related behaviour, including the

Stages of Change Model, the Health Belief Model, the Health Promotion Model,

the Precede-Proceed Model, the Health Information Model, and many others. These

models help explain what happens during the patient education process, making

L. Naldi, F. Sassi (B )

Centro Studi GISED, Ospedali Riuniti, Bergamo, Italy

E. Stockfleth, C. Ulrich (eds.), Skin Cancer after Organ Transplantation, Cancer

Treatment and Research, C Springer Science+Business Media LLC 2009

417

react registro eventi avversi cutanei

Obiettivi

• Ottenere una precisa caratterizzazione degli eventi avversi gravi dermatologici

• Monitorare i tassi di incidenza

• Valutare i fattori eziologici con particolare attenzione per farmaci di recente introduzione sul mercato

• Valutare mortalità e morbidità associate alle reazioni

• Migliorare la gestione clinica attraverso la costituzione di una collaborazione in rete (rete lombarda per la gestione delle reazioni cutanee gravi da farmaco)

Centri Partecipanti Responsabile FARMACOVIGILANZA Responsabile DERMATOLOGIA

ISTITUTI OSPEDALIERI CREMONA Catia Barosi Enrico Pezzarossa

OSP TREVIGLIO - CARAVAGGIO Lavinia Gilberti, Mariella Di Matteo

Francesco Accaria

OSPEDALE NIGUARDA CA’ GRANDA Giuseppe Vighi Donata Calò, Antonella Citterio, Jan Schroeder

OSPEDALI CIVILI BRESCIA Daria Bettoni Andrea Brezzi

ISTITUTO DEI TUMORI MILANO Barbara Re Marco Cusini

A.O. VALTELLINA VALCHIAVENNA SONDRIO

Lucia Canclini Luisa Frattini

A.O. S ANTONIO ABATE DI GALLARATE Giovanna Monina Silvia Fossati

A.O. BOLOGNINI DI SERIATE Antonio Strippoli Antonio Barcella

PRESIDIO OSPEDALIERO A MANZONI LECCO

Paolo Corti Domenico Fideli

A.O. G. SALVINI GARBAGNATE MILANESE Franca Borin Andrea Bigardi

A.O. DELLA PROVINCIA DI LODI Elena Gambarana Claudia De Filippi

A.O. OSPEDALE S. ANNA COMO Luisa Clerici Giuseppe Laria

IRCCS S MATTEO PAVIA Ester Guarnone Antonio Borroni, Camilla Vassallo

A.O. LUIGI SACCO Emilio Clementi, Sonia Radice Gianluca Tadini

A.O. OSPEDALE MAGGIORE DI CREMA Luigi Brambilla, Alessandra Ragazzi

Serena Percivalle

A.O. DI DESIO E VIMERCATE Giuseppina Gilberti Elena Perotta

A.O. S CARLO BORROMEO Anna Maria Fiori Pasquale Bruni

OSPEDALI RIUNITI DI BERGAMO Monia Lorini Luigi Naldi

SAN RAFFAELE Camilla Ferri Massimo Cantori

LEGNANO Piercarlo Erpoli Anna.Tosi

VARESE Anna Malesci Alberico Motolese

HUMANITAS Maria Fazio Marcello Monti

Registro regionale di reazioni

avverse gravi dermatologiche

2009-

Notifiche casi TEN, SJS, AGEP,DRESS (aprile 2009-marzo 2013)

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registri?






Europe-wide observational network on rare skin disease (REDSkin network)

Issues

• No single centre can collect enough cases to reliably assess risk factors, prognostic variables or disease outcome for rare diseases

• An harmonised joined action on rare diseases can rapidly improve knowledge optimizing costs and resources

• As documented by a few successful projects (e.g., the RegiSCAR programme, the GeneSkin project) a modular combination of research activities is feasible for motivated people

Disease of interest for a piloting phase

• Pyoderma gangrenosum

• Hidrosadenitis suppurativa

• Sweet syndrome

• Linear IgA dermatosis

• Cicatricial pemphigoid

• Generalized pustular psoriasis

• Cutaneous small vessel vasculitis

• Sinergie

• Valorizzazione delle competenze

• Confronti di esperienze diverse

• Un miglioramento della pratica

clinica

In sintesi, i registri all’interno di reti

collaborative permettono di ottenere:

i registri come strumenti per la ricerca indipendente · i registri come strumenti per la ricerca...

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