Workshop:
Progetto DDS: Risultati e considerazioni – Torino, 25/02/2014
Il valore sociale della ricerca scientifica:
sperimentazione e valutazione degli
interventi di prevenzione
Fabrizio Faggiano
Università del Piemonte Orientale
Valore sociale della prevenzione
- Valore primario della salute
- La prevenzione come strategia preferibile
(citata in ogni documento ufficiale!)
- Ma, il significato è ideologico
- e la prevenzione non possiede uno status
scientifico comparabile con quello di altre
branche della medicina
Valore sociale della ricerca in prevenzione
• Orientare la pratica vs problemi prioritari
– Il GBD
GBD 2010 – Italia
Occupational risks
1,7 Drug use
Alcohol use
2,3
Ambient PM pollution
2,7
DALY Italia 2010 = 16.275.000
1,5
Dietary risks
13,5
High total colesterol
3,5
High fasting plasma
glucose
5,0
High blood pressure
11,1
Physical activity
5,6
High BMI
8,7
Smoking
10,1
Valore sociale della ricerca in prevenzione
1. Orientare la pratica vs problemi prioritari
– Il GBD
2. Valutare (l’efficacia, il costo/efficacia,
l’applicabilità, la trasferibilità) per selezionare
«Best Practices»
Perché valutare?
• Un intervento di prevenzione è
–
–
–
–
una tecnologia sanitaria
che agisce su sistemi complessi (bio-, psico- sociali)
per ottenere cambiamenti di comportamento individuali
basato sulle buone intenzioni
• Quindi è paternalismo etico
– che si giustifica solo se efficace, sicuro, costoefficace per la comunità (utilitarismo sociale)
• La valutazione è quindi indispensabile
Everithing is complex in healthcare..
1. La catena causale è complessa
2. L’apparato teorico è recente e ancora fragile
3. Gli interventi non sono «intrinsecamente»
sicuri
4. Gli interventi non sono «intrinsecamente»
efficaci
The paradigm of prevention
other influencing
factors
confounding factors
moderators
programme
time
con. causes
disease
risk factors
etiology
effectiveness
impact on health
The paradigm of substance use prevention
prevention
program
?
smoking,
drugs
disease
etiology
effectiveness
impact on health
The paradigm of substance use prevention
prevention
program
BLACK
BOX
smoking,
drugs
disease
etiology
effectiveness
impact on health
What is there in the black box?
• A constellation of factors associated to risky behaviours
• and that are targeted by programs (-> mediators)
1. Individual factors
• Character traits
₋ impulsivity, sensation seeking, hopelessness, anxiety sensitivity
• Knowledge about risks
• ….
2. Environmental factors
•
•
•
•
•
Mass media (advertisements, films, TV)
Peer and family influence
Other models (teachers, health professionals, politicians)
Availability and accessibility
….
Theoretical bases of prevention
• Reasoned action attitude (Fishbein and Ajzen in
1980) / Health belief model (Rosenstock 1950) –
human behaviour is rational, and persons acts on the
bases of their perception of utility, or of risks,
associated to a behaviour. Perceived risks and
benefits for health are the key factors in motivating
the action
• Problem behaviour theory (Jessor and Jessor, 1977)
– problem behaviour is that socially defined as
source of concern, or as undesirable by the social
and/or legal norms of society.
Theoretical bases of prevention
• Social learning theory (Bandura 1977) / Social norms theory
(Campbell, 1964; Durkheim, 1951, Perkins 1986) – People
tend to adopt the attitudes of the group and act in
accordance with group expectations . With a particular
emphasis on the importance of observing emotional reaction
of others
• Gateway Drugs Hypothesis (Kandel, Science, 1975) - It
assumes a causal chain sequence in which (a) tobacco is used
prior to the onset of (b) cannabis and the use of cannabis
increases the likelihood of using (c) other illicit drugs
• Psychological vulnerability (Sher, 2000) - Personality factors
(hopelessness, anxiety sensitivity, impulsivity, and sensation
seeking) are a predictive risk factors for substance misuse in
adolescence
The problem
• … THEORIES ALONE cannot predict the success of prevention
programs, because some complex, sensitive systems are
involved (psychological, and social systems).
• As for medicines, active prevention components can act in
the expected direction (doing good), but also in an
unexpected one (doing harm)
knowledge
on risks
prevent
from use
(mediator)
increase
curiosity
The problem
• … THEORIES ALONE cannot predict the success of prevention
programs, because some complex, sensitive systems are
involved (psychological, and social systems).
• As for medicines, active prevention components can act in
the expected direction (doing good), but also in an
unexpected one (doing harm)
impulsivity
reduce
drug use
(mediator)
modify
personality
The problem
• … THEORIES ALONE cannot predict the success of prevention
programs, because some complex, sensitive systems are
involved (psychological, and social systems).
• As for medicines, active prevention components can act in
the expected direction (doing good), but also in an
unexpected one (doing harm)
self-efficacy
increase
resistance
(mediator)
consolidate
decision to use
La prevenzione è spesso inefficace, a volte
dannosa
Issue
ALC
CVD
IDU
NPS
OBE
PRE
TOB
Tot
Int. Arms
N.°
(%) col
24,65
124
1,39
7
17,89
90
12,33
62
30
5,96
35
6,96
30,82
155
503
100,00
Fav. Int.
N.° (%) row
Fav. Ctrl
N.° (%) row
NS Int.
N.° (%) row
48
2
32
19
8
5
57
171
4
0
5
0
0
0
7
16
72
5
53
43
22
30
91
316
38,71
28,57
35,56
30,65
26,67
14,29
36,77
34,00
3,23
0
5,56
0
0
0
4,52
3,18
58,06
71,43
58,89
69,35
73,33
85,71
58,71
62,82
100,00
Int.: Intervetion; Fav.: Favouring; Ctrl: Control; NS: Not significant; NPS: Neuro-psychiatirc;
HPR: Health Promotion; TOB: Tobacco; CVD: Cardiovascular Disease; IDU: Illicit Drugs Use; ALC: Alcohol;
PRE: Pregnancy; OBE: Obesity
All bad art is the result of good
intentions
• Several programs
– based on reference theories
– planned by very experienced expert groups from
multidisciplinary fields
– well funded
• … have shown iatrogenic effects once evaluated
(harms instead of beneficial effects)
– Life Education Australian school-based program (1995)
– the American National Youth Anti-drug Media Campaign
(2008)
– Montana Meth program (2010)
– Take Charge of Your Life (ASAPS study 2009)
The case of Life Education
• Life Education is a school-based program based on
Moskowitz Model (knowledge + positive life)
• Developed in Australia during 1988-1992
• In a first evaluation, it resulted in a good increase in
knowledge of drug effects and in a fair decrease of
intentions to use drugs
• It has been disseminated across all Australia (and in
many other countries) by law
The case of Life Education
• After its dissemination a study had been
conducted to evaluate the effects on behavior:
• The evaluation study involved 1800 intervention
students and 1800 controls
• Main results:
• Cigarettes:
• Alcohol:
• Other substances:
RR=1.6
RR=1.4
RR=1.4
The case of Life Education
When the data are extrapolated to the state-wide
smoking and drinking estimates …
…of all smoking among year 6 schollchildren, 25% of
girls’ and 19% of boys’ smoking could be attributed to
participation in Life Education, as could 22% of all
boys’ recent drinking.
• The program was extended to all Australia, UK, USA,
… India, China, … South Africa….
• The findings suggest that intervention programmes
should be thoroughly evaluated prior to widespread
implementation
Hawthorne, Addiction, 1995
American National Youth Anti-drug
Media Campaign
• planned by the National Drug Control Policy
(ONDCP)
• funded in 1997 by the United States Congress with
$1.5 billion dollars
• main objective: “to educate and enable America’s
youth to reject illegal drugs as well as alcohol and
tobacco”
• televised antidrug public service announcements
(PSAs) broadcasted 1998-2004
American National Youth Anti-drug
Media Campaign
• Evaluation provides no evidence of positive effect in
relation to teen drug use, and shows some
indications of a negative impact.
• the past month use of marijuana appeared
significantly increased by 2.5% among 14-18 years
(Orwin, GAO, 2006).
• RR of marijuana use in past year: 1.21 (1.19-1.65)
• Antimarijuana Social Norms Scale: -6.3 (-10.4,-2.2)
Hornik, AAAPSS, 2009
Montana Meth Project
• A mass media campaign against the use of
Methamphetamine 2005
• The central component of the program is a graphic
advertising campaign that portrays
methamphetamine users as unhygienic, dangerous,
untrustworthy, and exploitive
• The campaign has been associated with increases in
the acceptability of using methamphetamine and
decreases in the perceived danger of using drugs
J Health Econ. 2010 Sep;29(5):732-42.
Prev Sci. 2008 Dec;9(4):256-63.
The Adolescent Substance Abuse
Prevention Study (ASAPS)
NIDA (US) developed an evidence-based substance
abuse prevention program with curricula for the 7th and
9th grades, delivered by DARE officers
Take Care of Your Life (TCYL) present all the
characteristics of a Best Practice
• based on a Comprehensive Social Influence
approach
• 10 lessons + a booster session
The program has been evaluated by a large CRCT
study (20000 students involved !) , following a cohort
of students from the 7th through the 11th grades
ASAPS Main Effects
Controls
Sloboda, DAD, 2009
Other examples
• Spark study: promoting physical activity in
primary schools have increased significantly Body
Mass Index (BMI) of interventions group at the
18-month follow-up (Sallis 1993)
• Il Postponing Sexual Involvement curriculum,
well spread in US, once evaluated in California
with a RCT, showed: an increase of frequency of
sexual intercourses, of number of partners, of
STDs (NS), and pregnancies (p<0.05), both in the
peer-leaded and in the adult-leaded harm (Kirby
1997)
And what do you think about this?
Press release - 21 January 2013
Agreement between Italian National
Department of Antidrugs Policies and the
Ministry of Education.
…..DPA will provide to schools
videoconferences of experts on the field of
drugs and neurosciences….
Processo di sviluppo di tecnologie
sanitarie
• Tutte le tecnologie sanitarie che agiscono su
sistemi complessi hanno processi di sviluppo,
valutazione e implementazione regolamentati
Il processo di sviluppo del farmaco
Pharmaceutical Research and Manufacturers of America. Drug Discovery and Development: understanding the R&D process
[Internet]. 2007 [cited 2011 Jul 21]. Available from: http://www.phrma.org/sites/default/files/159/rd_brochure_022307.pdf
Ruolo della ricerca scientifica
• Valutare
– efficacia
– sicurezza
• La vlutazione di interventi di prevenzione è un
compito complesso, a causa dei numerosi
bias:
– selection bias
– confounding
– performance bias
– information bias
• che devono essere controllati
Ruolo della ricerca scientifica
• L’unico modo per valutare una tecnologia
sanitaria e ottenere risutati non distorti è
randomizzare
– l’intervento deve essere assegnato in modo
casuale al gruppo di intervento
– e si suoi effetti confrontati con il gruppo di
controllo
Valore sociale della ricerca in prevenzione
1. Orientare la pratica vs problemi prioritari
– Il GBD
2. Valutare (l’efficacia, il costo/efficacia,
l’applicabilità, la trasferibilità) per selezionare
«Best Practices»
3. Orientare la pratica preventiva vs la selezione
di interventi efficaci
High quality scientific evidence is needed
• la scelta di utilizzare un intervento di
prevenzione implica una pesante
responsabilità scientifica e etica
“High quality scientific evidence is needed
when professionals intervene in the lives
of other people” (Ian Chalmers)
Are we doing our duty?
• How interventions are matched to prevention needs in
Europe?
1. … seized from evidence (systematic reviews) (?)
2. … trough an informal process of selection of existing
interventions
3. … by a systematic use of “creative prevention”
• development of new interventions based on theories, variation of existing
interventions, on “new ideas”. Always on good intentions
• Virtually everybody can “be creative”, develop a prevention
program, apply it on the target population
•
•
•
•
•
Public health professionals
Teachers
Public officers
Private sector
NGOs…
Are we doing our duty?
• A survey of prevention interventions carried
out during 2008 showed
– 1501 different interventions carried out against
the 4 risk factors of Gaining Health (Tobacco,
alcohol, diet and physical activity)
– Around 14 were evaluated by observational
studies,
– 1 was evaluated by a RCT
– 1476 didn’t have any evaluation!
Coffano, GSA, 2010
Summary of the current situation
• delivery systems of prevention interventions
are rarely centrally organized
• programs delivered in the practice are usually:
– not evaluated
– probably ineffective
– possibly iatrogenic
• … and this is not good in a public health
perspective
Valore sociale della ricerca in prevenzione
1. Orientare la pratica vs problemi prioritari
– Il GBD
2. Valutare (l’efficacia, il costo/efficacia,
l’applicabilità, la trasferibilità) per selezionare
«Best Practices»
3. Orientare la pratica preventiva vs l’adozione
di interventi efficaci
4. Supportare lo sviluppo di programmi efficaci
How research can support program
developers?
• Some interventions are simple (like a medicine)
• Some others are a complex amalgam of different
ingredients…
– in average programs addressed 8.5 content areas each (out of 23
content areas identified!) (Hansen 2007)
– programs are not truly theory driven and they do not adhere usually
to a theory’s tenets
• The effectiveness of any single prevention intervention is the
result of the specific combination of ingredients (the recipe)
Components
Risk
knowledg
2. To be in a
group
Refusal
skills
3. Alcohol …..
Believes on
consequence
4. Reality
check
Intentions
…..
5. Smoking
…
Risk
preception
6. Express
yourself
Normative
believes
7. Get up,
stand up
Parent
acceptability
8. Party tiger
..
Communicati
on skills..
9. Drugs …….
Self esteem
…
10, Coping
competences
Drugs
attitudes
11. Problem
solving
Decision
making skills
12. goal
setting
Problem
solving skills
Mediators
1. Opening
Unplugged
The process of prevention research
• All the ingredients of Unplugged have been
evaluated together (trial results are an average of
the ingredients’ effect)
• and it is virtually impossible to disentangle the
effect of a specific component
• This is highly inefficient, because:
– what have to be changed (to improve the program)?
– single effective ingredient cannot be identified (to develop
novel interventions)
– “Current evaluation …is not able to measure more than the
average effect of … amalgams of … content areas that are
independent of formal theories”
Il progetto DDS
• una alleanza virtuosa fra ricerca, sviluppo e
pratica sul campo
• per valutare un intervento
• comprendere cosa funziona e come funziona,
e cosa non funziona
• per fare avanzare la conoscenza
In sintesi
centri di
sviluppo
centri di
valutazione
ricerca &
sviluppo
valutazione
pratica
analisi dei bisogni
implementazione