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Amsterdam, The Netherlands
Where is the evidence produced?
Where is the evidence to be applied?
Kor vert retningslinjene laga?
Kor skal retningslinjene brukast?
Lokal kontekst, klinisk, samfunn
Kunnskap omeffekt av tiltak
Korleis ta ei rett avgjerd?
BESLUTNING
Verdiar ogpreferansar hos
pasienten/ samfunnet
Determinants of health
Genetic
inheritance
Lifestyle
Health
Status
Physical environment
Socio-economic
conditions
Biological
environmentHealth
services
Evidence based public health Proposed definition ECDC:
• Integration of the best available evidence with the knowledge and considered judgements from stakeholders and experts to benefit the needs of a population
RESEARCH
POLICY
PRACTICE
EBPH is an Iterative process
Uncertainties
• Constraints, uncertainties and assumptions having an impact on the risk assessment should be explicitly considered at each step in the risk assessment and documented in a transparent manner and should be quantified to the extent that is scientifically achievable (Codex Alimentarius)
Health Care Uncertainty
• Diagnosis
• Selecting interventions
• targeting
• timing
• Organizing Care
• Communication (including communication of risks and benefits)
• The patient experience
• Prognosis
• Health Needs Assessment
Why do scientists disagree
The cultural context
The scientists themselves
Their approaches to science
Their scientific judgements
Their social judgements
The communication of the evaluation
(EEA - a total of 40 subcategories mentioned)
| 14
Some consepts Evidence based
Narrow understanding A B
Wider: the best available of all knowledge
The best available evidence
A buzzword
Knowledge based From authority to evidence
Professional criticism of medical methods
Science based
Research based
Experience based
Tested experience
| 15
Knowledge vs information
Kark: What is actually the difference between information and knowledge?
Hårek: Information is what you tell others, knowledge is what you keep for yourself!
| 16
What is the knowledge base? Systematic review of all the best studies in the world on a
specific topic
One or more reliable studies
Consensus among experts
My own knowledge
My own experience
My opinion
| 17
Mapping the unkowns The known unknowns
(what you know that you don’t know)
Unknown knowledge
(knowledge that you don’t know about)
Mistakes
(what you thought you knew)
The unknown unknowns
(what we still don’t know anything about)
Taboos
(we know it, but we don’t like it)
Denied or suppressed knowledge
(psychological problems!)
Traditional evidence pyramid
Systematic reviews of RCTs and
meta-analyses
RCTs
Cohort studies
Case-control studies
Case series, case reports
“Expert opinion”, lab research
Time & Resources
Level of
Evidence
Level of Evidence vs Time
To move from evidence to recommendation
The considered judgement: To diminish uncertainty To weigh risks and considerations To make the guidance implementable Consider:
- Values- Professional experience- Local context- Recourses- Long term effects- Ethical aspects- Legal considerations- and more
Certainty Level vs considerations
…
Legal
Ethics
Acceptability
Economy
Local context
Time & Resources
Certainty
Level
Judgments of evidence and
considerations
Time & Resources
Level of Evidence
&
Certainty Levels
Kompleksiteten i folkehelsearbeidet EHEC Starta i Tyskland
Spreidde seg til Frankrike
Affiserte Spania
Kom frå England, trudde vi
Men smittekjelda var i Egypt, viste det seg
Identifikasjon av bakterien skjedde i Kina!
Avansert klinisk behandling nødvending
Frå internasjonal storpolitikk, via molekylær DNA printing til avansert klinisk medisin på kort tid!
Definitions guidelines Dictionary: A statement or other indication of policy or procedure by
which to determine a course of action.
NICE’s clinical guidelines are recommendations, based on the best available evidence, for the care of people by healthcare professionals. They are relevant to clinicians, health service managers and commissioners, as well as to patients and their families and carers. (2009)
WHO; Guidelines are systematically developed evidence-based statements which assist providers, recipients and other stakeholders to make informed decisions about appropriate health interventions. (2003)
WordsGuidelines
Guidance
Manuals
Treatment protocols
Reference documents
Standard operating procedures
Should all be evidence based and context sensitive
GRADE system
Grade of recommendation• Strong = Benefits clearly outweigh harms or vice versa.
• Weak = Benefits and harms closely balanced.
Quality of evidence • High = Further research is very unlikely to change our confidence in
the estimate of effect.
• Moderate = Further research is likely to have an important impact on ourconfidence in the estimate of effect and may change the estimate
• Low = Further research is very likely to have an important impact onour confidence in the estimate of effect and is likely to change the estimate
• Very low = Any estimate of effect is very uncertain
Where GRADE fits
Prioritize problems, establish panel, conflict of interest
Systematic review
Searches, selection of studies, data collection and analysis
Assess the relative importance of outcomes
Prepare evidence profile: Quality of evidence for each outcome and summary of findings
Assess overall quality of evidence
Decide direction and strength of recommendation
Draft guideline
Consult with stakeholders and / or external peer reviewer
Disseminate guideline
Implement the guideline and evaluate
GR
AD
E
How does NICE use evidence?MSCC Advanced
Breast Ca
Consensus alone 32% 44%
Observational studies 40% 16%
RCTs 7% 37%
Other guidance 17% -
‘Extrapolation’ 3% -
Health economic studies 1% 2%
Audit data 1% -
Problem of one
Solution for one
Knowledge from many (RCTs, Cohorts etc)
Selection biasAttrition biasConfoundingPublication bias
ValuesContextGeneticsSubgroupsComorbidity
Generalizing(well knownresearch field)
IndividualizingContextualizing(less knownresearch field)
Generalizing vs individualizing
Other lines of evidence
Examples of such lines are
– studies of exposure
– studies of spread
– studies of causality
– outbreak investigations
– lab research
– animal experiments
– mathematic modelling.
Features of Useful Information
• Trustworthy (pre-appraised)
• Concise
• Easy to understand
• Easy to access
• Clear implications for practice
Factors relevant for the importance of a health policy decision (Decide)
Seriousness of a problemWhat are the consequences
Quality of evidenceWhat kind of evidence is there for the different options?
BenefitsAre the desirable effects large enough?
Adverse effectsAre the undesirable effects small enough?
Number of people affected
More important factors..
Resources Will the option save or spend resources?
Value for moneyHow is the relation between benefits and adverse effects?
Impacts on equityWould the option reduce health inequities?
ImplementabilityCan the option be brought about?
AcceptabilityWill stakeholders find it acceptable?
Rådgivning ved FHI, Definisjon
• Med FHIs rådgivende aktivitet mener vi de samlede aktiviteter som inngår i å benytte et samlet kunnskapsgrunnlag samt i mange tilfeller også juridiske, økonomiske og etiske overlegninger til å utforme best mulige, relevante og rettidige råd og vurderinger om folkehelsen, helse- og omsorgstjenesten og forhold som kan påvirke helsetilstanden i befolkningen og formidle disse rådene til dem som kan benytte dem.
• Aktiviteten gjelder både ad hoc-råd, altså råd gitt for å håndtere en bestemt hendelse, og varige råd for alle typer av en hendelse.
• Råd og vurderinger kjennetegnes av at de har en konklusjon og anbefaling til målgruppene.
Strategien 2016-20
• Vi skal gi bistand, råd, veiledning og informasjon til kommunale, fylkeskommunale og statlige myndigheter, helsepersonell og befolkningen innenfor instituttets samfunnsoppdrag i samsvar med Smittevernloven og Folkehelselovens bestemmelser.
• Vi skal gi kunnskapsgrunnlag til helsemyndigheter og helse- og omsorgstjenesten om effekt og sikkerhet, samt helseøkonomiske og andre konsekvenser knyttet til nye eller etablerte metoder.
• Vi skal ha standardiserte og transparente prosedyrer for risikovurderinger og råd.
Avgrensning mot andre rådgivere
• Nasjonale
• Internasjonale
• Private
• Det er et mål at overlappende områder identifiseres og håndteres slik at dobbeltarbeid og uklarhet unngås.
Tre prinsipper for rådgivning
• 1. Kvalitetsprinsippet
• FHI skal gi råd av god kvalitet. Det betyr best mulige, relevante og rettidige råd:
• Idealet om høy kvalitet kan likevel utfordres av en rekke forhold:– Begrensninger i tilgjengelig tid
– Begrensninger i tilgjengelige ressurser
– Begrensninger i kunnskapsgrunnlaget slik at råd må gis under usikkerhet
– Intern uenighet mellom fagpersoner
Prinsipper forts.
• 2. Åpenhetsprinsippet
• Ved all rådgivning skal instituttet være åpent om rådets vitenskapelige og øvrige grunnlag, underliggende vurderinger og eventuelle interessekonflikter. Eventuelle usikkerheter og risikoer skal fremheves, kommuniseres og om mulig kvantifiseres.
• 3. Forholdsmessighetsprinsippet
• Ved all rådgivning skal instituttet tilpasse sin bruk av tid og ressurser for et gitt råd til rådets betydning for folkehelsa og samfunnets ressursbruk.
Mandat for utvalg
• «Folkehelseinstituttets utvalg for rådgivning og vurdering skal:
• fremme en god kultur for kunnskapsbasert rådgivning og vurdering ved instituttet,
• bidra til oppfølging av kapitlet om vurdering og råd i instituttets strategi 2016-2020,
• identifisere og foreslå håndtering av områder der instituttets rådgivning overlapper med andre etaters rådgivning, og
• lage FHIs metodebok for rådgivning og vurdering med beskrivelse av prosessene for produksjon av rådene, formidling og implementering av rådene samt oppfølging og evaluering av rådene.»
“A health threat anywhere is a health threat everywhere”
Source: The Lancet (2012) 380:9857;1946-55