Knowledge synthesis and implementation - the huge ...€¦ · Evidence-Based Healthcare in the...

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Knowledge synthesis and implementation - the huge challenges of today and tomorrow Gerd Antes Institute for Medical Education University Hospital, LMU Munich, Germany ([email protected], (@gerdantes) European JBI symposium of Evidence-Based Healthcare in the Czech Republic Brno 13 December 2018

Transcript of Knowledge synthesis and implementation - the huge ...€¦ · Evidence-Based Healthcare in the...

Page 1: Knowledge synthesis and implementation - the huge ...€¦ · Evidence-Based Healthcare in the Czech Republic Brno 13 December 2018 . Conflicts of interest ± Till 31 Oct 2018 ±

Knowledge synthesis and implementation - the huge challenges

of today and tomorrow

Gerd Antes

Institute for Medical Education University Hospital, LMU Munich, Germany

([email protected], (@gerdantes)

European JBI symposium of

Evidence-Based Healthcare in the Czech Republic Brno 13 December 2018

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Conflicts of interest

– Till 31 Oct 2018

– 50% Cochrane Germany Foundation (tax-based charity)

– 50% Institute for Evidence in Medicine (for Cochrane Germany Foundation)

– Potential intellectual conflict: Long-lasting commitment to Evidence and Systematic Reviews

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Contents

– Inflation of unnecessary trials and SRs

– Growing problem in the publication process: predatory journals

– Soft science?

Real World Data (RWD), Big Data and Artificial Intelligence (AI)

– One world? Knowledge in English – implementation in ? language

– New science or better old science?

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Neumann

What is the optimal decision for the selection of the right diagnostic procedure or the best therapy?

?

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Neumann

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Neumann

Information from similar persons under same conditions

trials – trials – trials - trials

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The path to the truth

Counterfactual thinking: What would happen if . . .

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Two crucial targets

1. Minimization of systematic errors (risk of bias)

2. Control of random errors (play of chance)

Gold standard is not the randomized controlled trial but the criteria to control error and to maximize benefit

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Transfer of Research into Practice

Answers to medical questions

• Clinical (randomised / controlled) studies

• Epidemiological (observational -) studies

. . . .

Evid

en

ce

a

pp

lica

tion

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? • Practicing physicians

• Health authorities, sickness funds, insurances, institutions

• Clinical research

• Patients

50 %

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1968 McMaster Univ. Hamilton, Canada 1971 Archie Cochrane, UK 1996 EBM in Germany 1998 Cochrane Germany 2018 Cochrane Czech Rep

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Transfer of research results into practice

Patients / healthy persons

Research / studies / data

Patients / healthy persons

Application / benefit / harm / costs

Literature based synthesis (SR; Cochrane classic)

Individual- patient-data- based synthesis (IPD SR)

Access to trial reports (SR from authority data)

Access to trial data (SR from authority data)

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Basic research

Pre-clinical research

Animal experiments

Clinical research

Health services research

Public Health Translation

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The trial deluge

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194 271 355 476 649 1241

1468 2071

2550 2855

3893 4535

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RCTs (Reports) in Medline Overall: 436.827

22 Sept 2017

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The truth

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194 271 355 476 649 1241

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RCTs (Reports) in Medline (PubMed) Overall: 436.827

22 Sept 2017

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194 271 355 476 649 1241

1468 2071

2550 2855

3893 4535

5647

6762

7591

8261

9490

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RCTs (Reports) in Medline (PubMed) Overall: 436.827

22 Sept 2017

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Youtube (now)

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Transfer of Research into Practice

Clinical studies (experimental, randomised, controlled, prospective)

Epidemiological studies (observational, retrospective)

Systematic Reviews

Health Technology Clinical Guidelines Patient Information Assessment (HTA)

Disease Clinical Management Programs (DMPs) Pathways (CPs)

EB

M

glo

ba

l lo

cal

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Unnessary Trials and SRs

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RCTs of aprotinin in cardiac surgery to stop bleeding Lancet 2005

Clinical Trials 2005

1987

2002

Cited 2018 No stopping rule for trials Ethics approval for unnecessary trials

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Knowledge accumulation: A good principle failing

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194 271 355 476 649 1241

1468 2071

2550 2855

3893 4535

5647

6762

7591

8261

9490

10382 10357

11530 11164

12257

13484

15199

17360

19087

20614

22510

25333

27445

29638

29131

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RCTs in Medline (PubMed) Gesamtanzahl: 436.827

Stand 22. 9. 2017

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<15% by Cochrane

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Systems of wrong incentives, agendas driven by science and scientists‘ careers, maldevelopment of journals . . .

Commentary M. J. Page D. Moher Blog Pubmed Commons

Ioannidis, J. et al.

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Open access, data sharing . . . A new enemy?

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Old: The poor can‘t read New: The poor can‘t write

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Open-Access

– Author fees are business model for new journals

– Immediate consequence: growth, equivalent to loss of quality in a limited market

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Tangled web.The location of a journal's publisher, editor, and bank account are often continents apart.

John Bohannon Science 2013;342:60-65

Published by AAAS

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+ WDR SZ

Closely linked to “Presentations at World Congress for Urology . . . . .“

More than 5000 German scientists published in predatory journals Including directors of institutions, the rector of a university . . .

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Joint statement of v.-Humboldt-St DFG Fraunhofer HRK Dt. Akad. Naturf. DAAD Helmholtz (25 July 2018)

– Complaints: scientists deceived, damaged trust into science

– Self-repair of science is sufficient

– Emphasis that articles in those journals may be high quality

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Surprised and downplaying the issue

– No statement before july 2018

– Who focusses on “Fake Science“ ignores the real problems

– Storm in a teacup: predatory journals are irrelevant

– Presentations and texts from G. Antes describing Predatory Journals since october 2015

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Richard Horton, Editor of The Lancet Jan 2017

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1 Jan 2017

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A further obstacle: The language

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Transfer of Research into Practice

Answers to medical questions

• Clinical (randomised / controlled) studies

• Epidemiological (observational -) studies

. . . .

Kn

ow

led

ge

Tra

ns

lati

on

English language

Implementation: local/national languages

5% of world population anglophone

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Seriously underfunded

1000+ lay language summaries in German

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Observational studies “sufficient“: Real world data

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Relevant for Real-World-Data (RWD)

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The new competitor: Big data, artificial intelligence, personalized medicine .

. .

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Big Data: A Revolution That Will Transform How We Live, Work and Think Kenneth Cukier Viktor Mayer-Schönberger

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Big Data Hype: The Mantras

Big Data

– can analyze unstructured data

– can easily solve every problem by using more data

– needs ownership moving from owner to user

– cannot reproduce results because everything is changing every second: real-time results

– The era of causality is over, now is the era of correlation (enabled by unlimited access to data)

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Neue Züricher Zeitung 11 Jan. 2015

Chris Anderson 16/2007 Wired Magazine: The End of Theory. The Data Deluge Makes the Scientific Method Obsolet

Science in megalomania

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How Big Data makes us and our life predictable

The End of Randomness

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Transfer of research results into practice

patients / healthy persons

Research / studies / data

patients / healthy persons

application / benefit

Literature based synthesis (SR; Cochrane classical)

Individual-data- based synthesis (IPD SR)

Access to trial data or or trial reports (SR from authority data)

Artificial Intelligence

Data drilling

Machine learning

Big data

Dr. Watson

Knowledge Systems Deep learning system

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Investment at MD Anderson Houston: $62 million

Large amounts of electronic patient records . . . will help to avoid any wrong diagnosis and treatment

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Deutsches Ärzteblatt, 15. April 2016

Golden future or empty promises?

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Solutions?

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Since 2011 2017 access to 85% of articles behind paywall

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13 Dec 2018

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Orthodox

– clearly defined question

– prospective

– based on protocol

– good scientific practice

– quality

– overarching principle: risk-of-bias

– rigid methodology

– reproducibility

– transparence, data sharing

– crisis of science

– Basic model: incremental progress, research in context

The new world

– unplanned, unintended

– quality of results?

– reproduciibility?

– principles of modeling?

– significance, clinical relevance

– results under uncertainty?

– non-transparent!

– clinical outcome?

– renaissance of surrogates

Basic model: disruptiv

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http://www.cebm.net

From Experiment to Real World Data XXL

Level der

Evidenz

I

II

III

IV

V

Systematic Reviews

Experimental studies

Observational studies

Big Data (AI)

Bia

s

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Summary

– Enormous progress to use knowledge from trials and studies: Global knowledge – local implementation

– Evidence world based on systematic reviews as key technology for knowledge synthesis and translation

– Erosion and damage of key concepts in current development: serious confrontation with the old quality world of EBM clinical epidemiology

– Return to quality and quality assessment as leading principle

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May 2013 in German (English: Testing Treatments)

pdf and als html free on de.testingtreatments.org

– www.cochrane.de

– www.cochrane.org

– www.thecochranelibrary.com

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Masaryk University

Centre

CEBHC

KT

Czech National Centre for Evidence-Based Healthcare and Knowledge Translation

Masaryk University

Centre