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NUTRITION & HEALTH RESEARCH @TNO
TNO acting as a field lab for health measurements
Wilrike Pasman, PhD
HEALTHY LIVING
LIFESTYLE AS MEDICINE TO CURE TYPE 2
DIABETES
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PERSONALISED DIGITAL HEALTHCARE IS DEVELOPING
RAPIDLY (eHealth) Challenge: How can we further improve the quality of digital healthcare?
HUMAN STUDIES IN A UNIT
Health
&
Nutrition
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ON LOCATION
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DIY Blood test
INCREASE IN DO-IT-YOURSELF METHODS FOR
MONITORING OWN HEALTH
Devices
Apps
Tests
Questionnaires
Body weight
Cholesterol
Blood pressure Activity
Glucose
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Genetics swab
Internet
Field lab
studies, with
primary care
(physician,
dietitian)
HUMAN HEALTH RESEARCH
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Big, controlled,
expensive studies
Past
Present
Future
Lean & mean research with
a simple research question
To the consumer at home for
health research and support
(monitoring), HDC,
n=1 studies
Shift from data to substantiate research to:
• Data for research as such
• Empowerment of people
• Monitoring / prevention
HUMAN RESEARCH: WMO & GDPR
Research with participants/
respondents
Research with
data / material of
people
According to
WMO
Not according to
WMO
Not according to
WMO
Handle data of
subjects with
care (integrity)
Handle data of
subjects with
care (integrity)
Protection
personal data
(privacy)
Protection
personal data
(privacy)
Protection
personal data
(privacy)
WMO: ‘Wet Medisch-wetenschappelijk Onderzoek met mensen’
Law Medical-scientific Research with subjects:
- Medical – scientific research (invasive, burden for subjects)
- The subject is exposed to (repeated) treatments / interventions / rules NAV op lokatie 31 mei 2018
METC
approval
Internal TC
Non-WMO TNO
Quality, safety, in line with
journals and clients
TYPE OF STUDY
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Dependent upon:
Complexity of research question
Fase of the product/research
Location
Researchers/conduct people
Recruitment target group
Conduct
RCT Field lab
DIY/
online
@
Location
CONDUCTING A DIVERSITY OF STUDIES
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PREPARATION & CONDUCT
ANALYSES & REPORTING
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1. COLLABORATION: CONTROLLED, CLASSICAL RCT
Metabolic ward (CRO)
Protocol
Complex RQ, design, methods
Trained nurses
Answer to RQ
Well controlled and conducted
Applicable to consumers (‘ecological validity’)
Expensive, only big companies NAV op lokatie 31 mei 2018
2. LEAN & MEAN STUDY – BREAKFAST@LAB
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Examine the satiating effect
of different types of breakfasts
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Controlled
Answer RQ
Simple
People need to visit TNO/lab (time)
3. FIELD LAB STUDIES: P4@HILLEGOM
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All 8 GPs practices
2 POH (‘nurses’)
1 Physiotherapist
1 Dietitian
A medical center in
center of Hillegom
(blood sampling and
OGTT)
In collaboration with
TNO
Hillegom: 21.000
inhabitants
About 30 new diabetes
patients a year
In real life data and practice
Low burden for patient, all at hand (own town)
General practitioner more involved
Data collection, storage, missing data (data manager)
DELTA DIFFERENCE
Δ-3.0±0.6mmol/mol Δ-0.4±0.1mmol/L Δ-8.1±0.7kg Δ-2.8±0.2kg/m2
p<0.0001
BACKGROUND AIM METHODS RESULTS DISCUSSION
4. DO IT YOURSELF– BREAKFAST@HOME
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At home; easy, simple, fast
Compliance? Correct?
LOCATION EFFECT HUNGER BREAD A-B
Appetite ratings of wholegrain breakfasts evaluated under laboratory and free-living conditions
Same results found on both locations
Lab
4. DO IT YOURSELF – COFFEE@HOME
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Easy to implement in real life data and practice
Need a clear, strict protocol
Control/compliance difficult to monitor
Selective group of subjects
*** Results similar to EFSA caffeine claim ***
EXPERIENCES BASED ON DIFFERENT TYPES OF STUDY
Time!
Level of control (site-high, @home-low)
Simple & clear protocol needed, video, portal,24h helpdesk (@home)
Train the team members (POH is no data managers)
Communication (team, subjects)
Drop out rate high when tools/gadget are too much or unclear
More subjects needed due to variation in conduct
Social media: fast recruitment and screening
Real world setting (field lab, @home); patient/subject specific
Easy to implement in daily setting (@home)
……………………………………
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CONCLUSION
Depending on the RQ the type of study needs to be defined; all types of
study conduct co-exist
Each type of study has pro’s and cons
Upcoming Health Data Cooperatives or DIY health data monitoring
communities are promissing with respect to evaluation (empowerment
and research), but some data safety and privacy issues need to be
solved first
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CONTACT
+31 6 4684 7306
@Wilrike68
linkedin.com/in/wilrikepasman/
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