nutritional epidemiology, research integrity, research ethics, nutrition, diet see http://www.gesiinitiative.com/gesi-webinars for recordings

1. NUTRITIONAL EPIDEMIOLOGY:
BETTER RESEARCH FOR THE RIGHT REASONS
Prof. Dr. Carl Lachat, Prof. Dr. Wim Pinxten, and MSc Dana Hawwash, 16th May 2018
Carl.lachat@ugent.be wim.pinxten@uhasselt.be Dana.Hawwash@UGent.be
DEPARTMENT OF FOOD TECHNOLOGY, SAFETY AND HEALTH

2. IN THIS PRESENTATION
̶ Research waste and concerns in nutritional epidemiology
̶ Reporting guidelines
̶ Research priority setting
̶ Ethical reflections
16/05/18

3. PROBLEM SETTING…
̶ 2014 Lancet series on research waste
̶ 2010 in biomedical research US$240 billion
̶ Of more than 25 000 reports published in six leading basic-science
journals between 1979 and 1983,
̶ 101 included confident claims that the new discoveries had
clear clinical potential,
̶ 5 had resulted in interventions with licensed clinical use by
2003,
̶ 1 led to the development of an intervention used widely

4. THE RESEARCH CYCLE
4
Priority
setting and
questions
selection
Research
design and
outcome
definition
Data
management
and analysis
Research
reporting and
publishing

5. ENSURING COMPLETENESS OF FINDINGS
5
Priority
setting and
questions
selection
Research
design and
outcome
definition
Data
management
and analysis
Research
reporting and
publishing

6. WHY BETTER REPORTING MATTERS
http://researchwaste.net
• Poor reporting is a major source of research waste
• Published trial reports: 40–89% were non-replicable1
• Most studies had at least one primary outcome changed, introduced, or omitted from the
protocol1
• Research papers are incomplete
• Authors may not know what essential information to include
• Reviewers/editors may not know what should be included
• Consequence
• Incorrect interpretation of findings
• Loss of studies and information
1 Glasziou et al. 2014.. The Lancet, 383, 267-276

7. NUTRITIONAL EPIDEMIOLOGY
̶ Assess the diet-disease relationship in humans
̶ Nutritional epidemiology is one of the younger disciplines
in epidemiology
̶ Indications that reporting is problematic
E.g. 13 of the 17 literature reviews for the 5th revision of the Nordic Nutrition
Recommendations report a lack of methodological details causing lower quality
rating or exclusion of papers.3
3Nordic Council of Ministers (2014)

8. ̶ Challenges to assess dietary intake and exposure
̶ Diet (...) represents an unusually complex set of
exposures that are strongly intercorrelated.
METHODOLOGICAL CHALLENGES

9. STROBE-STATEMENT
̶ STROBE: STrengthening the Reporting of OBservational studies
̶ Evidence-based, minimum set of recommendations for reporting of
observational studies.
• A set of 22 items to report cohort studies, case-control studies and
cross-sectional studies.
̶ STROBE-extensions: provide guidance for specific areas e.g.
̶ STREGA: Genetic Associations
̶ STOBE-ME: Molecular Epidemiology
̶ STROME-ID: Infectious Diseases
̶ …

10. STROBE-NUT
̶ An extension of the STROBE-statement for nutritional
epidemiology and dietary assessment
̶ Checklist of 24 recommendations
̶ Use checklist together with
̶ STROBE-nut explanation and elaboration document
̶ Other STROBE extensions e.g. STROBE-ME

11. METHOD
̶ Start 2014
̶ Collaboration between 4
research groups
̶ Input from 3 Delphi rounds with
53 external experts
̶ Consensus through 3 face-to-
face meetings

13. CHALLENGES
̶ How do users understand and apply STROBE-nut?
̶ From better reporting to better research?
̶ Continuous & interactive process to improve recommendations
̶ Submit feedback, comments, and new evidence on
www.strobe-nut.org

14. CONSIDERATION OF VALUES WHEN
SETTING PRIORITIES IN NUTRITION
RESEARCH: GUIDANCE FOR
TRANSPARENCY
HAWWASH D, PINXTEN W, AUBERT BONN N, VERSTRAETEN R, KOLSTEREN P, LACHAT C: CONSIDERATION OF VALUES WHEN SETTING PRIORITIES IN
NUTRITION RESEARCH: GUIDANCE FOR TRANSPARENCY , ADV NUTR 2018 (IN PRESS)
14

15. THE RESEARCH CYCLE
15
Priority
setting and
questions
selection
Research
design and
outcome
definition
Data
management
and analysis
Research
reporting and
publishing

16. CHALLENGES WHEN SETTING PRIORITIES
FOR RESEARCH
̶ What are research priority
setting exercises?
̶ Why are they important?
Priority
setting and
questions
selection
Research
design and
outcome
definition
Data
management
and analysis
Research
reporting and
publishing

17. THE PRIORITY SETTING CYCLE
1
Assessing
the
situation
2 Setting
the scene
3
Choosing
the best
method
4
Planning
priority
setting
5 Setting
priorities
6 Making
priorities
work
17
Montorzi G, de Haan S, IJsselmuiden C: Priority Setting For Research for Health A management process for countries. In: COHRED Manuals and Guidelines Series. Council on
Health Research for Development (COHRED); 2010.

18. 18
Montorzi G, de Haan S, IJsselmuiden C: Priority Setting For
Research for Health A management process for countries. In:
COHRED Manuals and Guidelines Series. Council on Health
Research for Development (COHRED); 2010.

19. WHAT IS LACKING? WHAT NEEDS TO BE
DONE?
̶ Consideration of values in priority setting is not automatic. Values are rarely made explicit and a
systematic way of defining and considering values is generally lacking
̶ Stakeholders involved in the process come with their own values and interests
̶ Reflections on whose interests are served, are relevant for readers and they enhance transparency
and accountability
̶ There exist a few ethical frameworks for priority setting exercises including the Accountability for
Reasonableness by Norman Daniels
̶ However current frameworks for priority setting often pre-define values
̶ And they are generally theoretical, without consideration of practical implementation
19

20. THE PRIORITY SETTING CYCLE
1
Assessing
the
situation
2 Setting
the scene
3
Choosing
the best
method
4
Planning
priority
setting
5 Setting
priorities
6 Making
priorities
work
20
Montorzi G, de Haan S, IJsselmuiden C: Priority Setting For Research for Health A management process for countries. In: COHRED Manuals and Guidelines Series. Council on
Health Research for Development (COHRED); 2010.

21. METHODOLOGY
A 3-step approach was used to develop the guidance tool:
(1) A mapping review of nutrition research priority setting
exercises
(2) Identifying values reported in the papers of the mapping review
using qualitative content analysis and organizing them in a tool
(3) consultation round with the authors of the priority setting
exercises on the developed tool.
21

22. STEP 1 MAPPING REVIEW
̶ 5 online databases were screened including Medline, ISI Web of
Knowledge, Cochrane Library, and Turning Research Into Practice
(TRIP) and Excerpta Medica database (EMBASE)
̶ The search syntax was developed in Medline using PICO (population,
intervention, control, and outcomes) model
̶ Grey literature documents were obtained using Grey Literature Report,
and targeted websites
̶ External experts were consulted.
22
Verstraeten R, Hawwash D, Lachat C, Bonn N, Pinxten W, Gillespie S, Holdsworth, A B: Nutrition prioritisation: three inter-dependent (mapping, methodology, and ethics) systematic review outputs.
. PROSPERO 2016.

23. STEP 1 MAPPING REVIEW
RESULTS
23

24. STEP 1 MAPPING REVIEW RESULTS
Of the 27 studies reviewed:
̶ 40.7% used a combination of different methods to set priorities
̶ 59.3% described the represented stakeholders
̶ 49.1% reported on follow-up activities.
̶ All priority-setting exercises were led by research groups based
in high-income countries.
24

25. STEP 2 VALUE EXTRACTION AND TOOL DEVELOPMENT
̶ Building on qualitative analysis, we developed our own strategy
of extracting values by the support of Prof Wim Pinxten
̶ Values were defined as general descriptions of what matters
(e.g. ‘honesty’), that are not formulated in a measurable way
(which we would define as a norm, e.g. ‘don’t lie’).
̶ A value was seen as an action focused on achieving a sole
purpose (i.e., an end) and not on an action carried out to achieve
something further (i.e., means to an end).
25

26. STEP 2 VALUE EXTRACTION AND TOOL DEVELOPMENT
RESULTS
̶ Through iterative qualitative content analysis, 2 researchers
coded all the papers independently, then discussed differences
in coding until agreement was reached.
̶ Values found were initially grouped in 8 clusters: understanding,
impact, feasibility, efficacy, equity, soundness, sustainability, and
novelty.
̶ The 8 clusters found were simplified into 3 values: ‘feasibility’,
‘impact’ and ‘accountability’.
26

27. STEP 3 CONSULTATION ROUND
The first and last authors of all the retrieved papers in
step 1 were contacted to provide feedback on the tool
and/or comment on the wording.
27

28. STEP 3 CONSULTATION ROUND RESULTS
̶ 17 authors who replied to participate in the consultation round, and 7
authors provided feedback
̶ Authors represented scholars and leading agencies in nutrition
including the Global Alliance for Improved Nutrition, the Bill & Melinda
Gates Foundation and COHRED.
̶ In response to the feedback, the layout of the tool was simplified.
̶ Comments related to rewording of sentences, and logical ordering of
values in the table were considered
28

29. VALUE ORIENTED GUIDANCE TOOL FOR PRIORITY SETTING
EXERCISES
29

30. 30

31. THE IMPORTANCE OF THE GUIDANCE TOOL
̶ The tool aims to be inclusive and builds on what is currently reported in the literature.
Although it is developed for nutrition research, we consider it equally useful to other
types of research that rely on broad stakeholder involvement.
̶ Provides a set of values that can be systematically discussed in the process of research
priority setting.
̶ Serves as a reporting instrument to increase transparency on how values were
considered
̶ Improves rational use of limited resources for research.
̶ Aims to draw attention on the accountability and ensures attention regarding values
during this process.
31

32. CALL FOR ACTION
̶ The proposed tool requires testing and evaluation by various
stakeholder groups to ensure its correct understanding and application
̶ We seek and encourage contributions from groups who work on
research prioritization and are willing to apply the tool in their process
to contact us
̶ We developed a manual to assist when using and testing the tool
32
Hawwash D, Pinxten W, Bonn AN, Lachat C. Tool to Consider Values When Setting Research
Priorities: Manual for Use. 2018 [cited 2018 15th January 2018]. Available from:
http://hdl.handle.net/1854/LU-8544974.

33. AN ETHICAL APPROACH
33

34. WHAT IS ETHICS ABOUT?
34
- On what matters
-Values as a central concept
-Large variety of values

35. WHAT IS ETHICS ABOUT
35
VALUES
&
DILEMMA’S
Image: http://lenwilson.us/good-fast-cheap/

36. ETHICS AS A DISIPLINE
̶ 'applied’ ethics
̶ empirical ethics?
36

37. EMBEDDING ETHICS
̶ Challenge: embedding ethical reflection in various scientific and
other practices
̶ Problem: how to organise a more systematic approach to
embed ethical reflection in practice?
̶ Ethical reflection is not an automatic process
̶ Values are often taken for granted, but can easily be ignored
in practice
̶ Approach: systematic consideration of values extracted from
previous priority setting exercises and other sources
̶ Values as a common language and interest
̶ Open-ended approach: not imposing values, but fostering
consideration of values
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38. THANK YOU FOR
LISTENING
QUESTIONS?
38