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Doctors 2.0 & YOU - 2017 - Methodological and ethical issues of connected devices
1. Methodological
and ethical issues
of use of
connected
devices
Olivier AROMATARIO, Linda CAMBON
EHESP, chaire de prévention des
cancers, UMR 5061 CRAPE/ARENES
2. Background
An integral part of all aspects of everyday life, a large proportion in the field of health
The “eHealth” movement : to change health behaviors and health care (Dupagne 2011;
Robin 2014; Wiederhold 2012)
100,000 applications in the health sector, 70% related to the well-being segment, almost 5
million people in France
Increasing life expectancy, increasing number of chronic diseases, growth of outpatient
management :
=> an important place alongside conventional curative and preventive
health policies and management
Few data are available in prevention : What is the real value of these devices as a support
for prevention behaviours ?
3. The uses
The quantified self
A way of socialization,
a source of valorisation
A new model of prevention ?
The weaknesses
5. Quantified-self objective
The socio-technological quantified – self movement (Arruabarrena and Quettier 2013;
Pharabond, Nikolski, and Granjon 2013) :
objective monitoring of health and health behaviours by
quantification of health-related activities or constants
promotes self-knowledge (Gadenne, Devesa, and Wolf 2012, Martin
2014) based on figures provided by connected body sensors on
scales, blood pressure monitors or pedometers that send information
to a smartphone
As prevention : To collect, measure and compare various biological, physical,
behavioral and environmental parameters concerning lifestyle activities (sleeping,
eating, physical exercise, etc.) (Reiter et al. 2008)
to improve well-being and maintain or improve the subject’s health
by measuring of consumptions (smoking, alcohol, calories) or
activities (work time, leisure activities, physical exercise, etc.)
to record and analyse (biomedical) data (blood pressure, pulse) in the
specific setting of the doctor-patient relationship in the context of a
specific risk
6. Why ?
To induce a perception of the body, modelled in an essentially
technical relationship determined by quantitative data
To objectively visualize behaviours as part of a strategy of self-
knowledge and self-construction, although these strategies are not
always maintained in the long term (Arruabarrena and Quettier
2013, Mondoux 2012)
Modifies the frontiers between the fields of well-being, health and
health care => now constitute a continuum between normal and
pathological rather than a breaking-point
7. Socialisation/valorisation objective
Sharing of the data collected and analysed (Martin, 2014)
Users belong to internet-connected communities :
valorisation of their efforts
Encourages reassurance according to various
configurations
Users as part of the social interaction economy (Manski, 1993) :
the behavioural dynamics are linked to the
dynamics of social relationships,
depends on the influence from social groups
8. 3 types of use
Surveillance
measurement of a risk, the threshold playing a central role
usually defined by external, often medical norms. Ex. BMI
not focused on action, but on self-surveillance
the results can sometimes be a source of anxiety and may not lead to data sharing
the advice shared on social networks according to a logic of mutual assistance and support
Routinization or regularity
to replace a bad habit by a more favourable health behavior. Ex. smoking cessation or adoption of
lifestyle and dietary measures
an action or a change, the central element is regularity driven by motivation
sharing on social networks designed to arise encouragement, but the subject may also prefer to
avoid other peoples’ opinions.
Performance
the various measurements become self-determined objectives
enhance motivation and improve performance
social networking allows the sharing of experiences as well as competition
the norms derived from the challenge
9. In fact,
Not really “a standardization of private activities” :
discussion between users is rare
alignment of practices between the users not
really a dominant expectation
measuring practices tend to decline with time
(Pharabond, Nikolski, and Granjon 2013) : 1/3 stop
using their device in less than 6 months, 39% of
commercial apps are used less than 10 times
A technological mediatisation and social mediation (Arruabarrena and
Quettier 2013)
allowing renewed forms of self-exposure or self-narration
an opportunity to communicate according to new codes (Aguiton et
al. 2009; Caldwell 2014).
10. So,
As tools for quantification of activity, allowing users to
measure their activities
assess their progress
project themselves towards a target
constitute a self-construction tool providing an objective
measure of self-control ….assuming that the self can be defined
by these variables !
As self-positioning ways in the community
vectors of collective socialization
an opportunity to seek advices and encouragements
=> could they be integrated into or in place of the conventional prevention
11. Two opposite hypothesis
To transform the subject’s relationship to his/her
body and health by adopting and consequently
normalizing behaviours (Martin 2014)
To contribute to a new representation of the body
and health by promoting empowerment : People
would be better able to make more favourable
adaptive choices (Sandrin-Berthon 2010, Salmon
and Tallec 2014)
13. What about the support to change ?
Few studies with key functions of efficacy (Aromatario, 2017)
Practical use (ergonomics) and communication modes : rapid, responsive, relevant,
tips, hints, etc.
Ability to cater to user needs (ability to adapt)
Intervention by an external person (professional coaching and/or social support)
Factors of individual motivation : effective on motivated people
Unequal access to the health system (geographic and social) : might increase
inequalities, might decrease them
Main findings : The most effective applications are those which allow the person to find ways to change
one’s behavior in one’s environment, those that help identify the individual and environmental factors
influencing the behaviours and help to act on it: It is not only about self-quantification and socialization !
Behaviour Change Theories are not really used (only 20% of publications), only cited, not described and
not assessed.
Sometimes, BCTs taxonomy (Michie, 2013) is cited but there’s no detail on BCTs use. When it is, 4 BCTs
are only cited: Goals and Planning, Monitoring, Shape of knowledge, Social Support...
None related to the support of change itself ? The main aim of prevention !
14. What about inequalities ?
The digital divide may further accentuate the health divide between users with
access to this technology and those without access to it ! (Brouard 2015;
Granjon 2011)
3 reasons :
Access to the technologies (Eng et al. 1998)
Financial and technological limits of systems to provide the
technologies (territorial inequalities) (Viswanath and Kreuter
2007)
Individual characteristics influence access and resort (culture,
education, value, etc.) (Kreuter and McClure 2004; Berland et al.
2001)
However, few efficacy studies explore this question when it’s a big issue in
15. What about external validity ?
Studies with high internal validity design (RCTs)
No detail on the black box of the intervention : how do they work ?
Currently, a blind spot : explanation of the mechanism of efficacy
What SD key-components are effective ?
In which conditions ?
On whom ?
How do we understand the positive or negative role of these
devices without this information ?
17. Needs
More research on :
The ethical questions : what impact of their use
on inequalities and why record data if they fail
to help change behaviors
The methodological questions :
What works, ok ? On whom ?
.... HOW do they work ? What is their black box ?
18. To change the paradigm
=> Not as tools, but as complex interventions (Moore et al,
2015)
=> The role of the context (Moore et al, 2015, Hawe, 2009
Cambon 2012, 2013)
An intervention makes sense by interacting with the
context : it becomes a complex system and needs to
be evaluated as such (Shiell, 2008)
=> The black box
19. To open the black box (Moore et al, 2015)
Which resort(s) or lever(s) could be effective?
Program theory
Is this intervention effective, efficient ?
Efficacy/effectiveness research
Efficiency
How does this intervention work ?
Implementation research (feasibility, acceptability, reliability, fidelity, quality, safety,
coverage, sustainability, etc.)
Causal mechanisms between action and outcomes
Influence of contextual components
What is the transferability of the intervention ?
Applicability and transferability in different contexts
20. The black box (Moore et al, 2015)
To figure out :
if it will produce the same outcomes in other contexts
if the failure is due to the intervention or its delivery
if it is set up in an other context, it would be also ineffective
To compare interventions which have been set up in the same way
To understand why a same intervention produces different outcomes in
different contexts
21. To understand the mechanisms : the
theory-driven evaluation
Causal mechanisms = core elements to understand interventions
Many overlapping theory-driven evaluation approaches (Coryn, 2009 ; Funnell,
2011)
Theory-Based Evaluation (TBE) aims to examine
how hypothesised causal chains play out in
practice (Weiss, 1997)
22. Theory Of Change TOC (Weiss, 1995)
The assumptions about what needs to be in place for the ToC to occur
made explicit, as well as the contextual factors which influence the
ToC.
Additional elements : beneficiaries, research evidence supporting the
ToC, actors in the context, timelines and indicators, etc.
Combining stakeholders (workshops or interviews) expertise,
evidences and sociological or psychological theories (Sullivan, 2006)
(De Silva, 2014).
To strengthen RCTs and other evaluations : building and validating
program theories of interventions that are then empirically tested
(Bonnel, 2012)