Received: 27 December 2019 Accepted: 5 June 2020

DOI: 10.1002/sam.11475

RESEARCH ARTICLE

The future of precision health is data-driven

decision support

John Sperger† Nikki L. B. Freeman† Xiaotong Jiang David Bang

Daniel de Marchi Michael R. Kosorok

Department of Biostatistics, University of

North Carolina at Chapel Hill, Chapel
Hill, North Carolina
Correspondence
John Sperger, Department of Biostatistics,
University of North Carolina at Chapel
Hill, Chapel Hill, NC.
Email: jsperger@live.unc.edu
Abstract
In the applied sciences, the ultimate goal is not just to acquire knowledge
but to turn knowledge into action. The next wave for data disciplines may be
experimental designs and analytical methods for closing the gap between the
“real-world” situations faced by decision-makers and their idealized represen-
tations in optimization problems, and the health sciences are poised to be the
discipline where these developments substantially improve lives. We discuss
three recent trends in research—experimental designs and analytical meth-
ods for precision medicine and pragmatic trials; technological developments in
sensors, wearables, and smartphones for measuring health data; and methods
addressing algorithmic bias and model interpretability—and argue that these
seemingly disparate trends point to a future where data-driven decision support
tools are increasingly used to promote wellbeing.

KEYWORDS
clinical decision-making, decision support systems, machine learning, precision medicine

1 I N T RO DU CT ION has focused on developing statistical tools for precision

The era of data-driven decision support is arriving, and the
health sciences have the potential to be the field where
it makes the most significant impact on people’s lives.
From rapid advancements in sensors, wearables, and elec-
tronic health records (EHRs) to nimble analytic methods
in statistics, data science, machine learning (ML), and
artificial intelligence (AI), the data types available, the
infrastructure for storing and accessing those data, and the
methods for synthesizing data into credible recommen-
dations are tremendous resources to harness for health
care decision improvement. To this end, much of our work
†
John Sperger and Nikki L. B. Freeman shared co-first authorship.
medicine, “ … the paradigm wherein patient heterogene-
ity is leveraged through data-driven approaches to improve
treatment decisions so that the right treatment is given to
the right patient at the right time” [13]. The short history
of contemporary precision medicine is exhilarating and
includes the application of Markov decision process the-
ory to sequential health care decision-making [7,17], the
advent of the sequential, multiple assignment, random-
ized trial (SMART) [21], and the translation of the search
for optimal treatment regimes from a statistical problem
into a ML problem [32,34,35]. To further clarify our stance,
we emphasize that we take “precision” to mean advancing
health science by leveraging heterogeneity to find optimal
or near-optimal interventions for people or populations.

Stat Anal Data Min: The ASA Data Sci Journal. 2020;1–7. wileyonlinelibrary.com/sam © 2020 Wiley Periodicals LLC 1
2 SPERGER et al.
This view is counter to the use of “precision” that narrowly
focuses on using “-omics” type data exclusively or near
exclusively. Our notion may include “-omics” data but also
includes other sources of patient and group heterogeneity
as not all heterogeneity or all illness is due to genetic fac-
tors. Confusion around the use of precision has, at times,
clouded discussions around precision methods in health.
We believe in a bold future in which the precision
medicine framework of embracing patient heterogeneity
as a rich source of information for better decision-making
serves as a model for other disciplines, improves health
outcomes, and enables new lines of scientific inquiry
by identifying sources of heterogeneity for investigation.
In our view, decision support is the ultimate goal for
the future of statistics and ML. Decision support and
health care are fundamentally causal—the goal is to act
to improve outcomes, and intervention generally requires
knowledge of the causal mechanism or, at a minimum, the
ability to predict what will happen if treatment is given.
The critical element for tailored data-driven decision sup-
port to improve outcomes is heterogeneity. Ignoring het-
erogeneity implicitly assumes that differences in response
to treatment do not exist or do not rise to the level of clin-
ical significance. The numerous determinants of health,
including environmental, social, behavioral, and genetic
factors, create the heterogeneity necessary for tailoring to
be effective, and recent technological developments are
making it feasible to measure factors once impossible or
cost-prohibitive.
2 T H E POW E R OF DE SIG N
Inherently causal, data-driven decision-making weighs
the “what-ifs” of each choice and the resultant conse-
quences. In an imaginary but useful world to consider,
weighing choices in this way is easy. The consequence of
each course of action for each person would be known
at the time of the decision, and the optimal choices
would be the ones with the best outcomes. In the real
world, decision-making is harder. For a specific person,
only one decision can be made, and only one outcome
observed; the only way forward with this missing data
problem is to consider the effects of decisions in the
aggregate. With aggregation, potential confounders and
selection biases threaten valid causal inferences. Mean-
while, decision-making is often complicated by trade-offs
and tensions between proximal and distal outcomes. From
this seemingly hopeless situation, designed studies, when
feasible, provide a powerful way to overcome these chal-
lenges. As the types of health care decisions being analyzed
through precision methods become more complex and
data-driven decision support strategies are used in novel
settings and contexts, innovations in study design and how
data from those studies are analyzed will be needed. We
believe that the legacy of well-designed studies and the
ongoing quest to improve study design by statisticians in
the medical and health sciences are compelling reasons to
believe that precision thinking and data-driven decision
support are poised to radically change health care.
Lauded as the “gold standard” of evidence, the ran-
domized controlled trial (RCT) is the traditional tech-
nology for making causal inferences in health care and
thereby providing the engine for decision support and
evidence-based medicine. Through careful selection cri-
teria, randomization, and, when possible, blinding, the
design features of RCTs, theoretically, bypass problems of
selection bias and confounding and enable us to make
inferences about the expected outcomes of the choices
(treatments and/or actions) at hand. Unfortunately, this
comes at a cost. First, RCTs often have stringent inclu-
sion criteria to ensure adequate homogeneity among the
study participants. Homogeneity of this type improves the
internal validity of the study, but the study sample and,
therefore, the inferences from the study may not reflect
the actual diversity in the affected population. Moreover,
most RCTs analyze for the “one-size-fits-all” treatment,
comparing the effect of giving everyone one treatment to
the effect of giving everyone a different therapy, which
may be a placebo or care as usual. Given the heterogene-
ity inherent in human health, it is likely that in many
cases, different types of patients would benefit from dif-
ferent types of treatments. Finally, because of the cost and
administrative burden of RCTs, analyses usually consider
a relatively short-term outcome and do not factor in the
long-term efficacy of the treatments, second-line therapies
in the case of first-line therapy failure, patient preferences,
and treatment side effects.
The current frontier of study design attempts to address
the shortcomings of the traditional RCT to produce data
for which causal inferences are valid but also reflect the
diversity and heterogeneity in patients observed in clini-
cal practice and leverage that diversity for improved out-
comes overall. Two exciting contemporary designs are
pragmatic trials and SMARTs. Pragmatic trials seek to
provide directly relevant evidence for decision-making by
evaluating treatments under conditions similar to usual
patient care rather than the idealized setting of a tradi-
tional RCT while maintaining internal validity through
randomization and careful measurement of treatment
fidelity and adherence [8]. To this end, pragmatic trials
typically include few exclusion criteria, use outcome mea-
surements collected as part of routine care or that present
a minimal burden and could become part of routine
care, and randomize between multiple active interven-
tions. One recent innovative example combines pragmatic
SPERGER et al.
trial design with EHR data collection to minimize patient
burden and compares two active interventions and usual
care to prevent suicide attempts [26]. SMARTs sequen-
tially randomize patients at critical decision points [21].
Consequently, SMARTs produce the type of information
that can be used to discover optimal dynamic treatment
regimes, treatment strategies across time tailored to indi-
vidual patient characteristics that maximize (or minimize,
depending on context) the desired outcome. A SMART can
help answer the question of what types of patients benefit
most from having one therapy versus a different ther-
apy, a distinction from the “one-size-fits-all” paradigm,
and does so by embracing patient heterogeneity as infor-
mation to capitalize on rather than as a nuisance to be
excluded. Because of the sequential randomization struc-
ture, SMARTs can determine which second-line therapies
are best for which types of patients if front-line therapies
fail. Moreover, analyses of SMARTs can balance competing
proximal and distal outcomes into the resulting recom-
mended dynamic treatment regimes.
Together, SMART and pragmatic trials have moved
us closer to having the optimal data for more practical,
more clinically relevant data-driven decision support in
the future. We believe that design thinking will continue
to move us in the direction of clinically actionable, fully
data-supported decision-making in health care. In the near
future, we believe that an essential next step is designing
validation studies for decision support tools. The dynamic
treatment rules derived from SMART trials are inferred
from the SMART trial sample; assessing whether they
hold up more generally and whether they reliably improve
the effectiveness of care is an important next step. This
type of assessment can provide valuable feedback on how
to improve methods for deriving treatment rules. More
importantly, this type of assessment can aid in building
trust among practitioners in implementing decision sup-
port tools in the daily practice of health care. Another
near-future frontier for design thinking is constructing
studies that incorporate patient preferences. Health care
decisions are deeply personal, and what are acceptable
risks and levels of discomfort for one patient may be dif-
ferent from another. Incorporating these preferences into
the health care decision-making process is often referred to
as shared decision-making. Formal integration of patient
preferences into a data-driven approach has been explored
in the precision medicine literature [3,14,18], but the inte-
gration of patient preferences into formal study design
is still a crucial aspect of health care decision-making
that has yet to be captured fully. Even farther into the
future, we envision the role of study design to be ever-
more essential to building decision support tools. Through
carefully designed health care systems constructed for
ongoing studies and analyses, semi-automated continual
3
reassessment methods will become routine aspects of
health care improvement. The collected data will support
reinforcement learning for hypothesis generation, finding
problems, and testing solutions that can be seen in the
data without the need for substantial human intervention
that can push hypotheses tested toward personal biases.
These yet-to-be-realized innovations to statistical design
for improving health care, like more traditional designs
that have provided a cornerstone for building evidence
in the medical and health sciences, are poised to push
the science forward by opening up the types and scope
of questions that can be answered using a formal causal
framework and warranting optimism for the transforma-
tive power of data-driven decision support in health care
to improve lives.
3 THE PRO MISE O F EMERGING
DATA S O U RC E S
Technological developments in sensors and wearable tech-
nologies and the ubiquity of smartphones are making
it possible to measure and act on a greater array of
health determinants than ever before. Wearable sensors
collect real-time EKG data, body temperature, activity
level, sleep patterns, and blood glucose levels while smart-
phone apps capture frequent snapshots of mental health
over time and measure social and behavioral patterns.
Meanwhile, substantial advances in the measurement and
methods for analyzing genomic and metabolomic data
such as single-cell sequencing have been made, though
they have not yet reached the point of cost-effectiveness for
widespread uses.
Recent work has focused on applying ML tools to these
data for prediction. For example, deep learning archi-
tectures have shown remarkable ability to predict sepsis
[10,23] from patient vital signs, hospital records, fluid
information, laboratory test results, treatment orders, and
free-text medical records. Deep learning has also been
applied to computed chest tomography volumes to pre-
dict lung cancer risk [1]. Methodological developments
outside of deep learning, such as Bayesian rule lists, have
also shown impressive predictive ability. They have been
applied to predicting strokes from a high dimensional fea-
ture space, yielding a posterior distribution over possible
decision lists; this approach provides risk predictions as
interpretable as the traditional risk models used in clinical
practice and yields more accurate results [15].
The focus of current work on prediction highlights
some of the challenges of working with the types of data
and volume of data coming from emerging data collec-
tion technologies. First, incorporating data collected from
consumers of wearable products, purchases of smartphone
4 SPERGER et al.
apps, highly specialized disease-specific sensors, and
deeply specific “-omics” analyses into a rigorous causal
framework is challenging as the individuals with access
to these technologies—and hence also the ones generat-
ing the data to train ML and AI algorithms—may look
different than those individuals without access. Dealing
with this type of confounding is essential for unbiased,
trustworthy decision support. Second, self-reported data
from a smartphone app or mass-marketed consumer wear-
able is different in quality from data collected by trained
medical personnel in EHRs or collected from approved
medical devices. Ensuring data quality while integrating
data from a wide range of sources will be a crucial step.
Another challenge associated with observational data of
this type is whether the action or treatment of interest
is even in the observed data. Having a massive volume
of data is not equivalent to having enough information
for the clinically relevant question at hand. Finally, meth-
ods for integrating functional, longitudinal, cross-sectional
data from many different levels—the molecular to the
environmental—into formal sequential decision analyses
will be needed to efficiently use information captured by
emerging technologies.
Despite these real challenges, hints to the future for
using these data are already here. Micro-randomized tri-
als (MRTs) support just-in-time adaptive interventions,
mobile health (mHealth) technologies that try to improve
individuals’ health by delivering the right intervention
component at the right time and location [11]. MRTs
are designed for causal analyses of intervention compo-
nents and those effects over time. HeartSteps, an mHealth
intervention, tailors prompts for individuals to get up
and walk based on their context (current situation). An
MRT to assess the efficacy of HeartSteps’ activity sug-
gestions has illustrated the promise of using mHealth
data for formal data-driven analysis for decision support
[12]. Progress has also been made in estimating optimal
dynamic treatment regimes from mHealth data. Applied
to data from continuous glucose monitors, physical activ-
ity trackers, and self-reported dietary intake data from
patients with type 1 diabetes, V-learning is an example
of the types of methodological developments that will
be needed to capture the nuance in complex health
care decision support [17]. MRTs and the methodological
advances from the field of precision medicine are moving
beyond prediction and using new data sources for preci-
sion decision-making that more fully capture health care
decision-making processes. The opportunities in this line
of research are wide open; it is indeed an exciting time to
be a part of building the precision medicine framework
and extending precision methods to decision-making more
generally.
4 THE POSSIBILITY O F C ARING
DEC ISION SUPPORT
Truly optimizing a decision requires an extremely
restricted context where all the relevant costs and bene-
fits can be measured. While data sources, experimental
designs, and analytical methods are bridging the gap
between the idealized decision problems our methods
optimize and the actual problems facing decision-makers,
the existence of this gap causes problems when algorith-
mic decision making is applied without due care. There
is a growing appreciation for what some of the common
omissions are, such as societal fairness, and developing
methods to address these shortcomings will be significant
work. Interpretable models also present a more gen-
eral remedy for addressing this gap by allowing human
decision-makers to better understand what the model
does and does not consider. The potential for data-driven
decision support in health care to benefit people’s lives
directly is vast but the wellspring of that potential, that
health care can literally be a matter of life or death, also
means that the utmost care must be taken to avoid harm.
With this in mind, data-driven decision support must be
fair, transparent, and accountable both to patients and
physicians.
Tailoring treatments to patient characteristics necessi-
tates treating people differently, and addressing fairness
considerations will be essential for the adoption of decision
support tools to benefit all of society. Having no intention
to discriminate is not enough as the numerous examples of
bias in ML tools for prediction and decision support amply
demonstrate [22,36]. Addressing fairness requires defining
it, and to complicate matters, there are multiple definitions
of algorithmic fairness that are mutually exclusive except
in special cases [2,4,16]. “Anti-classification” approaches
emphasize excluding specific protected attributes like sex
from being used for decision making. Other definitions,
including classification parity and calibration permit the
use of protected attributes but require that some perfor-
mance metric (possibly predictive, possibly causal) has
parity across groups defined by the protected attribute.
The mathematical formalization of fairness measures is
in its infancy, and within these categories of metrics, we
expect exciting developments in the coming years. How-
ever, we view the choice between these general classes
of fairness measure as a question of context and values,
not an open technical question. For certain diseases and
conditions, incorporating protected characteristics such as
biological sex is critical to our scientific understanding
and our statistical modeling [27]. A risk prediction tool
for prostate cancer which ignored biological sex would be
missing an important attribute. Additionally, when bias
SPERGER et al.
exists in society related to a protected attribute, ignoring
that attribute is likely to propagate bias. This point has
been forcefully raised in the health inequities literature
generally and in the epidemiological literature on racism
as a fundamental cause of adverse health outcomes [30].
Model interpretability will play a key role in making
precision health decisions transparent to patients and clin-
icians and making it possible to hold models accountable.
Interpretable models permit auditing by domain experts,
help generate new scientific hypotheses, and allow com-
peting outcomes in fuzzy decision scenarios to be weighed
[6]. Research on interpretable classes of models spans
decades but until recently received comparatively little
attention compared to successes enjoyed by black-box
ML methods. As these black-box methods began to be
deployed in domains like finance where decisions can
severely impact people, their inscrutability has led to calls
for a right to an explanation when algorithmic decision
making is employed. This push is exemplified by the “right
to explanation” codified in the European Union’s General
Data Protection Regulation implemented in May 2018 [5]
though the true scope of the regulations is a matter of ongo-
ing legal debate [19,29]. Two competing approaches have
arisen, which emphasize either models which are inter-
pretable by design or which employ methods to peer into
black-box models and explain them [9]. Recent advances
in interpretable models include super-sparse linear integer
models [31] and Bayesian rule lists [15] for prediction and
decision trees for decision support [33]. It remains an open
point of debate whether explainability is enough, or, if not,
under what circumstances does explainability suffice [24].
What counts as interpretable depends on the audience;
a table of regression coefficients for a generalized linear
model may be interpretable to a statistician but not a clin-
ician or a patient. Moreover, we recognize that there are
important settings where unexplainable models which are
effective need to be employed to improve outcomes while
similarly effective but explainable models are being devel-
oped. How to appropriately balance both black-box and
interpretable approaches will be fundamental to scrutinize
going forward.
In the future, we believe checking models for bias and
interpretability will be as natural as plotting regression
diagnostics, but getting there will take interdisciplinary
efforts. Statistical prediction tools have outperformed clin-
ical judgment for certain tasks for more than half a century,
but their widespread adoption has been slow and piece-
meal [20]. There are myriad psychological, sociological,
and economic reasons for this which are beyond our ken,
but as methodological researchers, we can contribute to
the adoption of decision support tools by developing meth-
ods and diagnostic tools which narrow the gap between
the available evidence and the needs of decision-makers
5
and by recognizing the limits of what we can do on our
own. Methodological development for decision support
and optimization will involve numerous fields, including
applied math, computer science, economics, operations
research, and statistics. Identifying the needs of patients
and clinicians, the gaps between the existing evidence and
the decisions being made, and how best to communicate
what we do and do not know and the uncertainty will
involve patients, clinicians, and activists as well as experts
in design, health behavior, human-computer interaction,
political science, psychology, sociology, and other fields.
5 CO N C LU S I O N
Propelled by emerging technologies and novel streams of
data, many areas of statistical science are rapidly mov-
ing toward developing and employing methods that are
directly applicable to decision-making and decision sup-
port. With this in mind, we believe that the next wave
in statistics is the development of designs and methods
for closing the gap between the data that exists and the
creation of actionable evidence for realistic decision sup-
port. In the statistics of health, some progress toward
this end has been made. Pragmatic trials and SMARTs,
advances in the interpretability and fairness of algorithms,
and serious methodological work for rigorously incor-
porating patient preferences and dealing with multiple
outcomes are all advances toward building the statistical
foundation for generating useful, actionable evidence for
settings and decisions actually observed in the practice of
health care.
With our optimism for the promise of precision health
comes a serious understanding that many challenges lay
ahead. As a relatively new framework, we highlight one
particularly important challenge: helping our clinical and
non-statistician collaborators not only understand but har-
ness the precision health toolbox to improve patient lives.
Potential collaborators can face a high barrier to entry with
this type of research. Formulating a research question in
the precision health and defining its associated estimands
are not covered in the methods curriculum included in the
training of practitioner-researchers and non-statisticians.
Even after overcoming the “what-is-precision-health” hur-
dle, collaborators eager to use precision health approaches
in their research will need to garner institutional and
peer buy-in to successfully navigate precision health stud-
ies to completion. For example, precision health studies
can have a higher cost due to data management require-
ments, and implementation may be more challenging
when there is re-randomization; clearly articulating and
weighing the trade-offs between precision health meth-
ods and traditional methods in these types of situations
6 SPERGER et al.
to peers less familiar with precision health thinking will
be essential for justifying the potential additional study
complexity and cost. Furthermore, after completing a pre-
cision health study, communicating the results can be
difficult. Bridging these gaps between methodological and
applied research and from applied research to clinical
practice will require interdisciplinary effort, outreach, and
trust-building. Steps to this end are varied and range from
the softer, often-overlooked skills of facilitating conver-
sation and convening voices from different disciplines to
developing reporting guidelines similar to CONSORT or
STROBE [25,28] to improve the understanding and crit-
ical appraisal of precision health studies. Work will also
be needed to ensure that health institutions and the gen-
eral public trust in the decision support tools produced by
researchers and systems established for patients and advo-
cates to provide feedback on and oversight of these tools
and their impacts.
Certainly, more work needs to be done before the full
potential of data-driven decision support can be realized.
The young and active field of precision medicine has much
to contribute in terms of precision methods and decision
process methodology for tailoring methods to individuals.
Actualizing those methods in the broader context of public
health, an area often concerned with larger social struc-
tures with individual-level analogs, and more generally
health, which includes the individuals’ whole environ-
ment and physical and social network, is still a challenge
for the future. Nonetheless, the progress toward building
the decision support tools of the future is compelling and
in few places is it more compelling than in health care.
We believe that health care is strongly positioned to be
the place where advances in decision support not only
touch but improve lives, and we optimistically embrace
that future.
ORCID
John Sperger https://orcid.org/0000-0002-2273-5353
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