Introduction
The much-discussed urgency of addressing the obesity epidemic does not obviate the
need for well-reasoned actions based on the best available evidence. To the contrary,
as underscored by the Institute of Medicine (IOM) report on Accelerating Progress
in Obesity Prevention — Solving the Weight of the Nation (1), the urgency of addressing
the epidemic compels actions, often policy-related and for both the short- and long-term,
that are feasible, work well, and work together, and that do not waste scarce resources
or have unintended adverse consequences. This essay highlights findings and implications
of a prior IOM report, Bridging the Evidence Gap in Obesity Prevention — A Framework
to Inform Decision Making (2), in the view of 2 of the IOM study committee members
(Appendix) and a colleague who is involved in evaluation of Kaiser Permanente’s Community
Health Initiatives. Below we describe the evidence framework that resulted from the
study committee’s consensus process and provide some examples of how it can be applied
to evaluate existing evidence and inform the generation of new evidence.
Decisions about obesity prevention are being made daily in communities, states, and
countries worldwide. The Bridging the Evidence Gap report explains that timely and
credible evidence is needed to help decision makers decide what to do and understand
how to do it, distinguish actions that are likely to be effective from those that
are not, justify particular actions in high-risk populations, quantify likely effects,
estimate costs and cost-effectiveness, set priorities regarding specific outcomes,
determine who benefits, and anticipate potential problems. The report sponsors — Kaiser
Permanente, The Robert Wood Johnson Foundation, and the Centers for Disease Control
and Prevention — were motivated by their perception that effective approaches to obesity
prevention were proving difficult to identify, creating a risk that ongoing efforts
to address the problem would be ill-conceived or haphazard.
Below we describe the evidence framework that resulted from the study committee’s
consensus process and provide some examples of how it can be applied to evaluate existing
evidence and inform the generation of new evidence. The full Bridging the Evidence
Gap report and related summaries, as well as the presentations from 2 workshops convened
by the committee, are available from IOM at www.iom.edu/Reports/2010/Bridging-the-Evidence-Gap-in-Obesity-Prevention-A-Framework-to-Inform-Decision-Making.aspx.
Using Tools From Evidence-Based Public Health
Early in its deliberations, the study committee decided that it would be essential
to understand how various forms of evidence are generated and used in obesity prevention
efforts and are related to core concepts in the broader sphere of evidence-based public
health (EBPH) (2,3). This conclusion was based on a review of the available evidence
base for obesity prevention and the judgment that the research approaches being applied,
both for specific studies and for evidence synthesis, were framed too narrowly, were
inconsistent with respect to how obesity prevention was being conceptualized, and
were not focused on the types of intervention or policy questions relevant to obesity
prevention in a public health context.
Described by Kohatsu et al, EBPH is a process of integrating science-based interventions
with community preferences to improve the health of populations (4). As in evidence-based
medicine (EBM), the basic principles of scientific validity apply in EBPH. However,
in EBPH, approaches for achieving scientific validity and rigor are broadened to allow
for a more balanced consideration of both internal and external validity to assess
effectiveness (ie, are results shown as a result of implementing the program) and
relevance (ie, can findings be generalized to new settings and populations) in public
health contexts, which can be very different from the therapeutic settings addressed
in EBM. The potential distinctions can be highlighted by reference to common challenges
in evidence-based practice in public health, social work, medicine, nursing, and psychology,
as identified by Satterfield et al, related to 1) how evidence should be defined,
2) how and when population-level contextual factors should enter the decision-making
process; 3) the definition and role of the experts or key stakeholders, and 4) what
variables should be considered when selecting an evidence-based practice (eg, age,
social class) (5). The IOM study committee considered each of the challenges within
the specific context of obesity prevention, and the L.E.A.D. framework provides specific
guidance about how to address them.
To align with the core concepts of EBPH, approaches and tools should be geared to
the types of research and practice issues that arise in public health (6,7). For example,
in obesity prevention, much of the relevant evidence relates to environmental circumstances
and policies that influence the likelihood that people will achieve and maintain food
intake and physical activity patterns that prevent or limit excess weight gain. Preventive
strategies involving environmental and policy changes are designed to provide opportunities,
support, and cues to help people develop healthier behaviors and to make it easier
to practice these behaviors. Environmental and policy changes may complement individual-level
programs and can benefit all people exposed to the environment rather than focusing
on changing the behavior of one person at a time. Alterations in the policy environment
may affect behaviors directly (eg, raising the price of sugar-sweetened beverages
may decrease consumption) or by altering social norms (eg, worksite policies that
promote physical activity may increase physical activity by providing social support)
(8).
The L.E.A.D. Framework Elements: Locate Evidence, Evaluate It, Assemble It, and Inform
Decisions
Although to date few approaches to EBPH have been systems-based, evidence gathering
and use in the L.E.A.D. framework has a systems perspective (Figure 1). Precisely
because systems approaches may be daunting to researchers and practitioners who have
been acculturated to value simplicity and to focus on and isolate specific issues,
chapter 4 of the report is devoted to explaining the concepts of systems thinking
and how it has been and can be used to inform decisions about obesity prevention.
Key messages in that chapter emphasize the importance of addressing the multilevel
and dynamic complexity of real-world contexts, attempting to consider the whole picture
even when focusing on one aspect, and considering interactions among types and levels
of interventions. This perspective helps to anticipate a broader set of outcomes —
both positive and adverse — that may be associated with a policy or program and also
to see how a particular policy or program might be enhanced or inhibited by others
or by situational factors. This, in turn, helps to define what type of information
is relevant, whether the information gathered is sufficiently comprehensive, and what
its implications are. Also, the use of systems thinking or perspectives in the L.E.A.D.
framework does not require the use of mathematical modeling approaches, simulations,
or causal mapping techniques used in formal systems science; however, the potential
value of such approaches is recognized and encouraged when appropriate, complementary
to (not substitutes for) other types of evidence, and some examples are provided.
Figure 1
The IOM L.E.A.D. Framework to Inform Decision Making About Obesity Prevention. Adapted
from the Institute of Medicine (2).
Flow chart
The figure has a diamond-shaped outer frame. Two sides are labeled “Systems perspective”;
the other 2, “Opportunities to generate evidence.” Inside the diamond is a column
of boxes that describe each element in the L.E.A.D. process. At the top is a circle
that reads, “Specify questions.” The four boxes read as follows: “Locate Evidence:
Identify and gather the types of evidence that are potentially relevant to the questions;
Evaluate Evidence: Apply standards of quality as relevant to different types of evidence;
Assemble Evidence: Select and summarize evidence according to considerations for its
use; Inform Decisions: Use evidence in the decision-making process.”
Specifying Questions
The L.E.A.D. framework adapts an EBPH typology recommended by the International Obesity
Task Force (3,9) for specifying questions (Figure 2). The “why” questions help decision
makers frame reasons for considering or taking an action based on issues in their
specific locality, region, or situation, which may include posing questions to assess
baseline status or resources of the relevant population or setting. The “what” questions
focus on selection of specific programmatic or policy initiatives and may include
assessments of the potential effectiveness or value of approaches designed for specific
settings (eg, schools, worksites, faith organizations) or subpopulations (eg, children
of different ages, ethnic minority populations, low-income populations). “How” questions
prompt for information about implementation issues, including resources required,
how effects can be sustained over time, and factors that determine the generalizability
or transferability of an approach tested in one setting to another setting.
Figure 2
Questions that guide the gathering of evidence. Adapted from the Institute of Medicine
(2).
Flow chart
The figure depicts a circle containing 3 questions connected by arrows. The circle
is titled “Decisions.” The questions are “WHY should we do something about this problem
in our situation?”; WHAT specifically should we do about this problem?”; and “HOW
do we implement this information for our situation?”
Locating and Evaluating Evidence
The L.E.A.D. framework identifies several different types of evidence and study designs
that can be useful for informing decisions about obesity prevention and provides resources
and explanations in the report narrative and appendices. L.E.A.D. does not imply lowering
standards for the quality of evidence used in public health compared with medicine.
Rather, it introduces the concept that broader and different standards are needed
to account for the complexity and practicalities associated with issues that arise
in obesity prevention and other public health problems (eg, tobacco use, environmental
health issues). Evidence sources may be quantitative or qualitative or a combination
of both and may come from academic research, program evaluations, surveys, polls,
reports, or policy documents related to obesity or to other public health issues from
which parallels can be drawn. Specific study designs and methods identified in the
report include experiments and quasi-experiments, qualitative research, mixed methods,
evidence synthesis methods, parallel evidence, and expert knowledge. The point is
to be systematic but much more inclusive when determining what constitutes useful
evidence related to a particular question. Evidence quality is then to be evaluated
by standards appropriate to that type of evidence rather than by a single standard.
Examples of existing criteria for assessing quality of evidence from these different
methods are provided.
One way that EBPH differs from EBM is that it relies less on randomized controlled
trials and more on approaches that assess external validity. Study design cannot be
the sole criterion for whether evidence is useful. A randomized controlled trial is
the most rigorous design for hypothesis testing (10) but is not feasible for many
examples of obesity interventions because the evaluator cannot randomly assign exposure
(eg, a policy). Randomized designs also may provide incomplete information if the
experiments evaluate artificial scenarios that have limited or only partial relevance
to what happens in reality. Partial relevance might occur if the trial manipulates
only 1 or 2 of several variables that interact in a dynamic manner to affect an outcome.
In general, studies of obesity prevention have tended to overemphasize internal validity
(eg, well-controlled efficacy trials) while giving sparse attention to external validity
(eg, the translation of science to the various circumstances of practice) (11,12).
The work of Klesges et al shows that some contextual variables (eg, cost, program
sustainability) are missing entirely in the peer-reviewed literature on obesity prevention
(13). Conversely, rigorous evaluations of nonrandomized, “natural experiments” can
be informative for many obesity prevention questions. Natural experiments refer to
naturally occurring circumstances in which different populations are exposed or not
exposed to a potentially causal factor (eg, a stringent new school food policy) such
that the situation resembles a true experiment in which study participants are assigned
to exposed and unexposed groups (14). These types of studies often involve “messier”
study designs (ie, complex, multilevel, multisector interventions) and suggest the
need to take a broader perspective in identifying evidence and pay greater attention
to external validity and situational or population-specific variables. The real world
is actually “messy” or, more formally, complex. In a natural experiment, the strongest
design possible (internal validity) is essential, and elements of external validity
must be addressed. The L.E.A.D. framework guidance is designed to help incorporate
this complexity into evidence rather than controlling for it, which detracts from
and may completely remove contextual relevance.
Assembling Evidence and Informing Decisions
The ultimate goal of the L.E.A.D. framework process is to assemble evidence in a way
that is useful to decision makers. The framework recommends a standard template that
can be used to report results to decision makers, which prompts for 1) a statement
of the question, 2) a transparent description of the strategy used to locate the evidence,
3) a table reporting the evidence, and 4) a summary of the evidence organized as answers
to the EBPH-derived questions (Figure 2). Because policy questions often focus on
selecting the most feasible intervention, especially detailed guidance is provided
about how to interpret and assemble evidence related to “what” questions. This guidance
includes a discussion of how one might apply theory or program logic and a systems
lens in interpreting evidence, considerations for weighting different types of evidence,
and potential ways to blend information from disparate sources and to evaluate effects.
Potentially useful tools and frameworks for grading and assembling different types
of evidence are identified and include tools used in EBM: meta-analytic approaches
to determine intervention effect size and the GRADE (Grading of Recommendations Assessment,
Development, and Evaluation) system for evaluating factors affecting the strength
of recommendations. Other tools identified of particular relevance to public health
applications include realist reviews that use mixed methods to assess intervention
effectiveness, the systematic review approach of the Guide to Community Preventive
Services framework for translating evidence into recommendations, the RE-AIM framework
(Reach, Effectiveness, Adoption, Implementation, and Maintenance) for translating
research into practice, the Health Canada risk assessment and management framework,
the International Obesity Task Force obesity prevention portfolio approach for selecting
a set of interventions, and the Green and Kreuter framework for identifying program
components and interventions (“matching, mapping, pooling, and patching”) (9,15-19).
In addition to the systems perspective, recognizing opportunities to generate new
evidence is also recommended as a theme of the L.E.A.D. framework. Such opportunities
might arise at any stage of the process. Generation of new evidence is critical not
only because of the dearth of suitable evidence about obesity-relevant environmental
and policy changes but also to keep the evidence base current with the dynamics of
the obesity problem. The “why,” “what,” and “how” questions in Figure 2 should guide
the type of evidence generated. EBPH approaches to filling evidence gaps include program
evaluations and natural experiments. This is termed “practice-based evidence” and
may also include pre-evaluations or “evaluability assessments” of promising programs
and continuous quality improvement. The case study (Box) of data collection in support
of school-based physical activity interventions by evaluating programs in northern
California communities illustrates the L.E.A.D. concept of using practice settings
to increase the evidence base.
Box. L.E.A.D. Framework Case Study
Kaiser Permanente Healthy Eating Active Living Community Health Initiative (HEAL-CHI)
Background
Obesity is a major health problem among both adults and children in the United States
(20,21). In California, more than 60% of adults are obese or overweight (22). Being
either obese or overweight increases the risk for many chronic diseases (eg, heart
disease, type 2 diabetes, certain cancers, stroke) (23). The prevalence of obesity
is higher in ethnic minority populations compared with non-Hispanic whites. Moreover,
progress being made in curbing the epidemic may not reach all groups equally. The
prevalence of high body mass index in California children is declining in some groups
but remains high and is not declining among American Indians and African Americans
(24).
Context
Reversing the obesity epidemic requires a sustained effort at multiple levels, including
environmental and policy changes (25). Since children spend a large fraction of their
day at school, schools offer a promising environment for intervention. Recommended
school strategies include increasing healthier food choices, and increasing the amount
of time spent in physical education classes (25,26). Numerous communities in the Kaiser
Permanente (KP) Community Health Initiatives (27) have implemented school-based programs
targeting either food or physical activity behaviors. This case study focuses specifically
on attempts to increase physical activity through in-school or after-school physical
activity programs in the 3 communities in the KP Northern California HEAL-CHI initiative.
Evidence Base
School physical education programs are one of the few areas in environmental obesity
prevention where the Centers for Disease Control and Prevention (CDC) Guide to Community
Preventive Services has made a positive recommendation (28), on the basis of many
evidence-based programs, including the CATCH program (29) that has been widely disseminated.
CDC and the Institute of Medicine have also made recommendations that include extracurricular
(eg, after school) physical activity programs but the evidence for the effectiveness
of those programs is more limited.
As recommended in the L.E.A.D. framework, an approach to increasing the evidence base
is to evaluate community interventions that either attempt to implement existing programs
such as CATCH or create new programs developed by schools and communities themselves.
Although these evaluations do not use experimental designs, they follow the recommendations
in the LE.A.D. report that advocate for taking advantage of all opportunities to increasing
the evidence and exploring alternative, nonexperimental research designs.
Lessons and Future Directions
The HEAL-CHI evaluation used a logic model approach to assessing intervention impact
that combined estimates of the reach and strength of the interventions with population-level
measures of physical activity, nutrition, and overweight (eg, surveys of youth and
adults). In particular, we assessed whether there were significant positive population-level
changes where “high-dose” (ie, high reach and strength) interventions were implemented.
The information about reach and strength came from independent assessments of the
number of people exposed and the intensity of the interventions. For example, one
high-dose intervention was an after school physical activity program that one-quarter
of all children participated in that added 20 minutes per day of moderate to vigorous
physical activity. Results indicated that in almost half of the cases (4 of 9) where
high-dose interventions were implemented, significant positive changes favored the
intervention. For example, in the community implementing the after-school physical
activity program, the percentage of seventh graders doing vigorous physical activity
at least 20 minutes per day increased from 61% to 67%, while the percentage in comparison
communities declined from 56% to 51%.
Implications
The HEAL-CHI initiative used L.E.A.D. thinking at several points — both in applying
criteria for interventions and in evaluating the results. Our experience suggests
that L.E.A.D. may be a useful approach for incorporating evidence into community-based
obesity prevention initiatives. The L.E.A.D. framework encourages both taking a broader
view of the existing evidence and using an array of designs in doing evaluations that
add to the evidence base. If the L.E.A.D. framework is widely adopted, publishing
results such as those we found in the HEAL-CHI initiative in peer-reviewed publications
will be easier.
Implications and Future Directions
The Bridging the Evidence Gap report directs recommendations to decision makers in
the policy and programmatic arenas as well as to those who fund, generate, and publish
evidence about obesity prevention and other complex public health challenges. Central
themes are to apply the L.E.A.D. framework as a guide in the use and generation of
evidence and to incorporate systems-thinking into research activities. The report
also recommends the development of resources to support evidence-based public policy
decision making and research, including researcher training, compendiums of knowledge,
registries of implementation experience, and guidance on standards for evidence evaluation
where they are lacking. The need for a public-private consortium to take up dissemination,
support for, and further development of the L.E.A.D. framework is emphasized.
In the approximately 2 years since the Bridging the Evidence Gap report was released,
it has gained visibility among potential users. The report page on the IOM website
has generated more than 17,000 page views. The L.E.A.D. framework has been presented
at national and international meetings and cited in journal articles and policy documents.
Scanning approximately 40 identified citations indicates that most have involved referencing
the report in support of the importance of developing comprehensive multistakeholder
and multisectoral strategies, taking a systems perspective, or using expanded approaches
to evidence-gathering or choice of study designs. Applications of the framework reflected
in published documents include a CDC Division of Nutrition, Physical Activity, and
Obesity fact sheet that explains how the framework relates to potential uses of their
research and practice-based initiatives, evidence sources, and guidance documents
(30); adaptation of L.E.A.D. concepts to describe implications of a systems approach
for policy and actions to address the global obesity epidemic (31); use of L.E.A.D.
concepts to justify and propose a design for a large-scale demonstration and evaluation
of a comprehensive community-based obesity prevention strategy beginning in early
life (32); use of L.E.A.D. elements as the primary method for a review of progress
made by the food industry, governments, and schools in implementing recommendations
of 2 earlier IOM reports on childhood obesity (33,34); and extensive use of L.E.A.D.
framework perspectives and evidence review guidance in the IOM report that recommends
a set of systems-oriented and interrelated strategies to accelerate progress in obesity
prevention (1).
What does this mean for obesity prevention and for advancing appreciation for the
science and practice of EBPH? The answer depends on further use of frameworks such
as L.E.A.D. In an ideal sense, L.E.A.D. could become a transformative and integrative
EBPH paradigm and tool, as intended by the IOM study committee that developed it.
The transformational aspect is the positioning of evidence needs in a public health
context and demonstrating that rigor and relevance can be achieved using EBPH concepts
and tools. Advances in obesity prevention will depend in part on articulating the
value of multiple and varied types of information for answering policy and practice
questions. If widely adopted and used, L.E.A.D. could become a critical component
of identifying and using evidence-informed strategies for achieving national health
objectives (35). Such use is likely to better link the practice of public health with
the science of public health.