Article

Converging on Bladder Health through Design

Thinking: From an Ecology of Influence to a Focused
Set of Research Questions
Jessica B. Lewis 1,*, Sonya S. Brady 2, Siobhan Sutcliffe 3, Ariana L. Smith 4,
Elizabeth R. Mueller 5, Kyle Rudser 6, Alayne D. Markland 7, Ann Stapleton 8, Sheila Gahagan 9,
Shayna D. Cunningham 10 and
Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium 11
1 Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, CT 06520, USA
2 Division of Epidemiology and Community Health, University of Minnesota School of Public Health,
Minneapolis, MN 55454, USA; [email protected]
3 Department of Surgery, Division of Public Health Sciences, Washington University School of Medicine,

St. Louis, MO 63110, USA; [email protected]

4 Department of Surgery, Division of Urology, Perelman School of Medicine, University of Pennsylvania,

Philadelphia, PA 19104, USA; [email protected]

5 Division of Female Pelvic Medicine and Reconstructive Surgery, Stritch School of Medicine, Loyola

University Chicago, Loyola University Medical Center, Maywood, IL 60153, USA; [email protected]
6 Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis,

MN 55455, USA; [email protected]

7 Department of Medicine, Division of Gerontology, Geriatrics, and Palliative Care, School of Medicine,

University of Alabama and the Geriatric Research, Education, and Clinical CenterBirmingham,
AL 35233, USA; [email protected]
8 Department of Medicine, Division of Allergy and Infectious Disease, University of Washington,

Seattle, WA 98195, USA; [email protected]

9 Department of Pediatrics, University of California, San Diego, CA 92161, USA;

[email protected]
10 Department of Social and Behavioral Sciences, Yale School of Public Health, New Haven, CT 06520, USA;

[email protected]
11 Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN 55455, USA;

[email protected]
* Correspondence: [email protected]

Received: 23 May 2020; Accepted: 16 June 2020; Published: 17 June 2020

Abstract: Lower urinary tract symptoms affect a substantial number of women in the United States
(U.S.) and globally. In 2015, the Prevention of Lower Urinary tract Symptoms in women (PLUS)
Research Consortium was funded to establish the scientific basis for prevention efforts by (1)
understanding healthy bladder function and (2) identifying risk and protective factors for bladder
health in women across the lifecourse. This transdisciplinary consortium generated a list of over 600
candidate risk and protective factors for bladder health in women and girls and refined and
prioritized these into 29 focused research questions to inform a national longitudinal observational
study in the U.S. This paper describes that process using design thinking, a human-centered set of
principles and strategies by which innovations are developed, as a framework. Design thinking is
an iterative process consisting of five stages: Empathizing with end-users of innovations, Defining
core principles girding the work, Ideation of all possible solutions, and rapid-cycle Prototyping and
Testing of solutions. Lessons learned are offered to inform future prevention science research
endeavors that might benefit from such an approach.

Keywords: lower urinary tract symptom; design thinking; prevention; bladder health;
transdisciplinary; public health; women; research question development

Int. J. Environ. Res. Public Health 2020, 17, 4340; doi:10.3390/ijerph17124340 www.mdpi.com/journal/ijerph
Int. J. Environ. Res. Public Health 2020, 17, 4340 2 of 17

1. Introduction
Lower urinary tract symptoms (LUTS) affect a substantial number of women and girls in the
United States (U.S.) and across the globe [1–8]. Nearly one in four women over the age of 30 in the
U.S. experience poor bladder health, based on the frequency and impact of LUTS, with increasing
prevalence over the lifecourse [6]. Much research on LUTS in women and girls has focused on
identifying and treating those who are already suffering from symptoms. In 2015, the U.S. National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) funded a transdisciplinary
scientific initiative to create a prevention research agenda for LUTS in women and girls [9]. The
Prevention of Lower Urinary tract Symptoms (PLUS) Research Consortium brings together
investigators from seven universities and a scientific and data coordinating center (SDCC) with
expertise in over 60 disciplinary areas, including medicine, nursing, public health, psychology,
sociology, epidemiology, social welfare, anthropology, biostatistics, community engagement, and
prevention science [10]. The charge of the PLUS Consortium was to establish the scientific basis for
future prevention intervention studies by (1) developing a better understanding of healthy bladder
function and (2) identifying risk and protective factors for bladder health in U.S. women across the
lifecourse [9].
The PLUS Consortium began its work by developing a research definition that would allow for
the description of the current state of bladder health in U.S. adolescent and adult women across the
lifecourse [11]. The consortium then developed a conceptual framework, which defined the broad
levels of ecology that it would consider as spheres of influences on bladder health across the
lifecourse. Levels of ecology included individual biology (e.g., bladder microbiome) and individual
cognitive and behavioral factors (e.g., depression, fluid intake habits), interpersonal factors (e.g., peer
norms), institutional factors (e.g., workplace and school policies regarding toilet access), and societal
factors (e.g., laws governing access to healthcare; Figure 1) [12]. With this conceptual framework in
place, the consortium began a process of identifying the most promising candidate risk and protective
factors for bladder health in women. This process sought first to define the universe of risk and
protective factors that one could investigate in the broadest possible sense and then to hone that
macrocosm into specific research questions that the consortium would ultimately investigate.
In this manuscript, we describe the processes used to generate, iterate upon, test, and finally
select factors for investigation, using the principles of design thinking as a framework to elucidate
this process. Although the PLUS Consortium did not prospectively adopt design thinking as the
organizing principle for this effort, this framework is well aligned with the process in which the PLUS
Consortium engaged. We describe the lessons learned and how the consortium may have been
further served by aligning more closely with design thinking principles, a priori. This case study may
inform future prevention science research, particularly when a complex array of interrelated factors
may contribute to health outcomes.
Int. J. Environ. Res. Public Health 2020, 17, 4340 3 of 17

Figure 1. Prevention of Lower Urinary tract Symptoms (PLUS) Conceptual Framework adapted from Glass and McAtee (2006); published in Brady et al. (2018).
Int. J. Environ. Res. Public Health 2020, 17, 4340 4 of 17

2. Methods

2.1. Overview of Design Thinking

The field of design began with the conceptualization and creation of material objects (e.g.,
appliances) and evolved to include the notion of constructing experiences (e.g., software user
interface) [13]. Design thinking describes a set of principles and strategies by which innovations—
broadly defined—are developed. The core tenets of design thinking include understanding end
users’ desires, creating models to examine complex problems, developing prototypes to explore
solutions, and tolerating failure as teams iterate on prototypes toward an optimal solution [14,15].
This approach has been used by corporate strategy teams, government services, and social change
campaigns—and increasingly by health professionals—to solve complex problems [16–19]. Applying
principles of design thinking to the development of research questions may likewise foster more
comprehensive and innovative studies to inform prevention science and health promotion activities
[13,14].
Design thinking is human-centered. It prioritizes building an understanding of the “end users”
of the solution—i.e., the people for whom the solution is being created. When applied to the
development of research questions, design thinking is aligned with strategies that engage different
stakeholders, including scientific and lay communities [20,21]. Design thinking is also a creative
process. Rather than being constrained by current practice and familiarity biases, design thinking
asks innovators to visualize a world without accustomed limits to imagine entirely new solutions.
Design thinking is aligned with the tenets of transdisciplinary science. It values working in
multidisciplinary collaborative teams and gathering a wide range of perspectives. It iterates upon a
comprehensive set of ideas to solve complex problems, using action-oriented rapid cycle prototyping
of solutions (Figure 2) [13,14].

Figure 2. Stages of the design thinking process.

Design thinking is an iterative process consisting of five stages: (1) Empathize, (2) Define, (3)
Ideate, (4) Prototype, and (5) Test [22]. The last two steps may be repeated many times until the
optimal design has been achieved. During the Empathize stage, teams consider who the end user of
the solution will be and what their core values and perspectives are to ensure the solution will be
appropriate to their requirements. During the Define stage, teams consider the goals, skills available,
and core principles that frame the work ahead. During the Ideate stage, teams value creative thinking
and brainstorming as they generate the widest variety of possible solutions. With this foundational
work accomplished, the Prototype and Test cycle begins, as teams undertake a process of creating
possible solutions and then eliciting feedback on these potential solutions to shape and re-shape them
until an optimal conclusion has been achieved [22].
The PLUS Consortium engaged in a thoughtful and iterative process to identify the risk and
protective factors it would investigate as potential influences on bladder health for girls and women
Int. J. Environ. Res. Public Health 2020, 17, 4340 5 of 17

across the lifecourse. Below, we describe the development of the PLUS prevention research agenda
within the framework of design thinking.

2.2. Empathize
In design thinking, the first stage of solving a problem is to empathize with the end-user of the
solution. In our case, the immediate end-user of the solution (i.e., the research questions generated
by this process) is the PLUS Consortium itself—and the ultimate end-users are the scientific and lay
communities who are interested in, or affected by, the answers to the research questions generated.
Thus, the NIDDK defined the immediate end users of these research questions when they chose
investigator teams for the PLUS Consortium. Experienced investigators represented the interests of
not only their disciplines, but also the many constituencies of patients and community members with
whom they have worked and whose bladder health they have sought to understand and improve.
Investigators had expertise across the lifecourse (e.g., adolescents, older adults), levels of ecology
(e.g., interpersonal relationships, institutional structures), patient and community demographics
(e.g., rural/urban regions, racial/ethnic groups, sexual/gender minorities), and risk and protective
factors within different levels of ecology (e.g., microbiome, health behaviors, adverse childhood
experiences, community characteristics, healthcare access).
Through weekly calls and quarterly in-person meetings, the consortium dedicated significant
time to developing a common understanding of members’ core values and standpoints. Strategies to
develop a common understanding included transdisciplinary engagement, educating membership
about different research perspectives and content areas, and engaging in focused discussion that
surfaced assumptions and viewpoints [10]. Members engaged in Myers–Briggs personality typing
and facilitated sharing of types to enhance communication and empathy with respect to different
work styles.
Further, the consortium dedicated time to understanding the broader community of adolescent
and adult women’s core values and perspectives through community engagement activities and a
large qualitative study (i.e., SHARE: Study of Habits, Attitudes, Realities, and Experiences of bladder
health) [23]. Through this immersive process to empathize with the end-users of research questions,
the consortium identified known and unknown needs and brought new insights to the work ahead
[24]. This was essential to ensure the research questions developed would be appropriate to end
users.

2.3. Define
The second stage of innovation in design thinking is to define the core principles that frame the
work, synthesizing and incorporating what was learned in the Empathize stage. During the first year
of its work together, consortium members developed a shared understanding of the principles of
prevention science. Prevention science is based on the premise that effective health promotion
necessitates an understanding of what leads to disease and how best to avoid precursors and
exposures. To identify potential antecedents to human dysfunction and health (i.e., risk and
protective factors), prevention scientists conduct etiologic studies that examine risk and protective
factors within individuals (e.g., genes, cells, tissues, organs, multi-organ systems) and across the
levels of social ecology surrounding individuals (e.g., family, peer group, school or workplace,
healthcare system, neighborhood, community, society) [25–28]. Prevention scientists apply a life
course developmental perspective to investigate how accumulated risk and protection lead to
trajectories of health or disease [29–32]. Risk and protective factors identified through etiologic
research become candidates for prevention efforts, which may include health promotion programs
and changes to practices and policies within institutions and governments [33,34].
Candidate risk and protective factors considered by a research team are often constrained by the
theories and practices that serve as resources for idea generation within disciplines represented on
the team [35]. To further our goal of conducting transdisciplinary research, PLUS Consortium
members developed a conceptual framework to organize potential risk and protective factors into
areas of study that would facilitate the development of new, innovative research questions at
Int. J. Environ. Res. Public Health 2020, 17, 4340 6 of 17

multiple levels of biology and social ecology [12]. The PLUS Consortium conceptual framework was
intentionally comprehensive, as it represented the entire ecology from which we could consider
possible influences on women’s bladder health [12]. The consortium drew from separate, but
complementary theoretical traditions and contemporary writings, including social ecological models,
biopsychosocial models of health, Glass and McAtee’s Society–Behavior–Biology Nexus, and the
World Health Organization’s conceptual framework for action on the social determinants of health
(Figure 1) [27,28,34,36–38]. The consortium’s efforts toward defining the core principles of its work
established the essential elements that would scaffold the solutions generated (i.e., the research
questions).

2.4. Ideate
The third stage of the design thinking process is idea generation. During this stage, team
members are encouraged to think broadly and move beyond the obvious to increase innovation. This
is a time to challenge assumptions, provoke new ideas, and tolerate the unknown. During this stage,
there is no attempt to evaluate ideas raised, establishing a safe space for creativity. The concepts
generated through the ideation process both fuel the discovery process and provide the starting point
for the generation of prototype solutions [22,39].
Once the PLUS Consortium had established a conceptual framework to bound its work, it
engaged in a series of activities towards the generation and prioritization of research questions. The
consortium convened in multiple rounds of subgroup configurations with defined conceptual tasks.
The PLUS Terminology, Conceptual Frameworks and Models (TCFM) sub-committee—comprised
of members representing each research center and the SDCC, as well as a diverse array of
disciplines—began this ideation process. TCFM developed an initial list of risk and protective factors
that could be studied within each of the following domains represented in the conceptual framework:
(1) biology/body, (2) mind/behavior, (3) interpersonal relationships, (4) institutions, and (5)
community and society [12].
To generate an even broader list of risk and protective factors of interest, the consortium
implemented an ideation exercise with the entire consortium membership at an in-person meeting.
Large sheets of paper were attached to the walls of the meeting space to represent five domains (i.e.,
levels of ecology). Consortium members were given colorful sticky notes and asked to think of as
many candidate risk and protective factors for bladder health as they could. Consortium members
circulated through the meeting space, discussed their factors with others, and affixed their sticky
notes to the domain that best represented the factor, with some factors crossing domains. After this
opportunity for the entire membership to contribute ideas, subcommittee members further
developed the list to ensure that all risk and protective factors discussed had been captured. The
TCFM subcommittee spent an additional month generating and collecting additional risk and
protective factors of potential interest from consortium members, expanding the universe of potential
factors under consideration for study.
By design, the interests of individual research members and research centers within the PLUS
Consortium are broad. It is thus not surprising that the consortium generated over 600 potential risk
and protective factors for potential study in this manner. While such an exercise and resulting
product appeared overwhelming, this activity ensured that consortium members had considered all
that was possible to study, including factors that may not have been considered within any single
disciplinary group.
The Ideate stage of design thinking includes a space for both divergent (i.e., associative, creative)
and convergent (i.e., focused, analytic) thinking [40]. Once a universe of ideas has been defined, these
ideas must be filtered, narrowed, and synthesized into something that can be prototyped and tested.
PLUS Consortium members next engaged in a convergent thinking activity to prioritize the potential
600+ risk and protective factors for study. This activity grouped consortium members by their
research center and the SDCC (i.e., each funded site). Each site was asked to prioritize and rank order
their “top 20” risk and protective factors for study. The criteria guiding this prioritization included
(1) innovation/novelty, (2) potential for intervention/modifiability, (3) potential impact on public
Int. J. Environ. Res. Public Health 2020, 17, 4340 7 of 17

health, (4) contribution to health equity, (5) importance to stakeholders/at-risk populations, (6)
feasibility for study, (7) ease of measurement, and (8) prevalence. This exercise was challenging and
offered opportunities for sites to identify constellations of risk and protective factors of interest that
could be grouped. For example, “toileting environment” encompassed a variety of specific factors of
interest, including privacy, cleanliness, and safety. Similarly, “mental health” encompassed a variety
of specific factors, including symptoms of attention deficit hyperactivity disorder, depression, and
posttraumatic stress.
Across the 7 research centers and SDCC, “top 20” lists were integrated to identify 44 unique
constellations of over 400 factors ranked most important across the consortium (see Brady et al., 2018,
Supplemental Appendix, for a complete list of prioritized factors). Prioritized risk and protective
factors were classed further by the SDCC into 8 research themes: (1) biopsychosocial ecology of stress
and brain health; (2) toileting environment, access, habits, and techniques; (3) pregnancy and
childbirth; (4) physical health and medical conditions; (5) musculoskeletal health; (6) lifestyle
behaviors; (7) infections and microbiome; and (8) hormonal status across the lifespan. A figure was
created to depict themes as the spokes of a wheel, conveying that all themes were important to study
(Figure 3). Within a research theme, risk and protective factors could be examined across all levels of
biology and social ecology defined within the PLUS Consortium conceptual framework. Further,
themes were considered across life stages to encourage the development of research questions
incorporating a lifecourse perspective [29].

Figure 3. PLUS Consortium research themes.

2.5. Prototype and Test

During the Prototype and Test stages, iterations of a solution are generated and tested quickly
with a high tolerance for failure, prioritizing action and forward momentum [39]. The prototyping
Int. J. Environ. Res. Public Health 2020, 17, 4340 8 of 17

process surfaces problems and next solutions. It develops an end-product through risk-taking,
failure, and pivoting until the desired result is achieved [13].
The consortium began prototyping its solution (i.e., a focused set of research questions) by
dividing into two broad work groups to define how it would measure the 44 constellations of
prioritized risk and protective factors in a national longitudinal observational study. The Individual
Risk and Protective Factors work group focused on factors involving biology, the body, mind, and
behavior, while the Environmental Risk and Protective Factors work group focused on factors
involving interpersonal relationships, institutions, community, and society. These work groups were
also divided methodologically, with the Individual Risk and Protective Factors work group focusing
on measurement at the individual level (e.g., surveys, specimen collection, physical exams) and the
Environmental Risk and Protective Factors work group focusing on direct measurement of the
environment (e.g., review of employer toileting policies, observation of wait times or cleanliness of
facilities, environmental scan of public restroom availability). During that time, consortium members
divided the 44 constellations of prioritized risk and protective factors among small teams of
investigators with relevant content expertise who worked to identify potential measures for each
factor.
For a number of reasons, the consortium decided to pivot in a new direction seven months into
this process. The consortium opted to restructure this work to examine risk and protective factors
across all levels of ecology, rather than dividing between individual and environmental levels of
ecology. Originally, the Environmental Risk and Protective Factors work group had been tasked with
considering influences at the interpersonal, institutional, community, and societal levels. However,
this became overwhelming as it was difficult for members of this group to remain focused on
environmental-level measurement (e.g., direct observation), rather than individual-level
measurement of environmental factors (e.g., perceived peer norms rather than actual norms,
perceived control rather than actual environmental facilitators and constraints for toileting
behaviors). Content expertise was divided across the two work groups for a given research theme
(Figure 3), diluting effectiveness. Further, groups were considered too large to be nimble. Lastly, the
consortium decided it was premature to consider measurement of risk and protective factors without
having developed specific research questions that reflected these factors first, as the most appropriate
measure for each factor might vary depending on the specific research question. For example, to
examine the impact of physical activity on bladder health and LUTS, one could measure participation
in high impact sports among adolescent women; prenatal and postpartum walking, running, and
other forms of exercise among women across lifetime births; or a myriad of other forms of physical
activity that are relevant during specific life stages and in specific contexts. Therefore, the consortium
disbanded the Individual Risk and Protective Factors and Environmental Risk and Protective Factors
work groups.
To develop and refine a more specific set of research questions, the consortium decided to
assemble members into Theme Teams corresponding to the 8 research themes defined (Figure 3).
Theme Teams were charged with developing specific research questions within their theme,
considering all levels of ecology. To aid in the development of research questions, Theme Teams were
encouraged, but not required, to develop conceptual models to depict the proposed mechanisms by
which risk and protective factors could be associated with bladder health (e.g., mediation pathways)
and the conditions under which such associations may occur (e.g., potential effect modification) [35].
It proved important to place risk and protective factors into the context of specific research questions
to (1) ensure the biological or theoretical plausibility of proposed effects, (2) identify potential
mechanisms or mediation pathways that could be explored in the national longitudinal observational
study, and (3) identify overlapping mechanisms across research themes and questions to prioritize
data collection. Having a better understanding of proposed mechanisms also aided in the selection
of appropriate measures (e.g., type, duration, and timing of physical activity within a given life stage
and context).
Theme Team activities resulted in the generation of 28 “working” research questions (i.e.,
prototypes) covering a broad range of candidate risk and protective factors for bladder health.
Int. J. Environ. Res. Public Health 2020, 17, 4340 9 of 17

Research question champions within Theme Teams presented their questions for the full
consortium’s consideration (i.e., tested their prototypes) on two occasions. On the first occasion, they
presented prototypes on a bi-weekly all-consortium call to allow members of other Theme Teams to
weigh in on their developing research questions and to identify possible areas of synergy. On the
second occasion, Theme Teams presented refined questions at an in-person meeting of the entire
consortium.
To help the consortium evaluate the prototype questions, Theme Teams were given criteria for
presentations. Theme Teams were to (1) identify the candidate risk and protective factors (i.e.,
independent variables) and outcomes of interest (i.e., dependent variable) within questions, (2) justify
the importance of the question from the scientific literature, (3) assess feasibility for study in a
longitudinal observational study of adolescent and adult women from the general population (i.e.,
prevalence of risk/protective factors, ability to assess by recall, requirement of any specific sample
characteristics), and (4) determine whether their question required the development or validation of
new measures or in-person measures (e.g., exam, biospecimen collection).
During the next in-person meeting of the entire consortium, Theme Teams presented refined
questions. Theme Teams were asked to rank-order their presentation of questions by priority. The
consortium’s Study Design and Methodology Group developed a list of possible scientific and
practical considerations to assist Theme Team and consortium members in further prioritizing
research questions (i.e., testing prototypes). Prioritization criteria facilitate impartial (as opposed to
impassioned) and objective evaluation of questions and promote a transparent prioritization process
guided by a common language and vision (e.g., considerations of greatest importance to the
consortium). The list of considerations was refined by surveying consortium members about which
considerations they considered to be of greatest importance for prioritizing research questions and
by soliciting community input. Scientific and practical considerations clustered into 5 main themes:
(1) significance (i.e., ultimate impact on bladder health), (2) proxy power (i.e., relatedness to other
research questions), (3) feasibility of measurement, (4) public health relevance (i.e., possible impact
beyond bladder health), and (5) uniqueness to PLUS (i.e., how well positioned the consortium versus
other research groups would be to answer the question). In total, there were 23 considerations for
each individual research question: 16 scientific (e.g., “If the research question relates to a modifiable
factor, would the associated intervention be easy to implement/well-accepted? Low cost?”) and 7
logistic (e.g., “What is the length of time/number of items needed to address each construct?”), along
with 2 additional considerations regarding the overall set of research questions (i.e., “Do our
questions address all levels of our conceptual framework?” and “Do our questions address the full
lifecourse?”). These considerations were presented to the full consortium at this meeting (Table 1).

Table 1. Prioritization considerations for research questions.

1. Does the research question involve a modifiable factor (i.e., does it inform prevention)?
a. Primordial: Does it involve a risk/protective factor that can be prevented/promoted in
unexposed individuals?
Scientific Considerations

b. Primary: Does it involve a risk/protective factor that can be modified to

reduce/enhance its influence in exposed individuals?
c. Secondary: Does it involve a risk/protective factor that can be used for screening
women with early LUTS?
2. If the research question relates to a modifiable factor, would the associated intervention be easy
to implement/well-accepted? Low cost?
3. Does the research question inform groups more or less susceptible to the influence of a
particular risk or protective factor (i.e., effect modification)?
4. Does the research question involve a risk or protective factor with a high prevalence
(i.e., potential for high population attributable risk/impact)?
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5. Does the research question have the potential for policy level impact?
6. Is the research question timely?
7. Does the research question relate to a risk/protective factor specific to bladder health
(not general health)?
8. Does the research question help us understand women’s health, health behaviors, and health
decision-making more broadly (i.e., does it have implications beyond bladder health?)?
9. Is the research question supported by a plausible mechanism (e.g., biological, psychological,
etc.)?
10. Does the research question address a novel risk/protective factor?
11. Does the research question provide confirmatory data for a less well-established factor?
12. Does the research question provide confirmatory data for a more well-established factor?
13. Is the research question important enough that any result (positive, inverse, null) will move the
field forward?
14. Could the research question push the field into new directions of inquiry or novel areas of
research?
15. Is the research question well-positioned for the uniqueness of the consortium, or is it better
suited to an individual research group or to existing data/ongoing studies?
16. Does the research exemplify transdisciplinary science?
17. Can the research question be addressed in a sample of the general population or does it require
recruitment of a specific population?
Practical Considerations

18. How many constructs are needed to answer the research question?
19. What is the degree of invasiveness of assessment of each construct (e.g., self-report, physical
examination, recall/real-time assessment)?
20. What is the length of time/number of items needed to address each construct?
21. Do any of the necessary constructs contribute to answering more than one research question?
22. Does the research question overlap with multiple themes?
23. Will the research question provide preliminary data for additional grants/pilot projects?
Regarding the overall pool of research questions:
a. Do the questions address all levels of our conceptual framework?
b. Do the questions address the full lifecourse?

Ahead of the next in-person meeting, the consortium conducted a consortium-wide survey
asking investigators to assign each research question to 1 of 4 prioritization categories for a national
longitudinal observational study, on the basis of scientific and practical considerations (Table 1).
Categories included: (1) high priority to measure at baseline; (2) high priority, but not necessary at
baseline; (3) low priority for the observational study; and (4) low priority for PLUS Consortium. At
the in-person meeting, the results of the survey were presented and discussed. Most research
questions garnered strong support by consortium members and were primarily distributed to
categories 1 and 2. However, there was substantial variability; only 2 questions did not have anyone
classify them as low priority. The consortium considered each refined research question (new
prototypes) and whether corresponding measures should be included in the national longitudinal
observational study, first through small group discussions and then in a consortium-wide discussion
moderated by a trained professional moderator. Through this prototype testing process, the
consortium selected research questions as relevant to the its future work and only one question was
Int. J. Environ. Res. Public Health 2020, 17, 4340 11 of 17

eliminated from consideration due to low support (i.e., “Do periodontal behaviors/status affect
bladder health?”), leaving 27 prioritized research questions.
As the work of the consortium progressed and the design of the national longitudinal
observational study began to take form, additional research questions began to be informally
proposed (new prototypes), motivating the consortium to perform a final check to ensure that all
important research questions had been identified. A survey was distributed to consortium members
to request review of the 27 research questions and proposal of any additional, potentially important
questions (testing). A total of 13 additional research questions were generated and prioritized in a
similar manner as the original 27 questions. Two of these new questions were primarily distributed
to categories 1 and 2, bringing our final tally of prioritized research questions to 29 (next prototype;
Table 2). Although this step delayed progress to a small degree on the development of the
observational study, it also provided consortium members with time to reflect on the full scope of
their work and to identify important areas of investigation that had been omitted in the initial
generation and narrowing of research questions.
The 29 research questions developed through this process were then taken up by the Study
Design and Methodology Group for the planned national longitudinal observational study,
ATTRIBUTES: Assessments Taken over Time: Relationships Influencing Bladder and Urinary Tract
Experiences Study. The work of the Study Design and Methodology Group to continue refinement
of questions and plan the national longitudinal observational study that will utilize these questions
in some form is beyond the scope of this paper.

3. Discussion

3.1. Lessons Learned

We have described the process the PLUS Consortium used to identify the risk and protective
factors it will investigate as potential influences on bladder health for women across the lifecourse.
We mapped this process onto a design-thinking framework, which closely aligns with the strategies
we employed. Although, we did not enter this process with an a priori intention to use a design
thinking framework, we learned several lessons through this endeavor that may be instructive for
other research groups aiming to identify a comprehensive and novel set of prevention science
research questions in a new or neglected area of science.
Beginning with the intention of utilizing a design thinking process may have helped us to engage
in this work more efficiently in several ways. While design thinking processes are iterative by nature,
had we begun with this orientation, we would have re-ordered certain activities for better efficiency
(Table 2). For example, it would have been ideal for the consortium to have engaged community
stakeholders earlier in the process (at the Empathy stage) to inform the Ideation, Prototype, and Test
stages of research question development. Although some consortium members were experienced in
community engagement work, other members were less familiar with this field and reluctant to
engage the community “too early” (i.e., before we had a clear path forward). Had we decided to use
a design thinking perspective a priori, Empathy stage requirements would have forced the
consortium to move more quickly to gather community perspectives and understandings in this
earliest stage of design thinking. Our qualitative focus group study (i.e., SHARE) did not begin until
July of 2017. Results required the consortium to revisit measure development work to ensure that
community perspectives, language, and understanding of bladder health were incorporated
appropriately. The consortium convened Rapid Assessment Partners (i.e., RAPs) of community
members to gain feedback on particular issues. However, a broader, more systematic community
engagement effort at the start of PLUS could have replaced some of these later efforts and better
informed the Empathy stage.
Int. J. Environ. Res. Public Health 2020, 17, 4340 12 of 17

Table 2. Lessons learned: Sequence of activities and proposed revisions for future research.

Dates PLUS Consortium Activities Proposed Revisions to Sequence or

Timing
7/15- PLUS investigators bring diverse
clinical/community experience
7/15- Remote calls and in-person
meetings with transdisciplinary
investigators
9/15- Webinars share transdisciplinary
Empathize

knowledge and perspectives

9/15 Myers–Briggs type sharing
7/17– SHARE Qualitative Study This activity would have been more
4/18 helpful to begin earlier. It began during
Prototyping and Testing, requiring
revisiting of measures. A broad
community engagement process early in
this phase would have been preferable.
7/15 U.S. National Institute of Diabetes
and Digestive and Kidney Diseases
defines inclusion in PLUS
Define

9/15– PLUS develops research definition

7/17 of bladder health
7/15– PLUS establishes conceptual
9/15 framework
9/16– Terminology, Conceptual
10/16 Frameworks and Models (TCFM)
sub-committee generates list of
candidate risk and protective
factors
11/15 Consortium participates in sticky This could have preceded the TCFM
Ideate

notes ideation exercise: 600 factors generation of factors.

identified
11/15– TCFM refines list of factors
12/15
1/16– Members rank top 20 determinants;
2/16 44 prioritized factors across 8
themes
1/17– Individual and Environmental Consensus on a process to formulate
Prototype and Test

7/17 Work Groups develop measures research questions and measure of risk
for risk/protective factors and protective factors at the Define stage
would have prevented shifting directions.
8/17– Theme Teams develop research Consensus on a plan to determine key
6/18 questions covariates would have prevented
Int. J. Environ. Res. Public Health 2020, 17, 4340 13 of 17

investigators from trying to incorporate

key covariates into questions to ensure
their inclusion, leading to more novel
questions.
10/17 Theme Teams present research
and questions to entire consortium for
11/17 comment
11/17 Study Design and Methodology It would have been helpful at the Define
Group (1) defines criteria to stage for the PLUS Consortium to have
prioritize research questions and determined the scientific and practical
(2) gathers consortium feedback considerations of greatest importance to
about which scientific and practical the consortium. These criteria could have
considerations are most important been used to prioritize and select risk and
for prioritization protective factors and research questions
of highest importance efficiently through a
transparent and objective process.
4/18– PLUS reviews 27 questions and
2/19 generates and prioritizes missing
questions in a similar manner
2/19 PLUS adopts 29 research questions
for refinement and use in a national
longitudinal observational study

We also discovered that it would have been helpful at the Define stage to have agreed upon a
process for narrowing, selecting, and refining the risk and protective factors we would study.
Without an agreed upon strategy, we cycled through several rounds and methods of narrowing
down factors to converge on a focused set of research questions. We employed (1) individual
consortium member ranking; (2) site level ranking; (3) group discussions, debates, and moderated
deliberations; and (4) assessments of proposed questions using various criteria. These were useful
exercises; however, had PLUS defined the considerations of greatest importance for the consortium
in selecting risk and protective factors and formulating research questions, such criteria could have
been used to promote a transparent and systematic prioritization process guided by a common
language and vision. Without defined criteria in place to weigh the importance of different risk and
protective factors and assess our prototype questions, we struggled to come to consensus.
Establishing a consensus was important because proposed research questions could not all be
answered in a single data collection timepoint.
Additionally, some members of the consortium believed that it was better to begin with the
identification of variables and measurement strategies and proceed to developing research questions
(i.e., inductive reasoning), while other members believed that research questions should be
developed first and variables and measurement strategies should follow, on the basis of these
questions (i.e., deductive reasoning). This reflected an epistemic divide. Those investigators who
favored inductive reasoning were mainly concerned about incomplete operationalization (i.e., failing
to measure potentially relevant variables). Those investigators who favored deductive reasoning
believed that theoretical frameworks and other conceptual tools would aid the consortium in
identifying the most important risk and protective factors to measure. Because the process for
narrowing the universe of risk and protective factors was not pre-defined, the consortium ended up
beginning in one direction (i.e., inductive reasoning within the Individual and Environmental Risk
and Protective Factors work groups) and then changing approaches seven months later (i.e.,
Int. J. Environ. Res. Public Health 2020, 17, 4340 14 of 17

deductive reasoning within Theme Teams). It would have been advantageous to clarify the process
that would be used to generate and test prototypes earlier, during the Define stage. For example, one
approach would have been for Theme Teams to work on the development of research questions and
corresponding conceptual models using deductive reasoning, while another work group could
identify covariates and other “core” measures using inductive reasoning.
Similarly, while we had a process for surfacing risk and protective factors, we did not define a
plan at the start for how key covariates would be identified and incorporated. In an effort to ensure
that certain covariates would be incorporated, Theme Teams began to form less novel research
questions that centered around covariates to ensure their inclusion in data collection. Had a process
for identifying key covariates been defined earlier, Theme Teams would not have been constrained
by concerns that they needed to incorporate key covariates into research questions. Further, Theme
Teams were encouraged—but not required—to build conceptual models to accompany their research
questions; this was because there were so many questions under consideration and it seemed a
burdensome task to build conceptual models for questions that may or may not be prioritized. Had
a prioritization process been in place earlier, a smaller set of questions with accompanying conceptual
models could have been built to guide measurement efforts.
Although better alignment with a design thinking framework may have helped us consider
some issues earlier in our timeline, we accomplished activities consistent with design thinking. The
fact that the consortium attempted one strategy and then changed mid-stream to another strategy is
well aligned with the design thinking notion of being willing to fail. Design thinking requires risk
taking. Innovation is necessarily messy. Although we would recommend that prevention scientists
and transdisciplinary science teams consider such questions a priori, it is an anticipated part of the
design thinking process that one cannot anticipate everything and therefore must be willing to move
forward boldly and start again as needed. Further, in each stage of the consortium’s work,
investigators had the opportunity to work with many sets of colleagues, which helped to prevent the
regeneration of new silos within the consortium. This allowed us to build a strong, resilient, adaptable
transdisciplinary team.

3.2. Limitations
Design thinking provided a useful framework to describe our process. However, there are
limitations to its use. This approach may be challenging at first for health researchers and the
scientific community, who typically take a linear approach to problem solving. Training in design
thinking methodology is not readily available to health professionals and scientists. Further, design
thinking is process that requires time and commitment to investigate and understand users’ needs,
define what is critical, explore entirely new ideas, experiment with those ideas, and iterate. It requires
time to fail and start again. It can be challenging to carve the space and freedom to engage in such a
process. Nonetheless, this approach holds a great deal of promise to inform prevention science and
transdisciplinary research when combined with rigorous scientific standards and methodologies.

4. Conclusions
Prevention science seeks to uncover multi-level risk and protective factors for health and disease
that can be used to inform later interventions. Beginning with a human-centered approach that
considers social and environmental contexts of end-users positions scientists to better utilize the
knowledge they gain for health promotion practice. Using a design thinking process can be a useful
strategy to generate a comprehensive and novel set of research questions. This may be particularly
valuable in areas of prevention science where less work has been done to identify multi-level
determinants of health.
Good research must begin with good research questions. Achieving consensus on which
questions to prioritize when addressing complex health issues can be challenging. Applying
principles of design thinking to the development of research questions may facilitate fruitful
collaboration, yield transdisciplinary frameworks to understand complex phenomena, and clarify
ideas of how to maximize co-learning to develop effective public health solutions.
Int. J. Environ. Res. Public Health 2020, 17, 4340 15 of 17

Author Contributions: Conceptualization, J.B.L. and S.C.; writing—original draft preparation, J.B.L., S.S.B., S.S.,
A.L.S., and K.R.; writing—review and editing, J.B.L., S.S.B., S.S., A.L.S., E.R.M., A.D.M., K.R., A.S., S.G., and
S.D.C. All authors have read and agreed to the published version of the manuscript.

Funding: This work was supported by the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) at the National Institutes of Health (NIH), grant numbers: U01DK106786, U01DK106853,
U01DK106858, U01DK106898, U01DK106893, U01DK106827, U01DK106908, and U01DK106892; National
Institute on Aging; NIH Office of Research on Women’s Health; and NIH Office of Behavioral and Social Sciences
Research. The content of this article is solely the responsibility of the authors and does not necessarily represent
the official views of the National Institutes of Health.

Acknowledgments: Participating research centers: Loyola University Chicago—2160 S. 1st Avenue, Maywood,
IL 60153-3328 (Linda Brubaker, Multi-PI; Elizabeth R. Mueller, Multi-PI; Colleen M. Fitzgerald, Investigator;
Cecilia T. Hardacker, Investigator; Jeni Hebert-Beirne, Investigator; Missy Lavender, Investigator; and David A.
Shoham, Investigator); University of Alabama at Birmingham—1720 2nd Ave South, Birmingham, AL 35294
(Kathryn L. Burgio, PI; Tamera Coyne-Beasley, Investigator; Cora E. Lewis, Investigator; Alayne D. Markland,
Investigator; Gerald McGwin, Investigator; Camille P. Vaughan, Investigator; and Beverly Williams,
Investigator); University of California San Diego—9500 Gilman Drive, La Jolla, CA 92093-0021 (Emily S. Lukacz,
PI; Sheila Gahagan, Investigator; D. Yvette LaCoursiere, Investigator; and Jesse N. Nodora, Investigator);
University of Michigan—500 S State Street, Ann Arbor, MI 48109 (Janis M. Miller, PI; Lawrence Chin-I An,
Investigator; and Lisa Kane Low, Investigator); University of Minnesota, Scientific and Data Coordinating
Center (SDCC)—3 Morrill Hall, 100 Church St SE, Minneapolis, MN 55455 (Bernard L. Harlow, Multi-PI; Kyle
Rudser, Multi-PI; Sonya S. Brady, Investigator; John Connett, Investigator; Haitao Chu, Investigator; Cynthia S.
Fok, Investigator; Todd Rockwood, Investigator; and Melissa Constantine, Investigator); University of
Pennsylvania—Urology, 3rd FL West, Perelman Bldg, 34th & Spruce St, Philadelphia, PA 19104 (Diane K.
Newman PI; Amanda Berry, Investigator; C. Neill Epperson, Investigator; Heather Klusaritz, Investigator;
Kathryn H. Schmitz, Investigator; Ariana L. Smith, Investigator; Ann E. Stapleton, Investigator; and Jean F.
Wyman, Investigator); Washington University in St. Louis—One Brookings Drive, St. Louis, MO 63130 (Siobhan
Sutcliffe, PI; Aimee James, Investigator; Jerry Lowder, Investigator; and Melanie R. Meister, Investigator); Yale
University—PO Box 208058 New Haven, CT 06520-8058 (Leslie Rickey, PI; Deepa Camenga, Investigator;
Shayna D. Cunningham, Investigator; Toby Chai, Investigator; and Jessica B. Lewis, Investigator); Steering
Committee Chair: Mary H. Palmer, School of Nursing, University of North Carolina at Chapel Hill; NIH
Program Office: National Institute of Diabetes and Digestive and Kidney Diseases, Division of Kidney, Urologic,
and Hematologic Diseases, Bethesda, MD (NIH Project Scientist: Tamara Bavendam).

Conflicts of Interest: The authors declare no conflict of interest. The funders had no role in the design of the
study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to
publish the results.

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