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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_612_Библиотеки_им_академика_М_И_Перельмана
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although
understanding
these
structural
factors can
guide quality
measurement
and careful
planning of
guidelines
across
surgeons
and may not
be
generalizable
to other
practice
areas
PROs or
procedurespecific
complications
with details
Understand Mediating Factors and Outcomes
This step applies to both the development of health equity research
and any complex clinical problem. A strong research question starts
with a conceptual model that considers the mediators and
unmeasured confounders of a possible causal relationship. Some
models may resemble a process map, charting the sequence of
events or the levels of influence contributing to an outcome. In other
cases, it may represent the application of social and political
determinants of health.12 Although some conceptual models are
developed to a question, others are adapted from previously
published models. Although mapping this out can seem basic, a
conceptual model can refine the research question, inform the
analysis, and assist reviewers in following the proposal. It is an
iterative process that can further assist in refining the scope and
design of the research question. It is also aided by clinical
observations and a review of the current literature.
In considering the inequities to access to immediate breast
reconstruction, a review of the literature would suggest consideration
for distribution of trained plastic surgeons,2 travel distance for
patients,13 financial distress of associated hospitals,14 and status of
state Medicaid expansion15 be included within a conceptual model.
In this way, literature reviews inform the development and
modification of conceptual models to understand the previously
described mediators and confounders.16 In some areas, the
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researcher may find models that have been previously adapted in
that topic.
We present an initial conceptual model in Figure 15.1A with further
elements expanded in Figure 15.1B. This conceptual model adapts
previously published conceptual models of political determinants of
health and surgical disparities measurement.
12,17
Again, these
models are revised as the project is developed, and a large-scale
research plan may have multiple conceptual models. The first may
explain how the research question fits within the larger problem. A
second (or third) may walk collaborators and reviewers through the
relationship between the outcome(s) of interest and the other
considerations in the analysis. A broad conceptual model may
include policy decisions if they are of interest and if there is a
hypothesized or previously demonstrated association between that
policy decision and a mediator or outcome. For instance, if
conducting a multistate or national study, the magnitude of disparity
could be compared between expansion states and those that have
not expanded Medicaid. If conducting a single-state study in 2023
with a cancer registry in Texas, expansion status would not be a
variable in the analysis but would be a limitation to generalizing
single-state findings to states with different safety-net policies. In the
event Texas expanded Medicaid during the study period, the impact
of the policy change could be studies as was done following
expansion in New York.
18
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FIGURE 15.1. A. Conceptual model of the impact of
political and social determinants of health on breast
reconstruction. B. Expansion of the conceptual model of
the impact of political and social determinants of health on
breast reconstruction.
This is also an opportunity to consider study designs that more
deeply explore outcomes beyond the binary. After all, increasing
access to reconstruction does not mean a reconstruction rate of
100% of all mastectomy patients. Singh et al. used a mixed methods
study design to explore the perspectives of women who decided to
forgo reconstruction. This approach captured themes of distrust and
inadequate counseling.19 These are key opportunities to intervene
but are not captured in retrospective databases. If considering a
more exploratory design, a conceptual model or framework is often
based in theory to help develop an interview guide. For instance,
several frameworks exist to conceptualize patient decision making
including the Ottawa Decisional Support Framework.
20
Find Interventions That Work
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Persistent inequities in access to breast reconstruction have been
well described, and there is work ongoing to identify mediators to
access and identify opportunities to intervene.21 Few studies across
all surgical specialties have tested effective interventions. A scoping
review by Bonner et al found few studies across many surgical
specialties that evaluated interventions to mitigate racial and ethnic
inequities.22 However, there are plastic surgeons actively developing
such interventions. For example, a community outreach effort in
underserved Philadelphia neighborhoods improved awareness of
reconstructive options and resources.
23
Once an intervention has been developed or piloted, there are
many options for evaluation. In addition to the cohort studies or
randomization, there is growing attention to the use of
implementation science to improve delivery. Implementation science
refers to the study of changing practice. However, the language in
this space is variable and descriptions often refer to practice
adoption, scaling up, or dissemination.
24,25
Although the goal in
making evidence-based practices widespread is to improve clinical
outcomes, an implementation science researcher measures
outcomes of acceptability and sustainability.26 In other words,
implementation science is not about designed to measure if the
practice change works, it studies if the change can be emulated and
maintained elsewhere.
27
DEVELOPING THE CLINICAL PROBLEM INTO A
STRONG RESEARCH QUESTION
Whether in a position to design a study or looking to gather more
information, the best research emerges from problems observed in
clinical practice. For some, this may be inequitable outcomes; for
others, it may be the promise of a new product or technique. The
next step in research development, as discussed above, is to
confirm that this same thought has not already occurred to another
researcher and been answered with high-quality evidence. For many
clinical questions, a practicing surgeon is well-versed in the existing
knowledge gap and the latest discoveries in the space. This
facilitates quick recognition of novel questions among those that
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unknowingly repeat a landmark study on a smaller scale. However,
mentees often bring ideas to translate from other specialties and
focuses that reflect their own interests. Advising them requires
assisting them in determining if the question has already been
answered and why it is worth investigating. We summarize an
approach to development of high-impact questions in Figure 15.2.
FIGURE 15.2 Pathway from problem to research
question.
This step requires identifying the existence of a knowledge gap.
This can be the combination of published peer reviewed literature
and clinical experience. After identifying the problem, the researcher
should become well-versed with the current state of knowledge and
begin thinking of questions to ask to fill a compelling knowledge gap.
Once this list of questions is created, the researcher must consider
whether and how to proceed as not all the proposed research
questions can or should be investigated. Some researchers will have
more questions than can be answered during a single career and
others may have one question that will still span careers. Some
proposed questions may be easily investigated, and others may
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remain unanswered until additional data are collected. We
recommend crafting research questions that meet the FINER criteria
proposed by Hulley, although the order of the elements is not
important (Figure 15.3).
28
FIGURE 15.3 The FINER criteria.
At this point, a researcher has found a knowledge gap surrounding
a clinical problem has been identified and has sketched out many of
the components of a complex problem. A research question narrows
this large unknown topic and complex relationships into a
manageable scope. A surgeon-scientist should consider what aspect
of the problem (or the initial conceptual model) is most interesting or
important to them. In other words, a researcher who is most
energized when thinking about improving the patient decision
making around reconstruction would be most impactful in that
research space.
Vetting With “So What?”
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We propose vetting potential research ideas by asking so what?29 In
other words, if this study is conducted and there is no difference,
what will that mean for clinical practice? Conversely, if there is a
difference, what will that mean? For instance, another single-center
study of a practice demonstrating worse outcomes for breast
reconstruction patients with comorbidities is not novel. However, if
the dedicated researcher develops a relationship with a smoking
cessation program and finds better outcomes after a pilot referral
program, they have evidence to support expansion of the program
and may even disseminate the idea to other practices. Mentors and
colleagues can also assist in this process, as researchers can
develop tunnel vision that may make it difficult to identify broader
implications or consider negative findings. Sometimes the so what
flows seamlessly from the introduction of the problem and obvious
knowledge gap. However, when a researcher struggles to answer so
what? for their own proposal, the project should be scrutinized. If a
researcher cannot make a compelling case for a project, they will not
make an impact in the field.
Develop Impact Statements
We prioritize development of impact statements in response to so
what? early in the project proposal. Impact statements should
include the impact of all possible findings. In other words, if the study
finds no difference between two cessation cohorts, what will that
mean? What if the referral program shows a decrease in wound
infection rate? In other words, an impact statement summarizes what
the potential results would add to the current state of knowledge. It is
not necessary to overstate these impacts or implications. However,
this thought process takes the researcher’s thought process beyond
the overused “further studies are required.” In other words, is there
an audience for this research and does it have the potential to
change practice?
Back to the issues of breast reconstruction, at this point in the
health equity research landscape, another single-center study
demonstrating persistent inequities will lack impact. However, if there
is a need to rally institutional support for interventions to solve these
issues, or to benchmark current outcomes to document prospective
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improvement, this analysis may be a useful first step. The work that
is now necessary, and will be high impact, are evidence-based
interventions that improve access and outcomes and studies of their
implementation and dissemination.
There are promising efforts to engage patients not just as research
subjects but also as members of the research team. Do not be afraid
to speak with patients and patient advocates to find out what issues
they have encountered. A patient collaborator can assist in vetting
research plans. Inclusive research teams can further develop into
community partnerships for future community-based efforts. There is
increased attention to community-based participatory research
(CBPR), but it requires long-term commitment and is not as simple
as hosting an information session and expecting improved study
recruitment. CBPR incorporates community members part of the
research team at all steps of the project. Developing a communitybased intervention requires a team familiar with CBPR and strong
community partnerships.
30
Consider Feasibility
With experience, the ability to foresee problems and products is
accelerated. Once a researcher has used a database for one project,
they will have a better understanding of its opportunities and
limitations. For a young investigator or an established researcher
venturing into a new research area, a diverse research team can
assist in vetting feasible research questions. A mentee may have a
very compelling response to so what? for a national study on patient
satisfaction, but there may be a reason the project has not yet been
conducted by other interested researchers. In other words, there is
not an answer to the question of “how?” For instance, although the
Breast-Questionnaire (BREAST-Q) is being adopted for prospective
follow-up, it is not currently captured in insurance claims
datasets.
31,32
If the outcome of interest (in this case patient-reported
outcome measures) was not captured in the dataset, the project is
not feasible. On the other hand, a multisite project with long-term
prospective patient-reported outcomes collection may be very well
planned, but beyond the scope of a trainee research budget. These
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are issues of feasibility: does the researcher have the data, the
expertise, the time, the team, the funds? For instance, Medicare
claims are a rich source of data but largely reflect a patient
population that is over 65 years.33 This may be a large dataset to
investigate injuries and conditions more common in this population,
such as distal radius fractures. However, plastic surgeons
considering these datasets for plastic surgery–specific complications
should review available data dictionaries carefully before
proceeding.34 Data dictionaries refer to the list of available variables,
often with descriptions and how the entries were error-checked.
These are available publicly for some datasets, and papers using
datasets are often a good reference for previously discussed
limitations.
Although ruling out a project can be disappointing, we recommend
keeping examples of projects that did not pass the feasibility hurdle.
This serves two purposes: examples for other trainees and
researchers of the project elements to evaluate before proceeding
and to have on hand should a better dataset or suitable extramural
grant opportunity becomes available. Root cause analysis of these
failed projects can help revise the plan and focus the researcher on
missteps to avoid.35 Beyond asking if it is feasible to conduct a study
with available data, it is also important to consider if it is feasible for
the researcher and team given constraints on resources and time. A
researcher should always have a list of idle or future projects to
maintain momentum.
Refining the Question
After identifying a compelling knowledge gap, it can be tempting to
launch into the definitive project to fill the gap. The reality is often
there are many possible approaches to research questions, each of
which adds new knowledge to the field. As the researcher considers
the scope of their research project, the PICOS criteria can assist in
taking the conceptual to the practical. The team should consider
available data or the need to collect new data, funding, capacity, and
purpose. The PICOS criteria (Figure 15.4) walk the researcher
through the outline of what will become the methods section of any
published study findings.36 Outcomes (primary and secondary) have
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formed the basis of much of the above development process. The
population of interest often follows this outcome in the clinical
research space. In other words, if the project is investigating
oncologic breast reconstruction access and outcomes, the
population of interest is those undergoing partial or total mastectomy.
Similarly, the choice of study design (S) is often directed by the prior
PICOS criteria.
FIGURE 15.4 The PICOS criteria.
At this stage, however, the researcher must consider the specifics
of the population that will be studied. This requires considering the
conceptual model and the goal of the project. At the same time, the
question begins to focus on the intervention of interest. This does not
imply that all research questions are trials, rather it narrows the
scope of the project. The research team could assign the type of
reconstruction as the intervention or compare the format of
reconstructive preoperative discussion (virtual vs in-person). As the
researcher decides these elements, they will create question-method
pairings to find the best study design for their purpose.
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