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colleagues but also with industry, policymakers, and patients. The
reason for emphasis on the so what is to underscore the “now
what?” Many projects end with “future research is required.” We
propose an actionable research plan so that a researcher can build a
body of work and expertise. These high-impact projects can inform
patient education material development and advocacy with
professional societies and policy makers and change surgical
practice.
QUESTIONS
1. A researcher is interested in investigating quality of free flap
reconstruction. When discussing available datasets, their
mentor asks what the focus on the project will be. The
Donabedian framework proposes three domains of quality:
a. Patient, Surgeon, Hospital
b. Structure, Process, Outcome
c. Diagnosis, Treatment, Morbidity
d. Intervention, Comparison, Outcome
2. A team of plastic surgery residents is interested in exploring
the impact of work-hour restrictions on reconstructive
outcomes. They propose an interrupted time series design.
Causal inference and randomized controlled trials are similar
in that they:
a. Blind researchers to intervention assignments.
b. Support causation rather than association.
c. Address unmeasured confounders.
d. Evaluate policy changes.
3. Systematic bias refers to:
a. Random error causing the measurement to differ from the
true measurement.
b. Variables in the analysis that relate the independent and
dependent variables.
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c. A measurement error that over- or underestimates the
value repeatedly.
d. Unconscious preference for one approach.
4. A research team is considering a multi-institutional trial to
evaluate robotic-assisted DIEP flap harvest. Some of the
interested sites have structured robotic training, and others do
not. Several additional limitations of the proposed study are
identified during development of the analytic plan. The next
best step is:
a. Consider a different question given the presence of
limitations.
b. Ignore these limitations in the development process and
address them in the manuscript.
c. Only consider limitations specific to your area of expertise
(eg, robotic training).
d. Review the literature to see how other researchers have
addressed known limitations of multi-institutional trials.
5. A grand rounds speaker introduces the growing use of
patient-reported outcome measures. To incorporate WOUNDQ scores in your upcoming chronic wound research proposal,
you should:
a. Request NSQIP data
b. Request TOPS data
c. Consider a prospective design instead
d. Reach out to patients in your institutional dataset from
2010 to 2020 and administer the WOUND-Q.
ANSWERS AND EXPLANATIONS
1. Answer: b. The Donabedian framework has been applied to
surgical outcomes research to consider quality within three
domains: structure, process, and outcomes.7 Although
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outcomes research often focuses on discrete measurement of
patient-reported and provider-documented outcomes, this
framework can help new and established researchers consider
alternative approaches to improving outcomes for patients within
their specialty and across their healthcare systems. Variables
can also be assessed and measured at the patient, surgeon,
and hospital levels. This is not a framework for quality
measurement, but surgeon and hospital outcomes can be
incorporated into an analysis using multilevel modeling.
Intervention, comparison, and outcome are components of the
PICOS criteria.
2. Answer: b. Causal inference and randomized controlled
trials can both support causation. They share that strength,
compared with other designs that support association. Patients,
surgeons, hospitals, or even neighborhoods can be randomized
to treatments with or without researcher blinding in randomized
controlled trials. Causal inference studies are retrospective
analyses in which researchers know which groups received the
intervention. Careful recognition of potential confounders is
important for study design of both. One of the key assumptions
of causal inference is that no unmeasured confounders exist.
3. Answer: c. Systematic bias differs from random error
(chance) in that it is consistent variation causing the measured
association to differ from the true association. This systematic
error results from information bias (as in a device or measure
that over- or underreports a value), confounding, and selection
bias. Mediators differ from confounders in that they are a part of
the causal pathway, connecting the independent and dependent
variables. Mediators do not contribute to systematic bias,
although they should be included in a carefully designed analytic
plan.
4. Answer: d. In addition to conducting a literature review to
clarifying knowledge gaps, it is important to know what has been
published with your data sources or outcomes. There may be
recognized limitations with prior attempts to tailor the analysis
accordingly. Every study design will have limitations, which is
why all manuscripts address them in the discussion. However, a
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rigorous study considers these limitations early in the design
and analytic process. Waiting until the discussion allows for a
few sentences to discuss them but can result in those limitations
having more impact on the results than if addressed proactively.
Although it is important to apply the unique approach of a
surgeon to understanding the clinical implications of study
design and findings, a multidisciplinary research team must
consider all limitations.
5. Answer: c. Incorporating these domain scores will entail
prospective data collection. WOUND-Q domain scores are not
captured in TOPS or NSQIP. To date, neither are any of the
other Q portfolio scales (eg, BREAST-Q or LYMPH-Q). This is
one of the considerations when designing a study using existing
retrospective datasets. Although current research efforts
incorporating these scales may create datasets available for
future use, these PROM (patient-reported outcomes measures)
are not included in datasets created prior to their development.
As a result, if patient-reported outcomes are the priority for
understanding the clinical problem, it may be necessary to
design a prospective data collection approach.
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