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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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