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stated in the ASPS code of ethics, we should “strive continually to
improve medical knowledge” and “practice a method of healing
founded on a scientific basis.”
7
QUESTIONS
1. A patient chose not to undergo a free flap reconstruction to
save his traumatized lower limb. This consideration satisfies
which of the four pillars of ethics?
a. Autonomy
b. Beneficence
c. Nonmaleficence
d. Justice
e. None of the above
2. A non–English-speaking patient is contemplating the choices
for breast reconstruction. Which of the following avenue is
most appropriate for obtaining suitable informed consent?
a. Use Google translate
b. English-speaking family member
c. Professional translator
d. A family friend
e. None of the above
ANSWERS AND EXPLANATIONS
1. Answer: a. All patients have the right to make their own
informed choice. Despite the best judgment of the surgeon,
patients may chose not to accept a seemingly suitable treatment
option. The autonomy of the patient must be respected.
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2. Answer: c. To avoid undue influence, having a professional
translator is most appropriate to provide objective interpretation
of the treatment choices. We need to avoid coercion by family
members and acquaintances in deriving a decision that is
principally the patient’s choice.
REFERENCES
1. Audi R, ed. Cambridge Dictionary of Philosophy. 2nd ed.
Cambridge University Press; 2001:88-89, 284-289, 749.
2. Bauchner H, Fontanarosa PB, Thompson AE. Professionalism,
governance, and self-regulation of medicine. JAMA.
2015;313(18):1831-1836.
3. American College of Surgeons. Statements on Principles. Accessed
May 3, 2023. hps://www.facs.org/about-
acs/statements/statements-on-principles/
4. Chappell AG, Kane RL, Wood SM, Wesco AB, Chung KC.
Representation of ethics in the plastic surgery literature: a
systematic review. Plast Reconstr Surg. 2021;148(2):289e-298e.
5. Atiyeh BS, Kadry M, Hayek SN, Moucharafieh RS. Aesthetic
surgery and religion: Islamic law perspective. Aesthetic Plast Surg.
2008;32(1):1-10.
6. Chandrasekar B, Rahman S, Hampton T. Global bioethics: plastic
surgeons need more than four principles. Plast Reconstr Surg.
2022;150(5):1129e-1130e.
7. American Society of Plastic Surgeons Code of Ethics. Accessed
May 3, 2023.
hps://www.plasticsurgery.org/documents/Governance/aspscode-of-ethics.pdf
https://t.me/med1917
8. American Board of Plastic Surgery Code of Ethics. Accessed May
3, 2023. hps://www.abplasticsurgery.org/media/18234/ABPS-
Code-of-Ethics-final-Approved-5-2020.pdf
9. Gray R, Tanna N, Kasabian A. Conflict of interest at plastic
surgery conferences: is it significant? Plast Reconstr Surg.
2019;144(2):308e-313e.
Characterizing the top 1% of plastic surgeon recipients of industry
payments. Plast Reconstr Surg. 2023;151(4):707e-708e.
relationship between industry and surgery. J Hand Surg Am.
2011;36(8):1352-1359.
medical devices. Kaiser Health News. Published March 7, 2019.
Accessed May 3, 2023. hps://kealthnews.org/news/hidden-fda-
database-medical-device-injuries-malfunctions/
payments by Allergan, Inc to plastic surgery and related specialties
in 2018. Ann Plast Surg. 2021;86(1):4-8.
the disclosure of conflicts of interest in hand and upper extremity
surgery: a review of the nerve allograft industry. J Am Acad
Orthop Surg. 2022;30(22):1083-1089.
models. Philos Ethics Humanit Med. 2018;13(1):2.
role in evidence-based medicine. Plast Reconstr Surg.
2011;128(1):305-310.
of shared decision making. Patient Educ Couns. 2023;111:107681.
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1996;26(6):S1-S27.
Accessed May 3, 2023.
hps://apps.who.int/gb/bd/pdf_files/BD_49th-en.pdf#page=6
facial transplantation. Clin Plast Surg. 2007;34(2):233-250.
transplantation: a systematic review. J Hand Surg Am.
2018;43(1):84.e1-84.e15.
ethics of penile transplantation: preliminary recommendations.
Transplantation. 2017;101(6):1200-1205.
persons with gender dysphoria. Plast Reconstr Surg.
2018;141(3):388e-396e.
surgery. JAMA Surg. 2022;157(8):651-652.
affirming surgeries and mental health outcomes. JAMA Surg.
2021;156(7):611-618.
therapeuticalization of cosmetic surgery. Bioethics. 2020;34(4):431-
441.
medicine. Philos Ethics Humanit Med. 2021;16(1):14.
medicalization? Med Health Care Philos. 2019;22(1):119-128.
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and respect for patient autonomy—reconcilable ends in aesthetic
surgery? J Plast Reconstr Aesthet Surg. 2011;64(1):11-16.
current knowledge and contemporary debates. J Womens Health.
2010;19(7):1393-1407.
opinion, number 795. Obstet Gynecol. 2020;135(1):e36-e42.
cosmetic surgeries. Clin Obstet Gynecol. 2020;63(2):277-288.
enhancement through female genital cosmetic surgery creates
ethical and rights dilemmas. Int J Gynaecol Obstet. 2013;122(2):169-
172.
symptomatology before and after labiaplasty. Plast Reconstr Surg.
2020;146(3):526-536.
safety and optimizing outcomes of labiaplasty: a systematic review
and meta-analysis. Plast Reconstr Surg. 2022;150(4):776e-788e.
Accessed May 3, 2023. hps://www.amc.org.au/cosmetic-surgery/
Accessed May 3, 2023. hps://flboardofmedicine.gov
of ethical and professional social media content. Plast Reconstr
Surg. 2019;144(1):118e-125e.
media unethical “medutainment”? AMA J Ethics. 2018;20(4):328-
335.
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2008;206(6):1204-1209.
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CHAPTER 15 Principles of Research
Designs and Outcomes Research
Jacqueline N. Byrd and Kevin C. Chung
KEY POINTS
Start with a clinical problem.
Translate the problem into an impactful research
question.
Explore possible impact by answering “so what?”
Match question to most appropriate study design.
Consider feasibility and limitations early.
“Discovery consists of seeing what everybody has seen and thinking
what nobody else has thought.”
Albert von Szent-Gyorgyi
INTRODUCTION
Whether in academic or private practice, plastic surgeons encounter
challenging clinical problems daily. There is an ever-expanding
volume of surgical research, with many questions not yet asked or
answered. Staying on top of the strongest evidence requires a
rigorous approach to scrutinizing published research and developing
original investigations. Additionally, conducting high-quality, highimpact outcomes research needs an investment of time, personnel,
and resources. The best motivation for this investment arises from
questions encountered in clinical practice that can be answered with
a methodology of interest. This is sometimes summarized as
answering the questions that keep the researcher up at night. In this
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chapter, we will present a rigorous and systematic approach to
developing research questions and review the applications of a
selection of useful methodologies.
The complexity of our healthcare system creates challenges and
opportunities for researchers. There are many approaches to
understanding the contributing factors to surgical outcomes. Many
surgeons use the terms outcomes research and health services
research (HSR) interchangeably, although others consider outcomes
research to be a subset of HSR. On the other hand, some are not
familiar with HSR at all. HSR focuses on the delivery, financing, and
policy around healthcare. The “outcomes” of interest can also vary
from morbidity and mortality to out of pocket cost and even receipt of
the surgery.1 The focus of this chapter will be on clinical outcomes
research, with introduction of additional methodologies to investigate
delivery and policy as well. Outcomes research using retrospective
claims data has traditionally used available outcomes such as
mortality, surgical site infection, and readmission. However, there is
increasing attention to other outcomes like cost (financial toxicity)
and satisfaction (patient-centered outcomes).
A CASE-BASED OVERVIEW
To highlight our approach to reviewing the literature and developing
research plans, we consider a breast reconstruction access and
outcomes scenario.
Clinical Problem Example
Dr. Smith trained at a public tertiary care hospital and is now a
year out of training in a suburban private practice. She reads an
article in Annals of Surgery about a lack of interventions toward
surgical equity and reflects on the difference in her breast
reconstruction patient caseloads between training and practice.
She speaks to her partners about potential community-based
interventions. How can she transform this clinical problem into a
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rigorous research design that motivates systemic and practice
change?
As this problem deals with issues of inequity, a researcher should
first consider the broader body of research into health and surgical
equity. The framework put forth by Ayanian divides inequity research
into three consecutive phases: describing the disparity,
understanding the relationship of mediating factors and outcomes,
and determining interventions that work.
2
Despite this three-pronged structure, this is not a plan for a
specific aims page, rather a sequential approach to a vexing and
multifactorial problem. As potential questions arise, such a
framework encourages a researcher to consider possible
approaches. Background research using a preferred search tool
(whether PubMed or Google Scholar) can identify other researchers
with similar interests and the knowledge to date. This does not need
to be a formal systematic review of all research ever conducted on
the general topic, rather this is to confirm the question has not
already been answered before the investment of time and resources
to redo the investigation.
Describe the Inequity
A surgeon noticing racial differences in presentation or outcome can
quickly use basic statistics to test for differences in access or
outcomes. Although a descriptive study appears to be a
straightforward study design and is often the starting point for new
researchers, these studies must be planned and designed
deliberately and rigorously. Disparities in rate and type of
reconstruction are well described.
3,4
Once these inequities have
been observed and measured, there is a moral imperative to act to
eliminate them.5 There is growing attention to health equity tourism,
a term coined by Dr. Lett to refer to the growing body of researchers
publishing findings of racial inequity without identifying or proposing
actionable solutions.6 In our case example, thoughtful use of
descriptive data can help identify opportunities for intervention.
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However, these descriptive data must not be viewed as the definitive
research product.
The design of a descriptive study must include deliberate
consideration of outcome selection. For instance, is the ultimate plan
to improve clinical outcomes of breast reconstruction in vulnerable
patients, eliminate barriers to receiving reconstruction, or address
the distance to nearest cancer center? As described by Donabedian,
these can be categorized as outcome, process, or structure
measures of quality (Table 15.1).
7,8
It is important to recognize that
many of the quality metrics currently used are not specialty specific
and may not capture outcomes specific to plastic and reconstructive
surgeries.9 This has been seen in the early implementation of valuebased payment systems by the Centers for Medicare and Medicaid
Services (CMS), with measures designed to apply to internal
medicine and hand surgery, with slow rollout of more tailored
measures.
10,11
TABLE 15.1. THE DONABEDIAN FRAMEWORK:
STRUCTURE, PROCESS, AND OUTCOMES
Structure Process Outcomes
Examples Case volume Opioid
prescribing
Patientreported pain
Distribution
of plastic
surgeons
Time to
replantation
Loss of
replanted
digit
Advantage Easy to
measure
Clear targets
for system
redesign
These are
what matters
to surgeons
and patients
Challenges Not direct
targets for
surgeon-led
interventions,
Processes
are not
always
standardized
Available
retrospective
data rarely
include
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