Phẫu Thuật Tạo Hình Grabb & Smith’s (Bản Cập Nhật – Kevin C. Chung)

Balloon angioplasty
2 wk
1 y
Bare-metal stent
1 mo
1 y
Drug-eluting stent
6 mo
1 y
Coronary artery bypass graft
1 y
1 y
*P2Y12 platelet inhibitors include clopidogrel (Plavix), prasugrel (Effient), and ticagrelor (Brilinta).
This table summarizes 2016 ACC recommendations regarding the minimum duration of DAPT depending on cardiac intervention and timing
of noncardiac surgery. It is advised to communicate the decision to perform surgery and the associated risks with the physician managing the
patient’s medications.
DAPT, dual antiplatelet therapy; NSTE-ACS, non–ST-elevation acute coronary syndrome; SIHD, stable ischemic heart disease; STEMI, ST-
segment elevation myocardial infarction.
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Anemia and Blood Disorders
Preoperative anemia is associated with increased morbidity and mortality. 4,5 The World Health
Organization (WHO) and Centers for Disease Control (CDC) define anemia as <13 g/dL in a male and
<12 g/dL in a female. 6 The most common cause for anemia is iron deficiency, and this is treated with oral
or intravenous (IV) iron supplementation.
Most blood disorders can be ruled out by simple, but focused, history-taking and does not necessitate
workup if no pertinent findings are uncovered. 7 Screening laboratory studies are ill-advised and may
yield false positive results, leading to unnecessary additional workup and delaying surgery. 8,9 Therefore,
routine preoperative testing is not only of little clinical benefit but costly in healthy patients undergoing
elective procedures. 10
Clotting disorders are estimated at 5% to 10% in the general population. The most common
hypercoagulable
state
is
factor
V
Leiden,
whereas
other
common
disorders
include
hyperhomocysteinemia, lupus anticoagulant, and deficiencies in protein C, protein S, or antithrombin. To
screen for serious hypercoagulability disorders, one must inquire about a patient’s history of venous
thromboembolism (VTE) and, in a female, spontaneous abortions or miscarriages. Patients already on an
oral anticoagulant should be sent back to the physician managing their medication or referred to a
hematologist to formulate a plan for bridging pre- and postoperatively. A patient who has suffered a VTE
within the last month may require placement of an inferior vena cava filter, especially if resumption of
anticoagulation could be delayed more than 12 hours postoperatively. A prophylactic inferior vena cava
filter may be considered in newly diagnosed cancer patients who cannot afford to delay surgery but
require a complex resection and reconstruction, as these patients are at high risk of VTE.
On the other spectrum of the coagulation cascade, an estimated 1% of patients have a bleeding disorder,
most commonly some form of hemophilia or von Willebrand disease. 11 To rule out any issues with
coagulopathy, one should ask about personal or family history of bruising or bleeding tendencies after
dental extractions, minor trauma, or previous surgery. In women, a history of menorrhagia or excessive
postpartum bleeding should warrant further investigation. Patients known or discovered to have a
bleeding abnormality should be referred to a hematologist for perioperative management.
Summary of recommendations for preoperative screening for coagulation disorders:
History should guide preoperative testing for bleeding or coagulation disorders
Routine screening laboratory tests do not necessarily correlate with clinical findings and therefore
may only confound the picture
A history of bruising, bleeding, or thromboembolism should prompt further investigation
Patients with a known hypocoagulable or hypercoagulable disorder should be referred to a
hematologist
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Diabetes
Uncontrolled or poorly controlled diabetes is a risk factor for overall complications, especially wound
healing problems. If indicated, a hemoglobin A1c can verify that the patient’s 3-month average blood
glucose is within an acceptable range for the proposed surgery. Studies have shown an increase in
postoperative complications in patients with a hemoglobin A1c >6.5%. 12,13 Concern for elevated blood
glucose or hemoglobin A1c preoperatively should prompt a referral to an endocrinologist or PCP.
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Modifiable Risk Factors
Modifiable risk factors include body mass index (BMI), tobacco use, and nutrition status, among other
things. The surgeon should not agree to any procedure until these factors have been optimized to his or
her satisfaction. The patient should be held accountable for meeting these expectations before any consent
is signed. Ideally, BMI should be optimized preoperatively, as several studies have demonstrated an
increased risk of complications in patients with a BMI above 35 kg/m2; this is mostly true for chest and
trunk procedures 14-17 but has not held true in hand surgery. 18
The most easily modifiable risk factor is the use of nicotine products. With smokeless tobacco products
becoming more popular, surgeons should specifically ask about whether patients vape, dip, or use other
sources of nicotine including cessation products, as they will never volunteer this information. Although
there is no agreed upon consensus on the optimal time to abstain from nicotine prior to a surgical
procedure, most would agree that at least 4 weeks is best to decrease the risk of complications. If patient
noncompliance is suspected, a urine cotinine test can be checked prior to surgery.
A thorough history and examination must elucidate a patient’s past surgeries, especially those pertinent
to the anatomic site in question. The surgeon must pay attention to previous scars and be mindful of
disrupted vascular connections that could lead to untoward outcomes. 19,20 Additionally, one must rule
out a history of postoperative wound infection or known colonization with methicillin-resistant
Staphylococcus aureus. High-risk patients should be screened for MRSA colonization and a decolonization
protocol used preoperatively, as this has shown a significant reduction in surgical site infection (SSI). 21,22
A typical treatment regimen includes 5 days of nasal mupirocin ointment and chlorhexidine baths.
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Psychiatric History
Patients seeking elective plastic surgery may harbor a psychiatric diagnosis, most commonly narcissistic
personality, histrionic personality, or body dysmorphic disorder. 23,24 Many surgeons consider body
dysmorphic disorder a clear contraindication to any surgical procedure, as the results will never be
satisfactory to the patient. The acronym SIMON (single, immature, male, overly expectant, and
narcissistic) should be in the back of a surgeon’s mind, especially when evaluating rhinoplasty patients,
as those who fit these criteria generally have worse outcomes and lead to malpractice claims. 25 Referral to
a mental health specialist may be indicated should the mental stability of a patient be uncertain.
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Surgical Planning
Informed Consent
It behooves the surgeon to conduct a proper informed consent, reviewing all risks, benefits, and
alternatives to the planned surgical procedure. An appropriate informed consent process requires a face-
to-face discussion with the patient, providing ample time to ask and answer questions. Early education of
potential complications can decrease postoperative patient dissatisfaction if an adverse event occurs. The
surgeon should discuss alternatives—surgical and nonsurgical—available to the patient, even if the
surgeon does not offer all options. As is the case with any elective procedure, it is the physician’s duty to
educate the patient that not undergoing said operation is an option.
The legal definition of a minor, or one who cannot sign a binding contract or consent, is governed by each
state, but in most states, the minimum age is 18 years. However, each state also has a set of circumstances
whereby a minor may become emancipated and provide his or her own consent. Legally, only one parent
of a minor needs to sign a consent for it to be valid.
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Surgery Location/Certification
Although some procedures can be performed in more than one setting—office, outpatient, or inpatient—
patient and procedural factors must be taken into consideration when choosing the surgical location.
Patient safety should be the top priority when making this decision and should not be compromised for
any reason. Accreditation of both staff and surgical setting is required. Several agencies provide
certification for hospitals or surgery centers, including the Joint Commission on Accreditation of
Healthcare Organizations, Accreditation Association for Ambulatory Health Care, and American
Association for Accreditation of Ambulatory Surgery Facilities.
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Medications
Management of patient medications in the perioperative period: 1
Take on day of surgery
Statin
Pulmonary medication
Cardiovascular medication except those listed below
Stop on day of surgery
Angiotensin-converting enzyme inhibitor and angiotensin-receptor blocker
Diuretic medication
Diabetic medication
Stop 1 to 2 weeks before surgery
Blood thinner
Monoamine oxidase inhibitor
Herbal medication
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Site-Specific Considerations
For any patient undergoing an elective breast procedure, the surgeon should at minimum follow the most
recent mammography guidelines. 26 Certain patients under the age of 40 years may warrant a screening
mammogram based on personal or family history. 27 When planning tissue transfer procedures, one must
ensure that vessels sacrificed during harvest of the flap will not compromise the blood supply to the
remaining tissue, as this could lead to disastrous consequences. 28
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Operating Room Time
Increased surgery time is correlated with greater morbidity and linked to increased rates of hypothermia,
SSI, thrombotic events, and hospital admission. 29-31 Patients presenting for elective surgery may desire
multiple anatomic sites addressed simultaneously. Staging procedures may have to be done to minimize
operative time, blood loss, and surgeon fatigue. Reconstructive procedures involving more than one
anatomic site should include more than one team, when feasible, to carry out the operation more
expeditiously.
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Perioperative Care
Appropriate patient preparation includes attention to VTE prophylaxis, body temperature, antibiotic
timing and duration, fluid shifts, and positioning in the operating room. In any female capable of
childbearing, a day-of-surgery pregnancy test 32 should be obtained to rule out an unknown pregnancy.
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Communication
Clear, timely communication before, during, and after surgery is essential to deliver good patient care.
The surgeon must communicate with the patient’s PCP and other medical specialists as needed during
the perioperative period. Intraoperatively, communication between members of the operating room team
—nursing, anesthesia, and surgical staff—is critical for any procedure to be executed well and without
complications. When there is a breakdown in communication, there is bound to be a problem.
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Universal Protocol
It is imperative that the nationally mandated Joint Commission Universal Protocol be followed and
proper time-out be performed prior to the start of any surgical procedure. This process protects the patient
by requiring the health care team to agree that the procedure about to be performed is on the correct
patient, site, and side, if applicable.
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Deep Vein Thrombosis Prophylaxis
Intermittent pneumatic compression devices must be on and 
 functioning at least 30 minutes prior to
induction of anesthesia. If not contraindicated, patients should be encouraged to ambulate with assistance
postoperatively on the day of surgery. The 2005 Caprini risk-assessment model for VTE 33 is a validated
tool for plastic and reconstructive surgery, 34 and surgeons should refer to recommendations for
appropriate mechanical and chemical prophylaxis.
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Antibiotics and Skin Preparation
Shaving the surgical site the day before a procedure is associated with an increased risk of SSI. Patients
should be advised to shave at least 2 days preoperatively; if not, clippers should be used to trim the
surgical site before the skin site preparation in the operating room. Chlorhexidine-alcohol is preferred as
the surgical skin antiseptic of choice, as it has been shown to be more efficacious than povidone-iodine. 35
Preoperative IV antibiotics should be based on the surgical procedure being performed, taking into
consideration any patient allergies. Patients who claim to have an allergy to penicillin should be further
questioned regarding whether the allergy is life-threatening. Antibiotic prophylaxis should be
administered according to the surgical care improvement project guidelines. 36 A list of common options
is provided in Table 16.2. Redosing is indicated for every two half-lives (t1/2) elapsed, or blood loss is
greater than 1500 mL. No data justify continued prophylactic use beyond 24 hours, despite widespread
practice to continue postimplant placement or until drains are removed. To the contrary, prolonged use
of antibiotics may promote resistant strains of bacteria. Minor procedures being performed in the
operating room do not require preoperative antibiotics.
TABLE 16.2
Common Antibiotics Used for Preoperative Surgical Prophylaxis a
Antibiotic
Timing (Before Skin Incision)
Pediatric Dose
Adult Dose
Half-Life (t1/2)
Cefazolin
30–60 min
30 mg/kg
2 g (3 g for ≥120 kg)
2 h
Clindamycin
60 min
10 mg/kg
900 mg
3 h
Vancomycin
2 h
15 mg/kg
15 mg/kg
6 h
aDose should be repeated for every two half-lives or blood loss exceeding 1500 mL. Cefazolin is the agent of choice, and if a patient has a
true allergy to cephalosporins, the second-line antibiotic is clindamycin. Vancomycin is not recommended except in patients who are
colonized with or have a history of infection with methicillin-resistant Staphylococcus aureus.
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Fluid Balance
Fluid balance is critical in many plastic surgery procedures, especially with increasing operating time.
Anesthesia studies show improved outcomes with balanced fluid management rather than restrictive or
traditional liberal fluid administration. 37 If a Foley catheter is in place, an output of 30 to 50 mL/h is a
reasonable goal for the anesthesia team to maintain, as fluid overload can have disastrous consequences.
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Warming
Hypothermia, defined as body temperature less than 36°C, is an independent risk factor for bleeding and
postoperative wound healing complications. 38 The most effective method of maintaining normothermia
is by prewarming the patient with forced warm air for at least 15 minutes prior to the procedure. 39
Several intraoperative techniques can be used to prevent or combat hypothermia: covering regions
outside of the surgical site, using forced warm air and/or a warming blanket, maintaining of an ambient
room temperature of at least 21°C, and using of warm IV and irrigation fluids. Although cutaneous
temperature monitoring is frequently used, it is less accurate than other methods such as esophageal,
bladder, or rectal temperature monitoring.
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Patient Positioning
Intraoperative positioning is important in the prevention of VTE, as well as in avoiding nerve and ocular
damage. Bony prominences should be appropriately padded to prevent a pressure nerve injury. Knees
should be gently flexed to 15° and shoulders abducted no more than 90°. When prone, eyes should be
well protected against pressure and the neck should be comfortably positioned in neutral alignment. If
the surgical procedure necessitates an intraoperative position change, this should be well coordinated
and executed to prevent patient injury.
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Postoperative Care
Blood and Fluid Monitoring
Blood transfusions are indicated for all patients with a hemoglobin level below 7 g/dL and are indicated
above this threshold for certain patients, such as those with symptomatic anemia or a cardiac history. 40
Fluid shifts are common in the postoperative period, and a Foley catheter can be helpful to guide
resuscitation and monitor urine output. If a Foley catheter is present, it should be removed as soon as
possible, preferably within 48 hours postoperatively unless justified for longer.
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Ambulation
Ambulation postoperatively is the best preventative measure against VTE. Patients should be encouraged
to ambulate as early as the evening after surgery if it will not compromise the outcome of the procedure.
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Warning Signs/Complications
Knowledge of how to prevent and manage complications for the procedure in question is paramount,
and the inexperienced surgeon should not tackle a case without experience. The surgical site can develop
several issues, including but not limited to erythema, cellulitis, deep tissue infection, seroma, hematoma,
vascular compromise, or wound dehiscence. Hematoma incidence is higher in breast procedures,
combined procedures, and male patients. 41 An expanding hematoma in any location is an indication to
return to the operating room as soon as possible to evacuate the clot and control the source of bleeding.
Drains can indicate an evolving hematoma if output remains sanguineous, especially with bright red
drainage. A drain that is no longer holding suction may indicate a wound dehiscence or drain extrusion
from the wound.
Systemic warning signs include fevers, lower extremity edema, diarrhea, and sustained or increased need
for supplemental oxygen. Although temperature spikes may be common postoperatively, a sustained
fever or alternating fevers and chills is a cause for investigation. Lower extremity edema can be a sign of
VTE or heart failure. An inability to wean off oxygen postoperatively should raise suspicion in an
otherwise healthy patient who underwent a minor procedure.
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Follow-Up
Patients are seen postoperatively within a week of surgery after a major procedure or within 2 weeks
after a minor procedure. It is best to leave the initial postoperative dressing in place until seen in clinic,
although the patient may remove an outer layer to allow for showering 1 or 2 days after surgery. If drains
are used, patients are seen weekly until all have been removed; a common criterion is output less than
30 mL/d. If a major procedure was performed, lifting is restricted to 5 kg for 6 weeks to decrease the risk
of wound dehiscence. As long as the procedure performed does not interfere with the ability to drive,
then a patient can drive once no longer taking narcotic medication.
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Questions
1. A 45-year-old woman is referred for immediate breast reconstruction after mastectomy scheduled
in 12 days. She has had two vaginal deliveries and desires autologous breast reconstruction. She
smokes seven cigarettes a day and is otherwise healthy. What is the best approach?
a. Ask her to quit immediately and proceed with surgery
b. Delay her reconstruction until she is nicotine free for at least 4 weeks
c. Deny her surgery for her smoking habit
d. Proceed with surgery, as this is a cancer-related procedure
e. Refer her to another physician willing to operate on smokers
2. A 67-year-old male presents for correction of ptotic skin after a 60-kg weight loss 2 years after his
Roux-en-Y gastric bypass. Current BMI is 29.5 kg/m2 and has been stable for 6 months. Medical
history is significant for ST-elevation myocardial infarction 4 months ago treated with a drug-eluting
stent. What is the evidence-based approach to the management of this patient with respect to
surgery?
a. Proceed with surgery with the patient on all his medications
b. Have the patient hold his antiplatelet medications for 2 weeks prior to surgery
c. Have the patient hold his antiplatelet medications 2 days prior to surgery
d. Delay surgery for at least 2 months
e. Tell the patient he is too high risk to have surgery given his cardiac history
3. On a busy clinic day with many patients, you see a new patient referred to you by a local
orthopedic surgeon for coverage of a leg defect after planned melanoma resection. The anticipated
defect on the anterior calf includes skin and subcutaneous tissue down to fascia, leaving a wound
with 5 cm diameter. What is the best course of action?
a. Ask the medical assistant in the clinic to carry out the consent process and move on to the next
patient because you are running behind
b. Have an informed consent with the patient and explain all options and risks
c. Offer the patient a free flap reconstruction because you completed a microsurgery fellowship
d. Tell the patient that his best option is a skin graft and have him sign the consent form
4. A 14-year-old girl presents desiring correction of mammary hypertrophy. She is accompanied by
her father. Her history includes a rapid 1-year history of breast growth, and recently she complains
of difficulty fitting in a bra and playing lacrosse, which she has done since 9 years of age. What is the
appropriate management of this patient who desires a breast reduction?
a. Have the father sign the consent form
b. Have the patient sign the consent form
c. Refuse to perform the procedure until the patient is at 18 years of age so she can sign her own
consent
d. Require the patient to return with both parents so that they may both sign the consent form
e. Require the patient to return with the mother to sign the consent form
1. Answer: b. Smoking is a modifiable risk factor that can increase complications after surgery.
Nicotine can lead to vasoconstriction and reduced oxygenation of healing tissues, leading to
increases in wound healing problems and infection. The best option is to counsel the patient to stop
and agree to perform her reconstruction—an elective portion of her cancer treatment—once she is off
nicotine for at least 4 weeks. If noncompliance is suspected, a urine cotinine test can be checked. It
can take up to 10 days to get the results back, so it should not be performed close to the surgical date.
Having a smoking policy in place can avoid postoperative complications.
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2. Answer: d. Current guidelines after cardiac stenting recommend at least 6 months of DAPT:
aspirin and clopidogrel or equivalent. Stopping or holding either or both medications is associated
with a high risk of stent thrombosis. Any elective noncardiac surgery should be delayed until after
the patient has completed the minimum duration of therapy. Additionally, the surgeon should
ideally obtain clearance from a cardiologist before proceeding with surgery.
3. Answer: b. The purpose of informed consent is to have a face-to-face discussion between a
physician and patient. Critical to the discussion is an unbiased presentation of possible risks,
benefits, and alternatives. The person performing the informed consent process must be able to
perform the procedure in question, so this task should not be left to a medical assistant. Furthermore,
a patient should be offered all reasonable treatment options, not just simply the option that puts a
physician’s specialty/subspecialty training to use. Even though a skin graft may be the best option for
coverage, a surgeon should do his or her due diligence to go through the R/B/A rather than make the
patient sign the consent form.
4. Answer: a. Either parent, or a legal guardian, of a minor may consent to a surgical procedure. The
patient in question is 14 years old, and in no state is that of legal age to provide consent. It is not
necessary to have the mother, or both parents, sign the consent. Given the severity of the symptoms,
it is appropriate to proceed with a breast reduction and there is no need to wait until the patient’s
18th birthday.
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References
Fleisher, LA, Fleischmann, KE, Auerbach, AD, et al. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management
of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on
practice guidelines. J Am Coll Cardiol. 2014;64(22):e77-e137.These are the latest guidelines for preoperative workup of patients undergoing
noncardiac surgery. It is important to review this document (or the most up-to-date document at the time) to assure that patients are being
appropriately evaluated before surgery. As always, institutional policies may vary and may not be in line with the guidelines here.
Jordan, SW, Mioton, LM, Smetona, J, et al. Resident involvement and plastic surgery outcomes: an analysis of 10,356 patients from the
American College of Surgeons National Surgical Quality Improvement Program database. Plast Reconstr Surg. 2013;131(4):763-773.
Levine, GN, Bates, ER, Bittl, JA, et al. 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with
coronary artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice
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Clark, JR, McCluskey, SA, Hall, F, et al. Predictors of morbidity following free flap reconstruction for cancer of the head and neck. Head Neck.
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Musallam, KM, Tamim, HM, Richards, T, et al. Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective
cohort study. Lancet. 2011;378(9800):1396-1407.
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Technical Consultation on the Assessment of Iron Status at the Population Level. 2nd ed. Geneva, Switzerland: World Health
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Kaplan, EB, Sheiner, LB, Boeckmann, AJ, et al. The usefulness of preoperative laboratory screening. JAMA. 1985;253(24):3576-3781.
Peterson, P, Hayes, TE, Arkin, CF, et al. The preoperative bleeding time test lacks clinical benefit: College of American Pathologists’ and
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Dumanian, GA, Bontempo, FA, Johnson, PC. Evaluation and treatment of the plastic surgical patient having a potential to bleed. Plast
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Fischer, JP, Shang, EK, Nelson, JA, et al. Patterns of preoperative laboratory testing in patients undergoing outpatient plastic surgery
procedures. Aesthet Surg J. 2014;34(1):133-141.A study examining data from ambulatory plastic surgery procedures over 5 years from the NSQIP
database. 8645 patients were analyzed, and the results showed that preoperative laboratory analysis is of little benefit in this patient population.
Mensah, PK, Gooding, R. Surgery in patients with inherited bleeding disorders. Anaesthesia. 2015;70(suppl 1):112-120.
Endara, M, Masden, D, Goldstein, J, et al. The role of chronic and perioperative glucose management in high-risk surgical closures: a case for
tighter glycemic control. Plast Reconstr Surg. 2013;132(4):996-1004.
Galdyn, I, Lewis, P, Gupta, S. Retrospective analysis of hemoglobin A1C levels in plastic surgery patients with postoperative morbidity: a
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Fischer, JP, Nelson, JA, Kovach, SJ, et al. Impact of obesity on outcomes in breast reconstruction: analysis of 15,937 patients from the ACS-
NSQIP datasets. J Am Coll Surg. 2013;217(4):656-664.
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from the 2005-2011 NSQIP datasets. J Plast Surg Hand Surg. 2014;48(5):334-339.
Gupta, V, Winocour, J, Rodriguez-Feo, C, et al. Safety of aesthetic surgery in the overweight patient: analysis of 127,961 patients. Aesthet Surg
J. 2016;36(6):718-729.
Fischer, JP, Basta, MN, Wink, JD, et al. Optimizing patient selection in ventral hernia repair with concurrent panniculectomy: an analysis of
1974 patients from the ACS-NSQIP datasets. J Plast Reconstr Aesthet Surg. 2014;67(11):1532-1540.
Lipira, AB, Sood, RF, Tatman, PD, et al. Complications within 30 days of hand surgery: an analysis of 10,646 patients. J Hand Surg Am
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Laporta, R, Longo, B, Sorotos, M, et al. Tips and tricks for DIEP flap breast reconstruction in patients with previous abdominal scar.
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2000;106(5):1004-1008.A retrospective study of 10 women undergoing secondary breast reduction. Seven out of 10 women had a reduction using a
different pedicle from the primary reduction. This is important because the surgeon does not need to rely on operative reports of a previous reduction
before proceeding with repeat surgery.
van Rijen, M, Bonten, M, Wenzel, R, Kluytmans, J. Mupirocin ointment for preventing Staphylococcus aureus infections in nasal carriers.
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Humphreys, H, Becker, K, Dohmen, PM, et al. Staphylococcus aureus and surgical site infections: benefits of screening and decolonization
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Shridharani, SM, Magarakis, M, Manson, PN, Rodriguez, ED. Psychology of plastic and reconstructive surgery: a systematic clinical review.
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Picavet, VA, Prokopakis, EP, Gabriëls, L, et al. High prevalence of body dysmorphic disorder symptoms in patients seeking rhinoplasty.
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Gorney, M, Martello, J. Patient selection criteria. Clin Plast Surg. 1999;26(1):37-40.
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Saydam, FA, Basaran, K, Ceran, F, Mert, B. Foot ischemia after a free fibula flap harvest: immediate salvage with an interpositional
sapheneous vein graft. J Craniofac Surg. 2014;25(5):1784-1786.
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Fogarty, BJ, Khan, K, Ashall, G, Leonard, AG. Complications of long operations: a prospective study of morbidity associated with prolonged
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Hardy, KL, Davis, KE, Constantine, RS, et al. The impact of operative time on complications after plastic surgery: a multivariate regression
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Apfelbaum, JL, Connis, RT, Nickinovich, DG, American Society of Anesthesiologists Task Force on Preanesthesia Evaluation . Practice
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Caprini, JA. Thrombosis risk assessment as a guide to quality patient care. Dis Mon. 2005;51(2-3):70-78.
Pannucci, CJ, Bailey, SH, Dreszer, G, et al. Validation of the Caprini risk assessment model in plastic and reconstructive surgery patients. J
Am Coll Surg. 2011;212(1):105-112.A landmark article that examined the 2005 Caprini for the purposes of plastic surgery patients and validated the
results from that original study. When performing outpatient plastic surgery procedures, this is the model that should be used to stratify VTE risk and
guide prophylaxis.
Darouiche, RO, Wall, MJ, Itani, KM, et al. Chlorhexidine-alcohol versus povidone-iodine for surgical-site antisepsis. N Engl J Med.
2010;361(1):18-26.
Rosenberger, LH, Politano, AD, Sawyer, RG. The surgical care improvement project and prevention of postoperative infection, including
surgical site infection. Surg Infect (Larchmt). 2011;12(3):163-168.The Surgical Care Improvement Project (SCIP) has been revolutionary in guiding
many facets of the perioperative care of patients. This paper gives recommendations regarding postoperative infection prophylaxis. Readers should refer
to other articles on SCIP guidelines as the data are high evidence.
Shin, CH, Long, DR, McLean, D, et al. Effects of intraoperative fluid management on postoperative outcomes: a hospital registry study. Ann
Surg. 2018;267(6):1084-1092.
Kurz, A, Sessler, DI, Lenhardt, R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten
hospitalization: study of Wound Infection and Temperature Group. N Engl J Med. 1996;334(19):1209-1215.
Horn, EP, Bein, B, Böhm, R, et al. The effect of short time periods of preoperative warming in the prevention of perioperative hypothermia.
Anaesthesia. 2012;67(6):612-617.
Carson, JL, Duff, A, Poses, RM, et al. Effect of anaemia and cardiovascular disease on surgical mortality and morbidity. Lancet.
1996;348(9034):1055-1060.
Kaoutzanis, C, Winocour, J, Gupta, V, et al. Incidence and risk factors for major hematomas in aesthetic surgery: analysis of 129,007 patients.
Aesthet Surg J. 2017;37(10):1175-1185.
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C H A P T E R 1 7
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Ethics in Plastic Surgery
Christian J. Vercler
Key Points
The patient-surgeon relationship is fiduciary in nature and cannot be reduced to merely an exchange
of goods and services.
Surgeons should not operate on family members.
Relationships with industry introduce inherent biases into research and practice that must be
acknowledged and thoughtfully managed.
Using patient images on social media is rife with ethical pitfalls that the plastic surgeon must avoid.
Innovation is inherent in plastic surgery, and the surgeon has the duty to responsibly conduct
research in a way that balances scientific rigor and at patient’s best interests.
Promoting the autonomy of a patient in decision-making requires understanding their values and
interpreting them in the context of the surgical options.
Informed consent is a process, not just a signature on a form.
The right or wrong course of action can sometimes be unclear in the practice of plastic surgery. There is
no one universally accepted account of what constitutes the good life in our secular pluralist society—in
fact, there are many competing ideas. Ethics involves disciplined reflection on these moral ambiguities.
Laws, policies, and published guidelines can assist in drawing the boundaries beyond which we should
not go, but these things alone do not define what is ethical. Certainly, unethical behavior persists despite
a myriad of laws, policies, and guidelines intended to prevent it. Unlike in science, where data illuminate
what is factual, ethics deals with values, where a factual statement does not carry with it a moral
imperative. Generally, there are three approaches in moral inquiry: What kind of person do you become
by doing this? Is this act itself ethical (and the intentions that justify it)? What are the outcomes? This
chapter will not fully articulate the philosophical rationale for the positions put forth. These are provided
in many of the references. Understanding basic principles in ethics can help one to deal with a myriad of
ethical issues as they arise, just as understanding the basic principles of plastic surgery prepares one for a
host of difficult surgical problems.
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Ethics and Professionalism
Professionalism refers to behaviors that are expected from individuals who take on the mantle of a
profession in a way that holds them to a higher standard and sets them apart from nonprofessionals.
Professionalism among plastic surgeons is extremely important, given the nature of the patient-surgeon
relationship, which is one of inherent power and knowledge imbalance. This must be a fiduciary
relationship, that is, the health, well-being, and best interests of the patient must always be prioritized. 1
This is the foundational principle of surgical ethics. Although there is not a bright line that separates
ethics from professionalism, the general understanding is that the particular professional standards
inherent to the practice of plastic surgery may change, but that ethical principles are more broadly based
concepts that are less mutable. 2
Both the American Society of Plastic Surgeons (ASPS) and the American Board of Plastic Surgeons
(ABPS) have a code of ethics that members must follow (Tables 17.1 and 17.2). These are concepts that
every plastic surgeon must know. A recent survey of plastic surgery program directors 3 identified
interpersonal communication, informed consent, and billing as the issues within ethics and
professionalism that are the most important to teach residents. Inappropriate billing is certainly a
professionalism issue, but it also may constitute fraud. This chapter will not cover billing further other
than to note that ignorance of the law generally is not a valid excuse. Surgeons who lack good
communication skills may find themselves in a situation when their behavior is being understood as
unprofessional, but that will also not be discussed further in this chapter. Informed consent for an
operation is the critical activity that must precede an operation and will be discussed at length, in
addition to several other topics that are important in daily practice.
TABLE 17.1
American Board of Plastic Surgery Code of Ethics—General Principles
I. Medical professionals shall provide their services with respect for human dignity. Physicians should merit the confidence of patients
entrusted to their care, and render to each a full measure of service and devotion.
I. Physicians shall strive to improve their medical knowledge and skills, and avail their patients and colleagues of the benefit of their
professional attainments. Physicians have an affirmative duty to disclose new medical advances to patients and colleagues.
I. The honored ideals of the medical profession imply that the responsibility of the physician extends both to the individual patient
and to society. Activities that improve the health and well-being of the individual, as well as the community, deserve the interest
and participation of the physician.
I. Plastic surgeons shall provide competent and scientifically sound medical and surgical services, while respecting the rights and
privacy of their patients.
American Board of Plastic Surgery. ABPS Code of Ethics. Available at
2011.pdf. Revised May 18, 2018.
TABLE 17.2
American Society of Plastic Surgeons Code of Ethics—General Principles
I. The principal objective of the medical profession is to render services to humanity with full respect for human dignity. Members
should merit the confidence of patients entrusted to their care, rendering to each a full measure of service and devotion.
I. Members should strive continually to improve medical knowledge and skill, and make available to their patients and colleagues the
benefits of their professional achievements. Members have an affirmative duty to disclose new medical advances to patients and
colleagues.
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I. Members should practice a method of healing founded on a scientific basis and should not voluntarily associate professionally with
anyone who violates this principle.
I. Members should observe all laws, uphold the dignity and honor of the profession, and accept its self-imposed disciplines. They
should expose, without hesitation, illegal or unethical conduct of fellow members of the profession.
I. Members may choose whom to serve. In emergency situations, however, members should render service to the best of their ability.
Having undertaken the care of a patient, a member may not neglect the patient, and until the patient has been discharged, a member
may discontinue services only after giving adequate notice.
I. Members should provide services under the terms and conditions that permit the free and complete exercise of sound medical
judgment and skill.
I. A member should seek consultation upon request, in doubtful or difficult cases, or whenever it appears that the quality of medical
service may be enhanced thereby.
I. A member may not reveal a patient’s confidence, any observed characteristics of the patient, or any information obtained from the
patient in a professional capacity, without such patient’s consent or unless required to do so by law or unless it becomes necessary to
protect the welfare of the patient or of the community.
I. The honored ideals of the medical profession imply that the responsibilities of the member extend not only to the patient but also to
society. Activities that have the purpose of improving both the health and well-being of the patient and the community deserve the
interest and participation of the member.
I. To assist the public in obtaining medical services, members are permitted to make their services known through advertising.
Advertising, however, entails the risk that the member may employ practices that are false, fraudulent, deceptive, or misleading.
Regulation is, therefore, necessary and in the public interest. Subsection II of the Specific Principles permits public dissemination of
truthful information about medical services, while prohibiting false, fraudulent, deceptive, or misleading communications, and
restricting direct solicitation.
I. In their public and private communications with or concerning patients and colleagues made in a professional capacity or
environment, members shall strive to use accurate and respectful language and images.
Code of Ethics of the American Society of Plastic Surgeons.
Reproduced with permission from American Society of Plastic Surgeons. Available at
documents/Governance/asps-code-of-ethics.pdf.
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Truthfulness and Error Disclosure
Most specific principles in the ASPS Code of Ethics relate directly to transparency and truthfulness. For
example, misleading patients through deceptive advertising, failing to report licensing sanctions,
fraudulent billing, etc. are all forbidden. Deception and subterfuge are clearly outside the bounds of
acceptable behavior for a plastic surgeon, but the profession calls to an even higher level of transparency.
Surgical errors are devastating to both the patient and the surgeon. Although it goes against our impulse
to save face, disclosing these errors is essential for several reasons. At the interpersonal level, the harm-
causing error threatens the trustworthiness of the surgeon, particularly if it remains undisclosed.
Paradoxically, a growing body of evidence supports that patients are less likely to sue when an error is
accompanied by disclosure, apology, and an offer to make it right. Disclosure of error also facilitates
improvement of systems issues at the institutional level. 4
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Operating on Family Members
Emergencies aside, the plastic surgeon should avoid operating on family members when possible. 5
Interestingly, Slavin and Goldwyn found that 88% of plastic surgeons surveyed said that they would
perform aesthetic surgery on a family member and 84% said that they had. 6 However, familial
relationships and interpersonal dynamics are fundamentally different than the patient-surgeon
relationship, which at the very least assumes that the patient is free to refuse the operation or seek a
second opinion. Prudence and judgment come with experience, and the wisdom of the surgical
community for generations has continued to admonish surgeons to avoid operating on family members. 7
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Privacy and Confidentiality
This issue is tightly regulated by the Health Insurance Privacy and Accountability Act (HIPAA), and
several issues around privacy and confidentiality are referenced in the ASPS Code of Ethics. Patient’s
health information should not be shared with anyone except those directly involved in the care of that
patient. This is particularly relevant in the practice of plastic surgery, as patient photos are routinely
taken on phones and shared over unsecured networks. To ensure patient privacy, photos should be taken
on devices that are encrypted, shared over secure networks, and shown only to those individuals
involved in the care of the patient. Consent for the use of photos beyond patient care, such as for
education and advertising, requires explicit written consent. 8
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Advertising and Social Media
The ASPS has guidelines for the use of advertising that reflect professional values of truthfulness and
privacy. Photos used in advertising must show results as truthfully as possible. Showing atypical results
with the claim that the results are typical is prohibited, also are the claims about being the best plastic
surgeon and so on. The use of models who idealize standards of beauty and are not patients is
commonplace. This skirts the admonition by ASPS to avoid language and images that induce insecurities
and a desire for the operation. Advertising has moved from print, to web-based, to now more ephemeral
app-based platforms such as Twitter, Instagram, and Snapchat. The utmost respect for our patients must
guide the use of these mediums. 9,10
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Relationships With Industry and Conflicts of Interest
Plastic surgery is an innovative field, and relationships with industry facilitate that innovation. 11
Financial relationships with companies that are motivated by profit rather than the best interests of the
patient constitute a conflict of interests that the plastic surgeon must address. These conflicts of interest
affect not only patient care but also research findings. 12 For the innovating plastic surgeon, these
inevitable conflicts of interest are not to be avoided at all costs, but rather to be actively and thoughtfully
managed. The Physician Payments Sunshine Act (PPSA) requires all payments made by biomedical
companies to physicians to be openly reported via the Open Payments Program (OPP). The idea is that
greater transparency will potentially mitigate the effects the payments might have on the surgeon’s
decision-making. 13
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Informed Consent
Justice Benjamin Cardozo’s words from the 1914 decision in Schloendorff v. Society of New York Hospital set
the backdrop for any discussion of informed consent: “a surgeon who performs an operation without his
patient’s consent commits an assault for which he is liable in damages”—hence the contemporary
practice of having a patient sign a consent form before any procedure. The form is a legal document.
Actual informed consent, however, requires that (1) the patient is a competent adult with decision-making
capacity, and (2) that the patient understands the risks, benefits, and alternatives to the proposed
operation. Competency is a legal designation and is task specific. A patient is incompetent for making medical
decisions when a judge declares it and that judgment is permanent. At this point, a legal guardian is
appointed and is recognized as the authorized decision-maker.
Decision-making capacity, on the other hand, waxes and wanes. For example, a patient who is drunk, or
sedated, or uremic, may lack decision-making capacity for a time but may regain it later. This is a clinical
determination that does not need to be made by a psychiatrist, although his or her expertise is helpful in
difficult cases. When a patient lacks decision-making capacity, a surrogate decision-maker must make
decisions for the patient based on substituted judgment. Substituted judgment requires that the surrogate
knows the patient’s values well and can use them to apply to the situation at hand to try to make the
decision the patient would make if they were able. These issues become especially difficult around the
end of life because most people lose decision-making capacity as part of the dying process. Fortunately,
most plastic surgery patients are not terminal, but many patients may have fluctuating levels of cognition
that require a working understanding of these concepts. Surrogates may be named in a living will, or
assigned as a durable power of attorney for health care (DPOA-H). If these legally appointed individuals
are not available, then spouses and family are turned to for consent to treatment.
Ensuring that the patient understands the risks, benefits, and alternatives to the proposed operation is a
difficult but necessary task. Even though many patients implicitly trust their surgeons, the act of
discussing risks, benefits, and alternatives demonstrates respect for the individual personhood of the
patient. By showing respect for the patient’s autonomy in this way, the plastic surgeon is fulfilling a
significant ethical duty. However, when a patient refuses an indicated operation, things become more
complicated. Simply accepting a refusal of an operation can lead to patient harm and loss of the proposed
benefit. In certain cases, the surgeon must also ensure that the patient is giving an informed dissent. That is,
that the refusal of the proposed operation is not based on a misunderstanding of the facts (e.g., “the
implant is not infected”) or on false beliefs (e.g., “magic will heal this”). If a competent adult with
decision-making capacity understands the risks, benefits, and alternatives of an operation and refuses the
procedure, then the surgeon must follow that decision, even if the outcome for the patient is loss of life or
limb.
The right of a competent adult to refuse any operation offered by a surgeon does not extend to a positive
right to demand any operation a patient desires. Surgeons are given the responsibility to refuse to
perform operations that do more harm than good, that are physiologically futile, or that do not meet the
overall goals of care or best interests of the patient. Also, a parent may not refuse an operation for a child
if the refusal will bring harm to the child. 14 These are some of the limits to autonomy.
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Summary
Although there are many individual topics within plastic surgery ethics, the foundational principles are
as follows: (1) respect the individual personhood of the patient, (2) prioritize the interests of the patient
over your own, and (3) shoulder the responsibility of maintaining an honest relationship with the patient
and society.
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Questions
1. A 65-year-old man with 15% TBSA (total body surface area) flame burns on his upper extremity is
intubated for smoke inhalation. His daughter refuses excision and grafting for his burns and requests
that the patient be taken off the ventilator and allowed to die, citing a discussion with him that he
would never want to live on a ventilator. What should you do?
a. Honor her request; she is the appropriate surrogate decision-maker.
b. Ask to see paperwork (e.g., DPOA-H or living will) to confirm her statements, and then
remove the ventilator.
c. Seek a court-appointed guardian to approve the operation and ongoing critical care
interventions.
d. Continue to treat the patient and call the ethics committee.
e. Have another MD sign the consent along with you and document in the chart that the
operations are an emergency and must be performed.
2. A father brings his 1-year-old son with a left unilateral complete cleft lip and palate to your clinic
for evaluation. He states that he does not want to have his son’s cleft lip or palate repaired and is in
your office only because his pediatrician coerced him to come. He thinks that operating on his baby
to force society’s standards of beauty on him is barbaric. He also has been applying an herbal balm on the
lip and palate and believes that it is getting better with this treatment. What do you do?
a. Tell him that you have to fix his palate because that is a functional operation for speech but
that he does not need to have his lip repaired.
b. Tell him that the lip and palate both need to be repaired and that you will report him to Child
Protective Services if he refuses to let the operations occur.
c. Call hospital security to escort the child to the operating room for immediate lip repair.
d. Take some photos to document the child’s appearance and thank him for coming to your
office. Have him follow-up in 6 months.
3. Which of the following must you do to maintain patient privacy when using photos of them?
a. Obtain informed consent for all intended uses.
b. Take the photos on an encrypted device.
c. Store photos on an encrypted drive.
d. All of the above.
4. You are performing an abdominoplasty and inadvertently buttonhole the flap with the Bovie and
burn the skin. You notice that the Bovie is set to 85. The defect is large enough that you decide to
excise it and close it primarily. In follow-up, the patient asks what the incision is. She seems to think
you removed a mole from the area (you did not). What did you tell her?
a. “I’m sorry, but that’s an area where I inadvertently burned through your skin. The
electrocautery was set much higher than I usually use it and we are investigating as to why that
occurred.”
b. “Yes, don’t worry about that mole. You are better off without it.”
c. “That’s from an equipment malfunction. It could have been much worse. You’re lucky.”
d. “That’s nothing. Don’t worry about it.”
5. You maintain a professional Instagram account where you post before and after photos of your
patients, who have all given written informed consent for this specific purpose. One of your patients
on whom you did a facelift, blepharoplasty, and laser resurfacing posts a selfie and tags you, giving
you credit for her look. She messages you and asks you to repost her photo on your page. You notice
that she has used a filter to alter the photo giving her skin a much smoother appearance than your
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procedure did and the angle from which the photo is taken gives her neckline a more defined angle
than you achieved with your facelift. Which of the following violates the ASPS Code of Ethics?
a. Repost the photo to your account. There are no privacy or confidentiality concerns as she has
already posted the photo to her account identifying as her surgeon.
b. Repost the photo, but in the description state results not typical and note that a filter was used
to enhance the appearance of the skin.
c. Have her come back to your office for a set of postoperative photos that adhere to the
photographic standards of the ASPS, sign a consent for use of images on social media, and post
as a before and after in the same style as the other images on your account.
d. Ask her to continue to post photos of herself using these same techniques while tagging you,
and additionally to add #bestplasticsurgeonever to the post.
e. Answers a and d.
f. Answers b and c.
1. Answer: d. Choice a is incorrect because it is not clear that her daughter is the appropriate
surrogate decision-maker. She could be if she was designated by a DPOA-H document, or if there
was no other available next-of-kin. Choice b is incorrect because even if documentation was
produced confirming that the patient would not want to live on a ventilator, it is imprudent to make a
hasty decision in the acute setting, as it is not clear that the patient will need to live on the vent and
may be weaned expeditiously. Choice c is incorrect because the patient has a next-of-kin who is
available to aid with decisions, using substituted judgment (i.e., speaking to what the patient would
want for himself if he could speak). Choice e is also incorrect—the two-MD consent is a misnomer that
refers to cases where an urgent or emergent procedure is needed and delaying the procedure would
result in significant harm to the patient. This is more accurately characterized as presumed consent
(where it is presumed that most reasonable people would prefer the urgent operation), and some
hospitals have a policy that the urgency of the situation has to be documented by a second MD. This
concept does not apply in this scenario. Choice d is the correct answer because it facilitates a more in-
depth assessment of the values that seemingly conflict in this case. The issues that require clarifying
are: whether the daughter is the appropriate surrogate decision-maker; if she is, whether she is truly
making judgments that reflect the patient’s values. Living wills are documents that are executed by
persons to guide end-of-life care. They are helpful in guiding decisions when a patient has a terminal
diagnosis, which is not the case in this scenario. In most cases, it is not necessary to consult a hospital
ethics committee; their expertise can help guide cases or mediate disputes when there is a conflict in
values.
2. Answer: b. Parents are not allowed to make decisions that will harm their child. Articulation
errors continue to worsen when palates are not repaired by 12 months. So, d is incorrect because it
would allow his palate to go unrepaired until 18 months. Getting Child Protective Services involved
can be the encouragement that a family might need to adhere to surgical recommendations so that a
situation as in c is not needed.
3. Answer: d. Identifying patient information, including photos, should be handled in a manner
compliant with HIPAA, and if photos are used to do anything other than direct patient care, such as
education or in a promotional way on social media, specific consent for those uses must be obtained.
4. Answer: a. Apologizing, being honest, and discussing steps that are being taken to prevent the
error from occurring again in the future is the best way to approach errors. The other answers
involve deception.
5. Answer: e. The ASPS Code of Ethics specifically addresses deceptive or misleading practices in
advertising and these tenets apply to posts on social media accounts as well. Choice a is incorrect
because even if the patient has given tacit consent by putting her image online, the image uses
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different light, poses, or photographic techniques to misrepresent the results achieved by the individual, which
is forbidden. Choice d violates that same principle and but also violates the admonition to not claim
superiority over other surgeons with similar training. Only answers b and c adhere to the guidelines
set forth by the ASPS.
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References
Vercler, CJ. Surgical ethics: surgical virtue and more. Narrat Inq Bioeth. 2015;5(1):45-51.Brief introduction to a series of articles written by surgeons
about ethical dilemmas they have encountered. It introduces the idea that surgeons have unique ethical responsibilities to their patients.
Preminger, BA, Hansen, J, Reid, CM, Gosman, AA. Plast Reconstr Surg. 2018;141(4):1071-1072.
Bennett, KG, Ingraham, JM, Schneider, LF, et al. The teaching of ethics and professionalism in plastic surgery residency: a cross-sectional
survey. Ann Plast Surg. 2017;78(5):552-556.
Vercler, CJ, Buchman, SR, Chung, KC. Discussion harm-causing errors with patients: an ethics primer for plastic surgeons. Ann Plast Surg.
2015;74(2):140-144.Introduction to ethical reasoning and to applying different approaches to a case where an error occurred resulting in harm to a
patient. The ethical arguments for disclosing harm-causing medical errors to patients are summarized, including a review of data that support better
outcomes in cases where full disclosure and apology occurs. Practical recommendations on how to do it are also discussed.
Gold, KJ, Golman, EB, Kamil, LH, et al. No appointment necessary? Ethical challenges in treating friends and family. N Engl J Med.
2014;371(13):1254-1258.
Slavin, SA, Goldwyn, RM. A family operation: plastic surgeons who perform aesthetic surgery on spouses or other family members. Plast
Reconstr Surg. 2010;125(3):1018-1023.
Jones, JW, McCullough, LB, Richman, BW. The ethics of operating on a family member. J Vasc Surg. 2006;42(5):1033-1035.
Bennett, KG, Bonawitz, SC, Vercler, CJ. Guidelines for the ethical publication of facial photographs and review of the literature. Cleft Palate
Craniofac J. 2019; 56(1):7-14. doi:10.1177/1055665618774026.
Bennett, KG, Vercler, CJ. When is posting about patients on social media unethical medutainment? Am Med Assoc J Ethics. 2018;20(4):384-391.
Bennett, KG, Berlin, NL, MacEachern, MP, et al. Ethical and professional use of social media in surgery: a systematic review of the literature.
Plast Reconstr Surg. 2018;142(3):388e-398e.Engagement in social media is part of contemporary plastic surgery practice. This systematic review
summarizes published guidelines of the ethical and professional use of social media, draws upon well-established principles in ethics and
professionalism, and provides a set of guidelines to follow to ensure compliance with the tenets of the Code of Ethics of the American Board of Plastic
Surgery and American Society of Plastic Surgeons.
Wang, Y, Kotsis, SV, Chung, KC. Applying the concepts of innovation strategies to plastic surgery. Plast Reconstr Surg. 2013;132(2):483-490.
Lopez, J, Lopez, S, Means, J, et al. Financial conflicts of interest: an association between funding and findings in plastic surgery. Plast Reconstr
Surg. 2015;136(5):690e-697e.
Ahmed, R, Lopez, J, Bae, S, et al. The dawn of transparency: insights from the physician payment sunshine act in plastic surgery. Ann Plast
Surg. 2017;78(3):315-323.
Diekama, D. Parental refusals of medical treatment: the harm principle as threshold for state intervention. Theor Med Bioeth. 2004;25(4):243-
264.
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C H A P T E R 1 8
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Principles of Research Designs and Outcomes
Research
Chelsea A. Harris and Kevin C. Chung
Statistical thinking will one day be as necessary a qualification for 

efficient citizenship as the ability to read and
write.
H.G. Wells
Key Points
How to develop and evaluate a research question
Defining populations and sampling techniques
Major statistical terms and concepts
Prominent study designs
Sources of bias
Medical knowledge is expanding at exponential rates. In 1950, scholars estimated that it would take
50 years for medical knowledge to double; by 2010, this period had shrunk to just 3.5 years. If trends
continue, by 2020, medical knowledge will double in a mere 73 days. In this climate of ever-increasing
information, being able to design impactful studies and interpret the medical literature is essential to
being an effective academic plastic surgeon. This chapter will review the fundamental principle of
research design.
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Developing Your Research Question
Answering the Who Cares? Question
Formulating a good research question is at the core of performing excellent research (Figure 18.1).
Without an impactful question, researchers risk wasting time and effort on a problem no one cares about
solving. In fact, selecting meaningless research topics may actually make it harder for others to obtain
relevant, quality data by forcing them to sift through more low-quality data in what is often an already
crowded field. Thus, when beginning a project, researchers must first be able to make a strong case to
potential readers why they should care. For more experienced researchers, a reminder to answer the Who
cares? question may seem obvious. However, habitually evaluating topics through this lens will help the
team make broader connections and prevent embarking on projects whose sole aim is to produce a
published manuscript.
FIGURE 18.1 Developing quality research questions.
As a corollary, researchers should also carefully consider whether answering a particular question
requires a scientific process. Take, for example, surgery residents’ emotional well-being at work. As
demonstrated by multiple randomized trials, this is a growing area of scientific interest and easily passes
the Who cares? test. However, a study that examines whether throwing scalpels at residents damages their
emotional well-being is not needed. Besides being unethical, the question is readily answerable with
some common sense. Although this is clearly an extreme example, there are many instances when clinical
knowledge and rational thought are sufficient, and further scientific examination is not warranted.
Finally, a focus on the Who cares? question should not preclude research on rare diseases or highly
specific topics. Often insight derived from an esoteric project can be applied to multiple conditions or
problems. Rather, investigators should begin by addressing the Who cares? question to help structure their
approach and maximize impact. At the very least, a clearly defined case for why their work matters will
facilitate later efforts to publish and disseminate their work. 1,2
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Steps to Formulating an Impactful Research Question
Once the team has selected an impactful issue, the next step is to appropriately narrow the question. For
example, everyone can agree that cancer is an important topic; however, the question What causes cancer?
is clearly too broad. Adapting the PICOS criteria (Figure 18.2), which were first developed in the context
of structuring systematic reviews, can be helpful in systematically defining the scope of your question. 3
Of course, investigators should also be wary of narrowing their question too much, as undue restrictions
can actually make performing the research more difficult and may reduce some of the potential Who
cares? factors.

FIGURE 18.2 PICOS criteria.
As investigators move through the PICOS criteria, they should also begin to evaluate whether their
developing question is answerable with their available resources. Do they have access to the population
in question? Has the relevant exposure variable been measured with enough accuracy and consistency
that it can be used to generate meaningful results? Would the outcome manifest in the relevant
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timeframe? Prematurely attempting to answer the research question without carefully considering study
feasibility is a setup for wasted effort.
Finally, prior to commencing investigation, prudent researchers must ensure that their question has not
already been answered. 
 A systematic literature review should readily reveal pertinent studies; however,
similar publications do not necessarily mean the research team should abandon their project. Substantial
differences between the published study population and the current target population, small sample
sizes, serious methodologic flaws, or long time lapses all leave room for additional study. However, if the
current literature fully addresses the query, it is time to come up with a new question.
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Selecting a Population and Sampling Technique
Defining the population and the study sample is an important first step in beginning your research. This
should begin by creating inclusion criteria (the conditions prospective subjects must meet to be relevant
to the outcome) and exclusion criteria (the characteristics that disqualify prospective subjects). The pool
of people who meet these clearly defined criteria represents the study population. The study sample is
the subset that you will assess in the study.
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Effect Size and Generalizability
How well the study sample represents the larger population from which they were drawn speaks to how
generalizable the study is. In other words, the degree to which study findings apply to the greater
population will depend on how closely the sample and the population match. If researchers include 100%
of the parent population in their sample, their findings (assuming the study is done well) will be perfectly
generalizable. If the sample is narrowed to 63-year-old men named Steve currently admitted to room 612,
the findings are unlikely to be broadly applicable.
When weighing how restrictive it is to make inclusion and exclusion criteria, researchers also have to
consider the anticipated effect size among different subsets of the population. Prioritizing generalizability
may dilute the strength of a proposed association. For example, if a pharmacist is trying to test the
benefits of a weight loss drug, including people with only 2 or 3 pounds of excess body weight may make
it more difficult to demonstrate an effect than testing the drug in patients with body mass indices above
40. Although, as we will detail later, there are some statistical methods that can overcome this issue, it
remains an important upfront consideration.
There are some additional nuances to note when considering population and study sample (Figure 18.3 ).
First, the defining inclusion/exclusion criteria should actually be a two-staged process. When authors
report inclusion and exclusion criteria in academic journals, they often include practical considerations
such as the ability to speak English or ability to consent. These sorts of logistical concerns should only be
applied when selecting the study sample from the population, not in defining the population itself. The
goal in defining the population is to establish the boundaries of all possible study candidates based on
exposures and disease potential.
FIGURE 18.3 Steps in determining a study sample.
Researchers must also be mindful of the de facto exclusion criteria they introduce in how they recruit their
sample. For example, if they invite individuals to join their study through e-mail, they may
unintentionally exclude people with low literacy and those with no access to a computer. As will be
discussed in greater detail in the section explaining bias, researchers must carefully consider how the
exclusion criteria and sampling techniques they employ may stand to alter their results. 4
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Understanding the Sampling Unit
Most data exist in some sort of structure; thus, researchers must decide at what level they wish to study.
For example, if the team is interested in obesity, they could decide to study neighborhoods, families, or
individuals (Figure 18.4). The source material (e.g., a list of all the individuals in a neighborhood) is called
the sampling frame. The level at which subjects are enrolled (e.g., family) is called the primary sampling unit.
If researchers then perform additional sampling that either goes into finer details (the individual) or
aggregates to broader categories (neighborhood), this level is the secondary sampling unit. 5
FIGURE 18.4 Examples of different sampling units.
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