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postoperative pain control regimen. Which of the following interventions is associated with reduced perioperative opioid requirements?
a. Patient education on expected levels of postoperative pain b. Ketorolac administration prior to extubation and for the first 3 days postoperatively
c. TAP block
d. Postoperative multimodal pain control regimen consisting of acetaminophen, NSAIDs,
gabapentin, and opioids
e. All of the above
ANSWERS AND EXPLANATIONS
Answer: c.  This patient with obesity (1 point) and oral contraceptive pills (1 point) has a Caprini
score of 2, which is considered low risk for VTE. Her VTE risk can be managed with patient education, intraoperative mechanical prophylaxis with sequential compression devices, and early postoperative ambulation. Pharmacologic prophylaxis is not indicated in low-risk patients undergoing low-risk surgical procedures for VTE. In an already low-risk patient, there is no need to stop oral contraceptive pills prior to surgery. While obesity is a risk factor for VTE, this patient is otherwise low risk, and preoperative weight loss is not required.
Answer: a.  Antibiotic prophylaxis is indicated in clean procedures of the breast; therefore, this patient undergoing mastopexy requires perioperative prophylaxis. The duration of antibiotics should be limited to a single perioperative dose of cefazolin administered within 30 to 60 minutes of incision time. Current literature does not provide any evidence that postoperative systemic antibiotics can lower the incidence of SSI. However, increased duration of antibiotics has been shown to increase bacterial diversity, rates of gram-negative infections, allergic reactions, and Clostridium difficile colitis.
Answer: e.  Opioid dependency is one of the most common complications of elective surgery. Surgeons should strive to reduce the quantity and duration of opioid consumption following surgery. Current literature suggests that opioid consumption may be reduced through patient education and multimodal pain regimens. Pain regimens should use a variety of oral nonopioid medications, in addition to local anesthetic blocks and IV ketorolac.
REFERENCES
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2. Fu RH, Toyoda Y, Li L, Baser O, Rohde CH, Oerburn DM. Smoking and postoperative complications in plastic and general surgical procedures: a propensity score-matched analysis of 294,903 patients from the national surgical quality improvement program database from 2005 to
2014. Plast Reconstr Surg. 2018;142(6):1633-1643.
3. Harrison B, Khansa I, Janis JE. Evidence-based strategies to reduce postoperative complications in plastic surgery. Plast Reconstr Surg. 2016;138(3 suppl l):51S-60S.
4. Chen CL, Shore AD, Johns R, Clark JM, Manahan M, Makary MA. The impact of obesity on breast surgery complications. Plast Reconstr Surg. 2011;128(5):395e-402e.
5. Sieffert MR, Fox JP, Abbo LE, Johnson RM. Obesity is associated with increased health care charges in patients undergoing outpatient plastic surgery. Plast Reconstr Surg. 2015;135(5):1396-
1404.
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6. Srinivasa DR, Clemens MW, Qi J , et al. Obesity and breast reconstruction: complications and patient-reported outcomes in a multicenter, prospective study. Plast Reconstr Surg. 2020;145(3):481e-490e.
7. Keller U. Nutritional laboratory markers in malnutrition. J Clin Med Res. 2019;8:775.
8. Reich MS, Fernandez I, Mishra A, Kafchinski L, Adler A, Nguyen MP. Diabetic control predicts surgical site infection risk in orthopaedic trauma patients. J Orthop Trauma. 2019;33(10):514-517.
9. Goltsman D, Morrison KA, Ascherman JA. Defining the association between diabetes and plastic surgery outcomes: an analysis of nearly 40,000 patients. Plast Reconstr Surg Glob Open. 2017;5(8):e1461.
American College of Surgeons NSQIP data. J Am Coll Surg. 2018;226(2):173-181.e8.
postoperative complications: a retrospective cohort analysis. Plast Reconstr Surg. 2022;150:82S-94S.
following panniculectomy in the elderly. Plast Reconstr Surg Glob Open. 2020;8(7):e2987.
psychosocial function of children with craniofacial anomalies. Plast Reconstr Surg. 2017;140(4):776-
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cosmetic surgery. Plast Reconstr Surg. 2004;113(4):1229-1237.
Reconstr Surg. 2013;132(6):1759-1762.
thromboembolism in middle aged women: prospective cohort study. BMJ. 2009;339:b4583.
guide. Plast Reconstr Surg. 2017;139(2):520e-532e.
risk assessment and prophylaxis in plastic surgery. Plast Reconstr Surg. 2022;149(1):121e-129e.
thromboembolism prophylaxis. Mayo Clin Proc. 2020;95(12):2775-2798.
reoperative hematoma. Plast Reconstr Surg. 2012;129(1):160-168.
stratification, pathophysiology, clinical presentation, diagnosis and nonthrombotic pulmonary embolism. Exp Clin Cardiol. 2013;18(2):129-138.
NEJM Evidence. 2022;1:EVID2100050.
mastectomy: is stopping testosterone before top surgery really necessary? Plast Reconstr Surg. 2023;151(2):421-427.
venous thromboembolism and other complications. Plast Reconstr Surg. 2021;147(4):1008-1017.
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consumption paerns for plastic and reconstructive surgery patients. Plast Reconstr Surg. 2021;147(4):669e-679e.
hospital consumer assessment of healthcare providers and systems survey. JAMA. 2017;317(19):2013-2015.
expectations for postoperative opioid prescriptions. Ann Plast Surg. 2020;84(6S suppl 5):S437-S440.
ambulatory plastic surgery with an opioid-restrictive pain protocol. Ann Plast Surg. 2020;84(6S suppl 5):S431-S436.
the perioperative period. Plast Reconstr Surg. 2017;140(4):613e-619e.
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nonsteroidal antiinflammatory drugs for postoperative analgesia in outpatient rhinoplasty. Plast Reconstr Surg. 2021;147(1):56-62.
procedures: a nationwide Claims analysis. Plast Reconstr Surg. 2018;142(4):472e-480e.
plastic surgery: an evidence-based consensus conference statement from the American Association of Plastic Surgeons. Plast Reconstr Surg. 2015;135(6):1723-1739.
immediate prosthetic breast reconstruction: evidence from 683 consecutive reconstructions without prophylaxis. Plast Reconstr Surg. 2023;151(5):730e-738e. doi:10.1097/PRS.0000000000010073
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CHAPTER 14 Ethics of Plastic Surgery
Loree K. Kalliainen
KEY POINTS
Cultural differences need to be taken into account when discussing treatment options.
Practical application of codes of ethics includes valuing dignity, confidentiality, informed consent, competent practice, scientific justification, and appropriate advertising.
Open disclosure of relationships with industry and conflicts of interest in academic forums maintains integrity of the field of plastic surgery.
INTRODUCTION
Plastic surgery has traditionally valued novelty and innovation and, in doing so, routinely faces ethical questions regarding appropriate and optimal application of our skills. We work with patients who are healthy but wish to present themselves to the world in a new way as well as patients with life-altering injuries, birth differences, or acquired conditions. People of all cultures have modified their bodies for cultural and personal purposes through recorded history, but the speed and variety of change has increased over the past several decades. Our techniques have likewise continuously improved, facilitating evermore complex and elegant solutions to our patients’ concerns, needs, and desires. This chapter will review principles of ethics and discuss the many ways in which ethical questions are related to our practices as plastic surgeons.
DEFINITIONS
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Ethics is the branch of philosophy that discusses applications of the moral ideas of right and wrong. Applied ethics is a further subdivision of philosophy and includes discussions of practical questions of the nature of “right actions” in the fields of medicine, science, business, and law. This can be further divided into macro- and microethics. Macroethics in surgery are related to big picture questions such as societal issues of distributive justice and the nature of ethical principles. Microethics deals with the doctor-patient relationships, the consent process, and the individual choices made in practice. Professional ethics are those moral principles promoted by professional societies and expected of members, and ideally are those personally held and practiced by professionals.1 A profession is defined as how one masters a complex body of knowledge requiring advanced education. Members of a profession are autonomous, are self-regulatory, and chosen by other members of the profession. Members are formally organized, follow a code of ethics, and serve a useful purpose in society.2 Professionalism is an expectation of all surgeons and, per the Accreditation Council for Graduate Medical Education, includes commitments to “carrying out professional responsibilities, adherence to ethical principles, and sensitivity to a diverse patient population.”
3
ETHICAL PRINCIPLES
Following the creation of the Belmont Report which serves to protect research subjects, Beauchamp and Childress defined the classic four pillars of ethics widely used today in ethical situations with patients: autonomy, beneficence, nonmaleficence, and justice.
4
Autonomy is defined as respect for another’s choices. Beneficence is keeping the patient’s welfare in mind by respecting their choices, protecting them from harm, and actively working toward their own good. Nonmaleficence is the avoidance of intentional harm. Justice considers how benefits and risks are distributed among a group which includes the consideration of distribution of scarce resources and of differing needs of group members for resources. Articles in the plastic surgery literature have infrequently discussed ethics, but inclusion of the ethical principles has increased since 2017. The
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most common practice area discussing ethics was that of esthetic surgery followed by composite tissue allografting. Furthermore, the most common principle discussed was autonomy/informed consent.
4
Though the four ethical pillars have been understood and applied in research since 1979, routine, overt, adoption in daily clinical practice is not common. A more practical method to view and apply ethics in daily patient care was developed by Jonsen. The four elements of his “box method” are indication, context, patient choices, and quality of life.
4
The principalist view above is not necessarily shared by all persons. Given the increasing diversity of backgrounds of people living in the United States, it is important to consider that people from other cultures have different priorities and perspectives regarding their health, decision-making, the role of religion, acceptability of procedures and medications, and the roles of family and community. Efforts should be made to identify and adapt to preferences that are important to patients from other cultures.
5,6
The American Society of Plastic Surgeons (ASPS) and the American Board of Plastic Surgery (ABPS) both have published codes of ethics.
7,8
Each discusses the importance of valuing our patients’ dignity, maintaining confidentiality, operating with competence and using techniques with scientific merit, and maintaining the boundaries of advertising. The ASPS code also includes a discussion of the informed consent process.7 It is the duty of all plastic surgeons and plastic surgery trainees to familiarize themselves with the codes and to follow them accordingly.
Informed Consent
As has been discussed broadly in the literature, informed consent is not a paper but a process. It includes a description of the planned procedure; discussion of why the procedure has been chosen; risks, benefits, and alternatives (including nonoperative approaches); and reasonable expectations of the procedure.7 When multiple options are reasonable, each should be discussed thoroughly with the patient who then should make the final choice. For example, including videos of the procedure and written information from
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professional societies in the informed consent process empowers patients to make better decisions for their health. Reviewing a prewritten algorithm or making notes and drawings during the visit are helpful for the patient and their family as the volume of information can be daunting. Or, in complex situations, it is valuable to schedule a second visit to review options. In addition, patients must be told if the procedure is part of a research study, whether the surgeon has conflicts of interest related to the procedure, and if any elements of the procedure are considered off-label use. Written information should be in the patient’s preferred language, and the language of documents should be at a reading level appropriate for the patient. For non–English-speaking patients, a professional translator must be used—whether by telephone, video, or in person. Family members, friends, or the patient’s employer should not be used as translators. When using a translator, it is important for the surgeon to speak in short, declarative sentences using nontechnical language. Patients should be asked to state back their interpretation of the procedure. It is recommended that the consent process be done at a time before the day of surgery (unless this is not possible, such as in urgent trauma situations). This also serves as a cooling off procedure to ensure that the patient is making a thoughtful and unhurried choice after receiving educational information. Many patients are well-educated regarding their options and many only believe that they are. It is the surgeon’s responsibility to provide a full and accurate picture of all key elements related to the procedure. The procedure should be reviewed on the day of surgery and any questions clarified. Patients should be suggested at their initial visit or visits that they write down questions that arise after the visit. If the patient appears to be uncertain about proceeding or has questions demonstrating a major lack of understanding on the day of surgery, strong consideration should be given to rescheduling the procedure.
Conflicts of Interest
The Physician Payment Sunshine Act was created in 2010 to disclose payments from industry to physicians.9 The goal of this program was to reveal potential sources of bias related to relationships with industry held by physicians. Payments in the Open
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Payments Database (OPD) range from accepting lunch at a meeting to consultations for professional opinions to creation of a technology. It is recommended that physicians check their OPD data annually to confirm accuracy and challenge erroneous entries.
Innovation is valuable and has been an intrinsic part of our specialty, but it is important to be aware of the potential influence industry has on research and practice. More than 50% of plastic surgeons (and many presenting at national meetings) have some relationship with industry, and more than half of all payments by industry ($46 million) have been made to 1% of board-certified plastic surgeons. Furthermore, almost all the surgeons were male (95%) and in private practice (77%).10 Awareness of speakers’ and authors’ conflicts is important in evaluating content of information presented at meetings and in publications before deciding whether to incorporate the proposed material into one’s practice. Reading at least three varying opinions on any topic is a useful exercise while attempting to triangulate your way toward an objective truth.
Given the expense of research and product development and the diminishing funding for research, surgeon involvement in research and collaboration with industry are important. Investigators should be aware, though, of the specifics within contracts with industry. If restrictions are placed on study design or dissemination of all findings by the industry sponsor, the relationship should be reconsidered. Research has found that published industry­sponsored research is more likely to be supportive of the product under investigation. This may be related to biases by journals against negative findings or restriction of publication of data by the industry sponsor. Industry has also withheld negative findings that have only been revealed after large-scale complications related to the medication or treatment become known.11 Even the US Food and Drug Administration has withheld from public scrutiny over one million reports of harm related to medical devices since 2016.
12
Disclosure of Relationships
A high percentage of speakers, moderators, panelists, and instructors at national plastic surgery meetings have received
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industry funds related to royalties, licenses, and consulting fees.
9
Panelists, moderators, and instructors were the most common roles of surgeons who received industry payments, and many speakers, when stating their disclosures, will only make disclosure they feel relevant to that session. It is incumbent upon the listener to review complete listings of conflicts of interest to determine for themselves the potential degree of impact of these biases.
Guidelines which may be helpful in managing conflicts include monitoring the OPD, recusing oneself at meetings where the source of conflict is being discussed, using a variety of products in clinical practice to challenge personal biases, and disclosing all sources of conflict to patients, employers, and audiences.13 Retrospective studies have found incomplete reporting of conflicts of interest; most are relatively small monetary sums related to food and beverage and are infrequently associated with research.14 As even minimal interactions with industry can create favorable conscious and unconscious biases toward products, it is important for authors to disclose all payments.
13,14
ETHICS AND EVIDENCE-BASED MEDICINE
Research evidence has been stratified into levels since the 1980s, making it easier to determine the effectiveness of treatments based on the quality of the research data. The initial goal was to attempt to substitute true knowledge for the power-based wisdom that was the status quo.15 Stratification is based on study design—the randomized controlled trial (RCT) (level 1) being at the apex and the case report (level 5) at the base. Stratification is based on the quality of the design and likelihood of avoidance of the most common types of bias and statistical error. Modifications of the levels of evidence have been made depending on whether the study design is therapeutic, prognostic, diagnostic, symptom prevalence, or economic, whether it is a systematic review or an individual one, and if it is prospective or retrospective. Studies are further defined by whether they can be strongly recommended (grade A) or considered an option (grades C and D).
16
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