2017 HSC Section 2 - Practice Management

Winford et al

Because informed consent makes up a significant and seemingly easily preventable proportion of claims against otolaryngologists, a look into how the informed consent pro- cess can be improved is warranted. Two studies highlighted above allude to informed consent being an issue in 26% and 37% of the cases, respectively. 15,18 The current study showed a similar result, with 27% of the cases involving informed consent. Understanding the informed consent pro- cess has been reviewed in several articles since 2000. 19-23 The legal standard for informed consent is typically the ‘‘reasonable patient’’ or ‘‘reasonable physician’’ standard, outlined as follows: what would the typical physician dis- cuss about the intervention (the reasonable physician stan- dard), and what would the average patient need to know to make an informed decision (the reasonable patient stan- dard)? In Wolf et al, 19 otolaryngologists were surveyed to identify what risks were discussed preoperatively. Nearly all discussed CSF leak (99.1%), bleeding (96.7%), orbital injury (96.7%), and infection (84.8%). Fewer otolaryngolo- gists discussed changes in smell (40.2%), cerebrovascular accident (17.9%), and death (28%). 19 In a follow-up study, Wolf et al 20 studied the patient perspective as it relates to what risks patients wish to be made aware of prior to ESS. They found that 69% of patients wished to be informed of complications that occur as infrequently as 1 in 100 cases, regardless of severity. 20 It is important for any surgeon to be aware of the expecta- tions and level of understanding of a patient when going through the process of informed consent. For otolaryngologists specifically, it has been shown that there are wide variations in the practice of informed consent and preoperative counseling among surgeons performing ESS. 21 Existing studies have reviewed demographic details involved in the informed con- sent process for sinus surgery. One study found that younger patients, Caucasian patients, and more educated patients wished to know about complications at the lowest risk levels more so than black patients or uneducated patients. 22 A con- clusion from a similar study discovered that patients felt that discussion of potential complications, especially CSF leak and vision changes, was important. Although these discussions trig- gered anxiety, this did not contribute to a significant number of case cancellations. 23 With the advent of technological advances and changing surgical approaches, the relationship of the use or nonuse of state-of-the-art equipment and its subsequent effect on liti- gation must be queried. Considering the recent escalated use of image guidance in ESS, the question of the impact of this technology on ESS litigation was addressed in a recent study by Eloy et al. 24 In this study, 30 malpractice cases over the past 10 years (2004-2013) were examined. In 26 (86.7%) of the cases, image guidance was not used; how- ever, its nonuse was not specified as an alleged cause of negligence. In the 4 (13.3%) cases that image guidance was used, this factor did not contribute to the decision to initiate litigation, nor did it affect the case outcomes. This led to the conclusion that using imaging guidance does not neces- sarily make one more vulnerable to malpractice litigation. 24

In conclusion, otolaryngologists should be informed of the reasons for litigation in the treatment of sinonasal dis- ease. Awareness of the location of the skull base and orbit during any sinonasal procedure is paramount when it comes to avoiding complications. Ensuring adequate well-informed consent and documenting to this effect is a significant factor in avoiding medical malpractice in sinonasal surgery. One limitation of this study is the relatively low number of cases (26) identified in the 2 legal databases. This number is in keeping with the previous studies. Both databases gave sim- ilar results, with LexisNexis including 2 additional cases not present in Westlaw. The voluntary nature of the case submis- sions, the different organization of the case summaries, incomplete information, and the need for a subscription are weaknesses of these databases. There are also elements of recall and reporting bias due to the voluntary nature of the case submissions. This most certainly leads to an underesti- mation of the frequency of malpractice cases in sinonasal dis- ease. Search terms from previous studies were not explicit and so could not be replicated. A unified database dedicated to medical malpractice that is not reliant on voluntary sub- mission and that is easily accessible to physicians is needed. Complete information on the allegations of malpractice, ver- dict, and award amount would be very beneficial for further analysis of specific litigation. Author Contributions Tyler W. Winford , design of work, data analysis, drafting, presen- tation, final approval, accountability for all aspects of work; Jordan L. Wallin , design of work, critical revision, final approval, accountability for all aspects of work; John D. Clinger , design of work, critical revision, final approval, accountability for all aspects of work; Aaron M. Graham , data analysis, interpretation of data, final approval, accountability for all aspects of work. 1. Studdert DM, Mello MM, Brennan TA. Medical malpractice. N Engl J Med . 2004;350:283-292. 2. Studdert DM, Mello MM, Gawande AA. Claims, errors, and compensation payments in medical malpractice litigation. N Engl J Med . 2006;354:2024-2033. 3. Hertz BT, Arthurs J. Malpractice rates plateauing: the only thing to fear may be fear itself. Med Econ . 2011;88:24-25, 28-29, 32. 4. Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to physician specialty. N Engl J Med . 2011;365: 629-636. 5. Stankiewicz JA. Complications of sinus surgery. In: Bailey BJ, ed. Head and Neck Surgery: Otolaryngology . Vol 1. Philadelphia, PA: Lippincott Williams & Wilkins; 2001:401. 6. Blake DM, Svider PF, Carniol ET, Mauro AC, Eloy JA, Jyung RW. Malpractice in otology. Otolaryngol Head Neck Surg . 2013;149:554-561. Disclosures Competing interests: None. Sponsorships: None. Funding source: None. References

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