2017 HSC Section 2 - Practice Management

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,

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%).

In a follow-up study,

Wolf et al

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.

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.

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.

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.

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.

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.

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.

Disclosures

Competing interests:

None.

Sponsorships:

None.

Funding source:

None.

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Winford et al

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