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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_1450_Библиотеки_им_академика_М_И_Перельмана
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84 E. Wilson and K. Schroeder
whom, and via what platform. Delivering too much information increases the poten-
tial risk that patients may fail to focus on important details or become unnecessarily
concerned with incredibly rare outcomes. In contrast, a consent discussion that is
too limited from the patient’s perspective may foster a feeling in patients and their
families that there is an effort to hide information or that healthcare professionals are
limited in their interest in caring for patients. High-intensity/acuity situations (i.e.
obstetrics and emergency departments), efforts to obtain consent in patients with
limited capacity (i.e. in the setting of inebriation or polypharmacy), special patient
populations (i.e. athletes, language barriers, and pediatrics), dealing with unknown
consequences of a proposed intervention in the setting of pre-existing neurologic
disease, and working with procedural learners/trainees can conspire to complicate
the ability to achieve a satisfying consent discussion. However, there are a number of
considerations and processes that, once utilized, can contribute to a more satisfying
and appropriate consent process.
2 Historical Perspectives
There are, unfortunately, a series of historical landmark cases and studies that high-
light inappropriate, inadequate, or omitted consent processes for research or clinical
activities and it is shocking how recently one might peer back into our collective
history to observe episodes of consent misconduct. An early leader in the fight for
ethical research conduct was Henry K. Beecher, an anesthesiologist, who was instru-
mental in stopping a wide range of inappropriate clinical trials that included exposing
unknowing participants to live viruses and injected cancer cells [1]. It wasn’t until
1972 that the Tuskegee Syphilis Study was finally terminated after a whistle blower
brought to light the abuse of these research subjects [2]. In similar ways, historical
disclosure for clinical patients has also been equally disturbing and contemporane-
ously paternalistic. In 1914, litigation established that “Every human being of adult
years and sound mind has a right to determine what shall be done with his own body.”
However, it took more than 40 additional years for the term “informed consent” to
become recognized within the medicolegal domain [3]. Medical paternalism resulted
in many patients being passive participants in their medical care and patients were
frequently told, not asked, what medical therapies they might accept. As recently
as the 1960’s, it was common practice to withhold a cancer diagnosis from patients
and, at that time, 90% of physicians preferred to not share this information with
their patients [4]. Even in 2010, 55% of surveyed anesthesiologists and surgeons felt
that the consent process was inappropriate since patients remember little of what is
disclosed to them. In addition, nearly 30% of those surveyed believed that there was
no need to disclose major risks with an incidence greater than 1/100 [5]. It is impor-
tant to acknowledge the complicated history and continued evolution of informed
consent to fully understand how the process of consent has ascended in its level of
(perceived) importance and now represents a critical element of the patient-physician
relationship.
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Pain Management Consent Considerations 85
The current state of consent for perioperative regional anesthesia procedures was
best described by a 2007 survey study. In this study, 79 respondents answered a
variety of questions related to their standard disclosure of information prior to
the performance of regional anesthesia procedures. Of note, 26% of respondents
reported that they only disclosed medical risk for medicolegal purposes instead
of aiding patients in an informed decision-making process. In addition, the study
found that disclosure of common and benign/low severity complications for periph-
eral regional and neuraxial procedures was completed by most respondents. As an
example, 71% of respondents disclosed a risk of local pain following an interscalene
block. However serious complications including paralysis (21%), seizures (39%),
pneumothorax (37%), cardiac arrest (18%), and death (28%) were disclosed much
less frequently. This same pattern held for spinal anesthesia where 73% of study
participants disclosed a risk of local pain/discomfort but information for paralysis
(43%), cardiac arrest (18%), and death (32%) was much less frequently divulged. The
etiology for the poor risk disclosure for serious adverse events is likely multifactorial
but could include not wanting to frighten patients prior to a procedure, not wanting
to have patients decline a procedure, an unclear understanding of risk on the part of
the providers, or a lack of provider comfort discussing issues of such magnitude. In
addition, this study found that the incidences of severe complications disclosed for
a number of potentially serious adverse events did not correlate well with what was
available in the contemporary literature [6]. The results of this study indicate that,
even for experts, there is additional work that needs to be done to ensure that our
patients remain an active and informed participant in decisions relevant to medical
management [7].
The reality is that a real or perceived lack of an adequate consent process and
documentation may now be utilized as a legal strategy to paint a physician as uncaring
and inattentive to detail. If for no other reason than the avoidance of medico-legal
entanglements, it behooves our profession to embrace the tenets of contemporary
consent discussions and documentation.
3 Consent
The consent process can be distilled into four distinct components that must be
satisfied to ensure that the patients are appropriately positioned to participate in
medical decision making.
Required Elements of Informed Consent:
1. Voluntariness
2. Disclosure
3. Understanding
4. Capacity
At first glance, voluntariness may seem the most obvious of the four consent
elements. To satisfy this element of consent, patients must make a decision regarding
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86 E. Wilson and K. Schroeder
their own health and the plan for care delivery without coercion and, ultimately, grant
permission for treatment to proceed. In this process, it is critically important that
patients are aware that they possess the ability to make the ultimate decision regarding
delivery of medical and procedural care. In many cases, patients may not feel that
they have the ability to impact the course of care delivery and efforts should be made
to correct this perception. Ensuring voluntariness may be as simple as validating
that the consent process contains the exact phrase “this is your decision to make
and only you can grant permission for us to proceed.” In some cases, voluntariness
may be complicated by a variety of dynamics that might arise in the perioperative
arena. For example, patients may present with a family member or other person
(i.e., athletic trainer/agent/coach) who may seek to impose their ideas and values
regarding treatment preferences on the patient. Patients need to know that no amount
of procedural momentum removes their ability to terminate a procedure or change
the direction of a treatment plan.
Disclosure is a key component of the consent process that is frequently misun-
derstood and poorly applied. For the purposes of medical intervention (whether
medicinal or procedural), it is important to disclose the reported purpose of the
proposed intervention. Patients should not present to the operating room or proce-
dural area without a clear understanding of why they are there. Patients need to
know the risks, benefits and potential complications of the proposed intervention
and how their pre-existing medical conditions impact each of those. As mentioned
previously, the results of the Brull et. Al. study highlight our profession’s collective
unease with disclosure of risks of substantial consequence [6]. An effort needs to be
made to ensure that rare but serious risks are disclosed to patients. In the event that
a healthcare professional finds discussing these sorts of rare events uncomfortable,
there are a number of alternatives including pre-prepared printed and audiovisual
modalities that can augment the conversation. This risk disclosure discussion should
be tailored to the individual patient and the act of customizing this discussion helps to
galvanize a strong relationship between the healthcare professional and the patient.
For example, if the patient is a professional athlete there may be more time spent
discussing the potential risks of long-term motor weakness or the potential for a
delayed return to sport following a regional anesthesia procedure. In patients with
pre-existing neurologic disease, it may be incredibly appropriate to disclose that there
are unknown risks associated with the provision of regional anesthesia techniques
and that there may be an unknown elevated risk associated with undergoing these
procedures. In patients with a history of opioid abuse or misuse, it may be appropriate
to discuss how the application of regional anesthesia techniques may be an important
component of limiting the need for post-procedural opioid administration.
Beyond the risks of a proposed intervention, it is important to disclose clinical
alternatives. For example, alternatives to regional anesthesia may include additional
doses of opioid or other analgesics. In discussions of analgesic alternatives, it is
important to acknowledge that there are risks associated with these procedures/
therapeutics and efforts should be made to provide a reasonable risk/benefit discus-
sion for these alternatives [8]. It is also important to disclose that there may be risks
associated with delaying or foregoing a certain procedure [9]. For example, there is
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Pain Management Consent Considerations 87
evidence to suggest that foregoing an epidural blood patch following an inadvertent
dural puncture may increase the risk of chronic headache and low back pain [10].
With the proliferation of available regional anesthesia procedures and trainees
of multiple disciplines, disclosure of personal procedure experience may also be an
appropriate component of the consent discussion. It is also appropriate to disclose
to patients if a medication is being used in an off-label fashion or if there is limited
data yet available to support the use of a particular agent. While these discussions
have the potential to be uncomfortable, they do help to strengthen relationships with
patients and demonstrate empathy and caring.
Obviously, it would be impossible to disclose every possible risk potentially asso-
ciated with a given intervention or medication. Therefore, it is important to consider
those risks that possess a threshold incidence level or that might be of particular
importance to a patient. In the United States, disclosure thresholds are subject to
state-specific disclosure standards that vary from state to state and include the reason-
able patient standard, the professional standard or a hybrid version. The reasonable
patient standard requires physicians to disclose information to an extent that would be
expected by a reasonable patient whereas the professional standard should encom-
pass elements of disclosure expected by a reasonable medical practitioner under
the same or similar conditions. Where this distinction becomes important is in a
medicolegal setting. States with the reasonable patient disclosure standard encounter
medical malpractice verdicts in favor of plaintiffs more frequently than states with
a professional standard of disclosure [11]. These standards are highly variable and
can change over time with changes in case law. It is therefore important to establish
a good working relationship with your hospital’s legal team to better understand the
medicolegal environment that exists as a guide to local disclosure norms.
The next component of consent requires patients to understand their condition
and appreciate the risks and benefits of a proposed procedure or treatment modality.
Assessing understanding and capacity can be difficult but there are some pathways/
techniques that may be helpful. One simple modality for assessing understanding and
capacity is the “teach back” method. In this exercise, patients are simply asked to
provide a description of the proposed intervention and, in so doing, demonstrate the
ability to retain and process relevant and important information. Grisso and Apple-
baum further clarified questions that might be asked to further evaluate a patient’s
ability to understand their situation and the proposed intervention. These authors
have proposed that understanding can be assessed by asking the patient the following
questions [12].
Please tell me in your own words:
1. The problem with your health now.
2. The recommended treatment.
3. The possible risks and benefits of the treatment.
4. Alternatives to the proposed treatment.
5. The risks and benefits of avoiding the proposed treatment.
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88 E. Wilson and K. Schroeder
Finally, patients need to have adequate capacity to make decisions regarding
their medical treatment. The terms consent and capacity are frequently and erro-
neously utilized in an interchangeable fashion. As has previously been made clear
here, consent is a process that requires a number of elements to ensure that patient
autonomy and self-determination is respected. Capacity is the ability of an indi-
vidual to weigh available information and communicate a decision or preference.
Capacity determinations are generally made by the clinician obtaining consent and
these determinations can be occasionally challenging [13]. What makes capacity
determinations unique is that they are intervention specific—meaning that patients
may have the capacity to make some decisions but lack the capacity to make larger
and more meaningful/impactful decisions [14]. For example, a patient exposed to
significant opioid analgesics may have the capacity to make a decision regarding
intravenous line placement or antibiotic therapeutics. However, this same patient
may lack the capacity to make a determination regarding a surgical procedure or
therapeutic agent associated with the potential for significant risk. While any clini-
cian caring for a patient has the ability to make assessments of patient capacity, there
are clinical tools that may have utility in aiding these assessments. For example,
the MacArthur test and Mini-Mental State Examination (MMSE) may have a role
in aiding in capacity assessments when there is a lack of clear capacity consensus
[15, 16].
The ideal scenario for how information should be conveyed to patients has yet
to be determined. Certainly, the classic approach of sitting with the patient and
having a discussion of the risks and benefits of a proposed intervention has a certain
appeal and familiarity. These discussions offer tremendous value as an opportunity
to build rapport and establish a relationship between the patient and the healthcare
professional. With an oral consent process, it becomes important for the healthcare
professional to diligently document relevant aspects of the consent discussion. The
important take-away with this approach is that if the consent discussion documen-
tation is not completed, it would be difficult to later “prove” that it had taken place.
There may be some benefits associated with the use of prepared video, multi-media
or print material. When compiling this material, it is important to consider that the
average American reads at the 8th grade reading level and that, in general, currently
available medical information and consent materials are beyond the reading capabil-
ities of many of our patients [17, 18]. The American Society of Anesthesiologists has
created decision guides for neuraxial anesthesia that help explain these procedures
and offer patients opportunities to reflect and generate questions prior to interacting
with their anesthesiologist. These initiatives may offer the promise of ensuring that
patients arrive for surgery already informed regarding the proposed procedure with
ample opportunity to reflect and weigh potential risks and benefits [19].
Despite our collective best efforts to provide a thoughtful and complete consent
discussion for our patients, it seems that, in many circumstances, we may be failing
to effectively deliver information in a manner that induces significant procedural
recall. A study of patients receiving consent information at a dedicated preoperative
clinic two weeks prior to a planned surgical procedure revealed that on the day of
surgery, 26% of patients could not recall any risks related to anesthesia, 37% could
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Pain Management Consent Considerations 89
not recall any major risks, and 84% could not recall any minor risks [20]. When
the ability to recall consent and risk discussions for regional anesthesia procedures
has been evaluated, the data demonstrates that patient recall of risks is incredibly
low. In one study of patients presenting for shoulder arthroplasty and interscalene
nerve block, risk recall was significantly worse for the interscalene block than for the
surgical procedure and 45% of patients were unable to recall a single risk related to
the provision of interscalene analgesia [21]. In a study of 125 patients presenting for
arthroscopic shoulder surgery and interscalene block, only 21% of patients were able
to remember all four major risks (long-term nerve damage, seizure, life-threatening
event, and damage to the covering of the lung) immediately following a scripted
consent discussion [22].
Given the limitations related to consent discussions, there is an evolving body of
literature suggesting that these discussions might be augmented via the utilization of
a variety of presentation formats. In one study, a small, laminated information card
was presented to women interested in labor analgesia. All women had the standard
consent discussion with an anesthesiologist but those women who were also able to
refer to this laminated information card had a significant improvement in recall of
the process and potential risks [23]. In another study of laboring women, patients
were asked to certify that they had read a form detailing the benefits and risks of
epidural analgesia. This study demonstrated that the addition of a written consent
form improved recall and improved the women’s subjective ability to “remember
and appreciate the different anesthetic options, risks, and procedures [24].”
4 Unique Consent Circumstances
There are a number of patient populations where the informed consent process may
take on heightened importance or be subject to additional significant considerations.
Athletes are one example where the stakes associated with a potential adverse event
related to a regional anesthesia technique can be incredibly high. In one high profile
case of litigation following a peripheral regional anesthesia procedure, a profes-
sional athlete sought $180 million in damages after they failed to return to their sport
following knee surgery and an adductor canal block [25]. In athletes and other highly
skilled individuals (dancers, musicians, etc.), it is important to consider and discuss
the implications of any possible post-procedure decrement in motor or sensory func-
tion. For example, limited studies have indicated that femoral nerve blocks performed
for anterior cruciate ligament repair have been associated with persistent strength
deficits at six months, an increased time until athletes are able to return to sport, and
an increased risk of re-injury [26, 27]. These patients may also suffer from significant
financial pressure and lack of autonomy that may impose undue pressure while these
athletes weigh their individual risk/benefit profile [28, 29].
The involvement of trainees represents an additional layer of complexity that
should be discussed with patients and requests to limit trainee involvement should
be honored. What is not yet well codified is how detailed these consent discussions
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90 E. Wilson and K. Schroeder
need to be so that patients are aware of the experience level of who is caring for
them but not unduly concerned about the lack of trainee experience [30, 31]. Beyond
traditional modeling behavior, there is some evidence to suggest that simulation may
have a role in preparing anesthesia trainees to better deliver consent information [32].
Obstetric patients represent another patient population where the acuity of the
event, ongoing pain, and dynamic changes in patient condition can introduce chal-
lenges in the consent process. However, it is important to consider that, despite
occasional time pressures, these patients generally wish to know all the risks asso-
ciated with epidural analgesia prior to proceeding [33]. In addition, it is likely fair
to conclude that other patients in pain are similarly interesting in being informed of
relative risks and benefits associated with proposed analgesic interventions. Obstetric
patients do represent a wonderful model for how patients in pain can be consented
for interventional procedures. In one study of obstetric patients, those in pain had
similar recall of epidural risks compared to those who were not in pain at the time
of risk disclosure. In addition, those women who had a consent discussion while in
pain were generally satisfied with the communication relevant to the procedure [34].
In a similar fashion, patients with language or other barriers to understanding
consent discussions represent a patient population that requires additional consid-
eration. There is substantial evidence describing a decreased rate of regional anes-
thesia and analgesia for an array of obstetric and surgical populations in patients with
language barriers [35, 36]. The etiology of this difference may be multi-factorial but
the convenience of the healthcare professional should not be a consideration for the
avoidanceof analgesic interventions and procedures. Substantial interpretive services
and language lines are now ubiquitously available and there should therefore be no
real reason to avoid standard consent discussions with these patients.
There are circumstances where regional anesthesia may be requested following
a surgical procedure where either the anesthesia professional failed to discuss the
proposed intervention, the surgical procedure unexpectedly converts to one that is
substantially more extensive, or patients have more pronounced difficulties with anal-
gesic management than anticipated. The consent process in postoperative patients
can certainly be compromised secondary to polypharmacy and delirium. In fact,
previous research has demonstrated that delirium in the recovery room is incredibly
common (35%) and multiple cognitive domains are impacted. Even in patients who
appear awake, significant deficits may remain [37]. In these circumstances, it may be
helpful to consider if patients have the capacity to consent to a procedure that is more
limited in potential risks (i.e., in the setting of pre-existing neurologic disease, is it
possible that patients might possess the capacity to consent to fascial plane but not
epidural analgesia). It may also be helpful in these scenarios to enlist the assistance of
surrogate decision makers or people who know the patient and can reaffirm that the
patient would normally consent to the proposed intervention or procedure. Finally,
conversion to more extensive surgical procedures is not an uncommon event and
therefore including and documenting a regional anesthesia consent discussion for
all patients undergoing laparoscopic surgery may satisfactorily avoid most consent
consternations.
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Pain Management Consent Considerations 91
There are circumstances where patients initially refuse regional anesthesia but
later change their mind after encountering the pain associated with their surgical
procedure. Practitioners of obstetric anesthesia will frequently encounter this situ-
ation when patients present with a pre-commitment directive or birth plan that
outlines how they would like to avoid epidural analgesia but change course when
they encounter significant pain in the process of delivery [38]. The management of
these Ulysses contracts can be challenging because they pit the autonomous wishes
of the patient against themselves [39]. Should the lucid wishes of a patient who has
prepared their perioperative analgesic plan be honored or should the autonomy of
the patient who may be altered via poly-pharmacy but who now has a more thorough
understanding of the discomfort associated with a surgical/labor procedure/process
be allowed to make a decision regarding their analgesic management? Sadly, there
are no easy answers in these situations. Ideally, there would be an opportunity to
discuss with patients their hesitancy to accept a therapeutic regimen or procedure.
In this conversation, if might also be helpful to discuss with the patient what the
management course will be if the patient does change their mind following their
surgical procedure and thorough documentation of this conversation is absolutely
essential.
5 Conclusion
In conclusion, informed consent is more than a discrete conversation, form, video,
software platform, or interactive demonstration. Rather, informed consent is a process
that requires time to engage with patients and determine/discuss information mate-
rial to their values and current medical condition to adequately develop a patient
centered care plan. Through active engagement in this process, significant benefits
will be realized for both the provider and patient. Patient safety will be enhanced
as patients are given the opportunity to disclose additional information during the
consent discussions that could potentially impact the relative risk of certain adverse
outcomes. Additionally, both patient and healthcare professional satisfaction will be
improvedby establishing rapport and strengthening relationships during the informed
consent process.
Key Takeaways
1. Key elements of consent include voluntariness, disclosure, understanding, and
capacity.
2. Informed consent is best accomplished as a process instead of a discrete event.
3. Individual patient characteristics and values need to be considered when
presenting consent information.
4. Risks material to proposed interventions must be disclosed and efforts should be
made to ensure the accuracy of risk disclosure information.
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92 E. Wilson and K. Schroeder
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