Informed consent responsibility for patients at risk for postoperative vision loss

Postoperative Vision Loss

Elements of an Informed Consent Form

Patients Who May be Unable to Make Healthcare Decisions

Recommendations for Decreasing POVL

Four Elements of Negligence

Prudent Behaviors in Medical Informed Consent

Cortical Blindness (Vision loss after…, 2009, ¶ 6).

CRAO: Central Retinal Artery Occlusion (Chang & Miller, 2005, Introduction section, ¶ 1).

IGT: Iowa Gambling Task (Northoff, 2006, p. 70).

Ischemic Optic Neuropathy (Vision loss after…, 2009, ¶ 6).

IOP: Intraocular Pressure (Gilbert, 2006, ¶ 4).

MacCAT-T: MacArthur Competence Assessment Tool (Northoff, 2006, p. 70).

NQF: National Quality Forum (Clarke, Johnston & Finley, 2007, p. 395).

OR: Operating Room (Clarke, Johnston & Finley, 2007, p. 396).

POION: Perioperative Ischemic Optic Neuropathy (Chang & Miller, 2005, Introduction section,

¶ 1).

POVL: Perioperative Visual Loss (Gilbert, 2006, ¶ 2).

RVO: Retinal Vascular Occlusion (Vision loss after…, 2009, ¶ 6).

CHAPTER II

LITERATURE REVIEW

"Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault, for which he is liable in damages"

- Justice Benjamin Cardozo,

(as cited in Paterick, Carson, Allen & Paterick, 2008, p. 313).

Introduction

Prior to the patient receiving medical care, the patient or an individual authorized to consent for the patient, must sign a consent form (Informed consent in anesthesia, 2010). Whether or not the patient who signed a consent form prior to a medical procedure was actually informed constitutes a critical, common concern in medical malpractice lawsuits. During the literature review for this study, which examines concerns related to informed consent, the researcher addresses the primary research question: Who is responsible for informed consent in regard to the patient at risk for postoperative vision loss? Sub-questions considered during the review of the literature include:

1. What is informed consent?

2. What is postoperative vision loss?

3. Who may be responsible for informed consent?

James Neill (2003) explains the goals of the literature review in the article, "How to write a literature review." Neil asserts that: "Understanding a body of professional literature is much like mapping and analyzing the geography of an unknown island..." (¶ 1). As the researcher explores the "island of knowledge" relating to the focus of the designated study, informed consent, key features of the formerly unfamiliar island typically materialize; for instance:

A clear answer to… [the study's] research question a good sense of what has been thoroughly investigated and in what areas useful new work might be done a broader understanding of the question as it relates to other, related areas of knowledge research hypotheses interesting, new questions (Neill, 2003)

According to Lawrence A. Machi, and Brenda T. McEvoy (2008) in Literature Review: Six Steps to Success, the following six steps to pick to model for the development of a literature review:

Step1: Select a topic.

Step 2: Search the literature.

Step 3: Develop the argument.

Step 4: Survey the literature.

Step 5: Critique the literature.

Step 6: Write the review (Machi & McEvoy, 2008, p. x).

Despite good intent, informed consent, according to Bonnie Booth (2008) in the article, "Informed consent at the heart of New York lawsuit," may not be, and in fact is seldom actually "informed." "According to AMA policy, physicians must honor the basic policy of informed consent 'unless a patient is unconscious or otherwise incapable of consenting, and harm from failure to treat is imminent' (Booth, ¶ 13). In their quest to create a consent form that veers away from legalese and medical terminology, which in turn confuses the average patient, researchers from both law and medicine have invested massive amounts of time and energy investigating informed consent procedures. In the U.S., informed consent is well grounded and common law (Informed consent…, 2010). Some states, however, currently define and set criteria for informed consent by statute, rather than common law (Booth).

Informed Content

Informed consent entails the process whereby a physician effectively communicates and explains in detail a procedure and the risk of the considered procedure to a patient prior to the procedure being performed. To complement the overall health of the patient, the physician needs to convey the complete process of the procedure, including risks, and educate the patient as to why the procedure is necessary. Dr. Colleen E. O'Leary (2006), Associate Professor and Interim Chair, Department of Anesthesiology, State University of New York Upstate Medical University, Syracuse, New York, asserts in the article, "Informed consent for anesthesia: Has the time come for a separate written consent document?," that the physician should present available alternative procedures and identify potential risks, as well as, probable benefits of the prospective alternatives.. In the surgical procedure, properly educating and informing the patient of the risks and benefits involved in the procedure, will given the patient a better understanding and help him make the decision to undergo the suggested medical intervention.

Prior to performing a procedure, a physician is ethically required when practicing medicine in all 50 states in specific statutes, to effectively communicate to a patient, basic component of any and every procedure, along with the risks and benefits of that procedure, before it is performed. Due to the myriad of information available on the internet, many contemporary patients are informed and ready to openly communicate with their physicians regarding medical procedures. O'Leary (2006) states: "Many doctors provide them [patients] with the information necessary for informed decision-making but do not adequately document the discussion" (¶ 2). When the doctor fails to properly document informed consent regarding a medical procedure and the unexpected complications occur, he may susceptible to legal litigation. According to the Joint Commission on Accreditation of Healthcare Organizations, the physician must documentation all elements of informed consent "in a form, progress notes or elsewhere in the record (Standard RI.2.4.0)" (¶ 5). In most instances, the patient signs a surgical consent form prior to the day of the procedure; typically during a preoperative appointment; often even before the patient meets their anesthesiologist.

A major challenge physicians confront regarding informed consent is that the physician or surgeon performing the procedure is not trained to discuss the risk anesthesia presents. As administering anesthesia is the responsibility of the anesthesiologist, O'Leary (2006) purports, "many anesthesiology practices rely on a sentence in the surgical consent document that may state something such as 'anesthesia' is required for the procedure, and there are associated risks & #8230;" (¶ 8). In some states, as physicians and surgeons do not want to be liable if complications occur, they will not allow a paragraph or even a single sentence regarding the word anesthesia in their particular consent form. O'Leary (2006) stresses that as professionals, anesthesiologists must invest time ensure their patients understand the anesthesia care plan.

Anesthesiologists have crusaded for a number of years for patients and surgeons to recognize and understand that their medical practice differs from that of their colleagues, a distinct part of the patient's medical procedure. O'Leary (2006) notes an old adage frequently taught in anesthesiology residency training programs purports when one does not write something down, some may argue that it did not occur. Some anesthesiologists, as well as physicians, contend the consent process should be separate so the patient may be educated and informed of the risks and benefits of both the anesthesia process and the surgical procedure itself.

It is imperative for medical professionals to understand the difference between securing the patient's signature on an informed consent form and actually effectively communicating pertinent, valuable information about a medical procedure to the patient. The article, "Informed consent in anesthesia," (2010) published by the American Association of Nurse Anesthetists, asserts that "often health providers assume that if they possess some evidence, such as a signed form, indicating that the patient has given consent, they have met the requirements of the law" (¶ 3). This presumption, albeit, proves false, and over time has birthed controversy in the medical profession. For medical professionals to prevent this "oversight," they could approach informed consent by focusing on effective communication and deliberately educating the patient about the upcoming medical procedure.

The patient cannot make a knowledgeable decision about a medical procedure unless the medical professional has communicated precise, straightforward, understandable information about the procedure. "By definition, the concept of informed consent implies that the patient has elected to have or forgo a medical or surgical procedure after having been provided with sufficient information to make an informed decision" (Informed consent…, 2010, ¶ 4). Because patients differ in levels of education, as well as factors such as culture and language, all medical professionals cannot know for certain whether or not a patient thoroughly understands the informed consent process. Consequently, physicians must make the informed consent process as clear and easy to understand as possible.

If the informed consent process ultimately turns in to a legal battle, medical professionals must present repute evidence proving the informed consent process. When the court determines evidence to be intangible or weak, the legal battle or dispute will focus on how the informed consent was communicated to the patient and whether or not the patient actually understood it. More times than not, a patient will argue that he did not understand what the physician stated to him; even amidst documented proof the medical professional and the patient did engage in an informed conversation. "The fact that a meeting took place does not necessarily mean that there was a meeting of the minds" (Informed consent…, 2010, ¶ 5). This issue leads some health care providers to assert that informed consent forms possess little value, particularly when a legal battle ensues and the professional cannot prove the patient did, in fact, understand the informed consent process.

Currently, lawyers routinely challenge informed consent forms in courtrooms throughout the United States (U.S.). "The model consent forms incorporate substantial details of anesthesia techniques, risks and other elements of 'informed consent', so that a strong presumption is established on its face" (Informed consent…, 2010, ¶ 7). During the informed consent process, to help inoculate the physician against lawsuits, healthcare providers must follow strict guidelines. They need to early explain and communicate properly each aspect of the consent form to the patient.

Two different and distinct philosophies of liability exist regarding informed consent. One: The common law battery may be defined as unauthorized touching of a patient without confirmed valid written consent, even if the action did not ham the patient. The second philosophy involves negligent failure to warn. This may occur when a healthcare provider does not inform the patient of the risks of a procedure or offer alternative attainable procedures. In 1914, a legal dispute between Scholendorff vs. Society of New York Hospitals began the foundation for informed consent laws by Justice Cardozo, noted at start of this chapter (Informed consent…, 2010).

Justice Cardozo stated the principle of the right of self-determination when he wrote: "Every human being of adult years and sound mind has a right to determine what shall be done with his own body, and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages. This is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained." (Informed consent…, 2010, ¶ 8)

Figure 1 depicts elements that should be clear in standard informed consent forms.

Figure 1: Elements of an Informed Consent Form (adapted from Informed consent…, 2010, ¶ 9).

As the Courts have defined what must be discussed with a patient for a patient to decide whether or not his right of self-determination has been fulfilled and understood, an informed consent form should contain both well communicated information about the procedure and documented proof of the risks.

The process of informing a patient about a medical procedure, particularly a surgical procedure, generally begins at their first healthcare appointment. The article, "Informed consent in the operating room" (1998), explains that "in contrast, the informed consent for anesthesia is often obtained in the minutes before surgery in which the anesthesiologist and patient meet for the first time" (¶ 1). A number of other considerations exist that medical professionals need to ponder when informing a patient about a medical procedure. Some circumstances may lessen or hinder a patient's ability to understand informed consent. Figure 2 illustrates examples of some situations where a patient may not be able to make health care decisions.

Figure 2: Patients Who May be Unable to Make Healthcare Decisions (adapted from Informed consent…, 1998, ¶ 2).

Healthcare providers may at times encounter a problem with a patient who has been sedated or received pain medication immediately before his procedure is to take place. Sometimes, for healthcare providers to obtain the necessary informed consent forms, the patient may be denied particular pain medications before their procedure. "When pain medications are withheld, patients may feel pressured to consent in order to obtain medication to relieve their suffering (Informed consent…, 1998, ¶ 3). On the other hand, some healthcare providers feel that premedication may help a patient decide to undergo a medical procedure, because he, as a result is able to concentrate on the healthcare decisions, instead of his pain. Most healthcare providers agree that medical personnel should never withhold pain medication from a patient suffering and in pain to obtain informed consent.

Regardless of how insignificant the risks of anesthesia may appear, healthcare providers must discuss all the details. Some physicians cite statistics, such as approximately one in 50,000 patients risk death while under anesthesia. During general anesthesia, the approximately one in 50,000 risk of death for a healthy patient may be compared "to that of the risk of death in an automobile accident (about twice that), as a way of putting perspective on the information being provided" (Informed consent…, What information…section, 1998, ¶ 2). This may or may not influence whether or not a person chooses to undergo a medical procedure.

A.M. Chen, D.R. Leff, J. Simpson, S.J.D. Chadwick and P.J. Mcdonald (2006), all with the Departments of Gastroenterology and General Surgery, North West London Hospitals NHS Trust, London, United Kingdom, conducted the study, "Variations in consenting practice for laparoscopic cholecystectomy." This study was designed "to compare the difference in consenting practice amongst trainees and consultant surgeons for laparoscopic cholecystectomy with specific reference to the documentation of significant risks of surgery" (Chen, Leff, Simpson, Chadwick & Mcdonald, p. 482). Ultimately, the authors found that a significant variation existed between the three grades of participating clinicians involved when acquiring the patient's consent.

As no consensus mandates what complication must be discussed with the patient, the professional soliciting the consent and implementing the provision of information, vital to the consent process, determines what is related. The legal position regarding the provision of information, Chen, Leff, Simpson, Chadwick and Mcdonald (2006) explain, proves identical to that judging whether the physician had been negligent in his care.

In the past, a doctor would not be held negligent if it was found that he acted in accordance with a reasonable body of medical opinion. & #8230;Current case law, therefore, places the burden on the clinician obtaining the consent to make a balanced judgment regarding what information needs to be disclosed to the patient. The only guide it offers is that all "material" and "significant" complications should be disclosed (Chen, Leff, Simpson, Chadwick & Mcdonald, 2006, p.485).

From their study, Chen, Leff, Simpson, Chadwick and Mcdonald (2006) assert that as trainees mention complications more than consultants do, they may be a better choice for taking consent. The authors also found that more often than not, conclude, physicians do not provide patients are with adequate information they may need to make an informed choice. Consequently, even though a standardized consent form may possibly overwhelm some patients with pointless information, Chen, Leff, Simpson, Chadwick and Mcdonald recommend that if each surgeon would adapt a consent form for his particular practice, this would complement legal and ethical concerns.

Few, limited circumstances occur when a medical care provider may intervene without consent. When a patient under the age of 18, a minor, requires medical treatment, complicated informed consent issues may arise. In some circumstances, such as abortions, access to contraceptives, or treating sexually transmitted diseases, legal council may be brought in to clarify general rules of informed consent.

Anesthesiologists who encounter minors or patients, unable to comprehend informed consent, must attain consent from a person who can legally provide it for the patient. Some states have specific statutes that contain a list of people who may give and sign consent forms for that patient. A few examples of individuals who may substitute and give consent for a minor or patient unable to comprehend consent include:

A parent (usually only one is necessary) for a minor child.

A husband or wife for their spouse.

A guardian for their ward.

Any adult standing in loco parentis (place of the parent) for a minor. (Often defined in state statutes or case law; example, the principal of a boarding school.) (Informed consent…, 2010, ¶ 14).

In extreme circumstances strictly defined by the law, other parties may be solicited or permitted to sign consent forms.

A common exception to the rule of obtaining informed consent occurs when an emergency situation arises. In general, as the consent would be implied, consent is not required during an actual emergency. In such instance, albeit, the physicians must be certain the patient is in fact, experiencing a real emergency. In Canterbury vs. Spence, the federal court states: "An emergency exists when the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent and outweighs any harm threatened by the proposed treatment" (Informed consent…, 2010, ¶ 15). It is generally assumed, for instance, that a person will choose to permit a physician to perform necessary medical procedures in to save his life or extremities. In a true emergency situation, if a physician follows medical guidelines in the best interest of the patient, he will not likely be liable if something out of his control occurs.

Currently, as surgeons perform a growing number of same-day surgeries and surgeries at ambulatory surgical centers rather than hospitals, increasing problems for healthcare providers occur. At times, as the patient normally arrives within an hour prior to the start of his procedure, the physician does not have adequate time to spend quality time with his patient before the procedure.

As informed consent is required by law, the anesthesiologists also requires adequate time in the pre-evaluation to explain the risks of anesthesia. In LeBeuf vs. Atkins, the court states: "The preanesthetic evaluation is integral to the informed consent process and the provision of quality anesthetic care. The information elicited from such an evaluation concerning the patient's history might influence the requisite disclosure" (Informed consent…, 2010, ¶ 17). Healthcare providers must ensure the patient arrives at the surgical site in adequate time for the professional individual to comply with the legal requirements for conveying and explaining informed consent.

The anesthesiologists must explain the informed consent form and the procedure itself - not merely hand the patient the consent form and request that he sign it. In the case of Brown vs. Dahl, the court argued that in regard to the anesthesiologists: The individual does not fulfill the requirement to obtain an informed consent "by having the patient sign a consent form unless the proper information has been provided to the patient. The health care provider must supply the information, not just respond to questions" (Informed consent…, 2010, ¶ 18). This will ensure that patients, as well as, healthcare providers concur regarding their impending medical procedure.

R.A. Wheeler (2007), Consultant Pediatric and Neonatal Surgeon, asserts in the study, "Consent: luck or law?," that the physician must obtain consent for any uninvited physical contact. Even though oral consent proves adequate in English law for the physician to routinely needs to touch his patient during a simple examination or for some more invasive interventions, an understandably low threshold exists for obtaining written consent. The question arises, albeit, in regard to treating children who are patients . "From whom should consent be obtained, whether oral or written, when dealing with child patients?" (Wheeler, p. 627). When the child has not obtained sufficient capacity to provide his personal consent, the physician seeking consent should know the only individuals possessing parental responsibility for a child can provide legal consent.

During a one month study period, Wheeler (2007) found that out of one hundred children admitted for either elective or emergency surgery, the mother signed75 consent forms; married fathers signed 17 by married fathers; either an adult with parental responsibility, or the competent children signed four other forms. Unmarried fathers, who did not possess parental responsibility signed the remaining four remaining forms. These four children, according to the law, were technically, in a narrow, legal sense, had been assaulted as the consent was not valid.

Safe Surgery

In the study, "Getting surgery right," Dr. John R. Clarke, Janet Johnston and Edward D. Finley (2007), all with the Department of Surgery, Drexel University, Philadelphia, Pennsylvania, examined a number of reports from hospitals and ambulatory surgical centers in a state requiring that wrong-site surgery be reported. The review of the reports revealed "wrong-part, wrong-side, wrong-procedure, and wrong-person surgery from the initiation of the statewide reporting requirement on June 28, 2004 until December 31, 2006" (Clarke, Johnston & Finley, 2007, p. 396). During the 30-month time period:

…there were 427 reports of near misses (253) or surgical interventions started (174) involving the wrong patient (34), wrong procedure (39), wrong side (298), and/or wrong part (60); 83 patients had incorrect procedures done to completion. Procedures on the lower extremities were the most common (30%). Common contributions to errors resulting in the initiation of wrong-site surgery involved patient positioning (20) and anesthesia interventions (29) before any planned time-out process, not verifying consents (22) or site markings (16), and not doing a proper time-out process (17). Actions involving operating surgeons contributed to 92. Common sources of successful recovery to prevent wrong-site surgery were patients (57), circulating nurses (30), and verifying consents (43). Interestingly, 31 formal time-out processes were unsuccessful in preventing "wrong" surgery. (Clarke, Johnston & Finley, 2007, p. 395)

At any one hospital, wrong-site surgery was reported to insurance companies or a lawsuit once every 5 to 10 years. Even with formal site verification, according to Clarke, Johnston and Finley (2007) report, this type error continues to occur regularly, particularly wrong-side surgery. "Verification, starting with verification of the consent, needs to occur at multiple points before the incision" (Ibid., p. 395). Wrong-site surgery is not noted as being a concern related during the informed consent process.

Medical Ethics

Patients and physicians possess the ethical, moral, and legal obligation to comprehend the medical informed consent process. In the journal publication, "Medical informed consent: General considerations for physicians," Timothy J. Paterick, Geoff V. Carson, Marjorie C. Allen and Timothy E. Paterick (2008), all with the Mayo Clinic, assert that "negligence per se occurs when an actor's violation of a statute or regulation causes the kind of harm the statute was intending to prevent" (p. 313). The authors stress that physicians also have an ethical and moral obligation to offer their patients the best treatments available for their medical condition. Healthcare providers, albeit, as numerous others noted in this literature review contend, must also advise their patients that along with the benefits of the medical procedure, risks may also be involved.

As numerous states have codified medical informed consent to differing degrees, physicians need to educate themselves regarding their particular states' statutory laws in the area of informed consent. "The jurisdictions vary, and violation of the statute can be considered intrinsically negligent or merely a rebuttable presumption of negligence.. Further, every practicing physician should understand the underpinnings of the common-law analysis of medical informed consent and negligence" (Paterick, Carson, Allen & Paterick, 2008, p. 313). Although the varying common law and statutory law may create a burden on physicians, failure to comply with state's statute may lead to the physician begin liable for per se negligence

As noted earlier in this study's literature review, informed consent consists of the legal incarnation of the concept that each person possess the right to make decisions affecting his personal health. The patient's understanding of the numerous potential risks of proposed treatment proves critical to medical informed consent. As patients consider the potential risks and benefits involved in their medical decisions, acknowledging those potential risks and benefits during the informed consent process helps them make informed decisions (Paterick, Carson, Allen & Paterick, 2008).

Risk, according to Paterick, Carson, Allen and Paterick (2008), may be defined as the exposure to a possibility of injury or loss. This particular definition includes two specific components:

1. Chance related to uncertain events - those that are unpredictable in any single case, but for which a probability that an event will occur in any 1 case can be estimated through statistical pooling of large databases, and

2. injury or loss, including any consequences for which the patient sustains a disability. The law places a positive obligation on physicians to disclose information about the risks to any patient who is at risk of an adverse event, that is, who will suffer injury if a chance event occurs (Paterick, Carson, Allen & Paterick, 2008, p. 314).

Throughout the years, the legal analysis of medical informed consent evolved from an allegation of battery to an allegation of negligence. In medicine, battery may occur when the physician performs a particular treatment without the patient's consent, or "performs a substantially different procedure than the one for which consent was given, or exceeds the scope of the consent, or when a physician other than the one to whom consent was given carries out the procedure" (Paterick, Carson, Allen & Paterick, 2008, p. 314). Developed from the intentional tort of battery, medical informed consent law helps protect individuals from experiencing undesired physical touching of their body by others who do not have either express or implied consent of the individual touched.

The courts currently consistently characterize lack of informed consent as to constitute the physician's negligence to disclose crucial information to patients. For liability of the physician defendant, negligence requires that four elements be established. Figure 4 depict s the 4 elements required to prove negligence of a physician.

Figure 4: Four Elements of Negligence (adapted from Paterick, Carson, Allen & Paterick, 2008, p. 314).

Paterick, Carson, Allen and Paterick (2008) present the question as to whether a patient may withdraw consent after he signs a medical consent form. The answer: "Consent must be freely given and can be freely withdrawn at any time. Whether consent was given orally or in writing does not affect the patient's ability to change or withdraw consent" (Paterick, Carson, Allen & Paterick, 2008, p. 317). Some physicians may the patient to reflect on his decision for 24 to 48 hours for patients following his consent to the treatment strategy. During this time, as the patient weighs his alternatives, he will either confirm of negate his decision.

Table 1 presents a synopsis of prudent behaviors physicians engaged in the process of medical informed consent.

Table 1: Prudent Behaviors in Medical Informed Consent (adapted from Paterick, Carson, Allen & Paterick, 2008, p. 314).

The physician directly involved in the proposed treatment should conduct the informed consent discussion. The discussion should include the treatment, the risks and benefits of treatment, and alternative therapies with associated risks and benefits.

The physician directly involved in the proposed treatment should discuss the most likely outcome with no treatment, on the basis of the best available medical or surgical evidence.

The physician directly involved in the proposed treatment should always discuss the severe risks, such as death, paralysis, loss of cognition, or loss of a limb, even if the probability of occurrences is negligible.

The physician involved in the proposed treatment should always disclose less severe risks that occur frequently. Courts do not place emphasis solely on consequences; they recognize frequency as an important component of risk.

The physician directly involved in the proposed treatment must understand that the medical consent form is not medical consent; it represents evidence that the consent process occurred. The dialogue between the patient and physician is the essence of the consent process.

The physician directly involved in the proposed treatment should document all patient-imposed restrictions in the medical record and the discussion with the patient about how the restrictions limit the physician's ability to provide standard medical care.

The physician directly involved in the proposed treatment may advise the patient to seek care with an alternative health care provider if the restrictions imposed by the patient seem to inhibit good medical practice and seem likely to lead to a suboptimal medical outcome.

The physician directly involved in the proposed treatment must understand the informed consent can be withdrawn at any time. When physicians allow 24 to 48 hours for patients to reflect after consent to a treatment strategy, the period of reflection validates the notion of informed consent. Withdrawal of consent should include a discussion and documentation through a withdrawal of consent form on which time and date are noted. When physicians and patients take medical informed consent seriously, the patient-physician relationship becomes a partnership, with shared authority, decision making, and responsibility for outcomes

The physician directly involved in the proposed treatment can enhance the informed consent process through appropriate use of additional learning materials, such as pamphlets and video, and through involvement of support staff, such as physician assistants, in providing information that can be discussed by the responsible physician.

Georg Northoff (2006), Department of Psychiatry, Section for Neurophilosophy, University of Magdeburg, Germany, ponders which neuropsychological functions prove vital for the decision making involved when the patient provides valid informed consent. In the journal publication, "Neuroscience of decision making and informed consent: An investigation in neuroethics," Northoff explains that progress in neuroscience permits the individual "to reveal the neuronal correlates of psychological processes involved in ethically relevant notions such as informed consent. Informed consent involves decision making, the psychological and neural processes of which have been investigated extensively in neuroscience" (p. 70). As a result, the neuroscience of decision making may, in time, provide empirical and hence descriptive criteria; contributing to an ethics of informed consent.

Nevertheless, as descriptive criterion has to be separated from normative measures, the neuroscience of decision making cannot replace the ethics of informed consent. The neuroscience of decision making, however, "could complement the current ethics, resulting in what can be called neuroethics of informed consent. It is concluded that current progress in the neurosciences could complement and change the way in which we approach ethical problems in neuropsychiatry" (Northoff, 2006, p. 70). Even though progress in neuroscience may permit one to expose the neuronal correlates of decision making involved during the process informed consent, a "neuroscience of decision making" such as this could permit one to build up brain based (empirical) informed consent criteria. Northoff further explains:

The often used MacArthur Competence Assessment Tool -- Treatment (MacCAT-T) relies predominantly on cognitive abilities such as understanding, appreciation, expression of choice, and reasoning. In contrast, emotional abilities are rather neglected. However, considering recent empirical studies, the inclusion of emotional abilities seems rather urgent. Relying on the Iowa Gambling Task (IGT), Damasio demonstrated that decision making is guided and modulated emotionally.It requires subsequently not only cognitive function, as is often presupposed, but also emotional function. (Northoff, 2006, p. 70)

The neuroscience of decision making will never replace the ethics of informed consent, Northoff (2006) asserts. It may, on the other hand, complement the ethics of informed consent as it provides empirical and accordingly, descriptive criteria.

At Risk for Postoperative Vision Loss

In the case study, "Bilateral ischemic optic neuropathy after transurethral prostatic resection: A case report," Luis M. Sadaba, Alfredo Garcia-Layana, Miguel J. Maldonado and Jose M. Berian (2006), all with Clinica Universitaria de Navarra, Universidad de Navarra, Pamplona (Navarra), Spain, explain risk factors for postoperative optic neuropathy. "Postoperative optic neuropathy has been associated with nonocular surgery; risk factors include a combination of prolonged surgical times, acute systemic hypotension, anemia due to blood loss, or prone positioning" (Sadaba, Garcia-Layana, Maldonado & Berian, p. 1). From their study, Sadaba, Garcia-Layana, Maldonado and Berian (2006) conclude that postoperative visual loss may result from numerous mechanisms, which may include:

Anterior and posterior ischemic optic neuropathy, cortical blindness, retinal artery occlusion, and ophthalmic venous obstruction (Sadaba, Garcia-Layana, Maldonado & Berian, 2006, p. 2).

Ischemic optic neuropathy may only rarely present as an early and critical perioperative complication that could simultaneously engage both optic nerves . "…Prolonged controlled hypotension and intraoperative anemia could increase the risk of ischemic optic neuropathy in patients with predisposing factors" (Ibid.). Sadaba, Garcia-Layana, Maldonado and Berian (2006) conclude that TURP (transurethral resection of the prostate) syndrome also constitutes one more typical entity that may after transurethral prostatic resection.

Michael D. Sanders and William F. Hoyt (1969), both with the Neuro-ophthalmology Service of the Departments of Neurology and Ophthalmology, and the Division of Neurological Surgery, University of California School of Medicine, San Francisco, report that a high incidence of visual failure accompanies carotid-cavernous fistula. In the study, "Hypoxic ocular sequelae of carotid-cavernous fistulae Study of the causes of visual failure before and after neurosurgical treatment in a series of 25 cases," Sanders and Hoyt note that although a myriad of "articles and monographs have described the ocular complications of carotidcavernous fistula both before and after surgery, & #8230; the patho-physiology of these changes has never received the detailed and systematic attention it deserves" (p. 82). To approach this problem, Sanders and Hoyt critically analyze the preoperative and postoperative causes contributing to impaired vision in a series of 25 carotid-cavernous fistulae, treated and studied at the University of California Medical Center during a10-year span. Sanders and Hoyt (1969) conclude:

Strong evidence has been produced to support the hypoxic hypothesis as the major aetiological factor for the ocular signs of carotid-cavernous fistula. Consideration of ocular haemodynamics and their relation to ocular pressure enables a more rational interpretation of the ocular findings. The benign natural history of the disease contrasts with the severe ocular and cerebral hazards of surgery. The failure of angiography to detect preoperatively the potential patient with a poor surgical prognosis is disappointing. Visual preservation as the major objective is stressed, and we suggest that a thorough ocular evaluation may contribute information about the size of the shunt -and the ability of collateral vessels to compensate. The gradual onset and paucity of ocular signs in cases with external carotid shunts should also be considered. (Sanders & Hoyt, 1969, p. 95)

Conclusion

The person responsible for obtaining the patient's informed consent for a medical procedure is the person who actually provides either the diagnostic, medical or surgical procedure itself, even if the medical procedure is being performed at a hospital. Even when the patient's primary care provider orders or recommends the medical procedure, the specialist actually performing the procedure is responsible for securing informed consent from that patient. It is the ethical and moral obligation of anesthesiologists, nevertheless, to inform patients of the risk of undergoing anesthesia, not the surgeon performing the surgical procedure. A number of factors sometimes affect a patient's ability to give informed consent before a surgical procedure. These may include, but not limited to the fact that the patient is a minor child, a mentally ill patient, patients under the influence of drugs or alcohol.

POVL, a devastating, lasting complication occurs sometimes after surgical procedures. It may occur even after a non-ocular surgical procedure. The highest rates of POVL occur after cardiac or spinal surgical procedures. Decreased blood supply to the eyes or pressure to the eyes may constitute one of the causes that lead to POVL. Accordingly, the length of a surgical procedure may also be a risk factor for POVL for patients undergoing surgical procedures.

POVL and POION may occur after spinal procedures, even if the patient is not positioned in the prone position. Several factors may contribute to these complications after a surgical procedure. They include hypotension, extended or longer surgeries, preoperative and postoperative anemia, and whether or not the patient is hydrated before and during the surgical procedure. To decrease the risk of POVL and POION, healthcare providers should make certain these levels are monitors and correct before the surgical procedure. Patients undergoing either cardiac or spinal procedures may more likely experience complications of POVL. Additional risks factors include, younger patients, male patients; anemic patients, patients that require a blood transfusion and patients with other medical disorders. In the U.S., the rates of POVL decreased between 1996 and 2005. Patients at highest risk for POVL after a surgical procedure were under the age of 18 and patients undergoing spinal fusions and cardiac procedures.

In some instances, children need to undergo a surgical procedure and the natural parents are unavailable to give consent for the procedure. The Children Act in 1989 set guidelines for healthcare providers to know what to do and where to turn to get informed consent for the child undergoing a surgical procedure with no natural parent there to sign consent forms.

Wrong-site surgeries are caused by mistakes made by surgeons and the facilities where these surgeries occur. They primarily occur from improper communication with the patients, not marking the area to be operated on before surgery, and lack of teamwork among the healthcare professionals themselves. To prevent wrong-site surgeries, healthcare professionals need to communicate effectively with each other, as well as, the patient from the moment treatment begins until the patient is discharged and released from the hospital or healthcare facility.

Patients consistently need information regarding their laparoscopic cholecystectomy procedure well before the procedure is performed; with preprinted information on surgical procedures given to patients at their initial healthcare visit. The more information the patient possesses, the easier it becomes for him to make a decision about his medical procedure. Consent should not be secured prior to the day the surgical procedure is performed.

Informed consent should base the patient/physician relationship. Physicians should understand that informed medical consent involves educating the patient about his treatment, which will in turn foster a mutual alliance for patient and physician.

Patients with both anemic and have high blood pressure are reportedly at greatest risk for nonarteritic ischemic optic neuropathy, a sudden, painless vision loss. Although rare, a devastating complications of the cerebral area may occur from untreated carotid cavernous fistulae. Destructive complications from carotid occlusive procedures, on the other hand, are common.

Neuroethics, one of the newest revelations in neuroscience, may help scientist discover what part of the brain relates to moral decision making, such as decisions made in the informed consent process. During informed consent, the physician educates the patient on medical test or procedures needed for his well being or to save or extend his life. The informed consent process constitutes not only ethical concerns, but involves legal issues ones as well.

During the literature review, the researcher expanded considerations noted at the start of this study; relating to how postoperative vision loss and informed consent will affect patients undergoing surgical procedures. The next chapter, the methodology, relates how the researcher aims to further enhance the understanding of who is responsible for informed consent for patients at risk for postoperative vision loss after a surgical procedure.