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.
Postoperative Vision Loss
An infrequent complication that appears t be increasing over the past 10 years includes loss of vision after a non-ocular surgical procedure. Dr. Molly E. Gilbert (2006), Assistant Professor of ophthalmology at the University of Illinois-Chicago Eye and Ear Infirmary, examines this concern in the article, “New informa journal article clarifies understanding of post-operative visual loss.” Due to the devastating impact on a patient’s quality of life, along with the medicolegal implications for surgeons and patient, experts strive to understand why and how often this malady occurs. Ascertaining the number of cases of perioperative visual loss (POVL) that actually occur, proves impossible, however, as it is not known how many of the cases are actually reported.
Certain surgical procedures more than others may cause cases of POVL caused. Gilbert (2006) further asserts: “A wide variety of surgical interventions have been associated with POVL, including cardiopulmonary bypass, lumbar spine surgery, neck dissection, abdominal procedures, hip surgery, cholecystectomy, parathyroidectomy, prostate surgery, pleurodesis and rotator cuff surgery” (¶ 2). While some cases of POVL occur because of the surgery itself or even the anesthesia, nevertheless, some instances of POVL occur due to a pre-existing medical condition in certain patients.
Disruption of blood supply to the eyes during a surgical procedure, whether from direct pressure to the eyes or to the blood supply itself may cause POVL. Gilbert (2006) explains that in several causes of POVL after non-ocular surgery, complications may include central retinal artery or vein occlusion, ischemic optic neuropathy, and cortical blindness. In addition, if a patient’s blood flow or blood pressure is interrupted or obstructed in some way, POVL may occur.
The way a patient’s body is positioned during and after surgery may also lead to POVL. Gilbert (2006) explains that “one study showed that there was a higher increase of intraocular pressure (IOP) in patients whose heads were supported by pillows vs. patients whose heads were supported by pins in the prone position” (¶ 4). Other studies reveal that the IOP increased simultaneously with the more time a patient was positioned and stayed in the prone position. Some healthcare providers claim that the amount of intravenous fluids given during a surgical procedure may contribute to an increase in IOP.
The length of a surgical procedure, according to a number of studies, may be a risk factor for eye injury. Gilbert (2006) asserts that “the risk is increased further with endotracheal intubation and in patients undergoing surgery of the head or neck” (¶ 5). According to the Scoliosis Research Study, healthcare providers should maintain systolic blood pressure and protect the position of the eyes during surgical procedures. A POVL registry has been established and set up by The American Society of Anesthesiologists, which has also ascertained the risk of placing patients in the prone position. The ASA recommends crefully watching blood loss of patients, particularly during extended surgical procedures.
Healthcare providers and researchers agree that a wide variety of factors may cause POVL. As a result, this makes the complication difficult to prevent and predict. Currently, no sound treatments exist for POVL. Gilbert (2006) purports that “many patients have certain clinical factors that could predispose them to developing POVL” (¶ 7). Consequently, it is vital that the educators of medical professionals, especially anesthesiologists, teach the risk factors of POVL to decrease the chances of this devastating complication to occur. Figure 3 depicts some recommendations for decreasing the chance of POVL.
Figure 3: Recommendations for Decreasing POVL (adapted from, Gilbert, 2006, ¶ 9).
In the article, “Perioperative visual loss: What do we know, what can we do?,” Br. J, Anaesth (2009), Department of Anaesthesia and Critical Care, University of Chicago, points out that the highest cases of POVL reportedly occur after cardiac and spine surgical procedures. Retinal vascular occlusion and ischaemic optic neuropath, according to Anaesth, constitute the primary causes of visual loss that occur after non-ocular surgery.
Typically, the only eye injuries patients undergoing surgical procedures experience are corneal abrasions from improper placement of face masks or from surgical drapes. In the case study, “The incidence of vision loss due to perioperative ischemic optic neuropathy associated with spine surgery,” Dr. Shu-Hong Chang and Dr. Neil R. Miller (2005), both in the Neuro-Ophthalmology Unit, Departments of Ophthalmology, Neurology, and Neurosurgery, Johns Hopkins University, Baltimore, Maryland, investigate this concern. These authors assert that nevertheless, a number of case reports relating further serious complications which resulted in permanent vision loss “have appeared in the ophthalmology, anesthesiology, and surgical literatures since the 1940s. Vision loss in those cases can be separated into two types: those due to central retinal artery occlusion (CRAO) and those due to perioperative ischemic optic neuropathy (POION)” (Chang and Miller, Introduction section, ¶ 1). A number of reports involving CRAO involve patients undergoing spinal surgeries; positioned in the prone position. Chang and Miller (2005) explain:
…With the exception of proximal embolism from the ipsilateral internal carotid artery in cardiac surgery patients, the most common etiology of perioperative CRAO is direct external pressure on the eye. In these instances, the intraocular pressure exceeds systemic blood pressure, thereby decreasing blood flow through the central retinal artery with resultant retinal ischemia and vision loss. (Introduction section, ¶ 2)
The more common cause of vision loss after mom-ocular surgical procedures occurs from POION more so than CRAO. Chang and Miller (2005) explain that even though this problem appears to occur too sporadically to permit prospective, “single-center studies of the risk factors that predispose to its occurrence, multiple case reports and small series have described an association between POION and anemia, hypotension, long duration of surgery, excessive hydration, or a combination of these factors” (Introduction section, ¶ 3). Cardiac surgical procedures that require a patient to be put on a pulmonary bypass machine are one of the most common causes of POION.
Patients who undergo surgical procedures of the head, neck or the spine, especially positioned in the prone position, also have a higher risk of POION. Chang and Miller (2005) assert that “much of the literature on POION associated with spine surgery has consisted of individual case reports or small series of patients with optic neuropathies after various types of noncardiac surgery” (Introduction section, ¶ 4). There have been two specific studies conducted on the occurrence of POION on patients who underwent spinal surgical procedures.
A retrospective study conducted over a 12-year period at a major university in the U.S. revealed that out of 10,000 surgeries where a patient was positioned in the prone position for a spinal procedure, no cases of POION were reported. A different study, however, published in 1997 by Spine, over a 9-year period, reported a 0.12% occurrence of POION in 3,450 spinal procedures. Chang and Miller (2005) assert that the hefty experience with spine surgery at the Johns Hopkins Hospital, “in addition to the presence of an active neuro-ophthalmology service that consults on all cases of perioperative ischemic optic neuropathy,” (Introduction section, ¶ 5) led to the determination of the incidence of POION following spine surgery at their specific facility.
The article, “Perioperative vision loss most common after cardiac surgery or spinal fusion” (2009), purports that research indicates patients who undergo cardiac surgery and spinal fusion are more prone to experience POVL than patients experiencing other operations. “…Even with these two types of procedures, the absolute risk of POVL is very small” (“Perioperative vision loss…,” ¶ 1). Still, a dearth exists of exact estimates relating the frequency of POVL in regularly performed operations.
Dr. Steven Roth and colleagues, from the University of Chicago Medical Center, utilized data from the Nationwide Inpatient Sample from more than 5.6 million patients to approximately calculate the rate of POVL for numerous more common nonocular surgeries performed in the U.S. The analysis by Roth and colleagues included “knee arthroplasty, cholecystectomy, hip/femur surgical treatment, spinal fusion, appendectomy, colorectal resection, laminectomy without fusion, coronary artery bypass grafting (CABG), and cardiac valve procedures. POVL was defined as a discharge diagnosis of ischemic optic neuropathy, cortical blindness, or retinal vascular occlusion (“Perioperative vision loss…,” 2009, ¶ 5).
For cardiac surgery and spinal fusion, rates of POVL per 10,000 operations were 8.6 and 3.09, respectively. At the other end of the spectrum was appendectomy, with a rate of 0.12 per 10,000 operations. Further analysis confirmed that cardiac surgery, spinal fusion, and also orthopedic surgery carried significantly higher risks of all three types of POVL (Perioperative vision loss…, 2009, ¶ 6). Due to high rates of cortical blindness, patients younger than 18 years had the highest prevalence of POVL at 4.37 cases per 10,000 operations. Subjects older than 50 years were at increased risk for developing ischemic optic neuropathy and retinal vascular occlusion (“Perioperative vision loss…,” 2009, ¶ 7).
Vision loss after a non-ocular surgical procedure proves rare which makes is difficult for healthcare providers to understand and treat. The article, “Vision loss after non-ocular surgery is rare but potentially devastating,” (2009) explains that vision loss after non-ocular surgery generally results from cortical blindness, ischemic optic neuropathy or retinal vascular occlusion. Researchers from the University of Chicago presented rates of POVL from 1996 to 2005 at a meeting for the American Society of Anesthesiologists. This constitutes the most extensive information and report of POVL rates to date.
Dr. Steven Roth, one author of the study, relayed that incidences of POVL have been increasing over the last several years. He asserts that in earlier studies, POVL rates were typically found in smaller institutions or hospitals. Dr. Roth explains that his colleagues utilized the Nationwide Inpatient Sample (NIS) to gain a more detailed account of POVL rates in their study which evaluated the prevalence of POVL in the eight most commonly performed U.S. operative procedures, which includes cardiac and spine surgery (“Vision loss after…,” 2009). Researchers, as well as, physicians stress that more research and studies are needed on POVL.
Researchers retrospectively studied the NIS from 1996 to 2005 in a stratified sample of approximately 20% of U.S. community hospitals. Among 5,679,422 eligible discharges examined through the NIS database, 1326 contained a diagnosis code for POVL with a rate of 2.35/10,000. The eight surgeries evaluated in the analysis were hip/femur surgery, knee replacement, gallbladder removal, cardiac surgery, appendectomy, colon resection, laminectomy without fusion and spinal fusion. (“Vision loss after…,” 2009, ¶ 4)
Findings from the study by Roth and his colleagues mirror changes in anesthetic and surgical practice, albeit, also confirm the need for further study. Nevertheless, the trend relating decreased rates of POVL in each category reassure clinicians and for patients who undergo surgery. Encouraging results should not be perceived as suggesting vigilance should be decreased. Vigilance anesthesiologists and other clinicians display in the operating room leads to improved patient safety, and in turn better satisfaction with treatments (“Vision loss after…,” 2009, ¶ 8).
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.
REFERENCES
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Chang, S.H. & Miller, N.R. (2005). The incidence of vision loss due to perioperative ischemic optic neuropathy associated with spine surgery. The Johns Hopkins Hospital. Lippincott Williams & Wilkins.
Chen, A.M., Leff, D.R., Simpson, J., Chadwick, S.D. & McDonald, P.J. (2006). Variations in consenting practice for laparoscopic cholecystectomy. The Royal College of Surgeons of England. Ann R. Coll Surg Engl 2006; 88: 482 — 485.
Clarke, J.R., Johnston, J. & Finley, E.D. (2007). Getting surgery right. Annals of Surgery.
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Gilbert, M.E. (2008). New informa journal article clarifies understanding of post-operative visual loss. Medical News Today. Retrieved January 25, 2010 from http://www.medicalnewstoday.com/articles/125277.php
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RESEARCH
Alan, relative, with regard to medical procedures using anesthesia, may have an optical affect, lost partial vision in his right eye; not related to anesthesia. Reported he
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