Patients With Relevant Information Required

¶ … patients with relevant information required to make an informed decision preparatory to a medical intervention is an established ethical and legal responsibility of the healthcare community. Although specific requirements vary from jurisdiction to jurisdiction, it has become well established that certain procedures must be followed in any healthcare setting in order to ensure that patients fully understand the need for a proposed treatment, as well as its implications and possible alternatives, including doing nothing at all. In some cases, healthcare professionals have a formal set of procedures they are required to follow for this purpose, which is the case with nurses practicing in the United Kingdom. The purpose of the study proposed herein is to critically assess the current and expected knowledge and application of informed consent procedures by perioperative nurses and operating department practitioners in the United Kingdom today. To accomplish this purpose, a review of the relevant secondary literature is combined with an analysis of the primary data the results from the administration of a custom questionnaire to representatives from these two groups of healthcare professionals to assess their level of understanding and awareness of their legal and ethical rights as they relate to the provision of informed consent.

TABLE of CONTENTS

CHAPTER 1: INTRODUCTION

Statement of the Problem

Purpose of Study

Importance of Study

Rationale of Study

Overview of Study

Definition of Key Terms

CHAPTER 2: REVIEW of RELATED LITERATURE

CHAPTER 3: METHODOLOGY

Description of the Study Approach

Data-gathering Method and Database of Study

Subjects

Evaluating the Role of the Perioperative Nurse in the Informed Consent Process

Informed consent is at the heart of all medical decisions. -- Joyce Robins, co-director of Patient Concern in the United Kingdom

CHAPTER 1: INTRODUCTION

Statement of the Problem

The epigram above makes it clear that clinicians in all settings have a fundamental responsibility to their patients to ensure that they understand what medical procedures are being offered, what the risks of those procedures might be, and any alternatives -- including no intervention at all -- are disclosed in full. Given its legal and ethical imperative, it is not surprising that there has been a great deal of attention paid to the issue of when, where and why informed consent must be obtained. In this regard, Wear points out that, "Clinicians often respond to ethical issues by first inquiring as to what the relevant law dictates. The instinct is a prudent one. It is not very sensible to discuss ethical options that the law prohibits, or attempt to fashion a response when the law has already provided one and insists upon it" (1999: 9). The laws and regulations concerning informed consent, though, differ significantly from place to place and time to time, making across-the-board analyses difficult or even impossible. As Wear emphasizes, "The law regarding informed consent varies across jurisdictions and countries, so in a global sense there is no single and settled sense of the law to explicate, not even on the level of basic principles and criteria" (1999: 9).

Notwithstanding the paucity of uniformity in informed consent approaches, obtaining the informed consent of patients is an expected component of clinical practice around the world (Sugarman, McCrory, Powell, Krasny, Adams, Ball & Cassell 1999). According to Sugarman and his associates, "In concert with strong theoretical justifications, an array of laws, regulations, court cases, policy statements, and professional guidelines emphasize the need for obtaining meaningful informed consent. Moreover, strong popular reactions to alleged failures to obtain consent, such as those in response to human radiation experiments conducted during the Cold War, underscore this professional, legal, and philosophical expectation" (1999: 1). The expectations and responsibilities of clinicians that are associated with informed consent counseling, then, are firmly based on ethical and legal grounds that are common to all treatment settings that emphasize the fundamental right of humans to decide for themselves what is in their best interests, even if such a decision runs contrary to evidence-based practice and the experience of the healthcare treatment team. In this regard, Wear emphasizes that, "The new ethos of patient autonomy, for its part, enjoys broad societal consensus regarding many of its basic prescriptions. Further, like the law, the new ethos seems to presume that certain needs as well as patient abilities are usually present in the same form and degree. But such univocal presumptions regarding patient abilities and needs clearly run afoul of clinical experience and its supporting empirical literature" (1999:66). Moreover, there are some powerful cross-cultural differences that can affect the informed consent counseling process in ways that may prevent patients from making the decision they would prefer as the result of coercion on the part of the counseling clinician. In this environment, identifying current levels of knowledge of informed consent requirements and procedures among perioperative nurses and operating department practitioners represents a timely and valuable enterprise, which is the purpose of this study as described further below.

Purpose of Study

The overarching purpose of the proposed study is to critically assess the current and expected knowledge and application of informed consent procedures by perioperative (anesthetic) nurses and operating department practitioners (ODPs) in the UK today. To achieve this purpose, the proposed study will combine a review of the relevant secondary literature with the primary data that emerges from the administration of a custom questionnaire to approximately 300 to 350 perioperative nurses and operating room practitioners to gauge their current levels of understanding and awareness of their legal and ethical rights as they relate to the provision of informed consent. The results of this analysis may identify trends in knowledge gaps that can be used to develop educational initiatives that target these areas of deficiency among these clinicians.

Importance of Study

The importance of the proposed study relates to the fundamental right of all patients to be adequately informed concerning any treatments, procedures, and surgical interventions that are proposed by healthcare practitioners so that they can make an informed decision, a process that is a patient's legal right and an ethical responsibility of clinicians (Lea & Thomas-Lawson 2001). According to Lea and Thomas-Lawson, "Informed consent is the voluntary permission that a client, or someone acting on the client's behalf, gives to the health care provider to do something to or for that client after disclosure of adequate information to make a decision. Founded on the principles of respect for autonomy (the right to self-determination) and beneficence, the obligation of informed consent is both ethical and legal" (2001: 146). It is important to note, though, that the informed consent process involves far more than simply providing patients with a "laundry list" of medical descriptions and alternatives, but rather involves the formulation of a therapeutic alliance between clinician and patient that can provide the framework in which a truly informed decision can be made by the patient. In this regard, Lea and Thomas-Lawson add that, "The goal of actualizing client choices, including the right to accept or refuse interventions, is protected by the process of informed consent. The process is characterized by mutual participation, respect, and shared decision making between the client and healthcare provider, not merely by giving information or persuading the client" (2001: 146). Although specific requirements vary according to geographic setting, a common feature that characterizes the nurse-patient relationship in any setting is the need for nurses to understand the tenets of informed consent and recognize their legal and ethical responsibilities. In this regard, Lea and Thomas-Lawson emphasize that, "It is not surprising that the topic of informed consent and the attending principles appear in all current medical and nursing texts regardless of specialty focus (2001: 146).

Because perioperative nurses and operating department practitioners are important components of the overall healthcare team, it is important for them to thorough understand their responsibilities with regards to informed consent as well. Although some clinicians have argued that operating room practitioners "have little or no influence on direct care," Corbett emphasizes that, "This is not solely true in all operating rooms since people respond in amazing ways when given some control over what they do. The more ownership they feel, the more interest they will have, and the harder they will try and do a good job" (emphasis added) (2009: 38). Consequently, perioperative nurses and ODP are in a particularly well suited position to assist patients with informed consent counseling throughout the surgical process. In this regard, Corbett adds that, "All patients have common care needs worldwide during their preoperative, intraoperative and postoperative journey. To facilitate these needs, we have an obligation to ensure that organizational issues relating to our practice are delivered efficiently and that the educational needs of the team are identified and addressed" (2009: 38). Although the principles of informed consent have been codified and are articulated in a professional code of conduct for healthcare professionals in the UK, innovations in medicine and surgery are making the provision of "truly informed" informed consent more difficult all of the time. A good example of this can be found in a report from a practicing physician, Dr. Merrill, in the UK. Following his experience with heart surgery using innovating surgical techniques, the physician noted the problems he experienced in understanding all of his alternatives compared to a simpler earlier procedure, and finally trusted to the advice of his cardiologist to surgically intervene. In response to the experience, Dr. Merrill emphasized that, "As a physician talking to colleagues, I had the best information possible under the circumstances. But it wasn't the same as my hernia repair. The experience brought home to me the realization that the progress of medicine has made informed consent impossible -- even for me" (Merrill 1999: 190).

Rationale of Study

Taken together, the foregoing issues indicate that there is an ongoing need for an assessment of knowledge levels of informed consent among perioperative nurses and operating department practitioners. Perioperative nurses and operating department practitioners, though, are frequently subjected to an enormous amount of stress in a fast-moving and hectic environment, diminishing their ability to provide the level of informed consent counseling that patients need and deserve. According to Salas, Bowers and Eden, "All individuals are susceptible to what is known as human performance limitations. Many health care workers fail to recognize that their abilities may be limited, particularly when they are fatigued, unwell, or otherwise stressed" (2001: 268). These issues are particularly pronounced among anesthesiologists, surgeons, anesthetic nurses, and surgical nurses (Salas et al. 2001). Therefore, by identifying current areas of deficiency in the understanding of informed consent requirements and responsibilities among perioperative nurses and ODPs, timely interventions can be formulated to address these issues so that they will be better prepared to provide their patients with the type of informed consent counseling they need, even during periods of stress and fatigue.

Overview of Study

This proposed study will use a five-chapter format to achieve the research purpose above stated. Chapter one will be used to introduce the issues under consideration, as well as a statement of the problem, the purpose, importance and rationale of the study. Chapter two of the proposed study delivers a critical review of the relevant and peer-reviewed literature concerning informed consent requirements and the specific legal and ethical responsibilities of healthcare providers, including nursing staff. Chapter three will be used to more fully describe the study's methodology, including a description of the study approach, the data-gathering method, the database of study consulted, and the subjects to be used in the study. Chapter four will consist of an analysis of the secondary and primary data developed during the research process and chapter five will present the study's findings, including a summary of the research and recommendations.

Definition of Key Terms

NHS: National Health Service

Operating room practitioner: According to Corbett (2009), "Operating room practitioners are a highly professional group, working behind the doors of an environment that is unfamiliar to the public. It is also new to some nursing colleagues who have never before been exposed to the three main areas of patient care: the anaesthetic room, operating room and recovery" (2009: 37).

Perioperative nurse: A perioperative nurse (or in some settings, also called an operating room nurse), is a member of the surgical team who is responsible for providing care to patients prior to, during and following the completion of their surgical procedures (Novotny, Lippman, Sanders & Fitzpatrick 2003).

CHAPTER 2: REVIEW of RELATED LITERATURE

Chapter Introduction

This chapter provides an overview of informed consent and why it is important in any healthcare setting, followed by a discussion concerning various cultural factors that should be taken into account during the informed consent counseling process. Finally, a review of the informed consent requirements for nurses and operating room practitioners in the United Kingdom is followed by a brief summary of the chapter.

Informed Consent Overview

Nurses have always been involved in obtaining informed consent from clients undergoing diagnostic tests and various interventions. Involvement of nurses in obtaining informed consent from subjects for research protocols/studies is more recent. There are no obvious differences in the legal standards for obtaining informed consent for the purpose of therapy/treatment or research; however, the character of consent provided for therapy differs from that given for research. Clients are offered therapy/treatment when there is substantial evidence that they will benefit directly; however, clients are solicited to participate in research studies that may not directly affect their well-being (Lee & Thomas-Lawson 2001).

According to Tobin, the informed consent required in order to provide any type of medical treatment, including surgery, and the process is comprised of three key components as follows:

1. Communication of necessary information which includes three essential elements: (a) the risks of the proposed treatment, (c) viable alternative treatments, and (c) likely outcomes in the absence of treatment;

2. Comprehension of that information by the patient; and,

3. Subsequent consent to treatment (2008: 111).

Although every patient and treatment setting is unique, these elements are common to all informed consent procedures administered by the perioperative nurse (Tobin 2008). In addition, Lachman emphasizes that, "Legally, informed consent is a requirement, unless there are extremely specific circumstances, especially if the person meets competency requirements" (2006: 37). In other words, if people are competent, they have an inalienable and fundamental right to make decisions about their medical treatment, violations of which can carry severe consequences for the healthcare provider. According to Siegel, "Medical ethics and tort law enshrine patient autonomy at the heart of the informed consent dialogue" (2008: 1694). This means that the healthcare provider must ensure that persuasion is not used as a means of coercing a patient to agree to a surgical procedure even if all evidence-based practices indicates that such intervention is needed and may spell the difference between life and death. Rather, Siegel maintains that for the perioperative nurse, "The goal of informed consent counseling is not to intervene in a patient's understanding of her own self-interest, her family's interest or the appropriate balance between them (e.g. whether to risk cardiovascular surgery that might improve quality of life but poses a threat to longevity or whether to undergo chemotherapy that might increase longevity but reduce quality of life). Instead, a professional seeks to provide the patient information about possible benefits and risks of various courses of treatment that would enable the patient to make the medical decisions that -- in her judgment -- best serve her own self-interest and the interests of others dependent upon her" (2008: 1695).

Perioperative nurses and OPDs are just human, of course, and may unknowingly and unintentionally present a compelling argument in favor of a given intervention to the point where the patient's preferences are overridden in favor of the intervention favored by the healthcare providers and the treatment team. In this regard, King and Moulton (2006) note that this tendency can be problematic in a significant percentage of cases: "Around one-third of all medical decisions should depend largely on the values and preferences of the patient, rather than the norms of physician practice. Patient preferences for information disclosure, risk taking, quality of life outcomes and tolerance of side effects differ greatly amongst the patient population, yet variations in treatment decisions often do not reflect differences in patient choice" (2006: 429). Moreover, withholding important information concerning potential alternatives, including doing nothing at all, are contrary to the tenets of informed consent. As Calloway points out, "In cases where patient lifestyle, personal preferences and values are indicative of the most appropriate treatment choice, [clinicians] are not in the best position to make treatment decisions and should not limit disclosure of alternatives" (2006: 429).

There are some sound reasons for the informed consent requirements as well that may or may not be required to be reduced to writing, but which must nevertheless be clearly communicated between practitioner and patient. In this regard, Cobb notes that, "Disclosing information relating to patient treatment enables the patient to knowingly consent to - or to reject - the treatment that the healthcare provider is proposing. The informed consent paradigm should not be solely relegated to a simple form, although written confirmation to the patient to memorialize the process is always advisable" (2005: 330). The foregoing requirements and considerations are fairly straightforward and can be used as a useful framework in which the informed consent process is applied and for what purposes, but there are some other factors involved in the patient-clinician relationship that may affect the informed consent counseling process, and these issues are discussed further below.

Cultural Issues and Informed Consent

Although legally and ethically required, there are some important cross-cultural issues involved in the delivery of informed consent protocols that can affect the perioperative nurse-patient relationship based on fundamentally different worldviews. In her recent study, "The Effect of Culture on Beliefs Related to Autonomy and Informed Consent," Calloway reports that, Our personal world has become a global one and the impact of various cultures causes us to reflect on many previously held beliefs related to autonomy and informed consent within a multicultural framework" (2009: 69). In an increasingly multicultural society such as exists in the United Kingdom today, these are particularly important issues for perioperative nurses and OPDs practicing in National Health Service facilities where a wide range of cultures are represented. It is therefore important for clinicians to understand how these cross-cultural differences may affect the informed consent counseling process and what may be involved in obtaining informed consent from people of different backgrounds and cultures. For example, Calloway emphasizes that, "As nurses, we are educated to function as an advocate for the patient in articulating those concerns which the patient and family may be hesitant to address. It is our responsibility to become more knowledgeable regarding the beliefs held by people of different cultures in order to raise awareness and make changes as needed in the healthcare system" (2009: 69). Based on her experiences, Calloway suggests that the most often cited disparity in the delivery of healthcare services in the UK today is related to culture and informed consent.

Because there are formal policies in place concerning the legal and ethical responsibilities of nurses in the UK concerning informed consent, Calloway questions whether culture should be taken into account in the decision concerning what should be disclosed and to whom. Although the examples Calloway cites are from North America, many of the same cross-cultural misadventures could be reasonably expected to occur in a comparably multicultural society such as the UK. Some of the representative examples of how cross-cultural differences can affect the informed consent process include the following anecdotal accounts concerning cultures that are represented in the UK today:

1. In the Chinese culture, a similar attitude is taken regarding truth telling. People fear that openly acknowledging an impending death is like casting a death curse upon the person; it will make the person despair and die even sooner.

2. Another example of cultural conflict with informed consent is highlighted by an account of a 55-year-old Vietnamese man with end-stage liver disease due to chronic hepatitis B infection. When cancerous masses were discovered in his liver the family requested that he not be told of his diagnosis, as this would cause him to give up hope. Even the Vietnamese interpreter who was brought in to translate stated that if the provider told the patient that he had cancer, that she would not translate this if it was not the family's wish. This lack of full disclosure was seen as the ethically correct choice in the Vietnamese culture while in the Anglo-American culture this was a viewed as preventing individual autonomy.

3. In the Ethiopian culture, full disclosure of dire news is also seen as unethical. Three cases of Ethiopian patients in hospitals in the United States whose families requested that they not be told of the terminal nature of their illness showed that in one case the surgeon went against the husband' wishes and told the patient that she had stomach cancer. She was shocked and dismayed by the news and indicated that she believed the surgeon was cruel and inconsiderate and asked that he be removed as her physician. With the new provider, treatment and prognosis discussions were held only with her husband. In Ethiopia where family's importance dominates over that of individual members, any information including the diagnostic facts belongs to the family. Caring in this culture is seen as offering hope and the patient-healer relationship is seen as paternalistic and protective.

4. Russian families are notified first of a terminal diagnosis and family members decide if the patient should be told (Calloway 2009: 69).

The foregoing anecdotal accounts are also congruent with the findings provided by King and Moulton who emphasize, "While many patients want to be given information and be involved in the decision, patient preferences for the role they play in treatment decisions vary widely" (2006: 430).

Informed Consent Requirements for Advanced Practice Nurses and Operating Room Practitioners in the United Kingdom

As to informed consent requirements for nurses and midwives practicing in the UK, the Nursing & Midwifery Council's "Standards of conduct, performance and ethics for nurses and midwives" (hereinafter alternatively "the Code") generally stipulates that these healthcare practitioners:

1. Must ensure that they gain consent before they begin any treatment or care;

2. They must respect and support people's rights to accept or decline treatment and care;

3. They must uphold people's rights to be fully involved in decisions about their care;

4. They must be aware of the legislation regarding mental capacity, ensuring that people who lack capacity remain at the centre of decision making and are fully safeguarded; and,

5. They must be able to demonstrate that they have acted in someone's best interests if they have provided care in an emergency.

The Code further generally stipulates that it is presumed that all adults possess the requisite mental capacity to either consent or refuse treatment, unless the following conditions are present:

1. They are unable to take in or retain information provided about their treatment or care;

2. They are unable to understand the information provided; and/or,

3. They are unable to weigh up the information as part of the decision-making process.

The Code also emphasizes that while the determination concerning an adult's capacity to consent or not remains primarily with the treating physician, "Nurses . . . have a responsibility to participate in discussions about this assessment" (2008: 3). In this regard, nurses practicing in the UK have three main professional responsibilities concerning obtaining informed consent as follows:

1. To make the care of people their first concern and ensure they gain consent before they begin any treatment or care.

2. Ensure that the process of establishing consent is rigorous, transparent and demonstrates a clear level of professional accountability.

3. Accurately record all discussions and decisions relating to obtaining consent (2008:4).

Finally, the Code generally stipulates that there must be valid consent obtained from competent individuals; such individuals may be others who are legally acting on the patients' behalf but no other person besides the patient can provide informed consent if the patient is competent, with the exceptions outlined in Table 1 below, the first domain to be measured by the custom questionnaire, followed by a listing of the other domains, edited only for relevance and clarity.

Table 1

Domains of the Nursing & Midwifery Council's "Standards of conduct, performance and ethics for nurses and midwives"

Domain

Standards of conduct, performance and ethics for nurses

Domain No. 1:

Emergency situations

An adult who becomes temporarily unable to consent due to, for example, being unconscious, may receive treatment necessary to preserve life. In such cases the law allows treatment to be provided without the person in the care of a nurse consent, as long as it is in the best interests of that person. Medical intervention considered being in the persons best interest, but which can be delayed until they can consent, should be carried out when consent can be given. Exceptions to this are where the person has issued an advanced directive detailing refusal of treatment.

Domain No. 2:

Obtaining consent

Obtaining consent is an ongoing process instead of a one-time affair. When a person is told about proposed treatment and care, it is important that the information is given in a sensitive and understandable way. The person should be given enough time to consider the information and the opportunity to ask questions if they wish to. Nurses should not assume that the person in their care has sufficient knowledge, even about basic treatment, for them to make a choice. The code supports involving people in the care giving processes. It clearly states: "You must uphold people's rights to be fully involved in decisions about their care." It is essential that they are given sufficient information to enable them to determine whether or not to accept or decline treatment and care. This right is supported in the code where it states: "You must respect and support people's rights to accept or decline treatment and care." If a person feels the information they have received is insufficient, they could make a complaint to the NMC or take legal action. Most legal action is in the form of an allegation of negligence. It is therefore essential that nurses ensure that they: "…share with people, in a way they can understand, the information they want or need to know about their health." In exceptional cases, for example, where consent was obtained by deception or where not enough information was given, this could result in an allegation of battery (or civil assault in Scotland); however, only in the most extreme cases is criminal law likely to be involved.

Domain No. 3:

Who should obtain consent?

The nurse proposing to perform a procedure should obtain consent, although there may be some situations where this may be delegated to another. When choosing to delegate the nurse must: "… establish that anyone you delegate to is able to carry out your instructions" and "… confirm that the outcome of any delegated task meets required standards." Usually the individual performing a procedure should be the person to obtain consent. In certain circumstances, nurses may seek consent on behalf of colleagues if they have been specially trained for that specific area of practice. There may be occasions where nurses, although caring for the person, are not responsible for either obtaining consent or performing the procedure. In these cases the nurse is often best placed to know and to judge what information the person requires in order to make a decision. Nurses are reminded of the importance of communication within the team and are advised that any concerns regarding a persons understanding of a procedure should be communicated appropriately. Such difficulties in understanding could be as a result of language differences. Interpreters may be required to assist in such cases. The Code on these two points specifically states: "You must keep your colleagues informed when you are sharing the care of others" and "You must make arrangements to meet peoples language and communication needs."

Domain No. 4:

Forms of consent

A person in the care of a nurse may demonstrate their consent in a number of ways. If they agree to treatment and care, they may do so verbally, in writing or by implying (by co-operating) that they agree. Equally they may withdraw or refuse consent in the same way. Verbal consent, or consent by implication, will be enough evidence in most cases. Written consent should be obtained if the treatment or care is risky, lengthy or complex. This written consent stands as a record that discussions have taken place and of the person's choice. If a person refuses treatment, making a written record of this is just as important. A record of the discussions and decisions should be made.

Domain No. 5:

When consent is refused

Legally, a competent adult can either give or refuse consent to treatment, even if that refusal may result in harm or death to him or herself. Nurses must respect their refusal just as much as they would their consent. It is important that the person is fully informed and, when necessary, other members of the health care team are involved. A record of refusal to consent, as with consent itself, must be made. The law and professional bodies recognise the power of advanced directives or living wills. These are documents made in advance of a particular condition arising and show the persons treatment choices, including the decision not to accept further treatment in certain circumstances. Although not necessarily legally binding, they can provide very useful information about the wishes of a person who is now unable to make a decision.