The process of consent is giving adequate amount of information to the patient about the procedure/intervention. This involves an effective communication process between the patient and the physician. This is the duty of the physician to disclose the information to the patient in such a way that would be easier for the patient to make the most appropriate decision about their treatment plan. At the same time the patient must utilize his/her mental abilities to analyze the information and make the decision about the treatment. This involves the intellectual and cognitive mental fields of both patient and the physician. The process of consent will be at stake if both the physician and the patient fail to communicate well. There is a raising concern about what and how much information should be given to the patient in a way that makes the patient understand the information and decides about the prospective intervention or treatment. The communication of medical information to patients is even more demanding because of the need to explain scientific issues with plain language. Physicians should also communicate medical information in a caring and compassionate way. If these requirements are met, the clinician-patient relationship will be founded on trust and alliance. This process could halt if the physician is unable to transfer the information well. At this scenario, the nurses would be at forefront for empowering the patient by performing the role of educator and advocate of the patient and explaining the patient with the information they need about the procedure.
I was doing my duty in the oncology ward caring a patient who was diagnosed as “esophageal cancer” and he is a candidate of peg-tube for feeding. The patient had gone through the chemotherapy and radiation therapy. The procedure had to be done in the radiology department under digital subtraction angiography fluoroscopy machine. The patient was explained about the procedure in the ward by the attending oncologist. The patient was emaciated and with lean body structure and he was in immense need for the food passage that bypass the tumor site without which the patient would be in great hazard of developing symptoms that can seriously threaten the life of the patient. We being the nursing staff prepared the patient and took that patient to the radiology department. As we reached the radiology department, the resident doctor who was supposed to do the procedure took the consent. While he was explaining the procedure and its prose and cones, he used a lot of medical terminologies like, infection, propulsion out, stoma formation, obstruction, seepage, and septicemia. He told the percentage of these complications at the same time with each terminology. My patient got confused and fell into predicament of calculations of complications. He asked for some time from the resident doctor to make decision. As soon as the resident left, the patient asked me about what to do? He also asked me what the resident was talking about and what the meanings of those revolting difficult medical words are. I explained the procedure and the expected complication in simple language. He was so confused and wanted to talk to his relative before making any decision. He refused to get that procedure at that time and ask me to take him back to the ward. We tried to convince him but all in vain and we took him to the ward.
At some other time, I was taking care of a patient who was diagnosed as stomach cancer. He was the candidate of surgery. The surgeon came to the patient and after assessing the patient, he haphazardly told the patient that he would open his chest and cut through the abdomen and would took the stomach out of the body in a casual manner. The patient and his wife with children stunned and look to the doctor in an enigma. The surgeon left the ward afterword leaving the baffled and scared people behind. Despite the counseling of nursing staff and junior doctors, the patient was so terrified and panic that he left the hospital on leaving against medical advice (LAMA).
What is informed consent?
Informed consent is the communication process between a patient and physician that ultimately results in the patient’s agreement to undergo a treatment or procedure as furnished by American Medical Association (AMA).
Any person or patient who is directly subjected to medical treatment, healthcare intervention, or research is required to give consent. This requirement is due to the principles of non-munificence and beneficence. This is the fundamental duty of the health care providers to respect the dignity of any human and health care providers do not act against a person’s whish and not present the information that proves to be ambiguous and confusing and instigate a communication process that is not based on shared decision. Informed consent facilitates the shared decision among patient and the physician.
Medical ethics requires the obtaining of informed consent before any intervention or medical treatment or research. The international guidelines about the informed can be found in World Medical Association’s Declaration of Helsinki and in the Council for International Organization of Medical Sciences (CIOMS). The draft of International Ethical Guidelines for Biomedical Research Involving Human Subjects is also put forward by the mutual effort of CIOMS and World Health Organization. The declaration of Helsinki and CIOMS guidelines provide the underpinning concepts of informed concept and its procedure (AMA).
There are few basic requirements to be fulfilled to proceed with an effective consent process.
Capacity to consent
Full disclosure of relevant information to the patient by physician.
Adequate comprehension of the information by all participants.
Voluntary decision to participate and withdraw from participation at any stage without prejudice to the participant. Participant withdrawal should be accepted and withdrawing participants should not be expected to give any reasons for their decision.
Why informed consent?
In those instances where nurses are required by employers to witness a client’s signature on the consent form, it must be understood that this action does not constitute obtaining the client’s consent. Nurses who witness consents, however, are ethically obliged to assess the client’s understanding of the proposed treatment and to inform the physician and/or the appropriate agency representative if there is reason to believe the client has any misunderstanding regarding the nature, purpose, inherent risks or alternatives of his or her treatment.
Nurses are accountable for all aspects of their professional practice and must act always in such a manner as to promote and safeguard the interests and well-being of clients as elaborated by Canadian Nurses Association (CNA).
Contributing factors for debility in informed consent process
Many factors impact the comprehension of informed consent information. They include formal education, method of presentation, nature of information, vocabulary levels, age, literacy skills, and cultural-differences. Furthermore the understanding of “risk” information and the cognitive biases of quantitative (percentage of occurrence of side effect) or qualitative (understanding of different side effects) probability that the risk imposes are also crucial in decision making about whether to receive the intervention or not. If the consent taking process is too much flooded in presentation of medical terminologies and mathematical percentages, than there is a huge chance of misleading at the patient side. Additionally, individuals facing cancer and other chronic conditions have strong emotional feelings created by needs for self-preservation and multiple personal, psychosocial, economic, and family concerns. Such feelings may cause individuals to make quick decisions without weighing alternatives thoroughly. Providing too much complex information (overload) can lead to poor understanding, miscommunication about roles of care taker and care provider, expectations and outcome of the procedures, and ultimately contribute to misinformed consent or decline from the procedure. Ensuring comprehension of the complex nature of cancer care related interventions (e.g. PICC line insertion, gastrostomy, and stoma formation) is a challenge; innovative communication interventions must be developed to facilitate informed decision-making.
The poor understanding of certain questions may not always be due to poor understanding but rather the consequence of poorly communicated information. King et al (2005), in their analysis of consent forms reported that vagueness, inconsistency and overstatement may all promote confusion about what subjects can expect from receiving the experimental
Moreover, the results from studies showed that disputes over informed consent are usually associated with concerns that the episode of care was substandard in other ways. Different types of concerns may interact. Dissatisfaction with other aspects of care, such as its technical quality, may prompt patients to reflect unhappily on the consent process; misunderstandings emanating from the consent process may lead patients to second-guess the quality of the care that followed; it may also be true that clinicians who have problems with the consent process also experience problems delivering other aspects of care. The most likely scenario is that a mix of concerns operate synergistically, producing a sufficiently negative perception of the overall care experience to move patients to complain or litigate. (King et al., 2005)
Communication is essential to everyday life and is the centre of professional practice.
The way in which people communicate is unique and influences the quality of the relationships with those they interact with (Jootun & McGhee, 2011 P. 40). Furthermore Jootun and McGhee (2011 P.41), illustrate that this process requires a vast range of skills in intrapersonal and interpersonal processing, listening, observing, speaking, questioning, analyzing and evaluating.
Good communication is the foundation of safe, effective patient and family-centered care, whereas poor communication is often cited as the thrust for malpractice suits, non-adherence to treatment regimens, and patient dissatisfaction (Knops & Lamba, 2010). Furthermore these authors suggest that failure to align communication styles and goals can lead to miscommunication and frustration. Additionally Williams et al, (2008) refer to effective communication as fundamental for mutual understanding, informed decision making, and effective delivery of health care.
In a qualitative study carried out to find out barriers to effective communication across the primary and secondary interface, communication issues across each of the stages of the patient journey included content, tone, style, and format (Farquhar et al, 2005). However most often it was the speed at which information was received that caused difficulties. It explains that language and culture are inextricably bound and cross-cultural communication is complex. Furthermore speaking the same language does not guarantee effective intercultural communication. If both the patient and caregiver speak national language, it does not satisfy the cultural coherent exchange of ideas (2005).
This discussion also takes account that, who are the people more vulnerable to decline to their treatment due to consent process. In view of Tait (2009) the vulnerable populations are persons who are relatively or absolutely incapable of protecting their own interest through negotiations for informed consent. Those generally accepted as being vulnerable include children, prisoners, pregnant women, fetuses, mentally disabled persons, and economically or educationally disadvantaged individuals. These populations were identified after the historical examples in which research subjects were exploited for the purpose of medical research. Vulnerable people are more prone to misunderstand the medical information given and make decision that is crucial for their health.
Prevalence of refusal of treatment due to consent process
Miscommunication leads to dissatisfaction from the health care provider and also from the health care agency. This may lead to “leaving against medical advice”(LAMA). Leaving against medical advice discharges continues to be a highly prevalent problem of health care quality, representing as many as 2% of all hospital discharges (Alfander, 2009). Furthermore, patients discharged LAMA, taken as a whole, are an at-risk group for both morbidity and mortality. If the patient decline to take the procedure than he or she will again present to the hospital with more severity and complication. This would not only lead to worsening of the patient’s condition and would claim on the financial bill either by the patient or by any agency. This mismanagement would make the job of primary physician more difficult. In a study Baptist (2007) found that patients with asthma who were discharged LAMA had a 4-times higher risk of readmission to the emergency department within 30 days (21.7% vs 5.4%) and almost a 3-times higher risk of readmission to the hospital within 30 days (8.5% vs 3.2%).
A total of 3.4% (263/7846) of medical negligence claims and 11.5% (218/1898) of conciliated complaints involved allegations of deficiencies in the consent process (Gogos, 2011). In 65% of claims and 54% of complaints, the consent allegation stood alongside other allegations about the quality of care rendered. Subsequent analysis of the data of the same research revealed that more than half (57%) of the cases were against surgeons. Four surgical subspecialties – plastic, general, orthopedic and ophthalmic surgery – accounted for 81% of all cases against surgeons. Obstetrics-gynaecology (14%) and general practice (11%) were the other prevalent specialties. Collectively, surgeons, obstetrician-gynaecologists and GPs were involved in 82% of cases that made allegations before the court of law due the deficiencies in the consent process. That shows that there is a role of nurses for improvement in the consent process.
Further analysis of the data in the same research revealed that in 71% of cases the primary allegation was, the treatment had not been fully understood, and the process by which consent was obtained was unsatisfactory. Consent process allegations involved situations in which patients felt rushed, pressured to proceed, or regarded the language used as incomprehensible (Gogos, 2011). It clearly showed that the process of consent was dissatisfactory and patients were not aware of the procedure adequately.
Targum et al., (1998) found an approximately 30% decrease in total LAMA discharges among psychiatric inpatients in a private hospital that used a nurse as a patient advocate. The advocate’s responsibility was to help explore a “patient’s preconceptions about hospitalization and to address fears and complaints about it.” Involving a nurse for counseling the patient in treatment process and in education about their procedures in clinical setting for consent taking process may produce the similar results.
It can be anticipated that the consequences of the refusal of treatment due to lacking in consent process are increased in the estimated cost of the particular disease management and higher risk of worsening of the patients’ condition and readmission due to the same reason. In case of the admitted patients there may be a delay in the treatment or intervention. In this prevailing scenario nurses has the pivotal rule to participate in the consent process as patients’ educator and advocate.
Theoretical support and strategies to resolve problem
Consent taking process is the most crucial step in the treatment regimen for acute as well as in chronic conditions. To make it more satisfactory and worthy for the patients, nurses may play their role of patients’ educator and advocate. Nurses may participate in the consent process with the physicians as delegator in addition to the role of nurses as witness. Theory of delegation is applied in this concept. The national council of State Board of Nursing (NCSBN) issued a concept paper on delegation in 1995. This conceptualization places the selection of role-appropriate assignment to personal in the context of the client’s needs. So in case the patient is not able to understand the information provided by the physician, nurses may take over the role of educator. This role is taken by nurses to address the needs of patient that is right of patient to be informed about their medical condition, the risks and benefits of treatment and appropriate alternatives as furnished by the Patient Bill of Rights (1998) adopted by the United States Government.
Nurses seek to ensure that care is authorized by informed choice, and are guided by this idea when participating in the consent process in cooperation with other members of the health care team (Canadian Nurses Association, 2002).
While registered nurses are responsible for explaining to the client the care and treatment they give, physicians are legally responsible for informing clients of impending medical or surgical treatment, risks, benefits, and alternatives as furnished by the Canadian Nurses Association (2002). It further explains that
“In those instances where nurses are required by employers to witness a client’s signature on the consent form, it must be understood that this action does not constitute obtaining the client’s consent only. Nurses who witness consents, however, are ethically obliged to assess the client’s understanding of the proposed treatment and to inform the physician and/or the appropriate agency representative if there is reason to believe the client has any misunderstanding regarding the nature, purpose, inherent risks or alternatives of his or her treatment.”(2002)
Nurses are accountable for all aspects of their professional practice and must act always in such a manner as to promote and safeguard the interests and well-being of clients. Hence, while caring for the patient they are guided by the concept that patient is adequately informed when they participate in the consent taking process.
It is recommended that the nurses should assume the role of educator and advocate of the patient in consent taking process. Physician may take a delegated consent by allowing the nurses to explain the good and bad outcomes of the intervention when finding the patient in a confused state. A preplanning can be done by the physician and nurses before actually presenting themselves in front of patient for taking the delegated consent. As patient advocate, the nurse may ask questions from the patient to determine whether the patient has received sufficient information to make an informed decision. Nurses may educate the patient as needed. Canadian Association of Nurses (2002) further reiterates that the professional nurse should initiate appropriate action if the established tenets of informed consent are not duly processed and implemented. This action includes, but is not limited to:
Consulting with the responsible healthcare practitioner to seek resolution
Utilizing an agency’s policies, procedures and channels to assure protection of the patient, and
Reporting unresolved informed consent issues to the appropriate professional and/or regulatory bodies.
Furthermore, it is anticipated from the health care providers to use of plain language for taking consent that is not enriched with pure medical terminologies. The communication process must involve the feedback from the patient about his understanding of the content and context of consent-procedure. The cultural considerations are of immense importance while explaining the treatment and any intervention. As discussed above, using the same language that the patient speaks does not guarantee that the communication process is culturally coherent. So, cultural diversity and socioeconomic status must be kept in mind while educating the patient about particular intervention. The communication process should be sensitive in terms of gender. Proper time and acknowledgement of the patients’ concerns are paramount to the effective communication between the patients and health care provider.
Patients must be given appropriate information in a way they can understand to enable them to make informed decisions about care. Successful relationships between healthcare staff and patients depend on trust and respect. Effective communication is the key to enabling patients to make informed decisions that is absolutely needed for the beneficence of the patient. This may require specific arrangements to cater for individual language and communication needs or the use of an advocate or medical interpreter. Receiving inaccurate, outdated information or having information withheld or ambiguous, is problematic, whereas supportive, understanding communication is encouraging. The process of consent taking by the health care providers could be at risk due to poor communication process that is scarce in use of plane language and time, less coherent in cultural diversity, and socioeconomic sensitivity. Nurses are at the crucial position by playing their role as educator and patients’ advocate in a delegated consent taking process along with the duty of witness to the consent.