|Year : 2013 | Volume
| Issue : 3 | Page : 205-210
Counseling and informed consent in surgical practice
Ajaga Okeoghene Monday1, Nwabuoku Stanley Emeka1, Ahmed Muhammed2, Garba Ekundayo Stephen2
1 Department of Surgery, Ahmadu Bello University Teaching Hospital, Zaria, Nigeria
2 Department of Surgery, Ahmadu Bello University Teaching Hospital; Department of Surgery,Ahmadu Bello University, Zaria, Nigeria
|Date of Web Publication||28-Mar-2014|
Department of Surgery, Division of Urology, Ahmadu Bello University/Ahmadu Bello University Teaching Hospital, Zaria
Source of Support: None, Conflict of Interest: None
Background: In medieval times, physicians concealed information about patient's health from them with the hope of giving them better care, the rationale being that the doctor knows better than the patient and should therefore direct the patient's care. This is obviously no longer acceptable in modern day practice.
Objective: Increasing rate of litigations and the desire to provide patient with more participation in their own treatment, attain higher ethical standards and greater patient's safety have heightened the need for the surgeon to be conversant with what comprises and how to obtain informed consent.
Materials and Methods: We reviewed current literature, including, original and review articles obtained through a search of PubMed database, Medline and Google scholar using the keywords: Counseling, informed, consent, surgical, practice.
Results: The concept of consent is continuously evolving, whereas litigations can sanitize medical practice it must not be the driving tool, rather, practices should be evidence based. It is therefore necessary for the surgeon to be conversant with the relevance, modes, elements and application of a valid informed consent as well as methods of improving the process of obtaining informed consent. Patients should be fully involved in the management of their surgical conditions.
Conclusion: A big gap exists between the theoretical/legal best practice and the daily practice of informed consent. An optimally informed patient will have more realistic expectations regarding a surgical procedure and its associated risk.
Keywords: Consent, counseling, informed, practice, surgical
|How to cite this article:|
Monday AO, Emeka NS, Muhammed A, Stephen GE. Counseling and informed consent in surgical practice. Arch Int Surg 2013;3:205-10
| Introduction|| |
In medieval times, physicians concealed information about patient's health from them with the hope of giving them better care. The rationale was that the doctor knows better than the patient and should therefore direct the patient's care.  Doctors, by default, were assumed to possess absolute authority in decision-making regarding patients care.  Thomas percival in his book on ethics in 1803 wrote that patients have a right to truth but when the physician can provide better treatment by lying or withholding information, he is advised to do as he thought best.  This is obviously no longer acceptable in modern day practice. Earlier attempts at providing guidelines to physicians in 1847 by the American medical association code of ethics among other things stated that the physician should fully disclose all patients details truthfully when talking to other physicians; however, it was silent on disclosure of clinical information the patient is required to know. ,
In the US, the earliest litigation on informed consent reached the supreme court of Minnesota in 1905. In this case, a patient consented to an operation on the right ear. During the operation, the surgeon discovered that the left ear was in worse condition than the right. He proceeded to operate on the left ear and was held liable for battery.  In a landmark case in 1914, a surgeon who removed a malignant tumor against a patient wish was found guilty of battery. The premise of this judgment was that every human being of adult age and sound mind has a right to determine what should be done with his body. 
Counseling is a confidential dialogue between a patient and the care provider aimed at enabling the patient to make personal decisions related to their illness, cope with the disease or social and emotional stress.  It involves the application of good communication skills modified by experience, providing clear, unambiguous and honest information about the patient's illness. The concept of informed consent was introduced when the rights of the patient to his/her care were recognized, it became apparent that proper patients' counseling based on knowledge of the disease condition/procedure; consequences, risks and availability of alternatives should precede consent. Thus, adequate counseling is a prerequisite to a properly obtained informed consent, it is even more important than the mere physical signing of the consent document.
Initially simple consent involving patient acceptance of treatment or not was all that was required without the need for explicit details of patient's illness, the procedure to be carried out and the possible complication. Overtime, emphasis shifted from simple consent to informed consent. Informed consent is a voluntary authorization by a patient or research subject, with full comprehension of the risk involved, for diagnostic, investigative or therapeutic procedure.  It is a process that involves complete and honest disclosure of the disease condition or procedure to the patient to facilitate subsequent decision-making. It is legal documentation and whereas documentation is important in satisfying the legal aspect of the consent process, initial proper counseling constitutes the most important ethical requirement.  In all, the patient's right to autonomy must be respected even if it leads to harm or death.  A surgeon who therefore performs an operation on a patient without his patient's consent commits assault (battery) for which he is liable to damages except in cases of emergency, where the patient is unconscious or when it is deemed necessary to operate urgently to save the patient's life before obtaining consent. 
The patient's autonomy is equally important. Respect for autonomy obligates the physician to seek for the greater balance of good over harm and the good and harm are understood and balanced by the patients' perspective. The surgeon no longer possesses the power to act unilaterally or on the clinical judgment alone except in exceptional circumstances as stated above. Failure to obtain consent renders a physician liable for negligence and battery. 
| Relevance and Indication|| |
Increasing rate of litigations and the desire to provide patient with more participation in their own treatment, attain higher ethical standards, organizational moral and greater patient's safety have heightened the need for informed consent. The indications for obtaining an informed consent include: All surgical procedures under general anesthesia, any procedure which carries a risk, procedures under local anesthesia if significant un toward event is possible, invasive diagnostic or therapeutic procedures, research, chemotherapy and blood transfusion. ,
| Modes of Consent|| |
Consent can either be implied or expressed.  Expressed consent can be verbal or written. Written consent should be obtained for patients undergoing procedures involving anesthesia, complex treatments with a significant risk and side-effect or research. No alteration should be made to the consent form after signing, as doing such will render it invalid and untenable in a court of law.
Consent should preferably be obtained by someone capable of carrying out the procedure or someone who has received special training to do so. Consent can be obtained in advance and remains valid as long as the treatment option has not changed. If extra procedures become necessary, a fresh consent should be obtained. However, whenever possible, even if consent was duly obtained at a significant date in advance, the patient or subject should be made to reaffirm the consent after a brief counseling shortly before the procedure.
| Elements of a Valid Informed Consent|| |
This involves providing the patient with adequate information about their clinical condition. Patients should know the diagnosis, the treatment options available, alternative treatment options and details of the procedure, the risks involved, benefits and potential complications. It is also important that the patient be counseled on the consequences of non-treatment. All these must be explained in lay terms to the patient. ,
How much should a patient know?
The amount of information a patient should be provided with by the doctor has always been a controversial subject. What constitutes adequate information for a valid informed consent is still open to debate. This has led to the development of models of disclosure  which include:
Under this model, the surgeon discloses no more than what other physicians would disclose under similar circumstances. This model has been criticized for being too centered on the health care provider without giving much consideration to the patient. The views and reservations of the patient are completely neglected by this model and thus unacceptable in modern day practice.
Reasonable person model
Under this model, the surgeon discloses information that is material to a reasonable person's decision making. It is difficult to satisfy because, what constitutes a reasonable person is vaguely defined and what is relevant to one person might not be relevant to another.
Subjective standard model
Under this model, the surgeon discloses information that is relevant to the particular patient being treated. This requires that the physician must have a good knowledge about the patient and an understanding of his beliefs and values.
None of these models alone is perfect. Perhaps a combination of the models might give a better outcome. Whatever the approach adopted by the surgeon, it is important that the patient is warned about any action that may pose a substantial risk. The caregiver or researcher should mention significant things that would affect the decision of a reasonable patient. The patient should also be informed of any complication of the procedure that is likely to occur in more than 1% of the time rather than limiting disclosure of complications to only the common or major ones. Although the burden of care lies with the surgeon, it is important that the surgeon withholds his opinion until after disclosure or except on direct request of the patient.
| Competence|| |
This refers to the ability of the patient to both understand the information provided and form a reasonable judgment based on the potential consequences of his/her decision. It is important that the surgeon not only provides the information to the patient but also ensure that the patient comprehends fully the information being served. Using the teach-back technique in which patients are asked to reiterate in their own words their understanding of the risk and benefit of a procedure can achieve this. They are encouraged to ask questions or seek clarification at any point in the entire process. ,
| Voluntariness|| |
Refers to the subject's right to freely exercise his/her decision without being subjected to external pressure such as coercion, manipulation or other influences. This is a very important part of the consent process as any consent obtained by coercion or any form of manipulation cannot be legally valid. The patient must be able to arrive at a decision free from all forms of pressure either by hospital staff or family members. 
Thus, the elements of a valid informed consent can be summarized as follows:
- Explanation of the procedures to be followed and the purposes of each; those procedures that are experimental should be identified as such.
- Description of any attendant discomfort and risk that can reasonably be expected.
- Description of any benefit that can reasonably be expected.
- Disclosure of any appropriate alternative procedures that might be advantageous to the patient.
- There should be a provision that the person is free to withdraw his consent or to discontinue treatment or participation in the project or activity at any time without prejudice to the subject.
Following complete disclosure to the patient or subject, they should be given adequate time to synthesize the information and make up their mind. The patient reserves the right to refuse treatment or defer consent. The surgeon must not vocalize disappointment, anger or threaten to refuse future treatment toward the patient for their choice; however, the possible consequences of refusing treatment must be clearly explained to the patient.
| Other Considerations|| |
Pediatric age group
Obtaining consent in pediatric age group poses a unique challenge because children are considered incompetent to give an informed consent. In Nigeria, the legal age for consent is 18 years.  However children older than 16 years can give consent for surgical procedures if they can fully comprehend the procedure and understand the inherent risk involved.  If a child refuses consent for a procedure viewed to be in the best interest of the child, the child's parent or a legal guardian can give consent for the procedure nullifying the child's refusal. For children younger than 16 years, the parent or someone with loco parentis (parental responsibility) or a legally appointed guardian can give consent. However, in some countries, children between 13 and 16 years can give consent if they can demonstrate their capacity to understand the proposed procedure and alternative treatment as well as risk and benefit of each of the option.  Furthermore, the assent of child between the age of 7 and 16 is required in some countries especially for research and procedures that pose minimal risk and for which the child stands no risk if they object. Whatever the age of the child, they must be carried along in the treatment process and attempts made to explain each stage of the treatment process to them.
In a situation in which the parent or legal guardian refuses consent for a minor and the decision is viewed not to be in the best interest of the minor, a court injunction can be sort to nullify the parents' decision. However, in such a scenario, the opinion of the ethical committee of the hospital should be sort before further action is taken. 
Patients can become incompetent of giving an informed consent by reason of a mental illness, dementia or as a complication of disease process. This group of patients poses another challenge. In cases in which there is a chance of the patient regaining capacity and there is minimal risk if surgery is delayed, it is best that such procedures be deferred to a time when the patient is capable of making an informed decision.  However, if the procedure cannot be delayed or there is little chance of the patient recovering his capacity, then consent can be obtained from a surrogate decision-maker who is usually a family member in our environment or any person appointed by a competent court of law.  In a situation in which a patient has appointed a surrogate decision maker before losing their capacity to give an informed consent, then all decision of care must be left to the surrogate decision maker.
Consent in emergency situations constitutes an exceptional circumstance; in this situation, the need to preserve life supersedes any other consideration. Thus in case of emergency where there is an imminent threat to the life of a patient and the benefits of intervention are adjudged to outweigh the risks, the surgeon can go ahead to institute treatment without obtaining consent after due consultation with a suitably qualified colleague. 
After going through the rigors of obtaining an informed consent, it is important that the consent be properly documented for legal reasons and for proper understanding by the patient. In documenting an informed consent, there must be clear description of the proposed procedure, risks involved, anesthetic technique, complication and prognosis. There should be a documentation of possible alternative treatment and the option of no treatment. As much as possible, questions asked by the patient must be documented and there must be provision for authorization by the patient as well as an independent (neutral) witness with the surgeon also penning his attestation. 
Barriers to informed consent
Although the importance of informed consent is well-known to most surgeons, it is not routinely obtained in daily practice due to many factors amongst which are: Lack of clinician time especially in our environment where there are insufficient health workers and a huge patient's burden. This is one of the most important barriers to routinely obtaining informed consent, as the entire process is time consuming. Other factors include confusion among clinicians when informed consent is needed, caution among surgeons about giving too much information, communication barriers between the surgeon and the patient, perception by patients that informed consent is just a legal release for the doctor or hospital.  Ignorance of patients of their right to either accept or reject treatment is another factor as well as poorly designed and legalistic consent forms, which makes it difficult for the patient to comprehend. 
Sociocultural and economic influence in consent taking in Nigeria
The influence of sociocultural and economic factors in a multicultural society like Nigeria must not be overlooked; decision-making in this society is often not an exclusive prerogative of the affected individual but a collective burden on the entire family and occasionally the community. While it is most desirable that the patient or subject at the receiving end should give the consent, in our environment where communal living and extended family system is prevalent, decisions are a bit more complicated, thus we may come across patients with the capacity to give informed consent but choses to relinquish that right to the older family members. Final decisions are made after consultations among family members and the caregiver.
The practice of relinquishing rights to relatives in our environment is often based on established family norms and believes that the wisdom of the older family members supersedes and will ensure a decision in the best interest of the patient. However, the health care provider must ensure that no coercion, deceit, economic or financial gains are involved and the final decision is consistent with expected standards of medical care and where they are not, the appropriate authorities should be informed. Once it is obvious that the patient has left decisions related to his/her care in the hands of the relatives voluntarily, then the decision of the patient must be respected and the relatives duly consulted and counseled before any procedure. , It must also be said that even in the event the care giver suspects foul play or coercion, enforcement is difficult because of the high physical and economic dependence on relatives in the management of patients in our health care system, majority of our patients have no any form of health insurance and there is no government social security system that covers the health expenses of such patients, thus if a patient decides against the family wishes they stand the risk of losing the economic and physical support and in extreme cases outright abandonment. This often encountered scenario puts the care provider at a cross road between insisting on patients right and stand the risk of an abandoned patient and a family decision that is potentially detrimental to the patient. The situation is made worse by an ineffective protective legal system and law enforcement. It is therefore imperative that appropriate laws be promulgated by the government health regulatory authorities to protect the rights and provide financial support system to carter for the health care needs of such patients.
Ways of improving informed consent
In order to improve the process of informed consent, it is important that efforts be made to raise the level of awareness of patients, surgeons, other health care personnel as well as the hospital ethical committee on the importance, components and acceptable means of obtaining an informed consent. This may involve organizing seminars/CMEs to address all aspects of informed consent including, the challenges that are commonly encountered and ways of overcoming them, communication techniques, malpractice/litigation and the results of recent research findings. Periodic training of health care personnel would also afford them the opportunity of getting to know the trends in the practice of informed consent.
Adequate counseling would also facilitate the process of obtaining an informed consent.  This should be begun as soon as the diagnosis has been made and it is important at this point to engage the patient in a dialogue about the nature of the pathology and scope of the management with the aim of getting to know his/her views regarding these. , Counseling can then be tailored toward clearing "grey" areas and correcting areas where the patient may have been misinformed. This is preferably done in a quiet, private place with only people whom the patient permits around. 
Improving communication between the surgeon and the patient will also enhance taking an informed consent.  It is important that the patient comprehends what the surgeon has to say before being asked to give consent. This may sometimes necessitate the use of an interpreter who may be more proficient in the language the patient understands. The use of teach-back technique during counseling would lead to greater understanding by the patient. Counseling should be done using simple terms and where technical terms are inevitably used; they must be clearly explained and understood by the patient while avoiding medical jargons. Subsequent counseling sessions should begin with the surgeon reviewing the patient's comprehension from the previous session by entertaining questions from the patient, reinforcing correct perceptions and correcting wrong impressions. The patient should be given enough time between counseling sessions to process the information received during the previous session. A clear understanding of the plan of management eases decision making by the patient.
Improving consent forms would invariably aid the process of obtaining informed consent.  This may involve reviewing and re-designing current consent forms. The forms may also have to be adapted to suit the existing socio-cultural peculiarities of the region where the health care facility is situated. Consent forms should be designed in plain language using active voice and simple sentences with the object close to the subject in every sentence. Jargons, abbreviations, highly technical terms and italics should be avoided in consent forms.
It is the surgeon's duty to explain the possible consequences of non-treatment and benefits of the treatment; if the patient refuses, it must be documented clearly. Discharge against medical advice must be clearly documented with signature of the patient or guardian.  Such patients should not be denied treatment on subsequent presentation, however, if the attending surgeon is not comfortable with treating such patient, the patient should be referred to an appropriate and suitably competent colleague either in the same facility or elsewhere. 
| Conclusion|| |
Informed consent is one of the bedrocks of good clinical practice in surgery but the process involved in obtaining adequate informed consent can pose some challenges especially where there are peculiarities regarding the patient's age, mental status and socio-cultural beliefs. An appropriately counseled patient is more likely to be optimally informed, have more realistic expectations regarding a surgical procedure and its associated risk and give or refuse to give consent being fully aware of its consequences. Documentation in all cases is important and should be in simple and clear terms. The concept of informed consent is constantly changing bringing about the need for all involved in health care delivery to update their knowledge of this process periodically.
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