Consent taking in neurosurgery: Education and tips for safe practice
Neurosurgery is the most difficult branch of surgery and interventions may occasionally lead to a poor prognosis. Most of the times, one would assume that the likely outcome of a surgery is going to be good; however, not so uncommonly, the results may be devastating. Poor outcomes are further compounded by litigations, which are rising. The safety for neurosurgeon is the consent signed by the patient that ensures some defense. There are no guidelines given by the society and the controlling authorities on what constitutes a real consent. Some judgments by Supreme Court have given us some lead; however, a large part of the complexities involved in the consent process remain unresolved. We, therefore, have to frame our own guidelines and standards that shall be uniformly adapted by all of us. We can even set a precedent for other disciplines of surgery to follow regarding consent-taking for neurosurgery. This shall also serve as a foundation for the wider benefit and safety of surgeons from other disciplines. This paper is an attempt to simplify the complexities of the consent taking process and aims to provide adequate education and information about the nuances of informed consent.
Keywords: Consent; informed consent; neurosurgery
Cases of medical malpractice in India are on the rise despite full devotion of the physicians to their profession and the patients. The increase in litigations can be attributed to several reasons. This is essentially due to the high expectations of the patient, poor communication by the doctor, financial escapism, nonsatisfaction of the patient, or sometimes, unfortunately, due to professional rivalry.
Consent taking is the process by which a physician obtains permission to perform an act on the patient's body, either for diagnostic or therapeutic purposes. It also protects the treating doctor from litigations in the case of therapeutic misadventure. It is, therefore, not just a document to be signed by the patient as a mere formality.
A complete understanding of the consent and the guidelines or codes for executing the consent are not yet defined or settled. The Supreme Court of India has laid down a few guidelines through some judgments; however, much still needs to be clarified before one clearly understands the realm of consent; and, apply it in in the right spirit in our clinical practice.
The judgments of the courts cannot, by any standards, be the benchmark for us to define the nuances of consent; nor has any court ever given any guidelines with regard to consent taking to medical professionals. All major judgments related to consent taking, hitherto, rely upon the concepts of good medical practices, which unfortunately are not adhered to by some of us at various times. Various judgments have provided some directions to follow so as to minimize the risk of damage in medical misadventures.
It is generally presumed that, if consent is obtained, a doctor is absolved of all wrong-doing or complications that may occur during the treatment of a patient. Merely obtaining a consent for the treatment is not an absolute defense against filing a case. The consent has to be explicit, informative on most aspects related to the treatment, and should follow some principles pertaining to ethics in medical treatment.
Based upon some judgments of the courts, this article is an attempt to clarify and unravel some of the prevailing misconceptions regarding an informed consent. It also suggests methods to be adopted by the surgeon so that the consent taken is valid for conducting a safe medical practice.,,,,
The evolution of the consent process can be traced back to the law of Fieda, a royal system of 'blood for blood,' i.e., justification in killing someone who kills a person. In the year 1252, the Anglo-Norman Law initiated the concept of blood money, that is, provision of monitory equivalent for a life., A major change in this practice was introduced by Romans in the year 1268 when they advocated “Cum volenti at scienti non fiat inijuria,” i.e., with consent and knowledge, no injury is done. This was perhaps the first description of the concept of consent taking.
Since then, there have been significant changes in the process of obtaining consent. It is not clear when the change from simply oral information (oral consent) to written consent materialized. The older system of written consent in India that was prevalent until the 1990s simply used to be inclusion of two lines:
“I am willing for my operation under any kind of anaesthesia, the risks and complications of which have been explained to me by Dr. on duty…”
This system of consent taking that was prevalent for more than three decades was later challenged in court for being insufficient and inexplicit. It is apprehended that the way consent taking process is changing, it is likely that consent will become a bipartite or tripartite agreement between the patient, health provider, and insurer. Consent may even further change as per the Indian Contract Law 1872, wherein the expense of treatment including the cost of various disposals will need to be spelled out clearly. It may also further deteriorate to a level wherein the damage liability and the ways of settlement, including compensations, will become a part of the prior consent process. If such a change ever happens, it will be a big disaster for medical practice as the faith in the profession will be at the point of no return and most students will prefer to avoid medicine as a career.
Currently, every institution frames its own consent taking documents, and in the absence of any standard formats for taking informed consent, the process has become even more confusing.,,,,,,,,,,,
An informed consent, to be valid, relies upon the ability of the person giving consent, to have an understanding of the pros and cons of the procedures, including surgery. It would obviously depend upon the educational status, age, and maturity of mind of the patient to be able to discern and completely understand the various nuances prevalent in the language of the consent form. It may be the duty of the doctor to ensure that the patient or relatives have understood all aspects of the consent process. In the United Kingdom, the elements of consent are defined with reference to the patient and a consent is considered to be valid and “real” when:
The concept of “informed consent” developed by the American courts, while retaining the basic requirements of consent taking, shifts the onus of making the patient completely understand the medical procedure being performed on the doctor. Thus, it is the doctor's duty to disclose the necessary information to the patient in order to secure his consent.,,,,
Theoretically, there are several ways by which a person can express his willingness for examination and treatment. According to the Oxford dictionary, consent is a voluntary agreement to perform an act, and in the medical field, it refers to performing an act on a patient's body for diagnostic or therapeutic purposes.
Implied Consent: As one enters the doctor's clinic for treatment, it is obvious that the person has already given some affirmations to conduct his/her examination. This, however, is restricted to asking history and performing simple examinations. Special clinical examination, such as per rectal or per vaginal examination, are not covered by implied consent. Needless to stress that presence of a female attendant is desirable during simple examination by a male doctor. Consent expressed can be oral or written or both.
Most cited definitions in the legal literature refer to In Canterbury v. Spence - 1972 judgment in defining informed consent. Though this judgment concerns a case in the USA, several judgments in India including those by the Supreme Court have relied upon it. It refers to consent as well as informed consent in broader ways.
In Canterbury v. Spence - (464) Federal Reporter 2d. 772, the United States Courts of Appeals, District of Columbia Circuit, emphasized the element of Doctor's duty in 'informed consent' thus: “It is well established that the physician must seek and secure his patient's consent before commencing an operation or other course of treatment. It is also clear that the consent, to be efficacious, must be
Ingredients of informed consent
“Informed consent” as defined in Taber's Cyclopedic Medical Dictionary, refers to various essential ingredients that should be a part of the informed consent. Various articles in the published literature have suggested ways to incorporate several essential points in a meaningful consent.,,,,,,,,,,
Indications and objectives of the procedure
The surgeon shall clearly explain the reasons for which a surgical procedure is being offered and the aims to be achieved with the surgery. It may be to take a biopsy to reach a diagnosis, subtotal or near-total removal of a tumor so as to decrease the mass effect, clipping of an aneurysm to prevent rebleeding, instrumentation to stabilize the spine for an early mobilization, and so on.
Procedure during surgery
The entire procedure and the steps involved are not likely to be understood by the patient. A general outline of the steps should be highlighted. It includes shaving hair, cutting skull or spine, some basic steps involved in core surgery, placement of drains, nasal tampons in transnasal surgery, application of stitches or staples, and the likely day of stich removal. Drawing of some figures in the case records pertaining to the procedure are desirable. These may act as a proof in favor of the defense.
Risks and complications
The most important part of the informed consent is to enumerate and explain the likely complications that may occur during a surgery. As many complications have the possibility of occurring during treatment despite all relevant precautions, it is advisable to incorporate all possible risks even if the operating surgeon and his/her team are most competent. Although it is not compulsory to list rare complications, it is safer to give some indication of even these rare events.
The apprehension of a patient to undergo surgery is justified, and his/her expectations can be far from realistic when compared with the final outcome. One has to ensure that the patient and his/her family are aware of the outcome of the procedure, e.g., glioma is not a curative surgery; head injury, and subarachnoid hemorrhage are not one-time insults; rather, the initial ictus is a harbinger of a dynamic set of processes that will sequentially follow it. Hence, any surgery or procedure being performed may have a limited role in allaying the insult to the brain or spinal cord. The outcome of the case depends upon the ability of the brain or spinal cord to revert back to its original functional status primarily from the initial injury, and secondarily, from the insults sustained due to the surgical procedure.
It is a good medical practice to also intimate the patient regarding other options available for the treatment of a disease. Such options are only to be given for the well-established treatment modalities, e.g., stereotactic radiosurgery for small brain tumors, endoscopy in hydrocephalus, coiling of an aneurysm, surgery in intractable epilepsy and functional disorders. Alternate systems of medical treatments, such as Ayurveda and Homeopathy, have no proven basis for treatment of any illness requiring neurosurgical intervention; hence, they are not included under the ambit of alternative options.
Risk of no treatment
It is the right of the patient to refuse treatment. The denial of a recommended treatment may pose threat to life or irreversible damage to the function of a body part. At times, a delay in obtaining consent for surgery may contribute to a poor outcome as well. Therefore, a note informing the reason for the delay or refusal to give consent should be incorporated in the records.
Composition of an ideal consent form
An ideal informed consent may be difficult to define as it may change over a period of time due to insertions of newer text as per the demands of the case. As of today, the informed consent shall be framed in a manner that provides maximum information related to the procedure to the patient. An ideal informed consent may include the following:
Name of the patient, gender, age, central register (CR) Number
It is not uncommon to have patients with similar names in any busy centers. Similarly, in India, many names are common to both male and female patients. Rarely, two patients of the same name and disease are admitted. In order to avoid errors of identity, the CR number, age, and gender should be incorporated in every consent form.
In addition, when such common nomenclatures are encountered, the errors resulting in an incorrect blood transfusion may be prevented by taking due care. Incorrect blood transfusions would amount to “resp ipsa liquator,” wherein there may be liability on the doctors including the anesthetists, as normally, transfusion during surgery is monitored by them.
Name of the main surgeon and team
The rationale of declaring the name of the surgeon is related to the patient having the right to choose his operating surgeon. In most of the private sector hospitals, the operating surgeon is the same as the one who has been following the case in the outpatient department (OPD). On the other hand, a patient in the Government sector visits a hospital and is checked in the OPD by any of the several doctors on duty. It is not possible for a senior surgeon to perform all those surgeries scheduled in his department, as the number of cases being evaluated for surgery is very large. It is, therefore, advisable to inform the patient that the surgery, when indicated, will be conducted by any member of the team provided the operator is fully competent to perform it. It would be expected that a senior person has examined the case before the decision for surgery has been taken. For any case, however, the name of the consultant, the post-doctoral surgeon/assistant as well as the postgraduate resident should be clearly notified on the consent form.
Name of the anesthetists and their team
The team of anesthetists involved in the case should examine the patient at least a day before the surgery. The risks and complications pertaining to anesthesia given at the time of surgery should be explained to the patient by the anesthetists separately. It is desirable that the senior anesthetist explains the risk himself/herself or deputes a qualified person to do so. Whether or not a separate consent by the anesthetist is mandatory is still disputed. However, it may be desirable as a part of good medical practice.
It may also not be out of context that the names of the staff nurse and the operation theatre technicians be recorded in the operation notes as well. There are certain responsibilities of both the nurses and the technician during the procedure that may have a bearing in the event that complications occur, e.g., counting of cotton patties, instruments, problems in lubricating of the cautery plate that can produce burns at the local site.
Diagnosis and nature of the primary disease
While most of the diseases requiring surgical intervention have a preoperative diagnosis, one should not be dogmatic about it until the final biopsy is reported. The patients should always be intimated that the final diagnosis may be different from the primary one for which the current plan of surgery was devised. The patient, therefore, must know that a benign-looking lesion may, later on, turn out to be malignant on histopathological examination and may require additional radiotherapy or chemotherapy, e.g., in the case of a glioma.
Kind of surgery or procedure to be performed
A surgery can be performed as an emergency or elective procedure. Emergency surgery may be lifesaving, organ saving, or both. For an emergency surgery, it may be possible that a surgeon may have overlooked certain parameters that may have some negative effect on the outcome later. For patients having a history of diabetes mellitus, coronary artery disease, bronchial asthma, chronic pulmonary obstructive disease, or any other previous illness, it may be possible that the above mentioned conditions may not be entirely under control at the time of emergency surgery. It may also be possible to miss out some information in the history-taking, which may contribute to the poor outcome of the patient later on. Situations like these are not uncommon in daily practice. Any procedure thus performed under non-ideal conditions, in terms of patient fitness for the surgery, should be documented for safety. It is, therefore, imperative to make note of whether or not the surgery is an emergency, and if so, the reasons for assigning it as an emergency procedure.
Kind of anesthesia and risks
Separate consent: As mentioned above, the nature of the risk and complications associated with the delivery of anesthesia and the management thereafter, are best explained by the anesthetist involved in the case. The informed consent, therefore, shall explain the related aspects in a separate paragraph or in an additional consent form. As no guidelines have been framed for the anesthetists to take a separate consent so far, the various risks of sitting position, prone position, and drug interactions are some of the issues that are better explained by the team of anesthetists.
Need for harvesting bone, nerve, and fascia
It is common for a neurosurgeon to give a second incision elsewhere in the body apart from the scalp during the same surgery e.g. on the iliac crest for harvesting a bone graft, on the lateral malleolus for harvesting of sural nerve, or on the thigh for harvesting fascia lata. Any additional incision over any part of the body other than the site of surgery should be clearly mentioned.
Requirement of any implant or device
Need for the placement of any implants in the brain or spine, or a device in any part of the body, should be clearly mentioned. It would be good practice to inform the risks of implant failure, device-related malfunctions, and their maintenance to the patient. The change of battery or adjustment of pressure in flow-regulated shunts and their care should be conveyed and written down in the consent form. The risk of malfunction of the magnetic devices in magnetic resonance imaging suites and during screening at the airport and other places should also be informed to the patient.
Need for blood transfusion
Requirement of blood or its products during or after surgery is routine practice. Though it may be uncommon, an allergic reaction or a risk of transfusion related diseases may incite a litigation. The ethical issues related to taking consent from a patient who is a Jehovah Witness, where transfusion of blood products is prohibited, may be clarified as well.
Human immunodeficiency virus (HIV) testing tests and fallacies in interpretations
It is a common practice to test a patient for their HIV status before surgery. Whereas most of the times, the patient does not suffer from it, the rationale in conducting this test is for the safety and prophylaxis of the operating team in case of an accidental exposure to the virus by the medical personnel. The consent of the patient for testing for HIV is mandatory. Due to the stigma attached to the disease and the requirement to notify it as per law, the test should be repeated before labeling a case as HIV-positive. The result of the test may at times be fallacious, and the patient should be informed about it.
Post-operative ventilators and the likely duration
For safety, it is advisable to take consent for postoperative ventilation in every case. The duration of ventilation and complications related to it, e.g., ventilator-associated pneumonia, tracheostomy for airway hygiene and maintenance should be discussed and incorporated.
Site and side of surgery
WHO guidelines advocate that the site and side of surgery should be discussed with the patient and the document stating the side of surgery should be signed by the patient as a safety measure. It may be a useful exercise to avoid performing an operation on the worng side in the patient.
Special risks involved in the procedure
The results and recovery following surgery are governed by the principles of good health. Any additional co-morbid conditions can affect the results of a properly conducted operation. Each of these comorbid situations can affect the heart, lung, kidney, and brain in various ways and can pose a threat to life. Each of these diseases shall be identified and mentioned in the consent form as compounding threats. Some of these co-morbidities and the added risks due to their presence are well known [Table 1].
Consent process presupposes that a patient has understood the information provided and is in a sound mind to give a valid consent. Based upon the various parameters, we have designed a new consent form of two pages. The front page has all the relevant information that should be included in a general consent form and the back side has specific information related to the procedure. We obtain a signature of the patient on both pages separately [Figure 1] and [Figure 2].
We strongly advocate the incorporation of additional safety features in the form of the following sentences:
A text covering the following lines shall be useful for all kinds of procedures
Cancelled/Postponed cases: Not uncommon, the cases posted for surgery are postponed for various reasons. Whether a re-consent is required in such cases is a matter of debate. The consent obtained within 72 h shall remain valid unless a patient requires some additional clarification. As the law and guidelines are silent on this aspect, there is additional safety in obtaining a fresh signature as a measure of reassurance, even though it may not be necessary to take the signature again legally.
Consent in pediatric cases
Generally, an consent form signed by parents is to be obtained for children of age less than 12 years. Between the age of 12–18 years, only a restricted consent, not involving risk of life, is valid. For most neurosurgical surgeries, the signature of both parents shall be preferably obtained.
Who should obtain consent
It has been unequivocally decided that the consent has to be obtained by the person from the team who is going to operate the case. An intern or house surgeon may not be a suitable person in neurosurgery to provide details needed for an informed consent. It is only the Senior resident/MCh/DNB student or a postgraduate resident in surgery, beside a consultant, who is in a position to deliberate upon and understand the entire steps of surgery. Therefore, consent shall be solicited by the particular medical personnel who are qualified and experienced to obtain it.
Who can give consent
The process of consent under contract is defined in the Indian Penal code (IPC) sections 88 and 90. In clinical practice, it is safe to obtain consent from a patient, his/her spouse, adult children, parents, brother/sister, and other blood relatives or friends, in that preferred order. If it is apprehended that a case may land up in a problem of altered sensorium, it would be advisable that the patient discloses the name of the person who will be authorizing the medical team to take decisions thereof. In absence of parents, a proxy consent can be obtained by the Principal of the school, the lawful guardians, or the care giver.
Extent of disclosure
The details provided to the patient shall cover some of the common consequences of a procedure. Rare complications and sequel add to confusion and may be omitted. Moreover, listing all uncommon things including death may scare the patients and may affect their ability to give a valid consent. Having said so, 'rare' and 'uncommon' are phrases of ambiguity. It may vary from an individual experience and be based on the expertise of the medical personnel involved. The various judgments, however, support limited disclosure so as to cover the common occurrences only.
Time for obtaining consent
In an emergency case, consent is generally obtained instantly. It may not be possible to frame all the sentences that are needed to constitute a valid consent. The practice in obtaining consent in elective surgery shall begin from the time a patient is seen first in the OPD, and hence is given adequate opportunity to think and decide about the surgery. The consent signed only on the day of the surgery in elective cases may result in difficulty for the doctor, as the patient may allege time constraints in understanding the philosophy of consent. Hence, it may be safe to begin the explanation for the informed consent well in time and to take consent at least a day before surgery.
There are several unresolved upcoming issues, which may later on become contentious. Issues pertaining to the use of the patient's radiological pictures for publication and research may find its place in the consent form. Intraoperative recordings and their use for various purposes and denial of treatment (informed refusal) are some of the other features that need to be sorted out. Patient may even have a right to an informed discharge.
Objective assessments of patient's ability to give real consent and the battery of tests to be used are already evolving, and in future, the role of a psychiatrist to evaluate the ability of a patient to give an informed consent will be another challenging task
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
[Figure 1], [Figure 2]