A balanced approach to informed consent

by Zakari Tata, MD

Informed consent has continued to generate a lot of interest in medicine worldwide.

The reason is because patients in medicine and subjects in clinical trials need protection from the multitude of injuries and harms that have been caused by intentional or accidental actions. The controversies generated by various lapses of informed consent, in my opinion, have not been addressed and more safeguards need to be put in place to guard against harm.

Currently, signing an agreement after a reasonable discussion before major testing, clinical trials, surgery or other significant procedures serves as informed consent in medical practice. A lot of errors have occurred with vulnerable people signing on paper that meant they understood most of the ramifications of what they consented too. A vulnerable status can develop due to social issues like education and class or by factors related to illness.

The subject of informed consent centers on protecting the patients autonomy in decision-making. This autonomy model is poorly defined because autonomy in illness is conditional and can be affected by temporary conditions like mental state, anxiety, medications, metabolic changes, pain and multiple other factors.  I believe that when ones autonomy is challenged by some these situations, he or she becomes vulnerable.  At the same time, there is no objective measure of an ideal autonomy state. Physicians cannot always be aware of the state of the patients mind especially during an acute hospital admission.

Imagine a 70 yr old man presenting to the ER with crushing chest pain diagnosed as angina. Such a person will be under the influence of fear, hypoxia, morphine treatment for pain and intimidation by multiple trained physicians.  At this state he is vulnerable with impaired autonomy even though he may appear to be in control. Asking him to decide on medication management versus cardiac catheterization is not really ideal but we have limited options. The anxiety of such a situation will challenge anyone’s sense of self. This scenario I believe takes place daily in different ERs all the time. Sometimes this same patient may have undiagnosed dementia.

Patients frequently and should, trust medical personnel to act in good faith. Patients who are hospitalized are naturally anxious and under the influence of factors listed above and many others. Even in the outpatient setting, a patient in the clinic may easily agree to procedures because they are embarrassed or too intimidated to ask the physician.  They may unwittingly withhold information that may affect the physician’s decisions. This is understandable because patients may assume that physicians have a good understanding of what goes on in their individual lives

In many years of practice, I have encountered many patients who agreed to sign for procedures they did not understand for the wrong reasons. A patient once consented for a very invasive procedure because she claimed she was told that if she did not agree, she would have to pay out of pocket, all the hospital bills. While this sounds incredulous, a system that provides some checks and balances should be put in place. I have also encountered many patients who have been influenced by reality shows and scientific TV programs. This group readily welcome different surgeries, because it was on TV. These programs do not show the fine details of patient selection that accompanies these procedures.

New methods of obtaining informed consent need to be developed. For example, on arrival to the ER or admission to the hospital, patients especially those over 60 yrs could be asked to name a stakeholder to assist them with decision making. Permission could also be asked that the stakeholder be informed each time informed consent is obtained for major procedures. The consent forms could be designed to include a space that indicates if the patient has consulted with his chosen stakeholder or in the alternative waived the choice. This I will call balanced consent. It may not be ideal but may protect patients who are vulnerable from making errors. If at the onset on admission the patient declines to name a stakeholder, he or she may elect to sign a waiver. The purpose of this is to literally remind the patient before signing, to seek a personal second opinion from loved and trusted ones.

To further illustrate a case for Balanced Consent, I will relate the story of a friend of mine. This 48 year old physician was admitted as an emergency to the hospital in 2008. He signed for major surgery at 9 am in the morning. His brother called me for advice 6 hours later because this physician patient could not explain to his family what kind of surgery he was about to undergo. This is because he was in pain, on narcotics and quite anxious when he spoke to the surgeons. Under the provision for Balanced Consent I am advocating, he would have been asked to write on the form, the name of a trusted person or alternate to be contacted before he signed. This was quite disturbing because he did not even remember physically signing the form. The family intervened and a different option was decided on which was more satisfactory for him. As a physician he had a confident proactive family. This is a clear example of vulnerability in a normally very intelligent autonomous person.

In the outpatient setting as well before signing for major operations, such a process may prevent patients from signing up for procedures that may not be beneficial to them. Having a selected stakeholder contacted before they sign for such interventions may question and inform the physician from not harming the patient. Extra knowledge about family histories, previous experiences and forgotten medical histories may come to light.  A lot of physicians, I am sure have many experiences about how the story changes when another family member sheds new light. This process may be technically difficult to perform each time but more needs to be done to provide a balanced approach.

Informed consent in practical terms means simple empathic honest communication.  For this to be effective the patient needs to be well equipped to understand. Using a simplistic balanced approach especially in hospitals, where we actively encourage participitation from loved and trusted ones will save lives. Having the consent forms tailored to this effect will make patients think before they sign. This method may be cumbersome but the current system is not ideal and more needs to be done to protect the sick. The reality is that though most of the interventions are well intentioned, patients do not always understand.

In the ever-changing world of values, humanity has to always be one step ahead of technology.

Zakari Tata is a family physician.

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  • http://advocateyourself.blogspot.com Cheryl Handy

    Good idea but going to be tough for the elderly, confused patient. In those cases, docs will have to assess pt’s cognitive abilities to make *any* decision, including decision to name stakeholder or waive same.

  • http://www.consentcare.net Martin Young

    Absolutely right – a matter very close to my heart. Follow my link to see why!

    Here’s the rub however. Consent, no matter how well taken, is useless unless it is completely documented, for the simple fact that 70% of information is forgotten by the patient by the time the consultation is over. The details need to be considered in the patient’s own time before it can be considered complete.

    No patient’s level of risk is the same for any one procedure, so standardised consent forms do not suffice. Here is where technology is so important to assist in the process.

    Few patients to date realise the value in a detailed consent document that is in their own possession. This is a statement of medical diligence, attention to detail and high standard of ethical practice that speaks volumes about the doctor’s own attitude. It is the definitive ethical yardstick, giving very little away in clinical detail and specifics about the patient, other than a name, procedure and risk analysis.

    Informed consent deserves to be taken very seriously in an environment where the level of trust between doctor and patient is easily eroded. Sadly it is not. The results are more litigation, more defensive medicine, higher insurance premiums, higher costs.

    And yet, one can hardly even give away that technology for free. I’ve tried. Until patients, hospitals, insurers and funders demand it, doctors will be disinterested, doing as little as possible.

  • http://www.ServantLawyership.com Kathleen Clark

    Dr. Tata: Your last sentence says it all: humanity must always come before technology.
    The State of Washington now has, by statute, a process called Informed Patient Choice. Evidence that the physician explained the options to the patient, gave the patient videos to watch, had signed informed patient choice, patient questions were answered, paient’s overall status was considered, all weigh in to protect the physician from the tort of failure of informed consent. I don’t mean to make this about torts, just to point out that Washington gave this issue close consideration.
    Next step: balanced consent. In that regard, I recently heard of an intern handing a form for informed consent to a patient, without explanation of the surgery the patient was agreeing to. The surgeon told the intern to get the informed consent signed. The patient’s mother was in the room with the patient; the patient was fearful and on pain killers. The mother, after the surgery ended tragically, said she would have liked to have been consulted but did not feel her questions would be welcome. Think of the dfferent result that was possible with your idea of balanced consent.
    I don’t know wht state you live in but the President’s budget proposed $250M in grants through the DOJ to the states to evalute and improve med mal litigation statutes. I’m going to propose balanced consent in my state, in addition to several other improved practices, and know you will in yours! BTW, caps on damages are specifally excluded as proposals! These grants will provide a tremendous opportunity for legislative hearings in the various states to address practices that are effective.

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