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Editorials on Consent

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What Every Physician Should Know About Informed Consent

By V. F. Colon, MD

Informed consent is required by law to provide patients with the opportunity to make a fully informed decision regarding the nature of a medical or surgical intervention, which is recommended by a physician.

Every physician has the duty to inform a patient when an invasive or therapeutic intervention is indicated, but the surgical specialties have a special duty to fully explain the “material risks,” benefits and treatment alternatives to a patient so that he or she can consent to or decline the procedure.

Material risks are based on legal theory known as the Reasonable Person Standard. That standard was founded on the principal that certain operative or postoperative risks presented to a “reasonable person” may cause a patient to decline a proposed therapy or surgery.

Material risks are risks that are substantial in terms of seriousness, frequency and disability. Serious complications include such things as: wound dehiscence, infection, vascular or nerve damage and postoperative disability. Material risks generally pertain to loss of life, limb and quality of life. These risks must be presented to and understood by the patient in order to acquire a legally valid informed consent. When instructing patients of material risks, it is important to disclose certain severe but infrequent complications; just because they are infrequent they should not be disregarded.

It is required that patients be advised of the reasonable options to the proposed procedure; failure to provide them can complicate a legal defense should a problem related to the procedure arise, whether or not there was physician negligence.

Institutional General Consent forms are inadequate for the protection of surgeons or physicians because they do not meet the standard of care of fully informing patients as to risks, benefits and alternative therapeutic options for proposed procedures.

General Consent forms authorize institutional treatment and establish the basis for institutional billing purposes, but fail to provide evidence of an adequate informed consent process.

It is clearly the physician’s legal responsibility to acquire the informed consent. Many physicians delegate that task to others, e.g., a nurse or other assistant. Though frequently done, it is not a good idea. Should the issue of inadequate IC arise in a patient’s care, the surgeon is absolutely liable for the failure; that is what is known as vicarious liability.

It is obvious that many physicians do not acquire legally valid informed consents from patients prior to surgery. This places the physicians in unnecessary legal jeopardy, when in today’s technically sophisticated milieu relatively simple preparations can make this legally required activity nearly foolproof.

Physicians and surgeons have easy access to materials that can be used to produce very effective IC documents. Here’s what one can do:

  • Acquire surgical videos germane to your practice from the web or create surgical videos of your own explaining to patients how you plan to deal with their problem(s). A two- to five-minute video can provide the patient with an adequate explanation of the injury and the nature of the recommended repair.
  • After the video, it is essential to provide a personal Q&A opportunity for the patient and answer all questions.
  • Create a form which reflects the patient’s choice to view or decline to view the procedural video. The form should include a printed list of material risks, along with their frequencies and that the patient understands the risks and benefits of the proposed surgery, and reasonable treatment alternatives. It must also reflect that the patient was given the opportunity to ask questions of the operating physician which were fully answered.  When the form is signed by the patient it is placed in the record as evidence of a thorough and valid IC. When a physician establishes this process as “habit and practice,” it is an excellent and verifiable medico-legal tool.

Again, I emphasize that it is important to understand the specific duty of the operating surgeon to obtain IC. Using the methodology recommended above in conjunction with the patient having the opportunity to ask questions allows you to fulfill the tenets of the standard of care related to this issue.

I am providing you with this information as a friend and colleague and not as a legal advisor. If you wish to verify what I have written, I encourage you to discuss this with legal counsel. If you do these for your most commonly performed procedures, you will probably need to do them once. Review of content every year or so is a good idea.

ACPE: http://bl117w.blu117.mail.live.com/default.aspx#fid=1&fav=1&n=1280443930&mid=ab648395-aeef-11e0-a51d-00237de4a20a&fv=1

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RE-THINKING INFORMED CONSENT

Link: King rethinking informed consent

Making the case for shared medical decision making.

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Meaningful Consent

By John Halamka, MD

One major issue facing private and public Health Information Exchanges (HIE) is how to ensure patients privacy preferences are respected by obtaining their consent before data is shared.
More: http://thehealthcareblog.com/blog/2012/06/20/meaningful-consent-2/
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Written by cmps

July 15, 2011 at 3:22 pm

11 Responses

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  1. Shorten consent forms to enhance patient understanding

    By Karen M. Cheung

    Long, jargon-filled consent forms, not surprisingly, may result in patients not fully understanding their care, according to a Johns Hopkins University study published in the Journal of General Internal Medicine.

    Researchers looked at 124 informed consent documents of HIV/AIDs research patients and found that the median length of the form was 22 pages. In addition, the forms required at least a ninth-grade reading level, and confidentiality sections required a 12-grade reading level. The authors recommended that consent forms have simpler language.

    The recent stent scandal raised questions about patients’ informed consent. When Dr. Mark Midei of St. Joseph Medical Center in Maryland was convicted of performing unnecessary heart stents, many wonder whether his patients fully understood the medical procedures, its necessity, and effects, according to an editorial in The Baltimore Sun. In addition, the case highlighted the responsibility of informed content on the physician, the patient, and the organization. St. Joseph’s CEO Jeffrey K. Norman also recently announced he is resigning at the end of this month.

    “Consent forms are extremely long, exceeding recommendations for how much information readily can be processed. Networks should consider providing shorter consent templates, consistent with federal recommendations,” states the study.

    http://www.ama-assn.org/amednews/2011/08/01/prsd0803.htm

    http://www.springerlink.com/content/n2671q0593647610/

    Editors

    August 3, 2011 at 7:11 pm

  2. Informed Consent

    The principle of informed consent requires a physician to provide information about a patient’s medical condition and the available medical care options so that the patient may make an informed decision as to whether or not to consent to a proposed plan of treatment. The doctor must adequately inform the patient of the diagnosis, the nature and purpose of the treatment, any available alternatives, the benefits and risks of the procedure itself and the risks of not undergoing the procedure. In essence, under the concept of informed consent, the doctor must not only get the patient’s consent to treatment, but the treatment must be obtained from a fully informed patient.

    While consenting to treatment may impose certain limits on your rights, signing a statement assuming the risks involved with a procedure does not mean that you have no recourse if the health care provider fails to perform according to acceptable levels of care and is negligent. Though you may be consenting to certain risks inherent in the medical procedure, you generally do not consent to the negligence of the practitioner performing the procedure.

    Forms of consent

    Consent to a treatment can be given either orally or in writing, as is common where doctors provide consent forms for patients to sign. There are some situations where consent of a patient is implied, as where the patient exhibits conduct indicating a willingness to undergo the treatment, or in the case of an unconscious patient who is unable to consent, and there is no family member available to give consent on his or her behalf (and no living will which directs otherwise).

    If the patient is a child it is usually necessary for a parent or guardian to consent to any treatment, unless treatment is required in an emergency situation and the parent or guardian is unavailable to give consent. Exceptions may apply to situations where a minor seeks treatment for a sexually transmitted disease, or for alcohol or drug problems.

    Damages

    The damages a patient may recover in this kind of medical liability action are different from the damages that might be obtained in a medical malpractice negligence action. Because the liability relates to the lack of consent to a procedure, a patient may be able to recover damages even if the medical procedure was successful, whereas in a negligence case, the plaintiff is required to prove damages.

    Source: http://www.johnsonvorhees.com/content/embed/MO/pi/malp/malp_informconsent/

    Editors

    August 23, 2011 at 7:59 pm

  3. ONC aims to ease patient ‘informed’ consent problem

    WASHINGTON – Patient consent is one of the thornier issues in healthcare today. The benefits of patients allowing providers to share their data and those providers, in turn, playing nicely with competitors, stand to improve care both for individuals and global populations in myriad ways.

    http://www.govhealthit.com/news/onc-aims-ease-patient-consent-problem

    Dr. David Edward Marcinko MBA CMP™
    http://www.BusinessofMedicalPractice.com

    Dr. David Edward Marcinko MBA

    September 21, 2011 at 12:41 am

  4. Patients have trouble giving true informed consent

    Most of us would agree that doctors should not treat patients without their consent, except in special cases like emergency care for an unconscious patient. It’s not enough for doctors to ask “Is it OK with you if I do this?”

    http://www.kevinmd.com/blog/2013/01/patients-trouble-giving-true-informed-consent.html

    They should get informed consent from patients who understand the facts, the odds of success, and the risk/benefit ratio of treatments.

    Harriet A. Hall MD via Ann Miller RN MHA

    Harriet A. Hall MD

    January 2, 2013 at 12:16 pm

  5. Just sign here: That isn’t real informed consent

    An essay re-post by Peter Ubel, MD | In Physician | March 26, 2013

    Before patients can become savvy consumers of healthcare, they need information about their healthcare choices. Too often, such information is nearly impossible to get, especially when it requires doctors to give patients useful statistics about things like treatment side effects.

    Since publishing Critical Decisions this fall, I have received a number of emails from readers who have recognized their own medical histories in the pages of my book. I received a particularly entertaining email from a professor in Canada, who relayed the following story.

    He was in an emergency room suffering from kidney stones. And for those of you who have never experienced kidney stones, take it from my mother: they are insanely painful. “Worse than having twins,” she told me. (And this from a woman who, when I asked her how much it hurt to give birth to me, answered: “Ever tried to fart a football?”)

    Suffice it to say, then, that Professor Mike was in a whole lot of pain, at least until they gave him a dose of morphine. Then they decided they needed to further diagnose his problem.

    “You need a kidney x-ray,” he was told by the emergency room physician. Such an x-ray can show whether a huge stone is causing a dangerous blockage of urinary flow. Professor Mike nodded obediently. Then an x-ray tech showed up at his bedside and the conversation went something like this:

    “You need to drink this dye before your x-ray.”

    “Ok.”

    “The dye does have some side effects. It could cause a rash or it could cause death,” the tech continued. “Just sign here and we can take you to radiology.”

    “Umm, are you telling me that the chance of a rash is the same as a chance of death?,” Professor Mike asked.

    “Umm, there is a small probability of either one happening.”

    “What, exactly, are those probabilities?”

    The tech turned and left the room, frazzled by the professor’s unwillingness to sign the informed consent document without more information. A couple minutes later, the radiologist returned: “I understand you want more information. But we are reluctant to give patients specific probabilities of side effects, because we have learned that such numbers confuse them.”

    Professor Mike, with his advanced training in statistics, was unlikely to be confused by a few simple probabilities, so he pushed back and asked the doctor to give him estimates: “I don’t know them,” the radiologist responded.

    “Don’t know them? So what’s the real reason you don’t tell patients—you think the probabilities will confuse them, or you don’t know the probabilities?” Professor Mike, even with morphine coursing through his system, kept a clear head in the face of this absurd situation. He decided to help the radiologist think through the issue:

    “Approximately how many x-rays like this has your hospital done in the last few years?,” he asked.

    “Oh, at least 350,” the radiologist responded.

    “And how many deaths?”

    “None.”

    “Ok,” said Professor Mike. “I will sign the form. But if I die, my wife will sue the hell out of you, because this is not informed consent!”

    SOURCE: http://www.kevinmd.com/blog/2013/03/sign-real-informed-consent.html

    Peter Ubel is a physician and behavioral scientist who blogs at his self-titled site, Peter Ubel and can be reached on Twitter @PeterUbel. He is the author of Critical Decisions: How You and Your Doctor Can Make the Right Medical Choices Together.

    Editors

    March 27, 2013 at 12:11 pm

  6. Must a surgeon mention death as a complication?

    You bet they should!
    http://www.kevinmd.com/blog/2014/06/must-surgeon-mention-death-complication.html

    How about a podiatrist?

    Fred

    Fred

    June 10, 2014 at 11:04 pm

  7. How about Informed Refusal?

    Before undergoing many health care interventions, patients are asked to give their informed consent. In most cases, it represents a mere formality. The patient has come to the healthcare facility for the express purpose of undergoing the test or treatment, and after a quick explanation, the patient signs the consent form.

    But not always – sometimes patients elect not to go through with it.

    More By Richard Gunderman MD
    http://thehealthcareblog.com/blog/2013/08/18/informed-refusal/

    Editors

    July 2, 2014 at 12:17 am

  8. Obtaining Informed Consent in a Teaching Situation

    At all institutions with postgraduate training programs, resident physicians and surgeons participate in hands-on patient care to a substantial degree.

    http://www.thedoctors.com/KnowledgeCenter/PatientSafety/articles/CON_ID_000332

    Editors

    Editors

    October 7, 2014 at 12:40 pm

  9. Informed consent: Can patients ever truly be informed?

    I was thinking about informed consent, and a case I saw recently got me to take a little time and write about an issue frequently ignored in medical school.

    http://www.kevinmd.com/blog/2014/10/informed-consent-can-patients-ever-truly-informed.html

    Editors

    Editors

    October 7, 2014 at 12:42 pm

  10. Two cheers for medical paternalism

    In the NEJM, Lisa Rosenbaum looks at communication between doctors and patients and, as she has before, suggests that real clinical practice is more complex than orthodox bioethics makes it out to be. Discussing cases, including her own, she asks

    Might there, in fact, be such a thing in medicine as Too Much Information? … a view which she attributes to our received understanding of informed consent.

    Instead, Rosenbaum argues for a kind of paternalism, in which patients rest in a cognitive and emotional dependence on physicians. She’s getting something right, but it’s critical to get clear on what kind of paternalism we might accept.

    Let’s start with informed consent to treatment. Roughly, we have informed consent to medical treatment when a competent patient a) gets full disclosures about the treatment, b) understands these disclosures, and c) voluntarily consents to treatment. These requirements are motivated by a commitment to respect and promote the autonomy of patients. Rosenbaum suggests that this doctrine implies that the ideal patient would be making all his decisions jointly with his doctor, and the physician would be sharing all her information with her patient so that the latter’s choices would be fully informed.

    The informed consent doctrine, however, is not a complete model of doctor-patient relationships. I come to physicians for expert care, not a medical education. And I come to my doctor not only because she knows more than I know, but also because even if I knew what she knows, I might not trust myself to be the best judge of my situation when I am debilitated or in intense pain. If she sees that I am not ready to hear the bad news I’m OK with her waiting until I am in a better place.

    Moreover, I am looking not just for her cool appraisal, but also for the emotional experience of her firm commitment to my well-being. In the classic words of Francis Peabody,

    in man… disease at once affects and is affected by what we call the emotional life. Thus, the physician who attempts to take care of a patient while he neglects this factor is as unscientific as the investigator who neglects to control all the conditions that may affect his experiment… Time, sympathy and understanding must be lavishly dispensed… One of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.

    The commitment of the doctor and the faith of the patient in that commitment are constitutive of, and not ancillary to, the doctor-patient relationship. Rosenbaum captures this in a discussion of Franz Ingelfiner, a former editor of the NEJM:

    Ingelfinger describes his experience as a patient with adenocarcinoma… [a disease] he’d studied for much of his career. As he considered the trade-offs of chemotherapy and radiation, receiving contradictory expert opinions, he and his physician family members became “increasingly confused and emotionally distraught.” Finally, one physician friend told him, “‘What you need is a doctor.’” Ingelfinger notes, “He was telling me to forget the information . . . and to seek instead a person who would . . . in a paternalistic manner assume responsibility for my care. When that excellent advice was followed, my family and I sensed immediate and immense relief.”

    So I agree with Rosenbaum: we sometimes are, and should be, in a state of cognitive and emotional dependence on our medical caregivers. That is, patients both want and benefit from a kind of medical paternalism.

    So can we square this with informed consent and a concern with patient autonomy? First, let’s be clear that there are at least two kinds of paternalism. There is a hard paternalism, where superior and subordinate interpersonal roles are defined in ways that give all the agency to the superior. The traditional norms of doctor-patient relationships embodied this paternalism. The doctor is the authority; the patient does what he’s told. It is illuminating to read the first AMA Code of Ethics. It’s about the patient’s duties to the doctor, not what she owes the patient.

    The informed consent revolution overthrew hard paternalism. We now see that the patient is the agent in the doctor-patient relationship. My autonomy is not infringed if I delegate some of my choices to someone who works for me, has a better view of the facts, and whom I trust to make choices that serve my best interests.

    Importantly — and here I wish Rosenbaum had been clearer — I’m not asking the doctor to protect me from the truth. I count on my physician to force me to face upsetting facts, when that’s needed. Similarly, I expect her to ask me questions to clarify what I want and to press me for a choice when that’s needed, because sometimes I am the best judge of my own interests.

    For example, a friend gets migraines once a month, but this ceased when she started hormone replacement therapy. She’s now finding it difficult to get a prescription, because the medical profession has become convinced that the risks of HRT are greater than the benefits. But isn’t she the best judge of whether these risks are worth the escape from monthly disabling pain?

    So what Rosenbaum’s argument supports is a soft paternalism. Most of the time good physicians spare us irrelevant details, sometimes they press through our denial. This can’t be reduced to a rule, but no one ever said that doctoring was easy. The key thing is the context: it’s not the doctor’s expert authority that matters; it’s our interests as patients that matter.

    @Bill_Gardner

    @Bill_Gardner

    September 3, 2015 at 12:23 pm

  11. Informed consent defines 21st-century medicine

    By Sara Scarlet, MD

    I walk into a tiny ER room and shut the glass door behind me. The smell is dizzying. I look down and see a frail man lying on a stretcher. A soiled bandage on his left leg is halfway unfurled. He is diaphoretic. He sleepily opens his eyes when I say his name. For me, I have barely begun my assessment, but the writing is on the wall. This man will lose his leg, or he will die.

    I am a second-year resident. I have never actually performed an amputation, nor have I been formally trained in having high stakes discussions such as this. But nonetheless, here I am. My goal is to convey the gravity of the situation to this man and to consent him for an emergent operation that will render his life changed forever. What’s more, I know that for patients in his cohort — those with diabetes and end-stage renal disease requiring an amputation — have a sobering 30 percent five-year survival rate.

    I have seen conversations such as this play out one hundred different ways — obtaining informed consent is something that we surgeons do on a regular basis. All too often, the task is left to the most inexperienced members of the team. Trainees rattle through the risks, benefits, and alternatives of a given procedure at breakneck speed. They hold their breaths after asking about blood transfusion, CPR, and code status, hoping for a quick yes so that they may move on to the next signature or check box. In surgery, we are often praised for our “efficiency” and the speed with which we accomplish non-operative tasks. Informed consent is no exception. Despite witnessing the consenting process countless times, I’ve seen very few physicians sit down to obtain it. Further, I’ve seen even fewer navigate into the at times uncomfortable territory of goals of care and end of life decision making before a major operation.

    It’s time for a culture change.

    I’d argue that obtaining informed consent is one of the most important things that a surgeon does — akin to the last stitch of an aortic anastomosis, the life-saving jolt of electricity to jumpstart a fibrillating heart, or the first pass of a scalpel during an emergent laparotomy. Informed consent defines 21st-century medicine, contrasting sharply to the days of paternalistic care. Informed consent, when done properly, puts decision making into the hands of our patients. It can serve as a checkpoint to discuss goals of care and what constitutes a meaningful life for a particular patient.

    It’s time we teach our trainees how to obtain informed consent the proper way. We need to slow down, pull up a chair, and look people in the eyes. We need to truly know our patients — how they understand their diagnoses, how they interface with medicine, their socioeconomic status, and education level. We must address goals of care with clear “if-then” statements.

    When I teach younger residents how to obtain informed consent I often harp on a concept I learned in my undergraduate psychology class called theory of mind. Theory of mind is defined as “being able to infer the full range of mental states (beliefs, desires, intentions, imagination, emotions, etc.) that cause action.” In my opinion, theory of mind is an integral part of the consenting process that allows us to reverse roles, to see the world how our patients see it.

    Halfway through obtaining informed consent from my patient, my attending steps in. He snags a stool from the corner of the room. He sits directly in front of the sick man. He talks about what life will be like for him as a new amputee. He emphasizes the importance of diabetes control and smoking cessation. We may do everything we can and the man still may die. Would he want to live if it meant he could never go home again? He conveys the gravity of the current situation in a way that is pitch perfect. This, I think to myself, is how it’s done.

    For surgeon trainees, just like making our first cut, informed consent is a skill learned by example and should be done under the watchful eye of our mentors. It’s time to pay it forward. Next time you are the chief resident, the senior attending, or anywhere in between, take a trainee with you and teach him or her how to obtain informed consent the right way. Do away with the notions of “efficiency” and speed. Your patients and your pupils will be eternally grateful.

    NOTE: Sara Scarlet is a surgery resident.
    LINK: http://www.kevinmd.com/blog/2015/09/informed-consent-defines-21st-century-medicine.html

    Sara Scarlet MD

    September 11, 2015 at 2:04 am


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