Mark Hochhauser – Can the Informed Consent Process be Improved?

I am happy to welcome our Guest Blogger, Mark Hochhauser, Ph.D., here writing about patient informed consent –  a subject he is a national expert on.    

Before Mark begins, I have included an excerpt of consent language taken from a genetic testing patient form:

In many cases, a genetic test directly detects an abnormality. Molecular testing may detect a change in the DNA (mutation). Cytogenetic testing may identify whether there is extra, missing or rearranged genetic material. Biochemical methods are sometimes used to look at abnormalities in the protein products that are produced by the genes. Most tests are highly sensitive and specific. However, sensitivity and specificity are test dependent.” (Mayo Clinic)

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Written by Mark Hochhauser, PhD

I consentInformed consent is an essential part of medical treatment and clinical research. Ethical guidelines in the Declaration of Helsinki, Nuremburg Code, and US Code of Federal Regulations all emphasize that information given to patients and subjects should be written in “understandable language.”

For decades the Food and Drug Administration and National Cancer Institute have recommended that consent forms be written at a 6th-8th grade reading level. Unfortunately, that hasn’t happened. If anything, consent forms are getting longer and more complicated, instead of shorter and more understandable.

What seems to happening is that in their zeal to “comply” with regulations, drug and device companies and health care facilities are writing consent forms that will meet all regulatory requirements—except they will be incomprehensible to the average patient.

Researchers in health literacy and plain language have been trying to improve the quality of written information that’s given to patients and research subjects, but with very limited success. So…

1) Given your own health experiences, how would you describe the quality of the informed consent conversation and paper documents you’ve experienced?

2) What do you think hospitals, clinics, dental offices, etc. can do to better achieve “informed consent” with their patients?

3) Both medical care and research deal with sick patients across the lifespan. What do you think could be done to better communicate with patients aged 18-100+? Think about how your parents or grandparents deal with the written information they’re given.

4) Living in a multi-cultural society, what can be done to better communicate with patients and subjects with different language, culture, and communication backgrounds?

5) Some health care providers and researchers aggressively market their treatment and research services in ways that may conflict with true “informed” consent, sometimes by over-emphasizing the benefits and under-estimating the risks. Can you suggest some strategies for helping patients and subjects make more informed decisions?

 

More about Dr. Hochhauser 

Mark Hochhauser is a readability consultant in Golden Valley, MN. His 1973 PhD is in Experimental Psychology from the University of Pittsburgh. He’s researched the readability of consent forms, HIPAA notices and patient’s bill of rights, and has 125 presentations and 215 publications. For 21 years Mark’s been an IRB member at North Memorial Medical Center in Robbinsdale, MN. He’s consulted with 21 law firms and has testified as an expert witness on the readability, legibility and comprehension of consumer agreements.

23 replies
  1. Kebera Leach
    Kebera Leach says:

    From a personal standpoint, informed consent conversation has been virtually non-existent. Most of the time, forms are handed over by office/facility staff and I am told what the forms are but, there is no discussion of what the forms entail. I have no problem understanding the language of consent forms but that may not be the same for everyone. Print tends to be small and densely packed within paragraphs that most people don’t bother to read. It has given me the impression that expediency trumps patient comprehension when providers are delivering care.

    Achieving better “informed consent” with patients comes down to setting/patient population. For example, older patients, non-proficient or non-English speakers or those with a low level of general literacy (let alone health literacy) have a hard time understanding informed consent documents. Providers would have to place more emphasis on conversation and plain language (no regurgitation of jargon found within said documents).

    Simple changes such as increasing font size or not presenting consent in large blocks of text could help. Offices/facilities may consider bullet-pointed lists that show the individual and important components of the consent instead. “Listicles” have become a major form of web content and while all of them may not be so great, I think in healthcare we can learn from an industry based on catching a person’s attention with written content.

    Combating aggressive marketing of a provider or researcher would seem particularly hard to do. It seems that it would require more policing by governing bodies and peer networks. One way that patients could be helped is by making them aware of potential conflicts of interest that may exist. This website allows people to see who what/how physicians or institutions are being paid by pharma companies. Hospitals could utilize these list and offer them on demand. This would probably help elderly patients or those without online access who would like to know if their doctor has their best interests in mind or their own bottom line.

    http://onlinelibrary.wiley.com/doi/10.1002/cncr.29760/full
    http://www.newyorker.com/tech/elements/a-list-of-reasons-why-our-brains-love-lists
    https://openpaymentsdata.cms.gov

  2. Megan Kriaris
    Megan Kriaris says:

    Personally, I have found that the conversation between the patient and provider can be vastly improved. I have been with my grandmother where she was struggling to make sense of her forms in the doctors office and I had to sit down and help her sort through her options. This responsibility shouldn’t fall on me, but on her doctor. These documents are made by highly educated medical specialists, and that is exactly who these people are writing it for, instead of the population as a whole. There are many issues stemming from patient-provider communication. For example, informed consent being communicated from a provider to a patient can be confusing and the providers do not take the time to assist the population with understanding what they are consenting to. Another issue is that providers may leave out important information or other options because it would benefit them instead of the patient themselves. To achieve informed consent, the patient needs to make an educated and informed decision on their own, without coercion from others. The current system essentially makes patients a ‘yes man’ because they don’t know any better. By using simple language, pictures, and larger writing, people of all ages and education statuses would benefit and by allowing the patients to understand all of their options, put power back in the patient’s hands. With NYC being a very diverse population, it is important that the providers acknowledge and recognize the cultural barriers that may negatively impact the individual’s health. By having doctors and medical staff that speak a wide variety of other languages other than just english, those that are struggling with massive paper work not written in their native language can ask questions and feel comfortable talking to provider, breaking down a wall in patient-provider communication. Secondly, brochures and papers should be translated in different languages and simplified to further help those already disadvantaged in the US health system. Lastly, I propose that medical staff acknowledge and understand the customs and beliefs of the cultures or religions that the patients practice so the staff could think of other solutions so the patients don’t need to break their faith. By letting patients become more educated, patients will begin to ask more questions and become better informed of their health. It is important not to just trust what your doctor or provider tells you is best for you, but to question and educate yourselves on the many options that you have available to you.

  3. Nicole Margarella
    Nicole Margarella says:

    In an age where law suits are quite common, it is hard for a medical professional to be able to really simplify every risk a patient may be put in danger of when creating a consent form in certain professions. It puts doctors in a difficult position because if all of the risks aren’t laid out exactly so, there is always a potential law suit they may have to worry about. In previous comments, people have mentioned examples such as when we accept the terms and conditions to things like the company “Apple” in order to purchase music. Why doesn’t the agreement just say “I agree not to unlawfully redistribute this music”? Instead there are long pages and conditions and terms. This is for something as simple as music. The human body is profoundly more complicated than that. Everyone is built differently. Certain arteries and nerves and veins aren’t even always located in the same places. Different muscles and bones are different sizes. Someone could have a tumor they didn’t know existed, or a heart murmur, as well as many other less detected diseases that may arise different potential complications in a medical setting. So it is hard enough to come up with a form that fulfills every possible complication to someone if they were to have any sort of procedure done. I’ve worked in a doctor’s office and in my experience, I would say maybe a third of people actually ask about what they are signing. I would think the best bet is to have someone explain what everything means if they are confused. Patients should take an interest in knowing what could happen if they do not understand what is written rather than just signing a paper and hoping for the best. Signing without reading is basically a person giving up their right to start an issue if something should occur. I’ve personally signed many consent forms without fully reading them, in a sense hoping for the best, while knowing that what I was doing may involve risks, and you have to essentially decide if you’re willing to take them. I however would absolutely ask about any concerns I would have for myself before signing, and I think the rest of the non-medical population should as well. I also think it is an ethical responsibility of the doctor or any other medical professional not to “downplay” risks in order to get informed consent.

  4. jmaier830
    jmaier830 says:

    Understanding medical terminology is something that the average person does not understand. Medical terminology is a lot of jargon and I know for myself it means nothing if it is not in plain and simple English. Many times medical issues are not correctly explained and leave the patient with a lot of questions or doubt. In order to improve informed consent awareness needs to be raised, patients and doctors need to be educated, workshops need to be created, and sections of documents that are not necessary should be deleted. Common concerns should be raised, and forms should be improved. It is best to avoid confusion and all health facilities should be required to provide the same forms.

  5. Norma Reza Santos
    Norma Reza Santos says:

    I believe that the informed consent process not only can be improved, it should be mandated by law under a strict deadline to be “written in understandable language” as stated in the ethical guidelines of the declaration of Helsinki, Nuremburg Cod and the US code of federal regulations. In my own health experience;
    I had a medical challenge when I was younger. I had signed consent forms for specific treatments. When those treatments weren’t working and I was getting worse the medical professionals would not allow me to stop. They intimidated me by telling me if I didn’t continue to follow their program I would die.
    I had to leave them completely and go to an alternative medicine doctor to finally restore my health. The consent forms allowed them to perform drug experiments on me.

    In the blog example from Mayo Clinic regarding a genetic test; there are key health issues that are not addressed such as the negative effects of molecular, cytogenetic, or biochemical testing methods. The consent form states that most tests are “highly sensitive and specific.” Sensitive and specific to what?
    The form closes with the comment: sensitivity and specificity are “test dependent”. Dependent on or to what? If the tests are “highly sensitive” the patient has the right to be informed in detail.
    To better achieve “informed consent” the legal scale should be tipped to favor the patient instead of the drug and device companies, health care facilities, and insurance companies. Regulatory requirements should be specified to Doctors, healthcare facilities, and device/drug companies and other medical professionals, to provide information in “understandable language.” If not, they should face heavy fines and loss of license to practice.
    Then we would see these “professionals and companies” find a way to provide their information in direct and readable plain language.
    The “very limited success” researchers in health literacy have had to date may be traced to the institutional(American Medical Association)and corporate lobby power over the government (FDA).
    And the softness of the language used in trying to improve the quality of written information. For example, “…all emphasize” or …”should be”…would give a different message if the tone were; “directed to”or “will be.” Here the lawyers would be working on behalf of the patient and not for the AMA, medical/drug companies or insurance companies.
    This would have to take legislative action (government)to make this happen.
    It would be like someone “aggressively marketing” for the health of the patient (receiver) instead of the way it is now for the providers, of all ages 18 to 100+. It should be simple. It is only complicated because thats how the providers want it to be.
    The best strategy would be to go directly to legislative action to mandate change. Then maybe Dr. Hochhauser would have less time in court testifying as an expert witness on readability and understandability of agreements.
    In summary, I do think a procedure is necessary to clarify a diagnosed condition, and suggested (desired) treatment, benefits and risks, and alternatives to the patients ability to understand all of the consequences. That procedure would include a written explanation and the patient and doctors signature. Obviously, it should provided in every language spoken in this country.

  6. mholzwarth
    mholzwarth says:

    Mark,
    I cannot remember ever having a conversation about a consent form, they were just handed to me at the receptionist desks and I signed them (after a quick skim through) in the waiting room. I think I tend to trust doctors to do what’s best, just as we all trust Apple when we click “accept the terms and conditions” to their newest software updates without reading the nitty gritty! The South Park episode about the humancentiPad should have been enough to scare me into reading what I sign, but honestly I feel like if I don’t understand something I’m going to pretend I do and sign it anyway to move on.

    I work in a psychology research lab where everyday I have to obtain consent for a study trial. Our strategy here is to hand the participant a consent form in the waiting area to let them read it over. We then pull them into the experimental room and first explain the crucial aspects, such as confidentiality, risks and an overview of the procedure in conversational English. We then ask them to give us a quick summary of what we just said to check for comprehension before signing.

    I feel like this is relevant because we take time to make sure the participant understands, while in health care there is never enough time for anything. With all the pushes to meet patient quotas, see everyone that needs to be seen and being potentially understaffed, I feel like the best thing– but the hardest thing– would be to encourage a longer, vernacular conversation with a patient. Perhaps there could be a qualified person to sit with a patient and go over it so that it does not affect a doctors jam-packed schedule.

    People like the blogger here, Angie Woody, would be extremely beneficial to have more of. However, a way around having a bilingual person in the office is to use a telephone translator. In a free/low cost community orthopedic outpatient clinic I volunteered in at the University of Rochester Medical Center, there was a large amount of non-English speakers speaking a large variety of dialects. The doctor was able to sit face to face with a person regardless of their language and talk into a two lined phone with a translator on the other line– and it seemed to work well.
    But once again– this takes time and money.

    Overall health care reform would be ideal, giving more one-on-one time for a patient with a doctor who has been trained to communicate at appropriate levels of conversation. In the meantime, I think there should be more checks in place that get feedback from the person giving consent. If doctors had a standard lists of question that were designed to check for comprehension, I fell like overall consenting would be more informed.

  7. Sukramlis
    Sukramlis says:

    In my experience it all depends on the health facilities that a person visit, for instance if one goes to a hospital they will find themself filling out papers on top of papers on the other hand when someone goes a neighborhood dental office or clinic there would not be as much paper work to be done. In my opinion big health care organizations such as hospitals want their patients to be knowledgeable and be aware of the responsibilities that the hospital holds in regards to patient-Doctor care. I always find it simple and easy to ready whenever I visited my neighborhood health care facilities whereas whenever I visited the hospital I always find myself with tons for paper works, so I just sign without reading, I know it’s an irrational decision but “desperate times calls for desperate measure” I use that quote because at the hospital the lines are long and the workers push you around waiting there for hours, so the faster you fill out the paper work the faster you get to see a doctor. For instance if someone takes the time to read through every paper that is given to them they will never get to see the doctor.
    On the other hand, when ever I visited my community health care center I would read through the documents before I sign and give my consent this is because the documents are short, precise and written large enough so it’s easily readable. Another impressive aspect about going to community base Heath center is it is not crowded as a hospital and the doctors spend much more quality time for their patients. As for filling out paper works it is just so easy and understandable for anyone it does not require patient to have any knowledge on health literacy.

  8. Sandrine Konan
    Sandrine Konan says:

    To be honest, I find informed consent forms pretty long. I usually go to the dentist and most of the time I am feeling well, and when the medical assistant or receptionist hand me those forms, I just signed them not because I don’t know how to read or I don’t understand the material but because all the information are condensed and there is no space between those paragraphs that may give me the desire to go through the forms.
    I think the forms should be simplified in a way that the patient can read in less than five minutes. it should also take into account the health literacy of the community and make sure those forms are clear, simple and the eight grade level to ensure that most of the patients will actually get the message behind the forms.
    Also, there should probably be a prolongation of the time the doctor has to consult a patient. the interaction should start by explaining the forms so there is no misunderstanding between patient and doctor. when a patient go to the hospital, he seeks for more than a physical healing. he seeks for psychological and emotional healing so the doctor and the all medical personal should firstly care about the patient understanding of the material before going to the real issue.

  9. schiffer.lucas
    schiffer.lucas says:

    If it is indeed the case that informed consent forms need to be written at 6th to 8th grade level, then it begs the question of why we aren’t using the appropriate scholars to write such form. It seems strange to think of health care providers trying to write at a lower level than what their training has prepared them for. Wouldn’t having middle school students contribute to writing informed consent forms be an excellent tool for teaching health literacy? Perhaps there are objections there, still then wouldn’t it make a great deal of sense to have patients write the forms? Medical professionals are just that, professionals. Don’t we need amateurs to write the forms?

    And if health literacy is purportedly so low, doesn’t the information gap extend to health insurance? While the Affordable Care Act has succeeded in bringing insurance to so many who were previously uninsured, does the coverage really matter if it is neither understood nor utilized? Even barring these two preclusions, limited acceptance by providers of certain health plans still presents a substantial hurdle in obtaining care. To what extent then does the public understand that health care increasingly has two tiers of care? It would hardly suffice to say that informed consent is a patient centric issue but rather it speaks volumes to social issues at large.

  10. Laura Hirschfield
    Laura Hirschfield says:

    In my experience, the informed consent conversations that happen at doctors offices have been short and sweet without much room for questions to be asked. Each doctors office has their own version of a consent form, but the people who actually hand them out to the patients do not always know everything that is actually written on those forms. I am normally rushing to be seen by the doctor as quickly as possible so I skim the pages (there are always too many in my opinion) and I sign and date it. This is obviously not good, but when there are 5 pages to look over and there is a waiting room full of people you want to get in to your appointment as soon as possible. I like the idea of using iPads because they are easy to use and the font is clear, but at the same time this is an added cost that many offices may not be able to afford. I work at a large cancer hospital and the consent forms are lengthy and complicated, but patients are given a translator if they do not speak English. The authorization paperwork needs to be condensed and simplified. I think using online platforms for patients to be able to check their lab results and get copies of their MD notes is very effective and keeps the patient tuned in to what is happening with their care. Health care providers that over-emphasize the benefits and under-estimate the risks of a certain drug is something that I am personally passionate about as I almost lost a cousin because of this very thing. My cousin ended up on CNN to talk about her story. Here is the link if anyone is interested in watching it: http://www.cnn.com/videos/health/2015/04/06/ac-dnt-kaye-nuvaring-blood-clots-lawsuit.cnn
    Knowing the benefits and the risks of a drug, a procedure, or a treatment plan is something that cannot be taken lightly. Every single day we are bombarded with the newest weight loss pill, or the next cure for cancer and while there is a lot of fantastic progress happening in the world of science and medicine, we as patients and our providers must be attune to what our bodies are actually feeling/experiencing and what is the most beneficial and financial option for us. With the insurance companies and drug companies controlling the government it will be difficult to see changes made, but it must be done. Interaction outside of the actual doctors appointment between a doctor and a patient or a nurse and a patient needs to take place in some capacity whether it be a phone call, an email or a some other online platform. I have patients calling my all the time asking to get clarification on what the doctor intends for him/her and what the next steps are. Constant, clear and easy to understand communication is key.

  11. Grisselle DeFrank
    Grisselle DeFrank says:

    As a school based health educator a significant aspect of my work is to have adolescents understand and make choices regarding their reproductive/sexual health. This includes decisions about birth control and HIV/STI testing. Now New York State has different laws than other states regarding consent to medical care. In New York State a minor (a young person under the age of 18) does not require parental consent to receive reproductive health services.

    I can sometimes spend an hour or more with a patient answering questions about birth control, STIs/HIV and general reproductive health. Sometimes this is done over various sessions (as an aside the education adolescents are receiving from home/school/social networks regarding reproductive health is abysmal). I’m glad that as a health educator I can take the time to explain and answer questions about this very important topic and help them make informed decisions. I believe this is something that can be applied to other populations. Have individuals who are trained provide counseling to patients so that they can understand their condition, the available treatments, what their doctor recommends, and answer any questions that patients may have.

  12. Courtney
    Courtney says:

    The Henrietta Lacks story was brought up in an earlier post and I think this gives an excellent example of why written consent forms are meaningless. Even if she had been given a 4th grade reading level consent form; would it have been possible for her to understand, or for her doctors to understand, what she was consenting to? Ok, I know that sounds awful. I do not think people should be used for research studies without consent. However, there are so many imperfections about the health care system, it seems impossible to force providers to figure out ways to explain what can’t always be explained, especially in writing. In my opinion if a doctor does not disclose the risks of treatment to a patient with a face to face interaction, then that is a bad doctor. In Angie’s post she wrote about the benefits of a Patient Service Liaison. This position seems necessary at all medical facilities if they are determined for all their patients to understand treatment and give legit legal consent. Otherwise would a form change a patient’s opinion after their doctor just told them they needed this treatment? Written consent seems like it is more to protect the doctors than the patients.
    The ethics of written consent in the medical world has always been mysterious to me. I agree that patients are often ill informed. I spent most of my adult life working on an inpatient psychiatric unit and I never remember any patient stating, “I know I can’t sign myself back out of the hospital but that is ok. I completely understood everything I was agreeing to when I signed that consent form in the ER; even though I was actively hallucinating.”
    This is an extreme situation but it highlights the conundrum providers sometimes face when obtaining consent. Doctors sometimes push patients, even patients that are not capable of giving consent to sign for all kinds of reasons. Patients are generally sick and vulnerable. In all my time using doctors, hospitals, and even emergency rooms, I have never refused to sign a consent form. I’m curious if anyone else in this class has changed their mind about receiving treatment after reading the written consent form?
    Consenting to treatment is important, but only if you know what you are consenting to/ There is no way to measure if people really understand by obtaining just their signature. The solution to informing patients about their care may not be about writing or language but in actual human communication with verbal feedback. Less paper work, more interactions.

  13. Smiley (Ola)
    Smiley (Ola) says:

    From my personal experience the language of consent forms or medical forms are not written in the simplest form and are at times difficult to read for those without a certain degree of education. I can vividly recall explaining to my parents what the doctor wants them to do, when they bring home their prescriptions. I believe explaining consent forms can improve physicians and patients’ interaction. If both parties understand what they are trying to convey, it makes the interaction easier and more effective. But that is not the case for many consent forms and medical prescription or referral it’s like an unspoken language that only professionals in the field can understand which leaves out the masses.

    As we all know the U.S has low health literacy, and consent forms being written in complicated terms make it more difficult for the vast majority of the public to understand.

    I believe medical institutions should consider the fact that a large percentage of the U.S read and write below 8th grade level and English is not the first language for many. Therefore writing in a plain language can go a long way and can improve the delivery of health care along with patient interaction, also put into consideration people’s culture as well as individuals health believes as this can be a barrier to obtaining information.

    Lastly I believe images can be great way to communicate care to patients aged 18-100 and patients that English is not their first language. We can use imagines to depict the messages we are trying to convey.

    Marketing in general can be very deceiving, however when it comes to individual health it can be very misleading. As many health care providers and researchers are known for over emphasizing the benefits and under-estimating the risk which can put many lives at risk. This is why patient doctor interaction is essential. The interaction allows for communicating with one’s primary care doctor can prevent one from being misdiagnosed or taking the wrong prescription as well as increasing patient’s knowledge.

  14. Janani Bavanandan
    Janani Bavanandan says:

    1 – I have not had any experience obtain any health forms or documentation that had been too obscure for me to understand. Perhaps, it is because I have most of my medical work, whether it be primary care, dental work, lab work, etc. all done completed at smaller medical offices where family or family friends serve as providers and ease the process for me. The consent forms at these healthcare facilities is not excessively complex either. However, when I became an intern at Mount Sinai, the clearance process incorporated forms that I had to ask my family friends to help me with. My understanding, thus far, is that the more complex or vast an health institution becomes the more detailed, particular, and lengthy their health forms become.
    2 – I think they should have simplified versions or guidelines. A year ago, I was referred to a new dental lab to have all of my wisdom teeth taken out and they had done this. There were many consent forms to fill out and the entire process could have been excruciatingly overwhelming had the “helper” paper work/ guiding pamphlets not been there. In the midst of having sever tooth pain, it seems logical that the patient or the patient’s caretaker should not have to agonize over consent forms. The pamphlets were great and essentially walked the patient through the entire process and re-articulated (in simple terms) what was being asked for with all of the documentation involved in the process.
    3 – Simplicity is key moving froward, but with the aging population familiarity is significant as well because you would not want to them to feel as thought all current processes are over modernized for them. I think that if there was standard set of consent forms that have healthcare providers used perhaps that would bring some ease. This way a guiding pamphlets on what is being asked for could be set up and “universally” be delivered and shared with providers in the state, but national level criteria would be ideal. However, it the case that that is not possible, simplifying the language would speed up the process and increase customer satisfaction.
    4 – While at Mount Sinai, I spent some time serving as a patient navigator and I also worked with the The Center for Multicultural and Community Affairs on orienting the staff to be more multiculturally cognizant, especially as certain departments opened up to accepting more insurances. It is crucial to have bilingual staff and I also think bicultural staffing helps as well, as it brings a new level of understanding. It is also imperative to recognize that this city is only growing more diverse and so there will be and increasingly need for departments like the one established at Mount Sinai to be created in all of the other healthcare establishments across the city. The primary focus of this department at Mount Sinai is to be able to cater to and better train more diversified staff coming strong multicultural backgrounds, which ultimately brings a new level of comfort to those being served when are able to connect with their care provider.
    5 – Patients should certainly obtain second and third opinions before signing over consent, given that they have the ability to do so. It is important that patients try to stay as informed as possible and increase their own personal health literacy by reading online and exposing themselves to the different opportunities available. It’s a saddened reality that care provided to patients is not more straightforward, but this system had been in place for quite some time and seems to only seems be getting more and more complicated.

  15. Susanna Banks
    Susanna Banks says:

    Adam, I completely agree that financial incentives play a major role in how healthcare is currently practiced in the United States. However, I think that much of the written materials shared by medical providers are actually out of their hands. It is becoming more and more difficult for providers to practice outside of a major hospital networks, so most of these consent forms are being created en masse by the legal offices at the hospitals. Again, it’s coming down to financial concerns about liability instead of the accessibility of the information fro the patient.

  16. Etta Bernard
    Etta Bernard says:

    Unfortunately in the U.S. there are still high rates of illiteracy, whether it is related to health or not. During my undergraduate studies, I had the opportunity to complete an internship with the Baltimore City Health Department and while I was there, I went to a workshop related to illiteracy and its effect on one’s health. We looked at examples of websites dedicated to educating and improving health. However, while looking at some of these websites, especially ones seemingly geared toward at-risk populations, there seemed to be an automatic assumption from the authors on these websites that a) everyone can read at a high school level or higher and b) everyone has advanced health literacy. Even people at the workshop who had advanced college degrees had difficulty understanding some of these websites so I can only imagine how someone who is illiterate would be frustrated with the website and dismiss it altogether.

    It is easier to dismiss and leave a website if you are having trouble understanding it, but it can be much more difficult to not give consent to and thereby turn down a certain medication, treatment, etc. that could potentially be extremely beneficial despite not knowing or understanding the equal potential for dangerous side effects. People are giving consent without truly given consent due to pressure and with the understanding that if they do not sign the consent form, there will never be another chance to receive “X” treatment for their “Y” condition.

    I have had both positive and negative experiences related to consent forms. I had medical professionals give me a brief explanation of each section of the consent form of both the benefits and risks associated, which I was grateful for (maybe luck?). However, I have also had the frustration of being given forms that made no sense to me and I was left with the feeling that the writer of the form assumed the reader had also attended medical school and understood all medical terms. In addition, I have observed that due to the requirement of consent forms, they are delivered as if it is some ordinary routine that medical professionals tend to forget that many recipients are not as (health) literate as they are.

    Overall, I believe that in order to decrease the rate of health illiteracy, especially in regards to consent forms, there needs to be a major revision in how these consent forms are worded. In addition, I believe that medical professionals need to be trained in how to recognize if someone is illiterate. Someone who cannot read beyond a certain level might be embarrassed and not say anything and therefore not receive any treatment at all. One of the things I took away from the workshop mentioned before is how to recognize signs of illiteracy (at any level) and how to properly give the patient/client the opportunity for clarification without embarrassing them further. While it is important to focus on increasing someone’s awareness on health, it is equally important to provide the opportunity for that individual to maintain his or her dignity and pride while doing so.

    • Susanna Banks
      Susanna Banks says:

      Chris, I love this video and often use it to talk with my students about sexual consent, but never considered the implications for informed consent in healthcare. With my students I always emphasize that it is on you to ensure that your partner is consenting, but in healthcare it almost always seems to be the opposite. The onus is on the patient to ask questions or clarify confusing information, and as Isabella explains below, patients often feel judged when they do so. What if a medical provider asked you if you wanted a certain medication or procedure, instead of just mandating the course of treatment? In the doctor-patient relationship we seem to accept the power differential in a way that we don’t in other areas (including sexual negotiation).

    • Kriti JoshIi, CUNY SPH
      Kriti JoshIi, CUNY SPH says:

      Hello Professor,
      Such a simple, clear and straight forward explanation. Consent is everything, whether it’s tea, sex, research or medical treatment. I found the video not just interesting, but very educative. There has to be mutual understanding and agreement between the receiver and the provider, eliminating the communication gap. As Dr. Hochhauser said, “consent forms are getting longer and more complicated, instead of shorter and more understandable”. Not everyone has the same level of consciousness or education, so forcing them to drink “the tea” just because you’ve prepared it doesn’t mean it’s right or ethical.

  17. Nicola Farina
    Nicola Farina says:

    Dr. Hochhauser :
    To me, these consent forms become almost like a school examination where the patient in this case is trying to get everything filled out but without any study preparation. The issues with these forms become more of a serious concern because humans are not signing for cell phone contracts but their health that could be possibly be further compromised depending upon what treatment and the extent that the treatment is offered to he or she.
    I myself have difficulty following basic forms. Imagine how someone who is health illiterate or foreign tries to make out with these forms. In some cases patients feel desperate and vulnerable and the medical staff provides no explanation except to sign at the dotted line. If you are dealing with brand new cancer treatments, a patient could be signing their death certificate(Forgive me for saying that).
    To better achieve informed consent, these forms need to be simplified and have a consultant or an interpreter hired by the hospital or covered by some part of the patients medical inpatient or outpatient insurance if a signature is required. The patient has a right to understand consequences of the treatment they are receiving. With a high rate of health illiteracy, the hospital takes advantage of the patients rights and the patient can’t fully understand whats involved. My uncle is undergoing some new chemotherapy and there are always risks not clearly defined . Are human patients really patients or do they become experiments and numbers within the treatments and clinical trials that they receive ?
    Nicola

  18. Isabella Odonkor
    Isabella Odonkor says:

    As my own experiences with the medical realm have not been ideal, I understand all too well how it feels to be given the short end of the stick. When I go to visit a health professional, the provider almost never introduces themselves, smiles or asks enough questions. When prescribing medication, it purpose and need are never explained. Side effects of a drug and its way of combatting the health issue are never discussed. In addition, complex medical jargon are used and when I ask questions, a face is made and I am given a half thoughtful answer. I don’t think I have honestly ever been given informed con set because there was always vital information that my provider failed to mention.

    I think medical facilities can take steps towards providing informed consent perhaps by mandating a consent form to be filled out by patients after being diagnosed with a condition or being prescribed a medication. Prescriptions are often just slapped into a patients hands and they are expected to use it properly. Upon completion of the patients appointment the form would ask if they feel they have a good understanding of their condition or drug use. If a patient answers no, the provider would be required to reexplain desired information. I think another thing that would be really helpful is perhaps mandating a follow up call to the patient to ask what they have been doing for the condition. I know this is a bit of a stress and requires a lot of resources and efforts but if it means saving lives, I think its worth it.

    I think making written information easier for the 18-100 age group is definitely the elimination of complex language in conduction with increasing compactness of said material. One pagers and unclogged brochures I found are easiest for my colleagues and I to read because it is less intimating and looks as if it was meant for someone of my status (educational and age wise). For me, my feelings of self-efficacy are significantly heightened by simpler educational materials because if I can read the material I feel as if I can mock the suggested behavior. Material that is complex and cluttered decreases my feelings of self efficacy because even though I may read the material, the struggles of reading it discourages me from believing I can perform the health behavior because I was struggling to simply read about it.

    I definitely agree on the over empathizing of the benefits and under emphaziing of the risks. This can be seen in drug commercials where there is calming and soothing music playing while the person is seen smiling and completing tasks they were unable to do before they started taking the drug. At the end of the commercial side effects are rushed and slurred into a matter of 0.1 seconds leaving no time for the public to listen to the risks at all. By giving the benefits of the drug so much attention in the commercial (accompanied by the smiling and triumphed face of the patient after the drug) and giving so little attention at the very end of the commercial, the public may believe: 1) the benefits outweigh the risks dramatically and 2) the risks may not be severe since it was only mentioned briefly. I have noticed that in many commercial they mention “talk to your doctor to see if X drug is right for you” but often times their doctor has not taken the time to understand the patients condition well enough to recommend or dismiss the use of the drug.

    http://www.atomicsun.com/anthology/wp-content/uploads/2009/10/crestor_TSI_lg1.jpg

    This ad for example has the site effects so far off on the left its so difficult to notice.

    I think in the end, more personalized patient care would tremendously help in informed consent. There is a very fine line between informed consent and understood informed consent as well. More efforts need to be taken to assure that people understand their conditions and there for increase self efficacy.

  19. Natalia Williams
    Natalia Williams says:

    Thank you, Mark, for introducing me to a topic I truly did not know much about. When reading your post and some of the responses, my mind immediately jumped to my brother-in-law’s visit to the ER on Sunday night. He went because of chest pain and, as a twenty-something healthy male, this was distressing to him. After a series of tests, a woman came into the space from registration asking for pharmacy location, insurance information, etc. After wordlessly tapping away at the computer attached to the bed for a few minutes, she handed over an iPad and said, “Sign with your finger.” My brother-in-law, an immigrant who still struggles with his English at times, began to sign when I said, “Wait, wait, what is that for?” It was a consent from. I wondered how many people lying in an emergency room bed, in pain or distress, signed that tablet without thinking. This was an extremely inappropriate way to convey consent information, or any information for that matter. How do we ensure nurses and medical personnel of all sectors comply with consent rules? For now, there would need to be more oversight. While this only adds to the already confusing and crowded medical personnel sphere, it is the immediate response I have to this issue. I look forward to learning more.

  20. Kriti JoshIi, CUNY SPH
    Kriti JoshIi, CUNY SPH says:

    Hello Dr. Hochhauser,
    I feel like the case of Henrietta Lacks which was discussed in my previous class fits in well with this topic. Henrietta Lacks, being a poor, black and uneducated woman, had her cells been taken without her consent, and used for medical purpose throughout the world. Every patients or the study participants must be properly educated about their rights first, and a more comprehensible way should be figured out before signing the consent form, medical or any jargons should be clearly explained. It should also be the duty of the patients and their families to be aware about the content of the form. There should be clarity on the side effects, possible risks and financial considerations and not just the benefits of the treatment or research. Most of the time patients don’t even read the forms fully, which often can create imbalance in understanding the process or the result of the treatment. So it is indeed important to keep repeating & reminding these patients about the information, any changes or developments in the consent form in timely manner. It might also be helpful to use the multimedia formats like dvd, web or podcast to a different age groups of patients . We live in multicultural, multiracial, multiethnic society, the clinics, hospitals should avoid using the family members as the patient’s interpreter, and instead use a proper interpreter. Regularly check the validity/ expiry of the forms, provide the copies of the consent forms immediately to the patient. Above all, educate the staffs, give the patients enough time and opportunity to fully understand, accept or decline the content in the consent form.
    Thank You

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