Enhancing the informed consent process can also improve patient safety. Dr Dan Cohen, medical director of Datix, explains why.
It is an honor and privilege to practice medicine, to assume sacred responsibilities for advising and providing care to patients. Physicians have long recognized that recommendations and interventions can have both short and longer term consequences, with sometimes life-altering consequences for better or, sadly, for worse. We should be sobered by these responsibilities. We are a respected profession and our patients are also deserving of respect. We are obliged to them by a special covenant, primum non nocere: first do no harm.
The processes for obtaining informed consent are flawed, incomplete and often do not recognize the inherent autonomy of patients to make choices about their own healthcare. Although documents are signed and things appear to be neat and tidy, a deeper drill down into the substance of the informed consent processes can identify many opportunities for improvements and liability risk-reduction. Reducing this liability is therefore a crucial element for enterprise risk management.
I recently underwent an outpatient procedure and, after signing the consent form provided by the receptionist, I began to think about consent in all its dimensions. The process was not sufficient in several respects. The physician never actually sat with me to explain the risks and benefits of the procedure and the form was inadequate. Only when I pushed the issue did the kind of conversation that should have taken place actually happen to my satisfaction. Do you think this is uncommon? Think again!
Basis of the informed consent processes
Transparency is the quintessential element of the informed consent process. Inadequacies in this process may lead to unrealistic expectations, harm and even litigation. The process of seeking and obtaining consent involves physicians sharing sufficient information to support decision-making and ensuring that patients comprehend the information, resulting in a voluntary, autonomous decision to consent.
Challenges
Not all physicians are good communicators; their skills are often impaired by more talking and less asking and listening. Sophisticated and/or more assertive patients may fully engage in dialogue while others may assume a more passive role. Reasons for this abound and include reluctance to challenge authority, a willingness to accept recommendations for intervention out of fears regarding their illnesses and even a risk of alienation of their healthcare providers.
The role of the physician is to:
Assess each patient’s ability to understand, intellectually and cognitively, the clinical issues at hand and to communicate effectively about these issues;
Assure that a family member or patient advocate and translator are available if issues of intellectual or cognitive competency, language fluency or comprehension are identified;
Ask for and carefully listen to each patient’s concerns;
Explore relevant aspects of cultural and social circumstances and belief systems; and
Then and only then discuss the following:
Diagnosis and/or uncertainties regarding the diagnosis;
Nature of the proposed diagnostic or therapeutic intervention;
Benefits and risks of the intervention or non-intervention;
Anticipated clinical course and post-intervention care;
Alternatives to the proposed intervention; and
Potential or real conflicts of interest.
The role of the patient (or guardian) is to:
Listen carefully to the information and explanations provided;
Express any concerns or fears and discuss the impact of illness on life and lifestyle;
Convey full understanding of the risks and benefits of interventions and/or alternatives;
Volunteer information relevant to social, economic circumstances or belief systems;
Ask final questions before signing the consent form; and
Sign the consent documents only when completely satisfied with the information provided
Case studies
The informed consent process is particularly challenging when there are potential conflicts of interest between the missions of the institution, the personal and financial relationships of healthcare professionals with products and services they provide and the needs, wants and desires of patients, ie, what matters most to them.
#1: Informed consent for experimental therapy
The terrain of seeking informed consent for experimental therapy is slippery, particularly when somewhat effective therapy already exists or when there is a potential conflict between the mission of a research institution and the requirement to provide best-care options to patients. Discussions with patients to propose enrolment in clinical trials are mired in complex emotional and intellectual variables.
A particular trial, while potentially increasing disease-free survival, also may increase the likelihood of therapy-related morbidity and even mortality. Many patients are so overwhelmed and shocked by a frightening diagnosis that selective listening, hearing and understanding substantially confound the informed consent process.
Sally, a four-year-old child, has recently been diagnosed with acute myeloid leukemia. With standard therapy she has a 60 to 70% chance of long-term survival. She is being treated in a research cancer treatment center with a primary mission to enrol patients in clinical trials. The oncology postdoctoral fellow meets with the family to discuss treatment options. She explains the risks and benefits of standard and experimental therapy and then asks the parents what they would like to do.
The parents are frightened, bewildered and overwhelmed. They ask the doctor, “What do you think we should do?” She replies that both options are reasonable. Although she is hopeful that the experimental therapy will result in an improved outcome, she cannot be certain about this and mentions that it could result in a worse outcome. The parents reply, “Yes, we understand that, but if Sally were your child what would you do?”
The doctor responds, “I understand how difficult this must be for you. As Sally is not my child, I cannot really put myself in your shoes and help you with your decision. I can only say that I and the other doctors and nurses in this hospital will support whatever decision you make and we will provide Sally with the best care possible.
“If you would prefer, I can arrange for a patient advocate (often a trained social worker or psychologist) to join us and to help you with your decision. Whatever choice you make will be a good choice.”
This conversation takes place daily in pediatric cancer treatment centers. Although the case study above portrays the sensitivity required to have this difficult conversation, there is still a conflict of interest between what might be best for Sally and the underlying mission of the institution. In this instance, the oncology fellow dealt openly and succinctly with the issues at hand and it is hard to find fault with her approach. The challenge for the parents is that regardless of the option they select, if Sally dies they may forever feel guilty about their choice.
#2: Informed consent for care in a teaching hospital
In academic settings, patients should be provided information regarding the skills and experience of those who will be performing invasive procedures. Disclosure is often incomplete and consent is frequently obtained under the umbrella of “our team will be doing this procedure”, without clarifying who will actually hold the knife or insert the urinary catheter. Not all patients understand the roles of teaching hospitals, and supervision of trainees sometimes has been too lax.
A first-year house officer is being given the opportunity to insert a central venous catheter in a patient who requires close cardiovascular monitoring. He has never done this before although he has observed this procedure several times. His supervising resident asks him to obtain signed informed consent for the procedure. The house officer meets with the patient to discuss the procedure and mentions “the ICU team wishes to insert the central line catheter”. He does not specifically mention that he will insert the catheter but rather implies that this will be a team effort. The patient asks, “How many of these have you done before?” The house officer avoids directly answering the question and again mentions that the ICU team will do this together.
There were two flaws in this process. First, the junior house officer should not have been put in the position of obtaining signed informed consent for a procedure he had never performed. He cannot speak authoritatively from a position of experience, and the patient deserves better than that.
Second, the supervising senior resident, with considerable experience, should have explained the procedure in order to obtain consent and then should have mentioned that he would like the junior house officer to take the primary role in catheter insertion under direct side-by-side supervision. This would have reassured the patient and the junior house officer, and the patient would likely have consented with a more appropriate understanding of risks and benefits.
Patients and healthcare professionals in training are natural allies (or should be). Each stands to gain from the other as best outcomes are achieved by partnering for healthcare interventions. Unfortunately, many working in teaching hospitals assume that patients understand the complexities of the environment in which they are receiving care and that trainees will be involved in potentially invasive aspects of their care.
This is a flawed understanding, which subordinates the needs of the patient to the needs of the trainees and is the antithesis of patient centeredness. Trainees need to gain experience, of course, but also must learn to value honest and transparent communication in their relationships with patients.
#3: Informed consent when financial conflicts of interest exist
Conflicts of interest abound when those obtaining informed consent have a financial interest in the development and utilization of medical devices. Clinical recommendations, potentially mired by conflicted financial considerations, may not be fully vetted by patients unless communication is transparent. Patients often are subject to seductive pressures regarding newer technologies that may not yield better results than older technologies. Consent processes that do not include full disclosure are commonplace.
A patient with chronic degenerative arthritis is recommended for a right hip replacement. The institution at which he will undergo surgery has a reputation as a “center of excellence” for hip surgery although the institution does not provide outcomes data that supports the advertisement of excellence. The surgeon intends to employ a new artificial hip with metallic encasement manufactured by a company with which he has a financial relationship. The standard option involves the use of a hip prosthesis with plastic encasement that has been found to be safer than older metallic encasement prostheses.
During the informed consent process the surgeon refers to the routine nature of this procedure and the excellence of the institution and clinical staff. He does not address his or his institution’s financial relationship with the company that produces the device, nor does he discuss how this device might differ from others that are available. Thus, he does not succinctly discuss the risks and benefits of all options that are available.
His advocacy for a particular intervention from which he and his institution will benefit financially is a conflict that should have been disclosed. Both he and his institution are opening themselves to liability should problems be encountered.
Conclusion
Improving the informed consent process must include efforts to assist both patients and professionals. For patients, the inclusion of patient advocates during informed consent discussions may facilitate understanding of complex issues, therefore enhancing transparency. For professionals, training in the moral, ethical and legal dimensions for obtaining informed consent, as well as pragmatic communication skills can improve processes, safety and quality and reduce institutional risks.
There are unique challenges in obtaining informed consent that represent real opportunities for improvements in quality and safety. These improvements can substantially reduce institutional liability and enhance comprehensive enterprise risk management. Obtaining informed consent has everything to do with honor and privilege and mutual respect and about living up to the covenant. Patients, healthcare professionals and institutions all stand to gain.
About DAN COHEN
Dr Dan Cohen was formerly chief medical officer and executive medical director for the US Department of Defense health plan that provides or purchases healthcare services for more than nine million beneficiaries worldwide. As director, Office of the Chief Medical Officer, Cohen was responsible for important aspects of oversight for clinical quality, patient safety, population health and medical management initiatives across this comprehensive system. He trained in pediatrics and hematology/oncology at the Boston Medical Center, Boston University and the Boston Children’s Hospital, Dana Farber Cancer Institute, Harvard Medical School. He is a Senior Fellow of the Royal College of Paediatrics and Child Health and a Fellow of the American Academy of Pediatrics. He retains a faculty appointment in the Department of Pediatrics at the Uniformed Services University of Health Sciences School of Medicine, Bethesda, Maryland, US where he once served as dean for student development. He can be contacted at: dcohen@datixusa.com
Monkey Business Images / shutterstock.com
Monkey Business Images / shutterstock.com
Dr Dan Cohen, Datix, US, Risk Management
