Redefining informed consent: What do patients want to know?

It is a patient’s right to be sufficiently informed before consenting to any invasive health tests or procedures. But what exactly does that entail? In half of the states in the U.S., informed consent is defined by law as giving any information that a “reasonable patient” would wish to know, which is itself a vague definition. How can we provide informed consent if we don’t fully understand what patients want to know? 

In a recent study in The BMJ Open, CEO of Patient Safety America and Right Care Alliance member John James and his research partners conducted a survey of several patient groups to better understand what patients want to know before making a significant treatment decision. 

They found that, overwhelmingly, patients want more information on the benefits and harms of all treatment options, including:

  • Whether there are alternative treatment options to invasive procedures, such as doing nothing;
  • Whether a drug has been prescribed off-label or has a black-box warning;
  • The names and experience levels of clinicians performing their procedure; 
  • The out-of-pocket costs of treatment options; and
  • Knowing the nature of the recovery process after any invasive procedure, including infection risk.

Patients also approved of having certain tools and supports available during treatment decisions, such as:

  • Having the use of decision aids during conversations;
  • Having a family member present to advocate for them;
  • Having a full day to think over the treatment options before signing anything (for non-emergency procedures); and
  • Having the option of reviewing their medical records and making entries.

To learn more about the study and discuss the findings, we asked John James a few questions.

Lown Institute: How did you first think of the idea for this study?
John James: I got the idea for this study because I was frustrated by bureaucratic hurdles in my attempts to improve patient rights. The Center for Medicare and Medicaid Services (CMS) simply did not want to listen to the voice of a patient advocate. I saw an article noting that half of the states (including my home state of Texas) had defined informed consent as the information a “reasonable patient” would want to know. To my knowledge, no one had defined that in a systematic and comprehensive way, so I thought that gaining more information about what patients want to know would be valuable.  

How did you find the research and collaboration process?   
The research was great fun, especially when the survey results came in showing great consistency in what patients want to know. It was like magic when the national survey was accomplished in 1-2 days and the data were compiled. My former NASA colleague, Bob Scully, and my other collaborator, Darwin Eakins, were great to work with. I have to say that the requirements of the reviewers and editors made the paper into a bit of a monster; it’s harder for a non-expert to read now than in its original form.  

Why do you believe that studies like this are so necessary?   
This sort of study is essential if the voice of patient is to be heard as health care is made more affordable and safer (hopefully). Physician-driven informed consent and patient-centered informed consent are miles apart. If we want a health care system that supports genuine informed consent and shared decision making, we have to move toward patient-centered definitions of informed consent.   

How do you think treatment decisions would change if patients received all the answers to the questions in the survey? How would the clinician-patient relationship change?  
I believe there would be fewer invasive procedures and that patients’ trust in their doctors (which has declined) would greatly improve. The cost of health care would diminish some as less invasive procedures are chosen. Care would also be safer because the patient would know that they are in control of what is done to their body and that they have a say in what is entered in their medical record. That responsibility would impel them to be make sure the delivery of care is safe.  I think doctors would eventually like this version of informed consent because it would encourage a closer and more humane relationship with each patient. However, time management for clinicians could be a challenge, given that it takes more time to ask and answer these questions and have a conversation about harms and benefits of treatment options.  

What’s next for your research and writing on this topic?  
My plan is to co-write an article with some lawyers for a major legal journal. The goal for this paper would be to inform lawyers about the improved definition of informed consent in terms of what a reasonable patient wants before an invasive procedure is undertaken.