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Issues related to the consent process factored in 242 CRICO malpractice claims filed from 1997–2006, naming 317 physicians and reflecting more than $81 million in incurred losses. Difficulties in the consent process often reflect broader problems in physician-patient communication. Even with appropriate care, this can lead to malpractice allegations in which the plaintiff may claim:

  1. I expected Dr. Jones to do my surgery, but it was some other doctor.

  2. I’m in worse shape now than before; if I had known, 
    I wouldn’t have had it done.

  3. During the procedure, they just went ahead and took it out without asking me.

  4. They came into my room right before I was about to go under and started telling me what might go wrong. It was too late for me to change my mind.

  5. Afterwards, I found out I could have had this treated without surgery.

  6. I couldn’t really understand what the doctor was saying, I just signed the paper.

  7. We had agreed to a c-section, then when I was in labor, my doctor said a vaginal delivery would be safer.

  8. Once I got the test results, the doctor wanted me to decide right then and there.

  9. They all talked to my wife, but I was the one who was sick.

  10. They never told me this could happen.

Our Recommendation

Last April, the Centers for Medicare and Medicaid Services (CMS) issued new guidelines [pdf] on informed consent. Hospitals that accept Medicare or Medicaid patients were immediately required to follow these guidelines, which amend prior CMS conditions of participation related to informed decisions, surgical services, and medical records. Of course, hospitals must also comply with any state requirements for informed consent.

The new guidelines increase pressure on hospitals to ensure (and document) that patients know and understand what to expect before undergoing a procedure. Their processes will be exposed to renewed scrutiny. While the focus will likely be on policies, training, and documentation, it is important to keep the fundamental purpose in mind:

  • every patient has the right to know enough to effectively participate in decisions about the diagnostic and treatment choices available (including no treatment), and

  • once a decision to proceed is made, the patient needs to know enough to prepare for all of the potential outcomes discussed.

As with all patient communication, doctors engaged in the consent process are likely to encounter issues related to literacy, mental competence/capacity, cultural differences, rights of minors, etc. To reach the point where the patient understands the appropriate information well enough to make an informed decision requires a commitment of time, patience, and the skill to know how much information is enough…or too much. Failing to respect the consent process can be reframed, in court, as failing to respect the patient, a perception that further complicates defending an allegation of malpractice.

Additional Materials

September 1, 2007
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