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Eight Common Procedures
The universal consent form described eight commonly performed procedures: placement of an arterial catheter, a central venous catheter, a pulmonary artery catheter, a peripherally inserted central catheter, lumbar puncture, thoracentesis (surgical puncture through the chest wall with drainage of fluid from the thoracic cavity), paracentesis (surgical puncture through the abdominal wall with drainage or aspiration of fluid from the abdominal cavity), and intubation/mechanical ventilation.
Another researcher who has studied consent forms extensively says the University of Chicago proposal may be well intended, but it seems to violate the spirit of the informed consent process. Melissa Bottrell, MPH, project manager at the National Center for Ethics in Healthcare at the Veterans Administration Puget Sound Health Care System in Seattle, says the universal consent form may solve a practical problem for clinicians but does not benefit the patient.
"It seems like they’re trying to put a solution on the problem without realizing what the real problem is," she says. "They’re saying they don’t get documentation of consent, so that’s in essence a legal problem, a lack of consent. So [they are] trying to solve that with this form, but I worry that the real effect is that they get a piece of paper without going through a true process of informed consent."
Bottrell points out that the situation may change significantly after the universal consent form is signed. The patient’s condition may worsen or improve, for instance, or relatives may simply change their minds about what should be done for the patient.
The University of Chicago researchers say they urge clinicians to consider such a change in circumstances and repeat the informed consent process if necessary, but Bottrell says she doesn’t think that would happen much in a real-world environment. Once the consent is obtained, she says, clinicians are unlikely to consider whether it is still valid. "Informed consent is about shared decision making," she says, "but having this form signed before there might be a change in the patient’s decision-making status, or a change in the patient’s condition that would affect that decision, essentially allows the clinician to opt out of that shared decision-making process because they already have documented consent.
"There is coercive power with the clinician in the ICU saying we might need to do these eight procedures and want you to sign off on them now," Bottrell continues. "It puts the patient in a situation in which it seems shared decision making will be less likely to happen rather than more likely, which is not the goal of a consent form in the first place. It solves some of the practical problems with obtaining consent, but it doesn’t fulfill the sprit of obtaining informed consent."
Bottrell notes that the proposed universal consent form differs in one important way from consent forms used up front for multiple procedures such as weekly dialysis treatment. In those situations, the patient’s condition is unlikely to change significantly during the period covered by the consent form, she says.
Other Consent Forms Also Can Be Faulty
Even the standard consent forms used more commonly in all health care settings might not be as good as you think. Bottrell’s previous research suggested that many of them amount to nothing more than a waste of time and may actually create more of a litigation problem than they could ever prevent. She and her colleagues were amazed at how poorly most informed consent forms achieve their goals. Bottrell says most of the forms are "a waste of paper. They’re worthless."
Bottrell and her colleagues recommend a wholesale revamping of the informed consent process so that it revolves around a worksheet that the patient and doctor can work through together.
Rather than anything resembling a legal document, the worksheet should be a form that they can use to facilitate a personal discussion about the medical treatment, with plenty of questions prompting the patient to respond. Questions could include phrasing such as "This is a reasonable decision for me because . . . " with the patient filling in the rest as a demonstration that he or she has been adequately informed.
She also suggests that the same list of eight common procedures used in the University of Chicago universal consent form could be used as a checklist to prompt clinicians during the informed consent process in the ICU. That would be a better solution than asking for universal consent up front, she says.
"The problem is they’re trying to solve the problem of obtaining consent in emergency situations by just showing proof of documentation," she says. "You could just as easily have the same conversation without necessarily having the form signed. If it’s true that the physician does anticipate a number of procedures, you can have that conversation and use the checklist to remember to check them off and talk about them. It can be good to address these issues up front all at once but not obtain consent."
1. Davis N, et al. Improving the process of informed consent in the critically ill. JAMA. 2003;289:1963-1968.
2. Bottrell MM, et al. Hospital informed consent for procedure forms: Facilitating quality patient interaction. Arch Surg. 2000;135:26-33.