Informed Consent & Shared Decision Making - What patients like you and I want to know
~ by John T. James, member of the Patient Council
In many states informed consent is legally defined in terms of what a reasonable patient wishes to know; however, that remains undefined for a situation where a patient faces a possible invasive procedure, but wishes to make a fully informed decision and maintain control of what happens to him or her. My colleagues and I developed a 10-question survey that we administered to nursing students, mature health-professions educators and ordinary people across the U.S.
My colleagues and I affirmed that a reasonable patient would want to know far more information than is generally conveyed during typical shared-decision making and informed consent. Survey respondents wanted to know risks and benefits of all treatment options, the risks and benefits of off-label and box-warning drugs. They wished to view decision aids, know precisely who will perform their procedure, and their anticipated out-of-pocket costs. Their desire was for an advocate to be present during shared-decision making, have periodic opportunities to review their medical record, have a full day to review informed-consent documents, and to be made aware of expected outcomes and restrictions after the procedure (including the risk of infection). We expect our findings to have implications for what defines a reasonable-patient standard for informed consent.
I am offering this information to our RCA Patient Council members, especially those who may be anticipating an invasive medical procedure, so that you may better understand the questions that should be asked and the insights needed to optimize your care (Table 2). You will surely benefit from knowing the important pieces of information about your procedure — “all treatment options, risky drugs, decision aids, who will perform the procedure, and the cost” — before the surgery. The paper is open access, so anyone may read it here (link will open a PDF in a new browser tab).