Background: Written informed consent is not obtained uniformly for invasive medical procedures in critically ill patients across America. The general consent-to-treat is used by some institutions in lieu of separate, procedure-by-procedure consent.
Objectives: To determine whether hospitalized patients recall the general consent-to-treat and to ascertain their preferences regarding informed consent for invasive medical procedures.
Methods: A questionnaire was administered to patients admitted to a 325-bed community teaching hospital.
Results: Of 265 patients who participated in the study, only 8% correctly recalled all of the elements of the general consent-to-treat. One hundred twelve respondents (42.3%) trusted their doctors to perform necessary medical procedures, "as long as they were told what was going to happen and why the medical procedure was needed." These patients were older (67 vs 62 years, P = 0.02) and were less likely to hold college or advanced degrees (33% vs 44%, P = 0.04). One hundred fifty-three patients wanted to know the important benefits, risks and alternatives, and to give written permission for performance of medical procedures. On further questioning, 29 (19%) of 153 patients responded that no medical procedure should be done without getting consent first. Forty-three (28%) thought procedures with complications in < 1% of cases should not require consent, while nine (6%) thought consent should be required at a threshold of 10% complications. One hundred patients (65%) responded that procedures with small and nonserious risks (i.e., IV's, bladder catheters) should not require separate written consent.
Conclusions: The general consent-to-treat is not recalled well by hospitalized patients and is unlikely to suffice as informed consent for invasive medical procedures. A majority of patients do not want to have invasive procedures without first giving their informed consent.