Background: Informed consent forms should document and reflect the goals of informed consent and shared decision making. We conducted this study to examine the extent to which informed consent for procedure forms meet accepted informed consent standards, how well state informed consent statutes correlate with these standards, and whether existing forms can enhance the interactions between patients and physicians or other health care providers.
Hypothesis: Informed consent forms do not meet accepted standards. A different format may be more useful for patient-physician interactions.
Design: A content analysis was conducted of hospital informed consent for procedure forms from a random selection of hospitals in the 1994 American Hospital Association membership directory. Forms were examined for evidence of the basic elements of informed consent (nature of the procedure, risks, benefits, and alternatives) and items that might enhance patient-physician interactions and encourage shared decision making. UNIT OF ANALYSIS: From 157 hospitals nationwide, 540 hospital informed consent for procedure forms were examined.
Measurements and main results: Ninety-six percent of forms indicated the nature of the procedure, but risks, benefits, and alternatives were found less often. Only 26% of forms included all 4 basic elements, 35% included 3 of 4 elements, 23% had 2 of 4 elements, 14% had only 1 element, and 2% had none of the elements. Forms appear to authorize treatment (75%) or protect hospitals and caregivers from liability (59%) rather than clarify information about procedures (40%) or aid patients in decision making (14%). Forms from states with statutes that require that all 4 elements be provided were no more likely than other states to include them (Fisher exact test = 1.000). Fewer than 40% of forms supported models of shared decision making.
Conclusions: The content of most forms did not meet accepted standards of informed consent or patient-physician interactions. We propose a form that more fully supports the models of ideal informed consent and shared decision making to enhance the applicability of informed consent in the clinical setting.