Hospital informed consent for procedure forms - Facilitating quality patient-physician interaction

Background: Informed consent forms should document and reflect the goals of informed consent and shared decision making. We conducted this study to ex amine the extent to which informed consent for procedure forms meet accepte d informed consent standards, how well state informed consent statutes corr elate with these standards, and whether existing forms can enhance the inte ractions between patients and physicians or other health care providers. Hypothesis: Informed consent forms do not meet accepted standards. A differ ent format may be more useful for patient-physician interactions. Design: A content analysis was conducted of hospital informed consent for p rocedure forms from a random selection of hospitals in the 1994 American Ho spital Association membership directory. Forms were examined for evidence o f the basic elements of informed consent (nature of the procedure, risks, b enefits, and alternatives) and items that might enhance patient-physician i nteractions and encourage shared decision making. Unit of Analysis: From 157 hospitals nationwide, 540 hospital informed cons ent for procedure forms were examined. Measurements and Main Results: Ninety-six percent of forms indicated the na ture of the procedure, but risks, benefits, and alternatives were found les s 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 no ne of the elements. Forms appear to authorize treatment (75%) or protect ho spitals and caregivers from liability (59%) rather than clarify information about procedures (40%) or aid patients in decision making (14%). Forms fro m 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 i nformed consent or patient-physician interactions. We propose a form that m ore fully supports the models of ideal informed consent and shared decision making to enhance the applicability of informed consent in the clinical se tting.