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OBJECTIVE:

To characterize the informed consent process in routine, primary care office practice.

DESIGN:

Cross-sectional, descriptive evaluation of audiotaped encounters.

SETTING:

Offices of primary care physicians in Portland, Oregon.

PARTICIPANTS:

Internists (54%) and family physicians (46%), and their patients.

MEASUREMENTS AND MAIN RESULTS:

Audiotapes of primary care office visits from a previous study of doctor-patient communication were coded for the number and type of clinical decisions made. The discussion between doctor and patient was scored according to six criteria for informed decision making: description of the nature of the decision, discussion of alternatives, discussion of risks and benefits, discussion of related uncertainties, assessment of the patient’s understanding and elicitation of the patient’s preference. Discussions leading to decisions included fewer than two of the six described elements of informed decision making (mean 1.23, median 1.0), most frequent of these was description of the nature of the decision (83% of discussion). Discussion of risks and benefits was less frequent (9%), and assessment of understanding was rare (2%). Discussions of management decisions were generally more substantive than discussions of diagnostic decisions (p= .05).

CONCLUSIONS:

Discussions leading to clinical decisions in these primary care settings did not fulfill the criteria considered integral to informed decision making. Physicians frequently described the nature of the decision, less frequently discussed risks and benefits, and rarely assessed the patient’s understanding of the decision.

KEY WORDS: ethics, medical; informed consent; communication; physician-patient relationship; decision making.