This study coexamined the extent of discussion between physicians and patients leading to important clinical decisions in office practice. Important clinical decisions were common but were rarely preceded by substantive discussion. Discussion leading to clinical decisions tended to be more extensive for management decisions, particularly new prescriptions. The discussion of alternatives, risks and benefits, and uncertainty was also more common for management decisions.
Our definition of informed consent as informed decision making suggests that substantive discussions between doctors and patients should take place prior to a wide variety of clinical decisions. This study identifies the common clinical decisions in office practice for which such discussion would be important. This includes decisions regarding medications, diagnostic laboratory tests, and imaging studies. Decisions regarding office procedures that require a signed informed consent form, however, are rare. This suggests that applying a traditional concept of informed consent, often equated with written permission for invasive procedures, could result in missed opportunities to involve patients in the entire range of important clinical decisions in office practice.
The other important finding of this study is that discussions between physicians and patients leading to clinical decisions, so central to this broader concept of informed consent, typically included few of the important elements of informed decision making. Although one element, the description of the clinical decision, was discussed quite frequently, most discussions did not include the other elements of alternatives, risks and benefits, expression of uncertainty, assurance of understanding, and expression of patient preference. Discussion leading to management decisions tended to be more substantive, but still fell far short of fulfilling all these criteria. These findings suggest that informed decision making, as described by the President’s Commission and others, is not often achieved in routine office practice.
There are most likely several reasons for failure to achieve this ideal. First, one might ask if clinicians should engage in discussions that include all six elements of informed decision making before every clinical decision. Even a casual analysis of routine clinical practice suggests the answer is no, that extensive discussion is more important for some kinds of clinical decisions than for others. Although there is substantial evidence that patients generally want and expect to be involved in decision making, some authors have suggested that they would rather leave some decisions to physicians.24,25
Our study suggests that this kind of “sliding scale” for the extent of discussion leading to clinical decisions may already be an accepted tenet in medical practice. Physicians in this study typically held more extensive discussions about office procedures than about diagnostic laboratory tests. They were also more likely to discuss risks and benefits for new medication prescriptions than for imaging studies. Nevertheless, the findings of this study show that the importance of substantive discussion is underrecognized, even for clinical decisions recognized to be genuinely important, such as office procedures and new medication prescriptions. Furthermore, the ethical basis of informed consent, in our view, necessitates some level of discussion for virtually all clinical decisions.
The ethical purpose of informed consent is to foster the ability of patients to make informed, autonomous choices. Many bioethicists assert that the related ethical concepts of respect for autonomy and respect for persons entail a duty for physicians to provide the information necessary for the patient to be an informed participant in health care decisions.,2–4, ,18–20,26
As stated above, this concept of informed consent focuses on meaningful dialogue about virtually all decisions. Even fairly routine decisions, such as the decision to perform a routine blood test or electrocardiogram, need some form of dialogue to ensure the informed participation of the patient. As decisions become more important and complex, the level of dialogue needed becomes more extensive as well, leading to the comprehensive kinds of exchanges commonplace before invasive or risky surgical procedures.
Another reason physicians may not achieve the ideal level of informed consent is that they are too busy. Pressures to reduce the costs of care may be at odds with the need to spend more time in discussion with patients. Most clinicians presume the additional time needed for such discussion to be substantial, though this belief is untested.27
Insurers do not reimburse for extra time spent in lengthy discussions, though some authors have suggested that they should.3
Many health care systems are beginning to explore the use of other health care providers, support staff, and new interactive technologies in this process.7,28
Medical schools and residency training programs need to emphasize communication skills required to conduct brief, focused, yet comprehensive discussions leading to medical decisions.
A third reason clinicians may not fully discuss routine yet important medical decisions is a failure to recognize these decisions as warranting the same kind of attention to patient involvement as an invasive procedure. Perhaps this is a consequence of the inpatient-dominated training of physicians, in which important medical decisions are more likely to involve surgery or invasive procedures. As medical care moves increasingly into ambulatory settings, clinicians and educators need to expand their views of informed consent and recognize that seemingly routine clinical decisions deserve thoughtful discussion and sharing of decision making.
The findings of this study are consistent with those of previous studies of informed consent practices. Louis Harris and Associates evaluated physician self-reports of informed consent practices and found that although 96% of physicians routinely reported obtaining consent for surgical procedures, less than half did so for routine blood tests, diagnostic radiographs, or minor office procedures. Regarding disclosure, the physicians reported disclosing potential side effects 93% of the time, while patients reported receiving such information only 69% of the time.27
This gap highlights the weakness of evaluating physician practice with self-reporting. Although the difference could also be explained by imperfect patient recall, other studies suggest that physician self-evaluation tends to overestimate performance.29
Sulmasy and colleagues found that physician disclosure of information to patients undergoing routine medical procedures ranged from 90% for explaining the procedure to 53% for explaining the alternatives.12
This study has several strengths, one being the direct observation of physician behavior in discussions leading to routine clinical decisions. This has distinct advantages over indirect reports such as surveys or self-reports, which are susceptible to bias and problems with recall. Only a few studies of informed consent have used direct observation methods.,13–15
Lidz and Meisel studied informed consent practices for inpatient and outpatient surgery and cardiology patients, using a participant observer method. They directly observed interactions between physicians and 43 cardiology and 58 surgical patients. Through analysis of field notes and audiotapes, they found that information disclosure tended to be more formal and complete during inpatient consent than outpatient. In a limited analysis of 15 outpatient clinical decisions, however, they observed that patient involvement in decision making was more extensive in the outpatient setting.16
Our study used similar techniques to Lidz and Meisel, though on a much larger sample of outpatients and a much broader range of clinical decisions.
Wu and Pearlman evaluated communication surrounding informed consent for inpatient medical procedures, using direct observation. They found that although the rationale for the procedures was discussed frequently, the alternatives, risks, and benefits were discussed significantly less often.15
Still, their study concentrated on inpatient practice, and on medical procedures. Our study, by contrast, applies a direct observation approach to the full range of outpatient clinical decisions, a distinct strength.
Some possible limitations of this study should be addressed. One limitation of audiotapes is the inability to capture nonverbal communication. Because the analysis of discussion in our study focused mostly on information exchange, however, this is of less importance. Many authorities in doctor-patient communication assert that nonverbal communication is felt to be more important for social and emotional support in the doctor-patient encounter than for information exchange.30
Second, discussion leading to decisions may have taken place during other visits, resulting in an underestimation of the extent of physician-patient discussion related to a given decision. Furthermore, physicians and patients may have already established a method of decision making, in which a low level of information exchange might represent an acceptable norm to each. In an effort to ascertain the extent of this problem, we compared discussions related to decisions to prescribe a new medication with decisions concerning renewal of a medication. Our thinking was that new medication prescriptions represent an example of decisions that were not likely to be discussed in previous visits. We found no evidence that discussions for new medications were any more substantive, even though one might expect more detailed conversations, including intended benefits and side effects.
Because we used a new method for analyzing and coding the audiotaped office visits, the reliability of this method must be closely examined. We believe our method to be valid and reliable. Our method quantitates certain clear, identifiable verbal behaviors, hence meeting important criteria for communication analysis. The interobserver agreement in coding of 77% was well within the range of 70% to 90% that is typical for audiotape coding methods.30
The physicians studied were volunteers in a study of communication skills and may not have been representative of physicians in general. If anything, we suspect they would have engaged in more extensive discussions than the average physician. Also, the participants did not know that their performance relative to informed decision making was being evaluated.
In summary, we found that numerous decisions are made in each office visit, and often involve medications and diagnostic tests. Despite the recognized need to involve patients in these decisions, discussions leading up to routine clinical decisions were lacking in several important elements of informed decision making. Our findings suggest the need for larger, longitudinal studies of informed decision making practices, to further characterize factors that influence the extent of dialogue between physicians and patients and to test strategies to yield improvement.