Andrew Beck, BA

The cornerstones of American medical ethics include respect for patient autonomy and beneficence. Although informed consent is required for surgical procedures and transfusion of blood products, the overwhelming majority of medical treatments administered by physicians to hospitalized patients are given without discussing risks, benefits, and alternatives. Although patients may sign a general permission‐to‐treat form on admission to the hospital, informed consent for medical treatments is generally ad hoc, and there are no national standards or mandates. We hypothesized that given the choice, hospitalized patients would want to participate in informed decision making, especially for therapies associated with substantial risks and benefits.

METHODS

The Institutional Review Board of Bridgeport Hospital approved this study. Each day between June and August 2006, the hospital's admitting department provided investigators with a list that included names and locations of all patients admitted to the Department of Medicine inpatient service. All the patients were eligible for participation in the study. Patients were excluded if they were in a comatose state, were encephalopathic, or were judged to be severely demented. In addition, patients were assessed during the scripted intervention to ascertain whether they had the capacity to make informed decisions based on their ability: (a) to understand the presented information, (b) to consider the information in relation to their personal values, and (c) to communicate their wishes. If personnel doubted an individual's capacity in any of these 3 areas, they were not included in the study.

Study personnel read directly from the script (see Appendix) and recorded answers. Study personnel were permitted to reread questions but did not provide additional guidance beyond the questionnaire. Patients whose primary language was not English were interviewed through in‐house or 3‐way telephone (remote) translators.

Statistical analyses included the chi‐square test to examine responses across the 3 categories of answers (ie, always consent, qualified consent, waive consent) and simple comparisons of percentages. A P value < .05 was considered statistically significant.

RESULTS

A total of 634 patients were admitted to the medicine service during the study period June‐August 2006. Of these, 158 were judged to lack sufficient capacity by study personnel and were excluded from the study. Ninety‐five refused to participate, and 171 were discharged before the questionnaire could be administered. Two hundred and ten patients answered the questionnaire. They ranged in age from 18 to 96 years (mean age standard error, 63.3 1.1 years). One hundred and three (49%) were men, and 107 (51%) were women. A majority (67.5%) were white, 20% (42) were African American, and 11.9% (25) were Hispanic. Most (87.6%) had at least a high school education, and 35% had a college‐/graduate‐level education. Sixty‐seven percent had at least 2 comorbid conditions in addition to their principal reason for hospitalization. Their average acute physiology and chronic health care evaluation (APACHE II) score was 7.5 0.3 (median 7; range 0‐22).

Figure 1 shows the distribution of answers to each of the 4 questions.

Figure 1

DISCUSSION

The principal finding of this study is that most medical patients prefer to participate in making decisions about their medical care during acute hospitalization, even for relatively low‐risk treatments like potassium supplementation and administration of diuretics. Very few patients were prepared to waive consent and grant their physicians the absolute right to administer therapies such as thrombolysis, even if the risk of bleeding was estimated to be less than 5%. Whereas the elderly patients were less likely to prefer being asked to consent to treatments than were younger patients, most would want to be informed of even trivial therapies if time allowed.

In some situations older patients (65 years old) were more likely than younger patients (<65 years old) to allow their physicians to make unilateral decisions regarding their health care. This could be explained by those age 65 and older having grown up when physician paternalism was more prevalent in American medicine. In the 1970s physician paternalism waned, and respect for patient autonomy emerged as the dominant physicianpatient model. Patients who became adults after 1970 know only this relationship with their physician, and so it makes sense that they would be more inclined to prefer a participatory model.

These data complement and extend a series of studies we conducted with patients admitted to Bridgeport Hospital. Our data suggest that our patients wish to consent for end‐of‐life decisions,1, 2 invasive procedures,3 and, now, to be apprised of medical therapies administered during hospitalization. At the same time, we have found that consent practices at many centers are not consistent with these patient predilections.1, 2, 4 Our study suffered from having a small sample size obtained in one geographic location; so results should be generalized cautiously. Nonetheless, insofar as the expectations of patients for participation are not being met by the health care system in Connecticut (and we suspect elsewhere), clinicians, hospital administrators, and health care policy makers might consider whether more rigorous and explicit consent practices and policies are required. Another important limitation of the study was that patients included may not have entirely understood the implications of their answers (ie, how cumbersome to the system and bothersome to the patient seeking consent for every therapy could become). In fact, we cannot be certain that all patients truly understood the questions, some of which were complex. Nonetheless, these results support that considered in the abstract, most patients prefer to consent for medical therapies. Had the implications for safety and expediency been explained in detail, it is possible that patients would have waived the need to give consent for treatments with minimal risk. The questionnaire also presents an abbreviated list of risks and benefits for each intervention, and although it refers to the formal process of informed consent in its preamble, it uses terminology (ie, permission) that may not reflect the complexity of informed consent. Nonetheless, our goal was to examine the degree to which patients wished to participate in their medical decision making. Notwithstanding these weaknesses of the survey instrument, the data suggest patients want to be in the loop whenever possible.

There are no national standards of consent for medical treatments. The Veterans' Administration, which has led the way in many areas of patients' rights, has a policy:

Compliance with this standard (ie, consent for every new medication) is not routine in most acute care hospitals. Although some clinicians obtain formal consent for high‐risk therapies (perhaps out of respect for autonomy, perhaps to reduce medical‐legal liability), there are no explicit decision rules to guide clinicians regarding for which treatments they should obtain formal consent. Accordingly, some might obtain formal consent for thrombolysis for massive pulmonary embolus, and others might not. It is not clear that the consent‐to‐treat form signed during hospital admission would legally cover all medical therapies during hospitalization. The legal standard for informed consent is what any reasonable patient would want to consent for. Our data suggest that most reasonable patients wish to at least assent and perhaps consent for much of what they receive during hospitalization. Although we have been unable to find case law predicated entirely on failure to obtain consent prior to administration of a therapy that caused a complication, it is plausible that the reasonable patient standard could be used in this manner. Regardless, it is impractical to require consent for the thousands of medical therapies administered each day in hospitals. Requiring consent for all therapies, if respected rigidly, would threaten the safety and efficiency of American hospitals. Naturally, a balance betweem respect for autonomy, that is, informed consent for the riskiest therapies, and efficiency is necessary. Explicit guidelines issued by accrediting agencies or the federal government would be helpful. The rules for consent (and/or assent) should be more explicit and less arbitrary, that is, determined independently by each clinician.

In conclusion, these data demonstrate that when considered in the abstract, that is, without explaining the logistical hurdles that it would create, inpatients wish to participate in decision making for both low‐ and high‐risk treatments. Clinicians are faced with demands and obligations that preclude full consent for the myriad low‐risk treatments administered daily to hospitalized patients. Some treatments are likely to be covered implicitly under the general consent‐to‐treat process and paperwork. Nonetheless, clinicians should consider explaining the principal risks and benefits of moderate‐risk treatments in order to secure informed assent. Full informed consent may be most appropriate for very high‐risk therapies. Patients expect and deserve frequent communication with caregivers that balances their safety with their right to self‐determination.

The cornerstones of American medical ethics include respect for patient autonomy and beneficence. Although informed consent is required for surgical procedures and transfusion of blood products, the overwhelming majority of medical treatments administered by physicians to hospitalized patients are given without discussing risks, benefits, and alternatives. Although patients may sign a general permission‐to‐treat form on admission to the hospital, informed consent for medical treatments is generally ad hoc, and there are no national standards or mandates. We hypothesized that given the choice, hospitalized patients would want to participate in informed decision making, especially for therapies associated with substantial risks and benefits.

METHODS

The Institutional Review Board of Bridgeport Hospital approved this study. Each day between June and August 2006, the hospital's admitting department provided investigators with a list that included names and locations of all patients admitted to the Department of Medicine inpatient service. All the patients were eligible for participation in the study. Patients were excluded if they were in a comatose state, were encephalopathic, or were judged to be severely demented. In addition, patients were assessed during the scripted intervention to ascertain whether they had the capacity to make informed decisions based on their ability: (a) to understand the presented information, (b) to consider the information in relation to their personal values, and (c) to communicate their wishes. If personnel doubted an individual's capacity in any of these 3 areas, they were not included in the study.

Study personnel read directly from the script (see Appendix) and recorded answers. Study personnel were permitted to reread questions but did not provide additional guidance beyond the questionnaire. Patients whose primary language was not English were interviewed through in‐house or 3‐way telephone (remote) translators.

Statistical analyses included the chi‐square test to examine responses across the 3 categories of answers (ie, always consent, qualified consent, waive consent) and simple comparisons of percentages. A P value < .05 was considered statistically significant.

RESULTS

A total of 634 patients were admitted to the medicine service during the study period June‐August 2006. Of these, 158 were judged to lack sufficient capacity by study personnel and were excluded from the study. Ninety‐five refused to participate, and 171 were discharged before the questionnaire could be administered. Two hundred and ten patients answered the questionnaire. They ranged in age from 18 to 96 years (mean age standard error, 63.3 1.1 years). One hundred and three (49%) were men, and 107 (51%) were women. A majority (67.5%) were white, 20% (42) were African American, and 11.9% (25) were Hispanic. Most (87.6%) had at least a high school education, and 35% had a college‐/graduate‐level education. Sixty‐seven percent had at least 2 comorbid conditions in addition to their principal reason for hospitalization. Their average acute physiology and chronic health care evaluation (APACHE II) score was 7.5 0.3 (median 7; range 0‐22).

Figure 1 shows the distribution of answers to each of the 4 questions.

Figure 1

DISCUSSION

The principal finding of this study is that most medical patients prefer to participate in making decisions about their medical care during acute hospitalization, even for relatively low‐risk treatments like potassium supplementation and administration of diuretics. Very few patients were prepared to waive consent and grant their physicians the absolute right to administer therapies such as thrombolysis, even if the risk of bleeding was estimated to be less than 5%. Whereas the elderly patients were less likely to prefer being asked to consent to treatments than were younger patients, most would want to be informed of even trivial therapies if time allowed.

In some situations older patients (65 years old) were more likely than younger patients (<65 years old) to allow their physicians to make unilateral decisions regarding their health care. This could be explained by those age 65 and older having grown up when physician paternalism was more prevalent in American medicine. In the 1970s physician paternalism waned, and respect for patient autonomy emerged as the dominant physicianpatient model. Patients who became adults after 1970 know only this relationship with their physician, and so it makes sense that they would be more inclined to prefer a participatory model.

These data complement and extend a series of studies we conducted with patients admitted to Bridgeport Hospital. Our data suggest that our patients wish to consent for end‐of‐life decisions,1, 2 invasive procedures,3 and, now, to be apprised of medical therapies administered during hospitalization. At the same time, we have found that consent practices at many centers are not consistent with these patient predilections.1, 2, 4 Our study suffered from having a small sample size obtained in one geographic location; so results should be generalized cautiously. Nonetheless, insofar as the expectations of patients for participation are not being met by the health care system in Connecticut (and we suspect elsewhere), clinicians, hospital administrators, and health care policy makers might consider whether more rigorous and explicit consent practices and policies are required. Another important limitation of the study was that patients included may not have entirely understood the implications of their answers (ie, how cumbersome to the system and bothersome to the patient seeking consent for every therapy could become). In fact, we cannot be certain that all patients truly understood the questions, some of which were complex. Nonetheless, these results support that considered in the abstract, most patients prefer to consent for medical therapies. Had the implications for safety and expediency been explained in detail, it is possible that patients would have waived the need to give consent for treatments with minimal risk. The questionnaire also presents an abbreviated list of risks and benefits for each intervention, and although it refers to the formal process of informed consent in its preamble, it uses terminology (ie, permission) that may not reflect the complexity of informed consent. Nonetheless, our goal was to examine the degree to which patients wished to participate in their medical decision making. Notwithstanding these weaknesses of the survey instrument, the data suggest patients want to be in the loop whenever possible.

There are no national standards of consent for medical treatments. The Veterans' Administration, which has led the way in many areas of patients' rights, has a policy:

Compliance with this standard (ie, consent for every new medication) is not routine in most acute care hospitals. Although some clinicians obtain formal consent for high‐risk therapies (perhaps out of respect for autonomy, perhaps to reduce medical‐legal liability), there are no explicit decision rules to guide clinicians regarding for which treatments they should obtain formal consent. Accordingly, some might obtain formal consent for thrombolysis for massive pulmonary embolus, and others might not. It is not clear that the consent‐to‐treat form signed during hospital admission would legally cover all medical therapies during hospitalization. The legal standard for informed consent is what any reasonable patient would want to consent for. Our data suggest that most reasonable patients wish to at least assent and perhaps consent for much of what they receive during hospitalization. Although we have been unable to find case law predicated entirely on failure to obtain consent prior to administration of a therapy that caused a complication, it is plausible that the reasonable patient standard could be used in this manner. Regardless, it is impractical to require consent for the thousands of medical therapies administered each day in hospitals. Requiring consent for all therapies, if respected rigidly, would threaten the safety and efficiency of American hospitals. Naturally, a balance betweem respect for autonomy, that is, informed consent for the riskiest therapies, and efficiency is necessary. Explicit guidelines issued by accrediting agencies or the federal government would be helpful. The rules for consent (and/or assent) should be more explicit and less arbitrary, that is, determined independently by each clinician.

In conclusion, these data demonstrate that when considered in the abstract, that is, without explaining the logistical hurdles that it would create, inpatients wish to participate in decision making for both low‐ and high‐risk treatments. Clinicians are faced with demands and obligations that preclude full consent for the myriad low‐risk treatments administered daily to hospitalized patients. Some treatments are likely to be covered implicitly under the general consent‐to‐treat process and paperwork. Nonetheless, clinicians should consider explaining the principal risks and benefits of moderate‐risk treatments in order to secure informed assent. Full informed consent may be most appropriate for very high‐risk therapies. Patients expect and deserve frequent communication with caregivers that balances their safety with their right to self‐determination.

The cornerstones of American medical ethics include respect for patient autonomy and beneficence. Although informed consent is required for surgical procedures and transfusion of blood products, the overwhelming majority of medical treatments administered by physicians to hospitalized patients are given without discussing risks, benefits, and alternatives. Although patients may sign a general permission‐to‐treat form on admission to the hospital, informed consent for medical treatments is generally ad hoc, and there are no national standards or mandates. We hypothesized that given the choice, hospitalized patients would want to participate in informed decision making, especially for therapies associated with substantial risks and benefits.

METHODS

The Institutional Review Board of Bridgeport Hospital approved this study. Each day between June and August 2006, the hospital's admitting department provided investigators with a list that included names and locations of all patients admitted to the Department of Medicine inpatient service. All the patients were eligible for participation in the study. Patients were excluded if they were in a comatose state, were encephalopathic, or were judged to be severely demented. In addition, patients were assessed during the scripted intervention to ascertain whether they had the capacity to make informed decisions based on their ability: (a) to understand the presented information, (b) to consider the information in relation to their personal values, and (c) to communicate their wishes. If personnel doubted an individual's capacity in any of these 3 areas, they were not included in the study.

Study personnel read directly from the script (see Appendix) and recorded answers. Study personnel were permitted to reread questions but did not provide additional guidance beyond the questionnaire. Patients whose primary language was not English were interviewed through in‐house or 3‐way telephone (remote) translators.

Statistical analyses included the chi‐square test to examine responses across the 3 categories of answers (ie, always consent, qualified consent, waive consent) and simple comparisons of percentages. A P value < .05 was considered statistically significant.

RESULTS

A total of 634 patients were admitted to the medicine service during the study period June‐August 2006. Of these, 158 were judged to lack sufficient capacity by study personnel and were excluded from the study. Ninety‐five refused to participate, and 171 were discharged before the questionnaire could be administered. Two hundred and ten patients answered the questionnaire. They ranged in age from 18 to 96 years (mean age standard error, 63.3 1.1 years). One hundred and three (49%) were men, and 107 (51%) were women. A majority (67.5%) were white, 20% (42) were African American, and 11.9% (25) were Hispanic. Most (87.6%) had at least a high school education, and 35% had a college‐/graduate‐level education. Sixty‐seven percent had at least 2 comorbid conditions in addition to their principal reason for hospitalization. Their average acute physiology and chronic health care evaluation (APACHE II) score was 7.5 0.3 (median 7; range 0‐22).

Figure 1 shows the distribution of answers to each of the 4 questions.

Figure 1

DISCUSSION

The principal finding of this study is that most medical patients prefer to participate in making decisions about their medical care during acute hospitalization, even for relatively low‐risk treatments like potassium supplementation and administration of diuretics. Very few patients were prepared to waive consent and grant their physicians the absolute right to administer therapies such as thrombolysis, even if the risk of bleeding was estimated to be less than 5%. Whereas the elderly patients were less likely to prefer being asked to consent to treatments than were younger patients, most would want to be informed of even trivial therapies if time allowed.

In some situations older patients (65 years old) were more likely than younger patients (<65 years old) to allow their physicians to make unilateral decisions regarding their health care. This could be explained by those age 65 and older having grown up when physician paternalism was more prevalent in American medicine. In the 1970s physician paternalism waned, and respect for patient autonomy emerged as the dominant physicianpatient model. Patients who became adults after 1970 know only this relationship with their physician, and so it makes sense that they would be more inclined to prefer a participatory model.

These data complement and extend a series of studies we conducted with patients admitted to Bridgeport Hospital. Our data suggest that our patients wish to consent for end‐of‐life decisions,1, 2 invasive procedures,3 and, now, to be apprised of medical therapies administered during hospitalization. At the same time, we have found that consent practices at many centers are not consistent with these patient predilections.1, 2, 4 Our study suffered from having a small sample size obtained in one geographic location; so results should be generalized cautiously. Nonetheless, insofar as the expectations of patients for participation are not being met by the health care system in Connecticut (and we suspect elsewhere), clinicians, hospital administrators, and health care policy makers might consider whether more rigorous and explicit consent practices and policies are required. Another important limitation of the study was that patients included may not have entirely understood the implications of their answers (ie, how cumbersome to the system and bothersome to the patient seeking consent for every therapy could become). In fact, we cannot be certain that all patients truly understood the questions, some of which were complex. Nonetheless, these results support that considered in the abstract, most patients prefer to consent for medical therapies. Had the implications for safety and expediency been explained in detail, it is possible that patients would have waived the need to give consent for treatments with minimal risk. The questionnaire also presents an abbreviated list of risks and benefits for each intervention, and although it refers to the formal process of informed consent in its preamble, it uses terminology (ie, permission) that may not reflect the complexity of informed consent. Nonetheless, our goal was to examine the degree to which patients wished to participate in their medical decision making. Notwithstanding these weaknesses of the survey instrument, the data suggest patients want to be in the loop whenever possible.

There are no national standards of consent for medical treatments. The Veterans' Administration, which has led the way in many areas of patients' rights, has a policy:

Compliance with this standard (ie, consent for every new medication) is not routine in most acute care hospitals. Although some clinicians obtain formal consent for high‐risk therapies (perhaps out of respect for autonomy, perhaps to reduce medical‐legal liability), there are no explicit decision rules to guide clinicians regarding for which treatments they should obtain formal consent. Accordingly, some might obtain formal consent for thrombolysis for massive pulmonary embolus, and others might not. It is not clear that the consent‐to‐treat form signed during hospital admission would legally cover all medical therapies during hospitalization. The legal standard for informed consent is what any reasonable patient would want to consent for. Our data suggest that most reasonable patients wish to at least assent and perhaps consent for much of what they receive during hospitalization. Although we have been unable to find case law predicated entirely on failure to obtain consent prior to administration of a therapy that caused a complication, it is plausible that the reasonable patient standard could be used in this manner. Regardless, it is impractical to require consent for the thousands of medical therapies administered each day in hospitals. Requiring consent for all therapies, if respected rigidly, would threaten the safety and efficiency of American hospitals. Naturally, a balance betweem respect for autonomy, that is, informed consent for the riskiest therapies, and efficiency is necessary. Explicit guidelines issued by accrediting agencies or the federal government would be helpful. The rules for consent (and/or assent) should be more explicit and less arbitrary, that is, determined independently by each clinician.

In conclusion, these data demonstrate that when considered in the abstract, that is, without explaining the logistical hurdles that it would create, inpatients wish to participate in decision making for both low‐ and high‐risk treatments. Clinicians are faced with demands and obligations that preclude full consent for the myriad low‐risk treatments administered daily to hospitalized patients. Some treatments are likely to be covered implicitly under the general consent‐to‐treat process and paperwork. Nonetheless, clinicians should consider explaining the principal risks and benefits of moderate‐risk treatments in order to secure informed assent. Full informed consent may be most appropriate for very high‐risk therapies. Patients expect and deserve frequent communication with caregivers that balances their safety with their right to self‐determination.