Kathleen M. Mazor, EdD; Steven R. Simon, MD; Robert A. Yood, MD; Brian C. Martinson, PhD; Margaret J. Gunter, PhD; George W. Reed, PhD; Jerry H. Gurwitz, MD
Acknowledgments: The authors thank Andrew Giese and Ryan Tappin for technical assistance and Maureen Mondor and Patricia O'Mara for their support.
Grant Support: By the HMO Research Network Center for Education and Research on Therapeutics (CERTs) (AHRQ U18HS10391-01), the HMO Research Network CERTs Prescribing Safety Program (AHRQ U18HS11843-01), the National Patient Safety Foundation and the Commonwealth Fund (20030288) (Drs. Mazor and Gurwitz), and a Morgan–Zinsser Fellowship from the Academy at Harvard Medical School (Dr. Simon).
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Kathleen M. Mazor, EdD, Meyers Primary Care Institute, 630 Plantation Street, Worcester, MA 01605.
Current Author Addresses: Drs. Mazor, Yood, and Gurwitz: Meyers Primary Care Institute, 630 Plantation Street, Worcester, MA 01605.
Dr. Simon: Harvard Medical School and Harvard Pilgrim Health Care, 133 Brookline Avenue, Sixth Floor, Boston, MA 02215.
Dr. Martinson: HealthPartners Research Foundation, 8100 34th Avenue South, PO Box 1524, Minneapolis, MN 55440-1524.
Dr. Gunter: Lovelace Clinic Foundation, 2309 Renard Place SE, Suite 103-B, Albuquerque, NM 87106.
Dr. Reed: Preventive and Behavioral Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01655.
Author Contributions: Conception and design: K.M. Mazor, S.R. Simon, R.A. Yood, B.C. Martinson, M.J. Gunter, G.W. Reed, J.H. Gurwitz.
Analysis and interpretation of the data: K.M. Mazor, S.R. Simon, R.A. Yood, B.C. Martinson, M.J. Gunter, G.W. Reed, J.H. Gurwitz.
Drafting of the article: K.M. Mazor, J.H. Gurwitz.
Critical revision of the article for important intellectual content: K.M. Mazor, S.R. Simon, R.A. Yood, B.C. Martinson, G.W. Reed, J.H. Gurwitz.
Final approval of the article: K.M. Mazor, S.R. Simon, R.A. Yood, B.C. Martinson, M.J. Gunter, G.W. Reed, J.H. Gurwitz.
Provision of study materials or patients: K.M. Mazor.
Statistical expertise: G.W. Reed.
Obtaining of funding: K.M. Mazor.
Collection and assembly of data: K.M. Mazor.
Mazor K., Simon S., Yood R., Martinson B., Gunter M., Reed G., Gurwitz J.; Health Plan Members' Views about Disclosure of Medical Errors. Ann Intern Med. 2004;140:409-418. doi: 10.7326/0003-4819-140-6-200403160-00006
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Published: Ann Intern Med. 2004;140(6):409-418.
Appendix: Vignettes and Dialogues
Disclosing medical errors is ethically appropriate, but its effect on the doctor–patient relationship and the likelihood of patients seeking legal advice is unknown.
Clinical vignettes and questionnaires assessing patient opinion were mailed to members of a health maintenance organization. Each vignette varied the type of error, its severity, and the completeness of error disclosure. Respondents indicated that full disclosure improved trust, satisfaction, and emotional response. Decisions to seek legal advice were complex and were not necessarily deflected by full disclosure.
While full disclosure improved patient satisfaction, it did not prevent or increase the likelihood of seeking legal advice.
Since the publication of the Institute of Medicine's report, “To Err Is Human” (1), the problem of medical errors has gained increased recognition by the general public (2). Researchers and policymakers have begun to focus serious efforts on improving patient safety (3-6), but the complexity and uncertainty inherent in the practice of medicine make it unlikely that medical errors will ever be eliminated completely. When medical errors occur, effective physician–patient communication is critical. Ethical and professional guidelines emphasize that physicians have a responsibility to disclose medical errors (7-9), and recent standards link disclosure of adverse events to hospital accreditation (10). There may also be pragmatic reasons for disclosure—patients who pursue litigation may be motivated by a desire for a full explanation of the adverse event (11-13), and patients may be less likely to sue physicians who provide full and honest explanations (14).
Although the preponderance of opinion is that disclosure is the right thing to do when a medical error has resulted in patient injury, disclosure often does not occur (15-20). Several articles (21-33) and continuing medical education materials developed by national organizations (34) offer guidance, but there is limited empirical literature related to disclosure of medical errors to patients or families (11-20, 35-41). Of these articles, most focused on whether disclosure occurred or would occur; few examined the disclosure process or the consequences of disclosure in any way. Thus, the lack of empirical research in this area may be a barrier to disclosure.
We therefore undertook a study to assess patients' views of disclosure. We surveyed a representative sample of members of a large health plan to measure responses to a set of 8 vignettes, each of which described a medical error, the clinical outcome of the error, and a physician–patient dialogue about the event. The goals of the study were to examine the relationship of the error, severity of clinical outcome, and the level of disclosure to 5 dependent variables: likelihood of changing physicians, likelihood of seeking legal advice, patient satisfaction, trust, and emotional response. We also sought to determine patients' attitudes, beliefs, and preferences about medical errors and disclosure in general.
We conducted a mailed questionnaire survey of 1500 members of a New England–based health maintenance organization. Member names were randomly sampled from a master list of all health plan members 21 to 85 years of age (n= 130 009). Selected members were sent a letter indicating that they would be receiving the questionnaire, followed approximately 1 week later by the questionnaire. A $5 cash incentive was enclosed with the questionnaire. Nonrespondents were sent a reminder postcard 1 week later and a second copy of the questionnaire 1 week after. The response rate was calculated as the number of usable completed surveys returned (958 surveys) divided by the number of mailed surveys (1500 surveys) minus the number of surveys returned by the mail service as undeliverable (47 surveys).
The study protocol was approved by the institutional review boards of the participating institutions.
The questionnaire was developed on the basis of a systematic review of the literature (11-20, 35-41) and the results of 2 focus groups comprising 14 patient volunteers. The questionnaire was refined after pretesting for length and comprehensibility.
The final questionnaire, which is available from the first author, consisted of 4 sections: 1) a vignette describing a medication error and the clinical outcome of the error, followed by a physician–patient dialogue about the error; 2) items assessing participants' response to the scenario and dialogue; 3) items assessing attitudes, beliefs, and preferences about medical error and disclosure in general; and 4) background and demographic items. Each section is described in detail in this paper.
Eight versions of the questionnaire were developed to produce a completely crossed factorial design with 2 levels each of the following variables: type of medication error (inadequate monitoring of antiepileptic medication vs. prescribing penicillin when penicillin allergy is documented), clinical outcome of the error (life-threatening outcome vs. less serious outcome), and level of physician disclosure about the error (nondisclosure with limited information and responsibility vs. full disclosure with high information, responsibility, and promise to prevent recurrences). Figure 1 summarizes the vignette and dialogue combinations comprising each condition, and the Appendix presents them in detail. Each participant received only 1 version; that is, a single error and outcome vignette with a corresponding dialogue wherein the physician and patient or family member discussed the error and its outcome. Distribution of versions was randomized.
Although most medical errors are considered systems errors (42) rather than the responsibility of individual providers, the actions of the treating physician may contribute to, or mitigate the results of, an error. Furthermore, the physician will often be considered—by the health care team and by the patient—to be the most appropriate person to speak to the patient or family after an error has occurred (43-45). We therefore chose vignettes in which the physician had direct involvement in the error and restricted our focus to the physician as communicator. These decisions were not intended to contradict the importance of a systems approach to patient safety or perpetuate a culture of blame, but rather to provide a starting point for study in this important area.
Three items were included to assess whether the vignettes were effective in communicating as intended; these items queried whether respondents perceived that an error had been made in each scenario and dialogue combination, whether the physician was perceived as responsible, and whether the error was perceived as preventable. Five response options were provided: “strongly disagree,” “disagree,” “agree,” “strongly agree,” and “don't know.”
Respondents were instructed to imagine themselves as the patient or family member in the vignette and dialogue and to respond accordingly. Two items, developed for this study, focused on behavior. Respondents were asked to indicate whether they would change physicians or seek legal advice. The same 5 response options mentioned earlier were provided. For the analysis, responses were recoded to be dichotomous, with “agree” or “strongly agree” responses compared with all others. Patient satisfaction was assessed by using 5 items drawn from the American Board of Internal Medicine Patient Satisfaction Questionnaire (46). Trust in the physician was assessed by using 8 items drawn from the Trust in Physician Scale (47) plus 1 supplemental item (“This doctor seemed to be withholding important information.”). Item wording was modified slightly to refer to the vignette rather than a real encounter. Five semantic differential items were developed for this study to assess emotional response: “angry” or “calm,” “frightened” or “reassured,” “worried” or “relieved,” “wronged” or “respected,” and “dissatisfied” or “satisfied.” All were on a 5-point scale; the most positive response option (for example, “reassured”) was assigned a value of 5, and the most negative response option (for example, “worried”) was assigned a value of 1. The variable emotional response was computed as the mean across the 5 semantic differential items, with higher scores indicating a more positive emotional response.
A set of 9 items was developed on the basis of the focus group interviews and a review of the literature to measure attitudes and beliefs about medical errors and disclosure in general. Five response options were provided: “strongly disagree,” “disagree,” “neutral,” “agree,” and “strongly agree”. Nine items were developed to assess respondents' preferences for action after a medical error. These items were also based on the review of the literature on disclosure and were intended to directly assess preferences for commonly recommended responses to error (for example, “I would want to know the full details of how the error occurred.”). Again, 5 response options were provided: “strongly disagree,” “disagree,” “neutral,” “agree,” and “strongly agree.”
Final items queried personal experience with medical error or injury, history of having filed a lawsuit against a physician or other health care provider, sex, education, age, and race or ethnicity.
We compared background characteristics of respondents and nonrespondents by using a chi-square test for sex and a t-test for age. Associations between the 3 design variables (type of medication error, severity of clinical outcome, and level of disclosure) and the 2 dichotomously coded variables (likelihood of changing physicians and likelihood of seeking legal advice) were modeled by using logistic regression analysis. Odds ratios and 95% CIs were estimated. The association between design variables and patient satisfaction, trust, and emotional response was modeled by using linear regression analysis. Linear regression coefficients and 95% CIs were estimated. All regression analyses were conducted by evaluating 3 models: a main-effects model that included only the 3 design variables; an interaction model that included the 3 design variables plus all 2-way and 3-way interactions (where terms for 3-way interactions were not statistically significant, further analyses were conducted to test for statistically significant 2-way interactions); and a full model that included adjustment for age, sex, education, race or ethnicity, personal experience with errors and personal suffering due to errors in addition to the 3 design variables and any statistically significant design variable interactions determined by the interaction model.
Model-based means and percentages were estimated by setting other variables in the model to their mean values.
Chi-square tests were used to assess whether each of the design variables (type of error, severity of clinical outcome, and level of disclosure) influenced responses to the items intended to measure general attitudes, beliefs, and perceptions related to medical error, using a criterion value of a P value less than 0.01.
Statistical analyses were done with Stata software, version 8 (Stata Corp., College Station, Texas), and SPSS software, version 11.5 (SPSS, Inc., Chicago, Illinois).
The funding source had no role in the collection, analysis, or interpretation of the data or in the decision to submit the manuscript for publication.
A total of 958 completed usable questionnaires were returned, for a response rate of 66%. Table 1 presents the characteristics of survey respondents. Compared with nonrespondents, respondents were more likely to be female (57% of respondents were female, compared with 44.7% of nonrespondents; Pearson chi-square, 21.2; P< 0.001). Respondents were also older than nonrespondents (mean age for respondents, 51.9 years; nonrespondents, 45.0 years; t= 8.29; P< 0.001). Most respondents (91.6%) reported their race or ethnicity as white, which is consistent with the U.S. census statistics for this area for the year 2000, in which 89.6% of respondents identified themselves as white (48). With respect to education, 28.5% of respondents 25 years of age or older reported earning a 4-year college degree or higher compared with 27% of census respondents 25 years of age or older (48).
Almost one third of the sample (31.4%) reported personal experience of a medical error in their own treatment or that of a close family member, 12.1% reported having personally suffered an injury or harm as the result of a medical error, and 1.4% reported having filed a claim or lawsuit against a physician or other health care provider (Table 1). This rate of reporting personal experience with error is slightly lower than the rate reported by a national survey in which 42% of the public and 35% of physicians reported experience with an error in their own care or that of a family member (19).
The randomization of questionnaire versions resulted in groups that were balanced in terms of age, sex, education, race or ethnicity, and personal experience with errors and personal suffering due to errors (data not shown).
In response to the validation items, most respondents in all conditions agreed that the physician had made an error (95.8%), that the physician was at fault (88.8%), and that the incident could have been prevented (94.8%).
Figure 2 presents the observed data and Table 2 summarizes the results of the logistic regression analyses for patients' likelihood of changing physicians. All 3 independent variables, type of medication error (inadequate monitoring of antiepileptic medication vs. prescribing penicillin when penicillin allergy is documented), clinical outcome of the error (life-threatening outcome vs. less serious outcome), and level of physician disclosure about the error (nondisclosure with limited information and responsibility vs. full disclosure with high information, responsibility, and promise to prevent recurrences) were related to the likelihood of changing physicians. Nondisclosure, life-threatening outcome, and the inadequate monitoring error all increased the likelihood of changing physicians (Table 2). However, interpretation of the odds ratios for this model is complicated by the statistically significant 2-way interaction (error situation by clinical outcome, likelihood ratio test; P= 0.03). This suggests that the effect of the clinical outcome may vary depending on the error; we therefore constructed separate models for each error situation (Table 2). The results of these additional analyses suggest that while the effect of disclosure was similar in the 2 error situations studied here, clinical outcome had a somewhat greater effect in the missed allergy error situation compared with the monitoring error situation (odds ratios, 3.086 [95% CI, 2.10 to 4.53] vs. 1.724 [CI, 1.18 to 2.51], respectively).
Top. Numbers are percentages of respondents expressing agreement. Bottom. Numbers are mean ratings (1 = most negative response; 5 = most positive response).
Figure 2 reports the observed data and Table 2 reports the results of the logistic regression analyses for patients' likelihood of seeking legal advice. Overall, nondisclosure, life-threatening outcome, and the inadequate monitoring error were all associated with a higher likelihood of seeking legal advice (Table 2). However, a statistically significant 3-way interaction was found (likelihood ratio test vs. full model; P= 0.04), again complicating the interpretation of the odds ratios for the main-effects model and suggesting that the effect of disclosure may vary depending on the clinical outcome and the type of error. We therefore constructed 4 separate regression models, 1 for each error and outcome combination (Table 2). The results of these additional analyses suggest that the level of disclosure had little effect on the likelihood of seeking legal advice in 3 of the 4 error-and-outcome situations. However, for the missed allergy and serious outcome situation, those in the nondisclosure situation were much more likely to indicate that they would seek legal advice than those in the full disclosure situation (odds ratio, 6.593 [CI, 2.17 to 19.96]). Figure 2 illustrates these relationships and highlights the relatively high percentage of respondents who indicated that they would probably seek legal advice under some conditions.
Inclusion of age, sex, education, race or ethnicity, personal experience with errors, and personal suffering because of errors resulted in less than a 5% change in the odds ratios reported in Table 2. However, older patients were less likely to indicate that they would probably change physicians (odds ratio, 0.88 [CI, 0.80 to 0.96]; P= 0.003; for each 10-year change in age) or seek legal advice (odds ratio, 0.81 [CI, 0.73 to 0.91]; P= 0.001; for each 10-year change in age).
Figure 2 presents the observed means and Table 3 presents the results of the linear regression analyses predicting patient satisfaction, trust in the physician, and patient's emotional response. Nondisclosure was associated with lower ratings on all 3 dependent measures: lower patient satisfaction, less trust in the physician, and a more negative emotional response. Similarly, the life-threatening clinical outcome was associated with less positive ratings on all 3 dependent measures than the less serious clinical outcome. Error type had a less consistent effect. The inadequate monitoring error was associated with lower trust and more negative emotional response than the missed allergy information error, but there was no difference in patient satisfaction in the 2 error situations. No statistically significant interactions were found for any of the 3 outcomes, suggesting that the effect of each independent variable was consistent regardless of the level of the other independent variables, at least for the conditions studied in this paper.
Inclusion of sex, education, race or ethnicity, personal experience with errors, and personal suffering because of errors in the models resulted in less than a 5% change in the regression coefficients (differences) reported in Table 3. There was a small effect of education on satisfaction, with the college-educated respondents reporting lower satisfaction (β = −0.1 [CI, −0.2 to 0.0]; P= 0.05). There was also a small effect of race or ethnicity, with nonwhite respondents reporting greater satisfaction (β = 0.3 [CI, 0.05 to 0.49]; P= 0.02). Trust decreased with increasing education (college vs. less than college education; β = −0.15 [CI, −0.25 to −0.05]; P= 0.002) and reporting of personal experience with medical errors (β = −0.14 [CI, −0.24 to −0.05]; P= 0.004). Emotional response became more positive with increasing age (β = 0.08 [CI, 0.04 to 0.12]; P= 0.001; age coded in 10-year units) and decreased with reporting of personal experience with medical errors (β = −0.21 [CI, −0.34 to −0.08]; P= 0.002).
Table 4 presents the percentage of respondents agreeing with statements intended to measure beliefs and attitudes about medical errors and disclosure in general. Of interest, almost half of all respondents (46.5%) expressed agreement with 2 apparently incompatible statements (“It is realistic to expect that doctors will make errors” and “Patients have a right to expect that their doctors will not make errors”). Table 4 also presents the percentage of respondents favoring various responses to a medical error, which are ordered from most desirable to least.
Our findings suggest that full disclosure after a medical error reduces the likelihood that patients will change physicians, improves patient satisfaction, increases trust in the physician, and results in a more positive emotional response. Full disclosure may also reduce the likelihood that patients will seek legal advice under some, but not all, circumstances. Considering the error or outcome situations studied here, we found that full disclosure had a statistically significant effect on the likelihood of seeking legal advice in only 1 situation (missed allergy error and serious clinical outcome).
Of the 3 independent variables in this study (type of error, severity of clinical outcome, and level of disclosure), only level of disclosure is controlled by the physician once an error is discovered. Our results suggest that physicians can influence the consequences of the disclosure process in a positive way if they disclose fully by explaining what occurred, acknowledging responsibility, apologizing, and promising to work to ensure that the error does not recur. These findings are consistent with the results of a recently published study that used focus groups (36). However, our results also suggest that physicians should not assume that full disclosure guarantees a positive response; patients are also influenced by the clinical outcome and the specifics of the error situation. Again, this is consistent with reports that the characteristics of the injury are influential in determining whether patients pursue litigation (49, 50). Thus, providers should be aware that, under some circumstances, full disclosure could have little effect. The percentage of respondents who agreed that they would seek legal advice was relatively high under some circumstances, which is clear from Table 2 and Figure 2. It is noteworthy, however, that complete disclosure did not increase the likelihood of patients agreeing that they would seek legal advice under any circumstance studied here.
Our findings confirmed that patients want to be told of medical errors, even if there is nothing that can be done about them. Few respondents agreed that some circumstances might justify nondisclosure. These observations are consistent with results of previous studies, in which most patients endorsed disclosure of medical errors (14, 19, 36, 37). Our findings also suggest that financial issues should be addressed when an error results in injury. Most patients would want medical fees associated with an error to be waived, and most favored financial compensation if an injury occurred. Relatively few patients favored compensation when no injury occurred. While we did not directly examine the effect of compensation on the likelihood of seeking legal advice, others have found that patients are more likely to consider legal action if the physician pursues payment when an injury has occurred (49) and that financial pressures (including medical bills associated with the adverse event) may motivate legal action (51).
The finding that almost half of the respondents expressed agreement with 2 seemingly contradictory statements—that “It is realistic to expect that doctors will make errors” and “Patients have a right to expect that their doctors will not make errors”—deserves comment. Although agreement with both statements may seem logically inconsistent, we feel that both beliefs are central to the public's attitudes about medical errors and that neither should be discounted. Gallagher and colleagues (36) reported similar attitudes among focus group participants who expressed a belief that medical errors are inevitable and that the possibility of experiencing an error in one's own care was frightening. Similarly, Brodsky and colleagues (52) reported that approximately 50% of survey respondents believed that it was not rare for physicians to make mistakes, but almost all respondents (99.3%) agreed that “People should be able to trust their doctors to give them the right care.”
Our findings make clear that when errors occur, most patients want detailed explanations, a sincere apology, and assurances that steps will be taken to prevent recurrences. At least in the abstract, safety is more important to patients than compensation or punishment. However, almost 4 in 10 respondents favored punishing the physician and an even greater number (> 6 in 10 respondents) favored reprimanding the physician. It is possible that the impersonal nature of the survey, which did not refer to the respondent's own physician, was responsible for these relatively high rates of endorsing negative consequences.
Our study has several limitations. Our use of vignettes and dialogues allowed us to systematically vary factors in ways that would be unethical to manipulate in practice. However, this approach assumes that responses to hypothetical situations are predictive of responses to real situations.
Because we drew our sample from a single geographic area, we cannot assess whether our conclusions are valid for other populations. The fact that the study was conducted in the context of a managed care plan may also have affected patients' perceptions and responses, especially about questions related to cost considerations.
Our findings add to the current knowledge of patients' beliefs, preferences, and attitudes about medical errors and disclosure but also highlight the need for additional research. Among the many unanswered questions is whether patients perceive errors as attributable to systems and how this relates to the primacy of the physician–patient relationship. The error events in the vignettes in this study were systems errors (that is, there were several points where systems changes could have prevented the adverse event), but we did not make this explicit to participants. Patients' responses would probably change if the vignettes stressed the complexity of the system. Future research efforts should consider the effect of such variations on patients' responses. Consideration of the systems perspective and its implications is also relevant to the disclosure dialogue. We chose to portray the physician as sole communicator in the dialogue with the patient or family member, but such conversations could include people other than or in addition to the physician; patient preferences and responses to such variations should be investigated.
There are several dimensions of the clinical outcome of the error that were not explicitly studied but seem to be influential. Future research should investigate the effect of variables such as the pain associated with the outcome; whether hospitalization, surgery, or therapy is required; whether the injury is temporary or permanent; and the patient's status before the injury. Several variables probably influence the disclosure process and patients' responses, including who initiates the conversation, timing of the conversation (relative both to the occurrence of the adverse event and to determination of causality), existence of a previous physician–patient relationship, and financial considerations.
Conventional wisdom suggests that when a patient is harmed by medical error, full disclosure—including acceptance of responsibility, an apology, and an explanation—will result in the best outcomes for both patient and physician. We found that full disclosure incorporating these elements and assurance of efforts to prevent recurrence resulted in more positive outcomes in terms of patient satisfaction, trust, and emotional response and decreased the likelihood of changing physicians. The effect of disclosure on the likelihood of seeking legal advice was more complex, suggesting strong situational influences in this area. Both the clinical outcome of the error and the specifics of the error situation influenced how people respond to medical errors. We conclude that full disclosure fulfills patients' expectations and may help sustain or strengthen the patient–physician relationship, but it may not prevent litigation under some circumstances.
Imagine that you notice a skin infection on your face. You don't pay much attention at first, but after 2 days it is still there and not getting any better. You make an appointment to see your regular doctor, Dr. H. Dr. H. examines your face and tells you that you will require antibiotic treatment. Dr. H. prescribes dicloxacillin to clear it up. Dr. H. does not ask you whether you have any medication allergies. You are allergic to penicillin. You go to your local pharmacy and get the prescription filled.
The error: Dicloxacillin is a form of penicillin. Dr. H. forgot to ask you whether you were allergic to any drugs and did not check your medical record for any notes regarding allergies to medication. Because you are allergic to penicillin, Dr. H. should not have prescribed this antibiotic. While you remember that you had an allergic reaction to pencillin as a child, you did not mention it since you did not realize that dicloxacillin is a form of penicillin.
Within an hour of taking your first dose of the medicine, you develop hives (itchy red bumps) on your neck, chest, and legs. You call Dr. H.'s office and tell the nurse your symptoms. Dr. H. promptly calls you back and tells you to stop taking the antibiotic. Dr. H. tells you to take Benadryl®, which will stop the hives. Dr. H. also schedules an appointment to see you the next day.
You take the Benadryl®, and when you wake up the next morning, you feel much better. The itchy red bumps have mostly gone away. You keep your appointment with Dr. H. that day anyway, just to be sure everything is fine.
Dr. H.: Hello. How are you doing?
You: I'm feeling okay. Better.
Dr. H.: Good, good. I'm very glad to hear it. The rash looks like it's almost gone. That Benadryl® I suggested seems to have done the trick. What do you think?
You: Yes, it's much better. It's really clearing up.
Dr. H.: Good, good. You know, I think that rash was an allergic reaction to the antibiotic I prescribed for you. I went back and looked in your chart after you called and told me you had developed a rash, and I realized that you have a history of having had an allergic reaction to penicillin. Did you remember that?
You: Yes, I know that. I know I am allergic to penicillin, but you didn't ask me that. You didn't ask me about any allergies.
Dr. H.: Right, and that was my mistake not to ask you and not to go back and check it in the chart. This medication wasn't penicillin, but it's in the same family of drugs and so it's not a surprise that you are allergic to it. I feel terrible that you had a reaction. I'm just thankful that it wasn't more serious, that you recovered from it, and it's not going to cause you any harm. But I do feel very badly that it happened to you and that it was because of my mistake.
You: If you had asked if I was allergic to penicillin, I would have told you I was.
Dr. H.: Right, and I should have asked. I was concerned about taking care of the infection on your skin, but I should have paid closer attention to your medical record or to asking you. I truly am very sorry that this happened to you. In fact, we have a committee on patient safety here that looks at exactly this type of problem. The first order of business at the next meeting will be to work out a system so that this doesn't happen again.
Dr. H.: Good, good. You know, sometimes people get a rash like that as a reaction to a medication, like the antibiotic you started taking for your skin infection. Unfortunately, medications can have side effects. That rash is one side effect some people get to this particular medication.
You: I know it doesn't look too serious now, but it really was itchy.
Dr. H.: I bet. Rashes can be itchy. It's too bad that rash developed, but these things happen. People sometimes do get rashes from medications. It is responding to the Benadryl® well though, so I wouldn't worry about it.
You: Was this an allergic reaction? Because I know that I am allergic to penicillin.
Dr. H.: There is a note in your medical record that you have a history of an allergy to penicillin. I checked when you called about the rash, and it is documented. But you know, every prescription is different and every person is different. Sometimes it's not possible to predict how a person's body will react.
Dr. H.: Right. And it's not unusual for someone to have a reaction like you did, medications do sometimes have side effects or cause reactions that we don't want. Sometimes it's unavoidable—someone starts receiving a treatment for one thing, like the infection on your face, and unfortunately the treatment for one problem ends up causing another. It is unfortunate, but it does happen.
Within an hour of taking your first dose of the medicine, you develop hives (itchy red bumps), a feeling of throat tightness, and difficulty breathing. Because you are having trouble breathing, you call 9-1-1, and an ambulance takes you to the emergency room.
In the emergency room you are given a number of treatments to help your breathing and relieve the throat tightness. The emergency room doctor tells you that you actually could have died from the reaction to the antibiotic and that you should never take a penicillin-related drug again. You stay in the hospital that night for observation, and on the next morning, Dr. H. visits you in the hospital.
You: Not good. It's been a terrible couple of days.
Dr. H.: I can imagine. I am very sorry to hear what you've been through. I've talked to the doctor here and looked at your chart, and it seems like you're doing much better. It looks like you're going home this morning.
You: I'll be glad to get out of here. The doctor here said that the medicine I was taking for that infection on my face is like penicillin and that I shouldn't have taken it since I have an allergy to penicillin. I didn't know what it was—I wouldn't have taken it if I had known it was penicillin. You didn't say that it was like penicillin.
Dr. H.: I didn't, and I am very sorry that I didn't. It's not exactly penicillin, but it is in the same family, so I shouldn't have prescribed it for you.
You: I know I am allergic to penicillin, but you didn't ask about any allergies.
Dr. H.: Right, and that was my mistake not to ask you and not to go back and check your chart before I wrote the prescription. This medication is similar to penicillin, so it's not a surprise that you are allergic to it. When I found out what had happened to you, I went back and checked your record, and it is documented there that you are allergic to penicillin. I feel terrible that you had a reaction and that it was due to my mistake. I'm just thankful you are recovering from it and it's not going to cause you any permanent harm. But I do feel very badly that it happened to you and that it was because of my mistake.
Dr. H.: Well, it is like penicillin in some ways, but it is not penicillin. But you know, every prescription is different and every person is different. Sometimes it's not possible to predict how a person's body will react.
Dr. H.: There is a note in your medical record that you have a history of an allergy to penicillin. I checked when I found out what happened, and it is documented.
You: Well, then I shouldn't have had this medication.
Dr. H.: We know that now. But these things aren't always predictable. It's not really unusual for someone to have a reaction to a medication. Medications do sometimes have side effects or cause reactions that we don't want. Sometimes it's unavoidable—someone starts on a treatment for one thing, like the infection on your face, and unfortunately the treatment for one problem ends up causing another. It is unfortunate, but it does happen.
Imagine that your father is in a nursing home. He has a history of seizures and has been on medicine to control the seizures for quite some time. When the nursing home doctor, Dr. H., sees your father for his annual exam, Dr. H. decides that the amount of seizure medication your father has been taking has been a little low. Dr. H. decides to increase your father's seizure medication and writes an order that he be given a higher dosage. Your father starts on the higher dose. His seizures remain under good control—he still has no seizures—but he starts to have trouble keeping his balance. He begins to need to use a walker to get around. Over the next 2 weeks, he becomes more and more unsteady.
One morning, your father falls as he is on his way to breakfast in the dining room. The fall is not due to a seizure but is due to the higher dose of seizure medication that is making him unsteady. Your father is sent by ambulance to the emergency room for evaluation.
The error: After increasing your father's seizure medication, Dr. H. should have monitored your father for potential side effects. If given at too high levels, some seizure medications can cause patients to become unsteady and lose their balance. Thus, a patient taking too much seizure medication may fall and suffer an injury. The doctor should have done a blood test to determine if your father was receiving too much medication.
The doctors at the emergency room determine that your father has a broken nose and 2 black eyes but no serious injuries. They check the blood level of the seizure medication and find it to be very high (in the toxic range). The next day you call Dr. H., the doctor at the nursing home, to find out what happened.
You: Hello. I'm calling to talk to you about my father. I was told that he fell yesterday and was sent to the ER. They said he's basically o.k. except for some bruising and a broken nose, but I'd like to know what happened.
Dr. H.: I'm glad you called. Your father did fall yesterday. Unfortunately, I think it may be due to his medication. About 2 weeks ago, I saw your father for his annual exam and at that time I decided to increase his seizure medication because it was low. However, after the fall we checked his blood and found out that your father was getting too much seizure medication. It is likely that the high level of this medication contributed to your father losing his balance and falling.
You: So he fell because you put him on such a high dose of the medicine?
Dr. H.: There may have been other factors involved, but it's true that the high level of seizure medication probably contributed to the fall. I should have checked your father's blood level a few days after I increased the dosage to see if it was too high. I might have been able to prevent his fall if I had checked his blood. I was focused on keeping the seizures under control, but I didn't follow up as I should have. I feel terrible that he fell and that I did not pick up the mistake earlier. I am sorry that it happened.
You: I just worry so much because he is getting older and I can't be there to take care of him all of the time.
Dr. H.: I understand. It's hard to watch people age, especially when they have accidents and get hurt. I assure you that we will take good care of him. In fact, we have a committee on patient safety here that looks at exactly this type of problem. The first order of business at the next meeting will be to work out a system so that this doesn't happen again.
Dr. H.: I'm glad you called. Your father did fall yesterday. We don't know exactly what caused the fall. He is elderly, he has seizures, and he is on a number of medications. Your father is in a nursing home because he has a lot of problems. So, there are many things that might have caused the fall or it may have been a combination of factors. Anyway, he seems to be doing a lot better now despite the accident.
You: At the emergency room, they said that the amount of seizure medication in his blood was very high. Do you think that caused the fall?
Dr. H.: It's hard to tell. As people get older, they become more unsteady, so a lot of elderly people fall and get hurt. His seizure medication was too low when I saw him, so it was increased to prevent seizures. What caused the fall is really unclear. We really don't know if maybe the seizure medication was a factor or if he fell for some other reason.
Dr. H.: I understand. It's hard to watch people age, especially when they have accidents and get hurt. These things are hard to predict. I assure you that we will take good care of him.
When your father gets to the emergency room, he is experiencing severe pain with any movement of his left leg. The emergency room doctors determine that your father's hip is broken. They also check the level of the seizure medication and find that it is very high (in the toxic range). The fracture will require surgery—inserting a screw and plate into your father's hip region. Your father survives the operation, but he will need extensive physical therapy in order to walk again.
You are with your father in his hospital room the next day when Dr. H. comes to your father's room to see how he is doing. You ask him what happened.
You: Hi, Dr. H. Thanks for coming by. My dad is really in awful shape.
Dr. H.: I wanted to check and see how things are going. I spoke to the doctors here and they said that the surgery went well.
You: He was in a lot of pain after the fall, and I think he's still in pain from the hip surgery. I was surprised when I found out that my father got hurt. The whole thing was a bit of a shock to me—he was fine the last time I saw him. Do you know why he fell yesterday?
Dr. H.: Well, about 2 weeks ago, I saw your father for his annual exam and at that time I decided to increase his seizure medication because it was a bit low. However, after the fall we checked his blood and found out that your father was getting too much of his seizure medication. It is likely that the high level of this medication caused your father to lose his balance and fall.
You: I just worry so much because he is getting older and I can't be there to take care of him all of the time. The surgeon said that if he is going to walk again, he'll need a lot of physical therapy. I just don't see how something like this could happen.
Dr. H.: I understand. We will work hard to help your father walk again. I will make sure that he gets the best therapy possible. I assure you that we will take good care of him. In fact, we have a committee on patient safety here that looks at exactly this type of problem. The first order of business at the next meeting will be to work out a system so that this doesn't happen again.
You: He was in a lot of pain after the fall, and I think he's still in pain from the hip surgery. I was surprised when I found out my father got hurt. The whole thing is a bit of a shock to me—he was fine the last time I saw him. Do you know why he fell yesterday?
Dr. H.: We don't know exactly what it was that caused the fall. Your father is elderly, he has seizures, and he is on a number of medications. As you know, your father is in a nursing home because he has a lot of problems. There are many things that might have caused the fall or it may have been a combination of factors. Anyway, he seems to be doing a lot better now despite the accident.
You: In the ER, they said that the amount of seizure medication in his blood was very high and that that could have been related to the fall. Do you think that caused the fall?
Dr. H.: It's hard to tell. As people get older, they become unsteady. A lot of elderly people fall and get hurt. His seizure medication was too low when I saw him, so it was increased to prevent seizures. What caused the fall is really unclear. We really don't know if the seizure medication was a factor or if he fell for some other reason.
Dr. H.: I understand. It's hard to watch people age, especially when they have accidents and get hurt. These things are hard to predict. At least he's doing better now. He has a lot of work ahead of him if he's going to walk again, but we'll all hope for the best. I will make sure he gets the best therapy possible. I assure you that we will take good care of him.
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Cittadinanzattiva Via mecenate 25 20138 Milan Italy
April 13, 2004
Patient complaints, disclosure of medical error and litigation
We fully agree that patients want to be told of medical errors even if there is nothing that can be done about them (1). Our independent patient's agency analyzed 100 written complaints of people about the reasons for complaining or taking legal advice. Thirty six out of 100 people wanted compensation, 18 an explanation, 14 wanted that it would not happen to anyone else, 12 that the doctors would be disciplined, 11 only for legal advice, and other reasons. We advise and encourage patients to report their complaints also to the local Health Authority: only 38, of 100 complaints we received, were reported from citizen to the hospitals' public relation offices. Twenty two were the written replay and explanations from the Institutions, sometimes with expressions of regret without acceptance of responsibility or an apology. Some doctors invited patients or their relatives to debate the case, but many people refused to meet the doctors: they do not trust them. Patients want that their complaint will be handled by an independent Agency. Unfortunately, in Italy, the National Health Service does not support a patient representative. As you wrote, decisions to seek legal advice were complex and were not necessarily deflected by a late full disclosure.
1. Mazor KM, Simon SR, Yood RA, Martinson BC, Gunter MJ, Reed GW, Gurwitz JH. Health plan members' views about disclosure of medical errors. Ann Intern Med 2004; 140: 409-418.
Roberto Natangelo Retired Physician. Cittadinanzattiva ( Active Citizenship. Via Mecenate n. 25. 20138 Milan. Italy) e-mail: roberto.natangelo @ libero.it
Eric N Grosch
June 1, 2004
-Health Plan Members' Views about Disclosure of Medical Errors
The Fifth Amendment protects the individual from an obligation to be a witness against himself and creates a tension with the physician's duty to disclose errors to patients.
Tension likewise stands between the physician's accepting the risk of treating a sick patient and the urge to secure justice that a patient or his family may feel by making the perceived architect of the patient's misery suffer as the patient has suffered. Russell said:
The reformative effect of punishment is a belief that dies hard, chiefly I think, because it is so satisfying to our sadistic impulses.
In the vignettes, clinicians cannot readily conceal their errors as the affected patients could probably discern a connection between error and consequence, so circumspect clinicians would probably consider their chances poor of leaving victims none the wiser by not disclosing.
In contrast, in another (hypothetical?) nightmare-vignette, the consequence of an error of omission was lethal but the clinician, motivated, however venally, by self-preservation, covered it up.
Such a clinician may consider the instruction to parents, aboard airlines, in case of loss of cabin-pressure, to hold the oxygen-mask to one's own face before doing so for an accompanying infant. By analogy, the clinician may feel justified in concealing his clinical error on the basis that he erred but without nefarious intent. In the interest of the greater good of serving other patients in need, he may justify his non- disclosure by the need he perceives to survive financially.
Bosk, the medical sociologist and merchant of sanctimony, in his influential book on his study of a surgical residency, admitted his desire to preserve himself and his field of investigation by concealing from patients and their families the clinical errors that he had understood surgeons had committed, lest he poison his successors' path by blowing the whistle.
Even when the clinician commits an error, it often fits the description of Berwick's analogy. The injustice of penalizing a physician heavily for no more serious a mental lapse than returning a borrowed item to the wrong place, though it may have more serious consequences, demonstrates why the argument that the penalty must fit, not the error, but the consequences of the error is an illustration of why the argument from consequence is a fallacy and why tort-law reform should distribute risk more equitably by making the informed consent, containing a human-error clause, a binding contract.
Eric N. Grosch, MD
1. Russell B. Ideas That Have Harmed Mankind. Girard, Kan. E Haldeman- Julius, 1946
2. Anon. Education and debate: An ethical dilemma: Medical errors and medical culture: An error of omission. BMJ. 2001 May 19;322(7296):1236-1240
3. Bosk CL. Forgive and remember managing medical failure. Chicago, University of Chicago Press 1979, pp. 199-200
4. Berwick DM. Not again! Preventing errors lies in redesign not exhortation. BMJ. 2001 Feb 3;322(7281):247-248
5. Walton DN. Argumentation Schemes for Presumptive Reasoning. Lawrence Erlbaum Associations, Mahwah, NJ, 1996
Physician with financial interest in tort-reform in medicine
Neurology, Seizure Disorders, Prevention/Screening.
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