Patient Education and Counseling 98 (2015) 446–452
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Communication study
Error disclosure and family members’ reactions: Does the type of error really matter? Daniela Leone a,*, Giulia Lamiani a, Elena Vegni a, Susan Larson b, Debra L. Roter b a b
Department of Health Science, University of Milan, San Paolo University Hospital, Milan, Italy Department of Public Health, John Hopkins University, Baltimore, USA
A R T I C L E I N F O
A B S T R A C T
Article history: Received 2 July 2014 Received in revised form 3 December 2014 Accepted 31 December 2014
Objective: To describe how Italian clinicians disclose medical errors with clear and shared lines of responsibility. Methods: Thirty-eight volunteers were video-recorded in a simulated conversation while communicating a medical error to a simulated family member (SFM). They were assigned to a clear responsibility error scenario or a shared responsibility one. Simulations were coded for: mention of the term ‘‘error’’ and apology; communication content and affect using the Roter Interaction Analysis System. SFMs rated their willingness to have the patient continue care with the clinician. Results: Clinicians referred to an error and/or apologized in 55% of the simulations. The error was disclosed more frequently in the clear responsibility scenario (p < 0.02). When the ‘‘error’’ was explicitly mentioned, the SFM was more attentive, sad and anxious (p 0.05) and less willing to have the patient continue care (p < 0.05). Communication was more patient-centered (p < 0.05) and affectively dynamic with the SFMs showing greater anxiety, sadness, attentiveness and respectfulness in the clear responsibility scenario (p < 0.05). Conclusions: Disclosing errors is not a common practice in Italy. Clinicians disclose less frequently when responsibility is shared and indicative of a system failure. Practice implications: Training programs to improve disclosure practice considering the type of error committed should be implemented. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Medical error Truth disclosure Apology RIAS Simulation
1. Introduction The past decade has brought attention to the number of preventable deaths and injuries attributable to medical errors and they have been identified by healthcare and policy institutes as a major challenge to patient safety [1,2]. Medical errors arise from a complex interaction of human and organizational factors and guidelines regarding honest and transparent disclosure of medical errors have been promulgated [2]. Disclosure of medical errors to patients and families is considered a core aspect of ethical practice [3] and endorsed by professional codes of conduct [4,5]. In 2001, the US Joint Commission on Accreditation of Healthcare Organizations required hospitals to disclose all unanticipated
* Corresponding author at: Department of Health Sciences, Universita` degli Studi di Milano, San Paolo University Hospital, Via di Rudinı` 8, 20142 Milan, Italy. Tel.: +003950323237; fax: +0039 02 50323015. E-mail addresses: [email protected], [email protected] (D. Leone), [email protected] (G. Lamiani), [email protected] (E. Vegni), [email protected] (S. Larson), [email protected] (D.L. Roter). http://dx.doi.org/10.1016/j.pec.2014.12.011 0738-3991/ß 2015 Elsevier Ireland Ltd. All rights reserved.
care outcomes to patients, even those that do not lead to substantial harm. Several studies have identified elements of appropriate disclosure [6,7]. Patients desire an explicit statement that an error has occurred, information about what went wrong and why, specific implications so they can make informed decisions, and a sincere apology by their physician that recognizes their suffering [8]. Competent disclosure has been associated with higher patient satisfaction, greater trust and less sanctions against the physicians [9,10]. Nevertheless, physicians are often reluctant to disclose medical errors because they fear losing their job, being involved in malpractice litigation, jeopardizing the trust of coworkers and facing their own failure [11]. Failure to disclose even hypothetical serious medical errors was reported by Gallagher and colleagues [7] to be as high as 58% based on survey responses of over 2500 medical and surgical physicians in the US and Canada. Willingness to disclose the error was especially low, averaging 32%, when the scenario represented a less obviously apparent error [7]. The emotional pressure commonly experienced after a medical error, coupled with a lack of legal protection, may reinforce
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clinicians’ instincts for self-preservation over their desire and professional obligation to tell patients the truth [12]. Despite growing attention to issues surrounding medical errors worldwide, few studies addressing medical error communication have been conducted within the European context [6,13]. In Italy, a culture of medical transparency is newly emerging and disclosure policies are guided only by the ethical code [14] and ministerial recommendations, not by specific laws. While there are no national initiatives to promote the identification and the analysis of medical errors, the past few years have witnessed the development of programs in regions and local hospitals. The aim of the current study is to contribute to this literature by conducting a small pilot study designed to explore how Italian clinicians disclose medical errors in a simulated encounter with a patient’s family member. Two common medical error scenarios are explored, one with a clear line of responsibility (a drug error) and a second in which shared lines of responsibility are identified reflecting a broader system error (a missed diagnosis and poor patient supervision). We posit the following hypotheses: (1) Clinicians will be more likely to explicitly note that an error was made and offer an apology in the clear compared with shared responsibility scenario. (2) Communication patterns between clinicians and simulated family members (SFM) will be more patient-centered and affectively engaged: (a) in the clear compared with shared responsibility scenario; and, (b) when an error is explicitly noted and an apology made. (3) The SFMs will be more willing to continue care with a clinician who admits an error and offers an apology.
2. Methods 2.1. Participants Participants in the current study were recruited from attendees at a continuing educational Program to Enhance Relational and Communication Skills (PERCS) on error disclosure [15]. Each PERCS workshop lasted 4 h and was open to interdisciplinary participants. The workshop begun with a brainstorming activity and a brief theoretical presentation including systemic definition of medical error. It continued with the enactment of two different scenarios portrayed by volunteering participants and actors, followed by a group discussion. All the enactments were conducted in a separate room and were simultaneously video-recorded and showed live on close-circuit television to the participants in the workshop room. Between 2010 and 2011, ten workshops were conducted in two hospitals in the center and north of Italy. The workshops were attended by 119 clinicians. Thirty-eight of these clinicians voluntarily self-selected to take part in simulations and all of them consented to the current study. In each simulation a physician generally led the conversation, accompanied by a nurse or another health care professional as decided by the participants. Demographic characteristics of participants in the enactments and of all participants to the workshop are reported in Table 1. 2.2. Data collection Two scenarios were developed for use in the workshop to illustrate distinct situations within which a medical error may occur. The first (drug error) was associated with a clear line of responsibility between the physician and the nurse, and the second (undiagnosed encephalopathy and poor patient supervision) reflected shared lines of responsibility as described in Table 2.
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Table 1 Demographic characteristics of participants in the enactments and of all participants to the workshop. Characteristics
Discipline Physician Nurse Other (risk manager, lab technician, mediators, etc.) Age Mean (s.d.) Years of experience Mean (s.d.) Gender Female Male Nationality Italian Other Presence of a mentor in error disclosure No Yes
Participants in the enactments N = 38 20 (53%) 16 (42%) 2 (5%)
46.02 (8.7)
All participants to the workshop N = 119 31 (26%) 49 (43%) 37 (31%)
45.59 (9.49)
19.8 (11.3)
20.12 (10.45)
28 (74%) 10 (26%)
97 (83%) 20 (17%)
37 (97%) 1 (3%)
114 (97%) 3 (3%)
31 (82%) 7 (18%)
95 (81%) 22 (19%)
Twenty simulations were performed (10 for each of the two error scenarios) throughout the conduct of the workshops. In most of the simulations (18 of the 20), two clinicians participated. In two cases, the simulation was conducted by a single clinician. Clinicians participated in only one simulation. Clinicians were oriented to the scenario and asked to communicate that an error had been made in the care of the patient to his/her family member. SFMs followed a script but adapted their emotional reactions and communication content to the clinicians’ communication style [16]. Following the session, the SFM rated their willingness to continue care of the patient with the clinician. Research demonstrated that simulated patients are realistic patient substitutes [17,18]. Specifically, several studies showed that analogue patients’ perceptions of communication largely overlap with clinical patients’ perceptions [19]. The SFMs were psychologists who had training and experience in acting and in assessing clinicians’ communication skills. Four SFMs were used throughout the workshops; two males and two females, ranging in age from 29 to 42. In each workshop the two scenarios were portrayed by two different actors. Two actors were trained to portray the first scenario and two other actors were trained to portray the second scenario. The study was approved by the Ethical Committee of the two participating hospitals. Table 2 Case scenarios used in the program to enhance relational and communication skills (PERCS)-medical error workshop. Clear responsibility scenario: Massimina Pecca is a 67-year-old patient hospitalized for a lung lobectomy. After surgery, the physician orders an infusion of morphine at 1.0 mg/h, using the ‘‘trailing zero’’, a practice prohibited by hospital policy. The nurse, not used to use of trailing zero, reads 10 mg/h and calls the physician asking the reason for such a high dose without mentioning the quantity. The physician replies that the dose is appropriate for the intervention. The nurse then starts the infusion at 10 mg/h causing a respiratory arrest. After admission in the ICU, Massimina recovers completely.
Shared responsibility scenario: Walter Fusi is a 63year-old patient hospitalized due to a chronic hepatopathy. The son reports symptoms of confusion and diarrhea, but the physician misses the diagnosis of encephalopathy. During the night, the patient leaves the ward unsupervised. Despite a search throughout the hospital, the patient is not found until the next day in an administrative building which was mistakenly left unlocked the night before. The patient suffered several bruises.
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2.3. Measures 2.3.1. Error disclosure and apology In order to rate specific elements of error disclosure, a coder reviewed the simulations to document: (1) clinicians’ explicit mention of the word ‘‘error’’ or ‘‘mistake’’; and, (2) clinicians’ explicit apology (for example: ‘‘I am sorry’’, ‘‘We apologize’’). Each simulated conversation was also divided into early, middle and late thirds to facilitate documentation of the placement of the word ‘‘error’’ and the stated apology within the context of the full session. 2.3.2. Communication content The simulations were coded using the Roter Interaction Analysis System (RIAS) [20]. The RIAS is a well validated and widely used coding system for categorizing verbal exchanges in the physician–patient interaction. The unit of analysis for RIAS coding is defined as a statement reflecting a complete thought or phrase, usually a simple sentence or a clause in a compound sentence, or it may be a single world. The statements are assigned to mutually exhaustive and exclusive coding categories applied to all speakers. The system includes 37 parallel patient and clinician codes (a total of 74 coding variables) and a few unique patient and clinician codes. Consequently, every expressed thought made throughout the visit is coded. In this study, a trained coder (DL) coded the simulations using the RIAS software. As in other studies of
this kind, related individual codes were combined to create 10 composite categories each for the clinician and simulator as follows: biomedical questions; psychosocial questions; biomedical information; psychosocial and lifestyle information; facilitation and activation; emotional expression; positive rapport; negative talk, social talk and procedural talk. Examples of the application of the RIAS categories are given in Table 3. In addition, a summary measure of patient-centeredness was used to reflect the overall session style. Consistent with previous studies, patient centeredness was calculated as a ratio of communication elements as follows: all clinician psychosocial and lifestyle categories (including questions and related information and counseling), all SFM questions and psychosocial and lifestyle statements, emotional expressions (both SFM and clinician), and clinician partnership building (asking for opinion, checking understanding, back channel cues of interest) divided by clinician biomedical information, biomedical questions and procedural statements and SFM biomedical information [20]. A random sample of 20% of the simulations were double coded by a second, trained RIAS coder (EV) and revealed high inter-rater agreement of 0.98 using Pearson correlation coefficient across the composites categories. 2.3.3. Emotional tone In addition to communication coding, the global affect of the leading clinician and SFM was rated on a 6-point Likert scale for
Table 3 Examples of the application of the Roter Interaction Analysis System (RIAS) to the enactments. RIAS composite categories Biomedical questions Questions on medical condition and treatment/procedures Lifestyle/psychosocial questions Questions on psychosocial and lifestyle issues Biomedical information Information on medical condition and treatment/procedures Biomedical counseling* (re: medical condition and therapeutic procedures and regimen) Lifestyle/psychosocial information Information on psychosocial and lifestyle issues Psychosocial counseling* (re: lifestyle and psychosocial issues) Emotional expression Concern Giving reassurance Empathy, legitimization
Excerpts from the simulations ‘‘Did your father have diarrhea yesterday?’’ (Clinician) ‘‘Is my mum on the ventilator now?’’ (SFM) ‘‘Does your mother get angry easily?’’ (Clinician) ‘‘How do you think my mother will react when she wakes up?’’ (SFM) ‘‘Your mother suffered from a side effect due to the drug’s dosage’’ (Clinician) ‘‘Yesterday evening my father was talking nonsense’’ (SFM) ‘‘If you see any further signs of distress in your mother, let us know’’ (Clinician)
‘‘We realized that your mother is not a simple person’’ (Clinician) ‘‘My father is a quite lively person’’ (SFM) ‘‘What is important now is to do not upset your mother’’ (Clinician) ‘‘We are so sorry for this’’ (Clinician) ‘‘My mother is in intensive care unit?!?’’(SFM) ‘‘First of all I want to reassure you about your father’s condition’’ (Clinician) ‘‘Now that I know she is well, I am feeling better’’ (SFM) ‘‘I can understand you are upset’’ (Clinician) ‘‘I can see that you cannot check the patients every minute’’ (SFM)
Partnering* ‘‘We are at your disposal for every clarification you need’’ (Clinician) Facilitation/activation Asking for opinion* Asking for understanding Paraphrasing Asking for reassurance Positive rapport Agreements, approvals, compliments Negative talk Disagreements, criticism Social talk (personal) Non medical chit-chat Procedural talk Directions and instructions (re: the medical care process) *
Clinician-only category.
‘‘What do you think about what happened?’’ (Clinician) ‘‘Is it clear?’’ (Clinician) ‘‘You say that yesterday you told the doctor your father was confused?’’ (Clinician) ‘‘So you are saying that he moved around the hospital’’ (SFM) ‘‘Is she well now?!?’’ (SFM) ‘‘I know, you are right.’’ (Clinician) ‘‘Ok, thank you’’ (SFM) ‘‘No I don’t think your father was abandoned!’’ (Clinician) ‘‘Did you poison my mother?!?’’ (SFM) ‘‘Hi, I am the head physician of the ward’’(Clinician) ‘‘I am Mr. Fusi’s daughter’’ (SFM) ‘‘Now my colleague will give you some explanations’’(Clinician) ‘‘First I want to see my mother, and then we’ll talk’’ (SFM)
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the following affective dimensions: anger/irritation, anxiety/ nervousness, dominance/assertiveness, interest/attentiveness, friendliness/warmth, responsiveness/engagement, sympathetic/ empathetic, respectfulness, and interactivity (assigned to both clinician and SFM), depression/sadness and emotional distress/ upset (assigned only to the SFM) and hurried/rushed (assigned only to the clinician). A random sample of 50% of the simulations was double coded by a third coder (GL) to calculate the inter-rater agreement on affect ratings. Ratings within 1 scale point was considered as agreement and inter-rater agreement was good, averaging 81% (range 60–100%). 2.3.4. Likelihood of continuing in care At the end of each simulation, the SFM rated his/her willingness to have their family member continue in care with the leading clinician on a 5-point Likert scale item (1 = absolutely not; 5 = yes, without reservations). 2.4. Data analysis All the statistical analyses were performed with SPSS 19 for Windows. Descriptive statistics were calculated. Chi2 was performed to analyze if the clinicians’ mention of the word error and the presence of apology differed across the two scenarios and across the three parts of the encounter. T-test for independent samples was performed to assess differences in communication, global affect, likelihood to continue physician care across the two error scenarios. T-test was also used to assess if the clinicians use of the word error and the apology affected ratings of SFMs global affect and reported likelihood to continue physician care.
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shared responsibility scenario [m = 0.85 vs 0.52, respectively; (95% CI: 0.02/0.65); p = 0.04]. Inspection of specific communication categories in Table 4 shows that clinicians conveyed significantly less biomedical information (47 vs 63 statements, p = 0.02) but tended to give more lifestyle/psychosocial information (1.8 vs 0.2 statements; p = 0.07) and tended to use fewer facilitation/activation statements (0.3 vs 2.1 statements, p = 0.08) in the clear rather than shared responsibility scenarios. In a parallel manner, the SFM also engaged in more biomedical exchange in the shared responsibility scenario (9.3 vs 4.9 statements, respectively, p = 0.004). SFMs also expressed more emotion in the clear responsibility scenario (36.9 vs 2, respectively, p = .02). 3.3. Emotional tone Coder ratings of clinician global affect did not differ across scenarios (data not shown), but SFM affect ratings were related to scenario (Table 5). SFMs showed greater anxiety, sadness, attentiveness and respectfulness in the clear responsibility scenario. 3.4. Likelihood to continue physician care SFM ratings of likelihood to continue physician care of their family member did not differ across scenarios. Fourteen family members stated they would absolutely or probably want the patient to continue in care, five indicated that they would absolutely or probably not continue, and one was neutral. Likelihood of continuing care was higher in simulations in which the word error was not mentioned [m = 4.4 vs 3.2 (95% CI: 0.14/2.25); p = 0.03]. The offer of an apology did not affect these ratings.
3. Results 4. Discussion and conclusion 3.1. Error disclosure and clinicians’ apology 4.1. Discussion Clinicians first introduced the word ‘‘error’’ or ‘‘mistake’’ in 11 sessions, SFM introduced the term error in 2 sessions and error was not mentioned at all in 7 of the sessions. Clinicians mentioned the word ‘‘error’’ more frequently in the context of clear rather than shared responsibility (8 vs 3 error mentions, respectively; p < 0.02). Clinicians proffered an apology (e.g. ‘‘I’m sorry’’; ‘‘I apologize for this’’) in 11 sessions and there were no differences in the frequency of apologies when responsibility was clear or shared (5 vs 6 apologies, respectively; p > 0.05). In seven simulations clinicians mentioned both the word error and apologized. There were no differences regarding placement (early, middle or toward the end) of the term error or apology over the session (data not presented). In the 13 sessions in which an error was explicitly mentioned, SFMs were rated by coders as appearing more attentive [m = 4.46 vs 4 (95% CI: –0.77/–0.15); p = 0.008], sad [m = 1.69 vs 1.14 (95% CI: –1025/–0.074); p = 0.026] and anxious [m = 4.54 vs 3.71 (95% CI: –165/–0.002); p = 0.05] than in the seven sessions without mention of an error. There were no differences in SFMs affect in sessions with or without a clinician apology. 3.2. Communication content As reflected in Table 4, the simulated conversations averaged 7 min (range = 4.76–11.06 min) and clinicians verbally dominated by a ratio of 2:1, with the SFM contributing 33% of session statements and clinicians contributing 67% of all statements. Neither the length of the conversation nor clinicians verbal dominance differed by scenario. However, session communication was significantly more patient centered in the clear rather than the
While there have been a few US studies that explored how physicians disclose medical errors to patients within a simulation context [21,22], the present study is the first to describe how Italian clinicians are likely to communicate a medical error. Moreover, to our knowledge this is the first simulation study to explore differences in error disclosure under two common but importantly distinct circumstances: clear error responsibility versus shared lines of responsibility indicative of a system failure [23]. Our findings highlight the difficulty clinicians have in being completely transparent in error discussions [24]. We found that explicit reference to errors or mistakes were made by clinicians in only slightly more than half (55%) of the study simulations. Similarly, an explicit apology was apparent in 55% of the simulations. Interestingly, Chan et al. [21] in their 2005 study of error disclosures by US surgeons reported similar rates with 57% of physicians using the words error or mistake and 47% making an explicit verbal apology. More recently, Hannawa [22] reported that virtually all the physicians in her US simulation study included an apology in their error disclosures. However, the quality of the apology was rated as poor and interpreted by the author as a statement of sympathy rather than personal responsibility for harm. Assisting clinicians in developing more transparent and effective disclosure practices constitutes an important step in addressing and ultimately reducing the gap between what it is known in theory and the clinical practice. As hypothesized, we found that clinicians were more likely to explicitly acknowledge that an error occurred in their communication when the lines of responsibility were clear rather than shared. We were surprised, however, that the offer of an apology did not follow suit. Clinicians both mentioned the word error and
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Table 4 Overall characteristics of simulation communication across scenarios. Communication characteristics
Medical error scenario type
Length of sessions (in min) Ratio of clinician to SFM statements Percentage of statements Clinician SFM Overall patient centeredness score RIAS composite categories Biomedical question Clinician SFM Lifestyle/psychosocial questions Clinician SFM Biomedical information Clinician SFM Lifestyle/psychosocial information Clinician SFM Emotional expression Clinician SFM Facilitation/activation Clinician SFM Positive rapport Clinician SFM Negative talk Clinician SFM Social talk (personal) Clinician SFM Procedural talk Clinician SFM
Shared responsibility mean (SD)
7.2 (1.64) 2.2 (0.79)
7.3 (1.8) 2.2 (0.22)
1.29/1.96 0.61/0.65
0.67 0.95
66% 34% 0.85 (0.35) Mean category frequency (SD)
67% 33% 0.52 (0.32) Mean category frequency (SD)
-39.1/9.1 -27.67/17.47 0.02/0.64 95% C I
0.207 0.641 0.04 p-Value
0.1 (0.32) 3.5 (1.9)
1.0 (1.33) 5.8 (2.1)
1.86/0.06 4.18/0.42
0.06 0.02
0.1 (0.32) 0.6 (0.84)
0.1 (0.32) 0.0 (0.0)
0.3/0.3 0.003/1.2
1 0.05
47.3 (11.51) 4.9 (2.47)
63.4(15.58) 9.3 (3.43)
28.97/3.23 7.21/1.59
0.02 0.004
1.8 (2.44) 1.7 (2.16)
0.2 (0.42) 0.9 (1.29)
0.16/3.36 0.87/2.47
0.07 0.33
5.7 (2.83) 36.9 (16.06)
30.5(17.98) 2 (3.65)
9.62/22.42 0.63/6.77
0.41 0.02
0.3 (0.48) 9.5 (3.14)
2.1 (2.88) 9.6(4.06)
3.88/0.28 3.51/3.31
0.08 0.95
9.4 (4.90) 7.3 (6.29)
10.8(5.47) 9.5 (3.98)
6.28/3.48 7.14/2.74
0.55 0.36
2.1 (1.85) 18.9 (14.09)
5.7 (7.1) 20.2(14.41)
8.48/1.28 14.69/12.09
0.14 0.84
4.5 (1.78) 2.6 (1.35)
4.9 (1.91) 3.5 (0.85)
2.13/1.33 1.96/0.16
0.63 0.09
9.9 (3.54) 2.2(1.48)
8.5 (3.48) 1.2 (1.13)
1.89/4.69 0.24/2.24
0.38 0.11
Table 5 Affective ratings of simulated family members across medical error scenarios.
Angry Anxious Sad Emotional distressed Dominant Attentive Friendly Responsiveness Sympathetic Respectful Interactive
Medical error scenario type
95% CI
p-Value
(1.16) (0.95) (0.32) (0.79)
1.69/0.49 0.41/1.79 0.37/1.23 0.26/1.26
0.26 0.004 0.001 0.18
4.2 (0.63) 4 (0.0) 1.7 (0.67) 3.8 (0.42) 1.7 (0.82) 2.9 (0.88) 4 (0.47)
1.11/0.11 0.23/0.97 0.25/0.85 0.1/0.9 0.4/1 0.07/1.53 0.62/0.22
0.1 0.005 0.27 0.11 0.38 0.03 0.33
Clear responsibility Mean affect ratings (SD)
Shared responsibility Mean affect ratings (SD)
3.7 4.8 1.9 4.7
4.3 3.7 1.1 4.2
(1.16) (0.42) (0.57) (0.82)
3.7 (0.67) 4.6 (0.52) 2 (0.47) 4.2 (0.63) 2 (0.67) 3.7 (0.67) 3.8 (0.42)
p-Value
Clear responsibility mean (SD)
apologized in only seven simulations. It appears that clinicians did not necessarily link taking clear responsibility for an error with the offer of an apology. Despite other studies showing that patients appreciate an apology after an error [8], it is possible that clinicians in our study failed to offer an apology because they were fearful of litigation as there is nothing akin to the US Apology Laws [3] in the Italian legal context.
SFM global affect ratings
95% CI
As hypothesized, session communication was more patientcentered and affectively dynamic in the clear rather than shared responsibility scenario. In the clear responsibility scenario, the focus of the verbal exchange was more socio-emotional in nature, the SFM was rated as more attentive, but also more distressed and sad, while in the shared responsibility scenario the verbal exchange was more task-focused and affectively neutral. In a parallel manner, sessions that included an explicit reference to an error compared with others were more affectively dynamic with the SFM being rated as showing greater interest but also more sadness and anxiety. Finally, and contrary to our hypothesis, SFMs willingness to continue the patient in care with the clinician was higher when clinicians did not explicitly acknowledge the medical error. This result is consistent with those of several other studies [3,25,26], suggesting that acknowledgment of an error, as indicated in the error disclosure guidelines [3,27], may not have a positive effect on the interaction, at least in the short run. It is comprehensible that after an error is disclosed there is a breach of trust in the doctor– patient relationship. We agree with others who have concluded that error acknowledgment should be endorsed for ethical reasons, but not necessarily for utilitarian reasons [3,26]. Contrary to our hypothesis, the SFMs willingness to continue care did not differ if the clinician apologized or not. It is possible that the failure to link the apology to acknowledgment of an error might have been perceived by the SFM as a statement of sympathy rather than personal responsibility for harm, as suggested by Hannawa [22].
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The study has several limitations. First, as an exploratory pilot study conducted within the context of a CME program on error disclosure, only one-third of all attendees volunteered to take part in the simulations and consented to participate in the study by making their sessions available for analysis. While volunteers did not differ from non-volunteers in age, years of experience, gender or having a mentor in error disclosure, they are likely to have differed in other ways, including confidence and comfort, and perhaps skills, in conducting an error disclosure simulation. As a consequence, we can only assume that the study observations reflect best rather than common practice. There is a second limitation associated with the conduct of a small exploratory pilot study that is related to the possibility of failing to uncover relationships because of very limited statistical power. Consequently, we note suggested trends indicating clinicians making more lifestyle/psychosocial information (1.8 vs 0.2 statements; p = 0.07) and fewer facilitation/activation statements (0.3 vs 2.1 statements, p = 0.08) in the clear relative to share responsibility scenario. It is also possible that some significant results were spurious suggesting a difference between scenario types by chance because of multiple comparisons. However, we were careful to reduce the large number of communication variables coded by the RIAS to 10 composites and affect ratings for clinician and SFM and only conducted contrasts in line with stated hypotheses. Despite evidence that clinicians’ behavior in simulations are indicative of their clinical behavior with patients [28,29], the extent to which the study results may be generalizable to actual practice is, as noted above, limited. Similarly, the responses by SFMs may not be indicative of actual family member responses in a similar circumstance, however, simulated patients have been used to evaluate clinician behavior for over 30 years and their ratings have established predictive and concurrent validity [18]. Finally, we are limited by the nature of our observational system and it is possible that important aspects of these exchanges were not assessed. It is possible that nonverbal communication, not captured in the global affect ratings, played a role in the disclosure conversations. Recent literature suggests that when disclosing medical errors a good deal of meaning is conveyed by nonverbal cues [22,30]. Clinician nonverbal involvement is associated with higher patient ratings of closeness, trust, empathy, satisfaction and forgiveness, and with lower ratings of patient emotional distress and avoidance [31]. It is possible that clinicians’ empathic statements or verbal apologies were not enough for an effective disclosure if they were not coupled with consistent nonverbal messages. Future studies should investigate the impact of nonverbal communication on error disclosure outcomes. Our findings are that the disclosure of an error is followed by strong negative emotions. Without the skills to respond to the anger, anxiety and sadness that error disclosures are likely to elicit, physicians will have little ability to help their patients, or themselves, through the process. Unfortunately, in Italy medical training programs on error disclosure are relatively underdeveloped and not widely available to practitioners. Only 18% of the clinicians in our study stated that they had a mentor in error disclosure. Given the specificity of these conversations and the importance of the healthcare organizations’ policies, development and evaluation of skills training programs should be a priority [27,32]. 5. Conclusion Our findings suggest that linking apology to an acknowledgment of an error is a relatively uncommon practice among Italian clinicians. Moreover, the type of error affected the practice of disclosure. When the lines of responsibility were shared, clinicians
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disclosed less and the conversations were less patient-centered and affectively dynamic and more task-focused. This should be considered when planning the communication to patients and families. Finally, communicating medical errors elicits strong negative emotions by patients. Clinicians who decide to be transparent with their patients should be prepared to handle these emotions. 6. Practice implications Educational programs on error disclosure should address the context within which an error is committed when communicating with patients and families. Moreover, training should acknowledge the need to acknowledge and respond to negative patient emotions such as anger, sadness and anxiety that error disclosures may elicit. The observed disclosure practice in the Italian context suggests that a revision of the legal system may be necessary in order to encourage greater clinician transparency. Acknowledgements We thank the actors and the clinicians who participated in the study. All authors confirm all personal identifier have been removed or disguised so the persons described are not identifiable and cannot be identified throughout the details of the story. References [1] Institute of Medicine. Committee on Quality of Health Care in America, to err is human: building a safer health system. Washington, DC: National Academy Press; 2000. [2] Joint Commission on Accreditation of Health Care Organizations. Disclosing medical error: a guide to an effective explanation and apology. Oakbrook Terrace, IL: Joint Commission Resources; 2007. [3] Truog RD, Browning RD, Johnson JA, Gallagher TH. Talking with patients and families about medical errors. Baltimore, MD: The John Hopkins University Press; 2011. [4] American Medical Association Council on Ethical and Judicial Affairs. Code of medical ethics, annotated current opinions. Chicago, IL: American Medical Association; 2004–2005. [5] American Nurses Association, Code of ethics for nurses, Nursesbooks, 2015, [Accessed April 10, 2010 at] http://www.nursingworld.org/codeofethics [6] Hannawa AF. Principles of medical ethics: implications for the disclosure of medical errors. Medicoleg Bioeth 2012;2:1–11. [7] Gallagher TH, Garbutt JM, Waterman AD, Flum DR, Larson EB, Waterman BM, et al. Choosing your words carefully: how physicians would disclose harmful medical errors to patients. Arch Intern Med 2006;166:1585–93. [8] Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patients’ and physicians’ attitudes regarding the disclosure of medical errors. J Amer Med Assoc 2003;289:1001–7. [9] Schwappach DLB, Koek CM. What makes an error unacceptable? A factorial survey on the disclosure of medical errors. Int. J. Qual. Health Care 2004;16:317–26. [10] Mazor KM, Simon SR, Yood RA, Martinson BC, Gunter MJ, Reed GW, et al. Health plan members’ views about disclosure of medical errors. Ann Intern Med 2004;140:409–18. [11] Banja J. Medical errors and medical narcissism. Sudbury, MA: Jones and Bartlett Publishers; 2005. [12] Hamm G, Kraman SS. New standards, new dilemmas: reflections on managing medical mistakes. Bioeth Forum 2001;17:19–25. [13] Hannawa AF, Beckman H, Mazor KM, Paul N, Ramsey JV. Building bridges: future directions for medical error disclosure research. Patient Educ Couns 2013;92:319–27. [14] Federazione Nazionale degli Ordini dei Medici Chirurghi e degli Odontoiatri. Codice di Deontologia Medica; 2014. [15] Lamiani G, Meyer EC, Leone D, Vegni E, Browning DM, Rider EA, et al. Crosscultural adaptation of an innovative approach to learning about difficult conversations in healthcare. Med Teach 2011;33:e57–64. [16] Pascucci RC, Weinstock PH, O’Connor BE, Fancy KM, Meyer EC. Integrating actors into a simulation program: a primer. Simul Healthc 2014;9:120–6. [17] Saebø L, Rethans JJ, Johannessen T, Westin S. Standardized patients in general practice-a new method for quality assurance in Noway. Tidsskr Nor Laegeforen 1995;115:3117–9 [in Norwegian]. [18] Beullens J, Rethans JJ, Goedhuys J, Buntinx F. The use of standardized patients in research in general practice. Fam Pract 1997;14:58–62.
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[19] van Vliet LM, van der Wall E, Albada A, Spreeuwenberg PM, Verheul W, Bensing JM. The validity of using analogue patients in practitioner–patient communication research: systematic review and meta-analysis. J Gen Inter Med 2012;27:1528–43. [20] Roter DL, Larson S. The Roter interaction analysis system (RIAS): utility and flexibility for analysis of medical interactions. Patient Educ Couns 2002;46:243–51. [21] Chan DK, Gallagher TH, Reznick R, Levinson W. How surgeons disclose medical errors to patients: a study using standardized patients. Surgery 2005;138:851–8. [22] Hannawa AF. Shedding light on the dark side of doctor–patient interactions: verbal and nonverbal messages physicians communicate during error disclosures. Patient Educ Couns 2011;84:344–51. [23] Reasons J. Human error: models and management. Brit Med J 2000;320:768–70. [24] Blendon RJ, DesRoches CM, Brodie M, Benson JM, Rosen AB, Schneider E, et al. Views of practicing physicians and the public on medical errors. N Engl J Med 2002;347:1933–40. [25] Mazor KM, Reed GW, Yood RA, Fischer MA, Baril J, Gurwitz JH. Disclosure of medical errors. What factors influence how patients respond? J Gen Intern Med 2006;21:704–10.
[26] The Full Disclosure Working Group. When things go wrong: responding to adverse events. A consensus statement of the Harvard hospitals, Massachusetts Coalition for the Prevention of Medical Errors. Boston: The Full Disclosure Working Group; 2006. [27] Gallagher TH, Studdert D, Levinson W. Disclosing harmful medical errors to patients. N Engl J Med 2007;356:2713–9. [28] Erby LA, Roter DL, Biesecker BB. Examination of standardized patient performance: accuracy and consistency of six standardized patients over time. Patient Educ Couns 2011;85:194–200. [29] van der Vleuten C, Swanson D. Assessment of clinical skills with standardized patients: state of the art. Teach Learn Med 1990;2:58–76. [30] Hannawa AF. Disclosing medical errors to patients: effects of nonverbal involvement. Patient Educ Couns 2014;94:310–3. [31] Hannawa AF. Explicitly implicit: examining the importance of physician nonverbal involvement during error disclosures. Swiss Med Wkly 2012;142: w13576. [32] National Quality Forum. Safe practices for better healthcare. Washington, DC: National Quality Forum; 2007 [Accessed June 1, 2007, at] hhttp://www. qualityforum.org/projects/completed/safe_practices/i.
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Patient Education and Counseling journal homepage: www.elsevier.com/locate/pateducou
Communication study
Error disclosure and family members’ reactions: Does the type of error really matter? Daniela Leone a,*, Giulia Lamiani a, Elena Vegni a, Susan Larson b, Debra L. Roter b a b
Department of Health Science, University of Milan, San Paolo University Hospital, Milan, Italy Department of Public Health, John Hopkins University, Baltimore, USA
A R T I C L E I N F O
A B S T R A C T
Article history: Received 2 July 2014 Received in revised form 3 December 2014 Accepted 31 December 2014
Objective: To describe how Italian clinicians disclose medical errors with clear and shared lines of responsibility. Methods: Thirty-eight volunteers were video-recorded in a simulated conversation while communicating a medical error to a simulated family member (SFM). They were assigned to a clear responsibility error scenario or a shared responsibility one. Simulations were coded for: mention of the term ‘‘error’’ and apology; communication content and affect using the Roter Interaction Analysis System. SFMs rated their willingness to have the patient continue care with the clinician. Results: Clinicians referred to an error and/or apologized in 55% of the simulations. The error was disclosed more frequently in the clear responsibility scenario (p < 0.02). When the ‘‘error’’ was explicitly mentioned, the SFM was more attentive, sad and anxious (p 0.05) and less willing to have the patient continue care (p < 0.05). Communication was more patient-centered (p < 0.05) and affectively dynamic with the SFMs showing greater anxiety, sadness, attentiveness and respectfulness in the clear responsibility scenario (p < 0.05). Conclusions: Disclosing errors is not a common practice in Italy. Clinicians disclose less frequently when responsibility is shared and indicative of a system failure. Practice implications: Training programs to improve disclosure practice considering the type of error committed should be implemented. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Medical error Truth disclosure Apology RIAS Simulation
1. Introduction The past decade has brought attention to the number of preventable deaths and injuries attributable to medical errors and they have been identified by healthcare and policy institutes as a major challenge to patient safety [1,2]. Medical errors arise from a complex interaction of human and organizational factors and guidelines regarding honest and transparent disclosure of medical errors have been promulgated [2]. Disclosure of medical errors to patients and families is considered a core aspect of ethical practice [3] and endorsed by professional codes of conduct [4,5]. In 2001, the US Joint Commission on Accreditation of Healthcare Organizations required hospitals to disclose all unanticipated
* Corresponding author at: Department of Health Sciences, Universita` degli Studi di Milano, San Paolo University Hospital, Via di Rudinı` 8, 20142 Milan, Italy. Tel.: +003950323237; fax: +0039 02 50323015. E-mail addresses: [email protected], [email protected] (D. Leone), [email protected] (G. Lamiani), [email protected] (E. Vegni), [email protected] (S. Larson), [email protected] (D.L. Roter). http://dx.doi.org/10.1016/j.pec.2014.12.011 0738-3991/ß 2015 Elsevier Ireland Ltd. All rights reserved.
care outcomes to patients, even those that do not lead to substantial harm. Several studies have identified elements of appropriate disclosure [6,7]. Patients desire an explicit statement that an error has occurred, information about what went wrong and why, specific implications so they can make informed decisions, and a sincere apology by their physician that recognizes their suffering [8]. Competent disclosure has been associated with higher patient satisfaction, greater trust and less sanctions against the physicians [9,10]. Nevertheless, physicians are often reluctant to disclose medical errors because they fear losing their job, being involved in malpractice litigation, jeopardizing the trust of coworkers and facing their own failure [11]. Failure to disclose even hypothetical serious medical errors was reported by Gallagher and colleagues [7] to be as high as 58% based on survey responses of over 2500 medical and surgical physicians in the US and Canada. Willingness to disclose the error was especially low, averaging 32%, when the scenario represented a less obviously apparent error [7]. The emotional pressure commonly experienced after a medical error, coupled with a lack of legal protection, may reinforce
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clinicians’ instincts for self-preservation over their desire and professional obligation to tell patients the truth [12]. Despite growing attention to issues surrounding medical errors worldwide, few studies addressing medical error communication have been conducted within the European context [6,13]. In Italy, a culture of medical transparency is newly emerging and disclosure policies are guided only by the ethical code [14] and ministerial recommendations, not by specific laws. While there are no national initiatives to promote the identification and the analysis of medical errors, the past few years have witnessed the development of programs in regions and local hospitals. The aim of the current study is to contribute to this literature by conducting a small pilot study designed to explore how Italian clinicians disclose medical errors in a simulated encounter with a patient’s family member. Two common medical error scenarios are explored, one with a clear line of responsibility (a drug error) and a second in which shared lines of responsibility are identified reflecting a broader system error (a missed diagnosis and poor patient supervision). We posit the following hypotheses: (1) Clinicians will be more likely to explicitly note that an error was made and offer an apology in the clear compared with shared responsibility scenario. (2) Communication patterns between clinicians and simulated family members (SFM) will be more patient-centered and affectively engaged: (a) in the clear compared with shared responsibility scenario; and, (b) when an error is explicitly noted and an apology made. (3) The SFMs will be more willing to continue care with a clinician who admits an error and offers an apology.
2. Methods 2.1. Participants Participants in the current study were recruited from attendees at a continuing educational Program to Enhance Relational and Communication Skills (PERCS) on error disclosure [15]. Each PERCS workshop lasted 4 h and was open to interdisciplinary participants. The workshop begun with a brainstorming activity and a brief theoretical presentation including systemic definition of medical error. It continued with the enactment of two different scenarios portrayed by volunteering participants and actors, followed by a group discussion. All the enactments were conducted in a separate room and were simultaneously video-recorded and showed live on close-circuit television to the participants in the workshop room. Between 2010 and 2011, ten workshops were conducted in two hospitals in the center and north of Italy. The workshops were attended by 119 clinicians. Thirty-eight of these clinicians voluntarily self-selected to take part in simulations and all of them consented to the current study. In each simulation a physician generally led the conversation, accompanied by a nurse or another health care professional as decided by the participants. Demographic characteristics of participants in the enactments and of all participants to the workshop are reported in Table 1. 2.2. Data collection Two scenarios were developed for use in the workshop to illustrate distinct situations within which a medical error may occur. The first (drug error) was associated with a clear line of responsibility between the physician and the nurse, and the second (undiagnosed encephalopathy and poor patient supervision) reflected shared lines of responsibility as described in Table 2.
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Table 1 Demographic characteristics of participants in the enactments and of all participants to the workshop. Characteristics
Discipline Physician Nurse Other (risk manager, lab technician, mediators, etc.) Age Mean (s.d.) Years of experience Mean (s.d.) Gender Female Male Nationality Italian Other Presence of a mentor in error disclosure No Yes
Participants in the enactments N = 38 20 (53%) 16 (42%) 2 (5%)
46.02 (8.7)
All participants to the workshop N = 119 31 (26%) 49 (43%) 37 (31%)
45.59 (9.49)
19.8 (11.3)
20.12 (10.45)
28 (74%) 10 (26%)
97 (83%) 20 (17%)
37 (97%) 1 (3%)
114 (97%) 3 (3%)
31 (82%) 7 (18%)
95 (81%) 22 (19%)
Twenty simulations were performed (10 for each of the two error scenarios) throughout the conduct of the workshops. In most of the simulations (18 of the 20), two clinicians participated. In two cases, the simulation was conducted by a single clinician. Clinicians participated in only one simulation. Clinicians were oriented to the scenario and asked to communicate that an error had been made in the care of the patient to his/her family member. SFMs followed a script but adapted their emotional reactions and communication content to the clinicians’ communication style [16]. Following the session, the SFM rated their willingness to continue care of the patient with the clinician. Research demonstrated that simulated patients are realistic patient substitutes [17,18]. Specifically, several studies showed that analogue patients’ perceptions of communication largely overlap with clinical patients’ perceptions [19]. The SFMs were psychologists who had training and experience in acting and in assessing clinicians’ communication skills. Four SFMs were used throughout the workshops; two males and two females, ranging in age from 29 to 42. In each workshop the two scenarios were portrayed by two different actors. Two actors were trained to portray the first scenario and two other actors were trained to portray the second scenario. The study was approved by the Ethical Committee of the two participating hospitals. Table 2 Case scenarios used in the program to enhance relational and communication skills (PERCS)-medical error workshop. Clear responsibility scenario: Massimina Pecca is a 67-year-old patient hospitalized for a lung lobectomy. After surgery, the physician orders an infusion of morphine at 1.0 mg/h, using the ‘‘trailing zero’’, a practice prohibited by hospital policy. The nurse, not used to use of trailing zero, reads 10 mg/h and calls the physician asking the reason for such a high dose without mentioning the quantity. The physician replies that the dose is appropriate for the intervention. The nurse then starts the infusion at 10 mg/h causing a respiratory arrest. After admission in the ICU, Massimina recovers completely.
Shared responsibility scenario: Walter Fusi is a 63year-old patient hospitalized due to a chronic hepatopathy. The son reports symptoms of confusion and diarrhea, but the physician misses the diagnosis of encephalopathy. During the night, the patient leaves the ward unsupervised. Despite a search throughout the hospital, the patient is not found until the next day in an administrative building which was mistakenly left unlocked the night before. The patient suffered several bruises.
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2.3. Measures 2.3.1. Error disclosure and apology In order to rate specific elements of error disclosure, a coder reviewed the simulations to document: (1) clinicians’ explicit mention of the word ‘‘error’’ or ‘‘mistake’’; and, (2) clinicians’ explicit apology (for example: ‘‘I am sorry’’, ‘‘We apologize’’). Each simulated conversation was also divided into early, middle and late thirds to facilitate documentation of the placement of the word ‘‘error’’ and the stated apology within the context of the full session. 2.3.2. Communication content The simulations were coded using the Roter Interaction Analysis System (RIAS) [20]. The RIAS is a well validated and widely used coding system for categorizing verbal exchanges in the physician–patient interaction. The unit of analysis for RIAS coding is defined as a statement reflecting a complete thought or phrase, usually a simple sentence or a clause in a compound sentence, or it may be a single world. The statements are assigned to mutually exhaustive and exclusive coding categories applied to all speakers. The system includes 37 parallel patient and clinician codes (a total of 74 coding variables) and a few unique patient and clinician codes. Consequently, every expressed thought made throughout the visit is coded. In this study, a trained coder (DL) coded the simulations using the RIAS software. As in other studies of
this kind, related individual codes were combined to create 10 composite categories each for the clinician and simulator as follows: biomedical questions; psychosocial questions; biomedical information; psychosocial and lifestyle information; facilitation and activation; emotional expression; positive rapport; negative talk, social talk and procedural talk. Examples of the application of the RIAS categories are given in Table 3. In addition, a summary measure of patient-centeredness was used to reflect the overall session style. Consistent with previous studies, patient centeredness was calculated as a ratio of communication elements as follows: all clinician psychosocial and lifestyle categories (including questions and related information and counseling), all SFM questions and psychosocial and lifestyle statements, emotional expressions (both SFM and clinician), and clinician partnership building (asking for opinion, checking understanding, back channel cues of interest) divided by clinician biomedical information, biomedical questions and procedural statements and SFM biomedical information [20]. A random sample of 20% of the simulations were double coded by a second, trained RIAS coder (EV) and revealed high inter-rater agreement of 0.98 using Pearson correlation coefficient across the composites categories. 2.3.3. Emotional tone In addition to communication coding, the global affect of the leading clinician and SFM was rated on a 6-point Likert scale for
Table 3 Examples of the application of the Roter Interaction Analysis System (RIAS) to the enactments. RIAS composite categories Biomedical questions Questions on medical condition and treatment/procedures Lifestyle/psychosocial questions Questions on psychosocial and lifestyle issues Biomedical information Information on medical condition and treatment/procedures Biomedical counseling* (re: medical condition and therapeutic procedures and regimen) Lifestyle/psychosocial information Information on psychosocial and lifestyle issues Psychosocial counseling* (re: lifestyle and psychosocial issues) Emotional expression Concern Giving reassurance Empathy, legitimization
Excerpts from the simulations ‘‘Did your father have diarrhea yesterday?’’ (Clinician) ‘‘Is my mum on the ventilator now?’’ (SFM) ‘‘Does your mother get angry easily?’’ (Clinician) ‘‘How do you think my mother will react when she wakes up?’’ (SFM) ‘‘Your mother suffered from a side effect due to the drug’s dosage’’ (Clinician) ‘‘Yesterday evening my father was talking nonsense’’ (SFM) ‘‘If you see any further signs of distress in your mother, let us know’’ (Clinician)
‘‘We realized that your mother is not a simple person’’ (Clinician) ‘‘My father is a quite lively person’’ (SFM) ‘‘What is important now is to do not upset your mother’’ (Clinician) ‘‘We are so sorry for this’’ (Clinician) ‘‘My mother is in intensive care unit?!?’’(SFM) ‘‘First of all I want to reassure you about your father’s condition’’ (Clinician) ‘‘Now that I know she is well, I am feeling better’’ (SFM) ‘‘I can understand you are upset’’ (Clinician) ‘‘I can see that you cannot check the patients every minute’’ (SFM)
Partnering* ‘‘We are at your disposal for every clarification you need’’ (Clinician) Facilitation/activation Asking for opinion* Asking for understanding Paraphrasing Asking for reassurance Positive rapport Agreements, approvals, compliments Negative talk Disagreements, criticism Social talk (personal) Non medical chit-chat Procedural talk Directions and instructions (re: the medical care process) *
Clinician-only category.
‘‘What do you think about what happened?’’ (Clinician) ‘‘Is it clear?’’ (Clinician) ‘‘You say that yesterday you told the doctor your father was confused?’’ (Clinician) ‘‘So you are saying that he moved around the hospital’’ (SFM) ‘‘Is she well now?!?’’ (SFM) ‘‘I know, you are right.’’ (Clinician) ‘‘Ok, thank you’’ (SFM) ‘‘No I don’t think your father was abandoned!’’ (Clinician) ‘‘Did you poison my mother?!?’’ (SFM) ‘‘Hi, I am the head physician of the ward’’(Clinician) ‘‘I am Mr. Fusi’s daughter’’ (SFM) ‘‘Now my colleague will give you some explanations’’(Clinician) ‘‘First I want to see my mother, and then we’ll talk’’ (SFM)
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the following affective dimensions: anger/irritation, anxiety/ nervousness, dominance/assertiveness, interest/attentiveness, friendliness/warmth, responsiveness/engagement, sympathetic/ empathetic, respectfulness, and interactivity (assigned to both clinician and SFM), depression/sadness and emotional distress/ upset (assigned only to the SFM) and hurried/rushed (assigned only to the clinician). A random sample of 50% of the simulations was double coded by a third coder (GL) to calculate the inter-rater agreement on affect ratings. Ratings within 1 scale point was considered as agreement and inter-rater agreement was good, averaging 81% (range 60–100%). 2.3.4. Likelihood of continuing in care At the end of each simulation, the SFM rated his/her willingness to have their family member continue in care with the leading clinician on a 5-point Likert scale item (1 = absolutely not; 5 = yes, without reservations). 2.4. Data analysis All the statistical analyses were performed with SPSS 19 for Windows. Descriptive statistics were calculated. Chi2 was performed to analyze if the clinicians’ mention of the word error and the presence of apology differed across the two scenarios and across the three parts of the encounter. T-test for independent samples was performed to assess differences in communication, global affect, likelihood to continue physician care across the two error scenarios. T-test was also used to assess if the clinicians use of the word error and the apology affected ratings of SFMs global affect and reported likelihood to continue physician care.
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shared responsibility scenario [m = 0.85 vs 0.52, respectively; (95% CI: 0.02/0.65); p = 0.04]. Inspection of specific communication categories in Table 4 shows that clinicians conveyed significantly less biomedical information (47 vs 63 statements, p = 0.02) but tended to give more lifestyle/psychosocial information (1.8 vs 0.2 statements; p = 0.07) and tended to use fewer facilitation/activation statements (0.3 vs 2.1 statements, p = 0.08) in the clear rather than shared responsibility scenarios. In a parallel manner, the SFM also engaged in more biomedical exchange in the shared responsibility scenario (9.3 vs 4.9 statements, respectively, p = 0.004). SFMs also expressed more emotion in the clear responsibility scenario (36.9 vs 2, respectively, p = .02). 3.3. Emotional tone Coder ratings of clinician global affect did not differ across scenarios (data not shown), but SFM affect ratings were related to scenario (Table 5). SFMs showed greater anxiety, sadness, attentiveness and respectfulness in the clear responsibility scenario. 3.4. Likelihood to continue physician care SFM ratings of likelihood to continue physician care of their family member did not differ across scenarios. Fourteen family members stated they would absolutely or probably want the patient to continue in care, five indicated that they would absolutely or probably not continue, and one was neutral. Likelihood of continuing care was higher in simulations in which the word error was not mentioned [m = 4.4 vs 3.2 (95% CI: 0.14/2.25); p = 0.03]. The offer of an apology did not affect these ratings.
3. Results 4. Discussion and conclusion 3.1. Error disclosure and clinicians’ apology 4.1. Discussion Clinicians first introduced the word ‘‘error’’ or ‘‘mistake’’ in 11 sessions, SFM introduced the term error in 2 sessions and error was not mentioned at all in 7 of the sessions. Clinicians mentioned the word ‘‘error’’ more frequently in the context of clear rather than shared responsibility (8 vs 3 error mentions, respectively; p < 0.02). Clinicians proffered an apology (e.g. ‘‘I’m sorry’’; ‘‘I apologize for this’’) in 11 sessions and there were no differences in the frequency of apologies when responsibility was clear or shared (5 vs 6 apologies, respectively; p > 0.05). In seven simulations clinicians mentioned both the word error and apologized. There were no differences regarding placement (early, middle or toward the end) of the term error or apology over the session (data not presented). In the 13 sessions in which an error was explicitly mentioned, SFMs were rated by coders as appearing more attentive [m = 4.46 vs 4 (95% CI: –0.77/–0.15); p = 0.008], sad [m = 1.69 vs 1.14 (95% CI: –1025/–0.074); p = 0.026] and anxious [m = 4.54 vs 3.71 (95% CI: –165/–0.002); p = 0.05] than in the seven sessions without mention of an error. There were no differences in SFMs affect in sessions with or without a clinician apology. 3.2. Communication content As reflected in Table 4, the simulated conversations averaged 7 min (range = 4.76–11.06 min) and clinicians verbally dominated by a ratio of 2:1, with the SFM contributing 33% of session statements and clinicians contributing 67% of all statements. Neither the length of the conversation nor clinicians verbal dominance differed by scenario. However, session communication was significantly more patient centered in the clear rather than the
While there have been a few US studies that explored how physicians disclose medical errors to patients within a simulation context [21,22], the present study is the first to describe how Italian clinicians are likely to communicate a medical error. Moreover, to our knowledge this is the first simulation study to explore differences in error disclosure under two common but importantly distinct circumstances: clear error responsibility versus shared lines of responsibility indicative of a system failure [23]. Our findings highlight the difficulty clinicians have in being completely transparent in error discussions [24]. We found that explicit reference to errors or mistakes were made by clinicians in only slightly more than half (55%) of the study simulations. Similarly, an explicit apology was apparent in 55% of the simulations. Interestingly, Chan et al. [21] in their 2005 study of error disclosures by US surgeons reported similar rates with 57% of physicians using the words error or mistake and 47% making an explicit verbal apology. More recently, Hannawa [22] reported that virtually all the physicians in her US simulation study included an apology in their error disclosures. However, the quality of the apology was rated as poor and interpreted by the author as a statement of sympathy rather than personal responsibility for harm. Assisting clinicians in developing more transparent and effective disclosure practices constitutes an important step in addressing and ultimately reducing the gap between what it is known in theory and the clinical practice. As hypothesized, we found that clinicians were more likely to explicitly acknowledge that an error occurred in their communication when the lines of responsibility were clear rather than shared. We were surprised, however, that the offer of an apology did not follow suit. Clinicians both mentioned the word error and
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Table 4 Overall characteristics of simulation communication across scenarios. Communication characteristics
Medical error scenario type
Length of sessions (in min) Ratio of clinician to SFM statements Percentage of statements Clinician SFM Overall patient centeredness score RIAS composite categories Biomedical question Clinician SFM Lifestyle/psychosocial questions Clinician SFM Biomedical information Clinician SFM Lifestyle/psychosocial information Clinician SFM Emotional expression Clinician SFM Facilitation/activation Clinician SFM Positive rapport Clinician SFM Negative talk Clinician SFM Social talk (personal) Clinician SFM Procedural talk Clinician SFM
Shared responsibility mean (SD)
7.2 (1.64) 2.2 (0.79)
7.3 (1.8) 2.2 (0.22)
1.29/1.96 0.61/0.65
0.67 0.95
66% 34% 0.85 (0.35) Mean category frequency (SD)
67% 33% 0.52 (0.32) Mean category frequency (SD)
-39.1/9.1 -27.67/17.47 0.02/0.64 95% C I
0.207 0.641 0.04 p-Value
0.1 (0.32) 3.5 (1.9)
1.0 (1.33) 5.8 (2.1)
1.86/0.06 4.18/0.42
0.06 0.02
0.1 (0.32) 0.6 (0.84)
0.1 (0.32) 0.0 (0.0)
0.3/0.3 0.003/1.2
1 0.05
47.3 (11.51) 4.9 (2.47)
63.4(15.58) 9.3 (3.43)
28.97/3.23 7.21/1.59
0.02 0.004
1.8 (2.44) 1.7 (2.16)
0.2 (0.42) 0.9 (1.29)
0.16/3.36 0.87/2.47
0.07 0.33
5.7 (2.83) 36.9 (16.06)
30.5(17.98) 2 (3.65)
9.62/22.42 0.63/6.77
0.41 0.02
0.3 (0.48) 9.5 (3.14)
2.1 (2.88) 9.6(4.06)
3.88/0.28 3.51/3.31
0.08 0.95
9.4 (4.90) 7.3 (6.29)
10.8(5.47) 9.5 (3.98)
6.28/3.48 7.14/2.74
0.55 0.36
2.1 (1.85) 18.9 (14.09)
5.7 (7.1) 20.2(14.41)
8.48/1.28 14.69/12.09
0.14 0.84
4.5 (1.78) 2.6 (1.35)
4.9 (1.91) 3.5 (0.85)
2.13/1.33 1.96/0.16
0.63 0.09
9.9 (3.54) 2.2(1.48)
8.5 (3.48) 1.2 (1.13)
1.89/4.69 0.24/2.24
0.38 0.11
Table 5 Affective ratings of simulated family members across medical error scenarios.
Angry Anxious Sad Emotional distressed Dominant Attentive Friendly Responsiveness Sympathetic Respectful Interactive
Medical error scenario type
95% CI
p-Value
(1.16) (0.95) (0.32) (0.79)
1.69/0.49 0.41/1.79 0.37/1.23 0.26/1.26
0.26 0.004 0.001 0.18
4.2 (0.63) 4 (0.0) 1.7 (0.67) 3.8 (0.42) 1.7 (0.82) 2.9 (0.88) 4 (0.47)
1.11/0.11 0.23/0.97 0.25/0.85 0.1/0.9 0.4/1 0.07/1.53 0.62/0.22
0.1 0.005 0.27 0.11 0.38 0.03 0.33
Clear responsibility Mean affect ratings (SD)
Shared responsibility Mean affect ratings (SD)
3.7 4.8 1.9 4.7
4.3 3.7 1.1 4.2
(1.16) (0.42) (0.57) (0.82)
3.7 (0.67) 4.6 (0.52) 2 (0.47) 4.2 (0.63) 2 (0.67) 3.7 (0.67) 3.8 (0.42)
p-Value
Clear responsibility mean (SD)
apologized in only seven simulations. It appears that clinicians did not necessarily link taking clear responsibility for an error with the offer of an apology. Despite other studies showing that patients appreciate an apology after an error [8], it is possible that clinicians in our study failed to offer an apology because they were fearful of litigation as there is nothing akin to the US Apology Laws [3] in the Italian legal context.
SFM global affect ratings
95% CI
As hypothesized, session communication was more patientcentered and affectively dynamic in the clear rather than shared responsibility scenario. In the clear responsibility scenario, the focus of the verbal exchange was more socio-emotional in nature, the SFM was rated as more attentive, but also more distressed and sad, while in the shared responsibility scenario the verbal exchange was more task-focused and affectively neutral. In a parallel manner, sessions that included an explicit reference to an error compared with others were more affectively dynamic with the SFM being rated as showing greater interest but also more sadness and anxiety. Finally, and contrary to our hypothesis, SFMs willingness to continue the patient in care with the clinician was higher when clinicians did not explicitly acknowledge the medical error. This result is consistent with those of several other studies [3,25,26], suggesting that acknowledgment of an error, as indicated in the error disclosure guidelines [3,27], may not have a positive effect on the interaction, at least in the short run. It is comprehensible that after an error is disclosed there is a breach of trust in the doctor– patient relationship. We agree with others who have concluded that error acknowledgment should be endorsed for ethical reasons, but not necessarily for utilitarian reasons [3,26]. Contrary to our hypothesis, the SFMs willingness to continue care did not differ if the clinician apologized or not. It is possible that the failure to link the apology to acknowledgment of an error might have been perceived by the SFM as a statement of sympathy rather than personal responsibility for harm, as suggested by Hannawa [22].
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The study has several limitations. First, as an exploratory pilot study conducted within the context of a CME program on error disclosure, only one-third of all attendees volunteered to take part in the simulations and consented to participate in the study by making their sessions available for analysis. While volunteers did not differ from non-volunteers in age, years of experience, gender or having a mentor in error disclosure, they are likely to have differed in other ways, including confidence and comfort, and perhaps skills, in conducting an error disclosure simulation. As a consequence, we can only assume that the study observations reflect best rather than common practice. There is a second limitation associated with the conduct of a small exploratory pilot study that is related to the possibility of failing to uncover relationships because of very limited statistical power. Consequently, we note suggested trends indicating clinicians making more lifestyle/psychosocial information (1.8 vs 0.2 statements; p = 0.07) and fewer facilitation/activation statements (0.3 vs 2.1 statements, p = 0.08) in the clear relative to share responsibility scenario. It is also possible that some significant results were spurious suggesting a difference between scenario types by chance because of multiple comparisons. However, we were careful to reduce the large number of communication variables coded by the RIAS to 10 composites and affect ratings for clinician and SFM and only conducted contrasts in line with stated hypotheses. Despite evidence that clinicians’ behavior in simulations are indicative of their clinical behavior with patients [28,29], the extent to which the study results may be generalizable to actual practice is, as noted above, limited. Similarly, the responses by SFMs may not be indicative of actual family member responses in a similar circumstance, however, simulated patients have been used to evaluate clinician behavior for over 30 years and their ratings have established predictive and concurrent validity [18]. Finally, we are limited by the nature of our observational system and it is possible that important aspects of these exchanges were not assessed. It is possible that nonverbal communication, not captured in the global affect ratings, played a role in the disclosure conversations. Recent literature suggests that when disclosing medical errors a good deal of meaning is conveyed by nonverbal cues [22,30]. Clinician nonverbal involvement is associated with higher patient ratings of closeness, trust, empathy, satisfaction and forgiveness, and with lower ratings of patient emotional distress and avoidance [31]. It is possible that clinicians’ empathic statements or verbal apologies were not enough for an effective disclosure if they were not coupled with consistent nonverbal messages. Future studies should investigate the impact of nonverbal communication on error disclosure outcomes. Our findings are that the disclosure of an error is followed by strong negative emotions. Without the skills to respond to the anger, anxiety and sadness that error disclosures are likely to elicit, physicians will have little ability to help their patients, or themselves, through the process. Unfortunately, in Italy medical training programs on error disclosure are relatively underdeveloped and not widely available to practitioners. Only 18% of the clinicians in our study stated that they had a mentor in error disclosure. Given the specificity of these conversations and the importance of the healthcare organizations’ policies, development and evaluation of skills training programs should be a priority [27,32]. 5. Conclusion Our findings suggest that linking apology to an acknowledgment of an error is a relatively uncommon practice among Italian clinicians. Moreover, the type of error affected the practice of disclosure. When the lines of responsibility were shared, clinicians
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disclosed less and the conversations were less patient-centered and affectively dynamic and more task-focused. This should be considered when planning the communication to patients and families. Finally, communicating medical errors elicits strong negative emotions by patients. Clinicians who decide to be transparent with their patients should be prepared to handle these emotions. 6. Practice implications Educational programs on error disclosure should address the context within which an error is committed when communicating with patients and families. Moreover, training should acknowledge the need to acknowledge and respond to negative patient emotions such as anger, sadness and anxiety that error disclosures may elicit. The observed disclosure practice in the Italian context suggests that a revision of the legal system may be necessary in order to encourage greater clinician transparency. Acknowledgements We thank the actors and the clinicians who participated in the study. All authors confirm all personal identifier have been removed or disguised so the persons described are not identifiable and cannot be identified throughout the details of the story. References [1] Institute of Medicine. Committee on Quality of Health Care in America, to err is human: building a safer health system. Washington, DC: National Academy Press; 2000. [2] Joint Commission on Accreditation of Health Care Organizations. Disclosing medical error: a guide to an effective explanation and apology. Oakbrook Terrace, IL: Joint Commission Resources; 2007. [3] Truog RD, Browning RD, Johnson JA, Gallagher TH. Talking with patients and families about medical errors. Baltimore, MD: The John Hopkins University Press; 2011. [4] American Medical Association Council on Ethical and Judicial Affairs. Code of medical ethics, annotated current opinions. Chicago, IL: American Medical Association; 2004–2005. [5] American Nurses Association, Code of ethics for nurses, Nursesbooks, 2015, [Accessed April 10, 2010 at] http://www.nursingworld.org/codeofethics [6] Hannawa AF. Principles of medical ethics: implications for the disclosure of medical errors. Medicoleg Bioeth 2012;2:1–11. [7] Gallagher TH, Garbutt JM, Waterman AD, Flum DR, Larson EB, Waterman BM, et al. Choosing your words carefully: how physicians would disclose harmful medical errors to patients. Arch Intern Med 2006;166:1585–93. [8] Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patients’ and physicians’ attitudes regarding the disclosure of medical errors. J Amer Med Assoc 2003;289:1001–7. [9] Schwappach DLB, Koek CM. What makes an error unacceptable? A factorial survey on the disclosure of medical errors. Int. J. Qual. Health Care 2004;16:317–26. [10] Mazor KM, Simon SR, Yood RA, Martinson BC, Gunter MJ, Reed GW, et al. Health plan members’ views about disclosure of medical errors. Ann Intern Med 2004;140:409–18. [11] Banja J. Medical errors and medical narcissism. Sudbury, MA: Jones and Bartlett Publishers; 2005. [12] Hamm G, Kraman SS. New standards, new dilemmas: reflections on managing medical mistakes. Bioeth Forum 2001;17:19–25. [13] Hannawa AF, Beckman H, Mazor KM, Paul N, Ramsey JV. Building bridges: future directions for medical error disclosure research. Patient Educ Couns 2013;92:319–27. [14] Federazione Nazionale degli Ordini dei Medici Chirurghi e degli Odontoiatri. Codice di Deontologia Medica; 2014. [15] Lamiani G, Meyer EC, Leone D, Vegni E, Browning DM, Rider EA, et al. Crosscultural adaptation of an innovative approach to learning about difficult conversations in healthcare. Med Teach 2011;33:e57–64. [16] Pascucci RC, Weinstock PH, O’Connor BE, Fancy KM, Meyer EC. Integrating actors into a simulation program: a primer. Simul Healthc 2014;9:120–6. [17] Saebø L, Rethans JJ, Johannessen T, Westin S. Standardized patients in general practice-a new method for quality assurance in Noway. Tidsskr Nor Laegeforen 1995;115:3117–9 [in Norwegian]. [18] Beullens J, Rethans JJ, Goedhuys J, Buntinx F. The use of standardized patients in research in general practice. Fam Pract 1997;14:58–62.
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