Document Type : Original article
Subjects
Abstract
Background: It is well known that disclosure of Medical Errors (MEs) is the duty of physicians and it is the right of patients to be aware of any error occurring in their medical care process. This study was planned to asses to what extent the patients expect to be informed of the occurrence of MEs, they prefer who reports the medical error to them, and what are the influential factors in taking legal action against physicians in disclosed MEs from their point of view.
Methods: In this cross-sectional study, eligible patients admitted to academic hospitals of Guilan (Poorsina; Razi; Alzahra; Amir Al-Momenin; Dr. Heshmat), were interviewed directly and a questionnaire which was divided into four sections was filled out. The first part was about socio-demographic data of the responders and the next three sections included their preferences towards the type of MEs to be disclosed, who is responsible for this task, and in which conditions they sue against the medical team.
Results: About 96.6% of the patients believed that MEs had to be disclosed to the patients. Moreover, 29.3% preferred to be informed about all MEs that occurred during their medical care even if it caused no harm. 51.1% expected that physician who committed the error informs the error. On the whole age, gender, employment status, residency and education were among the influential factors of the patients’ willingness and point of view and filing a lawsuit against physicians.
Conclusion: Based on the findings of this study, it is recommended that all minor and major MEs should be disclosed sympathetically by the physician who committed the error.
Keywords: Medical errors, Physicians, Research report
Introduction
Medical Errors (MEs) are defined as a preventable adverse effect of care, whether or not it is evident or harmful to the patient. MEs include medication, diagnostic advise, surgical procedures and falls. Under this situation, which is unpredictable, informed consent cannot be obtained. MEs could be harmful to the patient in different degrees or restricted to near miss, since the error was detected in time or the patient was just lucky (1,2).
Regardless of the outcome of a ME when it occurs, it should be reported and also disclosed to the patient. The correct process of ME disclosure comprises clear statement that the error or even a reversible complication occurred, by whom, the reason and the way to prevent it, and ultimately an apology (3,4). In terms of near-miss ME disclosure to the patients, different approaches have been considered. Some scholars believe that when an ME has not resulted in any complication, disclosing it to the patient may lead to increased stress and anxiety (5,6). Another challenging aspect of the issue is who is responsible to disclose MEs. It is well known that with respect to preferences and attitudes of the patients towards ME reporting, several benefits are associated with it. However, despite valuable literature in this field, there are still several unanswered questions such as patients’ attitude and preferences toward the issue. In general, the issue is very challenging and studies have pointed to the necessity of integrating the concept of the legislation training courses in the curriculum at undergraduate and postgraduate levels, including physicians and nursing (7-9). It should be noted that studies in Iran have also emphasized this issue (10).
Obviously, due to the differences in cultures and beliefs, the findings of other studies could not be translated to other areas. To the best our knowledge, most studies in this field have been conducted in the West and it is the first study in Guilan province that planned to obtain empirical evidence on patients’ views on MEs disclosure.
Materials and Methods
After the approval of the study protocol by the Research Ethics Committee, this cross-sectional descriptive study was conducted in academic hospitals affiliated with Guilan University of Medical Sciences (GUMS) (Poorsina; Razi; Alzahra; Amir Al-Momenin; Dr. Heshmat). Firstly, the purpose of the study was explained to the patients and informed consent was obtained.
Inclusion criteria: Guilan resident patients, aged above 18, hospitalized in Guilan academic centers, and being able to communicate.
Exclusion criteria
Difficulties in communication such as different languages or speaking disorders, not agreed to participate and migrated from other areas. The data collection tool was a questionnaire taken from the study of Hammami et al (11) which was filled out via a face-to-face interview. The questionnaire was translated from the English version using the backward-forward method and its content validity was confirmed by 10 faculty members. In order to evaluate the stability and clarity of the mentioned questionnaires, the translated version was tested on 30 patients. The questionnaires were divided into four parts including socio-demographic data (gender, age, and level of education and patients’ place of residency) and three sections assessing their preferences towards which type of MEs should be disclosed, who is responsible for this task, and in which conditions they sue against the medical team.
Statistical analysis
The achieved data were analyzed by Statistical Package for the Social Sciences software (SPSS) version 21 Armonk, NY: IBM Corp. Frequency, mean and standard deviation were used to describe the data. In order to analyze the data, considering the necessary preconditions, independent T test, chi square and Fisher’s exact test were utilized. A p-value of less than 0.05 was considered significant.
Sample size
According to Hammami et al’s study reverence (11), in which 22.7% of the participants preferred that minor errors should be reported, and considering 95% confidence interval and a 5% margin of error, a sample size of 270 was calculated.
Results
Finally, the data from 270 patients (60% male), with the mean age of 39.12±14.5 years were analyzed. Participants with diploma (34.1%), employed (51.9%), married (64.1%) and urban dwellers (81.9%) constituted the highest percentage of the study subjects, and merely 3.3% of patients had a history of complaining against medical team (Table 1). Regarding the provision of ME reports to the patients, 36.6% of the responders selected the item “I prefer to be informed about a ME that occurred during my medical care if it caused a major harm”, followed by the option “I prefer to be informed about all MEs that occurred during my medical care even if it did not cause any harm” (29.3%). Considering the responsible person providing the error report, the option “I prefer that the physician who committed the ME, informs me about the ME that occurred to me” (51.5%) was the most chosen answer. The majority of patients (64.1%) stated that “I will complain in case of major harm” (Table 2). There was a statistically significant relationship between patients’ preferences regarding the disclosure of MEs according to their individual characteristics such as gender, age, education, and place of residence. As most female patients (39.8), those under 40 years old (36.4), with a diploma (33.7) or university education (52.7), and urban residents (31.2) tended to be aware of medical errors even without any harm. But the majority of men (35.8), individuals over 40 years old (36.1), illiterate (48.7) or less than a diploma (38.5), and rural residents (45.9) tended to be aware of MEs only in case of serious harms. Also, patients who had a history of legal action against doctors, significantly expected more to be aware of MEs even without any harm (77.8) (p<0.05) (Table 3). Furthermore, a significant association was found between patients’ preferences for the person presenting them the error in terms of gender (p=0.003), age (p=0.001), education (p=0.006), place of residence (p=0.048), employment status (p=0.029), and marital status (p=0.001).
Table 1. Demographic data of the responders
|
Variables |
Status |
Number (percent) |
|
Gender |
Male |
162(60) |
|
Female |
108(40) |
|
|
Age (year) |
<40 |
162(60) |
|
>40 |
108(40) |
|
|
Age (year) Mean±SD (min-max) |
39.12±14.5 (13-79) |
|
|
Level of education |
Illiterate |
39(14.4) |
|
Elementary- secondary school |
65(24.1) |
|
|
Diploma |
92(34.1) |
|
|
University degree |
74(27.4) |
|
|
Employment status |
Employed |
140(51.9) |
|
Unemployed |
120(44.4) |
|
|
Medical staff |
10(3.7) |
|
|
Marital status |
Single |
94(34.8) |
|
Married |
173(64.1) |
|
|
Divorced |
3(1.1) |
|
|
Residency |
Urban |
221(81.9) |
|
Rural |
49(18.1) |
|
|
History of complaint against doctors |
Yes |
9(3.3) |
|
No |
261(96.7) |
|
Table 2. The frequency of patients’ preferences regarding disclosure of medical errors
|
Questions |
Patients’ preferences |
Number (percent) |
|
Which type of error should be disclosed? |
I prefer not to be informed about any medical error that occurred during my medical care |
20(7.4) |
|
I prefer to be informed about any medical error that occurred during my medical care |
250(96.6) |
|
|
I prefer to be informed about a medical error that occurred during my medical care if it caused a major harm |
88(32.6) |
|
|
I prefer to be informed about a medical error that occurred during my medical care if it caused at least a moderate harm |
37(13.7) |
|
|
I prefer to be informed about a medical error that occurred during my medical care if it caused any harm, even a minor one |
46(17) |
|
|
I prefer to be informed about all medical error that occurred during my medical care even if it did not cause any harm |
79(29.3) |
|
|
Who should disclose the error? |
Any employee in the hospital can inform me about the medical error that occurred to me |
45(16.7) |
|
Any physician in the hospital can inform me about the medical error that occurred to me |
21(7.8) |
|
|
I prefer that the physician who committed the medical error informs me about the medical error that occurred to me |
139(51.5) |
|
|
I prefer that the direct manager of the physician who committed the medical error informs me about the medical error that occurred to me |
36(13.3) |
|
|
I prefer that the medical director of the hospital informs me about the medical error that occurred to me |
10(3.7) |
|
|
I prefer that the chief executive director of the hospital informs me about the medical error that occurred to me |
19(7) |
|
|
Under what conditions do you take legal action against the doctor? |
I will not complain |
44(16.3) |
|
I will complain in case of major harm |
173(64.1) |
|
|
I will complain in case of any kind of harm |
41(15.2) |
|
|
I will complain even if there is no harm |
12(4.4) |
Table 3. The frequency of patients responses regarding preferences for disclosure of medical errors according to demographic variables
|
Variables |
Status |
Unwillingness to be aware of the medical errors |
Willing to be aware of medical errors with major harms |
Willing to be aware of medical errors with moderate harms |
willing to be aware of medical errors with minor harms |
Willingness to be aware of medical error even without harms |
p-value |
|
Number (percent) |
Number (percent) |
Number (percent) |
Number (percent) |
Number (percent) |
|||
|
Gender |
Male |
16(9.9) |
58(35.8) |
23(14.2) |
29(17.9) |
36(22.2) |
0.02 |
|
Female |
4(3.7) |
30(27.8) |
14(13) |
17(15.7) |
43(39.8) |
||
|
Age (year) |
<40 |
7(4.3) |
49(30.2) |
20(12.3) |
27(16.7) |
59(36.4) |
0.009 |
|
>40 |
13(12) |
39(36.1) |
17(15.7) |
19(17.6) |
20(18.5) |
||
|
Level of education |
Illiterate |
11(28.2) |
19(48.7) |
1(2.6) |
6(15.4) |
2(5.1) |
0.001 |
|
Elementary-Secondary school |
5(7.7) |
25(38.5) |
11(16.9) |
17(26.2) |
7(10.8) |
||
|
Diploma |
4(4.3) |
29(31.5) |
15(16.3) |
13(14.1) |
31(33.7) |
||
|
University degree |
0(0) |
15(20.3) |
10(13.5) |
10(13.5) |
39(52.7) |
||
|
Employment status |
Employed |
7(5) |
42(30) |
28(20) |
23(16.4) |
40(28.6) |
0.09 |
|
Unemployed |
13(10.8) |
42(35) |
9(7.5) |
21(17.5) |
35(29.2) |
||
|
Medical staff |
0(0) |
4(40) |
0(0) |
2(20) |
4(40) |
||
|
Marital status |
Single |
5(5.3) |
31(33) |
8(8.5) |
17(18.1) |
33(35.1) |
0.379 |
|
Married |
15(8.7) |
56(32.4) |
29(16.8) |
29(16.8) |
44(25.4) |
||
|
Divorced |
0(0) |
1(33.3) |
0(0) |
0(0) |
2(66.7) |
||
|
Residency |
Urban |
12(5.4) |
65(29.4) |
37(16.7) |
38(17.2) |
69(31.2) |
0.0001 |
|
Rural |
8(16.3) |
23(45.9) |
0(0) |
8(16.3) |
10(20.4) |
||
|
History of complaints against doctors |
Yes |
0(0) |
0(0) |
2(22.2) |
0(0) |
7(77.8) |
0.01 |
|
No |
20(7.7) |
88(33.7) |
35(13.4) |
46(17.6) |
72(27.6) |
Table 4. Frequency of patient responses regarding their preferences regarding who should disclose errors based on demographic variables
|
Variables |
Status |
Any employee in the hospital |
Any physician in the hospital |
The physician who committed the medical error |
Direct manager of the physician who committed the medical error |
The medical director of the hospital |
chief executive director of the hospital |
p-value |
|
Number (percent) |
Number (percent) |
Number (percent) |
Number (percent) |
Number (percent) |
Number (percent) |
|||
|
Gender |
Male |
29(17.9) |
7(4.3) |
83(51.2) |
30(18.5) |
4(2.5) |
9(5.6) |
0.003 |
|
Female |
16(14.8) |
14(13) |
56(51.9) |
6(5.6) |
6(5.6) |
10(9.3) |
||
|
Age (year) |
<40 |
27(16.7) |
7(4.3) |
83(51.2) |
16(9.9) |
10(6.2) |
19(11.7) |
0.001 |
|
>40 |
18(16.7) |
14(13) |
56(51.9) |
20(18.5) |
0(0) |
0(0) |
||
|
Level of education |
Illiterate |
12(30.8) |
5(12.8) |
19(48.7) |
3(7.7) |
0(0) |
0(0) |
0.006 |
|
Elementary-Secondary school |
12(18.5) |
6(9.2) |
41(63.1) |
4(6.2) |
0(0) |
2(3.1) |
||
|
Diploma |
12(13) |
7(7.6) |
43(46.7) |
17(18.5) |
6(6.5) |
7(7.6) |
||
|
University degree |
9(12.2) |
3(4.1) |
36(48.6) |
12(16.2) |
4(5.4) |
10(13.5) |
||
|
Employment status |
Employed |
23(16.4) |
5(3.6) |
73(52.1) |
26(18.6) |
6(4.3) |
7(5) |
0.029 |
|
Unemployed |
22(18.3) |
14(11.7) |
60(50) |
10(8.3) |
4(3.3) |
10(8.3) |
||
|
Medical staff |
0(0) |
2(20) |
6(60) |
0(0) |
0(0) |
2(20) |
||
|
Marital status |
Single |
10(10.6) |
3(3.2) |
53(56.4) |
9(9.6) |
9(9.6) |
10(10.6) |
0.001 |
|
Married |
35(20.2) |
18(10.4) |
83(48) |
27(15.6) |
1(0.6) |
9(5.2) |
||
|
Divorced |
0(0) |
0(0) |
3(100) |
0(0) |
0(0) |
0(0) |
||
|
Residency |
Urban |
32(14.5) |
18(8.1) |
110(49.8) |
34(15.4) |
10(4.5) |
17(7.7) |
0.048 |
|
Rural |
13(26.5) |
3(6.1) |
29(59.2) |
2(4.1) |
0(0) |
2(4.1) |
||
|
History of complaints against doctors |
Yes |
0(0) |
0(0) |
2(22.2) |
4(44.4) |
1(11.1) |
2(22.2) |
0.01 |
|
No |
45(17.2) |
21(8) |
137(52.5) |
32(12.3) |
9(3.4) |
17(6.5) |
It was also notable that patients with a history of complaining against doctors, significantly more preferred to be informed about the error by the direct manager of the therapeutic team (44.4%), while others believed that at-fault doctor was responsible for this task (52.5%) (p=0.01) (Table 4). A statistically significant relationship was observed between reactions of the patients towards disclosure of MEs and their gender (p=0.001), age (p=0.003), education (p=0.0001), place of residency (p=0.0001), employment status (p=0.005) and history of complaints against doctors (p=0.036). As the majority of illiterate individuals (56.4%) stated that they will not complain in any case, but those with higher education stated that they will complain in case of serious harms (Table 5).
Table 5. The frequency of patients responses regarding their reactions in case of disclosure of medical errors based on demographic variables
|
Variables |
Status |
I will not complain
|
I will complain in case of major harm |
I will complain in case of any kind of harm |
I will complain even if there is no harm |
p-value |
|
Number (percent) |
Number (percent) |
Number (percent) |
Number (percent) |
|||
|
Gender |
Male |
25(21.6) |
105(64.8) |
19(11.7) |
3(1.9) |
0.001 |
|
Female |
9(8.3) |
68(63) |
22(20.4) |
9(8.3) |
||
|
Age (year) |
|
16(9.9) |
108(66.7) |
30(18.5) |
8(4.9) |
0.003 |
|
|
28(25.9) |
65(60.2) |
11(10.2) |
4(3.7) |
||
|
Level of education |
Illiterate |
22(56.4) |
13(33.3) |
4(10.3) |
0(0) |
0.0001 |
|
Elementary-Secondary school |
10(15.4) |
47(72.3) |
7(10.8) |
1(1.5) |
||
|
Diploma |
5(5.4) |
64(69.6) |
15(16.3) |
8(8.7) |
||
|
University degree |
7(9.5) |
49(66.2) |
15(20.3) |
3(4) |
||
|
Employment status |
Employed |
27(19.3) |
95(67.9) |
18(12.9) |
0(0) |
0.005 |
|
Unemployed |
15(12.5) |
72(60) |
21(17.5) |
12(10) |
||
|
Medical staff |
2(20) |
6(60) |
2(20) |
0(0) |
||
|
Marital status |
Single |
11(11.7) |
60(63.8) |
19(20.2) |
4(4.3) |
0.423 |
|
Married |
33(19.1) |
110(63.6) |
22(12.7) |
8(4.6) |
||
|
Divorced |
0(0) |
3(100) |
0(0) |
0(0) |
||
|
Residency |
Urban |
23(10.4) |
147(66.5) |
39(17.6) |
12(5.4) |
0.0001 |
|
Rural |
21(42.9) |
26(53.1) |
2(4.1) |
0(0) |
||
|
History of complaints against doctors |
Yes |
0(0) |
5(55.6) |
2(22.2) |
2(22.2) |
0.036 |
|
No |
44(16.9) |
168(64.4) |
39(14.9) |
10(3.8) |
Discussion
This survey was planned to investigate the views of patients on the pattern of MEs disclosure by medical team, in Guilan; Northern Iran. Studies have shown that physicians’ empathic apology when a ME occurs, leads to better patient feeling, as he/she appreciates that the at-fault physician is also suffering. Thus, the suspension and anger of the patients would be smoothened. In fact, an apology that is properly worded and reflects empathy, leads to a better doctor-patient relationship and forgiveness (12,13). Indeed, compassion is a vital concept that plays an important role in both medical care and ethical issues (14).
In a similar study conducted by Hammami MM et al in the Arab population, it was found that 60% of the responders would prefer to be informed about all types of MEs resulting in harm or not, and 4.5% of all believed that MEs disclosure is not necessary and cannot improve the conditions. In addition, 63% of the patients expected that the at-fault physician disclosed the ME and gave them an explanation. They found that older patients significantly preferred that they should be informed of near-miss MEs and the main care physician gave them the required information. In their study, a higher level of education was associated with a greater preference for being informed about MEs (11). Ock M et al from Korea reported that 99.9% of the responders believed that MEs should be clearly discussed with the patient and 93.3% wanted to know even about near misses. 96.6% of them stated that MEs disclosure results in patients’ safety as physicians pay more attention to the treatment process and 94.1% agreed that they would trust the doctors more in this way (15). Norrish et al from Oman demonstrated that only 5% of their cases did not want to be informed of MEs. 60% reported that the physician had to inform the patient a ME even without an injury. 27% believed that no type of ME, even serious errors would not be disclosed by the medical team (16). According to Gu et al’s study conducted in China, almost all the responders asked to be informed about all types of MEs reached them. They also believed that the guilty physician should give them a complete and detailed explanation, via a face-to-face conversation immediately after the error occurred (17).
Ushie et al from Nigeria reported that most of the responders were mistrustful of the MEs disclosure process. The biggest triggers to litigation were the severity of the error and the negligence of the physicians. They stated that disclosure of MEs by physicians reduced the patients’ intention to act against them. They also mentioned that financial difficulties and economic problems originated from MEs, lead to legal actions (18). Heidari et al from Iran reported that 99.1% of their patients expected to be informed of MEs. Also, 93.1% of them believed that it was the duty of doctors to give them an explanation of the event. They also declared that physicians’ honesty and planning to treat the complication were the two main factors preventing them from dealing legally with doctors (19). As mentioned above, the results of studies are not the same. It should be noted that area-specific situations were important and the studied population was different in terms of beliefs and culture. Furthermore, the study questionnaires and the way of filling them were among the influential factors. Obviously, a direct interview at the right time by an expert, results in more accurate findings, compared to sending the questionnaire by e-mail. Moreover, the attitude of patients exposed to MEs differs from other individuals according to their previous experiences. Whether the physician at fault had empathetically communicated with the real victims and attempted to treat the complication or who ignored the error with no apology drew different responses. Finally, due to the extremely limited literature in our country, more studies are welcomed to answer many questions, such as how much empathy and attempt of physician to apology work, in other words, how much sympathy and regret of the doctor is reasonable.
Limitations
This study took place at academic centers and the private sector was excluded; hence our findings could not be generalized. Moreover, we did not compare individuals who were actually exposed to MEs with those who were randomly interviewed. Definitely, the attitude of a patient who himself or a close relative has been affected by MEs is very different from a person who imagines how would react in that situation. Due to the lack of similar studies in our country let alone in Guilan province, we could not compare these findings with other studies. Furthermore, we could not compare patients’ preferences and wishes toward ME disclosure with the actual performance of physicians to discover the real gaps in this field.
Conclusion
The outcomes of this survey provide evidence of how patients react to MEs and their main expectations. This opens up a picture for caregivers to better communicate with patients. Further well-planned studies are strongly recommended to limit the gap between patients’ wishes and expectations toward MEs disclosure and clinicians’ professionalism in the real world.
Acknowledgement
The authors would like to thank members of the Anesthesiology Research Center, Guilan University of Medical Sciences, Mohadese Ahmadi, and Mahin Tayefeh Ashrafie, for their collaboration in this study. This study protocol was approved by the Research Ethics Committee of the Guilan University of Medical Sciences: (Ref: IR.GUMS.REC.1401.547).
Conflict of Interest
The authors declared no conflict of interest.
References