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Abstract
Background Medical error (ME) is a serious public health problem and a leading cause of death. The reported adverse incidents in China were much less than western countries, and the research on patient safety in rural China’s primary care institutions was scarce. This study aims to identify the factors contributing to the under-reporting of ME among general practitioners in township health centres (THCs).
Methods A qualitative semi-structured interview study was conducted with 31 general practitioners working in 30 THCs across 6 provinces. Thematic analysis was conducted using a grounded theory approach.
Results The understanding of ME was not unified, from only mild consequence to only almost equivalent to medical malpractice. Common coping strategies for THCs after ME occurs included concealing and punishment. None of the participants reported adverse events through the National Clinical Improvement System website since they worked in THCs. Discussions about ME always focused on physicians rather than the system.
Conclusions The low reported incidence of ME could be explained by unclear concept, unawareness and blame culture. It is imperative to provide supportive environment, patient safety training and good examples of error-based improvements to rural primary care institutions so that ME could be fully discussed, and systemic factors of ME could be recognised and improved there in the future.
- Medical error, measurement/epidemiology
- Incident reporting
- Safety culture
- Attitudes
- PRIMARY CARE
Data availability statement
Data are available upon reasonable request. The data that support the findings of this study are available from the Vanke School of Public Health, Tsinghua University (email: lihange@tsinghua.edu.cn), on reasonable request. The interview data are in Chinese. Further consent for using by other institutions should be obtained from the interviewees.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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WHAT IS ALREADY KNOWN ON THIS TOPIC
The level of medical institution could significantly impact patient safety reporting attitudes. The self-reported incidence of medical error was very low in rural China in our previous survey.
WHAT THIS STUDY ADDS
This study, across thirty township health centres in six provinces, explores how general practitioners conceptualise medical error and how the township health centres cope with medical errors. The understanding of medical error is not unified and punishing healthcare professionals for medical error prevails.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
This study reveals the insufficient attention given to medical errors in primary care institutions in rural areas and calls for the urgency to improve safety culture there.
Introduction
Patient safety is a bottom-line issue in healthcare. Unfortunately, as medical science and healthcare system are extensive and complicated, medical error (ME) has been verified to be a serious public health problem and a leading cause of death.1–3
Blaming and punishing for ME made by well-intentioned health workers alienates them to prevent such problem from recurring,4 so that a culture of blame must be broke down.1 5 In the meantime, we all wished it might be possible for the bad experience suffered by one patient to become a source of transmitted learning that benefits future patients.6 7 In 2005, WHO published a guideline to help countries to develop reporting systems in order to improve patient safety.8 After almost 20 years, the patient safety research was unequally distributed (mostly from North America) and research on incident reporting was underrepresented.9 In addition, the level of hospital could significantly impact attitudes toward incident reporting.10 11
The Chinese government embarked on calling for proactive reporting of medical safety (adverse) event in 2007. The national reporting system was developed in 2011 and became the predecessor of the present China’s National Clinical Improvement System (www.ncis.cn).12 Since 2015, the National Health Commission of the People’s Republic of China annually published the National Report on the Service, Quality and Safety in Medical Care System. The adverse events reported in Chinese hospitals was around 1 per 100 hospitalisations,13 much less than western countries.14 15 Previous study showed that the safety culture was not sufficiently established at Chinese tertiary hospitals.16 17 To make things worse, China’s annual national report failed to provide the incidence of adverse events in primary care institutions. Little evidence exists on the safety of medical care currently delivered in rural China.18 19
To explore the status quo of patient safety in rural China, from December 2021 to February 2022, we conducted an anonymous questionnaire survey in township health centres (THCs) in nine provinces. Typically, a THC has 10–20 physicians and a total of 40 staff to provide essential medical and public health services to rural population.20 THCs act as the hub in rural areas, as shown in figure 1. The respondents were all members of a compulsory service programme initiated by the Chinese government since 2010.21 This programme sponsored medical students for their 5-year bachelor education and 3-year standardised residency training. In return, the grantees were required to serve in designated THCs as general practitioners for 3 years.22 23 For the question ‘Are you concerned you have made any medical errors that harmed patients in the last 3 months?’, only 1.6% (50/3087) of the participants answered ‘yes’. The question was based on similar measurements from western surveys,24 and this rate was 13.3% among the US physicians in family medicine.25 Why is the self-reported rate of ME so low in rural China? The aim of this study is to find out the current perspectives on ME held by general practitioners in THCs and to seek the explanations for low self-reported rate of ME in rural China.
The organisation of health care system in China. Township health centres provide primary medical service and basic public health service in rural areas.
Methods
Design, setting and participants
This study was conducted in the central and western part of China where the compulsory service programme was implemented. The participating physicians were all members of national compulsory service programme and were recruited by purposive and snowball sampling for feasibility considerations, as not all township health centres have this kind of physicians. The seeds were provided by the National Health Commission, and other participants were referred by the seeds. All the participants were interviewed separately to avoid mutual inspirations. The interviews lasted 20–70 min. An online informed consent was obtained. Participants were offered ¥200 as incentives to complete the interview. Recruitment ceased when data saturation was achieved. The final sample consisted of 31 participants.
Data collection
Author HL, with both clinical and management experience, conducted or observed all interviews from November 2022 to March 2023. Due to the COVID-19 pandemic, all the interviews were online via video (Tencent Meeting).
The interview guide included several open-ended questions to collect their perceptions on ME from multiple aspects: the concept of ME, the incidence of ME in his/her THC, the attitude towards ME and the management after ME happens (box 1). All the interviews were audio-recorded and transcribed verbatim.
The interview guide
Open ended questions:
From your own perspective, what is the concept of medical error?
What is the difference between medical error and medical malpractice? *
In a previous questionnaire, participants were asked: ‘Are you concerned you have made any medical errors that harmed patients in the last 3 months?’ The proportion of the respondents who answered ‘yes’ was 1.6%. Do you think the result is reasonable? Or is there any bias in the result?
Do you think that a doctor who made a medical error is not a good doctor? Why?
What is the management or measures if a doctor in your township health centre realise that a medical error was made?
*This question was added since the fifth participant.
Data analysis
Thematic analysis was used and conducted using NVivo V.12 software. Two of the investigators (HL and ZG) independently coded the transcripts, and developed a list of main themes and subthemes using a grounded theory approach. The preliminary themes were reviewed by the entire research team. Discrepancies were settled by a third investigator WY, who also has both clinical and management experience, to form the final set of themes.
Patient and public involvement
While patients and the public were important in developing safety culture, they were not actively involved in the design, or conduct, or reporting, or dissemination plans of this research as this research focused on the perceptions of physicians.
Results
The data saturation was achieved after 23 interviews, confirmed with 8 interviews. Among the 31 participants, 23 were men and 8 were women, with the age between 27 and 36 years, as shown in table 1. They worked in 30 different THCs of 6 provinces in China for 0–4 years. About half of the participants had administrative posts such as vice president of the THC and director of the department of general practice. The key themes are outlined in table 2.
Demographic characteristics of the participants
Key themes
The concept of ME
When asked ‘From your own perspective, what is the concept of medical error?’, a few participants confessed that they do not know the concept well. Many participants emphasised the essence of ‘error’. Various synonyms of ‘error’ such as ‘fault’, ‘mistake’ and ‘omission’ were mentioned, as well as some words with moral concerns, for example, ‘reckless’ (GP19) and ‘irresponsible’ (GP11). ‘I think medical error involves drug dosage, drug usage not standard or unreasonable, and drug contraindication. Also included are missed diagnosis, wrong diagnosis, inappropriate treatment or delayed treatment.’ (GP12).
Some participants proposed that MEs were incidents that caused harm to patients. ‘I think medical error means that it causes some financial, mental or physical damage to patients due to medical treatment.’ (GP1). The word ‘damage’ was used by many participants. Others mentioned ‘loss’ (GP14), ‘disease aggravation’ (GP25) and ‘adverse outcome’ (GP30).
As to the relationship between ME and medical malpractice, major differences exist. Some believed ME comprised medical malpractice because ‘medical error is broader’ (GP15) and ‘no medical malpractice happens without errors’ (GP17). Some regarded ME and medical malpractice are separate as ‘medical error does not jeopardize patients’ life, but medical malpractice does’ (GP12). Several participants stated that the difference between medical malpractice and ME lies in subjective reasons. ‘Medical malpractice is related to lack of job ethics.’ (GP27). A few participants even considered the two phrases basically the same in rural area. ‘It is difficult to identify medical error. If the medical error didn’t endanger patient’s life, it will be covered up and denied by the doctors. So, in primary medical units, the identification of medical error is equal with medical malpractice.’ (GP31).
Comments on the low reported incidence of ME
When the participants were told the reported incidence of ME in the recent 3 months was 1.6% in a previous questionnaire survey, a few of them found it hard to give any comments as they ‘don’t pay attention to this issue’ (GP15). Some participants believed that this figure reflected the reality. ‘I think this figure is reasonable because severe patients do not come to THC. Those who come here are with common diseases. The possibility of wrong diagnosis or wrong treatment is low.’ (GP29). Some others realised that this figure could be influenced by the understanding of ME. ‘If we only count the medical claims, this rate may be less than 1%. However, if the judgement is based on medical industry standard, I dare to say that 20% may not be too much.’ (GP11). In addition, some said many ME remained undiscovered when ‘the patients do not come again and there’s no follow-up’ (GP24). Meanwhile, many participants attributed this low figure to concealing. ‘They were unwilling to admit it. Because the medical environment makes them afraid. When the medical errors were not discovered by others, they just claimed that they had no medical errors at all.’ (GP13).
Attitudes towards ME made by others
Many participants regarded ME ‘inevitable’ (GP21) and quoted proverbs such as ‘to err is human (人非圣贤，孰能无过)’ (GP17), and ‘even Homer sometimes nods(智者千虑，必有一失)’ (GP22). Accordingly, they considered the physicians with ME ‘pardonable and understandable’ (GP23). On the other hand, some participants proposed that whether the physician should be blamed for ME depended on ‘the sense of responsibility’ (GP19), ‘the conscience’ (GP29) or ‘the attitude afterwards’ (GP18), while others considered ME more relevant to ‘knowledge reservoir’ (GP25) or ‘experience’ (GP27). Also, several participants mentioned ‘If a physician makes errors very often, there must be some problem with him/her’ (GP20), or ‘If a doctor repeatedly makes medical errors, he/she should have serious self-reflection’ (GP1). Only one participant said that ‘medical progress comes at the cost of medical errors’ (GP23) and ME was seen not only as something negative but also as a pathway for improvement.
Subsequent management of ME
When ME was discovered in a THC, many participants said they would ‘correct it and remedy it timely’ (GP4) and ‘minimize the damage’ (GP18). Some participants talked about ‘communications with the patients’ (GP8) and ‘generally, people will understand and forgive minor mistakes’ (GP30). However, some participants frankly stated that ME would be covered up. ‘If the patient wasn’t aware of the medical error and no substantial damage was made, the physician will usually conceal the information.’ (GP6). ME would be reported to senior physicians or leadership of the THCs ‘especially for the major errors’ (GP1) and ‘for solutions’ (GP30). Physicians may suffer punishment by the THC, both financially and reputationally. ‘The performance score will be deducted, and a notice of criticism depends’ (GP7). A discussion will be held to find ‘which process went wrong’ (GP14) and ‘to give everyone a warning’ (GP20). However, most of the discussions were focused on physicians. Here is an example:
An in-patient diagnosed with chest pain didn’t have the ECG examination on the day he was admitted. The patient was extremely fatigue and breathed heavily. Because we do not have a bedside ECG machine, the doctor in charge said to the patient: ‘Today you will have the infusion first. We’ll send you to do the ECG examination tomorrow’. The next day the patient died suddenly on the way to doing the ECG examination. We discussed the case right the day the patient died. The lesson we learned is that no matter what the situation is, the ECG should always be done on the admission day for patients of this kind. (GP5)
None of the participants reported adverse events through the National Clinical Improvement System website since they worked in THCs. Some participants had not heard of this system, but more said they knew it, though never used it. The common pathway in THCs is to report to the person in charge of medical affairs, for example, the vice president of the THC. Where will the report go afterwards was not known by the participants.
Discussion
This is the first qualitative study investigating perceptions of ME among primary care providers in multiple THCs of rural China. This study shows that the awareness of ME in rural primary care institutions is not sufficient and urges the implementations to improve patient safety there. The low reported incidence of ME could be explained by unclear concept, unawareness and blame culture.
The concept of ME is the prerequisite to study it. Unfortunately, error means different things to different people.26 Despite a growing body of literature on ME, few studies defined ME directly. In the famous report ‘to err is human’ published by US Institute of Medicine, error was defined as ‘the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim’ and ‘not all errors result in harm’.1 The WHO’s definition of error was almost the same.27 Grober and Bohnen defined ME as ‘an act of omission or commission in planning or execution that contributes or could contribute to an unintended result’, which synthesised both outcome feature and process feature of ME.28
In China, there is an absence of an explicit definition of ME in laws and regulations. Academic scholars believed that ‘Medical error shares the same essence with medical malpractice. The only difference between the two is that medical error doesn’t cause severe outcome as medical malpractice does’.29 The Chinese textbook ‘Health Care Administration’ defined ME as ‘caused by medical institutions and their medical staff violating health laws and regulations. Although there is fault, no personal harm, i.e., the harm has not reached the level of adverse consequences is caused’.30 However, in the real world, Chinese general practitioners in THCs had different understandings. Some focused on the outcome and some focused on the ‘wrong’ feature. Some narrowed ME to mild consequence but others believed the concept of ME is broad, including medical malpractice.
The confusion and overlapping between ME and medical malpractice hindered data collection, analysis and further collaborative work to improve healthcare delivery. When ME is connected to medical malpractice or claims, it became severe, unforgivable and culpable. ME with mild consequence or near miss is more common and it is the chance we discover systemic flaws and the opportunity to prevent further medical malpractice. Therefore, it is a very valuable experience and should not be mixed up with medical malpractice. Understanding the distinction between blameworthy behaviour and inevitable human errors and appreciating the systemic factors that underlie most failures in complex systems are essential.4 Our study highlights the clarification of ME definition in China. To facilitate the discussion of the ME caused by the system, a new word to distinguish inevitable human errors with blameworthy behaviours is warranted. This word could be ‘medical pitfall’ or ‘systemic pitfall’ to remind us that anyone can make the error in that circumstance so that the very person should not be blamed.
Technically, it is difficult to measure the incidence of ME precisely. For instance, the approaches used to measure diagnostic error include autopsy studies, surveys, standardised patients, diagnostic testing audits, malpractice claims, case reviews and voluntary reports.31 Each approach has advantages and limitations. This interview manifested that concealing ME existed in questionnaire surveys and in practice. Incident reporting had not yet reached its potential.32 The National Clinical Improvement System failed to gather information in THCs, leaving this field untouched and ignored.
The stigmatisation of ME in THCs is another concern. ME is regarded by some physicians to be associated with moral concerns such as reckless and irresponsible. Physicians with more MEs are suspected to be problematic. A common process for THCs after ME occurs is punishment. There are discussions on the cause of ME in THCs, but the conclusions are generally focused on the flaws of physicians. The fear of the negative consequences associated with reporting is the most commonly reported cause of under-reporting worldwide.33 The blame culture undermines the report willingness of the physicians, as denial and silence stems from our need to avoid pain.34 A paradigm shift is urgently needed from a blame culture to a trusting and just one.35 The solution to error lies not in accountability or punishment to individuals but rather in redesigning the system to reduce the risk for error and in minimising the consequences when errors occur.4
Although some researchers found that smaller institutions tend to have a better safety culture compared with large institutions.11 36 The THCs in rural China face greater challenges, such as absolute authority of leadership, shortage of human resources and less qualified staff.37 When we spend our every effort to improve patient safety in urban hospitals, the rural primary care institutions should not be forgotten, as they are the prerequisite to tiered medical services and an important component to achieve health equity. In the future, more awareness should be raised on the quality and safety of medical service in rural areas.
In the past, we did not know the grim facts of the neglection of ME in rural areas and we did not go into this thinking. A wide range of interventions could be done to promote safety culture there. First and foremost, we should realise that safety culture in rural areas could be very poor and we should talk openly about it. At the national level, the concept of ME should be clarified, and primary care institutions should be formally required (rather than encouraged) to use the National Clinical Improvement System. The judicial decision should be more lenient to those who report ME and should take system reasons into account as well, so that doctors will worry less about lawsuit when reporting ME. At the THC level, education on safety culture to the head and the staff of THC is urgent. Routine follow-up of THC patients should be facilitated to discover ME. Good domestic and foreign examples of systemic improvements after the ME report should be provided to THC for reference. Effective feedbacks should be given to the reporter, and systemic changes are encouraged.38 Also, we should invite patients and their family members to actively participate in this process. There is still a long way to go.
Limitations
This study has some limitations. First, as ME is a sensitive topic, the respondents would be prone to avoid the painful memory and will not share their deep feelings for their own safety, which will cause bias to the results. To facilitate them fully express their thoughts, the study team assured them their identities will be kept confidential. To build trust and make a friendly atmosphere, the participants were invited to tell their education experience and recent achievements before ME questions. The ME questions were designed not focused on the participants’ own incidents, but rather the incidents of other physicians, to minimise the shame and embarrassment they may feel.
Second, there is selection bias. Provided by the National Health Commission, the seed participants had better career development than the vast majority of physicians in THCs and were regarded as role models. Other participants were referred by the seeds and were also with bachelor degree and 3-year residency training experience. The participants we encountered had better education background and were more qualified than the average level of physicians in THCs.39 In China, as many as 58.2% of the licensed physicians in THCs do not have a bachelor degree.40 In another view, even among the most qualified physicians of THCs, the understanding of ME is not clear and the blame culture prevails, leaving the status quo of THCs more worrisome. This study is the first exploration of this kind in China, which may help with the future studies with more robust sampling methods.
Third, our sample is limited to physicians. Nurses, pharmacists, technicians, caregivers and patients themselves are all important participants to discover and reduce ME.41–43 Future studies could be broader interviews, questionnaire surveys (eg, Safety Attitudes Questionnaire) and incident reporting system data follow-ups with safety interventions to evaluate the changes.
Conclusion
The low reported incidence of ME could be explained by unclear concept, unawareness and blame culture. It is imperative to provide a supportive environment, patient safety training and good examples of error-based improvements to rural primary care institutions so that ME could be fully discussed and systemic factors of ME could be recognised and improved there in the future.
Data availability statement
Data are available upon reasonable request. The data that support the findings of this study are available from the Vanke School of Public Health, Tsinghua University (email: lihange@tsinghua.edu.cn), on reasonable request. The interview data are in Chinese. Further consent for using by other institutions should be obtained from the interviewees.
Ethics statements
Patient consent for publication
Ethics approval
This study involves human participants and was approved by Institution Review Board of Tsinghua University. Reference Number: 20210131. Participants gave informed consent to participate in the study before taking part.
Acknowledgments
We acknowledge the guidance of Dr Shuang Ma, who works at Peking Union Medical College Hospital and serves as an expert on quality control for the National Health Commission of the People’s Republic of China.
References
Footnotes
Contributors HL and JZ conceptualised and designed the study. HL, ZG and WY conducted the interviews. Coding of data was carried out by HL and ZG, and supervised by WY and JZ. YC contributed to the methodology. HL and YH drafted the manuscript. All authors contributed to the revision, editing and approval of the final version of the manuscript. JZ and HL are responsible for all aspects of the study.
Funding This work was funded by The National Social Science Fund of China (BLA220240) and Vanke School of Public Health, Tsinghua University (2022BH007).
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.