Risk management and empirical study of the doctor-patient relationship: based on 1790 litigation cases of medical damage liability disputes in China.

BACKGROUND: Compensation for medical damage liability disputes (CMDLD) seriously hinders the healthy development of hospitals and undermines the harmony of the doctor-patient relationships (DPR). Risk management in the DPR has become an urgent issue of the day. The study aims to provide a comprehensive description of CMDLD in China and explore its influencing factors, and make corresponding recommendations for the management of risks in the DPR. METHODS: This study extracted data from the China Judgment Online - the official judicial search website with the most comprehensive coverage. Statistical analysis of 1,790 litigation cases of medical damage liability disputes (COMDLD) available from 2015 to 2021. RESULTS: COMDLD generally tended to increase with the year and was unevenly distributed by regions; the compensation rate was 52.46%, the median compensation was 134,900 yuan and the maximum was 2,234,666 yuan; the results of the single factor analysis showed that there were statistically significant differences between the compensation for different years, regions, treatment attributes, and trial procedures (P < 0.05); the correlation analysis showed that types of hospitals were significantly negatively associated with regions (R=-0.082, P < 0.05); trial procedures were significantly negatively correlated with years (R=-0.484, P < 0.001); compensat- ion was significantly positively correlated with years, regions, and treatment attributes (R = 0.098-0.294, P < 0.001) and negatively correlated with trial procedures (R=-0.090, P < 0.01); regression analysis showed that years, treatment attributes, and regions were the main factors affecting the CMDLD (P < 0.05). CONCLUSIONS: Years, regions, treatment attributes, and trial procedures affect the outcome of CMDLD. This paper further puts forward relevant suggestions and countermeasures for the governance of doctor-patient risks based on the empirical results. Including rational allocation of medical resources to narrow the differences between regions; promoting the expansion and sinking of high-quality resources to improve the level of medical services in hospitals at all levels; and developing a third-party negotiation mechanism for medical disputes to reduce the cost of medical litigation.

Forensic Identification and Evaluation of 25 Obstetric Brachial Plexus Palsy Medical Damage Cases.

OBJECTIVES: To analyze the high risk factors of obstetric brachial plexus palsy (OBPP), and to explore how to evaluate the relationship between fault medical behavior and OBPP in the process of medical damage forensic identification. METHODS: A retrospective analysis was carried out on 25 cases of medical damage liability disputes related to OBPP from 2017 to 2021 in Beijing Fayuan Judicial Science Evidence Appraisal Center. The shortcomings of hospitals in birth weight assessment, delivery mode selection, labor process observation and shoulder dystocia management, and the causal relationship between them and the damage consequences of the children were summarized. RESULTS: Fault medical behavior was assessed as the primary cause in 2 cases, equal cause in 10 cases, secondary cause in 8 cases, minor cause in 1 case, no causal relationship in 1 case, and unclear causal force in 3 cases. CONCLUSIONS: In the process of forensic identification of OBPP, whether medical behaviors fulfill diagnosis and treatment obligations should be objectively analyzed from the aspects of prenatal evaluation, delivery mode notification, standardized use of oxytocin, standard operation of shoulder dystocia, etc. Meanwhile, it is necessary to fully consider the objective risk of different risk factors and the difficulty of injury prevention, and comprehensively evaluate the causal force of fault medical behavior in the damage consequences.

Analysis of the characteristics and risk factors affecting the judgment results of medical damage liability disputes in 3172 second-instance and retrial cases in China.

BACKGROUND: Medical disputes remain a global public health problem. However, an analysis of the characteristics and risk factors affecting the judgment results of medical damage liability disputes in second-instance and retrial cases in China has yet to be conducted. METHODS: We conducted a systematic search and evaluation of second-instance and retrial cases among all medical damage liability disputes in China Judgments Online; SPSS 22.0 was used for the statistical analysis. A χ2 test or likelihood ratio Chi-square test was used to compare differences between groups, and multivariate logistic regression analysis was performed to determine independent risk factors that could affect the judgment results of medical disputes. RESULTS: We included 3172 second-instance and retrial cases among all medical damage liability disputes in the analysis. The results showed that 48.04% of cases were unilateral appeals by the patient, and medical institutions were responsible for providing compensation in 80.64% of these cases. Cases involving compensation ranged from Chinese Yuan (CNY) 100 000 to 500 000 ranked first (40.95%); 21.66% were non-compensation cases. Cases involving mental damage compensation of less than CNY 20 000 accounted for 39.03%. Violations of medical treatment and nursing routines accounted for 64.25% of all cases. In addition, re-identification in 54.59% of cases changed the initial appraisal opinion. Independent risk factors for medical personnel to lose a lawsuit in a multivariate logistic regression model included appeal originator [patient side: OR = 18.809 (95% CI 11.854-29.845); both sides: OR = 22.168 (95% CI 12.249-40.117)], change of the original verdict (OR = 5.936, 95% CI 3.875-9.095), judicial identification (OR = 6.395, 95% CI 4.818-8.487), violations of medical treatment and nursing routines (OR = 8.783, 95% CI 6.658-11.588), and non-standard medical document writing (OR = 8.500, 95% CI 4.805-15.037). CONCLUSION: Our study clarifies the characteristics of second-instance and retrial cases among all medical damage liability disputes in China from multiple perspectives and identifies the independent risk factors for medical personnel losing a lawsuit. This study could help medical institutions prevent and reduce medical disputes, at the same time, it could be helpful for medical institutions to provide better medical treatment and nursing services for patients.

The dilemma and outlet of judicial determination of medical liability in China.

Medical damage liability is directly related to the diagnosis and treatment behavior of medical institutions. It is the most basic form of liability because patients enter the doctor-patient relationship with the expectation that they will receive highly professional medical services from the medical institution. This paper outlines the features of the development of China's medical damage liability system, points out the problems of the system in practice, and proposes improvements. It explores how to solve the legal dilemma of identifying medical liability in China from three perspectives: perfecting the formation and adoption procedures of expert opinions, standardizing the identification of fault by medical institutions, and standardizing the application of the rules of reducing liability for the cause.

Forensic Analysis of Eighteen Tubal Pregnancy-Related Medical Damage.

OBJECTIVES: To analyze the cases of medical damage after misdiagnosis of tubal pregnancy, to explore the causes of medical damage, the causal relationship between medical malpractice and the damage consequences, as well as the causative potency, in order to provide evaluation ideas for forensic identification of such cases. METHODS: Eighteen cases of forensic identification of tubal pregnancy related medical damage were collected and retrospectively analyzed from the aspects of age, maternity history, fertility requirements, risk factors, diagnosis and treatment, medical malpractice, damage consequences, and causative potency. RESULTS: All 18 cases were tubal pregnancy, of which 17 cases had medical malpractice, resulting in 14 cases of affected tubal resection, 2 cases of hemorrhagic shock death, 1 case of intrauterine fetal death and affected tubal resection. The other case had the consequence of affected tubal resection, but there was no malpractice in the treatment. CONCLUSIONS: Correct diagnosis is helpful to make appropriate treatment plan, prevent disease progression and reduce serious adverse consequences and the occurrence of medical disputes. Scientific and reasonable analysis of the causal relationship between medical malpractice and damage consequences and the causative potency is of great significance to the successful settlement of medical disputes.

Forensic Analysis of Eighteen Tubal Pregnancy-Related Medical Damage / 法医学杂志

OBJECTIVES@#To analyze the cases of medical damage after misdiagnosis of tubal pregnancy, to explore the causes of medical damage, the causal relationship between medical malpractice and the damage consequences, as well as the causative potency, in order to provide evaluation ideas for forensic identification of such cases.@*METHODS@#Eighteen cases of forensic identification of tubal pregnancy related medical damage were collected and retrospectively analyzed from the aspects of age, maternity history, fertility requirements, risk factors, diagnosis and treatment, medical malpractice, damage consequences, and causative potency.@*RESULTS@#All 18 cases were tubal pregnancy, of which 17 cases had medical malpractice, resulting in 14 cases of affected tubal resection, 2 cases of hemorrhagic shock death, 1 case of intrauterine fetal death and affected tubal resection. The other case had the consequence of affected tubal resection, but there was no malpractice in the treatment.@*CONCLUSIONS@#Correct diagnosis is helpful to make appropriate treatment plan, prevent disease progression and reduce serious adverse consequences and the occurrence of medical disputes. Scientific and reasonable analysis of the causal relationship between medical malpractice and damage consequences and the causative potency is of great significance to the successful settlement of medical disputes.

Litigation analysis of medical damage after total knee arthroplasty: a case study based on Chinese legal database in the past ten years.

BACKGROUND: The medical damage litigations after knee arthroplasty are on the rise year by year. However, few studies examined the litigation after knee arthroplasty. This study analyzed the litigation of medical damage after knee replacement in the past ten years based on a Chinese database. It synthesized the focus of the dispute in these cases to provide a reference for doctors to reduce the risk of litigation. METHODS: Retrospectively analyzed were medical damage litigations after total knee arthroplasty in the past ten years (June 2011-June 2021) from the "Wolters Kluwer Legal Information Database". The data collected included the characteristics of patients, causes of litigation, the results of litigation and the amount of compensation. RESULTS: A total of 110 litigation cases were analyzed, including 40 male patients (36.3%) and 70 female patients (63.6%). The top cause of litigation was infection (43.6%). The most common factor leading to the doctor losing the case was "complications caused by operational error" (P < 0.05). Complications, such as amputation, postoperative ischemic stroke and infection, were more likely to result in higher compensation. CONCLUSIONS: The prevention of infection and the avoidance of operational errors are very important in avoiding medical litigations. Moreover, avoiding disabling complications or a protracted course of disease could significantly reduce the amount of compensation. In addition, full and reasonable communication, paying full attention to the reaction of patients, and timely diagnosis could also effectively minimize the risk of litigation and loss.

Comparison of Medical Dispute Resolution Mechanisms in China and Abroad.

Medical disputes are one of the common problems concerned by the whole world. All countries and regions have established their own medical dispute resolution mechanisms, in accordance with their own national conditions. Medical dispute identification opinions, as one of the important bases for identifying the responsibilities of both doctors and patients, play a pivotal role in the process of dispute settlement. A reasonable medical dispute resolution mechanism and standardized medical dispute identification model can help resolve disputes flexibly and reduce the conflict between doctors and patients. This paper briefly compares the medical dispute resolution mechanism and identification mode of China and several other representative countries (the United States, Britain, France, Germany, Italy, Japan, etc.), and discusses their respective characteristics and shortcomings, to bring some enlightenment to the medical dispute resolution and identification in our country.

Research on the Identification Model of Medical Damage.

OBJECTIVES: To understand the perceptions of doctors, patients and forensic examiners on the current situation of medical disputes and medical damage identification in China, and to explore the medical damage identification model that is more conducive for the resolution of medical disputes. METHODS: A questionnaire was designed, and in-service clinicians, forensic examiners and inpatients in Sichuan Province and Chongqing City were randomly selected from April to November 2019. SPSS 22.0 software was used to analyze the data of various survey results. RESULTS: Compared with patients (24.92%), doctors (61.72%) believed that the current doctor-patient relationship was more tense than before; both doctors and patients were more inclined to choose voluntary consultation and people's mediation to resolve medical disputes; forensic examiners have the highest level of cognition of medical and health-related laws and regulations, followed by doctors and patients; 66.72% of doctors and 78.41% of patients believed that medical damage identification was necessary, and they were more inclined to entrust forensic identification institutions; different groups all believed that forensic examiners and doctors should participate in the identification together, 80.94% of doctors believed that the appraisal institutions should be responsible for the forensic opinion, not the appraiser. CONCLUSIONS: It is suggested that the Medical Association identification and forensic identification should learn from each other and formulate basic unified rules for the identification of medical damage. It is suggested to standardize the behavior of medical damage forensic identification institutions and appraisers, to improve their own appraisal level, actively invite clinical medical experts for consultation in identification, and promote the standardized, scientization of forensic identification.

Comparation between Guidance for Judicial Expertise of Medical Malpractice and Medical Association Identification Rules of Medical Damage.

On the basis of retaining the technical identification system of medical negligence, the Medical Association Identification Rules of Medical Damage mainly provides technical services for various types of conciliation work about doctor-patient dispute. Its identification work is still influenced by the thinking of medical negligence technical identification and has certain administrative color. Guidance for Judicial Expertise of Medical Malpractice is mainly reflected that the trial of civil cases and pre-trial mediation of courts need service. Its procedures and evidence review are strictly required by the litigation rules and has the characteristics of public legal services provided as a third-party neutral institution. Technical identification of medical damage, whether organized by the Medical Association or the forensic identification institutions, is carried out under the background of the current Regulations on the Prevention and Treatment of Medical Disputes and the Civil Code of the People's Republic of China; both have a corresponding positive role in regulating the medical damage identification activities, and have also laid a certain foundation for the establishment of a unified identification system in the future in China. To understand the different characteristics of the medical damage identification rules issued by the Chinese Medical Association and the Ministry of Justice, and to improve the understanding of the standardization of the forensic identification of medical damage, a comparative study was conducted on Medical Association Identification Rules of Medical Damage and Guidance for Judicial Expertise of Medical Malpractice from seven aspects: Concept and legal status, entrust of identification, identification acceptance, identification procedures, identification presentation meeting, theory of medical malpractice evaluation, consequences and causality of medical damage. The subject of evaluation, the function of evidence review, the role of consulting experts, the technical standard system of malpractice evaluation and other contents were emphatically analyzed.

Correlation analysis between the judgment of medical damage liability disputes related to off-label drug use and evidence-based evidence / 中国药房

OBJECTIVE To explore wheth er there is a relationship between the judgment results of medical damage liability disputes related to off-label drug use and evidence-based evidence. METHODS By searching for medical damage liability disputes related to off-label drug use up to 2021 on pkulaw.cn ，documents were extracted to record objective factors ，subjective factors and judgment results ；whether there was evidence-based evidence was judged according to Off-label Drug Use List and Evidence-based Evaluation Standards for Off-label Drug Use of Guangdong Pharmaceutical Association ；univariate analysis was adopted to test the relationship between the judgment results and evidence-based evidence. RESULTS A total of 57 cases were included. Cases mainly occurred in the eastern China （63.2％）and tertiary hospitals （64.9％），the main appraisal agency was the appraisal center or institute（61.4％），and the most common type of off-label drug use was overdose drug use （45.6％）. Among the judgment results ， 23 cases（40.4％）of off-label drug use had a causal relationship with medical damage ，most of the responsibility of doctors was secondary responsibility （28.1％），and the actual compensation amount of the most cases were less than 100，000 yuan（54.4％）. There were 25 cases（43.9％）with evidence-based evidence. Univariate analysis found that for off-label drug use the claim amount of the case with evidence-based evidence was significantly higher than that of the case without evidence-based evidence （P＝ 0.040），and there was no significant correlation between evidence-based evidence and the actual compensation amount of the case （P＝0.741），causality determination （P＝0.256），liability type （P＝0.598）or appraisal agency （P≥0.260）. CONCLUSIONS There is no significant correlation between the judgment results of medical damage liability disputes related to off-label drug use and evidence-based evidence ，indicating that there may be certain differences between judicial trials and medical science. The off-label drug use should be regulated by establishing a complete off-label drug use management system and standardizing informed consent procedure for off-label drug use. 1610307322@pku.edu.cn

Comparation between Guidance for Judicial Expertise of Medical Malpractice and Medical Association Identification Rules of Medical Damage / 法医学杂志

On the basis of retaining the technical identification system of medical negligence, the Medical Association Identification Rules of Medical Damage mainly provides technical services for various types of conciliation work about doctor-patient dispute. Its identification work is still influenced by the thinking of medical negligence technical identification and has certain administrative color. Guidance for Judicial Expertise of Medical Malpractice is mainly reflected that the trial of civil cases and pre-trial mediation of courts need service. Its procedures and evidence review are strictly required by the litigation rules and has the characteristics of public legal services provided as a third-party neutral institution. Technical identification of medical damage, whether organized by the Medical Association or the forensic identification institutions, is carried out under the background of the current Regulations on the Prevention and Treatment of Medical Disputes and the Civil Code of the People's Republic of China; both have a corresponding positive role in regulating the medical damage identification activities, and have also laid a certain foundation for the establishment of a unified identification system in the future in China. To understand the different characteristics of the medical damage identification rules issued by the Chinese Medical Association and the Ministry of Justice, and to improve the understanding of the standardization of the forensic identification of medical damage, a comparative study was conducted on Medical Association Identification Rules of Medical Damage and Guidance for Judicial Expertise of Medical Malpractice from seven aspects: Concept and legal status, entrust of identification, identification acceptance, identification procedures, identification presentation meeting, theory of medical malpractice evaluation, consequences and causality of medical damage. The subject of evaluation, the function of evidence review, the role of consulting experts, the technical standard system of malpractice evaluation and other contents were emphatically analyzed.

Research on the Identification Model of Medical Damage / 法医学杂志

OBJECTIVES@#To understand the perceptions of doctors, patients and forensic examiners on the current situation of medical disputes and medical damage identification in China, and to explore the medical damage identification model that is more conducive for the resolution of medical disputes.@*METHODS@#A questionnaire was designed, and in-service clinicians, forensic examiners and inpatients in Sichuan Province and Chongqing City were randomly selected from April to November 2019. SPSS 22.0 software was used to analyze the data of various survey results.@*RESULTS@#Compared with patients (24.92%), doctors (61.72%) believed that the current doctor-patient relationship was more tense than before; both doctors and patients were more inclined to choose voluntary consultation and people's mediation to resolve medical disputes; forensic examiners have the highest level of cognition of medical and health-related laws and regulations, followed by doctors and patients; 66.72% of doctors and 78.41% of patients believed that medical damage identification was necessary, and they were more inclined to entrust forensic identification institutions; different groups all believed that forensic examiners and doctors should participate in the identification together, 80.94% of doctors believed that the appraisal institutions should be responsible for the forensic opinion, not the appraiser.@*CONCLUSIONS@#It is suggested that the Medical Association identification and forensic identification should learn from each other and formulate basic unified rules for the identification of medical damage. It is suggested to standardize the behavior of medical damage forensic identification institutions and appraisers, to improve their own appraisal level, actively invite clinical medical experts for consultation in identification, and promote the standardized, scientization of forensic identification.

Comparison of Medical Dispute Resolution Mechanisms in China and Abroad / 法医学杂志

Medical disputes are one of the common problems concerned by the whole world. All countries and regions have established their own medical dispute resolution mechanisms, in accordance with their own national conditions. Medical dispute identification opinions, as one of the important bases for identifying the responsibilities of both doctors and patients, play a pivotal role in the process of dispute settlement. A reasonable medical dispute resolution mechanism and standardized medical dispute identification model can help resolve disputes flexibly and reduce the conflict between doctors and patients. This paper briefly compares the medical dispute resolution mechanism and identification mode of China and several other representative countries (the United States, Britain, France, Germany, Italy, Japan, etc.), and discusses their respective characteristics and shortcomings, to bring some enlightenment to the medical dispute resolution and identification in our country.

Analysis of 240 Cases of Medical Damage Liability Disputes Caused by Medication Error / 中国药房

OBJECTIVE：To study general chara cteristics and medication of medical damage liability disputes cases caused by medication error ， and to provide references for related departments and medical staff for preventing and reducing medication-induced medical disputes. METHODS ：A total of 240 cases of medical damage liability disputes cases caused by medication error were collected from Peking University ’s Fabao Law Database during Jan. 2001 to Feb. 2020，and analyzed in terms of general situation ，damage outcome ，level of the hospital involved ，liability judgment and compensation ，types of medication error and drug types. RESULTS ：medication-related medical damage liability disputes accounted for 25.3％ of overall medical damage disputes ；the most damage result of patients was death （68.3％）；medical negligence forensic appraisal was conducted as the main appraisal pattern with a proportion of 57.9％；the average case compensation was 203，000 yuan；the hospitals involved were mainly tertiary hospitals （48.8％）；the main type of medication error involved was prescription error ； chemical medicine was mainly involved ，of which the top three categories were systemic antibacterial ，systemic corticosteroids and antipsychotics. CONCLUSIONS ：ADR caused by medication errors are the common causes of medical disputes. Medical institutions should focus on improving the relevant systems and processes ，strengthen the construction of pharmaceutical information and automation system ，and reduce the probability of medication errors ；at the same time ，great importance should be paid to the cultivation of pharmaceutical talents in hospital ，give full play to the role of pharmacists ，and strengthen the monitoring and intervention of medication errors. Finally ，the relevant national judicial departments should constantly improve the settlement mechanism of medical damage liability disputes to provide reasonable protection for both doctors and patients.

[A restricted view on the identification of litigation cases of traditional Chinese medicine in the Republic of China: a case study of Yan Yulin].

Medical appraisal is one of the important means to determine whether there are faults in medical behavior and to deal with medical disputes. The issue of whether the medical lawsuit of traditional Chinese medicine should be submitted to traditional Chinese medicine, western medicine or forensic identification began to be debated since the Republic of China. With the efforts of the traditional Chinese medicine community, the Prescription Appraisal Committee of the National Medical Center of the Republic of China was established, which obtained the peer appraisal right for the lawsuit of traditional Chinese medicine. This paper takes the case of Yan Yulin's negligence causing death, which was sent by Shandong High Court to the National Medical Center in 1937, as an example, to explore the general situation of the identification system of the traditional Chinese medicine litigation in the period of the Republic of China, in order to provide reference for the establishment of the judicial identification system of medical damage in traditional Chinese medicine.

[Research Status on Off-label Use in Appraisal for Medical Malpractice].

Off-label use is widely happened in medical practice. But for now, there is no clear legalistic demarcation for the behaviour of off-label use. Even in medical and legal fields, the consensus has not been reached. Once the behaviour of off-label use caused medical damage, it is difficult for appraisal profession to provide a clear demarcation. This article reviews the status of clinical domestic and foreign off-label use, the research status in the fields of laws and regulations and the basic consensus of domestic off-label use, for peer reference.

Challenge and solution to medical damage idntification / 中国法医学杂志

By the end of 2017, the Supreme People's Court issue a judical interpretation called Tort law of China·Medical damage liability. It formulates some new rules about identification. It stipulates qualification of new appraiser; clears requirement of medical fault judgment; clears the requirement of causal relationship; defines procedure of medical damage identification and so on. However, there exist the dual identification model. Under the new rules, medical damage identification will face new challenges, especially some stipulates about qualification of appraisers, and expert assistants' views become the basis of the verdict. Those will effect medical examiners' working directly in China. So, I put forward following suggestions: ①Medical identification must be scientific, public welfare, normative.②It is trend for medical damage identification back to peer review. ③A unified library of clinical expert appraisers should be establised. ④We should reasearch the theorys, principles and methods of medical damege identification.

Research Status on Off-label Use in Appraisal for Medical Malpractice / 法医学杂志

Off-label use is widely happened in medical practice. But for now, there is no clear legalistic demarcation for the behaviour of off-label use. Even in medical and legal fields, the consensus has not been reached. Once the behaviour of off-label use caused medical damage, it is difficult for appraisal profession to provide a clear demarcation. This article reviews the status of clinical domestic and foreign off-label use, the research status in the fields of laws and regulations and the basic consensus of domes-tic off-label use, for peer reference.

On the retention and revision directions of the Regulations on Handling of Medical Malpractice / 中华医院管理杂志

The authors discussed the retention and revision of the Regulations on the Handling of Medical Malpractice following the enforcement of the Tort Liability Law.These discussions also covered the amendment of the concept of medical malpractice,and the reforms to make on the medical malpractice appraisal system built upon the Regulations following the enforcement.In the meantime of applying the Law to judge cases of medical malpractice,the Regulations as an administrative regulations issued by the State Council,should be revised before playing its role in preventing medical malpractice,medical dispute handling,and penalising medical institutions and medical workers of malpractice.