Application of traditional indexes and adverse events in the ophthalmologic perioperative medical quality evaluation during 2010-2012

AIM: To evaluate the medical quality of ophthalmologic perioperative period during 2010-2012 in our hospital. METHODS: The relevant data of perioperative period were collected in our hospital during 2010-2012, and the medical quality of perioperative period was evaluated by using the traditional evaluation indexes and adverse events. Whereby, the traditional indicators include vision changes, improving of intraocular pressure, diagnostic accordance rate before and after operation, cure improvement rate, successful rescue rate, and incidence of surgical complications, etc Adverse events are associated with ophthalmologic perioperative events including pressure sores, postoperative wound infection, drug adverse events, and equipment related adverse events. RESULTS: There were 1483, 1662 and 1931 ophthalmic operations in our hospital in the year 2010, 2011 and 2012, respectively. From traditional index analysis, the proportions of vision improvement for each year were 96.43%, 96.76% and 97.32%, respectively; the rates of intraocular pressure improvement were 87.50%, 85.72% and 90.17%, respectively ( P <0.05); the diagnostic accordance rates before and after operation were 99.86%, 99.94% and 99.90%, respectively; cure improvement rates were 99.73%, 99.93% and 99.84%, respectively; the successful rescue rates were 82.98%, 81.46% and 76.66%, respectively; the complications incidence rates were 18.44%, 17.52% and 17.97%, respectively. The negative factor analysis results showed that: among all the patients of ophthalmic surgeries in our hospital during 2010 and 2012, only one case of postoperative wound infection was found in 2011, and also only one case of tumbling in 2010. The adverse drug events for each year were 1 case (0.07%), 2 cases (0.12%), and 4 cases (0.21%), respectively; the medical device adverse events for each year were 3 cases (0.20%), 5 cases (0.30%), and 6 cases (0.31%), respectively. Noticeably, only one case with postoperative infection of endophthalmitis was found in 2011. Moreover, no pulmonary infection or pulmonary embolism occurred during the three years. The perioperative adverse event rates for each year were 0.34% (5/1483), 0.48% (8/1662) and 0.52% (10/1931), respectively. Though incidence was rising during the three years, no statistical significance was observed (P>0.05). It is the same case with drugs and medical devices adverse events (P>0.05). CONCLUSION: Traditional indicators reflect an excellent operation of the perioperative ophthalmologic quality, whereas adverse events analysis indicates some underlying problems. Compared with the traditional indexes for medical quality evaluation, the index of adverse events is more reasonable and easier to make an objective evaluation for medical quality of ophthalmologic perioperation, facilitating further refine analysis. Reasonable application of the adverse events indicators helps hospital to make the detailed quality control measures.

Patient Safety,Adverse Healthcare Events and Near-Misses in Obstetric Care—A Systematic Literature Review

Systematic development of a patient safety culture is necessary because lack of quality care leads to human suffering. The aim of this review was to identify evidence of obstetric adverse events (AEs) and near-misses in the context of patient safety. We conducted a search of the published literature from Europe, Australia and the USA in the following databases: Cinahl, Cochrane, Maternity and Infant Care, Ovid, Pro-quest and PubMed, guided by PRISMA procedures. A total of 427 studies were screened, 15 full papers retrieved and nine studies included in the final thematic analysis. The selected papers address a broad spectrum of adverse patient safety events in obstetric care. The themes that emerged were: type of AEs, near-misses and their consequences, strategies to support and improve Patient Safety (PS) and domains related to the WHO Patient Safety competence outcomes. The findings of the first theme were grouped into the following categories: healthcare professionals’ perspectives on ethical conflicts, attributing blame and responsibility, and patients’ perspectives on lack of trust and involvement, as well as medication errors. The second theme, strategies to support interventions to improve PS, was based on two sub-themes: communicating effectively and gaining competence by learning from adverse events, while the third theme was domains related to the WHO Patient Safety competence outcomes. In conclusion, few studies have examined strategies for managing AEs despite the existence of programmes that target the implementation of changes, such as improved teamwork training. In addition to exploring strategies to make safety a priority for patients and healthcare professionals, it is of the utmost importance to improve communication with patients and between professionals in order to maintain and enhance safety. Efforts by organizations and individuals to continuously develop knowledge about the risk of AEs and the use of best practice guidelines are also essential.

A Retrospective Analysis on 1330Adverse Event Reports of Qingkailing in China:Further Perception of Its Risks and Rational Use

Qingkailing (QKL)is a modern preparation exploited according to the traditional Chinese medicine theory.It becomes the second leading cause of adverse drug events (ADEs)in all traditional Chinese medicine injections.The safety evaluation and rational use of QKL are of special importance.This retrospective study used data from Adverse Drug Reaction Monitoring Center of Hubei Province in China from January 2012 to December 2014.ADE cases induced by QKL were collected and analyzed according to patients'demographics,characteristics of drugs involved,characteristics of ADEs,causality,and outcomes.A total of 1330 qualified ADEs were included.Most ADEs occurred within 30 min after administration and the 0-10 years old age group had the highest number of ADEs.The common ADEs included anaphylactic reaction,dyspnea and nausea.Serious reactions accounted for 5.19%.Combination with cephalosporin (74/146,50.69%) caused more ADEs than other drugs did.Serious attention should be paid when QKL is used for children,and combination with cephalosporin should be avoided.

Why Don’t We Adequately Identify and Manage Adverse Drug Reactions despite Having the Needed Information?

Importance/Objective: Adverse Drug Reactions (ADRs) are unavoidable, but recognizing and addressing ADRs early can improve wellness and prevent permanent injury. We suggest that available medical information and digital/electronic methods could be used to manage this major healthcare problem for individual patients in real time. Methods: We searched the available digital applications and three literature databases using the medical subject heading terms, adverse drug reaction reporting systems or management, filtered by clinical trial or systemic reviews, to detect publications with data about ADR identification and management approaches. We reviewed the reports that had abstract or summary data or proposed or implemented methods or systems with potential to identify or manage ADRs in clinical settings. Results: The vast majority of the 481 reports used retrospectively collected data for groups of patients or were limited to surveying one population group or class of medication. The reports showed potential and definite associations of ADRs for specific drugs and problems, mostly, but not exclusively, for patients in hospitals and nursing homes. No reports described complete methods to collect comprehensive data on ADRs for individual patients in a healthcare system. The digital applications have ADR information, but all are too cumbersome or incomplete for use in active clinical settings. Several studies suggested that providing information about potential ADRs to clinicians can reduce these problems. Conclusion and Relevance: Although investigators and government agencies agree with the need, there is no comprehensive ADR management program in current use. Informing the patient’s healthcare practitioners of potential ADRs at the point of service has the potential for reduction of these complications, which should improve healthcare and reduce unneeded costs.

Regulatory gaps in India’s medical device framework:The case of Johnson and Johnson’s faulty hip implants

The Johnson and Johnson faulty hip implant case represents one of the most significant crises in medical device history,impacting nearly 93000 patients worldwide.In response to alarming failure rates and a global recall in August 2010,countries such as Australia,the United States,and the United Kingdom quickly implemented revision surgeries and reimbursement programs to protect patient safety.In stark contrast,India's response was alarmingly delayed;defective implants continued to be sold even after the global recall.By the time the import license was revoked,and the Central Drugs Standard Control Organization issued a recall notice,these implants had already been involved in 4700 surgeries across India.This paper explores the systemic weaknesses in India’s medical device regulatory framework that contributed to this delayed action,resulting in many patients suffering from serious health complications.It highlights deficiencies in monitoring and reporting mechanisms,inadequate regulatory oversight,and insufficient approval processes.Furthermore,the inability to trace affected patients and provide necessary compensation underscores significant gaps in regulation.Although subsequent legislative reforms were introduced,this paper argues that substantial loopholes remain,posing risks for future incidents.Thus,urgent,comprehensive,and enforceable regulatory measures are needed to increase patient safety.

The Adverse Event Profile in Patients Treated with Transferon^TM(Dialyzable Leukocyte Extracts): A Preliminary Report

Background: Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. TransferonTM is DLE manufactured by National Polytechnic Institute (IPN), and is registered by Mexican health-regulatory authorities as an immunomodulatory drug and commercialized nationally. The proposed mechanism of action of TransferonTM is induction of a Th1 immunoregulatory response. Despite that it is widely used, to date there are no reports of adverse events related to the clinical safety of human DLE or TransferonTM. Objective: To assess the safety of TransferonTM in a large group of patients exposed to DLE as adjuvant treatment. Methods: We included in this study 3844 patients from our Clinical Immunology Service at the Unit of External Services and Clinical Research (USEIC), IPN. Analysis was performed from January 2014 to November 2014, searching for clinical adverse events in patients with immune-mediated diseases and treated with TransferonTM as an adjuvant. Results: In this work we observed clinical nonserious adverse events (AE) in 1.9% of patients treated with TransferonTM (MD 1.9, IQR 1.7 - 2.0). AE were 2.8 times more frequently observed in female than in male patients. The most common AE were headache in 15.7%, followed by rash in 11.4%, increased disease-related symptomatology in 10%, rhinorrhea in 7.1%, cough in 5.7%, and fatigue in 5.7% of patients with AE. 63% of adverse event presentation occurred from day 1 to day 4 of treatment with TransferonTM, and mean time resolution of adverse events was 14 days. In 23 cases, the therapy was stopped because of adverse events and no serious adverse events were observed in this study. Conclusion: TransferonTM induced low frequency of nonserious adverse events during adjuvant treatment. Further monitoring is advisable for different age and disease groups of patients.

Critical values of monitoring indexes for perioperative major adverse cardiac events in elderly patients with biliary diseases

BACKGROUND Major adverse cardiac events(MACE) in elderly patients with biliary diseases are the main cause of perioperative accidental death, but no widely recognized quantitative monitoring index of perioperative cardiac function so far.AIM To investigate the critical values of monitoring indexes for perioperative MACE in elderly patients with biliary diseases.METHODS The clinical data of 208 elderly patients with biliary diseases in our hospital from May 2016 to April 2021 were retrospectively analysed. According to whether MACE occurred during the perioperative period, they were divided into the MACE group and the non-MACE group.RESULTS In the MACE compared with the non-MACE group, postoperative complications, mortality, hospital stay, high sensitivity troponin-Ⅰ(Hs-TnI), creatine kinase isoenzyme(CK-MB), myoglobin(MYO), B-type natriuretic peptide(BNP), and Ddimer(D-D) levels were significantly increased(P < 0.05). Multivariate logistic regression showed that postoperative BNP and D-D were independent risk factors for perioperative MACE, and their cut-off values in the receiver operating characteristic(ROC) curve were 382.65 pg/mL and 0.965 mg/L, respectively.CONCLUSION The postoperative BNP and D-D were independent risk factors for perioperative MACE, with the critical values of 382.65 pg/mL and 0.965 mg/L respectively. Consequently, timely monitoring and effective maintenance of perioperative cardiac function stability are of great clinical significance to further improve the perioperative safety of elderly patients with biliary diseases.

Adverse effects of oral antiviral therapy in chronic hepatitis B

Oral nucleoside/nucleotide analogues(NAs) are currently the backbone of chronic hepatitis B(CHB) infection treatment. They are generally well-tolerated by patients and safe to use. To date, a significant number of patients have been treated with NAs. Safety data has accumulated over the years. The aim of this article is to review and update the adverse effects of oral NAs. NAs can cause class adverse effects(i.e., myopathy, neuropathy, lactic acidosis) and dissimilar adverse effects. All NAs carry a "Black Box" warning because of the potential risk for mitochondrial dysfunction. However, these adverse effects are rarely reported. The majority of cases are associated with lamivudine and telbivudine. Adefovir can lead to dose- and time-dependent nephrotoxicity, even at low doses. Tenofovir has significant renal and bone toxicity in patients with human immunodeficiency virus(HIV) infection. However, bone and renal toxicity in patients with CHB are not as prominent as in HIV infection. Entecavir and lamivudine are not generally associated with renal adverse events. Entecavir has been claimed to increase the risk of lactic acidosis in decompensated liver disease and high Model for End-Stage Liver Disease scores. However, current studies reported that entecavir could be safely used in decompensated cirrhosis. An increase in fetal adverse events has not been reported with lamivudine, telbivudine and tenofovir use in pregnant women, while there is no adequate data regarding entecavir and adefovir. Further long-term experience is required to highlight the adverse effects of NAs, especially in special patient populations, including pregnant women, elderly and patients with renal impairment.

Nursing-related Patient Safety Events in Hospitals

To explore the method of identifying nursing-related patient safety events, types, contributing factors and evaluate consequences of these events in hospitals of China, incident report program was established and implemented in 15 patient units in two teaching hospitals of China to get the relevant information. Among 2935 hospitalized patients, 141 nursing-related patient safety events were reported by nurses. Theses events were categorized into 15 types. Various factors contributed to the events and the consequence varied from no harm to patient death. Most of the events were pre- ventable. It is concluded that incident reporting can provide more information about patient safety, and establishment of a program of voluntary incident reporting in hospitals of China is not only urgent but also feasible.

Preventing medication errors in neonatology: Is it a dream?

Since 1999, the problem of patient safety has drawn particular attention, becoming a priority in health care. A "medication error"(ME) is any preventable event occurring at any phase of the pharmacotherapy process(ordering, transcribing, dispensing, administering, and monitoring) that leads to, or can lead to, harm to the patient. Hence, MEs can involve every professional of the clinical team. MEs range from those with severe consequences to those with little or no impact on the patient. Although a high ME rate has been found in neonatal wards, newborn safety issues have not been adequately studied until now. Healthcare professionals working in neonatal wards are particularly susceptible to committing MEs due to the peculiarities of newborn patients and of the neonatal intensive care unit(NICU) environment. Current neonatal prevention strategies for MEs have been borrowed from adult wards, but many factors such as high costs and organizational barriers have hindered their diffusion. In general, two types of strategies have been proposed: the first strategy consists of identifying human factors that result in errors and redesigning the work in the NICU in order to minimize them; the second one suggests to design and implement effective systems for preventing errors or intercepting them before reaching the patient. In the future, prevention strategies for MEs need to be improved and tailored to the special neonatal population and the NICU environment and, at the same time, every effort will have to be made to support their clinical application.

Establishment and application of medication error classification standards in nursing care based on the International Classification of Patient Safety

Objective:To standardize the classification,reporting and analysis of medication errors in nursing in order to improve patient safety management by achieving real-time monitoring and systemic analysis.Methods:A system of classifying nurse-related adverse drug effects into four category grades was developed based on the framework provided by the International Classification of Patient Safety.Three investigators used the system to classify 1343 nursing-related drug adverse events reported between January 2006 and December 2010 at 15 tertiary medical institutions in Shanghai.Results:The classification standard incorporated all relevant information provided in the reporting system and revealed that the greatest frequency of drug adverse events resulted from staff-related factors.In particular,the largest number of events resulted from routine violations,followed by technology type errors of negligence and fault.Conclusion:Application of this classification system will help nursing administrators to accurately detect system-and process-related defects leading to medication errors,and enable the factors to be targeted to improve the level of patient safety management.

Medical Errors in Greece: An Economic Analysis of Compensations Awarded by Civil Courts (2000-2009)

Medical errors are reported with increased frequency both in Europe and in the United States of America and measures are put in place to deal with the problem. In Greece, more and more patients think that it is likely to experience a medical error during health care delivery and the organizations they can turn to if this happens are hardly enough and with meagre response. The consequences of medical errors are multiple and complex with significant financial implications. Nowadays there is an urgent need to resolve problems that refer to cost containment in the Greek Health System. Some research findings from the review of 128 compensations awarded by civil courts for the years 2000 to 2009 for medical errors in Greece are quite interesting. The mean compensation amounted to €292,613 representing 35.41% of claimed compensation. Only a small proportion of medical errors gain publicity as the majority of claims get settled out of court, covered by the insurance policy or the hospitals. The burden of the obvious and hidden cost affects not only the patient, his family and the hospital but also the whole of the society. This comes from our estimation that the level of compensation awarded by the civil courts for medical errors is remarkable high. Unfortunately only some estimates of the cost are possible due to the lack of statistical data. The creation of an independent oversight body for the review of medical errors and complaints nationwide as well as the modernization of the hospitals’ monitoring systems is necessary in order to handle the medical error phenomenon. Above all, cooperation and trust between patients, health care professionals, hospital managers, medical boards and the government are essential to get to the root of the problem.

Evidence-based expert consensus on clinical management of safety of Bruton’s tyrosine kinase inhibitors(2024)

Bruton’s tyrosine kinase inhibitors(BTKis)have revolutionized the treatment of B-cell lymphomas.However,safety issues related to the use of BTKis may hinder treatment continuity and further affect clinical efficacy.A comprehensive and systematic expert consensus from a pharmacological perspective is lacking for safety issues associated with BTKi treatment.A multidisciplinary consensus working group was established,comprising 35 members from the fields of hematology,cardiovascular disease,cardio-oncology,clinical pharmacy,and evidencebased medicine.This evidence-based expert consensus was formulated using an evidence-based approach and the Delphi method.The Joanna Briggs Institute Critical Appraisal(JBI)tool and Grading of Recommendations Assessment,Development,and Evaluation(GRADE)approach were used to rate the quality of evidence and grade the strength of recommendations,respectively.This consensus provides practical recommendations for BTKis medication based on nine aspects within three domains,including the management of common adverse drug events such as bleeding,cardiovascular events,and hematological toxicity,as well as the management of drug-drug interactions and guidance for special populations.This multidisciplinary expert consensus could contribute to promoting a multi-dimensional,comprehensive and standardized management of BTKis.

Proprotein convertase subtilisin/kexin type 9 inhibitors in peripheral artery disease:A review of efficacy,safety,and outcomes

Peripheral artery disease(PAD)is a common condition characterized by atherosclerosis in the peripheral arteries,associated with concomitant coronary and cerebrovascular diseases.Proprotein convertase subtilisin/kexin type 9(PCSK9)inhibitors are a class of drugs that have shown potential in hypercholesterolemic patients.This review focuses on the efficacy,safety,and clinical outcomes of PCSK9 inhibitors in PAD based on the literature indexed by PubMed.Trials such as FOURIER and ODYSSEY demonstrate the efficacy of evolocumab and alirocumab in reducing cardiovascular events,offering a potential treatment option for PAD patients.Safety evaluations from trials show few adverse events,most of which are injection-site reactions,indicating the overall safety profile of PCSK9 inhibitors.Clinical outcomes show a reduction in cardiovascular events,ischemic strokes,and major adverse limb events.However,despite these positive findings,PCSK9 inhibitors are still underutilized in clinical practice,possibly due to a lack of awareness among care providers and cost concerns.Further research is needed to establish the long-term effects and cost-effectiveness of PCSK9 inhibitors in PAD patients.

我国医疗质量安全不良事件数据分析

目的:通过数据分析和挖掘,分析在保障患者安全、提升医疗质量安全水平等方面存在的问题并提出建议。方法:主要采用横向比较方法对2018-2021年医疗质量安全不良事件进行分析,总结2018-2021年医疗质量安全不良事件发生的规律。结果:近年来医疗不良事件的上报数量和质量存在明显差异,为了提升医疗安全不良事件的报告频率和报告质量,需要一套综合性的策略来应对这一挑战。结论:医疗安全不良事件填报系统管理模式标准化;优化不良事件信息报告渠道;建立完善的预防措施;加强沟通培训,沟通信息透明化。

Delphi study for developing a checklist of adverse events associated with acupotomy

Background Acupotomy,a more invasive procedure than acupuncture,involves the use of a thicker needle with an integrated knife at the tip,necessitating safety research.We aimed to define relevant adverse events(AEs)and create a standardized form of the ACUPOtomy-related AEs CHECKlist(ACUPOCHECK).Methods Before conducting the Delphi process,a systematic review and pilot prospective study were conducted to gather information on previously reported AEs.Using these data,pilot versions of the ACUPOCHECK and Delphi questionnaires were developed.The Delphi questionnaire involved selecting types of AE for inclusion,establishing separate criteria for acupotomy-related AEs,and achieving a consensus on AE assessment.Thirteen Korean doctors with experience in acupotomy or AE research were recruited to participate in each Delphi round.Consensus was considered to have been reached if the critical value for the content validity ratio met or exceeded 0.538.Results The final ACUPOCHECK was developed using four rounds of the Delphi method and one face-to-face consensus meeting.It included 12 local AEs(pain,hemorrhage,bruise,hematoma,edema,pruritus,rash,infection,nerve damage,dysesthesia,movement impairment,and pneumothorax)and 14 systemic AEs(disease aggravation,needle fatigue,sleepiness,procedural nausea,procedural vomiting,procedural headache,procedural dizziness,sweating,procedural shock,syncope,dyspnea,procedural pain,sleep disorder,and postprocedural infection).Separate criteria were established for pain,hemorrhage and bruising:pain was defined as pain that occurrs during daily activities and persists for longer than 72 h,hemorrhage as bleeding that continues for≥3 min despite pressure application,and bruising as having a bruise with a diameter of≥3 cm.Open-ended descriptions were allowed for AEs not covered by the checklist,and severity and causality were assessed using the Common Terminology Criteria for Adverse Events and modified World Health Organization-Uppsala Monitoring Center criteria.Conclusion ACUPOCHECK provides a standardization framework that can help research on traditional practices as well as new tools and techniques that are more invasive and may cause more severe AEs.Subsequent studies will use ACUPOCHECK to develop rational safety guidelines for acupotomy techniques.

Safety of different acupuncture manipulations for posterior circulation ischemia with vertigo

Acupuncture at Fengchi（GB20） in the posterior neck improves vertigo.However,subarachnoid hemorrhage and spinal epidural hematoma have been reported to occur after acupuncture in the posterior neck.Therefore,in the present study,we assessed the safety of acupuncture at Fengchi.Laboratory tests and adverse event reports were used to evaluate the safety of different acupuncture manipulations for the treatment of posterior circulation ischemia with vertigo.A total of 136 patients were randomly assigned to four groups.Verum acupuncture was conducted with different needle insertion directions（contralateral paropia or prominentia laryngea） and different needle twisting frequencies（60 or 120 times/minute） at Fengchi and matching acupoints（for example,Zhongwan [CV12],Qihai [CV6],Zusanli [ST36],and Fenglong [ST40]）.The patients received 14 treatments over 3–4 weeks.Routine blood analysis,hepatic and renal function tests,urine and feces tests and electrocardiography were performed before the first treatment session and after the final session.Adverse events were recorded after every session.Of the 136 patients,120 completed the study.There were no significant differences between pretreatment and posttreatment test results in any of the groups.Only five patients suffered from minor adverse events（needling pain,slight hematoma and transient chest tightness）.No serious adverse events were found.Our results indicate that a 14-session course of needling at Fengchi is relatively safe for treating posterior circulation ischemia with vertigo.

Transplantation of autologous peripheral blood mononuclear cells in the subarachnoid space for amyotrophic lateral sclerosis:a safety analysis of 14 patients

There is a small amount of clinical data regarding the safety and feasibility of autologous peripheral blood mononuclear cell transplantation into the subarachnoid space for the treatment of amyotrophic lateral sclerosis.The objectives of this retrospective study were to assess the safety and efficacy of peripheral blood mononuclear cell transplantation in 14 amyotrophic lateral sclerosis patients to provide more objective data for future clinical trials.After stem cell mobilization and collection,autologous peripheral blood mononuclear cells（1 × 109） were isolated and directly transplanted into the subarachnoid space of amyotrophic lateral sclerosis patients.The primary outcome measure was incidence of adverse events.Secondary outcome measures were electromyography 1 week before operation and 4 weeks after operation,Functional Independence Measurement,Berg Balance Scale,and Dysarthria Assessment Scale 1 week preoperatively and 1,2,4 and 12 weeks postoperatively.There was no immediate or delayed transplant-related cytotoxicity.The number of leukocytes,serum alanine aminotransferase and creatinine levels,and body temperature were within the normal ranges.Radiographic evaluation showed no serious transplant-related adverse events.Muscle strength grade,results of Functional Independence Measurement,Berg Balance Scale,and Dysarthria Assessment Scale were not significantly different before and after treatment.These findings suggest that peripheral blood mononuclear cell transplantation into the subarachnoid space for the treatment of amyotrophic lateral sclerosis is safe,but its therapeutic effect is not remarkable.Thus,a large-sample investigation is needed to assess its efficacy further.

Safety of fecal microbiota transplantation in Chinese children: A single-center retrospective study

BACKGROUND Fecal microbiota transplantation(FMT) is the administration of fecal bacterial liquid from healthy donors to a recipient's digestive tract, which is recommended as a therapeutic method for recurrent Clostridium difficile infection(CDI). Many clinical trials focusing on different diseases are in progress. To date, scarce research and long-term follow-up have been conducted on FMT in children or on the proper guidelines. Our center first performed FMT to treat a 13-month-old boy with severe CDI in 2013. Until February 2018, our center had performed 114 pediatric FMT procedures in 49 subjects. AIM To investigate the safety of FMT in children. METHODS A retrospective study was conducted on 49 patientswho underwent 114 FMT treatments at our hospital. All FMT processes followed uniform standards. Adverse events(AEs) related to FMT were divided into shortterm(48 h post-FMT) and long-term(3 mo). All potential influencing factors for AEs, such as gender, age, time of FMT infusion, route of administration, disease type, immune function state, and donor relative genetic background, were analyzed as independent factors. The significant independent factors and risk ratio with 95% confidence interval(CI) were assessed by multivariate logistic regression analysis.RESULTS Forty-nine patients(mean age 68.1 mo, range 4 to 193 mo) were recruited. Their average follow-up time after the first FMT was 23.1 mo. The incidence of short-term AEs was 26.32%(30/114). The most common shortterm AEs were abdominal pain, diarrhea, fever, and vomiting, which were all self-limited and symptom-free within 48 h. Two severe AEs occurred, and one patient died in the fourth week after FMT. All-cause mortality was 2.04%. As independent factors, age(P = 0.006) and immune state(P = 0.002) had significant effects. Age greater than 72 mo seemed to be correlated with more AEs than age 13 to 36 mo(P = 0.04). In multivariate logistic regression analysis, immune state was an independent risk factor for AE occurrence(P = 0.035), and the risk ratio in immunodeficient patients was 3.105(95%CI: 1.080-8.923).CONCLUSION Although FMT was proven to be tolerated in children, we need to be more cautious with immunodeficient patients. The effect on children's long-term health is unpredictable.

Defensive medicine:It is time to finally slow down an epidemic

Defensive medicine is widespread and practiced the world over, with serious consequences for patients, doctors, and healthcare costs. Even students and resi-dents are exposed to defensive medicine practices and taught to take malpractice liability into consideration when making clinical decisions. Defensive medicine is generally thought to stem from physicians' perception that they can easily be sued by patients or their relatives who seek compensation for presumed medical errors. However, in our view the growth of defensive medicine should be seen in the context of larger changes in the conception of medicine that have taken place in the last few decades, undermining the patient–physician trust, which has traditionally been the main source of professional satisfaction for physicians. These changes include the following: time directly spent with patients has been overtaken by time devoted to electronic health records and desk work; family doctors have played a progressively less central role; clinical reasoning is being replaced by guidelines and algorithms; the public at large and a number of young physicians tend to believe that medicine is a perfect science rather than an imperfect art, as it continues to be; and modern societies do not tolerate the inevitable morbidity and mortality. To finally reduce the increasing defensive behavior of doctors around the world, the decriminalization of medical errors and the assurance that they can be dealt with in civil courts or by medical organizations in all countries could help but it would not suffice. Physicians and surgeons should be allowed to spend the time they need with their patients and should give clinical reasoning the importance it deserves. The institutions should support the doctors who have experienced adverse patient events, and the media should stop reporting with excessive evidence presumed medical errors and subject physicians to "public trials" before they are eventually judged in court.