The Awareness and Experience About Endoscopic Adverse Events Among South Korean Endoscopists

Background/Aims: The number of endoscopic procedures and related adverse events is increasing. We investigated South Korean endoscopists’ awareness and experience of endoscopic adverse events. Materials and Methods: We used Google Forms to conduct an online questionnaire survey among South Korean endoscopists from December 11 to 29, 2020. The survey comprised 30 questions developed by members of the Quality Management Committee of the Korean Society of Gastrointestinal Endoscopy. Results: In total, 475 endoscopists participated in the survey. Of these, 454 (95.6%) were board-certified gastroenterologists and 255 (53.7%) had >10 years of endoscopy experience. Most participants had experienced serious adverse events requiring hospitalization (80.4%, 382/475); however, only 100 (21.1%) were aware of programs for the prevention and management of adverse endoscopic events in their affiliated endoscopy centers. Most participants (98.5%, 468/475) agreed with the need for education on medical accidents for healthcare workers. Responses were inconsistent regarding the definition of adverse events formulated by the 2010 American Society for Gastrointestinal Endoscopy Workshop. Most participants were not aware of the minimal standard terminology (76.6%, 364/475) and had not used it when writing endoscopy reports (88.8%, 422/475). Responses were inconsistent regarding which events to record in endoscopy records. Conclusion: Further discussion on the nationwide adverse-event reporting system and education program for adverse events related to endoscopy is needed to ensure the safety of patients and endoscopists.


INTRODUCTION
As interest in health increases, the number of screening endoscopies also rises rapidly. 1,2Moreover, ever greater numbers of aged people with comorbidities are undergoing screening or diagnostic endoscopy in the aging society. 3,4Because of the preference for minimally invasive treatments and advances in endoscopic technology, new advanced techniques in therapeutic endoscopy have been developed to replace surgery.Endoscopic resection of tumors, endoscopic stricture dilatation, and endoscopic ultrasound-guided drainage are some examples of those new advanced techniques. 5 Endoscopic procedures, especially if performed on elderly people with multiple comorbidities, could be associated with a higher risk of adverse events.Major adverse events include bleeding, perforation, and cardiopulmonary events.Moreover, Turk J Gastroenterol 2023; 34 (9): 932-942 the risk increases if therapeutic interventions are conducted during endoscopic procedures. 3,6Therefore, it is essential for endoscopists to be aware of the risk factors for endoscopy-related adverse events, recognize their occurrence quickly, and take timely and appropriate measures. 7 consensus definitions of endoscopic adverse events have been established in South Korea until now.Some South Korean endoscopists confuse complications with incidents or adverse events.The lack of a standardized definition hampers the comparison of data from different hospitals and studies on quality improvement.Therefore, we used an online questionnaire survey to investigate South Korean endoscopists' awareness and experience of endoscopic adverse events.

Data Resources
A survey commissioned by the Quality Management Committee of the Korean Society of Gastrointestinal Endoscopy comprising 30 questions formulated by members of the committee (Supplementary Material 1) was conducted online using Google Forms in December 2020.The survey, targeting South Korean endoscopists who perform endoscopic procedures in South Korea, covered the participants' baseline characteristics, the experience of endoscopic adverse events, awareness of the definition of an endoscopic adverse event, the terminology used in clinical practice, and recording of endoscopic adverse events in endoscopy reports.The survey was conducted anonymously, and all responses were collected and analyzed.

Grouping of Participants
For comparison, the participants were divided into gastroenterologist/expert, gastr oente rolog ist/n on-ex pert, and non-gastroenterologist groups.The gastr oente rolog ist/ e xpert group (group 1) comprised endoscopists who majored in gastroenterology and had >10 years of experience in endoscopic procedures.The gastr oente rolog ist/ non-ex pert group (group 2) comprised endoscopists who majored in gastroenterology and had <5 years of experience in endoscopic procedures.The non-gastroenterologist group (group 3) comprised endoscopists who majored in medical fields other than gastroenterology, with no restriction on years of experience.Participants who did not satisfy any of the 3 criteria were excluded from the intergroup analysis.

Statistical Analysis
The response rates for each question were expressed as numbers with percentages.Values were compared among groups by analysis of variance.Statistical analysis was performed using International Business Machines Statistical Package for the Social Sciences Statistics for Windows, version 25.0 (IBM Corp.; Armonk, NY, USA).Statistical significance was set at P < .05.

Main Points
• Most Korean endoscopists have experienced endoscopic adverse events.However, there are no consensus definitions of endoscopic adverse events and unified reporting system or program for their prevention and management.

•
Most participants recognized the need for education on adverse endoscopic events and related medical accidents.

•
This study emphasized the need for the establishment of consensus definitions and a unified reporting system and program for the prevention and management of endoscopy-related adverse events to ensure the safety of patients and endoscopists.2).
Most of the participants (87.8%, 417/475) stated that their medical care was influenced by the news about the imprisonment of physicians involved in endoscopic adverse events (P = .049).The proportion of participants affirming a negative influence of the news was higher in group 2 (92.5%, 99/107) than in group 1 (83.5%,66/79) and group 3 (81.4%,17/21).Almost all participants (98.5%, 468/475) agreed that there is a need for education on medical accidents for healthcare workers (P = .375).Also, approximately four-fifths (81.1%, 385/475) of the participants agreed with the need for a database for post-registration of delayed endoscopic adverse events (P = .204)(Table 2).

Awareness of the Definition of Endoscopic Adverse Events
Awareness of the definition of endoscopic adverse events was assessed based on 8 questions regarding the statement by the American Society for Gastrointestinal Endoscopy (ASGE) workshop 2010 8 and the Minimal Standard Terminology (MST) 9 (Table 3).
Four hundred nine participants (86.1%, 409/475) agreed with the 2010 ASGE workshop's proposed definition of an adverse event as one preventing completion of the planned procedure and/or resulting in hospitalization, a prolonged hospital stay, another procedure (requiring sedation/anesthesia), or subsequent medical consultation (P = .062).Three-quarters of the participants (75.0%, 356/475) agreed with the 2010 ASGE workshop's suggestion that the severity of an adverse event should be graded by the degree of its disturbance to the patient and any resulting changes to the plan of care (P = 0.986).However, fewer participants (62.9%, 299/475) agreed that temporary ventilation support by bagging or the nasal airway during conscious sedation does not constitute an adverse event (P = .111).Moreover, 60.0% (285/475) of the participants stated that an unintended episode that occurred during endoscopy but resolved without interruption to the intended procedure was not an adverse event (P = .219)(Table 3).
Less than one-quarter (23.4%, 111/475) of the participants were aware of the MST (P = .009).Only 11.2% (53/475) of the participants stated that they used the MST when writing endoscopy reports (P = .037).Few of the participants (3.8%, 18/475) answered that they recorded adverse events in endoscopy reports in accordance with the MST (P = .599).Approximately two-thirds of the participants (65.9%, 313/475) agreed with the MST that the need for hospitalization, prolongation of a planned hospital stay, or an additional procedure was important in defining the severity of an adverse event (P = .852)(Table 3).

Terminology for Endoscopic Adverse Events in Clinical Practice
South Korean endoscopists use the Korean word "UBALJEUNG" or "HAPBYEONGJEUNG" when communicating with patients regarding endoscopic adverse events.The Korean word "UBALJEUNG" refers to an event or symptom that occurs accidentally, and "HAPBYEONGJEUNG" refers to a disease that occurs with another disease or postoperatively.Some South Korean physicians believe that "UBALJEUNG" has a strong nuance, emphasizing value-neutral unanticipated problems that arise following medical/surgical procedures, whereas "HAPBYEONGJEUNG" involves a value judgment.
In defining adverse events related to diagnostic endoscopy, 56.3% (267/475) and 28.0% (133/475) of the participants responded that 3 and 7 days, respectively, would be appropriate standards (P = .506)."Late" adverse events are events that occur later than general endoscopic adverse events but with a clear causal relationship.
In this study, 46.4% (220/475) of the participants answered that 1 week would be the appropriate standard.Also, 40.4% (192/475) of the participants stated that the standard should differ according to procedure type and purpose (P = .698)(Table 4).

Recording Endoscopic Adverse Events in the Endoscopy Report
Regarding temporary bleeding after biopsy using forceps that required control using epinephrine spray, 38.7% (184/475) of the participants answered that they would record the event as an adverse event in the endoscopy report (P = .647).Also, 20.2% (96/475) of the participants responded that they would record temporary desaturation requiring oxygen supplementation with full recovery during conscious sedation as an adverse event in the endoscopy report (P = .668)(Table 5).Less than one-half (48.2%, 229/475) of the participants agreed that no record is needed in the endoscopy report if a temporary unintended episode occurs but fully resolves and the intended procedure is completed with only a temporary halt, oxygen supplementation, or administration of an antispasmodic, analgesic, or antihypertensive medication (P = .026).More than half (59.4%, 282/475) of the participants answered that recording of such events in the endoscopy centers' record files is necessary, while recording in the endoscopy report is not (P = .526)(Table 5).

DISCUSSION
It is essential for endoscopists to be aware of endoscopic adverse events, including their prevention, early detection, and management.Therefore, we used an online questionnaire survey to investigate South Korean endoscopists' awareness and experience of endoscopic adverse events.The Quality Management Committee of the Korean Society of Gastrointestinal Endoscopy developed a 30-question survey, and 475 endoscopists participated in it.Most of the participants had majored in gastroenterology; however, the endoscopists were not acquainted with the unified definition of endoscopic adverse events provided by the 2010 ASGE workshop and were not familiar with the MST.Although most of the participants had experienced serious endoscopic adverse events requiring hospitalization, only 21.1% were aware of programs for the prevention and management of endoscopic adverse events in their affiliated endoscopy centers.Most of the participants stated that their active medical care was affected by the news of the imprisonment of physicians involved in endoscopic adverse events, and almost all participants agreed with the need for healthcare workers to receive education on medical accidents.
In addition to years of experience, other factors, such as patient-or procedure-risk factors, contribute to adverse events. 3,6In this study, all participants in group 1 had >10 years of experience in performing endoscopy and were affiliated with certified tertiary/university hospitals.Thus, they would have performed more high-risk endoscopic procedures in patients with risk factors.This explains why participants in group 1 had more experience with endoscopic adverse events compared with the other groups.
Fatigue and excessive workloads result in carelessness and increase the incidence of accidents, 10,11 , which also applies to patient care in hospitals. 12Performing too many endoscopies per hour causes fatigue and reduced attention, both by endoscopists and other healthcare workers, and reduces attention to patient safety and the allowance of sufficient observation during endoscopy to detect significant lesions.In South Korea, starting at the age of 40 years, people are provided free biannual esoph agoga strod uoden oscop y for gastric cancer screening by the National Cancer Screening Program.Likewise, for colorectal cancer screening, starting at the age of 50 years, a free colonoscopy is provided in the event of the annual fecal occult blood test being positive. 13,14Moreover, medical fees in South Korea are very low.As a result, endoscopists typically perform large numbers of endoscopies in a short time.The percentages of participants who had performed large numbers of endoscopies in a week were higher in groups 2 and 3 than those in group 1.Large numbers of endoscopies performed within a short period by nonexpert endoscopists led to an increased rate of endoscopic adverse events. 15vertheless, the percentages of the participants who were aware of programs for the prevention and management of endoscopic adverse events in their affiliated endoscopy centers and collecting and statistically analyzing data on endoscopic adverse events in their affiliated endoscopy centers were low and much lower in group 2 and group 3 than that in group 1.These data show that participants in group 2 and group 3 were not well acquainted with endoscopic adverse events and were not conducting quality improvement programs in their affiliated endoscopy centers, which are essential to prevent such events. 16This might be partly explained by a lack of interest related to a low level of experience of endoscopic adverse events in these groups and may reflect insufficient education on adverse events.Therefore, education on preventing, recognizing, and appropriately managing adverse events should be provided not only to endoscopists who majored in gastroenterology but also to those who did not. 17e proportion of participants who stated that their medical care was affected by the news of the imprisonment of physicians involved in endoscopic adverse events was higher in group 2. A lack of knowledge on preventing, recognizing, and appropriately managing adverse events might have contributed to the non-experts' fear of medical accidents or adverse events.Although most medical accidents or adverse events are resolved via the physician-patient relationship or a settlement between the affiliated medical institution and the patient, the number of lawsuits related to endoscopic adverse events is increasing rapidly.Therefore, education should include the non-medical aspects of adverse events, such as the Turk J Gastroenterol 2023; 34(9): 932-942 principles and skills of the physician-patient relationship.Indeed, almost all participants agreed with the need for healthcare workers to receive education on medical accidents. 18,19Endoscopists should be trained in endoscopyrelated medical accidents via a minimal curriculum. 20oreover, arbitration agencies, such as the courts, the South Korean Medical Dispute Mediation and Arbitration Agency, and the South Korean Consumer Agency, should render fair judgments. 21 is desirable that adverse events are recognized during endoscopic procedures and action is taken immediately.However, symptoms/signs of adverse events often manifest after the patient has returned home; such late events include delayed perforation 22 and delayed bleeding. 23In this study, the participants learned of the adverse event most frequently as a result of the patient's actions.To ensure favorable outcomes, it is important to take appropriate measures without delay, and patients should be informed of the symptoms/signs indicative of endoscopic adverse events and response guidelines before they return home.For example, the possibility of delayed bleeding or perforation should be described to patients undergoing endoscopic polypectomy.It would be desirable to track and check the patients' symptoms/signs after they have returned home, but this is not easily feasible.
In this study, most of the participants agreed with the need for a database allowing post-registration of delayed endoscopic adverse events.The registration system would be useful for collecting and analyzing data on adverse events irrespective of the time of occurrence or medical institution, thereby helping to improve overall safety related to endoscopy.However, to enable the system, definitions and terminologies for adverse events must be defined first.In this study, the responses to questions using the definitions of adverse events provided by the ASGE workshop 2010 8 and MST 9 showed marked variation.Also, the terminology for adverse events is not unified, and it is unclear which events need to be recorded.Thus, there is a need for endoscopists to be sufficiently educated.An atmosphere should be established in which honest and exact record-keeping does not increase the fear of the consequences of legal disputes.There should be no fear of the fact that an adverse event has occurred or of discussing it with patients and co-workers.To this end, objective and reasonable arbitration between judicial and arbitration agencies is essential. 21Endoscopists should be protected from legal jeopardy resulting from unavoidable adverse events. 24is study had the following limitations.First, not all endoscopists in South Korea participated in this study.Most participants were endoscopists working at hospital-level institutions.Considering that more than half of all endoscopies are conducted at clinic-level institutions, the participants might not have been representative of all South Korean endoscopists.Nevertheless, our results show that participants' level of knowledge was low despite their experience of endoscopy and related adverse events.Another limitation is the low response rate of the survey.We think the response rate was low because the survey encouraged voluntary participation without forcing or granting the benefit of the response.Third, the participants were grouped according to their major and endoscopy experience.However, this was necessary to compare levels of awareness and knowledge of endoscopic adverse events among the groups.Third, we were unable to propose a unified definition of adverse events or classification of their severity and timing.More research and discussion are needed to establish a unified definition and classification.

Section 1 . 1 - 1 . 3 . 1 - 5 . 1 - 6 . 1 - 7 .Section 2 . 2 - 1 . 2 - 3 . 5 . 6 . 7 . 8 .] 3 - 1 . 2 . 3 . 2 . 3 . 4 . 4 - 1 . 4 - 2 . 5 - 1 . 2 . 3 . 5 - 4 .
Baseline characteristics of the survey participants What is your sex?What is your major?a) Gastroenterology b) Internal medicine, other than gastroenterology c) General surgery d) Pediatrics e) Family medicine 1-4.What is your affiliated medical institution's classification?a) Health examination center b) Clinic c) Hospital d) General hospital e) Certified tertiary hospital/university hospital How many years have you performed endoscopy?a) Less than 2 years b) More than 2 years but less than 5 years c) More than 5 years but less than 10 years d) More than 10 years but less than 15 years e) More than 15 years How many esoph agoga strod uoden oscop ies do you perform per week?(Average in the past year) a) Less than 10 b) More than 10 but less than 30 c) More than 30 but less than 50 d) More than 50 but less than 70 e) More than 70 How many colonoscopies do you perform per week?(Average in the past year) a) Less than 10 b) More than 10 but less than 30 c) More than 30 but less than 50 d) More than 50 but less than 70 e) More than 70 Experience of endoscopic adverse events Have you ever experienced a serious endoscopic adverse event requiring hospitalization?a) Yes b) No 2-2.How have you obtained information on endoscopic adverse events?(multiple responses are allowed) a) Noticed during or immediately after endoscopy b) Noticed during the hospitalization period (for hospitalized patients) c) Telephone contact with the patient d) Outpatient clinic visit of the patient e) Emergency room visit of the patient f) Unaware of the occurrence of an adverse event g) Via the dispute mediation committee of the affiliated medical institution How have you resolved medical disputes involving endoscopic adverse events?(Multiple responses are allowed) a) Physician-patient relationship b) Settlement between the affiliated medical institution and the patient c) The Korea Medical Association Medical Indemnity Mutual d) Mediation by the Korea Medical Dispute Mediation and Arbitration Agency or the Korean Consumer Agency e) Lawsuit 2-4.Are there programs for the prevention and management of endoscopic adverse events in the affiliated endoscopy centers?Do you collect and statistically analyze data on endoscopic adverse events in the affiliated endoscopy centers?Has your medical care been affected by the news of the imprisonment of physicians involved in endoscopic adverse events?Do you think education on medical accidents is needed for healthcare workers?Do you think a database for post-registration of delayed endoscopic adverse events is needed?a) Yes b) No c) Difficult to answer Section 3. Awareness of the definition of an endoscopic adverse event [The American Society for Gastrointestinal Endoscopy (ASGE) workshop 2010In the ASGE workshop 2010, an adverse event was defined as an event that prevents completion of a planned procedure and/or results in hospitalization, a prolonged hospital stay, another procedure (requiring sedation/anesthesia), or subsequent medical consultation.Do you agree?The ASGE workshop 2010 graded the severity of an adverse event based on the degree of its disturbance to the patient and any resulting changes in the plan of care.Do you agree?The ASGE workshop 2010 did not define temporary ventilation support by bagging or nasal airway use during conscious sedation to be an adverse event.Do you agree?a) Yes b) No c) Difficult to answer 3-4.|If an unintended episode occurred during endoscopy but resolved without interrupting completion of the intended procedure, would you consider it an adverse event?Do you use the MST when writing an endoscopy report?Do you record adverse events in accordance with the MST in the endoscopy report?In the MST, hospitalization, prolongation of a planned hospital stay, and the need for an additional procedure for recovery are important in defining the severity of an adverse event.Do you agree?a) Yes b) No c) Difficult to answer Section 4. Terminology on endoscopic adverse events in clinical practice Which of the following words do you use when communicating with patients suffering serious bleeding/perforation related to endoscopy?a) UBALJEUNG b) HAPBYEONGJEUNG c) UBALJEUNG/ HAPBYEONGJEUNG, without distinction d) Difficult to answer In the definition of an adverse event related to diagnostic endoscopy, how many days do you think would be an appropriate standard?a) Within 1 day b) Within 2 days c) Within 3 days d) Within 7 days e) Within 14 days f) Within 21 days g) The standard should differ according to the adverse event h) Difficult to answer 4-3."Late adverse event" is an event that occurs later than general endoscopic adverse events, but with a clear causal relationship.For a "late adverse event," how many days do you think should be the appropriate standard?a) 1 week b) 2 weeks c) 3 weeks d) 4 weeks e) The standard should differ depending on the procedure type and purpose Section 5. Recording endoscopic adverse events in the endoscopy report Do you record temporary bleeding after forceps biopsy that is controlled by epinephrine spray as an adverse event in the endoscopy report?Do you record temporary desaturation requiring oxygen supplementation with full recovery during conscious sedation as an adverse event in the endoscopy report?a) Yes b) No c) Difficult to answer 5-Do you agree that endoscopy report recording is not necessary for a temporary unintended episode that fully resolves, and the intended procedure finishes with only a temporary halt, oxygen supplementation, or administration of an antispasmodic, analgesic, or antihypertensive medication?a) Yes (does not need to be recorded) b) No (needs to be recorded) c) Difficult to answer Do you agree that recording in the endoscopy centers' records is necessary, even though recording in the endoscopy report is not necessary, if a temporary unintended episode occurs but fully resolves, and the intended procedure finishes with only a temporary halt, oxygen supplementation, or administration of an antispasmodic, analgesic, or antihypertensive medication?a) Yes (needs to be recorded) b) No (does not need to be recorded) c) Difficult to answer

Table 2 .
Experience of Endoscopic Adverse Events Group 1: gastr oente rolog ist/e xpert group comprised endoscopists who majored in gastroenterology and had >10 years of experience in endoscopic procedures; Group 2: gastr oente rolog ist/n on-ex pert group comprised endoscopists who majored in gastroenterology and had <5 years of experience in endoscopic procedures; Group 3: non-gastroenterologist group comprised endoscopists who majored in medical fields other than gastroenterology, with no restriction on years of experience.*Analyzed 673 answers by 475 responders; ¶ analyzed 537 answers by 416 responders.

Table 3 .
Awareness of the Definition of an Endoscopic Adverse EventThe ASGE workshop 2010 graded the severity of an adverse event based on the degree of its disturbance to the patient and any resulting changes in the plan of care.Do you agree?
The ASGE workshop 2010 did not define temporary ventilation support by bagging or nasal airway use during conscious sedation to be an adverse event.Do you agree?Group 1: gastr oente rolog ist/e xpert group comprised endoscopists who majored in gastroenterology and had >10 years of experience in endoscopic procedures; Group 2: gastr oente rolog ist/n on-ex pert group comprised endoscopists who majored in gastroenterology and had <5 years of experience of endoscopic procedures; Group 3: non-gastroenterologist group comprised endoscopists who majored in medical fields other than gastroenterology, with no restriction on years of experience.ASGE, American Society for Gastrointestinal Endoscopy; MST, Minimal Standard Terminology.

Table 4 .
Terminology on Endoscopic Adverse Events in Clinical Practice Group 1: gastr oente rolog ist/e xpert group comprised endoscopists who majored in gastroenterology and had >10 years of experience in endoscopic procedures; Group 2: gastr oente rolog ist/n on-ex pert group comprised endoscopists who majored in gastroenterology and had <5 years of experience in endoscopic procedures; Group 3: non-gastroenterologist group comprised endoscopists who majored in medical fields other than gastroenterology, with no restriction on years of experience.

Table 5 .
Recording Endoscopic Adverse Events in the Endoscopy Report Group 1: Gastr oente rolog ist/e xpert group comprised endoscopists who majored in gastroenterology and had >10 years of experience in endoscopic procedures; Group 2: gastr oente rolog ist/n on-ex pert group comprised endoscopists who majored in gastroenterology and had <5 years of experience in endoscopic procedures; Group 3: non-gastroenterologist group comprised endoscopists who majored in medical fields other than gastroenterology, with no restriction on years of experience.