Adverse Events In Surgical Patients Research Articles

Inter-Rater Agreement of the Classification of Intraoperative Adverse Events (ClassIntra) in Abdominal Surgery.

Adverse events in surgical patients can occur preoperatively, intraoperatively, and postoperatively. Universally accepted classification systems are not yet available for intraoperative adverse events (iAEs). ClassIntra has recently been developed and validated as a tool for grading iAEs that occur between skin incision and skin closure irrespective of the origin, that is, surgery, anesthesia, or organizational. The aim of this study is to assess the inter-rater agreement of ClassIntra and assess its predictive value for postoperative complications in elective abdominal surgery. This study is a secondary use of data from the LAParotomy or LAParoscopy and ADhesiolysis (LAPAD) study, with detailed data on incidence and management of intra-operative and post-operative complications. Data were collected in a cohort of elective abdominal surgeries. Two teams graded all recorded events in the LAPAD study according to ClassIntra. Cohen Kappa coefficient was calculated to determine inter-rater agreement. Uni- and multivariable linear regression was used to assess the predictive value of the ClassIntra grades for postoperative complications. IAEs were rated in 333 of 755 (44%) surgeries by team 1, and in 324 of 755 (43%) surgeries by team 2. Cohen kappa coefficient for ClassIntra grades was 0.87 [95% confidence interval (CI) 0.84-0.90]. Discrepancies in grading were most frequent for intraoperative bleeding and adhesions' associated injuries. At least 1 postoperative complication was observed in 278 (37%) patients. The risk of a postoperative complications increased with every increase in severity grade of ClassIntra. Intraoperative hypotension [mean difference (MD) 23.41, 95% CI 12.93-33.90] and other organ injuries (MD 18.90, 95% CI -4.22 - 42.02) were the strongest predictors for postoperative complications. ClassIntra has an almost perfect inter-rater agreement for the classification of iAEs. An increasing grade of ClassIntra was associated with a higher incidence of postoperative complications. Discrepancies in grading related to common complications in abdominal procedures mostly consisted of intraoperative bleeding and adhesion-related injuries. Grading of interoperative events in abdominal surgery might further improve by consensus regarding the definitions of a number of frequent events.

Association of Gabapentinoids With the Risk of Opioid-Related Adverse Events in Surgical Patients in the United States

The use of gabapentinoids in multimodal postoperative analgesia is increasing; however, when coadministered with opioids, these drugs may potentiate central nervous system and respiratory depression. To evaluate the association between perioperative coadministration of gabapentinoids and opioids with inpatient opioid-related adverse events in surgical patients. This cohort study used propensity score trimming, stratification, and weighting of adults admitted for a major surgery between October 2007 and December 2017 who were treated with opioids on the day of surgery and included in the Premier Research database. Data analysis was conducted from February to April 2020. Gabapentinoids (gabapentin or pregabalin) coadministered with opioids starting the day of surgery vs opioid therapy without gabapentinoids. Primary outcome was opioid overdose. Secondary outcomes included respiratory complications, unspecified adverse effects of opioid use, and a composite of these 3 outcomes. Patients were followed up for as long as 30 days from the day of surgery until deviation from the initial treatment regimen or discharge. Gabapentinoids with opioids were administered to 892 484 of 5 547 667 eligible admissions (16.1%; mean [SD] age, 63.5 [11.8] years; 353 315 [39.6%] men). Among the 4 655 183 patients who received opioids only, the mean (SD) age was 63.7 (14.7) years, and 1 913 284 (41.1%) were men. Overall, 441 overdose events were identified, with absolute risks of 1.4 per 10 000 patients with gabapentinoid exposure and 0.7 per 10 000 patients receiving opioids only. Following propensity score trimming, the cohort included 737 383 patients exposed to gabapentinoids and 3 002 480 patients receiving opioids only. The primary analysis yielded the adjusted hazard ratio of 1.95 (95% CI, 1.49-2.55), and the number needed to treat for an additional overdose to occur was 16 914 patients (95% CI, 11 556-31 537 patients). Adjusted hazard ratios for secondary outcomes were 1.68 (95% CI, 1.59-1.78) for respiratory complications, 1.77 (95% CI, 1.61-1.93) for unspecified adverse effects of opioids, and 1.70 (95% CI, 1.62-1.79) for the composite outcome. The results were consistent across sensitivity analyses and subgroups identified by key clinical factors. In this real-world cohort study of patients who underwent major surgery, concomitant use of gabapentinoids with opioids was associated with increased risk of opioid overdose and other opioid-related adverse events; however, the absolute risk of adverse events was low.

Limitações na implementação da lista de checagem de cirurgia e impactos na segurança do paciente cirúrgico

Objetivo: identificar na literatura as dificuldades encontradas na adesão à lista de verificação de cirurgia segura nos hospitais para o aumento da segurança do paciente em organizações de saúde com centro cirúrgico. Método: trata-se de uma revisão integrativa da literatura que buscou verificar as dificuldades encontradas para adesão à lista de verificação de cirurgia segura nos hospitais. Resultados: constatou-se que há unanimidade quanto a importância da utilização das listas de checagem nas cirurgias, tendo uma das literaturas apontado a ocorrência de evento adverso em unidade em que não havia a sua implementação. Identificou-se a falta de treinamentos voltados para a inserção da lista de verificação nas ações educativas institucionais, sendo a principal dificuldade apontada a falta de recursos humanos para condução da checagem em várias salas cirúrgicas e as múltiplas cirurgias realizadas simultaneamente. Pôde-se depreender ainda a existência do entendimento de que o uso da lista de verificação pode gerar desconforto no profissional que o conduz. Não foram identificadas relações entre eventos adversos em pacientes cirúrgicos e a implementação das listas de checagem. Conclusão: o uso da lista de verificação é negligenciado em seu preenchimento e existem inúmeras dificuldades para sua implementação, além da falta de motivação para sua efetiva inserção por equipes cirúrgicas. Evidenciou-se a ausência de uma cultura de registro/notificação segundo a literatura analisada, condição que pode interferir no gerenciamento de indicadores voltados à implantação da meta “cirurgia segura” e melhores práticas nessas unidades.

以病人安全为主线的鱼骨导引式手术护理流程设计

目的：为降低手术病人护理相关并发症和不良事件，提高病人安全性。方法：用思维导图编制了以病人安全为主线的手术护理流程图。结果：流程设置10大环节，每环节包括5~7项性质类似的节点。流程以病人安全为主线，结合手术护理相关管理制度、操作常规和指南，导引对疾病、麻醉和手术对机体影响的预警和可预防性医疗不良事件的防范措施实施。结论：流程能对手术病人风险和可预防性医疗不良事件双管齐下的防范，可提高病人的安全性和医疗质量。 Objective: To reduce the nursing related complications and adverse events in surgical patients and to improve the safety of patients. Methods: The flow chart of operation nursing with patient safety was prepared with mind map. Results: The process includes 10 major links, each of which includes 5~7 similar nodes. The process takes the patient safety as the main line, combined with the relevant management system routine and guide of surgical nursing. It can guide warning and the prevention of disease, anesthesia and surgery on the body’s effects and injuries and preventable medical adverse events. Conclusions: The process could provide a two-pronged prevention of surgical patient risk and preventable medical adverse events, improving patient safety and quality of care.

Usefulness of Administrative Databases for Risk Adjustment of Adverse Events in Surgical Patients

PurposeThe aim of this study was to assess the usefulness of clinical–administrative databases for the development of risk adjustment in the assessment of adverse events in surgical patients. MethodsThe study was conducted at the Hospital of Navarra, a tertiary teaching hospital in northern Spain. We studied 1602 hospitalizations of surgical patients from 2008 to 2010. We analysed 40 comorbidity variables included in the National Surgical Quality Improvement Programme (NSQIP) of the American College of Surgeons using 2 sources of information: The clinical and administrative database (CADB) and the data extracted from the complete clinical records (CR), which was considered the gold standard. Variables were catalogued according to compliance with the established criteria: sensitivity, positive predictive value and kappa coefficient>0.6. ResultsThe average number of comorbidities per study participant was 1.6 using the CR and 0.95 based on CADB (p<.0001). Thirteen types of comorbidities (accounting for 8% of the comorbidities detected in the CR) were not identified when the CADB was the source of information. Five of the 27 remaining comorbidities complied with the 3 established criteria; 2 pathologies fulfilled 2 criteria, whereas 11 fulfilled 1, and 9 did not fulfil any criterion. ConclusionCADB detected prevalent comorbidities such as comorbid hypertension and diabetes. However, the CADB did not provide enough information to assess the variables needed to perform the risk adjustment proposed by the NSQIP for the assessment of adverse events in surgical patients.

Validez de las bases de datos administrativas para realizar ajustes de riesgo en el análisis de los efectos adversos producidos en pacientes quirúrgicos

PurposeThe aim of this study was to assess the usefulness of clinical-administrative databases for the development of risk adjustment in the assessment of adverse events in surgical patients. MethodsThe study was conducted at the Hospital of Navarra, a tertiary teaching hospital in northern Spain. We studied 1602 hospitalizations of surgical patients from 2008 to 2010. We analysed 40 comorbidity variables included in the National Surgical Quality Improvement (NSQIP) Program of the American College of Surgeons using 2 sources of information: The clinical and administrative database (CADB) and the data extracted from the complete clinical records (CR), which was considered the gold standard. Variables were catalogued according to compliance with the established criteria: sensitivity, positive predictive value and kappa coefficient >0.6. ResultsThe average number of comorbidities per study participant was 1.6 using the CR and 0.95 based on CADB (p<.0001). Thirteen types of comorbidities (accounting for 8% of the comorbidities detected in the CR) were not identified when the CADB was the source of information. Five of the 27 remaining comorbidities complied with the 3 established criteria; 2 pathologies fulfilled 2 criteria, whereas 11 fulfilled 1, and 9 did not fulfil any criterion. ConclusionCADB detected prevalent comorbidities such as comorbid hypertension and diabetes. However, the CABD did not provide enough information to assess the variables needed to perform the risk adjustment proposed by the NSQIP for the assessment of adverse events in surgical patients.

Detection of Adverse Events in General Surgery Using the “Trigger Tool” Methodology

IntroductionSurgery is one of the high-risk areas for the occurrence of adverse events (AE). The purpose of this study is to know the percentage of hospitalization-related AE that are detected by the “Global Trigger Tool” methodology in surgical patients, their characteristics and the tool validity. Materials and methodsRetrospective, observational study on patients admitted to a general surgery department, who underwent a surgical operation in a third level hospital during the year 2012. The identification of AE was carried out by patient record review using an adaptation of “Global Trigger Tool” methodology. Once an AE was identified, a harm category was assigned, including the grade in which the AE could have been avoided and its relation with the surgical procedure. ResultsThe prevalence of AE was 36.8%. There were 0.5 AE per patient. 56.2% were deemed preventable. 69.3% were directly related to the surgical procedure. The tool had a sensitivity of 86% and a specificity of 93.6%. The positive predictive value was 89% and the negative predictive value 92%. ConclusionsPrevalence of AE is greater than the estimate of other studies. In most cases the AE detected were related to the surgical procedure and more than half were also preventable.The adapted “Global Trigger Tool” methodology has demonstrated to be highly effective and efficient for detecting AE in surgical patients, identifying all the serious AE with few false negative results.

Detección de efectos adversos en cirugía general mediante la aplicación de la metodología «Trigger Tool»

IntroductionSurgery is one of the high-risk areas for the occurrence of adverse events (AE). The purpose of this study is to know the percentage of hospitalisation-related AE that are detected by the «Global Trigger Tool» methodology in surgical patients, their characteristics and the tool validity. Material and methodsRetrospective, observational study on patients admitted to a general surgery department, who underwent a surgical operation in a third level hospital during the year 2012. The identification of AE was carried out by patient record review using an adaptation of «Global Trigger Tool» methodology. Once an AE was identified, a harm category was assigned, including the grade in which the AE could have been avoided and its relation with the surgical procedure. ResultsThe prevalence of AE was 36,8%. There were 0,5 AE per patient. 56,2% were deemed preventable. 69,3% were directly related to the surgical procedure. The tool had a sensitivity of 86% and a specificity of 93,6%. The positive predictive value was 89% and the negative predictive value 92%. ConclusionsPrevalence of AE is greater than the estimate of other studies. In most cases the AE detected were related to the surgical procedure and more than half were also preventable.The adapted «Global Trigger Tool» methodology has demonstrated to be highly effective and efficient for detecting AE in surgical patients, identifying all the serious AE with few false negative results.

Reducing the Burden of Surgical Harm

To perform a systematic review of interventions used to reduce adverse events in surgery. Many interventions, which aim to improve patient safety in surgery, have been introduced to hospitals. Little is known about which methods provide a measurable decrease in morbidity and mortality. MEDLINE, EMBASE, and Cochrane databases were searched from inception to Week 19, 2012, for systematic reviews, randomized controlled trials (RCTs), and cross-sectional and cohort studies, which reported an intervention aimed toward reducing the incidence of adverse events in surgical patients. The quality of observational studies was measured using the Newcastle-Ottawa Scale. RCTs were assessed using the Cochrane Collaboration's tool for assessing risk of bias. Ninety-one studies met inclusion criteria, 26 relating to structural interventions, 66 described modifying process factors. Only 17 (of 42 medium to high quality studies) reported an intervention that produced a significant decrease in morbidity and mortality. Structural interventions were: improving nurse to patient ratios (P = 0.008) and Intensive Care Unit (ITU) physician involvement in postoperative care (P < 0.05). Subspecialization in surgery reduced technical complications (P < 0.01). Effective process interventions were submission of outcome data to national audit (P < 0.05), use of safety checklists (P < 0.05), and adherence to a care pathway (P < 0.05). Certain safety technology significantly reduced harm (P = 0.02), and team training had a positive effect on patient outcome (P = 0.001). Only a small cohort of medium- to high-quality interventions effectively reduce surgical harm and are feasible to implement. It is important that future research remains focused on demonstrating a measurable reduction in adverse events from patient safety initiatives.

Obstructive Sleep Apnea and Surgery: Quality Improvement Imperatives and Opportunities.

Obstructive sleep apnea (OSA) is more common in surgical candidates than in the general population and may increase susceptibility to perioperative complications that range from transient desaturation to catastrophic injuries. Understanding the potential impact of OSA on patients' surgical risk profile is of particular interest to otolaryngologists, who routinely perform airway procedures-including surgical procedures for treatment of OSA. Whereas the effects of OSA on long-term health outcomes are well documented, the relationship between OSA and surgical risk is not collinear, and clear consensus on the nature of the association is lacking. Better guidelines for optimization of pain control, perioperative monitoring, and surgical decision making are potential areas for quality improvement efforts. Many interventions have been suggested to mitigate the risk of adverse events in surgical patients with OSA, but wide variations in clinical practice remain. We review the current literature, emphasizing recent progress in understanding the complex pathophysiologic interactions noted in OSA patients undergoing surgery and outlining potential strategies to decrease perioperative risks.

Evaluation of seasonal variation in the incidences of bacterial infection among surgical patients

Introduction: Although a lot of attention has been paid to the prevention of nosocomial infections, surgical site infections (SSIs) continue to comprise a major proportion of all adverse events in surgical patients. So this study is designed to evaluate the common pathogens prevalent in surgical patients and find its seasonal trend. &#x0D; Method: This is a prospective analytical study of all operated cases in General Surgery Unit III, Bir Hospital fromMarch 2010 to February 2011. Evaluation of bacteriological culture pattern among patients with wound infection 0 to 30 days after the operation was done. &#x0D; Result: There were total of 564 elective and 292 emergency operations. Surgical site infection rate was 12.1%, 18.2%, 12.2% and 10.7% respectively in spring, summer, autumn and winter seasons. Staphylococcus and Enterococcus were the most common gram positive organisms isolated which were lower in colder seasons as compared to the other seasons while gram negative E coli, Acenatobacter, Pseudomonas and Enterobacter showed predominance in the warmer season. &#x0D; Conclusion: If further validated, our findings could have important implications for future infection prevention intervention studies and for choice of empirical antimicrobial therapy among hospitalized adults.

Safety in the Operating Room: Team Approach Saves Lives

Improvements in technology, classic peer review, and even relentless determination of the individual practitioner have proven insufficient to eliminate adverse events in surgical patients. Preventing avoidable harm must focus on changing the operating room culture from one of separate--and well-meaning individuals--to a cohesive approach by surgeons, anesthesiologists, nurses, and associated or health staff. Neily and colleagues report the results of a comprehensive team training program implemented across 74 Veterans Health or facilities, which was associated with an 18% reduction in annual mortality (rate ratio = 0.82; P = 0.01).

Development of an Online Morbidity, Mortality, and Near-Miss Reporting System to Identify Patterns of Adverse Events in Surgical Patients

To design a Web-based system to track adverse and near-miss events, to establish an automated method to identify patterns of events, and to assess the adverse event reporting behavior of physicians. A Web-based system was designed to collect physician-reported adverse events including weekly Morbidity and Mortality (M&M) entries and anonymous adverse/near-miss events. An automated system was set up to help identify event patterns. Adverse event frequency was compared with hospital databases to assess reporting completeness. A metropolitan tertiary care center. Identification of adverse event patterns and completeness of reporting. From September 2005 to August 2007, 15,524 surgical patients were reported including 957 (6.2%) adverse events and 34 (0.2%) anonymous reports. The automated pattern recognition system helped identify 4 event patterns from M&M reports and 3 patterns from anonymous/near-miss reporting. After multidisciplinary meetings and expert reviews, the patterns were addressed with educational initiatives, correction of systems issues, and/or intensive quality monitoring. Only 25% of complications and 42% of inpatient deaths were reported. A total of 75.2% of adverse events resulting in permanent disability or death were attributed to the nature of the disease. Interventions to improve reporting were largely unsuccessful. We have developed a user-friendly Web-based system to track complications and identify patterns of adverse events. Underreporting of adverse events and attributing the complication to the nature of the disease represent a problem in reporting culture among surgeons at our institution. Similar systems should be used by surgery departments, particularly those affiliated with teaching hospitals, to identify quality improvement opportunities.

Development of an Online Morbidity, Mortality, and Near-Miss Reporting System to Identify Patterns of Adverse Events in Surgical Patients—Invited Critique

Every day we apply years of rigorous training to work in an extremely high-risk and litigious environment. Yet, in no other industry are consequential errors dealt with in such a haphazard, reactionary, and secluded manner.

A Systemic Review of Obstructive Sleep Apnea and Its Implications for Anesthesiologists

Obstructive sleep apnea (OSA) is present in a significant proportion of the population, but the majority of patients remain undiagnosed. It is crucial that anesthesiologists and surgeons recognize the increased perioperative risks associated with undiagnosed OSA. We present a systematic review of the literature on the perioperative management of surgical patients with OSA. The scope of this review is restricted to publications in all surgical specialties and in the adult patient population. The main search key words were: "perioperative care," "sleep apnea," "obstructive sleep apnea," "perioperative risk," and "perioperative care." The databases Medline, Embase, Biological Abstract, Science Citation Index, and Healthstar were searched for relevant English language articles from 1966 to March 2007. The literature supports an increased perioperative risk in OSA patients. The American Society of Anesthesiologists guidelines support the routine screening for OSA during preoperative assessment, and methods of OSA screening are discussed in this review. This review suggests a number of perioperative management strategies to reduce surgical risk in patients with OSA. However, apart from the consensus-based American Society of Anesthesiologists guidelines, it is important to note that evidence-based recommendations are lacking in the literature. This review suggests ways to screen for OSA in the preoperative setting and proposes perioperative management strategies. The ultimate goal is to reduce the perioperative risk of OSA patients but, to realize that goal, research will be needed to determine whether screening for OSA and/or adapting specific perioperative management approaches translates into a lessening of adverse events in surgical patients with undiagnosed OSA.

Detection of adverse events in surgical patients using the Trigger Tool approach

Background:Most studies of healthcare complications identify surgery as a major contributor to the overall burden of complicated care that leads to injury or death. Indeed, surgical adverse events account for...

Patient Harm in General Surgery-A Prospective Study

Introduction: Retrospective case record analysis indicates that 3% to 17% of hospital inpatients experience harm from their management, surgical patients being particularly at risk. Retrospective record analysis is prone to omission bias, leading to an unknown degree of inaccuracy. Aims: We aimed to determine the true rate of adverse events in surgical patients by continuous enhanced prospective surveillance and independent analysis by experienced surgeons. Methods: Admissions to a surgical ward for a single month were prospectively studied, matching their clinical course against staff expectations. An experienced surgeon identified unexpected events and classified them as potentially or actually adverse or not. Three independent consultant surgeons validated these findings and evaluated the preventability of adverse events. Results: One hundred thirteen patients were studied: 84 (74%) were emergencies, and 29 (26%) were elective admissions; 61 patients (54%) underwent an invasive procedure. There were 52 adverse or potentially adverse events in 45 patients (40%). Twenty-nine adverse events occurred in 26 patients (23%), of which, 8 were considered preventable. Invasive procedures were associated with adverse events (34% versus 9.6%; χ21 = 14.52; P = 0.0004), but no difference was observed between emergency and elective admissions (25% versus 24%). There was no significant difference in risk between patients older and younger than 70 years (24% versus 23%; χ21 = 0.686; P > 0.25). Conclusions: Continuous enhanced prospective surveillance revealed an unexpectedly high rate of potential and actual adverse events among surgical patients, especially in association with invasive maneuvers. This method may be more sensitive than case record review and detects a clinically relevant set of events.

Adverse events in surgical patients in Australia.

To determine the adverse event (AE) rate for surgical patients in Australia. A two-stage retrospective medical record review was conducted to determine the occurrence of AEs in hospital admissions. Medical records were screened for 18 criteria and positive records were reviewed by two medical officers using a structured questionnaire. Admissions in 1992 to 28 randomly selected hospitals in Australia. Five hundred and twenty eligible admissions were randomly selected from in-patient database in each hospital. A total of 14,179 medical records were reviewed, with 8747 medical and 5432 surgical admissions. Measures included the rate of AEs in surgical and medical admissions, the proportion resulting in permanent disability and death, the proportion determined to be highly preventable, and the identification of risk factors associated with AEs. The AE rate for surgical admissions was 21.9%. Disability that was resolved within 12 months occurred in 83%, 13% had permanent disability, and 4% resulted in death. Reviewers found that 48% of AEs were highly preventable. The risk of an AE depended on the procedure and increased with age and length of stay. The high AE rate for surgical procedures supports the need for monitoring and intervention strategies. The 18 screening criteria provide a tool to identify admissions with a greater risk of a surgical AE. Risk factors for an AE were age and procedure, and these should be assessed prior to surgery. Prophylactic interventions for infection and deep vein thrombosis could reduce the occurrence of AEs in hospitals.