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      Assessment of the incidence and nature of adverse events and their association with human error in neurosurgery. A prospective observation

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          Abstract

          Introduction

          Adverse events in surgery are a relevant cause of costs, disability, or death, and their incidence is a key quality indicator that plays an important role in the future of health care. In neurosurgery, little is known about the frequency of adverse events and the contribution of human error.

          Research question

          To determine the incidence, nature and severity of adverse events in neurosurgery, and to investigate the contribution of human error.

          Material and methods

          Prospective observation of all adverse events occurring at an academic neurosurgery referral center focusing on neuro-oncology, cerebrovascular and spinal surgery. All 4176 inpatients treated between September 2019 and September 2020 were included. Adverse events were recorded daily and their nature, severity and a potential contribution of human error were evaluated weekly by all senior neurosurgeons of the department.

          Results

          25.0% of patients had at least one adverse event. In 25.9% of these cases, the major adverse event was associated with human error, mostly with execution (18.3%) or planning (5.6%) deficiencies. 48.8% of cases with adverse events were severe (≥SAVES-v2 grade 3). Patients with multiple adverse events (8.6%) had more severe adverse events (67.6%). Adverse events were more severe in cranial than in spinal neurosurgery (57.6 vs. 39.4%).

          Discussion and conclusion

          Adverse events occur frequently in neurosurgery. These data can serve as benchmarks when discussing quality-based accreditation and reimbursement in upcoming health care reforms.

          The high frequency of human performance deficiencies contributing to adverse events shows that there is potential to further eliminate avoidable patient harm.

          Highlights

          • Prospective observation of all patients treated at an academic neurosurgical center.

          • Investigation of the incidence and severity of adverse events and their relation to human error.

          • 25.0% of patients had at least one adverse event.

          • Human error was involved in 25.9% of cases with adverse events.

          • These data provide benchmarks for tertiary care neurosurgery and health care reform.

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          Most cited references25

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          Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.

          Although quality assessment is gaining increasing attention, there is still no consensus on how to define and grade postoperative complications. This shortcoming hampers comparison of outcome data among different centers and therapies and over time. A classification of complications published by one of the authors in 1992 was critically re-evaluated and modified to increase its accuracy and its acceptability in the surgical community. Modifications mainly focused on the manner of reporting life-threatening and permanently disabling complications. The new grading system still mostly relies on the therapy used to treat the complication. The classification was tested in a cohort of 6336 patients who underwent elective general surgery at our institution. The reproducibility and personal judgment of the classification were evaluated through an international survey with 2 questionnaires sent to 10 surgical centers worldwide. The new ranking system significantly correlated with complexity of surgery (P < 0.0001) as well as with the length of the hospital stay (P < 0.0001). A total of 144 surgeons from 10 different centers around the world and at different levels of training returned the survey. Ninety percent of the case presentations were correctly graded. The classification was considered to be simple (92% of the respondents), reproducible (91%), logical (92%), useful (90%), and comprehensive (89%). The answers of both questionnaires were not dependent on the origin of the reply and the level of training of the surgeons. The new complication classification appears reliable and may represent a compelling tool for quality assessment in surgery in all parts of the world.
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            The incidence and nature of surgical adverse events in Colorado and Utah in 1992.

            Despite more than three decades of research on iatrogenesis, surgical adverse events have not been subjected to detailed study to identify their characteristics. This information could be invaluable, however, for guiding quality assurance and research efforts aimed at reducing the occurrence of surgical adverse events. Thus we conducted a retrospective chart review of 15,000 randomly selected admissions to Colorado and Utah hospitals during 1992 to identify and analyze these events. We selected a representative sample of hospitals from Utah and Colorado and then randomly sampled 15,000 nonpsychiatric discharges from 1992. With use of a 2-stage record-review process modeled on previous adverse event studies, we estimated the incidence, morbidity, and preventability of surgical adverse events that caused death, disability at the time of discharge, or prolonged hospital stay. We characterized their distribution by type of injury and by physician specialty and determined incidence rates by procedure. Adverse events were no more likely in surgical care than in nonsurgical care. Nonetheless, 66% of all adverse events were surgical, and the annual incidence among hospitalized patients who underwent an operation or child delivery was 3.0% (confidence interval 2.7% to 3.4%). Among surgical adverse events 54% (confidence interval 48.9% to 58.9%) were preventable. We identified 12 common operations with significantly elevated adverse event incidence rates that ranged from 4.4% for hysterectomy (confidence interval 2.9% to 6.8%) to 18.9% for abdominal aortic aneurysm repair (confidence interval 8.3% to 37.5%). Eight operations also carried a significantly higher risk of a preventable adverse event: lower extremity bypass graft (11.0%), abdominal aortic aneurysm repair (8.1%), colon resection (5.9%), coronary artery bypass graft/cardiac valve surgery (4.7%), transurethral resection of the prostate or of a bladder tumor (3.9%), cholecystectomy (3.0%), hysterectomy (2.8%), and appendectomy (1.5%). Among all surgical adverse events, 5.6% (confidence interval 3.7% to 8.3%) resulted in death, accounting for 12.2% (confidence interval 6.9% to 21.4%) of all hospital deaths in Utah and Colorado. Technique-related complications, wound infections, and postoperative bleeding produced nearly half of all surgical adverse events. These findings provide direction for research to identify the causes of surgical adverse events and for targeted quality improvement efforts.
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              Error in medicine

              L L Leape (1994)
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                Author and article information

                Contributors
                Journal
                Brain Spine
                Brain Spine
                Brain & Spine
                Elsevier
                2772-5294
                20 December 2021
                2022
                20 December 2021
                : 2
                : 100853
                Affiliations
                [1]Department of Neurosurgery, Klinikum Rechts der Isar, School of Medicine, Technical University of Munich, Ismaninger Str. 22, 81675, Munich, Germany
                Author notes
                []Corresponding author. Ismaninger Str. 22, 81675, Munich, Germany. Hanno.Meyer@ 123456tum.de
                Article
                S2772-5294(21)00853-5 100853
                10.1016/j.bas.2021.100853
                9560675
                36248119
                01265010-aac5-44f6-8cff-0089f3d94655
                © 2021 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 8 September 2021
                : 10 December 2021
                : 16 December 2021
                Categories
                Article

                postoperative complications,patient harm,patient safety,health care reform,outcome assessment, health care,quality indicators, health care

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