Interobserver Reliability of Spinal Adverse Events Severity System - Neuro (SAVES-N): A Prospective Adverse Event Reporting System for Neurosurgical Cases

Castle-Kirszbaum, Mendel; Danks, Andrew; Xenos, Chris; Lai, Leon T.; Timms, Craig; Drnda, A.; Homapour, Babak; Lim, Kai-Zheong; Jhoomun, Tanya; Dhillon, Rana; Asaid, Mina; Goldschlager, Tony

doi:10.1016/j.wneu.2018.05.121

Cited by 3 publications

(11 citation statements)

References 17 publications

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“…After screening by title and abstract and full text review, 3,754 titles were removed for not meeting inclusion criteria. Finally, 15 studies were included: 1 systematic review, 25 2 clinical trials, 26,27 8 observational studies, 20,[28][29][30][31][32][33][34] 3 qualitative studies, [35][36][37] and 1 mixed study. 38 The details of the selection process are summarized in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses diagram (Fig.…”

Section: Resultsmentioning

confidence: 99%

“…-The 8 observational-cohorts-studies 20,[28][29][30][31][32][33][34] and the mixed study 38 were rated as having poor quality. The main methodological flaws were found in the reporting of characteristics of recruited participants, the time of exposure, and follow-up.…”

Section: Methodological Quality Of Included Studiesmentioning

confidence: 99%

“…24 In addition to the method, the reliability between observers can also affect the active report system that, among others, depends on the expertise of the reviewer in finding the REUE that is being looked. A study 32 found how the interobserver reliability can vary when reporting events depending on the grade of expertise of the professional who is evaluating it. In the same study, 32 an index GWET AC 2 was used to measure the interobserver reliability on the use of a system of severity of REUE in spine-Neuro (SAVES-N).…”

Section: Barriers and Facilitators In Report Systemsmentioning

confidence: 99%

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Hospital Adverse Event Reporting Systems: A Systematic Scoping Review of Qualitative and Quantitative Evidence

et al. 2020

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Introduction:Reducing the incidence of reportable events with undesirable effects (REUE) is a priority in the hospital environment, which is why reporting systems have been implemented to identify and manage them. Information is required regarding the performance of reporting systems, barriers, or facilitators for reporting and strategies that improve passive reporting.Methodology: Systematic scoping review of the literature that included studies performed in the population exposed to the occurrence of REUE in the health system (teams, patients, and family). A search was performed in Cochrane Database of Systematic Reviews, Epistemonikos, MEDLINE (PubMed), MEDLINE In-Process and MEDLINE Daily Update, EMBASE, LILACS, and databases of the World Health Organization and Pan-American Health Organization.Results: Fifteen studies were found, 1 systematic review, 2 clinical trials, 8 observational studies, 3 qualitative studies, and 1 mixed study. In 4 of them, the effectiveness of active versus passive reporting systems was compared. The measures to improve the passive systems were education about REUE, simplification of the reporting format, activities focused on increasing the motivation for self-report, adoption of self-report as an obligatory institutional policy, and using specific report formats for each service. Conclusions:There is information that allows to find differences between the performance of the active and passive reporting systems. The reviewed research articles found that passive techniques significantly underreported adverse events. It is recommended that institutions adopt both active and passive techniques in adverse event surveillance. New studies should be directed to answer the comparative efficiency of the reporting systems.

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Section: Resultsmentioning

confidence: 99%

Section: Methodological Quality Of Included Studiesmentioning

confidence: 99%

Section: Barriers and Facilitators In Report Systemsmentioning

confidence: 99%

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Hospital Adverse Event Reporting Systems: A Systematic Scoping Review of Qualitative and Quantitative Evidence

et al. 2020

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“…Albeit innovative, their integration of the consequences of AE was solely based on a subjective assessment of their likely duration and it did not account for the severity of the resulting disability. Castle-Kirszbaum et al 26 later modified the SAVES-V2 to include cranial events, but little change was made to the severity system. More recently, Gozal et al 27 classified AE in five categories based on their causes.…”

Section: Discussionmentioning

confidence: 99%

“…A standardized identification, documentation, and classification of AE is a prerequisite to compare data across the literature and, 22,23 despite several attempts at harmonization, their report remains highly inconsistent. 6,7,19,[24][25][26][27] In 2001, Bonsanto et al 24 classified AE according to their nature. Houkin et al 7 , in 2009, categorized AE based on their nature, their cause and the morbidity and mortality in which they resulted.…”

Section: Discussionmentioning

confidence: 99%

Adverse Events in Surgical Neurology: The Novel Therapy-Disability-Neurology (TDN) Grade

Terrapon

Zattra

Voglis

et al. 2020

Preprint

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Background The most widely used classifications of adverse events (AE) in surgical neurology assign a grade to AE that depends on the therapy used to treat them or on new neurologic deficits. Both concepts have substantial shortcomings in grading AE severity. We present a novel multidimensional approach to this challenge and aim at validating the new grading system. Methods The new Therapy-Disability-Neurology (TDN) grading system classifies AE into five grades, depending on the associated therapy, disability, and neurologic deficits. We conducted a two-center study on 6071 interventions covering the whole neurosurgical spectrum with data prospectively recorded between January 2013 and September 2019 at the University Hospital Zurich (USZ) and at the Fondazione IRCCS Istituto Neurologico Carlo Besta (FINCB). Findings Using data from USZ, a positive correlation was found between the severity of AE and the length of hospital stay (LOS) as well as treatment cost. Each grade was associated with a greater deterioration of the Karnofsky Performance Status Scale (KPS) at discharge and at follow-up. Additionally, there was a correlation between the severity of AE and absolute KPS values. When using the same methods on an external validation cohort from FINCB, correlations between the grade of AE, LOS, and KPS at discharge were even more pronounced. Interpretation Our results suggest that the TDN grade is consistent with clinical and economic repercussions of AE and thus reflects AE severity. It is objective, practical, easily interpreted, and enables comparison between different medical centers. The TDN grade will constitute an important step forward towards a more precise and standardized documentation of AE and ultimately lead to a more critical and patient-centered appraisal of process and outcome measures in surgical neurology. Funding None.

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Adverse Events in Neurosurgery: The Novel Therapy-Disability-Neurology Grade

et al. 2021

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BACKGROUND The most widely used classifications of adverse events (AEs) in neurosurgery define their severity according to the therapy used to treat them. This concept has substantial shortcomings because it does not reflect the severity of AEs that are not treated, such as new neurological deficits. OBJECTIVE To present a novel multidimensional and patient-centered classification of the severity of AE in neurosurgery and evaluate its applicability. METHODS The Therapy-Disability-Neurology (TDN) grading system classifies AEs depending on the associated therapy, disability, and neurological deficits. We conducted a 2-center retrospective observational study on 6071 interventions covering the whole neurosurgical spectrum with data prospectively recorded between 2013 and 2019 at 2 institutions from 2 countries. RESULTS Using the first patient cohort (4680 interventions), a positive correlation was found between severity of AE and LOS as well as treatment cost. Each grade was associated with a greater deterioration of the Karnofsky Performance Status Scale (KPS) at discharge and at follow-up. When using the same methods on the external validation cohort (1391 interventions), correlations between the grades of AE, LOS, and KPS at discharge were even more pronounced. CONCLUSION Our results suggest that the TDN grade is consistent with clinical and economic repercussions of AE and thus reflects AE severity. It is easily interpreted and enables comparison between different medical centers. The standardized report of the severity of AE in the scientific literature could constitute an important step forward toward a more critical, patient-centered, and evidence-based decision-making in neurosurgery.

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Interobserver Reliability of Spinal Adverse Events Severity System - Neuro (SAVES-N): A Prospective Adverse Event Reporting System for Neurosurgical Cases

Cited by 3 publications

References 17 publications

Hospital Adverse Event Reporting Systems: A Systematic Scoping Review of Qualitative and Quantitative Evidence

Hospital Adverse Event Reporting Systems: A Systematic Scoping Review of Qualitative and Quantitative Evidence

Adverse Events in Surgical Neurology: The Novel Therapy-Disability-Neurology (TDN) Grade

Adverse Events in Neurosurgery: The Novel Therapy-Disability-Neurology Grade

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