Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation

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Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation

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dc.contributor.author Mirza, Sohail K. en_US
dc.contributor.author Deyo, Richard A. en_US
dc.contributor.author Heagerty, Patrick J. en_US
dc.contributor.author Turner, Judith A. en_US
dc.contributor.author Lee, Lorri A. en_US
dc.contributor.author Goodkin, Robert en_US
dc.date.accessioned 2010-04-21T15:53:58Z
dc.date.available 2010-04-21T15:53:58Z
dc.date.issued 2006 en_US
dc.identifier.citation Mirza S, Deyo R, Heagerty P, et al. Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation. BMC Musculoskeletal Disorders. 2006;7(1):53. en_US
dc.identifier.other 10.1186/1471-2474-7-53 en_US
dc.identifier.uri http://www.biomedcentral.com/1471-2474/7/53 en_US
dc.identifier.uri http://hdl.handle.net/1773/15758
dc.description.abstract Background: Independent of efficacy, information on safety of surgical procedures is essential for informed choices. We seek to develop standardized methodology for describing the safety of spinal operations and apply these methods to study lumbar surgery. We present a conceptual model for evaluating the safety of spine surgery and describe development of tools to measure principal components of this model: (1) specifying outcome by explicit criteria for adverse event definition, mode of ascertainment, cause, severity, or preventability, and (2) quantitatively measuring predictors such as patient factors, comorbidity, severity of degenerative spine disease, and invasiveness of spine surgery. Methods: We created operational definitions for 176 adverse occurrences and established multiple mechanisms for reporting them. We developed new methods to quantify the severity of adverse occurrences, degeneration of lumbar spine, and invasiveness of spinal procedures. Using kappa statistics and intra-class correlation coefficients, we assessed agreement for the following: four reviewers independently coding etiology, preventability, and severity for 141 adverse occurrences, two observers coding lumbar spine degenerative changes in 10 selected cases, and two researchers coding invasiveness of surgery for 50 initial cases. Results: During the first six months of prospective surveillance, rigorous daily medical record reviews identified 92.6% of the adverse occurrences we recorded, and voluntary reports by providers identified 38.5% (surgeons reported 18.3%, inpatient rounding team reported 23.1%, and conferences discussed 6.1%). Trained observers had fair agreement in classifying etiology of 141 adverse occurrences into 18 categories (kappa = 0.35), but agreement was substantial (kappa = 0.61) for 4 specific categories: technical error, failure in communication, systems failure, and no error. Preventability assessment had moderate agreement (mean weighted kappa = 0.44). Adverse occurrence severity rating had fair agreement (mean weighted kappa = 0.33) when using a scale based on the JCAHO Sentinel Event Policy, but agreement was substantial for severity ratings on a new 11-point numerical severity scale (ICC = 0.74). There was excellent interrater agreement for a lumbar degenerative disease severity score (ICC = 0.98) and an index of surgery invasiveness (ICC = 0.99). Conclusion: Composite measures of disease severity and surgery invasiveness may allow development of risk-adjusted predictive models for adverse events in spine surgery. Standard measures of adverse events and risk adjustment may also facilitate post-marketing surveillance of spinal devices, effectiveness research, and quality improvement. en_US
dc.description.sponsorship This work was supported by grants from the National Institutes of Health/National Institute of Arthritis, Musculosketal, and Skin Disorders 5K23AR48979 and 5P60-AR48093. en_US
dc.language.iso en_US en_US
dc.title Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation en_US
dc.type Article en_US


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