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

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          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 inter-rater 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.

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          Most cited references 56

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          Comorbidity measures for use with administrative data.

          This study attempts to develop a comprehensive set of comorbidity measures for use with large administrative inpatient datasets. The study involved clinical and empirical review of comorbidity measures, development of a framework that attempts to segregate comorbidities from other aspects of the patient's condition, development of a comorbidity algorithm, and testing on heterogeneous and homogeneous patient groups. Data were drawn from all adult, nonmaternal inpatients from 438 acute care hospitals in California in 1992 (n = 1,779,167). Outcome measures were those commonly available in administrative data: length of stay, hospital charges, and in-hospital death. A comprehensive set of 30 comorbidity measures was developed. The comorbidities were associated with substantial increases in length of stay, hospital charges, and mortality both for heterogeneous and homogeneous disease groups. Several comorbidities are described that are important predictors of outcomes, yet commonly are not measured. These include mental disorders, drug and alcohol abuse, obesity, coagulopathy, weight loss, and fluid and electrolyte disorders. The comorbidities had independent effects on outcomes and probably should not be simplified as an index because they affect outcomes differently among different patient groups. The present method addresses some of the limitations of previous measures. It is based on a comprehensive approach to identifying comorbidities and separates them from the primary reason for hospitalization, resulting in an expanded set of comorbidities that easily is applied without further refinement to administrative data for a wide range of diseases.
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            The Self-Administered Comorbidity Questionnaire: a new method to assess comorbidity for clinical and health services research.

            To develop the Self-Administered Comorbidity Questionnaire (SCQ) and assess its psychometric properties, including the predictive validity of the instrument, as reflected by its association with health status and health care utilization after 1 year. A cross-sectional comparison of the SCQ with a standard, chart abstraction-based measure (Charlson Index) was conducted on 170 inpatients from medical and surgical care units. The association of the SCQ with the chart-based comorbidity instrument and health status (short form 36) was evaluated cross sectionally. The association between these measures and health status and resource utilization was assessed after 1 year. The Spearman correlation coefficient for the association between the SCQ and the Charlson Index was 0.32. After restricting each measure to include only comparable items, the correlation between measures was stronger (Spearman r = 0.55). The SCQ had modest associations with measures of resource utilization during the index admission, and with health status and resource utilization after 1 year. The SCQ has modest correlations with a widely used medical record-based comorbidity instrument, and with subsequent health status and utilization. This new measure represents an efficient method to assess comorbid conditions in clinical and health services research. It will be particularly useful in settings where medical records are unavailable.
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              Radiographic analysis of the sagittal alignment and balance of the spine in asymptomatic subjects.

              There is an increasing recognition of the clinical importance of the sagittal plane alignment of the spine. A prospective study of several radiographic parameters of the sagittal profile of the spine was conducted to determine the physiological values of these parameters, to calculate the variations of these parameters according to epidemiological and morphological data, and to study the relationships among all of these parameters. Sagittal radiographs of the head, spine, and pelvis of 300 asymptomatic volunteers, made with the subject standing, were evaluated. The following parameters were measured: lumbar lordosis, thoracic kyphosis, T9 sagittal offset, sacral slope, pelvic incidence, pelvic tilt, intervertebral angulation, and vertebral wedging angle from T9 to S1. The radiographs were digitized, and all measurements were performed with use of a software program. Two different analyses, a descriptive analysis characterizing these parameters and a multivariate analysis, were performed in order to study the relationships among all of them. The mean values (and standard deviations) were 60 degrees 10 degrees for maximum lumbar lordosis, 41 degrees +/- 8.4 degrees for sacral slope, 13 degrees +/- 6 degrees for pelvic tilt, 55 degrees +/-10.6 degrees for pelvic incidence, and 10.3 degrees +/- 3.1 degrees for T9 sagittal offset. A strong correlation was found between the sacral slope and the pelvic incidence (r = 0.8); between maximum lumbar lordosis and sacral slope (r = 0.86); between pelvic incidence and pelvic tilt (r = 0.66); between maximum lumbar lordosis and pelvic incidence, pelvic tilt, and maximum thoracic kyphosis (r = 0.9); and, finally, between pelvic incidence and T9 sagittal offset, sacral slope, pelvic tilt, maximum lumbar lordosis, and thoracic kyphosis (r = 0.98). The T9 sagittal offset, reflecting the sagittal balance of the spine, was dependent on three separate factors: a linear combination of the pelvic incidence, maximum lumbar lordosis, and sacral slope; the pelvic tilt; and the thoracic kyphosis. This description of the physiological spinal sagittal balance should serve as a baseline in the evaluation of pathological conditions associated with abnormal angular parameter values. Before a patient with spinal sagittal imbalance is treated, the reciprocal balance between various spinal angular parameters needs to be taken into account. The correlations between angular parameters may also be useful in calculating the corrections to be obtained during treatment.
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                Author and article information

                Journal
                BMC Musculoskelet Disord
                BMC Musculoskeletal Disorders
                BioMed Central (London )
                1471-2474
                2006
                20 June 2006
                : 7
                : 53
                Affiliations
                [1 ]Center for Cost and Outcomes Research, University of Washington, Seattle, Washington, USA
                [2 ]Department of Orthopedics and Sports Medicine, University of Washington, Seattle, Washington, USA
                [3 ]Department of Neurological Surgery, University of Washington, Seattle, Washington, USA
                [4 ]Department of Medicine, University of Washington, Seattle, Washington, USA
                [5 ]Department of Health Services, University of Washington, Seattle, Washington, USA
                [6 ]Department of Biostatistics, University of Washington, Seattle, Washington, USA
                [7 ]Department of Psychiatry and Behavioral Sciences and Department of Rehabilitation Medicine, University of Washington, Seattle, Washington, USA
                [8 ]Department of Anesthesiology, University of Washington, Seattle, Washington, USA
                Article
                1471-2474-7-53
                10.1186/1471-2474-7-53
                1562418
                16787537
                Copyright © 2006 Mirza et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                Categories
                Research Article

                Orthopedics

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